Page Range | 31461-31830 | |
FR Document |
Page and Subject | |
---|---|
80 FR 31463 - Integration of National Bank and Federal Savings Association Regulations: Licensing Rules | |
80 FR 31829 - National Oceans Month, 2015 | |
80 FR 31827 - National Caribbean-American Heritage Month, 2015 | |
80 FR 31825 - Lesbian, Gay, Bisexual, and Transgender Pride Month, 2015 | |
80 FR 31823 - Great Outdoors Month, 2015 | |
80 FR 31819 - African-American Music Appreciation Month, 2015 | |
80 FR 31628 - Self-Regulatory Organizations; The NASDAQ Stock Market, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 4626(b)(3) | |
80 FR 31642 - Peninsula Corridor Joint Powers Board-Petition for Declaratory Order | |
80 FR 31486 - Fisheries Off West Coast States; the Highly Migratory Species Fishery; Closure | |
80 FR 31596 - Product Cancellation Order for Certain Pesticide Registrations | |
80 FR 31481 - Alkyl (C8-20 | |
80 FR 31624 - Establishment of Atomic Safety and Licensing Board; Entergy Nuclear Operations, Inc. | |
80 FR 31598 - Alternative Method for Calculating Off-Cycle Credits Under the Light-Duty Vehicle Greenhouse Gas Emissions Program: Applications From Fiat Chrysler Automobiles, Ford Motor Company, and General Motors Corporation | |
80 FR 31634 - Notice of Request To Release Airport Property | |
80 FR 31470 - Completion of Requirement To Promulgate Emissions Standards | |
80 FR 31560 - Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Blowout Preventer Systems and Well Control | |
80 FR 31571 - Central Idaho Resource Advisory Committee | |
80 FR 31583 - 36(b)(1) Arms Sales Notification | |
80 FR 31612 - National Institute of Arthritis and Musculoskeletal and Skin Diseases: Notice of Closed Meeting | |
80 FR 31611 - Center for Scientific Review: Notice of Closed Meetings | |
80 FR 31610 - National Institute of Arthritis and Musculoskeletal and Skin Diseases: Notice of Closed Meeting | |
80 FR 31609 - National Institute of Mental Health: Notice of Closed Meetings | |
80 FR 31610 - National Institute of Mental Health: Notice of Closed Meetings | |
80 FR 31608 - Center for Scientific Review: Notice of Closed Meetings | |
80 FR 31608 - Center for Scientific Review: Notice of Closed Meeting | |
80 FR 31643 - Agency Requests for Reinstatement of a Previously Approved Information Collection(s): Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments and for Grants and Cooperative Agreements With Institutions of Higher Education, Hospitals, and Other Nonprofit Organizations | |
80 FR 31612 - Agency Information Collection Activities: Application for Foreign-Trade Zone Admission and/or Status Designation, and Application for Foreign-Trade Zone Activity Permit | |
80 FR 31636 - Qualification of Drivers; Exemption Applications; Vision | |
80 FR 31538 - Emergency Solutions Grants (ESG) Program, Solicitation of Comment on Specific Issues | |
80 FR 31643 - Michael Williams-Continuance in Control Exemption-Boot Hill & Western Railway Holding Co., Inc. | |
80 FR 31642 - San Joaquin Valley Railroad Co.-Amended Lease and Operation Exemption-Sunset Railway Company | |
80 FR 31641 - Motor Carrier Safety Advisory Committee (MCSAC): Public Meeting | |
80 FR 31594 - Authorization of Subgrants | |
80 FR 31588 - Applications for New Awards; Native American-Serving Nontribal Institutions Program | |
80 FR 31580 - 36(b)(1) Arms Sales Notification | |
80 FR 31560 - Oil and Gas Leasing; Royalty on Production, Rental Payments, Minimum Acceptable Bids, Bonding Requirements, and Civil Penalty Assessments | |
80 FR 31601 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements | |
80 FR 31602 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings With the Office of Orphan Products Development | |
80 FR 31603 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792 | |
80 FR 31634 - Fine Arts Committee Notice of Meeting | |
80 FR 31575 - Caribbean Fishery Management Council (CFMC); Public Meeting | |
80 FR 31575 - Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permits | |
80 FR 31635 - Qualification of Drivers; Exemption Applications; Vision | |
80 FR 31604 - Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration; Extension of Comment Period | |
80 FR 31602 - Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intention To Participate | |
80 FR 31640 - Qualification of Drivers; Exemption Applications; Vision | |
80 FR 31605 - National Vaccine Injury Compensation Program; List of Petitions Received | |
80 FR 31604 - Graduate Psychology Education Program | |
80 FR 31623 - National Council on the Arts 185th Meeting | |
80 FR 31461 - Expanding the Size of the Board of Immigration Appeals | |
80 FR 31610 - Proposed Collection; 60-Day Comment Request; Evaluation of the Science Education Partnership Award (SEPA) Program, OD | |
80 FR 31466 - Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide; Confirmation of Effective Date | |
80 FR 31521 - Schedules of Controlled Substances: Removal of [123 | |
80 FR 31587 - Proposed Collection; Comment Request | |
80 FR 31622 - National Advisory Committee on Occupational Safety and Health (NACOSH) | |
80 FR 31632 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change Relating to CDS Procedures for CDX North America Index CDS Contracts | |
80 FR 31627 - Self-Regulatory Organizations; Boston Stock Exchange Clearing Corporation; Notice of Filing of Proposed Rule Change To Amend the Amended and Restated Certificate of Incorporation and By-Laws of The NASDAQ OMX Group, Inc. | |
80 FR 31625 - Self-Regulatory Organizations; Stock Clearing Corporation of Philadelphia; Notice of Filing of Proposed Rule Change To Amend the Amended and Restated Certificate of Incorporation and By-Laws of The NASDAQ OMX Group, Inc. | |
80 FR 31571 - National Urban and Community Forestry Advisory Council Meeting | |
80 FR 31618 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Allseen Alliance, Inc. | |
80 FR 31619 - Notice Pursuant to The National Cooperative Research and Production Act of 1993-DVD Copy Control Association | |
80 FR 31619 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Petroleum Environmental Research Forum Project No. 2013-10, Pressure Relief Valve (PRV) Stability Research Program | |
80 FR 31573 - Export Trade Certificate of Review | |
80 FR 31574 - Meeting of the Advisory Committee on Commercial Remote Sensing | |
80 FR 31485 - Principles of Reasonable Cost Reimbursement; Payment for End-Stage Renal Disease Services; Optional Prospectively Determined Payment Rates for Skilled Nursing Facilities | |
80 FR 31572 - Request for Nominations of Members To Serve on the National Advisory Committee on Racial, Ethnic, and Other Populations | |
80 FR 31595 - Pesticide Product Registration; Receipt of Applications for New Uses; Correction and Reopening of Comment Period | |
80 FR 31576 - Office Depot, Inc., Provisional Acceptance of a Settlement Agreement and Order | |
80 FR 31561 - Federal Acquisition Regulation; Consolidation and Bundling of Contract Requirements | |
80 FR 31579 - Intent To Grant an Exclusive License for a U.S. Government-Owned Invention | |
80 FR 31579 - Intent To Grant an Exclusive License of U.S. Government-Owned Patents | |
80 FR 31467 - Drawbridge Operation Regulation; Lake Washington Ship Canal, Seattle, WA | |
80 FR 31574 - Civil Nuclear Energy Export Opportunity Seminar | |
80 FR 31617 - Renewal of Approved Information Collection; OMB Control No. 1004-0034 | |
80 FR 31624 - New Postal Product | |
80 FR 31466 - Drawbridge Operation Regulation; Columbia River, Vancouver, WA | |
80 FR 31607 - National Institute of Environmental Health Sciences; Notice of Closed Meetings | |
80 FR 31607 - National Institute of Environmental Health Sciences; Notice of Closed Meeting | |
80 FR 31609 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings | |
80 FR 31586 - Judicial Proceedings Since Fiscal Year 2012 Amendments Panel (Judicial Proceedings Panel); Notice of Federal Advisory Committee Meeting | |
80 FR 31620 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH) | |
80 FR 31467 - Security Zone; Portland Rose Festival on Willamette River, Portland, OR | |
80 FR 31619 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of Termination, Suspension, Reduction, or Increase in Benefit Payments | |
80 FR 31520 - Veterinary Feed Directive Regulation Questions and Answers; Draft Guidance for Industry; Availability | |
80 FR 31707 - Veterinary Feed Directive | |
80 FR 31568 - Notice of Request for Extension of Approval of an Information Collection; Special Need Requests Under the Plant Protection Act | |
80 FR 31570 - Notice of Request for Extension of Approval of an Information Collection; Health Certificates for the Export of Live Crustaceans, Finfish, Mollusks, and Related Products | |
80 FR 31569 - Notice of Request for an Extension of Approval of an Information Collection; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
80 FR 31625 - Nanotechnology-Related Public Webinars | |
80 FR 31487 - Energy Conservation Program: Test Procedures for Ceiling Fans | |
80 FR 31737 - Takes of Marine Mammals Incidental to Specified Activities; U.S. Navy Training and Testing Activities in the Northwest Training and Testing Study Area | |
80 FR 31613 - Land Acquisitions; Soboba Band of Luiseno Indians of California | |
80 FR 31525 - International Traffic in Arms: Revisions to Definitions of Defense Services, Technical Data, and Public Domain; Definition of Product of Fundamental Research; Electronic Transmission and Storage of Technical Data; and Related Definitions | |
80 FR 31505 - Revisions to Definitions in the Export Administration Regulations | |
80 FR 31645 - Energy Conservation Program: Energy Conservation Standards for Residential Dehumidifiers |
Animal and Plant Health Inspection Service
Forest Service
Census Bureau
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
Bureau of Safety and Environmental Enforcement
Indian Affairs Bureau
Land Management Bureau
Antitrust Division
Drug Enforcement Administration
Executive Office for Immigration Review
Occupational Safety and Health Administration
National Endowment for the Arts
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Surface Transportation Board
Comptroller of the Currency
Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
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Executive Office for Immigration Review, Department of Justice.
Interim rule with request for comments.
This rule amends the Department of Justice regulations relating to the organization of the Board of Immigration Appeals (Board) by adding two Board member positions, thereby expanding the Board to 17 members.
Please submit written comments to Jean King, Acting General Counsel, Executive Office for Immigration Review, 5107 Leesburg Pike, Suite 2600, Falls Church, VA 20530. To ensure proper handling, please reference RIN No. 1125-AA79 or EOIR docket No. 183 on your correspondence. You may submit comments electronically or view an electronic version of this interim rule at
Jean King, Acting General Counsel, Executive Office for Immigration Review, 5107 Leesburg Pike, Suite 2600, Falls Church, VA 20530, telephone (703) 305-0470 (not a toll-free call).
Please note that all comments received are considered part of the public record and made available for public inspection online at
If you want to submit personally identifiable information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online, you must include the phrase “PERSONALLY IDENTIFIABLE INFORMATION” in the first paragraph of your comment. You must also locate all the personally identifiable information you do not want posted online in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment but do not want it to be posted online, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on
Personally identifiable information identified and located as set forth above will be placed in the agency's public docket file, but not posted online. Confidential business information identified and located as set forth above will not be placed in the public docket file. If you wish to inspect the agency's public docket file in person by appointment, please see the
The Executive Office for Immigration Review (EOIR) administers the Nation's immigration court system. Generally, cases commence before an immigration judge when the Department of Homeland Security (DHS) files a charging document against an alien with the immigration court.
Decisions of the immigration judges are subject to review by EOIR's appellate body, the Board of Immigration Appeals (Board), which currently comprises 15 permanent Board members. The Board is the highest administrative tribunal for interpreting and applying U.S. immigration law. The Board's decisions can be reviewed by the Attorney General, as provided in 8 CFR 1003.1(g) and (h). Decisions of the Board and the Attorney General are subject to judicial review.
EOIR's mission is to adjudicate immigration cases by fairly, expeditiously, and uniformly interpreting and administering the Nation's immigration laws. This includes the initial adjudication of aliens' cases in immigration courts nationwide, as well as appellate review by the Board when appeals are timely filed. In order to more efficiently accomplish EOIR's commitment to promptly decide a large volume of cases, as well as review a large quantity of appeals of those cases, this rule amends the Department's regulations relating to the organization of the Board by adding two Board member positions, thereby expanding the Board from 15 to 17 members.
Expanding the number of Board members is necessary at this time for two primary reasons. First, EOIR is currently managing the largest caseload the immigration court system has ever seen. At the end of FY 2014, there were 418,861 total cases pending at the immigration courts, marking an increase of 62,831 cases pending above those at the end of FY 2013.
Second, after the hiring freeze was lifted in fiscal year (FY) 2014, the Department processed and identified for hire 25 immigration judge candidates. Also in FY 2014, the Department advertised for and is now in the process of selecting a substantial number of additional immigration judges. The Department expects that, as these new immigration judges enter on duty, the number of decisions rendered nationwide by immigration judges will increase and, in turn, the number of appeals filed with the Board will also increase.
The current caseload at the Board is burdensome and may become overwhelming in the future for a Board of 15 members. At the same time, if the Board becomes too large, it may have difficulty fulfilling its responsibility of providing coherent direction with respect to the immigration laws. In particular, because the Board currently issues precedent decisions only with the approval of a majority of permanent Board members, a substantial increase in Board members may make the process of issuing such decisions more difficult.
Keeping in mind the goal of maintaining cohesion and the ability to reach consensus, but recognizing the challenges the Board faces in light of its current and anticipated increased caseload, the Department has determined that two members should be added to the Board at this time. These changes are necessary to maintain an efficient system of appellate adjudication in light of the increasing caseload.
This rule is exempt from the usual requirements of prior notice and comment and a 30-day delay in effective date because, as an internal delegation of authority, it relates to a matter of agency organization, procedure, or practice.
Under the Regulatory Flexibility Act (RFA), “[w]henever an agency is required by section 553 of [the RFA], or any other law, to publish general notice of proposed rulemaking for any proposed rule . . . the agency shall prepare and make available for public comment an initial regulatory flexibility analysis.” 5 U.S.C. 603(a). Such analysis is not required when a rule is exempt from notice and comment rulemaking under 5 U.S.C. 553(b). Because this is a rule of internal agency organization and therefore is exempt from notice and comment rulemaking, no RFA analysis under 5 U.S.C. 603 is required for this rule.
This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.
The Department has determined that this rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, “Regulatory Planning and Review,” and the Office of Management and Budget has concurred in this determination. Nevertheless, the Department certifies that this regulation has been drafted in accordance with the principles of Executive Order 12866, section 1(b), and Executive Order 13563, “Improving Regulation and Regulatory Review.” Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits, including consideration of potential economic, environmental, public health, and safety effects, distributive impacts, and equity. The benefits of this interim rule include providing the Department with an appropriate means of responding to the increased number of appeals to the Board. The public will benefit from the expansion of the number of Board members because such expansion will help EOIR better accomplish its mission of adjudicating cases in a timely manner. The Department does not foresee any burdens to the public or the Department.
This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.
The provisions of the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this interim rule because there are no new or revised recordkeeping or reporting requirements.
This action pertains to agency management and personnel and, accordingly, is not a “rule” as that term is used by the Congressional Review Act (CRA) (Subtitle E of the Small Business Regulatory Enforcement Fairness Act (SBREFA)), 5 U.S.C. 804(3). Therefore, the reports to Congress and the Government Accountability Office specified by 5 U.S.C. 801 are not required.
Administrative practice and procedure, Aliens, Immigration, Legal services, Organization and functions (Government agencies).
Accordingly, for the reasons stated in the preamble, the Attorney General is amending part 1003 of chapter V of title 8 of the Code of Federal Regulations as follows:
5 U.S.C. 301; 6 U.S.C. 521; 8 U.S.C. 1101, 1103, 1154, 1155, 1158, 1182, 1226, 1229, 1229a, 1229b, 1229c, 1231, 1254a, 1255, 1324d, 1330, 1361, 1362; 28 U.S.C. 509, 510, 1746; sec. 2 Reorg. Plan No. 2 of 1950; 3 CFR, 1949-1953 Comp., p. 1002; section 203 of Pub.L. 105-100, 111 Stat. 2196-200; sections 1506 and 1510 of Pub.L. 106-386, 114 Stat. 1527-29, 1531-32; section 1505 of Pub.L. 106-554, 114 Stat. 2763A-326 to -328.
(a)(1) * * * The Board shall consist of 17 members.* * *
In rule document 2015-11229 beginning on page 28346 in the issue of Monday, May 18, 2015, make the following correction:
On pages 28475 through 28477, in Appendix 1 to Part 24, the form should appear as follows:
Food and Drug Administration, HHS.
Final rule; confirmation of effective date.
The Food and Drug Administration (FDA or we) is confirming the effective date of April 21, 2015, for the final rule that appeared in the
Effective date of final rule published in the
Laura A. Dye, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1275.
In the
We gave interested persons until April 20, 2015, to file objections or requests for a hearing. We received no objections or requests for a hearing on the final rule. Therefore, we find that the effective date of the final rule that published in the
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Office of Food Additive Safety, we are giving notice that no objections or requests for a hearing were filed in response to the March 20, 2015, final rule. Accordingly, the amendments issued thereby became effective April 21, 2015.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Interstate 5 (I-5) Bridges across the Columbia River, mile 106.5, between Portland, Oregon, and Vancouver, Washington. The deviation is necessary to facilitate the movement of heavier than normal roadway traffic associated with the Independence Day fireworks show near the I-5 Bridges. This deviation allows the bridges to remain in the closed-to-navigation position during the event.
This deviation is effective from 9 p.m. to 11:59 p.m. on July 4, 2015.
The docket for this deviation, [USCG-2015-0460] is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
The Oregon Department of Transportation has requested that the I-5 Bridges across the Columbia River remain closed to vessel traffic to facilitate heavier than normal roadway traffic volume associated with a fireworks show on July 4, 2015 near the bridges. The I-5 Bridges cross the Columbia River at mile 106.5, and provide three designated navigation channels with vertical clearances ranging from 39 to 72 feet above Columbia River Datum 0.0 while the lift spans are in the closed-to-navigation position.
The normal operating schedule for the I-5 Bridges are in accordance with 33 CFR 117.869, which states that the draws shall open on signal except that the draws need not open 6:30 a.m. to 9 a.m. and from 2:30 p.m. to 6 p.m. Monday through Friday, excluding federal holidays.
This deviation period is from 9 p.m. to 11:59 p.m. on July 4, 2015. The deviation allows the lift spans of the I-5 Bridges across the Columbia River, mile 106.5, to remain in the closed-to-navigation position and need not open for maritime traffic from 9 p.m. to 11:59 p.m. on July 4, 2015.
The bridge shall operate in accordance with 33 CFR 117.869 at all other times. Waterway usage on this part of the Columbia River includes vessels ranging from commercial tug and tow vessels to recreational pleasure craft.
Vessels able to pass through the bridge in the closed positions may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridges must return to their regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs three Seattle Department of Transportation bridges: The Ballard Bridge, mile 1.1, the Fremont Bridge, mile 2.6, and the University Bridge, mile 4.3, all crossing the Lake Washington Ship Canal at Seattle, WA. The deviation is necessary to accommodate heavier than normal roadway traffic associated with a fireworks display over Lake Union. This deviation allows the bridges to remain in the closed-to-navigation position prior to and immediately after the fireworks display.
This deviation is effective from 9 p.m. on July 4, 2015 to 1 a.m. on July 05, 2015.
The docket for this deviation, [USCG-2015-0459] is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
Seattle Department of Transportation (SDOT) has requested a temporary deviation from the operating schedule for the Ballard Bridge, mile 1.1, the Fremont Bridge, mile 2.6, and the University Bridge, mile 4.3, all crossing the Lake Washington Ship Canal at Seattle, WA. The requested deviation is to accommodate heavier than normal roadway traffic associated with the 4th of July fireworks display over Lake Union, Seattle, WA. The deviation period is from 9 p.m. on July 4, 2015 to 1 a.m. on July 05, 2015. To facilitate this event, the draws of the bridges will be maintained in the closed-to-navigation positions as follows: the Fremont Bridge, mile 2.6, need not open for vessel traffic from 9 p.m. on July 4, 2015 to 12:30 a.m. on July 5, 2015; the Ballard Bridge, mile 1.1, and the University Bridge, mile 4.3, need not open for vessel traffic from 10 p.m. on July 4, 2015 to 1 a.m. July 5, 2015.
The Ballard Bridge, mile 1.1, provides a vertical clearance of 29 feet in the closed position, the Fremont Bridge, mile 2.6, provides a vertical clearance of 14 feet in the closed position, and the University Bridge, mile 4.3, provides a vertical clearance of 30 feet in the closed position; all clearances are referenced to the mean water elevation of Lake Washington. The normal operating schedule for all three bridges is in accordance with 33 CFR 117.1051 stating; all three bridges need not open from 7 a.m. to 9 a.m. and from 4 p.m. to 6 p.m. Monday through Friday for vessels less than 1000 tons. The normal operating schedule for these bridges also requires one hour advance notification for bridge openings between 11 p.m. and 7 a.m. daily. Waterway usage on the Lake Washington Ship Canal ranges from commercial tug and barge to small pleasure craft.
Vessels able to pass through the bridge in the closed positions may do so at anytime. The bridge will be able to open for emergency vessel responding to emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Interim final rule.
The Coast Guard is permanently amending the Portland Rose Festival on Willamette River security zone. This regulation is enforced annually during the Portland, Oregon Rose Festival on the waters of the Willamette River between the Hawthorne and Steel Bridges. This final rule will eliminate inconsistencies between the actual event dates and the enforcement period published in the Code of Federal Regulations. This will serve to better inform the public of the security zone.
This rule is effective on June 3, 2015. This rule will be enforced on JUNE 3, 2015 through JUNE 8, 2015.
Comments and related material must be received by the Coast Guard on or before July 6, 2015.
Requests for public meetings must be received by the Coast Guard June 10, 2015.
Documents mentioned in this preamble are part of Docket Number USCG-2015-0484. To view documents mentioned in this preamble as being available in the docket, go to
You may submit comments, identified by docket number, using any one of the following methods:
(1)
(2)
(3)
See the “Public Participation and Request for Comments” portion of the
If you have questions on this rule, call or email Mr. Ken Lawrenson, Waterways Management Division, MSU Portland, Oregon, Coast Guard; telephone 503-240-9319, email
We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to
If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online at
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the
We do not now plan to hold a public meeting. But you may submit a request for one, using one of the methods specified under
The security zone that is the subject of this rulemaking was first established as of June 4, 2003 following the Coast Guard's publication of a final rule in the
The Coast Guard is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a Notice of Proposed Rulemaking (NPRM) with respect to this rule. Waiting for a 30-day notice period to run would be impracticable because the Coast Guard did not receive the necessary information in time for this regulation to undertake both an NPRM and a 30-day delayed effective date. Additionally, waiting for a 30-day notice period to run would be impracticable, as delayed promulgation may result in injury or damage to persons and vessels from the hazards associated with the Festival. Furthermore, the changes made by this final rule address the enforcement period. As no changes will be made to the regulation in any other aspect, it is unnecessary for the Coast Guard to publish an NPRM with a notice and comment period. As currently published, the security zone enforcement period is not inclusive of the dates for the 2015 event and possible future event dates.
The basis for this rule is 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish security zones.
This final rule will eliminate inconsistencies with the actual event dates and the enforcement period that currently appears in 33 CFR 165.1312. This will serve to better inform the public of the security zone.
This rule will revise 33 CFR 165.1312 paragraph (d) to indicate that the regulation will be enforced annually in June for a period of 6 days. Additionally, we note that the specific dates of enforcement will be published
This change will allow the Coast Guard to more accurately notify the public of the security zone by eliminating the scenarios in which the actual event dates would fall outside the published enforcement period.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. The Coast Guard bases this finding on the fact that the no changes to the security zone were made beyond clarifying the enforcement period.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities some of which may be small entities: The owners and operators of vessels intending to transit or anchor in the security zone during the times this zone is enforced. This security zone will not have a significant economic impact on a substantial number of small entities for the following reasons: Vessels desiring to transit this area of the Willamette River may do so by scheduling their trips in the early morning or evening when the restrictions on general navigation imposed by this section will not be in effect.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the “For Further Information Contact” section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(d)
Environmental Protection Agency (EPA).
Final rule.
In this action the Environmental Protection Agency (EPA) finalizes its proposed determination that the EPA completed its statutory obligation under the Clean Air Act (CAA) to promulgate emissions standards for source categories accounting for not less than 90 percent of the aggregated emissions of each of seven specific hazardous air pollutants (HAP) enumerated in the CAA. On December 16, 2014, the EPA published the proposed determination that stated the basis for the agency's conclusion that it completed this obligation in February of 2011 by identifying the promulgated standards that collectively satisfy this obligation and provided the public an opportunity to comment on the EPA's determination. This action finalizes the EPA's determination.
This action is effective on June 3, 2015.
The EPA has established a docket for this rulemaking under Docket ID Number EPA-HQ-OAR-2004-0505. All documents in the docket are listed in the
For questions about this action, contact Mr. Nathan Topham, Office of Air Quality Planning and Standards; Sector Policies and Programs Division, Metals and Inorganic Chemicals Group (D243-02); Environmental Protection Agency; Research Triangle Park, NC 27111; telephone number: (919) 541-0483; fax number: (919) 541-3207; email address:
In addition to being available in the docket, an electronic copy of this final action will also be available on the Internet through the EPA's Technology Transfer Network (TTN) Web site, a forum for information and technology exchange in various areas of air pollution control. Following signature by the EPA Administrator, the EPA will post a copy of this final action at:
Under CAA section 307(b)(1), judicial review of this final action is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by August 3, 2015. Under CAA section 307(b)(2), the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings brought by the EPA to enforce the requirements. Section
CAA section 112(c)(6) requires the EPA to take action with respect to the sources of seven specific persistent, bioaccumulative HAP. The section states, “With respect to alkylated lead compounds, polycyclic organic matter, hexachlorobenzene, mercury, polychlorinated biphenyls, 2,3,7,8-tetrachlorodibenzofurans and 2,3,7,8-tetrachlorodibenzo-p-dioxin, the Administrator shall, not later than 5 years after November 15, 1990, list categories and subcategories of sources assuring that sources accounting for not less than 90 per centum of the aggregate emissions of each such pollutant are subject to standards under subsection (d)(2) or (d)(4) of this section.”
CAA section 112(c)(6) requires the EPA to ensure that source categories responsible for at least 90 percent of the aggregate emissions of each of the seven specified pollutants are subject to standards under CAA sections 112(d)(2) or 112(d)(4). It requires the EPA to list, by November 15, 1995, source categories assuring that sources responsible for 90 percent of the aggregate emissions are subject to emission standards pursuant to CAA section 112(d)(2) or (d)(4), and to promulgate such standards by November 15, 2000. Under CAA section 112(d)(2), the EPA imposes emission standards that require “the maximum degree of reduction in emissions of the [HAP]” that the EPA concludes are achievable based on a consideration of factors identified in the statute. CAA section 112(d)(2). These standards are referred to as “maximum achievable control technology” or “MACT” standards. CAA section 112(d)(4) authorizes the EPA to set a health-based standard for a limited set of HAP for which a health threshold has been established, and that standard must provide for “an ample margin of safety.” CAA section 112(d)(4).
On December 16, 2014, the EPA published in the
This action finalizes the EPA's proposed determination that the Agency has promulgated emissions standards for source categories pursuant to CAA sections 112(d)(2) and (4) sufficient to satisfy the CAA section 112(c)(6) requirement that sources accounting for not less than 90 percent of the aggregate emissions of seven specific HAP are subject to standards under CAA sections 112(d)(2) or 112(d)(4).
As noted in the proposed rule, the emissions standards that collectively satisfy the 90 percent requirement under CAA section 112(c)(6) were set by the EPA under two approaches: (1) Through standards that directly regulated CAA section 112(c)(6) HAP; and (2) through standards that set emission limits for another HAP or compound,
The EPA noted in the proposed determination that, with respect to some of the CAA section 112(d)(2) standards that utilized the surrogacy approach, specifically those promulgated prior to the EPA's development of the baseline emissions inventory for CAA section 112(c)(6) and issuance of the 1998 listing notice, the EPA did not specifically indicate in those rulemaking records that the standards would be counted towards satisfying the 90 percent requirement in CAA section 112(c)(6). For these standards, the 2014 proposed determination explained how the surrogate standards control the CAA section 112(c)(6) HAP along with other HAP from the source categories and ensure that the sources of CAA section 112(c)(6) HAP emissions are “subject to
Table 1 of this preamble provides a list of the source categories listed under CAA section 112(c)(6), the names of the national standards that apply to those source categories, the
During the public comment period for the proposed determination, we received comments from three organizations: the Council of Industrial Boiler Owners (CIBO), the Coalition for Clean Air Implementation (CCAI), and Sierra Club. The CIBO and CCAI submitted comments supporting our proposed determination that we have fulfilled the CAA section 112(c)(6) obligations and agreed with our use of surrogate pollutants. Sierra Club submitted comments claiming that a number of previously promulgated standards identified in the proposed determination are unlawful for purposes of CAA section 112(d)(2) such that those standards may not count toward satisfying the 90 percent requirement in CAA section 112(c)(6). A summary of significant public comments received during the comment period and the EPA's response to those comments are provided below in this section of this preamble. All the remaining public comments received during the comment period and the EPA's responses to those comments are presented in the
The commenter states that although the EPA may set surrogate standards for HAP where it is reasonable to do so, see
As an example of a reasonable surrogate, the commenter asserts that particulate matter (PM) is a reasonable surrogate for metallic HAP only where the EPA demonstrates that (1) the metallic HAP are “invariably present” in the surrogate pollutant such that there is a strong correlation between the two; (2) the control technology used for PM control “indiscriminately captures” the metallic HAP along with the PM; and (3) the means by which sources achieve reductions in PM are the only means by which they achieve reductions” in metallic HAP emissions.
The commenter states that the EPA's use of “total HAP,” “total organic HAP,” and other such aggregate measures as “surrogates” for pollutants that fit into those categories is a definition maneuver and not a technical determination. The commenter states that this approach to surrogacy is unlawful because it conflicts with EPA's statutory obligation under sections 112(c)(6) and 112(d), and also the commenter asserts with the EPA's own interpretation of those provisions, see
Additionally, the commenter states that saying that POM is a constituent of total HAP, for example, is just a different way of saying it is a HAP—something that Congress already clearly indicated by listing POM as a HAP in section 112(b). The commenter believes that such statements do nothing to demonstrate that emissions of total HAP identify the best performing sources with respect to POM and what sources can achieve with respect to POM. The commenter believes that if the EPA had authority to create surrogates by simply defining a group of pollutants to include all the pollutants it must regulate, it would abrogate the limits that decisions of the United States Court of Appeals for
The commenter argues that section 112(c)(6) is a provision that specifically addresses seven persistent bioaccumulative toxics that Congress recognized were particularly harmful. The commenter believes that for sources the EPA lists as contributing to 90 percent of the total emissions of one or more of these pollutants, the EPA must set a standard for that pollutant ensuring the maximum emissions reduction. The commenter states that Congress would not have singled out these seven pollutants if it intended for the EPA only to set a single limit for the aggregate of emissions of all the different HAP.
The commenter states that even if it were permissible in general for the EPA to evade its standard-setting obligations by defining the surrogate “pollutant” as a group of pollutants, the EPA's surrogacy claims in this rule are unlawful and arbitrary because they lack supporting data or analysis. The commenter argues that the EPA's surrogacy explanations in the proposed determination are standards under section 307(d) because they are first-time claims that the relevant pollutants are subject to standards. The EPA must according to the commenter comply with the requirements of section 307(d) governing CAA rulemakings for all of those previously issued standards. The commenter maintains the EPA has not complied with these requirements because according to the commenter the EPA has not provided documentation, data, or analysis in support of its proposed determination. For this reason, the commenter concludes that the EPA has violated section 307(d) by failing to explain the “methodology used in obtaining the data and in analyzing the data” in the proposed determination, by failing to provide opportunity for informed public participation and input, and by unlawfully basing the Agency's conclusions on information or data which has not been made available to the public through the docket. The commenter also believes that the EPA has acted arbitrarily and capriciously by failing to provide substantial record evidence in support of its proposed section 112(c)(6) determination, by failing to consider relevant factors, and by failing to provide a rational connection between the facts found and the conclusion made.
The proposed determination memorializes and provides notice that the EPA has fulfilled, via numerous other previous regulatory actions, its duties under section 112(c)(6) of the CAA. The proposal lists CAA section 112(d)(2) or 112(d)(4) standards previously promulgated by the EPA and proposed the conclusion that the listed standards cover sources that, in the aggregate, emit 90 percent or more of the pollutants specifically identified in CAA section 112(c)(6). The commenter does not challenge that conclusion. In fact, no commenter suggests that the source categories listed did not emit, in the aggregate prior to regulation, 90 percent or more of the specified pollutants or that the source categories are not subject to the CAA section 112(d)(2) standards identified. Instead, the commenter seeks to use the proposed determination to reopen standards that were finalized by the EPA in some cases more than 20 years ago. The commenter argues that the EPA must now demonstrate, for each previously promulgated rule, that each standard reduces HAP “to the extent that [112] (d)(2)-(3) requires,” that in each rulemaking the EPA properly identified “the best performing sources,” and that the EPA must provide documentation, data and analysis to support the validity of the standards in the previously promulgated rules. CAA section 112(c)(6) imposes no such obligation on the EPA. As explained below, the commenter aims to collaterally attack prior EPA actions. All comments that raise such collateral attacks are outside the scope of the proposed CAA section 112(c)(6) determination. All of the rules relied upon by the EPA in this determination were promulgated through notice and comment rulemaking consistent with CAA section 307(d), and were final agency actions subject to judicial review. CAA section 112(c)(6) does not provide commenters another opportunity to belatedly challenge these prior EPA actions, nor does it mandate that the EPA re-promulgate or otherwise re-open for purposes of section 112(c)(6) standards that were previously promulgated under section 112(d)(2).
As an initial matter, it is important to understand the specific duties that CAA section 112(c)(6) imposes on the EPA, especially since the commenter consistently paraphrases the statutory language to assert there are duties beyond which the CAA requires by its terms. CAA section 112(c)(6) requires the EPA, with respect to seven specified HAP—alkylated lead compounds, polycyclic organic matter, hexachlorobenzene, mercury, polychlorinated biphenyls, 2,3,7,8-tetrachlorodibenzofurans and 2,3,7,8-tetrachlorodibenzo-p-dioxin—to “list categories and subcategories of sources assuring that sources accounting for not less than 90 per centum of the aggregate emissions of each such pollutant are subject to standards under subsection (d)(2) or (d)(4) of this section.” The provision requires the listing to be done by November 15, 1995, and requires that sources accounting for not less than 90 percent of aggregate emissions of each of the enumerated pollutants be subject to CAA section 112(d)(2) or (4) standards by November 15, 2000. CAA section 112(c)(6) does not require the EPA to submit a report stating that the agency has subjected those sources to such standards, or establish a deadline for any such report.
The CAA section 112(d)(2) standards (also referred to as maximum achievable control technology or MACT standards), which commenter seeks to collaterally
For all the rules that the commenter seeks to collaterally attack, the public was on notice during each specific rulemaking that the EPA was setting MACT standards for the HAP, including the CAA section 112(c)(6) HAP, emitted by the source category. Parties, including the commenter, could have challenged the adequacy of those standards at the time they were issued if they believed the standards did not sufficiently reduce the HAP emitted by the source category, in whatever manner those standards took with respect to regulating each HAP individually or collectively through a surrogate. See
For the reasons stated above, because the commenter challenges the sufficiency of the underlying standards as they apply to certain CAA section 112(c)(6) HAP, the commenter should have raised these issues in timely, direct challenges to those rules. CAA section 112(c)(6) does not allow for challenges to the legitimacy of CAA section 112(d) standards adopted in prior rulemakings outside the 60-day window for challenging those standards established in CAA section 307(b)(1). Moreover, in the proposed determination, EPA did not re-opened those previously promulgated standards, either to review their adequacy for controlling any emitted HAP (including section 112(c)(6) HAP) under section 112(d)(2), or for any other purpose. Therefore, this final determination itself cannot provide a new opportunity to challenge those previously promulgated rules under either section 112(d)(2) or section 112(c)(6).
In addition to raising belated comments, the commenter argues that CAA section 112(c)(6) requires the EPA to set a “specific limit” for each of the CAA section 112(c)(6) HAP. It is not clear what the commenter means by a “specific limit.” The commenter may be arguing that the EPA cannot rely on CAA section 112(d)(2) or (d)(4) standards that use surrogates to demonstrate that it has satisfied its obligation under CAA section 112(c)(6). However, it appears that the commenter is arguing that CAA section 112(c)(6) somehow limits the EPA's discretion to use particular types of surrogates when setting MACT standards. The commenter specifically objects to the EPA's standard for total HAP or total hazardous organic pollutants. There is no statutory support for either argument. Indeed, as other sections of the CAA illustrate, Congress knew how to require pollutant-specific standards. For example, CAA section 129(a)(4) explicitly requires the EPA to set numeric standards “for the [enumerated] substances or mixtures” listed in that subsection. That provision expressly requires the EPA to set numerical emissions limitations “for” a list of nine substances emitted by solid waste incineration units, and expressly authorizes the regulation of other pollutants through, among other things, surrogate standards. Unlike CAA section 129(a)(4), the terms of CAA section 112(c)(6) do not direct the EPA to set such standards “for” the CAA section 112(c)(6) HAP. Congress conspicuously did not take this approach in CAA section 112(c)(6), and, thus, left intact the EPA's discretion to establish surrogate standards.
CAA section 112(c)(6) requires the Agency to assure that “sources accounting for” at least 90 percent of the emissions of the listed HAP are “subject to standards” under CAA sections 112(d)(2) or (d)(4), without specifying the form of those standards, or how those standards must operate or be applied to those sources. The provision does not expressly state that the EPA can meet CAA section 112(c)(6) only by setting specific standards “for” the listed HAP, unlike CAA section 129(a)(4). As the commenter notes, the United States Court of Appeals for the District of Columbia Circuit upheld the
Moreover, CAA section 112(c)(6) contains a numeric benchmark only as to source categories responsible for the percentage of aggregate baseline emissions that must be controlled, not the amount of emissions of each enumerated HAP that must be reduced. As this Court explained in
The commenter also contends that the present determination constitutes a separate CAA 307(d) rulemaking with regard to many of the previously and elsewhere promulgated surrogate standards that the EPA credits towards satisfying the requirement in CAA section 112(c)(6) that source categories accounting for 90 percent of the aggregate enumerated HAP be subjected to CAA section 112(d)(2) or (4) standards. The commenter argues that the EPA must demonstrate anew the validity of the prior separate rulemaking actions and provide data and documentation to support specific aspects of those rules to satisfy the general rulemaking requirements of CAA section 307(d) and the requirements of CAA section 112. There is no statutory basis for this argument, which is an attempt to use this non-statutorily required determination that the EPA has satisfied its CAA section 112(c)(6) obligation to reopen numerous rules, many of which were finalized over a decade ago, as a means to force a non-required re-opening of such standards. Moreover, the commenter's assertion that the proposed CAA section 112(c)(6) determination was the first time the EPA provided notice of its claim that the surrogate standards were being credited for controlling the CAA section 112(c)(6) HAP is inaccurate, assuming it is even relevant (nothing in section 112(c)(6), after all, requires EPA to “provide notice,” either sequentially or ultimately, that the Agency has finally discharged its duty to set section 112(d)(2) standards for the subject source categories accounting for 90 percent of the aggregate section 112(c)(6) HAP. In any event, contrary to the commenter's assertion, the EPA provided such notice of its expectations to discharge its section 112(c)(6) responsibilities when the Agency published the 1998 listing notice identifying the source categories that, based on the 1990 emissions inventory, are responsible for 90 percent of the aggregate emissions of each of the seven pollutants identified in section 112(c)(6) from stationary, anthropogenic sources (
Section 112(c)(6) does not require that the EPA take an additional, separate final regulatory action to re-open any previously promulgated standards, and the EPA in fact did not reopen these prior actions in the proposed CAA section 112(c)(6) determination. Therefore, the proposed notice does not support a belated, backdoor attack on rules that were in some cases issued more than 20 years ago. The proposed CAA section 112(c)(6) determination is a simple, discretionary accounting of the EPA's previous regulatory efforts, explaining in mathematical terms that the EPA has previously listed sources
The United States Court of Appeals for the District of Columbia Circuit specified in
In addition, as discussed above, the 1998 listing notice provided sufficient notice that the EPA intended to rely on previously issued MACT standards to satisfy the CAA section 112(c)(6) requirement, to the extent that the public did not recognize that it was already on notice regarding the MACT standards' applicability to all HAP emitted by the source categories at the time those standards were issued. If the commenter believed one or more of the standards listed in that 1998 notice did not adequately address the CAA section 112(c)(6) HAP, it should have filed an administrative petition making the argument that the 1998 notice constituted new information concerning the substance of those previously issued standards and asked the EPA to amend the original rules that established the MACT standards. In fact, as stated above, the commenter filed an administrative petition on several of the rules addressed in its comments and did not challenge the EPA's denial of that 2001 petition. Assuming arguendo that the 1998 notice provided an opportunity to challenge the previously issued MACT standards, any such challenge is now time barred because the commenter should have brought the challenge to those rules within 6 years of the 1998 notice, wherein the EPA included those source categories in the CAA section 112(c)(6) inventory. See 28 U.S.C. 2401(a) (requiring civil actions against the United States to be brought within 6 years after the right of action first accrues). For source categories included in but regulated after the 1998 listing, the commenter was on notice and should have commented directly on surrogacy and other issues at the time the standards were promulgated, even if the EPA did not reiterate in the rulemaking record that the EPA was counting those sources' standards toward the 90 percent requirement.
The commenter's main concern appears to be the EPA's use of “total HAP” or “total organic HAP” as surrogates for certain CAA section 112(c)(6) HAP. The commenter claims such approach is unlawful under the plain language of CAA section 112(c)(6) because according to the commenter that provision requires the EPA to set a MACT standard “
To the extent the commenter is claiming that a surrogate cannot be a group of HAP (
For the reasons stated above, the EPA is not required in this action to re-evaluate previously promulgated MACT standards and respond to the belated comments on the substance of these standards, as the commenter claims. Congress deliberately promoted the value of finality of the EPA's standards in requiring parties to challenge rules within 60 days of promulgation under CAA section 307(b)(1), and in precluding opportunities to randomly challenge standards in post-promulgation fora such as civil or criminal enforcement proceedings. See CAA section 307(b)(2). Moreover, nothing in CAA section 112(c)(6) serves as an exception to this emphasis on
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose an information collection burden under the PRA because it does not contain any information collection activities.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This action does not alter any of the standards discussed in this document.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications, as specified in Executive Order 13175. This action does not materially alter the stringency of any standards discussed in this document. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 because the EPA does not believe the environmental health risks or safety risks addressed by this action present a disproportionate risk to children. A health and risk assessment was not performed for this action because it does not alter any of the regulations discussed in this action.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low income or indigenous populations because it does not affect the level of protection provided to human health or the environment. An environmental justice evaluation was not performed for this action because it does not alter any of the regulations discussed in this action.
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of D-glucopyranose, oligomeric, 6-(dihydrogen citrates), C
This regulation is effective June 3, 2015. Objections and requests for hearings must be received on or before August 3, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0678, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Publishing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0678 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 3, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0678, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for alkyl polyglucoside (C
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by alkyl polyglucoside (C
AGEs have low acute toxicity via the oral route (oral LD
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats (OCSPP Guideline 870.3650 study), there were no observed adverse effects for parental systemic or reproductive/developmental toxicity at 1,000 mg/kg/day.
A 2-year chronic oral study in rats treated with citric acid was available for review. Rats were administered 5 percent or 3 percent citric acid (approx. 2,000 or 1,200 mg/kg/day) in the diet. There were no adverse effects observed at 2,000 mg/kg/day. Chronic studies were also available for the rabbit and dog. There were no adverse effects observed in either study at doses up to 1,500 and 1,400 mg/kg/day, respectively.
Neurotoxicity studies with AGEs were not available for review. However, neurotoxicity was not observed in the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test at concentrations as high as 1,000 mg/kg/day (limit dose).
Mutagenicity studies on several surrogate chemicals did not indicate positive response for mutagenic effects. The Agency further evaluated the carcinogenic potential of alkyl polyglucoside (C
Alkylpolyglycosides are rapidly hydrolyzed in intestine and liver. The cleavage products, sugars and long-chain alcohols, enter the pathways of lipid and carbohydrate metabolism.
Specific information on the studies received and the nature of the adverse effects caused by, can be found at
Alkylglycosides are rapidly hydrolyzed in intestine and liver. The cleavage products, sugars, and long-chain alcohols enter the pathways of lipid and carbohydrate metabolism. Based on the low acute toxicity of AGEs, the body's ability to rapidly metabolize these substances, the expected metabolites being fatty acids and carbohydrates (which are normal constituents of the body), and the lack of observed adverse effects for repeat dose studies at the limit dose (1,000 mg/kg/day), no endpoint of concern was identified.
1.
Dietary exposure to AGEs can occur from eating food treated with alkyl polyglucoside (C
2.
3.
Alkyl polyglucoside (C
4.
EPA has not found Alkyl polyglucoside (C
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infant and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. The database is considered adequate for FQPA assessment. Fetal susceptibility was not observed in the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in the rat. There were no toxic effects observed in either study at the highest doses tested, 1,000 mg/kg/day. Signs of neurotoxicity were not observed in any of the submitted studies. No treatment related effects in a functional observational battery—(FOB) and on motor activity parameters were observed at doses up to 1,000 mg/kg/day; EPA has concluded that a developmental neurotoxicity study is not required. Signs of potential immunotoxicity were not observed in any of the submitted studies. Based on its assessment of available data for AGEs as discussed in Unit IV.A., EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children, and has conducted a qualitative assessment. As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.
Taking into consideration all available information on D-qlucopyranose, oligomeric, 6-(dihydrogen citrates), C
C
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
One comment was received in response to the notice of filing. The comment received was from a private citizen who opposed any pesticide product that leaves a residue above 0.00. The Agency understands the commenter's concerns and recognizes that some individuals believe that no residue of pesticides should be allowed. However, under the existing legal framework provided by FFDCA section 408, EPA is authorized to establish pesticide tolerances or exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by the statute.
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for D-glucopyranose, oligomeric, 6-(dihydrogen citrates), C
This action establishes exemptions from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemptions in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
In Title 42 of the Code of Federal Regulations, Parts 1 to 399, revised as of October 1, 2014, make the following two corrections:
(h) * * *
(iii) For cost reporting periods beginning during fiscal year 2000, by 45 percent; and
(e) Pursuant to section 101 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA) as revised by section 314 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), using the best available data, the Secretary will issue a new regulation with a newly refined case-mix classification system to better account for medically complex patients. Upon issuance of the new regulation, the temporary increases in payment for certain high cost patients will no longer be applicable.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting fishing with large-mesh drift gillnet (DGN) gear (
Effective 12:01 a.m. Pacific Daylight Time (PDT), May 29, 2015, through 11:59 p.m. PDT, August 31, 2015.
Lyle Enriquez, West Coast Region (WCR), NMFS, (562) 980-4025,
The DGN fishery is managed under the Fishery Management Plan (FMP) for U.S. West Coast Fisheries for Highly Migratory Species (HMS) (50 CFR part 660, subpart K). The fishery occurs off the coast of California. The regulations provide that “No person may fish with, set, or haul back drift gillnet gear in U.S. waters of the Pacific Ocean east of the 120° W. meridian from June 1 through August 31 during a forecasted, or occurring, El Niño event off the coast of southern California” (50 CFR 660.713(c)(2)). This area, which falls within the Southern California Bight (SCB), is referred to in the regulations as the “Pacific loggerhead conservation area.”
Under 50 CFR 660.713(c)(2)(ii), the AA relies on information developed by NOAA offices, such as the Climate Prediction Center (CPC) and the West Coast Office of the Coast Watch program to make the determination that an El Niño event is forecasted or occurring off southern California. The AA uses monthly sea surface temperature (SST) charts to determine whether there are warmer-than-normal SSTs off southern California “during the months prior to the closure months for years in which an El Niño event has been declared” by the CPC. Specifically, the AA uses SST data from the third and second months prior to the month of closure.
NMFS published these regulations to protect ESA-listed loggerhead sea turtles in accordance with a reasonable and prudent alternative (RPA) in NMFS's 2000 biological opinion on issuance of an incidental take permit for the DGN fishery under the Marine Mammal Protection Act. The biological opinion concluded that loggerhead bycatch in the DGN fishery was likely to jeopardize the continued existence of loggerhead sea turtles, and recommended adoption of a RPA under which the fishery would be closed in this area during the summer months when El Niño conditions are present to avoid the likelihood of jeopardy.
The CPC forecasts and declares when El Niño conditions exist based on conditions in equatorial waters, but does not forecast or declare when El Niño conditions exist off southern California. The Coast Watch program publishes maps of SST off the California coast through the Environmental Research Division's Data Access Program.
On March 5, 2015, the CPC issued an El Niño advisory, declaring that El Niño conditions were present in equatorial waters. Subsequent CPC updates on April 9, 2015, and May 14, 2015, stated that El Niño conditions remain in these waters. The May 14, 2015, update predicts that there is an approximately 90 percent chance that El Niño will continue through the northern hemisphere summer of 2015, and a greater than 80 percent chance it will last through the end of 2015.
In May 2015, NMFS WCR staff reviewed the SST anomalies in the SCB during March and April of 2015, relying on SST maps available through NOAA's Coast Watch Program (for details see
This action is required by regulations at 50 CFR 660.713 and is exempt from Office of Management and Budget review under Executive Order 12866.
NMFS finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) for the time-area closure of the DGN fishery. For the reasons set forth below, notice and comment procedures are impracticable and contrary to the public interest. For the same reasons, NMFS also finds good cause under 5 U.S.C. 553(d)(3) to waive the general requirement for a 30-day delay in effectiveness for this action. This measure is based upon the best available information and is necessary for the conservation of loggerhead sea turtles. The closure period anticipated by the regulation ends, at the latest, on August 31, 2015. A delay in effectiveness may allow the fishery to interact with and injure or kill loggerhead sea turtles that may occur within the SCB during the time period in which the regulation was intended to protect loggerheads.
16 U.S.C. 1801
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Supplemental notice of proposed rulemaking.
In this supplemental notice of proposed rulemaking (SNOPR), the U.S. Department of Energy (DOE) proposes a number of changes to the proposed test procedure rule published on October 17, 2014. Specifically, DOE proposes to clarify that a ceiling fan is not subject to the test procedure if the plane of rotation of the ceiling fan's blades cannot be within 45 degrees of horizontal, rather than exempt air circulators (or air-circulating fan heads) from the test procedure. DOE also proposes to test high-volume small-diameter ceiling fans according to test procedures based on the current DOE test procedure for ceiling fans, rather than the Air Movement and Control Association International, Inc. (AMCA) 230 test procedure. All ceiling fans larger than seven feet in diameter would still be tested according to a test procedure based on the AMCA 230 test procedure, but all ceiling fans less than seven feet in diameter would be tested according to test procedures based on the current DOE test procedure. DOE also proposes that the test require mounting all ceiling fans with blade spans less than or equal to seven feet to the real ceiling, rather than a false ceiling, during testing. The proposed test method would also increase the number of speeds at which ceiling fans with blade spans greater than seven feet are tested, and clarify the weighting associated with each tested speed in the energy efficiency metric and update the test room dimensions for ceiling fans with blade spans greater than seven feet. Finally, DOE proposes to clarify the effective date corresponding to the NOPR proposal to reinterpret the statutory definition of a ceiling fan to include hugger ceiling fans.
DOE will accept comments, data, and information regarding this SNOPR until August 17, 2015. See section V, “Public Participation,” for details.
Any comments submitted must identify the SNOPR for Test Procedures for Ceiling Fans, and provide docket number EERE-2013-BT-TP-0050 and/or regulatory information number (RIN) number 1904-AD10. Comments may be submitted using any of the following methods:
1.
2.
3.
4.
For detailed instructions on submitting comments and additional information on the rulemaking process, see section V of this document (Public Participation).
Docket: The docket is available for review at
A link to the docket Web page can be found at:
For further information on how to submit a comment, review other public comments and the docket, or participate in the public meeting, contact Ms. Brenda Edwards at (202) 586-2945 or by email:
DOE intends to incorporate by reference the following industry standard into 10 CFR part 430: ANSI/AMCA 230-12 (“AMCA 230”), Air Movement and Control Association Laboratory Methods of Testing Air Circulating Fans for Rating and Certification. Copies of ANSI/AMCA 230-12 can be obtained from the American National Standards Institute, 25 W. 43rd Street, 4th Floor, New York, NY 10036, 212-642-4900, or go to
Title III of the Energy Policy and Conservation Act (42 U.S.C. 6291,
Under EPCA, this energy conservation program consists essentially of four parts: (1) Testing; (2) labeling; (3) Federal energy conservation standards; and (4) certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products must use as the basis for certifying to DOE that their products comply with the applicable energy conservation standards adopted pursuant to EPCA and for making other representations about the efficiency of those products. (42 U.S.C. 6293(c) and 6295(s)) Similarly, DOE must use these test requirements to determine whether the products comply with any relevant standards promulgated under EPCA. (42 U.S.C. 6295(s))
After careful consideration of comments received on the NOPR, DOE is issuing this SNOPR to propose that manufacturers are not required to test ceiling fans pursuant to the test procedure if the plane of rotation of the ceiling fan's blades cannot be within 45 degrees of horizontal. This approach replaces that in the proposed rule issued on October 17, 2014 (79 FR 62521) (October 2014 NOPR), where DOE proposed to exempt ceiling fans from the test procedure based on the potentially ambiguous terms “air circulator” or “air-circulating fan head”. DOE also proposes test procedures for high-volume small-diameter ceiling fans based on the current DOE ceiling fan test procedure and require all ceiling fans with blade spans less than or equal to seven feet to be mounted directly to the real ceiling during testing. In addition, for ceiling fans with blade spans greater than seven feet, DOE proposes to increase the number of speeds at which the fans are tested and clarify the weighting associated with each speed in the proposed energy efficiency metric, as well as update the test room dimensions.
This SNOPR summarizes and addresses comments received on the NOPR that are related to the changes proposed in this SNOPR. DOE received comments on the NOPR regarding a number of other topics that are not addressed in this SNOPR; these comments will be addressed in the final rule. The following paragraphs summarize the proposed changes in this SNOPR, with further detail provided in Section III, Discussion.
DOE proposes that manufacturers not be required to test a ceiling fan pursuant to the test procedure if the plane of rotation of the ceiling fan's blades cannot be within 45 degrees of horizontal. This proposal would replace DOE's NOPR proposal that the test procedure does not apply to air circulators (or air-circulating fan heads), thereby removing any ambiguity associated with the terms “air circulator” or “air-circulating fan heads.” This proposal ensures that only those ceiling fans whose performance the test procedure was designed to evaluate will be subject to the test procedure.
DOE proposes to test high-volume small-diameter ceiling fans according to test procedures based on the current DOE test procedure for ceiling fans, rather than the Air Movement and Control Association International, Inc. (AMCA) 230 test procedure. As a result, all ceiling fans with blade spans less than or equal to seven feet would be tested according to the test procedures for low-volume ceiling fans proposed in the NOPR, with the distinction that high-volume small-diameter ceiling fans would be tested only at high speed, whereas low volume ceiling fans would be tested at both high speed and low speed, as proposed in the NOPR.
DOE proposes to test all ceiling fans with blade spans less than or equal to seven feet with the ceiling fan mounted to the real ceiling, rather than a false ceiling, while maintaining the required vertical distance between the air velocity sensor heads and the bottom of the ceiling fan blades. This would provide a better representation of ceiling fan efficiency and would likely incur less test burden than testing with the ceiling fan mounted to a false ceiling.
DOE proposes to test all ceiling fans with blade spans greater than seven feet at five speeds spaced equally over the range of available speeds: 20%, 40%, 60%, 80%, and 100% of the measured maximum speed revolutions per minute (rpm). DOE also proposes to clarify the weighting associated with each tested speed in the energy efficiency metric.
DOE proposes to update the test room dimensions for all ceiling fans with blade spans greater than seven feet. The updates represent potential increases to the required test room dimensions relative to those dimensions proposed in the NOPR for high-volume ceiling fans.
In the NOPR, DOE stated that the proposed test procedures would not apply to air circulators (or air-circulating fan heads) that are typically mounted on a pedestal but could also include wall, ceiling, or I-beam mounting brackets. DOE then referenced section 5.1.1 of AMCA 230-12 for the definition of an air circulator. In response, DOE received comments from Fanimation, Matthews Fan Company, and BAS requesting clarification of the definition of the term “air circulator,” as
Per suggestion by BAS to review other sections of AMCA 230 for a clearer definition of an air circulator, DOE reviewed AMCA 230-12 for more specific language, but only found potentially ambiguous language. DOE's intention in excluding air circulators from the test procedure was to ensure that only ceiling fans that could be properly assessed with the test procedure were subject to the test procedure. For example, DOE intended to exclude ceiling fans that only moved air horizontally, rather than primarily downward, as the test procedure is not designed to provide accurate performance data for such fans. In this supplemental proposal, DOE proposes that if the plane of rotation of a ceiling fan's blades cannot be within 45 degrees of horizontal, the ceiling fan is not subject to the test procedure. In this way, DOE is not specifically excluding “air circulators”; instead, DOE is excluding from the test procedure only ceiling fans that do not have the majority of their airflow directed vertically downward.
In the NOPR, DOE proposed different test methods for low-volume ceiling fans and high-volume, small-diameter ceiling fans. Specifically, DOE proposed to test low-volume ceiling fans according to a modified version of the current DOE test procedure, which is based on the “Energy Star Testing Facility Guidance Manual: Building a Testing Facility and Performing the Solid State Test Method for ENERGY STAR Qualified Ceiling Fans, Version 1.1.” In contrast, DOE proposed to test all high-volume ceiling fans (including high-volume small-diameter ceiling fans) according to the test procedure set forth in AMCA 230-12, but subject to the proposed test room dimensions set forth in the NOPR. These two test procedures are fundamentally different, as the NOPR low-volume ceiling fan test procedure determines airflow based on air velocity measurements, whereas the NOPR high-volume ceiling fan test procedure determines airflow based on load differential measured using a load cell.
Data presented by Big Ass Solutions (BAS) at the November 19, 2014 public meeting shows that the AMCA 230 test procedure results in a decrease in the measured performance for the same fan as compared to the NOPR test procedure for low-volume ceiling fans. (BAS, Public Meeting Transcript, No. 5 at pp. 63-64).
DOE recognizes the concerns put forth by BAS
In the NOPR, DOE proposed a different test procedure for all high-volume ceiling fans (including those with blade spans less than or equal to seven feet) in part because some large-diameter ceiling fans (
Therefore, DOE proposes to test all ceiling fans with blade spans less than or equal to seven feet according to the low-volume ceiling fan test procedures proposed in the NOPR, except that, as in the NOPR, high-volume small-diameter ceiling fans would be tested at only high speed while low-volume ceiling fans would be tested at both high and low speed. A further modification to the NOPR test procedure for low-volume ceiling fans and high-volume small-diameter ceiling fans is discussed in section III.C. High-volume small-
In the NOPR, DOE proposed to mount all low-volume ceiling fans to a false ceiling for testing. Using an adjustable-height false ceiling would allow the air velocity sensor height to remain constant, while the ceiling fan mounting height could be adjusted to obtain the required distance between the bottom of the ceiling fan blades and the air velocity sensors. The NOPR proposal was based on an assumption that mounting the ceiling fans to an adjustable-height false ceiling for testing would be less burdensome than adjusting the height of the air velocity sensors.
In response to the NOPR, at the November 2014 public meeting, BAS presented test results indicating a decrease in measured efficiency performance when a ceiling fan is mounted to a false ceiling rather than a real ceiling. (BAS, Public Meeting Transcript, No. 5 at pp. 125-126) BAS also stated that testing with the ceiling fan mounted to a real ceiling is more representative of actual use, and Fanimation and Minka Group agreed with Big Ass Solution's comments. (Id.; Fanimation, Public Meeting Transcript, No. 5 at p. 129; Minka Group, Public Meeting Transcript, No. 5 at p. 129) In regard to test burden, BAS indicated that keeping the false ceiling level and in correct position during testing is more burdensome than adjusting the height of the air velocity sensors. (BAS, Public Meeting Transcript, No. 5 at p. 131) Hunter Fan Company suggested that their lab uses a different air velocity sensor mounting system, and therefore it could be more burdensome to adjust the height of the air velocity sensors. (Hunter Fan Company, Public Meeting Transcript, No. 5 at p. 131)
DOE agrees with BAS that testing with the ceiling fan mounted to the real ceiling is more representative of actual use. DOE further acknowledges the concerns put forth by BAS—and the potential counterpoint provided by Hunter Fan Company—and has reviewed the proposal to mount all low-volume and high-volume small-diameter ceiling fans to a false ceiling during testing. DOE reviewed the data provided by BAS and noted a decrease in airflow efficiency of approximately 10% across the range of speeds tested when testing with a false ceiling rather than the real ceiling compelling. Additionally, DOE received test cost estimates from two test labs that show that testing with a false ceiling may be more financially burdensome than testing with the ceiling fan mounted to the real ceiling and adjusting the height of the air velocity sensors. The cost estimates received indicate a cost of $600-$1,800 for testing with a false ceiling, as opposed to $725-$1,500 for testing with the real ceiling. The minimum expected cost for testing with a real ceiling is higher than for testing with a false ceiling due to the one-time cost associated with implementing a change to the experimental set up to allow for the adjustment of the height of the air velocity sensors. The average variable test costs for testing with the real ceiling, however, are lower compared to testing with a false ceiling. DOE approximates the fixed costs for the one-time modification to be $2000 or less. DOE expects that test labs will be able to amortize the fixed costs over many tests. Consequently, the total average costs for testing with the real ceiling are lower than testing with a false ceiling.
Therefore, DOE proposes to mount all ceiling fans with blade spans less than or equal to seven feet to the real ceiling, rather than a false ceiling, for testing. DOE also clarifies that with this proposal to mount the ceiling fan to the real ceiling, the height of the air velocity sensors must be adjusted to achieve the specified vertical distance (43 inches) between the bottom of the fan blades and the air velocity sensor heads for each mounting configuration in which the ceiling fan is tested.
DOE proposed to test all high-volume ceiling fans—regardless of blade span—at high speed in the NOPR. DOE proposed testing only at a single speed because high-volume ceiling fans are often equipped with a speed controller that is continuously adjustable rather than having discrete speeds (
DOE believes it is preferable to align the DOE ceiling fan test procedure with the accepted industry test procedures—in this case AMCA 230—as much as possible. DOE also notes that testing at five speeds rather than just at high speed may provide a more holistic representation of a ceiling fan's performance over a range of service levels, which may in turn facilitate easier comparisons for consumers. Finally, MacroAir supported testing at five speeds. (MacroAir, No. 6 at p. 6) Given these points, DOE proposes in this SNOPR to test all ceiling fans with blade spans greater than seven feet at five equally-spaced speeds: 20%, 40%, 60%, 80%, and 100% of the rpm of the maximum achievable speed. DOE clarifies that these speed settings are to be based on actual rpm measurements, and also notes that this proposal has no effect on ceiling fans with blade spans less than or equal to seven feet, as set forth in III.B.
DOE is unaware of any ceiling fan with blade span greater than seven feet in diameter that does not have a speed controller that is continuously adjustable. DOE seeks comment and information on whether there are any ceiling fans with blade spans greater than seven feet for which the proposed test procedure in this SNOPR could not be applied (
The equation and daily operating hours proposed in the NOPR to calculate the efficiency of ceiling fans larger than seven feet in diameter would need to be updated to enable testing these fans at five speeds. In the NOPR, DOE proposed the following efficiency equation for all high-volume ceiling fans to be tested at only high speed:
Based on the proposal to test all ceiling fans with blade spans greater than seven feet at five speed settings, DOE proposes to use the following equation to calculate the weighted ceiling fan efficiency for these ceiling fans:
The daily operating hours at each of the five speeds are an input to this equation. In the NOPR, DOE proposed the following daily operating hours for all high-volume ceiling fans: 12 hours of active mode and 12 hours of non-active mode. In response to the proposed operating hours, MacroAir and BAS separately provided breakdowns of daily operating hours for large-diameter ceiling fans by speed setting (Table 1). (MacroAir, No. 6 at p. 5; BAS, No. 88
In their comments, BAS did not provide this breakdown in daily operating hours explicitly; instead, BAS presented an alternative hours of use analysis in which they presented annual hours of operation at each of four speeds. In this alternative analysis, BAS did not alter DOE's proposed 12 hours of active use per day, so DOE assumes BAS agreed with this value.
To account for both daily operating hours breakdowns, DOE calculated a simple average of the proposed operating hours by speed setting (in calculating this average, DOE mapped the 7.2 h at 25% speed suggested by BAS to the 20% speed setting). Using this simple average, DOE proposes in this SNOPR to use the daily operating hours in Table 2 for all ceiling fans with blade spans greater than seven feet for use in the efficiency calculation.
In the NOPR, DOE proposed to test all high-volume ceiling fans, including ceiling fans larger than seven feet in diameter, using a test procedure based on AMCA 230-12. Because AMCA 230-12 is only applicable to ceiling fans with blade spans of six feet or less, DOE proposed to modify the specified room dimensions to allow for the testing of larger ceiling fans. The NOPR proposed a test procedure with the following modifications to the room dimensions in AMCA 230-12: (1) The minimum distance between the ceiling and the blades of a ceiling fan being tested is 44 inches for all blade diameters, (2) ceiling fans larger than 6 feet in diameter must have a 20 foot clearance between the floor and the blades of the fan being tested, and (3) for ceiling fans larger than 6 feet in diameter, the minimum distance between the centerline of a ceiling fan being tested and walls and large obstructions all around is half the ceiling fan blade span plus 10 feet.
BAS stated during the public meeting that AMCA 230 is currently being revised and suggested that the test room dimensions proposed by DOE and the updated version of AMCA 230 be harmonized. (BAS, Public Meeting Transcript, No. 5 at pp. 141-142) BAS specifically disagreed with the proposed clearance above the ceiling fan blades. (BAS, Public Meeting Transcript, No. 5 at p. 143) Westinghouse did not comment on the clearance height above the ceiling fan blades, but did express acceptance of the ten feet of lateral clearance from the fan blade tips that DOE proposed. (Westinghouse, Public Meeting Transcript, No. 5 at p. 144)
AMCA has yet to release the updated version of AMCA 230, but the test room
DOE considered whether the room dimension requirements expected to be included in the updated version of AMCA 230 would limit any manufacturers' access to a test facility large enough to meet the proposed test procedure requirements. DOE notes that, for ceiling fans with blade spans greater than or equal to 10 feet, the minimum distance between the ceiling and the top of the blades and the minimum distance between the centerline of the ceiling fan and walls or large obstructions is greater for the dimensions suggested by MacroAir and the AMCA Committee than for the dimensions proposed in the NOPR. However, DOE does not believe that access to test facilities for ceiling fan manufacturers is significantly decreased by the increased test room dimensions proposed in this SNOPR relative to the test room dimensions proposed in the NOPR. Therefore, this SNOPR proposes that the test room dimensions for ceiling fans with blade spans larger than seven feet meet the following criteria: (1) Minimum distance between the ceiling and the blades of a ceiling fan being tested shall be 40% of the ceiling fan blade span; (2) Minimum distance between the floor and the blades of the fan shall be the larger of 80% of the ceiling fan blade span or 15 feet; and (3) Minimum distance between the centerline of a ceiling fan and walls and/or large obstructions is 150% of the ceiling fan blade span. DOE intends to review the final published version of AMCA 230 when it is available. If the test room dimensions specified in the final version are identical in substance to the test procedure test room requirements DOE has proposed for high-volume ceiling fans, DOE will consider incorporating AMCA 230 by reference in the rule. Alternatively, DOE may also decide to incorporate it by reference, but with modifications. DOE notes that in accordance with the proposal in section III.B of this SNOPR, the room dimensions would only apply to ceiling fans with blade spans greater than seven feet.
The Office of Management and Budget has determined that test procedure rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993). Accordingly, this regulatory action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB).
The Regulatory Flexibility Act (5 U.S.C. 601
DOE reviewed this proposed rule under the provisions of the Regulatory Flexibility Act (RFA) and the policies and procedures published on February 19, 2003. The proposed rule prescribes test procedure amendments that would be used to determine compliance with any amended energy conservation standards that DOE may prescribe for ceiling fans. DOE has prepared an initial regulatory flexibility analysis (IRFA) for this rulemaking. The IRFA describes potential impacts on small businesses associated with ceiling fan testing requirements. DOE seeks comment on the discussion below and will develop a final regulatory flexibility analysis (FRFA) for any final test procedures developed in this test procedure rulemaking.
DOE has transmitted a copy of this IRFA to the Chief Counsel for Advocacy of the Small Business Administration for review.
(1) Description of the reasons why action by the agency is being considered.
A description of the reasons why DOE is considering this test procedure is provided elsewhere in the preamble and not repeated here.
(2) Succinct statement of the objectives of, and legal basis for, the proposed rule.
The objectives of and legal basis for the proposed rule are stated elsewhere in the preamble and not repeated here.
(3) Description of and, where feasible, an estimate of the number of small entities to which the proposed rule will apply.
For the manufacturers of the covered ceiling fan products, the Small Business Administration (SBA) has set a size threshold, which defines those entities classified as “small businesses” for the purposes of the statute. DOE used the SBA's small business size standards to determine whether any small entities would be subject to the requirements of the rule. 13 CFR part 121. The size standards are listed by North American Industry Classification System (NAICS) code and industry description and are available at:
(4) Description of the projected compliance requirements of the proposed rule.
In the test procedure NOPR, DOE proposed to reinterpret the statutory definition of a ceiling fan to include hugger ceiling fans. DOE also proposed that high-volume fans meet the definition of a ceiling fan. The proposed changes in interpretation of the ceiling fan definition discussed above would result in the applicability of the design standards set forth in EPCA at 42 U.S.C. 6295(ff)(1) to the following types of fans 30 days after the publication of any final test procedure adopting such changes in interpretation:
1. Fans suspended from the ceiling using a downrod or other means of suspension such that the fan is not mounted directly to the ceiling;
2. Fans suspended such that they are mounted directly or close to the ceiling;
3. Fans sold with the option of being suspended with or without a downrod; and
4. Fans capable of producing large volumes of airflow.
DOE research indicates that all ceiling fans currently on the market, including hugger ceiling fans and high-volume ceiling fans, appear to meet the EPCA design standards. DOE conducted an analysis of Hansen Wholesale, an online wholesaler that sells over 2000 models of ceiling fans, including a wide variety of ceiling fan brands. Hansen Wholesale provides product specifications on its Web site, including the number of speeds and whether a ceiling fan is reversible. DOE examined all of the ceiling fans that were self-identified as hugger ceiling fans and found that they all had fan controls separate from lighting controls, were capable of being operated at more than one speed, and were capable of being operated in reverse.
For high-volume ceiling fans, DOE searched for product specifications on the Web sites of manufacturers of high-volume large-diameter ceiling fans and from Web sites of retailers of high-volume small-diameter ceiling fans. Only one high-volume ceiling fan model was found with a light kit, and the fan controls were separate from the lighting controls for that fan. All high-volume ceiling fans appeared to be capable of operating at more than one speed (typically with an adjustable speed control). High-volume ceiling fans are primarily sold for industrial purposes and are therefore not subject to the requirement to be capable of operating in reverse.
Based on this research, DOE does not expect any cost of complying with the design requirements for manufacturers of hugger or high-volume ceiling fans.
DOE proposes measures to limit the burden of testing on all manufacturers, including small business manufacturers, while providing a representative measurement of ceiling fan efficiency for consumers. Low-volume ceiling fans (excluding hugger fans) are currently required to test at high speed due to FTC's labeling requirement for ceiling fans. As discussed in more detail in the TP NOPR, DOE proposed to specify that low speed is to be tested as well as high speed to have a test procedure that is representative of typical use. DOE estimates that the cost to test at low speed, in addition to high speed, represents an average additional cost of $87.5 (or $175 per basic model) above the high-speed test cost.
DOE notes that if the concurrent rulemaking regarding energy conservation standards for ceiling fans results in efficiency performance standards, DOE would require testing for certification of two ceiling fans per basic model, the minimum sample size required by 10 CFR 429.11. To determine the potential cost of the proposed test procedure on small ceiling fan manufacturers under a potential energy conservation standard for ceiling fans, DOE estimated the cost of testing two ceiling fans. The cost of testing was then multiplied over the estimated number of basic models produced by a small manufacturer. The estimated cost of testing is discussed in further detail below.
In the test procedure NOPR, DOE proposed to: (1) Reinterpret the statutory definition of a ceiling fan such that it would include hugger ceiling fans; the proposed test method for hugger ceiling fans would be the same as the proposed test method for all other low volume ceiling fans; (2) clarify that low-volume ceiling fans should be tested at low and high speeds; (3) eliminate the requirement to use a test cylinder; and (4) add a test method for power consumption in standby mode.
In this SNOPR, DOE proposes to: (1) Not require testing of a ceiling fan if the plane of rotation of the ceiling fan's blades cannot be within 45 degrees of horizontal; (2) test high-volume small-diameter ceiling fans based on the current DOE ceiling fan test procedure; (3) require all ceiling fans with blade spans less than or equal to seven feet be mounted directly to the real ceiling during testing; (4) increase the number of speeds at which ceiling fans with blade spans greater than seven feet are tested, and also clarify the weighting associated with each speed in the energy efficiency metric; and (5) update the test room dimensions for all ceiling fans with blade spans greater than seven feet.
DOE estimated the cost to test a low-volume ceiling fan based on estimates from third-party testing facilities of the cost to perform the current ENERGY STAR test procedure for ceiling fans, which is similar to DOE's proposed test procedure, and the changes in cost associated with the key differences between the two test procedures. DOE's proposed test procedure for low-volume ceiling fans differs from the current ENERGY STAR test procedure in that it (1) requires testing at only two fan speeds instead of three, (2) requires mounting the ceiling fan to the real ceiling, (3) does not require the use of a test cylinder, (4) requires less warm up time before testing at low speed, (5) requires adjusting the height of the air velocity sensors, and (6) requires standby-mode testing.
In aggregate, DOE estimates that these differences will result in a lower test cost for the proposed DOE test procedure for low-volume ceiling fans when compared to the ENERGY STAR test procedure for ceiling fans. Testing at only two speeds instead of three yields a total test time that is approximately 35 minutes shorter than the ENERGY STAR test procedure. The proposed test procedure would also require mounting ceiling fans to the real ceiling, which would involve a one-time lab cost for a mechanism that allows for the adjustment of the height of the air velocity sensors to keep the distance
DOE's proposed test procedure, which would not require use of a test cylinder, also eliminates any potential costs associated with purchasing new test cylinders. If the test procedure required the use of test cylinders, then a new cylinder would be necessary to test any ceiling fan with a diameter that does not correspond to one of the cylinders in a test lab's existing inventory. Based on discussions with third-party testing facilities, DOE estimates that new test cylinders would cost approximately $2000-3000 per cylinder. By not using a cylinder, these costs will be avoided. Not requiring a test cylinder also shortens the test time of DOE's proposed test procedure relative to ENERGY STAR's test procedure for all low-volume ceiling fans, because time is not required to put a test cylinder in place for each test (estimated to take 15 minutes). Additionally, DOE's proposed test procedure only requires 15 minutes of warm up time before testing at low speed compared to 30 minutes in the ENERGY STAR test procedure, further reducing the relative amount of time required for DOE's proposed test procedure by 15 minutes. In total, DOE estimates that the typical time to perform the proposed test procedure will be shorter by 65 minutes compared to ENERGY STAR's test procedure.
The test procedure NOPR proposed to add a requirement for standby-mode testing for ceiling fans with standby functionality. A study performed by Lawrence Berkeley National Laboratory found that 7.4% of low-volume ceiling fans have standby capability.
Based on all of the differences between the test procedure proposed and the ENERGY STAR test procedure, and estimates from third-party testing facilities of the labor costs associated with these differences, DOE estimates that the test procedure proposed for standard, hugger and multi-head ceiling fans will cost $1500 on average per basic model, once the mechanism for the adjustment of the height of the air velocity sensors is constructed. Therefore, DOE estimates that the total weighted average test cost for the proposed test procedure and standby testing for standard, hugger and multi-head ceiling fans will be $1515. For multi-mount ceiling fans, DOE estimates that the test cost will be approximately double the cost for standard, hugger and multi-head ceiling fans.
For the approximately 25-35 small business manufacturers of low-volume ceiling fans that DOE identified, the number of basic models produced per manufacturer varies significantly from one to approximately 80. DOE notes that standard, hugger and multi-head ceiling fans represent about 95% of basic models for low-volume ceiling fans and multi-mount ceiling fans represent about 5% of basic models for low-volume ceiling fans. Therefore, based on the test cost per ceiling fan basic model, the weighted average testing cost in the first year would range from approximately $1515 to $127,243 for small manufacturers of ceiling fans. DOE expects this cost to be lower in subsequent years because only new or redesigned ceiling fan models would need to be tested.
The proposed test method for ceiling fans with blade span less than or equal to seven feet is also applicable to high-volume small-diameter ceiling fans. The key differences between the proposed test method for low-volume ceiling fans and high-volume small-diameter ceiling fans are that high-volume small-diameter ceiling fans require testing at only one fan speed instead of two speeds. DOE estimates that the test costs for high-volume small-diameter fans are reduced by $175 per basic model due to testing at one speed. Therefore a typical test for a single-headed high-volume small-diameter ceiling fan would cost approximately $1325 per basic model. DOE did not find accurate data on the percentage of high-volume small-diameter fans with standby capability, though DOE located some high-volume small-diameter fans without standby capability in web searches. To provide a conservative cost estimate, DOE made the assumption that all high-volume small-diameter fans should be tested for standby power. DOE estimates that the total test cost for the proposed test procedure and standby testing for a single-headed high-volume small-diameter ceiling fans will be $1525.
For the approximately 10-15 small business manufacturers of high-volume small-diameter ceiling fans that DOE identified, the number of basic models produced per manufacturer varies significantly from one to approximately 30. Therefore, based on the test cost per ceiling fan basic model, the testing cost in the first year would range from approximately $1525 to $45,750 for small manufacturers of high-volume small-diameter ceiling fans. DOE expects this cost to be lower in subsequent years because only new or redesigned ceiling fan models would need to be tested.
DOE estimated the cost to test a high-volume large-diameter ceiling fan based on discussions with testing facilities capable of performing the AMCA 230 test procedure as well as cost estimates based on the time and labor costs necessary to perform the proposed test procedure on high-volume large-diameter ceiling fans. DOE estimates that the one-time cost for a lab to buy a load-cell, a fabricated load-cell frame, power meter, and one air velocity sensor is approximately $4500. DOE estimates that the test procedure proposed in this SNOPR for high-volume large-diameter ceiling fans will cost manufacturers on average $7500 per basic model. Hence, DOE estimates that the total test cost for the proposed test procedure and standby testing for a high-volume large-diameter ceiling fans will be $7,700.
For the approximately 5-10 small business manufacturers of high-volume large-diameter ceiling fans that DOE identified, the number of basic models produced per manufacturer varies from one to 30. Therefore, based on the test cost per ceiling fan basic model, the testing cost in the first year would range from approximately $7700 to $231,000 for small manufacturers of high-volume large-diameter ceiling fans. DOE expects this cost to be lower in subsequent years because only new or redesigned ceiling fan models would need to be tested.
DOE used company reports from Hoovers.com, information from manufacturers' Web sites and feedback from manufacturers to estimate the revenue for the small business manufacturers of low and high-volume ceiling fans identified. The median revenue of the small business manufacturers of low-volume ceiling fans is approximately $15M. Relative to the median revenue for a small business manufacturer, the total testing cost ranges from 0.01 percent to 0.85 percent of the median revenue. The median revenue of the small business manufacturers of high-volume small-
For both low and high-volume ceiling fans, DOE does not expect that small manufacturers would necessarily have fewer basic models than large manufacturers, because ceiling fans are highly customized throughout the industry. A small manufacturer could have the same total cost of testing as a large manufacturer, but this cost would be a higher percentage of a small manufacturer's annual revenues. DOE requests comments on its analysis of burden to small businesses for testing ceiling fans according to the proposed test procedure.
(5) Relevant Federal rules which may duplicate, overlap or conflict with the proposed rule.
DOE is not aware of any other Federal rules that would duplicate, overlap or conflict with the rule being proposed.
(6) Description of any significant alternatives to the proposed rule.
DOE considered a number of industry and governmental test procedures that measure the efficiency of ceiling fans to develop the proposed test procedure in this rulemaking. There appear to be two common approaches to testing ceiling fans: An approach based on using air velocity sensors to calculate airflow, such as the current DOE test procedure for ceiling fans, ENERGY STAR's test procedure, and CAN/CSA-C814-10, and an approach based on using a load cell to measure thrust, such as AMCA 230.
In principle, either approach could be used to measure the airflow efficiency of all ceiling fans, but maintaining consistency with industry practice would minimize test burden for all ceiling fan manufacturers. Though a load-cell based approach appears to be a potentially simpler method of estimating airflow efficiency, in industry, low-volume ceiling fans have historically been tested according to the air-velocity sensor based approach. High-volume large-diameter ceiling fans, on the other hand, have historically been tested according to the load-cell based approach. It also appears to be cost-prohibitive to scale up the air-velocity sensor based approach to the high-volume large-diameter ceiling fans currently on the market given the number of sensors that would be required to cover ceiling fans 24 feet in diameter and the cost of constructing an appropriate rotating sensor arm.
DOE seeks comment and information on any alternative test methods that, consistent with EPCA requirements, would reduce the economic impact of the rule on small entities. DOE will consider the feasibility of such alternatives and determine whether they should be incorporated into the final rule.
All collections of information from the public by a Federal agency must receive prior approval from OMB. DOE has established regulations for the certification and recordkeeping requirements for covered consumer products and industrial equipment. 10 CFR part 429, subpart B. Currently, the certification requirement for ceiling fans only addresses design standards.
In this proposed rule, DOE proposes test procedure amendments that it expects will be used to develop and implement future energy conservation standards for ceiling fans. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Executive Order 13132, “Federalism,” 64 FR 43255 (Aug. 10, 1999), imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. (65 FR 13735 (Mar. 14, 2000)). DOE has examined this proposed rule and has tentatively determined that it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this proposed rule. States can petition DOE
Regarding the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Regarding the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and tentatively determined that, to the extent permitted by law, the proposed rule meets the relevant standards of Executive Order 12988.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)). The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. (62 FR 12820 (Mar. 18, 1997)). (This policy is also available at
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
Pursuant to Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (Mar. 18, 1988), DOE has determined that this proposed regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for Federal agencies to review most disseminations of information to the public under information quality guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
This regulatory action to amend the test procedure for measuring the energy efficiency of ceiling fans is not a significant regulatory action under Executive Order 12866 or any successor order. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects for this rulemaking.
Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91; 42 U.S.C. 7101
This proposed rule would incorporate testing methods contained in the following commercial standard: ANSI/AMCA Standard 230-12, “Laboratory Methods of Testing Air Circulating Fans for Rating and Certification.” The Department has evaluated this standard and is unable to conclude whether it fully complies with the requirements of section 32(b) of the FEAA, (
In this SNOPR, DOE proposes to incorporate by reference the test standard published by ANSI/AMCA, titled “Air Movement and Control Association Laboratory Methods of Testing Air Circulating Fans for Rating and Certification,” ANSI/AMCA 230-12. ANSI/AMCA 230-12 is an industry accepted test standard that specifies test methods for ceiling fans with blade spans less than six feet (and other air circulating fans) and is applicable to products sold in North America. The test procedures proposed in this SNOPR reference ANSI/AMCA 230-12 for the test apparatus and instructions for testing ceiling fans, as specified in Section 3 (“Units of Measurement”), Section 4 (“Symbols and Subscripts”), Section 5 (“Definitions”), Section 6 (“Instruments and Methods of Measurement”), and Section 7 (“Equipment and Setups”) of ANSI/AMCA 230-12. ANSI/AMCA 230-12 is readily available on AMCA's Web site at
DOE also proposes to incorporate by reference the test standard published by IEC, titled “Household electrical appliances—Measurement of standby power,” IEC 62301 (Edition 2.0). IEC 62301 is an industry accepted test standard that specifies methods for measuring the standby mode power of electrical products and is applicable to products sold in North America. The test procedures proposed in this SNOPR reference sections of IEC 62301 that address test conditions and procedures for measuring the standby mode power of ceiling fans capable of standby mode operation. IEC 62301 is readily available on IEC's Web site at
DOE will accept comments, data, and information regarding this proposed rule no later than the date provided in the
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Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a CD, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are written in English, free of any defects or viruses, and not secured. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:
1. Instead of specifically defining “air circulator” and exempting air circulators from the test procedure, DOE proposes to not subject a ceiling fan to the test procedure if the plane of rotation of the ceiling fan's blades cannot be within 45 degrees of horizontal. DOE requests comment on this approach.
2. DOE seeks comment on its proposal to test high-volume small-diameter ceiling fans based on the low-volume ceiling fans test procedures proposed in the NOPR, with the distinction that high-volume small-diameter ceiling fans would be tested at only high speed.
3. DOE seeks comment and any available data on average daily hours of use, fan speeds utilized, and fraction of time spent at each speed for high-volume small-diameter ceiling fans.
4. DOE seeks comment on the percentage of high-volume small diameter ceiling fans that come with standby capability.
5. DOE seeks comment on its proposal to mount all ceiling fans with blade spans less than or equal to seven feet to the real ceiling during testing.
6. DOE seeks comment on its proposal to test all ceiling fans with blade spans greater than seven feet at five equally-spaced speeds, specifically 20%, 40%, 60%, 80% and 100% of maximum speed achievable. DOE also specifically seeks information on whether there are any ceiling fans with blade spans greater than seven feet for which the proposed test procedure in this SNOPR could not be applied (
7. DOE seeks comment on the proposed daily hours of use for ceiling fans larger than seven feet in diameter.
8. DOE seeks comment on its proposal to harmonize the test room dimensions for testing high-volume large-diameter ceiling fans with the dimensions expected to be set forth in an updated version of AMCA 230.
The Secretary of Energy has approved publication of this proposed rule.
Confidential business information, Energy conservation, Household appliances, Imports, Reporting and recordkeeping requirements.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Incorporation by reference, Intergovernmental relations, Small businesses.
For the reasons stated in the preamble, DOE proposes to amend parts 429 and 430 of Chapter II, Subchapter D of Title 10, Code of Federal Regulations, as set forth below:
42 U.S.C. 6291-6317.
(a)
(1) The requirements of § 429.11 are applicable to ceiling fans; and
(2) For each basic model of ceiling fan selected for testing, a sample of sufficient size shall be randomly selected and tested to ensure that—
(i) Any represented value of the efficiency or airflow shall be less than or equal to the lower of:
(A) The mean of the sample, where:
(B) The lower 90 percent confidence limit (LCL) of the true mean divided by 0.9, where:
(ii) Any represented value of the wattage shall be greater than or equal to the higher of:
(A) The mean of the sample, where:
(B) The upper 95 percent confidence limit (UCL) of the true mean divided by 1.1, where:
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
(1) Is greater than 7 feet in diameter; or
(2) Has a blade thickness of less than 3.2 mm at the edge or a maximum tip speed that exceeds the threshold in the table in the definition of low-volume ceiling fan in this section and has a maximum airflow volume greater than 5,000 CFM.
(1) Is less than or equal to 7 feet in diameter; and
(2) Has a blade thickness greater than or equal to 3.2 mm at the edge and a maximum tip speed less than or equal to the limit in the table in this definition, or has a maximum airflow volume less than or equal to 5,000 CFM.
The addition reads as follows:
(d) * * *
(20) ANSI/AMCA 230-12 (“AMCA 230”), Air Movement and Control Association Laboratory Methods of Testing Air Circulating Fans for Rating and Certification, approved February 22, 2012, IBR approved for appendix U to subpart B of this part.
(w)
Prior to [DATE 180 DAYS AFTER PUBLICATION OF THE FINAL RULE IN THE
1.1.
1.2.
1.3.
1.4.
1.5.
1.6.
1.7.
1.8.
1.9.
1.10.
General instructions apply to characterizing the energy performance of both low-volume and high-volume ceiling fans. The test apparatus and test measurement used to characterize energy performance depend on the ceiling fan's blade span and, if the blade span is less than or equal to seven feet, whether the ceiling fan is low-volume or high-volume. If the plane of rotation of a ceiling fan's blades is not less than or equal to 45 degrees from horizontal, or cannot be adjusted based on the manufacturer's specifications to be less than or equal to 45 degrees from horizontal, the ceiling fan is not subject to these test procedures.
2.1. General instructions
Record measurements at the resolution of the test instrumentation. Round off calculations to the same number of significant digits as the previous step. Round the final ceiling fan efficiency value to the nearest whole number as follows:
2.1.1. A fractional number at or above the midpoint between the two consecutive whole numbers shall be rounded up to the higher of the two whole numbers; or
2.1.2. A fractional number below the midpoint between the two consecutive whole numbers shall be rounded down to the lower of the two whole numbers.
For multi-head ceiling fans, the effective blade span is the blade span of an individual fan head, if all fan heads are the same size. If the fan heads are of varying sizes, the effective blade span is the blade span of the largest fan head.
2.2. Test apparatus for ceiling fans with a blade span less than or equal to seven feet:
All instruments are to have tolerances within ±1% of reading, except for the air velocity sensors, which should have tolerances within ±5% of reading. Equipment is to be calibrated at least once a year to compensate for variation over time.
2.2.1.
The air delivery room dimensions are to be 20 ±0.75 ft. × 20 ±0.75 ft. with an 11 ±0.75 ft. high ceiling. The control room shall be constructed external to the air delivery room.
The ceiling shall be constructed of sheet rock or stainless plate. The walls shall be of adequate thickness to maintain the specified temperature and humidity during the test. The paint used on the walls, as well as the wall material, must be of a type that minimizes absorption of humidity and that keeps the temperature of the room constant during the test (
The room shall have no ventilation other than an air conditioning and return system used to control the temperature and humidity of the room. The construction of the room must ensure consistent air circulation patterns within the room. Vents must have electronically-operated damper doors controllable from a switch outside of the testing room.
2.2.2.
Hang the ceiling fan to be tested directly from the ceiling, according to the manufacturer's installation instructions. All standard and hugger ceiling fans shall be hung in the fan configuration that minimizes the distance between the ceiling and the fan blades. Multi-mount fans shall be hung and tested in two configurations: In the configuration that meets the definition of a standard ceiling fan, while minimizing the distance the ceiling and the lowest part of the fan blades; and in the configuration that meets the definition of a hugger ceiling fan, while minimizing the distance between the ceiling and the lowest part of the fan blades.
With the ceiling fan installed, adjust the height of the air velocity sensors to ensure the vertical distance between the lowest point on the ceiling fan blades and the air velocity sensors is 43 inches.
Either a rotating sensor arm or four fixed sensor arms can be used to take airflow measurements along four axes, labeled A-D. Axes A, B, C, and D are at 0, 90, 180, and 270 degree positions. Axes A-D can be designated either by using the four walls or four corners of the room. See Figure 1 of this appendix.
The amount of exposed wiring must be minimized. All sensor lead wires must be stored under the floor, if possible.
The sensors shall be placed at exactly 4-inch intervals along a sensor arm, starting with the first sensor at the point where the four axes intersect. Do not touch the actual sensor prior to testing. Enough sensors shall be used to record air delivery within a circle 8 inches larger in diameter than the blade span of the ceiling fan being tested. A proper experimental set-up is shown in Figure 2 of this appendix.
Table 1 of this appendix shows the appropriate number of sensors needed per each of four axes (including the first sensor at the intersection of the axes) for each fan size.
An RPM (revolutions per minute) meter, or tachometer, should be installed so that the RPM of the ceiling fan blades can be measured during testing.
Use an RMS sensor capable of measuring power with an accuracy of ±1% to measure ceiling fan power consumption. Prior to testing, the test laboratory must verify the performance of the sensor and sensor software to be used during the test.
2.2.3.
Multi-headed ceiling fans are to be hung from the ceiling such that one of the ceiling fan heads is directly over sensor 1 (
2.2.4.
For ceiling fans where the airflow is not directly downward, the ceiling fan head is to be adjusted such that the airflow is as vertical as possible prior to testing. The distance between the lowest point on the blades and the air velocity sensors should be the same as for all other low-volume ceiling fans (43 inches). For ceiling fans where a fully vertical orientation of airflow cannot be achieved, the ceiling fan is to be oriented such that any remaining tilt is aligned along one of the four sensor axes. Instead of measuring the air velocity for only those sensors directly beneath the ceiling fan, the air velocity is to be measured at all sensors along that axis, as well as the axis oriented 180 degrees with respect to that axis. For example, if the tilt is oriented along axis A, air velocity measurements are to be taken for all sensors along the A-C axis. No measurements would need to be taken along the B-D axis in this case.
2.3. Active mode test measurement for ceiling fans with blade spans less than or equal to seven feet.
2.3.1.
• The temperature and humidity setting shall be 76 degrees ±2 degrees Fahrenheit and 50% ±5% relative humidity. These shall be held constant during the entire test process.
• Allow the sensors to be turned on and the fan to run for 15 minutes at each fan speed/setting before taking readings.
• If present, the ceiling fan light fixture is to be installed but turned off during testing.
• If present, any heater is to be installed but turned off during testing.
• The tests shall be conducted with the fan connected to a supply circuit with a voltage of (a) 120 V for fans rated on the nameplate from 105 to 125 V; and (b) 240 V for fans rated on the nameplate from 208 to 250 V. The test voltage shall not vary by more than ±1% during the tests.
• The test shall be conducted with the fan connected to a supply circuit at the rated frequency.
• Air conditioning vents shall be closed during testing.
2.3.2.
Measure the airflow (CFM) and power consumption (watt) for low-volume ceiling fans at high and low speed. For high-volume ceiling fans with blade spans less than or equal to seven feet, measure the airflow and power consumption only at high speed.
Step 1: Make sure the transformer power is off. Hang fan and connect wires as directed by manufacturer's wiring instructions.
Step 2: Adjust the height of the air-velocity sensors such that the lowest point on the fan blades is 43 inches above the height of the sensor heads.
Step 3: Set the first sensor arm (if using four fixed arms) or single sensor arm (if using a single rotating arm) to the 0 degree Position (Axis A). If necessary, use marking as reference. If using a single rotating arm, adjust the sensor arm alignment until it is at the 0 degree position by remotely controlling the antenna rotator.
Step 4: Set software up to read and record air velocity, expressed in feet per minute (FPM) in 1 second intervals. (Temperature does not need to be recorded in 1 second intervals.) Record current barometric pressure.
Step 5: Allow test fan to run 15 minutes at rated voltage and at high speed. Turn off all environmental conditioning equipment entering the chamber (
Step 6: Begin recording readings. Take 100 readings (100 seconds run-time) and save these data.
Step 7: Similarly, take 100 readings (100 seconds run-time) for Axes B, C, and D; save these data as well. If using four fixed sensor arms, the readings for all sensor arms should be taken simultaneously.
Step 8: Repeat steps 3 through 7 above on low fan speed for low-volume ceiling fans. Note: Ensure that temperature and humidity readings are held within the required tolerances for the duration of the test (all tested speeds). It may be helpful to turn on environmental conditioning equipment between test sessions to ready the room for the following speed test.
Step 9: If testing a multi-mount ceiling fan, repeat steps 1 through 8 with the ceiling fan hung in the configuration (either hugger or standard) not already tested.
If a multi-head ceiling fan includes more than one type of ceiling fan head, then test at least one of each unique type. A fan head with different construction that could affect air movement or power consumption, such as housing, blade pitch, or motor, would constitute a different type of fan head.
Measure power input at a point that includes all power-consuming components of the ceiling fan (but without any attached light kit or heater energized). Measure power continuously at the rated voltage that represents normal operation over the time period for which the airflow test is conducted for each speed, and record the average value of the power measurement at that speed in watts (W).
Measure ceiling fan power consumption simultaneously with the airflow test, except for multi-head ceiling fans. For multi-head ceiling fans, measure power consumption at each speed continuously for 100 seconds with all fan heads turned on, and record the average value at each speed in watts (W).
2.4. Test apparatus for ceiling fans with blade spans greater than seven feet:
The test apparatus and instructions for testing ceiling fans with blade spans greater than seven feet shall conform to the requirements specified in Section 3 (“Units of Measurement”), Section 4 (“Symbols and Subscripts”), Section 5 (“Definitions”), Section 6 (“Instruments and Methods of Measurement”), and Section 7 (“Equipment and Setups”) of the Air Movement and Control Association (AMCA) International's “AMCA 230:
2.4.1. The test procedure is applicable to ceiling fans up to 24 feet in diameter.
2.4.2. A “ceiling fan” is defined as in § 430.2.
2.4.3. For all ceiling fans, the minimum distance between the ceiling and the blades of a ceiling fan being tested is 40% of the ceiling fan blade span.
2.4.4. For all ceiling fans, the minimum distance between the floor and the blades of a ceiling fan being tested is the larger of: 1) 80% of the ceiling fan blade span, and 2) 15 feet.
2.4.5. For all ceiling fans, the minimum distance between the centerline of a ceiling fan being tested and walls and/or large obstructions is 150% of the ceiling fan blade span.
2.5. Active mode test measurement for ceiling fans with blade spans greater than seven feet:
Calculate the airflow (CFM) and measure the power consumption (watt) for ceiling fans at high speed, 80% speed, 60% speed, 40% speed, and 20% speed. When testing at speeds other than high speed (
2.5.1. Measure power consumption at a point that includes all power-consuming components of the ceiling fan (but without any attached light kit or heater energized).
2.5.2. Measure power consumption continuously at the rated voltage that represents normal operation over the time period for which the load differential test is conducted.
2.6. Test measurement for standby power consumption
Standby power consumption must be measured for all ceiling fans that offer one or more of the following user-oriented or protective functions:
• The ability to facilitate the activation or deactivation of other functions (including active mode) by remote switch (including remote control), internal sensor, or timer.
• Continuous functions, including information or status displays (including clocks), or sensor-based functions.
Standby power consumption must be measured after completion of active mode testing and after the active mode functionality has been switched off (
2.6.1. Allow 3 minutes between switching off active mode functionality and beginning the standby power test. (No additional time before measurement is required.)
2.6.2. Measure power consumption continuously for 100 seconds, and record the average value of the standby power measurement in watts (W).
The efficacy of a ceiling fan is the
Using the airflow and power consumption measurements from section 2 (high and low speed for low-volume ceiling fans, only high speed for high-volume ceiling fans with blade spans less than or equal to seven feet) and section 3 (for all tested settings for ceiling fans with blade spans greater than seven feet) calculate the efficiency for any ceiling fan as follows:
Table 2 of this appendix specifies the daily hours of operation to be used in calculating ceiling fan efficiency:
The effective area corresponding to each sensor used in the test method for ceiling fans with blade spans less than or equal to seven feet is to be calculated with the following equations:
For sensor 1, the sensor located directly underneath the center of the ceiling fan, the effective width of the circle is 2 inches, and the effective area is:
For the sensors between sensor 1 and the last sensor used in the measurement, the effective area has a width of 4 inches. If a sensor is a distance
For the last sensor, the width of the effective area depends on the horizontal displacement between the last sensor and the point on the ceiling fan blades furthest radially from the center of the fan. The total area included in an airflow calculation is the area of a circle 8 inches larger in diameter than the ceiling fan blade span.
Therefore, for example, for a 42-inch ceiling fan, the last sensor is 3 inches beyond the end of the ceiling fan blades. Because only the area within 4 inches of the end of the ceiling fan blades is included in the airflow calculation, the effective width of the circle corresponding to the last sensor would be 3 inches. The calculation for the effective area corresponding to the last sensor would then be:
For a 46-inch ceiling fan, the effective area of the last sensor would have a width of 5 inches, and the effective area would be:
3.1.1.
To determine the airflow at a given speed for a multi-head ceiling fan, measure the airflow for each fan head. Repeat for each fan head. Testing of each fan head is not required if the fan heads are essentially identical (
Using the airflow and power consumption measurements from section 2 of this appendix, calculate ceiling fan efficiency for a multi-head ceiling fan as follows:
3.1.2.
Using a set of sensors that cover the same diameter as if the airflow were directly downward, the airflow at each speed should be calculated based on the continuous set of sensors with the largest air velocity measurements. This continuous set of sensors should be along the axis that the ceiling fan tilt is directed in (and along the axis that is 180 degrees from the first axis). For example, a 42-inch fan tilted toward axis A may create the pattern of air velocity shown in Figure 3 of this appendix. As shown in Table 1 of this appendix, a 42-inch fan would normally require 7 active sensors. However because the fan is not directed downward, all sensors must record data. In this case, because the set of sensors corresponding to maximum air velocity are centered 3 sensor positions away from the sensor 1 along the A axis, substitute the air velocity at A axis sensor 4 for the average air velocity at sensor 1. Take the average of the air velocity at A axis sensors 3 and 5 as a substitute for the average air velocity at sensor 2, take the average of the air velocity at A axis sensors 2 and 6 as a substitute for the average air velocity at sensor 3, etc. Lastly, take the average of the air velocities at A axis sensor 10 and C axis sensor 4 as a substitute for the average air velocity at sensor 7. Any air velocity measurements made along the B-D axis are not included in the calculation of average air velocity.
Bureau of Industry and Security, Commerce.
Proposed rule.
This proposed rule is part of the Administration's Export Control Reform Initiative. The Initiative will enhance U.S. national and economic security, facilitate compliance with export controls, update the controls, and reduce unnecessary regulatory burdens on U.S. exporters. As part of this effort, this rulemaking proposes revisions to the Export Administration Regulations (EAR) to include the definitions of “technology,” “required,” “peculiarly responsible,” “proscribed person,” “published,” results of “fundamental research,” “export,” “reexport,” “release,” “transfer,” and “transfer (in-country)” to enhance clarity and consistency with terms also found on the International Traffic in Arms Regulations (ITAR), which is administered by the Department of State, Directorate of Defense Trade Controls (DDTC). This rulemaking also proposes amendments to the Scope part of the EAR to update and clarify application of controls to electronically transmitted and stored technology and software. DDTC is concurrently publishing comparable proposed amendments to the ITAR's definitions of “technical data,” “required,” “peculiarly responsible,” “public domain,” results of “fundamental research,” “export,” “reexport,” “release,” and “retransfer” for the same reasons. Finally, this rulemaking proposes conforming changes to related provisions.
Comments must be received by August 3, 2015.
Comments may be submitted to the Federal rulemaking portal (
Hillary Hess, Director, Regulatory Policy Division, Office of Exporter Services, Bureau of Industry and Security at 202-482-2440 or
This proposed rule is part of the Administration's Export Control Reform (ECR) Initiative. The Initiative will enhance U.S. national and economic security, facilitate compliance with export controls, update the controls, and reduce unnecessary regulatory burdens on U.S. exporters. As part of this effort, this rulemaking proposes revisions to the Export Administration Regulations (EAR) to include the definitions of “technology,” “required,” “peculiarly responsible,” “proscribed person,” “published,” results of “fundamental research,” “export,” “reexport,” “release,” “transfer,” and “transfer (in-country)” to enhance clarity and ensure consistency with the International Traffic in Arms Regulations (ITAR), which is administered by the Department of State, Directorate of Defense Trade Controls (DDTC). This rulemaking also proposes amendments to the Scope part of the EAR to update and clarify application of controls to electronically transmitted and stored technology and software. The DDTC is concurrently publishing comparable proposed amendments to the ITAR's definitions of “technical data,” “required,” “peculiarly responsible,” “public domain,” results of “fundamental research,” “export,” “reexport,” “release,” and “retransfer” for the same reasons. Finally, this rulemaking proposes conforming changes to related provisions.
One aspect of the ECR Initiative includes amending the export control regulations to facilitate enhanced compliance while reducing unnecessary regulatory burdens. For similar national security, foreign policy, including human rights, reasons, the EAR and the ITAR each control,
Many parties are regulated by both the Commerce Department's EAR and the State Department's ITAR, particularly now that regulatory jurisdiction over many types of military items has been transferred from the ITAR to the EAR. Using common terms and common definitions to regulate the same types of items or actions is intended to facilitate enhanced compliance and reduce unnecessary regulatory burdens. Conversely, if different concerns between the two sets of export control regulations warrant different terms or different controls, then the differences should be clear for the same reason. Such clarity will benefit national security because it will be easier for exporters to know how to comply with the regulations and for prosecutors to be able to prosecute violations of the regulations. Such clarity will also enhance our economic security because it will reduce unnecessary regulatory burdens for exporters when attempting to determine the meaning of key words and phrases across similar sets of regulations. Finally, such harmonization and clarification is a necessary step toward accomplishing one of the ultimate objectives of the ECR initiative, which is the creation of a common export control list and common set of export control regulations.
BIS and DDTC have identified a series of similar terms in the EAR and the ITAR that are defined differently and that warrant either harmonization or the creation of similar structures that would identify more clearly the differences in how similar concepts are treated under the EAR and the ITAR. The proposed revisions to these terms are generally not intended to materially increase or decrease their existing scope. In particular, BIS and DDTC will continue to maintain their long-standing positions that “published” (or “public domain”) information and the results of “fundamental research” are excluded from the scope of “technology” subject to the EAR and the ITAR's “technical data.” Rather, the proposed changes are designed to clarify and update BIS policies and practices with respect to the application of the terms and to allow for their structural harmonization with their counterparts in the ITAR.
Harmonizing definitions does not mean making them identical. For example, under the EAR, technology may be “subject to” or “not subject to the EAR.” Technical data under the ITAR is subject to those regulations by definition. While the two terms have substantial commonality, they remain different terms used in different ways. This rulemaking proposes that, to the extent possible, similar definitions be harmonized both substantively and structurally. Substantive harmonization will mean using the same words for the same concepts across the two sets of regulations. Structural harmonization will mean setting forth similar definitions in a paragraph order that renders their similarities and differences clearly visible. This structural harmonization may require reserving certain paragraphs in an EAR definition if the corresponding paragraph does not exist in the ITAR definition, or vice versa.
A side-by-side comparison on the regulatory text proposed by both Departments is available on both agencies' Web sites:
An interim rule entitled “Export Administration Regulation; Simplification of Export Administration Regulations” (61 FR 12714) published March 25, 1996, established part 734, Scope of the Export Administration Regulations. The interim rule stated that part 734 “establishes the rules for determining whether commodities, software, technology, software, and activities of U.S. and foreign persons are subject to the EAR.” (61 FR at 12716) This rulemaking proposes to streamline and clarify part 734 while retaining its purpose and scope of control.
Section 734.2, currently titled “Important EAR terms and principles,” contains two sets of important definitions: A definition and description of “subject to the EAR,” and definitions of export, reexport, and a number of associated terms. This rulemaking proposes to retitle the section “Subject to the EAR,” retain the definition and description of that term, and create separate sections in part 734 to define “export,” “reexport,” “release,” and “transfer (in-country),” which will be described in greater detail below. This rulemaking proposes to remove current § 734.2(b)(7) regarding the listing of foreign territories and possessions in the Commerce Country Chart (Supplement No. 1 to part 738) because it duplicates current § 738.3(b).
Section 734.3(a) describes items (
Current § 734.7 sets forth that technology and software is “published” and thus not subject to the EAR when it becomes generally accessible to the interested public in any form, including through publication, availability at libraries, patents, and distribution or presentation at open gatherings.
This rulemaking proposes a definition of “published” with the same scope but a simpler structure. The proposed § 734.7(a) reads: “Except as set forth in paragraph (b), “technology” or “software” is “published” and is thus not “technology” or “software” subject to the EAR when it is not classified national security information and has been made available to the public without restrictions upon its further dissemination. This proposed definition is substantially the same as the wording of definitions adopted by the multilateral export control regimes of which the United States is a member: The Wassenaar Arrangement, Nuclear Suppliers Group, Missile Technology Control Regime, and Australia Group. The phrase “classified national security information” refers to information that has been classified in accordance with Executive Order 13526, 75 FR 707; 3
The current § 734.8 excludes most information resulting from fundamental research from the scope of the EAR. The section is organized primarily by locus, specifically by the type of organization in which the research takes place. This proposed rule would revise § 734.8, but it is not intended to change the scope of the current § 734.8. The proposed revisions streamline the section by consolidating different provisions that involve the same criteria with respect to prepublication review, removing reference to locus unless it makes a difference to the jurisdictional status, and adding clarifying notes. The proposed revisions also consistently use the description “arises during or results from fundamental research” to make clear that technology that arises prior to a final result is subject to the EAR unless it otherwise meets the provisions of § 734.8. Comments regarding whether the streamlined § 734.8 text is narrower or broader in scope than the current text in § 734.8 are encouraged.
Proposed notes clarify that technology initially transferred to researchers,
Issued in 1985, National Security Decision Directive (NSDD)-189 established a definition of “fundamental research” that has been incorporated into numerous regulations, internal compliance regimes, and guidance documents. Therefore, in this rulemaking, BIS has proposed a definition of “fundamental research” that is identical to that in NSDD-189. However, BIS solicits comment on a simpler definition that is consistent with NSDD-189, but not identical. Specifically, the alternative definition would read: “`Fundamental research' means non-proprietary research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community.” BIS believes that the scope of this wording is the same as that of the wording in NSDD-189 and seeks comment on whether the final rule should adopt the simpler wording.
The proposed definition of “fundamental research” includes references to “basic” and “applied” research. For clarity, this rulemaking proposes definitions of those terms. The definition of “basic research” in proposed § 734.8 is that currently defined in the EAR (§ 772.1), and in the Wassenaar Arrangement's General Technology Note as “basic scientific research.” The proposed definition of “applied research” was drawn from the Defense Federal Acquisition Regulation Supplement (48 CFR part 31.205-18). A possible alternative definition of applied research is that found in the 2014 Office of Management and Budget Circular A-11: “Systematic study to gain knowledge or understanding necessary to determine the means by which a recognized and specific need may be met.” (See proposed corresponding § 120.49 of the ITAR.)
Current § 734.9 states that educational information released by instruction in a catalog course or associated teaching laboratory of an academic institution is not subject to the EAR. This rulemaking proposes moving this exclusion to § 734.3(b) and removing § 734.9. This proposed rule is not intended to change the scope of the current § 734.9.
This rulemaking proposes to revise current § 734.10, “Patent applications,” for clarity. For example, instead of an internal cross-reference to the section of the EAR identifying items not subject to the EAR the revised section directly states that “technology” is not “subject to the EAR” if it is contained in the patent-related documents described in the section. For the sake of structural consistency with the ITAR's treatment of information in patents, paragraph (a)(1) is added to state that a patent or an open (published) patent application available from or at any patent office is
This rulemaking proposes minor conforming edits to current § 734.11, which describes specific national security controls. The proposed revisions do not change the scope of current § 734.11. As described below, this rulemaking proposes to remove Supplement No. 1 to part 734, “Questions and Answers—Technology and Software Subject to the EAR.” Questions and answers are illustrative rather than regulatory and are thus more appropriately posted as Web site guidance than published as regulatory text.
In § 734.2(b) of the current EAR, there are definitions of export, export of technology or software, and export of encryption source code and object code software. Section 772.1 also defines “export” as follows: “Export means an actual shipment or transmission of items out of the United States.” This rulemaking proposes to consolidate the definitions of “export” and “export of technology and software,” while moving “export of encryption source code and object code software” to a new § 734.13.
Proposed § 734.13(a) would have six paragraphs. Paragraphs (a)(4) and (5) would be reserved. The corresponding paragraphs in the ITAR would contain provisions that are not relevant to the EAR.
Proposed paragraph (a)(1) of the definition of “export” uses the EAR terms “actual shipment or transmission out of the United States,” combined with the existing ITAR “sending or taking an item outside the United States in any manner.”
Paragraph (a)(2), specifying the concept of transfer or release of technology to a foreign national in the United States, or “deemed export,” reflects the long-standing BIS practice of treating software source code as technology for deemed export purposes.
Paragraph (a)(3) includes in the definition of “export” transferring by a person in the United States of registration, control, or ownership (i) of a spacecraft subject to the EAR that is not eligible for export under License Exception STA (
Paragraphs (a)(4) and (a)(5) remain reserved, reflecting placeholders. The ITAR's parallel proposed provisions would control transfers to embassies within the United States and defense services. Neither topic is relevant to the EAR.
Paragraph (a)(6) defines as an export the release or other transfer of the means of access to encrypted data. This is intended to complement the exclusion of certain encrypted data from the definition of export, specified in proposed § 734.18(a)(4) and discussed below. Logically, providing the means to decrypt or otherwise access controlled technology or software that is encrypted should constitute a controlled event to the same extent as releasing or otherwise transferring the unencrypted controlled technology or software itself. Upon transfer of the means of access to encrypted technology or software, the technology or software would acquire the classification and control status of the underlying technology or software, as specified in proposed § 764.2(l). The meaning of “clear text” in the proposed definition is no different than an industry standard definition,
Paragraph (a)(6) of export and paragraph (a)(4) of reexport in this proposed rule and the DDTC companion proposed rule present different formulations for this control and the agencies request input from the public on which text more clearly describes the control. The agencies intend, however, that the act of providing physical access to unsecured “technical data” (subject to the ITAR) will be a controlled event. The mere act of providing physical access to unsecured “technology” (subject to the EAR) will not, however, be a controlled event unless it is done with “knowledge” that such provision will cause or permit the transfer of controlled “technology” in clear text or “software” to a foreign national.
This provision is not confined to the transfer of cryptographic keys. It includes release or other transfer of passwords, network access codes, software or any other information that the exporter “knows” would result in the unauthorized transfer of controlled technology. As defined in current § 772.1 of the EAR, “knowledge” includes not only positive knowledge that a circumstance exists or is substantially certain to occur, but also an awareness of a high probability of its existence or future occurrence.
Paragraph (b) of § 734.13 would retain BIS's deemed export rule as set forth in current § 734.2(b). It would also codify a long-standing BIS policy that when technology or source code is released to a foreign national, the export is “deemed” to occur to that person's most recent country of citizenship or permanent residency.
Paragraph (c) would state that items that will transit through a country or countries or will be transshipped in a country or countries to a new country, or are intended for reexport to the new country are deemed to be destined to the new country. This provision would be moved without change from current § 734.2(b)(6).
(See proposed corresponding revisions to § 120.17 of the ITAR.)
The current definitions of reexport and reexport of technology or software in § 734.2(b) are shipment or transmission of items from one foreign country to another foreign country, and release of technology or source code to a foreign national “of another country.” This rulemaking proposes to move the definition of “reexports” to new § 734.14. In general, the provisions of the proposed definition of reexport parallel those of the proposed definition of export discussed above, except that reexports occur outside of the United States. Paragraphs (a)(1) and (a)(2) mirror the current definition but divide it into two paragraphs so that one paragraph pertains to actual reexports and another paragraph is specific to deemed reexports. Paragraph (a)(3) expands on the existing reference to transfer of registration or operational control over satellites in the definition of reexport in § 772.1 to include transferring by a person outside the United States of registration, control, or ownership (i) of a spacecraft subject to the EAR that is not eligible for reexport under License Exception STA (
This provision changes the existing definition of “release” in § 734.2(b)(3) and adds it to new § 734.15. Notably, while existing text provides that “visual inspection” by itself constitutes a release of technical data or source code, the proposed text provides that such inspection (including other types of inspection in addition to visual, such as aural or tactile) must actually
The proposed text also clarifies that the application of “technology” and “software” is a “release” in situations where U.S. persons abroad use personal knowledge or technical experience acquired in the United States in a manner that reveals technology or software to foreign nationals. This clarification makes explicit a long-standing EAR interpretation. This provision complements proposed new § 120.9(a)(5) of the ITAR, which would include in the definition of “defense service” the furnishing of assistance (including training) to the government of a country listed in § 126.1 of the ITAR in the development, production, operation, installation, maintenance, repair, overhaul or refurbishing of a defense article or a part, component, accessory or attachment specially designed for a defense article. The proposed definition does not use the existing phrase “visual inspection by foreign nationals of U.S.-origin equipment and facilities” because such inspections do not
The current definition of transfer (in-country) is the “shipment, transmission, or release of items subject to the EAR from one person to another person that occurs outside the United States within a single foreign country” (§ 772.1). There is no difference between this phrase and the phrase “in-country transfer” that is used in the EAR. Variations in the use of the term will be harmonized over time.
This proposed rule would remove the definition from § 772.1 and add a revised definition to new § 734.16. This rulemaking proposes: “a transfer (in-country) is a change in end use or end user of an item within the same foreign country.” This revision eliminates any potential ambiguity regarding whether a change in end use or end user within a foreign country is or is not a “transfer (in-country).” This new text would parallel the term “retransfer” in the ITAR. (See proposed corresponding definition of retransfer in § 120.51 of the ITAR.)
Proposed new § 734.17, export of encryption source code and object code software, would retain the text of § 734.2(b)(9). It would be moved to this section with only minor conforming and clarifying edits so that it is under the section of the regulations that would define when such an “export” occurs rather than under the existing “important EAR terms and principles.” Describing when an export occurs in the “export of encryption source code and object code software” section of the regulations is more clear than under a general “important EAR terms and principles” heading.
Proposed new § 734.18 gathers existing EAR exclusions from exports, reexports, and transfers into a single provision, and includes an important new provision pertaining to encrypted technology and software.
Paragraph (a)(1) reflects that by statute, launching a spacecraft, launch vehicle, payload, or other item into space is not an export.
Paragraph (a)(2), based on existing text in § 734.2(b)(2)(ii), would state that the release in the United States of technology or software to U.S. nationals, permanent residents, or protected individuals is not an export.
Paragraph (a)(3) would move from current § 734.2(b)(8) text stating that shipments between or among the states or possessions of the United States are not “exports” or “reexports.” The word “moving” and `transferring” were inserted next to “shipment” in order to avoid suggesting that the only way movement between or among the states or possessions would not be a controlled event was if they were “shipped.”
Paragraph (a)(4) establishes a specific carve-out from the definition of “export” the transfer of technology and software that is encrypted in a manner described in the proposed section. Encrypted information—
This section specifies the conditions under which this part of the definition would apply. An important requirement is that the technology or software be encrypted “end-to-end,” a phrase that is defined in paragraph (b). The intent of this requirement is that relevant technology or software is encrypted by the originator and remains encrypted (and thus not readable) until it is decrypted by its intended recipient. Such technology or software would remain encrypted at every point in transit or in storage after it was encrypted by the originator until it was decrypted by the recipient.
BIS understands that end-to-end encryption is not used in all commercial situations, particularly when encryption is provided by third party digital service providers such as cloud SaaS (software as a service) providers and some email services. However, in many such situations, technology or software may be encrypted and decrypted many times before it is finally decrypted and read by the intended recipient. At these points, it is in clear text and is vulnerable to unauthorized release. BIS considered this an unacceptable risk and therefore specified the use of end-to-end encryption as part of the proposed definition. A key requirement of the end-to-end provision is to ensure that no non-US national employee of a domestic cloud service provider or foreign digital third party or cloud service provider can get access to controlled technology or software in unencrypted form.
Paragraph (a)(4)(iii) describes encryption standards for purposes of the definition. In this proposed rule, use of encryption modules certified under the Federal Information Processing Standard 140-2 (FIPS 140-2), supplemented by appropriate software implementation, cryptographic key management and other procedures or controls that are in accordance with guidance provided in current U.S. National Institute for Standards and Technology publications, would qualify as sufficient security. FIPS 140-2 is a well understood cryptographic standard used for Federal Government procurement in the United States and Canada, as well as for many other uses, both in the United States and abroad. However, BIS understands that companies may use hardware and software that has not been certified by NIST or that does not conform to NIST guidelines (
This paragraph also specifically excludes from the definition technology and software stored in countries in Country Group D:5 and Russia for foreign policy reasons in light of the embargoes and policies of presumptive denial now in place with respect to such countries.
Logically, providing keys or other information that would allow access to encrypted technology or software should be subject to the same type of controls as the actual export, reexport, or transfer of the technology or software itself. This is specifically addressed in the proposed § 734.13(a)(6) as part of the definition of “export.” In addition, the proposed § 764.2(1) states that for enforcement purposes such an unauthorized release will constitute a violation to the same extent as a violation in connection with the actual export, reexport, or transfer (in-country) of the underlying “technology” or “software.”
Paragraph (c) confirms that the mere ability to access “technology” or “software” while it is encrypted in a manner that satisfies the requirements in the section does not constitute the release or export of such “technology” or “software.” This responds to a common industry question on the issue. (See proposed corresponding § 120.52 of the ITAR.)
Proposed § 734.20, activities that are not deemed reexports, merely codifies
Under this guidance and new § 734.20, release of technology or source code by an entity outside the United States to a foreign national of a country other than the foreign country where the release takes place does not constitute a deemed reexport of such technology or source code if the entity is authorized to receive the technology or source code at issue, whether by a license, license exception, or situations where no license is required under the EAR for such technology or source code and the foreign national's most recent country of citizenship or permanent residency is that of a country to which export from the United States of the technology or source code at issue would be authorized by the EAR either under a license exception, or in situations where no license under the EAR would be required.
Release of technology or source code by an entity outside the United States to a foreign national of a country other than the foreign country where the release takes place does not constitute a deemed reexport if: (i) The entity is authorized to receive the technology or source code at issue, whether by a license, license exception, or through situations where no license is required under the EAR; (ii) the foreign national is a
This paragraph corresponds to § 124.16 of the ITAR, but the reference to Country Group A:5 instead of the countries in the corresponding ITAR section varies slightly. This variation is a function of BIS's national security and foreign policy assessment of the application of this proposed rule to the nationals of Country Group A:5 and as part of a general BIS effort to reduce the number of variations in groups of countries identified in the EAR consistent with U.S. national security and foreign policy interests. South Korea and Argentina are in Country Group A:5, but not in ITAR § 124.16. Malta, Albania, and Cyprus are in § 124.16, but not in Country Group A:5.
For nationals other than those of Country Group A:5 countries, which are close military allies of the United States, other criteria may apply. In particular, the section specifies the situations in which the releases would not constitute deemed exports in a manner consistent with § 126.18 of the ITAR. An additional paragraph on scope of technology licenses included in the Web site would not be included in this proposed § 734.20. It would be included in proposed § 750.7, discussed below. For purposes of this section, “substantive contacts” would have the same meaning as it has in § 126.18 of the ITAR. The proposed phrase “permanent and regular employee” is a combination of BIS's definition of “permanent employee,” as set forth in a BIS advisory opinion issued on November 19, 2007, and the ITAR's definition of “regular employee” in § 120.39. This proposed rule adds specific text excluding persons proscribed under U.S. law to make clear that § 734.20 does not authorize release of technology to persons proscribed under U.S. law, such as those on the Entity List or the Specially Designated Nationals List, or persons denied export privileges, and defines “proscribed person” in § 772.1. The US-UK Exchange of Notes and US-Canadian Exchange of Letters referred to in the existing online guidance can be found on the State Department's Web site. The URL's for the letter are not proposed to be published in the EAR since URL addresses periodically change. Upon implementation of a final rule in this regard, BIS will place the URL references in an “FAQ” section of its Web site.
Like the current definition of “technology” in the EAR (§ 772.1), the definition proposed in this rulemaking is based on the Wassenaar Arrangement definition of technology. It continues to rest on the Wassenaar-defined sub-definitions of “development,” “production,” and “use,” which are currently defined in § 772.1 and which this rulemaking does not propose to change. This rulemaking also does not propose to change BIS's long-standing policy that all six activities in the definition of “use” (operation, installation (including on-site installation), maintenance (checking), repair, overhaul and refurbishing) must be present for an item to be classified under an ECCN paragraph that uses “use” to describe the ”technology” controlled. See 71 FR 30842, May 31, 2006. The proposed definition includes, as does the current EAR definition, the terms “operation, installation, maintenance, repair, overhaul, or refurbishing (or other terms specified in ECCNs on the CCL that control `technology') of an item” because such words are used as to describe technology controlled in multiple ECCNs, often with “or” rather than the “and” found in “use.”
This rulemaking proposes to incorporate the definitions of “technical data” and “technical assistance” into the definition of “technology” as illustrative lists. The note in the existing definition of “technology” that “technical assistance” “may take the forms such as instruction, skills training, working knowledge, and consulting services” is not repeated given that the proposed definition and its examples would include any “technology” in such circumstances and in a manner that is harmonized with the ITAR's definition of technical data.
This rulemaking proposes to add a note to address a common industry question about modification. This proposed rule also would add three exclusions to clarify the limits of the scope of the definition in a manner consistent with long-standing BIS policy and interpretation of existing scope of “technology.” The first two insertions parallel exclusions in the ITAR and the third, the exclusion of telemetry data, mirrors specific exclusions inserted into both the ITAR and the EAR as part of recent changes regarding the scope of U.S. export controls pertaining to satellites and related items.
This rulemaking proposes to remove Supplement No. 1 to part 734, “Questions and Answers—Technology and Software Subject to the EAR.” Because the questions and answers are illustrative rather than regulatory, they are more appropriately posted as Web site guidance than included in the EAR.
This proposed rule retains the existing EAR definition of “required” in § 772.1, but proposes adding notes clarifying the application of the term. It removes the references in the existing definition to CCL Categories 4, 5, 6, and 9 to avoid the suggestion that BIS
To address common questions BIS has received regarding the meaning of the word “required,” BIS proposes adding two notes to address the questions. The first states that the references to “characteristics” and “functions” are not limited to entries on the CCL that use specific technical parameters to describe the scope of what is controlled. The “characteristics” and “functions” of an item listed are, absent a specific regulatory definition, a standard dictionary's definition of the item. It then includes examples of this point. The second refers to the fact that the ITAR and the EAR often divide within each set of regulations or between each set of regulations (a) controls on parts, components, accessories, attachments, and software and (b) controls on the end items, systems, equipment, or other articles into which those parts, components, accessories, attachments, and software are to be installed or incorporated. Moreover, with the exception of technical data specifically enumerated on the USML, the jurisdictional status of unclassified technical data or “technology” is the same as the jurisdictional status of the defense article or item to which it is directly related. Examples of this point are provided. (See proposed corresponding revisions to § 120.46 of the ITAR.)
This rulemaking proposes a definition of the currently undefined term “peculiarly responsible” in order to respond to common industry questions. The new definition would be modeled on the catch-and-release structure BIS adopted for the definition of “specially designed.” Thus, under the proposed definition, an item is “peculiarly responsible” for achieving or exceeding any referenced controlled performance levels, characteristics, or functions if it is used in “development,” “production,” “use,” operation, installation, maintenance, repair, overhaul, or refurbishing of an item subject to the EAR
This rulemaking proposes to amend the temporary export of technology provisions of existing License Exception TMP by revising § 740.9(a)(3) to clarify that the “U.S. employer” and “U.S. persons or their employees” using this license exception are not foreign subsidiaries. The proposed paragraph streamlines current text without changing the scope. (See proposed corresponding revisions to § 125.4(b)(9) of the ITAR.)
This proposed revision would implement in the EAR the interagency-agreed boilerplate for all licenses that was posted on the BIS Web site and began appearing on licenses December 8, 2014. It is a slight revision to the existing § 750.7(a), which states that licenses authorize only the transaction(s) described in the license application and the license application support documents. This proposed revision would also codify the existing interpretation that a license authorizing the release of technology to an entity also authorizes the release of the same technology to the entity's foreign nationals who are permanent and regular employees of the entity's facility or facilities authorized on the license, except to the extent a license condition limits or prohibits the release of the technology to nationals of specific countries or country groups.
This rulemaking proposes adding a new paragraph (l) to § 764.2 “Violations.” This paragraph would provide that the unauthorized release of decryption keys or other information that would allow access to particular controlled technology or software would, for enforcement purposes, constitute a violation to the same extent as a violation in connection with the export of the underlying controlled “technology” or “software.” Under these and other related provisions, the decryption keys (or other technology), while subject to the EAR, do not themselves retain the classification of the technology that they could potentially release. This allows them to be secured and transmitted independently of the technology they could be used to release. (See proposed corresponding revisions to § 127.1(b)(4) of the ITAR.)
With the changes proposed in this rulemaking, there would be stand-alone sections in the EAR to address the scope and meaning of “publicly available information,” “publicly available technology and software,” and “technical data.” To avoid redundancy, the existing definitions in § 772.1 would be removed. In light of the changes described above, the definitions of “basic scientific research,” “export,” “reexport,” “required,” “technology,” and “transfer” would be revised accordingly. A clarifying note would be added at the bottom of the definition that the use of “transfer” does not apply to the unrelated “transfers of licenses” provision in § 750.10 or the antiboycott provisions in Supplement No. 8 to part 760 of the EAR. It also states that the term “transfer” may also be included on licenses issued by BIS. In that regard, the changes that can be made to a BIS license are the non-material changes described in § 750.7(c). Any other change to a BIS license without authorization is a violation of the EAR.
BIS welcomes comments on any aspects of this proposed rule. With respect to the proposed revisions, BIS would like to receive comments that are as specific and well-supported as possible. Particularly helpful comments will include a description of a problem or concern, available data on cost or economic impact, and a proposed solution. BIS also welcomes comments on aspects of this proposed rule that the public considers effective or well designed.
BIS specifically solicits comment on the following issues:
1. Whether the revisions proposed in this rulemaking create gaps, overlaps, or contradictions between the EAR and the ITAR, or among various provisions within the EAR;
2. Whether the alternative definition of fundamental research suggested in the preamble should be adopted;
3. Whether the alternative definition of applied research suggested in the preamble should be adopted, or whether basic and applied research definitions are needed given that they are subsumed by fundamental research;
4. Whether the questions and answers in existing Supplement No. 1 to part 734 proposed to be removed by this rulemaking have criteria that should be retained in part 734;
5. With respect to end-to-end encryption described in the proposed revision of the definition of “Activities that are Not Exports, Reexports, or Transfers,” whether the illustrative standard proposed in the EAR rulemaking also should be adopted in the ITAR rulemaking; whether the safe harbor standard proposed in the ITAR rulemaking also should be adopted in the EAR rulemaking; or whether the two bodies of regulations should have different standards;
6. Whether encryption standards adequately address data storage and transmission issues with respect to export controls; and
7. Whether the proposed definition of “peculiarly responsible” effectively explains how items may be “required” or “specially designed” for particular functions.
8. The public is asked to comment on the effective date of the final rule. Export Control Reform rules that revised categories of the USML and created new 600 series ECCNs have had a six-month delayed effective date to allow for exporters to update the classification of their items. In general, rules effecting export controls have been effective on the date of publication, due to the impact on national security and foreign policy. As this proposed rule, and the companion proposed rule from the Directorate of Defense Trade Controls, revise definitions within the ITAR and the EAR and do not make any changes to the USML or CCL, a 30-day delayed effective date is proposed to allow exporters to ensure continued compliance.
Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 7, 2014, 79 FR 46959 (August 11, 2014), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.
1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this proposed rule has been reviewed by the Office of Management and Budget (OMB).
2. This proposed rule does not contain information collections subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
3. This proposed rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.
4. Pursuant to the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 601
The policy reasons for issuing this proposed rule are discussed in the background section of the preamble of this document, and are not repeated here.
The objective of this proposed rule (and a proposed rule being published simultaneously by the Department of State) is to provide greater clarity and precision in the EAR and the ITAR by providing common definitions and common terms to regulate the same types of actions. The proposed rule also seeks to express some concepts more clearly.
The proposed rule would alter definitions in the EAR. It also would update and clarify application of controls to electronically transmitted technology and software.
The legal basis for this proposed rule is 50 U.S.C. app. 2401
No other Federal rules duplicate, overlap, or conflict with this proposed rule.
This proposed rule would apply to all persons engaged in the export, reexport, or transfer of commodities, technology or software that is regulated by the EAR. BIS does not maintain data from which it can determine how many of those persons are small entities as identified in the Small Business Administration size standards. Nevertheless, BIS recognizes that some of those persons are likely to be small entities.
This proposed rule is unlikely to increase the number of transactions that must be reported to BIS because EAR reporting requirements apply only in five specific situations, none of which would change as a result of this proposed rule. Those situations are: Exports that do not require a license of items on the Wassenaar Arrangement Sensitive List; Exports of High Performance Computers; Exports of certain thermal imaging cameras that do not require a license; Certain exports of Conventional Arms; and 600 series major defense equipment.
Because recordkeeping requirements already apply to all transactions that are subject to the EAR, BIS expects that this proposed rule would not expand recordkeeping requirements.
It is possible that some of these changes would increase the number of
The following discussion describes the changes that would be made by this proposed rule. It is divided into two sections: Changes that BIS believes would not impose any new regulatory obligations; and Changes that are not intended to imposed any new regulatory obligation, but that BIS cannot state with certainty would not do so.
This proposed rule would make certain changes to clarify and streamline the definitions of comparable terms, phrases, and concepts between the EAR and the ITAR. Many of these changes are technical in nature and attempt to consolidate and re-phrase the definitions to enhance readability and to parallel the structure of the ITAR's definition of the same term. However, there are a small number of new provisions, but these changes would not impose any new regulatory burdens. Specifically, this proposed rule would make the following changes:
Remove § 734.2(b) which currently defines export, reexport, release, transfer (in country) and export of encryption source code or object code software, because those terms would be defined in separate sections. Section 734.2(b) also states the policy of applying license requirements that apply to a country to its dependencies and possessions; this policy is currently stated elsewhere in the EAR.
Create new separate sections defining export, reexport, release and export of encryption source code or object code software. Those terms would be clarified and presented in a more organized manner, but substantively unchanged from the existing regulatory text.
Create a new section identifying activities that are not exports, reexports, or transfers. This section restates the transactions that are excluded from the definition of export in current regulatory text and adds two additional activities that would be expressly declared not to be exports, rexports or transfers: space launches and sending, taking or storing certain technology or software abroad using specified cryptographic techniques. The former, although not expressly in the current regulatory text, is required by statute (
Clarify without substantively changing the provisions related to patent applications and add specific text stating that technology contained in a patent available from or at any patent office is not subject to the EAR. The addition reflects BIS' long-standing interpretation. To the extent that it could be characterized as new, its only effect would be to appear to release from the EAR technology that some readers of the EAR might have (erroneously) concluded was subject to the EAR.
Add to License Exception TMP text to emphasize that foreign subsidiaries of U.S. companies are neither U.S. employers nor “U.S. persons or their employees” as those terms are used in the license exception. This additional text adds no restriction that is not already imposed by the definition of “U.S. persons” that currently appears in the text of License Exception TMP.
Add text codifying in the EAR limits on transactions authorized by a license that currently are imposed by conditions on the license itself.
Add text prohibiting the release or other transfer of information (
This proposed rule would add definitions for two new terms “applied research,” and “peculiarly responsible” and revise the definitions of two existing terms “required” and “transfer (in-country).” It also would adopt BIS' interpretative guidance regarding deemed reexports as regulatory text. These changes are not intended to impose any regulatory obligations on regulated entities, but BIS cannot state with certainty that there will be no impact. This proposed rule would make the following changes:
Add to the existing definition of “fundamental research” a new definition of “applied research.” The information arising from fundamental research is not subject to the EAR. Fundamental research consists of basic and applied research where the results are ordinarily published and shared broadly within the scientific community. This proposed rule would retain the overall concept of fundamental research that is currently in the EAR, but would remove certain limitations based on the type of institution in which the research takes place, relocate the definition of “basic research” from the definitions section of the EAR to the section dealing with fundamental research and provide a definition of applied research.
Add to the EAR a definition of the term “peculiarly responsible.” That currently undefined term appears in the definitions of “specially designed” and of “required” in the EAR. This proposed rule would define that term.
Add to the EAR a definition of “proscribed person.” This definition does not create any new regulated class. It simply provides a clear, shorthand reference to a person who is already prohibited from receiving items or participating in a transaction that is subject to the EAR without authorization by virtue of U.S. law, such as persons on the Entity List, Specially Designated Nationals, or debarred parties.
Remove from the definition of the term “required” references to CCL Categories 4, 5, 6 and 9 to accurately reflect BIS' long-standing interpretation that its definition applies wherever the EAR imposes a license requirement for technology “required” for a particular process or activity.
In the definition of “transfer (in-country),” replace the phrase “shipment, transmission, or release of items subject to the EAR from one person to another person that occurs outside the United States within a single foreign country” with “a change in end use or end user of an item within the same foreign country.” This new text would parallel the term “retransfer” in the ITAR and would eliminate any potential ambiguity that a change in end use or end user within a foreign country is or is not a “transfer (in-country).”
Each of the foregoing changes would serve the overall policy goals of reducing uncertainty and harmonizing the requirements of the ITAR and the EAR. In most instances, reduced uncertainty will be beneficial to persons who have to comply with the regulations, particularly persons who engage in transactions subject to both sets of regulations. They would be able to make decisions more quickly and
This proposed rule also would add to the EAR a description of activities that are not deemed reexports. This description currently appears as interpretative guidance on BIS' Web site and closely tracks the regulatory text of the ITAR. Deemed reexports are releases of technology or software source code within a single foreign country by a party located outside the United States to a national of a country other than the country in which the releasing party is located. The guidance describes three situations in which that party may release the technology or source code without obtaining a license from BIS.
By adopting this guidance as regulatory text that closely tracks the text governing the same activities in the ITAR, BIS reduces both complexity and unnecessary differences between the two sets of regulations with the salutary effects of faster decision making, reduced need to contact BIS for advice and reduced possibility that small entities would be discouraged from exporting as noted above.
As required by 5 U.S.C. 603(c), BIS' analysis considered significant alternatives. Those alternatives are: (1) The preferred alternative of altering definitions and updating and clarifying application of controls to electronically transmitted technology and software; (2) Maintaining the
By altering definitions and updating and clarifying application of controls to electronically transmitted technology and software as this proposed rule would do, BIS would be reducing uncertainty for all parties engaged in transactions that are subject to the EAR. Potential ambiguities would be reduced; decisions could be made more quickly; the need to contact BIS for advice be reduced; and the possibility of inconsistent interpretations providing one party commercial advantages over others would be reduced. Persons (including small entities) engaged in transactions that are subject to the ITAR and transactions that are subject to the EAR would face fewer actual or apparent inconsistencies that must be addressed in their regulatory compliance programs. Although small entities, along with all other parties, would need to become familiar with the revised terminology, in the long run, compliance costs are likely to be reduced when compared to the present situation where the ITAR and the EAR use different terminology to regulate the same types of activity in the same manner. Therefore, BIS adopted this alternative.
If BIS chose to maintain the
If BIS chose to create a size threshold exempting small entities as currently defined by the SBA size standards from the changes imposed by this proposed rule, those entities would face a more complicated regulatory environment than larger entities. The small entities would continue to be subject to the EAR as a whole but without the benefit of the clarifications introduced by this proposed rule. The only way to make a size threshold beneficial to entities falling below the threshold would be to exempt them from all or at least many of the requirements of the EAR. However, doing so would create a major loophole allowing commodities, software, and technology that are controlled for export for national security or foreign policy reasons to go, without restriction, to any party abroad, undermining the interests that the regulations are intended to protect. Therefore, BIS has not adopted this alternative.
Exports.
Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.
Administrative practice and procedure, Exports, Law enforcement, Penalties.
For the reasons stated in the preamble, parts 734, 740, 750, 764, and 772 of the Export Administration Regulations (15 CFR subchapter C) are proposed to be amended as follows:
50 U.S.C. app. 2401
(b) The following are not subject to the EAR:
(3) Information and “software” that:
(i) Are “published,” as described in § 734.7;
(ii) Arise during, or result from, “fundamental research,” as described in § 734.8;
(iii) Concern general scientific, mathematical, or engineering principles commonly taught in schools, and released by instruction in a catalog course or associated teaching laboratory of an academic institution; or
(iv) Appear in patents or open (published) patent applications available from or at any patent office, unless covered by an invention secrecy order, or are otherwise patent information as described in § 734.10.
A printed book or other printed material setting forth encryption source code is not itself subject to the EAR (see § 734.3(b)(2)). However, notwithstanding § 734.3(b)(2), encryption source code in electronic form or media (
Except as set forth in part 760 of this title, information that is not within the scope of the definition of “technology” (see § 772.1 of the EAR) is not subject to the EAR.
(a) Except as set forth in paragraph (b) of this section, unclassified “technology” or “software” is “published,” and is thus not “technology” or “software” subject to the EAR, when it has been made available to the public without restrictions upon its further dissemination such as through any of the following:
(1) Subscriptions available without restriction to any individual who desires to obtain or purchase the published information;
(2) Libraries or other public collections that are open and available to the public, and from which the public can obtain tangible or intangible documents;
(3) Unlimited distribution at a conference, meeting, seminar, trade show, or exhibition, generally accessible to the interested public;
(4) Public dissemination (
(5) Submission of a written composition, manuscript or presentation to domestic or foreign co-authors, editors, or reviewers of journals, magazines, newspapers or trade publications, or to organizers of open conferences or other open gatherings, with the intention that the compositions, manuscripts, or publications will be made publicly available if accepted for publication or presentation.
(b) Published encryption software classified under ECCN 5D002 remains subject to the EAR unless it is publicly available encryption object code software classified under ECCN 5D002 and the corresponding source code meets the criteria specified in § 740.13(e) of the EAR.
(a) “Technology” that arises during, or results from, fundamental research and is `intended to be published' is thus not “subject to the EAR.”
The inputs used to conduct fundamental research, such as information, equipment, or software, are not “technology that arises during or results from fundamental research” except to the extent that such inputs are “technology” that arose during or resulted from earlier fundamental research.
There are instances in the conduct of research, whether fundamental, basic, or applied, where a researcher, institution or company may decide to restrict or protect the release or publication of “technology” contained in research results. Once a decision is made to maintain such “technology” as restricted or proprietary, the “technology,” if within the scope of § 734.3(a), becomes “subject to the EAR.”
(b)
(1) Prepublication review is conducted solely to ensure that publication would not compromise patent rights, so long as the review causes no more than a temporary delay in publication of the research results;
(2) Prepublication review is conducted by a sponsor of research solely to insure that the publication would not inadvertently divulge proprietary information that the sponsor has furnished to the researchers; or
(3) With respect to research conducted by scientists or engineers working for a Federal agency or a Federally Funded Research and Development Center (FFRDC), within any appropriate system devised by the agency or the FFRDC to control the release of information by such scientists and engineers.
Although “technology” arising during or resulting from fundamental research is not considered “intended to be published” if researchers accept restrictions on its publication, such “technology” will nonetheless qualify as “technology” arising during or resulting from fundamental research once all such restrictions have expired or have been removed.
Except as provided in § 734.11, “technology” that is subject to other publication restrictions, such as U.S. government-imposed access and dissemination controls, is not “intended to be published.”
(c)
(1) “Basic research” means experimental or theoretical work undertaken principally to acquire new knowledge of the fundamental principles of phenomena or observable facts, not primarily directed towards a specific practical aim or objective.
(2) “Applied research” means the effort that:
(i) Normally follows basic research, but may not be severable from the related basic research;
(ii) Attempts to determine and exploit the potential of scientific discoveries or improvements in technology, materials, processes, methods, devices, or techniques; and
(iii) Attempts to advance the state of the art.
“Technology” is not “subject to the EAR” if it is contained in:
(a) A patent or an open (published) patent application available from or at any patent office;
(b) A published patent or patent application prepared wholly from foreign-origin technology where the application is being sent to the foreign inventor to be executed and returned to the United States for subsequent filing in the U.S. Patent and Trademark Office;
(c) A patent application, or an amendment, modification, supplement or division of an application, and authorized for filing in a foreign country in accordance with the regulations of the Patent and Trademark Office, 37 CFR part 5; or
(d) A patent application when sent to a foreign country before or within six months after the filing of a United States patent application for the purpose of obtaining the signature of an inventor who was in the United States when the invention was made or who is a co-inventor with a person residing in the United States.
(a) If research is funded by the U.S. Government, and specific national security controls are agreed on to protect information resulting from the research, the provisions of § 734.3(b)(3) will not apply to any export or reexport of such information in violation of such controls. However, any export or reexport of information resulting from the research that is consistent with the specific national security controls may nonetheless be made under this provision.
(b) Examples of “specific national security controls” include requirements for prepublication review by the Government, with right to withhold permission for publication; restrictions on prepublication dissemination of information to non-U.S. citizens or other categories of persons; or restrictions on participation of non-U.S. citizens or other categories of persons in the research. A general reference to one or more export control laws or regulations or a general reminder that the Government retains the right to classify is not a “specific national security control.”
(a) Except as set forth in § 734.17, “export” means:
(1) An actual shipment or transmission out of the United States, including the sending or taking of an item out of the United States, in any manner;
(2) Releasing or otherwise transferring “technology” or “source code” (but not “object code”) to a foreign national in the United States (a “deemed export”);
(3) Transferring by a person in the United States of registration, control, or ownership of:
(i) A spacecraft subject to the EAR that is not eligible for export under License Exception STA (
(ii) Any other spacecraft subject to the EAR to a person in or a national of a Country Group D:5 country; or
(4) [Reserved]
(5) [Reserved]
(6) Releasing or otherwise transferring decryption keys, network access codes, passwords, “software” or other information with “knowledge” that such provision will cause or permit the transfer of other “technology” in clear text or “software” to a foreign national.
(b) Any release in the United States of “technology” or “source code” to a foreign national is a deemed export to the foreign national's most recent country of citizenship or permanent residency.
(c) The export of an item that will transit through a country or countries or will be transshipped in a country or countries to a new country, or are intended for reexport to the new country, is deemed to be an export to the new country.
(a) Except as set forth in §§ 734.18 and 734.20, “reexport” means:
(1) An actual shipment or transmission of an item from one foreign country to another foreign country, including the sending or taking of an item to or from such countries in any manner;
(2) Releasing or otherwise transferring “technology” or “source code” to a foreign national of a country other than the foreign country where the release or transfer takes place (a “deemed reexport”);
(3) Transferring by a person outside the United States of registration, control, or ownership of:
(i) A spacecraft subject to the EAR that is not eligible for reexport under License Exception STA (
(ii) Any other spacecraft subject to the EAR to a person in or a national of a Country Group D:5 country; or
(4) Releasing or otherwise transferring outside of the United States decryption keys, network access codes, passwords, “software,” or other information with “knowledge” that such provision will cause or permit the transfer of other “technology” in clear text or “software” to a foreign national.
(b) Any release outside of the United States of “technology” or “source code” subject to the EAR to a foreign national of another country is a deemed reexport to the foreign national's most recent country of citizenship or permanent residency, except as described in § 734.20.
(c) The reexport of an item subject to the EAR that will transit through a country or countries or will be transshipped in a country or countries to a new country, or are intended for reexport to the new country, is deemed to be a reexport to the new country.
(a) Except as set forth in § 734.18, “technology” and “software” are “released” through:
(1) Visual or other inspection by a foreign national of items that reveals “technology” or “source code” subject to the EAR to a foreign national;
(2) Oral or written exchanges with a foreign national of “technology” in the United States or abroad; or
(3) The application by U.S. persons of “technology” or “software” to situations abroad using personal knowledge or technical experience acquired in the United States, to the extent that the application reveals to a foreign national “technology” or “source code” subject to the EAR.
(b) [Reserved]
Except as set forth in § 734.18, a transfer (in-country) is a change in end use or end user of an item within the same foreign country. “Transfer (in-country)” is synonymous with “in-country transfer.”
(a) For purposes of the EAR, the export of encryption source code and object code software means:
(1) An actual shipment, transfer, or transmission out of the United States (
(2) A transfer of such software in the United States to an embassy or affiliate of a foreign country.
(b) The export of encryption source code and object code software controlled for “EI” reasons under ECCN 5D002 on the Commerce Control List (see Supplement No. 1 to part 774 of the EAR) includes:
(1) Downloading, or causing the downloading of, such software to locations (including electronic bulletin boards, Internet file transfer protocol, and World Wide Web sites) outside the U.S., or
(2) Making such software available for transfer outside the United States, over wire, cable, radio, electromagnetic, photo optical, photoelectric or other comparable communications facilities accessible to persons outside the United States, including transfers from electronic bulletin boards, Internet file transfer protocol and World Wide Web sites, unless the person making the software available takes precautions adequate to prevent unauthorized transfer of such code. See § 740.13(e) of the EAR for notification requirements for exports or reexports of encryption source code software considered to be publicly available or published consistent with the provisions of § 734.3(b)(3). Publicly available encryption software in object code that corresponds to encryption source code made eligible for License Exception TSU under § 740.13(e) of this subchapter is not subject to the EAR.
(c) Subject to the General Prohibitions described in part 736 of the EAR, such precautions for Internet transfers of products eligible for export under § 740.17(b)(2) of the EAR (encryption software products, certain encryption source code and general purpose encryption toolkits) shall include such measures as:
(1) The access control system, either through automated means or human intervention, checks the address of every system outside of the U.S. or Canada requesting or receiving a transfer and verifies such systems do not have a domain name or Internet address of a foreign government end-user (
(2) The access control system provides every requesting or receiving party with notice that the transfer includes or would include cryptographic software subject to export controls under the Export Administration Regulations, and anyone receiving such a transfer cannot export the software without a license or other authorization; and
(3) Every party requesting or receiving a transfer of such software must acknowledge affirmatively that the software is not intended for use by a government end user, as defined in part 772 of the EAR, and he or she understands the cryptographic software is subject to export controls under the Export Administration Regulations and anyone receiving the transfer cannot export the software without a license or other authorization. BIS will consider acknowledgments in electronic form provided they are adequate to assure legal undertakings similar to written acknowledgments.
(a) The following activities are not exports, reexports, or transfers:
(1) Launching a spacecraft, launch vehicle, payload, or other item into space.
(2) While in the United States, releasing technology or software to United States citizens, persons lawfully admitted for permanent residence in the United States, or persons who are protected individuals under the Immigration and Naturalization Act (8 U.S.C. 1324b(a)(3)).
(3) Shipping, moving, or transferring items between or among the United States, the District of Columbia, the Commonwealth of Puerto Rico, or the Commonwealth of the Northern Mariana Islands or any territory, dependency, or possession of the United States as listed in Schedule C, Classification Codes and Descriptions for U.S. Export Statistics, issued by the Bureau of the Census.
(4) Sending, taking, or storing technology or software that is:
(i) Unclassified;
(ii) Secured using end-to-end encryption;
(iii) Secured using cryptographic modules (hardware or software) compliant with Federal Information Processing Standards Publication 140-2 (FIPS 140-2) or its successors, supplemented by software implementation, cryptographic key management and other procedures and controls that are in accordance with guidance provided in current U.S. National Institute for Standards and Technology publications, or other similarly effective cryptographic means; and
(iv) Not stored in a country listed in Country Group D:5 (
(b)
(c) The ability to access “technology” or “software” in encrypted form that satisfies the criteria set forth in paragraph (a)(4) of this section does not constitute the release or export of such “technology” or “software.”
Releasing “technology” or “software” to any person with knowledge that a violation will occur is prohibited by § 736.2(b)(10) of the EAR.
(a) Release of “technology” or “source code” by an entity outside the United States to a foreign national of a country other than the foreign country where the release takes place does not constitute a deemed reexport of such “technology” or “source code” if:
(1) The entity is authorized to receive the “technology” or “source code” at issue, whether by a license, license exception, or situations where no license is required under the EAR for such “technology” or “source code;” and
(2) The entity is certain that the foreign national's most recent country of citizenship or permanent residency is that of a country to which export from the United States of the “technology” or “source code” at issue would be authorized by the EAR either under a license exception, or in situations where no license under the EAR would be required.
(b)
(1) The entity is authorized to receive the “technology” or “source code” at issue, whether by a license, license exception, or through situations where no license is required under the EAR;
(2) The foreign national is a
(3) Such employee is a national exclusively of a country in Country Group A:5; and
(4) The release of “technology” or “source code” takes place entirely within the physical territory of any such country.
(c)
(1) The entity is authorized to receive the “technology” or “source code” at issue, whether by a license, license exception, or situations where no license is required under the EAR;
(2) The foreign national is a
(3) The release takes place entirely within the physical territory of the country where the entity is located, conducts official business, or operates;
(4) The entity has effective procedures to prevent diversion to destinations, entities, end users, and end uses contrary to the EAR; and
(5) Any one of the following six (
(i) The foreign national has a security clearance approved by the host nation government of the entity outside the United States;
(ii) The entity outside the United States:
(A) Has in place a process to screen the foreign national employee and to have the employee execute a non-disclosure agreement that provides assurances that the employee will not disclose, transfer, or reexport controlled technology contrary to the EAR;
(B) Screens the employee for substantive contacts with countries listed in Country Group D:5 (see Supplement No. 1 to part 740 of the EAR). Although nationality does not, in and of itself, prohibit access to “technology” or “source code” subject to the EAR, an employee who has substantive contacts with persons from countries listed in Country Group D:5 shall be presumed to raise a risk of diversion, unless BIS determines otherwise;
(C) Maintains a technology security or clearance plan that includes procedures for screening employees for such substantive contacts;
(D) Maintains records of such screenings for the longer of five years or the duration of the individual's employment with the entity; and
(E) Will make such plans and records available to BIS or its agents for civil and criminal law enforcement purposes upon request;
(iii) The entity is a UK entity implementing § 126.18 of the ITAR (22 CFR 126.18) pursuant to the US-UK Exchange of Notes regarding § 126.18 of the ITAR for which the UK has provided appropriate implementation guidance;
(iv) The entity is a Canadian entity implementing § 126.18 of the ITAR pursuant to the US-Canadian Exchange of Letters regarding § 126.18 of the ITAR for which Canada has provided appropriate implementation guidance;
(v) The entity is an Australian entity implementing the exemption at paragraph 3.7b of the ITAR Agreements Guidelines; or
(vi) The entity is a Dutch entity implementing the exemption at paragraph 3.7c of the ITAR Agreements Guidelines.
(d)
(2)
(a) Is permanently (
(b) Is a contract employee who:
(i) Is in a long-term contractual relationship with the company where the individual works at the entity's facilities or at locations assigned by the entity (such as a remote site or on travel);
(ii) Works under the entity's direction and control such that the company must determine the individual's work schedule and duties;
(iii) Works full time and exclusively for the entity; and
(iv) Executes a nondisclosure certification for the company that he or she will not disclose confidential information received as part of his or her work for the entity.
If the contract employee has been seconded to the entity by a staffing agency, then the staffing agency must not have any role in the work the individual performs other than to provide the individual for that work. The staffing agency also must not have access to any controlled “technology” or “source code” other than that authorized by the applicable regulations or a license.
50 U.S.C. app. 2401
(a) * * *
(3) “Technology,” regardless of media or format, may be exported by or to a U.S. person or a foreign national employee of a U.S. person, traveling or on temporary assignment abroad, subject to the following restrictions:
(i) Foreign nationals may only export or receive such “technology” as they are authorized to receive through a license, license exception other than TMP or because no license is required.
(ii) “Technology” exported under this authorization may only be possessed or used by a U.S. person or authorized foreign national and sufficient security precautions must be taken to prevent the unauthorized release of the “technology.” Such security precautions include encryption of the “technology,” the use of secure network connections, such as Virtual Private Networks, the use of passwords or other access restrictions on the electronic device or media on which the “technology” is stored, and the use of firewalls and other network security measures to prevent unauthorized access.
(iii) The U.S. person is an employee of the U.S. Government or is directly employed by a U.S. person and not,
(iv) Technology” authorized under this exception may not be used for foreign production purposes or for technical assistance unless authorized through a license or license exception other than TMP.
(v) The U.S. person employer of foreign nationals must document the use of this exception by foreign national
50 U.S.C. app. 2401
(a)
50 U.S.C. app. 2401
(l) No person may “release” or otherwise transfer information, such as decryption keys, network access codes, or passwords, that would allow access to other “technology” in clear text or “software” with “knowledge” that the release will result, directly or indirectly, in an unauthorized export, reexport, or transfer of the “technology” in clear text or “software.” Violation of this provision will constitute a violation to the same extent as a violation in connection with the export of the controlled “technology” or “software.”
50 U.S.C. app. 2401
The revisions and additions read as follows:
(1) The Department of Commerce has determined otherwise in a commodity classification determination;
(2) [Reserved];
(3) It is identical to information used in or with a commodity or software that:
(i) Is or was in production (
(ii) Is EAR99 or described in an ECCN controlled only for Anti-Terrorism (AT) reasons;
(4) It was or is being developed with “knowledge” that it would be for use in or with commodities or software:
(i) Described in an ECCN; and
(ii) Also commodities or software either not enumerated on the CCL or the USML (
(5) It was or is being developed for use in or with general purpose commodities or software,
(6) It was or is being developed with “knowledge” that it would be for use in or with commodities or software described:
(i) In an ECCN controlled for AT-only reasons and also EAR99 commodities or software; or
(ii) Exclusively for use in or with EAR99 commodities or software.
The references to “characteristics” and “functions” are not limited to entries on the CCL that use specific technical parameters to describe the scope of what is controlled. The “characteristics” and “functions” of an item listed are, absent a specific regulatory definition, a standard dictionary's definition of the item. For example, ECCN 9A610.a controls “military aircraft specially designed for a military use that are not enumerated in USML paragraph VIII(a).” No performance level is identified in the entry, but the control characteristic of the aircraft is that it is specially designed “for military use.” Thus, any technology, regardless of significance, peculiar to making an aircraft “for military use” as opposed to, for example, an aircraft controlled under ECCN 9A991.a, would be technical data “required” for an aircraft specially designed for military use thus controlled under ECCN 9E610.
The ITAR and the EAR often divide within each set of regulations or between each set of regulations:
1. Controls on parts, components, accessories, attachments, and software; and
2. Controls on the end items, systems, equipment, or other items into which those parts, components, accessories, attachments, and software are to be installed or incorporated.
Moreover, with the exception of technical data specifically enumerated on the USML, the jurisdictional status of unclassified technical data or “technology” is the same as the jurisdictional status of the defense article or “item subject to the EAR” to which it is directly related. Thus, if technology is directly related to the production of a 9A610.x aircraft component that is to be integrated or installed in a USML VIII(a) aircraft, then the technology is controlled under ECCN 9E610, not USML VIII(i).
“
(a) Except as set forth in paragraph (b) of this definition:
(1) Information necessary for the “development,” “production,” “use,” operation, installation, maintenance, repair, overhaul, or refurbishing (or other terms specified in ECCNs on the CCL that control “technology”) of an item. “Technology” may be in any tangible or intangible form, such as written or oral communications, blueprints, drawings, photographs, plans, diagrams, models, formulae, tables, engineering designs and specifications, computer-aided design files, manuals or documentation, electronic media or information gleaned through visual inspection;
The modification of an existing item creates a new item and technology for the modification is technical data for the development of the new item.
(2) [Reserved];
(3) [Reserved];
(4) [Reserved]; or
(5) Information, such as decryption keys, network access codes, or passwords, that would allow access to other “technology” in clear text or “software.”
(b) “Technology” does not include:
(1) Non-proprietary general system descriptions;
(2) Information on basic function or purpose of an item; or
(3) Telemetry data as defined in note 2 to Category 9, Product Group E (see Supplement No. 1 to Part 774 of the EAR).
This definition of “transfer” does not apply to § 750.10 of the EAR or Supplement No. 8 to part 760 of the EAR. The term “transfer” may also be included on licenses issued by BIS. In that regard, the changes that can be made to a BIS license are the non-material changes described in § 750.7(c) of the EAR. Any other change to a BIS license without authorization is a violation of the EAR. See §§ 750.7(c) and 764.2(e) of the EAR.
Food and Drug Administration, HHS.
Draft revised guidance; availability.
The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry (GIF) #120 entitled “Veterinary Feed Directive Regulation Questions and Answers.” The purpose of this document is to describe the current Veterinary Feed Directive (VFD) requirements for veterinarians, feed manufacturers and other distributors, animal producers, and other parties involved in the distribution or use of medicated feed containing a veterinary feed directive drug (VFD feed). This draft revised guidance reflects changes to the VFD requirements under the VFD final rule.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 3, 2015.
Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Submit electronic comments on the draft guidance to
Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6856,
FDA is announcing the availability of a draft revised GFI #120 entitled “Veterinary Feed Directive Regulation Questions and Answers.” The audience for this draft guidance is comprised of veterinarians issuing VFD orders, feed mills manufacturing VFD feeds and other distributors, animal producers who obtain VFD feeds for use in treating their animals, and others. This draft revised guidance reflects changes to the VFD requirements under the VFD final rule published elsewhere in this edition of the
In 1996, Congress enacted the Animal Drug Availability Act (ADAA) to facilitate the approval and marketing of new animal drugs and medicated feeds. In passing the ADAA, Congress created a new regulatory category for certain animal drugs used in animal feed called veterinary feed directive (VFD) drugs. VFD drugs are new animal drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian. FDA published final regulations implementing the VFD-related provisions of the ADAA in 2000.
Elsewhere in this edition of the
This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on this topic. It does not establish any rights for or on any person and does is not binding on FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 558.6 have been approved under OMB control number 0910-0363.
Interested persons may submit either electronic comments regarding this document to
Persons with access to the Internet may obtain the draft guidance at either
Drug Enforcement Administration, Department of Justice.
Notice of proposed rulemaking.
The Drug Enforcement Administration proposes to remove [
Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before July 6, 2015. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
Interested persons, defined at 21 CFR 1300.01 as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811)”, may file a request for hearing or waiver of participation pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45, 1316.47, 1316.48, or 1316.49, as applicable. Requests for hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before July 6, 2015.
To ensure proper handling of comments, please reference “Docket No. DEA-415” on all correspondence, including any attachments.
•
•
•
John R. Scherbenske, Office of Diversion
Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the DEA for public inspection online at
If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.
Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to
An electronic copy of this document and supplemental information to this proposed rule are available at
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA) (5 U.S.C. 551-559). 21 CFR 1308.41-1308.45, and 21 CFR part 1316 subpart D. In accordance with 21 CFR 1308.44 (a)-(c), requests for hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing may be submitted only by interested persons, defined as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).” 21 CFR 1300.01. Such requests or notices must conform to the requirements of 21 CFR 1308.44 (a) or (b), and 1316.47 or 1316.48, as applicable, and include a statement of the interest of the person in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any waiver must conform to the requirements of 21 CFR 1308.44(c) and 1316.49, including a written statement regarding the interested person's position on the matters of fact and law involved in any hearing.
The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, but they are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purposes of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.
Under the CSA, each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c) and the current list of scheduled substances is published at 21 CFR part 1308.
Pursuant to 21 U.S.C. 811(a)(2), the Attorney General may, by rule, “remove any drug or other substance from the schedules if he [or she] finds that the drug or other substance does not meet the requirements for inclusion in any schedule.” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA, 28 CFR 0.100.
The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on his or her own motion, (2) at the request of the Secretary of the Department of Health and Human Services,
DaTscan is a single-dose, injectable diagnostic radiopharmaceutical for use in hospital settings with specialized gamma cameras. It was developed as a diagnostic tool for visualization of dopamine transporters (DAT) by using single photon emission computed tomography (SPECT) brain imaging. The Food and Drug Administration (FDA) approved the New Drug Application (NDA) for DaTscan on January 14, 2011, for the indication of visualizing striatal DATs in the brains of adult patients with suspected Parkinsonian syndromes (PS). [
Pursuant to 21 U.S.C. 811(b), (c), and (f), the HHS recommended to the DEA on November 2, 2010, that FDA-approved products containing [
In response, the DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by the HHS, and all other relevant data. The DEA and HHS collaborated further regarding the available information. By letter dated February 2, 2015, the HHS provided detailed responses to specific inquiries from the DEA (submitted by letter dated September 16, 2014). Upon further review of all of the available information, the DEA completed its own eight-factor review document on FDA-approved diagnostic products containing [
According to HHS and the DEA, there are no data demonstrating that individuals are administering quantities of DaTscan sufficient to create a hazard to their health or to the safety of other individuals or to the community. In clinical studies, DaTscan, due to its low concentrations of [
According to HHS review of Sponsor's calculation regarding psychoactive doses of DaTscan, approximately 6,000 vials of DaTscan would be required to produce a subjective “high” in humans from exposure to [
DaTscan blocks monoamine transporters, such as DAT and other monoamine transporters such as serotonin transporters. Ioflupane, the active pharmaceutical ingredient in DaTscan, was demonstrated to have an affinity to DAT that was approximately 10- and 100-fold greater than cocaine in rodent brain homogenates or in cells transfected with rat DAT (Neumeyer et al., 1996; Okada et al., 1998; Scheffel et al., 1997). As reported by HHS, non-radiolabeled ioflupane at doses >0.1 mg/kg, i.v. was able to substitute for cocaine in cocaine-trained rats (10 mg/kg, intraperitoneal administration) using a drug discrimination protocol which is predictive of subjective behavioral effects in humans.
HHS reviewed data from eight human clinical trials involving 942 subjects and nine years of post-approval use in Europe and found that there was not any clinical evidence of pharmacological effects resulting from DaTscan administration. The maximum dose of [
Although [
The international non-proprietary name of [
HHS states that meaningful extraction of [
On January 14, 2011, FDA approved the NDA for DaTscan with the indication of visualizing striatal dopamine transporters in the brains of adult patients with suspected Parkinsonian syndromes using SPECT imaging. As such, any FDA-approved diagnostic product containing [
According to HHS, there have been no reports of abuse of [
There have been no reports of abuse of [
According to the HHS, because of the limited amounts of manufactured DaTscan, the low concentration of [
As reviewed by HHS, non-radiolabeled ioflupane has cocaine-like properties. In a drug discrimination study in cocaine-trained rats, non-radiolabeled ioflupane produced cocaine-appropriate responding, which suggests that non-radiolabeled ioflupane may produce cocaine-like subjective effects in humans (HHS, 2010).
However, the available evidence suggests that there is no psychic or physiological dependence potential of FDA-approved diagnostic products containing [
[
Based on consideration of the scientific and medical evaluation and accompanying recommendation of the HHS and based on the DEA's consideration of its own eight-factor analysis, the DEA finds that the facts and all available and relevant data demonstrate that [
The CSA outlines the findings required to place a drug or other substance in any particular schedule (I, II, III, IV, or V). 21 U.S.C. 812(b). The Assistant Secretary for Health of the HHS recommended removal of “FDA approved products containing [
After consideration of the analyses and recommendation of the Assistant Secretary for Health of the HHS and review of all relevant and available data, the Administrator of the DEA, pursuant to 21 U.S.C. 812(b)(5), finds that:
(1) [
(2) [
(3) [
Based on these findings, the Administrator of the DEA concludes that [
On November 25, 2014, DEA published an interim final rule waiving the requirement of DEA registration for certain entities that are authorized under other federal or state authorities to administer DaTscan. 79 FR 70085. If finalized, this proposal to remove [
In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures done “on the record after opportunity for a
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of Executive Order 13175. This rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. The purpose of this rule is to remove [
If finalized, the proposed rule will affect all persons who would handle, or propose to handle, [
Although the DEA does not have a reliable basis to estimate the number of affected entities and quantify the economic impact of this proposed rule, a qualitative analysis indicates that, if finalized, this rule is likely to result in some cost savings for the healthcare industry. The affected entities will continue to meet existing Federal and/or state requirements applicable to those who handle radiopharmaceutical substances, including licensure, security, recordkeeping, and reporting requirements, which in many cases are more stringent than the DEA's requirements. However, the DEA estimates cost savings will be realized from the removal of the administrative, civil, and criminal sanctions for those entities handling or proposing to handle [
Because of these facts, this rule will not result in a significant economic impact on a substantial number of small entities.
On the basis of information contained in the “Regulatory Flexibility Act” section above, the DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501
This action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is proposed to be amended to read as follows:
21 U.S.C. 811, 812, 871(b), unless otherwise noted.
(b) * * *
(4) Coca leaves (9040) and any salt, compound, derivative or preparation of coca leaves (including cocaine (9041) and ecgonine (9180) and their salts, isomers, derivatives and salts of isomers and derivatives), and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include:
(i) Decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or ecgonine; or
(ii) [
Department of State.
Proposed rule.
As part of the President's Export Control Reform (ECR) initiative, the Department of State proposes to amend the International Traffic in Arms
The Department of State will accept comments on this proposed rule until August 3, 2015.
Interested parties may submit comments within 60 days of the date of publication by one of the following methods:
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•
Comments received after that date may be considered, but consideration cannot be assured. Those submitting comments should not include any personally identifying information they do not desire to be made public or information for which a claim of confidentiality is asserted because those comments and/or transmittal emails will be made available for public inspection and copying after the close of the comment period via the Directorate of Defense Trade Controls Web site at
Mr. C. Edward Peartree, Director, Office of Defense Trade Controls Policy, Department of State, telephone (202) 663-1282; email
The Directorate of Defense Trade Controls (DDTC), U.S. Department of State, administers the International Traffic in Arms Regulations (ITAR) (22 CFR parts 120 through 130). The items subject to the jurisdiction of the ITAR,
BIS is concurrently publishing comparable proposed amendments (BIS companion rule) to the definitions of “technology,” “required,” “peculiarly responsible,” “published,” results of “fundamental research,” “export,” “reexport,” “release,” and “transfer (in-country)” in the EAR. A side-by-side comparison on the regulatory text proposed by both Departments is available on both agencies' Web sites:
The Department proposes to revise the definition of “defense article” to clarify the scope of the definition. The current text of § 120.6 is made into a new paragraph (a), into which software is added to the list of things that are a “defense article” because software is being removed from the definition of “technical data.” This is not a substantive change.
A new § 120.6(b) is added to list those items that the Department has determined should not be a “defense article,” even though they would otherwise meet the definition of “defense article.” All the items described were formerly excluded from the definition of “technical data” in § 120.10. These items are declared to be not subject to the ITAR to parallel the EAR concept of “not subject to the EAR” as part of the effort to harmonize the ITAR and the EAR. This does not constitute a change in policy regarding these items or the scope of items that are defense articles.
The Department proposes to revise the definition of “technical data” in ITAR § 120.10 in order to update and clarify the scope of information that may be captured within the definition. Paragraph (a)(1) of the revised definition defines “technical data” as information “required” for the “development,” “production,” operation, installation, maintenance, repair, overhaul, or refurbishing of a “defense article,” which harmonizes with the definition of “technology” in the EAR and the Wassenaar Arrangement. This is not a change in the scope of the definition, and additional words describing activities that were in the prior definition are included in parentheticals to assist exporters.
Paragraph (a)(1) also sets forth a broader range of examples of formats that “technical data” may take, such as diagrams, models, formulae, tables, engineering designs and specifications, computer-aided design files, manuals or documentation, or electronic media, that may constitute “technical data.” Additionally, the revised definition includes certain conforming changes intended to reflect the revised and newly added defined terms proposed elsewhere in this rule.
The proposed revised definition also includes a note clarifying that the modification of the design of an existing item creates a new item and that the “technical data” for the modification is “technical data” for the new item.
Paragraph (a)(2) of the revised definition defines “technical data” as
Paragraph (a)(3) of the revised definition defines “technical data” as also including classified information that is for the “development,” “production,” operation, installation, maintenance, repair, overhaul, or refurbishing of a “defense article” or a 600 series item subject to the EAR. Paragraph (a)(5) of the revised definition defines “technical data” as also including information to access secured “technical data” in clear text, such as decryption keys, passwords, or network access codes. In support of the latter change, the Department also proposes to add a new provision to the list of violations in § 127.1(b)(4) to state that any disclosure of these decryption keys or passwords that results in the unauthorized disclosure of the “technical data” or software secured by the encryption key or password is a violation and will constitute a violation to the same extent as the “export” of the secured information. For example, the “release” of a decryption key may result in the unauthorized disclosure of multiple files containing “technical data” hosted abroad and could therefore constitute a violation of the ITAR for each piece of “technical data” on that server.
Paragraph (b) of the revised definition of “technical data” excludes non-proprietary general system descriptions, information on basic function or purpose of an item, and telemetry data as defined in Note 3 to USML Category XV(f) (§ 121.1). Items formerly identified in this paragraph, principles taught in schools and “public domain” information, have been moved to the new ITAR § 120.6(b).
The proposed definition removes software from the definition of “technical data.” Specific and catch-all controls on software will be added elsewhere throughout the ITAR as warranted, as it will now be defined as a separate type of “defense article.”
The Department proposes a definition of “required” in a new § 120.46. “Required” is used in the definition of “technical data” and has, to this point, been an undefined term in the ITAR. The word is also used in the controls on technology in both the EAR and the Wassenaar Arrangement, as a defined term, which the Department is now proposing to adopt:
The proposed definition of “required” contains three notes. These notes explain how the definition is to be applied.
Note 1 provides that the definition explicitly includes information for meeting not only controlled performance levels, but also characteristics and functions. All items described on the USML are identified by a characteristic or function. Additionally, some descriptions include a performance level. As an example, USML Category VIII(a)(1) controls aircraft that are “bombers” and contains no performance level. The characteristic of the aircraft that is controlled is that it is a bomber, and therefore, any “technical data” peculiar to making an aircraft a bomber is “required.”
Note 2 states that, with the exception of “technical data” specifically enumerated on the USML, the jurisdictional status of unclassified “technical data” is the same as that of the commodity to which it is directly related. Specifically, it explains that “technical data” for a part or component of a “defense article” is directly related to that part or component, and if the part or component is subject to the EAR, so is the “technical data.”
Note 3 establishes a test for determining if information is peculiarly responsible for meeting or achieving the controlled performance levels, characteristics or functions of a “defense article.” It uses the same catch-and-release concept that the Department implemented in the definition of “specially designed.” It has a similarly broad catch of all information used in or for use in the “development,” “production,” operation, installation, maintenance, repair, overhaul, or refurbishing of a “defense article.” It has four releases that mirror the “specially designed” releases, and one reserved paragraph for information that the Department determines is generally insignificant. The first release is for information identified in a commodity jurisdiction determination. The second release is reserved. The third release is for information that is identical to information used in a non-defense article that is in “production,” and not otherwise enumerated on the ITAR. The fourth release is for information that was developed with knowledge that it is for both a “defense article” and a non-defense article. The fifth release is information that was developed for general purpose commodities.
In the companion rule, BIS proposes to make Note 3 into a stand-alone definition for “peculiarly responsible” as it has application outside of the definition of “required.” The substance of Note 3 and the BIS definition of “peculiarly responsible” are identical. DDTC asks for comments on the placement of this concept.
The Department proposes to add § 120.47 for the definition of “development” and § 120.48 for the definition of “production.” These definitions are currently in Notes 1 and 2 to paragraph (b)(3) in § 120.41, the definition of “specially designed.” Because “technical data” is now defined, in part, as information “required” for the “development” or “production” of a “defense article,” and these words are now used in the definition of a “defense service,” it is appropriate to define these terms. The adoption of these definitions is also done for the purpose of harmonization because these definitions are also used in the EAR and by the Wassenaar Arrangement.
The Department proposes to revise the definition of “public domain” in ITAR § 120.11 in order to simplify, update, and introduce greater versatility into the definition. The existing version of ITAR § 120.11 relies on an enumerated list of circumstances through which “public domain” information might be published. The Department believes that this definition is unnecessarily limiting in scope and insufficiently flexible with respect to the continually evolving array of media, whether physical or electronic, through which information may be disseminated.
The proposed definition is intended to identify the characteristics that are common to all of the enumerated forms of publication identified in the current rule—with the exception of ITAR § 120.11(a)(8), which is addressed in a new definition for “technical data that arises during, or results from, fundamental research”—and to present those common characteristics in a streamlined definition that does not require enumerated identification
The proposed definition requires that information be made available to the public without restrictions on its further dissemination. Any information that meets this definition is “public domain.” The definition also retains an exemplary list of information that has been made available to the public without restriction and would be considered “public domain.” These include magazines, periodicals and other publications available as subscriptions, publications contained in libraries, information made available at a public conference, meeting, seminar, trade show, or exhibition, and information posted on public Web sites. The final example deems information that is submitted to co-authors, editors, or reviewers or conference organizers for review for publication to be “public domain,” even prior to actual publication. The relevant restrictions do not include copyright protections or generic property rights in the underlying physical medium.
Paragraph (b) of the revised definition explicitly sets forth the Department's requirement of authorization to release information into the “public domain.” Prior to making available “technical data” or software subject to the ITAR, the U.S. government must approve the release through one of the following: (1) The Department; (2) the Department of Defense's Office of Security Review; (3) a relevant U.S. government contracting authority with authority to allow the “technical data” or software to be made available to the public, if one exists; or (4) another U.S. government official with authority to allow the “technical data” or software to be made available to the public.
The requirements of paragraph (b) are not new. Rather, they are a more explicit statement of the ITAR's requirement that one must seek and receive a license or other authorization from the Department or other cognizant U.S. government authority to release ITAR controlled “technical data,” as defined in § 120.10. A release of “technical data” may occur by disseminating “technical data” at a public conference or trade show, publishing “technical data” in a book or journal article, or posting “technical data” to the Internet. This proposed provision will enhance compliance with the ITAR by clarifying that “technical data” may not be made available to the public without authorization. Persons who intend to discuss “technical data” at a conference or trade show, or to publish it, must ensure that they obtain the appropriate authorization.
Information that is excluded from the definition of “defense article” in the new § 120.6(b) is not “technical data” and therefore does not require authorization prior to release into the “public domain.” This includes information that arises during or results from “fundamental research,” as described in the new § 120.49; general scientific, mathematical, or engineering principles commonly taught in schools, and information that is contained in patents.
The Department also proposes to add a new provision to § 127.1 in paragraph (a)(6) to state explicitly that the further dissemination of “technical data” or software that was made available to the public without authorization is a violation of the ITAR, if, and only if, it is done with knowledge that the “technical data” or software was made publicly available without an authorization described in ITAR § 120.11(b)(2). Dissemination of publicly available “technical data” or software is not an export-controlled event, and does not require authorization from the Department, in the absence of knowledge that it was made publicly available without authorization.
“Technical data” and software that is made publicly available without proper authorization remains “technical data” or software and therefore remains subject to the ITAR. As such, the U.S. government may advise a person that the original release of the “technical data” or software was unauthorized and put that person on notice that further dissemination would violate the ITAR.
The Department proposes to move “fundamental research” from the definition of “public domain” in ITAR § 120.11(a)(8) and define “technical data that arises during, or results from, fundamental research” in a new ITAR § 120.49. The Department believes that information that arises during, or results from fundamental research is conceptually distinguishable from the information that would be captured in the revised definition of “public domain” that is proposed in this rule. Accordingly, the Department proposes to address this concept with its own definition. The new definition of “technical data that arises during, or results from, fundamental research” is consistent with the prior ITAR § 120.11(a)(8), except that the Department has expanded the scope of eligible research to include research that is funded, in whole or in part, by the U.S. government.
The Department proposes to revise the definition of “export” in ITAR § 120.17 to better align with the EAR's revised definition of the term and to remove activities associated with a defense article's further movement or release outside the United States, which will now fall within the definition of “reexport” in § 120.19. The definition is revised to explicitly identify that ITAR §§ 126.16 and 126.17 (exemptions pursuant to the Australia and UK Defense Trade Cooperation Treaties) have their own definitions of “export,” which apply exclusively to those exemptions. It also explicitly references the new § 120.49, “Activities that are Not Exports, Reexports, or Retransfers,” which excludes from ITAR control certain transactions identified therein.
Paragraph (a)(1) is revised to parallel the definition of “export” in proposed paragraph (a)(1) of § 734.13 of the EAR. Although the wording has changed, the scope of the control is the same. The provision excepting travel outside of the United States by persons whose personal knowledge includes “technical data” is removed, but the central concept is unchanged. The “release” of “technical data” to a foreign person while in the United States or while travelling remains a controlled event.
Paragraph (a)(2) includes the control listed in the current § 120.17(a)(4) (transfer of technical data to a foreign person). The proposed revisions replace the word “disclosing” with “releasing,” and the paragraph is otherwise revised to parallel proposed paragraph (a)(2) of § 734.13 of the EAR. “Release” is a newly defined concept in § 120.50 that encompasses the previously undefined term “disclose.”
Paragraph (a)(3) includes the control listed in the current § 120.17(a)(2) (transfer of registration, control, or ownership to a foreign person of an aircraft, vessel, or satellite). It is revised to parallel proposed paragraph (a)(3) of § 734.13 of the EAR.
Paragraph (a)(4) includes the control listed in the current § 120.17(a)(3) (transfer in the United States to foreign embassies).
Paragraph (a)(5) maintains the control on performing a “defense service.”
Paragraph (a)(6) is added for the “release” or transfer of decryption keys,
Paragraph (a)(7) is added for the release of information to a public network, such as the Internet. This makes more explicit the existing control in (a)(4), which includes the publication of “technical data” to the Internet due to its inherent accessibility by foreign persons. This means that before posting information to the Internet, you should determine whether the information is “technical data.” You should review the USML, and if there is doubt about whether the information is “technical data,” you may request a commodity jurisdiction determination from the Department. If so, a license or other authorization, as described in § 120.11(b), will generally be required to post such “technical data” to the Internet. Posting “technical data” to the Internet without a Department or other authorization is a violation of the ITAR even absent specific knowledge that a foreign national will read the “technical data.”
Paragraph (b)(1) is added to clarify existing ITAR controls to explicitly state that disclosing “technical data” to a foreign person is deemed to be an “export” to all countries in which the foreign person has held citizenship or holds permanent residency.
The Department proposes to revise the definition of “reexport” in ITAR § 120.19 to better align with the EAR's revised definition and describe transfers of items subject to the jurisdiction of the ITAR between two foreign countries. The activities identified are the same as those in paragraphs (a)(1) through (4) of the revised definition of “export,” except that the shipment, release or transfer is between two foreign countries or is to a third country national foreign person outside of the United States.
The Department proposes to add § 120.50, the definition of “release.” This term is added to harmonize with the EAR, which has long used the term to cover activities that disclose information to foreign persons. “Release” includes the activities encompassed within the undefined term “disclose.” The activities that are captured include allowing a foreign person to inspect a “defense article” in a way that reveals “technical data” to the foreign persons and oral or written exchanges of “technical data” with a foreign person. The adoption of the definition of “release” does not change the scope of activities that constitute an “export” and other controlled transactions under the ITAR.
The Department proposes to add § 120.51, the definition of “retransfer.” “Retransfer” is moved out of the definition of “reexport” in § 120.19 to better harmonize with the EAR, which controls “exports,” “reexports” and “transfers (in country)” as discrete events. Under this new definition, a “retransfer” occurs with a change of end use or end user within the same foreign territory. Certain activities may fit within the definition of “reexport” and “retransfer,” such as the disclosure of “technical data” to a third country national abroad. Requests for both “reexports” and “retransfers” of “defense articles” will generally be processed through a General Correspondence or an exemption.
The Department proposes to add § 120.52 to describe those “activities that are not exports, reexports, or retransfers” and do not require authorization from the Department. It is not an “export” to launch items into space, provide “technical data” or software to U.S. persons while in the United States, or move a “defense article” between the states, possessions, and territories of the United States. The Department also proposes to add a new provision excluding from ITAR licensing requirements the transmission and storage of encrypted “technical data” and software.
The Department recognizes that ITAR-controlled “technical data” may be electronically routed through foreign servers unbeknownst to the original sender. This presents a risk of unauthorized access and creates a potential for inadvertent ITAR violations. For example, email containing “technical data” may, without the knowledge of the sender, transit a foreign country's Internet service infrastructure en route to its intended and authorized final destination. Any access to this data by a foreign person would constitute an unauthorized “export” under ITAR § 120.17. Another example is the use of mass data storage (
The intent of the proposed ITAR § 120.52(a)(4) is to clarify that when unclassified “technical data” transits through a foreign country's Internet service infrastructure, a license or other approval is not mandated when such “technical data” is encrypted prior to leaving the sender's facilities and remains encrypted until received by the intended recipient or retrieved by the sender, as in the case of remote storage. The encryption must be accomplished in a manner that is certified by the U.S. National Institute for Standards and Technology (NIST) as compliant with the Federal Information Processing Standards Publication 140-2 (FIPS 140-2). Additionally, the Department proposes that the electronic storage abroad of “technical data” that has been similarly encrypted would not require an authorization, so long as it is not stored in a § 126.1 country or in the Russian Federation. This will allow for cloud storage of encrypted data in foreign countries, so long as the “technical data” remains continuously encrypted while outside of the United States.
The Department proposes to revise § 125.4(b)(9) to better harmonize controls on the “release” of controlled information to U.S. persons abroad and to update the provisions. The most significant update is that foreign persons authorized to receive “technical data” in the United States will be eligible to receive that same “technical data” abroad, when on temporary assignment on behalf of their employer. The proposed revisions clarify that a person going abroad may use this exemption to “export” “technical data” for their own use abroad. The proposed revisions also clarify that the “technical data” must be secured while abroad to prevent unauthorized “release.” It has been long-standing Department practice to hold U.S. persons responsible for the “release” of “technical data” in their possession while abroad. However, given the nature of “technical data” and the proposed exception from licensing for transmission of secured “technical data,” the Department has determined it is necessary to implement an affirmative obligation to secure data while abroad.
The Department proposes to add § 123.28 to clarify the scope of a license, in the absence of a proviso, and to state that authorizations are granted based on the information provided by the applicant. This means that while providing false information to the U.S. government as part of the application process for the “export,” “reexport,” or “retransfer” of a “defense article” is a violation of the ITAR, it also may void the license.
Proposed revisions of the “defense service” definition were published on April 13, 2011, RIN 1400-AC80 (
The Department reviewed comments on that first proposed definition and, when the recommended changes added to the clarity of the regulation, the Department accepted them. For the Department's evaluation of those public comments and recommendations regarding the April 13, 2011, proposed rule (the first revision),
Parties commenting on the second revision expressed concern that the definition of “defense service” in paragraph (a)(1) was premised on the use of “other than public domain information.” The observation was made that with the intent of removing from the definition of a “defense service” the furnishing of assistance using “public domain” information, but not basing the assistance on the use of “technical data,” the Department was continuing to require the licensing of activities akin to those that were based on the use of “public domain” information. The Department has fully revised paragraph (a)(1) to remove the use of the “other than public domain information” or “technical data” from the determination of whether an activity is a “defense service.” Furthermore, the Department has added a new provision declaring that the activities described in paragraph (a)(1) are not a “defense service” if performed by a U.S. person or foreign person in the United States who does not have knowledge of U.S.-origin “technical data” directly related to the “defense article” that is the subject of the assistance or training or another “defense article” described in the same USML paragraph prior to performing the service. A note is added to clarify that a person will be deemed to have knowledge of U.S.-origin “technical data” if the person previously participated in the “development” of a “defense article” described in the same USML paragraph, or accessed (physically or electronically) that “technical data.” A note is also added to clarify that those U.S. persons abroad who only received U.S.-origin “technical data” as a result of their activities on behalf of a foreign person are not included within the scope of paragraph (a)(1). A third note is added to clarify that DDTC-authorized foreign person employees in the United States who provide “defense services” on behalf of their U.S. employer are considered to be included with the U.S. employer's authorization, and need not be listed on the U.S. employer's technical assistance agreement or receive a separate authorization for those services. The Department also removed the activities of design, development, and engineering from paragraph (a)(1) and moved them to paragraph (a)(2).
Commenting parties recommended revising paragraph (a)(1) to remove the provision of “technical data” as a “defense service,” because there are already licensing requirements for the “export” of “technical data.” The Department confirms that it eliminated from the definition of a “defense service” the act of furnishing “technical data” to a foreign person. Such activity still constitutes an “export” and would require an ITAR authorization. New paragraph (a)(1) is concerned with the furnishing of assistance, whereas the “export” of “technical data” alone, without the furnishing of assistance, is not a “defense service.” The “export” of “technical data” requires an authorization (Department of State form DSP-5 or DSP-85) or the use of an applicable exemption.
Commenting parties recommended the definition be revised to explicitly state that it applies to the furnishing of assistance by U.S. persons, or by foreign persons in the United States. The Department partially accepted this recommendation. However, the Department notes that ITAR § 120.1(c) provides that only U.S. persons and foreign governmental entities in the United States may be granted a license or other approval pursuant to the ITAR, and that foreign persons may only receive a “reexport” or “retransfer” approval or approval for brokering activities. Therefore, approval for the performance of a defense service in the United States by a foreign person must be obtained by a U.S. person, such as an employer, on behalf of the foreign person. Regarding a related recommendation, the Department also notes that the furnishing of a type of assistance described by the definition of a “defense service” is not an activity within the Department's jurisdiction when it is provided by a foreign person outside the United States to another foreign person outside the United States on a foreign “defense article” using foreign-origin “technical data.”
In response to commenting parties, the Department specified that the examples it provided for activities that are not “defense services” are not exhaustive. Rather, they are provided to answer the more frequent questions the Department receives on the matter. The Department removed these examples from paragraph (b) and included them as a note to paragraph (a).
A commenting party recommended that paragraphs (a)(5) and (a)(6), regarding the furnishing of assistance in the integration of a spacecraft to a launch vehicle and in the launch failure analysis of a spacecraft or launch vehicle, respectively, be removed, and that those activities be described in the USML categories covering spacecraft
Commenting parties recommended the Department define the term “tactical employment,” so as to clarify what services would be captured by paragraph (a)(3). The Department determined that employment of a “defense article” should remain a controlled event, due to the nature of items now controlled in the revised USML categories. After ECR, those items that remain “defense articles” are the most sensitive and militarily critical equipment that have a significant national security or intelligence application. Allowing training and other services to foreign nationals in the employment of these “defense articles” without a license would not be appropriate. Therefore, the Department removed the word “tactical” and converted the existing exemption for basic operation of a “defense article,” authorized by the U.S. government for “export” to the same recipient, into an exclusion from paragraph (a)(3).
A commenting party recommended the Department address the instance of the integration or installation of a “defense article” into an item, much as it addressed the instance of the integration or installation of an item into a “defense article.” Previously, the Department indicated this would be the subject of a separate rule, and addressed the “export” of such items in a proposed rule (
A commenting party requested clarification of the rationale behind selectively excepting from the “defense services” definition the furnishing of services using “public domain” information. The Department did so in paragraph (a)(1), and now excludes those services performed by U.S. persons who have not previously had access to any U.S. origin “technical data” on the “defense article” being serviced. In contrast, the Department did not do so in paragraphs (a)(2) and (a)(3) and former paragraphs (a)(5) and (a)(6). In the case of paragraph (a)(2), the rationale for not doing so is that the activities involved in the development of a “defense article,” or in integrating a “defense article” with another item, inherently involve the advancement of the military capacity of another country and therefore constitute activities over which the U.S. government has significant national security and foreign policy concerns. To the extent that an activity listed in paragraph (a)(1), such as modification or testing, is done in the “development” of a “defense article,” such activities constitute “development” and are within the scope of paragraph (a)(2). With regard to paragraph (a)(3), the furnishing of assistance (including training) in the employment of a “defense article” is a type of activity that the Department believes warrants control as a “defense service,” due to the inherently military nature of providing training and other services in the employment of a “defense article” (changes to paragraph (a)(3) are described above). The services described in former paragraphs (a)(5) and (a)(6) (and now in USML Categories IV(i) and XV(f)) are pursuant to Public Law 105-261.
A commenting party recommended limiting paragraph (a)(2) to the integration of ECCN 9A515 and 600 series items into defense articles, saying that the regulations should focus on items subject to the EAR with a military or space focus. The Department's focus with this provision is in fact the “defense article.” Items that are to be integrated with a “defense article,” which may not themselves be defense articles, may be beyond the authority of the Department to regulate. The Department did not accept this recommendation.
A commenting party recommended limiting the definition of integration to changes in the function of the “defense article,” and to exclude modifications in fit. For the purposes of illustration, this commenting party used one of the examples provided by the Department in the note to paragraph (a)(2): The manufacturer of the military vehicle will need to know the dimensions and electrical requirements of the dashboard radio when designing the vehicle. In this instance, paragraph (a)(2) would not apply, as this example addresses the manufacture of a “defense article,” which is covered by paragraph (a)(1). If the radio to be installed in this vehicle is subject to the EAR, the provision to the manufacturer of information regarding the radio is not within the Department's licensing jurisdiction. In an instance of a service entailing the integration of an item with a “defense article,” where there would be modification to any of the items, the Department believes such assistance would inherently require the use of “technical data.” Therefore, this exclusion would be unacceptably broad. However, the Department has accepted the recommendation to clarify the definition and exclude changes to fit to any of the items involved in the integration activity, provided that such services do not entail the use of “technical data” directly related to the “defense article.” Upon review, changes to fit are not an aspect of integration, which is the “engineering analysis needed to unite a `defense article' and one or more items,” and therefore are not captured in paragraph (a)(2). The modifications of the “defense article” to accommodate the fit of the item to be integrated, which are within the activity covered by installation, are only those modifications to the “defense article” that allow the item to be placed in its predetermined location. Any modifications to the design of a “defense article” are beyond the scope of installation. Additionally, while minor modifications may be made to a “defense article” without the activity being controlled under (a)(2) as an integration activity, all modifications of defense articles, regardless of sophistication, are activities controlled under (a)(1) if performed by someone with prior knowledge of U.S.-origin “technical data.” “Fit” is defined in ITAR § 120.41: “The fit of a commodity is defined by its ability to physically interface or connect with or become an integral part of another commodity” (
Commenting parties recommended revising paragraph (a)(2) to provide that such assistance described therein would be a “defense service” only if U.S.-origin “technical data” is exported. The law and regulations do not mandate this limitation. Section 38 of the Arms Export Control Act provides that the President is authorized to control the “export” of defense articles and defense services. The ITAR, in defining “defense article,” “technical data,” and “export,” does not provide the qualifier “U.S.-
A commenting party recommended revising paragraph (a)(2) so that the paragraph (a)(1) exception of the furnishing of assistance using “public domain” information is not nullified by paragraph (a)(2), as most of the activities described in paragraph (a)(1) involve integration as defined in the note to paragraph (a)(2). The Department believes each of the activities described in paragraphs (a)(1) and (a)(2) are sufficiently well defined to distinguish them one from the other. Therefore, the Department does not agree that paragraph (a)(2) nullifies the intention of paragraph (a)(1), and does not accept this recommendation.
A commenting party requested clarification that providing an item subject to the EAR for the purposes of integration into a “defense article” is not a “defense service.” The provision of the item in this instance, unaccompanied by assistance in the integration of the item into a “defense article,” is not within the scope of “the furnishing of assistance,” and therefore is not a defense service.
Commenting parties recommended clarification on whether the servicing of an item subject to the EAR that has been integrated with a “defense article” would be a “defense service.” The Department notes that such activity is not a “defense service,” provides it as an example of what is not a “defense service” in the note to paragraph (a), and also notes that it would be incumbent on the applicant to ensure that in providing this service, “technical data” directly related to the “defense article” is not used.
Commenting parties expressed concern over the potential negative effect of paragraph (a)(2) and the definition in general on university-based educational activities and scientific communication, and recommended clarification of the relationship between the definition of “defense services” and the exemption for the “export” of “technical data” at ITAR § 125.4(b)(10). Disclosures of “technical data” to foreign persons who are bona-fide and full time regular employees of universities continue to be exports for which ITAR § 125.4(b)(10) is one licensing exemption. The Department believes that, in most cases, the normal duties of a university employee do not encompass the furnishing of assistance to a foreign person, in the activities described in paragraph (a). Therefore, in the context of employment with the university, the Department does not perceive that the foreign person's use of the “technical data” would be described by ITAR § 120.9(a)(2), or any part of paragraph (a).
In response to the recommendation of one commenting party, the Department added a note clarifying that the installation of an item into a “defense article” is not a “defense service,” provided no “technical data” is used in the rendering of the service.
A commenting party recommended clarification of the licensing process for the “export” of an EAR 600 series item that is to be integrated into a “defense article.” The Department of Commerce has “export” authority over the 600 series item, and the exporter must obtain a license from the Department of Commerce, if necessary. The exporter must also obtain an approval from the Department of State to provide any “defense service,” including integration assistance pursuant to paragraph (a)(2).
A commenting party recommended removing “testing” as a type of “defense service,” stating it was not included in the definition of “organizational-level maintenance.” In including testing as part of the former definition but not of the latter, the Department does not perceive an inconsistency or conflict. To the extent that certain testing is within the definition of organization-level maintenance, that testing is explicitly excluded, as organizational-level maintenance is not covered under the definition of a “defense service.” However, all other testing remains a “defense service.” The Department intends for the furnishing of assistance to a foreign person, whether in the United States or abroad, in the testing of defense articles to be an activity requiring Department approval under the conditions of paragraph (a)(1). The Department did not accept this recommendation.
Commenting parties provided recommendations for revising the definitions of “public domain” information and “technical data.” Those definitions are proposed in this rule as well. To the extent that evaluation of the proposed changes to “defense services” hinges on these terms, the Department invites commenting parties to submit analyses of the impact of these revised definitions on the revised “defense service” definition in this proposed rule.
Commenting parties recommended clarification of the regulation regarding the furnishing of assistance and training in organizational-level (basic-level) maintenance. The Department harmonized paragraph (a)(1) and the example regarding organizational-level maintenance by revising the Note to Paragraph (a), which sets forth activities that are not “defense services,” so that it specifically provides that “the furnishing of assistance (including training) in organizational-level (basic-level) maintenance of a defense article” is an example of an activity that is not a defense service.
In response to commenting parties, the Department clarifies that the example of employment by a foreign person of a natural U.S. person as not constituting a “defense service” is meant to address, among other scenarios, the instance where such a person is employed by a foreign defense manufacturer, but whose employment in fact does not entail the furnishing of assistance as described in ITAR § 120.9(a). By “natural person,” the Department means a human being, as may be inferred from the definition of “person” provided in ITAR § 120.14.
In response to the recommendation of a commenting party, the Department confirms that, as stated in a Department of Commerce notice, “Technology subject to the EAR that is used with technical data subject to the ITAR that will be used under the terms of a Technical Assistance Agreement (TAA) or Manufacturing License Agreement (MLA) and that would otherwise require a license from [the Department of Commerce] may all be exported under the TAA or MLA” (
The Department invites public comment on any of the proposed definitions set forth in this rulemaking. With respect to the revisions to ITAR § 120.17, the Department recognizes the increasingly complex nature of telecommunications infrastructure and the manner in which data is transmitted, stored, and accessed, and accordingly seeks public comment with special emphasis on: (1) How adequately the proposed regulations address the technical aspects of data transmission and storage; (2) whether
The public is also asked to comment on the effective date of the final rule. Export Control Reform rules that revised categories of the USML and created new 600 series ECCN have had a six-month delayed effective date to allow for exporters to update the classification of their items. In general, rules effecting export controls have been effective on the date of publication, due to the impact on national security and foreign policy. As this proposed rule and the companion proposed rule from the Bureau of Industry and Security revise definitions within the ITAR and the EAR and do not make any changes to the USML or CCL, the Department proposes (should the proposed rule be adopted) a 30-day delayed effective date to allow exporters to ensure continued compliance.
The Department of State is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the U.S. government and that rules implementing this function are exempt from sections 553 (rulemaking) and 554 (adjudications) of the Administrative Procedure Act (APA). Although the Department is of the opinion that this proposed rule is exempt from the rulemaking provisions of the APA, the Department is publishing this rule with a 60-day provision for public comment and without prejudice to its determination that controlling the import and export of defense services is a foreign affairs function.
Since the Department is of the opinion that this proposed rule is exempt from the rulemaking provisions of 5 U.S.C. 553, there is no requirement for an analysis under the Regulatory Flexibility Act.
This proposed amendment does not involve a mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
For purposes of the Small Business Regulatory Enforcement Fairness Act of 1996 (the “Act”), a major rule is a rule that the Administrator of the OMB Office of Information and Regulatory Affairs finds has resulted or is likely to result in: (1) An annual effect on the economy of $100,000,000 or more; (2) a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and foreign markets.
The Department does not believe this rulemaking will have an annual effect on the economy of $100,000,000 or more, nor will it result in a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions, or have significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and foreign markets. The proposed means of solving the issue of data protection are both familiar to and extensively used by the affected public in protecting sensitive information.
This proposed amendment will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this proposed amendment does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this proposed amendment.
Executive Orders 12866 and 13563 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributed impacts, and equity). The executive orders stress the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the proposed rule has been reviewed by the Office of Management and Budget (OMB).
The Department of State has reviewed the proposed amendment in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, Executive Order 13175 does not apply to this rulemaking.
This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35; however, the Department of State seeks public comment on any unforeseen potential for increased burden.
Arms and munitions, Classified information, Exports.
Arms and munitions, Exports, Reporting and recordkeeping requirements.
Arms and munitions, Exports, Crime, Law, Penalties, Seizures and forfeitures.
Accordingly, for the reasons set forth above, title 22, chapter I, subchapter M, parts 120, 123, 125, and 127 are proposed to be amended as follows:
Secs. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2794; 22 U.S.C. 2651a; Pub. L. 105-261, 112 Stat. 1920; Pub. L. 111-266; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.
(a)
(b) The following are not defense articles and thus not subject to the ITAR:
(1) [Reserved]
(2) [Reserved]
(3) Information and software that:
(i) Are in the public domain, as described in § 120.11;
(ii) Arise during, or result from, fundamental research, as described in § 120.46;
(iii) Concern general scientific, mathematical, or engineering principles commonly taught in schools, and released by instruction in a catalog course or associated teaching laboratory of an academic institution; or
(iv) Appear in patents or open (published) patent applications available from or at any patent office, unless covered by an invention secrecy order.
Information that is not within the scope of the definition of technical data (
(a)
(1) The furnishing of assistance (including training) to a foreign person (
“Knowledge of U.S.-origin technical data” for purposes of paragraph (a)(1) can be established based on all the facts and circumstances. However, a person is deemed to have “knowledge of U.S.-origin technical data” directly related to a defense article if the person participated in the development of a defense article described in the same USML paragraph or accessed (physically or electronically) technical data directly related to the defense article that is the subject of the assistance, prior to performing the service.
U.S. persons abroad who only receive U.S.-origin technical data as a result of their activities on behalf of a foreign person are not included within paragraph (a)(1).
Foreign person employees in the United States providing defense services as part of Directorate of Defense Trade Controls-authorized employment need not be listed on the U.S. employer's technical assistance agreement or receive separate authorization to perform defense services on behalf of their authorized U.S. employer.
(2) The furnishing of assistance (including training) to a foreign person (
“Integration” means any engineering analysis (
(3) The furnishing of assistance (including training) to a foreign person (
(4) Participating in or directing combat operations for a foreign person (
(5) The furnishing of assistance (including training) to the government of a country listed in § 126.1 of this subchapter in the development, production, operation, installation, maintenance, repair, overhaul or refurbishing of a defense article or a part component, accessory or attachments specially designed for a defense article.
The following are examples of activities that are not defense services:
1. The furnishing of assistance (including training) in organizational-level (basic-level) maintenance (
2. Performance of services by a U.S. person in the employment of a foreign person, except as provided in this paragraph;
3. Servicing of an item subject to the EAR (
4. The installation of any item into a defense article, or the installation of a defense article into any item;
5. Providing law enforcement, physical security, or personal protective services (including training and advice) to or for a foreign person (if such services necessitate the export of a defense article a license or other approval is required for the export of the defense article, and such services that entail the employment or training in the employment of a defense article are addressed in paragraph (a)(3) of this section);
6. The furnishing of assistance by a foreign person not in the United States;
7. The furnishing of medical, logistical (other than maintenance), translation, financial, legal, scheduling, or administrative services;
8. The furnishing of assistance by a foreign government to a foreign person in the United States, pursuant to an arrangement with the Department of Defense; and
9. The instruction in general scientific, mathematical, or engineering principles commonly taught in schools, colleges, and universities.
(b) [Reserved]
(a)
(1) Information required for the development (
The modification of an existing item creates a new item and technical data for the modification is technical data for the development of the new item.
(2) Information enumerated on the USML (
(3) Classified information for the development, production, operation, installation, maintenance, repair, overhaul, or refurbishing of a defense article or a 600 series item subject to the EAR;
(4) Information covered by an invention secrecy order; or
(5) Information, such as decryption keys, network access codes, or passwords, that would allow access to other technical data in clear text or software (
(b)
(1) Non-proprietary general system descriptions;
(2) Information on basic function or purpose of an item; or
(3) Telemetry data as defined in note 3 to USML Category XV(f) (
(a) Except as set forth in paragraph (b) of this section, unclassified information and software are in the public domain, and are thus not technical data or software subject to the ITAR, when they have been made available to the public without restrictions upon their further dissemination such as through any of the following:
(1) Subscriptions available without restriction to any individual who desires to obtain or purchase the published information;
(2) Libraries or other public collections that are open and available to the public, and from which the public can obtain tangible or intangible documents;
(3) Unlimited distribution at a conference, meeting, seminar, trade show, or exhibition, generally accessible to the interested public;
(4) Public dissemination (
(5) Submission of a written composition, manuscript or presentation to domestic or foreign co-authors, editors, or reviewers of journals, magazines, newspapers or trade publications, or to organizers of open conferences or other open gatherings, with the intention that the compositions, manuscripts, or publications will be made publicly available if accepted for publication or presentation.
(b) Technical data or software, whether or not developed with government funding, is not in the public domain if it has been made available to the public without authorization from:
(1) The Directorate of Defense Trade Controls;
(2) The Department of Defense's Office of Security Review;
(3) The relevant U.S. government contracting entity with authority to allow the technical data or software to be made available to the public; or
(4) Another U.S. government official with authority to allow the technical data or software to be made available to the public.
Section 127.1(a)(6) of this subchapter prohibits, without written authorization from the Directorate of Defense Trade Controls, U.S. and foreign persons from exporting, reexporting, retransfering, or otherwise making available to the public technical data or software if such person has knowledge that the technical data or software was made publicly available without an authorization described in paragraph (b) of this section.
An export, reexport, or retransfer of technical data or software that was made publicly available by another person without authorization is not a violation of this subchapter, except as described in § 127.1(a)(6) of this subchapter.
(a) Except as set forth in § 120.52, § 126.16, or § 126.17 of this subchapter,
(1) An actual shipment or transmission out of the United States, including the sending or taking of a defense article outside of the United States in any manner;
(2) Releasing or otherwise transferring technical data or software (source code or object code) to a foreign person in the United States (a “deemed export”);
(3) Transferring by a person in the United States of registration, control, or ownership of any aircraft, vessel, or satellite subject to the ITAR to a foreign person;
(4) Releasing or otherwise transferring a defense article to an embassy or to any agency or subdivision of a foreign government, such as a diplomatic mission, in the United States;
(5) Performing a defense service on behalf of, or for the benefit of, a foreign
person, whether in the United States or abroad;
(6) Releasing or otherwise transferring information, such as decryption keys, network access codes, passwords, or software, or providing physical access, that would allow access to other technical data in clear text or software to a foreign person regardless of whether such data has been or will be transferred; or
(7) Making technical data available via a publicly available network (
(b) Any release in the United States of technical data or software to a foreign person is a deemed export to all countries in which the foreign person has held citizenship or holds permanent residency.
(a) Except as set forth in § 120.52,
(1) An actual shipment or transmission of a defense article from one foreign country to another foreign country, including the sending or taking of a defense article to or from such countries in any manner;
(2) Releasing or otherwise transferring technical data or software to a foreign person of a country other than the foreign country where the release or transfer takes place (a “deemed reexport”);
(3) Transferring by a person outside of the United States of registration, control, or ownership of any aircraft, vessel, or satellite subject to the ITAR to a foreign person outside the United States; or
(4) Releasing or otherwise transferring outside of the United States information, such as decryption keys, network access codes, password, or software, or providing physical access, that would allow access to other technical data in clear text or software to a foreign person regardless of whether such data has been or will be transferred.
(b) [Reserved]
(a) As applied to technical data, the term
The references to “characteristics” and functions” are not limited to entries on the USML that use specific technical parameters to describe the scope of what is controlled. The “characteristics” and “functions” of an item listed are, absent a specific regulatory definition, a standard dictionary's definition of the item. For example, USML Category VIII(a)(1) controls aircraft that are “bombers.” No performance level is identified in the entry, but the characteristic of the aircraft that is controlled is that it is a bomber. Thus, any technical data, regardless of significance, peculiar to making an aircraft a bomber as opposed to, for example, an aircraft controlled under ECCN 9A610.a or ECCN 9A991.a, would be technical data required for a bomber and thus controlled under USML Category VIII(i).
The ITAR and the EAR often divide within each set of regulations or between each set of regulations:
1. Controls on parts, components, accessories, attachments, and software; and
2. Controls on the end items, systems, equipment, or other items into which those parts, components, accessories, attachments, and software are to be installed or incorporated.
With the exception of technical data specifically enumerated on the USML, the jurisdictional status of unclassified technical data is the same as the jurisdictional status of the defense article or item subject to the EAR to which it is directly related. Thus, if technology is directly related to the production of an ECCN 9A610.x aircraft component that is to be integrated or installed in a USML Category VIII(a) aircraft, the technology is controlled under ECCN 9E610, not USML Category VIII(i).
Technical data is “peculiarly responsible for achieving or exceeding the controlled performance levels, characteristics, or functions” if it is used in or for use in the development (including design, modification, and integration design), production (including manufacture, assembly, and integration), operation, installation, maintenance, repair, overhaul, or refurbishing of a defense article unless:
1. The Department of State has determined otherwise in a commodity jurisdiction determination;
2. [Reserved];
3. It is identical to information used in or with a commodity or software that:
i. Is or was in production (
ii. Is not a defense article;
4. It was or is being developed with knowledge that it is for or would be for use in or with both defense articles and commodities not on the U.S. Munitions List; or
5. It was or is being developed for use in or with general purpose commodities or software (
(b) [Reserved]
(a)
(1) Conducted in the United States at an accredited institution of higher learning located; or
(2) Funded, in whole or in part, by the U.S. government.
The inputs used to conduct fundamental research, such as information, equipment, or software, are not “technical data that arises during or results from fundamental research” except to the extent that such inputs are technical data that arose during or resulted from earlier fundamental research.
There are instances in the conduct of research, whether fundamental, basic, or applied, where a researcher, institution, or company may decide to restrict or protect the release or publication of technical data contained in research results. Once a decision is made to maintain such technical data as restricted or proprietary, the technical data becomes subject to the ITAR.
(b)
Although technical data arising during or resulting from fundamental research is not considered “intended to be published” if researchers accept restrictions on its publication, such technical data will nonetheless qualify as technical data arising during or resulting from fundamental research once all such restrictions have expired or have been removed.
Research that is voluntarily subjected to U.S. government prepublication review is considered intended to be published for all releases consistent with any resulting controls.
Technical data resulting from U.S. government funded research which is subject to government-imposed access and dissemination or other specific national security controls qualifies as technical data resulting from fundamental research, provided that all government-imposed national security controls have been satisfied.
(c)
(1)
(2)
(i) Normally follows basic research, but may not be severable from the related basic research;
(ii) Attempts to determine and exploit the potential of scientific discoveries or improvements in technology, materials, processes, methods, devices, or techniques; and
(iii) Attempts to advance the state of the art.
(a) Except as set forth in § 120.52, technical data and software are released through:
(1) Visual or other inspection by foreign persons of a defense article that reveals technical data or software to a foreign person; or
(2) Oral or written exchanges with foreign persons of technical data in the United States or abroad.
(b) [Reserved]
Except as set forth in § 120.52 of this subchapter, a
(a) The following activities are not exports, reexports, or retransfers:
(1) Launching a spacecraft, launch vehicle, payload, or other item into space;
(2) While in the United States, releasing technical data or software to a U.S. person;
(3) Shipping, moving, or transferring defense articles between or among the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands or any territory, dependency, or possession of the United States as listed in Schedule C, Classification Codes and Descriptions for U.S. Export Statistics, issued by the Bureau of the Census; and
(4) Sending, taking, or storing technical data or software that is:
(i) Unclassified;
(ii) Secured using end-to-end encryption;
(iii) Secured using cryptographic modules (hardware or software) compliant with the Federal Information Processing Standards Publication 140-2 (FIPS 140-2) or its successors, supplemented by software implementation, cryptographic key management and other procedures and controls that are in accordance with guidance provided in current U.S. National Institute for Standards and Technology publications; and
(iv) Not stored in a country proscribed in § 126.1 of this subchapter or the Russian Federation.
(b) For purposes of this section, end-to-end encryption means the provision of uninterrupted cryptographic protection of data between an originator and an intended recipient, including between an individual and himself or herself. It involves encrypting data by the originating party and keeping that data encrypted except by the intended recipient, where the means to access the data in unencrypted form is not given to any third party, including to any Internet service provider, application service provider or cloud service provider.
(c) The ability to access technical data or software in encrypted form that satisfies the criteria set forth in paragraph (a)(4) of this section does not constitute the release or export of such technical data or software.
See § 127.1 of this subchapter for prohibitions on the release or transfer of technical data or software, in any form, to any person with knowledge that a violation will occur.
Secs. 2, 38, and 71, 90, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2753; 22 U.S.C. 2651a; 22 U.S.C. 2776; Pub. L. 105-261, 112 Stat. 1920; Sec. 1205(a), Pub. L. 107-228; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.
Unless limited by a condition set out in a license, the export, reexport, retransfer, or temporary import authorized by a license is for the item(s), end-use(s), and parties described in the license application and any letters of explanation. DDTC grants licenses in reliance on representations the applicant made in or submitted in connection with the license application, letters of explanation, and other documents submitted.
Secs. 2, 38, and 71, 90, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2651a; 22 U.S.C. 2776; Section 1514, Pub. L. 105-261; Pub. L. 111-266; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.
(e) Unless limited by a condition set out in an agreement, the export, reexport, retransfer, or temporary import authorized by a license is for the item(s), end-use(s), and parties described in the agreement, license, and any letters of explanation. DDTC approves agreements and grants licenses in reliance on representations the applicant made in or submitted in connection with the agreement, letters of explanation, and other documents submitted.
Secs. 2 and 38, 90, 90 Stat. 744 (22 U.S.C. 2752, 2778); 22 U.S.C. 2651a; E.O. 13637, 78 FR 16129.
(b) * * *
(9) Technical data, including classified information, regardless of media or format, exported by or to a U.S. person or a foreign person employee of a U.S. person, travelling or on temporary assignment abroad subject to the following restrictions:
(i) Foreign persons may only export or receive such technical data as they are authorized to receive through a separate license or other approval.
(ii) The technical data exported under this authorization is to be possessed or used solely by a U.S. person or authorized foreign person and sufficient security precautions must be taken to prevent the unauthorized release of the technology. Such security precautions include encryption of the technical data, the use of secure network connections, such as virtual private networks, the use of passwords or other access restrictions on the electronic device or media on which the technical data is stored, and the use of firewalls and other network security measures to prevent unauthorized access.
(iii) The U.S. person is an employee of the U.S. government or is directly employed by a U.S. person and not by a foreign subsidiary.
(iv) Technical data authorized under this exception may not be used for foreign production purposes or for defense services unless authorized through a license or other approval.
(v) The U.S. employer of foreign persons must document the use of this exemption by foreign person employees,
(vi) Classified information is sent or taken outside the United States in accordance with the requirements of the Department of Defense National Industrial Security Program Operating Manual (unless such requirements are in direct conflict with guidance provided by the Directorate of Defense Trade Controls, in which case such guidance must be followed).
Sections 2, 38, and 42, 90, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2791); 22 U.S.C. 401; 22 U.S.C. 2651a; 22 U.S.C. 2779a; 22 U.S.C. 2780; E.O. 13637, 78 FR 16129.
(a) * * *
(6) To export, reexport, retransfer, or otherwise make available to the public technical data or software if such person has knowledge that the technical data or software was made publicly available without an authorization described in § 120.11(b) of this subchapter.
(b) * * *
(4) To release or otherwise transfer information, such as decryption keys, network access codes, or passwords, that would allow access to other technical data in clear text or to software that will result, directly or indirectly, in an unauthorized export, reexport, or retransfer of the technical data in clear text or software. Violation of this provision will constitute a violation to the same extent as a violation in connection with the export of the controlled technical data or software.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Regulatory review; request for comments.
On December 5, 2011, HUD published an interim rule entitled “Homeless Emergency Assistance and Rapid Transition to Housing: Emergency Solutions Grants Program and Consolidated Plan Conforming Amendments” (interim rule). The comment period for the interim rule ended on February 3, 2012. Because recipients and subrecipients have now had more experience implementing the interim rule, HUD recognizes that they may have additional input and comments for HUD to consider in its development of the ESG final rule (final rule). Therefore, this document takes comments for 60 days to allow additional time for public input, and for HUD to solicit specific comment on certain issues.
Interested persons are invited to submit comments responsive to this request for information to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-7000. Communications must refer to the above docket number and title and should contain the information specified in the “Request for Comments” of this notice.
To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the rule.
Norm Suchar, Director, Office of Special Needs Assistance Programs, Office of Community Planning and Development, Department of Housing and Urban Development, 451 7th Street SW., Room 7262, Washington, DC 20410-7000, telephone number (202) 708-4300 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339.
The Homeless Emergency Assistance and Rapid Transition to Housing Act of 2009 (HEARTH Act) (Division B of Pub. L. 111-22), enacted into law on May 20, 2009, amended the McKinney-Vento Homeless Assistance Act (42 U.S.C. 11371
The HEARTH Act broadened the emergency shelter and homelessness prevention activities of the Emergency Solutions Grants program beyond those of its predecessor program, the Emergency Shelter Grants program, and added short- and medium-term rental assistance and services to rapidly re-house persons experiencing homelessness. The change in the program's name reflects the change in the program's focus from addressing the needs of homeless people in emergency or transitional shelters to assisting people to quickly regain stability in permanent housing after experiencing a housing crisis or becoming homeless.
On December 5, 2011, at 76 FR 75954, HUD published an interim rule for ESG entitled “Homeless Emergency Assistance and Rapid Transition to Housing: Emergency Solutions Grants Program and Consolidated Plan Conforming Amendments.”
The interim rule took effect on January 4, 2012, and the public comment period for the interim rule ended on February 3, 2012. HUD has carefully reviewed all comments received in response to the interim rule. However, since the issuance of the interim rule, communities have gained valuable experience implementing the Emergency Solutions Grants (ESG) program, and HUD has been working with and hearing from ESG recipients, ESG subrecipients, Continuums of Care (CoCs), interest and advocacy groups, and other stakeholders to gather information about this experience. As is the case with any new program, ESG recipients and subrecipients have raised questions and issues about various components of the interim rule. HUD appreciates the questions and feedback provided to date, and consequently has decided to re-open the public comment period on the interim rule for the purpose of seeking broader input on implementation of the interim rule, before HUD makes final decisions for the final rule. In fact, HUD is raising many of the issues for consideration in this notice in order to be able to more clearly establish in the final rule what is or is not eligible and what the limitations are with ESG funds, in many cases based on recipient or subrecipient feedback. This notice offers an opportunity for ESG recipients and subrecipients, the public, and all interested parties to provide their feedback about particular issues in the interim rule.
Re-opening public comment period for the interim rule supports HUD's goals of increasing public access to and participation in developing HUD regulations and other related documents, and promoting more efficient and effective rulemaking through public involvement.
Since HUD issued the ESG interim rule, the following significant statutory or regulatory changes have occurred or are in progress, which will impact the ESG program:
a. MAP-21. On July 18, 2012, President Obama signed into law the “
• Changed the applicable environmental review requirements from 24 CFR part 50 back to part 58.
• Defined the term “local government” to include an instrumentality of a unit of general purpose local government (other than a public housing agency) to act on behalf of the local government with regard to ESG activities, and to include a combination of general purpose local governments.
• Defined the term “State” to include an instrumentality of a State to act on behalf of the State with regard to ESG activities.
• Allowed a metropolitan city and urban county that each receive an ESG allocation and are in the same Continuum of Care (CoC) to receive a joint allocation of ESG funds.
HUD's ESG final rule will incorporate these statutory changes, which are in effect now. Later in this notice, HUD seeks comment on specifics related to implementing joint allocations and instrumentalities.
b. VAWA 2013. The Violence Against Women Reauthorization Act (VAWA) of 2013 (Pub. L. 113-4, 127 Stat. 54) was enacted on March 7, 2013. On August 6, 2013, at 78 FR 47717, HUD issued a
c. OMB OmniCircular. On December 26, 2013, at 78 FR 78590, the Office of Management and Budget (OMB) issued final guidance on administrative costs, cost principles and audit requirements for federal awards. This final guidance supersedes and streamlines requirements from OMB Circulars A-21, A-87, A-110, and A-122 and Circulars A-89, A-102, and A-133. OMB has finalized the guidance in Title 2 of the Code of Federal Regulations (CFR). OMB charged federal agencies with adopting the policies and procedures in the final guidance by December 26, 2014. HUD is in the process of adopting
d. Equal Access rule. The “Equal Access to Housing in HUD Programs—Regardless of Sexual Orientation or Gender Identity” final rule (77 FR 5662) was published on February 3, 2012. It amends 24 CFR 5.105 to create a new regulatory provision that generally prohibits HUD's assisted and insured housing programs, including ESG, from considering a person's marital status, sexual orientation, or gender identity (a person's internal sense of being male or female) in making housing assistance available. CPD Notice 15-02, “Appropriate Placement for Transgender Persons in Single-Sex Emergency Shelters and Other Facilities,” published in February 2015, provides guidance on how recipients of ESG funding can ensure compliance with this rule.
e. Definition of Chronically Homeless. HUD intends to finalize the definition of “chronically homeless,” which affects 24 CFR part 91 (the Consolidated Plan regulations). Once published, it will apply to part 91, and the current definition will be amended. This will establish a consistent definition of chronically homeless across HUD's homeless assistance programs.
f. HMIS final rule. HUD intends to publish a final rule for Homeless Management Information Systems (HMIS). Once published, this rule will apply to all entities using the CoC's HMIS, including Consolidated Plan jurisdictions (both those that receive ESG funds and those that do not) and ESG subrecipients. The ESG regulations will reflect applicable HMIS requirements following promulgation of the HMIS final rule.
In re-opening the public comment period for the ESG rule, HUD strives to present a structure to this notice that is informative and encourages meaningful public input to the questions posed by HUD. Accordingly, this notice commences with solicitation of comments on definitions and then generally follows the organization of the regulations in the interim rule. This notice describes specific areas of the interim rule on which HUD seeks additional public comment, in order to assist HUD in deciding policy for the final ESG rule. In addition to seeking additional feedback and comment on certain provisions of the ESG interim rule, for some provisions, HUD proposes specific language for comment. This notice contains some regulatory language to provide context to certain questions or proposed language presented by HUD, but it may be helpful to the reader to review this notice in conjunction with the interim rule. HUD appreciates and values the feedback that commenters provide, particularly feedback that draws on their experience with the interim rule.
The issues addressed in this notice are limited; there are several reasons for this. First, HUD has received public comments on numerous issues, and many of these comments are sufficient for HUD to be able to make a decision—in some cases, a change—for the final rule. Such issues are not specifically addressed in this notice. For example, HUD is planning to change the income requirement for re-evaluation from “at or below 30 percent AMI” to “below 30 percent AMI” to match the requirement at initial intake, because many people have been confused by the distinction. Second, some issues—including the definition of “homeless,” the corresponding recordkeeping requirements, and the definition of “chronically homeless”—are not subject to further public comment. Public comment for the definition of “homeless” and the corresponding recordkeeping requirements were addressed in the Defining Homeless final rule published in the December 5, 2011,
HUD seeks comments on possible changes to several definitions included in the interim rule at §§ 91.5 and 576.2.
1. At risk of homelessness (§§ 91.5 and 576.2): HUD received many comments requesting further elaboration about the condition referenced at § 576.2(1)(iii)(G), which states: “Otherwise lives in housing that has characteristics associated with instability and an increased risk of homelessness, as identified in the recipient's approved Consolidated Plan.” HUD recognizes that, given the variety of types, characteristics, and conditions of housing in urban, suburban, and rural areas around the country, this definition could encompass many different housing situations. However, it is important to note that this condition focuses on characteristics of the
HUD is considering adding specificity to this condition in the ESG final rule, and seeks comments on the following questions:
a. What types of housing conditions exist in your region that would support this interpretation, or what housing conditions exist that would necessitate different regulatory language?
b. What characteristics, if any, should be added to this portion of the definition of “At Risk of Homelessness” to aid recipients in determining who is at risk of homelessness?
For the corresponding recordkeeping requirement, see Section II.C.19.a. of this notice.
2. Emergency shelter (§§ 91.5 and 576.2): The definition of “emergency shelter” in the interim rule states: “Any facility, the primary purpose of which is to provide a temporary shelter for the homeless in general or for specific populations of the homeless, and which
HUD's proposed changes to the definition of emergency shelter are designed to convey the following: (1) It is not solely the structure of the building that makes something an emergency shelter, it is its purpose—essentially temporary sleeping accommodation—and local zoning laws and building codes determine whether a particular use or structure is allowed in an area; (2) The primary purpose of emergency shelter is to provide a habitable place for a homeless individual or family to sleep, and occupancy by an individual or family in an emergency shelter is temporary (no rights of tenancy are conferred by occupancy); and (3) The homeless shelter provider and program participant relationship is fundamentally different than that of a landlord-tenant relationship.
Below is a discussion of the intent of the proposed changes as well as specific questions for public comment.
a. Adding “building or portion of a building.” HUD recognizes that an emergency shelter can take many shapes, especially in rural areas and during local emergencies (
The requirements that apply to each emergency shelter would apply to each building or portion of a building used as an emergency shelter. Further, each separate building would be considered a separate emergency shelter, even if multiple buildings are located on the same site. However, multiple emergency shelters (whether whole buildings or portions of buildings) could comprise a single emergency shelter
With respect to this idea, HUD seeks comment on the following specific questions:
(1) If HUD were to add “building or portion of a building” to the definition of “emergency shelter,” are there any particular issues or challenges that it would cause for ESG recipients and subrecipients, and if so, what are they? Or, would this be a helpful addition, and if so, how?
(2) Alternatively, HUD is considering adding “building, buildings, or portions(s) of a building.” However, in order to consider multiple buildings to be a single emergency shelter, HUD would need to make additional qualifications to be consistent with the nondiscrimination and other ESG requirements. HUD seeks comment on the following questions related to this proposal:
(a) Should HUD require the shelter buildings to be within a certain distance of each other to be considered the same emergency shelter? For example, could two emergency shelter buildings on opposite sides of a large urban county be considered a single emergency shelter, or should HUD set a distance limit? Is there a circumstance under which there would be an advantage—either administrative or otherwise—to consider two emergency shelter buildings as a single shelter, especially if they can be administered as the same project, with the same written standards and other rules?
(b) Should HUD require the buildings to be operated by the same subrecipient to be considered the same emergency shelter?
(c) Are there any other requirements HUD should establish in order to establish commonalities that makes the different buildings a single emergency shelter?
(d) If multiple shelter buildings could be considered a single project, would it make a significant difference in your community if HUD were to adopt “building, buildings, or portion” of a building, as opposed to “building or portion of a building?”
(3) Are there any other considerations about this distinction that are important for HUD to take into account in determining the final rule on this topic?
b. Clarifying that occupancy in an emergency shelter must not create any rights of tenancy under state or local law. In formally recognizing that a facility could include an apartment or other building to serve as an emergency shelter, HUD aims to distinguish emergency shelter provided by a recipient or subrecipient where the shelter resident is sleeping in an apartment or other standard unit from the provision of rental assistance. This bolsters the requirement that emergency shelter is temporary. Therefore, HUD is considering adding the following sentence to the definition of emergency shelter: “
c. Establishing a clearer distinction between emergency shelter and transitional housing, including removing “leases or occupancy agreements” from the definition. The primary distinction between emergency shelter and transitional housing is incorporated into the statutory definitions of these terms in the McKinney-Vento Act, as follows: The purpose of an emergency shelter is to provide temporary shelter; the purpose of transitional housing is “to facilitate the movement of individuals and families experiencing homelessness to permanent housing within 24 months.” HUD's proposed definition incorporates two related issues for the public to consider:
(1) In the ESG and CoC Program interim rules, HUD attempted to further clarify for recipients the distinction between the two by stating that transitional housing projects must require a lease or occupancy agreement and emergency shelters could not. HUD received many questions about what constitutes an occupancy agreement, and has since determined that this is not necessarily the best way to make this distinction. This is in part because an occupancy agreement is, simply, a document that is a contract between two parties that is not a legal lease under local landlord/tenant law (though in some communities an occupancy agreement meets the requirements of a lease). Therefore, HUD is proposing removing the phrase “and which does not require occupants to sign leases or occupancy agreements” from the definition of emergency shelter.
(2) In its place, HUD is considering adding to the definition a requirement that each emergency shelter must be designated as such on the most recent Housing Inventory Count (HIC) for the applicable CoC for the geographic area, in order to establish a clear and consistent location to identify the status for each emergency shelter or transitional housing project each year. Under this proposal, each recipient or subrecipient would be required to choose the status of a particular project, based on the primary purpose of the project, as either emergency shelter or transitional housing, and indicate this designation formally on the HIC. Per this proposal, the purpose of the project would become the distinguishing factor, as designated on the HIC. This designation would only apply to the project's eligibility for funding under HUD's CoC or ESG Programs.
HUD recognizes that in some ESG-funded “transitional shelter” projects, program participants tend to stay for longer than 3 or 6 months, and the program has a heavy service focus. HUD intends to require these types of projects to carefully consider their purpose. HUD also notes that if a subrecipient's emergency shelter contains overnight sleeping accommodations (
If included in the final rule, HUD plans to issue guidance to help recipients and subrecipients make this determination. This Notice is not intended to provide that guidance; rather, it is intended to introduce this concept, and seek public comment on it in order to determine whether to move forward with it in the ESG final rule, and in the CoC final rule. HUD seeks public comment on including a requirement in the definition of emergency shelter for recipients and subrecipients to designate emergency shelter projects on the HIC; specifically the following questions:
(a) Would it be helpful to include a provision making the HIC the required place for designating whether a particular bed is considered emergency shelter or transitional housing? Or would it create an unnecessary burden, or would it make no difference since emergency shelters must be designated on the HIC already?
(b) If added, should it be included in the definition of emergency shelter or elsewhere in the final rule (
(c) Finally, HUD has considered that there may be an ESG subrecipient with an emergency shelter in an area that is either not covered by a CoC or where the CoC has not submitted a HIC, for some reason. Has this scenario occurred? Should HUD address this in the final rule?
d. Removing or altering the concept of “grandfathering in” projects in the interim rule. The ESG interim rule includes the following language, “Any project funded as an emergency shelter under a Fiscal Year 2010 Emergency [Shelter] Grant may continue to be funded under ESG.” The current language was intended to continue funding of “transitional shelters” which were included in the definition of “emergency shelter” under the Emergency Shelter Grants Program. HUD is considering whether to remove, alter, or maintain this clause in the definition, based on the changes described above which more clearly define an emergency shelter versus transitional housing.
If HUD were to remove this clause, HUD recognizes that there may be some facilities currently classified as emergency shelters that would not meet the revised definition of emergency shelter as proposed, and these facilities would not be eligible for continued funding under the ESG Program. HUD seeks comment on the following questions related to this issue:
(1) If removing the “grandfathering” clause
(2) If removing the “grandfathering” clause
(3) How could HUD change the definition of emergency shelter—specifically, the “grandfathering clause”—to ensure that beds that are truly needed as emergency shelter in the community can continue to receive ESG funds in the future?
e. Ensuring that emergency shelters are placed in locations that are not inconsistent with an area's zoning and
(1) Would it be helpful in ensuring that all recipients and subrecipients understand the context in which emergency shelter must be provided, especially if it is a building or portion of a building that is not traditionally used as emergency shelter, or would including this language make no practical difference?
(2) If HUD were to include this requirement, would it be most appropriate in the definition or the elsewhere in the final rule (
(3) Additionally, would it be helpful to remind recipients and subrecipients in the final rule that all emergency shelters must be operated consistently with state or local law? If so, should that reminder be incorporated into the definition of emergency shelter or elsewhere in the final rule?
f. Other comments. In addition to the specific feedback requested above, HUD seeks any additional feedback on this the revised, proposed definition of emergency shelter.
3. Local government and State (Instrumentalities) (§ 576.2): MAP-21 expanded the statutory definition of “local government” to include an instrumentality of the unit of general purpose local government, other than a public housing agency, provided that the instrumentality is established pursuant to legislation and designated by the chief executive to act on behalf of the local government regarding activities funded under title IV of the McKinney-Vento Act. MAP-21 also expanded the statutory definition of “state” to include any instrumentality of a state that is designated by the governor to act on behalf of the state.
HUD is considering the following standards for recognizing instrumentalities under ESG and seeks comments on the following proposals, specifically how burdensome it would be to obtain this information:
a. Instrumentality of a State. For HUD to recognize an instrumentality as the state for ESG, the state must submit the following to the local HUD field office:
(1) The governor's written designation of the instrumentality to act on behalf of the state with respect to activities funded under ESG; and
(2) A legal opinion from the attorney general of the state that the instrumentality either:
(a) Meets each of the following criteria:
(i) Is used for a governmental purpose and performs a governmental function;
(ii) Performs its function on behalf of the state;
(iii) The state has the authority to appoint members of the governing body of the entity, or the control and supervision of the entity is vested in the state government;
(iv) Statutory authority is needed by the state to create and/or use the entity; and
(v) No part of the net earnings inures to the benefit of any private shareholder, member or individual; or
(b) The entity otherwise qualifies as an instrumentality of the state under its state law.
b. Instrumentality of a local government. For HUD to recognize an instrumentality as the metropolitan city or urban county for ESG, the metropolitan city/urban county must submit the following to the local HUD field office:
(1) The chief executive's written designation of the instrumentality to act on behalf of the metropolitan city/the urban county with respect to activities funded under ESG; and
(2) Certification by the metropolitan city or urban county (chief executive or authorized attorney for the metropolitan city or urban county) that:
(a) The instrumentality is established pursuant to legislation to act on behalf of the metropolitan city/the county with regard to homeless assistance activities, but is not a public housing authority/agency; and
(b) The instrumentality either:
(i) Meets the following criteria:
(A) The entity is used for a governmental purpose and performs a governmental function;
(B) The entity performs its function on behalf of the metropolitan city/the county;
(C) The metropolitan city/the county has the authority to appoint members of the governing body of the entity or the control and supervision of the entity is vested in the metropolitan city/the county;
(D) State or local statutory authority is needed to create and/or use the entity; and
(E) No part of the net earnings inures to the benefit of any private shareholder, member or individual; or
(ii) Otherwise qualifies as an instrumentality of the metropolitan city/urban county under its state or local law.
4. Project (§ 576.2): HUD is considering adding a definition of “project,” in order to establish a clear meaning for the term's primary use in the ESG final rule. HUD is considering that this definition read as follows:
Project means an activity or group of related activities under a single program component, designed by the recipient or subrecipient to accomplish, in whole or in part, a specific objective, and which uses a single HMIS implementation for data entry on these activities. A project may include both ESG-funded and non-ESG-funded activities. This definition does not apply to the term “project” when used in the requirements related to environmental review, project-based rental assistance, or the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970.
HUD seeks comment on the following questions related to the definition of “project:”
(1) HUD could allow each recipient or subrecipient to self-define the project in accordance with HUD's definition (such as the one proposed above), such as in a recipient's Annual Action Plan, in a subrecipient's request for funding from the recipient, or in the subrecipient agreement. Should HUD require recipients or subrecipients to formally define or declare each project, and should HUD define how it should be done? If so, what should that requirement be?
(2) What are the potential effects—positive and negative—of adopting the proposed definition?
(3) Are there suggestions for alternate definitions or changes to this definition?
5. Rapid Re-housing (§ 91.5): HUD is reviewing whether to revise the definition in § 91.5 as follows (italicized text replaces current language):
1. Submission of Action Plans—Timing (§ 91.15 and § 91.115): HUD is considering revising the Consolidated Plan regulations to prohibit Consolidated Plan jurisdictions from submitting Action Plans to HUD before formula allocations have been announced for each fiscal year, as explained in CPD Notice 2014-015, published on October 21, 2014.
2. Reimbursement for Pre-Agreement Costs in the Entitlement Community Development Block Grant (CDBG) Program (§ 570.200(h)): In conjunction with CPD Notice 2014-15 HUD issued a waiver to certain CDBG Entitlement grantees to allow them to reimburse themselves for costs incurred as of the earlier of the grantee's program year start date or the date the Consolidated Plan/Action Plan is received by HUD. Should HUD revise the Consolidated Plan rule to prohibit submission of Action Plans before formula allocations have been announced, as described above, HUD would also pursue a conforming revision to the Entitlement CDBG program regulations; such a change would permanently adopt the alternative requirements provided by the waiver. HUD seeks comment on this proposal. (See also the discussions of §§ 91.15 and 91.115, and § 91.500 in sections II.B.1 and II.B.7 of this Notice, respectively.)
3. Area-Wide Systems Coordination Requirements—Consultation and Coordination (§ 91.100(a)(2) and (d), § 91.110(b) and (e), § 576.400(a), (b), and (c)): See Section II.C.12 of this Notice for more detail.
4. Housing and Homeless Needs Assessment (§ 91.205 and § 91.305):
a. “Nearing the termination of rapid re-housing assistance” (§ 91.205(b)(1)(i)(K) and § 91.305(b)(1)(i)(K)). HUD is reconsidering the inclusion of the following element in the housing needs assessment (currently required as a narrative in the Consolidated Plan): “Formerly homeless families and individuals who are receiving rapid re-housing assistance and are nearing the termination of that assistance.” HUD originally included this element to encourage Consolidated Plan jurisdictions to identify those households who are housed but who might be more likely to become homeless again than other households, and to focus on helping these families stay housed after their rapid re-housing assistance ends. HUD received a comment indicating that the requirement to obtain this data is too burdensome for states, and is considering removing the requirement for both states and local governments due to the difficulty in obtaining consistent and accurate data. Alternatively, HUD could attempt to clarify the requirement by changing it to “Formerly homeless families and individuals who are receiving
(1) Is this information useful as a part of a jurisdiction's analysis of housing needs and its planning process? If so, in what ways? If not, should HUD eliminate this as a requirement in the final rule for states, local governments, or both?
(2) Is there a better way for HUD to encourage jurisdictions to identify and focus efforts on the households most likely to become homeless again? HUD seeks suggestions about how the requirement could be changed to make it easier to capture this or similar information.
b. Estimating needs for States (§ 91.305(b)(1)(i)). For states, the interim rule also added a requirement to estimate the number and type of families in need of housing assistance for public housing residents (paragraph (b)(1)(i)(F)) and families on the public housing and Housing Choice Voucher tenant-based waiting list (paragraph (b)(1)(i)(G)). HUD received a comment that it is too burdensome for states to collect this data, and is reconsidering the inclusion of both of these elements for states. HUD seeks comment on the following questions:
(1) Is this information useful as a part of a state's analysis of housing needs and its planning process? If so, in what ways?
(2) How are states collecting this data? Are states obtaining reliable estimates on these elements?
(3) Should HUD remove either of these elements from the housing needs assessment of the Consolidated Plan for states, and why or why not?
c. Estimation of homeless data (§ 91.305(c)(i) and § 91.205(c)(i)). The interim rule requires Consolidated Plan jurisdictions to include, in their Housing and Homeless Needs Assessment, the following:
HUD expects Consolidated Plan jurisdictions to obtain this data from CoCs, and CoCs will be able to obtain most elements from the local HMIS and the PIT count. However, CoCs must ensure that the data reflects the boundaries of the Consolidated Plan jurisdiction rather than the boundaries of the CoC. The HMIS Data Standards Manual at
(1) What steps are CoCs currently carrying out to disaggregate CoC-wide data for the Consolidated Plan jurisdiction, when their geographies do not align?
(2) What are the barriers to obtaining accurate data for these measures at the Consolidated Plan jurisdiction level?
(3) Are Consolidated Plan jurisdictions using this data for planning or other purposes, and how?
(4) Based on the information above, should HUD make any additional changes to the regulation? If so, what would be most helpful?
d. Scope of Consolidated Plan Data for States (§ 91.305). In its Action Plan, each state is required to describe “. . . the geographic areas of the state . . . in which it will direct assistance during the ensuing program year, giving the rationale for the priorities for allocating investment geographically . . .” (required at § 91.320(f) for the Action Plan and found in the eCon Planning Suite on screen AP-50). Because the information gathered for the Consolidated Plan Housing and Homeless Needs Assessment establishes the need in the state and is the basis for the Strategic Plan and Action Plan, it is important for the public and for HUD to understand the scope of data being reported. However, there might be great variance in the universe of data that states report in their Needs Assessment: Some states include data from entitlement jurisdictions that receive their own allocation of Community Development Block Grant (CDBG), HOME Investment Partnerships (HOME), ESG, and/or Housing Opportunities for Persons With AIDS (HOPWA) funding, some only report data on non-entitlement jurisdictions, and some states include partial data from entitlement jurisdictions. In fact, the eCon Planning Suite pre-populates some default data in compliance with different program regulations that require entitlement jurisdictions' data to be either included or excluded for different parts of the Consolidated Plan Needs Assessment. Because
In the final rule, HUD is considering adding one of the following requirements to § 91.305 to help obtain the most precise data possible so that each state can better demonstrate how it is tracking and addressing homelessness in its area, and seeks comments on which option HUD should select, if any:
(1) The state has the option to include in its Homeless Needs Assessment data on entitlement jurisdictions within its boundaries, and must cite all data sources. If the state's Needs Assessment includes data from any entitlement jurisdictions, it must cite which entitlement jurisdictions' data is included and the source of that data (if appropriate, the state could reference the applicable entitlement jurisdiction's Consolidated Plan). If the state's Homeless Needs Assessment is limited to non-entitlement areas' data, then the Consolidated Plan must indicate this; or
(2) The state must only report non-entitlement data in its Homeless Needs Assessment. If a state intends to allocate funds to an entitlement jurisdiction, the state would be required to incorporate the entitlement jurisdiction's data in its Homeless Needs Assessment by reference only (
e. Funding services to people on tribal lands (§§ 91.205, 91.305). HUD intends to provide ESG recipients with the discretion to choose whether or not to use ESG to fund nonprofit organizations serving people living on tribal lands. HUD is considering adding the following language: “An ESG recipient may fund activities in tribal areas located within the recipient's jurisdiction, provided that the recipient includes these areas in its Consolidated Plan.” HUD seeks comment on this proposal—specifically:
(1) What effects will this requirement have?
(2) How are ESG recipients already including tribal areas in their consolidated planning process?
(3) If included, should this language be added at part 91 or in part 576?
f. States' use of HMIS and PIT data (§ 91.305(c)(1)). The interim rule does not include the following requirement for states, which is in the regulation for local governments: “At a minimum, the recipient must use data from the Homeless Management Information System (HMIS) and data from the Point-In-Time (PIT) count conducted in accordance with HUD standards.” HUD is considering including this requirement for states in the final rule, because most states are already obtaining this data from CoCs and HMIS systems, and this change would make the collection consistent with the requirement for metropolitan cities and urban counties. HUD seeks comment on this addition.
g. Coordination between the Con Plan jurisdiction and CoC on Planning (24 CFR 91.100(a)(2)(i) and 91.110(b)(1)). Currently, the consultation provisions at 24 CFR 91.100(a)(2)(i) and 91.110(b)(1) require each Consolidated Planning jurisdiction to consult with the applicable CoC(s) when preparing the portions of the consolidated plan describing the jurisdiction or state's homeless strategy and the resources available to address the needs of homeless persons and persons at risk of homelessness. In order to develop this strategy, Con Plan jurisdictions must assess the needs and identify available resources to address those needs. For the final rule, HUD is considering specifying that the consultation
HUD expects that in many places, especially where the geographic boundaries of CoCs and Con Plan jurisdiction are coterminous, CoCs and Con Plan jurisdictions are already coordinating to align the strategies in the Con Plan and CoC plan. HUD has received questions about what acceptable consultation, participation, and collaboration consist of, between the CoCs and Con Plan jurisdictions, and especially for states. The purpose of proposing this requirement would be to specify the requirements and ensure that Con Plan jurisdictions and CoCs are collaborating on all aspects of the plan that directly impact the homeless goals and strategies, in order to develop a more complete and cohesive strategy to end homelessness in these overlapping plans.
HUD seeks comment on this concept, specifically:
(1) Would this requirement facilitate or improve collaboration and coordination between CoCs and Con Plan jurisdictions on homelessness activities? If so, how? If not, why not?
(2) Are the current consultation requirements in the interim rule sufficient for Con Plan jurisdictions to establish the needs and strategies for addressing homelessness in the jurisdiction?
(3) Should HUD include this requirement, or are there other ways that HUD could, in the final rule, facilitate better coordination between CoCs and Con Plan jurisdictions to ensure that their plans establish closely aligned and complementary goals to end homelessness?
5. Process for Making Subawards (§§ 91.220(l)(4)(iii) and 91.320(k)(3)(iii)):
HUD received comments from numerous respondents recommending that HUD require ESG recipients to describe how they will use performance data to select subrecipients. Based on these comments, HUD is considering including language in the final rule that would implement this suggestion, and seeks comments on what impact this would have on ESG recipients. For those recipients that currently select subrecipients based on performance data, HUD seeks feedback about processes currently used, including any specific performance indicators. Additionally, HUD seeks comment on whether there are any further requirements that HUD should include related to selecting subrecipients based on performance to help recipients implement this proposed requirement.
6. Written Standards for ESG Recipients (§ 91.220(l)(4) and § 91.320(k)(3), and § 576.400(e)): See section II.C.14 of this Notice for more detail.
7. HUD Approval of Action Plans (§ 91.500): HUD is considering amending the list of examples of substantially incomplete Action Plans at § 91.500(b), to include plans which do not reflect a jurisdiction's actual allocation amounts for that year. HUD envisions that this would also cover situations in which a jurisdiction submits a proposed plan on which it has conducted citizen participation, which neither reflects actual allocation amounts nor contains contingency language on how the jurisdiction will adjust its plan to reflect actual amounts. (See also the discussions of §§ 91.15 and 91.115, and § 570.200 in sections II.B.1 and II.B.2 of this Notice, respectively.)
8. Performance Reports Related to Homelessness for ESG Recipients (§ 91.520(g)): HUD proposes to require that ESG recipients and subrecipients use HMIS (except those subrecipients that are prohibited from doing so under VAWA) in compliance with the forthcoming HMIS rule, to collect and report on data in the Consolidated Annual Performance Evaluation Report (CAPER), as specified by HUD, and seeks comments on this proposal.
1. Emphasis on Rapid Re-housing: HUD has been encouraging ESG recipients to spend more of their funds on rapid re-housing, since it is often a cost-effective way to make a significant impact on homelessness in a community and help achieve the national goal of ending homelessness. HUD is considering ways to continue this policy, and seeks feedback on what requirements and/or incentives could be established in the final rule for recipients to focus more on rapid re-housing, or whether HUD should simply continue to encourage this focus through guidance.
HUD received several comments recommending that HUD limit the amount of funds that an ESG recipient can spend on homelessness prevention activities. However, HUD cannot place a cap on homelessness prevention activities without a statutory change. Instead, HUD seeks creative ways to encourage more rapid re-housing—possibly through the final rule. For example, if a recipient intended to spend funds on homelessness prevention, HUD could require the recipient to justify, in the Consolidated Plan, how meeting the needs of persons at risk of homelessness is more effective at ending homelessness (without this justification, the Consolidated Plan would be determined substantially incomplete and could not be approved). Another option could be to establish performance measures and link the local CoC application scoring to ESG recipients' achievement of those measures. Another option could be to require only the rent reasonableness standard for rapid re-housing activities, but require both the Fair Market Rent (FMR) and rent reasonableness standard for homelessness prevention activities. HUD seeks comments on whether to adopt these or suggestions for other methods to increase the amount of funds recipients spend on rapid re-housing activities.
2. Street Outreach and Emergency Shelter Components (§ 576.101 and § 576.102):
a. Essential services under the Emergency Shelter Component (§ 576.102(a)). The interim rule states that ESG funds may be used for costs of providing essential services to individuals and families in an emergency shelter. HUD has received feedback that this could be interpreted in two different ways:
(1) Only individuals and families who spent the prior night in an emergency shelter can receive ESG-funded essential services, no matter where those services are provided; or
(2) Anyone who meets the homeless definition can receive essential services, as long as the services are provided in the emergency shelter.
HUD proposes to clarify who can receive essential services under the Emergency Shelter component—including in day shelters—by changing the language as follows (proposed portions italicized):
ESG funds may be used for costs of providing essential services to homeless families and individuals
In other words, if an individual or family meets Category 1 of the homeless definition (excluding those in transitional housing) and is staying in an overnight or day shelter, they can receive eligible essential services in that shelter. Otherwise, if an individual or family meets Category 1 of the homeless definition (excluding those in transitional housing) and is referred by a shelter, they can receive eligible essential services at any provider's location. This change would widen the array of essential services that can be provided to those most in need—expanding the language to allow ESG funds to be used to pay for facility-based essential services to most persons sleeping on the street. HUD would require the referral from an emergency shelter as a linkage to the Emergency Shelter component, under which the services will be provided. HUD would consider this change in order to improve service coordination and also to ensure that the services charged to the grant are necessary and appropriate to the individual or family. HUD wants to encourage, to the extent possible, that non-facility-based services are provided by mainstream programs, not ESG. HUD seeks comment on this proposed change.
b. “Unavailable” and “Inaccessible” Services (§ 576.101(a) and § 576.102(a)). Under the Street Outreach and Emergency Shelter components of the interim rule, ESG funds may only be used for certain essential services “to the extent that other appropriate [emergency health services, emergency mental health services, mental health services, outpatient health services, legal services, substance abuse treatment services] are unavailable or inaccessible within the community.” HUD has received questions and comments about this requirement, specifically, what it means to be “unavailable or inaccessible.” HUD had originally included this restriction in order to prioritize ESG funds for housing rather than services that should be available through mainstream systems. However, HUD recognizes that sometimes services are necessary and not provided by any other resource; in these cases, certain essential services are eligible under ESG. HUD is not considering removing this restriction from the regulation in the final rule, but is considering changes to help communities implement the requirement and document compliance. HUD specifically seeks additional comment on:
(1) Whether HUD should define or set a standard for “unavailable” and “inaccessible” within the rule, and if so, what definition or standard would best help recipients and subrecipients implement this requirement?
(2) Whether only one term should be used, and if so, which one and why?
(3) How have recipients and subrecipients implemented this requirement under the interim rule? Have they documented it for each program participant, or generally at the community level, and why? What can HUD learn from these experiences that it should implement in the final rule?
c. Day shelters (§ 576.102(a)). While a shelter that provides temporary daytime accommodations and services can be funded as an emergency shelter under the ESG interim rule, HUD receives questions about day shelters and is therefore considering explicitly stating in the final rule that day shelters are emergency shelters, and specifying the conditions under which a day shelter may receive funding under the Emergency Shelter component, including several requirements to ensure that ESG funds are used for homeless persons most in need. HUD is considering adding the following language at 576.102(a):
(1) What impact would adding these requirements for day shelters have in your community? For instance, would this require any changes to emergency shelter policies or procedures in your community?
(2) What changes, if any, would need to be made to this provision of the regulation so that your community can fund or continue to fund day shelters with ESG?
(3) Are there any changes to the documentation requirements for program participants in emergency shelters that would be needed for day shelters?
d. Involuntary family separation (§ 576.102(b)). This requirement states that “The age of a child under age 18 must not be used as a basis for denying any family's admission to an emergency shelter that uses ESG funding or services and provides shelter to families with children under age 18.” HUD interprets this provision to mean that if a shelter serves any families with children, the shelter must serve all members of a family with children under 18, regardless of age or gender. HUD is not proposing to change this provision because it is statutory. However, HUD is considering possible regulatory changes that would help recipients and subrecipients implement the statutory provision, and seeks ideas based on actual issues that have occurred in communities.
HUD is also proposing that a shelter must serve all members of the family together if the members of the family so choose (
e. Fees in emergency shelters (§ 576.102). In the past, HUD has allowed emergency shelters to charge reasonable fees for staying in the shelter. HUD is considering revising this policy, in the final rule, to explicitly allow emergency shelters to charge reasonable occupancy fees, but specify that the amount of the fee charged must account for the capacity of the client to afford to pay the fee, and the fee itself cannot be a barrier to occupancy in the shelter, and this fee must be counted as program income. Additionally, HUD will consider adding language prohibiting recipients or subrecipients providing Rapid Re-housing or Homelessness Prevention assistance to charge program participants any costs above any required contribution to rent payments. This change would increase consistency between the requirements of the ESG Program and the CoC Program. HUD seeks comment on these ideas.
f. Minimum Period of Use—Street Outreach component (§ 576.101(b)). The current minimum period of use requirement states: “The recipient or subrecipient must provide services to homeless individuals and families for at least the period during which ESG funds are provided.” This language comes from the statute, which requires that the recipient certify, with respect to the Street Outreach and Emergency
g. Minimum Period of Use—Emergency Shelter component (§ 576.102(c)). HUD seeks comment on the following:
(1) Essential services and shelter operations. Similar to the minimum period of use change being considered under the Street Outreach component, HUD is considering clarifying the language at 576.102(c)(2) as follows (changed language is italicized) to help recipients and subrecipients understand how to comply with this requirement: “Where the recipient or subrecipient uses ESG funds solely for essential services or shelter operations, the recipient or subrecipient must provide services or shelter to homeless individuals and families
(2) Renovation. Under the Emergency Shelter component, HUD is proposing the following language at § 576.102(c)(1), to account for partial building renovations and renovations of seasonal shelters (proposed portions italicized): “Each building
(3) Subrecipient agreement. HUD is considering requiring that the applicable period of use must be stated in the subrecipient agreement.
(4) Requirements that apply during minimum period of use. HUD is considering revising § 576.102(c)(1) and (2) to clarify and expand the requirements that apply during the minimum period of use when emergency shelters expend ESG funds for Operating Costs, Essential Services for a shelter project, or Renovation, as follows (as a reminder, for Operating Costs and Essential Services, the minimum period of use is the period during which the ESG services are provided; for Renovation, it is 3 or 10 years, as applicable):
(i) Each person who stays in the shelter must be homeless as defined under § 576.2;
(ii) Program participant and shelter data must be entered into the local HMIS (or comparable database, as applicable) as required under § 576.400(f);
(iii) The shelter must meet the minimum habitability standards for emergency shelters under § 576.403(b);
(iv) The recipient or subrecipient must maintain records for the shelter and the shelter applicants and program participants as required under § 576.500, including documentation of each program participant's eligibility and homeless status (§ 576.500(b)) and confidentiality requirements for survivors of domestic violence (§ 576.500(x));
(v) The shelter must meet the faith-based activities requirements under § 576.406 and the nondiscrimination requirements and affirmative outreach requirements in § 576.407.
h. Essential Services for Street Outreach, Case Management (§ 576.101(a)(2)) and Emergency Shelter, Case Management (obtaining identification documents) (§ 576.102(a)(1)(i)). HUD is considering explicitly allowing ESG funds to be used to pay for recipient or subrecipient staff time to help program participants obtain identification documents such as birth certificates and social security cards, and for the cost of such documents, if they are necessary to help a program participant obtain public benefits, employment, housing, or other mainstream resources.
i. Local Residency Requirements. HUD is considering establishing a requirement, in the final rule, that recipients must not deny services or shelter funded under the Emergency Shelter and Street Outreach components based on whether or not their last permanent residence was in the jurisdiction. That is, if a person is homeless on the streets of a jurisdiction and is seeking emergency shelter there, they must be able to receive ESG-funded assistance, regardless of whether their last residence was inside or outside of the jurisdiction. HUD seeks comment on this idea, and feedback about any issues that this might raise with the implementation of ESG or communities' efforts to end homelessness.
3. Rapid Re-housing component (defining “rapid” and “as quickly as possible”) (§ 576.104): This section states, “ESG funds may be used to provide housing relocation and stabilization services and short- and/or medium-term rental assistance as necessary to help a homeless individual or family move as quickly as possible into permanent housing and achieve stability in that housing.” HUD has received questions about what “rapid” and “as quickly as possible” mean in practice, and is considering whether to establish a standard or time limit in which an individual or family could be rapidly re-housed. HUD is considering the following options: Setting the standard at a particular number of days (possibly 7, 30, or some other time limit over 30 days) per individual; setting a standard at an average number of days for an ESG recipient; requiring communities to set a standard based on local data and systems; or continuing the current policy and not setting such a standard. HUD seeks comments on:
(1) Should HUD establish a standard or time limit for rapid re-housing? Why or why not?
(2) If HUD should set such a standard or time limit, what would be an appropriate limit, based on local experiences with rapid re-housing?
(3) If HUD should set a standard at a particular number of days, at what point would the “clock” start—at the initial intake assessment, at the point the program participant is determined eligible and enrolled in the program, or other? Should HUD define it or allow the recipient or subrecipient to define it?
(4) What impact the proposed number of days would have on local program administration. For example, would this conflict with any local goals or other program requirements?
(5) If implemented, what should the consequence be if a recipient or subrecipient does not meet the standard?
4. Housing Relocation and Stabilization Services (§ 576.105):
a. Late fees. HUD is considering explicitly allowing late fees on the program participant's utility and rental payments (other than late fees
b. Court costs (§ 576.105(b)(4)). HUD is considering allowing, as a legal services activity under § 576.105(b)(4), court costs incurred by the landlord during an eviction proceeding as an eligible ESG cost, so long as it is necessary for the program participant to pay them in order to be stabilized in their housing. HUD is considering adding this because payment of this cost may help prevent homelessness for the program participant and it may be an incentive for landlords to work with the program participant. HUD seeks comment on this proposal, specifically:
(1) Should HUD allow a property owner's court costs to be eligible under ESG? Why or why not?
(2) Should HUD allow ESG to be used to pay a property owner's court costs only when a court orders the tenant to pay those costs?
(3) If HUD should allow such costs, how would recipients/subrecipients determine and document that the costs are “necessary” to stabilize a program participant's housing? Should HUD impose any limits on the amount of such costs that may be paid with ESG funds?
c. Trash removal (§ 576.105(a)(5)). HUD is considering including trash removal as an eligible utility cost at § 576.105(a)(5), in part to be consistent with the definition of utility used to calculate gross rent for purposes of FMR, and in part because in some places, particularly rural areas, tenants are required to pay for trash removal. HUD seeks comment on this proposal.
d. Mediation (§ 576.105(b)(3)). Under the interim rule, mediation cannot be used to help eligible individuals and families (including homeless youth) move back into housing they have left, when that might be the best placement for them, and the option they would choose. As such, HUD is considering adding language at § 576.105(b)(3) to allow ESG funds to pay for mediation services—under both the Rapid Re-housing and Homelessness Prevention components—to help individuals and families move back into their former housing and/or move in with friends or family members, after they have already moved to an emergency shelter, the streets, or another place described in paragraph (1) of the homeless definition or, for homelessness prevention, after the program participant has moved to other, temporary, housing. HUD proposes the following language (italicized language added): “ESG funds may be used pay for mediation between the program participant and the owner or person(s) with whom the program participant is living
(1) What impact would this rule change have?
(2) Are there other concerns HUD should be aware of regarding placing individuals and families in such housing situations?
e. Broker fees (§ 576.105(b)(1)). HUD is considering explicitly allowing ESG to pay for fees to real estate agents, or “broker fees,” so long as the fee is reasonable and necessary for the household to obtain appropriate permanent housing, by including language at § 576.105(b)(1), Housing Search and Placement activities. HUD seeks comment on this proposal; specifically, is this a necessary cost in order to quickly move individuals and families to permanent housing?
f. Housing Stability Case Management (§ 576.105(b)(2)). HUD has received numerous questions about the language in the interim rule stating that for ESG housing stability case management, “. . . assistance cannot exceed 30 days during the period the program participant is seeking permanent housing . . .” HUD included this provision recognizing that many clients are enrolled in Rapid Re-housing while residing in shelters, but intentionally limited it, for two main reasons. First, HUD intended this restriction as an incentive to quickly re-house program participants, since any case management over 30 days would have to be paid with non-Federal funds or, if applicable, charged under the Street Outreach component or Emergency Shelter component, which are subject to an expenditure cap. Second, HUD intended that recipients/subrecipients that provide case management to persons in shelter under the Rapid Re-housing program focus on placing these program participants into housing. HUD aims to ensure that recipients/subrecipients are helping program participants obtain housing and not just charging essential services costs for persons in shelter to the Rapid Re-housing component in order to get around the Emergency Shelter/Street Outreach cap. However, HUD recognizes that sometimes it takes longer than 30 days to rapidly re-house a program participant. In addition, one recipient noted that HUD allows the payment of storage fees for up to 3 months under the Rapid Re-housing component and requires monthly case management to be provided during that time, but only allows housing stability case management to be charged to the Rapid Re-housing component for up to 30 days. Therefore, HUD seeks comment on the following questions related to this provision of the rule:
(1) For program participants who are receiving assistance under both the Emergency Shelter and Rapid Re-housing components (
(2) Has the 30-day limit on charging housing stability case management to the Rapid Re-housing component had an effect on increasing the rates at which program participants find housing? If not, why not?
(3) If HUD were to change the limit to 90 days, what impact would this have?
(4) If HUD eliminated this restriction, is there a different way to distinguish between housing stability case management and case management under the emergency shelter component, which is subject to the cap?
g. Credit reports (§ 576.105(b)(5) and § 576.105(b)(2)). At § 576.105(b)(5), Credit Repair, and § 576.105(b)(2), Housing Stability Case Management, HUD is considering allowing ESG funds to be used to pay for a credit report for program participants being assisted under the Homelessness Prevention and Rapid Re-housing components, if the program participant has exhausted all opportunities to receive a free credit report in a given year and if the report is necessary to stabilize the individual or family in their current housing or quickly move them to permanent housing. HUD seeks comments from providers' experience on whether this would be a helpful addition to the rule, or whether it would not make a difference if included.
5. Short-Term and Medium-Term Rental Assistance (§ 576.106):
a. Rental assistance in shared housing—general. HUD proposes to clarify in the final rule that ESG funds may be used to provide rental assistance in shared housing. Except for the FMR requirements (established under § 576.106(d)(1) and addressed below), all ESG requirements that apply to rental assistance would apply to rental assistance provided in shared housing. Among other things, these requirements include the following:
• There must be a legally-binding, written lease between the owner and the program participant;
• There must be a rental assistance agreement between the recipient or subrecipient and the owner;
• The housing must meet ESG habitability standards;
• The program participant must meet the eligibility requirements for either Rapid Re-housing or Homelessness Prevention assistance;
• The rental assistance must be provided in accordance with the applicable written standards;
• Rental assistance may not be provided to a program participant who is receiving tenant-based rental assistance, or living in a housing unit receiving project-based rental assistance or operating assistance, through other public sources; and
• The shared housing must meet the rent reasonableness standards.
HUD seeks comments on these ideas; specifically:
(1) Whether HUD should adopt these policies for rental assistance in shared housing, and, if so, any concerns or issues that may arise in implementation;
(2) Suggestions about documentation that HUD should require in order to reduce fraud or ensure that the landlord is not a “support network” that can assist the program participant without rental or financial assistance, such as a family member or friend;
(3) Whether HUD should include all of the above or whether any elements should be added or deleted from the list; and
(4) How could providing ESG rental assistance to individuals and families that share housing work under state or local law? How do recipients/subrecipients currently make this type of arrangement work, especially with respect to a program participant's lease, and if the other renters are not ESG program participants?
b. Rental assistance in shared housing—FMR. With respect to the FMR for shared housing, HUD is considering establishing the following standard: When assisting an individual or family with rental assistance in shared housing, recipients and subrecipients would be required to use an adjusted FMR that is the household's pro-rata share of the FMR for the shared housing unit size. For example, in the case of a single-person household who will occupy one bedroom in a 4-bedroom house, the FMR used would be the household's pro-rata share of the 4-bedroom FMR (
c. Rent restrictions (Fair Market Rent) (§ 576.106(d)): The ESG interim rule states that “rental assistance cannot be provided unless the rent does not exceed the FMR established by HUD, as provided under 24 CFR part 888, and complies with HUD's standard of rent reasonableness, as established under 24 CFR 982.507.” HUD received feedback expressing concern that, unlike the Housing Choice Voucher program, the ESG program uses FMR to limit the units for which rental assistance may be provided, and this does not provide enough flexibility for recipients and subrecipients to quickly find available units. Two of HUD's goals are to ensure that the units for which ESG assistance is provided will be affordable to program participants after the assistance ends, and limit the amount that may be expended on a given household so that more program participants can be assisted. However, HUD is considering alternatives for changes to the final rule to provide recipients and subrecipients with more flexibility in order to quickly find appropriate units. The options HUD is considering to include in the final rule, on which HUD seeks feedback are as follows:
(1) ESG funds could be used to pay rental assistance for units where the rent is at or below the payment standard set by the PHA for the area (
(2) ESG funds could be used to pay rental assistance for units where the rent is above FMR, but ESG funds could only be used to pay up to the FMR amount (any amount of rent above the FMR would have to be paid by either the program participant, or the recipient/subrecipient with non-ESG funds). However, HUD is concerned that allowing program participants to pay for the cost of a unit above FMR might disadvantage those who need the ESG assistance most, since it might be easier to find units above the FMR and therefore, those who are more able to contribute to the rent would be more likely to receive ESG assistance. Therefore, HUD also seeks comments as to as the extent of this risk and if there are any requirements that can be put into place to prevent this practice.
(3) ESG could require only the rent reasonableness standard for rapid re-housing, but require both the FMR and rent reasonableness standard for homelessness prevention assistance. This might be one way to both increase flexibility and also encourage recipients and subrecipients to provide more rapid re-housing assistance.
(4) HUD could adopt the standard used in the HOPWA program, described at 24 CFR 574.320(a), which allows recipients (or possibly subrecipients) to establish a rent standard that is no more than the published FMR used for Housing Choice Vouchers or the “HUD-approved community-wide exception rent for the unit size. However, on a unit by unit basis, the [recipient] may increase that amount by up to 10 percent for up to 20 percent of the units assisted.”
(5) HUD could maintain the FMR and/or rent reasonableness standards but add in some other type of flexibility—HUD seeks suggestions for additional options.
Note that in all cases HUD is planning to continue to require that the unit at least meet the rent reasonableness standard. Finally, one of HUD's primary concerns is that the program participants be able to remain in the unit after the assistance ends. If HUD included one of the above options to provide more flexibility to recipients and subrecipients by paying higher rents, how could they ensure that the units would remain affordable to program participants without housing assistance?
In addition, HUD is considering only allowing a recipient to pay rent over the FMR if the recipient includes its proposal to do so in the Consolidated Plan/Action Plan. That way, the recipient would be required to obtain and assess citizen feedback as to whether additional flexibility is necessary in its area before being able to pay rents above FMR.
d. Last month's rent, security deposits, and rental arrears (§§ 576.105(a) and 576.106).
(1) HUD is considering re-categorizing “last month's rent” and “security deposit” as rental assistance, rather than housing relocation and stabilization services (financial assistance), because last month's rent is counted in the maximum-allowed 24 months of assistance, which could be confusing. Last month's rent is often paid at the same time as the security deposit, so it might make sense to consider them together. If this change is made, the FMR/rent reasonableness standards and lease and rental assistance agreement requirements would apply when security deposits and last month's rent are used to move a program participant into a unit. HUD will also consider consistency with the CoC Program in making a final decision. HUD seeks
(2) HUD is considering explicitly stating that the FMR and rent reasonableness standards apply when rental arrears are being paid for a unit in which the program participant is staying, but not when the rental arrears are being paid for a unit in which the program participant no longer lives or is leaving. HUD seeks comment on this and any potential issues that could arise if HUD were to adopt this policy.
e. Providing subrecipients with discretion to set caps and conditions (§ 576.106(b)). HUD is considering changing the language as follows, to enable subrecipients to set caps on the assistance provided to a household (italicized language added): “Subject to the requirements of this section, the recipient
f. Rental Assistance Agreement requirements (§ 576.106(e)).
(1) HUD is considering listing the elements that must, at a minimum, be included in the rental assistance agreement. The following two elements are already required in the interim rule, and HUD plans to keep them in the final rule:
• The same payment due date, grace period, and late payment penalty requirements as the program participant's lease; and
• A provision requiring the owner to give the recipient/subrecipient a copy of any notice to the program participant to vacate the housing unit, or any complaint used under state or local law to commence an eviction action against the program participant.
HUD seeks comment on which, if any, of the following new requirements to include, and seeks suggestions on any others that should be required:
• The term of the assistance (
• The type of assistance being provided (
• The amount of funds to be paid by the recipient/subrecipient and the amount to be paid by the tenant;
• the address of the property for which payments are being made; and
• the signature and date of both the recipient/subrecipient representative and the property owner.
(2) The interim rule states that “a recipient or subrecipient may make rental assistance payments only to an owner with whom the recipient or subrecipient has entered into a rental assistance agreement.” HUD proposes to specify in the final rule that when ESG Rapid Re-housing assistance, either project-based or tenant-based, is used to assist a program participant to move into housing owned by a recipient or subrecipient, a rental assistance agreement is not required. However, under this proposal, the organization would be required to document and maintain on file the elements required to be included in a rental assistance agreement. HUD seeks comment on this proposal.
g. Lease (§ 576.106(g)). HUD is proposing to add the following requirement to the lease provision of the ESG final rule, for tenant-based rental assistance (it currently only applies to PBRA), and seeks comments on this proposal: “
h. Using ESG funds for an unoccupied unit. HUD is considering allowing ESG recipients to choose to continue to assist a current program participant with ESG funds, in tenant- or project-based rental assistance, when a program participant is in an institution (such as a hospital or jail) during a portion of the time they are receiving ESG assistance. If implemented, ESG funds could be used for up to 90 days while that program participant is in the institution. However, if the recipient/subrecipient has knowledge that the program participant will not exit the institution before 90 days (
i. Advance payments of rental assistance (§ 576.105(a)(3)). HUD is considering prohibiting payments of rental assistance to a property owner for more than 1 month at a time in advance (except when providing an advance payment of the last month's rent under section § 576.105(a)(3)), and seeks comments on this idea.
j. Subleasing. Under the interim rule, subleasing—that is, the person or organization that holds the primary lease with the owner enters into a lease with an individual to rent the unit—is not allowed, for either tenant-based or project-based rental assistance. If HUD allowed subleasing in the final rule:
(1) Would this allow recipients to more effectively serve program participants?
(2) Would it make a significant difference for program participants? In what ways would it help them?
(3) What language could HUD include in the final rule that would ensure that (a) program participants' rights are protected, and (b) the appropriate payments are made to the owner?
k. Tenant-based rental assistance (TBRA) (§ 576.106(h)). HUD has received numerous questions about whether recipients may provide ESG assistance outside their Con Plan jurisdiction, allow program participants to move outside their jurisdiction, or limit assistance to residents of the jurisdiction. HUD is considering changing the language at § 576.106(h)(2) to specify the circumstances under which any of the options listed above may be carried out. HUD is considering the following revisions, and seeks comment on them:
(1) Under ESG TBRA, the program participant must be able to choose the unit in which they will live, with the following specifications:
(i) The recipient may allow a program participant to choose a unit outside of the recipient's jurisdictional boundaries, may limit TBRA to the recipient's jurisdictional boundaries, or, when necessary to facilitate the coordination of supportive services, may limit TBRA to a designated geographic area that encompasses, overlaps, or falls within the recipient's jurisdictional boundaries.
(ii) Unless otherwise specified by the recipient, a unit of general purpose local government that administers TBRA as a subrecipient may allow a program participant to choose a unit outside of the local government's jurisdictional boundaries, may limit TBRA to the local government's jurisdictional boundaries, or, when necessary to facilitate the coordination of supportive services, may limit TBRA to a designated geographic area—such as the CoC's geographic area—that encompasses, overlaps, or falls within the recipient's jurisdictional boundaries.
(iii) Unless prohibited by the recipient, a private nonprofit organization that administers TBRA as a subrecipient may allow a program participant to choose a unit outside of the recipient's jurisdictional boundaries or, when necessary to facilitate the coordination or provision of services, may limit TBRA to a designated geographic area—such as the CoC's geographic area or a smaller area within the recipient's jurisdiction—that encompasses, overlaps, or falls within the recipient's jurisdictional boundaries.
(2) The amount or type of assistance cannot be conditioned on the program participant moving outside the jurisdiction's boundaries (that is, a recipient or subrecipient may not require that a program participant move outside the jurisdiction in order to receive the rental assistance).
(3) HUD is considering establishing a requirement, in the final rule, that recipients must not deny ESG Rapid Re-housing assistance to homeless individuals and families based on whether or not their last permanent residence was in the recipient's jurisdiction. That is, if a person is homeless on the streets or in an emergency shelter in a jurisdiction and is seeking ESG-funded Rapid Re-housing assistance, they must be able to be assessed for, and, if eligible, receive, ESG Rapid Re-housing assistance, regardless of whether their last residence was inside or outside of the jurisdiction. HUD seeks comment on this idea, and feedback about any issues that this might raise with the implementation of ESG or communities' efforts to end homelessness.
l. Project-based rental assistance (PBRA) (§ 576.106(i)). HUD received many comments about how to implement PBRA for the Rapid Re-housing and Homelessness Prevention components. HUD recognizes that using ESG funds to provide PBRA for these types of assistance is challenging; however, including PBRA as an option for recipients and subrecipients to use when providing assistance is statutorily required. Therefore, HUD is looking for ways to further align the rule with TBRA and eliminate some of the burdensome requirements. However, at its core, PBRA is a different type of housing solution and carries with it special considerations. Below are issues related to PBRA about which HUD is considering revisions to the rule and on which HUD seeks additional public comment. HUD welcomes other suggestions on ways to improve the administration of PBRA as well.
(1) HUD is considering defining “project-based rental assistance” as follows: “Project-based rental assistance, for purposes of the ESG program, means rental assistance that a recipient or subrecipient provides for individuals or families who live in a specific housing development or unit, and the assistance is attached to the development or unit.”
(2) Some commenters recommended that HUD remove the 1-year lease requirement and allow for a lease like TBRA with a flexible term. HUD is considering adopting this recommendation, but seeks additional comment on potential impacts that this policy would have.
(3) The interim rule, at § 576.106(i)(4), provides that if the project-based rental assistance payments are terminated for a particular program participant, the household may stay in its unit (subject to the terms of the lease) and the rental assistance may be moved to another unit in the same building. HUD is considering allowing the assistance to be transferred to another unit in a different building in the same development, and seeks comment on this idea, particularly whether it would increase flexibility.
6. Administrative Activities (§ 576.108) & Indirect Costs (§ 576.109):
a. Training. For § 576.108(a)(2), HUD is considering changing the language in the final rule to allow ESG to pay for the costs of a subrecipient to attend a training provided by the recipient on ESG, and more clearly establish the limits of the training allowed under ESG, as follows: “Eligible training costs include the costs of providing training on ESG requirements and attending HUD-sponsored,
b. Other comments. HUD seeks other feedback regarding changes it should make for the final rule about eligible Administrative costs and indirect costs. However, note that the 7.5 percent cap on Administrative costs is statutory and therefore HUD is prohibited from changing it. Also, HUD must also comply with the OMB requirements on cost principles when making any changes to the language.
7. Submission Requirements and Grant Approval (Joint Agreements) (§ 576.200): MAP-21 included a provision allowing the following: “A metropolitan city and an urban county that each receive an allocation under such title IV [of the McKinney-Vento Homeless Assistance Act] and are located within a geographic area that is covered by a single continuum of care may jointly request the Secretary of Housing and Urban Development to permit the urban county or the metropolitan city, as agreed to by such county and city, to receive and administer their combined allocations under a single grant.” In the final rule, HUD is considering establishing the requirements for recipients to request a joint allocation of ESG funds, and seeks comment on the following ideas:
a. Coordination with CDBG. A jurisdiction may
b. Timing of the joint agreement. The first time the jurisdictions enter into a joint agreement, the entities may enter into a joint agreement for any program year (that is, they would not have to wait until the next time the urban county requalifies as an urban county to enter into a joint agreement). However, the duration of the agreement must be until the next time the urban county requalifies as an urban county (currently this occurs every 3 years).
c. Lead entity responsibilities. The recipients must select a “lead entity” for the joint grant, which must be the lead entity for CDBG. The responsibilities of the lead entity are as follows:
(1) The lead entity, as the ESG recipient, assumes full responsibility for the execution of the ESG program under 24 CFR part 576, with respect to the Consolidated Plan requirements at 24 CFR part 91, and with respect to the joint grant. HUD will hold the lead entity accountable for the accomplishment of the ESG program, for following its Consolidated Plan, the grant agreement, and for ensuring that actions necessary for such accomplishment are taken by all subrecipients; and
(2) The lead entity is required to submit the ESG portions of the Action Plan and the CAPER for the entire geographic area encompassed by the joint agreement.
d. Cooperation agreement. The jurisdictions must execute a legally binding “cooperation agreement” that establishes each recipient's desire to combine their grant allocations and administer a joint ESG program, establishes which government will be the lead entity, identifies and authorizes the lead entity to act in a representative
e. Requirements of the joint request. The lead entity must submit the joint request to HUD before the entities start their Consolidated Plan in the eCon Planning Suite (this is because a single identification is required in the system). At a minimum, the joint request must include:
(1) A letter from the lead entity that identifies which governments seek to combine their grant allocations and administer a joint ESG program for their jurisdictions and indicates which federal fiscal year(s) grants the governments seek to combine;
(2) A copy of the cooperation agreement; and
(3) Documentation that shows the lead entity has sufficient authority and administrative capacity to administer the joint grant on behalf of the other government (if the joint agreement arrangement requires the lead entity to provide assistance outside its jurisdiction, the lead entity may want to consider including this in the documentation, specifically).
f. Approval of the joint request. A joint request will be deemed approved unless HUD notifies the city and the county otherwise within 45 days following submission of the joint request.
g. Consolidated Plan requirements.
(1) The metropolitan city and urban county must align their Consolidated Plan program years (done via the process at § 91.10).
(2) For the program year that the jurisdictions enter into a joint agreement, HUD is reviewing whether to require the lead entity to submit a new Consolidated Plan (because the former Consolidated Plan would no longer reflect the correct recipient and information). However, in the case that entities enter into a joint agreement in the middle of an urban county requalification period, this would not “restart the clock” for that time period.
i. Grant amount total. When two or more entities enter into a cooperation agreement and sign a joint grant agreement with HUD, the grant amount is the sum of the amounts authorized for the individual ESG recipients.
j. ESG subrecipient. An urban county or metropolitan city that has entered into a joint agreement under the ESG program is permitted to apply to the state for ESG funds, if the state allows.
8. Matching Requirement (§ 576.201):
HUD has received numerous questions seeking clarifications on the match requirements. HUD is carefully reviewing whether and how to amend and clarify this section, with the goal of helping recipients better understand the match requirement and be able to meet it. HUD seeks comment on the following ideas:
a. Additional sources of matching contributions. HUD received a comment requesting that HUD reconsider § 576.201(c)(1), in which all matching contributions must meet all requirements that apply to the ESG funds provided by HUD . . .” HUD is considering adding exceptions to this rule—that is, HUD is considering providing a list of activities that are not eligible to be paid for with ESG funds but could be used as match, because they are technically eligible according to the statute, but not by rule. This list would include costs such as: Training costs for ESG recipients/subrecipients at ESG-related (but not HUD-sponsored) conferences such as those hosted by the National Alliance to End Homelessness or the Council of State Community Development Agencies (COSCDA); or the cash value of
b. Cash match. HUD is considering additional ways to enable subrecipients to contribute match to the recipient's program to meet the matching requirement. Section 416 of the McKinney-Vento Homeless Assistance Act states that recipients are “required to supplement the [ESG funding] . . . with an equal amount of funds from sources other than [ESG].” HUD has interpreted this requirement to mean that the matching funds must be contributed to and used to support the recipient's ESG program. Any policy designed to improve flexibility must meet this statutory requirement. Given this restriction, HUD seeks feedback and ideas for ways to clarify or expand the current regulatory language to improve recipients' ability to meet the matching requirement. One possible scenario HUD is considering changing the regulation to allow is where a subrecipient conducts two (or more) ESG-eligible activities—for example, emergency shelter and rapid re-housing—but only has an agreement with the recipient to receive ESG funds for one—for example, rapid re-housing. HUD is considering changing the rule to allow the funds spent on emergency shelter activities (in this example) to be used to meet the matching requirement, if the activity is conducted in accordance with all ESG requirements and if the recipient includes this emergency shelter activity as a part of the recipient's overall program design (
c. Noncash contributions (depreciation of donated buildings) (§ 576.201(d)(2)). The interim rule does not allow the depreciation of the value of a donated building to be used as match, because currently, for donated buildings, match only includes the purchase value of the building in the year it was donated. HUD is considering allowing depreciation of donated buildings to be used as a source of in-kind match in the final rule, by changing the language at § 576.201(d)(2) to the following:
d. Memorandum of understanding for noncash services as match. For noncash services (
e. When to count matching funds. HUD proposes to clarify that the matching funds are counted as match for the ESG program when the allowable cost is incurred, or, for in-kind match,
f. Other programs as match for ESG. Sometimes, other programs cannot be used as match for ESG because their requirements conflict with ESG requirements. For example, HOME TBRA funds may be used for more than 24 months, whereas ESG funds are capped at 24 months of assistance (also, HOME TBRA funds must not require services, whereas ESG requires monthly case management under the interim rule—see section II.C.15.b. of this Notice). In the final rule, HUD is considering specifying that when HOME TBRA, or any program where the program time limit may be extended beyond 24 months, is used as match for the ESG Program funds, any renewal to extend that other program's assistance beyond 24 months would not invalidate its use as match for ESG for up to 24 months. In other words, the ESG recipient would be able to count as match the HOME TBRA funds that meet all of the ESG requirements for up to 24 months (if the case management requirement is removed, as discussed below), but not count any funds expended beyond that time period. HUD seeks comment on this idea.
9. Obligation, Expenditure, and Payment Requirements (§ 576.203(a)(i)):
a. State as HMIS lead. To account for situations where the state is the HMIS lead, HUD is considering augmenting the state obligation requirement, as follows: “
b. Exceptions. HUD is considering adding an exception to § 576.203, to allow HUD to grant a recipient an extension of up to 3 months for the obligation requirements and up to 12 months for the expenditure deadline, for good cause.
c. Subrecipient agreements. HUD is considering establishing, in the final rule, minimum elements that must be included in any subrecipient agreement. Although 2 CFR part 200 includes certain elements that must be provided to subrecipients at the time of the award (at 2 CFR part 200.331), the ESG rule contains more specific language about the ESG requirements that apply to subrecipients and language that must be included in the subrecipient agreement (such as any written standards the recipient requires the subrecipient to develop), so it might be helpful to include them all in one place. HUD seeks comment on whether it would be most helpful to include the minimum required elements for a subrecipient agreement in the regulation (
10. Pre-Award Costs (§ 576.204): HUD is reviewing whether to explicitly allow pre-award costs in the final rule, and to describe requirements that must be met before charging them to the grant. HUD is considering including the following language:
11. Reallocations (§§ 576.301, 576.302, and 576.303):
a. Timeframe for substantial amendments (§ 576.301(c), § 576.302(c), and § 576.303(d)). HUD is considering lengthening the time allowed for a recipient to submit a substantial amendment to its Consolidated Plan when the recipient has received reallocated funds, from 45 days after the date of notification to 60 or 90 days after the date of notification, or even allowing state recipients to reallocate the funds within its normal Consolidated Plan allocation process. This would allow recipients to have more time and flexibility to align the substantial amendment and funds with the following year's Consolidated Plan/Action Plan. HUD seeks comment on this proposal.
b. Reallocation of State ESG funds (§ 576.302). HUD is also considering changes to the process when a State declines its ESG allocation, which is described at § 576.302. HUD seeks comment on the following two options:
(1) Remove the paragraph at § 576.302(a)(2), which requires HUD to make ESG funds available to all of the non-urban counties in a state. HUD is considering this change because it believes it might be administratively infeasible for a number of reasons, including that each of the non-urban counties would be required to develop and submit an abbreviated Consolidated Plan that meets HUD's requirements. It is likely that the metropolitan cities and urban counties that already receive an allocation of CDBG funds are those best suited for, and capable of, administering the ESG program; or
(2) Change the requirement so that the funds declined by a state are distributed by formula to other state recipients.
c. Reallocation of local government ESG funds (§ 576.301(d)). HUD is considering the following change related to reallocation of grant funds returned by a metropolitan city or an urban county, under § 576.301(d) (changed or added sections italicized):
The same requirements that apply to grant funds allocated under § 576.3 apply to grant funds reallocated under this section, except that the state must distribute:
(ii) If funds remain, to private nonprofit organizations and units of general purpose local government located throughout the state; and
(iii) If funds remain, to private nonprofit organizations and units of general purpose local government located throughout the state,
12. Area-Wide Systems Coordination Requirements—Consultation and Coordination (§ 91.100(a)(2) and (d), § 91.110(b) and (e), § 576.400(a), (b), and (c)):
a. ESG recipient Consultation with Continuums of Care. HUD recognizes that for some ESG recipients, such as states that must coordinate with many CoCs and metropolitan cities/urban counties that must coordinate with regional CoCs, the requirements in this section of the regulation can present a challenge. However, HUD believes that this consultation process is critical for the ESG recipient to be able to plan for the best use of resources in the relevant area(s). HUD has received many questions about how ESG recipients should consult with the CoC(s) to meet the current requirements effectively. Based on these questions, HUD seeks general comment on the following questions to inform the inclusion of any additional consultation requirements in the final rule:
(1) The practices and processes that recipients and CoCs have used to meet the consultation requirements and
(2) HUD received a comment that it may be particularly difficult for ESG recipients to consult and coordinate with Balance of State CoCs. HUD is interested in hearing from other state recipients on whether they are experiencing a similar challenge. HUD also seeks comment on whether there are any requirements that could be added or removed from the interim rule to alleviate this issue.
(3) With respect to reallocation of funds under § 576.301, HUD is considering adding a stronger role for CoCs, in particular to help decide where the funds should be allocated. HUD is considering requiring that a state ESG recipient consult with the CoC covering the jurisdiction that returned the funds, and, if funds remain after the state distributed funds in accordance with § 576.301(d)(1), then the state must consult with CoCs covering other areas of the state in which it proposes to distribute the funds in accordance with § 576.301(d)(2). HUD seeks comment on this potential requirement.
(4) Should HUD specify different standards for consultation for different types or sizes of jurisdictions? For example, when the metropolitan city's or urban county's jurisdiction covers the exact geographic area as the CoC, HUD could require monthly consultation; for a county-based CoC with more than one ESG recipient, HUD could require consultation four times per year with each ESG recipient; for a state ESG recipient that includes multiple CoCs, HUD could require a lower level of consultation. HUD seeks feedback on this concept.
(5) Should HUD require an MOU between the CoC and the Consolidated Plan jurisdiction detailing how they will collaborate?
b. Defining “consultation,” “coordinating,” and “integrating.” HUD received several comments requesting a definition of “consultation” with CoCs (§ 576.400(a)), examples of “coordinating and integrating” ESG-funded activities with other programs targeted to homeless people in the area covered by the CoC (§ 576.400(b)) and with mainstream resources for which homeless and persons at risk of homelessness might be eligible (§ 576.400(c)). Therefore, HUD seeks comment on the following questions:
(1) Should definitions of “consultation,” “coordinating,” and “integrating” be included in HUD's regulations in 24 CFR part 91 and/or 24 CFR part 576? Considering the manner in which your jurisdiction currently consults, coordinates, and integrates, what should the definition(s) include? HUD is particularly interested in how an ESG recipient whose jurisdiction is incorporated into multiple CoCs' geographic areas, especially states, meets these requirements and what sort of definition would work best for these recipients.
(2) Instead of establishing one definition, HUD could require jurisdictions to define these terms themselves in their Consolidated Plan, and meet their own requirements. Would jurisdictions prefer this option? HUD specifically requests examples of definitions that jurisdictions would implement.
(3) Should HUD set a different standard for states? If so, how should it be different?
c. Improving collaboration between ESG recipients and CoCs. HUD is considering a change to the CoC Program interim rule and the ESG interim rule that would require all CoC boards to include a member from at least one Emergency Solutions Grants program (ESG) recipient's staff located within the CoC's geographic area. HUD would consider this change in order to promote meaningful collaboration between CoCs and ESG recipients. For states and other recipients whose jurisdictions cover more than one CoC, this might mean that a representative of the recipient would be required to be on multiple CoC boards. When a CoC's geographic area contains multiple ESG recipients' jurisdictions, it might mean that not all ESG recipients will be required to be on the CoC's board. However, when asked to participate on the CoC's board, ESG recipients would be required to participate. Ultimately, it is the responsibility of the CoC to develop a process for selecting the board. HUD is requesting comment on this proposed requirement for ESG recipients, including potential challenges. Ensuring that ESG recipients are coordinating closely with the CoC is important to HUD; therefore, in communities where ESG recipients and/or CoCs do not believe that this requirement is feasible, HUD asks commenters to provide suggestions for how ESG recipients can be involved in the CoC at one of the core decision-making levels.
d. Consulting with tribal groups. HUD received several comments requesting that HUD include tribal groups as a part of the required consultation process. Should HUD require consultation with tribal groups to the extent that the recipient intends to fund organizations serving people or activities on tribal lands?
e. Requiring coordination with CoC and Rural Housing Stability Programs (§ 576.400(b)). HUD proposes to add the CoC and Rural Housing Stability Programs to the list of “other targeted homeless services” with which ESG recipients must coordinate, at § 576.400(b).
f. Other feedback. In general, with respect to the consultation and coordination requirements:
(1) HUD seeks suggestions about particular provisions of the regulation that could be added or removed to assist with implementation and to make the process more useful for jurisdictions and CoCs.
(2) HUD also seeks feedback about current experiences with the consultation requirements, including what processes and procedures recipients are currently using to meet the requirements, how well these are working in the community, and whether there are specific impediments with the current consultation requirements.
13. Area-Wide Systems Coordination Requirements—Coordinated Assessment (§ 576.400(d)): HUD received numerous comments on the coordinated assessment requirement in the first public comment period, particularly related to what costs are eligible and how to charge them to the ESG grant. HUD is considering addressing these issues in guidance or including clarifications in the final rule. In addition, HUD intends to change the term “coordinated assessment” to “coordinated entry” in both the ESG and CoC final rules, and therefore uses the term “coordinated entry” in this Notice. However, HUD has also received questions about the following issues, and seeks comment as to whether any changes should be made in the final rule with respect to these questions:
a. Coordinated entry for walk-ins. How would coordinated entry work under circumstances where the recipient or subrecipient conducts intake based on who walks in—for example, legal services provided on site at a courthouse? Are there special considerations for such instances that HUD should consider in the final rule?
b. Coordinated entry and Street Outreach. Section 576.400(d): HUD is considering changing § 576.400(d) to clarify that that use of the coordinated entry is not required when providing services under the Street Outreach component. However, the use of coordinated entry will continue to be required by recipients and subrecipients of all other forms of ESG assistance.
14. Area-Wide Systems Coordination Requirements—Written Standards for ESG Recipients (§§ 91.220(l)(4) and 91.320(k)(3), and 576.400(e)): In its Action Plan, each ESG recipient must establish and consistently apply, or, if it is a state, elect to require that its subrecipients establish and consistently apply, written standards for providing ESG assistance, in accordance with § 91.320(k)(3) for states and § 91.220(l)(4) for metropolitan cities and urban counties and territories. HUD seeks comment on the following questions related to the required written standards:
a. When subrecipients receive ESG funds from multiple recipients. An ESG recipient or subrecipient could be subject to differing, or even conflicting, written standards. For example, this could occur when a nonprofit subrecipient receives ESG funds from both a state and local government and is subject to two sets of written standards. HUD seeks comments on recipient and subrecipient experiences with multiple funding sources and complying with conflicting written standards. Specifically:
(1) What have recipients and subrecipients done to resolve any conflicts or prevent confusion?
(2) Has this been a significant issue? Should HUD address this issue in the final rule, and if so, how? One option could be for HUD to require the local (metropolitan city or urban county) recipient's standards to supersede the state's standards when there is a conflict. What issues might arise if HUD were to establish this requirement?
b. Asset policy. Under the former Homelessness Prevention and Rapid Re-Housing Program (HPRP), HUD recommended that grantees and subgrantees develop policies to evaluate a household's assets, as a part of considering the full array of “resources and support networks” available to a program participant. HUD also recommended that this policy be consistent throughout the CoC. Under the ESG written standards, HUD is considering requiring recipients to develop such a policy regarding the treatment of assets, in order to more consistently and completely assess a household's resources during the initial and reevaluation for Homelessness Prevention and reevaluations for Rapid Re-housing assistance. HUD seeks comment on local experiences with this under HPRP and whether adding this as a requirement in the written standards would help provide consistency in assessing resources and assets during the initial evaluation and reevaluations for ESG assistance.
c. Written standards for subrecipients of local governments. In order to provide a greater amount of local flexibility in limiting and prioritizing eligibility for ESG assistance, HUD is considering allowing ESG recipients that are local governments and territories to pass the requirement to establish written standards down to their subrecipients, similar to the regulation for states at §§ 91.320(k)(3) and 576.400(e)(2).
d. Other feedback. HUD will carefully consider the written standards to be included in the final rule, and seeks feedback about the current written standards, based on recipient and subrecipient experiences. Specifically:
(1) How have the existing written standards helped the recipient or subrecipient design and run its ESG program?
(2) Are there other written standards that HUD should be require? Are there any that are not useful?
(3) Are there any where a slight clarification in the language would help recipients understand and implement the requirement more effectively?
e. Written standards for projects. If HUD were to adopt the definition of “project” proposed earlier in this Notice, HUD would consider allowing written standards to be established at the project level. The purpose of doing this would be to improve the ease of administering the program, for recipients and subrecipients. For example, if an emergency shelter project consists of more than one emergency shelter buildings, allowing a recipient—or even a subrecipient—to establish written standards at the project level may be administratively easier. HUD seeks comment on whether this would be helpful, or whether there might be any problems with adopting written standards at the project level.
f. Limiting eligibility and targeting ESG assistance. HUD proposes to specify, in the final rule (either in the written standards at § 576.400(e) or at § 576.407), when and how recipients and subrecipients may establish stricter criteria for eligibility and target assistance to particular groups and subpopulations of homeless persons. Under the interim rule, the recipient, or subrecipient, under limited circumstances, may only allow targeting or limiting of eligibility via the written standards; if not included with sufficient specificity, subrecipients may not target program participants or impose stricter eligibility criteria. For example, a project designed for homeless veterans and their families must serve homeless persons who are not veterans unless the applicable written standards explicitly authorize that project or project type to limit eligibility to veterans and their families. HUD seeks to make this process simpler, and establish clearer guidelines. HUD is considering allowing subrecipients to target and set stricter eligibility criteria with the approval of the recipient—without requiring that the policy be included in the written standards—or allowing the recipient to establish a policy for targeting or setting stricter eligibility criteria for all subrecipients in the written standards.
Specifically, HUD seeks comment on the following questions regarding the requirements at § 576.400(e) related to establishing stricter eligibility criteria or prioritizing ESG assistance:
(1) At what level should decisions about targeting and eligibility for homelessness prevention and rapid re-housing be made—the recipient level, the CoC level, the subrecipient level, or some combination? Have the existing requirements to include such decisions in the applicable written standards created an impediment to the recipient's or subrecipient's flexibility? If so, how?
(2) Likewise, at what level should decisions about emergency shelter and street outreach be made—the local government recipient level, the CoC level, the subrecipient level, or some combination?
(3) Is it burdensome for recipients to include specific policies for setting stricter eligibility criteria or targeting assistance in their written standards in the Action Plan?
(4) What impact would these proposed policies have on the program participants?
(5) HUD welcomes other feedback and thoughts about the targeting/eligibility proposal described above.
15. Evaluation of Program Participant Eligibility and Needs (§ 576.401):
a. Initial evaluations (§ 576.401(a)). HUD is reviewing whether to distinguish between an initial evaluation under the Street Outreach and Emergency Shelter components and an initial evaluation under the Homelessness Prevention and Rapid Re-housing components. Specifically, HUD is considering providing that, while an initial evaluation will still be required under Street Outreach and Emergency Shelter, the recipient/subrecipient will not be required to determine “the amount and type of assistance the individual or family needs to regain stability in permanent housing” as a part of the evaluation for assistance. HUD seeks feedback as to whether this would be helpful, or if any important information could be lost if HUD does not require this.
b. Housing stability case management requirements (§ 576.401(e)(i)). The interim rule requirements for monthly meetings with a case manager and developing a housing stability case plan are intended to help ensure that the ESG-funded emergency, short-, or medium-term assistance will be effective in assisting program participants regain long-term housing stability and avoid relapses into homelessness. It also has the effect of emphasizing that ESG is intended to serve those who are most in need of the assistance. Finally, it helps recipients ensure that they are spending scarce ESG funds on program participants that are still in the units. However, HUD received many comments about this requirement, and has also determined that this case management requirement prevents recipients and subrecipients from using HOME TBRA funds as match for ESG because services must not be mandatory when providing HOME TBRA assistance. HUD seeks additional comment on the following questions:
(1) HUD requests that recipients/subrecipients inform HUD about their experiences with these requirements; for example, how does your organization fulfill these requirements? If HUD were to clarify in the final rule that a meeting by phone or videoconference would suffice (which is allowed now but not explicit in the rule), does that make a difference? If HUD were to allow the monthly meeting to simply consist of a brief check-in or follow-up with the program participant (but still be charged as a case management activity), would that help?
(2) If HUD should change the requirement, what would be a more preferable case management requirement? For example, HUD could change the language to require program participants to meet with a case manager “at a frequency appropriate to the client's needs.” What might be the positive and negative effects of making this change?
(3) Are these requirements effective in assisting the program participants to achieve stability? Do they encourage recipients/subrecipients to serve those who are most in need? If not, then knowing that the intended purpose of case management is to ensure that the ESG-funded emergency, short- or medium-term assistance will be effective in helping program participants regain long-term housing stability and avoid relapses into homelessness, is there a requirement that could be added—instead of case management—that would meet the intended purpose, but not require recipients or subrecipients to conduct monthly case management?
16. Shelter and Housing Standards (§ 576.403): HUD received significant feedback and comment about the “habitability standards,” and seeks comments on the following proposals:
a. Essential services only (emergency shelters). Under the interim rule, if a shelter only receives ESG funds for essential services costs, it is not currently required to meet the minimum standards for emergency shelters at § 576.403(a). HUD is reviewing whether to require an emergency shelter to meet these minimum standards if the emergency shelter receives ESG funding for essential services. This would include emergency shelters, including day shelters that receive non-ESG funds for operating expenses but use ESG for the provision of essential services to persons in the shelter. It would not include a subrecipient that receives ESG for essential services only but is not an emergency shelter (
b. Housing Relocation and Stabilization Services only (Homelessness Prevention assistance to remain in unit). HUD is considering removing the requirement that a unit must meet the minimum habitability standards for permanent housing when homelessness prevention assistance, under § 576.105(b) (services only), is used to help a program participant remain in the unit. Alternatively, HUD could allow ESG funds to be used to help a program participant remain in their unit for a short time (up to 30 days) before an inspection is performed. In this case, if the unit does not meet the habitability standards at the time of inspection, recipients/subrecipients would be prohibited from using any additional ESG assistance to help the program participant remain in their unit; however, ESG funds could be used to help the program participant move to a new unit. HUD seeks comment on these two options.
c. Housing Quality Standards. Some recipients might prefer to use HUD's Housing Quality Standards (HQS) instead of the ESG habitability standards; however, HQS is less stringent in the areas of fire safety and interior air quality, which is why it cannot be used to meet the habitability standards under the interim rule. However, HUD recognizes that HQS is the standard used for other HUD programs, and allowing it to be used may reduce the burden of meeting this requirement for some recipients and subrecipients. Therefore, for the final rule, HUD is considering explicitly allowing a certification that a particular permanent housing unit meets HQS to qualify as meeting the minimum standards for permanent housing under ESG.
17. Conflicts of Interest (§ 576.404):
a. Organizational conflicts of interest (§ 576.404(a)). Based on experiences with HPRP, HUD included a provision in the ESG interim rule that was intended to ensure that recipients or subrecipients would not “feather their own nests”—that is, steer program participants into housing that they own or only serve those that are already in housing that they own. This provision, at § 576.404(a), states: “No subrecipient may, with respect to individuals or families occupying housing owned by the subrecipient, or a parent or subsidiary of the subrecipient, carry out the initial evaluation required under § 576.401 or administer homelessness prevention assistance under § 576.103.” With respect to this conflict of interest provision:
(1) HUD is considering including recipients in this conflict of interest requirement. Based on recipient/subrecipient experiences, is this an issue that warrants concern?
(2) For rapid re-housing only, HUD is considering removing this provision altogether. That is, HUD could allow recipients/subrecipients to rapidly re-house “Category 1” homeless program participants into housing that they or their parent/subsidiary organization owns, because in some cases, these providers might be some of the most well-suited in the community to provide the assistance that persons being rapidly re-housed need. Are there any potential issues with this? Should HUD leave the requirement in place as-is, to prevent potential steering or conflicts of interest?
(3) For homelessness prevention assistance and rapid re-housing assistance (if HUD retains the conflict of interest requirement for rapid re-housing), HUD is considering adding a provision to prohibit recipients/subrecipients from providing housing search and placement services to assist program participants to move into housing that the recipient/subrecipient owns. HUD seeks comment on this idea.
b. Individual conflicts of interest (§ 576.404(b)). It is generally HUD's policy under its homeless programs to prohibit personal conflicts of interest. For example, if a city staff member makes decisions about grants and also sits on the board of directors of a potential subrecipient, this should be a conflict of interest that requires an exception from HUD. This was omitted from the ESG interim rule; HUD is considering including this provision in
18. Other Federal Requirements—Limiting Eligibility and Targeting (§ 576.407): The emergency shelter or housing may be limited to a specific subpopulation so long as the recipient/subrecipient does not discriminate against any protected class under federal nondiscrimination laws in 24 CFR 5.105 (
a. Rapid Re-housing and Homelessness Prevention. A project
b. Emergency shelters. Recipients and subrecipients may exclusively serve a particular homeless subpopulation in emergency shelter if the shelter addresses a need identified by the recipient and meets one of the following conditions:
(1) The emergency shelter may be limited to one sex where it consists of a single structure with shared bedrooms or bathing facilities such that the considerations of personal privacy and the physical limitations of the configuration of the emergency shelter make it appropriate for the shelter to be limited to one sex;
(2) The shelter may be limited to families with children, but if it serves families with children, it must serve all families with children (it may not separate based on the age of a child under 18, regardless of gender);
(3) If the shelter serves at least one family with a child under the age of 18, the shelter may exclude registered sex offenders and persons with a criminal record that includes a violent crime from the project so long as the child is served in the shelter; and
(4) An emergency shelter may limit admission to or provide a preference to subpopulations of homeless individuals and families who need the specialized services provided (
19. Recordkeeping and Reporting Requirements (§ 576.500):
a. At risk of homelessness (§ 576.500(c)(1)(iv)). Under the “at risk of homelessness” recordkeeping requirements at § 576.500(c)(1)(iv), HUD is considering including, in the final rule, specific documentation standards for each of the seven conditions that would be required for a program participant to qualify for assistance under this definition. Note that HUD will consider comments received here with the other comments requested on this characteristic earlier in this document. The changes are as follows:
(A) Has moved because of economic reasons two or more times during the 60 days immediately preceding the application for homelessness prevention assistance. Acceptable documentation includes, but is not limited to:
(B) Is living in the home of another because of economic hardship. Acceptable documentation includes, but is not limited to:
(C) Has been notified in writing that their right to occupy their current housing or living situation will be terminated within 21 days after the date of application for assistance. Acceptable documentation is:
(D) Lives in a hotel or motel and the cost of the hotel or motel stay is not paid by charitable organizations or by Federal, State, or local government programs for low-income individuals. Acceptable documentation includes, but is not limited to:
(E) Lives in a single-room occupancy or efficiency apartment unit in which there reside more than two persons or lives in a larger housing unit in which there reside more than 1.5 persons per room, as defined by the U.S. Census Bureau. Acceptable documentation includes, but is not limited to:
(F) Is exiting a publicly funded institution, or system of care. Acceptable documentation is:
(G) Otherwise lives in housing that has characteristics associated with instability and an increased risk of homelessness, as identified in the recipient's approved Consolidated Plan. Acceptable documentation includes, but is not limited to:
b. Determinations of ineligibility—Street Outreach (§ 576.500(d)). HUD is proposing that for the Street Outreach component, HUD will not require recipients/subrecipients to keep documentation of the reason(s) for determinations of ineligibility, in order to reduce a recordkeeping burden. HUD seeks comment on any issues that may arise if this requirement is eliminated.
c. Maintenance of effort recordkeeping requirement (§ 576.500(l)). The interim rule states: “The recipient and its subrecipients that are units of general purpose local government must keep records to demonstrate compliance with the maintenance of effort requirement, including records of the unit of the general purpose local government's annual budgets and sources of funding for street outreach and emergency shelter services.” This might be an overly burdensome recordkeeping requirement for recipients and subrecipients that are in compliance with this requirement—that is, how does a local government demonstrate that it is
d. Records of services and assistance provided (§ 576.500(l)). Currently, only recipients are required to “keep records of the types of essential services, rental assistance, and housing stabilization and relocation services provided under the recipient's program, and the amounts spent on these services and assistance.” HUD is considering adding “and subrecipients” to this recordkeeping requirement, and seeks comment on whether this change would be burdensome or useful.
e. Period of record retention (§ 576.500(y)(2) and (3)). Under the interim rule, records for major renovation or conversion must be retained until 10 years after the date ESG funds are first obligated, but the minimum period of use requirements, at § 576.102(c)(1), begin at the date of first occupancy after the completed renovation. HUD is considering whether to change the record retention requirements so that they are the same as the “minimum period of use” requirements in § 576.102(c), as follows: “
20. Recipient Sanctions (§ 576.501(c)): Under the interim rule, at § 576.501(c), when a recipient reallocates or reprograms ESG funds as a part of subrecipient sanctions, these funds must be expended by the same deadline as all other funds. HUD is considering removing this expenditure requirement to provide recipients, especially states, with additional flexibility in situations where a subrecipient compliance issue or other impediment causes delays in the recipient's ability to expend all of the funds by the 24-month deadline. HUD seeks comment on this proposal.
Bureau of Safety and Environmental Enforcement (BSEE), Interior.
Notice of proposed rulemaking; extension of comment period.
The BSEE is extending the public comment period on the Notice of proposed rulemaking entitled “Oil and Gas and Sulphur Operations on the Outer Continental Shelf—Blowout Preventer Systems and Well Control,” which was published in the
The comment period for the notice of proposed rulemaking published in the
You may submit comments on the proposed rulemaking by any of the following methods. Please use the Regulation Identifier Number (RIN) 1014-AA11 as an identifier in your message.
• Federal eRulemaking Portal:
• Mail or hand-carry comments to the Department of the Interior (DOI); Bureau of Safety and Environmental Enforcement; Attention: Regulations and Standards Branch; 45600 Woodland Road, Sterling, Virginia 20166. Please reference “Oil and Gas and Sulphur Operations on the Outer Continental Shelf—Blowout Preventer Systems and Well Control, 1014-AA11” in your comments and include your name and return address. Please note that this address for BSEE is new; however, any comments already submitted to BSEE's former address (381 Elden St., Herndon, VA 20171) do not need to be resubmitted to the new address.
• Public Availability of Comments—Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Kirk Malstrom, Regulations and Standards Branch, 202-258-1518,
The BSEE published a notice of proposed rulemaking on Blowout Preventer Systems and Well Control on April 17, 2015 (80 FR 21504). This proposed rule is intended to consolidate equipment and operational requirements that are common to other subparts pertaining to offshore oil and gas drilling, completions, workovers, and decommissioning. This proposed rule would focus, at this time, on blowout preventer (BOP) requirements, including incorporation of industry standards and revision of existing regulations. The proposed rule would also include reforms in the areas of well design, well control, casing, cementing, real-time well monitoring, and subsea containment. The proposed rule would address and implement multiple recommendations resulting from various investigations of the
After publication of the proposed rule, BSEE received requests from various stakeholders asking BSEE to extend the comment period on the proposed rule. The majority of those requests sought extensions of 120 days, which would triple the length of the original 60-day comment period. One comment requested a 30-day extension. BSEE also received a written comment from another stakeholder urging BSEE not to extend the comment period because the proposed rule has been in development since the
The BSEE has considered those requests and has determined that extending the original 60-day comment period by an additional 30 days will provide sufficient additional time for review of and comment on the proposal without unduly delaying a final rulemaking decision. Accordingly, written comments must be submitted by the extended due date of July 16, 2015. The BSEE may not fully consider comments received after this date.
Bureau of Land Management, Interior.
Advance notice of proposed rulemaking; extension of comment period.
On April 21, 2015, the Bureau of Land Management (BLM) published in the
The comment period for the ANPR published April 21, 2015 (80 FR
Dylan Fuge, Office of the Director, at 202-208-5235, Steven Wells, Division of Fluid Minerals, at 202-912-7143, or Jully McQuilliams, Division of Fluid Minerals, at 202-912-7156, for information regarding the substance of this ANPR. For information on procedural matters or the rulemaking process generally, you may contact Anna Atkinson, Regulatory Affairs, at 202-912-7438. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339, 24 hours a day, 7 days a week to contact the above individuals.
If you wish to comment, you may submit your comments by any one of several methods:
Please make your comments as specific as possible by confining them to issues directly related to the content of the ANPR, and explain the basis for your comments. The comments and recommendations that will be most useful and likely to influence agency decisions are:
1. Those supported by quantitative information or studies; and
2. Those that include citations to, and analyses of, the applicable laws and regulations.
The BLM is not obligated to consider or include in the Administrative Record for the rule comments received after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the address listed under
Before including your address, telephone number, email address, or other personal identifying information in your comment, be advised that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask in your comment to withhold from public review your personal identifying information, we cannot guarantee that we will be able to do so.
The ANPR was published on April 21, 2015 (80 FR 22148), with a 45-day comment period closing on June 5, 2015. The ANPR poses questions and seeks information related to potential updates and changes to the BLM's existing regulations governing Federal onshore oil and gas leases related to royalty rates, annual rental payments, minimum acceptable bids, bonding requirements, and civil penalty assessments. Following publication of the ANPR, the BLM received requests for extension of the comment period. In response to those requests, the BLM has decided to extend the comment period on the rule for 14 days, until June 19, 2015.
Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Proposed rule.
DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement sections of the Small Business Jobs Act of 2010 and regulatory changes made by the Small Business Administration, which provide for a Governmentwide policy on the consolidation and bundling of contract requirements.
Interested parties should submit written comments to the Regulatory Secretariat at one of the addresses shown below on or before August 3, 2015 to be considered in the formation of the final rule.
Submit comments in response to FAR Case 2014-015 by any of the following methods:
•
•
Ms. Mahruba Uddowla, Procurement Analyst, at 703-605-2868, for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite FAR Case 2014-015.
DoD, GSA, and NASA are proposing to revise the FAR to implement regulatory changes made by the Small Business Administration (SBA) in its final rule which was published in the
Section 1312 of the Jobs Act amends the Small Business Act at 15 U.S.C. 644(q) to require Federal agencies to include in each solicitation for any multiple-award contract above the substantial bundling threshold of the Federal agency a provision soliciting bids from any responsible source, including responsible small business teaming arrangements or joint ventures of small business concerns. Section 1312 requires the FAR be amended to establish a Governmentwide policy regarding contract bundling, including regarding the solicitation of teaming and joint ventures, and to require agencies to publish said policy on their agency Web site. Section 1312 also requires the head of the Federal agency to publish on the Web site of the Federal agency a list and rationale for any bundled contract for which the Federal agency solicited bids or that was awarded by the agency.
Section 1313 amends the Small Business Act at 15 U.S.C. 657q to define the term “consolidation of contract requirements” to mean the use of a solicitation to obtain offers for a single contract or a multiple-award contract to satisfy two or more requirements of the Federal agency for goods or services that have been provided to or performed for the Federal agency under two or more separate contracts, each of which was lower in cost than the total cost of the contract for which the offers are solicited. The National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013 (2013 NDAA), Public Law 112-239, section 1671 further amended the definition of consolidation to include construction requirements.
Further, section 1313 prohibits the agency from carrying out an acquisition strategy that includes consolidation of contract requirements of the Federal agency with an estimated total value exceeding $2 million, unless the Senior Procurement Executive or Chief Acquisition Officer for the Federal agency, before carrying out the acquisition strategy—
• Conducts market research;
• Identifies any alternative contracting approach that would involve a lesser degree of consolidation of contract requirements;
• Makes a written determination that the consolidation of contract requirements is necessary and justified;
• Identifies any negative impact by the acquisition strategy on contracting with small business concerns; and
• Ensures that steps will be taken to include small business concerns in the acquisition strategy.
Amendments to the FAR are proposed by this rule. The proposed changes are summarized in the following paragraphs.
A.
B.
C.
• FAR 7.103—This section is amended to clarify that agencies are to ensure that unnecessary and unjustified consolidation is avoided.
• FAR 7.104—This section is amended to remove the substantial bundling thresholds at FAR 7.104. The substantial bundling thresholds are relocated to the proposed new section FAR 7.107-4, Substantial Bundling, for clarity and consistency with the new proposed structure of FAR 7.107. An additional revision was made to clarify that small business is to be a discipline that is represented in the acquisition planning team.
• FAR 7.105—This section is amended by adding a reference to the statutory authority for limiting the use of acquisition strategies involving the consolidation of contract requirements.
• FAR 7.107—This section is amended by revising the title of the section and adding the statutory authority for the consolidation of contract requirements. This section also proposes to clarify that if a requirement is considered both consolidated and bundled, the agency must follow the guidance regarding bundling. In addition, this section is amended by restructuring FAR 7.107 to add proposed subsections FAR 7.707-1, General, FAR 7.107-2, Consolidation of contract requirements, FAR 7.107-3 Bundling, FAR 7.107-4 Substantial Bundling, FAR 7.107-5 Notifications, and 7.107-6 Solicitation provision. The proposed revisions are as follows:
○ FAR 7.107-1—General. This proposed new section provides information relevant to both consolidation and bundling, such as evaluation of benefits, substantial benefits, and applicability.
○ FAR 7.107-2—Consolidation of contract requirements. This proposed new section is added to clarify that an agency may not conduct an acquisition exceeding $2 million that is a consolidation of contract requirements unless the agency's Senior Procurement Executive or Chief Acquisition Officer: (1) Justifies the consolidation by showing that the benefits of the consolidated acquisition substantially exceed the benefits of each possible alternative approach that would involve a lesser degree of consolidation and (2) identify any negative impact by the acquisition strategy on contracting with small business concerns.
○ FAR 7.107-3—Bundling. This proposed new section clarifies language regarding the requirements a contracting officer must adhere to prior to conducting an acquisition strategy that involves the bundling of contract requirements.
○ FAR 7.107-4—Substantial Bundling. This proposed new section includes the substantial bundling thresholds relocated from FAR 7.104(d) and existing documentation requirements.
○ FAR 7.107-5—Notifications. This proposed new section is added to require Federal agencies to: (1) Notify current small business contractors of an agency's intent to bundle a contract requirement that was not previously bundled at least 30 days prior to the issuance of the solicitation; (2) provide public notification of an agency's intent to bundle by publishing on the agency's
○ FAR 7.107-6—Solicitation Provision. This proposed new section is added to prescribe a new provision 52.207-XX “Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts)”, in solicitations for multiple-award contracts that are estimated to be above the agency's substantial bundling threshold.
D.
E.
F.
G.
• FAR 15.304, Evaluation factors and significant subfactors. This section is amended by adding references to the consolidation of contract requirements.
H.
• FAR 16.505, Ordering. This section is amended to apply consolidation requirements to orders.
• FAR 16.506, Solicitation provisions and contract clauses. This section is amended by adding a cross-reference to the prescription in FAR Subpart 7.1 for a new provision “Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts)”.
I.
• FAR 19.201 General policy and 19.202-1 Encouraging small business participation in acquisitions. These sections are amended by adding references to the consolidation of contract requirements.
J.
• FAR 52.207-XX, Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts). This section is amended to include this provision in solicitations for multiple-award contracts when the estimated contract value is expected to exceed the agency's substantial bundling threshold. The agency shall consider offers from any responsible source, including responsible small business concerns and teaming arrangements or joint ventures of small business concerns.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
The change may have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
DoD, GSA, and NASA are proposing to amend the FAR to provide uniform guidance consistent with SBA's final rule which was published in the
The objective of this proposed rule is to alleviate the adverse effects of contract bundling and consolidation on small business concerns competing for Federal contracts. This rule provides a balance between the benefits of bundling and consolidation and the obstacles they create for small businesses. The authorizing legislation for this action is sections 1312 and 1313 of the Small Business Jobs Act of 2010, Public Law 111-240, and section 1671 of the NDAA for FY 2013 Public Law 112-239. Section 1671 in conjunction with section 1313 now provides for a Governmentwide requirement and threshold for consolidated contracts.
This rule may have a positive economic impact on any small business entity that wishes to participate in the Federal procurement arena. Analysis of the System for Award Management (SAM) database indicates there are over 351,203 small business registrants that can potentially benefit from the implementation of this rule.
This rule does not impose any new reporting, recordkeeping or other compliance requirements. The rule does not duplicate, overlap, or conflict with any other Federal rules.
The Regulatory Secretariat has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat. DoD, GSA, and NASA invite comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2014-015), in correspondence.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, DoD, GSA, and NASA propose amending 48 CFR parts 2, 5, 7, 8, 10, 12, 15, 16, 19, and 52 as set forth below:
40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 51 U.S.C. 20113.
The revised and added text reads as follows:
(b) * * *
(2) * * *
(1) Means the consolidating or combining of two or more requirements for supplies or services, previously provided or performed under separate smaller contracts, into a solicitation for a single contract, a multiple-award contract, a task order or delivery order that is likely to be unsuitable for award to a small business concern (but may be suitable for award to a small business with a Small Business Teaming Arrangement) due to—
(i) The diversity, size, or specialized nature of the elements of the performance specified;
(ii) The aggregate dollar value of the anticipated award;
(iii) The geographical dispersion of the contract performance sites; or
(iv) Any combination of the factors described in paragraphs (1)(i), (ii), and (iii) of this definition.
(2) “Separate smaller contract” as used in this definition, means a contract that has been performed by one or more small business concerns or that was suitable for award to one or more small business concerns.
(3) This definition does not apply to a contract that will be awarded and performed entirely outside of the United States.
(4) (See 7.107-4 for a description of substantial bundling.)
(1) Means a solicitation for a single contract, a multiple-award contract, a task order, or a delivery order to satisfy—
(i) Two or more requirements of the Federal agency for supplies or services that have been provided to or performed for the Federal agency under two or more separate contracts, each of which was lower in cost than the total cost of the contract for which offers are solicited; or
(ii) Requirements of the Federal agency for construction projects to be performed at two or more discrete sites.
(2)
(1) Means an arrangement where—
(i) Two or more small business concerns have formed a joint venture; or
(ii) A potential small business prime contractor (“offeror”) agrees with one or more other small business concerns to have them act as its subcontractors under a specified Government contract. A Small Business Teaming Arrangement between the offeror and its small business subcontractor(s) exists through a written agreement between the parties that—
(A) Is specifically referred to as a
(B) Sets forth the different responsibilities, roles, and percentages (or other allocations) of work as it relates to the acquisition; and
(2) May include two business concerns in a mentor-protege relationship so long as both the mentor and the protege are small or the protege is small and the concerns have received an exception to affiliation pursuant to 13 CFR 121.103(h)(3)(ii) or (iii).
(3) See 13 CFR 121.103(b)(9) regarding the exception to affiliation for offers received from Small Business Teaming Arrangements.
(g)
(u) * * *
(2) Avoid unnecessary and unjustified consolidation or bundling of contract requirements that precludes small business participation as prime contractors (see 7.107) (15 U.S.C. 631(j) and 15 U.S.C. 657(q)).
(d) The planner shall coordinate the acquisition plan or strategy with the cognizant small business specialist when the strategy contemplates an acquisition meeting the dollar amounts for substantial bundling unless the contract or task order or delivery order is entirely reserved or set-aside for small business under part 19. The small business specialist shall notify the agency Office of Small and Disadvantaged Business Utilization or the Office of Small Business Programs if the strategy involves consolidation or bundling that is unnecessary, unjustified, or not identified as consolidated or bundled by the agency (see 7.107 for further guidance regarding consolidation and bundling).
(b)
(ii) Consider required sources of supplies or services (see part 8) and sources identifiable through databases including the Governmentwide database of contracts and other procurement instruments intended for use by multiple agencies available at
(iii) Include consideration of small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns (see part 19).
(iv) Consider the impact of any consolidation or bundling that might affect participation of small businesses in the acquisition (see 7.107) (15 U.S.C. 644(e) and 15 U.S.C. 657(q)). When the proposed acquisition strategy involves the consolidation or bundling of contract requirements, identify the incumbent contractors and contracts affected by the consolidation or bundling.
(v) Address the extent and results of the market research and indicate their impact on the various elements of the plan (see part 10).
(a) Consolidation and bundling of contract requirements may provide substantial benefits to the Government. However, because of the potential impact on small business participation, the agency shall conduct market research and any required analysis to determine whether consolidation is necessary and justified in accordance with 15 U.S.C. 657(q) or if bundling is necessary and justified pursuant to 15 U.S.C. 644(e)(2).
(b) A consolidated or bundled requirement is necessary and justified if the benefits of the acquisition strategy substantially exceed the benefits of each of the possible alternative contracting approaches identified.
(c) Such benefits may include—
(1) Cost savings;
(2) Price reduction;
(3) Quality improvements that will save time or improve or enhance performance or efficiency;
(4) Reduction in acquisition cycle times, or
(5) Better terms and conditions.
(d) Benefits are substantial if individually, in combination, or in the aggregate the anticipated financial benefits are equivalent to—
(1) Ten percent of the estimated contract or order value (including options) if the value is $94 million or less; or
(2) Five percent of the estimated contract or order value (including options) or $9.4 million, whichever is greater, if the value exceeds $94 million.
(e) Reduction of administrative or personnel costs alone is not sufficient justification for consolidation or bundling unless the cost savings are expected to be at least 10 percent of the estimated contract or order value (including options) of the consolidated or bundled requirements. For consolidated requirements, the Senior Procurement Executive or Chief Acquisition Officer must make a determination of the cost savings (15 U.S.C. 657(q)(c)(2)).
(f) If the requirement is considered both consolidated and bundled, the agency shall follow the guidance regarding bundling in 7.107-3 and 7.107-4).
(g) The requirements of this section do not apply—
(1) Except 7.107-4, if a cost comparison analysis will be performed in accordance with OMB Circular A-76; and
(2) To orders against single-agency task-order contracts or delivery-order contracts, if the requirement was considered in determining that the consolidation or bundling of the underlying contract was necessary and justified.
(a) Before conducting an acquisition that is a consolidation of contract requirements with an estimated total dollar value exceeding $2 million, the Senior Procurement Executive or Chief Acquisition Officer shall make a written determination that the consolidation of contract requirements is necessary and justified, after ensuring that—
(1) Market research has been conducted;
(2) Any alternative contracting approaches that would involve a lesser degree of consolidation of contract requirements have been identified;
(3) The determination is coordinated with the agency's Office of Small Disadvantaged Business Utilization or the Office of Small Business Programs;
(4) Any negative impact by the acquisition strategy on contracting with small business concerns has been identified; and
(5) Steps are taken to include small business concerns in the acquisition strategy.
(b) The Senior Procurement Executive or Chief Acquisition Officer may determine that the consolidation of contract requirements is necessary and justified if, as compared to the benefits that would be derived from the alternative contracting approaches identified under paragraph (a)(2) of this subsection, consolidation would derive substantial benefits (see 7.107-1(d)).
(c) If a determination is made, the contracting officer shall include it in the acquisition strategy documentation and provide it to SBA upon request.
(a) Before conducting an acquisition strategy that involves the bundling of contract requirements, the agency shall make a written determination that the bundling is necessary and justified. A bundled requirement is considered necessary and justified if the agency would obtain measurably substantial benefits as compared to meeting its agency's requirements through separate smaller contracts or orders.
(b) The agency shall quantify the specific benefits identified through the use of market research and other techniques to explain how their impact would be measurably substantial (see 10.001(a)(2)(iv) and (a)(3)(vi)).
(c) Without power of delegation, the service acquisition executive for the military departments, the component acquisition executive for the Defense Logistics Agency, the Under Secretary of Defense for Acquisition, Technology and Logistics for the defense agencies, or the Deputy Secretary or equivalent for the civilian agencies may determine that bundling is necessary and justified when—
(1) The expected benefits do not meet the thresholds for a substantial benefit but are critical to the agency's mission success; and
(2) The acquisition strategy provides for maximum practicable participation by small business concerns.
(d) In assessing whether cost savings and/or price reduction would be achieved through bundling, the agency and SBA shall—
(1) Compare the price that has been charged by small businesses for the work that they have performed; or
(2) Where previous prices are not available, compare the price, based on market research, that could have been or could be charged by small businesses for the work not previously performed by other than a small business.
(e) If a determination is made, the contracting officer shall include it in the acquisition strategy documentation and provide it to SBA upon request.
(a)(1) Substantial bundling is any bundling that results in a contract or order with an estimated value of—
(i) $8 million or more for the Department of Defense;
(ii) $6 million or more for the National Aeronautics and Space Administration, the General Services Administration, and the Department of Energy; or
(iii) $2.5 million or more for all other agencies.
(2) These thresholds apply to the cumulative estimated dollar value (including options) of—
(i) Multiple-award contracts;
(ii) Task orders or delivery orders issued against a GSA Schedule contract; or
(iii) Task orders or delivery orders issued against a task-order or delivery-order contract awarded by another agency.
(b) In addition to addressing the requirements for bundling (see 7.107-3), when the proposed acquisition strategy involves substantial bundling, the agency shall document in its strategy—
(1) The specific benefits anticipated to be derived from substantial bundling;
(2) An assessment of the specific impediments to participation by small business concerns as contractors that result from substantial bundling;
(3) Actions designed to maximize small business participation as contractors, including provisions that encourage small business teaming;
(4) Actions designed to maximize small business participation as subcontractors (including suppliers) at any tier under the contract, or order, that may be awarded to meet the requirements;
(5) The determination that the anticipated benefits of the proposed bundled contract or order justify its use; and
(6) Alternative strategies that would reduce or minimize the scope of the bundling, and the rationale for not choosing those alternatives.
(a)
(1) The contracting officer shall notify each small business performing a contract that it intends to bundle the requirement with one or more other requirements at least 30 days prior to the issuance of the solicitation for the bundled requirement.
(2) The notification shall provide the name, phone number and address of the applicable SBA procurement center representative (PCR), or if a PCR is not assigned to the procuring activity, the SBA Office of Government Contracting Area Office serving the area in which the buying activity is located (see subpart 19.4 regarding the duties and responsibilities of the SBA PCR).
(3) This notification shall be documented in the contract file.
(b)
(1) The agency shall publish on its Web site a list and rationale for any bundled requirement for which the agency solicited offers or issued an award. The notification shall be made within 30 days of the agency's data certification regarding the validity and verification of data entered in the Federal Procurement Data System to the Office of Federal Procurement Policy (see 4.604).
(2) In addition, the agency is encouraged to provide to
(c)
(1) The amount of savings and benefits achieved under the prior consolidation or bundling of contract requirements;
(2) Whether such savings and benefits will continue to be realized if the contract remains consolidated or bundled; and
(3) Whether such savings and benefits would be greater if the procurement requirements were divided into separate solicitations suitable for award to small business concerns.
(d)
The contracting officer shall insert the provision at 52.207-XX, Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts), in solicitations for multiple-award contracts above the substantial bundling threshold of the agency.
(c) * * *
(2) Shall comply with all FAR requirements for a consolidated or bundled contract when the task order or delivery order meets the definition at 2.101(b) of “consolidation” or “bundling”; and
(a) * * *
(2) * * *
(iv) Before soliciting offers for acquisitions that could lead to a consolidated or bundled contract (15 U.S.C. 644(e)(2)(A) and 15 U.S.C. 657q);
(B) Disaster relief to include debris removal, distribution of supplies, reconstruction, and other disaster or emergency relief activities (see 26.205); and
(3) * * *
(vi) Determine whether consolidation is necessary and justified (see 7.107-2) (15 U.S.C. 657q);
(vii) Determine whether bundling is necessary and justified (see 7.107-3) (15 U.S.C. 644(e)(2)(A)); and
(c) If an agency contemplates awarding a consolidated or bundled contract, the agency—
(1) When performing market research, should consult with the agency small business specialist and the local Small Business Administration procurement center representative (PCR). If a PCR is not assigned, see 19.402(a); and
(2) Shall notify any affected incumbent small business concerns of the Government's intention to bundle the requirement and how small business concerns may contact the appropriate Small Business Administration procurement center representative (see 7.107-5(a).
(d) * * *
(3) Insert the provision at 52.207-XX, Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts), as prescribed at 7.107-6.
(c) * * *
(3) * * *
(ii) For solicitations involving the consolidation of contract requirements or bundling that offer a significant opportunity for subcontracting, the contracting officer shall include a factor to evaluate past performance indicating the extent to which the offeror attained applicable goals for small business participation under contracts that required subcontracting plans (15 U.S.C. 637(d)(4)(G)(ii)).
(4) For solicitations involving the consolidation of contract requirements or bundling that offer a significant opportunity for subcontracting, the contracting officer shall include proposed small business subcontracting participation in the subcontracting plan as an evaluation factor (15 U.S.C. 637(d)(4)(G)(i)).
(a) * * *
(8) * * *
(iii) Shall comply with all FAR requirements for a consolidated or bundled contract when the task order or delivery order meets the definition at 2.101(b) of “consolidation” or “bundling”.
(i) See 7.107-6 for use of 52.207-XX, Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangement or Joint Ventures (Multiple-Award Contracts) in solicitations for multiple-award contracts above the substantial bundling threshold of the agency.
(c) * * *
(5) * * *
(i) Identify proposed solicitations that involve significant bundling and work with the agency acquisition officials and SBA to revise the procurement strategies for such proposed solicitations to increase the probability of participation by small businesses as prime contractors through Small Business Teaming Arrangements;
(11) * * *
(ii) Adequacy of consolidated or bundled contract documentation and justifications; and
(iii) Actions taken to mitigate the effects of necessary and justified consolidation of contract requirements or contract bundling on small businesses.
(e)(1) * * *
(iii) The proposed acquisition is for a consolidated or bundled requirement. (See 7.107-5(a) for mandatory 30-day notice requirement to incumbent small business concerns.) The contracting officer shall provide all information relative to the justification for the consolidation of contract requirements or contract bundling, including the acquisition plan or strategy, and if the acquisition involves substantial bundling, the information identified in 7.107-4. The contracting officer shall also provide the same information to the agency Office of Small and Disadvantaged Business Utilization.
(2) Provide a statement explaining why the—
(v) The consolidation of contract requirements or bundling is necessary and justified.
(3) Process the 30-day notification concurrently with other processing steps required prior to the issuance of the solicitation.
(4) If the contracting officer rejects the SBA procurement center representative's recommendation made in accordance with 19.402(c)(2), document the basis for the rejection and notify the SBA procurement center representative in accordance with 19.505.
As prescribed in 7.107-6, insert the following provision:
(a)
(1) Means an arrangement where—
(i) Two or more small business concerns have formed a joint venture; or
(ii) A potential small business prime contractor (“offeror”) agrees with one or more other small business concerns to have them act as its subcontractors under a specified Government contract. A Small Business Teaming Arrangement between the offeror and its small business subcontractor(s) exists through a written agreement between the parties that—
(A) Is specifically referred to as a “Small Business Teaming Arrangement” or “Small Business Teaming Agreement”; and
(B) Sets forth the different responsibilities, roles, and percentages (or other allocations) of work as it relates to the acquisition; and
(2) May include two business concerns in a mentor-protege relationship so long as both the mentor and the protege are small or the protege is small and the concerns have received an exception to affiliation pursuant to 13 CFR 121.103(h)(3)(ii) or (iii).
(3) See 13 CFR 121.103(b)(9) regarding the exception to affiliation for offers received from Small Business Teaming Arrangements.
(b) The Government is soliciting and will consider offers from any responsible source, including responsible small business concerns and offers from Small Business Teaming Arrangements or joint ventures of small business concerns.
Animal and Plant Health Inspection Service, USDA.
Extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Animal and Plant Health Inspection Service (APHIS) to request an extension of approval of an information collection associated with the regulations to allow States to impose prohibitions or restrictions on specific articles in addition to those required by APHIS to help protect against the introduction and establishment of plant pests.
We will consider all comments that we receive on or before August 3, 2015.
You may submit comments by either of the following methods:
• Federal eRulemaking Portal: Go to
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2015-0039, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.
Supporting documents and any comments we receive on this docket may be viewed at
For information on special need requests under the Plant Protection Act, contact Mr. Jonathan Jones, National Policy Manager, PHP, PPQ, APHIS, 4700 River Road Unit 137, Riverdale, MD 20737; (301) 851-2128. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
The regulations in “Subpart-Preemption and Special Need Requests” allow States or political subdivisions of States to request approval from APHIS to impose prohibitions or restrictions on the movement in interstate commerce of specific articles that pose a plant health risk that are in addition to the prohibitions and restrictions imposed by APHIS. This process requires information collection activities, including a pest data detection survey with a pest risk analysis showing that a pest is not present in a State, or, if already present, the current distribution in the State, and that the pest would harm or injure the environment and/or agricultural resources of the State or political subdivision.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Animal and Plant Health Inspection Service, USDA.
Extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with qualitative customer and stakeholder feedback on service delivery by the Animal and Plant Health Inspection Service.
We will consider all comments that we receive on or before August 3, 2015.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For copies of more detailed information on this information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, IMC, ITD, MRPBS, APHIS, 4700 River Road Unit 123, Riverdale, MD 20737; (301) 851-2727.
By qualitative feedback, we mean information that provides useful insights on perceptions and opinions, but not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences, and expectations; provide an early warning of issues with service; or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services. This collection will allow for ongoing generic, collaborative, and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.
The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on Agency's services will be unavailable.
APHIS will only submit a collection for approval under this generic clearance if it meets the following conditions:
• The collection is voluntary;
• The collection is low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and is low-cost for both the respondents and the Federal Government;
• The collection is non-controversial and does not raise issues of concern to other Federal agencies;
• The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;
• Personally identifiable information is collected only to the extent necessary and is not retained;
• Information gathered is intended to be used only internally for general service improvement and program management purposes and is not intended for release outside of APHIS (if released, APHIS must indicate the qualitative nature of the information);
• Information gathered will not be used for the purpose of substantially informing influential policy decisions;
• Information gathered will yield qualitative information; and
• The collection will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.
Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding this study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
As a general matter, this information collection will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the collection
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Animal and Plant Health Inspection Service, USDA.
Extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with health certificates for the export of live crustaceans, finfish, mollusks, and related products.
We will consider all comments that we receive on or before August 3, 2015.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For information on health certificates for the export of live crustaceans, finfish, mollusks, and related products, contact Dr. Christa Speekmann, Import-Export Specialist-Aquaculture, NIES, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737; (301) 851-3365. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
Many countries that import animals from the United States require a certification that the United States is free of certain diseases. These countries may also require the certification statement to contain additional declarations regarding the U.S. animals or products being exported. U.S. trading partners are increasing import requirements, which must be addressed using one of the three APHIS export health certificates or country specific export health certificates. The three APHIS export health certificates are USDA, APHIS, Veterinary Services (VS) Form 17-141 (Health Certificate for the Export of Live Finfish, Mollusks, and Crustaceans (and their Gametes); USDA, APHIS, VS Form 17-140 (United States Origin Health Certificate); and USDA, APHIS Form 7001 (United States Interstate and International Certificate of Health Examination for Small Animals).
The certificates are completed by an accredited veterinarian and must be signed by the accredited veterinarian who inspects the animals prior to their departure from the United States, and endorsed by APHIS.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Forest Service, USDA.
Notice of meeting.
The National Urban and Community Forestry Advisory Council (Council) will meet in Coral Gables, Florida. The Council is established consistent with the Federal Advisory Committee Act of 1972 and the 1990 Farm Bill, Cooperative Forestry Assistance Act, Section 9 of the Cooperative Forestry Assistance Act, as amended by Title XII, Section 1219. Additional information concerning the Council, including meeting summary/minutes, can be found by visiting the Council's Web site at:
The meeting will be held on:
• Wednesday, June 16, 2015 from 8:30 a.m.-4:00 p.m.
• Thursday, June 17, 2015 from 8:30 a.m.-4:00 p.m.
• Friday, June 18, 2015 from 8:30 a.m.-12:00 p.m., or until Council business is completed.
All meetings are subject to cancellation. For updated status of the meeting prior to attendance, please contact the person listed under
The meeting will be held at the John Martin's Restaurant (2nd Level), 253 Miracle Mile, Coral Gables, Florida 33134. Written comments may be submitted as described under
Nancy Stremple, Executive Staff to the National Urban and Community Forestry Advisory Council, 201 14th Street SW., Yates Building (3 South Central), Washington, DC 20024, or by cell phone 202-309-9873. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to provide:
(1) Review the status of the next National Ten Year Urban Forest Action Plan;
(2) Meet with State and local urban forestry partners;
(3) Tour local urban and forestry restoration, volunteer and conservation efforts;
(4) Finalize the Work Plan action items;
(5) Discuss National Grants;
(6) Hear updates from past grant recipients;
(7) Receive Forest Service updates on program activities and budget; and
(8) Hear feedback from the submitted accomplishment/recommendations report.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing by June 2, 2015 to be scheduled on the agenda. Council discussion is limited to Forest Service staff and Council members; however, persons who wish to bring urban and community forestry matters to the attention of the Council may file written statements with the Council's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Nancy Stremple, Executive Staff to the National Urban and Community Forestry Advisory Council, 201 14th Street SW., Yates Building (3 South Central), Washington, DC 20024, or by email at
Forest Service, USDA.
Notice of meeting.
The Central Idaho Resource Advisory Committee (RAC) will meet in Salmon, Idaho. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site:
The meeting will be held at 9:30 a.m. on June 29-July 1, 2015.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the Public Lands Center, 1206 S. Challis Street, Salmon, Idaho.
Written comments may be submitted as described under
Amy Baumer, RAC Coordinator, by phone at 208-756-5145 or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is:
1. To review and vote on project proposals for 2015.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by June 26, 2015, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Amy Baumer, Public Affairs Officer; 1206 S. Challis Street; Salmon, Idaho 83467; by email to
Bureau of the Census, Commerce.
Notice of request for nominations.
The Bureau of the Census (Census Bureau) is requesting nominations of individuals and organizations to the National Advisory Committee on Racial, Ethnic, and Other Populations. The Census Bureau will consider nominations received in response to this notice, as well as from other sources. The “SUPPLEMENTARY INFORMATION” section of this notice provides committee and membership criteria.
Please submit nominations by July 6, 2015.
Please submit nominations by Email to the
Kimberly L. Collier, Assistant Division Chief, Customer Liaison Marketing Services Offices, U.S. Census Bureau, Room 8H185, 4600 Silver Hill Road, Washington, DC 20233, telephone (301) 763-6590, or by Email to
The National Advisory Committee on Racial, Ethnic, and Other Populations (“The Committee”) was established in accordance with the Federal Advisory Committee Act (FACA), Title 5, United States Code, Appendix 2. The following provides information about the Committee, membership, and the nomination process.
1. The Committee provides insight, perspectives, expertise and advice to the Director of the Census Bureau on the full spectrum of Census surveys and programs. The Committee assists the Census Bureau in developing appropriate research/methodological, operational, and communication strategies to reduce program/survey costs, improve coverage and operational efficiency, improve the quality of data collected, protect the public's and business units' privacy and enhance public participation and awareness of Census programs and surveys, and make data products more useful and accessible.
2. The Committee advises on topics such as: Hidden households, language barriers, students and youth, aging populations, American Indian and Alaska Native tribal considerations, new immigrant populations, populations affected by natural disasters, highly mobile and migrant populations, complex households, poverty populations, race/ethnic minorities, rural populations and population segments with limited access to technology. The Committee also advises on data privacy and confidentiality concerns, administrative records, marketing, social media, the dynamic nature of new businesses, minority ownership of businesses, as well as other concerns impacting Census survey design and implementation.
3. The Committee discusses census policies, research and methodology, tests, operations, communications/messaging and other activities and advises regarding best practices to improve censuses, surveys, operations and programs. The Committee's expertise and experiences help identify cost efficient ways to increase participation among hard to count segments of the population as well as ensuring that the Census Bureau's statistical programs are inclusive and continue to provide the Nation with accurate, relevant, and timely statistics.
4. The Committee uses formal advisory committee meetings, webinars, web conferences, working groups, and other methods to accomplish its goals, consistent with the requirements of the FACA. The Committee is encouraged to use Census Regional Office knowledge to help identify regional, local, tribal and grass roots issues, and capture regional and local perspectives about Census Bureau surveys and programs. The Committee should use technology and video/web conferencing to reduce meeting and travel costs, and to more fully engage local and regional working groups and hard to count populations.
5. The Committee functions solely as an advisory body under the FACA.
1. The Committee will consist of up to 32 members who serve at the discretion of the Director.
2. The Committee aims to have a balanced representation among its members, considering such factors as geography, age, gender, race, ethnicity, technical expertise, community involvement, knowledge of hard to count populations, and familiarity with Census Bureau programs and/or activities.
3. The Committee aims to include members from diverse backgrounds, including state, local and tribal governments, academia, research, national and community-based organizations, and the private sector.
4. Membership shall include individuals, Special Government Employees (SGE), who are selected for their personal expertise with the topics highlighted above and/or representatives of organizations reflecting diverse populations, national, state, local and tribal interests, organizations serving hard to count populations, and community-based organizations. SGEs will be subject to the ethical standards applicable to SGEs. Members will be individually advised of the capacity in which they
5. Membership is open to persons who are not seated on other Census Bureau stakeholder entities (
6. Generally, members will serve for a three-year term. All members will be reevaluated at the conclusion of each term with the prospect of renewal, pending advisory committee needs. Active attendance and participation in meetings and activities (
7. Members are selected in accordance with applicable Department of Commerce guidelines.
1. Members of the Committee serve without compensation, but receive reimbursement for committee-related travel and lodging expenses.
2. The Committee meets at least twice a year, budget permitting, but additional meetings may be held as deemed necessary by the Census Director or Designated Federal Officer. All Advisory Committee meetings are open to the public in accordance with the FACA.
1. Nominations should satisfy the requirements described in the Membership section above.
2. Individuals, groups, and/or organizations may submit nominations on behalf of candidates. A summary of the candidate's qualifications (resume´ or curriculum vitae)
3. The Department of Commerce is committed to equal opportunity in the workplace and seeks a diverse Advisory Committee membership.
Notice of Application to Amend the Export Trade Certificate of Review Issued to California Almond Export Association, LLC (“CAEA”), Application No. (99-9A005).
The Office of Trade and Economic Analysis (“OTEA”) of the International Trade Administration, Department of Commerce, has received an application to amend an Export Trade Certificate of Review (“Certificate”). This notice summarizes the proposed amendment and requests comments relevant to whether the amended Certificate should be issued.
Joseph Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. Sections 4001-21) (“the Act”) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing Title III are found at 15 CFR part 325 (2015). Section 302(b)(1) of the Export Trade Company Act of 1982 and 15 CFR 325.6(a) require the Secretary to publish a notice in the
Interested parties may submit written comments relevant to the determination whether an amended Certificate should be issued. If the comments include any privileged or confidential business information, it must be clearly marked and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked as privileged or confidential business information will be deemed to be nonconfidential.
An original and five (5) copies, plus two (2) copies of the nonconfidential version, should be submitted no later than 20 days after the date of this notice to: Export Trading Company Affairs, International Trade Administration, U.S. Department of Commerce, Room 21028, Washington, DC 20230.
Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary for determining whether or not to issue the amended Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 99-9A005.”
ITA, DOC.
Notice of Civil Nuclear Energy Export Opportunity Seminar.
This notice sets forth the proposed agenda for a Civil Nuclear Energy Export Opportunity Seminar.
The meeting is scheduled for Thursday, June 18, 2015, at 1:00 p.m. Eastern Daylight Time (EDT).
The meeting will be held at Westinghouse Electric Company (1000 Westinghouse Drive, Cranberry Township, PA, 16066).
Mr. Jonathan Chesebro, Office of Energy & Environmental Industries, ITA, Room 4053, 1401 Constitution Ave. NW., Washington, DC 20230. (Phone: 202-482-1297; Fax: 202-482-5665; email:
The meeting will be disabled-accessible. Seating is limited and available on a first-come, first-served basis.
Email your name, title, and organization to
National Oceanic and Atmospheric Administration, Department of Commerce.
Notice of Public Meeting.
The Advisory Committee on Commercial Remote Sensing (ACCRES) will meet June 30, 2015.
The meeting is scheduled as follows: June 30, 2015, 9:00 a.m.-12:00 p.m. The meeting will be open to the public.
The meeting will be held at the Department of Commerce Room 1412, 1401 Constitution Avenue, Washington, DC 20230.
As required by section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1982), notice is hereby given of the meeting of ACCRES. ACCRES was established by the Secretary of Commerce (Secretary) on May 21, 2002, to advise the Secretary through the Under Secretary of Commerce for Oceans and Atmosphere on long- and short-range strategies for the licensing of commercial remote sensing satellite systems.
The meeting will be open to the public pursuant to Section 10(d) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, as amended by Section 5(c) of the Government in Sunshine Act, Public Law 94-409 and in accordance with Section 552b(c)(1) of Title 5, United States Code.
The Committee will receive a presentation on commercial remote sensing issues and updates of NOAA's licensing activities. The committee will also receive comments on its activities.
These meetings are physically accessible to people with disabilities. Requests for special accommodations may be directed to ACCRES, NOAA/NESDIS/CRSRA, 1335 East West Highway, Room 8260, Silver Spring, Maryland 20910.
Any member of the public wishing further information concerning the meeting or who wishes to submit oral or written comments should contact Tahara Dawkins, Designated Federal Officer for ACCRES, NOAA/NESDIS/CRSRA, 1335 East West Highway, Room 8260, Silver Spring, Maryland 20910. Copies of the draft meeting agenda can be obtained from Richard James at (301) 713-0572, fax (301) 713-1249, or email
The ACCRES expects that public statements presented at its meetings will not be repetitive of previously-submitted oral or written statements. In general, each individual or group making an oral presentation may be limited to a total time of five minutes. Written comments (please provide at least 15 copies) received in the NOAA/NESDIS/CRSRA on or before June 15, 2015; will be provided to Committee members in advance of the meeting. Comments received too close to the meeting date will normally be provided to Committee members at the meeting.
Tahara Dawkins, NOAA/NESDIS/CRSRA, 1335 East West Highway, Room 8260, Silver Spring, Maryland 20910; telephone (301) 713-3385, fax (301) 713-1249, email
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The Caribbean Fishery Management Council's (Council) Panel of Experts will hold a meeting.
The meeting will be held on June 16-18, 2015, from 9 a.m. to 5 p.m.
The meeting will be held at the CFMC Headquarters, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918.
Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918, telephone: (787) 766-5926.
The Panel of Experts will meet to discuss the items contained in the following agenda:
The established times for addressing items on the agenda may be adjusted as necessary to accommodate the timely completion of discussion relevant to the agenda items. To further accommodate discussion and completion of all items on the agenda, the meeting may be extended from, or completed prior to the date established in this notice.
The meeting is open to the public, and will be conducted in English. Fishers and other interested persons are invited to attend and participate with oral or written statements regarding agenda issues.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be subjects for formal action during the meeting. Actions will be restricted to those issues specifically identified in this notice, and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided that the public has been notified of the Council's intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. For more information or request for sign language interpretation and/other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918, telephone (787) 766-5926, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments.
The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit application contains all of the required information and warrants further consideration. This Exempted Fishing Permit would allow four commercial fishing vessels to fish outside of the limited access sea scallop regulations in support of bycatch reduction research.
Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed Exempted Fishing Permits.
Comments must be received on or before June 18, 2015.
You may submit written comments by any of the following methods:
•
•
Shannah Jaburek, Fisheries Management Specialist, 978-282-8456.
NOAA awarded the Coonamesset Farm Foundation (CFF) a grant through the 2015 Atlantic sea scallop research set-aside program, in support of a project titled, “Determination of the Impacts of Dredge Speed on Bycatch Reduction and Scallop Selectivity.”
CFF submitted a complete application for an EFP on March 30, 2015. The project would look at how high towing speeds using the Turtle Deflector Dredge (TDD) impact scallop catch per unit of
CFF is requesting exemptions that would allow four commercial fishing vessels be exempt from the Atlantic sea scallop days-at-sea (DAS) allocations at 50 CFR 648.53(b); crew size restriction at § 648.51(c); Closed Area I Closed Area at § 648.58(a), Closed Area II Closed Area at § 648.58(b); and Nantucket Lightship Closed Area at § 648.58(c). It would also exempt the from possession limits and minimum size requirements specified in 50 CFR part 648, subparts B and D through O, for sampling purposes only. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.
Four vessels would conduct scallop dredging in June-September 2015, on a total of four 7-day trips, for a total of 28 DAS. Each trip would complete approximately 15 tows per day for an overall total of 420 tows for the project. All trips would take place in the open areas of Southern New England and Georges Bank as well as in Georges Bank scallop closed areas. Trips would be centralized around areas with high yellowtail and winter flounder bycatch and in areas that contain a wide range of scallop sizes to examine changes in size selectivity due to tow speed.
All tows would be conducted with two tandem 15-foot (4.57-meter) TDD dredges for a duration of 60 minutes with a tow speed range of 4-5.5 knots. One dredge would be rigged with a 7-row apron and twine top hanging ratio of 2:1, while the other dredge would be rigged with a 5-row ring apron and 1.5:1 twine top hanging ratio. Both dredge aprons would use 4-inch (10.16-cm) rings. Each tow pair would be conducted in a straight line varying between higher and lower speeds with dredge positions in an AB-BA alternating pattern with a wire scope of three to one plus ten fathoms.
For all tows the sea scallop catch would be counted into baskets and weighed. One basket from each dredge would be randomly selected and the scallops would be measured in 5-mm increments to determine size selectivity. Finfish catch would be sorted by species and then counted, weighed and measured in 1-mm increments. Depending on the volume of scallops and finfish captured, the catch would be subsampled as necessary. No catch would be retained for longer than needed to conduct sampling and no catch would be landed for sale.
CFF has requested these exemptions to allow them to conduct experimental dredge towing without being charged DAS, as well as deploy gear in access areas that are currently closed to scallop fishing. Participating vessels would need crew size waivers to accommodate science personnel and possession waivers would enable them to conduct finfish sampling activities.
If approved, the applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.
16 U.S.C. 1801
Consumer Product Safety Commission.
Notice.
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the
Any interested person may ask the Commission not to accept this agreement or otherwise comment on its contents by filing a written request with the Office of the Secretary by June 18, 2015.
Persons wishing to comment on this Settlement Agreement should send written comments to the Comment 15-C0004 Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Room 820, Bethesda, Maryland 20814-4408.
Sean R. Ward, Trial Attorney, Office of the General Counsel, Division of Compliance, Consumer Product Safety Commission, 4330 East West Highway,
The text of the Agreement and Order appears below.
1. In accordance with the Consumer Product Safety Act, 15 U.S.C. 2051-2089 (“CPSA”) and 16 CFR 1118.20, Office Depot, Inc. (“Office Depot” or “Firm”), and the United States Consumer Product Safety Commission (“Commission”), through its staff, hereby enter into this Settlement Agreement (“Agreement”). The Agreement, and the incorporated attached Order, resolve staff's charges set forth below.
2. The Commission is an independent federal regulatory agency, established pursuant to, and responsible for the enforcement of, the CPSA, 15 U.S.C. 2051-2089. By executing the Agreement, staff is acting on behalf of the Commission, pursuant to 16 CFR 1118.20(b). The Commission issues the Order under the provisions of the CPSA.
3. Office Depot is a corporation, organized and existing under the laws of the state of Delaware, with its principal place of business in Boca Raton, Florida.
4. Between May 2006 and August 2009, Office Depot sold in the United States approximately 150,000 Quantum Realspace PRO
5. The Quantum Chair is a “consumer product” “distributed in commerce,” as those terms are defined or used in sections 3(a)(5), (8) of the CPSA, 15 U.S.C. 2052(a)(5), (8). Office Depot was a “retailer” of the Quantum Chair, as such term is defined in section 3(a)(13) of the CPSA, 15 U.S.C. 2052(a)(13).
6. The Quantum Chair is defective and creates an unreasonable risk of serious injury because the bolts attaching the seatback on the Quantum Chair can loosen and detach, posing a fall and injury hazard to consumers.
7. Office Depot first received notice of a Quantum Chair failure in 2007 when a consumer reported to Office Depot that the seatback loosened or detached on the Quantum Chair, causing the consumer to sustain injuries.
8. In 2008, Office Depot became aware that, in an effort to eliminate seatback detachment, the manufacturer of the Quantum Chair made two design changes to the Quantum Chair and a change to the accompanying instructions.
9. In 2008 and 2009, Office Depot received 13 additional reports of injury, some requiring medical attention, and 33 total reports of the seatback detaching.
10. Despite having information regarding the defect in and risk of injury relating to the Quantum Chair, Office Depot did not notify the Commission immediately of such defect or risk, as required by section 15(b)(3) and (4) of the CPSA, 15 U.S.C. 2064(b)(3) and (4). Office Depot never notified the Commission about the Quantum Chair as required by the CPSA.
11. Between 2003 and 2012, Office Depot imported into the United States and sold approximately 1.4 million Gibson Leather Task Chairs (“Gibson Chair”).
12. The Gibson Chair is a “consumer product” “distributed in commerce,” as those terms are defined or used in sections 3(a)(5), (8) of the CPSA, 15 U.S.C. 2052(a)(5), (8). Office Depot was a “manufacturer” of the Gibson Chair, as such term is defined in section 3(a)(11) of the CPSA, 15 U.S.C. 2052(a)(11). Office Depot also was a “retailer” of the Gibson Chair, as such term is defined in section 3(a)(13) of the CPSA, 15 U.S.C. 2052(a)(13).
13. The Gibson Chair is defective and creates an unreasonable risk of serious injury because the mounting weld can break and separate the seat from the base of the Gibson Chair, posing a fall hazard to consumers.
14. Office Depot first received notice of a Gibson Chair failure in 2005, when one consumer reported to Office Depot that the seat broke and separated from the base of the Gibson Chair, causing the consumer to sustain injuries.
15. Office Depot continued to receive reports of injuries and incidents involving breakage of the Gibson Chair mounting plate weld and the resulting separation of the seat from the base of the Gibson Chair, with some injuries requiring medical attention. Office Depot settled the claims of several consumers who reported injuries resulting from the Gibson Chair's failure.
16. In all, Office Depot received 25 reports of injuries and 153 incident reports from consumers of the seat breaking and separating from the base of the Gibson Chair.
17. Despite having information regarding the defect in and risk of injury relating to the Gibson Chair, Office Depot did not notify the Commission immediately of such defect or risk, as required by section 15(b)(3) and (4) of the CPSA, 15 U.S.C. 2064(b)(3) and (4). Office Depot failed to notify the Commission about the Gibson Chair until December 14, 2012, after receiving staff's letter requesting a Full Report. Office Depot recalled the Gibson Chair on May 22, 2014.
18. In failing to inform the Commission immediately about the Quantum Chair and the Gibson Chair (together, “Subject Products”), Office Depot knowingly violated section 19(a)(4) of the CPSA, 15 U.S.C. 2068(a)(4), as the term “knowingly” is defined in section 20(d) of the CPSA, 15 U.S.C. 2069(d).
19. Pursuant to section 20 of the CPSA, 15 U.S.C. 2069, Office Depot is subject to civil penalties for its knowing failure to report, as required under section 15(b) of the CPSA, 15 U.S.C. 2064(b).
20. This Agreement does not constitute an admission by Office Depot that the law has been violated. Office Depot neither admits nor denies the staff's charges set forth above, including but not limited to the contention that the Subject Products “contain[] a defect which could create a substantial product hazard . . . or create[] an unreasonable risk of serious injury or death,” 15 U.S.C. 2064(b); that Office Depot did not notify the Commission in a timely manner, in accordance with 15 U.S.C. 2064(b); and that there was any allegedly “knowing” violation of the CPSA as that term is defined in 15 U.S.C. 2069(d).
21. The Quantum recall notice states that Office Depot received 14 reports of injuries in connection with about 150,000 Quantum chairs sold. There were fewer reports of consumers seeking medical treatment in connection with any reported injuries. The Gibson recall notice states that Office Depot received 25 reports of injuries in connection with about 1.4 million Gibson chairs sold. There were fewer reports of consumers seeking medical treatment in connection
22. The Subject Products passed multiple safety tests administered by independent third party testing organizations.
23. Following discussions with Office Depot, the manufacturer of the Quantum Chair reported the Quantum Chair to the CPSC in April 2009. Therefore, Office Depot did not make its own report.
24. At all relevant times, Office Depot has had a product safety compliance program, including dedicated product safety personnel and appropriate product safety testing.
25. As a retailer, Office Depot sells thousands of products and relies on product testing, conducted pursuant to voluntary industry standards, in order to protect its consumers. Office Depot reviews and reacts to consumer complaints and parts requests associated with office chairs.
26. Office Depot enters into this Agreement to settle this matter without the delay and expense of litigation. Office Depot enters into this Agreement and agrees to pay the amount referenced below in compromise of staff's charges.
27. Under the CPSA, the Commission has jurisdiction over the matter involving the Subject Products described herein and over Office Depot.
28. The parties enter into the Agreement for settlement purposes only. The Agreement does not constitute an admission by Office Depot or a determination by the Commission that Office Depot violated the CPSA's reporting requirements.
29. In settlement of staff's charges, and to avoid the cost, distraction, delay, uncertainty, and inconvenience of protracted litigation or other proceedings, Office Depot shall pay a civil penalty in the amount of three million, four hundred thousand dollars ($3,400,000) (“Settlement Payment”) within thirty (30) calendar days after receiving service of the Commission's final Order accepting the Agreement. The payment shall be made by electronic wire transfer to the Commission via:
30. After staff receives this Agreement executed on behalf of Office Depot, staff shall promptly submit the Agreement to the Commission for provisional acceptance. Promptly following provisional acceptance of the Agreement by the Commission, the Agreement shall be placed on the public record and published in the
31. This Agreement is conditioned upon, and subject to, the Commission's final acceptance, as set forth above, and it is subject to the provisions of 16 CFR 1118.20(h). Upon the later of: (i) Commission's final acceptance of this Agreement and service of the accepted Agreement upon Office Depot, and (ii) the date of issuance of the final Order, this Agreement shall be in full force and effect and shall be binding upon the parties.
32. Effective upon the later of: (i) the Commission's final acceptance of the Agreement and service of the accepted Agreement upon Office Depot, and (ii) and the date of issuance of the final Order, for good and valuable consideration, Office Depot hereby expressly and irrevocably waives and agrees not to assert any past, present, or future rights to the following, in connection with the matter described in this Agreement: (i) an administrative or judicial hearing; (ii) judicial review or other challenge or contest of the Commission's actions; (iii) a determination by the Commission of whether Office Depot failed to comply with the CPSA and the underlying regulations; (iv) a statement of findings of fact and conclusions of law; and (v) any claims under the Equal Access to Justice Act.
33. Office Depot has and shall maintain a compliance program designed to ensure compliance with the CPSA with respect to any consumer product imported, manufactured, distributed, or sold by Office Depot. Office Depot's compliance program shall contain the following elements: (i) written standards and policies, including those designed to convey effectively to personnel responsible for CPSA compliance information (whether in the form of complaints, parts requests, incident reports, or otherwise) that may relate to or impact CPSA compliance; (ii) a mechanism for confidential employee reporting of compliance-related questions or concerns to either a compliance officer or to another senior manager with authority to act as necessary; (iii) effective communication of company compliance-related policies and procedures regarding the CPSA to the appropriate employees through training programs or otherwise; (iv) Office Depot senior management responsibility for, and general board oversight of, CPSA compliance; and (v) retention of all CPSA compliance-related records for at least five (5) years, and reasonable availability of such records, insofar as they are not protected by attorney-client, work product, or other privilege, to staff upon reasonable request.
34. Office Depot has, and shall maintain and enforce, a system of internal controls and procedures designed to ensure that, with respect to all consumer products imported, manufactured, distributed, or sold by Office Depot: (i) information required to be disclosed by Office Depot to the Commission is recorded, processed, and reported in accordance with applicable law; (ii) all reporting made to the Commission is timely, truthful, complete, accurate, and in accordance with applicable law; and (iii) prompt disclosure is made to Office Depot's management of any significant deficiencies or material weaknesses in the design or operation of such internal controls that are reasonably likely to affect adversely, in any material respect, Office Depot's ability to record, process, and report to the Commission in accordance with applicable law.
35. Upon reasonable request of staff, Office Depot shall provide written documentation of its internal controls and procedures, including, but not limited to, the effective dates of the procedures and improvements thereto. Office Depot shall cooperate fully and truthfully with staff and shall make available all non-privileged information and materials, and personnel deemed necessary by staff to evaluate Office Depot's compliance with the terms of the Agreement.
36. The parties acknowledge and agree that the Commission may publicize the terms of the Agreement and the Order.
37. Office Depot represents that the Agreement: (i) is entered into freely and voluntarily, without any degree of duress or compulsion whatsoever; (ii) has been duly authorized; and (iii) constitutes the valid and binding obligation of Office Depot, enforceable against Office Depot in accordance with its terms. Office Depot will not directly or indirectly receive any reimbursement, indemnification, insurance-related payment, or other payment in connection with the civil penalty to be paid by Office Depot pursuant to the Agreement and Order. The individuals signing the Agreement on behalf of Office Depot represent and
38. The signatories represent that they are authorized to execute this Agreement.
39. The Agreement is governed by the laws of the United States.
40. The Agreement and the Order shall apply to, and be binding upon, Office Depot and each of its successors, transferees, and assigns, and a violation of the Agreement or Order may subject Office Depot, and each of its successors, transferees and assigns, to appropriate legal action.
41. The Agreement and the Order constitute the complete agreement between the parties on the subject matter contained therein.
42. The Agreement may be used in interpreting the Order. Understandings, agreements, representations, or interpretations apart from those contained in the Agreement and the Order may not be used to vary or contradict their terms. For purposes of construction, the Agreement shall be deemed to have been drafted by both of the parties and shall not, therefore, be construed against any party for that reason in any subsequent dispute.
43. The Agreement may not be waived, amended, modified, or otherwise altered, except as in accordance with the provisions of 16 CFR 1118.20(h). The Agreement may be executed in counterparts.
44. If any provision of the Agreement or the Order is held to be illegal, invalid, or unenforceable under present or future laws effective during the terms of the Agreement and the Order, such provision shall be fully severable. The balance of the Agreement and the Order shall remain in full force and effect, unless the Commission and Office Depot agree in writing that severing the provision materially affects the purpose of the Agreement and the Order.
Dated:
Dated:
Dated:
Upon consideration of the Settlement Agreement entered into between Office Depot, Inc. (“Office Depot”), and the U.S. Consumer Product Safety Commission (“Commission”), and the Commission having jurisdiction over the subject matter and over Office Depot, and it appearing that the Settlement Agreement and the Order are in the public interest, it is:
By order of the Commission.
Department of the Army, DoD.
Notice.
In accordance with 35 U.S.C. 209 (e) and 37 CFR 404.7 (a)(1)(i), announcement is made of the intent to grant an exclusive, royalty-bearing, revocable license to US Patent number 7,702,473, issued April 20, 2010, entitled, “Submersible portable in-situ automated water quality biomonitoring apparatus and method” and US Patent number 6,988,394, issued January 24, 2006, entitled, “Apparatus and method of portable automated biomonitoring of water quality” and US Patent number 6,393,899, issued May 28, 2002, entitled, “Apparatus and method for automated biomonitoring of water quality” and US Patent number 6,058,763 issued May 9, 2000, entitled, “Apparatus and method for automated biomonitoring of water quality” and Canada Patent number 2,515,062 issued April 17, 2012, entitled “Apparatus and method of portable automated biomonitoring of water quality” to Solution Resources, LLC, with its principal place of business at 7906 Juniper Drive, Frederick, MD 21702.
Commander, U.S. Army Medical Research and Materiel Command, ATTN: Command Judge Advocate, MCMR-JA, 504 Scott Street, Fort Detrick, MD 21702-5012.
For licensing issues, Mr. Barry Datlof, Office of Research & Technology Assessment, (301) 619-0033. For patent issues, Ms. Elizabeth Arwine, Patent Attorney, (301) 619-7808, both at telefax (301) 619-5034.
Anyone wishing to object to the grant of this license can file written objections along with supporting evidence, if any, within 15 days from the date of this publication. Written objections are to be filed with the Command Judge Advocate (see
Department of the Army, DoD.
Notice.
In accordance with 35 U.S.C. 209(e), and 37 CFR 404.7 (a)(1)(i), announcement is made of the intent to grant an exclusive, revocable license, to U.S. Provisional Patent No. 61/884,630, filed September 30, 2013, entitled “Intelligent Focused Assessment with Sonography for Trauma,” and foreign
Commander, U.S. Army Medical Research and Materiel Command, ATTN: Command Judge Advocate, MCMR-JA, 504 Scott Street, Fort Detrick, Frederick, MD 21702-5012.
For licensing issues, Barry M. Datlof, Office of Research and Technology Applications (ORTA), (301) 619-0033. For patent issues, Ms. Elizabeth Arwine, Patent Attorney, (301) 619-7808, both at telefax (301) 619-5034.
Anyone wishing to object to the grant of this license can file written objections along with supporting evidence, if any, within 15 days from the date of this publication. Written objections are to be filed with the Command Judge Advocate (see
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-36 with attached transmittal, policy justification, and Sensitivity of Technology.
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Israel—Joint Direct Attack Munition Tail Kits and Munitions
The Government of Israel has requested a possible sale of 14,500 KMU-556C/B Joint Direct Attack Munitions (JDAM) tail kits consisting of 10,000 for Mk-84; 500 for Mk-83; and 4,000 for Mk-82; 3,500 Mk-82 bombs; 4,500 Mk-83 bombs; 50 BLU-113 bombs; 4,100 GBU-39 Small Diameter bombs; 1,500 Mk-83 Paveway kits; 700 BLU-109 Paveway kits; 3,000 AGM-114K/R Hellfire Missiles, 250 AIM-120C Advanced Medium Range Air-to-Air Missiles; and 500 DSU-38A/B Detector Laser Illuminated Target kits for JDAMs. The total estimated cost $1.879 billion.
The United States is committed to the security of Israel, and it is vital to U.S. national interests to assist Israel to develop and maintain a strong and ready self-defense capability. This proposed sale is consistent with those objectives.
The proposed sale of this equipment will provide Israel the ability to support its self-defense needs. These munitions will enable Israel to maintain operational capability of its existing systems and will enhance Israel's interoperability with the United States. Israel, which already has these munitions in its inventory, will have no difficulty absorbing the additional munitions into its armed forces.
The proposed sale of these munitions will not alter the basic military balance in the region.
The principal contractors will be The Boeing Company in St. Charles, Missouri; Lockheed-Martin Company in Archbald, Pennsylvania; General Dynamics in Garland, Texas; Elwood National Forge Co. in Irvine, Pennsylvania; and Raytheon Missile Systems in Tucson, Arizona. There are no known offset agreements in connection with this proposed sale.
Implementation of this proposed sale will require travel of U.S. Government or contractor representatives to Israel on a temporary basis for program technical support and management oversight.
There is no adverse impact on U.S. defense readiness as a result of this sale.
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1. The Joint Direct Attack Munition (JDAM) is a guidance tail kit that converts unguided free-fall bombs into accurate, adverse weather “smart” munitions. With the addition of a new tail section that contains an inertial navigational system and a global positioning system guidance control unit, JDAM improves the accuracy of unguided, general-purpose bombs in any weather condition. JDAM can be launched from very low to very high altitudes in a dive, toss and loft, or in straight and level flight with an on-axis or off-axis delivery. JDAM enables multiple weapons to be directed against single or multiple targets on a single pass. The JDAM All Up Round (AUR) and all of its components are Unclassified, and technical data for JDAM is classified up to Secret.
2. The GBU-39 Small Diameter Bomb (SDB) is a 250-lb class precision guided munition that is intended to provide aircraft with an ability to carry a high number of bombs. The weapon offers day- or night-, adverse weather-, precision-engagement capability against pre-planned fixed or stationary soft, non-hardened, and hardened targets, and provides greater than 50 Nautical Miles of standoff range. Aircraft are able to carry four SDBs in place of one 2,000-lb bomb. The SDB is equipped with a Global Positioning Satellite (GPS)-aided inertial navigation system. The SDB and all of its components are Unclassified; technical data are classified up to Secret.
3. The AIM-120C-7 Advanced Medium Range Air-to-Air Missile (AMRAAM) is a radar guided missile featuring digital technology and micro-miniature solid-state electronics. AMRAAM capabilities include look-down/shoot-down, multiple launches against multiple targets, resistance to electronic countermeasures, and interception of high- and low-flying and maneuvering targets. The AMRAAM All Up Round (AUR) is classified Confidential, major components and subsystems range from Unclassified to Confidential, and technical data and other documentation are classified up to Secret.
4. The DSU-38A/B is a laser-illuminated target detector that adds a Precision Laser Guidance Set (PLGS) to inventory JDAMs, giving the weapon system optional semi-active laser guidance in addition to its other Global Positioning System/Inrertial Navigation System (GPS/INS) guidance modes. The DSU-38A/B is a DSU-33 form-factored passive laser seeker that can be easily installed in the field to the front of existing JDAM weapons and is connected to the Guidance Set via an externally mounted strap-on harness kit. The DSU-38 provides an additional capability to engage mobile targets moving up to 70 mph. The addition of the DSU-38 Laser sensor combined with additional cabling and mounting
5. The AGM-114R Hellfire II is an air-to-ground missile used against heavy and light armored targets, thin-skinned vehicles, urban structures, bunkers, caves and personnel. The missile is Inertial Measurement Unit (IMU) based, with a variable delay fuse, improved safety and reliability. The highest level of release for the Hellfire missile is Secret, based upon the software. The highest level of classified information that could be disclosed by a proposed sale or by testing of the end item is Secret; the highest level that must be disclosed for production, maintenance, or training is Confidential. Reverse engineering could reveal confidential information. Vulnerability data, countermeasures, vulnerability/susceptibility analyses, and threat definitions are classified Secret or Confidential.
6. If a technologically advanced adversary obtained knowledge of the specific hardware and software elements in the systems described above, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
7. A determination has been made that Government of Israel can provide substantially the same degree of protection of the sensitive technology associated with these systems as the U.S. Government. This proposed sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
8. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of Israel.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittals 15-17 with attached transmittal, policy justification, and Sensitivity of Technology.
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The Government of Saudi Arabia has requested a sale of ten (10) MH-60R multi-mission helicopters fourteen (14) APS-153(V) Multi-Mode radars (10 installed, 2 spares and 2 for testing); twenty-four T-700 GE 401 C engines (20 installed and 4 spares); twelve (12) APX-123 Identification Friend or Foe transponders (10 installed and 2 spares); fourteen (14) AN/AAS-44C(V) Multi-Spectral Targeting Systems Forward Looking Infrared Radars (10 installed, 2 spares, and 2 for testing); twenty-six (26) Embedded Global Positioning System/Inertial Navigation Systems with Selective Availability/Anti-Spoofing Module (20 installed and 6 spares); and Link-16 capability; one-thousand (1,000) AN/SSQ-36/53/62 Sonobuoys; thirty-eight (38) AGM-114R Hellfire II missiles; five (5) AGM-114 M36-E9 Captive Air Training missiles; four (4) AGM-114Q Hellfire Training Missiles; three-hundred eighty (380) Advanced Precision Kill Weapons System rockets; twelve (12) M-240D crew served weapons; and twelve (12) GAU-21 crew served weapons. Also included are spare engine containers; facilities study and design; spare and repair parts; support and test equipment; communication equipment; aerial refueling services; ferry support; publications and technical documentation; personnel training and training equipment; U.S. Government and contractor engineering, technical and logistics support services; and other related elements of logistical and program support. The estimated cost is $1.9 billion.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a strategic regional partner, which has been, and continues to be, an important force for political stability and economic progress in the Middle East.
The proposed sale will improve Saudi Arabia's capability to meet current and future threats from enemy weapon systems. The MH-60R Multi-Mission Helicopter will provide the capability to identify, engage, and defeat maritime security threats along with the ability to perform secondary missions including vertical replenishment, search and rescue, and communications relay. Saudi Arabia will use the enhanced capability as a deterrent to regional threats and to strengthen its homeland defense.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractors will be Sikorsky Aircraft Corporation in Stratford, Connecticut; and Lockheed Martin Corporation in Owego, New York. There are no known offset agreements in connection with this potential sale.
Implementation of this proposed sale will require the assignment of additional U.S. Government and/or contractor representatives to Saudi Arabia.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
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1. The MH-60R Multi-Mission Helicopter focuses primarily on anti-submarine and anti-surface warfare missions. The MH-60R carries several sensors and data links to enhance its ability to work in a network centric battle group and as an extension of its home ship/main operating base. The mission equipment subsystem consists of the following sensors and subsystems: An acoustics systems consisting of a dipping sonar and sonobuoys, Multi-Mode Radar (MMR) with integral Identification Friend or Foe (IFF) interrogator, Electronic Support Measures (ESM), Integrated Self-Defense (ISD), and Multi-Spectral Targeting System (MTS). The aircraft processes sensor data onboard, and transmits data via Common Data Link (CDL) (also referred to as Hawklink), or Link-16. It can carry AGM-114A/B/K/R Hellfire missiles, as well as Mk 46 or Mk 54 torpedoes to engage surface and sub-surface targets. The Saudi MH-60R platform will include provisions for both the Mk 46 and the Mk 54 light weight torpedo. The MH-60R weapons system is classified up to Secret. Unless otherwise noted below, MH-60R hardware and support equipment, test equipment and maintenance spares are unclassified except when electrical power is applied to hardware containing volatile data storage. Technical data and documentation for MH-60R weapons systems (to include sub-systems and weapons listed below) are classified up to Secret. The sensitive technologies include:
a. The AGM-114R HELLFIRE missile is an air-to-surface missile with a multi-mission, multi-target, precision strike
b. Advanced Precision Kill Weapons System (APKWS) laser guided rocket to counter the fast attack craft and fast inshore attack craft threat. APKWS hardware is Unclassified.
c. Communications security devices contain sensitive encryption algorithms and keying material. The purchasing country has previously been released and utilizes COMSEC devices in accordance with set procedures and without issue. COMSEC devices will be classified up to Secret when keys are loaded.
d. Identification Friend or Foe (IFF) (KIV-77) contains embedded security devices containing sensitive encryption algorithms and keying material. The purchasing country will utilize COMSEC devices in accordance with set procedures. The AN/APX-123 is classified up to Secret.
e. GPS/PPS/SAASM—Global Positioning System (GPS) provides a space-based Global Navigation Satellite System (GNSS) that has reliable location and time information in all weather and at all times and anywhere on or near the Earth when and where there is an unobstructed line of sight to four or more GPS satellites. Selective Availability/Anti-Spoofing Module (SAASM) (AN/PSN-11) is used by military GPS receivers to allow decryption of precision GPS coordinates. In addition, the GPS Antenna System (GAS-1) provides protection from enemy manipulation of the GPS system. The GPS hardware is Unclassified. When electrical power is applied, the system is classified up to Secret.
f. Ku-Band CDL (AN/ARQ-59; also referred to as Hawklink) and Link-16 capability to enable network centric capabilities, and improve data communications leading to a Common Operating Picture (COP). Link-16 implementation will be consistent with capabilities already in operation with Saudi Arabian defense forces. CDL implementation will utilize commercial encryption. The AN/ARQ-59 hardware is unclassified when COMSEC module is not loaded with a key, when a key is loaded it is classified up to Secret. The Link-16 hardware is Unclassified. When electrical power is applied it is classified up to Secret.
g. Acoustics algorithms are used to process dipping sonar and sonobuoy data for target tracking and for the Acoustics Mission Planner (AMP), which is a tactical aid employed to optimize the deployment of sonobuoys and the dipping sonar. Acoustics hardware is Unclassified. The acoustics system is classified up to Secret when environmental and threat databases are loaded and/or the system is processing acoustic data.
h. The AN/APS-153 multi-mode radar with an integrated IFF and Inverse Synthetic Aperture (ISAR) provides target surveillance/detection capability. The AN/APS-153 hardware is unclassified. When electrical power is applied and mission data loaded, the AN/APS-153 is classified up to Secret.
i. The AN/ALQ-210 (ESM) system identifies the location of an emitter. The ability of the system to identify specific emitters depends on the data provided by Saudi Arabia. The AN/ALQ-210 hardware is Unclassified. When electrical power is applied and mission data loaded, the AN/ALQ-210 system is classified up to Secret.
j. The AN/AAS-44C(V) Forward Looking Infrared Radar (FLIR) uses the Multi-spectral Targeting System (MTS) that allows it to operate in day/night and adverse weather conditions. Imagery is provided by an Infrared sensor, a color/monochrome DTV, and a Low-Light TV. The AN/AAS-44C(V) hardware is Unclassified. When electrical power is applied, the AN/AAS-44C(V) is classified up to Secret.
k. Ultra High Frequency/Very High Frequency (UHF/VHF) Radios (ARC 210) contain embedded sensitive encryption algorithms and keying material. The purchasing country will utilize COMSEC devices in accordance with set procedures. The ARC-210 hardware is Unclassified. When electrical power is applied and mission data loaded, the ARC-210 is classified up to Secret.
l. Satellite Communications Demand Assigned Multiple Access (SATCOM DAMA) and Single Channel Ground to Air Radio Systems (SINCGARS), which provide increased, interoperable communications capabilities with US forces. SATCOM DAMA and SINCGARS hardware is Unclassified. When electrical power is applied and mission data loaded these systems are classified up to Secret.
2. All the mission data, including sensitive parameters, is loaded from an off board station before each flight and does not stay with the aircraft after electrical power has been removed. Sensitive technologies are protected as defined in the program protection and anti-tamper plans. The mission data and off board station are classified up to Secret.
3. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures which might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
4. A determination has been made that the recipient country can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
5. All defense articles and services listed in this transmittal have been authorized for release and export to Saudi Arabia.
Department of Defense.
Notice of meeting.
The Department of Defense is publishing this notice to announce the following Federal Advisory Committee meeting of the Judicial Proceedings since Fiscal Year 2012 Amendments Panel (“the Judicial Proceedings Panel” or “the Panel”). The meeting is open to the public.
A meeting of the Judicial Proceedings Panel will be held on Thursday, June 18, 2015. The Public Session will begin at 9:00 a.m. and end at 5:00 p.m.
The George Washington University, School of Law, Faculty Conference Center, 2000 H St. NW., Washington, DC 20052.
Ms. Julie Carson, Judicial Proceedings Panel,
This public meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.
Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics, DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by August 3, 2015.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Office of Economic Adjustment, 2231 Crystal Drive, Suite 520, Arlington, Virginia 22202, ATTN: Nia Hope, or call at 571-213-6791.
Office of Postsecondary Education, Department of Education.
Notice.
Notice inviting applications for new awards for fiscal year (FY) 2015.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.031X.
Applications Available: June 3, 2015.
Deadline for Transmittal of Applications: July 6, 2015.
Deadline for Intergovernmental Review: September 1, 2015.
This priority is:
Projects that are designed to increase the number and proportion of high-need students (as defined in this notice) who are academically prepared for, enroll in, or complete on time college, other postsecondary education, or other career and technical education.
These priorities are:
Academic tutoring and counseling programs and student support services.
Projects that are designed to leverage technology through implementing high-quality accessible digital tools, assessments, and materials that are
This priority is:
Projects that support activities that strengthen Native American language preservation and revitalization.
In developing logic models, applicants may want to use resources such as the Pacific Education Laboratory's Education Logic Model Application (
Title III, part A, section 319 of the HEA (20 U.S.C. 1059f).
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2016 from the list of unfunded applicants from this competition.
The Department is not bound by any estimates in this notice.
1.
At the time of submission of their applications, applicants must certify their total undergraduate headcount enrollment and that 10 percent of the IHE's enrollment is Native American. An assurance form, which is included in the application materials for this competition, must be signed by an official for the applicant and submitted.
To qualify as an eligible institution under the NASNTI Program, an institution must also be—
(i) Accredited or pre-accredited by a nationally recognized accrediting agency or association that the Secretary has determined to be a reliable authority as to the quality of education or training offered;
(ii) Legally authorized by the State in which it is located to be a junior or community college or to provide an educational program for which it awards a bachelor's degree; and
(iii) Designated as an “eligible institution” by demonstrating that it has: (A) an enrollment of needy students as described in 34 CFR 607.3; and (B) below average educational and general expenditures per full-time equivalent (FTE) undergraduate student as described in 34 CFR 607.4.
The notice for applying for designation as an eligible institution was published in the
(b) A grantee under the Developing Hispanic-Serving Institutions (HSI) Program, which is authorized by title V, part A of the HEA, may not receive a grant under any HEA, title III, part A program, including the NASNTI Program. Further, a current HSI Program grantee may not give up its HSI grant in order to receive a grant under any title III, part A program.
An eligible HSI that is not a current grantee under the HSI Program may apply for a FY 2015 grant under all title III, part A programs for which it is eligible, as well as under the HSI Program. However, a successful applicant may receive only one grant.
2. a.
b.
1.
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
You can also obtain an application via the Internet using the following address:
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2.
Page Limit: The application narrative (Part III of the application) is where you, the applicant, address the selection criteria, the absolute priority, the competitive preference priorities, and the invitational priority that reviewers use to evaluate your application. We have established mandatory page limits. You must limit the section of the application narrative that addresses:
• The selection criteria to no more than 50 pages.
• The absolute priority to no more than three pages.
• A competitive preference priority, if you are addressing one or both, to no more than three pages (for a total of six pages if you address both).
• The invitational priority to no more than two pages, if you address it.
Accordingly, under no circumstances may the application narrative exceed 61 pages.
Please include a separate heading for the absolute priority and for each competitive preference priority and invitational priority that you address.
For the purpose of determining compliance with the page limits, each page on which there are words will be counted as one full page. Applicants must use the following standards:
• A “page” is 8.5″ x 11″, on one side only, with 1” margins at the top, bottom, and both sides. Page numbers and an identifier may be within the 1″ margins.
• Double space (no more than three lines per vertical inch) all text in the application narrative, except titles, headings, footnotes, quotations, references, and captions and all text in charts, tables, figures, and graphs. These items may be single-spaced. Charts, tables, figures, and graphs in the application narrative count toward the page limits.
• Use a font that is either 12 point or larger, or no smaller than 10 pitch (characters per inch). However, you may use a 10-point font in charts, tables, figures, graphs, footnotes, and endnotes.
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman or Arial Narrow) will not be accepted.
The page limit does not apply to Part I, the Application for Federal Assistance (SF 424); the Supplemental Information for SF 424 Form; Part II, the Budget Information Summary Form (ED Form 524); and Part IV, the assurances and certifications. The page limit also does not apply to the table of contents, the one-page abstract, the resumes, the bibliography, or the letters of support. If you include any attachments or appendices, these items will be counted as part of the application narrative for purposes of the page-limit requirement. You must include your complete response to the selection criteria and priorities in the application narrative.
We will reject your application if you exceed the page limits.
3.
Applications Available: June 3, 2015.
Deadline for Transmittal of Applications: July 6, 2015.
Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to section IV. 7.
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
Deadline for Intergovernmental Review: September 1, 2015.
4.
5.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry (CCR)), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet. A DUNS number can be created within one to two business days.
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data entered into the SAM database by an entity. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.
Once your SAM registration is active, you will need to allow 24 to 48 hours for the
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page:
7.
Applications for grants under the NASNTI Program, CFDA number 84.031X, must be submitted electronically using the Governmentwide Grants.gov Apply site at
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under
You may access the electronic grant application for the NASNTI Program at
Please note the following:
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: the Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• You must upload any narrative sections and all other attachments to your application as files in a PDF (Portable Document) read-only, non-modifiable format. Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF or submit a password-protected file, we will not review that material.
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by email. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact one of the people listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the Grants.gov system;
and
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Bora Mpinja, U.S. Department of Education, 1990 K Street NW., Room 6023, Washington, DC 20006-8513. FAX: (202) 502-7681.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address:
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
If your application is postmarked after the application deadline date, we will not consider your application.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
c.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address:
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
a.
1. The magnitude of the need for the services to be provided or the activities to be carried out by the proposed project. (10 points)
2. The extent to which the proposed project will focus on serving or otherwise addressing the needs of disadvantaged individuals. (5 points)
3. The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses. (5 points)
b.
1. The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable. (10 points)
2. The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs. (5 points)
3. The extent to which the proposed project is supported by strong theory (as defined in this notice). (10 points)
c.
1. The extent to which the services to be provided by the proposed project are appropriate to the needs of the intended recipients or beneficiaries of those services. (5 points)
2. The extent to which the services to be provided by the proposed project
d.
In addition, the Secretary considers:
1. The qualifications, including relevant training and experience, of the project director or principal investigator. (5 points)
2. The qualifications, including relevant training and experience, of key project personnel. (5 points)
e.
1. The extent to which the budget is adequate to support the proposed project. (3 points)
2. The extent to which the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project. (2 points)
f.
1. The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks. (10 points)
2. The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project. (2.5 points)
3. The adequacy of mechanisms for ensuring high-quality products and services from the proposed project. (2.5 points)
g.
1. The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project. (5 points)
2. The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible. (5 points)
3. The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes. (5 points)
2.
In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
Awards will be made in rank order according to the average score received from a panel of three non-Federal reviewers.
3.
(1) Faculty development;
(2) Funds and administrative management;
(3) Development and improvement of academic programs;
(4) Acquisition of equipment for use in strengthening management and academic programs;
(5) Joint use of facilities; and
(6) Student services.
For the purpose of these funding considerations, we use 2012-2013 data. If a tie remains after applying the tie-breaker mechanism above, priority will be given to applications from IHEs that have the lowest endowment values per FTE enrolled student.
4.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary
4.
a. The percentage change, over the five-year period, in the number of full-time degree-seeking undergraduates enrolled at NASNTIs (
b. The percentage of first-time, full-time degree-seeking undergraduate students at two-year NASNTIs who were in their first year of postsecondary enrollment in the previous year and are enrolled in the current year at the same NASNTI;
c. The percentage of first-time, full-time degree-seeking undergraduate students enrolled at four-year NASNTIs who graduate within six years of enrollment; and
d. The percentage of first-time, full-time degree-seeking undergraduate students enrolled at two-year NASNTIs who graduate within three years of enrollment.
5.
Bora Mpinja or Don Crews, U.S. Department of Education, 1990 K Street NW., 6th floor, Washington, DC 20006-8513. You may contact these individuals at the following email addresses or telephone numbers:
If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.
Applicants should periodically check the Department's Web site for the title III, part A programs for further information. The address is:
You may also access documents of the Department published in the
Office of Postsecondary Education, Department of Education.
Notice.
Pursuant to the Education Department General Administrative Regulations, this notice authorizes institutions of higher education and consortia of institutions of higher education that are grant recipients under the Centers for International Business Education (CIBE) Program (CFDA 84.220A), Language Resource Centers (LRC) Program (CFDA 84.229A), National Resource Centers (NRC) Program (CFDA 84.015A), and the Undergraduate International Studies and Foreign Language (UISFL) Program (CFDA 84.016A) to make subgrants, subject to the limitations described in this notice. The subgrants must support project activities, including, but not limited to, the development of international business training programs, the development of area studies, international studies, and world language courses, teacher training workshops, the dissemination of instructional materials, faculty development opportunities, and outreach.
Cheryl E. Gibbs, U.S. Department of Education, 1990 K Street NW., Room 6087, Washington, DC 20006. Telephone: (202) 502-7634 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
Parts A and B of Title VI of the HEA do not authorize grantees to make subgrants. Through this notice, pursuant to 34 CFR 75.708(b), we authorize grantees under the CIBE, NRC, LRC, and UISFL programs to make subgrants under certain circumstances.
This notice does
You may also access documents of the Department published in the
Environmental Protection Agency (EPA).
Notice; correction and reopening of comment period.
EPA issued a notice in the
Comments, identified by the docket identification (ID) listed in the body of this document, must be received on or before July 6, 2015.
Follow the detailed instructions as provided under
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
The Agency included in the April 15, 2015
The dockets for these actions, identified by docket identification (ID) numbers EPA-HQ-OPP-2015-0180 for Cyprodinil; EPA-HQ-OPP-2015-0014 for Mefenoxam; EPA-HQ-OPP-2015-0179 for Flutriafol; EPA-HQ-OPP-2014-0922 for Zoxamide; and EPA-HQ-OPP-2014-0232 for Novaluron, are available at
This document reopens the public comment period for the Pesticide Product Registration; Receipt of Applications for New Uses notice, which was published in the
FR Doc. 2015-08478 published in the
1. On page 20222, third column, under the document entitled “Pesticide Product Registration; Receipt of Applications for New Uses”, under the heading SUMMARY, the first paragraph, third line, correct “active ingredients” to read “new uses”.
2. On page 20223, first column, 7 lines from the bottom of the page, correct “active ingredients” to read “new uses”.
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's order for the cancellations, voluntarily requested by the registrants and accepted by the Agency, of the products listed in Table 1 of Unit III., pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Any distribution, sale, or use of the products subject to this cancellation order is permitted only in accordance with the terms of this order, including any existing stocks provisions.
The cancellations are effective June 3, 2015.
Joseph Nevola, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8037; email address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2009-1017, is available at
Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
This notice announces the cancellation, as requested by registrants, of products registered under FIFRA section 3 (7 U.S.C. 136a). These registrations are listed in sequence by registration number in Table 1 of this unit.
Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in Table 1 of this unit.
This cancellation order follows a notice of receipt of voluntary cancellation requests received from the registrants that issued in the
The comment period closed on April 13, 2015. EPA received three comments. The comments agreed with the product cancellations. For this reason, the Agency does not believe that the comments submitted during the comment period merit further review or a denial of the requests for voluntary cancellation.
Further, the registrants did not withdraw their requests.
Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)), EPA hereby approves the requested cancellations of the registrations identified in Table 1 of Unit III. Accordingly, the Agency hereby orders that the product registrations identified in Table 1 of Unit III. are canceled. The effective date of the cancellations that are the subject of this order is June 3, 2015. Any distribution, sale, or use of existing stocks of the products identified in Table 1 of Unit III. in a manner inconsistent with any of the provisions for disposition of existing stocks set forth in Unit VI. will be a violation of FIFRA.
Existing stocks are those stocks of registered pesticide products which are currently in the United States and which were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. The existing stocks provisions for the products subject to this order are as follows.
The registrants have indicated to the Agency via written response that there are no existing stocks because no production has ever occurred. Therefore, no existing stocks date is necessary. Registrants are prohibited from selling or distributing the existing stocks of products listed in Table 1 of Unit III., except for export consistent with FIFRA section 17 (7 U.S.C. 136o) or for proper disposal. In addition, because no production has ever occurred, persons other than the registrants are prohibited from selling, distributing, or using the existing stocks.
The registrant has indicated to the Agency via written response that they will not sell or distribute any existing stocks after December 31, 2014, and as of that date will no longer have any current stock. Therefore, no existing stocks date for the registrant is necessary. The registrant is prohibited from selling or distributing existing stocks of the product listed in Table 1 of Unit III., except for export consistent with FIFRA section 17 (7 U.S.C. 136o) or for proper disposal. Persons other than the registrant may sell, distribute, or use the existing stocks until such stocks are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled product.
Since the notice in the
The registrants may continue to sell and distribute existing stocks of products listed in Table 1 of Unit III. until June 2, 2016, which is 1 year after the publication of this Cancellation Order in the
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is requesting comment on applications from Fiat Chrysler Automobiles LLC (“FCA”), Ford Motor Company (Ford) and General Motors Corporation (GM) for off-cycle carbon dioxide (CO
Comments must be received on or before July 6, 2015.
Submit your comments, identified by Docket ID No. EPA-HQ- OAR-2015-0282, by one of the following methods:
•
•
• Fax: (202) 566-1741.
•
•
Roberts French, Environmental Protection Specialist, Office of Transportation and Air Quality, Compliance Division, U.S. Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105. Telephone: (734) 214-4380. Fax: (734) 214-4869. Email address:
EPA's light-duty vehicle greenhouse gas (GHG) program provides three pathways by which a manufacturer may accrue off-cycle carbon dioxide (CO
Under the regulations, a manufacturer seeking to demonstrate off-cycle credits with an alternative methodology (
• Use modeling, on-road testing, on-road data collection, or other approved analytical or engineering methods;
• Be robust, verifiable, and capable of demonstrating the real-world emissions benefit with strong statistical significance;
• Result in a demonstration of baseline and controlled emissions over a wide range of driving conditions and number of vehicles such that issues of data uncertainty are minimized;
• Result in data on a model type basis unless the manufacturer demonstrates that another basis is appropriate and adequate.
Further, the regulations specify the following requirements regarding an application for off-cycle CO
• A manufacturer requesting off-cycle credits must develop a methodology for demonstrating and determining the benefit of the off-cycle technology, and carry out any necessary testing and analysis required to support that methodology.
• A manufacturer requesting off-cycle credits must conduct testing and/or prepare engineering analyses that demonstrate the in-use durability of the technology for the full useful life of the vehicle.
• The application must contain a detailed description of the off-cycle technology and how it functions to reduce CO
• The application must contain a list of the vehicle model(s) which will be equipped with the technology.
• The application must contain a detailed description of the test vehicles selected and an engineering analysis that supports the selection of those vehicles for testing.
• The application must contain all testing and/or simulation data required under the regulations, plus any other data the manufacturer has considered in the analysis.
Finally, the alternative methodology must be approved by EPA prior to the manufacturer using it to generate credits. As part of the review process defined by regulation, the alternative methodology submitted to EPA for consideration must be made available for public comment.
Using the alternative methodology approach discussed above, Fiat Chrysler Automobiles (FCA) is applying for credits for model years prior to 2014, and thus prior to when the list of default credits becomes available. FCA has applied for off-cycle credits using the alternative demonstration methodology pathway for the following technologies: High efficiency exterior lighting, solar reflective glass/glazing, solar reflective paint, and active seat ventilation. The application covers 2009-2013 model year vehicles. All of these technologies are described in the predetermined list of credits available in the 2014 and later model years. The methodologies described by FCA are generally consistent with those used by EPA to establish the predetermined list of credits in the regulations, and would result in the same credit values as described in the regulations. The magnitude of these credits is determined by specification or calculations in the regulations based on vehicle-specific measurements (
Using the alternative methodology approach discussed above, Ford Motor Company (Ford) is applying for credits for model years prior to 2014, and thus prior to when the list of default credits becomes available. Ford has applied for off-cycle credits using the alternative demonstration methodology pathway for the following technologies: High efficiency exterior lighting, solar reflective glass/glazing, solar reflective paint, active seat ventilation, active aerodynamics, active transmission warm-up, active engine warm-up, and engine idle start-stop. All of these technologies are described in the predetermined list of credits available in the 2014 and later model years. The application covers 2012 and 2013 model year vehicles. The methodologies described by Ford are generally equivalent to those used by EPA to establish the predetermined list of credits in the regulations, and would result in the same credit values as described in the regulations. The magnitude of these credits is determined by specification or calculations in the regulations based on vehicle-specific measurements (
Using the alternative methodology approach discussed above, GM is applying for credits for model years 2013 through 2015. These credits are for a component of the air conditioning system that results in air conditioning efficiency credits beyond those provided in the regulations. GM has applied for off-cycle credits for the Denso SAS air conditioner compressor with variable crankcase suction valve technology. GM is requesting an off-cycle GHG credit of 1.1 grams CO
The “5-cycle” methodology would not adequately measure the real world GHG reduction benefits of either the EVDC or the variable CS valve. Only one of the five tests is conducted with the air conditioner on and that test cycle represents worse case conditions (
GM worked with Denso to perform bench testing of EDVC with and without the variable CS valve and quantified the difference. Based on this analysis, GM determined an off-cycle credit of 1.1 grams of CO
EPA has reviewed the applications for completeness and is now making the applications available for public review and comment as required by the regulations. The off-cycle credit applications submitted by FCA, Ford, and GM (with confidential business information redacted) have been placed in the public docket (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, “Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On January 15, 2015, the Agency submitted a proposed collection of information entitled, “Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, “Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On March 4, 2015, the Agency submitted a proposed collection of information entitled, “Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0787. The approval expires on May 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice; request for notification of participation.
The Food and Drug Administration (FDA) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the generic drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Submit notification of intention to participate by August 14, 2015.
Submit notification of intention to participate in monthly stakeholder meetings by email to
Connie Wisner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1718, Silver Spring, MD 20993-0002, 240-402-7946,
FDA is requesting that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify the Agency of their intent to participate in periodic consultation meetings on the reauthorization of GDUFA. GDUFA authorizes FDA to collect fees from drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities. GDUFA requires that generic drug manufacturers pay user fees to finance critical and measurable generic drug program enhancements. The statutory authority for GDUFA expires at the end of September 2017. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the human generic drug review process. Section 744C(d) (21 U.S.C. 379j-43(d)) of the FD&C Act requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program, including representatives from patient and consumer groups, health care professionals, and scientific and academic experts. FDA will initiate this process on June 15, 2015, by holding a public meeting at which stakeholders and other members of the public will be given an opportunity to present their views on reauthorization (80 FR 22204). The FD&C Act further requires that FDA continue meeting with these stakeholders at least once every month during negotiations with the regulated industry to continue discussions of stakeholder views on the reauthorization.
FDA is issuing this
If you intend to participate in continued periodic stakeholder consultation meetings regarding GDUFA reauthorization, please provide notification by email to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by July 6, 2015.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Patient Protection and Affordable Care Act (Pub. L. 111-148) contains a subtitle called the Biologics Price Competition and Innovation Act of 2009 (Title VII Subtitle A) (BPCI Act) that amends the Public Health Service Act (42 U.S.C. 262) (PHS Act) and other statutes to create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. Section 351(k) of the PHS Act, added by the BPCI Act, allows a company to submit an application for licensure of a biosimilar or interchangeable biological product. The BPCI Act also amends section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications in the definition of “human drug application” for the purposes of the prescription drug user fee provisions. The BPCI Act directs FDA to develop recommendations for a biosimilar biological product user fee program for fiscal years 2013 through 2017. FDA's recommendations for a biosimilar biological product user fee program were submitted to Congress on January 13, 2012.
FDA's biosimilar biological product user fee program requires FDA to assess and collect user fees for certain meetings concerning biosimilar biological product development (BPD meetings), investigational new drug applications (INDs) intended to support a biosimilar biological product application, and biosimilar biological product applications and supplements. Form FDA 3792, the Biosimilars User Fee Cover Sheet, requests the minimum necessary information to determine the amount of the fee required, and to account for and track user fees. The form provides a cross-reference of the fees submitted for a submission with the actual submission by using a unique number tracking system. The information collected is used by FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research to initiate the administrative screening of biosimilar biological product INDs, applications, and supplements, and to account for and track user fees associated with BPD meetings.
In the
Respondents to this collection of information are manufacturers of biosimilar biological product candidates. Based on the number of Form FDA 3792s we have received, we estimate the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice of availability; extension of comment period.
The Food and Drug Administration (FDA or Agency) is extending the comment period in the notice of availability that appeared in the
FDA is extending the comment period in the notice of availability published on February 19, 2015 (80 FR 8874) which includes comment on information collection issues under the Paperwork Reduction Act of 1995 (the PRA). Submit either electronic or written comments on the draft standard MOU or on information collection issues under the PRA by July 20, 2015.
Submit written requests for single copies of the MOU to Edisa Gozun, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, suite 5100, Silver Spring, MD 20993-0002. Send one self-addressed label to assist that office in processing your request. See the
Submit electronic comments on the new draft standard MOU or on the collection of information to
Edisa Gozun, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, suite 5100, Silver Spring, MD 20993-0002, 301-796-3110.
In the
The Agency is extending the comment period both for the draft standard MOU and for information collection issues under the PRA for 30 days, until July 20, 2015. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying resolution of these important issues.
Interested persons may submit either electronic comments regarding this document to
Persons with access to the Internet may obtain the draft standard MOU at
Health Resources and Services Administration, HHS.
Notice of Class Deviation from Competition Requirements for Graduate Psychology Education Program from Open to Limited Competition.
The Health Resources and Services Administration (HRSA) is issuing a limited competition for awards among the 40 current Graduate Psychology Education (GPE) Program grantees whose project periods end June 30, 2016. No more than $1,000,000 will be made available in federal fiscal year (FY) 2015 in the form of 1-year project period grants. These awards are specifically for interprofessional training of doctoral psychology graduate students and interns to address the psychological needs of military personnel, veterans, and their families in civilian and community-based settings, including those in rural areas. An estimated five grants will be awarded with a ceiling amount of $190,000 per grant for 1 year. These funds will be used to establish, expand, and/or enhance activities that were funded under the FY 2013 GPE Program.
Program funds are to be used for stipend support for interns and doctoral students, faculty development, curriculum and instructional design, program content enhancement, program infrastructure development, and the
Eligible Grant Recipients:
Title VII, Sections 750 and 755(b)(1)(J) of the Public Health Service (PHS) Act (42 U.S.C. 294 and 42 U.S.C. 294e(b)(1)(J)).
Cynthia Harne, Public Health Analyst, Division of Nursing and Public Health, Behavioral and Public Health Branch, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, Room 9-89, Rockville, Maryland 20857, phone (301) 443-7661, fax (301) 443-0791, or email
Health Resources and Services Administration, HHS.
Notice.
The Health Resources and Services Administration (HRSA) is
For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place NW., Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857; (301) 443-6593.
The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10
A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists, for each covered childhood vaccine, the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the
Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:
1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and
2. Any allegation in a petition that the petitioner either:
a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or
b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.
In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading “For Further Information Contact”), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
U.S. Customs and Border Protection, Department of Homeland Security.
30-Day notice and request for comments; Extension of an existing collection of information.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Application for Foreign-Trade Zone Admission and/or Status Designation (CBP Forms 214, 214A, 214B, and 214C) and Application for Foreign-Trade Zone Activity Permit (CBP Form 216). This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Written comments should be received on or before July 6, 2015 to be assured of consideration.
Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to
Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of International Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177, at 202-325-0265.
This proposed information collection was previously published in the
CBP Forms 214, 214A, 214B, and 214C, which make up the
These FTZ forms are authorized by 19 U.S.C. 81 and provided for by 19 CFR 146.22, 146.32, 146.39, 146.40, 146.41, 146.44, 146.52, 146.53, and 146.66. These forms are accessible at:
Bureau of Indian Affairs, Interior.
Notice of final agency determination.
The Assistant Secretary—Indian Affairs made a final agency determination to acquire approximately 410.23 +/− acres of land in trust for the Soboba Band of Luiseno Indians, California, for gaming and other purposes on May 19, 2015.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Bureau of Indian Affairs, MS-3657 MIB, 1849 C Street NW., Washington, DC 20240; Telephone (202) 219-4066.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by 209 Departmental Manual 8.1, and is published to comply with the requirements of 25 CFR 151.12(c)(2)(ii) that notice of the decision to acquire land in trust be promptly provided in the
On May 19, 2015, the Assistant Secretary—Indian Affairs issued a decision to accept approximately 410.23+/− acres of land into trust for the Soboba Band of Luiseno Indians, California (Tribe), under the authority of the Indian Reorganization Act of 1934, 25 U.S.C. 465. The Assistant Secretary—Indian Affairs determined that the Tribe's request also meets the requirements of the Indian Gaming Regulatory Act's “contiguous” exemption, 25 U.S.C. 2719(a)(1), to the general prohibition contained in 25 U.S.C. 2719(a) on gaming on lands acquired in trust after October 17, 1988.
The 410.23 acres are located in San Jacinto, Riverside County, California, and are described as follows:
Those portions of Parcels 1 and 2 of Parcel Map 19805 in the County of Riverside, State of California, as shown by map on file in book 123 pages 22 through 25, inclusive of Parcel maps, records of Riverside County, California, lying easterly and southerly of a line described as follows:
That portion of lots 1 and 3 of the Jose A. Estudillo Subdivision of Tract VII of the Rancho San Jacinto Viejo, as shown by map on file in book 6 page 304 of maps, records of San Diego County, California, described as follows:
Lots 1 through 6 inclusive of Tract No. 21943, as shown by map on file in book 239 page(s) 90 through 94 inclusive, of maps, records of Riverside County, California.
That portion of that certain 80.00 foot wide avenue, vacated, lying between lots 3 and 4 of the Jose A. Estudillo Subdivision of Tract VII of the Rancho San Jacinto Viejo, as shown by map on file in book 6 page(s) 304 of maps, records of San Diego County, California, described as follows:
An easement inuring to the benefit of parcels 3 and 3a for the purpose of drainage, desilting facilities, slopes, pedestrian and golf cart circulation, vehicular access, and/or utilities, (including, without limitation, the construction, installation and maintenance of improvements for sewer, water, telephone, gas, electrical and any other utility services), as set forth in and limited by that certain easement agreement made as of September 23, 1983, between Daon Corporation, a Delaware Corporation and Diet Center Incorporated, an Idaho Corporation, recorded September 24, 1982 as Instrument No. 165704 of official records of Riverside County, California.
That portion of lot 4 of the San Diego Jose A Estudillos Subdivision of Tract 7 of Rancho San Jacinto Viejo, as per the map thereof record in book 6, page(s) 304 of miscellaneous maps in the office of the county recorder of said county and state, consisting of seven and eighty-seven hundredths (7.87) acres, more or less, as more particularly described as follows:
That portion of lot 4 of the San Diego Jose A Estudillos Subdivision of Tract 7 of Rancho San Jacinto Viejo, as per the map thereof recorded in book 6, page(s) 304 of miscellaneous maps in the office of the county recorder of said county and state, consisting of two and three-tenths (2.30) acres, more or less, as more particularly described as follows:
That portion of lots 1, 2, and 3 of Hot Springs Tract, as shown by map on file in book 8 page 5 of maps, records of Riverside County, California, described as follows:
That portion of Tract VI, as shown by map of partition of Rancho San Jacinto Viejo, made under decree of superior court of state of California, in and for the county of San Diego, dated March 9, 1882 and recorded in book 43, page(s) 161 of deeds, San Diego County records, lying northeasterly of Auburn Avenue as shown on map of Olmsteads Subdivision on file in book 4, page(s) 261 of maps, San Diego County records.
Government lots 5, 6, 7 and 8 in fractional section 24, township 4 south, range 1 west, San Bernardino base and meridian, as shown by United States Government Survey approved May 8, 1885.
Parcels 1, 2 and 3 of parcel map 19805, in the County of Riverside, State of California, as per map recorded in book 123, page(s) 22 through 25, inclusive of parcel maps, in the Office of the County Recorder of said county, together with that portion of lots 1, 2 and 3 of Hot Springs Tract as shown by map on file in book 8, page(s) 5 of maps, said Riverside County, California, lying southerly of the southerly right of way line of Soboba Road, 100.00 feet wide, and together with that portion of lots 3, 4, 5 and 6 of the Jose A. Estudillo Subdivision of Tract VII of the Rancho San Jacinto Viejo as shown by map on file in book 6, page(s) 304 of maps, records of San Diego County, California, and portions of the vacated streets, lying westerly of the westerly right of way line of said Soboba Road, as said portions of Hot Springs Tract and Jose A. Estudillo Subdivision as shown on map of said Parcel Map No. 19805.
Bureau of Land Management, Interior.
30-day notice and request for comments.
The Bureau of Land Management (BLM) has submitted an information collection request to the Office of Management and Budget (OMB) to continue the collection of information about transfers and assignments of leases for oil, gas, and geothermal resources. The Office of Management and Budget (OMB) has assigned control number 1004-0034 to this information collection.
The OMB is required to respond to this information collection request within 60 days but may respond after 30 days. For maximum consideration, written comments should be received on or before July 6, 2015.
Please submit comments directly to the Desk Officer for the Department of the Interior (OMB #1004-0034), Office of Management and Budget, Office of Information and Regulatory Affairs, fax 202-395-5806, or by electronic mail at
Please indicate “Attn: 1004-0034” regardless of the form of your comments.
Jennifer Spencer at 202-912-7146 (oil and gas) or Lorenzo Trimble at 775-861-6567 (geothermal resources). Persons who use a telecommunication device for the deaf may call the Federal Information Relay Service at 1-800-
The Paperwork Reduction Act (44 U.S.C. 3501-3521) and OMB regulations at 5 CFR part 1320 provide that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond. In order to obtain and renew an OMB control number, Federal agencies are required to seek public comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d) and 1320.12(a)).
As required at 5 CFR 1320.8(d), the BLM published a 60-day notice in the
1. Whether the collection of information is necessary for the proper functioning of the BLM, including whether the information will have practical utility;
2. The accuracy of the BLM's estimate of the burden of collecting the information, including the validity of the methodology and assumptions used;
3. The quality, utility and clarity of the information to be collected; and
4. How to minimize the information collection burden on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other forms of information technology.
Please send comments as directed under
The following information pertains to this request:
• Form 3000-3, Assignment of Record Title Interest in a Lease for Oil and Gas or Geothermal Resources; and
• Form 3000-3a, Transfer of Operating Rights (Sublease) in a Lease for Oil and Gas or Geothermal Resources.
The estimated annual burdens are itemized in the following table:
Notice is hereby given that, on May 1, 2015, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Devon alli, Atlanta, GA, has withdrawn as a party to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and AllSeen Alliance intends to file additional written notifications disclosing all changes in membership.
On January 29, 2014, AllSeen Alliance filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on February 9, 2015. A notice was published in the
Notice is hereby given that, on May 6, 2015, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Hakuto Taiwan, Taipei, TAIWAN; Laser Video, Moscow, RUSSIA; Renesas Mobile Corporation, Tokyo, JAPAN, Renesas Micro Systems Co., Ltd., Yokohama, JAPAN; Shenzhen MTC Co., Ltd., Futain District, Shenzhen, PEOPLE'S REPUBLIC OF CHINA; and Tanashin Denki Co., Ltd., Tokyo, JAPAN, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and DVD CCA intends to file additional written notifications disclosing all changes in membership.
On April 11, 2001, DVD CCA filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on February 6, 2015. A notice was published in the
Notice is hereby given that, on April 6, 2015, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: ExxonMobil Research & Engineering Company, Fairfax, VA; BP Products North America Inc., Naperville, IL; Chevron U.S.A. Inc., a Pennsylvania corporation, acting through its Chevron Energy Technology Company division, Houston, TX; The Dow Chemical Company Midland, Midland, MI; Flint Hills Resources LP, Wichita, KS; Phillips 66 Company, Houston, TX; LyondellBasell Industries, Houston, TX; Marathon Petroleum Company LP, Findlay, OH; Shell Global Solutions (US) Inc., Houston, TX; Valero Energy Corp., San Antonio, TX; Bayer MaterialScience LLC, Pittsburgh, PA; and Siemens Energy, Inc., Houston, TX. The general area of PERF Project No. 2013-10's planned activity is, through cooperative research efforts, to better understand pressure relief valve (PRV) stable operation by creating a model, set of equations, or other tool that can be used by engineers to predict stability (
Notice.
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, “Notice of Termination, Suspension, Reduction, or Increase in Benefit Payments,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before July 6, 2015.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-6881 (this is not a toll-free number); or by email:
Contact Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
44 U.S.C. 3507(a)(1)(D).
This ICR seeks approval under the PRA for revisions to the Notice of Termination, Suspension, Reduction, or Increase in Benefit Payments information collection. Coal mine operators, their representatives, and their insurers who have been identified as responsible for paying Black Lung benefits to an eligible miner or an eligible surviving dependent of the miner are called Responsible Operators (ROs). An RO who pays benefits to a beneficiary is required to report any change in the benefit amount to the Division of Coal Mine Workers' Compensation within the OWCP. Form CM-908, when properly completed and submitted, notifies the agency of the change in the beneficiary's benefit amount and the reason for the change. This information collection has been classified as a revision, because of minor enhancements to Form CM-908; however, no changes to the content in the form of the form are proposed. Federal Mine Safety and Health Act of 1977 section 432 authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Occupational Safety and Health Administration (OSHA), Labor.
Request for nomination of members to serve on the Maritime Advisory Committee for Occupational Safety and Health.
OSHA invites interested persons to submit nominations for membership on the Maritime Advisory Committee for Occupational Safety and Health.
You must submit nominations for MACOSH membership (POSTMARKED, SENT, TRANSMITTED, OR RECEIVED) by July 20, 2015.
You may submit nominations and supporting materials by one of the following methods:
OSHA will post submissions in response to this
The Assistant Secretary of Labor for Occupational Safety and Health invites interested persons to submit nominations for membership on MACOSH.
The Secretary of Labor renewed the MACOSH charter for two years on April 30, 2015. MACOSH is a Federal Advisory Committee established under the authority of the Occupational Safety and Health Act (OSH Act) (29 U.S.C. 651
MACOSH reports to the Secretary of Labor through OSHA, and functions solely as an advisory body. MACOSH provides recommendations and advice to the Department of Labor and OSHA on various policy issues pertaining to safe and healthful employment in the maritime industries. The Secretary of Labor consults with MACOSH on various subjects, including: Ways to increase the effectiveness of safety and health standards that apply to the maritime industries, injury and illness prevention, the use of stakeholder partnerships to improve training and outreach initiatives, and ways to increase the national dialogue on occupational safety and health. In addition, MACOSH provides advice on enforcement initiatives that will improve the working conditions and the safety and health of workers in the maritime industries. The Committee meets approximately two times per year. Committee members serve without compensation, but OSHA provides travel and per diem expenses. Members serve a two-year term, which begins from the date of appointment by the Secretary of Labor. The current MACOSH membership term expires on January 16, 2016.
MACOSH consists of not more than 15 members appointed by the Secretary of Labor. The Agency seeks committed MACOSH members who have a strong interest in the safety and health of workers in the maritime industries. The U.S. Department of Labor is committed to equal opportunity in the workplace. The Secretary of Labor will appoint members to create a broad-based, balanced and diverse committee reflecting the shipyard, longshoring, and commercial fishing industries, and representing affected interests such as employers, employees, safety and health professional organizations, government organizations with interests or activities related to the maritime industry, academia, and the public.
Nominations of new members or resubmissions of former or current members will be accepted in all categories of membership. Interested persons may nominate themselves or submit the name of another person whom they believe to be interested in, and qualified to serve on, MACOSH. Nominations may also be submitted by organizations from one of the categories listed above.
Nominations must include the following information:
(1) Nominee's contact information and current employment or position;
(2) Nominee's resume or curriculum vitae, including prior membership on MACOSH and other relevant organizations and associations;
(3) Maritime industry interest (
(4) A summary of the background, experience, and qualifications that addresses the nominee's suitability for membership; and
(5) A statement that the nominee is aware of the nomination, is willing to regularly attend and participate in MACOSH meetings, and has no conflicts of interest that would preclude membership on MACOSH.
OSHA will conduct a basic background check of candidates before their appointment to MACOSH. The background check will involve accessing publicly available, Internet-based sources.
The Secretary of Labor will select MACOSH members based on their experience, knowledge, and competence in the field of occupational safety and health, particularly in the maritime industries. Information received through this nomination process, and other relevant sources of information, will assist the Secretary of Labor in appointing members to MACOSH. In selecting MACOSH members, the
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice under the authority granted by 29 U.S.C. 655(b)(1) and 656(b), 5 U.S.C. App. 2, Secretary of Labor's Order No. 1-2012 (77 FR 3912), and 29 CFR part 1912.
Occupational Safety and Health Administration (OSHA), Labor.
Announcement of a NACOSH meeting.
NACOSH will meet June 18, 2015, in Washington, DC. In conjunction with the committee meeting, the NACOSH Temporary Workers Work Group will meet June 17, 2015.
OSHA will post in the public docket, without change, any comments, requests to speak, and speaker presentations, including any personal information that you provide. Therefore, OSHA cautions interested parties about submitting personal information such as Social Security numbers and birthdates.
NACOSH was established by Section 7(a) of the Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651, 656) to advise, consult with and make recommendations to the Secretary of Labor and the Secretary of Health and Human Services on matters relating to the administration of the OSH Act. NACOSH is a continuing advisory committee of indefinite duration.
NACOSH operates in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2), its implementing regulations (41 CFR part 102-3), and OSHA's regulations on NACOSH (29 CFR part 1912a).
The tentative agenda for the NACOSH meeting includes:
• An update from the Assistant Secretary of Labor for Occupational Safety and Health on key OSHA initiatives, including the severe injury reporting rule;
• Remarks from the Director of the National Institute for Occupational Safety and Health;
• NACOSH Emergency Response Subcommittee; and
• Report from the NACOSH Temporary Workers Workgroup on developing best practice language for protecting temporary workers as part of employers' injury and illness prevention programs.
OSHA transcribes and prepares detailed minutes of NACOSH meetings. OSHA posts the transcripts and minutes in the public docket along with written comments, speaker presentations, and other materials submitted to NACOSH or presented at NACOSH meetings.
Individuals requesting special accommodations to attend the NACOSH and NACOSH Work Group meetings should contact Ms. Jameson.
Because of security-related procedures, receipt of submissions by regular mail may experience significant delays. For information about security procedures for submitting materials by hand delivery, express mail, and messenger/courier service, please contact the OSHA Docket Office.
• The amount of time requested to speak;
• The interest you represent (
• A brief outline of the presentation.
PowerPoint presentations and other electronic materials must be compatible with PowerPoint 2010 and other Microsoft Office 2010 formats. The NACOSH Chair may grant requests to address NACOSH as time and circumstances permit.
OSHA also places in the public docket meeting transcripts, meeting minutes, documents presented at the NACOSH meeting, and other documents pertaining to NACOSH and NACOSH Work Group meetings. These documents may be available online at
Electronic copies of this
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice under the authority granted by 29 U.S.C. 656; 5 U.S.C. App. 2; 29 CFR part 1912a; 41 CFR part 102-3; and Secretary of Labor's Order No. 1-2012 (77 FR 3912 (1/25/2012)).
National Endowment for the Arts, National Foundation on the Arts and Humanities.
Notice of meeting.
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, notice is hereby given that a meeting of the National Council on the Arts will be held at Constitution Center, 400 7th St. SW., Washington, DC 20506. Agenda times are approximate.
Thursday, June 25, 2015 from 1:00 p.m. to 3:00 p.m. (This session will be closed for discussion of the National Medal of Arts) and Friday, June 26, 2015 from 9:00 a.m. to 11:15 a.m. in Conference Rooms A and B (This session will be open and also will be webcast).
Office of Public Affairs, National Endowment for the Arts, Washington, DC 20506, at 202/682-5570.
The meeting on June 26th will be open to the public on a space available basis. The tentative agenda is as follows: The session will begin at 9:00 a.m. with opening remarks and voting on recommendations for funding and rejection and guidelines, followed by updates from the Chairman. There also will be the following presentations (times are approximate): from 9:30 a.m. to 10:00 a.m.—
The Friday, June 26th session also will be webcast. To register to watch the webcasting of this open session of the meeting, go to
If, in the course of the open session discussion, it becomes necessary for the Council to discuss non-public commercial or financial information of intrinsic value, the Council will go into closed session pursuant to subsection (c)(4) of the Government in the Sunshine Act, 5 U.S.C. 552b, and in
Any interested persons may attend, as observers, Council discussions and reviews that are open to the public. If you need special accommodations due to a disability, please contact the Office of Accessibility, National Endowment for the Arts, 1100 Pennsylvania Avenue NW., Washington, DC 20506, 202/682-5733, Voice/T.T.Y. 202/682-5496, at least seven (7) days prior to the meeting.
Pursuant to delegation by the Commission,
This proceeding involves an application by Entergy Nuclear Operations, Inc. for a license amendment for Indian Point Nuclear Generating Station, Unit 2, which is located in Westchester County, New York. In response to a notice filed in the
The Board is comprised of the following administrative judges:
All correspondence, documents, and other materials shall be filed in accordance with the NRC E-Filing rule.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On May 27, 2015, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2015-79 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than June 4, 2015. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2015-79 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than June 4, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On May 27, 2015, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2015-78 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than June 4, 2015. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints James F. Callow to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2015-78 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, James F. Callow is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than June 4, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
National Nanotechnology Coordination Office, Office of Science and Technology Policy.
Notice of public webinars.
The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), will hold webinars periodically to share information with the general public and the nanotechnology research and development community. Topics covered may include announcements of new National Nanotechnology Initiative activities, discussions of technical subjects, introductions to resources available for specific areas such as education or sensors development, or other areas of potential interest to the nanotechnology community. The first webinar will be held June 25, 2015, to promote resources available on the newly developed Sensors Nanotechnology Signature Initiative (NSI) Web Portal (
The NNCO will hold multiple webinars between the publication of this Notice and December 31, 2015. The first webinar will be held on June 25, 2015, from 12 p.m. to 1 p.m. EDT.
These free, web-based events are open to the public. For current information about the webinars, please visit
Stacey Standridge, 703-292-8103,
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
SCCP is filing this proposed rule change with respect to amendments of the Amended and Restated Certificate of
In its filing with the Commission, SCCP included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. SCCP has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
As part of an ongoing global rebranding initiative, the Company has begun to refer to itself, both internally and externally, as Nasdaq, rather than NASDAQ OMX. For purposes of consistency with its marketing, communications and other materials, the Company has decided to change the legal names of NASDAQ OMX and certain of its subsidiaries to eliminate references to OMX. The Company therefore proposes to amend its Charter and By-Laws to change its legal name from The NASDAQ OMX Group, Inc. to Nasdaq, Inc.
Specifically, the Company proposes to file a Certificate of Amendment to its Charter with the Secretary of State of the State of Delaware to amend Article First of the Charter to reflect the new name. In addition, the Company proposes to amend the title and Article I(f) of the By-Laws to reflect the new name.
SCCP believes that its proposal is consistent with Section 17A(b)(3)(C) of the Act,
Specifically, NASDAQ OMX is proposing changes to its Charter and By-Laws to change NASDAQ OMX's legal name to Nasdaq, Inc. SCCP believes that the changes will eliminate confusion that may exist because of NASDAQ OMX's ongoing global rebranding as Nasdaq. As a result, SCCP believes that the proposals assure a fair representation of NASDAQ OMX's stockholders in the selection of directors and administration of NASDAQ OMX's affairs, as well as the affairs of SCCP.
Because the proposed rule change relates to the governance of NASDAQ OMX and not to the operations of SCCP, SCCP does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
BSECC is filing this proposed rule change with respect to amendments of the Amended and Restated Certificate of Incorporation (the “Charter”) and By-Laws (the “By-Laws”) of its parent corporation, The NASDAQ OMX Group, Inc. (“NASDAQ OMX” or the “Company”), to change the name of the Company to Nasdaq, Inc. The proposed amendments will be implemented on a date designated by NASDAQ OMX following approval by the Commission. The text of the proposed rule change is available on BSECC's Web site at
In its filing with the Commission, BSECC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. BSECC has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
As part of an ongoing global rebranding initiative, the Company has begun to refer to itself, both internally and externally, as Nasdaq, rather than NASDAQ OMX. For purposes of consistency with its marketing, communications and other materials, the Company has decided to change the legal names of NASDAQ OMX and certain of its subsidiaries to eliminate references to OMX. The Company therefore proposes to amend its Charter and By-Laws to change its legal name from The NASDAQ OMX Group, Inc. to Nasdaq, Inc.
Specifically, the Company proposes to file a Certificate of Amendment to its Charter with the Secretary of State of the State of Delaware to amend Article First of the Charter to reflect the new name. In addition, the Company proposes to amend the title and Article I(f) of the By-Laws to reflect the new name.
BSECC believes that its proposal is consistent with Section 17A(b)(3)(C) of the Act,
Specifically, NASDAQ OMX is proposing changes to its Charter and By-Laws to change NASDAQ OMX's legal name to Nasdaq, Inc. BSECC believes that the changes will eliminate confusion that may exist because of NASDAQ OMX's ongoing global rebranding as Nasdaq. As a result, BSECC believes that the proposals assure a fair representation of NASDAQ OMX's stockholders in the selection of directors and administration of NASDAQ OMX's affairs, as well as the affairs of BSECC.
Because the proposed rule change relates to the governance of NASDAQ OMX and not to the operations of BSECC, BSECC does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
(A) by order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
On March 22, 2013, the Commission approved a proposal by Nasdaq to establish a one-time voluntary accommodation policy for claims arising from system difficulties that Nasdaq experienced during the initial public offering (“IPO”) of Facebook, Inc. (“Facebook” or “FB”) on May 18, 2012.
On May 18, 2012, Nasdaq experienced system difficulties during the Nasdaq Halt and Imbalance Cross Process (the “Cross”) for the FB IPO. These difficulties delayed the completion of the Cross from 11:05 a.m. until 11:30 a.m.
As a result of the system difficulties, however, certain orders for FB stock that were entered between 11:11:00 a.m. and 11:30:09 a.m. in the expectation of participating in the Cross—and that were not cancelled prior to 11:30:09 a.m.—either did not execute or executed after 1:50 p.m. at prices other than the $42.00 price established by the Cross. (Other orders entered between 11:11:00 a.m. and 11:30:09 a.m., including cancellations, buy orders below $42.00, and sell orders above $42.00, were handled without incident.) System issues also delayed the dissemination of Cross transaction reports from 11:30 a.m. until 1:50 p.m. At 1:50 p.m., Nasdaq system difficulties were completely resolved.
Rule 4626(b)(3) provides that, as a result of these unique circumstances, Nasdaq would accommodate members for losses attributable to the system difficulties on May 18, 2012 in an amount not to exceed $62 million. Rule 4626(b)(3)(A) provides that all claims for such accommodation must arise solely from realized or unrealized direct
(i) SELL Cross orders that were submitted between 11:11 a.m. and 11:30 a.m. on May 18, 2012, that were priced at $42.00 or less, and that did not execute;
(ii) SELL Cross orders that were submitted between 11:11 a.m. and 11:30 a.m. on May 18, 2012, that were priced at $42.00 or less, and that executed at a price below $42.00;
(iii) BUY Cross orders priced at exactly $42.00 and that were executed in the Cross but not immediately confirmed; and
(iv) BUY Cross orders priced above $42.00 and that were executed in the Cross but not immediately confirmed, but only to the extent entered with respect to a customer that was permitted by the member to cancel its order prior to 1:50 p.m. and for which a request to cancel the order was submitted to Nasdaq by the member, also prior to 1:50 p.m.
As originally approved, Rule 4626(b)(3)(D) provided that all claims related to the FB IPO must be submitted in writing not later than 7 days after formal approval of the FB accommodation proposal by the Commission, which occurred on March 22, 2013. In recognition of the fact that the Passover and Good Friday holidays occurred during the week when claim submissions would otherwise be due, Nasdaq submitted an immediately effective proposed rule change to extend the deadline for claim submission until 11:59 p.m. on April 8, 2013.
Rule 4626(d)(3)(D) further provides that all claims shall be processed and evaluated by the Financial Industry Regulation Authority (“FINRA”), applying the standards set forth in Rule 4626. FINRA is authorized to request such supplemental information as it deems necessary to assist its evaluation of claims.
Rule 4626(b)(3)(E) required FINRA to provide to the Nasdaq Board of Directors and the Board of Directors of NASDAQ OMX an analysis of the total value of eligible 2013 Claims, and further provided that Nasdaq would file with the Commission a rule proposal setting forth the amount of eligible 2013 Claims under the standards set forth in Rule 4626 and the amount proposed to be paid to members by Nasdaq. This process was completed in 2013,
On March 15, 2013, UBS Securities LLC (“UBS”), a member of Nasdaq within the meaning of Rule 4626, filed a demand for arbitration against NASDAQ with the American Arbitration Association (“AAA”). In its demand, UBS sought to recover damages alleged to have been caused by Nasdaq in connection with the Facebook IPO. UBS cited provisions of the Services Agreement between Nasdaq and UBS as the basis for pursuing a claim in arbitration.
On April 4, 2013, Nasdaq filed an action in the Southern District of New York against UBS seeking declaratory and injunctive relief with respect to UBS's demand for arbitration. On April 16, 2013, NASDAQ moved preliminarily to enjoin UBS from proceeding with arbitration, arguing, inter alia, that the Services Agreement did not reflect an agreement by Nasdaq to arbitrate claims covered by Rule 4626. UBS cross-moved to dismiss NASDAQ's complaint and opposed the preliminary injunction motion. On June 18, 2013, the district court granted NASDAQ's motion for a preliminary injunction and denied UBS's cross-motion to dismiss.
On October 31, 2014, the Court of Appeals issued a decision affirming the district court's decision.
Under the proposed process for submission of new claims, a member that did not submit a claim prior to 11:59 p.m. ET on April 8, 2013 and that is not subject to a release executed and delivered to Nasdaq under Rule 4626(b)(3)(H) may submit a claim under Rule 4626(b)(3) prior to 11:59 p.m. ET on June 19, 2015 (each, a “2015 Claim” and collectively, the “2015 Claims”). All 2015 Claims shall be processed and evaluated by FINRA applying the accommodation standards set forth in paragraphs (b)(3)(A), (B), and (C) of Rule 4626 and as fully described in the Proposing Release, the Approval Order, and the Results Filing.
As was the case with 2013 Claims, FINRA will establish a working group consisting of FINRA Market Regulation Department analysts and managers (“FB Claims Team”). During the review process, the FB Claims Team will not perform any regulatory services for any Nasdaq market and will not own or have owned FB stock during the period since its IPO. A Steering Committee, composed of members of senior management of FINRA's Market Regulation Department, may provide
Following the completion of its analysis of 2015 Claims, FINRA shall provide to the Nasdaq Board of Directors and the Board of Directors of The NASDAQ OMX Group, Inc. an analysis of the total value of eligible 2015 Claims.
• All payments of 2015 Claims will be contingent upon the submission to Nasdaq, not later than 7 days after the member's receiving notice of the value its 2015 Claim, of an attestation detailing:
○ The amount of compensation, accommodation, or other economic benefit provided or to be provided by the member to its customers (other than customers that were brokers or dealers trading for their own account) in respect of trading in Facebook Inc. on May 18, 2012 (“Customer Compensation”), and
○ the extent to which the losses reflected in the “Member's Share”
Failure to provide the required attestation within the specified time limit will void the member's eligibility to receive an accommodation with respect to a 2015 Claim. Each member shall be required to maintain books and records that detail the nature and amount Customer Compensation and Covered Proprietary Losses with respect to 2015 Claims.
• All payments of 2015 Claims will be contingent upon the execution and delivery to Nasdaq of a release by the member of all claims by it or its affiliates against Nasdaq or its affiliates for losses that arise out of, are associated with, or relate in any way to the Facebook, Inc. IPO Cross or to any actions or omissions related in any way to that Cross, including but not limited to the execution or confirmation of orders in Facebook, Inc. on May 18, 2012. The member's failure to provide the required release within 14 days after receiving notice of the value its 2015 Claim will void the member's eligibility to receive an accommodation with respect to its 2015 Claim.
Nasdaq is requiring the submission of the attestation with respect to Customer Compensation because, as was the case with respect to 2013 Claims, Nasdaq believes that it is reasonable to make accommodation payments with respect to orders submitted on behalf of a member's customers only if the member has compensated or will compensate its customers in an amount that is at least equal to the amount of the accommodation payment. In addition, Nasdaq will prioritize the payment of accommodation funds used to compensate a member's customers above the payment of funds with respect to proprietary trading losses. However, Nasdaq notes that with respect to 2013 Claims, Nasdaq was able to pay the full amount the 2013 Claims, including proprietary trading losses. Moreover, based on Nasdaq's records with respect to the disposition of shares in the Cross, Nasdaq believes that it will likely be able to pay the full amount of 2015 Claims, including claims with respect to Covered Proprietary Losses. Nevertheless, because Rule 4626 includes an absolute limit of $62 million on the total value of accommodation payments with respect to the FB IPO, and because Nasdaq is not proposing to increase this limit, Nasdaq is proposing a proration mechanism that would be used in the event that the total value of 2015 Claims and 2013 Claims exceeds $62 million.
• First, if the member has provided Customer Compensation, the member will receive an amount equal to the lesser of the Member's Share or the amount of Customer Compensation (“Tranche A”);
• Second, the member will receive an amount with respect to Covered Proprietary Losses; provided, however, that the sum of payments to a member with respect to 2015 Claims shall not exceed the Member's Share (“Tranche B”).
In the event that the amounts calculated under Tranche A, together with the amounts previously paid with respect to 2013 Claims, exceed $62 million, the accommodation will be prorated among members eligible to receive accommodation under Tranche A based on the size of the amounts payable under Tranche A. In the event that Tranche A is paid in full and the amounts calculated under Tranche B, together with the amounts paid under Tranche A and the amounts previously paid with respect to 2013 Claims, exceed $62 million, the accommodation will be prorated among members eligible to receive accommodation under Tranche B based on the size of the amounts payable under Tranche B. If a member's eligibility to receive funds is voided for any reason under this rule, and the funds payable to other members must be prorated hereunder, the funds available to pay other members will be increased accordingly.
Thus, if the portion of 2015 Claims with respect to Customer Compensation, plus the total amount paid with respect to 2013 Claims, exceeds $62 million, the funds remaining under Rule 4626 will be prorated among members with 2015 Claims with respect to Customer Compensation. Similarly, if the portion of 2015 Claims with respect to Customer Compensation, plus the total amount paid with respect to 2013 Claims does not exceed $62 million, but such amount, together with the portion of 2015 Claims with respect to Covered Proprietary Losses exceeds $62 million, the funds remaining under Rule 4626 after payments with respect to Customer Compensation will be prorated among members with 2015 Claims with respect to Covered Proprietary Losses. Nasdaq believes that this proration mechanism is reasonable because members with 2013 Claims submitted timely claims under the terms of Rule 4626(b)(3) as originally proposed, while members with 2015 Claims are receiving the benefit of a subsequent amendment. Accordingly, to the extent that any proration is required to keep the overall cost of the program under the $62 million limit originally proposed and approved by the Commission, the effects of the proration should be borne solely
All payments of 2015 Claims shall be made in cash. Payments to a member shall be made as soon as practicable following the completion of all analysis and documents required under the rule.
Nasdaq believes that the proposed rule change is consistent with Section 6(b) of the Act
Nevertheless, although Nasdaq believes it is unlikely that proration of 2015 Claims in order to keep the total value of all claims within the $62 million limit authorized under the rule will be required, it is reasonable that members making claims under the 2015 Claim process would be required to incur the burden of any such proration that would be required, since such members opted not to file claims within the period originally contemplated by the rule.
Nasdaq believes that the proposed rule change will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Specifically, the proposed rule change does not relate to the provision of goods or services, nor does it impose regulatory restrictions on the ability of members to compete. Accordingly, the change does not affect competition in any respect.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On February 12, 2015, ICE Clear Europe Limited (“ICE Clear Europe”) filed with the Securities and Exchange Commission (“Commission”) a proposed rule change pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
ICE Clear Europe has submitted proposed amendments to its CDS Procedures to (i) revise the CDS Procedures to add a new section containing contract terms applicable to the CDX.NA Contracts that ICE Clear Europe proposes to accept for clearing; (ii) make conforming changes throughout the CDS Procedures to reference the CDX.NA Contracts; and (iii) make certain other clarifications, corrections and updates to the CDS Procedures (including for iTraxx Contracts and Single Name Contracts), as discussed in more detail herein. ICE Clear Europe has also proposed to make certain modifications to its CDS Risk Model Description and CDS End-of-Day Price Discovery Policy (the “CDS Pricing Policy”) to accommodate clearing of CDX.NA Contracts, as described herein.
ICE Clear Europe has proposed to amend Paragraphs 1, 4, 6, 9, 10 and 11 of the CDS Procedures, described below. All capitalized terms not defined herein are defined in the ICE Clear Europe Clearing Rules (the “Rules”).
In paragraph 1 of the CDS Procedures, references will be added to the defined terms “iTraxx Contract” and “CDX.NA Contract,” as such terms are set out in revised paragraphs 9 and 10 of the CDS Procedures, respectively. The definition of “Original Annex Date” will be modified to apply to CDX.NA Contracts in substantially the same manner it applies to iTraxx Contracts. In addition, the definition of “Protocol Excluded Reference Entity” in former paragraph 10.3 will be changed to “Protocol Excluded Corporate Reference Entity” and moved to paragraph 1, to reflect that such term is only used in the context of corporate reference entities. Accordingly, the definition will be revised to mean an Eligible Single Name Reference Entity that is a Standard European Corporate (as specified in the List of Eligible Single Name Reference Entities) and is an Excluded Reference Entity (as defined in the 2014 CDD Protocol). (Conforming changes will be made to references to that definition throughout the CDS Procedures.) In addition, a correction will be made to the cross-reference in definition of “New Trade” to properly refer to the definition set out in the applicable Contract Terms for the relevant contract.
In addition, amendments will be made to use the defined terms “Component Transaction” and “Clearing” throughout the Procedures in lieu of the undefined terms. Finally, various conforming references to the new or revised defined terms will be made throughout the CDS Procedures, various provisions of the CDS Procedures will be renumbered, and certain cross-references to prior paragraph 1.71 will be corrected.
Various clarifications will be made in Paragraph 9 of the CDS Procedures, which sets out the contract terms for iTraxx Contracts. Specifically, paragraph 9.1 will be modified to clarify that it specifies the additional Contract Terms applicable to all iTraxx Contracts cleared by the Clearing House. Paragraph 9.2(c)(i), which applies to iTraxx Contracts which are governed by the Standard iTraxx 2014 CDS Supplement, will be modified to make certain additional clarifications relating to initial payments and spun-out trades. Paragraph 9.2(c)(i)(B) will be added to reflect current clearing house (and market) practice that initial payments under cleared iTraxx Contracts (other than those for which a bilateral transaction is already recorded in Deriv/SERV) are made on the business day following the trade date (or, if later, the business day following the date of acceptance for clearing). New paragraph 9.2(c)(i)(D), which will address the reference obligation for a spun-out trade following a restructuring credit event, is substantially the same as the corresponding language in paragraph 9.3(c)(i)(D) for contracts subject to the Standard iTraxx Legacy CDS Supplement and was inadvertently omitted from prior amendments. A cross-reference in paragraph 9.2(c)(i)(E) will be updated. New paragraph 9.2(c)(i)(F) will provide that paragraph 5.7 of the Standard iTraxx 2014 CDS Supplement, which contains restrictions on delivery of Credit Event Notices and Successor Notices, does not apply to iTraxx Contracts (as the appropriate restrictions in the context of a cleared transaction are already addressed in the Rules and CDS Procedures, including Rule 1505).
As set forth in paragraph 9.2(c)(ii), changes will also be made to the terms of the iTraxx 2014 Confirmation with respect to iTraxx Contracts that are governed by the Standard iTraxx 2014 CDS Supplement. These amendments will include a clarification that references to the 2014 Credit Derivatives Definitions in the standard supplement and confirmation will be interpreted for cleared contracts as though they have the meaning ascribed to that term in the Rules and Procedures. In addition, a provision that there are no “Omitted Reference Entities” for purposes of the standard confirmation will be removed as that term is not used in the standard supplement and confirmation and is therefore unnecessary.
Similar clarifications will be made in paragraph 9.3, which relates to iTraxx Contracts which are governed by the
New paragraph 10 of the CDS Procedures will be added to set out the contract terms for CDX.NA Contracts. Paragraph 10.1 will provide that different sub-provisions of paragraph 10 will apply to CDX.NA Contracts depending on whether the Original Annex Date for the relevant index series falls before or after the Protocol Effective Date.
New paragraph 10.2 will apply to CDX.NA Contracts with an Original Annex Date on or after the Protocol Effective Date (
New paragraph 10.3 will apply to CDX.NA Contracts with an Original Annex Date before the Protocol Effective Date (
New paragraph 10.4 will contain procedures for updating the CDX.NA index version following a Credit Event or Succession Event. These provisions will be generally consistent with the comparable provisions for iTraxx contracts in paragraph 9.8. New paragraph 10.4(b) will add a similar procedure for implementing a new version of the CDX.NA standard terms supplement, if and when published, where contracts referencing the old and new versions of the supplement are determined by the Clearing House to be fungible.
Existing paragraph 10, which contains contract terms for Single Name Contracts, will be renumbered as paragraph 11 and cross references will be updated accordingly. In addition, various clarifying amendments will be made to this paragraph. The definitions of “STEC Contract” and “Non-STEC Single Name Contract” will be amended to clarify that the relevant Reference Entity type will be specified in the List of Eligible Single Name Reference Entities. The definition of “Single Name Contract Reference Obligations” will be amended to clarify that the applicable reference obligation will be specified in the List of Eligible Single Name Reference Entities and may differ between 2003-type CDS Contracts and 2014-type CDS Contracts. For 2014-type CDS Contracts, the reference obligation may be designated as the Senior Level Standard Reference Obligation that is specified from time to time on the SRO List published under the 2014 ISDA Definitions.
Paragraph 11.6(a)(i)(C) will be amended by adding a subsection (2) that will make a clarification as to the initial payment date for Single Name Contracts that corresponds to the change in payment date discussed above for iTraxx Contracts. A change will be made in paragraph 11.6(a)(ii) to conform to the changes made to the definition of Single Name Contract Reference Obligation discussed above.
In general, under ICE Clear Europe's proposal, the existing risk methodology that applies to index CDS will also apply to the CDX.NA Contracts. However, ICE Clear Europe proposes to make certain amendments to its CDS Risk Model Description and CDS Pricing Policy to address CDX.NA Contracts.
In the CDS Risk Model Description, the index decomposition offset methodology, which is used to determine portfolio margin benefits from correlated long and short positions, is proposed to be modified to address multi-region risk factors. Under the revised methodology, portfolio margin benefits are provided first for risk factors within the same region. After the same-region risk analysis is completed, any cross-region benefits for index risk factors are determined. Cross-region benefits apply only to index risk factors. The revised description thus addresses scenarios in which margin offsets may be provided between appropriately correlated positions in iTraxx Contracts and positions in CDX.NA Contracts. The revisions also provide that where risk factor profits and losses are calculated in different currencies, they will be converted into the same base currency (Euro) for purposes of calculation of portfolio margin benefits.
ICE Clear Europe also proposes to amend its CDS Pricing Policy to cover the CDX.NA Contracts. The amendments include submission requirements with respect to CDX.NA Contracts and changes to reflect that certain determinations with respect to firm trades for CDX.NA Contracts are made as of the North American end-of-day.
Section 19(b)(2)(C) of the Act
The Commission finds that the proposed rule change is consistent with Section 17A of the Act
Additionally, the Commission believes that the proposed rule change, as it relates to various clarifying and conforming changes with respect to iTraxx Contracts and single name CDS Contracts, is designed to promote the prompt and accurate clearance and settlement of securities transactions and in general, to protect investors and the public interest, consistent with Section 17A(b)(3)(F) of the Act.
The Commission therefore finds that the proposed rule change is designed to promote the prompt and accurate clearance and settlement of securities transactions and, to the extent applicable, derivative agreements, contracts, and transactions and, in general, to protect investors and the public interest in accordance with Section 17A(b)(3)(F) of the Act.
On the basis of the foregoing, the Commission finds that the proposal is consistent with the requirements of the Act and in particular with the requirements of Section 17A of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
The Fine Arts Committee of the Department of State will meet on June 2, 2015 at 9:00 a.m. in the Henry Clay Room of the Harry S. Truman Building, 2201 C Street NW., Washington, DC. The meeting will last until approximately 3:00 p.m. and is open to the public.
The agenda for the committee meeting will include a summary of the work of the Fine Arts Office since its last meeting on November 14, 2014 and the announcement of gifts and loans of furnishings as well as financial contributions from January 1, 2014 through December 31, 2014.
Public access to the Department of State is strictly controlled and space is limited. Members of the public wishing to take part in the meeting should telephone the Fine Arts Office at (202) 647-1990 or send an email to
Federal Aviation Administration (FAA), DOT.
Notice of intent to rule on request to release airport property at the Liberal Mid-America Regional Airport (LBL), Liberal, Kansas.
The FAA proposes to rule and invites public comment on the release of land at the Liberal Mid-America Regional Airport (LBL), Liberal, Kansas, under the provisions of 49 U.S.C. 47107(h)(2).
Comments must be received on or before July 6, 2015.
Comments on this application may be mailed or delivered to the FAA at the following address: Lynn D. Martin, Airports Compliance Specialist, Federal Aviation Administration, Airports Division, ACE-610C, 901 Locust Room 364, Kansas City, MO 64106.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to: Debra S. Giskie, Airport Manager, Liberal Mid-America Regional Airport & Airport Industrial Park, City of Liberal, P.O. Box 2199, Liberal, KS 67901, (620) 626-2207.
Lynn D. Martin, Airports Compliance Specialist, Federal Aviation Administration, Airports Division, ACE-610C, 901 Locust Room 364, Kansas City, MO 64106, (816) 329-2644,
The FAA invites public comment on the request to release approximately 11.38 acres of airport property at the Liberal Mid-America Regional Airport (LBL) under the provisions of 49 U.S.C. 47107(h)(2). On March 13, 2015, the City of Liberal City Manager requested from the FAA that approximately 11.38 acres of property be released for sale to the City of Liberal. On May 26, 2015, the FAA
The following is a brief overview of the request:
Liberal Mid-America Regional Airport (LBL) is proposing the release of a parcel, totaling 11.38 acres. The release of land is necessary to comply with Federal Aviation Administration Grant Assurances that do not allow federally acquired airport property to be used for non-aviation purposes. The sale of the subject property will result in the surface lands being released at the Liberal Mid-America Regional Airport (LBL), from the conditions of the AIP Grant Agreement Grant Assurances, but retaining any mineral rights. In accordance with 49 U.S.C. 47107(c)(2)(B)(i) and (iii), the airport will receive fair market value for the property, from the City of Liberal and will be subsequently sold to Wal-Mart.
Any person may inspect, by appointment, the request in person at the FAA office listed above under
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 16 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
This decision is effective June 20, 2015. Comments must be received on or before July 6, 2015.
You may submit comments bearing the Federal Docket Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2000-7165; FMCSA-2006-26066; FMCSA-2007-27515; FMCSA-2009-0054; FMCSA-2009-0086; FMCSA-2010-0354; FMCSA-2011-0024; FMCSA-2013-0022; FMCSA-2013-0024; FMCSA-2013-0026], using any of the following methods:
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Charles A. Horan, III, Director, Carrier, Driver and Vehicle Safety Standards, 202-366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption from the vision requirements in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce, for a two-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The procedures for requesting an exemption (including renewals) are set out in 49 CFR part 381.
This notice addresses 16 individuals who have requested renewal of their exemptions in accordance with FMCSA procedures. FMCSA has evaluated these 16 applications for renewal on their merits and decided to extend each exemption for a renewable two-year period. They are:
The exemptions are extended subject to the following conditions: (1) That each individual has a physical examination every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application for additional two year periods. In accordance with 49 U.S.C. 31136(e) and 31315, each of the 16 applicants has satisfied the entry conditions for obtaining an exemption from the vision requirements (65 FR 33406; 65 FR 57234; 68 FR 13360; 70 FR 12265; 71 FR 63379; 72 FR 1050; 72 FR 21313; 72 FR 27624; 72 FR 32703; 74 FR 11988; 74 FR 19267; 74 FR 19270; 74 FR 21427; 74 FR 23472; 74 FR 28094; 75 FR 72863; 76 FR 2190; 76 FR 17481; 76 FR 21796; 76 FR 25762; 76 FR 28125; 76 FR 32016; 76 FR 32017; 77 FR 74273; 78 FR 12815; 78 FR 16912; 78 FR 22596; 78 FR 22598; 78 FR 22602; 78 FR 24300; 78 FR 29431; 78 FR 30954; 78 FR 32703; 78 FR 32708; 78 FR 37274). Each of these 16 applicants has requested renewal of the exemption and has submitted evidence showing that the vision in the better eye continues to meet the requirement specified at 49 CFR 391.41(b)(10) and that the vision impairment is stable. In addition, a review of each record of safety while driving with the respective vision deficiencies over the past two years indicates each applicant continues to meet the vision exemption requirements. These factors provide an adequate basis for predicting each driver's ability to continue to drive safely in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of two years is likely to achieve a level of safety equal to that existing without the exemption.
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2000-7165; FMCSA-2006-26066; FMCSA-2007-27515; FMCSA-2009-0054; FMCSA-2009-0086; FMCSA-2010-0354; FMCSA-2011-0024; FMCSA-2013-0022; FMCSA-2013-0024; FMCSA-2013-0026), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, got to
To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of applications for exemptions, request for comments.
FMCSA announces receipt of applications from 23 individuals for exemption from the vision requirement in the Federal Motor Carrier Safety Regulations. They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. If granted, the exemptions would enable these individuals to qualify as drivers of commercial motor vehicles (CMVs) in interstate commerce.
Comments must be received on or before July 6, 2015. All comments will be investigated by FMCSA. The exemptions will be issued the day after the comment period closes.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2015-0049 using any of the following methods:
• Federal eRulemaking Portal: Go to
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Charles A. Horan, III, Director, Carrier, Driver and Vehicle Safety Standards, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” FMCSA can renew exemptions at the end of each 2-year period. The 23 individuals listed in this notice have each requested such an exemption from the vision requirement in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting an exemption will achieve the required level of safety mandated by statute.
Mr. Altobelli, 39, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/60, and in his left eye, 20/20. Following an examination in 2014, his optometrist stated, “Based on the results of his eye examination, Mr. Altobelli has sufficient vision to perform the driving tasks required to operate a commercial vehicle safely.” Mr. Altobelli reported that he has driven straight trucks for 21 years, accumulating 420,000 miles. He holds a Class B CDL from Connecticut. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Bingham, 46, has had amblyopia strabismus in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/200. Following an examination in 2015, his optometrist stated, “Field of vision in each eye tests 120 degrees in the horizontal meridians, and has sufficient vision to perform the driving tasks he is required to operate a commercial vehicle.” Mr. Bingham reported that he has driven straight trucks for 8 years, accumulating 4,000 miles, and tractor-trailer combinations for 4 years, accumulating 4,000 miles. He holds a Class A CDL from North Carolina. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Buckley, 62, has a retinal detachment in his right eye due to a traumatic incident in childhood. The visual acuity in his right eye is no light perception, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “Mr. Buckley has maintained a commercial license for over forty years with no driving incidents. In my opinion, there I [
Mr. Clark, 27, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/30, and in his left eye, 20/60. Following an examination in 2014, his ophthalmologist stated, “In my medical opinion, given his stable eye examination, he has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Clark reported that he has driven straight trucks for eight years, accumulating 68,000 miles, and tractor-trailer combinations for five years, accumulating 12,500 miles. He holds a Class A CDL from New York. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Clymer, 69, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/200, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “In my opinion, Mr. Clymer has sufficient acuity to operate a commercial vehicle.” Mr. Clymer reported that he has driven straight trucks for 53 years, accumulating 530,000 miles, and tractor-trailer combinations for 53 years, accumulating 1.33 million miles. He holds an operator's license from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Dalton, 51, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/50, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “Normal VF no issues driving.” Mr. Dalton reported that he has driven straight trucks for 35 years, accumulating 87,500 miles, tractor-trailer combinations for 33 years, accumulating 660,000 miles, and buses for 3 years, accumulating 3,000 miles. He holds a Class A CDL from North Carolina. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Fry, 27, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/60. Following an examination in 2015, his optometrist stated, “With this testing and that performed at the routine eye exam on 1/12/15 the patient has sufficient vision to safely perform the driving tasks required to operate a commercial vehicle.” Mr. Fry reported that he has driven straight trucks for 4 years, accumulating 10,000 miles, and tractor-trailer combinations for 4 years, accumulating 12,000 miles. He holds a Class A CDL from Kansas. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Ginther, 58, has had enucleation in his left eye since 2012 due to ocular melanoma. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “U.S. Department of Transportation . . . Provided these findings [
Mr. Giordano, 47, has had strabismic amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/30, and in his left eye, 20/150. Following an examination in 2014, his optometrist stated, “In my opinion, Mr. Giordano has sufficient vision and peripheral field of vision to perform tasks required to operate a commercial vehicle.” Mr. Giordano reported that he has driven straight trucks for 4 years, accumulating 200,000 miles, and tractor-trailer combinations for 10 years, accumulating 500,000 miles. He holds a Class A CDL from Connecticut. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Groves, 53, has had a retinal scar in his right eye since 2013. The visual acuity in his right eye is 20/100, and in his left eye, 20/20. Following an examination in 2014, his optometrist stated, “Although Mr. Groves has a moderate amount of decreased central vision in the right eye, I believe his overall acuity, depth perception, and peripheral vision is sufficient to safely operate a commercial vehicle.” Mr. Groves reported that he has driven straight trucks for 15 years, accumulating 1.69 million miles, and tractor-trailer combinations for 20 years, accumulating 3.5 million miles. He holds a Class A CDL from West Virginia. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Guzman-Olguin, 47, has had a retinal detachment in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, light perception. Following an examination in 2014, his optometrist stated, “In my professional opinion, Mr. Guzman is capable of driving a commercial vehicle to the extent his test results conform to the law and with any visual aids that are required by law for monocular driver.” Mr. Guzman-Olguin reported that he has driven straight trucks for 7 years, accumulating 36,400 miles. He holds an operator's license from Illinois. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Hines, 58, has a prosthetic left eye due to a traumatic incident in childhood. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2014, his ophthalmologist stated, “There is no ocular reason that should prevent you from operating any motor vehicle.” Mr. Hines reported that he has driven straight trucks for 38 years, accumulating 19,000 miles, and tractor-trailer combinations for 35 years, accumulating 2.1 million miles. He holds a Class A CDL from New Jersey. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Keranen, 43, has had amblyopia in his right eye since birth. The visual acuity in his right eye is 20/60, and in his left eye, 20/20. Following an examination in 2014, his optometrist stated, “It is my medical opinion that James Keranan has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Keranen reported that he has driven straight trucks for 16 years, accumulating 400,000 miles. He holds a chauffer's license from Michigan. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Kilpatrick, 36, has had angle closure and a retinal detachment causing a visual field defect in his right eye since 2012. The visual acuity in his right eye is 20/40, and in his left eye, 20/15. Following an examination in 2015, his optometrist stated, “In my opinion [
Mr. Lear, 60, has had aphakia in his right eye since 1990. The visual acuity in his right eye is 20/250, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “I believe that Mr. Lear has sufficient vision to continue to perform the driving tasks required to operate a commercial vehicle as he has been doing over the past 25 years.” Mr. Lear reported that he has driven straight trucks for 43 years, accumulating 860,000 miles, and tractor-trailer combinations for 43 years, accumulating 215,000 miles. He holds a Class A CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. May, 53, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/25, and in his left eye, 20/60. Following an examination in 2014, his optometrist stated, “In my medical opinion, Mr. Christopher May has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. May reported that he has driven straight trucks for 30 years, accumulating 300,000 miles, and tractor-trailer combinations for 22 years, accumulating 880,000 miles. He holds a Class AM CDL from Georgia. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Nissen, 35, has corneal scarring and reduced vision in his right eye due to a traumatic incident in 2003. The visual acuity in his right eye is 20/45, and in his left eye, 20/20. Following an examination in 2014, his optometrist stated, “Based on these findings, I feel Nathan C. Nissen has the visual abilities to continue operating a commercial motor vehicle in interstate commerce because the visual loss in his right eye occurred in 2003 and has been stable since that time.” Mr. Nissen reported that he has driven straight trucks for 14 years, accumulating 9,800 miles, and tractor-trailer combinations for 14 years, accumulating 700,000 miles. He holds a Class A CDL from Iowa. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Reed, 49, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/50. Following an examination in 2014, his optometrist stated, “U.S. Dept. of Transportation . . . With corrective lenses, I feel that Mr. Reed is safe to drive.” Mr. Reed reported that he has driven tractor-trailer combinations for 27 years, accumulating 2.83 million miles. He holds an operator's license from Kentucky. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Richter, 59, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/400. Following an examination in 2015, his optometrist stated, “I believe Mr. Richter has sufficient vision to preform [
Mr. Rotenberger, 41, has had amblyopia in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, 20/100. Following an examination in 2014, his optometrist stated, “Based on the exam findings and the fact the Dave has been driving and operating heavy machinery on the farm for the last 25 years without incident, it is my medical opinion that David Rotenberger has sufficient vision to operate a commercial vehicle for farm use.” Mr. Rotenberger reported that he has driven straight trucks for 30 years, accumulating 75,000 miles, and tractor-trailer combinations for 25 years, accumulating 625,000 miles. He holds an operator's license from North Dakota. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Tomecek, 54, has had amblyopia in his right eye since birth. The visual acuity in his right eye is 20/500, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated that Mr. Tomecek does not have any conditions or diseases that would make him an unsafe driver. Mr. Tomecek reported that he has driven straight trucks for 28 years, accumulating 336,000 miles. He holds a Class B CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Vaughn, 71, has had complete loss of vision in his right eye since 2012 due to a central vein occlusion. The visual acuity in his right eye is hand motion, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “Mr. Vaughn has been driving commercially since his vision loss in 2012. He should have sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Vaughn reported that he has driven straight trucks for 8 years, accumulating 80,000 miles, and tractor-trailer combinations for 40 years, accumulating 5.5 million miles. He holds a Class A CDL from North Carolina. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Weiss, 56, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/70, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “In my opinion, Mr. Weiss has sufficient vision to perform driving tasks required to operate a commercial vehicle.” Mr. Weiss reported that he has driven straight trucks for 38 years, accumulating 3.04 million miles. He holds a Class A CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA will consider all comments and material received during the comment period and may change this notice based on your comments.
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 15 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
This decision is effective June 28, 2015. Comments must be received on or before July 6, 2015.
You may submit comments bearing the Federal Docket Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2011-0092], using any of the following methods:
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Charles A. Horan, III, Director, Carrier, Driver and Vehicle Safety Standards, 202-366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption from the vision requirements in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce, for a two-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The procedures for requesting an exemption (including renewals) are set out in 49 CFR part 381.
This notice addresses 15 individuals who have requested renewal of their exemptions in accordance with FMCSA procedures. FMCSA has evaluated these 15 applications for renewal on their merits and decided to extend each exemption for a renewable two-year period. They are:
The exemptions are extended subject to the following conditions: (1) That each individual has a physical examination every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the requirements in 49 CFR 391.41(b)(10), and (b) by a medical examiner who attests that the individual is otherwise physically qualified under 49 CFR 391.41; (2) that each individual provides a copy of the ophthalmologist's or optometrist's report to the medical examiner at the time of the annual medical examination; and (3) that each individual provide a copy of the annual medical certification to the employer for retention in the driver's qualification file and retains a copy of the certification on his/her person while driving for presentation to a duly authorized Federal, State, or local enforcement official. Each exemption will be valid for two years unless rescinded earlier by FMCSA. The exemption will be rescinded if: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315.
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application for additional two year periods. In accordance with 49 U.S.C. 31136(e) and 31315, each of the 15 applicants has satisfied the entry conditions for obtaining an exemption from the vision requirements (76 FR 25766; 76 FR 37885; 78 FR 37270). Each of these 15 applicants has requested renewal of the exemption and has submitted evidence showing that the vision in the better eye continues to meet the requirement specified at 49 CFR 391.41(b)(10) and that the vision impairment is stable. In addition, a review of each record of safety while driving with the respective vision deficiencies over the past two years indicates each applicant continues to meet the vision exemption requirements. These factors provide an
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2011-0092), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, got to
To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of meeting.
FMCSA announces that its MCSAC will meet on Monday and Tuesday, June 15-16, 2015, to complete its recommendations concerning the Agency's Beyond Compliance initiative, provide ideas the Agency should consider for updating its strategic plan, and receive a briefing concerning FMCSA's current research projects. The meeting is open to the public and there will be a period of time at the end of each day for the public to submit oral comments.
Ms. Shannon L. Watson, Senior Policy Advisor, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590, (202) 385-2395,
MCSAC was established to provide FMCSA with advice and recommendations on motor carrier safety programs and motor carrier safety regulations. MCSAC is composed of up to 20 voting representatives from safety advocacy, safety enforcement, labor, and industry stakeholders of motor carrier safety. The diversity of the Committee ensures the requisite range of views and expertise necessary to discharge its responsibilities. The Committee operates as a discretionary committee under the authority of the U.S. Department of Transportation (DOT), established in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App. 2. See FMCSA's MCSAC Web site for additional information about the committee's activities at
The truck and motorcoach industries and the DOT have invested significant resources to research, develop, and test strategies and technologies to reduce truck and bus crashes. In September 2014, the Commercial Vehicle Safety Alliance submitted a request to FMCSA to consider initiating a pilot program to investigate the benefits and feasibility of voluntary compliance. Citing research that has been underway for several years, the Agency established an Alternative Compliance initiative the goal of which is to analyze the concept and gather data to support how this concept might be developed and implemented. During its March 2015 meeting, the Agency tasked the MCSAC, with its collective expertise on transportation safety, with identifying options for the motor carrier safety community to promote programs that could improve safety beyond the standards established in FMCSA regulations.
FMCSA is updating its Strategic Plan to align with the new FY2014-FY2018 DOT Strategic Plan that was released in November 2014. The new FMCSA Plan would extend to FY2018; the current Plan ends in FY2016. The revised Plan would include the status on strategies FMCSA employed in the FY2012-FY2016 plan as well as new programs and strategies FMCSA plans to implement by FY2018. FMCSA is presenting an overview of the draft Strategic Plan to the MCSAC to obtain stakeholder feedback. FMCSA plans to publish the updated Strategic Plan by September 30, 2015.
FMCSA maintains an active research program to promote the Agency's understanding of factors impacting safe driver behavior and carrier operations. The Agency also examines new technologies for their potential to improve motor carrier safety and the enforcement of commercial motor vehicle safety regulations. At the June 2015 MCSAC meeting, FMCSA plans to present its portfolio of current and planned research activities for committee members' information and comment. FMCSA will also use the opportunity to solicit Committee input on additional areas of safety research.
Oral comments from the public will be heard during the last half-hour of the meetings each day. Should all public comments be exhausted prior to the end of the specified period, the comment period will close. Members of the public may submit written comments on the topics to be considered during the meeting by Wednesday, June 10, 2015, to Federal Docket Management System (FDMC) Docket Number FMCSA-2006-26367 using any of the following methods:
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By petition filed on May 19, 2015, the Peninsula Corridor Joint Powers Board (Caltrain), operator of the Caltrain commuter rail service between San Jose and San Francisco, Cal., seeks a declaratory order confirming that the requirements of the California Environmental Quality Act (CEQA), as applied to Caltrain, are fully preempted by virtue of 49 U.S. C. 10501(b). Caltrain states that it is a rail carrier subject to the Board's jurisdiction
Caltrain has requested that the Board issue an expedited declaratory order by June 30, 2015. Caltrain states that a Board order regarding preemption of CEQA issued prior to that date would eliminate controversy in advance of its initial state court appearance. To facilitate expedited consideration, Caltrain states that it has served a copy of its petition on all counsel of record in the state court lawsuits.
The Board has discretionary authority under 5 U.S.C. 554(e) and 49 U.S.C. 721 to issue a declaratory order to eliminate a controversy or remove uncertainty. Here, it is appropriate to institute a declaratory order proceeding so that the Board can consider the issue raised in Caltrain's petition regarding whether 10501(b) would preempt CEQA, as applied to Caltrain and its electrification project. The Board will therefore institute a proceeding to consider the matter. Interested persons may file substantive replies to Caltrain's petition by June 8, 2015.
1. A declaratory order proceeding is instituted.
2. Interested persons may file substantive replies to Caltrain's petition by June 8, 2015.
3. Notice of the Board's action will be published in the
4. This decision is effective on its service date.
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
San Joaquin Valley Railroad Co. (SJVR), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to continue to lease and operate approximately 19.75 miles of rail line from Sunset Railway Company (Sunset) between milepost 0.05 at Gosford, Cal., and milepost 19.8 at Levee, Cal.
In 1997, SJVR entered into a lease with Sunset under which SJVR leased the line between milepost 0.05 at Gosford and milepost 36.3 at Taft, Cal.
SJVR certifies that neither the amended lease nor the original lease from 1997 include an interchange commitment. Additionally, SJVR certifies that the projected annual revenues as a result of this transaction will not result in the creation of a Class II or Class I rail carrier, but that its projected annual revenues will exceed $5 million. Accordingly, SJVR is required, at least 60 days before this exemption is to become effective, to send notice of the transaction to the national offices of the labor unions with employees on the affected lines, post a copy of the notice at the workplace of the employees on the affected lines, and certify to the Board that it has done so. 49 CFR 1150.42(e).
SJVR, concurrently with its notice of exemption, filed a petition for waiver of the 60-day advance labor notice requirement under 1150.42(e), asserting that: (1) There will be no changes for
SJVR states that it intends to consummate the transaction on or shortly after the effective date of this transaction. The Board will establish in the decision on the waiver request the earliest date this transaction may be consummated.
If the notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to Docket No. FD 35926, must be filed with the Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. In addition, one copy of each pleading must be served on applicant's representative, Eric M. Hocky, Clark Hill PLC, One Commerce Square, 2005 Market Street, Suite 1000, Philadelphia, PA 19103.
Board decisions and notices are available on our Web site at
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Michael Williams (Williams), a noncarrier individual, has filed a verified notice of exemption pursuant to 49 CFR 1180.2(d)(2), to continue in control of Boot Hill & Western Railway Holding Co., Inc. (Holding), a noncarrier holding company owned and controlled by Williams, upon its becoming a common carrier.
This transaction is related to a concurrently filed verified notice of exemption in
The transaction may be consummated on June 17, 2015, (the effective date of this notice).
Williams currently owns and controls the following four Class III rail carriers: (1) BG & CM Railroad (76.2 miles of rail line in Idaho); (2) Ozark Valley Railroad (24.99 miles of purchased and leased rail line in Missouri); (3) Dakota Southern Railway Company (operating rights over two track segments in South Dakota); and (4) McCloud Railway (19.6 miles of rail line in California).
Williams certifies that: (1) BHWR does not connect with any other railroads owned and controlled by Williams; (2) the proposed transaction is not part of a series of anticipated transactions that would result in such a connection; and (3) the proposed transaction does not involve a Class I rail carrier. The proposed transaction is therefore exempt from the prior approval requirements of 49 U.S.C. 11323 pursuant to 49 CFR 1180.2(d)(2).
Under 49 U.S.C. 10502(g), the Board may not use its exemption authority to relieve a rail carrier of its statutory obligation to protect the interests of its employees. Section 11326(c), however, does not provide for labor protection for transactions under 11324 and 11325 that involve only Class III rail carriers. Accordingly, the Board may not impose labor protective conditions here because all of the carriers involved are Class III carriers.
If the verified notice contains false or misleading information, the exemption is void
An original and ten copies of all pleadings, referring to Docket No. FD 35925, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on: Charles H. Montange, Law Offices of Charles H. Montange, 426 NW 162d St., Seattle, WA 98177.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Department of Transportation.
Notice and request for comments.
The Department of Transportation (DOT) invites public comments about our intention to request the Office of Management and Budget (OMB) approval previously approved information collection. This information collection involves the use of various forms necessary because of management and oversight responsibilities of the agency imposed by OMB Circular 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. These forms include Application for Federal Assistance (SF-424), Federal Financial Report (SF-425), Request for Advance or Reimbursement (SF-270), and Outlay Report and Request for Reimbursement for Construction Programs (SF-271).
We are required to publish this notice in the
Written comments should be submitted by July 30, 2015.
You may submit comments [identified by Docket No. DOT-OST-2015-0112] through one of the following methods:
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Ellen Shields, Associate Director of the Financial Assistance Policy and Oversight Division, M-65, Office of the Senior Procurement Executive, Office of the Secretary, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590, (202) 366-4268. Refer to OMB Control Number 2105-0520.
There have also been adjustments to the burden estimates. In 2010, the Department estimated a combined total of 2,704 respondents and 189,280 burden hours. Due to a 35% decrease in appropriations, the Department has revised estimates and now has a combined total of 1,758 respondents and burden hours of 123,060. The estimated cost to respondents and the federal government has decreased by 35% in overhead expenses.
The Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended; and 49 CFR 1:48.
Issued in Washington, DC on May 29, 2015.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of Proposed Rulemaking and Announcement of Public Meeting.
The Energy Policy and Conservation Act of 1975 (EPCA), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including residential dehumidifiers. EPCA also requires the U.S. Department of Energy (DOE) to periodically determine whether more-stringent, amended standards would be technologically feasible and economically justified, and would save a significant amount of energy. In this document, DOE proposes amended energy conservation standards for different categories of residential dehumidifiers. This document also announces a public meeting to receive comment on these proposed standards and associated analyses and results.
The meeting will also be broadcast as a webinar. See section VII, “Public Participation” for webinar registration information, participant instructions, and information about the capabilities available to webinar participants. The public meeting will be held at the U.S. Department of Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue SW., Washington, DC 20585.
Any comments submitted must identify the NOPR for Energy Conservation Standards for Residential Dehumidifiers, and provide docket number EERE-2012-BT-STD-0027 and/or regulatory information number (RIN) number 1904-AC81. Comments may be submitted using any of the following methods:
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Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this proposed rule may be submitted to Office of Energy Efficiency and Renewable Energy through the methods listed above and by email to
For detailed instructions on submitting comments and additional information on the rulemaking process, see section VII, “Public Participation.”
A link to the docket Web page can be found at:
Mr. Bryan Berringer, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371. Email:
Mr. Peter Cochran, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-9496. Email:
For further information on how to submit a comment, review other public comments and the docket, or participate in the public meeting, contact Ms. Brenda Edwards at (202) 586-2945 or by email:
Title III, Part B
Pursuant to EPCA, any new or amended energy conservation standard must be designed to achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) Furthermore, the new or amended standard must result in a significant conservation of energy. (42 U.S.C. 6295(o)(3)(B)) EPCA also provides that not later than 6 years after issuance of any final rule establishing or amending a standard, DOE must publish either a notice of determination that standards for the product do not need to be amended, or a notice of proposed rulemaking including new proposed energy conservation standards. (42 U.S.C. 6295(m)(1)) Once complete, this rulemaking will satisfy this statutory provision.
In accordance with these and other statutory provisions discussed in this notice, DOE proposes amended energy conservation standards for residential dehumidifiers. The proposed standards, which correspond to trial standard level 3 (described in section V.A), divide residential dehumidifiers into two categories: Portable and whole-home. The proposed minimum allowable integrated energy factor (IEF) standards, which are expressed in liters (L) of moisture removed per kilowatt-hour (kWh), are shown in Table I.1. These proposed standards, if adopted, would apply to all products listed in Table I.1 and manufactured in, or imported into, the United States on or after the date three years after the publication of the final rule for this rulemaking.
Table I.2 presents DOE's evaluation of the economic impacts of the proposed standards on consumers of residential dehumidifiers, as measured by the average life-cycle cost (LCC) savings and the payback period (PBP). The average LCC savings are positive for all product classes and the PBP is significantly less than the average lifetimes for portable
DOE's analysis of the impacts of the proposed standards on consumers is described in section IV.F of this NOPR.
The industry net present value (INPV) is the sum of the discounted cash flows to the industry from the base year through the end of the analysis period (2015 to 2048). Using a real discount rate of 8.43 percent,
DOE's analyses indicate that the proposed standards would save a significant amount of energy. The lifetime full-fuel-cycle (FFC) energy savings for residential dehumidifiers purchased in the 30-year period that begins in the first full year of compliance with the amended standards (2019-2048) amount to 0.32 quads.
The cumulative net present value (NPV) of total consumer costs and savings for the proposed residential dehumidifier standards ranges from $1.04 billion (at a 7-percent discount rate) to $2.27 billion (at a 3-percent discount rate). This NPV expresses the estimated total value of future operating-cost savings minus the estimated increased product costs for residential dehumidifiers purchased in 2019-2048.
In addition, the proposed standards would have significant environmental benefits. The energy savings described above (for dehumidifiers purchased in the 2019-2048 period) are estimated to result in cumulative emission reductions of 19.3 million metric tons (Mt)
The value of the CO
Table I.3 summarizes the national economic costs and benefits expected to result from the proposed standards for residential dehumidifiers.
The benefits and costs of today's proposed standards, for products sold in 2019-2048, can also be expressed in terms of annualized values. The monetary values for the total annualized net benefits are the sum of: (1) The national economic value of the benefits in reduced operating costs, minus (2) the increase in product purchase and installation costs, plus (3) the value of the benefits of CO
Although DOE believes that the benefits of operating cost savings and CO
Estimates of annualized benefits and costs of the proposed standards are shown in Table I.4. The results under the primary estimate are as follows. Using a 7-percent discount rate for benefits and costs other than CO
DOE has tentatively concluded that the proposed standards represent the maximum improvement in energy efficiency that is technologically feasible and economically justified, and would result in the significant conservation of energy. DOE further notes that products achieving these standard levels are already commercially available for all product classes covered by today's proposal. Based on the analyses described above, DOE has tentatively concluded that the benefits of the proposed standards to the Nation (energy savings, positive NPV of consumer benefits, consumer LCC savings, and emission reductions) would outweigh the burdens (loss of INPV for manufacturers and LCC increases for some consumers).
DOE also considered more stringent energy efficiency levels as potential standards, and is still considering them in this rulemaking. However, DOE has tentatively concluded that the potential burdens of the more-stringent energy efficiency levels would outweigh the projected benefits. Based on consideration of the public comments DOE receives in response to this notice and related information collected and analyzed during the course of this rulemaking effort, DOE may adopt energy efficiency levels presented in this notice that are either higher or lower than the proposed standards, or some combination of level(s) that incorporate the proposed standards in part.
The following section briefly discusses the statutory authority underlying today's proposal, as well as some of the relevant historical background related to the establishment of standards for residential dehumidifiers.
Title III, Part B of EPCA established the Energy Conservation Program for Consumer Products Other Than Automobiles, a program covering most major household appliances (collectively referred to as “covered products”), which includes the types of residential dehumidifiers that are the subject of this rulemaking. (42 U.S.C. 2(a)(6295(cc))) EPCA, as amended, prescribes energy conservation
Pursuant to EPCA, DOE's energy conservation program for covered products consists essentially of four parts: (1) Testing; (2) labeling; (3) the establishment of Federal energy conservation standards; and (4) certification and enforcement procedures. The Federal Trade Commission (FTC) is primarily responsible for labeling, and DOE implements the remainder of the program. Subject to certain criteria and conditions, DOE is required to develop test procedures to measure the energy efficiency, energy use, or estimated annual operating cost of each covered product. (42 U.S.C. 6293(b)) Manufacturers of covered products must use the prescribed DOE test procedure as the basis for certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA and when making representations to the public regarding the energy use or efficiency of those products. (42 U.S.C. 6293(c) and 6295(s)) Similarly, DOE must use these test procedures to determine whether the products comply with standards adopted pursuant to EPCA. (42 U.S.C. 6295(s)) The DOE test procedures for residential dehumidifiers currently appear at title 10 of the Code of Federal Regulations (CFR) part 430, subpart B, appendix X.
DOE must follow specific statutory criteria for prescribing new or amended standards for covered products. Any new or amended standard for a covered product must be designed to achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) Furthermore, DOE may not adopt any standard that would not result in the significant conservation of energy. (42 U.S.C. 6295(o)(3)) Moreover, DOE may not prescribe a standard: (1) For certain products, including residential dehumidifiers, if no test procedure has been established for the product, or (2) if DOE determines by rule that the proposed standard is not technologically feasible or economically justified. (42 U.S.C. 6295(o)(3)(A)-(B)) In deciding whether a proposed standard is economically justified, and after receiving comments on the proposed standard, DOE must determine whether the benefits of the standard exceed its burdens. (42 U.S.C. 6295(o)(2)(B)(i)) DOE must make this determination by, to the greatest extent practicable, considering the following seven factors:
(1) The economic impact of the standard on manufacturers and consumers of the products subject to the standard;
(2) The savings in operating costs throughout the estimated average life of the covered products in the type (or class) compared to any increase in the price, initial charges, or maintenance expenses for the covered products that are likely to result from the imposition of the standard;
(3) The total projected amount of energy, or as applicable, water, savings likely to result directly from the imposition of the standard;
(4) Any lessening of the utility or the performance of the covered products likely to result from the imposition of the standard;
(5) The impact of any lessening of competition, as determined in writing by the Attorney General, that is likely to result from the imposition of the standard;
(6) The need for national energy and water conservation; and
(7) Other factors the Secretary of Energy (Secretary) considers relevant. (42 U.S.C. 6295(o)(2)(B)(i)(I)-(VII))
Further, EPCA, as codified, establishes a rebuttable presumption that a standard is economically justified if the Secretary finds that the additional cost to the consumer of purchasing a product complying with an energy conservation standard level will be less than three times the value of the energy savings during the first year that the consumer will receive as a result of the standard, as calculated under the applicable test procedure. (42 U.S.C. 6295(o)(2)(B)(iii))
EPCA, as codified, also contains what is known as an “anti-backsliding” provision, which prevents the Secretary from prescribing any amended standard that either increases the maximum allowable energy use or decreases the minimum required energy efficiency of a covered product. (42 U.S.C. 6295(o)(1)) Also, the “Secretary may not prescribe an amended or new standard under this section if the Secretary finds (and publishes such finding) that interested persons have established by a preponderance of the evidence that the standard is likely to result in the unavailability in the United States in any covered product type (or class) of performance characteristics (including reliability), features, sizes, capacities, and volumes that are substantially the same as those generally available in the United States at the time of the Secretary's finding.” (42 U.S.C. 6295(o)(4))
Additionally, 42 U.S.C. 6295(q)(1) specifies requirements when promulgating a standard for a covered product that has two or more subcategories. DOE must specify a different standard level for a type or class of covered product that has the same function or intended use, if DOE determines that products within such group: (A) Consume a different kind of energy from that consumed by other covered products within such type (or class); or (B) have a capacity or other performance-related feature which other products within such type (or class) do not have and such feature justifies a higher or lower standard. (42 U.S.C. 6294(q)(1)) In determining whether a performance-related feature justifies a different standard for a group of products, DOE must consider such factors as the utility to the consumer of the feature and other factors DOE deems appropriate.
Federal energy conservation requirements generally supersede State laws or regulations concerning energy conservation testing, labeling, and standards. (42 U.S.C. 6297(a)-(c)) DOE may, however, grant waivers of Federal preemption for particular State laws or regulations, in accordance with the procedures and other provisions set forth under 42 U.S.C. 6297(d).
Finally, pursuant to the amendments contained in the Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140, any final rule for new or amended energy conservation standards promulgated after July 1, 2010, is required to address standby mode and off mode energy use. (42 U.S.C. 6295(gg)(3)) Specifically, when DOE adopts a standard for a covered product after that date, it must, if justified by the criteria for adoption of standards under EPCA (42 U.S.C. 6295(o)), incorporate standby mode and
EPCA prescribes energy conservation standards for residential dehumidifiers manufactured on or after October 1, 2012. In a final rule published on March 23, 2009, DOE codified these standards at 10 CFR 430.32(v)(2). 74 FR 12058. The current standards are set forth in Table II.1 below.
As amended by the Energy Policy Act of 2005 (EPACT 2005), EPCA established the first energy conservation standards for residential dehumidifiers manufactured as of October 1, 2007, based on the EF metric. EISA 2007 subsequently amended EPCA to prescribe new energy conservation standards for dehumidifiers manufactured on or after October 1, 2012. In a final rule published on March 23, 2009, DOE codified the standards at 10 CFR 430.32(v)(2). 74 FR 12058.
DOE initiated today's rulemaking pursuant to 42 U.S.C. 6295(m)(1), which requires DOE, no later than 6 years after issuance of any final rule establishing or amending a standard, to publish either a notice of determination that standards for the product do not need to be amended, or a NOPR that includes new proposed energy conservation standards. As noted above, DOE issued the last final rule for residential dehumidifiers on March 23, 2009.
DOE initiated this rulemaking by issuing an analytical Framework Document, “Energy Conservation Standards Rulemaking Framework Document for Residential Dehumidifiers.” 77 FR 49739 (Aug. 17, 2012). The Framework Document explained the issues, analyses, and process that DOE anticipated using to develop energy conservation standards for residential dehumidifiers.
DOE held a public meeting on September 24, 2012, to solicit comments from interested parties regarding the Framework Document and DOE's proposed analytical approach. DOE sought feedback from interested parties on these subjects and provided information regarding the rulemaking process that DOE would follow. Interested parties discussed the following major issues at the public meeting: Rulemaking schedule; test procedure revisions; product classes; technology options; efficiency levels (ELs); and approaches for each of the analyses performed by DOE as part of the rulemaking process.
Comments received following the publication of the framework document helped DOE identify and resolve issues related to the subsequent preliminary analysis. In the preliminary analysis, DOE conducted in-depth technical analyses in the following areas: (1) Engineering; (2) markups to determine product price; (3) energy use; (4) life-cycle cost and payback period; and (5) national impacts. The preliminary technical support document (TSD) that presented the methodology and results of each of these analyses is available at
DOE also conducted, and included in the preliminary TSD, several other analyses that supported the major analyses or were expanded upon for today's NOPR. These analyses included: (1) The market and technology assessment; (2) the screening analysis, which contributes to the engineering analysis; and (3) the shipments analysis,
DOE published a notice of public meeting and availability of the preliminary TSD on May 22, 2014. 79 FR 29380. DOE subsequently held a public meeting on June 13, 2014, to discuss and receive comments on the preliminary TSD. DOE received comments on topics including: Whole-home dehumidifier coverage and test procedures, product classes, design options, ELs, use of experience curves, shipments projections, social cost of carbon estimates and the associated monetization of carbon dioxide, and small business impacts. After reviewing these comments, DOE gathered additional information, held further discussions with manufacturers, performed product testing, and completed and revised the various analyses described in the preliminary analysis. The results of these analyses are presented in this NOPR.
DOE developed this proposed rule after considering verbal and written comments, data, and information from interested parties that represent a variety of interests. The following discussion addresses issues raised by these commenters.
When evaluating and establishing energy conservation standards, DOE divides covered products into product classes by the type of energy used or by capacity or other performance-related features that justify differing standards. In making a determination whether a performance-related feature justifies a different standard, DOE must consider such factors as the utility to the consumer of the feature and other factors DOE determines are appropriate. (42 U.S.C. 6295(q))
Existing energy conservation standards divide residential dehumidifiers into five product classes based on the number of pints per day of moisture that the product removes from ambient air at test conditions, as measured by the current DOE test procedure. In this rulemaking, DOE is proposing new product classes that differentiate between portable and whole-home residential dehumidifiers. For portable residential dehumidifiers, DOE is proposing the following three product classes based on the product capacity in number of pints per day of moisture removed from ambient air at
The product classes for portable residential dehumidifiers analyzed for today's NOPR are different from those examined in DOE's initial analysis, while the product classes for whole-home residential dehumidifiers are the same. DOE initially analyzed five product classes for portable residential dehumidifiers based on product capacity. Due, in part, to comments received on the preliminary TSD, DOE is proposing only the three product classes discussed above. Comments received relating to the scope of coverage and product classes are discussed in section IV.A of this proposed rule.
EPCA specifies that the dehumidifier test criteria used under the ENERGY STAR
On October 31, 2012, DOE published a final rule to establish a new test procedure for dehumidifiers that references ANSI/AHAM Standard DH-1-2008, “Dehumidifiers,” (ANSI/AHAM DH-1-2008) for both energy use and capacity measurements. 77 FR 65995 (Oct. 31, 2012). The final rule also adopted standby and off mode provisions that satisfy the requirement in EPCA for DOE to include measures of standby mode and off mode energy consumption in its test procedures for residential products, if technically feasible. (42 U.S.C. 6295(gg)(2)(A)) This new DOE test procedure, codified at that time at 10 CFR part 430, subpart B, appendix X1, established a new metric, IEF, which incorporates measures of active, standby, and off mode energy use.
DOE subsequently removed the existing test procedures at appendix X and redesignated the test procedures at appendix X1 as appendix X. 79 FR 7366 (Feb. 7, 2014). Any representations of energy use, including standby mode or off mode energy consumption, or efficiency of portable dehumidifiers must be made in accordance with the results of testing pursuant to the redesignated appendix X.
On May 21, 2014, DOE published a NOPR proposing further amendments to residential dehumidifier test procedures. 79 FR 29272. In addition to making clarifications and corrections, the proposed amendments would create a new appendix, appendix X1, which would: (1) Require certain active mode testing at a lower ambient temperature; (2) add a measure of fan-only mode energy consumption in the IEF metric; and (3) include testing methodology and measures of performance for whole-home dehumidifiers.
On February 4, 2015, DOE published a supplemental notice of proposed rulemaking (SNOPR). 80 FR 5994. In the SNOPR, DOE maintained its proposals from the NOPR, except that DOE proposed: (1) Various adjustments and clarifications to the whole-home dehumidifier test setup and conduct; (2) a method to determine whole-home dehumidifier case volume; (3) a revision to the method for measuring energy use in fan-only operation; (4) a clarification to the relative humidity and capacity equations; and (5) additional technical corrections and clarifications.
In response to the May 2014 Notice, June 2014 public meeting, and February 2015 SNOPR, DOE received comments from interested parties related to the test procedure. DOE addressed these issues in the test procedure final rule to establish appendix X1, and based its analysis in this notice on capacities and efficiencies determined according to the appendix X1 test procedure.
In each energy conservation standards rulemaking, DOE conducts a screening analysis based on information gathered on all current technology options and prototype designs that could improve the efficiency of the products or equipment that are the subject of the rulemaking. As the first step in such an analysis, DOE develops a list of technology options for consideration in consultation with manufacturers, design engineers, and other interested parties. DOE then determines which of those means for improving efficiency are technologically feasible. DOE considers technologies incorporated in commercially available products or in working prototypes to be technologically feasible. (10 CFR part 430, subpart C, appendix A, section 4(a)(4)(i))
After DOE has determined that particular technology options are technologically feasible, it further evaluates each technology option in light of the following additional screening criteria: (1) Practicability to manufacture, install, and service; (2) adverse impacts on product utility or availability; and (3) adverse impacts on health or safety. (10 CFR part 430, subpart C, appendix A, section 4(a)(4)(ii)-(iv)) Section IV.B of this proposed rule discusses the results of the screening analysis for residential dehumidifiers, particularly the designs DOE considered, those it screened out, and those that are the basis for the standards considered in this rulemaking. For further details on the screening analysis for this rulemaking, see chapter 4 of the NOPR TSD.
When DOE proposes to adopt an amended standard for a type or class of covered product, it must determine the maximum improvement in energy efficiency or maximum reduction in energy use that is technologically feasible for such product. (42 U.S.C. 6295(p)(1)) Accordingly, in the engineering analysis, DOE determined the maximum technologically feasible (max-tech) improvements in energy efficiency for residential dehumidifiers, using the design parameters for the most efficient products available on the market or in working prototypes. The max-tech levels that DOE determined for this rulemaking are described in section IV.C.1.b of this proposed rule and in chapter 5, section 5.3.2 of the NOPR TSD.
For each trial standard level (TSL), DOE projected energy savings from application of the TSL to residential dehumidifiers purchased in the 30-year period that begins in the first full year of compliance with the proposed standards (2019-2048).
DOE uses its NIA spreadsheet models to estimate energy savings from potential amended standards. The NIA spreadsheet model (described in section IV.H of this notice) calculates savings in site energy, which is the energy directly consumed by products at the locations where they are used. Based on the site energy, DOE calculates national energy savings (NES) in terms of primary energy savings at the site or at power plants, and also in terms of full-fuel-cycle (FFC) energy savings. The FFC metric includes the energy consumed in extracting, processing, and transporting primary fuels (
To adopt any new or amended standard for a covered product, DOE must determine that such action would result in “significant” energy savings. (42 U.S.C. 6295(o)(3)(B)) Although the term “significant” is not defined in the Act, the U.S. Court of Appeals for the District of Columbia Circuit, in
As noted above, EPCA provides seven factors to be evaluated in determining whether a potential energy conservation standard is economically justified. (42 U.S.C. 6295(o)(2)(B)(i)) The following sections discuss how DOE has addressed each of those seven factors in this rulemaking.
In determining the impacts of a potential amended standard on manufacturers, DOE conducts a manufacturer impact analysis (MIA), as discussed in section IV.J of this proposed rule. DOE first uses an annual cash-flow approach to determine the quantitative impacts. This step includes both a short-term assessment—based on the cost and capital requirements during the period between when a regulation is issued and when entities must comply with the regulation—and a long-term assessment over a 30-year period. The industry-wide impacts analyzed include: (1) Industry net present value (INPV), which values the industry on the basis of expected future cash flows; (2) cash flows by year; (3) changes in revenue and income; and (4) other measures of impact, as appropriate. Second, DOE analyzes and reports the impacts on different types of manufacturers, including impacts on small manufacturers. Third, DOE considers the impact of standards on domestic manufacturer employment and manufacturing capacity, as well as the potential for standards to result in plant closures and loss of capital investment. Finally, DOE takes into account cumulative impacts of various DOE regulations and other regulatory requirements on manufacturers.
For individual consumers, measures of economic impact include the changes in LCC and PBP associated with new or amended standards. These measures are discussed further in the following section. For consumers in the aggregate, DOE also calculates the national NPV of the economic impacts applicable to a particular rulemaking. DOE also evaluates the LCC impacts of potential standards on identifiable subgroups of consumers that may be affected disproportionately by a national standard.
EPCA requires DOE to consider the savings in operating costs throughout the estimated average life of the covered product in the type (or class) compared to any increase in the price of, or in the initial charges for, or maintenance expenses of, the covered product that are likely to result from the standard. (42 U.S.C. 6295(o)(2)(B)(i)(II)) DOE conducts this comparison in its LCC and PBP analysis.
The LCC is the sum of the purchase price of a product (including its installation) and the operating expense (including energy, maintenance, and repair expenditures) discounted over the lifetime of the product. The LCC analysis requires a variety of inputs, such as product prices, product energy consumption, energy prices, maintenance and repair costs, product lifetime, and discount rates appropriate for consumers. To account for uncertainty and variability in specific inputs, such as product lifetime and discount rate, DOE uses a distribution of values, with probabilities attached to each value. For its analysis, DOE assumes that consumers will purchase the covered products in the first full year of compliance with amended standards.
The LCC savings for the considered ELs are calculated relative to a base case that reflects projected market trends in the absence of amended standards. DOE identifies the percentage of consumers estimated to receive LCC savings or experience an LCC increase, in addition to the average LCC savings associated with a particular standard level. DOE's LCC and PBP analyses are discussed in further detail in section IV.F.
Although significant conservation of energy is a separate statutory requirement for adopting an energy conservation standard, EPCA requires DOE, in determining the economic justification of a standard, to consider the total projected energy savings that are expected to result directly from the standard. (42 U.S.C. 6295(o)(2)(B)(i)(III)) As discussed in section IV.H.1, DOE
In establishing classes of products, and in evaluating design options and the impact of potential standard levels, DOE evaluates potential standards that would not lessen the utility or performance of the considered products. (42 U.S.C. 6295(o)(2)(B)(i)(IV)) Based on data available to DOE, the standards proposed in this proposed rule would not reduce the utility or performance of the products under consideration in this rulemaking.
EPCA directs DOE to consider the impact of any lessening of competition, as determined in writing by the Attorney General, that is likely to result from a proposed standard. (42 U.S.C. 6295(o)(2)(B)(i)(V)) It also directs the Attorney General to determine the impact, if any, of any lessening of competition likely to result from a proposed standard and to transmit such determination to the Secretary within 60 days of the publication of a proposed rule, together with an analysis of the nature and extent of the impact. (42 U.S.C. 6295(o)(2)(B)(ii)) DOE will transmit a copy of this proposed rule to the Attorney General with a request that the Department of Justice (DOJ) provide its determination on this issue. DOE will publish and respond to the Attorney General's determination in the final rule.
DOE also considers the need for national energy conservation in determining whether a new or amended standard is economically justified. (42 U.S.C. 6295(o)(2)(B)(i)(VI)) The energy savings from the proposed standards are likely to provide improvements to the security and reliability of the nation's energy system. Reductions in the demand for electricity also may result in reduced costs for maintaining the reliability of the nation's electricity system. DOE conducts a utility impact analysis to estimate how standards may affect the nation's needed power generation capacity, as discussed in section IV.M.
The proposed standards also are likely to result in environmental benefits in the form of reduced emissions of air pollutants and greenhouse gases associated with energy production. DOE reports the emissions impacts from the proposed standards, and from each TSL it considered, in section IV.K of this proposed rule. DOE also reports estimates of the economic value of emissions reductions resulting from the considered TSLs, as discussed in section IV.L.
EPCA allows the Secretary of Energy, in determining whether a standard is economically justified, to consider any other factors that the Secretary deems to be relevant. (42 U.S.C. 6295(o)(2)(B)(i)(VII)) To the extent interested parties submit any relevant information regarding economic justification that does not fit into the other categories described above, DOE could consider such information under “other factors.”
As set forth in 42 U.S.C. 6295(o)(2)(B)(iii), EPCA creates a rebuttable presumption that an energy conservation standard is economically justified if the additional cost to the consumer of a product that meets the standard is less than three times the value of the first year's energy savings resulting from the standard, as calculated under the applicable DOE test procedure. DOE's LCC and PBP analyses generate values used to calculate the effects that proposed energy conservation standards would have on the PBP for consumers. These analyses include, but are not limited to, the 3-year payback period contemplated under the rebuttable-presumption test. In addition, DOE routinely conducts an economic analysis that considers the full range of impacts to consumers, manufacturers, the nation, and the environment, as required under 42 U.S.C. 6295(o)(2)(B)(i). The results of this analysis serve as the basis for DOE's evaluation of the economic justification for a potential standard level (thereby supporting or rebutting the results of any preliminary determination of economic justification). The rebuttable presumption payback calculation is discussed in section IV.F.10 of this proposed rule.
DOE used three spreadsheet tools to estimate the impact of today's proposed standards. The first spreadsheet calculates LCCs and PBPs of potential standards. The second provides shipments forecasts, and then calculates national energy savings and net present value of total consumer costs and savings expected to result from potential standards. Finally, DOE assessed manufacturer impacts, largely through use of the Government Regulatory Impact Model (GRIM).
Additionally, DOE estimated the impacts on utilities and the environment that would be likely to result from potential amended standards for residential dehumidifiers. DOE used a version of EIA's National Energy Modeling System (NEMS) for the utility and environmental analyses. The NEMS simulates the energy sector of the U.S. economy. EIA uses NEMS to prepare its
DOE develops information that provides an overall picture of the market for the products concerned, including the purpose of the products, the industry structure, manufacturers, market characteristics, and technologies used in the products. DOE's market and technology analysis activity includes both quantitative and qualitative assessments, based primarily on publicly available information. The subjects addressed in the market and technology assessment for this residential dehumidifier rulemaking include: (1) A determination of the scope of the rulemaking and product classes; (2) manufacturers and industry structure; (3) existing efficiency programs; (4) product shipments; (5) market and industry trends; and (6) technologies that could improve the energy efficiency of residential dehumidifiers. The key findings of DOE's market assessment are summarized below. See chapter 3 of the NOPR TSD for further discussion of the market and technology assessment.
EPCA defines a dehumidifier as product that is self-contained, electrically operated, mechanically encased, and a product that incorporates a refrigerated surface to condense moisture from the atmosphere. It further defines it as a refrigerating system with an electric motor; a fan for air circulation; and a means for collecting or disposing of the condensate. (42 U.S.C. 6291(34)) In the concurrent test procedure rulemaking, DOE is clarifying that this definition of a dehumidifier, codified at 10 CFR 430.2, does not apply to portable air conditioners, room air conditioners, or packaged terminal air conditioners.
Aprilaire Inc. (Aprilaire) commented to suggest that the EPCA definition for
In the concurrent test procedure rulemaking, DOE is also adding definitions to 10 CFR 430.2 for portable dehumidifiers and whole-home dehumidifiers. Portable dehumidifiers are designed to operate within the dehumidified space without ducting attached, although ducting may be attached optionally. Whole-home dehumidifiers are designed to be installed with inlet ducting for return process air and outlet ducting that supplies dehumidified process air to one or more locations in the dehumidified space.
Therma-Stor LLC (Therma-Stor) expressed concern that DOE is proposing to subdivide dehumidifiers into “portable” and “whole-home” dehumidifiers, as defined by their intended application or installation. According to Therma-Stor, this approach may not provide clear differentiation among products, and therefore DOE should revise the proposed definitions of each product type to accurately define specific attributes to avoid confusion in the marketplace. (Therma-Stor, No. 21 at p. 1) Due to the many similarities between certain portable and whole-home dehumidifiers and the inability to determine their intended use through examination of the product, DOE determined that design features associated with installation, namely the attachment of ducts, are the most reliable method for differentiation. The definitions established in the concurrent test procedure rulemaking separate the product types based on this differentiation. For those dehumidifiers that may be optionally configured in either manner, DOE would require that each configuration of these products be certified under corresponding portable and whole-home dehumidifier energy conservation standards.
When evaluating and establishing energy conservation standards, DOE divides covered products into product classes by the type of energy used or by capacity or other performance-related features that justify a different standard. In making a determination whether a performance-related feature justifies a different standard, DOE must consider such factors as the utility to the consumer of the feature and other factors DOE determines are appropriate. (42 U.S.C. 6295(q))
Under 42 U.S.C. 6295(cc)(2), residential dehumidifiers, manufactured on or after October 1, 2012, are divided into five product classes based on the capacity of the unit in pints of water extracted per day:
In the preliminary analysis conducted for this rulemaking, DOE considered the following portable dehumidifier product classes that were based on the existing product classes, but with capacities adjusted for the lower ambient temperature proposed in the May 2014 test procedure NOPR:
In the preliminary analysis, DOE also considered two product classes for whole-home dehumidifiers, differentiated by product case volume.
Aprilaire commented that portable and whole-home dehumidifiers are two different classes of product, in their construction as well as their intended application and function. Aprilaire commented that the National Renewable Energy Laboratory (NREL) technical report, NREL/TP-5500-61076, highlights the difference between portables and whole-home dehumidifiers, not only in application, size, and capacity, but also in performance. Aprilaire expressed concern that due to these many differences in the two types of dehumidifier products, the inclusion of both into one rule and test procedure may not be appropriate. Therefore, Aprilaire suggested that DOE not consider whole-home dehumidifiers in the rulemaking and test procedures at this time. (Aprilaire No. 20 at pp. 1-3)
Pacific Gas and Electric Company, Southern California Gas Company, San Diego Gas and Electric, and Southern California Edison (California Investor-Owned Utilities (IOUs)) supported extending coverage to whole-home dehumidifiers and regulating them as a separate product class from portable dehumidifiers, as they are designed and installed differently in order to properly take advantage of ducted configurations. According to the California IOUs, whole-home dehumidifiers require more energy than portable units, and the difference in energy use between high and low efficiency products is significant. The California IOUs further stated that whole-home dehumidifiers have a longer lifetime than portable dehumidifiers, and that due to the longer lifetime and large difference in energy use between whole-home dehumidifiers of varying efficiency, it is important to ensure that these products are efficient to realize savings for the duration of the expected lifetime. (California IOUs, No. 24 at pp. 1-2)
DOE notes that although portable and whole-home dehumidifiers have different applications and overall performance, they both: (1) Fall under
The California IOUs commented that there are a group of products in the 65 to 75 pint/day capacity range with significantly higher efficiencies than other dehumidifiers with capacities under 75 pints/day. The California IOUs suggested that DOE analyze these products to understand their technology options and whether or not lower-capacity units can achieve similar efficiencies, or whether a separate product class is necessary to develop more appropriate energy conservation standards for those products. (California IOUs No. 24 at pp. 3-4) DOE investigated the models with higher efficiencies near 75 pints/day rated capacity (as measured according to the current test procedure in 10 CFR part 430, subpart B, appendix X). DOE notes that these products typically have construction similar to whole-home dehumidifiers, but in a portable configuration. They include larger heat exchangers (and for some units, an inlet air-to-air heat exchanger), higher-volumetric flow rate blowers, and higher-capacity compressors. These units are currently rated at capacities between 65 and 75 pints/day, and although these capacities would decrease under the appendix X1 test procedure, DOE expects, based on its investigative testing, that the units would likely be classified in the proposed 45.01 pints/day or more product class. Accordingly, DOE considered higher efficiencies for this product class in this NOPR analysis than for the lower-capacity portable product classes (see section IV.C.1 of this proposed rule).
Appliance Standards Awareness Project (ASAP) asked why DOE proposed multiple product classes for portable dehumidifiers with capacities less than 45 pints/day. (ASAP, Public Meeting Transcript, No. 25 at p. 16)
The Joint Commenters also stated that DOE determined there is no inherent relationship between capacity and efficiency, and that efficiency is instead primarily a function of chassis size. The Joint Commenters further stated that the possibility that some manufacturers' current chassis components may make it difficult for them to meet higher ELs at certain capacities does not justify the use of separate product classes to shield those manufacturers from more stringent standards. The Joint Commenters further stated that, at most, the cost (not the ability) to meet a standard level is different from manufacturer to manufacturer. (Joint Commenters, No 23 at p. 2) The California IOUs commented that by “right-sizing” the chassis, manufacturers can produce high-efficiency dehumidifiers of any capacity. Thus, all product classes below 75 pints/day (based on the current test procedure in appendix X) should be consolidated into a single class. (California IOUs, No. 24 at p. 3)
AHAM supported maintaining several product classes for portable dehumidifiers, and agreed that DOE should not collapse portable dehumidifier product classes into two product classes (less than 75 pints/day and greater than 75 pints/day according to the current test conditions). AHAM also agreed that maintaining several product classes would allow DOE to individually consider appropriate ELs in each class that would take into account unique performance factors and costs. (AHAM, No. 22 at pp. 1-2) AHAM commented that it was concerned that the 65 degrees Fahrenheit (°F) ambient temperature test condition in the proposed test procedure for residential dehumidifiers, as opposed to the current 80 °F ambient temperature, would increase test-to-test variation and make it more difficult to establish product classes based on capacity thresholds. Therefore, AHAM stated that it may be necessary to combine two of the lower-capacity product classes, for a total of four portable dehumidifier product classes. (AHAM, No. 22 at p. 2) Therma-Stor commented that the number of product classes may need to be reduced or increased to reflect the (relative) range of ratings. (Therma-Stor, No. 21 at p. 1)
While all current product classes are able to reach similar maximum efficiencies under current test procedures, DOE observed that the two lowest capacity portable product classes considered for the preliminary analysis (20.00 pints/day or less and 20.01 to 30.00 pints/day) could not reach the same maximum IEF as the other product classes when tested under the appendix X1 test procedure. This suggested that there may be an inherent trend between capacity and efficiency at lower ambient test temperatures.
DOE also notes that product sizes and weights vary between products currently available on the market.
DOE also observed that there was no key difference in product characteristics for the two product classes analyzed for the preliminary analysis that DOE proposes to combine into a single product class in this NOPR. The 20.00 pints/day or less and 20.01 to 30.00 pints/day product classes had similar product characteristics and were able to achieve similar ELs under both the current and appendix X1 test procedures. Similarly, the 30.01 to 35.00 pints/day and 35.01 to 45.00 pints/day product classes had similar construction and measured efficiencies. For this NOPR analysis, DOE proposes combing the four lowest-capacity portable product classes analyzed in the preliminary analysis into two: 30.00 pints/day or less and 30.01 to 45.00 pints/day. DOE proposes maintaining the 45.01 pints/day or more product class as considered in the preliminary analysis because the larger chassis size and weight typically associated with these products would allow for consideration of certain design options, such as inlet pre-cooling heat exchangers, that would be infeasible in lower-capacity portable dehumidifiers.
AHAM stated that because dehumidifiers are typically rated at even number capacities, DOE should use odd number boundaries for the product classes, especially as standards become more stringent. AHAM commented that DOE's proposal to define product class boundaries at even numbers may cause findings of noncompliance simply due to test procedure variation. (AHAM, Test Procedure NOPR, No. 7 at p, 6) Based on a review of the products certified in DOE's Compliance Certification Database, DOE observed that approximately 75 percent of certified units are rated at a capacity that is a multiple of 10.
Therma-Stor commented that the current product classes, which are based on water removal capacity at 80 °F and 60-percent relative humidity, should be revised to reflect new capacity values if different ambient rating test conditions are chosen. (Therma-Stor, No. 21 at p. 1) As discussed previously, DOE adjusted its portable product classes to account for the updated test conditions at 65 °F ambient temperature.
Aprilaire agreed with using the volume of whole-home dehumidifiers as a product class differentiator, because installed location is one of the restrictions on these units rather than their capacity. However, Aprilaire requested clarification on the selection of 8.0 cubic feet as the threshold between product classes, and whether there was any relationship between this threshold and product capacity. Aprilaire commented that the differentiation of whole-home product classes based on case volume less than or greater than 8.0 cubic feet appears to be arbitrary and only based on products on the market today, and that product sizes exist today due to application and size constraints incurred during or after installation. Aprilaire noted its concern that the market for whole-home dehumidifiers and potential applications were not totally understood, and placing an arbitrary threshold may limit innovation and new product applications. Aprilaire stated that doing so would negatively impact the ability to obtain whole-home energy-efficient humidity control. (Aprilaire, Public Meeting Transcript, No. 25 at pp. 14-15; Aprilaire, No. 20 at p. 3) Therma-Stor also commented that basing whole-home dehumidifier product classes on case volume is arbitrary, and would be confusing in the marketplace. Therma-Stor suggested that whole-home product classes be based upon the same capacity metric as portable dehumidifiers. (Therma-Stor, No. 21 at p.1)
DOE considered whole-home product class differentiation based on those products that are installed in space-constrained locations. Many of the design options associated with improving efficiencies for these products, such as larger heat exchangers or an inlet pre-cooling heat exchanger, require making the unit physically larger. Whole-home units that are not space constrained may incorporate all of these design options and reach higher efficiencies. DOE observed that products available on the market with case volumes greater than 8.0 cubic feet are able to incorporate additional design options and reach higher efficiencies than products with volumes at or less than 8.0 cubic feet. DOE also expects that products with volumes of 8.0 cubic feet or less would be able to meet consumers' needs for space-constrained installations. DOE notes that switching to a capacity-based product class differentiation, as proposed for portable dehumidifier product classes, would not ensure products would maintain the smaller case sizes. Whole-home units at lower capacities could increase case size to incorporate all available design options and maximize heat exchanger sizes to reach high efficiencies, but the increased case size would also limit consumer applications. For these reasons, DOE proposes to maintain the two whole-home dehumidifier product classes based on case volume: Less than or equal to 8.0 cubic feet and greater than 8.0 cubic feet.
In summary, DOE proposes classifying portable products into three product classes, by merging two of the current five portable product classes into the other three, and classifying whole-home dehumidifiers in two product classes based on case volume, resulting in the following product classes:
In the remaining sections of this NOPR, presented product capacities and efficiencies are consistent with the appendix X1 test procedures.
In the preliminary market analysis and technology assessment, DOE identified 14 technology options that would be expected to improve the efficiency of residential dehumidifiers:
In response to the preliminary analysis, two commenters suggested additional technology options that DOE should consider, but the agency has determined that neither option merits further consideration. First, the Joint Commenters and California IOUs stated that DOE should include chassis size as a technology option for improving efficiency in the engineering analysis if it maintains separate portable dehumidifier product classes. (California IOUs, No. 24 at p. 2; Joint Commenters, No. 23 at p. 2) DOE notes that increasing chassis size does not itself increase product efficiency, but it allows the product to house larger heat exchangers, which does improve efficiency. DOE included larger heat exchangers as a design option, and considered any necessary chassis changes associated with the larger components in the engineering analysis.
Second, the California IOUs commented that DOE should consider the potential benefits from networked smart controls, which would allow dehumidifiers to benefit from time-of-use metering and other demand management schemes to maximize the time-value of energy production in participating utilities. They noted that as an added benefit, advanced sensors with more sophisticated reporting capabilities would alert the user when the unit begins to degrade significantly, requiring maintenance or replacement. (California IOUs, No. 24 at p. 5) The current and recently established DOE test procedures for dehumidifiers measure the site energy consumption in typical operation and do not reflect potential overall benefits related to demand management enabled by smart controls. Products incorporating smart controls would have the same (or lower) measured efficiencies according to the DOE test procedure because such controls consume additional energy to provide those features that are not directly related to energy efficiency. Additionally, DOE is not aware of any dehumidifiers currently available on the market or any working prototypes that incorporate a demand response function via smart controls. Accordingly, DOE did not consider smart controls as a design option to reach higher ELs in this analysis. DOE requests comment on any information or data about the availability of dehumidifiers with smart controls, including those currently available on the market or any working prototypes.
After identifying all potential technology options for improving the efficiency of residential dehumidifiers, DOE performed a screening analysis (see section IV.B of this proposed rule and chapter 4 of the NOPR TSD) to determine which technologies merited further consideration.
DOE uses the following four screening criteria to determine which technology options are suitable for further consideration in an energy conservation standards rulemaking:
1.
2.
3.
4.
In sum, if DOE determines that a technology, or a combination of technologies, fails to meet one or more of the above four criteria, it will be excluded from further consideration in the engineering analysis. The reasons for eliminating any technology are discussed below.
The subsequent sections include comments from interested parties pertinent to the screening criteria, DOE's evaluation of each technology option against the screening analysis criteria, and whether DOE determined that a technology option should be excluded (“screened out”) based on the screening criteria.
Based on teardowns and research, DOE determined that portable dehumidifiers with capacities up to 45 pints/day have little room to incorporate additional components within the product case (see chapter 4, section 4.2.1 of the NOPR TSD). DOE estimated that the addition of an effective pre-cooling air-to-air heat exchanger would require case sizes to, at a minimum, double. Because of the increased size and weight, DOE determined that incorporating a pre-cooling air-to-air heat exchanger in portable dehumidifiers with capacities up to 45 pints/day would have an adverse impact on product utility to consumers. Because this design option would result in the unavailability of products with the same size and volume as products currently available on the market, DOE screened out pre-cooling air-to-air heat exchangers as a design option for portable dehumidifiers with capacities up to 45 pints/day.
AHAM supported screening out pre-cooling air-to-air heat exchangers for smaller-capacity dehumidifiers. They noted that the pre-cooling heat exchangers would make larger-capacity products even bigger, because the enclosure would need to be bigger, which could impact portability and consumer utility. (AHAM, No. 22 at p. 6) DOE maintains its proposal to eliminate pre-cooling inlet air-to-air heat exchangers from further consideration for portable products with capacity less than 45 pints/day. For portable products with capacities greater than 45 pints/day, DOE notes that certain products available on the market already incorporate this technology option. Thus, DOE has maintained it as a potential design
In the preliminary analysis, DOE also identified heat pipes as a potential technology to increase dehumidifier efficiency. Heat pipes perform a similar function as pre-cooling air-to-air heat exchangers, lowering the inlet air temperature to increase the efficiency of the refrigeration system, except that heat pipes use a phase-change fluid to transfer heat between the two air streams. DOE estimated that the additional heat exchangers and fluid tubing for heat pipes would likely require significant increases in case size and overall weight for portable dehumidifiers with capacities of up to 45 pints/day, resulting in an adverse impact on product utility to consumers. Because this design option would result in the unavailability of products with the same weight and volume as products currently available on the market, DOE screened out heat pipes as a design option for portable dehumidifiers with capacities up to 45 pints/day. AHAM agreed that heat pipes should be screened out for smaller-capacity portable dehumidifiers due to their consumer utility impacts. (AHAM, No 22 at p. 6)
However, in the preliminary analysis, DOE retained heat pipes as a design option for whole-home dehumidifiers and portable dehumidifiers with capacities greater than 45 pints/day. DOE noted that many of these products already use larger case sizes to accommodate pre-cooling air-to-air heat exchangers. Products incorporating heat pipes would likely require similar case volumes as the products available on the market that include pre-cooling air-to-air heat exchangers, and would not likely impact consumer utility for whole-home dehumidifiers and portable dehumidifiers with capacities greater than 45 pints/day.
Regarding improved condenser and evaporator performance, AHAM commented that adjusting the cross-sectional area of the heat exchanger to increase heat transfer is feasible, but it will likely involve a change in enclosure size. AHAM suggested that DOE consider screening out this option for smaller capacities. (AHAM, No. 22 at p. 4) DOE agrees that increased heat exchanger areas may require an increase in enclosure size. However, larger coils requiring a larger case and chassis do not necessarily require moving to a product case as large as is needed for higher-capacity portable units (due to smaller heat exchangers as well as compressors, blowers, and condensate buckets). Accordingly, while there may be some increase in product sizes with increased heat exchanger area, DOE did not eliminate this technology option from further consideration because consumer utility could be maintained.
After a review of each technology, DOE found that all of the identified technologies, with the restrictions for pre-cooling air-to-air heat exchangers and heat pipes discussed above, met all four screening criteria and are suitable for further examination in DOE's analysis.
DOE determined that these technology options are technologically feasible because they are being used or have previously been used in commercially available products or working prototypes. DOE also finds that all of the remaining technology options meet the other screening criteria (
In the engineering analysis DOE establishes the relationship between the manufacturer production cost (MPC) and improved residential dehumidifier efficiency. This relationship serves as the basis for cost-benefit calculations for individual consumers, manufacturers, and the nation. DOE typically structures the engineering analysis using one of three approaches: (1) Design option; (2) efficiency level; or (3) reverse engineering (or cost assessment). The design-option approach involves adding the estimated cost and associated efficiency of various efficiency-improving design changes to the baseline to model different levels of efficiency. The efficiency-level approach uses estimates of costs and efficiencies of products available on the market at distinct efficiency levels to develop the cost-efficiency relationship. The reverse-engineering approach involves testing products for efficiency and determining cost from a detailed bill of materials (BOM) derived from reverse engineering representative products.
In the preliminary engineering analysis, DOE used a hybrid approach combining aspects of all three analytic methods described above. The efficiency-level approach for residential dehumidifiers, combined with the cost-assessment approach, allowed DOE to develop a cost for each product analyzed. DOE estimated that the costs for these products reflected the costs for typical units at their respective efficiency levels. This approach involved physically disassembling commercially available products, consulting with outside experts, reviewing publicly available cost and performance information, and modeling equipment cost. To ensure that DOE's analysis covered the entire range of capacities and efficiencies available on the market, DOE relied on the design-option approach to determine what changes would be needed for a particular unit to meet each incrementally higher EL.
For this NOPR, DOE followed the same general approach as for the preliminary engineering analysis, but modified the analysis based on comments from interested parties and to reflect the most current available information. This section provides more detail on how DOE selected the ELs used for its analysis and developed the MPC at each EL. Chapter 5 of the NOPR TSD contains further description of the engineering analysis.
A baseline unit is a product that just meets current Federal energy conservation standards and provides basic consumer utility. DOE uses the baseline unit for comparison in several phases of the NOPR analyses, including the engineering analysis, LCC analysis, PBP analysis, and NIA. To determine energy savings that will result from an amended energy conservation standard, DOE compares energy use at each of the higher energy ELs to the energy consumption of the baseline unit. Similarly, to determine the changes in price to the consumer that will result
As discussed in section IV.A.2 of this notice, DOE adjusted the existing dehumidifier product classes for the preliminary analysis to reflect capacities measured according to the test procedures proposed in the May 2014 Test Procedure NOPR. Similarly, DOE established baseline ELs in the preliminary engineering analysis by adjusting the existing baseline EFs to IEFs as would be measured under the proposed testing requirements. For the portable product classes, the most significant adjustments accounted for the lower ambient test temperature, and energy consumption in standby mode, off mode, and fan-only mode. DOE also established separate baseline efficiencies for the two proposed whole-home dehumidifier product classes. Table IV.7 and Table IV.8 present the baseline ELs developed for the preliminary analysis. Additional information on the development of these baseline ELs is included in chapter 5, section 5.3.1 of the preliminary TSD.
In response to the preliminary analysis, AHAM commented that if the test procedure includes a measure of fan-only mode energy use, AHAM would support the proposed baseline IEF based on units with fan-only mode. (AHAM, No. 22 at p. 3) DOE notes that the appendix X1 test procedure incorporates energy consumption in fan-only mode into the calculation of IEF, and DOE considered units with fan-only mode to determine the proposed baseline IEF in this analysis.
Aprilaire commented that it was not aware of any whole-home units that have a fan-only mode. According to Aprilaire, whole-home dehumidifiers use the HVAC air handler instead of the dehumidifier fan to circulate air inside the home. (Aprilaire, Public Meeting Transcript, No. 25 at pp. 23-24) Aprilaire's comment is consistent with what DOE observed during investigative testing. No whole-home units in DOE's test sample operated in fan-only mode. Accordingly, DOE has not adjusted the whole-home dehumidifier baseline levels to account for operation in this mode.
For this NOPR, DOE maintained the baseline efficiencies determined for the preliminary analysis, with updates to reflect the combined product classes as discussed in section IV.A.1 of this notice. DOE set the baseline efficiency level for the combined product classes at the lower of the two baseline IEF levels considered in the preliminary analysis for the two previously separate product classes, because that IEF would be based on the minimum energy conservation standard currently applicable for any product within the combined product classes. Table IV.9 and Table IV.10 present the baseline efficiency levels used in this NOPR analysis.
Additional details on the selection of baseline units may be found in chapter 5, section 5.3.1 of the NOPR TSD.
For the preliminary analysis, DOE considered incremental efficiency levels beyond the baseline that were based on existing efficiency levels (
In response to the preliminary analysis, AHAM commented that its members were conducting testing to compare performance at 80 °F and 65 °F ambient conditions, and if possible, AHAM would provide this aggregated data to DOE. (AHAM, No. 22 at p. 4) DOE has not received additional test data from AHAM at the time of this NOPR, and has therefore relied on its internal test data to establish appropriate IEF values for the incremental efficiency levels beyond the baseline.
Aprilaire noted that there was only about an 11-percent difference between the current DOE energy conservation standards and ENERGY STAR qualification criteria. Aprilaire stated that if the purpose of ENERGY STAR is to promote the best technology at the best value, the current DOE and ENERGY STAR requirements may not provide sufficient consumer choices and differentiation to promote using the latest technology. (Aprilaire, Public Meeting Transcript, No. 25 at pp. 48, 50) Although the U.S. Environmental Protection Agency (EPA), rather than DOE, establishes the ENERGY STAR qualification criteria, DOE selected the current ENERGY STAR level as the basis for an efficiency level in each portable product dehumidifier product class because many products available on the market are rated at that level. While the ENERGY STAR level does not represent a large jump in efficiency from the current DOE standards, on a percentage basis, the range of dehumidifier efficiencies on the market is not large, and the increase in efficiency from baseline to ENERGY STAR represents a significant increase in efficiency over this range. DOE also evaluated higher ELs than the ENERGY STAR level.
Aprilaire asked why there was such a large difference between the highest efficiency levels for the two whole-home product classes. (Aprilaire, Public Meeting Transcript, No. 25 at p. 33) DOE notes that the smaller case volume for the less than 8.0 ft
For the preliminary analysis, DOE used the maximum available efficiencies as the highest efficiency levels for its analysis, and requested feedback on whether these levels were appropriate. ASAP asked whether the max-tech levels should be higher than the current maximum available efficiency levels. ASAP also asked whether the max-tech level is independent of what level might be appropriate for a standard. (ASAP, Public Meeting Transcript, No. 25 at pp. 34-35) The Joint Commenters stated that DOE should evaluate potential efficiency improvements beyond the maximum available level, and should not use the maximum available level as a proxy for the max-tech levels. They stated that, for example, modest increases in chassis size, permanent-magnet fan motors, and additional heat exchanger improvements may provide further efficiency gains, and that the max-tech levels would likely be higher than the efficiency levels of the most-efficient currently available products. (Joint Commenters, No. 23 at pp. 2-3) The California IOUs commented that the max-tech efficiency level should be based on modeled efficiencies, as opposed to products currently available in the market. They stated that it is important for DOE to either physically test or model a true max-tech level of dehumidifier efficiency, and this level need not be constrained by cost or other factors that are present in normal commercial product development. The California IOUs stated that this max-tech option should incorporate every known measure to maximize efficiency (
DOE establishes the max-tech level as the maximum efficiency that is technologically feasible for the covered product. In analyzing potential standards, DOE is not constrained to selecting max-tech levels as the proposed standards levels. DOE agrees that dehumidifiers commercially
For the NOPR analysis, another key change to the efficiency levels considered for the preliminary analysis was to combine the previous four lowest capacity portable product classes into two, as discussed in section IV.A.1 of this proposed rule. The two portable product classes from the preliminary analysis with capacities less than 30.00 pints/day each have three identical intermediate efficiency levels. For the combined 30.01 to 45.00 pints/day product class, DOE used an IEF of 1.20 L/kWh for Efficiency Level 1. The previous Efficiency Level 1 for the 35.01 to 45.00 product class in the preliminary analysis was at an IEF of 1.30 L/kWh. DOE chose an IEF of 1.20 L/kWh as the appropriate level for the combined product class because this represents the baseline IEF with no fan-only mode; therefore, DOE concluded it would be appropriate to maintain the lower of the two IEFs at this level for the combined product class.
DOE also updated the efficiency levels for the whole-home dehumidifier classes based on the appendix X1 test procedures, which require a different ambient dry-bulb temperature (73 °F instead of 65 °F) from that proposed in the May 2014 Test Procedure NOPR and a different external static pressure (0.20 inches of water column instead of 0.5 and 0.25 inches of water column) from those proposed in the May 2014 Test Procedure NOPR and the February 2015 Test Procedure SNOPR).
Table IV.13 and Table IV.14 present the revised efficiency levels DOE considered in this NOPR analysis.
Additional details on the selection of incremental efficiency levels may be found in chapter 5, section 5.3.2 of the NOPR TSD.
Based on product teardowns and cost modeling conducted in the preliminary analysis, DOE developed overall cost-efficiency relationships for each product class considered in that analysis. DOE selected products covering the range of efficiencies available on the market for the teardown analysis. During the teardown process, DOE created detailed bills of materials (BOMs) that included all components and processes used to manufacture the products. DOE used the BOMs from the teardowns as an input to a cost model, which was used to calculate the MPC for products covering the range of efficiencies available on the market. The MPC accounts for labor, material, overhead, and depreciation costs that a manufacturer would incur in producing a specific dehumidifier. DOE also developed BOMS and MPCs for theoretical units that could implement the current max-tech for dehumidifier components.
For the preliminary analysis, DOE estimated that the costs for these products reflected the costs for typical units at their respective efficiency levels, consistent with the efficiency-level approach. DOE then used the design-option approach to determine what changes would be needed for a particular unit to meet each incrementally higher efficiency level. DOE constructed cost-efficiency curves for multiple manufacturers to reflect the incremental MPC corresponding to each manufacturer's product line and available platforms. DOE combined the individual cost-efficiency curves based on estimates of each manufacturer's market share to develop an overall cost-efficiency curve representative of the entire industry. Table IV. 15 shows the incremental MPCs developed in the preliminary analysis for each product class at each of the analyzed efficiency levels compared to the baseline MPC. The incremental MPCs are presented in 2012 dollars (2012$), which reflects the year in which the preliminary analysis teardowns and modeling were performed.
Section 5.5 of Chapter 5 of the preliminary TSD contains additional details on the analysis conducted in support of developing these MPC estimates.
DOE received multiple comments from interested parties on the engineering analysis and MPC estimates developed for the preliminary analysis. GE Appliances (GE) commented that it is very low cost to get to Efficiency Level 1 by eliminating fan-only mode because it only requires software changes. (GE, Public Meeting Transcript, No. 25 at p. 43) AHAM and GE commented that removing fan-only mode reduces consumer utility with longer defrost times at lower temperatures, less stability of the humidity in the environment, and stagnation of the air. AHAM also stated that for manufacturers that would not want to make these tradeoffs, Efficiency Level 1 would be nearly impossible to meet by combining other technology options. (AHAM, No. 22 at p. 3; GE, Public Meeting Transcript, No. 25 at p. 43) DOE continues to expect manufacturers would remove fan-only mode in products as a first step to improving efficiency because of the low cost and ease of implementation. Many units available on the market already do not incorporate fan-only mode. In manufacturer interviews, manufacturers typically stated that there would be no impact on consumer utility to remove fan-only mode. DOE also notes that although it asserts that manufacturers would remove fan-only mode to reach Efficiency Level 1, manufacturers may elect to incorporate other design options to improve efficiency to that level.
Aprilaire asked whether DOE considered in its analysis the limited availability of compressor technologies for the larger dehumidifiers. Aprilaire noted that compressors in larger dehumidifiers do not have a lot of new technologies and sizes available to them. Manufacturers would have to increase efficiency by increasing coil sizes or incorporating features such as air-to-air heat exchangers or wrap-around coils, which would be very expensive for the manufacturer. (Aprilaire, Public Meeting Transcript, No. 25 at pp. 23-24) AHAM commented that compressor efficiency has not been increasing significantly. Manufacturers may be seeking to incorporate higher efficiency compressors, but it is possible that compressors are reaching close to max-tech levels such that selecting a higher efficiency compressor may be cost prohibitive. (AHAM, No. 22 at p. 4)
For the preliminary engineering analysis, DOE identified the range of compressor capacities observed in dehumidifiers available on the market. DOE then identified the range of efficiencies for all available compressors within that capacity range. When evaluating higher compressor efficiencies, DOE considered the most efficient rotary R-410A compressor available in the required range of capacities, without requiring a switch to a different compressor technology. Additionally, DOE factored in the compressor efficiencies observed in products in its teardown sample when determining the overall efficiency gains that may be achieved through compressor improvements. If a dehumidifier already incorporated an efficient compressor, DOE relied on other design options such as increasing heat exchanger sizes to improve efficiencies.
In AHAM's comments on the preliminary engineering analysis cost estimates, it asked for more information on how a 3,000 Btu/h compressor would be estimated to cost less than $7. (AHAM, Public Meeting Transcript, No. 25 at p. 38) GE commented that because there are very few room air conditioner compressors rated as low as 5,000 Btu/h, the curve used to determine compressor prices is probably valid only down to 5,000 Btu/h. (GE, Public Meeting Transcript, No. 25 at p. 39) DOE notes that in the preliminary analysis, it relied on the room air conditioner compressor cost curve only over the range of capacities for which it was developed, 5,000 to 24,000 Btu/h. DOE used the $7 cost for a 3,000 Btu/h compressor as an example of an inappropriately low cost from extrapolating the cost curve below its lower limit (5,000 Btu/h). DOE did not use this cost estimate in the preliminary analysis or in this NOPR. In both the preliminary analysis and this NOPR, DOE estimated that compressor costs would continue to decrease for compressor capacities less than 5,000 Btu/h, but estimated a more conservative linear decrease in costs compared to extrapolating the room air conditioner curve. (For additional information, see chapter 5, section 5.5.5 of the preliminary TSD.)
ASAP asked if DOE had evaluated heat exchanger improvements other than increasing the cross-sectional area, and if so, which improvement had the largest impact. (ASAP, Public Meeting Transcript, No. 25 at p. 46) AHAM commented that manufacturers might choose to rely on heat exchanger sizes to improve condenser and evaporator performance, but larger coils mean more static pressure, thus adding more costly motors. (AHAM, No. 22 at pp. 3-4)
As part of the preliminary analysis, DOE considered additional heat exchanger design changes, including increasing the number of tube passes and heat exchanger depth in the direction of the air flow. DOE modeled the efficiency improvements of these changes, as well as an increase in cross-sectional area, and found that increasing the heat exchanger cross-sectional area resulted in the greatest efficiency improvement. As noted in section 5.5.1 and throughout chapter 5 of the preliminary TSD, DOE asserted that manufacturers would rely on this heat exchanger design change to reach higher efficiency levels. Manufacturers confirmed during interviews that they would typically rely on increased cross-sectional area rather than other heat exchanger design changes to reach higher efficiencies. In considering larger cross-sectional areas, DOE also did not assume a corresponding increase in motor power. DOE expects that the
ASAP asked whether a fixed standby power level is incorporated into each IEF level. ASAP noted that the preliminary analysis does not include reduced standby power as a design option, which is reasonable as long as the standby power levels at each efficiency level are low. ASAP further commented that the energy study that DOE cited in the preliminary TSD found standby power levels for some products to be as high as 12 watts (W), and requested confirmation that high standby power levels are not incorporated in the IEFs. (ASAP, Public Meeting Transcript, No. 25 at pp. 44-45) AHAM agreed with DOE's determination in the preliminary analysis that manufacturers would rely on changes other than low-standby-loss electronic controls to achieve the relatively large increments in efficiency levels. (AHAM, No. 22 at p. 5)
In section 5.5.3.2 of the preliminary TSD, DOE noted that while the average low-power mode power draw for units in its test sample was lower for a switch-mode power supply compared to a linear power supply (0.4 W compared to 1.2 W), these values, incorporated into the same unit, would have a negligible effect on the final rounded IEF. Accordingly, DOE did not consider improving low-power mode energy consumption at any efficiency level. If a unit did indeed have a 12 W low-power mode power draw, DOE expects that the manufacturer would switch to low-standby-power controls to improve IEF. However, DOE notes that the 12 W level was observed in the field, and does not necessarily reflect the control settings and operation of the unit as tested according to the low-power mode testing provisions in the appendix X1 test procedures. DOE did not observe any standby mode or off mode power levels higher than 4.5 W in its testing of a large sample of dehumidifiers from manufacturers representing over 80 percent of the market.
GE and AHAM commented that Underwriters Laboratories (UL) has a new standard, UL 474, which requires Arc Fault Circuit Interrupter (AFCI) protection to be added to all cord-connected dehumidifiers manufactured on or after February 6, 2017. Adding AFCI protection to dehumidifiers will increase standby power. According to GE, the increase in standby power would be about 0.5 W. (AHAM, No. 22 at p. 7; GE, Public Meeting Transcript, No. 25 at pp. 47-48) This estimated increase in low-power mode power draw is similar to the range in low-power mode power consumption that DOE observed among the units in its test sample, and which DOE determined had little or no effect on the final rounded IEF value. Accordingly, DOE determined that the new UL 474 standard would not require adjusting the IEF values considered for each efficiency level.
In chapter 5, section 5.5.3.2 of the preliminary TSD, DOE provided discussion on a number of design options that were not directly considered in the engineering analysis. These design options were described in chapter 3, section 3.14.2 of the preliminary TSD. AHAM agreed that:
1. A built-in hygrometer/humidistat would not result in efficiency gains.
2. Because the test procedure requires continuous unit operation at constant ambient conditions, it would not reflect improved control schemes and thus these should not be further considered in the analysis.
3. If DOE adopts the 65 °F ambient condition, manufacturers would likely adjust their units to avoid defrosts when operating at that condition, and thus improved defrost methods should not be considered further in the analysis.
4. Demand-defrost controls should not be considered because units on the market already feature sensor-based defrost control and because the test procedure would not capture efficiency improvements from it.
5. Any benefit associated with the unit's ability to adjust to varying ambient conditions would not be captured by the test procedure, and thus improved flow-control devices should not be further considered in the analysis.
6. Washable air filters are not a design option because all units DOE analyzed include this feature.
7. Improved refrigeration system insulation should not be considered as a design option because DOE did not observe a relationship between efficiency and insulation. (AHAM, No. 22 at pp. 4-6)
The California IOUs commented that measures that were rejected because their impact would not be directly observable under the current DOE test procedure—variable-speed compressors, permanent-magnet fan motors, improved controls (standby power consumption, relative humidity set-point accuracy, refrigerant flow controls, improved defrost controls), and improved insulation in the refrigeration system—all have the potential for significant energy use reduction and therefore should be considered as design options. The California IOUs stated that a number of areas for improving the accuracy and range of controls could greatly enhance overall dehumidifier efficiency, and although the majority of these measures would not significantly affect the rated active mode efficiency of dehumidifiers under the current test procedure, they should be considered as design options because future updates to the test procedure may properly account for these efficiency gains. (California IOUs, No. 24 at pp. 4 and 5) The California IOUs also commented that DOE should consider requiring dehumidifiers to contain hygrometers, which would reduce overall energy use by automatically controlling active mode operation based on ambient temperature and humidity conditions. They stated that more advanced controls are capable of using data from hygrometers to optimize compressor and fan usage by utilizing a pre-programmed compressor and fan schedule over a range of dry-bulb and wet-bulb temperature combinations. They also stated that because some hygrometers can be inaccurate, which could cause units to run much longer duty cycles than the user intends, DOE should consider requiring a certain hygrometer accuracy and should modify the test procedure to accommodate this measurement. (California IOUs, No. 24 at p. 5)
DOE identified these design options in the market and technology assessment because of their potential to increase dehumidifier efficiencies in real-world applications. However, because the benefits of these design options would likely not be measured under the appendix X1 test procedure, DOE determined that manufacturers would not likely incorporate the design options to existing products to reach higher efficiency levels. The appendix X1 test procedure determines dehumidifier performance under constant ambient conditions, and therefore would not reflect potential energy impacts of design options that improve controls to adjust unit operation to respond to ambient conditions. Accordingly, DOE requests comment on whether to promote installation of any of the design options identified by the California IOUs, even though the resulting efficiency gains would not be measurable with the existing test protocol.
ASAP and the Joint Commenters stated that DOE should include the efficiency improvements associated with permanent-magnet fan motors unless the savings are trivial. (ASAP, Public Meeting Transcript, No. 25 at pp. 45-46; Joint Commenters, No. 23 at pp. 2-3) The Joint Commenters also stated
In improving the max-tech efficiencies beyond the maximum available, as discussed in section IV.C.1.b of this proposed rule, DOE included a change to permanent-magnet fan motors. While manufacturers do not currently incorporate permanent-magnet fan motors in products available on the market, DOE determined that this is a technologically feasible change that would improve product efficiencies. The revised MPCs for the NOPR analysis reflect this design change, as well as others, at the max-tech efficiency level.
For the NOPR analysis, DOE also updated the incremental MPC estimates from the preliminary analysis to combine the four lower capacity portable product classes into two, as discussed in section IV.A.1 of this proposed rule. To combine the cost estimates from the previous separate portable product classes, DOE used the market shares discussed in the preliminary analysis (see chapter 9, section 9.3.3 of the preliminary TSD) to determine a weighted average of the previous cost estimates. Additionally, DOE updated the MPCs to 2013$, the most recent year for which full-year data was available at the time of this analysis. DOE notes that the whole-home test procedure revisions did not impact the MPC cost estimates for those product classes. DOE assumed products would maintain the same construction as considered for the preliminary analysis, with updated IEFs to reflect the proposed, revised test conditions. Table IV.16 presents the updated MPC estimates DOE developed for this NOPR.
Additional details on the development of the incremental cost estimates may be found in chapter 5 of the NOPR TSD.
The markups analysis develops appropriate markups in the distribution chain to convert the MPC estimates derived in the engineering analysis to consumer prices. At each step in the distribution channel, companies mark up the price of the product to cover business costs and profit margin. For residential dehumidifiers, the main parties in the distribution chain are manufacturers and retailers.
The manufacturer markup converts MPC to manufacturer selling price (MSP). DOE developed an average manufacturer markup by examining the annual Securities and Exchange Commission (SEC) 10-K reports filed by publicly traded manufacturers primarily engaged in appliance manufacturing and whose combined product range includes residential dehumidifiers.
For retailers, DOE developed separate markups for baseline products (baseline markups) and for the incremental cost of more efficient products (incremental markups). Incremental markups are coefficients that relate the change in the MSP of higher-efficiency models to the change in the retailer sales price. DOE relied on economic data from the U.S. Census Bureau to estimate average baseline and incremental markups.
Chapter 6 of the NOPR TSD provides details on DOE's development of markups for residential dehumidifiers.
DOE's energy use analysis estimated the range of energy use of residential dehumidifiers in the field,
A dehumidifier uses energy when the compressor is operating to remove moisture from the air. When the compressor is not operating, the dehumidifier may use energy for a fan-only mode that circulates air through the unit to sample the ambient relative humidity and to defrost the condenser coils. When neither the fan nor the compressor is operating, energy is used in standby mode or off mode to supply power for functions such as keeping a user panel lit.
DOE determined the annual energy consumption of residential dehumidifiers by multiplying the capacity (liters per day) by the hours of operation in dehumidification mode, dividing that quantity by the product efficiency, and adding the energy use for the fan mode and the standby and off mode.
The efficiency and capacity values were measured using a temperature of 80 °F and humidity set point of 60 percent, as stipulated in the current test procedure for dehumidifiers.
To estimate hours of operation in each mode, DOE used two recent field studies that measured daily hours of use in each operating mode for both portable and whole-home dehumidifiers.
DOE estimated the energy use for the fan mode and the standby and off mode using the hours of operation described above, along with data on average power in fan and standby modes from the field studies.
Chapter 7 of the NOPR TSD provides details on DOE's energy use analysis for residential dehumidifiers.
In determining whether an energy conservation standard is economically justified, DOE considers the economic impact of potential standards on consumers. The effect of new or amended energy conservation standards on individual consumers usually involves a reduction in operating cost and an increase in purchase cost. DOE used the following two metrics to measure consumer impacts:
• LCC (life-cycle cost) is the total consumer cost of an appliance or product, generally over the life of the appliance or product. The LCC calculation includes total installed cost (equipment manufacturer selling price, distribution chain markups, sales tax, and installation costs), operating costs (energy, repair, and maintenance costs), equipment lifetime, and discount rate. Future operating costs are discounted to the time of purchase and summed over the lifetime of the appliance or product.
• PBP (payback period) measures the amount of time it takes consumers to recover the estimated higher purchase price of a more energy-efficient product through reduced operating costs. Inputs to the payback period calculation include the installed cost to the consumer and first-year operating costs.
For any given EL, DOE measures the change in LCC relative to the LCC in the base case, which reflects the market in the absence of new or amended energy conservation standards, and includes baseline products as well as products with higher efficiency. In contrast, the PBP for a given EL is measured relative to the baseline product only.
For each product class efficiency level, DOE calculated the LCC and PBP for a nationally representative set of housing units. As stated previously, DOE developed household samples with RECS 2009 data. For each sample household, DOE determined the energy consumption for the residential dehumidifier and the appropriate electricity price. By developing a representative sample of households, the analysis captured the variability in energy consumption and energy prices associated with the use of residential dehumidifiers.
AHAM continues to oppose DOE's reliance on RECS 2009 for the LCC and PBP analysis. AHAM considers it difficult, if not impossible, to compare the results to the energy use measured in a controlled test procedure situation. (AHAM, No. 22 at p. 6)
The LCC and PBP analyses are designed to support DOE's consideration of the economic impact of potential standards on consumers of the products subject to the standard, as required by EPCA. (42 U.S.C. 6295(o)(2)(B)(i)(I)) The use of RECS 2009 to develop a consumer sample and to provide data for estimation of product energy use allows DOE to characterize the range of conditions in which covered appliances are operated. As a result, DOE is able to estimate how the energy savings would vary among households for each considered EL. Measurement of energy use in a controlled test procedure situation has a different purpose, which is to provide accurate and comparable measures of energy efficiency for particular covered products.
Inputs to the calculation of total installed cost include the cost of the product—which includes MPCs, manufacturer markups, retailer and distributor markups, and sales taxes—and installation costs. Inputs to the calculation of operating expenses include annual energy consumption, energy prices and price projections, repair and maintenance costs, product lifetimes, and discount rates. DOE created distributions of values for product lifetime, discount rates, and sales taxes, with probabilities attached to each value, to account for their uncertainty and variability.
The computer model DOE uses to calculate the LCC and PBP, which incorporates Crystal Ball
DOE calculated the LCC and PBP for all customers as if each were to purchase a new product in the expected year of compliance with amended standards. The amended standards would apply to residential dehumidifiers manufactured 3 years after the date on which the amended standards for residential dehumidifiers are published. At this time, DOE estimates publication of a final rule in 2016. Therefore, for purposes of its analysis, DOE used 2019 as the first year of compliance with any amended standards.
Table IV.17 summarizes the approach and data DOE used to derive inputs to the LCC and PBP calculations. The subsections that follow provide further discussion. Details of the spreadsheet model, and of all the inputs to the LCC and PBP analyses, are contained in chapter 8 of the NOPR TSD and its appendices.
To calculate consumer product costs, DOE multiplied the MPCs developed in the engineering analysis by the markups described above (along with sales taxes). DOE used different markups for baseline products and higher-efficiency products, because DOE applies an incremental markup to the increase in MSP associated with higher-efficiency products.
In the preliminary analysis, DOE projected future dehumidifier prices using a trend based on the appropriate Producer Price Index (PPI) series. AHAM submitted a comment on the preliminary analysis opposing the use of experience curves to project future product prices. (AHAM, No. 22 at pp. 6-7)
There is extensive literature supporting the use of experience curves (also known as learning curves) for a broad range of products. The approach that DOE has used in some rulemakings to derive an experience rate (defined as the fractional reduction in price expected from each doubling of cumulative production) is consistent with the methods used in numerous studies.
Installation cost includes labor, overhead, and any miscellaneous materials and parts needed to install the product. DOE used data from the 2013 RSMeans Residential Cost Data book to estimate the baseline installation cost for whole-home dehumidifiers. DOE found no evidence that installation costs would be impacted with increased efficiency levels.
For each sampled household, DOE determined the energy consumption for a residential dehumidifier at different efficiency levels using the approach described above in section IV.E of this notice.
DOE derived average annual residential electricity prices for 27 geographic regions using data from EIA's Form EIA-861 database.
To estimate energy prices in future years, DOE multiplied the average regional energy prices by the forecast of annual change in national-average residential energy price in the reference case from
Repair costs are associated with repairing or replacing product components that have failed in an appliance; maintenance costs are associated with maintaining the operation of the product. Typically, small incremental increases in product efficiency produce no, or only minor, changes in repair and maintenance costs.
During the 2013 preliminary analysis phase of the rulemaking, DOE requested information as to whether maintenance and repair costs are a function of efficiency level and product class. Manufacturers responded that these costs would not increase with efficiency. As a result, DOE assumed that repair and maintenance costs do not scale with the efficiency of residential dehumidifiers.
For portable dehumidifiers, DOE used lifetime estimates from the previous
In the calculation of LCC, DOE applies discount rates appropriate to households to estimate the present value of future operating costs. DOE estimated a distribution of residential discount rates for dehumidifiers based on consumer financing costs and opportunity cost of funds related to appliance energy cost savings and maintenance costs.
To establish residential discount rates for the LCC analysis, DOE identified all relevant household debt or asset classes in order to approximate a consumer's opportunity cost of funds related to appliance energy cost savings and maintenance costs. DOE then estimated the average percentage shares of the various types of debt and equity by household income group using data from the Federal Reserve Board's Survey of Consumer Finances (SCF) for 1995, 1998, 2001, 2004, 2007, and 2010.
To accurately estimate the share of consumers that would be affected by a standard at a particular efficiency level, DOE's LCC analysis considered the projected distribution of product efficiencies in the base case (
To estimate the efficiency distribution of standard residential dehumidifiers for 2014, DOE analyzed its Compliance Certification Database for residential dehumidifiers. To project the efficiency trend between 2014 and 2019, DOE used a 0.25 percent annual increase in shipment-weighted efficiency, as discussed in section IV.H. The estimated shares for the base-case efficiency distribution for residential dehumidifiers are shown in Table IV.18. See chapter 8, section 8.2.5 of the NOPR TSD for further information on the derivation of the base-case efficiency distributions.
The PBP is the amount of time it takes the consumer to recover the additional installed cost of more efficient products, compared to baseline products, through energy cost savings. PBPs are expressed in years. PBPs that exceed the life of the product mean that the increased total installed cost is not recovered in reduced operating expenses.
The inputs to the PBP calculation for each EL are the change in total installed cost of the product and the change in the first-year annual operating expenditures relative to the baseline. The PBP calculation uses the same inputs as the LCC analysis, except that discount rates are not needed.
As noted above, EPCA, as amended, establishes a rebuttable presumption that a standard is economically justified if the Secretary finds that the additional cost to the consumer of purchasing a product complying with an energy conservation standard level will be less than three times the value of the first year's energy savings resulting from the standard, as calculated under the applicable test procedure. (42 U.S.C. 6295(o)(2)(B)(iii)) For each considered EL, DOE determined the value of the first year's energy savings by multiplying the energy savings by the average energy price forecast for the year in which compliance with the amended standard would be required. The results of the rebuttable presumption PBP analysis are summarized in section V.B.1.c of this proposed rule.
DOE uses forecasts of annual product shipments to calculate the national impacts of potential amended energy conservation standards on energy use, NPV, and future manufacturer cash flows.
To determine shipments to the replacement market, DOE estimated a stock of dehumidifiers by vintage by integrating historical shipments starting from 1972. Over time, some units are retired and removed from the stock, triggering the shipment of a replacement unit. Depending on the vintage, a certain percentage of each type of unit will fail and need to be replaced. DOE based the retirement function on a probability distribution for the product lifetime that was developed in the LCC analysis. The shipments model assumes that no units are retired below a minimum product lifetime and that all units are retired before exceeding a maximum product lifetime.
To calibrate the estimated shipments with the historical data, DOE introduced into the model a market segment identified as existing households without dehumidifiers, also referred to as first-time owners. Based on the calibration, DOE estimated that 0.35 percent of existing households without a dehumidifier would annually purchase this product over the analysis period, 2019-2048.
Because the incremental cost of products meeting the considered standard levels is very low relative to the operating cost savings (see section V.B.1.a), DOE assumed that shipments would not be affected by the proposed standards. For details on the shipments analysis, see chapter 9 of the NOPR TSD.
AHAM stated that the historical shipments and the projected shipments do not seem to be logically connected—the historical shipments are jagged, going up and down, sometimes dramatically, while the future shipments show a relatively smooth, upward curve. (AHAM, No. 22 at p. 7) DOE used the average trend of historical shipments to forecast shipments for all dehumidifier product classes. The smoothed-line forecast is a product of this approach.
The NIA assesses the NES and the national NPV of total consumer costs and savings that would be expected to result from new or amended standards at specific efficiency levels. DOE calculates the NES and NPV based on projections of annual appliance shipments, along with the annual energy consumption and total installed cost data from the energy use and LCC analyses.
DOE evaluates the impacts of new and amended standards by comparing base-case projections with standards-case projections. The base-case projection characterizes energy use and consumer costs for each product class in the absence of new or amended energy conservation standards. DOE compares these projections with projections characterizing the market for each product class if DOE adopted new or amended standards at specific energy ELs (
DOE uses a spreadsheet model to calculate the energy savings and the national consumer costs and savings from each TSL. Interested parties can review DOE's analyses by changing various input quantities within the spreadsheet. The NIA spreadsheet model uses typical values (as opposed to probability distributions) as inputs.
Table IV.19 summarizes the inputs and methods DOE used for the NIA analysis for the NOPR. Discussion of these inputs and methods follows the table. See chapter 10 of the NOPR TSD for further details.
The NES analysis involves a comparison of national energy consumption of the considered products in each potential standards case (TSL) with consumption in the base case with no new or amended energy conservation standards. DOE calculated the national energy consumption by multiplying the number of units (stock) of each product (by vintage or age) by the unit energy consumption (also by vintage). Vintage represents the age of the product. DOE calculated annual NES based on the difference in national energy consumption for the base case (without amended efficiency standards) and for each higher efficiency standard. DOE estimated energy consumption and savings based on site energy and converted the electricity consumption and savings to primary energy (
In response to the recommendations of a committee on “Point-of-Use and Full-Fuel-Cycle Measurement Approaches to Energy Efficiency Standards,” appointed by the National Academy of Sciences, DOE announced its intention to use FFC measures of energy use and greenhouse gas and other emissions in the NIA and emissions analyses included in future energy conservation standards rulemakings. 76 FR 51281 (Aug. 18, 2011). After evaluating the approaches discussed in the August 18, 2011 notice, DOE published a statement of amended policy in the
A key component of the NIA is the trend in energy efficiency forecasted for the base case (without new or amended standards) and each of the standards cases. Section IV.F.8 of this notice describes how DOE developed a base-case energy efficiency distribution (which yields a shipment-weighted average efficiency) for each of the considered product classes for the first year of the forecast period. To project the trend in efficiency for residential dehumidifiers over the entire forecast period, DOE used a 0.25 percent annual increase based on the rate that was used for room air conditioners in DOE's 2011 rule making.
DOE used a “roll-up” scenario to establish the shipment-weighted efficiency for the year that standards are assumed to become effective (2019). In this scenario, product efficiencies in the base case that do not meet the standard under consideration would “roll up” to meet the new standard level, and the market share of products above the standard would remain unchanged.
To develop standards-case efficiency trends, DOE used an approach that assumes that the rate of adoption of more efficient products under the standards case occurs at a rate that ensures that the average total installed cost difference between the standards case and base case is constant over the entire forecast period. Because the total installed cost versus efficiency relationship for each product class demonstrates an increasing cost rate for more efficient products, the efficiency growth rate for each standards case is lower than the growth rate for the base case. For more information, see chapter 10, section 10.2 of the NOPR TSD.
The inputs for determining the NPV of the total costs and benefits experienced by consumers are: (1) Total annual installed cost, (2) total annual savings in operating costs, and (3) a discount factor to calculate the present value of costs and savings. DOE calculates net savings each year as the difference between the base case and each standards case in total savings in operating costs and total increases in installed costs. DOE calculates operating cost savings over the life of each product shipped during the forecast period.
As discussed in section IV.F.1 of this proposed rule, DOE developed residential dehumidifier price trends based on historical PPI data. Within the portable and whole-house product groups, DOE applied the same trends to forecast prices for each product class at each considered EL. By 2048, which is the end date of the forecast period, the average dehumidifier price is forecasted to drop 37 percent relative to 2013. DOE's projection of product prices for residential dehumidifiers is described in further detail in appendix 10C of the NOPR TSD.
To evaluate the effect of uncertainty regarding the price trend estimates, DOE investigated the impact of different product price forecasts on the consumer NPV for the considered TSLs for residential dehumidifiers. In addition to the default price trend, DOE considered two product price sensitivity cases: (1) A high price decline case based on an exponential fit using PPI data for 1988 to 2013; and (2) a low price decline case based on an experience rate derived using PPI and shipments data for 1991 to 2000. The derivation of these price trends and the results of these sensitivity cases are described in appendix 10C of the NOPR TSD.
The operating cost savings are energy cost savings, which are calculated using the estimated energy savings in each year and the projected price of the appropriate form of energy. To estimate energy prices in future years, DOE multiplied the average regional energy prices by the forecast of annual national-average residential energy price changes in the reference case from
In calculating the NPV, DOE multiplies the net savings in future years by a discount factor to determine their present value. For today's NOPR, DOE estimated the NPV of consumer benefits using both a 3-percent and a 7-percent real discount rate. DOE uses these discount rates in accordance with guidance provided by the Office of Management and Budget (OMB) to Federal agencies on the development of regulatory analysis.
In analyzing the potential impact of new or amended standards on consumers, DOE evaluates the impact on identifiable subgroups of consumers that may be disproportionately affected by a national standard. DOE evaluates impacts on particular subgroups of consumers by analyzing the LCC impacts and PBP for those particular consumers from alternative standard levels. For this NOPR, DOE analyzed the impacts of the considered standard levels on low-income households and senior-only households. Chapter 11 in the NOPR TSD describes the consumer subgroup analysis.
DOE performed an MIA to estimate the impacts of amended energy conservation standards on manufacturers of residential dehumidifiers. The MIA has both quantitative and qualitative aspects and includes analyses of forecasted industry cash flows, the industry net present value (INPV), investments in research and development (R&D) and manufacturing capital, and domestic manufacturing employment. Additionally, the MIA seeks to determine how amended energy conservation standards might affect manufacturing employment, capacity, and competition, as well as how standards contribute to overall regulatory burden. Finally, the MIA serves to identify any disproportionate impacts on manufacturer subgroups, including small business manufacturers.
The quantitative part of the MIA primarily relies on the Government Regulatory Impact Model (GRIM), an industry cash flow model with inputs specific to this rulemaking. The key GRIM inputs include data on the industry cost structure, unit production costs, product shipments, manufacturer markups, and investments in R&D and manufacturing capital required to produce compliant products. The key GRIM outputs are the INPV and the impact to domestic manufacturing employment. The model estimates the impacts of more stringent energy conservation standards on a given industry by comparing changes in INPV and domestic manufacturing employment between the base case and the various TSLs in the standards case. To capture the uncertainty relating to manufacturer pricing strategy following amended standards, the GRIM estimates a range of possible impacts under different markup scenarios.
The qualitative part of the MIA addresses manufacturer characteristics and market trends. Specifically, the MIA considers such factors as manufacturing capacity, competition within the industry, the cumulative impact of other DOE and non-DOE regulations, and impacts on manufacturer subgroups. The complete MIA is outlined in chapter 12, sections 12.1 and 12.2 of the NOPR TSD.
DOE conducted the MIA for this rulemaking in three phases. In Phase 1 of the MIA, DOE prepared a profile of the residential dehumidifier manufacturing industry. This included a top-down analysis of residential dehumidifier manufacturers that DOE used to derive preliminary financial inputs for the GRIM (
In Phase 2 of the MIA, DOE prepared a framework industry cash flow analysis to quantify the impacts of new and amended energy conservation standards. The GRIM uses several factors to determine a series of annual cash flows starting with the announcement of the standard and extending over a 30-year period following the effective date of the standard. These factors include annual expected revenues, costs of sales, SG&A and R&D expenses, taxes, and capital expenditures. In general, energy conservation standards can affect manufacturer cash flow in three distinct ways: (1) Create a need for increased investment; (2) raise production costs per unit; and (3) alter revenue due to higher per-unit prices and changes in sales volumes.
In addition, during Phase 2, DOE developed interview guides to distribute to manufacturers of residential dehumidifiers in order to develop other key GRIM inputs, including product and capital conversion costs, and to gather additional information on the anticipated effects of energy conservation standards on revenues, direct employment, capital assets, industry competitiveness, and subgroup impacts.
In Phase 3 of the MIA, DOE conducted structured, detailed interviews with representative manufacturers. During these interviews, DOE discussed engineering, manufacturing, procurement, and financial topics to validate assumptions used in the GRIM and to identify key issues or concerns. See section IV.J.4 for a description of the key issues raised by manufacturers during the interviews. As part of Phase 3, DOE also evaluated subgroups of manufacturers that may be disproportionately impacted by amended standards or that may not be accurately represented by the average cost assumptions used to develop the industry cash flow analysis. Such manufacturer subgroups may include small business manufacturers, low-volume manufacturers (LVMs), niche players, or manufacturers exhibiting a cost structure that largely differs from the industry average. DOE identified one dehumidifier manufacturer subgroup (small businesses) for which average cost assumptions may not hold.
Based on the size standards published by the Small Business Administration (SBA),
The manufacturer subgroup analysis is discussed in greater detail in chapter 12, section 12.6 of the NOPR TSD and in section V.B.2.d of this proposed rule.
DOE uses the GRIM to quantify the changes in industry cash flows resulting from amended energy conservation standards. The GRIM uses manufacturer costs, markups, shipments, and industry financial information to arrive at a series of base-case annual cash flows absent new or amended standards, beginning with the present year, 2014, and continuing through 2048. The GRIM then models changes in costs, investments, shipments, and manufacturer margins that may result from new or amended energy conservation standards and compares these results against those in the base-case forecast of annual cash flows. The primary quantitative output of the GRIM is the INPV, which DOE calculates by summing the stream of annual discounted cash flows over the full analysis period. For manufacturers of residential dehumidifiers, DOE used a real discount rate of 8.43 percent, the weighted-average cost of capital derived from industry financials and modified based on feedback received during confidential interviews with manufacturers.
The GRIM calculates cash flows using standard accounting principles and compares changes in INPV between the base case and the various TSLs. The difference in INPV between the base case and a standards case represents the financial impact of the amended standard on manufacturers at that particular TSL. As discussed previously, DOE collected the necessary information to develop key GRIM inputs from a number of sources, including publicly available data and interviews with manufacturers (described in the next section). The GRIM results are shown in section V.B.2.a of this notice. Additional details about the GRIM can be found in chapter 12, sections 12.4 and 12.5 of the NOPR TSD.
Manufacturing a higher efficiency product is typically more expensive than manufacturing a baseline product due to the use of more complex and typically more costly components. The changes in the MPCs of the analyzed products can affect the revenues, gross margins, and cash flow of the industry, making product cost data key GRIM inputs for DOE's analysis. For each EL for each product class, DOE used the MPCs developed in the engineering analysis, as described in section IV.C.2 of this proposed rule and further detailed in chapter 5 of the NOPR TSD. Additionally, DOE used information from its teardown analysis, described in section IV.C of this proposed rule, to disaggregate the MPCs into material and labor costs. These cost breakdowns and equipment markups were validated with manufacturers during interviews.
The GRIM estimates manufacturer revenues based on total unit shipment forecasts and the distribution of shipments by efficiency level. Changes in sales volumes and efficiency mix over time can significantly affect manufacturer finances. For this analysis, the GRIM used the NIA's annual shipment forecasts derived from the shipments analysis from 2015 (the base year) to 2048 (the end of the analysis period). See chapter 9 of the NOPR TSD for additional details on the shipments analysis.
For each standards case, the GRIM assumes a small, constant percentage shift in shipments to higher efficiency levels, reflecting the idea that some efficiency improvements will occur independent of amended standards. The GRIM also assumes all remaining shipments of products below the projected minimum standard levels would roll up (
Amended energy conservation standards may cause manufacturers to incur one-time conversion costs to bring their production facilities and product designs into compliance with the new standards. For the purpose of the MIA, DOE classified these one-time conversion costs into two major groups: (1) Product conversion costs and (2) capital conversion costs. Product conversion costs are one-time investments in research, development, testing, and marketing, focused on making product designs comply with the new energy conservation standard. Capital conversion expenditures are one-time investments in property, plant, and equipment to adapt or change existing production facilities so that new product designs can be fabricated and assembled.
If new or amended energy conservation standards require investment in new manufacturing capital, there also exists the possibility that they will render existing manufacturing capital obsolete. If the obsolete manufacturing capital is not fully depreciated at the time new or amended standards go into effect, these assets would be stranded and the manufacturer would have to write-down the residual value that had not yet been depreciated.
DOE used multiple sources of data to evaluate the level of product and capital conversion costs and stranded assets manufacturers would likely face to comply with amended energy conservation standards. DOE used manufacturer interviews to gather data on the level of investment anticipated at each proposed efficiency level and validated these assumptions using estimates of capital requirements derived from the product teardown analysis and engineering model described in section IV.C of this proposed rule. These estimates were then aggregated and scaled to derive total industry estimates of product and capital conversion costs and to protect confidential information.
In general, DOE assumes that all conversion-related investments occur between the year the final rule is published and the year by which manufacturers must comply with the new or amended standards. The investment figures used in the GRIM can be found in section V.B.2 of this proposed rule. For additional information on the estimated product conversion and capital conversion costs, see chapter 12, sections 12.4.7 and 12.4.8 of the NOPR TSD.
As discussed in section IV.D of this notice, MSPs include direct manufacturing production costs (
Modifying the aforementioned base-case markups in the standards case yields different sets of impacts on manufacturers. For the MIA, DOE modeled two standards-case markup scenarios to represent the uncertainty regarding the potential impacts on prices and profitability for manufacturers following the implementation of amended energy conservation standards: (1) A preservation of gross margin
The preservation of gross margin as a percentage of revenues markup scenario assumes that the baseline markup of 1.45 is maintained for all products in the standards case. Typically, this scenario represents the upper bound of industry profitability as manufacturers are able to fully pass through additional costs due to standards to their customers under this scenario.
The preservation of per-unit operating profits markup scenario is similar to the preservation of gross margin as a percentage of revenues markup scenario with the exception that in the standards case, minimally compliant products lose a fraction of the baseline markup. Typically, this scenario represents the lower bound profitability and a more substantial impact on the industry as manufacturers accept a lower margin in an attempt to offer price competitive entry level products while maintaining the same level of absolute operating profits, on a per-unit basis, that they saw prior to amended standards. Under this scenario, gross margin as a percentage decreases in the standards case.
During the public comment period following the preliminary analysis public meeting, trade associations and small business manufacturers of residential dehumidifiers provided several comments on the potential impact of amended energy conservation standards on manufacturers.
In response to the May 2014 Notice, AHAM suggested that Canada's Energy Efficiency Regulations mandate standards for dehumidifiers that are harmonized with the existing standards in the United States. For other products, AHAM stated that the Canadian standards currently or soon will lag behind the U.S. standards, even though Canada has expressed its desire for harmonization. AHAM believes that this disharmony will result in added burden for manufacturers and confusion to consumers. AHAM encouraged DOE to work closely with Natural Resources Canada (NRCan) as it promulgates revised dehumidifier standards so that NRCan can publish harmonized Canadian standards with the same projected compliance date as in the United States. AHAM stated that it will work with NRCan and DOE to accomplish this goal. (AHAM, No. 22 at pp. 2-3)
Therma-Stor commented that changes to the testing and rating procedures may lead to confusion in the marketplace as the public has become accustomed to the current dehumidifier rating scheme. Therma-Stor also commented that it will be necessary to educate dealers and consumers about a revised rating scheme which substantially changes the capacity and efficiency ratings of each dehumidifier model. As a small manufacturer, Therma-Stor stated that it has limited engineering design, manufacturing, and marketing resources at its disposal. Therma-Stor typically maintains and manufactures a given dehumidifier model design for several years. According to Therma-Stor, a substantial change in the test procedure may require it to re-engineer its current product designs and revise related literature. Due to their small size and limited resources, this re-engineering may require more time for small manufacturers than larger entities with larger resource pools (Therma-Stor, No. 21 at p. 2) and may place a larger burden on small manufacturers.
Therma-Stor also expressed concern about the divergence of rating test procedures between DOE and EPA ENERGY STAR programs. Therma-Stor believes that DOE and EPA should work together to harmonize the rating test procedures to minimize the cost, time, and complexity of compliance for manufacturers. Therma-Stor further requested that if the rating test procedures are significantly revised, a reasonable “grace period” between the publication of the final rule and enforcement of the rule should be provided to allow small manufacturers to make necessary revisions to their products and literature to achieve compliance.
DOE acknowledges that the new test procedure will result in a new rating system that will need to be properly conveyed to consumers via updated sizing recommendations in manufacturer product literature and Web sites. DOE notes that all manufacturers will be subject to the same shift in rating system.
While DOE also acknowledges that the presence of multiple standards and test procedures may place a disproportionate burden on small business manufacturers, DOE notes that EPA typically adopts the most recent
Aprilaire noted that energy conservation standards for whole-home dehumidifier products could negatively impact the development of this segment of the dehumidifier industry. Aprilaire explained that, as the whole-home dehumidifier segment is a relatively new industry, innovative products are being developed to help control whole-home latent conditions with minimal energy use. According to Aprilaire, this is achieved through combinations of application, latent removal techniques, and control methods and algorithms. Aprilaire believes that prematurely placing rules and tests that cannot anticipate some of these product designs and applications could limit the number of products on the market and hinder innovation. (Aprilaire, No. 20 at p. 2)
DOE understands that amended conservation standards will require manufacturers to divert at least a portion of R&D and/or capital expenditure resources to standards compliance in the years leading up to the projected compliance date, effectively taking these resources away from other projects. The effect of these investments on manufacturer cash flows is discussed further in section V.B.2.a of this proposed rule.
Aprilaire also commented that it believes DOE is singling out whole-home dehumidifiers for this rule, and ignoring other products which have functions built into them to obtain whole-home dehumidification, such as air conditioners. According to Aprilaire, separating one product from a larger category places an undue and unfair burden on whole-home dehumidifier manufacturers. Aprilaire referenced EPA document 402-F-13053, saying that EPA recognizes that there are multiple methods of controlling humidity, but the proposed standard only restricts the stand-alone whole-home dehumidification method. (Aprilaire, No. 20 at p. 2)
DOE regulations already cover central air conditioners and room air conditioners, and manufacturers of these products must demonstrate compliance with current energy conservation standards codified in 10 CFR 430.32(c) and (b), respectively.
To inform the MIA, DOE interviewed manufacturers with an estimated combined market share of approximately 70 percent. The information gathered during these interviews enabled DOE to tailor the GRIM to reflect the unique financial characteristics of the residential dehumidifier industry. These confidential interviews provided information that DOE used to evaluate the impacts of amended energy conservation standards on manufacturer cash flows, manufacturing capacities, and employment levels.
During the interviews, DOE asked manufacturers to describe the major issues they anticipate to result from the energy conservation standards proposed in this rulemaking. The following sections describe the most significant issues identified by manufacturers. DOE also includes additional concerns in chapter 12, section 12.3 of the NOPR TSD.
The majority of manufacturers interviewed emphasized concerns over the impact of new test conditions in the DOE dehumidifier test procedure on the rated capacity of their products. One manufacturer noted a 60-percent to 70-percent decrease in capacity and efficiency due to lower ambient temperatures for testing. Some manufacturers fear that a shift in rated capacity resulting from a change in test procedure will lead to confusion in the market, as consumers find it important to have the same apparent capacity in a replacement residential dehumidifier, even if it is simply a larger unit at a lower rating condition. Also, dehumidifiers with smaller capacities cannot reach the same efficiency as higher-capacity units due to limitations of the vapor-compression cycle, because the parasitic losses (
Other manufacturers indicated that as product ratings are modified to reflect the test results at the lower ambient temperature, the whole product classification system will need to be revisited, which will require a substantial investment in consumer education.
Multiple manufacturers interviewed expressed concerns that an amended energy conservation standard for residential dehumidifiers would have an adverse impact on price, noise level, and size, and would thus compromise consumer utility. Manufacturers are concerned that residential dehumidifiers would need to become physically larger to deliver the same moisture removal capacity to comply with new amended testing and energy conservation standards. For customers with space constraints, finding a product that best fits their needs may be more difficult under an amended standard. For example, some whole-home dehumidifiers must fit into a small attic or crawl space. If amended energy conservation standards for whole-home products cannot be met within the size constraints associated with this type of installation, part of the whole-home market segment may move to portable products, reducing consumer utility by forcing the unit into the living space. Additionally, larger portable dehumidifiers are already cumbersome to move around, making them close to the limit of what is considered portable. As such, consumers may be forced to purchase a lower-capacity dehumidifier or alternative product.
During interviews, many manufacturers stated that an industry-wide price increase of 25 percent would have major negative impacts on the portable dehumidifier market. Manufacturers went on to note that a price increase of 50 percent or more would cause the market to collapse entirely. A whole-home dehumidifier manufacturer stated that a 10-percent cost increase would have a significant impact on the whole-home market because any increases in manufacturer production costs are magnified due to the two-tiered distribution channel that is characteristic of the whole-home market (
One small manufacturer noted that it and its competitors in the whole-home segment would be disproportionately impacted by an amended energy conservation standard. Small business manufacturers have fewer human and capital resources than larger, more diversified portable unit manufacturers. Additionally, due to the low-volume nature of the residential whole-home dehumidifier market, small business manufacturers of whole-home products are disadvantaged in achieving the scale needed to exert purchasing power in sourcing components from vendors. One small business manufacturer noted that its lack of influence on suppliers ultimately impacts its ability to compete with larger manufacturers.
The emissions analysis consists of two components. The first component estimates the effect of potential energy conservation standards on power sector and site (where applicable) combustion emissions of CO
The analysis of power sector emissions uses marginal emissions factors calculated using a methodology based on results published for the
Combustion emissions of CH
The emissions intensity factors are expressed in terms of physical units per MWh or MMBtu of site energy savings. Total emissions reductions are estimated using the energy savings calculated in the national impact analysis.
For CH
The
SO
Because
The attainment of emissions caps is typically flexible among EGUs and is enforced through the use of emissions allowances and tradable permits. Under existing EPA regulations, any excess SO
Beginning in 2016, however, SO
CAIR established a cap on NO
The MATS limit mercury emissions from power plants, but they do not include emissions caps and, as such, DOE's energy conservation standards would likely reduce Hg emissions. DOE estimated mercury emissions reduction using emissions factors based on
As part of the development of this proposed rule, DOE considered the estimated monetary benefits from the reduced emissions of CO
The SCC is an estimate of the monetized damages associated with an incremental increase in carbon emissions in a given year. It is intended to include (but is not limited to) climate-change-related changes in net agricultural productivity, human health, property damages from increased flood risk, and the value of ecosystem services. Estimates of the SCC are provided in dollars per metric ton of CO
Under section 1(b)(6) of Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 5, 1993), agencies must, to the extent permitted by law, “assess both the costs and the benefits of the intended regulation and, recognizing that some costs and benefits are difficult to quantify, propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs.” The purpose of the SCC estimates presented here is to allow agencies to incorporate the monetized social benefits of reducing CO
As part of the interagency process that developed these SCC estimates, technical experts from numerous agencies met on a regular basis to consider public comments, explore the technical literature in relevant fields, and discuss key model inputs and assumptions. The main objective of this process was to develop a range of SCC values using a defensible set of input assumptions grounded in the existing scientific and economic literatures. In this way, key uncertainties and model differences transparently and consistently inform the range of SCC estimates used in the rulemaking process.
When attempting to assess the incremental economic impacts of CO
Despite the limits of both quantification and monetization, SCC estimates can be useful in estimating the social benefits of reducing CO
It is important to emphasize that the interagency process is committed to updating these estimates as the science and economic understanding of climate change and its impacts on society improves over time. In the meantime, the interagency group will continue to explore the issues raised by this analysis and consider public comments as part of the ongoing interagency process.
In 2009, an interagency process was initiated to offer a preliminary assessment of how best to quantify the benefits from reducing carbon dioxide emissions. To ensure consistency in how benefits are evaluated across Federal agencies, the Administration sought to develop a transparent and defensible method, specifically designed for the rulemaking process, to quantify avoided climate change damages from reduced CO
After the release of the interim values, the interagency group reconvened on a regular basis to generate improved SCC estimates. Specially, the group considered public comments and further explored the technical literature in relevant fields. The interagency group relied on three integrated assessment models commonly used to estimate the SCC: The FUND, DICE, and PAGE models. These models are frequently cited in the peer-reviewed literature and were used in the last assessment of the Intergovernmental Panel on Climate Change (IPCC). Each model was given equal weight in the SCC values that were developed.
Each model takes a slightly different approach to model how changes in emissions result in changes in economic damages. A key objective of the interagency process was to enable a consistent exploration of the three models, while respecting the different approaches to quantifying damages taken by the key modelers in the field. An extensive review of the literature was conducted to select three sets of input parameters for these models: Climate sensitivity, socio-economic and emissions trajectories, and discount rates. A probability distribution for climate sensitivity was specified as an input into all three models. In addition, the interagency group used a range of scenarios for the socio-economic parameters and a range of values for the discount rate. All other model features were left unchanged, relying on the model developers' best estimates and judgments.
The interagency group selected four sets of SCC values for use in regulatory analyses. Three sets of values are based on the average SCC from the three integrated assessment models, at discount rates of 2.5, 3, and 5 percent. The fourth set, which represents the 95th percentile SCC estimate across all three models at a 3-percent discount rate, was included to represent higher-than-expected impacts from temperature change further out in the tails of the SCC distribution. The values grow in real terms over time. Additionally, the interagency group determined that a range of values from 7 percent to 23 percent should be used to adjust the global SCC to calculate domestic effects,
The SCC values used for today's notice were generated using the most recent versions of the three integrated assessment models that have been published in the peer-reviewed literature.
Table IV.22 shows the updated sets of SCC estimates in 5-year increments from 2010 to 2050. The full set of annual SCC estimates between 2010 and 2050 is reported in appendix 14B of the NOPR TSD. The central value that emerges is the average SCC across models at the 3-percent discount rate. However, for purposes of capturing the uncertainties involved in regulatory impact analysis, the interagency group emphasizes the importance of including all four sets of SCC values.
It is important to recognize that a number of key uncertainties remain, and that current SCC estimates should be treated as provisional and revisable because they will evolve with improved scientific and economic understanding. The interagency group also recognizes that the existing models are imperfect and incomplete. The National Research Council report mentioned above points out that there is tension between the goal of producing quantified estimates of the economic damages from an incremental ton of carbon and the limits of existing efforts to model these effects. There are a number of analytical challenges that are being addressed by the research community, including research programs housed in many of the Federal agencies participating in the interagency process to estimate the SCC. The interagency group intends to periodically review and reconsider those estimates to reflect increasing knowledge of the science and economics of climate impacts, as well as improvements in modeling.
In summary, in considering the potential global benefits resulting from reduced CO
DOE multiplied the CO
As noted above, DOE has taken into account how amended energy conservation standards would reduce site NO
DOE is evaluating appropriate monetization of avoided SO
AHAM continues to believe that monetization of avoided CO
In response, DOE notes that EPCA directs DOE to consider the total projected amount of energy, or as applicable, water, savings likely to result directly from the imposition of the standard when determining whether a standard is economically justified. (42 U.S.C. 6295(o)(2)(B)(i)(III)) DOE interprets this to include energy used in the generation, transmission, and distribution of fuels used by appliances or equipment. In addition, DOE is using the FFC measure, which includes the energy consumed in extracting, processing, and transporting primary fuels. DOE's current accounting of primary energy savings and the FFC measure are directly linked to the energy used by appliances or equipment. DOE believes that energy used in manufacturing or transporting appliances or equipment falls outside the boundaries of “directly” as intended by EPCA. Thus, DOE did not consider such energy use and air emissions in the NIA or in the emissions analysis. DOE's analysis does account for impacts on CO
AHAM stated that DOE should wait for comments on the 2013 interagency report to be resolved before it relies on the 2013 estimates, and, until that time DOE should rely on the 2010 estimates as it has done in rulemakings prior to May 2013. (AHAM, No. 22 at p. 7)
The 2013 report provides an update of the SCC estimates based solely on the latest peer-reviewed version of the models, replacing model versions that were developed up to ten years ago in
The utility impact analysis estimates several effects on the power generation industry that would result from the adoption of new or amended energy conservation standards. In the utility impact analysis, DOE analyzes the changes in installed electrical capacity and generation that would result for each TSL. The analysis is based on published output from the NEMS associated with
DOE considers employment impacts in the domestic economy as one factor in selecting a proposed standard. Employment impacts include both direct and indirect impacts. Direct employment impacts are any changes in the number of employees of manufacturers of the products subject to standards, their suppliers, and related service firms. The MIA addresses those impacts. Indirect employment impacts from standards consist of the net jobs created or eliminated in the national economy, other than in the manufacturing sector being regulated, caused by: (1) Reduced spending by end users on energy; (2) reduced spending on new energy supply by the utility industry; (3) increased consumer spending on new products to which the new standards apply; and (4) the effects of those three factors throughout the economy.
One method for assessing the possible effects on the demand for labor of such shifts in economic activity is to compare sector employment statistics developed by the Labor Department's Bureau of Labor Statistics (BLS).
For the standard levels considered in today's NOPR, DOE estimated indirect national employment impacts using an input/output model of the U.S. economy called Impact of Sector Energy Technologies, Version 3.1.1 (ImSET).
DOE notes that ImSET is not a general equilibrium forecasting model, and understands the uncertainties involved in projecting employment impacts, especially changes in the later years of the analysis. Because ImSET does not incorporate price changes, the employment effects predicted by ImSET may over-estimate actual job impacts over the long run for this rule. Because ImSET predicts small job impacts resulting from this rule, regardless of these uncertainties, the actual job impacts are likely to be negligible in the overall economy. For more details on the employment impact analysis, see chapter 16 of the NOPR TSD.
The following section addresses the results from DOE's analyses with respect to potential energy conservation standards for residential dehumidifiers. It addresses the TSLs examined by DOE and the projected impacts of each of these levels if adopted as energy conservation standards for residential dehumidifiers. Additional details regarding DOE's analyses are contained in the NOPR TSD supporting this notice.
DOE analyzed the benefits and burdens of four TSLs for residential dehumidifiers. These TSLs were developed by combining specific ELs for each of the five product classes analyzed by DOE. DOE presents the results for the TSLs in this document, while the results for all ELs that DOE analyzed are in the NOPR TSD. Table V.1 presents the TSLs and the corresponding efficiency levels for residential dehumidifiers. TSL 4 represents the max-tech energy efficiency for all product classes. TSL 3 consists of the ELs below the max-tech level. TSL 2 consists of the gap-fill ELs below TSL 3 and above the baseline and EL 1 for product classes 1 and 2, while product class 3 through product class 5 repeat the same efficiency level as TSL 3. TSL 1 consists of the first EL above the baseline.
DOE analyzed the economic impacts on residential dehumidifier consumers by looking at the effects potential amended standards would have on the LCC and PBP. DOE also examined the impacts of potential standards on consumer subgroups. These analyses are discussed below.
In general, higher-efficiency products would affect consumers in two ways: (1) Purchase prices would increase, and (2) annual operating costs would decrease. Inputs used for calculating the LCC and PBP include total installed costs (
Table V.2 through Table V.11 show the LCC and PBP results for the ELs considered for each residential dehumidifier product class. In the first of each pair of tables, the simple payback period is measured relative to the baseline product. In the second table, the LCC savings are measured relative to the average LCC in the base case, which represents what consumers would purchase in the absence of amended standards (see section IV.F.8 of this proposed rule). Because some consumers purchase products with higher ELs in the base case, the average savings are less than the difference between the average LCC of EL 0 and the average LCC at each TSL.
As described in section IV.I of this proposed rule, DOE estimated the impact of the considered TSLs on low-income households and senior-only households.
As discussed above, EPCA provides a rebuttable presumption that an energy conservation standard is economically justified if the increased purchase cost for a product that meets the standard is less than three times the value of the first-year energy savings resulting from the standard. In calculating a rebuttable presumption PBP for the considered standard levels, DOE used discrete values and, as required by EPCA, based
Table V.17 presents the rebuttable-presumption PBPs for the considered TSLs.
DOE performed an MIA to estimate the impact of amended energy conservation standards on manufacturers of residential dehumidifiers. The section below describes the expected impacts on manufacturers at each TSL. Chapter 12 of the NOPR TSD explains the analysis in further detail.
The following tables illustrate the financial impacts (represented by changes in INPV) of amended energy conservation standards on manufacturers of residential dehumidifiers as well as the conversion costs that DOE estimates manufacturers would incur for all product classes at each TSL. To evaluate the range of cash-flow impacts on the residential dehumidifier manufacturing industry, DOE used two different markup scenarios to model the range of anticipated market responses to amended energy conservation standards.
To assess the lower (less severe) end of the range of potential impacts, DOE modeled a preservation of gross margin percentage markup scenario, in which a flat markup of 1.45 (
To assess the higher (more severe) end of the range of potential impacts, DOE modeled the preservation of per-unit operating profit markup scenario, which assumes that manufacturers would not be able to preserve the same overall gross margin, but instead would cut their markup for minimally compliant products to maintain a cost competitive product offering while maintaining the same overall level of operating profit in absolute dollars as in the base case. The two tables below show the range of potential INPV impacts for manufacturers of residential dehumidifiers. Table V.18 reflects the lower bound of impacts (higher profitability) and Table V.19 represents the upper bound of impacts (lower profitability).
Each scenario results in a unique set of cash flows and corresponding industry values at each TSL. In the following discussion, the INPV results refer to the sum of discounted cash flows through 2048, the difference in INPV between the base case and each standards case, and the total industry conversion costs required for each standards case.
Beyond impacts on INPV, DOE includes a comparison of free cash flow between the base case and the standards case at each TSL in the year before amended standards take effect to provide perspective on the short-run cash flow impacts in the discussion of the results below.
At TSL 1, DOE estimates the impact on INPV for manufacturers of residential dehumidifiers to range from -$2.5 million to -$3.0 million, or a decrease in INPV of 1.4 percent to 1.6 percent under the preservation of gross margin percentage markup scenario and the preservation of per-unit operating profit markup scenario, respectively. At this TSL, industry free cash flow is estimated to decrease by approximately 11.2 percent to $14.1 million, compared to the base-case value of $15.8 million in 2018, the year before the projected compliance date.
At TSL 1, the industry as a whole is expected to incur $3.9 million in product conversion costs attributed to upfront research, development, testing, and certification; as well as $1.3 million in one-time investments in property, plant and equipment (PP&E) necessary to manufacture redesigned platforms. The majority of industry conversion cost burden at TSL 1 would be felt by manufacturers of high-capacity portable and whole-home dehumidifiers, as more of these products are currently at the baseline than is the case for lower-capacity portable products. These baseline products may necessitate complete platform redesigns, which involve moving to a new case size to accommodate larger heat exchangers. These changes require upfront capital investments for new tooling to manufacturing production lines, among other changes. Additionally, it is assumed that manufacturers of high-capacity portable and whole-home dehumidifiers, the majority of which are small business manufacturers, will have to outsource testing of their products to third-party testing facilities, contributing to greater product conversion costs. In contrast, the large manufacturers of small portable dehumidifiers are assumed to have in-house testing capabilities which significantly reduce the cost of testing. DOE confirmed these assumptions regarding testing burdens during manufacturer interviews.
At TSL 2, DOE estimates the impact on INPV for manufacturers of residential dehumidifiers to range from −$3.1 million to −$4.4 million, or a decrease in INPV of 1.6 percent to 2.4 percent under the preservation of gross margin percentage markup scenario and the preservation of per-unit operating profit markup scenario, respectively. At this TSL, industry free cash flow is estimated to decrease by approximately 14.4 percent to $13.6 million, compared to the base-case value of $15.8 million in 2018, the year before the projected compliance date.
At TSL 2, the industry as a whole is expected to incur $5.1 million in product conversion costs associated with the upfront research, development, testing, and certification; as well as $1.7 million in one-time investments in PP&E to manufacturer products requiring platform redesigns. Similar to TSL 1, the majority of industry conversion cost burden at TSL 2 will be felt by manufacturers of high-capacity portable and whole-home dehumidifiers, as more products of these types are at the baseline than is the case for lower-capacity portable products, and will require complete
At TSL 3, DOE estimates the impact on INPV for manufacturers of residential dehumidifiers to range from −$31.3 million to −$34.9 million, or a decrease in INPV of 16.8 percent to 18.7 percent under the preservation of gross margin percentage markup scenario and the preservation of per-unit operating profit markup scenario, respectively. At this TSL, industry free cash flow is estimated to decrease by approximately 116.1 percent to −$2.5 million, compared to the base-case value of $15.8 million in 2018, the year before the projected compliance date.
At TSL 3, the industry as a whole is expected to spend $30.2 million in product conversion costs associated with the research and development and testing and certification, as well as $20.5 million in one-time investments in PP&E to manufacture redesigned platforms. While conversion costs remain relatively constant for manufacturers of high-capacity portable and whole-home dehumidifiers between TSLs 1, 2 and 3, the conversion costs for manufacturers of lower-capacity portable products increase substantially at TSL 3, as a greater portion of these products will require total platform redesigns. As with the high-capacity portable and whole-home dehumidifier market segment, platform redesigns for lower-capacity portable units will consist of moving products to a new case size to accommodate larger heat exchangers, and in turn will require capital investments in new tooling for larger cases. This upfront investment is in addition to higher R&D and testing expenditures. Because lower-capacity portable units represent approximately 97 percent of the market, conversion costs associated with this segment have a significant impact on total industry conversion costs for TSL 3.
At TSL 4, DOE estimates the impact on INPV for manufacturers of residential dehumidifiers to range from −$40.2 million to −$59.7 million, or a decrease in INPV of 21.6 percent to 32.0 percent under the preservation of gross margin percentage markup scenario and the preservation of per-unit operating profit markup scenario, respectively. At this TSL, industry free cash flow is estimated to decrease by approximately 186.4 percent to -$13.7 million, compared to the base-case value of $15.8 million in 2018, the year before the projected compliance date.
At TSL 4, the industry as a whole is expected to spend $48.1 million in product conversion costs associated with the research and development and testing and certification, as well as $33.1 million in one-time investments in PP&E for platform redesigns. Again, conversion costs remain relatively constant for manufacturers of high-capacity portable and whole-home dehumidifiers across TSLs 1, 2, 3, and 4. In contrast, the conversion cost burden for manufacturers of lower-capacity portable products increases substantially at TSL 4, as an increasingly larger portion of smaller portable products will require platform redesigns. Again, since lower-capacity portable units represent approximately 97 percent of the market, conversion costs associated with this segment have a significant impact on total industry conversion costs for TSL 4.
DOE used the GRIM to estimate the domestic labor expenditures and number of domestic production workers in the base case and at each TSL from 2015 to 2048. DOE used statistical data from the U.S Census Bureau's 2011
DOE notes that the MIA assessment of impacts on manufacturing employment focuses specifically on the production workers manufacturing the covered products in question, rather than a manufacturer's broader operations. Thus, the estimated number of impacted employees in the MIA is separate and distinct from the total number of employees used to determine whether a manufacturer is a small business for purposes of analysis under the Regulatory Flexibility Act.
The estimates of production workers in this section only cover those up to and including the line-supervisor level that are directly involved in fabricating and assembling a product within the OEM facility. In addition, workers that perform services that are closely associated with production operations are included. Employees above the working-supervisor level are excluded from the count of production workers. Thus, the labor associated with non-production functions (
In the GRIM, DOE used the labor content of each product and the manufacturing production costs from the engineering analysis to estimate the annual labor expenditures in the residential dehumidifier manufacturing industry. DOE used information gained through interviews with manufacturers to estimate the portion of the total labor expenditures that can be attributed to domestic production labor.
The employment impacts shown in Table V.20 represent the potential production employment that could result following amended energy conservation standards. These are independent of the employment impacts from the broader U.S. economy, which are documented in chapter 16 of the NOPR TSD.
DOE estimates that in the absence of amended energy conservation standards, there would be 214 domestic production workers for all manufacturers involved in manufacturing residential dehumidifiers in 2019. Using the 2011
Because production employment expenditures are assumed to be a fixed percentage of cost of goods sold and the MPCs typically increase with more efficient products, labor tracks the increased prices in the GRIM. As efficiency of dehumidifiers increases, so does the complexity of the products, generally requiring more labor to produce the product. However, because only 3 percent of residential dehumidifier manufacturing takes place domestically, employment impacts are expected to be minimal. DOE expects that there would be minimal employment impacts among domestic residential dehumidifier manufacturers for TSLs 1, 2, and 3. For TSL 4, the GRIM predicts a 21.9 percent increase in total domestic production employment following amended standards based on the increase in complexity and relative price of the high-capacity portable and whole-home dehumidifier segment.
During manufacturer interviews, some small businesses stated that, contrary to the above findings, domestic production and non-production employment in the industry may decrease as a result of amended standards for residential dehumidifiers, due to reduced shipments volumes and/or reduced margins.
Similarly, the above analysis does not account for the possible relocation of domestic jobs to lower-labor-cost countries because the potential relocation of U.S. jobs is uncertain and highly speculative. As mentioned above, the vast majority of residential dehumidifiers sold in the United States are manufactured abroad. However, almost all of the high-capacity portable and whole-home dehumidifiers are manufactured domestically. Feedback from manufacturers during NOPR interviews reveals that some domestic small businesses in the residential dehumidifier industry may be forced to make employment cuts or to shift production to new locations, including locations outside of the United States, as a result of amended energy conservation standards.
As noted previously, the majority of residential dehumidifiers sold in the United States are not produced domestically. However, feedback from domestic manufacturers of high-capacity portable products and whole-home dehumidifiers suggested that production of these products could shift abroad as a result of amended energy conservation standards. This could lead to a permanently lower production capacity within the residential dehumidifier industry.
Using average cost assumptions to develop an industry cash flow estimate is not adequate for assessing differential impacts among subgroups of manufacturers. Small manufacturers, niche players, or manufacturers exhibiting a cost structure that differs significantly from the industry average could be affected differently. DOE used the results of the industry characterization to group manufacturers exhibiting similar characteristics.
As previously mentioned, DOE identified five domestic small business manufacturers that may be disproportionately affected by the proposed energy conservation standards for residential dehumidifiers. These manufacturers are focused on one specific market segment (high-capacity portable and whole-home dehumidifiers) and, in terms of annual revenue, are at least one order of magnitude smaller than their diversified competitors (tens of millions compared to hundreds of millions). Due to this combination of market concentration and size, these small businesses are at risk of high, disproportionate impacts, depending on the TSL chosen.
DOE received feedback from small business manufacturers and OEM contractors through public comments and confidential interviews (see sections IV.J.3 and IV.J.4 of this proposed rule for a discussion of public comments and feedback received from dehumidifier manufacturers during the NOPR phase). These manufacturers expressed a high degree of concern relating to the magnitude of burdens and the disproportionate impacts that they believe will result from amended energy conservation standards for residential dehumidifiers.
Today's standards for residential dehumidifiers could cause small manufacturers to be at a disadvantage relative to large manufacturers. One way in which small manufacturers could be at a disadvantage is that they may be disproportionately affected by product and capital conversion costs. Product redesign, testing, and certification costs tend to be fixed per basic model and do not scale with sales volume. For each model, small businesses must make investments in research and development to redesign their products, but because they have lower sales volumes, they must spread these costs across fewer units. In addition, because small manufacturers have fewer engineers than large manufacturers, they need to allocate a greater portion of their available resources to meet a standard. Because engineers may need to spend more time redesigning and testing existing models as a result of the new standard, they may have less time to develop new products. Similarly, upfront capital investments in new manufacturing capital for platform redesigns, as well as depreciated manufacturing capital, can only be spread across a lower volume of shipments.
Furthermore, smaller manufacturers may lack the purchasing power of larger manufacturers. For example, since fan motor suppliers give discounts to manufacturers based on the number of motors they purchase, larger manufacturers may have a pricing advantage because they have higher volume purchases. This purchasing power differential between small and large manufacturers applies to other residential dehumidifier components as well, including compressors and heat exchangers. Some larger manufacturers of lower-capacity portable dehumidifiers may even manufacture
To access the capital required to cover the conversion costs associated with reaching the proposed standards, small business manufacturers would likely be forced to take on additional debt, whereas larger manufacturers of small portable products would be better equipped to fund purchases with existing cash flow from operations.
In terms of impacts to small business manufacturers associated with the specific TSLs outlined in this notice, as discussed in section V.B.2.d, disproportionate impacts will be greatest at TSLs 1 and 2, where relatively more high-capacity portable and home-whole dehumidifiers are at or below the baseline than is the case for the lower-capacity portable products. Additionally, it is assumed that small business manufacturers will be required to outsource the testing of their products to third-party testing facilities. In contrast, the large manufacturers of small portable dehumidifiers are assumed to have in-house testing capabilities, which significantly reduce the cost of testing. While the magnitude of the conversion cost burden increases slightly for small business manufacturers at TSLs 3 and 4, disproportionate impacts decrease substantially, as relatively more lower-capacity portable product platforms will require substantial redesign. Between TSLs 3 and 4, TSL 3 minimizes standards compliance burdens for small business manufacturers relative to the burdens of high-volume portable dehumidifier manufacturers.
Further detail and separate analysis of impacts on small business high-capacity portable and whole-home dehumidifier manufacturers are found in chapter 12, section 12.6 of the NOPR TSD, as well as in sections IV.J.3, IV.J.4, and V.B.2.d of this notice.
One aspect of assessing manufacturer burden is the cumulative impact of multiple DOE standards and the regulatory actions of other Federal agencies and States that affect the manufacturers of a covered product or equipment. While any one regulation may not impose a significant burden on manufacturers, the combined effects of several existing or impending regulations may have serious consequences for some manufacturers, groups of manufacturers, or an entire industry.
Companies that produce a wider range of regulated products may be faced with more capital and product development expenditures than their competitors. This can prompt those companies to exit the market or reduce their product offerings, potentially reducing competition. Smaller companies can be especially affected, since they have lower sales volumes over which to amortize the costs of compliance with new regulations.
In addition to DOE's energy conservation regulations for residential dehumidifiers, several other existing and pending regulations apply to these products and other equipment produced by the same manufacturers. The most significant of these additional regulations include several additional Federal energy conservation standards, and third-party certification programs (
To estimate the energy savings attributable to potential standards for residential dehumidifiers, DOE compared the energy consumption of those products under the base case to their anticipated energy consumption under each TSL. Table V.21 presents DOE's projections of the national energy savings for each TSL considered for residential dehumidifiers shipped in the 2019-2048 period. The savings were calculated using the approach described in section IV.H.1 of this notice.
OMB Circular A-4
DOE estimated the cumulative NPV of the total costs and savings for consumers that would result from the standard levels considered for residential dehumidifiers. In accordance with the OMB's guidelines on regulatory
Table V.23 shows the consumer NPV results for each TSL DOE considered for residential dehumidifiers. The impacts are counted over the lifetime of products purchased in 2019-2048.
The NPV results based on the aforementioned 9-year analytical period are presented in Table V.24. The impacts are counted over the lifetime of products purchased in 2019-2027. As mentioned previously, such results are presented for informational purposes only and are not indicative of any change in DOE's analytical methodology or decision criteria.
The above results reflect the use of a default trend to estimate the change in price for residential dehumidifiers over the analysis period (see section IV.F.1 of this notice). DOE also conducted a sensitivity analysis that considered one scenario with a lower rate of price decline than the reference case and one scenario with a higher rate of price decline than the reference case. The results of these alternative cases are presented in appendix 10C of the NOPR TSD. In the high price decline case, the NPV of consumer benefits is higher than in the default case. In the low price decline case, the NPV of consumer benefits is lower than in the default case.
As discussed above, DOE expects energy conservation standards for residential dehumidifiers to reduce energy bills for consumers of those products, and the resulting net savings to be redirected to other forms of economic activity. These expected shifts in spending and economic activity could affect the demand for labor. As described in section IV.N of this notice, DOE used an input/output model of the U.S. economy to estimate indirect employment impacts of the TSLs that DOE considered in this rulemaking. DOE understands that there are uncertainties involved in projecting employment impacts, especially changes in the later years of the analysis. Therefore, DOE generated results for near-term timeframe, where these uncertainties are reduced.
The results suggest that today's standards are likely to have negligible impact on the net demand for labor in the economy. The net change in jobs is so small that it would be imperceptible in national labor statistics and might be offset by other, unanticipated effects on employment. Chapter 16 of the NOPR TSD presents detailed results.
Based on testing conducted in support of this proposed rule, discussed in section IV.C.1.b of this notice, DOE has concluded that the TSL proposed in this NOPR would not reduce the utility or performance of the residential dehumidifiers under consideration in this rulemaking. Manufacturers of these products currently offer units that meet or exceed today's standards.
As discussed in section III.E.e, the Attorney General determines the impact, if any, of any lessening of competition likely to result from a proposed standard, and transmits such determination to DOE, together with an analysis of the nature and extent of such impact. (42 U.S.C. 6295(o)(2)(B)(i)(V) and (B)(ii))
DOE will transmit a copy of this NOPR and the accompanying NOPR TSD to the Attorney General, requesting that the DOJ provide its determination on this issue. DOE will consider DOJ's comments on the proposed rule in determining whether to proceed with the proposed energy conservation standards. DOE will also publish and respond to DOJ's comments in the
Enhanced energy efficiency, where economically justified, improves the nation's energy security, strengthens the economy, and reduces the environmental impacts or costs of energy production. Reduced electricity demand due to energy conservation standards is also likely to reduce the cost of maintaining the reliability of the electricity system, particularly during peak-load periods. As a measure of this reduced demand, chapter 15, section 15.3 in the NOPR TSD presents the estimated reduction in generating capacity for the TSLs that DOE considered in this rulemaking.
Energy savings from amended standards for residential dehumidifiers could also produce environmental benefits in the form of reduced emissions of air pollutants and greenhouse gases associated with electricity production. Table V.25 provides DOE's estimate of cumulative emissions reductions to result from the TSLs considered in this rulemaking. DOE reports annual CO
As part of the analysis for this proposed rule, DOE estimated monetary benefits likely to result from the reduced emissions of CO
Table V.26 presents the global value of CO
DOE is well aware that scientific and economic knowledge about the contribution of CO
DOE also estimated the cumulative monetary value of the economic benefits associated with NO
The NPV of the monetized benefits associated with emissions reductions can be viewed as a complement to the NPV of the customer savings calculated for each TSL considered in this rulemaking. Table V.28 presents the NPV values that result from adding the estimates of the potential economic benefits resulting from reduced CO
Although adding the value of customer savings to the values of projected emission reductions provides a valuable perspective, two issues should be considered. First, the national operating cost savings are domestic U.S. customer monetary savings that occur as a result of market transactions, while the value of CO
The Secretary of Energy, in determining whether a standard is economically justified, may consider any other factors that the Secretary deems to be relevant. (42 U.S.C. 6295(o)(2)(B)(i)(VII)) DOE did not consider any other factors for this NOPR.
When considering proposed standards, the new or amended energy conservation standard that DOE adopts for any type (or class) of covered product must be designed to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) In determining whether a standard is economically justified, the Secretary must determine whether the benefits of the standard exceed its burdens, considering to the greatest extent practicable the seven statutory factors discussed previously. (42 U.S.C. 6295(o)(2)(B)(i)) The new or amended standard must also “result in significant conservation of energy.” (42 U.S.C. 6295(o)(3)(B))
DOE considered the impacts of standards at each TSL, beginning with a maximum technologically feasible level, to determine whether that level was economically justified. Where the max-tech level was not justified, DOE then considered the next most efficient level and undertook the same evaluation until it reached the highest efficiency level that is both technologically feasible and economically justified and saves a significant amount of energy.
To aid the reader as DOE discusses the benefits and/or burdens of each TSL, tables present a summary of the results of DOE's quantitative analysis for each TSL. In addition to the quantitative results presented in the tables, DOE also considers other burdens and benefits that affect economic justification. These include the impacts on identifiable subgroups of consumers, such as low-income households and seniors, who may be disproportionately affected by a national standard (see section V.B.1.b).
DOE also notes that the economics literature provides a wide-ranging discussion of how consumers trade off upfront costs and energy savings in the absence of government intervention. Much of this literature attempts to explain why consumers appear to undervalue energy efficiency improvements. There is evidence that consumers undervalue future energy savings as a result of (1) a lack of information; (2) a lack of sufficient salience of the long-term or aggregate benefits; (3) a lack of sufficient savings to warrant delaying or altering purchases; (4) excessive focus on the short term, in the form of inconsistent weighting of future energy cost savings relative to available returns on other investments; (5) computational or other difficulties associated with the evaluation of relevant tradeoffs; and (6) a divergence in incentives (that is, renter versus owner; builder versus purchaser). Other literature indicates that with less than perfect foresight and a high degree of uncertainty about the future, consumers may trade off these types of investments at a higher than expected rate between current consumption and uncertain future energy cost savings. This undervaluation suggests that regulation that promotes energy efficiency can produce significant net private gains (as well as producing social gains by, for example, reducing pollution).
In DOE's current regulatory analysis, potential changes in the benefits and costs of a regulation due to changes in consumer purchase decisions are included in two ways. First, if consumers forego a purchase of a product in the standards case, this decreases sales for product manufacturers and the impact on manufacturers attributed to lost revenue is included in the MIA. Second, DOE accounts for energy savings attributable only to products actually used by
While DOE is not prepared at present to provide a fuller quantifiable framework for estimating the benefits and costs of changes in consumer purchase decisions due to an energy conservation standard, DOE is committed to developing a framework that can support empirical quantitative tools for improved assessment of the consumer welfare impacts of appliance standards. DOE has posted a paper that discusses the issue of consumer welfare impacts of appliance energy efficiency standards, and potential enhancements to the methodology by which these impacts are defined and estimated in the regulatory process.
Table V.29 and Table V.30 summarize the quantitative impacts estimated for each TSL for residential dehumidifiers. The efficiency levels contained in each TSL are described in section IV.A of this this.
DOE first considered TSL 4, which represents the max-tech efficiency levels. TSL 4 would save 0.79 quads of energy, an amount DOE considers significant. Under TSL 4, the NPV of consumer benefit would be $2.13 billion using a discount rate of 7 percent, and $4.96 billion using a discount rate of 3 percent.
The cumulative emissions reductions at TSL 4 are 47.1 Mt of CO
At TSL 4, the average LCC impact is a savings of $137 for PC1, $134 for PC2, $239 for PC3, $302 for PC4, and $542 for PC5. The simple PBP is 0.6 years for PC1, 0.5 years for PC2, 3.8 years for PC3, 5.5 years for PC4, and 4.0 years for PC5. The fraction of consumers experiencing a net LCC cost is 10.3 percent for PC1, 5.4 percent for PC2, 31.4 percent for PC3, 44.4 percent for PC4, and 39.9 percent for PC5.
At TSL 4, the projected change in INPV ranges from a decrease of $40.2 million to a decrease of $59.7 million, which correspond to decreases of 21.6 percent and 32.0 percent, respectively. Products that meet the efficiency standards specified by this TSL are forecast to represent less than 2 percent of shipments. As such, manufacturers would have to redesign nearly all products by the expected 2019 projected compliance date to meet demand. Redesigning all units to meet the current max-tech efficiency levels would require considerable capital and product conversion expenditures. At TSL 4, the capital conversion costs total as much as $33.1 million, 3.0 times the industry annual ordinary capital expenditure in 2018 (the year leading up to amended standards). DOE estimates that complete platform redesigns would cost the industry $48.1 million in product conversion costs. These conversion costs largely relate to the extensive research programs required to develop new products that meet the efficiency standards at TSL 4. These costs are equivalent to 8.9 times the industry annual budget for research and development. As such, the conversion costs associated with the changes in products and manufacturing facilities required at TSL 4 would require significant use of manufacturers' financial reserves (manufacturer capital pools), impacting other areas of business that compete for these resources and significantly reducing INPV. In addition, manufacturers could face a substantial impact on profitability at TSL 4. Because manufacturers are more likely to reduce their margins to maintain a price-competitive product at higher TSLs, especially in the lower-capacity portable segment, DOE expects that TSL 4 would yield impacts closer to the high end of the range of INPV impacts. If the high end of the range of impacts is reached, as DOE expects, TSL 4 could result in a net loss to manufacturers of 32.0 percent of INPV.
Beyond the direct financial impact on manufacturers, TSL 4 may also contribute to the potential unavailability of products at certain capacities across the five product classes. The efficiencies at TSL 4 are theoretical levels that DOE determined dehumidifiers could achieve by incorporating the most efficient type of each component. DOE is not aware of any dehumidifiers currently available on the market that achieve the TSL 4 efficiencies. To meet TSL 4, all products would be required to incorporate the highest efficiency compressors; however, manufacturers indicated that few such compressors are available in the range of compressor capacities suitable for residential dehumidifiers, and it is unlikely that substantially more would become available if standards at TSL 4 were adopted. In addition, the specific compressor capacities available at any given time are driven largely by the markets for other products with higher shipments (
The Secretary tentatively concludes that at TSL 4 for residential dehumidifiers, the benefits of energy savings, positive NPV of consumer benefits, emission reductions, and the estimated monetary value of the CO
DOE then considered TSL 3, which would save an estimated 0.32 quads of energy, an amount DOE considers significant. Under TSL 3, the NPV of consumer benefit would be $1.04 billion using a discount rate of 7 percent, and $2.27 billion using a discount rate of 3 percent.
The cumulative emissions reductions at TSL 3 are 19.3 Mt of CO
At TSL 3, the average LCC impact is a savings of $64 for PC1, $99 for PC2, $147 for PC3, $207 for PC4, and $416 for PC5. The simple PBP is 0.2 years for PC1 and PC2, 2.8 years for PC3, 1.3 years for PC4, and 1.4 years for PC5. The fraction of consumers experiencing a net LCC cost is zero percent for PC1, 0.5 percent for PC2, 11.7 percent for PC3, 8.4 percent for PC4, and 10.7 percent for PC5.
At TSL 3, the projected change in INPV ranges from a decrease of $31.3 million to a decrease of $34.9 million, which correspond to decreases of 16.8 percent and 18.7 percent, respectively. Products that meet the efficiency standards specified at this TSL level represent 37 percent of shipments in 2018 (the year leading up to amended standards). As such, manufacturers would have to overhaul a significant fraction of products by the 2019 projected compliance date to meet demand. Redesigning significant component systems or developing entirely new platforms to meet the efficiency levels specified by this TSL would require considerable capital and product conversion expenditures. At TSL 3, the estimated capital conversion costs total as much as $20.5 million, which is 1.8 times the industry annual capital expenditure in 2018 (the year leading up to the amended standards). DOE estimates that the redesigns necessary to meet these standards would cost the industry $30.2 million in product conversion costs. These conversion costs largely relate to the research programs and re-testing required to develop products that meet the efficiency standards set forth by TSL 3, and are 5.6 times the industry annual budget for research and development in 2018, the year leading up to amended standards. As such, the conversion costs associated with the changes in products and manufacturing facilities required at TSL 3 would still require significant use of manufacturers' financial reserves (manufacturer capital pools), impacting other areas of business that compete for these resources and significantly reducing INPV. Because manufacturers are more likely to reduce their margins to maintain a price-competitive product at higher TSLs, DOE expects that TSL 3 would yield impacts closer to the high end of the range of INPV impacts as indicated by the preservation of per-unit operating profit markup scenario. If this is the case, TSL 3 could result in a net loss of 18.7 percent in INPV to manufacturers of residential dehumidifiers.
Although some dehumidifiers may require higher efficiency compressors, the preservation of per-unit operating profit markup scenario efficiency levels specified at TSL 3 offer manufacturers multiple design pathways to meet the standard. This in turn offers manufacturers flexibility in meeting standards at this level and maintaining product offerings at certain capacities should a high efficiency compressor be unavailable at a given compressor capacity. To this end, units are already available that meet the efficiency levels specified at TSL 3.
The Secretary tentatively concludes that at TSL 3 for residential dehumidifiers, the benefits of energy savings, positive NPV of consumer benefits, emission reductions, estimated monetary value of the CO
After considering the analysis and the benefits and burdens of TSL 3, the Secretary tentatively concludes that this TSL will offer the maximum improvement in energy efficiency that is technologically feasible and economically justified, and will result in significant conservation of energy without eliminating or making unavailable any product classes or portions of product classes. Therefore, DOE today proposes to adopt TSL 3 for residential dehumidifiers. The proposed amended energy conservation standards for residential dehumidifiers, which are expressed as a minimum allowable IEF, are shown in Table V.31.
DOE requests comments on the proposed standards as well as any information or data that the agency should consider in adopting either a lower or higher TSL.
The benefits and costs of the proposed standards can also be expressed in terms of annualized values. The annualized net benefit is the sum of: (1) The annualized national economic value of the benefits from operating products that meet the proposed standards (consisting primarily of operating cost savings from using less energy, minus increases in product purchase costs, which is another way of representing consumer NPV), and (2) the monetary value of the benefits of CO
Table V.32 shows the annualized values for residential dehumidifiers under TSL 3, expressed in 2013$. The results under the primary estimate are as follows. Using a 7-percent discount rate for benefits and costs other than CO
Using a 3-percent discount rate for all benefits and costs and the SCC series corresponding to a value of $40.5/ton in 2015 (in 2013$), the estimated cost of the proposed standards for residential dehumidifiers in today's rule is $12.5 million per year in increased equipment costs, while the benefits are $142.7 million per year in reduced operating costs, $35.9 million per year in CO
Section 1(b)(1) of Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993), requires each agency to identify the problem that it intends to address, including, where applicable, the failures of private markets or public institutions that warrant new agency action, as well as to assess the significance of that problem. The problems that this proposed standards address are as follows:
(1) Insufficient information and the high costs of gathering and analyzing relevant information leads some consumers to miss opportunities to make cost-effective investments in energy efficiency.
(2) In some cases the benefits of more efficient equipment are not realized due to misaligned incentives between purchasers and users. An example of such a case is when the equipment purchase decision is made by a building contractor or building owner who does not pay the energy costs.
(3) There are external benefits resulting from improved energy efficiency of residential dehumidifiers that are not captured by the users of such equipment. These benefits include externalities related to public health, environmental protection, and national security that are not reflected in energy prices, such as reduced emissions of air pollutants and greenhouse gases that impact human health and global warming.
In addition, DOE has determined that today's regulatory action is a “significant regulatory action” under section (3)(f)(1) of Executive Order 12866. Accordingly, section 6(a)(3) of the Executive Order requires that DOE prepare a regulatory impact analysis (RIA) on this rule and that OIRA in OMB review this rule. DOE presented to OIRA for review the draft rule and other documents prepared for this rulemaking, including the RIA, and has included these documents in the rulemaking record. The assessments prepared pursuant to Executive Order 12866 can be found in the technical support document for this rulemaking.
DOE has also reviewed this regulation pursuant to Executive Order 13563. 76 FR 3281 (Jan. 21, 2011). Executive Order 13563 is supplemental to and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, agencies are required by Executive Order 13563 to: (1) Propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.
DOE emphasizes as well that Executive Order 13563 requires agencies to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. In its guidance, OIRA has emphasized that such techniques may include identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes. For the reasons stated in the preamble, DOE believes that this NOPR is consistent with these principles, including the requirement that, to the extent permitted by law, benefits justify costs and that net benefits are maximized.
The Regulatory Flexibility Act (5 U.S.C. 601
For the manufacturers of residential dehumidifiers, the SBA has set a size threshold, which defines those entities classified as “small businesses” for the purposes of the statute. DOE used the SBA's small business size standards to determine whether any small entities would be subject to the requirements of the rule. 65 FR 30836, 30848 (May 15, 2000), as amended at 65 FR 53533, 53544 (Sept. 5, 2000) and codified at 13 CFR part 121. The size standards are listed by NAICS code and industry description and are available at:
To estimate the number of companies that could be small business manufacturers of products covered by this rulemaking, DOE conducted a market survey using available public information to identify potential small manufacturers. DOE's research included searches of public databases (
DOE initially identified 25 manufacturers of residential dehumidifier products sold in the U.S. DOE then determined that of the 25 companies, 20 were either large manufacturers, exclusively import products manufactured overseas, or are foreign owned and operated. DOE identified the remaining five manufacturers as domestic manufacturers that meet the SBA's definition of a “small business” and manufacture products covered by this rulemaking.
Before issuing this Notice, DOE attempted to contact all the small business manufacturers of residential dehumidifiers identified. DOE was only able to establish contact with two small business manufacturers, both of which
The five domestic small business manufacturers of residential dehumidifiers identified account for a small fraction of total industry shipments. In 2014, 96.8 percent of residential dehumidifiers sold in the U.S. are small portable units (belonging to product classes 1 and 2) and are made by large, diversified manufacturers. The remaining 3.2 percent of the market consists of high-capacity portable and whole-home dehumidifiers, which are primarily manufactured by small business manufacturers.
Several factors may contribute to a disproportionate burden on small business manufacturers from amended energy conservation standards for residential dehumidifiers relative to their larger counterparts. One way in which small manufacturers could be at a disadvantage is that they may be disproportionately affected by product and capital conversion costs. Product redesign, testing, and certification costs tend to be fixed per basic model and do not scale with sales volume. Both large and small business manufacturers must make investments in R&D to redesign their products, but small businesses lack the sales volumes to sufficiently recoup these upfront investments without substantially marking up their products. Similarly, upfront capital investments in new manufacturing capital for platform redesigns, as well as depreciated manufacturing capital, can only be spread across a lower volume of shipments for small business manufacturers.
In addition, because small business manufacturers typically have fewer engineers than large manufacturers, they must allocate a greater portion of their available human resources to meet an amended regulatory standard. Because engineers may need to spend more time redesigning and testing existing models as a result of the amended standard, they may have less time to develop new products.
Furthermore, smaller manufacturers may lack the purchasing power of larger manufacturers. For example, because fan motor suppliers give volume discounts to manufacturers based on the number of motors they purchase, larger manufacturers may have a pricing advantage because they make higher volume purchases. This purchasing power difference between high-volume and low-volume orders applies to other residential dehumidifier components as well, including compressors and heat exchangers. DOE expects that certain larger manufacturers of lower-capacity portable dehumidifiers may even manufacture heat exchangers in-house. Additionally, because small business manufacturers produce higher-capacity units, they require larger/custom components (
In terms of access to the capital required to cover the conversion costs associated with reaching the proposed standards, small business manufacturers would likely be forced to take on additional debt, whereas larger diversified manufacturers of small portable products would be better equipped to fund purchases with existing cash flow from operations. Additionally, since the recession of 2007 and 2008, small business lending has dropped substantially due to a combination of tightened lending standards, increasing collateral requirements and reduced focus on small business credit markets. Thus, small businesses generally have access to less capital than do larger companies.
Since the standards in today's proposed rule for residential dehumidifiers could cause small manufacturers to be at a disadvantage relative to large manufacturers, DOE cannot certify that the proposed standards would not have a significant impact on a significant number of small businesses, and consequently, DOE has prepared this IRFA.
DOE estimates that the impacts on small business manufacturers are significantly disproportionate at TSLs 1 and 2, and relatively proportionate at TSLs 3 and 4. At TSL 3, the level proposed in today's notice, DOE estimates capital conversion costs of $1.7 million and product conversion costs of $5.0 million in the years leading up to the standard year for a typical small manufacturer. This is compared to capital conversion costs of $18.8 and product conversion costs of $25.2 million in the years leading up to the standard year for a typical large manufacturer. These costs and their impacts are described in detail below.
To estimate the potential impact on small business manufacturers, DOE used the GRIM results for high-capacity portables and whole-home dehumidifiers (product classes 3-5) to estimate the annual revenue, EBIT, capital expenditure, and R&D expense for a typical small manufacturer. DOE then compared these costs to the required product conversion costs at each TSL for both an average small manufacturer and an average large manufacturer. Table VI.1 and Table VI.2 show the capital and product conversion costs for a typical small manufacturer versus those of a typical large manufacturer. Table VI.3 and Table VI.4 report the total conversion costs as a percentage of annual R&D expense, annual revenue, and EBIT for a typical small and large manufacturer, respectively. In the following tables, TSL 3 represents the proposed standard.
Based on the above results for TSL 3, DOE understands that the potential conversions costs faced by small manufacturers may be greater than those faced by larger manufacturers. However, the disproportionality of these impacts would be much greater at TSLs 1 and 2. Small manufacturers have less engineering staff and lower R&D budgets. They also have lower capital expenditures annually. As a result, the conversion costs incurred by a small manufacturer would likely be a larger percentage of its annual capital expenditures, R&D expenses, revenue, and EBIT, than would be for a large manufacturer.
DOE is not aware of any rules or regulations that duplicate, overlap, or conflict with the rule being proposed today.
The discussion above analyzes the disproportionality of impacts on small businesses that would result from the other TSLs DOE considered. TSLs lower than the proposed TSL would not be expected to significantly reduce the impacts on small businesses, and would actually result in higher disproportionate impacts on small businesses. As a result, and given that DOE is required by EPCA to establish standards that achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified, DOE rejected the lower TSLs.
In addition to the other TSLs being considered, the NOPR TSD includes a regulatory impact analysis in chapter 17. For residential dehumidifiers, this report discusses the following policy alternatives: (1) No standard, (2) consumer rebates, (3) consumer tax credits, (4) manufacturer tax credits, and (5) early replacement. While these alternatives may mitigate to some varying extent the economic impacts on small entities compared to the standards, DOE determined that the energy savings of these alternatives are significantly smaller than those that would be expected to result from adoption of the proposed standard levels. Accordingly, DOE is declining to adopt any of these alternatives and is proposing the standards set forth in this rulemaking. (See chapter 17 of the NOPR TSD for further detail on the policy alternatives DOE considered.)
Additional compliance flexibilities may be available through other means. For example, individual manufacturers may petition for a waiver of the applicable test procedure. Further, EPCA provides that a manufacturer whose annual gross revenue from all of its operations does not exceed $8,000,000 may apply for an exemption from all or part of an energy conservation standard for a period not longer than 24 months after the effective date of a final rule establishing the standard. Additionally, Section 504 of the Department of Energy Organization Act, 42 U.S.C. 7194, provides authority for the Secretary to adjust a rule issued under EPCA in order to prevent “special hardship, inequity, or unfair distribution of burdens” that may be imposed on that manufacturer as a result of such rule. Manufacturers should refer to 10 CFR part 430, subpart E, and part 1003 for additional details.
Manufacturers of residential dehumidifiers must certify to DOE that their products comply with any
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.
Pursuant to the National Environmental Policy Act (NEPA) of 1969, DOE has determined that the proposed rule fits within the category of actions included in Categorical Exclusion (CX) B5.1 and otherwise meets the requirements for application of a CX. See 10 CFR part 1021, App. B, B5.1(b); 1021.410(b) and App. B, B(1)-(5). The proposed rule fits within this category of actions because it is a rulemaking that establishes energy conservation standards for consumer products or industrial equipment, and for which none of the exceptions identified in CX B5.1(b) apply. Therefore, DOE has made a CX determination for this rulemaking, and DOE does not need to prepare an Environmental Assessment or Environmental Impact Statement for this proposed rule. DOE's CX determination for this proposed rule is available at
Executive Order 13132, “Federalism,” 64 FR 43255 (Aug. 10, 1999), imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this proposed rule and has tentatively determined that it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this proposed rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297) No further action is required by Executive Order 13132.
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. 61 FR 4729 (Feb. 7, 1996). Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this proposed rule meets the relevant standards of Executive Order 12988.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531) For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. DOE's policy statement is also available at
Although today's proposed rule does not contain a Federal intergovernmental mandate, it may require expenditures of $100 million or more by the private sector. Specifically, the proposed rule will likely result in a final rule that could require expenditures of $100 million or more. Such expenditures may include: (1) investment in research and development and in capital expenditures by residential dehumidifiers manufacturers in the years between the final rule and the projected compliance date for the new standards, and (2) incremental additional expenditures by consumers to purchase higher-efficiency residential dehumidifiers, starting at the projected compliance date for the applicable standard.
Section 202 of UMRA authorizes a Federal agency to respond to the content requirements of UMRA in any other statement or analysis that accompanies the proposed rule. (2 U.S.C. 1532(c)) The content requirements of section 202(b) of UMRA relevant to a private sector mandate substantially overlap the economic analysis requirements that apply under section 325(o) of EPCA and Executive Order 12866. The
Under section 205 of UMRA, the Department is obligated to identify and consider a reasonable number of regulatory alternatives before promulgating a rule for which a written statement under section 202 is required. (2 U.S.C. 1535(a)) DOE is required to select from those alternatives the most cost-effective and least burdensome alternative that achieves the objectives of the proposed rule unless DOE publishes an explanation for doing otherwise, or the selection of such an alternative is inconsistent with law. As required by 42 U.S.C. 6295(o), today's proposed rule would establish energy conservation standards for residential dehumidifiers that are designed to achieve the maximum improvement in energy efficiency that DOE has determined to be both technologically feasible and economically justified. A full discussion of the alternatives considered by DOE is presented in the “Regulatory Impact Analysis” section of the NOPR TSD for today's proposed rule.
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
Under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (Mar. 18, 1988), DOE has determined that this regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for Federal agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed today's NOPR under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
DOE has tentatively concluded that today's regulatory action, which sets forth energy conservation standards for residential dehumidifiers, is not a significant energy action because the proposed standards are not likely to have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as such by the Administrator at OIRA. Accordingly, DOE has not prepared a Statement of Energy Effects on the proposed rule.
On December 16, 2004, OMB, in consultation with the Office of Science and Technology Policy (OSTP), issued its Final Information Quality Bulletin for Peer Review (the Bulletin). 70 FR 2664 (Jan. 14, 2005). The Bulletin establishes that certain scientific information shall be peer reviewed by qualified specialists before it is disseminated by the Federal Government, including influential scientific information related to agency regulatory actions. The purpose of the bulletin is to enhance the quality and credibility of the Government's scientific information. Under the Bulletin, the energy conservation standards rulemaking analyses are “influential scientific information,” which the Bulletin defines as scientific information the agency reasonably can determine will have, or does have, a clear and substantial impact on important public policies or private sector decisions.
In response to OMB's Bulletin, DOE conducted formal in-progress peer reviews of the energy conservation standards development process and analyses and has prepared a Peer Review Report pertaining to the energy conservation standards rulemaking analyses. Generation of this report involved a rigorous, formal, and documented evaluation using objective criteria and qualified and independent reviewers to make a judgment as to the technical/scientific/business merit, the actual or anticipated results, and the productivity and management effectiveness of programs and/or projects. The “Energy Conservation Standards Rulemaking Peer Review Report” dated February 2007 has been disseminated and is available at the following Web site:
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Any person who has plans to present a prepared general statement may request that copies of his or her statement be made available at the public meeting. Such persons may submit requests, along with an advance electronic copy of their statement in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format, to the appropriate address shown in the
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The public meeting will be conducted in an informal, conference style. DOE will present summaries of comments received before the public meeting, allow time for prepared general statements by participants, and encourage all interested parties to share their views on issues affecting this rulemaking. Each participant will be allowed to make a general statement (within time limits determined by DOE), before the discussion of specific topics. DOE will allow, as time permits, other participants to comment briefly on any general statements.
At the end of all prepared statements on a topic, DOE will permit participants to clarify their statements briefly and comment on statements made by others. Participants should be prepared to answer questions by DOE and by other participants concerning these issues. DOE representatives may also ask questions of participants concerning other matters relevant to this rulemaking. The official conducting the public meeting will accept additional comments or questions from those attending, as time permits. The presiding official will announce any further procedural rules or modification of the above procedures that may be needed for the proper conduct of the public meeting.
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Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person that would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:
1. The proposed product classes for residential dehumidifiers: (1) Portable, less than 30.00 pints/day; (2) portable, 30.01 to 45.00 pints/day; (3) portable, 45.01 or more pints/day; (4) whole-home, case volume less than or equal to 8.0 cubic feet; and (5) whole-home, case volume greater than 8.0 cubic feet (see section IV.A.2 of this notice or chapter 3 of the NOPR TSD).
2. Information or data about the availability of dehumidifiers with smart controls, including those currently available on the market or any working prototypes (see section IV.A.3 of this notice or chapter 3 of the NOPR TSD).
3. The efficiency levels considered for this analysis. DOE specifically seeks information from interested parties on whether the revised max-tech levels, which incorporate savings associated with permanent-magnet fan motors, are technologically feasible, and on whether the updated whole-home dehumidifier efficiency levels, which account for the updated test conditions, are appropriate. DOE also seeks comment on potential utility impacts at any of the analyzed efficiency levels (see section IV.C.1 of this notice or chapter 5 of the NOPR TSD).
4. Whether to promote installation of any of the design options, including variable-speed compressors, improved controls, and hygrometers, even though the resulting efficiency gains would not be measurable with the existing test procedure (see section IV.C.2 of this notice of chapter 5 of the NOPR TSD).
5. The determination that manufacturers would likely rely on improved compressor efficiency and increased heat exchanger sizes to achieve efficiencies below the max-tech level, and may incorporate permanent-magnet motors to further improve efficiency. DOE also requests feedback on the incremental manufacturer production costs DOE estimated at each efficiency level (see section IV.C.2 of this notice or chapter 5 of the NOPR TSD).
6. The inputs to the energy use determination for portable and whole-home dehumidifiers, especially the operating hours by mode for each product type (see section IV.E of this notice or chapter 7 of the NOPR TSD).
7. The base-case efficiency distribution for each product class (see section IV.F.8 of this notice or chapter 8 of the NOPR TSD).
8. Whether the annual efficiency improvement (
9. The inputs to the shipments model, particularly historical shipments of whole-home dehumidifiers, and the market share of portable dehumidifiers and whole-home dehumidifiers (see section IV.G of this notice or chapter 9 of the NOPR TSD).
10. Dehumidifier manufacturers that would be considered small businesses and the potential impacts of energy conservation standards on these manufacturers (see sections IV.J and V.B.2.d of this notice or chapter 12 of the NOPR TSD).
11. The proposed standards as well as any information or data that the agency should consider in adopting either a lower or higher TSL.
The Secretary of Energy has approved publication of this proposed rule.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Intergovernmental relations, Reporting and recordkeeping requirements, and Small businesses.
For the reasons set forth in the preamble, DOE proposes to amend part
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
(v) * * *
(3) Dehumidifiers manufactured on or after [date 3 years after the publication of the final rule] shall have an integrated energy efficiency ratio that meets or exceeds the following values:
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's current VFD regulation established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This amendment is intended to improve the efficiency of FDA's VFD program while protecting human and animal health.
This rule is effective October 1, 2015.
Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5939, email:
The purpose of this rulemaking is to revise FDA's VFD regulations to improve the efficiency of the VFD program while continuing to protect public health (human and animal health).
In 1996, Congress enacted the Animal Drug Availability Act (ADAA) (Pub. L. 104-250) to facilitate the approval and marketing of new animal drugs and medicated feeds. In passing the ADAA, Congress created a new regulatory category for certain animal drugs used in or on animal food (animal feed) called veterinary feed directive drugs (or VFD drugs). VFD drugs are new animal drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian. Any animal feed containing a VFD drug can only be fed to animals based upon an order, called a veterinary feed directive (VFD), issued by a licensed veterinarian in the course of the veterinarian's professional practice. FDA published final regulations implementing the VFD-related provisions of the ADAA in 2000 (see § 558.6 (21 CFR 558.6)) (65 FR 76924, December 8, 2000). In the decade since FDA published its VFD regulations, various stakeholders have informed the Agency that the existing VFD process is overly burdensome. In response to those concerns, FDA published several documents inviting public input on ways to improve the VFD process, including an advance notice of proposed rulemaking (ANPRM) (75 FR 15387, March 29, 2010) (March 2010 ANPRM); draft regulatory text for proposed regulation (77 FR 22247, April 13, 2012) (April 2012 draft proposed regulation); and a notice of proposed rulemaking (NPRM) (78 FR 75515, December 12, 2013) (December 2013 NPRM).
The VFD rule is the third of three core documents that FDA is using to announce and implement its policy framework for the judicious use of medically important antimicrobial drugs in food-producing animals. The first document, Guidance for Industry (GFI) #209, entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” published April 2012, set forth FDA's framework for instituting several key measures for ensuring the appropriate or judicious use of medically important antimicrobial drugs in food-producing animals. These measures include eliminating the feed and water use of medically important antimicrobial drugs for production purposes in food-producing animals and bringing all remaining therapeutic uses under the oversight of licensed veterinarians. The second document, GFI #213, entitled “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” published December 2013, outlined a detailed process and timeline for implementing the measures identified in GFI #209. Once GFI #213 is fully implemented, affected feed-use antimicrobial drugs are expected to transition from over-the-counter (OTC) to VFD marketing status. Given that most of the products affected by this effort are feed-use antimicrobial drugs this VFD regulation plays an important role since it outlines the requirements associated with veterinary authorization, distribution, and use of VFD drugs in animal feed.
The VFD drug process as outlined in this final rule includes important controls regarding the distribution and use of VFD drugs. In addition to providing accountability, this final rule also updates the VFD requirements to improve the efficiency of the process. These regulatory enhancements are important for facilitating the transition of a large number of OTC feed-use antimicrobial drugs to their new VFD status.
FDA intends to use a phased enforcement strategy for implementation of this final rule as OTC drugs become VFD drugs under GFI #213. FDA first intends to provide education and training for stakeholders subject to this final rule such as veterinarians, clients (animal producers), feed mill distributors and other distributors. Such education and training efforts are important for supporting effective implementation and compliance with the final rule. FDA will then engage in risk-based general surveillance, as well as for-cause inspection assignments. FDA intends to use information such as history of VFD use and the volume of VFD feed being produced to focus inspectional resources within the industry based on risk. FDA anticipates that it will utilize various sources for obtaining such information including such sources as FDA food and drug registration information, feed mill licensing information, the VFD distributor notifications FDA receives, and VFD distribution records maintained by drug sponsors and VFD distributors.
The provisions included in this final rule are based on stakeholder input received in response to multiple opportunities for public comment, including the March 2010 ANPRM, April 2012 draft proposed regulation, and the December 2013 NPRM.
This final rule makes several important changes from the proposed rule and several major changes to the current VFD regulations in part 558 (21 CFR part 558):
• The definition of “Category II” in part 558 is revised to remove the automatic Category II designation for VFD drugs. Instead, the categorization of VFD drugs will be determined on a case-by-case basis based on the likelihood that the particular drug at issue will produce an unsafe residue in edible products derived from treated animals, as is currently the case for non-VFD feed use drugs.
• The definition of veterinary feed directive (VFD) drug is revised to simply refer to the statutory definition to provide further clarity.
• The proposed definition of combination veterinary feed directive (VFD) drug is revised to reflect the
• The proposed definition of a “veterinary feed directive” is revised to remove language that is duplicated in the responsibilities of a veterinarian issuing a VFD.
• The proposed definition of the term “distributor” is revised to use the word “distributes” instead of the word “consigns” as had been proposed.
• The regulatory text proposed for § 558.6(a)(4) and (b)(8) is revised to clarify that the veterinarian is required to keep the original VFD (in hardcopy or electronically) and the distributor and client must keep a copy of the VFD (in hardcopy or electronically).
• The current requirement that copies of the VFD and records of the receipt and distribution of VFD feed must be kept for a period of 2 years is retained instead of being changed to 1 year as was proposed.
• The final rule provides that the veterinarian must issue the VFD in the context of a valid veterinarian-client-patient relationship (VCPR) as defined by the State requirements applicable to where the veterinarian practices veterinary medicine. In States that lack appropriate VCPR requirements applicable to VFDs, the veterinarian must issue the VFD consistent with the Federally defined VCPR standard, which is set forth in FDA's regulations at § 530.3(i) (21 CFR 530.3(i)).
• The VFD expiration date requirement in the final rule specifies that this is the date that authorization to feed the VFD feed to animals expires. Animals must not be fed the VFD feed after the expiration date of the VFD.
• The VFD requirement for approximate number of animals in the final rule specifies how the approximate number of animals should be determined.
• The final rule clarifies the affirmation of intent statements to be used in VFDs issued by licensed veterinarians to indicate whether a VFD drug may be used in conjunction with another drug in an approved, conditionally approved, or indexed combination VFD feed.
• The final rule clarifies the recordkeeping requirements to differentiate what records are required to be kept for distributors who manufacture VFD feed and those who do not manufacture the VFD feed.
The estimated one-time costs to industry from this final rule are $1,411,000, most of which are simply costs to review the rule and prepare a compliance plan. This equates to annualized costs of about $201,000 at a 7 percent discount rate over 10 years. We estimate that the government costs associated with reviewing the six VFD drug labeling supplements that are expected to be submitted by the three current VFD drug sponsors to be $1,900.
The expected benefit of this final rule is a general improvement in the efficiency of the VFD process. FDA estimates the annualized cost savings associated with the more efficient requirements of the VFD process to be $13,000 over 10 years at a 7 percent discount rate (annualized at $11,000 over 10 years at a 3 percent discount rate). Additionally, the reduction in veterinarian labor costs due to this rule is expected to result in a cost savings of about $7.87 million annually.
Before 1996, FDA had only two options for regulating the distribution of animal drugs: (1) Over-the-counter (OTC) and (2) by prescription (Rx). Drugs used in animal feeds were generally approved as OTC drugs. Although the Federal Food, Drug, and Cosmetic Act (the FD&C Act) did not prohibit the approval of prescription drugs for use in animal feed, such approvals would be impractical because many States have laws that would require a feed mill to have a pharmacist onsite to dispense prescription drugs. As additional animal drugs were developed, FDA determined the existing regulatory options—OTC and Rx—did not provide the needed safeguards or flexibility for these drugs to be prescribed or administered through medicated feed. FDA believed that these drugs, particularly certain antimicrobial drugs, should be subject to greater control than provided by OTC status. FDA believed this control would be critical to reducing unnecessary use of such drugs in animals and to slowing or preventing the potential for the development of bacterial resistance to antimicrobial drugs administered through medicated feed.
In 1996 Congress enacted the ADAA to facilitate the approval and marketing of new animal drugs and medicated feeds. As part of the ADAA, Congress recognized that certain new animal drugs intended for use in animal feed should only be administered under a veterinarian's order and professional supervision. Therefore, the ADAA created a new category of products called veterinary feed directive drugs (or VFD drugs).
VFD drugs are new animal drugs intended for use in or on animal feed, which are limited by an approved application, conditionally approved application, or index listing to use under the professional supervision of a licensed veterinarian. In order for animal feed containing a VFD drug (VFD feed) to be fed to animals, a licensed veterinarian must first issue an order, called a veterinary feed directive (or VFD), providing for such use. In the
It has been over a decade since FDA issued the final rule relating to VFDs. Although currently there are only a few approved VFD drugs, FDA has received comments from stakeholders characterizing the current VFD process as being overly burdensome. In response to these concerns, the Agency began exploring ways to improve the VFD program's efficiency. To that end, FDA initiated the rulemaking process through the publication of the March 2010 ANPRM. The March 2010 ANPRM requested public comment on whether efficiency improvements are needed and, if so, what specific revisions should be made to the VFD regulations. Subsequent to this, FDA published the
Recognizing that there would be challenges faced by animal producers and veterinarians as FDA phases in veterinary oversight of the therapeutic use of certain medically important antimicrobials, in the spring of 2013, FDA and the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service jointly sponsored a series of public meetings in various locations throughout the country (2013 public meetings). These meetings provided a forum to discuss potential challenges faced by animal producers in areas that may lack access to adequate veterinary services and to explore possible options for minimizing adverse impacts.
After considering the feedback received during the 2013 public meetings, as well as comments received on our March 2010 ANPRM and April 2012 draft proposed regulation, FDA published the December 2013 NPRM.
On April 13, 2012, FDA finalized a guidance document entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals” (GFI #209) (Ref. 1). This guidance document represents the Agency's current thinking regarding antimicrobial drugs that are medically important in human medicine and used in food-producing animals. Specifically, GFI #209 discusses FDA's concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when medically important antimicrobial drugs are used in food-producing animals in an injudicious manner. In addition, GFI #209 recommends two principles for assuring the appropriate or judicious use of medically important antimicrobial drugs in food-producing animals in order to help minimize antimicrobial resistance development: (1) Limit medically important antimicrobial drugs to uses in animals that are considered necessary for assuring animal health and (2) limit medically important antimicrobial drugs to uses in animals that include veterinary oversight or consultation.
On December 13, 2013, FDA finalized a second guidance document, GFI #213, entitled “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209” (Ref. 2). GFI #213 outlined a timeline and provided sponsors with specific recommendations on how they could voluntarily modify the use conditions of their medically important antimicrobial drug products administered in feed or water to align with the two judicious use principles announced in GFI #209. Once the use conditions of the affected products are changed, these products can no longer be legally used for production purposes, and can only be used for therapeutic purposes with the supervision of a licensed veterinarian.
Implementation of the judicious use principles set forth in GFI #209, particularly the second principle recommending that affected products be limited to uses in animals that include veterinarian oversight or consultation, reinforces the need for FDA to reconsider the current VFD program and how best to make the program more efficient and less burdensome for stakeholders while maintaining adequate protection for human and animal health. The majority of the antimicrobial animal drug products that are the focus of GFI #209 and GFI #213 are drugs approved for use in or on animal feed. All but a few of these drugs are currently available OTC without veterinary oversight or consultation and would be affected by the Agency's recommendation in the guidances to switch these products' marketing status from OTC to VFD. Therefore, it is important that the VFD process be as efficient as possible when FDA's judicious use policy is fully implemented to facilitate transition of these products from OTC to VFD marketing status. In addition, an overly burdensome VFD process could disrupt the movement of medicated feeds through commercial feed distribution channels, thereby impacting the availability of medicated feed products needed for addressing animal health issues.
This final rule amends FDA's regulations found in parts 514 and 558 (21 CFR parts 514 and 558) to change and clarify certain definitions (§ 558.3 (21 CFR 558.3)), clarify the general requirements for VFD drugs (§ 558.6(a) (21 CFR 558.6(a))), clarify the responsibilities of the VFD drug sponsor (§ 514.1(b) (21 CFR 514.1(b)), and clarify specific responsibilities of the veterinarian issuing the VFD (§ 558.6(b) (21 CFR 558.6(b))). Also, in this final rule we clarify the specific responsibilities of any person who distributes an animal feed containing a VFD drug (§ 558.6(c) (21 CFR 558.6(c))).
In this rulemaking, the Agency finalizes many of the provisions in the December 2013 NPRM. In addition, the final rule reflects revisions the Agency made in response to comments on the December 2013 NPRM and certain revisions made by the Agency on its own initiative after considering all of the comments it received. Based on the changes to the final rule from the proposed rule, the Agency has determined that the effective date for the final rule should be 120 days after publication.
This section summarizes comments FDA received in response to the December 2013 NPRM and the Agency's response to those comments. FDA received about 2,000 individual comments submitted to the docket on the December 2013 NPRM. Some of the comments contained signatures by multiple individuals or organizations. Comments were received from veterinary, feed manufacturing, and animal production associations, as well as consumer advocacy groups and individuals. Many of the comments received from veterinarian, feed manufacturing, animal production associations, and individuals generally supported the changes and requested some additional changes or clarification on particular issues. Many of the comments received from consumer advocacy groups and individuals raised concerns over whether the changes would sufficiently protect public health. FDA is making changes in the final rule to address these concerns where the Agency has determined such changes to be appropriate.
The order of the discussion reflects the order in the regulatory text and not the order of significance of a particular issue. To make it easier to identify comments and FDA's responses, the word “Comment,” in parentheses, appears before the comment's description, and the word “Response,” in parentheses, appears before FDA's response. Each comment is numbered to help distinguish between different comments. The number assigned to each comment is for organizational purposes and does not signify the comment's value or importance.
In addition to the comments specific to this rulemaking that we address in the following paragraphs, we received general comments expressing views about public health, the use of antimicrobials, antimicrobial resistance, antibiotic alternatives, animal husbandry practices, meat consumption,
The December 2013 NPRM proposed to remove VFD drugs from the definition of Category II drugs. In this final rule, we are keeping our proposed definition, which means that VFD drugs will no longer be automatically designated as Category II drugs. Category I drugs will remain defined as drugs that do not require a withdrawal period at the lowest use level in each species for which they are approved. Category II drugs will be defined as drugs that require a withdrawal period at the lowest use level for at least one species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern, regardless of whether a withdrawal period is required. As a result of this change, VFD drugs will be designated as either Category I or II based on the definitions in the final rule, including the existing VFD drug products that previously were automatically designated as Category II drugs.
(Comment 1) There were multiple comments supporting FDA's proposed change to the definition of “Category II” drugs to discontinue the automatic designation of VFD drugs as Category II drugs. These comments supported Category I and II definitions that use a public health risk-based approach to designate drugs based on the potential for unsafe drug residues in edible tissues as reflected by drug withdrawal periods. At least one comment also recognized that without this change, farm animals may be unable to receive the treatment they need due to supply chain disruptions. This comment noted that limiting the manufacturing of VFD feed from Type A medicated articles to licensed feed mills by automatically designating them as Category II would cause a serious disruption in VFD feed availability and unnecessarily cause harm to animals. The comment further noted that the proposed change to remove the automatic designation should greatly reduce the supply chain consequences.
(Response 1) We agree that this approach provides a consistent scientific rationale for designating VFD drugs as Category I or II and will help prevent potential VFD feed supply chain concerns. Therefore, in this final rule, we are keeping the definition proposed in the December 2013 NPRM.
The definitions proposed in the December 2013 NPRM designate drugs as Category II if a withdrawal period is required at the lowest approved use level for any species, or if the drug is regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required. The category in which a new animal drug is placed determines whether the Type A medicated article of that drug can be handled by a licensed or unlicensed mill. Type A medicated articles are the most concentrated form of the new animal drug and are used in the manufacture of another Type A medicated article, or a Type B or C medicated feed. A Type B medicated feed is intended solely for the manufacture of other Type B or Type C medicated feeds and contains a substantial quantity of nutrients with the new animal drug. A Type C medicated feed is intended as the complete feed for the animal or may be added on top of a usual ration, or offered as a supplement with other animal feed. A Type C medicated feed has the lowest concentration of the new animal drug. In order to reduce the potential to create unsafe drug residues, the manufacturing of medicated feeds with Category II Type A medicated articles is restricted to licensed feed mills. Licensed feed mills are generally better suited technically to manufacture feeds containing Category II drugs and are subject to more extensive good manufacturing practice requirements than unlicensed feed mills.
When the VFD regulations were implemented, FDA stated that “classifying a drug as Category II adds additional regulatory controls because feed manufacturing facilities must possess a medicated feed mill license and be registered with FDA. . . . Registered feed mills are required to be inspected at least every 2 years. Such inspections will help the Agency to ensure that VFD requirements are met” (65 FR 76924 at 76926). Since the regulations for VFD drugs were implemented over a decade ago, FDA's experience has not shown a continued need to ensure VFD requirements are met by automatically designating all VFD drugs as Category II drugs. Since January 8, 2001, when the initial VFD regulations became effective, FDA has only issued three warning letters for violations related to noncompliance with the VFD regulations (Ref. 3). Furthermore, licensed feed mills are now required to be inspected according to risk instead of at a set frequency. Drug categorization determines whether a facility needs to be licensed to handle the drug in the Type A form and is meant to provide additional regulatory oversight for the manufacturing of the drug to minimize the potential for drug residues to occur. In contrast, VFD designation is intended primarily to provide for veterinary supervision of the use of medicated feeds containing VFD drugs (VFD feeds). For VFD drugs that would otherwise be categorized as Category I drugs (
In addition, we agree this change will help prevent the potential supply chain disruptions for VFD feeds that otherwise are likely to occur once the Agency's policy regarding the judicious use of medically important antimicrobial drugs in food-producing animals is fully implemented. The existing definition of Category II drugs includes a provision that says
For these reasons, FDA is revising the definition of Category II to eliminate the automatic designation of VFD drugs into Category II. Once those medically important antimicrobial drugs that are currently marketed OTC are converted to VFD status as part of the implementation of FDA's judicious use policy, they will be placed in Category
(Comment 2) FDA also received multiple comments opposing the proposed change to the definition of a “Category II” drug. Most of these comments stated a concern about unlicensed feed mills handling Type A medicated articles for drugs that are VFDs or antimicrobials. The shared concern was that there would not be sufficient controls in place, or oversight over unlicensed feed mills, to ensure that these drugs are handled according to the requirements of the VFD regulation. One comment was concerned that without requiring VFD drugs to first go through a licensed feed mill, coupled with the proposed removal of the explicit Federal VCPR requirement and the proposed change to the definition of distributor, FDA would have no way to monitor the majority of VFD drug use.
(Response 2) At the time VFD regulations were initially issued in December 2000, FDA was concerned that adherence to VFD regulations would require additional regulatory oversight for the proper use of VFD drugs in VFD feed. After over a decade of experience, FDA has only issued three warning letters for compliance issues in the handling of VFD drugs as Type A medicated articles by licensed feed mills, or as Type B or C VFD feed by unlicensed feed mills (Ref. 3). Furthermore, unlicensed feed mills routinely handle Category I Type A medicated articles and are also required to adhere to current good manufacturing practices (CGMPs). Although FDA may not inspect unlicensed feed mills at the same frequency as licensed feed mills, they are inspected for cause when surveillance tools, such as tissue residue or feed sampling, determine that a problem has occurred (Ref. 4). State regulatory Agencies also inspect licensed and unlicensed feed mills (Ref. 5). Therefore, FDA does not believe VFD drugs require continued automatic designation as Category II drugs.
FDA recognizes that feed mill licensing is one method for FDA to maintain an inventory of feed mills that handle and use Type A VFD medicated articles; however, feed mill licensing is not the only way for FDA to be aware of VFD drug use. Furthermore, with respect to the concern raised in one of the comments that the change in the Category II definition, taken together with other proposed changes would diminish FDA's ability to monitor VFD use, the Agency is taking measures to address that concern. First, FDA has reintroduced an explicit VCPR requirement into the provisions for veterinarian supervision and oversight in the regulatory text. Second, FDA has also chosen not to proceed with the proposed changes to the definition of distributor outlined in the December 2013 NPRM and has clarified elsewhere in this document particular actions of on-farm processors that make them distributors.
FDA intends to use a phased enforcement strategy for implementation of this final rule as OTC drugs become VFD drugs under GFI #213. FDA first intends to provide education and training for stakeholders subject to this final rule, such as veterinarians, clients (animal producers), feed mill distributors and other distributors. These education and training efforts are important for supporting effective implementation and compliance with the final rule. As products change to VFD status under the process outlined in GFI #213, FDA will engage in general surveillance, as well as for-cause inspection assignments. These assignments will be risk-based and in response to adverse observations. In order to engage in a risk-based work planning approach, FDA intends to gather information, such as VFD use and the volume of VFD feed being produced within the industry. This information would be gathered through multiple sources, such as FDA food and drug registration information, feed mill licensing information, the VFD distributor notifications FDA receives, and VFD distribution records maintained by drug sponsors and VFD distributors. This information will allow FDA to focus inspectional resources within the industry based on risk.
Therefore, FDA is removing VFD drugs from the definition of Category II drugs. Instead of automatic Category II designation, VFD drugs will now be categorized according to the risk of drug residues based on whether they have a withdrawal period at the lowest level use in any species for which they are approved, or whether they are regulated on a “no residue” basis or with a zero tolerance because of carcinogenic concern. This includes the existing approved VFD drug products, each of which will either remain in Category II or be redesignated as Category I drugs based on whether they meet the definition of Category I or the revised definition of Category II.
In the December 2013 NPRM, we proposed changes to better align the definition of “veterinary feed directive (VFD) drug” in FDA's regulations with the statutory definition in section 504 of the FD&C Act (21 U.S.C. 354) and to provide additional clarity. We did not receive comments specifically related to our proposed change in definition. However, upon further review we are providing more clarity to the VFD drug definition in this final rule by using the statutory definition in the FD&C Act. That definition of a “veterinary feed directive (VFD) drug” states that it is “[a] drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 512(b), a conditionally-approved application filed pursuant to section 571, or an index listing pursuant to section 572 to use under the professional supervision of a licensed veterinarian. . . .” This change in § 558.3(b)(6) provides consistency between the statute and the regulation and helps to reduce the potential for confusion.
FDA did not receive specific comments regarding the addition of language in the proposed VFD definition in § 558.3(b)(7) stating that a VFD may be issued in hardcopy or through electronic means. However, upon further review, we are removing this duplicative language because similar language appears in § 558.6(b) concerning the responsibilities of the veterinarian issuing the VFD. Section 558.6(b) provides more clarity by specifying that a fax also can be used. This change avoids duplication in the regulatory text and helps to reduce potential reader confusion about whether transmitting a VFD by fax is allowed.
Also to help reduce the potential for confusion, FDA is removing the duplicative language concerning the oversight and supervision requirements
In the December 2013 NPRM, we proposed to change the definition of “distributor.” In particular, we proposed to change the phrase “any person who distributes a medicated feed containing a VFD drug to another person” to “any person who consigns a medicated feed containing a VFD drug to another person.” Many of the comments we received expressed concern that this definitional change was meant to narrow the scope of who is defined as a distributor.
(Comment 3) Some comments requested that we maintain the current definition that a distributor is any person who distributes a medicated feed containing a VFD drug to another distributor or to the client-recipient of the VFD. These comments were concerned that use of the term “consigns” instead of “distributes” in the proposed definition would exempt operations that were previously considered to be distributors. Some of these comments thought that the proposed changes would narrow the scope of the definition such that it would exclude from the distributor notification requirements the majority of facilities where medicated feeds are mixed. One comment supported the definition of distributor proposed in the December 2013 NPRM.
(Response 3) We used the term “consigns” in place of the term “distributes” with the intent to provide additional clarity; however, the comments we received indicated this proposed terminology was more confusing. In addition, many comments perceived this change as an attempt to narrow the definition of distributor. As stated in the December 2013 NPRM, our intent was to improve the clarity of this definition, not to narrow the scope. As a result of the comments received and the discussions that occurred at public meetings about this proposed change, we are retaining the existing term “distributes” as part of the definition of distributor.
In the December 2013 NPRM, we noted that “on-farm mixers that only manufacture medicated feeds for use in their own animals are not distributors.” Based on the comments, we would like to provide additional clarity. Some comments perceived this statement to exempt all on-farm mixers from requirements that apply to distributors. However, this statement was intended to describe a limited and specific situation in which FDA does not intend to consider on-farm mixers to be distributors. By on-farm mixers, we were specifically referring to any person who is mixing VFD feed on a “farm” as that term is defined in 21 CFR 1.227, who is only feeding that VFD feed to their own animals on that farm. In addition, the on-farm mixer must only be manufacturing VFD feed for their use in their own animals on their own farm (
(Comment 4) Some comments requested that all facilities that dispense feed to an animal production facility be required to submit a notification to FDA. One comment suggested we define a distributor as “any person who consigns a medicated feed containing a VFD drug to another distributor or to an animal production facility.”
(Response 4) FDA does not believe it is necessary to require that all persons who dispense VFD feed to an animal production facility submit a notification to FDA. For example, if a person purchases a Type B VFD feed and then mixes it on their farm into a Type C VFD feed and feeds it to their own animals on their farm in accordance with a lawful VFD, they are dispensing VFD feed to an animal production facility because the mixing operations are not part of the animal production facility. However, they are not acting as a “distributor” as that term is defined in § 558.3 because they are not distributing to another person. When a person who dispenses VFD feed to an animal production facility obtains the VFD feed from a distributor, they are required to submit a VFD or acknowledgment letter to the distributor from whom they obtained the VFD feed. This documentation allows FDA to identify users of VFD feed from the distributor's records for purposes of surveillance, inspection, or investigation. In addition, should a person who dispenses VFD feed to an animal production facility obtain a VFD Type A medicated article for manufacture of the VFD feed, the sponsor of the VFD Type A medicated article is required to maintain a record of distribution.
(Comment 5) One comment was concerned that the required one-time notification to FDA that someone is a distributor of VFD feeds could discourage distribution and sale of floor stock.
(Response 5) The requirement for a person distributing VFD feed to notify FDA when they first engage in such distribution is a statutory requirement. (See section 504(a)(3)(C) of the FD&C Act.) We understand that some businesses may choose not to engage in the sale of floor stock. However, in order to adequately protect public and animal health, FDA must be able to track the distribution of VFD feed, and one-time notification to FDA upon first engaging in the distribution of a VFD feed provides the minimum information needed for this tracking. We do not agree that the minimal burden of a one-time notification to FDA would be a significant factor in discouraging the distribution of floor stock. Furthermore, FDA believes there is no compelling reason to treat distributors who only sell floor stock differently from distributors who distribute VFD feed through other sales models.
(Comment 6) One comment requested clarification on whether a manufacturer of a Type B VFD feed who distributes the Type B VFD feed to an animal producer who then makes a Type C VFD feed needs to get an acknowledgement letter from the animal producer as opposed to a VFD.
(Response 6) When a manufacturer of a Type B VFD feed distributes the Type B VFD feed to an animal producer, the animal producer may manufacture a Type C VFD feed to either feed the VFD feed to his or her own animals and/or further distribute the Type C VFD feed to another distributor or client-recipient. If the Type B VFD feed is being shipped to an animal producer who is not a
The December 2013 NPRM did not propose a change to the definition of animal production facility. However, we received comment on the definition.
(Comment 7) A few comments requested that FDA define “animal production facility” more broadly to include the location where the medicated feed is made. These comments cited a concern that movement of VFD feed would be limited by this definition because shipment of VFD feed to an animal production facility must frequently go beyond the gate to a facility or feed mill where the animals are not housed.
(Response 7) The term animal production facility is defined as “a location where animals are raised for any purpose, but does not include the specific location where medicated feed is made.” (§ 558.3(b)(10)). The definition of animal production facility does not hinder the movement of feed between a feed mill and an animal production facility. VFD feed may be shipped from a distributor directly to an animal production facility, or may first be delivered to a facility or feed mill that is located where the animals are not housed. Provided the recipient of such feed has a lawful VFD and is the owner of both the facility or feed mill to which the feed was delivered and the animal production facility, further movement of that VFD feed to the actual animal production facility would not be limited and we would not consider such further movement to be the activity of a “distributor.”
In the December 2013 NPRM, we added a definition for the term “combination veterinary feed directive (VFD) drug.” In the final rule, we have further clarified that definition to align the language with the statutory definition of a veterinary feed directive drug.
In the December 2013 NPRM, we proposed that VFDs would no longer be specifically required to be produced in triplicate; however, all three involved parties (veterinarian, distributor, and client) still would be required to receive and keep a copy of the VFD, either electronically or in hardcopy. If the VFD is transmitted electronically, the veterinarian would no longer be required to send the original in hardcopy to the distributor.
(Comment 8) Many comments supported these changes. Some comments indicated that there was some confusion about whether an electronic copy of the VFD would satisfy the recordkeeping requirement.
(Response 8) To improve the clarity of this section, we have revised the regulatory text to more precisely indicate the recordkeeping requirements. An electronic copy of the VFD is sufficient for recordkeeping purposes. The original no longer needs to be sent to the distributor. As we stated in the December 2013 NPRM, this hardcopy requirement has become outdated by modern electronic communication and presents an unnecessary burden on the industry.
This revision further reduces the number of paper copies requiring physical recordkeeping space. The December NPRM, however, did not specify who should maintain the original. Because of the confusion indicated in the comments, we are revising the rule to specify that the original should be maintained by the veterinarian who issued the VFD and should be maintained in the manner it was generated, either electronic or hardcopy. The client and distributor should each also have a copy of the VFD, and that copy may be electronic or hardcopy.
(Comment 9) A few comments addressed the regulatory requirements for electronically generated documents. One comment asked what requirements would apply to records with an electronic signature. Another comment urged FDA to not require compliance with 21 CFR part 11 (part 11) for VFDs transmitted and stored electronically.
(Response 9) The regulations in part 11 (Electronic Records; Electronic Signatures) describe FDA's standards for assessing whether electronic records and electronic signatures are trustworthy and reliable and generally equivalent to paper records with handwritten signatures. Electronic records, such as an electronic VFD that meets the requirements of part 11, may be used in lieu of a paper VFD (
(Comment 10) One comment suggested that a paper VFD process would be unwieldy, costly, and burdensome.
(Response 10) There are relative advantages and disadvantages to generating and keeping records in either electronic or paper form. We believe that businesses should be able to decide what format (electronic or hard copy) they would like to use to fulfill the recordkeeping requirements. For that reason, we proposed regulations that removed the explicit requirement that
(Comment 11) One comment requested clarification about the caution statement required on labeling and advertising for VFD drugs and feeds containing VFD drugs. The comment recognized that for products in paper bags this would be appropriate, but wondered what would be required for feed that is delivered in bulk where there is no container.
(Response 11) As reflected in the regulatory text, all labeling and advertising for VFD drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs must prominently and conspicuously display the cautionary statement. In section 201(m) of the FD&C Act (21 U.S.C. 321(m)), “labeling” is defined as “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” Packaged food typically has a label affixed to the package or container; however, any labeling or advertising would also need to contain the statement. Bulk food typically does not have a label affixed to the container, but is accompanied by labeling to meet other requirements of the FD&C Act, such as displaying the common or usual name of the animal food, as well as any other information already required by existing regulations. FDA would expect that the caution statement be on this labeling, as well as any other labeling or advertising for the bulk food.
In the December 2013 NPRM, we proposed to reduce the length of time a VFD and records related to a VFD must be kept from the currently required 2 years to 1 year. We received many comments related to this requirement. After further considering this issue, we are retaining the existing 2-year recordkeeping requirement.
(Comment 12) We received many comments requesting FDA to maintain the current 2-year recordkeeping requirement. We also received several comments supporting the proposed 1-year recordkeeping period. Some of these comments supported the 1-year requirement because many VFD records are also required to be kept under the CGMP recordkeeping requirements for medicated feeds found in part 225 (21 CFR part 225), and those requirements specify a 1-year retention period. A few comments requested a requirement that records related to VFDs be kept for a period shorter than 1 year, or longer than 2 years.
(Response 12) In response to comments and after further consideration of the issue, we are requiring that VFDs and all required records related to VFDs for veterinarians, clients, and distributors be kept for a period of 2 years. This record retention period is the same as the current record retention requirement. Our purpose in proposing the 1-year recordkeeping requirement in the December 2013 NPRM was to better align the VFD recordkeeping requirements with those in the CGMP regulations in part 225 for medicated feed. All records required under part 558 of this chapter must be kept for 2 years. In addition, as discussed elsewhere in this document, we believe it is important that all parties be required to maintain VFD receipt and distribution records for 2 years, irrespective of whether the party is required to maintain receipt and distribution records under part 225 of this chapter. We believe that there are several benefits to a 2-year VFD record retention period.
The first benefit is that a 2-year VFD recordkeeping requirement aligns with the recently published Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals proposed rule (78 FR 64736; October 29, 2013). This proposed rule includes new CGMP requirements for operations that manufacture, process, pack, and hold animal food, including animal feed, and proposes a 2-year records retention period. Some of those recordkeeping requirements would also fulfill the VFD recordkeeping requirements. We believe that, because many operators manufacturing or distributing animal feed bearing or containing VFD drugs may be required to comply with these proposed CGMP requirements, they would benefit from such a recordkeeping requirement alignment.
In addition, while we still believe that a longer retention period ordinarily will not be critical in order to investigate violative drug residues in edible animal tissues, the longer record retention period would provide a more complete history of records, which is useful in identifying patterns of noncompliance with the VFD regulations during regular inspections.
As discussed elsewhere in this document, this final rule adds clarifying language that distributors who manufacture animal feed bearing or containing VFD drugs must keep VFD feed manufacturing records for 1 year in accordance with part 225. These manufacturing records are not required to be kept for 2 years unless they are also required to be kept under part 558 of this chapter (
FDA is requiring that any veterinarian issuing a VFD be licensed to practice veterinary medicine and operate in compliance with appropriate State defined veterinarian-client-patient relationship (VCPR) requirements or Federally defined VCPR requirements where no applicable and appropriate State VCPR requirements exist. Some States' licensing and practice requirements specify that a VCPR as defined by that State's law must exist before a VFD can be issued. In those States with VCPR requirements that include the key elements of a VCPR as described in the Federal definition (§ 530.3(i)), FDA intends to defer to the State VCPR requirement. This has the advantage of being able to leverage the accountability that comes with State licensing board oversight to ensure compliance with the VCPR requirement, while providing States the flexibility to adapt their VCPR requirements appropriately to local conditions. Although elements of a VCPR are discussed in the paragraphs that follow, FDA believes that in order for the State defined VCPR requirements to sufficiently “include the key elements of a VCPR as defined in § 530.3(i),” the State defined VCPR must at least address the concepts that the veterinarian: (1) Engage with the client to assume responsibility for making clinical judgments about patient health, (2) have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where patient is managed, and (3) provide for any necessary followup evaluation or care. In States where the practice requirements do not require that a VFD be issued within the context of a State defined VCPR, FDA is requiring that the VFD be issued within the context of a Federally defined valid VCPR.
(Comment 13) The majority of comments supported maintaining a veterinarian-client-patient relationship (VCPR) as a requirement for issuing a VFD. A large number of those comments asked FDA to maintain the Federal definition of a VCPR because some States either do not define VCPR in their State licensing and practice requirements, or they include a VCPR requirement for dispensing prescription drugs or controlled substances, but not for issuing a VFD. Many comments raised the specific concern that the veterinarian who issues a VFD should be required to have recently seen the animals specified in the VFD or visited the farm on which the animals were kept.
(Response 13) FDA agrees that a veterinarian-client-patient relationship is an important element of veterinary supervision and oversight of the VFD process. As stated in the December 2013 NPRM, our intent in revising the VCPR provisions was to “appropriately defer to existing regulatory oversight standards for veterinary professional conduct,” which are overseen by the State organizations responsible for the licensing of veterinarians. We did not intend to eliminate requiring a VCPR for the issuance of a lawful VFD. Instead, we intended to broaden the concept of supervision and oversight to include a VCPR and other practice requirements as defined by the State to allow for practice variations and the need for flexibility among State requirements.
After reviewing the comments, it is clear that some people have interpreted our proposed changes as a relaxation of the existing VCPR requirement. We acknowledge that not all States currently require that a VCPR must exist before a VFD can be issued and that there is some uncertainty as to when or if such States will choose to establish such a requirement subsequent to finalization of this rule. To address potential gaps in those States that currently lack VCPR requirements applicable to VFDs, we are changing the regulatory text to specify that in those States that require a VCPR that includes the key elements of the Federally defined VCPR in order for a veterinarian to issue a VFD, the veterinarian issuing the VFD must be operating within the context of a VCPR as that term is defined by the State. In all other cases, the veterinarian must be operating within the context of a valid VCPR as defined by FDA in § 530.3(i).
A review of the States that have VCPR requirements in place that are applicable to the issuance of VFDs reveals that those VCPR requirements typically provide that the animals or premises must recently have been seen by the veterinarian, or that the veterinarian otherwise have on-farm knowledge of the animals sufficient to make a diagnosis. Some States go further, requiring that the animals must have been seen by the veterinarian within a certain timeframe, or that the veterinarian has performed an actual examination of the animals. FDA, therefore, believes that recognizing State professional standards for issuing a VFD in accordance with VCPR requirements as prescribed by State law or, where no applicable State VCPR requirements exist, requiring the VFD to be issued in compliance with Federally defined VCPR requirements, addresses the concern raised by these comments that some States currently lack VCPR requirements applicable to VFDs, as well as the concern that the veterinarian should be required to have recently seen the animals specified in the VFD or visited the farm on which the animals are kept.
(Comment 14) A large number of comments did not specifically mention a VCPR requirement, but more broadly supported veterinary supervision and oversight of the VFD process.
(Response 14) We agree that veterinary supervision and oversight is important in the issuance of a VFD. We believe that the requirements we have included in the regulatory text will help ensure adequate veterinarian oversight and supervision over the use of VFD drugs in animal feed and are responsive to the comments received.
(Comment 15) A number of comments supported the proposed intent of the December 2013 NPRM to defer to State standards for the practice of veterinary medicine. These comments supported allowing flexibility for States to set practice standards that address the particular needs and concerns of the State, including the issue of veterinary shortages. Several comments also supported the intention to recognize professional expertise and oversight by State licensing boards to enforce professional conduct and practice requirements.
(Response 15) We agree that the practice of veterinary medicine has traditionally been regulated at the State level and that the States generally are in a better position to establish and enforce the requirements of the practice of veterinary medicine. However, not all States have appropriate VCPR requirements specifically applicable to the issuance of a VFD. As a result, we believe that the approach we proposed in the December 2013 NPRM to defer to State practice standards needs to be supplemented with Federally defined VCPR requirements that apply to States without such requirements, so that all VFDs will continue to be issued under veterinary supervision and oversight within the context of a defined and appropriate VCPR. This approach addresses both our original intent, as well as the concerns raised in the comments.
(Comment 16) A number of comments raised the concern that there is a shortage of veterinarians, or veterinarians with specialized expertise, in certain geographical areas. One comment said that the regulation did not fully address the veterinary shortage issue. A few comments requested that the rule should include an exemption for farms that have limited access to veterinarians, or FDA should make funds available to ensure the farms have access to veterinarians for treatment of sick animals. One comment requested that FDA work with USDA on an assistance program for small farmers to enable access to veterinary care and support the study of large animal medicine so more veterinarians will enter the field. At least one comment cited studies from the American Veterinary Medical Association (AVMA) and the Cornucopia Institute documenting the lack of access to affordable and competent veterinarians in rural areas. This comment also stated that, according to the American College of Poultry Veterinarians, there are only 235 veterinarians available to the poultry industry in the United States. One comment suggested that an exemption be made for farmers who cannot access a veterinarian and for species where the drug administration route of best efficacy is feed or water.
(Response 16) We recognize and share the concerns raised in the comments regarding the challenges that animal producers may face in accessing qualified veterinary care. In light of these concerns, FDA also carefully considered the feedback received on this issue from the April 2012 draft proposed regulation and the 2013 public meetings with stakeholders in rural areas to identify regulatory changes that might help to mitigate this concern. For example, FDA's intent in proposing in the December 2013 NPRM to remove the “one-size-fits-all” Federally defined VCPR standard was to allow the veterinary profession and States the flexibility needed “to adjust the specific criteria for a VCPR to appropriately align with current veterinary practice standards, technological and medical advances, and other regional considerations” (78 FR 75515 at 75518). In the NPRM, we stated that this greater flexibility “could allow veterinarians to
As veterinary oversight of the therapeutic use of certain medically important antimicrobials is phased in, FDA will continue to seek opportunities to work with our Federal, State, and other stakeholder partners to help address the practical issues associated with limited access to veterinary services in certain parts of the country.
(Comment 17) A few comments raised the concern that requiring veterinarian supervision and oversight would impose an unreasonable financial burden on small farmers. As a solution, these comments stated that a VCPR should be required only for confinement agricultural feeding operations and farms with more than $300,000 turnover, and small producers should be exempt from VCPR requirements. One comment suggested an exemption for species where the feed or water route of administration is the only practical means of effectively administering antimicrobial therapy.
(Response 17) We disagree that the requirements for veterinarian supervision and oversight should not apply to the VFDs issued to small farmers or for certain species. Section 504 of the FD&C Act (21 U.S.C. 354) requires that VFD drugs be used under a veterinarian's supervision. As a result, veterinary supervision for the use of VFD drugs is required, whether or not certain animal producers or operations would be exempt from State or Federally defined VCPR requirements. Therefore, exempting small animal producers or certain species from VCPR requirements would not likely result in any cost savings for their use of VFD drugs because the statute requires the veterinarian to be involved in the issuance of a VFD. In addition, it would be difficult and confusing for veterinarians to determine whether such an exemption would apply. For these reasons, FDA does not believe that this proposal is a viable solution.
Furthermore, FDA does not believe that continuing to require a VCPR, whether State or Federally defined, to issue a VFD results in an unreasonable financial burden on animal producers. FDA continues to believe that veterinary oversight of the use of medically important antimicrobial drugs in feed is a critical measure for ensuring judicious use of these drugs in support of efforts to minimize antimicrobial resistance. Maintaining a requirement for an appropriate VCPR is a fundamental element of providing for meaningful veterinary oversight. FDA will continue to seek opportunities to work with our Federal, State, and other stakeholder partners to help address the practical issues that arise as veterinary oversight of the therapeutic use of certain medically important antimicrobials is phased in.
(Comment 18) A few comments stated that the requirement for supervision and oversight was not clear, or advocated for specific requirements to be included as part of supervision and oversight. These comments requested more specific guidelines describing the amount of time the veterinarian must spend on the farm or ranch, how recently the veterinarian must have seen the animals or farm, whether the veterinarian needs to see the animals or visit the farm in person, and what it means for a veterinarian to be familiar with the client's operation. The comments also expressed concern that veterinarians be licensed in each State where there is a facility under the operation, and that the facility should be recently visited so that the veterinarian is familiar with the local conditions in which the animals are raised.
(Response 18) We have addressed these concerns by including more specific language about the requirements for veterinary supervision and oversight, including compliance with State licensing and practice requirements and the continued role of a VCPR in § 558.6(b)(1). The State and Federal definitions of VCPR set out the requirements for the veterinarian to establish an appropriate relationship with the client and the animal(s) for which services are being provided.
The first element of the Federal VCPR is that “A veterinarian has assumed the responsibility for making medical judgments regarding the health of (an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian” (§ 530.3(i)(1)). For the States that define a VCPR, all but one State includes in their definition a statement about the responsibility the veterinarian assumes in making medical judgments about the animal's health. Many of the States go further and specify the owner or animal producer's responsibility to follow the veterinarian's instructions.
The second element of the Federal definition of VCPR states that “There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s) . . .” (§ 530.3(i)(2)). In addition, the definition states that “[s]uch a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept” (§ 530.3(i)(3)). Typically, a veterinarian has an ongoing relationship with the client and the client's animals being treated such that the veterinarian is familiar with the animal production operation and has made previous visits to their facility(s). This relationship also allows the veterinarian to provide education to the client about appropriate use of medication, including storage, use, and withdrawal times. FDA expects that a veterinarian will only authorize use of a VFD feed in animals for which he or she has such knowledge and familiarity. For the States that define a VCPR, all but one State includes in their definition a statement about the veterinarian's knowledge of or acquaintance with the animal or operations. Most of the States that incorporate this knowledge or acquaintance criterion in their VCPR definition provide similar detail to the Federal definition about what constitutes sufficient knowledge, such as requirements that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by an examination or medically appropriate and timely visits. Some States are even more specific and specify the time period in which the animal must have been seen by the veterinarian. A few States do not have a knowledge or acquaintance criterion, but instead require that the veterinarian has actually examined the animal or a representative segment of the consignment or herd. Thus, in most States, these requirements regarding responsibility are the same or similar to the current Federal definition.
The third element of the Federal VCPR is that “The practicing veterinarian is readily available for followup in case of adverse reactions or failure of the regimen of therapy” (§ 530.3(i)(3)). The State VCPR definitions vary the most among each other and from the Federal definition in what they require regarding followup care. Seven States that define VCPR do not specify in their VCPR a requirement for followup veterinary availability. The primary role of the veterinarian in issuing a VFD is the supervision and oversight needed for the issuance of the VFD and feeding of the VFD feed. Even though some States do not have specific requirements about how readily available the veterinarian must be for followup, these States all have a requirement that the veterinarian is knowledgeable of, or acquainted with the animals, or farm, and/or the veterinarian has assumed the responsibility for making medical judgments regarding the health of the animal and its need for medical treatment.
Most of the States that have a VCPR requirement that applies to the issuance of VFDs define a VCPR in a manner consistent with the Federal VCPR. Like the Federally defined VCPR, the key elements of a VCPR for many of these States includes the requirements that the veterinarian issuing a VFD assume responsibility for the medical care of the animal and have sufficient knowledge of the animal or herd based on having recently seen and being personally acquainted with the keeping and care of the animals and/or perform an actual examination of the animal or herd or make timely visits to the operation. For that reason, we believe that deferring to the State VCPR standard for those States that define an appropriate VCPR applicable to VFDs will allow States the needed flexibility to factor regional considerations into their VCPR requirements while, at the same time, continuing to provide sufficient protection for human and animal health. In those States that do not define a VCPR that includes the key elements in the Federally defined VCPR, or in the States that define a VCPR but do not require it for the issuance of a VFD, the veterinarian is required to issue the VFD within the context of a valid VCPR as that term is defined by FDA at § 530.1(i). FDA will work with States to finalize its list of the States that have an appropriate VCPR that applies to VFDs. Once that task is complete, FDA will communicate that information to the public as part of the implementation of this final rule. FDA will also continue to work with the States and veterinary associations to foster the adoption of VCPR definitions that are sufficiently rigorous to ensure meaningful veterinary supervision and oversight.
With respect to the comment suggesting that a veterinarian who writes VFDs for a particular animal production operation needs to be licensed in each State where that operation has a facility, we disagree that such a requirement is necessary unless such licensing is required by the States where those facilities are situated. In other words, the veterinarian needs to be in compliance with the licensing requirements in the State(s) in which he or she is practicing veterinary medicine. The State laws and rules for licensing and practice determine for what activities a license is necessary and whether reciprocity or other programs that recognize licensure in another State may apply. It is the responsibility of the veterinarian to be familiar with the licensing and practice requirements for his or her activities in each State in which he or she practices veterinary medicine. A client who operates in multiple States may engage with one veterinarian who is in compliance with all of those States' licensing requirements, or may choose to engage more than one veterinarian to ensure that a veterinarian is available who complies with each of those States' licensing and practice requirements.
(Comment 19) Some comments raised concerns with FDA's proposed language and the potential impacts on public health if the Federal VCPR standard is eliminated. Comments also expressed concern with the lack of a description or explanation in the NPRM of how the Federal standard is overly burdensome, how State regulations and voluntary ethical principles will adequately substitute for a VCPR, and why a Federally defined VCPR is unnecessary to ensure appropriate use of VFD drugs when it is appropriate to guide drug use in other contexts.
(Response 19) As discussed elsewhere in this document, our intention was not to eliminate a VCPR standard, but instead to provide the flexibility of relying on States' standards for veterinary professional conduct, which are based on current veterinary practice standards, technological and medical advances, and other regional considerations. As discussed elsewhere in this document, based on the State defined VCPR standards that exist currently, we believe that an appropriate State defined VCPR standard affords a level of veterinarian supervision and oversight similar to the Federal VCPR standard, and helps ensure animals are being provided VFD drugs judiciously and for approved indications. Therefore, we do not think that this change will affect public health.
We stated in the December 2013 NPRM that our intent was to provide greater flexibility for veterinarians by deferring to the individual States for the specific criteria for acceptable veterinary professional conduct. In the final rule, the Agency has affirmed its decision to defer to State practice standards for acceptable veterinary professional conduct when those standards require a VCPR for the issuance of a VFD that includes the key elements of the Federally defined VCPR standard. In response to comments that some State practice standards do not require a VCPR for the issuance of a VFD, and because a VCPR is an important part of veterinarian supervision and oversight in the VFD process, we will require adherence to the Federally defined VCPR if an applicable and appropriate State VCPR standard is not in place.
As we have stated previously, many States have defined VCPR, and require a VCPR to exist in order for a veterinarian to issue a VFD. Many States also explicitly adopt the AVMA Principles of Veterinary Medicinal Ethics as part of their practice requirements, which includes a VCPR definition (Ref. 8). For States with a VCPR definition that does not include key elements of the Federally defined VCPR, or who do not require a VCPR for issuing a VFD, language in the regulatory text requires veterinarians to issue VFDs in compliance with the Federally defined valid VCPR. For the reasons stated previously, FDA believes a hybrid State and Federal VCPR approach is appropriate to help ensure sufficient veterinary oversight and supervision for the use of VFD drugs in or on animal feed.
(Comment 20) Several comments were concerned that the elimination of the Federally defined VCPR as proposed in the NPRM would result in FDA no longer being able to take enforcement action against veterinarians who issue a VFD for animals outside the context of a VCPR. Several comments supported FDA engaging in outreach and education to feed mills and veterinarians on the subject of veterinarian supervision and oversight as it pertains to VFDs as part of this Agency's compliance and enforcement processes.
(Response 20) We agree that it is important for regulations to be enforceable. The approach in the regulatory text allows either the States
FDA is committed to working with the State entities that license veterinarians in order to ensure that appropriate action is taken if the veterinarian does not issue VFDs in the context of an appropriate VCPR, or does not follow State licensing or practice requirements.
(Comment 21) A few comments requested clarification about the use of the terms “veterinary supervision” and “veterinary oversight” as used in the VFD regulation. The comments asked whether “oversight” means something different than the term “supervision” which is used in section 504, or whether the two terms are meant to be synonymous. The comments were concerned that oversight could be performed in place of supervision and that it was a less-stringent standard. One comment requested that FDA define “supervision or oversight” to mean that the veterinarian has visited the premises at least once per year or documented why an alternative visitation schedule is more appropriate.
(Response 21) For purposes of this regulation, the term “oversight” is meant to be a synonym of “supervision.” The phrase “supervision or oversight” was introduced in order to tie the oversight language FDA has used in other documents to the concept of veterinary “supervision,” which is the term used in section 504 of the FD&C Act. As discussed previously, the VCPR which is required for issuing a VFD controls how recently a veterinarian needs to have examined the animals or operation. As a result, FDA does not find it necessary to define the phrase “supervision or oversight” to mean that the veterinarian has visited the premises within a specific timeframe.
(Comment 22) A few comments were concerned about a potential conflict of interest between the veterinarian and the client. One comment said that the veterinarian should not have a fiduciary tie to production. One comment said that an oversight committee should be established to independently approve antibiotic use.
(Response 22) We understand the concern raised by these comments. However, most State practice requirements have a standard of ethics that addresses what constitutes a conflict of interest and the ethical standards veterinarians must observe in such circumstances. The requirement for the veterinarian issuing the VFD to comply with all State practice requirements includes compliance with standards of ethical conduct.
We disagree that an oversight committee should be established to independently approve antibiotic use. Currently, there are several points of oversight in the use of antibiotics. The drug is first reviewed for safety and effectiveness as part of the approval or indexing process. During this process, parameters are set that limit the drug's use to certain conditions and for certain approved uses, as reflected on the drug's approved labeling (Refs. 9, 10, and 11). In addition, VFD drugs are required to be used under a veterinarian's supervision. The veterinarian's role is to make a medically-based decision as to whether a particular VFD drug or combination VFD drug is appropriate for the treatment, control, or prevention of a specific disease. Should the veterinarian determine that a VFD drug should be used, he or she can only use the drug as stated on the approved labeling of that drug. Extralabel use (ELU) of medicated feed, including VFD feed, is prohibited by statute.
Furthermore, as part of the effort to implement the objectives of the National Strategy for Combating Antibiotic Resistance published in September 2014, FDA will be working with veterinary organizations, animal producer organizations, and other partners to identify and implement measures to foster stewardship of antibiotics in animals. These measures include educational outreach to veterinarians and animal producers to advance antibiotic stewardship and judicious use of antibiotics in agricultural settings (Ref. 12).
(Comment 23) Several comments supported ELU being allowed by veterinarians for VFD drugs.
(Response 23) ELU of a new animal drug in or on animal feed is illegal and results in the drug and feed being deemed unsafe under section 512(a) of the FD&C Act and adulterated under sections 501(a)(5) and (6) of the FD&C Act.
In the December 2013 NPRM, we proposed to remove the requirement that veterinarians include their license number and the name of the issuing State on the VFD. We received several comments on this issue and, after consideration of these comments, we are finalizing our proposal to not require veterinary licensing information on the VFD.
(Comment 24) One comment requested that we require the veterinarian to list their license number and State of licensure on the VFD for traceability and accountability. This comment indicated that these requirements were not a burden on the veterinarian because veterinarians use preprinted forms, and adding this information to their electronic signature is a one-time effort that takes only minutes to complete. A few comments supported the proposed change because they thought the required name and address of the veterinarian on the VFD would be sufficient if follow up with the veterinarian ever became necessary.
(Response 24) We disagree that including the veterinarian's license number and State of issuance on the VFD is necessary for traceability or accountability. The issuing veterinarian's name and address is sufficient for FDA to work with the State veterinary licensing boards to determine licensure status, in the event that there is a concern that a VFD has been illegally issued. Also, many State licensing boards maintain an online database that allows the public to search for a veterinarian's licensing status by their name.
We disagree that the low burden is outweighed by the benefit of requiring this information, because we do not believe that this information provides any additional benefit to determining the licensure status of veterinarians.
(Comment 25) One comment requested clarification on whether it is allowable to use an approved generic VFD drug as a substitute for an approved pioneer VFD drug in cases where the pioneer VFD drug is identified on a VFD.
(Response 25) The veterinarian is required to write the name of the VFD drug on the VFD. The veterinarian may choose to write the name of the pioneer or a generic (if available) VFD drug to complete this requirement. The veterinarian may choose to specify that a substitution by the feed manufacturer of either the pioneer or generic VFD drug identified on the form is not allowed. If the veterinarian does not specify that a substitution is not allowed, the feed manufacturer may use either the approved pioneer or an approved generic VFD drug to manufacture the VFD feed. However, the feed manufacturer may not substitute a generic VFD drug for a pioneer VFD drug in a combination VFD feed if the generic VFD drug is not part of an approved combination VFD drug.
(Comment 26) A few comments requested clarification about whether the feedlot manager's information is the correct information for the client name and address.
(Response 26) The client name and address should reflect the client in the veterinarian-client-patient relationship, which is typically the person responsible for feeding the animals the VFD feed. In many cases, a feedlot manager may be the appropriate individual.
The December 2013 NPRM proposed to retain the existing requirement that the location of the animals be specified on the VFD. In the proposed language, this requirement was listed separately from the required information about the number and species of animals. The NPRM also proposed to allow the issuing veterinarian, at his or her discretion, to provide more detailed information about the location of the animals to be fed the VFD feed. The regulatory text in this final rule reflects the approach proposed in the NPRM.
(Comment 27) A few comments suggested that the site or location at which the animals are located be determined broadly (
(Response 27) We expect that, in response to the requirement to enter information describing the premises where the animals are located, the veterinarian would enter information about the location of the animals that would allow someone to locate the animals. Typically, the address would be an appropriate way to identify the location; however, other generally recognized geographical indicators such a global positioning system (GPS) coordinate may be appropriate if a street address does not exist.
We recognize that an address for a facility may not provide enough information to identify the location of animals in a case where the VFD is meant to authorize that a very specific group of animals receive the animal feed bearing or containing the VFD drug. As a result, the veterinarian may use his or her discretion to enter additional information on the VFD that more specifically describes the location of the animals such as the site, pen, barn, stall, tank, or other descriptor. The veterinarian should consult with the client to determine whether the animals will remain at this more specific location until the expiration date of the VFD.
We understand that some groups of animals that are of similar age, weight range, etc., are managed in a similar manner, but may be housed in different physical locations. For example, a group of weaned pigs may be moved out of a nursery facility and transferred to multiple grow-out facilities for finishing. If a VFD is intended to authorize the use of a VFD feed in an identified group (approximate number) of animals that are located at more than one physical location, it is acceptable for a veterinarian to include multiple specified locations for that group of animals on the VFD. The veterinarian may write a VFD that covers animals in multiple locations (animal production facilities) to be fed the VFD feed by the expiration date on the VFD, provided he or she can do so in compliance with professional licensing and practice standards and provided the VFD feed is supplied to such multiple locations by a single feed manufacturer (distributor).
The December 2013 NPRM proposed to add new language to the requirement that the veterinarian enter the expiration date of the VFD on the form. The new language limits the veterinarian to using the expiration date that is specified in the approval, conditional approval, or index listing. Where such date is not specified, the veterinarian can write a VFD with an expiration date that does not exceed 6 months after the date of issuance of the VFD. The regulatory text in this final rule reflects this approach, with clarified language.
(Comment 28) Many comments supported the 6-month expiration period. Some comments also requested that the VFD expire when an animal is deceased, at 6 months, or based on the expiration date specified in the approved labeling, whichever is shorter.
(Response 28) We agree that a maximum 6-month expiration date in the absence of an expiration date specified in the approval, conditional approval, or index listing is appropriate. The date of expiration should be calculated by the calendar date, not the number of days. This will allow for easy calculation by veterinarians in the field. For example, using a 6-month expiration date for a VFD, if the VFD is written on July 10, then the expiration date would be January 10 of the following year. Using the same 6-month expiration date example, but having the VFD written on the last day of the month, the VFD expiration date would be the last day of the sixth month even if that month has fewer days. Thus, in this example, if the VFD is written on August 31, the expiration date would be the following February 28 during a regular calendar year, or February 29 during a leap year.
With respect to the comments requesting to have the VFD expire when an animal is deceased, at 6 months, or based the expiration date specified in the approved labeling, whichever is shorter, we do not agree with these
(Comment 29) Many comments requested the expiration period be shorter than 6 months. One comment requested that the VFD expire at the end of treatment. Some comments recommended expiration periods of 21 and 30 days. One comment recommended that the maximum expiration period be shortened to 90 days if VFD drugs are used for unapproved uses or for longer than 6 months, with the possibility of extension upon reassessment.
(Response 29) We disagree that a shorter expiration period is necessary for VFD drugs that do not specify an expiration date in their approval, conditional approval, or index listing. Even though a VFD can be written for a 6-month period does not mean the veterinarian will write all VFDs with a 6-month expiration date. The veterinarian will use his or her medical judgment to determine what expiration date is appropriate for the VFD, based on many factors including, but not limited to, the type of animal production facility and operation, the VFD drug or combination VFD drug at issue, the intended use of the VFD drug, and the health status, treatment history, and life cycle of the animals.
Also, a maximum expiration period of 6 months does not necessarily mean that the animals will consume the feed containing the VFD drug for 6 months. Rather, an expiration period of 6 months means that the authorization to feed the specified VFD product is lawful for 6 months. The veterinarian is also required to include on the VFD the duration of use, which limits the amount of time the animal feed bearing or containing the VFD drug can be fed. The duration of use must follow the duration that is specified in the approval, conditional approval, or index listing even if it is a shorter timeframe than the expiration date. If the veterinarian issues a new VFD after the expiration date of the first VFD, they can use their medical judgment, taking into account factors such as the life cycle and treatment history of the animal, to consider what expiration date would be appropriate for the new VFD, up to the 6-month maximum for VFD drugs that do not specify an expiration date in the approval, conditional approval, or index listing.
We disagree that a shorter VFD expiration period should be in place for VFD drugs used for unapproved uses, or those used longer than 6 months. Medicated feeds, including those bearing or containing a VFD drug, cannot legally be used in an extralabel (unapproved) manner; such use is prohibited by statute. As explained previously, the expiration date of the VFD does not control how long the VFD drug is to be used, but rather defines when it must be used by (
(Comment 30) Some comments requested that the maximum expiration date of a VFD be longer than 6 months. Most of these comments requested that the VFD expiration date be a maximum of 1 year.
(Response 30) We disagree that a maximum expiration date for a VFD should be longer than 6 months for VFD drugs that do not have an expiration date specified in their approval, conditional approval, or index listing. We think that a 6-month maximum VFD expiration date permits veterinarians, based on their medical judgment and knowledge of the animal production operation, to determine on a case-by case basis whether the maximum 6-month period is an appropriate expiration date for the VFD or whether a more limited period is warranted. When deemed appropriate, we expect that flexibility in applying the VFD expiration date can substantially reduce the administrative burden associated with issuing VFDs for a given animal production operation. Limiting the expiration to a maximum of 6 months ensures that the veterinarian is required, at least every 6 months, to review whether factors such as the type of animal production operation, animal health, or the need to use a VFD drug have changed when considering whether to issue another VFD.
(Comment 31) Several comments requested clarification about how the VFD expiration date relates to refills and reorders, the duration of use and the concept of standing orders. Several comments supported VFD drugs having clear limits on the duration of use. These comments did not specifically recommend an expiration date, but offered support for the risk criteria in GFI #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concerns.” Several comments were concerned that a VFD drug could be continuously used. Some of these comments requested that FDA not permit the continuous use of a VFD drug.
(Response 31) As previously discussed, the VFD expiration date defines the period of time for which the authorization to feed an animal feed containing a VFD drug is lawful. This period of time may be specified in the approved labeling of a given VFD drug (
We acknowledge the comments seeking limits on the duration of use of VFD drugs. However, the duration of use of VFD drugs (
Similar to the concept of refilling a prescription for 30 tablets with another 30 tablets, a refill or reorder in the VFD
FDA anticipates that the appropriate use of refills or reorders could vary considerably depending on the VFD drug and its use. Since we cannot predict what disease conditions, and what types of VFD drugs for the treatment, control, or prevention of those diseases, may exist in the future, appropriate limitations regarding refills and reorders and how they relate to the expiration date of the VFD must be considered on a case-by-case basis as part of the new animal drug approval process. In the context of antimicrobial VFD drugs, FDA envisions that the refill/reorder concept will have limited applicability.
The term “standing order” is not used in the regulatory text included in this final rule, but has been used in public meetings and by industry to refer to the situation in which a veterinarian issues a VFD for a VFD drug that does not have a label-defined VFD expiration date; therefore, the veterinarian is required to apply a VFD expiration date that does not exceed 6 months from the time the VFD is issued. In such a case, the veterinarian, in the context of a VCPR, would use his or her medical judgment and knowledge of the animal production facility and operation to determine the therapeutic needs for the VFD drug by the expiration date established by the veterinarian. As a result, the client would have the VFD authorization in place and could more quickly get the animal feed containing the VFD drug manufactured if and when the animals needed treatment. In addition, this practice would allow for clients with limited access to veterinarians to be able to receive a VFD within the confines of a VCPR and use it at a later date, but within the expiration date of the VFD, when the need for use of the animal feed containing the VFD drug occurs.
In the December 2013 NPRM, FDA proposed removing the requirement for a veterinarian to identify the amount of feed to be manufactured under the VFD, and modified the requirement to identify the number of animals to instead require the veterinarian to identify the approximate number of animals to be treated under the VFD.
(Comment 32) Multiple comments supported changing the requirement to identify the amount of feed manufactured to instead identify the approximate number of animals on the VFD. These comments recognized the current problems with calculating the amount of feed, including the need to write additional VFDs when feed volume is underestimated and recordkeeping for delivery of feed that only partially fulfills the amount of feed on the VFD. One comment also stated that this change will allow the amount of feed required to be determined by the feed manufacturer, which is how other feed orders are filled.
(Response 32) FDA agrees that the requirement to state the approximate number of animals instead of the amount of feed resolves the problems noted in the comments. FDA agrees that the feed manufacturer, in consultation with the client, has the experience necessary to determine the amount of feed that should be manufactured in order to treat the approximate number of animals identified by the veterinarian on the VFD.
(Comment 33) Several comments were concerned that the approximate number of animals was not clearly defined and were unsure how FDA intended to use the information in enforcing the VFD regulations. These comments were unsure of the scientific basis for specifying the number of animals. The comments were also concerned that the number of animals can change between the time the VFD is issued and the time it expires, and the requirement would add to increased time and costs. The comments requested clarification on the responsibility of the feed mill to address discrepancies between the number of animals and amount of feed.
(Response 33) FDA agrees that further clarity is needed for stakeholders to correctly calculate the approximate number of animals. Therefore, FDA is including additional language in the regulatory text at § 558.6(b)(3)(viii) to clarify how the approximate number of animals should be calculated. The approximate number of animals is the potential number of animals of the species and production class identified on the VFD that will be fed the VFD feed or combination VFD feed manufactured according to the VFD at the specified premises by the expiration date of the VFD. Because the VFD authorization targets the animals that need to be fed the VFD feed, FDA believes the approximate number of animals is an appropriate mechanism to limit the scope of use authorized by the VFD.
FDA recognizes that the number of animals to be covered under the VFD can change by the expiration date; animals may leave or enter the group being fed the VFD feed manufactured under the VFD for a variety of reasons. This is why FDA chose to include the term “approximate” in the requirement. FDA believes that veterinarians typically have enough information about the animal production operation to determine the approximate number of animals that will be entering or leaving the operation over a specific period of time.
FDA does not agree that determining the approximate number of animals will increase time or costs. Calculating the approximate number of animals should take less time than complying with the previous requirement to calculate the amount of feed because the calculation will include fewer factors to take into consideration. Furthermore, using the approximate number of animals may decrease costs because clients will have the flexibility to work directly with their feed supplier to ensure that the appropriate amount of feed is provided for the approximate number of animals authorized by the VFD. This reduces the burden of seeking an additional VFD in those cases where, if the previous requirement to specify the amount of feed on the VFD were still in effect, the veterinarian may have underestimated the amount of VFD feed the animals would consume.
FDA expects the feed mill to share expertise and work with the client and veterinarian to determine the appropriate amount of feed to be manufactured for the approximate number of animals authorized by the VFD and to retain the necessary records to document the amount of feed that was manufactured under the VFD. FDA expects that feed mills will only distribute VFD feeds in quantities that are commensurate with the approximate number of animals as specified by the veterinarian in the VFD. FDA anticipates that, as part of its inspectional activities, it will consider such factors as whether the amount of feed manufactured is reasonable relative to the approximate number of animals specified in the VFD.
(Comment 34) One comment was concerned that using the approximate number of animals would lead to overuse or stockpiling of medicated feeds, and would potentially remove veterinarian oversight from the process.
(Response 34) FDA disagrees with this comment. The veterinarian, with input from the client, will be responsible for identifying the approximate number of animals on the VFD. This level of veterinarian involvement is similar to the veterinarian's current role in identifying the amount of feed. FDA expects that feed mills will only distribute VFD feeds in quantities that are commensurate with the approximate number of animals specified in the VFD. In addition, the client has the responsibility to use the VFD feed within the constraints of the VFD as written by the veterinarian.
Furthermore, FDA does not believe that this change will lead to over-purchasing, stockpiling or unregulated use of VFD drugs or the VFD feeds manufactured with them. Medicated feeds can be susceptible to decomposition if they are stored for lengthy periods of time, making it unlikely that clients would stockpile economically valuable medicated feeds. In addition, other requirements on the VFD limit use of the VFD feed to a specified group of animals for a specified time period, which will help to regulate use and prevent stockpiling. FDA believes that feed mills will be able to more accurately determine the amount of feed to manufacture because they can work with the client as batches of feed are shipped under the VFD to adjust the amount of feed as feed consumption rates change among the animals. The Agency believes this will help to prevent overuse.
Therefore, FDA is revising the current requirement for the number of animals to be treated in § 558.6(b)(3)(viii) to mean an approximate number of animals to be fed the VFD feed by the expiration date on the VFD, due to the difficulty in determining the exact number of animals to be treated during the duration of the VFD. In addition, FDA is removing the existing requirement in § 558.6(a)(4)(vi) for veterinarians to specify the amount of feed to be fed to the animals listed on the VFD, as discussed elsewhere in this document. Veterinarians will instead be required in § 558.6(b)(3)(x) to include the duration of VFD drug use on the VFD in addition to the level of VFD drug in the feed, as is currently required.
In the December 2013 NPRM, FDA added to the language that requires the number of refills or reorders to be entered on the VFD to account for refills or reorders allowed as part of a conditional approval, or index listing in addition to an approval. FDA has updated the proposed language to clarify that when an approval, conditional approval, or index listing is silent on refills or reorders, they are not allowed.
(Comment 35) Some comments supported refills or reorders to continue to be entered on the VFD if refills or reorders are permitted by the approval, conditional approval, or index listing. A subset of these comments requested clarification about how refills or reorders relate to the other provisions of the VFD regulation and what the phrase “permitted by the approval, conditional approval, or index listing” means. One comment suggested that the need for refills or reorders be determined based on the duration of the disease period. One comment asked FDA to remove this requirement because it is likely to cause confusion among animal producers, veterinarians, and feed mills, as many existing OTC products that are changed to VFD status under the GFI #213 process do not have a refill listed on their label.
(Response 35) We agree that if a refill or reorder is permitted as part of the VFD drug approval, conditional approval, or index listing, the veterinarian is required to indicate on the VFD whether he or she is authorizing a refill or reorder and if so, the number of refills or reorders authorized within the limitations permitted by the approval, conditional approval, or index listing. In order for a refill or reorder to be permitted, it must be explicitly allowed in the VFD drug approval, conditional approval, or index listing. Clarifying language has been added to the regulatory text specifying that when the labeling for an approval, conditional approval, or index listing is silent in regards to refills or reorder, a refill or reorder is not permitted.
A refill or reorder is meant to apply to when the feed authorized under the VFD has been exhausted. The refill or reorder would provide authorization to obtain and feed additional VFD feed in the same total quantity and under the same conditions of the existing VFD by the expiration date of the VFD. Currently, there are no approved VFD drugs that allow refills or reorders as a condition of their approval, conditional approval, or index listing. A veterinarian can only authorize refills or reorders if the labeling of the product in question explicitly permits them. Therefore, refills or reorders are not permitted for an approval, conditional approval, or index listing of a VFD drug if the label of such product is silent on the labeling about refills or reorders.
Although there are no refills or reorders permitted for any current VFD drug approvals, there may be future VFD drugs that may be appropriately refilled or reordered as authorized by the veterinarian on the VFD according to their professional judgment up to the maximum number permitted by the VFD drug approval, conditional approval, or index listing. FDA anticipates that the appropriate use of refills or reorders could vary considerably depending on the VFD drug and its use. Since we cannot predict what disease conditions, and what types of VFD drugs for the treatment, control, or prevention of those diseases, may exist in the future, appropriate limitations regarding refills and reorders and how they relate to the expiration date of the VFD must be considered on a case-by-case basis as part of the new animal drug approval process. In the context of antimicrobial VFD drugs, FDA envisions that the refill/reorder concept will have limited applicability.
If a veterinarian writes a VFD that authorizes a refill or reorder for a VFD drug that does not permit a refill or reorder, or if the authorization exceeds the number of refills or reorders permitted, FDA would consider that to be ELU of the VFD drug. ELU of a drug on or in animal feed is prohibited by statute.
(Comment 36) Some comments supported limiting the number of refills or reorders. Several comments were concerned that without a limit to refills or reorders, the non-specific use of antibiotics for long periods of time would be allowed, or that veterinarians could write unlimited refills. A few comments requested that the requirement to list the number of refills or reorders on the VFD should be removed because it is difficult for the feed manufacturer to track.
(Response 36) FDA agrees that limiting refills or reorders is appropriate. However, those limitations should be based on the safety and effectiveness data, and intended use as evaluated and determined at the time of the VFD drug approval, conditional approval, or index listing. The approvals and index listings for the current VFD drugs do not permit refills or reorders.
FDA disagrees that the requirement to list the number of the refills or reorders on the VFD should be removed. Should a veterinarian authorize refills or reorders for a VFD drug as permitted by its approval, conditional approval, or index listing, this is necessary information for the feed mill to appropriately manufacture and for the
In the December 2013 NPRM, FDA proposed a new provision that would require the issuing veterinarian to include one of three “affirmation of intent” statements on the VFD regarding the use of a VFD drug in an approved, conditionally approved, or indexed combination in medicated feed. These “affirmation of intent” statements would either: (1) Allow the VFD drug to be used in any approved, conditionally approved, or indexed combination in VFD feed; (2) allow the VFD drug to be used only in specific approved, conditionally approved, or indexed combinations in VFD feed; or (3) not allow the VFD drug to be used in any approved, conditionally approved, or indexed combination in VFD feed. We received several comments on this new provision and have revised the language in the regulatory text to provide additional clarity in response to the comments received.
(Comment 37) A few comments expressed concern that the veterinarian would not have sufficient knowledge of approved combination VFD drugs. They were concerned that the veterinarian would write a VFD allowing a combination VFD drug that was not approved, conditionally approved, or indexed, or that he/she would not authorize a VFD for a combination VFD drug that was approved, conditionally approved, or indexed.
(Response 37) We understand this concern and have clarified the language in the regulatory text to more explicitly state the three “affirmation of intent” statements the veterinarian may make. These “affirmation statements” facilitate the process by which a veterinarian indicates his or her intent for authorizing the use of a VFD drug with other drugs (
This process of affirming intent will reduce the opportunity for a veterinarian to mistakenly authorize an illegal combination of drugs when he or she chooses to only authorize the VFD drug to be used in certain combination VFD feeds. In addition, veterinarians that create their own VFD can rely on the drug labeling to determine whether the drug is approved, conditionally approved, or indexed to be used in combination with another drug or drugs. In the situation where a VFD is authorizing the use of two or more VFD drugs in an approved, conditionally approved, or indexed combination in VFD feed, the VFD must contain information for all of the individual VFD drugs in the combination. A VFD that authorizes an unapproved combination is not a lawful VFD because ELU of medicated feeds, including feeds containing VFD drugs, is prohibited. We think that this approach balances reducing the risk of an illegal combination being mistakenly included on a VFD with the need for a veterinarian to be able use his or her medical judgment to limit the use of a VFD drug in combination with other drugs.
(Comment 38) One comment requested that additional information be provided in the preamble to the final rule explaining how currently approved, conditionally approved, or indexed combinations of drugs would be used when drugs included in such combinations are changed from OTC drugs to VFD drugs.
(Response 38) We agree that it would be helpful to further clarify the use of approved, conditionally approved, or indexed combination new animal drugs containing a VFD drug and one or more OTC or VFD drugs after such drugs in currently used combinations are changed from OTC to VFD. If any component drug in an approved, conditionally approved, or indexed combination drug is a VFD drug, the combination drug is a combination VFD drug and its use must comply with the VFD requirements. This is because combination drug products must meet the requirements of the drug in the combination that is most strictly regulated. In addition, section 504 of the FD&C Act requires a VFD in order to feed an animal feed bearing or containing a VFD drug to an animal. This is the case whether the VFD drug is being used in or on the feed by itself, or in combination with other OTC or VFD drugs.
An analogous situation is when an approved, conditionally approved, or indexed combination drug contains both Category I and Category II drugs. If the animal feed bearing or containing the combination drug is manufactured from a Category II Type A medicated article, the mill must be licensed and follow the requirements for a licensed medicated feed mill (which are stricter requirements).
(Comment 39) One comment requested that FDA modify the requirement that a veterinarian may not transmit a VFD by phone to state that the veterinarian must not verbally transmit a VFD because technology may allow for a written VFD to be transmitted by a phone.
(Response 39) FDA proposed in the December 2013 NPRM to change this provision for the reasons stated in the comment. FDA finalizes this change in the regulatory text.
(Comment 40) One comment requested that mixing directions not be allowed on a VFD because they are on the label directions.
(Response 40) We understand that non-required information that is placed on the VFD can create confusion and make it more difficult to locate required information on the form. FDA recommends the amount of information on the VFD be limited to the required and discretionary information listed in § 558.6(b)(3) and (4). FDA also recommends that non-required information the veterinarian chooses to include on a VFD in addition to the mandatory and discretionary information listed in § 558.6(b)(3) and (4) be in a place and manner that does not interfere with the information listed in § 558.6(b).
(Comment 41) A few comments requested that a uniform VFD format be required.
(Response 41) FDA understands that a uniform VFD format would help clients, veterinarians, and distributors (including feed mills) quickly identify relevant information on the VFD. However, FDA believes that requiring a specified format for the VFD would be too prescriptive. In this final rule, FDA is updating the regulatory text in § 514.1(b)(9) to clarify that as part of the application process, the sponsor must
In the December 2013 NPRM, we proposed to remove the requirement for distributors to keep records of receipt and distribution from § 558.6(e). We proposed this change because we were changing the retention period for records under the VFD rule from 2 years to 1 year and these records were already required to be kept by manufacturers to comply with the CGMP requirements set forth in part 225. However, as we considered this final rule, it became apparent that a distinction should be made between distributors who manufacture VFD feed and those who do not manufacture VFD feed, but only distribute VFD feed. The final rule provides that all distributors, regardless of whether they manufacture animal feeds bearing or containing VFD drugs or not, must keep records of receipt and distribution for 2 years from the date of issuance in accordance with § 558.6(c)(3). Although this requirement is duplicative for distributors that manufacture animal feeds bearing or containing VFD drugs and must comply with part 225, it is not duplicative for distributors who do not manufacture animal feeds bearing or containing VFD drugs and do not have to comply with part 225. In addition, we believe it is important that all distributors be required to maintain receipt and distribution records because these records are an important tool to trace the animal feed in the event of a recall or investigation of a potentially misbranded or adulterated product. Furthermore, by explicitly stating all VFD recordkeeping requirements in part 558, distributors are not required to refer to another part of the regulation to determine their specific VFD recordkeeping requirements.
Also, we have added clarifying language that distributors who manufacture animal feed bearing or containing VFD drugs must keep VFD feed manufacturing records for 1 year in accordance with part 225 of this chapter. These manufacturing records are not required to be kept for 2 years unless they are also required to be kept under part 558 (
(Comment 42) Multiple comments supported the proposed rule's intent to provide additional efficiency and flexibility in issuing VFDs. Several comments mentioned that providing drugs through animal feed is an important drug delivery tool. Several comments stated that the rule was a step in the right direction, but wanted more done to reduce antimicrobial use. Some comments supported the revisions to clarify that conditionally approved and indexed VFD drugs are included.
(Response 42) FDA believes that the rule achieves its intent to provide additional efficiency and flexibility in issuing VFDs. FDA recognizes the importance of animal feed as a drug delivery tool. FDA recognizes that certain revisions to this rule will facilitate a broader effort to assure the judicious use of antimicrobials in food-producing animals. FDA agrees that this rule provides additional clarity that VFD drugs that are conditionally approved or indexed drugs are also subject to the requirements in this final rule.
(Comment 43) Many comments indicated that FDA's approach should be mandatory, not voluntary. Some comments were concerned that the voluntary approach had no mechanism for enforcement or metric for success. Other comments were concerned that there were loopholes in the rule. One comment thought the rule was not strong enough to stop antibiotic use and antimicrobial resistance.
(Response 43) Many of these comments were unclear as to whether they were referring to the implementation of this rule or FDA's efforts to promote the judicious use of antibiotics in food-producing animals as outlined in the Agency's guidance documents GFIs #209 and #213. To the extent that these comments were applicable to the enforceability of this rule, FDA disagrees that this approach is voluntary. The requirements in the regulatory text are mandatory. As stated in the December 2013 NPRM, the Agency is amending the VFD regulations to make the VFD program as efficient as possible for stakeholders while maintaining adequate protection for human and animal health as FDA implements the judicious use principles for medically important antimicrobial new animal drugs approved for use in food-producing animals.
While not directly relevant to this rulemaking, FDA disagrees with the comments that say a voluntary approach to judicious use of antimicrobials cannot be effective. As of June 30, 2014, all sponsors of medically important antimicrobial new animal drug products covered by GFI #213 have agreed in writing that they intend to engage in the judicious use strategy by seeking withdrawal of approvals relating to any production uses and changing the marketing status of their products from OTC to use by VFD or prescription in order to limit the remaining therapeutic uses of these products in food-producing animals to use under the oversight or supervision of a licensed veterinarian. While GFI #213 specified a 3-year timeframe (until December 2016) for drug sponsors to voluntarily complete the recommended changes to their antimicrobial products, some sponsors have already begun to implement these changes (Ref. 13).
(Comment 44) Several comments requested clarification on how FDA intends to enforce the VFD requirements as drugs change from OTC status to VFD status as part of the implementation of GFI #213. These comments asked whether there would be a period of regulatory discretion, or the allowance of in-commerce labeling changes, in order to handle product on the market when the change occurs.
(Response 44) This question touches upon the broader implementation of GFI #213 and does not pertain specifically to the changes in this the December 2013 NPRM. However, we understand the practical implications of accommodating drug products already in distribution channels and are working to develop and provide further guidance to facilitate an orderly transition of medically important antimicrobial drugs from OTC to a marketing status (VFD or prescription) that requires veterinary oversight.
(Comment 45) One comment asked FDA to delay the implementation of the amended VFD regulation until after the implementation of GFI #213. This comment suggested that there was a conflict of interest in FDA issuing this
(Response 45) We have carefully considered all comments in finalizing this rule. As discussed in the December 2013 NPRM, it is important that the changes to increase efficiency in the VFD program occur prior to the transition of the existing medically important antimicrobial drugs approved for use in animal feed from their existing OTC status to VFD status as part of the implementation of GFI #213. Furthermore, at this time, all sponsors of the drugs identified in GFI #213 have publicly committed to fully engage in this Agency's judicious use strategy which calls for phasing out the use of medically important antimicrobials in food-producing animals for food production purposes and phasing in the oversight of a licensed veterinarian for the remaining therapeutic uses of such drugs (Ref. 13).
(Comment 46) Some comments suggested that FDA should collect and publicly report data about whether the effort to end subtherapeutic use of antibiotics is working. A few comments thought that VFDs should be submitted to FDA for compilation, analysis, and public reporting. A few comments opposed submitting VFDs to FDA because of the additional reporting burden. One comment further opposed the submission of VFDs to FDA because VFDs would not be an accurate tool in estimating antimicrobial use because they are reflective of the amount of antimicrobials authorized, not the amount of antimicrobials used. Another comment thought that FDA's access to VFDs during inspections was sufficient to assess compliance.
(Response 46) In response to the suggestion that FDA collect and publicly report data about whether the effort to end subtherapeutic use of antibiotics is working, FDA notes that the Agency has already committed to publishing information every 6 months about the progress of GFI #213 implementation (Ref. 13). In addition, FDA provides ongoing updates on its Web site regarding sponsor actions related to GFI #213 implementation (Ref. 13).
FDA does not agree that VFDs should be submitted for compilation, analysis and public reporting. Compliance with VFD regulations cannot be assessed by only reviewing the VFD. The VFD must be considered in the context of the operation. This review is ordinarily done during an inspection or investigation. FDA agrees that VFD data would not be an accurate reflection of antimicrobial use because the VFD only represents the amount of antibiotics authorized to be used, not the amount that actually is used. FDA currently receives antimicrobial sales and distribution data, collects antimicrobial resistance data under NARMS, and is developing additional mechanisms for collecting on-farm information regarding antimicrobial use and resistance (Ref. 15). It would be administratively burdensome for FDA to also receive, compile, and house VFDs in a central location. Furthermore, there are disclosure laws that would require FDA to redact most, if not all, of the information required on a VFD because it is considered confidential commercial information.
(Comment 47) Several comments were concerned that the changes to this rule did not sufficiently protect public health.
(Response 47) As previously discussed, it was not FDA's intention in the December 2013 NPRM to remove or lessen public health protections. The previous and current VFD regulatory text contains many provisions that are designed to protect public health. The VFD drug designation provides public health protection by allowing FDA to limit a drug's use in or on animal feed by requiring administration under a veterinarian's supervision and oversight as authorized in the VFD. When an animal drug has been designated a VFD drug, the veterinarian, distributor, and client must adhere to additional regulatory requirements than are applicable to the use of other animal drugs in medicated feed. These additional regulatory requirements are designed to protect public health by ensuring accountability for those individuals involved in the use of the VFD drug and VFD feed. These regulatory requirements also are designed to allow FDA to review the use of the VFD drug and VFD feed to ensure that the VFD drug and VFD feed are used according to the conditions and indications of use as specified in the approval, conditional approval or index listing, and within the supervision and oversight of a licensed veterinarian.
The veterinarian, distributor, and client all have several joint obligations that are intended to protect public health. The VFD feed may only be fed to animals by or upon a lawful VFD issued by the veterinarian. Public health is protected by limiting use of VFD drugs and VFD feed to use under the supervision of a veterinarian as indicated on the VFD because the veterinarian has medical expertise to determine when and how a VFD drug may be appropriately used in animals. All of these involved parties share responsibility in ensuring that a lawful VFD has been issued and the VFD feed is manufactured and used according to the terms of the VFD as issued by the veterinarian. Moreover, the regulations require that VFD drugs and VFD feed contain a caution statement that the VFD drug and resulting VFD feed are restricted to use by or on the order of a licensed veterinarian. In addition to the VFD, these involved parties also each have their specific responsibilities in ensuring that the VFD drug and resulting VFD feed is labeled and used according to the approval, conditional approval, or indexed conditions of use (not used in an extralabel manner). The VFD, VFD drug, and VFD feed are all required to contain a statement that ELU is not permitted. During the approval, conditional approval, or indexing process, FDA sets limitations on how animal drugs can be used based on the scientific evidence offered by the sponsor to show that the drug is safe and effective for the conditions of use. Public health is protected by limiting use of VFD drugs and VFD feed to conditions of use that are based on scientific evidence of safety and effectiveness that has been reviewed by FDA.
The veterinarian has several specific obligations that are intended to protect public health. The veterinarian is responsible for using his or her professional veterinary judgment to determine whether a VFD should be issued and what terms the VFD should contain as allowed by the relevant approval, conditional approval, or index listing. The veterinarian issuing the VFD is required to be licensed to practice veterinary medicine and be operating in compliance with applicable licensing and practice requirements. FDA has clarified that compliance with applicable licensing and practice requirements includes the expectation that the veterinarian is issuing the VFD in the context of an appropriate VCPR as discussed elsewhere in this document. The veterinarian is required to issue the VFD in writing and ensure that all of the required information is fully and accurately included on the VFD. The required information reflects several public health protections including, but not limited to information that: (1) Describes VFD drug, VFD feed, and the indication for which the VFD feed is authorized to be used; (2) describes the animal or group of animals to receive the VFD feed; (3) limits the use of the VFD feed based on the duration of feeding, the expiration date and the allowance of refills or reorders, if any; (4) allows or limits the use of the VFD drug in combination
The distributor also has several specific obligations that are intended to protect public health. The distributor may only fill a VFD if the VFD contains all of the required information. This requirement provides an additional opportunity for the VFD to be reviewed to ensure that it is complete and prohibits the distribution of the VFD feed if it is not. The distributor is also required to keep for 2 years the records of receipt and distribution of all of the VFD feed it distributes. This requirement protects public health by requiring records that would be important for tracing the VFD feed through the distribution system if a problem with the VFD feed were to occur. The distributor must notify FDA prior to that party's first distribution of VFD feed and must notify FDA of any changes in the distributor's contact information or ownership. This notification allows FDA to protect public health by maintaining an inventory of VFD feed distributors to be used for inspection and investigational purposes.
The VFD regulation also includes requirements specific to the client (animal producer) that are intended to protect public health. For example, the client may only feed the VFD feed to animals by or upon a lawful VFD issued by a licensed veterinarian in the course of the veterinarian's professional practice. As explained previously, the client is obligated to use the VFD feed as indicated on the VFD and as allowed in the VFD drug's approval, conditional approval, or index listing. Furthermore, the VFD feed cannot be fed to the animals after the expiration date of the VFD. These requirements protect public health by ensuring that the VFD feed is being fed to the animals under the veterinarian's supervision and oversight in accordance with the VFD and the conditions of approval, conditional approval, or index listing for the VFD drug or combination VFD drug at issue.
FDA has the responsibility for enforcing these requirements and ensuring that VFD drugs and VFD feeds are used according to these requirements that are intended to protect public health. The requirements for the veterinarian, distributor, and client allow FDA to review the use of VFD drugs and VFD feed in the field to determine whether VFD drugs and VFD feeds are being used consistent with the VFD issued by the veterinarian, as well as in accordance with the VFD drug's approval, conditional approval, or index listing.
FDA intends to use a phased enforcement strategy for implementation of this final rule. FDA first intends to provide education and training for stakeholders subject to this final rule such as veterinarians, clients (animal producers), feed mill distributors, and other distributors. These education and training efforts are important for supporting effective implementation and compliance with the final rule. As products are changed to VFD status under the GFI #213 process, FDA will then engage in general surveillance, as well as for-cause inspection assignments. These assignments will be risk-based and in response to adverse observations.
(Comment 48) A few comments requested that a prescription be required for farmers to use antibiotics for animals.
(Response 48) Congress enacted legislation in 1996 establishing a new class of restricted feed use drugs that may be distributed without invoking State pharmacy laws, veterinary feed directive drugs. The resulting language in section 504(c) of the FD&C Act explicitly states that veterinary feed directive drugs are not prescription drugs. However, use of a VFD drug requires supervision from a veterinarian and other restrictions that control access to the animal feed containing the VFD drug as it moves through the distribution chain. The regulatory text for this final rule continues to implement the restrictions and supervision as required by the statute.
(Comment 49) Several comments were concerned about the potential for the use of antibiotics in animals to result in drug residues in human food.
(Response 49) During the drug approval process, drug withdrawal requirements are considered and withdrawal limitations set. These withdrawal requirements are based on scientific information and state how soon an animal or products derived from an animal can become food for humans after a drug has been administered. FDA works closely with other Federal and State Agencies to monitor human food for unsafe drug residues and has a compliance program to take enforcement action when unsafe drug residues occur (Ref. 16).
(Comment 50) A few comments stated that antibiotic use has an environmental impact.
(Response 50) FDA is required under the National Environmental Policy Act of 1969 (NEPA) to evaluate all major FDA proposed actions to determine if they will have a significant impact on the human environment. To implement NEPA mandates, the FDA's Center for Veterinary Medicine (CVM) requires sponsors to submit to FDA during the approval process for the proposed use of their animal drug either an environmental assessment (EA) or a claim that it is within a categorical exclusion established by FDA. Categorical exclusions apply to classes of actions which FDA has determined do not individually or cumulatively significantly affect the quality of the human environment, and are ordinarily are excluded from the requirement to prepare an EA or an environmental impact statement (EIS). If a sponsor claims a categorical exclusion, CVM will determine whether the categorical exclusion applies and, if so, whether there are extraordinary circumstances that would require at least an EA. When an EA is submitted, CVM will evaluate the information contained in the EA, and may include additional information in the EA when warranted. If CVM determines that the proposed action may significantly impact the quality of the environment, an EIS must be prepared. If CVM makes a finding of no significant impact on the environment (FONSI) based on the EA, it will issue a FONSI, stating CVM's conclusion not to prepare an EIS (Ref. 17).
(Comment 51) Several comments requested training and outreach on the new VFD requirements. One comment specifically requested that we mandate training on the VFD process for veterinarians prior to allowing them to issue VFDs.
(Response 51) We agree that training and outreach are important components in successfully implementing these regulatory changes. We are engaging professional and trade associations, as well as other stakeholders, to leverage our education and outreach opportunities. However, we do not agree that training should be mandated for veterinarians prior to allowing them to lawfully issue VFDs. The requirements for veterinarians issuing a VFD are not very different or more complicated than other veterinary medical activities that veterinarians perform on a daily basis. We think that voluntary training or self-education, using materials developed by
FDA's authority for issuing this final rule is provided by section 504 of the FD&C Act (21 U.S.C. 354) relating to veterinary feed directive drugs. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.
FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action as defined by Executive Order 12866. We have developed a final regulatory impact analysis (FRIA) that presents the benefits and costs of this final rule to stakeholders and the government.
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the final rule would impose average annualized costs that amount to about 0.1 percent or less of average annual revenues on small entities, FDA concludes that it is very unlikely that the final rule will result in a significant impact on a substantial number of small entities.
The summary analysis of benefits and costs included in the Executive Summary of this document is drawn from the detailed FRIA, which is available at
This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the burden for annual reporting, recordkeeping, and third-party disclosure, including one-time burdens triggered upon implementation of this final rule. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
In 1996, the ADAA was enacted to facilitate the approval and marketing of new animal drugs and medicated feeds. Among other things, the ADAA created a new category of new animal drugs called veterinary feed directive drugs (or VFD drugs). VFD drugs are new animal drugs intended for use in or on animal feed, which are limited to use under the professional supervision of a licensed veterinarian in the course of the veterinarian's professional practice.
Currently, there are two VFD drugs under five approved animal drug applications. However, FDA has received feedback from stakeholders characterizing the current VFD process as being overly burdensome. In response to these concerns, FDA began exploring ways to improve the VFD program's efficiency. To this end, FDA published an ANPRM inviting public comment on possible VFD program efficiency improvements on March 29, 2010 (75 FR 15387). Based on the considerable public input received in response to the ANPRM, on April 13, 2012, FDA issued for public comment draft text for proposed revisions to the current VFD regulation at part 558 (77 FR 22247).
On December 12, 2013 (78 FR 75515), FDA issued a proposed rule which contained proposed revised information collection requirements at 78 FR 75522 to 75525. Many of the information collection requirements carry over from existing OMB control number 0910-0363; however, the section numbers for some of the information collection requirements have been redesignated in this final rule. Those one-time information collection requirements that are the direct result of this final rule are shown in tables under the heading “One-Time Costs.” The remaining information collection requirements associated with this final rule are shown in tables under the headings “Annual” or “Recurring Costs.”
Currently, under § 558.6(d)(1) (redesignated as § 558.6(c)(4)) a distributor of animal feed containing a VFD drug must notify FDA prior to the first time he distributes such VFD feed and this notification is required one time per distributor. Therefore, all active distributors of VFD feed must have already made notification to FDA of their intention to distribute such feed in order to be in compliance with the current regulation. In addition, a distributor must provide updated information to FDA within 30 days of a change in ownership, business name, or business address.
Because the reporting requirements for distributors under redesignated § 558.6(c)(4) are the same as the current requirements under § 558.6(d)(1), there is no new reporting burden for distributors other than the one-time burden hours and costs described in Table 1. FDA understands that current VFD feed distributors must review the final rule in order to determine which actions are necessary to comply with the new regulation. For these current VFD feed distributors we estimate review of the rule will take a one-time hourly burden of 4 hours to complete.
Burden hours and costs are derived from the Final Regulatory Impact Analysis (FRIA) associated with this final rule. Wage rates have been adjusted in the tables throughout to that reported in the FRIA.
The number of respondents multiplied by the number of responses per respondent equals the total responses. The total responses multiplied by the average burden per response equals the total hours.
There are additional reporting burdens for current VFD drug sponsors under OMB control numbers 0910-0032 (New Animal Drug Applications) and 0910-0669 (Abbreviated New Animal Drug Applications), described as follows:
All labeling and advertising for VFD drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs also are reported to FDA under OMB control number 0910-0032 and must prominently and conspicuously display the following cautionary statement: “Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian” (§ 558.6(a)(6)). This labeling statement is not subject to review by OMB because it is a “public disclosure[s] of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)). Therefore, an hourly and cost burden estimate for label supplement changes to the new specimen labeling for the Type A medicated article and the representative label for use by the feed manufacturer are not included.
The VFD must also include the following statement (§ 558.6(b)(3)(xiii)): “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted.” The burden associated with including this verbatim statement is not subject to review by OMB under the PRA (5 CFR 1320.3(c)(2)).
The veterinarian may restrict VFD authorization to only include the VFD drug(s) cited on the VFD or such authorization may be expanded to allow the use of the cited VFD drug(s) along with one or more OTC animal drugs in an approved, conditionally approved, or indexed combination VFD drug. The veterinarian must affirm his or her intent regarding combination VFD drugs by including one of the following statements on the VFD:
1. “This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drug(s) in combination with any other animal drugs.”
2. “This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” [List specific approved, conditionally approved, or indexed combination medicated feeds following this statement.]
3. “This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” (§ 558.6(b)(6)).
The burden associated with including these verbatim statements is not subject to review by OMB under the PRA (5 CFR 1320.3(c)(2)). The hourly and cost burdens to include these statements on the VFD as part of the rule are considered de minimis; however, as there are several other changes to the information on the VFD form itself that will occur as the result of this final rulemaking.
Section 558.6(b)(3) includes various changes to the information that would need to be included on the VFD form that is filled out by the veterinarian in order for the VFD to be valid, including but not limited to, deleting the requirement that the veterinarian must include the amount of feed needed to treat the animals. Each of the three drug sponsors that currently market VFD drugs have created VFD forms for their products. Three VFD drug sponsors × six VFD forms × 16 hours per respondent to make form changes = 96 total hours to change the VFD forms. Changes to the VFD form for the six approved VFD forms (for each of the three current VFD drug sponsors, there are separate VFD forms for each approved species and their related indication(s)) equals six VFD forms × $1,331 cost per form = approximately $8,000 one-time cost (see FRIA). NOTE: The hourly and cost burden estimates to include the revised verbatim statements
Under current § 558.6(f) and redesignated § 558.6(a)(1), an animal feed containing a VFD drug or a combination VFD drug may be fed to animals only by or upon a lawful VFD issued by a licensed veterinarian. Veterinarians issue three copies of the VFD: One for their own records, one for their client, and one to the client's VFD feed distributor (current § 558.6(b)(1)-(3) and redesignated § 558.6(a)(4) and redesignated § 558.6(b)(8)-(9)). The VFD includes information about the number and species of animals to receive feed containing one or more of the VFD drugs, along with all other information as required under § 558.6. Under current § 558.6(b)(4), if the veterinarian sends the VFD to the client or distributor by electronic means, he or she must assure that the distributor receives the original, signed VFD within 5 working days. Also, under current § 558.6(c), all involved parties (the veterinarian, the distributor, and the client) must retain a copy of the VFD for 2 years. In addition, VFD feed distributors must also keep receipt and distribution records of VFD feeds they manufacture and make them available for FDA inspection for 2 years (see current § 558.6(e)).
Veterinarians and clients must review the rule to ensure compliance with their respective new requirements. In Table 2, we estimate the hourly burden of this one-time review for both groups. (Review of the rule by VFD feed distributors is accounted for in Table 1.)
Recordkeeping costs are calculated as follows: 750,000 VFDs (an average of 375,000 VFDs issued for each of the two VFD drugs) issued in triplicate equals 2,250,000 VFDs issued and stored in files per year.
Assuming that currently all VFDs are issued and stored in hardcopy, we estimate it takes 300 large file cabinets to store these paper copy VFDs for 2 years, assuming 15,000 copies can be stored in a large file cabinet (see 64 FR 35966 at 35970). We estimate the average cost of a new file cabinet to be $600. Thus, we estimate that the current capital outlay for industry to store hardcopy VFDs for the required 2 years is $180,000 ($600 × 300 equals $180,000).
In the 2013 proposed rule, FDA proposed to reduce the recordkeeping requirement for copies of VFDs for all involved parties (proposed § 558.6(a)(4)) from 2 years to 1 year. After considering public comment, FDA has decided not to reduce the recordkeeping requirement from 2 years to 1 year in this final rule. However, as included in § 558.6(b)(8), the veterinarian will no longer be required to assure that a paper copy is received by the distributor within 5 working days of receipt if the original was faxed or otherwise transmitted electronically. This hardcopy requirement has become outdated by modern electronic communication and presents an unnecessary burden on the industry. This provision reduces the number of paper copies requiring physical recordkeeping space.
We anticipate approximately one-half of the food animal industry will use electronic VFD generation and recordkeeping during the next 3 years of the information collection. As the use of computers for electronic storage of records has increased substantially since 2000 and is expected to continue to do so regardless of this final rule, the only marginal cost that would offset some of the reduction in file cabinet storage space costs would be the additional computer storage space that may be needed for electronic VFD forms. Because the cost of electronic storage capacity on computers has become extremely low, FDA regards this as a negligible cost and has not estimated it.
Also, we anticipate that computer storage will eliminate the need for large amounts of physical space devoted to file cabinets. If, as we expect, one-half of the VFD recordkeepers (veterinarians, distributors, and clients) use electronic recordkeeping, this would result in a cost savings of $19,575 annually ($21.75 per square foot per year rental cost of space × 6 square feet per file cabinet × 150 filing cabinets = $19,575 annual savings for switching to computer storage) (Thorpe, K., J. Edwards, and E. Bondarenko, Cassidy Turley Commercial Real Estate Services. “U.S. Office Trends Report—2nd Quarter 2013.” Page 10.
In summary, we anticipate that the capital costs for recordkeeping will be reduced from $180,000 (storing all VFDs as hardcopies in file cabinets for 2 years) to $90,000 (as described in the FRIA, there is a 50 percent reduction in file cabinet costs due to electronic recordkeeping for 2 years (
Whether a paper copy is filed or whether the VFD is filed electronically, we calculate that the time spent to file the VFD is the same at 0.167 hours. As stated previously, distributors may receive an acknowledgement letter in lieu of a VFD when distributing VFD feed to another distributor. Such letters, like VFDs, are also subject to a 2-year record retention requirement. Thus, the recordkeeping burden for acknowledgement letters is included as a subset of the VFD recordkeeping burden. This combined recordkeeping burden, estimated at 18,788 hours in the 2000 final rule, is still cited in Table 2 of the currently approved Information Collection Request (ICR) for § 558.6 (OMB control number 0910-0363).
The number of respondents multiplied by the number of records per recordkeeper equals the total records. The total records multiplied by the average burden per recordkeeper equals the total hours.
VFD drug sponsors manufacture and label VFD drugs for use in medicated animal feed. FDA understands that sponsors must review the rule to ensure compliance with their disclosure requirements. In Table 3 we estimate the hourly burden of this review. (Review of the rule by VFD feed distributors is accounted for in Table 1 and by veterinarians and clients in Table 2.)
Section § 558.6(b)(8) would allow veterinarians to send VFDs to the client or distributor via fax or other electronic means (as is currently permitted under § 558.6(b)(4)). However, if a VFD is transmitted electronically, the veterinarian would no longer be required to assure that the original, signed VFD is given to the distributor within 5 days.
FDA estimates that a veterinarian currently requires about 0.25 hours to issue a VFD (
Currently, a distributor may only distribute a VFD feed to another distributor for further distribution if the originating distributor (consignor) first obtains a written acknowledgement letter from the receiving distributor (consignee) before the feed is shipped (current § 558.6(d)(2)). Because this current requirement is the same as that being finalized in § 558.6(c)(8), there is no new reporting burden.
The number of respondents multiplied by the number of disclosures per respondent equals the total annual disclosures. The total annual disclosures multiplied by the average burden per disclosure equals the total hours.
Additionally, we have clarified in the final rule that, if a distributor manufactures the VFD feed, the distributor must also keep VFD manufacturing records for 1 year in accordance with part 225 and that such records must be made available for inspection and copying by FDA upon request (§ 558.6(c)(4)). These record requirements are currently approved under OMB control number 0910-0152, Current Good Manufacturing Practice Regulations for Medicated Feed.
The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507(d) of the Paperwork Reduction Act of 1995.
Before the effective date of this final rule, FDA will publish a notice in the
The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the final rule will not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency concludes that the final rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
The following references have been placed on display in the Division of Dockets Management (see
Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements.
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 514 and 558 are amended as follows:
21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 371, 379e, 381.
(b) * * *
(9)
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
(b) * * *
(1) * * *
(ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required.
(6) A “veterinary feed directive (VFD) drug” is a drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 512(b) of the Federal Food, Drug, and Cosmetic Act, a conditionally approved application filed pursuant to section 571 of the Federal Food, Drug, and Cosmetic Act, or an index listing under section 572 of the Federal Food, Drug, and Cosmetic Act to use under the professional supervision of a licensed veterinarian. Use of animal feed bearing or containing a VFD drug must be authorized by a lawful veterinary feed directive.
(7) A “veterinary feed directive” is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian's professional practice that orders the use of a VFD drug or combination VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combination VFD drug to treat the client's animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the Food and Drug Administration.
(9) For the purposes of this part, a “distributor” means any person who distributes a medicated feed containing a VFD drug to another person. Such other person may be another distributor or the client-recipient of a VFD.
(11) An “acknowledgment letter” is a written (nonverbal) communication provided to a distributor (consignor) from another distributor (consignee). An acknowledgment letter must be provided either in hardcopy or through electronic media and must affirm:
(i) That the distributor will not ship such VFD feed to an animal production facility that does not have a VFD,
(ii) That the distributor will not ship such VFD feed to another distributor without receiving a similar written acknowledgment letter, and
(iii) That the distributor has complied with the distributor notification requirements of § 558.6(c)(5).
(12) A “combination veterinary feed directive (VFD) drug” is a combination new animal drug (as defined in § 514.4(c)(1)(i) of this chapter) intended for use in or on animal feed which is limited by an approved application filed under section 512(b) of the Federal Food, Drug, and Cosmetic Act, a conditionally approved application filed under section 571 of the Federal Food, Drug, and Cosmetic Act, or an index listing under section 572 of the Federal Food, Drug, and Cosmetic Act to use under the professional supervision of a licensed veterinarian, and at least one of the new animal drugs in the combination is a VFD drug. Use of animal feed bearing or containing a combination VFD drug must be authorized by a lawful VFD.
(a)
(2) A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD.
(3) Use and labeling of a VFD drug or a combination VFD drug in feed is limited to the approved, conditionally approved, or indexed conditions of use. Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted.
(4) All involved parties (the veterinarian, the distributor, and the
(5) All involved parties must make the VFD and any other records specified in this section available for inspection and copying by FDA upon request.
(6) All labeling and advertising for VFD drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs must prominently and conspicuously display the following cautionary statement: “Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.”
(b)
(i) Be licensed to practice veterinary medicine; and
(ii) Be operating in the course of the veterinarian's professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in § 530.3(i) of this chapter, the veterinarian must issue the VFD in the context of a valid VCPR as defined in § 530.3(i) of this chapter.
(2) The veterinarian must only issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug.
(3) The veterinarian must ensure that the following information is fully and accurately included on the VFD:
(i) The veterinarian's name, address, and telephone number;
(ii) The client's name, business or home address, and telephone number;
(iii) The premises at which the animals specified in the VFD are located;
(iv) The date of VFD issuance;
(v) The expiration date of the VFD. This date must not extend beyond the expiration date specified in the approval, conditional approval, or index listing, if such date is specified. In cases where the expiration date is not specified in the approval, conditional approval, or index listing, the expiration date of the VFD must not exceed 6 months after the date of issuance;
(vi) The name of the VFD drug(s);
(vii) The species and production class of animals to be fed the VFD feed;
(viii) The approximate number of animals to be fed the VFD feed by the expiration date of the VFD. The approximate number of animals is the potential number of animals of the species and production class identified on the VFD that will be fed the VFD feed or combination VFD feed at the specified premises by the expiration date of the VFD;
(ix) The indication for which the VFD is issued;
(x) The level of VFD drug in the VFD feed and duration of use;
(xi) The withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval;
(xii) The number of reorders (refills) authorized, if permitted by the drug approval, conditional approval, or index listing. In cases where reorders (refills) are not specified on the labeling for an approved, conditionally approved, or index listed VFD drug, reorders (refills) are not permitted;
(xiii) The statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted.”;
(xiv) An affirmation of intent for combination VFD drugs as described in paragraph (6) of this section; and
(xv) The veterinarian's electronic or written signature.
(4) The veterinarian may, at his or her discretion, enter the following information on the VFD to more specifically identify the animals authorized to be treated/fed the VFD feed:
(i) A more specific description of the location of animals (
(ii) The approximate age range of the animals;
(iii) The approximate weight range of the animals; and
(iv) Any other information the veterinarian deems appropriate to identify the animals specified in the VFD.
(5) For VFDs intended to authorize the use of an approved, conditionally approved, or indexed combination VFD drug that includes more than one VFD drug, the veterinarian must include the drug-specific information required in paragraphs (b)(2)(vi), (ix), (x), and (xi) of this section for each VFD drug in the combination.
(6) The veterinarian may restrict VFD authorization to only include the VFD drug(s) cited on the VFD or may expand such authorization to allow the use of the cited VFD drug(s) along with one or more over-the-counter (OTC) animal drugs in an approved, conditionally approved, or indexed combination VFD drug. The veterinarian must affirm his or her intent regarding combination VFD drugs by including one of the following statements on the VFD:
(i) “This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drug(s) in combination with any other animal drugs.”
(ii) “This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” [List specific approved, conditionally approved, or indexed combination medicated feeds following this statement.]
(iii) “This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.”
(7) The veterinarian must issue a written (nonverbal) VFD.
(8) The veterinarian must send a copy of the VFD to the distributor via hardcopy, facsimile (fax), or electronically. If in hardcopy, the veterinarian must send the copy of the VFD to the distributor either directly or through the client.
(9) The veterinarian must provide a copy of the VFD to the client.
(c) Responsibilities of any person who distributes an animal feed containing a VFD drug or a combination VFD drug:
(1) The distributor is permitted to fill a VFD only if the VFD contains all the information required in paragraph (b)(3) of this section.
(2) The distributor is permitted to distribute an animal feed containing a VFD drug or combination VFD drug only if it complies with the terms of the VFD and is manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug.
(3) The distributor must keep records of the receipt and distribution of all medicated animal feed containing a VFD drug for 2 years.
(4) In addition to other applicable recordkeeping requirements found in this section, if the distributor manufactures the animal feed bearing or containing the VFD drug, the distributor must also keep VFD feed manufacturing records for 1 year in accordance with part 225 of this chapter. Such records must be made available for inspection and copying by FDA upon request.
(5) A distributor of animal feed containing a VFD drug must notify FDA prior to the first time it distributes animal feed containing a VFD drug. The notification is required one time per distributor and must include the following information:
(i) The distributor's complete name and business address;
(ii) The distributor's signature or the signature of the distributor's authorized agent; and
(iii) The date the notification was signed.
(6) A distributor must also notify FDA within 30 days of any change in ownership, business name, or business address.
(7) The notifications cited in paragraphs (c)(5) and (c)(6) of this section must be submitted to the Food and Drug Administration, Center for Veterinary Medicine, Division of Animal Feeds (HFV-220), 7519 Standish Pl., Rockville, MD 20855, FAX: 240-453-6882.
(8) A distributor is permitted to distribute a VFD feed to another distributor only if the originating distributor (consignor) first obtains a written (nonverbal) acknowledgment letter, as defined in § 558.3(b)(11), from the receiving distributor (consignee) before the feed is shipped. Consignor distributors must retain a copy of each consignee distributor's acknowledgment letter for 2 years.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments and information.
NMFS has received a request from the U.S. Navy (Navy) for authorization to take marine mammals incidental to the training and testing activities conducted in the Northwest Training and Testing (NWTT) study area from November 2015 through November 2020. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue regulations and subsequent Letters of Authorization (LOAs) to the Navy to incidentally harass marine mammals. The Navy has also requested that NMFS authorize modifications to watchstander requirements for observed behavior of marine mammals during Major Training Events (MTEs) in the Hawaii-Southern California Training and Testing (HSTT), Atlantic Fleet Training and Testing (AFTT), Mariana Islands Training and Testing (MITT), and Gulf of Alaska Training (GOA) study areas. Modifications to the Navy watchstander requirements would require a revision to regulatory text in current regulations governing the taking and importing of marine mammals during testing and/or training activities in these study areas. There are no MTEs associated with Navy training and testing activities in the NWTT study area.
Comments and information must be received no later than July 17, 2015.
You may submit comments, identified by NOAA-NMFS-2015-0031, by any of the following methods:
•
•
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John Fiorentino, Office of Protected Resources, NMFS, (301) 427-8477.
A copy of the Navy's LOA application, which contains a list of the references used in this document, may be obtained by visiting the internet at:
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring, and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”
The National Defense Authorization Act of 2004 (NDAA) (Public Law 108-136) removed the “small numbers” and “specified geographical region” limitations indicated above and amended the definition of “harassment” as it applies to a “military readiness activity” to read as follows (section 3(18)(B) of the MMPA): “(i) Any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild [Level A Harassment]; or (ii) any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, including, but not limited to, migration, surfacing, nursing, breeding, feeding, or sheltering, to a point where such behavioral patterns are abandoned or significantly altered [Level B Harassment].”
On December 18, 2013, NMFS received an application from the Navy requesting two LOAs for the take of 26 species of marine mammals incidental to Navy training and testing activities to be conducted in the NWTT Study Area over 5 years. On September 26, 2014, the Navy submitted a revised LOA application to reflect updates to exposure estimates based on emergent
The Navy is requesting separate 5-year LOAs for training and testing activities to be conducted from 2015 through 2020. The Study Area includes the existing Northwest Training Range Complex, the Keyport Range Complex, Carr Inlet Operations Area, Southeast Alaska Acoustic Measurement Facility (SEAFAC), and Navy pierside locations where sonar maintenance or testing may occur (see Figure 1-1 of the LOA application for a map of the NWTT Study Area). The activities conducted within the NWTT Study Area are classified as military readiness activities. The Navy states that these activities may expose some of the marine mammals present within the NWTT Study Area to sound from underwater acoustic sources and explosives. The Navy is requesting authorization to take 26 marine mammal species by Level B (behavioral) harassment; 4 of those marine mammal species may be taken by injury (Level A harassment).
The LOA application and the January 2014 NWTT DEIS/OEIS contain proposed acoustic thresholds that were used to evaluate the Navy's AFTT and HSTT activities. The thresholds are based on evaluation of recent scientific studies; a detailed explanation of how they were derived is provided in the Criteria and Thresholds for Navy Acoustic Effects Analysis Technical Report (Finneran and Jenkins, 2012). NMFS is currently updating and revising all of its acoustic thresholds. Until that process is complete, NMFS will continue its long-standing practice of considering specific modifications to the acoustic thresholds currently employed for incidental take authorizations only after providing the public with an opportunity for review and comment. NMFS is requesting comments on all aspects of the proposed rule.
The Navy is also requesting that NMFS authorize modifications to watchstander requirements, unrelated to implementation of mitigation measures, for observed behavior of marine mammals during MTEs in the HSTT, AFTT, MITT, and GOA study areas. With these proposed modifications the Navy would no longer be required to report individual marine mammal sighting information during MTEs when mitigation is not occurring in the study area. After 5 years of collecting marine mammal sighting data for all animals sighted during MTEs, NMFS and Navy have determined that without the ability to obtain species information this data set does not provide for any meaningful analysis beyond that which may be possible using mitigation-related observations alone. The Navy and NMFS have thoroughly investigated several potential uses for the data prior to reaching this conclusion. Additionally, this reporting requirement places an undue administrative burden on ships watch teams. The Navy will continue to collect marine mammal sighting data during MTEs for every instance when any form of mitigation is employed such as powering down or securing sonar, maneuvering the ship, or delaying an event—in other words, in instances where animals are closer to the sound source around which mitigation measures are implemented. This data is useful in supporting mitigation effectiveness analyses and also may be helpful in supporting an understanding of the frequency with which marine mammals (generally, not by species) may be encountered or detected in close proximity to a particular source (
These modifications would be implemented through the revision of regulatory text for existing regulations governing the taking of marine mammals incidental to testing and/or training activities in HSTT, AFTT, MITT, and GOA study areas. Proposed revisions to the regulatory text are provided in the regulatory text at the end of this proposed rule. Proposed revisions to MITT regulatory text will be made in the MITT final rule, which is currently being prepared concurrent with the NWTT proposed rule and is expected to publish in the
The Navy's mission is to maintain, train, and equip combat-ready naval forces capable of winning wars, deterring aggression, and maintaining freedom of the seas. Section 5062 of Title 10 of the United States Code directs the Chief of Naval Operations to train all military forces for combat. The Chief of Naval Operations meets that direction, in part, by conducting at-sea training exercises and ensuring naval forces have access to ranges, operating areas (OPAREAs) and airspace where they can develop and maintain skills for wartime missions and conduct research, development, testing, and evaluation (RDT&E) of naval systems.
The Navy proposes to continue conducting training and testing activities within the NWTT Study Area, which have been ongoing for decades with some activities dating back to at least the early 1900s. The tempo and types of training and testing activities have fluctuated because of the introduction of new technologies, the evolving nature of international events, advances in war fighting doctrine and procedures, and force structure (organization of ships, submarines, aircraft, weapons, and personnel) changes. Such developments influence the frequency, duration, intensity, and location of required training and testing activities. The Navy analyzed many training and testing activities in the Study Area in the Tactical Training Theater Assessment and Planning Program Phase I and earlier documents, specifically the following environmental planning documents: Northwest Training Range Complex Final EIS/OEIS (U.S. Department of the Navy, 2010a), NAVSEA NUWC Keyport Range Complex Extension Final EIS/OEIS (U.S. Department of the Navy, 2010b), and the Final EIS for the Southeast Alaska Acoustic Measurement Facility (SEAFAC) (U.S. Department of the Navy, 1988). The Navy's LOA request covers training and testing activities that would occur for a 5-year period following the expiration of the first of the two current MMPA authorizations
The Navy's LOA application differs from the January 2014 NWTT DEIS/OEIS in that it contains updated information on the Washington Inland Waters stocks of harbor seals (Carretta
The Navy is requesting authorization to take marine mammals incidental to conducting training and testing activities. The Navy has determined that sonar use and underwater detonations are the stressors most likely to result in impacts on marine mammals that could rise to the level of harassment. Detailed descriptions of these activities are provided in the January 2014 NWTT DEIS/OEIS and in the LOA application (
The Navy routinely trains in the NWTT Study Area in preparation for national defense missions. Training activities and exercises covered in the Navy's LOA request are briefly described below, and in more detail within Chapter 2 of the January 2014 NWTT DEIS/OEIS. Training activities are categorized into eight functional warfare areas (anti-air warfare; amphibious warfare; strike warfare; anti-surface warfare; anti-submarine warfare; electronic warfare; mine warfare; and naval special warfare). The Navy determined that the following stressors used in these warfare areas are most likely to result in impacts on marine mammals:
The Navy's activities in anti-air warfare, electronic warfare, and naval special warfare do not involve stressors that could result in harassment of marine mammals. Therefore, these activities are not discussed further. The analysis and rationale for excluding these warfare areas is contained in the January 2014 DEIS/OEIS.
The mission of anti-surface warfare (ASUW) is to defend against enemy ships or boats. When conducting anti-surface warfare, aircraft use cannons, air-launched cruise missiles, or other precision-guided munitions; ships use torpedoes, naval guns, and surface-to-surface missiles; and submarines use torpedoes or submarine-launched, anti-ship cruise missiles. Anti-surface warfare training includes surface-to-surface gunnery and missile exercises, air-to-surface gunnery and missile exercises, and submarine missile or exercise torpedo launch events.
The mission of anti-submarine warfare (ASW) is to locate, neutralize, and defeat hostile submarine threats to surface forces. Anti-submarine warfare is based on the principle of a layered defense of surveillance and attack aircraft, ships, and submarines all searching for hostile submarines. These forces operate together or independently to gain early warning and detection, and to localize, track, target, and attack hostile submarine threats. Anti-submarine warfare training addresses basic skills such as detection and
The mission of mine warfare is to detect, and avoid or neutralize mines to protect Navy ships and submarines and to maintain free access to ports and shipping lanes. Mine warfare also includes offensive mine laying to gain control or deny the enemy access to sea space. Naval mines can be laid by ships, submarines, or aircraft. Mine warfare training includes exercises in which ships, aircraft, submarines, underwater vehicles, or marine mammal detection systems search for mines. Certain personnel train to destroy or disable mines by attaching and detonating underwater explosives to simulated mines. Other neutralization techniques involve impacting the mine with a bullet-like projectile or intentionally triggering the mine to detonate.
Other activities include pierside and at-sea maintenance of submarine and surface ship sonar systems.
Testing activities covered in the Navy's LOA request are briefly described below, and in more detail within Chapter 2 of the January 2014 NWTT DEIS/OEIS. The Navy researches, develops, tests, and evaluates new platforms, systems and technologies. Many tests are conducted in realistic conditions at sea, and can range in scale from testing new software to operating portable devices to conducting tests of live weapons (such as the Service Weapon Test of a torpedo) to ensure they function as intended. Testing activities may occur independently of or in conjunction with training activities.
Many testing activities are conducted similarly to Navy training activities and are also categorized under one of the primary mission areas described above. Other testing activities are unique and are described within their specific testing categories. Because each test is conducted by a specific component of the Navy's research and acquisition community, which includes the Navy's Systems Commands and the Navy's scientific research organizations, the testing activities described in the LOA application are organized first by that particular organization as described below and in the order as presented.
The Navy describes and analyzes the effects of its testing activities within the 2014 NWTT DEIS/OEIS. In its assessment, the Navy concluded that acoustic stressors from the use of underwater acoustic sources and underwater detonations resulted in impacts on marine mammals that rose to the level of harassment as defined under the MMPA. Therefore, the LOA application for NWTT provides the Navy's assessment of potential effects from these stressors in terms of the various activities in which they would be used.
The individual commands within the research and acquisition community included in the NWTT DEIS/OEIS and in the LOA application are:
• Naval Sea Systems Command (NAVSEA). Within NAVSEA are the following field activities:
• Naval Air Systems Command (NAVAIR)
NAVSEA is responsible for engineering, building, buying, and maintaining the Navy's ships and submarines and associated combat systems. NAVSEA is broken up into two types of warfare centers: NUWC and the Naval Surface Warfare Center (NSWC).
NUWC provides Fleet readiness support for submarines, surface ships, torpedoes, mines, land attack systems, and Fleet training systems. NAVSEA has several field activities operating out of Naval Base (NAVBASE) Kitsap, including NUWC Division Keyport, NSWCCD Detachment Puget Sound, and Puget Sound Naval Shipyard and Intermediate Maintenance Facility. NSWCCD Detachment Puget Sound also operates the SEAFAC facility in Alaska.
Each major category of NAVSEA activities in the Study Area is represented below. NUWC Division, Keyport and NSWCCD Detachment Puget Sound activities are grouped together in the discussion below to simplify review due to the diversity of activity types and locations they work in. Puget Sound Naval Shipyard and Intermediate Facility activities are grouped with the general activities conducted by NAVSEA. Numerous test activities and technical evaluations, in support of NAVSEA's systems development mission, often occur in conjunction with fleet activities within the Study Area.
NUWC Division Keyport's mission is to provide test and evaluation services and expertise to support the Navy's evolving manned and unmanned vehicle program activities. NUWC Keyport has historically provided facilities and capabilities to support testing of torpedoes, other unmanned vehicles, submarine readiness, diver training, and similar activities that are critical to the success of undersea warfare. Range support requirements for such activities include testing, training, and evaluation of system capabilities such as guidance, control, and sensor accuracy in multiple marine environments (
NSWCCD includes two organizations that conduct testing activities: NSWCCD, Detachment Puget Sound and NSWCCD SEAFAC. Detachment Puget Sound testing activities are aligned with its mission to provide research, development, test, and evaluation (RDT&E), analysis, acquisition support, in-service engineering, logistics and integration of surface and undersea vehicles and associated systems; develop and apply science and technology associated with naval architecture and marine engineering; and provide support to the maritime industry. Activities and support include engineering, technical, operations, diving, and logistics required for the RDT&E associated with:
These activities can be broken down into four major testing categories to include: System, Subsystem and Component Acoustic Testing Pierside; Performance Testing at Sea; Development Testing and Training; and Proof of Concept Testing.
NSWCCD SEAFAC makes high fidelity directive volumetric and line arrays passive acoustic signature measurements. The SEAFAC site includes directive line arrays and data collection and processing systems for real-time data analysis and signature evaluation.
SEAFAC provides the capability to perform RDT&E analyses to determine the sources of radiated acoustic noise, to assess vulnerability, and to develop quieting measures. Unforeseen emergent Navy requirements may influence actual testing activities during the time period under consideration. Testing activities that would occur at SEAFAC are identified to the extent practicable throughout this application.
NAVSEA also conducts tests that are not associated with NUWC Keyport or NSWCCD. Activities are conducted at Navy piers at NAVBASE Kitsap, Bremerton; NAVBASE Kitsap, Bangor; and Naval Station Everett; and in conjunction with fleet activities off the coast of Washington, Oregon, and northern California. Tests within this category include, but are not limited to, Life Cycle Activities, Shipboard Protection Systems and Swimmer Defense Testing, Unmanned Vehicle Testing, ASUW/ASW Testing, and New Ship Construction.
NAVAIR testing events generally fall into the primary mission areas used by the fleets. NAVAIR events include, but are not limited to, the testing of new aircraft platforms, weapons, and systems before those platforms, weapons and systems are integrated into the fleet. In this application, NAVAIR testing activities are limited to ASW testing of sonobuoys. The sonobuoys tested include both passive and active non-impulsive, sonobuoys using impulsive sources, and high duty cycle sonobuoys.
The Navy uses a variety of sensors, platforms, weapons, and other devices to meet its mission. Training and testing with these systems may introduce acoustic (sound) energy into the environment. This section describes and organizes sonar systems, ordnance, munitions, targets, and other systems to facilitate understanding of the activities in which these systems are used. Underwater sound is described as one of two types for the purposes of the LOA application: impulsive and non-impulsive. Underwater detonations of explosives and other percussive events are impulsive sounds. Sonar and similar sound producing systems are categorized as non-impulsive sound sources.
Modern sonar technology includes a variety of sonar sensor and processing systems. The simplest active sonar emits sound waves, or “pings,” sent out in multiple directions and the sound waves then reflect off of the target object in multiple directions. The sonar source calculates the time it takes for the reflected sound waves to return; this calculation determines the distance to the target object. More sophisticated active sonar systems emit a ping and then rapidly scan or listen to the sound waves in a specific area. This provides both distance to the target and directional information. Even more advanced sonar systems use multiple receivers to listen to echoes from several directions simultaneously and provide efficient detection of both direction and distance. The Navy rarely uses active sonar continuously throughout activities. When sonar is in use, the pings occur at intervals, referred to as a duty cycle, and the signals themselves are very short in duration. For example, sonar that emits a 1-second ping every 10 seconds has a 10-percent duty cycle. The Navy utilizes sonar systems and other acoustic sensors in support of a variety of mission requirements. Primary uses include the detection of and defense against submarines (anti-submarine warfare) and mines (mine warfare); safe navigation and effective communications; use of unmanned undersea vehicles; and oceanographic surveys. Sources of sonar and other active acoustic sources include surface ship sonar, sonobuoys, torpedoes, range pingers, and unmanned underwater vehicles.
Most ordnance and munitions used during training and testing events fall into three basic categories: projectiles (such as gun rounds), missiles (including rockets), and bombs. Ordnance can be further defined by their net explosive weight, which considers the type and quantity of the explosive substance without the packaging, casings, bullets, etc. Net explosive weight (NEW) is the trinitrotoluene (TNT) equivalent of energetic material, which is the standard measure of strength of bombs and other explosives. For example, a 12.7-centimeter (cm) shell fired from a Navy gun is analyzed at about 9.5 pounds (lb) (4.3 kilograms (kg)) of NEW. The Navy also uses non-explosive ordnance in place of high explosive ordnance in many training and testing events. Non-explosive ordnance munitions look and perform similarly to high explosive ordnance, but lack the main explosive charge.
Naval forces depend on effective defensive countermeasures to protect themselves against missile and torpedo attack. Defensive countermeasures are devices designed to confuse, distract, and confound precision guided munitions. Defensive countermeasures analyzed in the LOA application include acoustic countermeasures, which are used by surface ships and submarines to defend against torpedo attack. Acoustic countermeasures are either released from ships and submarines, or towed at a distance behind the ship.
The Navy divides mine warfare systems into two categories: Mine detection and mine neutralization. Mine detection systems are used to locate, classify, and map suspected mines, on the surface, in the water column, or on the sea floor. The Navy analyzed the following mine detection systems for potential impacts to marine mammals:
• Towed or hull-mounted mine detection systems. These detection systems use acoustic and laser or video sensors to locate and classify suspect mines. Fixed and rotary wing platforms, ships, and unmanned vehicles are used for towed systems, which can rapidly assess large areas.
• Airborne Laser Mine Detection Systems. Airborne laser detection systems work in concert with neutralization systems. The detection system initially locates mines and a neutralization system is then used to relocate and neutralize the mine.
• Unmanned/remotely operated vehicles. These vehicles use acoustic and video or lasers to locate and classify mines and provide unique capabilities in nearshore littoral areas, surf zones, ports, and channels.
Mine neutralization systems disrupt, disable, or detonate mines to clear ports and shipping lanes, as well as littoral, surf, and beach areas in support of naval amphibious operations. Mine neutralization systems can clear individual mines or a large number of mines quickly. The Navy analyzed the following mine neutralization systems for potential impacts to marine mammals:
• Towed influence mine sweep systems. These systems use towed equipment that mimic a particular ship's magnetic and acoustic signature triggering the mine and causing it to explode.
• Towed mechanical mine sweeping systems.These systems tow a sweep wire to snag the line that attaches a moored mine to its anchor and then uses a series of cables and cutters to sever those lines. Once these lines are cut, the mines float to the surface where Navy personnel can neutralize the mines.
• Unmanned/remotely operated mine neutralization systems. Surface ships and helicopters operate these systems, which place explosive charges near or directly against mines to destroy the mine.
• Projectiles. Small- and medium-caliber projectiles, fired from surface ships or hovering helicopters, are used to neutralize floating and near-surface mines.
• Diver emplaced explosive charges. Operating from small craft, divers put explosive charges near or on mines to destroy the mine or disrupt its ability to function.
Explosive charges are used during mine neutralization system training activities; however, only non-explosive mines or mine shapes would be used.
In order to better organize and facilitate the analysis of about 300 sources of underwater non-impulsive sound or impulsive energy, the Navy developed a series of source classifications, or source bins. This method of analysis provides the following benefits:
• Allows for new sources to be covered under existing authorizations, as long as those sources fall within the parameters of a “bin;”
• Simplifies the data collection and reporting requirements anticipated under the MMPA;
• Ensures a conservative approach to all impact analysis because all sources in a single bin are modeled as the loudest source (
• Allows analysis to be conducted more efficiently, without compromising the results;
• Provides a framework to support the reallocation of source usage (hours/explosives) between different source bins, as long as the total number and severity of marine mammal takes remain within the overall analyzed and authorized limits. This flexibility is required to support evolving Navy training and testing requirements, which are linked to real world events.
A description of each source classification is provided in Tables 1-3. Non-impulsive sources are grouped into bins based on the frequency, source level when warranted, and how the source would be used. Impulsive bins are based on the net explosive weight of the munitions or explosive devices. The following factors further describe how non-impulsive sources are divided:
• Frequency of the non-impulsive source:
• Source level of the non-impulsive source:
How a sensor is used determines how the sensor's acoustic emissions are analyzed. Factors to consider include pulse length (time source is on); beam pattern (whether sound is emitted as a narrow, focused beam, or, as with most explosives, in all directions); and duty cycle (how often a transmission occurs in a given time period during an event).
There are also non-impulsive sources with characteristics that are not anticipated to result in takes of marine mammals. These sources have low source levels, narrow beam widths, downward directed transmission, short pulse lengths, frequencies beyond known hearing ranges of marine mammals, or some combination of these factors. These sources were not modeled by the Navy, but are qualitatively analyzed in Table 1-4 of the LOA application and in the January 2014 NWTT DEIS/OEIS. These sources generally meet the following criteria:
The training and testing activities that the Navy proposes to conduct in the NWTT Study Area are listed in Tables 4-6. Detailed information about each proposed activity (stressor, training or testing event, description, sound source, duration, and geographic location) can be found in the LOA application and in Appendix A of the January 2014 NWTT DEIS/OEIS. NMFS used the detailed information in the LOA application and in Appendix A of the January 2014 NWTT DEIS/OEIS to analyze the potential impacts from training and testing activities on marine mammals. The Navy's proposed activities are anticipated to meet training and testing needs in the years 2015-2020.
Table 4 provides a quantitative annual summary of training activities by sonar and other active acoustic source class analyzed in the Navy's LOA request.
Table 5 provides a quantitative annual summary of testing activities by sonar and other active sources analyzed in the Navy's LOA request.
Table 6 provides a quantitative annual summary of training explosive source classes analyzed in the Navy's LOA request.
Table 7 provides a quantitative annual summary of testing explosive source classes analyzed in the Navy's LOA request.
In addition to potential impacts to marine mammals from activities using explosives or sonar and other active acoustic sources, the Navy also considered ship strike impacts to marine mammals. The Navy assessed that no additional stressors would result in a take and require authorization under the MMPA.
Vessel strikes may occur from surface operations and sub-surface operations (excluding bottom crawling, unmanned underwater vehicles). Vessels used as part of the Navy's proposed NWTT training and testing activities (proposed action) include ships, submarines and boats ranging in size from small, 16-foot (ft.) (5-meter [m]) rigid hull inflatable boats to aircraft carriers with lengths up to 1,092 ft. (333 m). Representative Navy vessel types, lengths, and speeds used in both training and testing activities are shown in Table 8.
Large Navy ships greater than 65 ft. (20 m) generally operate at speeds in the range of 10-15 knots for fuel conservation when cruising. Submarines generally operate at speeds in the range of 8-13 knots during transit and slower for certain tactical maneuvers. Small craft (for purposes of this discussion less than 65 ft. [20 m] in length) have much more variable speeds, dependent on the mission. While these speeds are representative, some vessels operate outside of these speeds due to unique training or safety requirements for a given event. Examples include increased speeds needed for flight operations, full speed runs to test engineering equipment, time critical positioning needs, etc. Examples of decreased speeds include speeds less than 5 knots or completely stopped for launching small boats, certain tactical maneuvers, target launch or retrievals, etc.
The number of Navy vessels in the Study Area varies based on training and testing schedules. Most activities include either one or two vessels, with an average of one vessel per activity, and last from a few hours up to 2 weeks. Vessel movement and the use of in-water devices as part of the proposed action would be concentrated in certain
The Navy is analyzing the potential environmental impacts of approximately 226 ongoing annual Maritime Security Operations events in Puget Sound and the Strait of Juan de Fuca. These critical events have been occurring since 2006 and exercise the Navy's Transit Protection System, where up to nine escort vessels provide protection during all nuclear ballistic missile submarine (SSBN) transits between the vessel's homeport and the dive/surface point in the Strait of Juan de Fuca or Dabob Bay. During a Transit Protection System event, the security escorts enforce a moving 1,000 yard security zone around the SSBN to prevent other vessels from approaching while the SSBN is in transit on the surface. These events include security escort vessels, U.S. Coast Guard personnel and their ancillary equipment and weapons systems. The Transit Protection System involves the movement of security vessels and also includes periodic exercises and firearms training (with blank rounds). Given the relative slow speed of the escorted and blocking vessels and multiple lookouts, no marine mammal vessel strikes are expected as a result of these events.
Navy policy (Chief of Naval Operations Instruction 3100.6H) requires Navy vessels to report all whale strikes. That information is collected by the Office of the Chief of Naval Operations Energy and Environmental Readiness Division (OPNAV N45) and cumulatively provided to NMFS on an annual basis. In addition, the Navy and NMFS also have standardized regional reporting protocols for communicating to regional NMFS stranding coordinators information on any Navy vessel strikes as soon as possible. These communication procedures will remain in place for the duration of the LOAs. There are no records of any Navy vessel strikes to marine mammals during training or testing activities in the NWTT Study Area.
Training and testing activities would be conducted in the Study Area throughout the year from November 2015 through November 2020.
The Study Area is composed of established maritime operating and warning areas in the eastern North Pacific Ocean region, including areas of the Strait of Juan de Fuca, Puget Sound, and Western Behm Canal in southeastern Alaska. The Study Area includes air and water space within and outside Washington state waters, and outside state waters of Oregon and Northern California. The Study Area includes four existing range complexes and facilities: The Northwest Training Range Complex (NWTRC), the Keyport Range Complex, Carr Inlet Operations Area, and SEAFAC. In addition to these range complexes, the Study Area also includes Navy pierside locations where sonar maintenance and testing occurs as part of overhaul, modernization, maintenance and repair activities at NAVBASE Kitsap, Bremerton; NAVBASE Kitsap, Bangor; and Naval Station Everett.
A range complex is a designated set of specifically bounded geographic areas and encompasses a water component (above and below the surface), and may encompass airspace and a land component where training and testing of military platforms, tactics, munitions, explosives, and EW systems occurs. Range complexes include established OPAREAs, Restricted Areas, and special use airspace (SUA), which may be further divided to provide better control of the area and events for safety reasons. These designations are further described in Chapter 2 of the LOA application.
The Study Area includes only the at-sea components of the training and testing areas and facilities. The Navy is using “at-sea” to cover activity in, on, and over the water, but not activity on or over the land, which may include activities in the surf zone or supported from shore-side locations.
Military activities in the Study Area occur (1) on the ocean surface, (2) beneath the ocean surface, and (3) in the air. To aid in the description of the ranges covered in the January 2014 NWTT DEIS/OEIS, the ranges are divided into three distinct geographic and functional subdivisions. All of the training and testing activities proposed in this application would occur in one or more of these three range subdivisions:
The Offshore Area of the Study Area includes air, surface, and subsurface OPAREAs extending generally west from the coastline of Washington, Oregon, and Northern California for a distance of approximately 250 nm into international waters. The eastern boundary of the Offshore Area is 12 nm off the coastline for most of the Study Area, including southern Washington, Oregon, and Northern California. The Offshore Area includes the ocean all the way to the coastline only along the Washington coast beneath the airspace of W-237 and the Olympic Military Operations Area (MOA) and the Washington coastline north of the Olympic MOA. The components of the Offshore Area are described below.
The SUA in the Offshore Area is comprised of Warning Area 237 (W-237), which extends westward off the coast of Northern Washington State and is divided into nine sub-areas (A-H, and J). The eastern boundary of W-237 lies 3 nm off the coast of Washington. The floor of W-237 extends to the ocean surface and the ceiling of the airspace varies between 27,000 ft. (8,200 m) in areas E, H, and J; 50,000 ft. (15,200 m) in areas A and B; and unlimited in areas C, D, F, and G, with a total area of 25,331 square nautical miles (nm
The Olympic MOA overlays both land (the Olympic Peninsula) and sea (extending to 3 nm off the coast of Washington into the Pacific Ocean). The MOA lower limit is 6,000 ft. (1,800 m) above mean sea level but not below 1,200 ft. above ground level, and the upper limit is up to, but not including, 18,000 ft. (5,500 m), with a total area coverage of 1,614 nm
Above the Olympic MOA is the Olympic Air Traffic Controlled Assigned Airspace (ATCAA), which has a floor coinciding with the Olympic MOA ceiling. The ATCAA has an upper limit of 35,000 ft. (10,700 m).
The Inland Waters includes air, sea, and undersea space inland of the coastline, from buoy “J” at 48° 29.6′ N, 125° W, eastward to include all waters of the Strait of Juan de Fuca and the Puget Sound. None of this area extends into Oregon or California. Within the Inland Waters are specific geographic components in which training and testing occur. The Inland Waters and its component areas are described below.
Restricted Area 6701 (R-6701, Admiralty Bay) is a Restricted Area over Admiralty Bay, Washington with a lower limit at the ocean surface and an upper limit of 5,000 ft. This airspace covers a total area of 56 nm
Chinook A and B MOAs are 56 nm
• Hood Canal EOD Training Range
• Crescent Harbor EOD Training Range
The Keyport Range Site is located adjacent to NAVBASE Kitsap, Keyport, providing approximately 3.2 nm
The DBRC Site includes the Dabob Bay and the Hood Canal from 1 mi. (1.6 km) south of the Hood Canal Bridge to the Hamma Hamma River, a total area of approximately 45.7 nm
Dabob Bay is a deep-water area in Jefferson County approximately 14.5 nm
Hood Canal averages a depth of 200 ft. (61 m) and is used for vessel sensor accuracy tests and launch and recovery of test systems where tracking is optional.
The Carr Inlet OPAREA is a quiet deep-water inland range approximately 12 nm
The Western Behm Canal is located in Southeast Alaska, near the city of Ketchikan, Alaska. SEAFAC is located in the Western Behm Canal and covers an area of 48 nm
SEAFAC is comprised of land-based facilities and in-water assets. The land-based facilities are located within 5.5 acres (2 hectares) on Back Island and are not included in the scope of this analysis. The in-water assets include two sites: the underway site and the static site. These assets and the operational area of SEAFAC are located in five restricted areas. The underway site arrays are in Area 1. The static site is in Area 2. All associated underwater cabling and other devices associated with the underway site are located in Area 3. Area 4 provides a corridor for utility power and a phone cable. Area 5 is an operational area to allow for safe passage of local vessel traffic. Notifications of invoking restriction of Area 5 occur at least 72 hours prior to SEAFAC operations in accordance with 33 CFR 34.1275. During test periods, all vessels entering Area 5 are requested to contact SEAFAC to coordinate safe passage through the area. Area 5 defines the SEAFAC Study Area boundary, which is comprised only of the in-water area and excludes the land-based supporting facilities and operations.
The SEAFAC at-sea areas are:
• Restricted Areas 1 through 5. The five restricted areas are located within Western Behm Canal. The main purposes of the restricted areas are to provide for vessel and public safety, lessen acoustic encroachment from non-participating vessels, and prohibit certain activities that could damage SEAFAC's sensitive in-water acoustic instruments and associated cables. Area 5 encompasses the entire SEAFAC operations area.
• Underway Measurement Site. The underway measurement site is in the center of Western Behm Canal and is 5,000 yards (yd.) (4,572 m) wide and 12,000 yd. (10,973 m) long. The acoustic arrays are located at the center of this area (Area 1).
• Static Site. The static site is approximately 2 nm northwest of Back Island. During testing, a vessel is tethered between two surface barges. In most scenarios, the vessel submerges to conduct acoustic measurements. The static site is located at the center of Area 2.
• Area 3 and Area 4. These restricted areas provide protection to underwater cables and bottom-mounted equipment they encompass.
Bottom-moored acoustic measurement arrays are located in the middle of the site. These instrumented arrays are established for measuring vessel signatures when a vessel is underway (underway site) and is at rest and moored (static site). The instruments are passive arrays of hydrophones sensing the acoustic signature of the vessels (
The sensors at SEAFAC are passive and measure radiated noise in the water, such as machinery on submarines and other underwater vessels. Vessels do not use tactical mid-frequency active sonar while undergoing testing at SEAFAC. Active acoustic sources are used for communications, range calibration, and to provide position information for units operating submerged on the range.
Twenty-nine marine mammal species are known to occur in the Study Area, including seven mysticetes (baleen whales), 16 odontocetes (dolphins and toothed whales), and six pinnipeds (seals and sea lions). Among these species, there are 50 stocks managed by NMFS or the U.S. Fish and Wildlife Service (USFWS) in the U.S. Exclusive Economic Zone (EEZ). These species and their numbers are presented in Table 9. Consistent with NMFS most recent Pacific Stock Assessment Report, a single species may include multiple stocks recognized for management purposes (e.g., killer whale), while other species are grouped into a single stock due to limited species-specific information (e.g., beaked whales belonging to the genus Mesoplodon).
Based on recent discussion with regional NMFS subject matter experts and subsequent to the publication of the 2014 SAR, the Navy and NMFS applied research presented in London
Information on the status, distribution, abundance, and vocalizations of marine mammal species in the Study Area may be viewed in Chapter 4 of the LOA application (
Cetaceans have an auditory anatomy that follows the basic mammalian pattern, with some changes to adapt to the demands of hearing underwater. The typical mammalian ear is divided into an outer ear, middle ear, and inner ear. The outer ear is separated from the inner ear by a tympanic membrane, or eardrum. In terrestrial mammals, the outer ear, eardrum, and middle ear transmit airborne sound to the inner ear, where the sound waves are propagated through the cochlear fluid. Since the impedance of water is close to that of the tissues of a cetacean, the outer ear is not required to transduce sound energy as it does when sound waves travel from air to fluid (inner ear). Sound waves traveling through the inner ear cause the basilar membrane to vibrate. Specialized cells, called hair cells, respond to the vibration and produce nerve pulses that are transmitted to the central nervous system. Acoustic energy causes the basilar membrane in the cochlea to vibrate. Sensory cells at different positions along the basilar membrane are excited by different frequencies of sound (Pickles, 1998).
Marine mammal vocalizations often extend both above and below the range of human hearing; vocalizations with frequencies lower than 20 Hz are labeled as infrasonic and those higher than 20 kHz as ultrasonic (National Research Council (NRC), 2003; Figure 4-1). Measured data on the hearing abilities of cetaceans are sparse, particularly for the larger cetaceans such as the baleen whales. The auditory thresholds of some of the smaller odontocetes have been determined in captivity. It is generally believed that cetaceans should at least be sensitive to the frequencies of their own vocalizations. Comparisons of the anatomy of cetacean inner ears and models of the structural properties and the response to vibrations of the ear's components in different species provide an indication of likely sensitivity to various sound frequencies. The ears of small toothed whales are optimized for receiving high-frequency sound, while baleen whale inner ears are best in low to infrasonic frequencies (Ketten, 1992; 1997; 1998).
Baleen whale vocalizations are composed primarily of frequencies below 1 kHz, and some contain fundamental frequencies as low as 16 Hz (Watkins
The toothed whales produce a wide variety of sounds, which include species-specific broadband “clicks” with peak energy between 10 and 200 kHz, individually variable “burst pulse” click trains, and constant frequency or frequency-modulated (FM) whistles ranging from 4 to 16 kHz (Wartzok and Ketten, 1999). The general consensus is that the tonal vocalizations (whistles) produced by toothed whales play an important role in maintaining contact between dispersed individuals, while broadband clicks are used during echolocation (Wartzok and Ketten, 1999). Burst pulses have also been strongly implicated in communication, with some scientists suggesting that they play an important role in agonistic encounters (McCowan and Reiss, 1995), while others have proposed that they represent “emotive” signals in a broader sense, possibly representing graded communication signals (Herzing, 1996). Sperm whales, however, are known to produce only clicks, which are used for both communication and echolocation (Whitehead, 2003). Most of the energy of toothed whale social vocalizations is concentrated near 10 kHz, with source levels for whistles as high as 100 to 180 dB re 1 µPa at 1 m (Richardson
An understanding of the basic properties of underwater sound is necessary to comprehend many of the concepts and analyses presented in this document. A summary is included below.
Sound is a wave of pressure variations propagating through a medium (
Acousticians have adopted a logarithmic scale for sound intensities, which is denoted in decibels (dB). Decibel measurements represent the ratio between a measured pressure value and a reference pressure value (in this case 1 µPa or, for airborne sound, 20 µPa). The logarithmic nature of the scale means that each 10-dB increase is a ten-fold increase in acoustic power (and a 20-dB increase is then a 100-fold increase in power; and a 30-dB increase is a 1,000-fold increase in power). A ten-fold increase in acoustic power does not mean that the sound is perceived as being ten times louder, however. Humans perceive a 10-dB increase in sound level as a doubling of loudness, and a 10-dB decrease in sound level as a halving of loudness. The term “sound pressure level” implies a decibel measure and a reference pressure that is used as the denominator of the ratio. Throughout this document, NMFS uses 1 µPa (denoted re: 1µPa) as a standard reference pressure unless noted otherwise.
It is important to note that decibel values underwater and decibel values in air are not the same (different reference pressures and densities/sound speeds between media) and should not be directly compared. Because of the different densities of air and water and the different decibel standards (
Sound frequency is measured in cycles per second, or Hertz (abbreviated Hz), and is analogous to musical pitch; high-pitched sounds contain high frequencies and low-pitched sounds contain low frequencies. Natural sounds in the ocean span a huge range of frequencies: from earthquake noise at 5 Hz to harbor porpoise clicks at 150,000 Hz (150 kHz). These sounds are so low or so high in pitch that humans cannot even hear them; acousticians call these infrasonic (typically below 20 Hz) and ultrasonic (typically above 20,000 Hz) sounds, respectively. A single sound may be made up of many different frequencies together. Sounds made up of only a small range of frequencies are called “narrowband”, and sounds with a broad range of frequencies are called “broadband”; explosives are an example of a broadband sound source and active tactical sonars are an example of a narrowband sound source.
When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Current data indicate that not all marine mammal species have equal hearing capabilities (Richardson
Southall
• Low frequency cetaceans (13 species of mysticetes): Functional hearing estimates occur between approximately 7 Hz and 30 kilohertz (kHz) (extended from 22 kHz based on data indicating that some mysticetes can hear above 22 kHz; Watkins, 1986; Ketten, 1998; Houser
• Mid-frequency cetaceans (larger toothed whales, beaked whales, and most delphinids): Functional hearing is estimated to occur between approximately 150 Hz and 160 kHz, with best hearing from 10 to less than 100 kHz (Johnson, 1967; White, 1977; Richardson
• High-frequency cetaceans (porpoises, river dolphins, and members of the genera
• Pinnipeds in water; Phocidae (true seals): Functional hearing is estimated to occur between approximately 75 Hz to 100 kHz, with best hearing between 1-50 kHz (Møhl, 1968; Terhune and Ronald, 1971, 1972; Richardson
• Pinnipeds in water; Otariidae (eared seals): Functional hearing is estimated to occur between 100 Hz and 40 kHz for Otariidae, with best hearing between 2-48 kHz (Schusterman
The pinniped functional hearing group was modified from Southall
Concurrent with the development of NOAA's Ocean Noise Strategy and draft “Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals,” NMFS is currently considering additional modifications to some of the functional hearing ranges proposed by Southall
When sound travels (propagates) from its source, its loudness decreases as the distance traveled by the sound increases. Thus, the loudness of a sound at its source is higher than the loudness of that same sound a kilometer away. Acousticians often refer to the loudness of a sound at its source (typically referenced to one meter from the source) as the source level and the loudness of sound elsewhere as the received level (
As sound travels from a source, its propagation in water is influenced by various physical characteristics, including water temperature, depth, salinity, and surface and bottom properties that cause refraction, reflection, absorption, and scattering of sound waves. Oceans are not homogeneous and the contribution of each of these individual factors is extremely complex and interrelated. The physical characteristics that determine the sound's speed through the water will change with depth, season, geographic location, and with time of day (as a result, in actual active sonar operations, crews will measure oceanic conditions, such as sea water temperature and depth, to calibrate models that determine the path the sonar signal will take as it travels through the ocean and how strong the sound signal will be at a given range along a particular transmission path). As sound travels through the ocean, the intensity associated with the wavefront diminishes, or attenuates. This decrease in intensity is referred to as propagation loss, also commonly called transmission loss.
This section includes a brief explanation of the two sound measurements (sound pressure level (SPL) and sound exposure level (SEL)) frequently used to describe sound levels in the discussions of acoustic effects in this document.
Sound pressure level (SPL)—Sound pressure is the sound force per unit area, and is usually measured in micropascals (µPa), where 1 Pa is the pressure resulting from a force of one newton exerted over an area of one square meter. SPL is expressed as the ratio of a measured sound pressure and a reference level.
The commonly used reference pressure level in underwater acoustics is 1 µPa, and the units for SPLs are dB re: 1 µPa. SPL is an instantaneous pressure measurement and can be expressed as the peak, the peak-peak, or the root mean square (rms). Root mean square pressure, which is the square root of the arithmetic average of the squared instantaneous pressure values, is typically used in discussions of the effects of sounds on vertebrates and all references to SPL in this document refer to the root mean square. SPL does not take the duration of exposure into account. SPL is the applicable metric used in the risk continuum, which is used to estimate behavioral harassment takes (see Level B Harassment Risk Function (Behavioral Harassment) Section).
Sound exposure level (SEL)—SEL is an energy metric that integrates the squared instantaneous sound pressure over a stated time interval. The units for SEL are dB re: 1 µPa
As applied to active sonar, the SEL includes both the SPL of a sonar ping and the total duration. Longer duration pings and/or pings with higher SPLs will have a higher SEL. If an animal is exposed to multiple pings, the SEL in each individual ping is summed to calculate the cumulative SEL. The cumulative SEL depends on the SPL, duration, and number of pings received. The thresholds that NMFS uses to indicate at what received level the onset of temporary threshold shift (TTS) and permanent threshold shift (PTS) in hearing are likely to occur are expressed as cumulative SEL.
The Navy has requested authorization for the take of marine mammals that may occur incidental to training and testing activities in the Study Area. The Navy has analyzed potential impacts to marine mammals from impulsive and non-impulsive sound sources and vessel strike.
Other potential impacts to marine mammals from training activities in the Study Area were analyzed in the Navy's January 2014 NWTT DEIS/OEIS, in consultation with NMFS as a cooperating agency, and determined to be unlikely to result in marine mammal harassment. Therefore, the Navy has not requested authorization for take of marine mammals that might occur incidental to other components of their proposed activities. In this document, NMFS analyzes the potential effects on marine mammals from exposure to non-impulsive sound sources (sonar and other active acoustic sources), impulsive sound sources (underwater detonations), and vessel strikes.
For the purpose of MMPA authorizations, NMFS' effects assessments serve four primary purposes: (1) To prescribe the permissible methods of taking (
More specifically, for activities involving non-impulsive or impulsive sources, NMFS' analysis will identify the probability of lethal responses, physical trauma, sensory impairment (permanent and temporary threshold shifts and acoustic masking), physiological responses (particular stress responses), behavioral disturbance (that rises to the level of harassment), and social responses (effects to social relationships) that would be classified as a take and whether such take would have a negligible impact on such species or stocks. This section focuses qualitatively on the different ways that non-impulsive and impulsive sources may affect marine mammals (some of which NMFS would not classify as harassment). Then, in the Estimated Take of Marine Mammals section, the potential effects to marine mammals from non-impulsive and impulsive sources will be related to the MMPA definitions of Level A and Level B harassment, along with the potential effects from vessel strikes, and we will attempt to quantify those effects.
Based on the literature, there are two basic ways that non-impulsive sources might directly result in physical trauma or damage: Noise-induced loss of hearing sensitivity (more commonly-called “threshold shift”) and acoustically mediated bubble growth. Separately, an animal's behavioral reaction to an acoustic exposure could lead to physiological effects that might ultimately lead to injury or death, which is discussed later in the Stranding section.
The following physiological mechanisms are thought to play a role in inducing auditory TS: Effects to sensory hair cells in the inner ear that reduce their sensitivity, modification of the chemical environment within the sensory cells, residual muscular activity in the middle ear, displacement of certain inner ear membranes, increased blood flow, and post-stimulatory reduction in both efferent and sensory neural output (Southall
PTS is considered auditory injury (Southall
Although the published body of scientific literature contains numerous theoretical studies and discussion papers on hearing impairments that can occur with exposure to a loud sound, only a few studies provide empirical information on the levels at which noise-induced loss in hearing sensitivity occurs in nonhuman animals. For marine mammals, published data are limited to the captive bottlenose dolphin, beluga, harbor porpoise, and Yangtze finless porpoise (Finneran
Marine mammal hearing plays a critical role in communication with conspecifics, and interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (
It is unlikely that the short duration of sonar pings or explosion sounds would be long enough to drive bubble growth to any substantial size, if such a phenomenon occurs. However, an alternative but related hypothesis has also been suggested: Stable bubbles could be destabilized by high-level sound exposures such that bubble growth then occurs through static diffusion of gas out of the tissues. In such a scenario the marine mammal would need to be in a gas-supersaturated state for a long enough period of time for bubbles to become of a problematic size. Recent research with
Yet another hypothesis (decompression sickness) has speculated that rapid ascent to the surface following exposure to a startling sound might produce tissue gas saturation sufficient for the evolution of nitrogen bubbles (Jepson
Although theoretical predictions suggest the possibility for acoustically mediated bubble growth, there is considerable disagreement among scientists as to its likelihood (Piantadosi and Thalmann, 2004; Evans and Miller, 2003). Crum and Mao (1996) hypothesized that received levels would have to exceed 190 dB in order for there to be the possibility of significant bubble growth due to supersaturation of gases in the blood (
Marine mammals use acoustic signals for a variety of purposes, which differ among species, but include communication between individuals, navigation, foraging, reproduction, and learning about their environment (Erbe and Farmer, 2000; Tyack, 2000). Masking, or auditory interference, generally occurs when sounds in the environment are louder than and of a similar frequency to, auditory signals an animal is trying to receive. Masking is a phenomenon that affects animals that are trying to receive acoustic information about their environment, including sounds from other members of their species, predators, prey, and sounds that allow them to orient in their environment. Masking these acoustic signals can disturb the behavior of individual animals, groups of animals, or entire populations.
The extent of the masking interference depends on the spectral, temporal, and spatial relationships between the signals an animal is trying to receive and the masking noise, in addition to other factors. In humans, significant masking of tonal signals occurs as a result of exposure to noise in a narrow band of similar frequencies. As the sound level increases, though, the detection of frequencies above those of the masking stimulus decreases also. This principle is expected to apply to marine mammals as well because of common biomechanical cochlear properties across taxa.
Richardson
The echolocation calls of toothed whales are subject to masking by high frequency sound. Human data indicate low-frequency sound can mask high-frequency sounds (
As mentioned previously, the functional hearing ranges of mysticetes, odontocetes, and pinnipeds underwater all encompass the frequencies of the sonar sources used in the Navy's MFAS/HFAS training exercises. Additionally, almost all species' vocal repertoires span across the frequencies of these sonar sources used by the Navy. The closer the characteristics of the masking signal to the signal of interest, the more likely masking is to occur. For hull-mounted sonar, which accounts for the largest takes of marine mammals (because of the source strength and number of hours it's conducted), the pulse length and low duty cycle of the MFAS/HFAS signal makes it less likely that masking would occur as a result.
In addition to making it more difficult for animals to perceive acoustic cues in their environment, anthropogenic sound presents separate challenges for animals that are vocalizing. When they vocalize, animals are aware of environmental conditions that affect the “active space” of their vocalizations, which is the maximum area within which their vocalizations can be detected before it drops to the level of ambient noise (Brenowitz, 2004; Brumm
Many animals will combine several of these strategies to compensate for high levels of background noise. Anthropogenic sounds that reduce the signal-to-noise ratio of animal vocalizations, increase the masked auditory thresholds of animals listening for such vocalizations, or reduce the active space of an animal's vocalizations impair communication between animals. Most animals that vocalize have evolved strategies to compensate for the effects of short-term or temporary increases in background or ambient noise on their songs or calls. Although the fitness consequences of these vocal adjustments remain unknown, like most other trade-offs animals must make, some of these strategies probably come at a cost (Patricelli
Classic stress responses begin when an animal's central nervous system perceives a potential threat to its homeostasis. That perception triggers stress responses regardless of whether a stimulus actually threatens the animal; the mere perception of a threat is sufficient to trigger a stress response (Moberg, 2000; Sapolsky
In the case of many stressors, an animal's first and sometimes most economical (in terms of biotic costs) response is behavioral avoidance of the potential stressor or avoidance of continued exposure to a stressor. An animal's second line of defense to stressors involves the sympathetic part of the autonomic nervous system and the classical “fight or flight” response which includes the cardiovascular system, the gastrointestinal system, the exocrine glands, and the adrenal medulla to produce changes in heart rate, blood pressure, and gastrointestinal activity that humans commonly associate with “stress.” These responses have a relatively short duration and may or may not have significant long-term effect on an animal's welfare.
An animal's third line of defense to stressors involves its neuroendocrine systems; the system that has received the most study has been the hypothalmus-pituitary-adrenal system (also known as the HPA axis in mammals or the hypothalamus-pituitary-interrenal axis in fish and some reptiles). Unlike stress responses associated with the autonomic nervous system, virtually all neuro-endocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction (Moberg, 1987; Rivier, 1995), altered metabolism (Elasser
The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and distress is the biotic cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose a risk to the animal's welfare. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other biotic function, which impairs those functions that experience the diversion. For example, when mounting a stress response diverts energy away from growth in young animals, those animals may experience stunted growth. When mounting a stress response diverts energy from a fetus, an animal's reproductive success and its fitness will suffer. In these cases, the animals will have entered a pre-pathological or pathological state which is called “distress” (Seyle, 1950) or “allostatic loading” (McEwen and Wingfield, 2003). This pathological state will last until the animal replenishes its biotic
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses have also been documented fairly well through controlled experiments; because this physiology exists in every vertebrate that has been studied, it is not surprising that stress responses and their costs have been documented in both laboratory and free-living animals (for examples see, Holberton
Studies of other marine animals and terrestrial animals would also lead us to expect some marine mammals to experience physiological stress responses and, perhaps, physiological responses that would be classified as “distress” upon exposure to high frequency, mid-frequency and low-frequency sounds. For example, Jansen (1998) reported on the relationship between acoustic exposures and physiological responses that are indicative of stress responses in humans (for example, elevated respiration and increased heart rates). Jones (1998) reported on reductions in human performance when faced with acute, repetitive exposures to acoustic disturbance. Trimper
Hearing is one of the primary senses marine mammals use to gather information about their environment and to communicate with conspecifics. Although empirical information on the relationship between sensory impairment (TTS, PTS, and acoustic masking) on marine mammals remains limited, it seems reasonable to assume that reducing an animal's ability to gather information about its environment and to communicate with other members of its species would be stressful for animals that use hearing as their primary sensory mechanism. Therefore, we assume that acoustic exposures sufficient to trigger onset PTS or TTS would be accompanied by physiological stress responses because terrestrial animals exhibit those responses under similar conditions (NRC, 2003). More importantly, marine mammals might experience stress responses at received levels lower than those necessary to trigger onset TTS. Based on empirical studies of the time required to recover from stress responses (Moberg, 2000), we also assume that stress responses are likely to persist beyond the time interval required for animals to recover from TTS and might result in pathological and pre-pathological states that would be as significant as behavioral responses to TTS.
Behavioral responses to sound are highly variable and context-specific. Many different variables can influence an animal's perception of and response to (nature and magnitude) an acoustic event. An animal's prior experience with a sound or sound source effects whether it is less likely (habituation) or more likely (sensitization) to respond to certain sounds in the future (animals can also be innately pre-disposed to respond to certain sounds in certain ways) (Southall
Exposure of marine mammals to sound sources can result in no response or responses including, but not limited to: increased alertness; orientation or attraction to a sound source; vocal modifications; cessation of feeding; cessation of social interaction; alteration of movement or diving behavior; habitat abandonment (temporary or permanent); and, in severe cases, panic, flight, stampede, or stranding, potentially resulting in death (Southall
Nowacek
Due to past incidents of beaked whale strandings associated with sonar operations, feedback paths are provided between avoidance and diving and indirect tissue effects. This feedback accounts for the hypothesis that variations in diving behavior and/or avoidance responses can possibly result in nitrogen tissue supersaturation and nitrogen off-gassing, possibly to the point of deleterious vascular bubble formation (Jepson
Maybaum (1993) conducted sound playback experiments to assess the effects of MFAS on humpback whales in Hawaiian waters. Specifically, she exposed focal pods to sounds of a 3.3-kHz sonar pulse, a sonar frequency sweep from 3.1 to 3.6 kHz, and a control (blank) tape while monitoring behavior, movement, and underwater vocalizations. The two types of sonar signals (which both contained mid- and low-frequency components) differed in their effects on the humpback whales, but both resulted in avoidance behavior. The whales responded to the pulse by increasing their distance from the sound source and responded to the frequency sweep by increasing their swimming speeds and track linearity. In the Caribbean, sperm whales avoided exposure to mid-frequency submarine sonar pulses, in the range of 1000 Hz to 10,000 Hz (IWC 2005).
Kvadsheim
In 2007, the first in a series of behavioral response studies, a collaboration by the Navy, NMFS, and other scientists showed one beaked whale (
Tyack
Stimpert
Results from a 2007-2008 study conducted near the Bahamas showed a change in diving behavior of an adult Blainville's beaked whale to playback of mid-frequency source and predator sounds (Boyd
In the 2007-2008 Bahamas study, playback sounds of a potential predator—a killer whale—resulted in a similar but more pronounced reaction, which included longer inter-dive intervals and a sustained straight-line departure of more than 20 km from the area. The authors noted, however, that the magnified reaction to the predator sounds could represent a cumulative effect of exposure to the two sound types since killer whale playback began approximately 2 hours after mid-frequency source playback. Pilot whales and killer whales off Norway also exhibited horizontal avoidance of a transducer with outputs in the mid-frequency range (signals in the 1-2 kHz and 6-7 kHz ranges) (Miller
Through analysis of the behavioral response studies, a preliminary overarching effect of greater sensitivity to all anthropogenic exposures was seen in beaked whales compared to the other odontocetes studied (Southall
There are few empirical studies of avoidance responses of free-living cetaceans to MFAS. Much more information is available on the avoidance responses of free-living cetaceans to other acoustic sources, such as seismic airguns and low-frequency tactical sonar, than MFAS.
Southall
In the Southall
The studies that address responses of low-frequency cetaceans to non-pulse sounds include data gathered in the field and related to several types of sound sources (of varying similarity to MFAS/HFAS) including: Vessel noise, drilling and machinery playback, low-frequency M-sequences (sine wave with multiple phase reversals) playback, tactical low-frequency active sonar playback, drill ships, Acoustic Thermometry of Ocean Climate (ATOC) source, and non-pulse playbacks. These studies generally indicate no (or very
The studies that address responses of mid-frequency cetaceans to non-pulse sounds include data gathered both in the field and the laboratory and related to several different sound sources (of varying similarity to MFAS/HFAS) including: Pingers, drilling playbacks, ship and ice-breaking noise, vessel noise, Acoustic Harassment Devices (AHDs), Acoustic Deterrent Devices (ADDs), MFAS, and non-pulse bands and tones. Southall
The studies that address responses of high frequency cetaceans to non-pulse sounds include data gathered both in the field and the laboratory and related to several different sound sources (of varying similarity to MFAS/HFAS) including: pingers, AHDs, and various laboratory non-pulse sounds. All of these data were collected from harbor porpoises. Southall
The studies that address the responses of pinnipeds in water to non-pulse sounds include data gathered both in the field and the laboratory and related to several different sound sources (of varying similarity to MFAS/HFAS) including: AHDs, ATOC, various non-pulse sounds used in underwater data communication; underwater drilling, and construction noise. Few studies exist with enough information to include them in the analysis. The limited data suggested that exposures to non-pulse sounds between 90 and 140 dB generally do not result in strong behavioral responses in pinnipeds in water, but no data exist at higher received levels.
The different ways that marine mammals respond to sound are sometimes indicators of the ultimate effect that exposure to a given stimulus will have on the well-being (survival, reproduction, etc.) of an animal. There is limited marine mammal data quantitatively relating the exposure of marine mammals to sound to effects on reproduction or survival, though data exists for terrestrial species to which we can draw comparisons for marine mammals.
Attention is the cognitive process of selectively concentrating on one aspect of an animal's environment while ignoring other things (Posner, 1994). Because animals (including humans) have limited cognitive resources, there is a limit to how much sensory information they can process at any time. The phenomenon called “attentional capture” occurs when a stimulus (usually a stimulus that an animal is not concentrating on or attending to) “captures” an animal's attention. This shift in attention can occur consciously or subconsciously (for example, when an animal hears sounds that it associates with the approach of a predator) and the shift in attention can be sudden (Dukas, 2002; van Rij, 2007). Once a stimulus has captured an animal's attention, the animal can respond by ignoring the stimulus, assuming a “watch and wait” posture, or treat the stimulus as a disturbance and respond accordingly, which includes scanning for the source of the stimulus or “vigilance” (Cowlishaw
Vigilance is normally an adaptive behavior that helps animals determine the presence or absence of predators, assess their distance from conspecifics, or to attend cues from prey (Bednekoff and Lima, 1998; Treves, 2000). Despite those benefits, however, vigilance has a cost of time; when animals focus their attention on specific environmental cues, they are not attending to other activities such as foraging. These costs have been documented best in foraging animals, where vigilance has been shown to substantially reduce feeding rates (Saino, 1994; Beauchamp and Livoreil, 1997; Fritz
Several authors have established that long-term and intense disturbance stimuli can cause population declines by reducing the body condition of individuals that have been disturbed, followed by reduced reproductive success, reduced survival, or both (Daan
The primary mechanism by which increased vigilance and disturbance appear to affect the fitness of individual animals is by disrupting an animal's time budget and, as a result, reducing the time they might spend foraging and resting (which increases an animal's activity rate and energy demand). For example, a study of grizzly bears reported that bears disturbed by hikers reduced their energy intake by an average of 12 kcal/minute (50.2 x 10
Lusseau and Bejder (2007) present data from three long-term studies illustrating the connections between disturbance from whale-watching boats and population-level effects in cetaceans. In Sharks Bay Australia, the abundance of bottlenose dolphins was compared within adjacent control and tourism sites over three consecutive 4.5-year periods of increasing tourism levels. Between the second and third time periods, in which tourism doubled, dolphin abundance decreased by 15 percent in the tourism area and did not change significantly in the control area. In Fiordland, New Zealand, two populations (Milford and Doubtful Sounds) of bottlenose dolphins with tourism levels that differed by a factor of seven were observed and significant increases in travelling time and decreases in resting time were documented for both. Consistent short-term avoidance strategies were observed in response to tour boats until a threshold of disturbance was reached (average 68 minutes between interactions), after which the response switched to a longer term habitat displacement strategy. For one population tourism only occurred in a part of the home range, however, tourism occurred throughout the home range of the Doubtful Sound population and once boat traffic increased beyond the 68-minute threshold (resulting in abandonment of their home range/preferred habitat), reproductive success drastically decreased (increased stillbirths) and abundance decreased significantly (from 67 to 56 individuals in short period). Last, in a study of northern resident killer whales off Vancouver Island, exposure to boat traffic was shown to reduce foraging opportunities and increase traveling time. A simple bioenergetics model was applied to show that the reduced foraging opportunities equated to a decreased energy intake of 18 percent, while the increased traveling incurred an increased energy output of 3-4 percent, which suggests that a management action based on avoiding interference with foraging might be particularly effective.
On a related note, many animals perform vital functions, such as feeding, resting, traveling, and socializing, on a diel cycle (24-hour cycle). Substantive behavioral reactions to noise exposure (such as disruption of critical life functions, displacement, or avoidance of important habitat) are more likely to be significant if they last more than one diel cycle or recur on subsequent days (Southall
In order to understand how the effects of activities may or may not impact stocks and populations of marine mammals, it is necessary to understand not only what the likely disturbances are going to be, but how those disturbances may affect the reproductive success and survivorship of individuals, and then how those impacts to individuals translate to population changes. Following on the earlier work of a committee of the U.S. National Research Council (NRC, 2005), New
In addition to outlining this general framework and compiling the relevant literature that supports it, New
When a live or dead marine mammal swims or floats onto shore and becomes “beached” or incapable of returning to sea, the event is termed a “stranding” (Geraci
Marine mammals are known to strand for a variety of reasons, such as infectious agents, biotoxicosis, starvation, fishery interaction, ship strike, unusual oceanographic or weather events, sound exposure, or combinations of these stressors sustained concurrently or in series. However, the cause or causes of most strandings are unknown (Geraci
Several sources have published lists of mass stranding events of cetaceans in an attempt to identify relationships between those stranding events and military sonar (Hildebrand, 2004; IWC, 2005; Taylor
Most of the stranding events reviewed by the International Whaling Commission involved beaked whales. A mass stranding of Cuvier's beaked whales in the eastern Mediterranean Sea occurred in 1996 (Frantzis, 1998) and mass stranding events involving Gervais' beaked whales, Blainville's beaked whales, and Cuvier's beaked whales occurred off the coast of the Canary Islands in the late 1980s (Simmonds and Lopez-Jurado, 1991). The stranding events that occurred in the Canary Islands and Kyparissiakos Gulf in the late 1990s and the Bahamas in 2000 have been the most intensively-studied mass stranding events and have been associated with naval maneuvers involving the use of tactical sonar.
Between 1960 and 2006, 48 strandings (68 percent) involved beaked whales, three (4 percent) involved dolphins, and 14 (20 percent) involved whale species. Cuvier's beaked whales were involved in the greatest number of these events (48 or 68 percent), followed by sperm whales (seven or 10 percent), and Blainville's and Gervais' beaked whales (four each or 6 percent). Naval activities (not just activities conducted by the U.S. Navy) that might have involved active sonar are reported to have coincided with nine or 10 (13 to 14 percent) of those stranding events. Between the mid-1980s and 2003 (the period reported by the International Whaling Commission), NMFS identified reports of 44 mass cetacean stranding events of which at least seven were coincident with naval exercises that were using MFAS.
During a Navy training event on March 4, 2011, at the Silver Strand Training Complex in San Diego, California, three or possibly four dolphins were killed in an explosion. During an underwater detonation training event, a pod of 100 to 150 long-beaked common dolphins were observed moving towards the 700-yd (640.1-m) exclusion zone around the explosive charge, monitored by personnel in a safety boat and participants in a dive boat. Approximately 5 minutes remained on a time-delay fuse connected to a single 8.76 lb (3.97 kg) explosive charge (C-4 and detonation cord). Although the dive boat was placed between the pod and the explosive in an effort to guide the dolphins away from the area, that effort was unsuccessful and three long-beaked common dolphins near the explosion died. In addition to the three dolphins found dead on March 4, the remains of a fourth dolphin were discovered on March 7, 2011 near Ocean Beach, California (3 days later and approximately 11.8 mi. [19 km] from Silver Strand where the training event occurred), which might also have been related to this event. Association of the fourth stranding with the training event is uncertain because dolphins strand on a regular basis in the San Diego area. Details such as the dolphins' depth and distance from the explosive at the time of the detonation could not be estimated from the 250 yd (228.6 m) standoff point of the observers in the dive boat or the safety boat.
These dolphin mortalities are the only known occurrence of a U.S. Navy training or testing event involving impulse energy (underwater detonation) that caused mortality or injury to a marine mammal. Despite this being a rare occurrence, the Navy has reviewed training requirements, safety procedures, and possible mitigation measures and implemented changes to reduce the potential for this to occur in the future. Discussions of procedures associated with these and other training and testing events are presented in the Mitigation section.
Over the past 16 years, there have been five stranding events coincident with military mid-frequency sonar use in which exposure to sonar is believed to have been a contributing factor: Greece (1996); the Bahamas (2000); Madeira (2000); Canary Islands (2002); and Spain (2006). Additionally, in 2004, during the Rim of the Pacific (RIMPAC) exercises, between 150 and 200 usually pelagic melon-headed whales occupied the shallow waters of Hanalei Bay, Kauai, Hawaii for over 28 hours. NMFS determined that MFAS was a plausible, if not likely, contributing factor in what may have been a confluence of events that led to the stranding. A number of other stranding events coincident with the operation of mid-frequency sonar, including the death of beaked whales or other species (minke whales, dwarf sperm whales, pilot whales), have been reported; however, the majority have not been investigated to the degree necessary to determine the cause of the stranding and only one of these stranding events, the Bahamas (2000), was associated with exercises conducted by the U.S. Navy. Most recently, the Independent Scientific Review Panel investigating potential contributing factors to a 2008 mass stranding of melon-headed whales in Antsohihy, Madagascar released its final report suggesting that the stranding was likely initially triggered by an industry seismic survey. This report suggests that the operation of a commercial high-powered 12 kHz multi-beam echosounder during an industry seismic survey was a plausible and likely initial trigger that caused a large group of melon-headed whales to leave their typical habitat and then ultimately strand as a result of secondary factors such as malnourishment and dehydration. The report indicates that the risk of this particular convergence of factors and ultimate outcome is likely very low, but recommends that the potential be considered in environmental planning. Because of the association between tactical mid-frequency active sonar use and a small number of marine mammal strandings, the Navy and NMFS have been considering and addressing the potential for strandings in association with Navy activities for years. In addition to a suite of mitigation intended to more broadly minimize impacts to marine mammals, the Navy and NMFS have a detailed Stranding Response Plan that outlines reporting, communication, and response protocols intended both to minimize the impacts of, and enhance the analysis of, any potential stranding in areas where the Navy operates.
Necropsies of eight of the animals were performed but were limited to basic external examination and sampling of stomach contents, blood, and skin. No ears or organs were
All available information regarding the conditions associated with this stranding event were compiled, and many potential causes were examined including major pollution events, prominent tectonic activity, unusual physical or meteorological events, magnetic anomalies, epizootics, and conventional military activities (International Council for the Exploration of the Sea, 2005a). However, none of these potential causes coincided in time or space with the mass stranding, or could explain its characteristics (International Council for the Exploration of the Sea, 2005a). The robust condition of the animals, plus the recent stomach contents, is inconsistent with pathogenic causes. In addition, environmental causes can be ruled out as there were no unusual environmental circumstances or events before or during this time period and within the general proximity (Frantzis, 2004).
Because of the rarity of this mass stranding of Cuvier's beaked whales in the Kyparissiakos Gulf (first one in history), the probability for the two events (the military exercises and the strandings) to coincide in time and location, while being independent of each other, was thought to be extremely low (Frantzis, 1998). However, because full necropsies had not been conducted, and no abnormalities were noted, the cause of the strandings could not be precisely determined (Cox
Necropsies were performed on five of the stranded beaked whales. All five necropsied beaked whales were in good body condition, showing no signs of infection, disease, ship strike, blunt trauma, or fishery related injuries, and three still had food remains in their stomachs. Auditory structural damage was discovered in four of the whales, specifically bloody effusions or hemorrhaging around the ears. Bilateral intracochlear and unilateral temporal region subarachnoid hemorrhage, with blood clots in the lateral ventricles, were found in two of the whales. Three of the whales had small hemorrhages in their acoustic fats (located along the jaw and in the melon).
A comprehensive investigation was conducted and all possible causes of the stranding event were considered, whether they seemed likely at the outset or not. Based on the way in which the strandings coincided with ongoing naval activity involving tactical MFAS use, in terms of both time and geography, the nature of the physiological effects experienced by the dead animals, and the absence of any other acoustic sources, the investigation team concluded that MFAS aboard U.S. Navy ships that were in use during the active sonar exercise in question were the most plausible source of this acoustic or impulse trauma to beaked whales. This sound source was active in a complex environment that included the presence of a surface duct, unusual and steep bathymetry, a constricted channel with limited egress, intensive use of multiple, active sonar units over an extended period of time, and the presence of beaked whales that appear to be sensitive to the frequencies produced by these active sonars. The investigation team concluded that the cause of this stranding event was the confluence of the Navy MFAS and these contributory factors working together, and further recommended that the Navy avoid operating MFAS in situations where these five factors would be likely to occur. This report does not conclude that all five of these factors must be present for a stranding to occur, nor that beaked whales are the only species that could potentially be affected by the confluence of the other factors. Based on this, NMFS believes that the operation of MFAS in situations where surface ducts exist, or in marine environments defined by steep bathymetry and/or constricted channels may increase the likelihood of producing a sound field with the potential to cause cetaceans (especially beaked whales) to strand, and therefore, suggests the need for increased vigilance while operating MFAS in these areas, especially when beaked whales (or potentially other deep divers) are likely present.
The bodies of the three stranded whales were examined post mortem (Woods Hole Oceanographic Institution, 2005), though only one of the stranded whales was fresh enough (24 hours after stranding) to be necropsied (Cox
Several observations on the Madeira stranded beaked whales, such as the pattern of injury to the auditory system, are the same as those observed in the Bahamas strandings. Blood in and around the eyes, kidney lesions, pleural hemorrhages, and congestion in the lungs are particularly consistent with the pathologies from the whales stranded in the Bahamas, and are consistent with stress and pressure related trauma. The similarities in pathology and stranding patterns between these two events suggest that a
Even though no definitive causal link can be made between the stranding event and naval exercises, certain conditions may have existed in the exercise area that, in their aggregate, may have contributed to the marine mammal strandings (Freitas, 2004): exercises were conducted in areas of at least 547 fathoms (1,000 m) depth near a shoreline where there is a rapid change in bathymetry on the order of 547 to 3,281 fathoms (1,000 to 6,000 m) occurring across a relatively short horizontal distance (Freitas, 2004); multiple ships were operating around Madeira, though it is not known if MFAS was used, and the specifics of the sound sources used are unknown (Cox
Eight Cuvier's beaked whales, one Blainville's beaked whale, and one Gervais' beaked whale were necropsied, six of them within 12 hours of stranding (Fernandez
The association of NATO MFAS use close in space and time to the beaked whale strandings, and the similarity between this stranding event and previous beaked whale mass strandings coincident with sonar use, suggests that a similar scenario and causative mechanism of stranding may be shared between the events. Beaked whales stranded in this event demonstrated brain and auditory system injuries, hemorrhages, and congestion in multiple organs, similar to the pathological findings of the Bahamas and Madeira stranding events. In addition, the necropsy results of Canary Islands stranding event lead to the hypothesis that the presence of disseminated and widespread gas bubbles and fat emboli were indicative of nitrogen bubble formation, similar to what might be expected in decompression sickness (Jepson
Only one animal, a calf, was known to have died following this event. The animal was noted alive and alone in the Bay on the afternoon of July 4, 2004, and was found dead in the Bay the morning of July 5, 2004. A full necropsy, magnetic resonance imaging, and computerized tomography examination were performed on the calf to determine the manner and cause of death. The combination of imaging, necropsy and histological analyses found no evidence of infectious, internal traumatic, congenital, or toxic factors. Cause of death could not be definitively determined, but it is likely that maternal separation, poor nutritional condition, and dehydration contributed to the final demise of the animal. Although it is not known when the calf was separated from its mother, the animals' movement into the Bay and subsequent milling and re-grouping may have contributed to the separation or lack of nursing, especially if the maternal bond was weak or this was an inexperienced mother with her first calf.
Environmental factors, abiotic and biotic, were analyzed for any anomalous occurrences that would have contributed to the animals entering and remaining in Hanalei Bay. The Bay's bathymetry is similar to many other sites within the Hawaiian Island chain and dissimilar to sites that have been associated with mass strandings in other parts of the U.S. The weather conditions appeared to be normal for that time of year with no fronts or other significant features noted. There was no evidence of unusual distribution, occurrence of predator or prey species, or unusual harmful algal blooms, although Mobley
The Hanalei event was spatially and temporally correlated with RIMPAC. Official sonar training and tracking exercises in the Pacific Missile Range Facility (PMRF) warning area did not commence until approximately 8 a.m. on July 3 and were thus ruled out as a possible trigger for the initial movement into the Bay. However, six naval surface vessels transiting to the operational area on July 2 intermittently transmitted active sonar (for approximately 9 hours total from 1:15 p.m. to 12:30 a.m.) as they approached from the south. The potential for these transmissions to have triggered the whales' movement into Hanalei Bay was investigated. Analyses with the information available indicated that animals to the south and east of
While causation of this stranding event may never be unequivocally determined, NMFS consider the active sonar transmissions of July 2-3, 2004, a plausible, if not likely, contributing factor in what may have been a confluence of events. This conclusion is based on the following: (1) The evidently anomalous nature of the stranding; (2) its close spatiotemporal correlation with wide-scale, sustained use of sonar systems previously associated with stranding of deep-diving marine mammals; (3) the directed movement of two groups of transmitting vessels toward the southeast and southwest coast of Kauai; (4) the results of acoustic propagation modeling and an analysis of possible animal transit times to the Bay; and (5) the absence of any other compelling causative explanation. The initiation and persistence of this event may have resulted from an interaction of biological and physical factors. The biological factors may have included the presence of an apparently uncommon, deep-diving cetacean species (and possibly an offshore, non-resident group), social interactions among the animals before or after they entered the Bay, and/or unknown predator or prey conditions. The physical factors may have included the presence of nearby deep water, multiple vessels transiting in a directed manner while transmitting active sonar over a sustained period, the presence of surface sound ducting conditions, and/or intermittent and random human interactions while the animals were in the Bay.
A separate event involving melon-headed whales and rough-toothed dolphins took place over the same period of time in the Northern Mariana Islands (Jefferson
Veterinary pathologists necropsied the two male and two female Cuvier's beaked whales. According to the pathologists, the most likely primary cause of this type of beaked whale mass stranding event was anthropogenic acoustic activities, most probably anti-submarine MFAS used during the military naval exercises. However, no positive acoustic link was established as a direct cause of the stranding. Even though no causal link can be made between the stranding event and naval exercises, certain conditions may have existed in the exercise area that, in their aggregate, may have contributed to the marine mammal strandings (Freitas, 2004): exercises were conducted in areas of at least 547 fathoms (1,000 m) depth near a shoreline where there is a rapid change in bathymetry on the order of 547 to 3,281 fathoms (1,000 to 6,000 m) occurring across a relatively short horizontal distance (Freitas, 2004); multiple ships (in this instance, five) were operating MFAS in the same area over extended periods of time (in this case, 20 hours) in close proximity; and exercises took place in an area surrounded by landmasses, or in an embayment. Exercises involving multiple ships employing MFAS near land may have produced sound directed towards a channel or embayment that may have cut off the lines of egress for the affected marine mammals (Freitas, 2004).
Several authors have noted similarities between some of these stranding incidents: They occurred in islands or archipelagoes with deep water nearby, several appeared to have been associated with acoustic waveguides like surface ducting, and the sound fields created by ships transmitting MFAS (Cox
Based on the evidence available, however, NMFS cannot determine whether (a) Cuvier's beaked whale is more prone to injury from high-intensity sound than other species; (b) their behavioral responses to sound makes them more likely to strand; or (c) they are more likely to be exposed to MFAS than other cetaceans (for reasons that remain unknown). Because the association between active sonar exposures and marine mammals mass stranding events is not consistent—some marine mammals strand without being exposed to sonar and some sonar transmissions are not associated with marine mammal stranding events despite their co-occurrence—other risk factors or a grouping of risk factors probably contribute to these stranding events.
Although the confluence of Navy MFAS with the other contributory factors noted in the report was identified as the cause of the 2000 Bahamas stranding event, the specific mechanisms that led to that stranding (or the others) are not understood, and there is uncertainty regarding the ordering of effects that led to the stranding. It is unclear whether beaked whales were directly injured by sound (
Although causal relationships between beaked whale stranding events and active sonar remain unknown, several authors have hypothesized that stranding events involving these species in the Bahamas and Canary Islands may have been triggered when the whales changed their dive behavior in a startled response to exposure to active sonar or to further avoid exposure (Cox
Because many species of marine mammals make repetitive and prolonged dives to great depths, it has long been assumed that marine mammals have evolved physiological mechanisms to protect against the effects of rapid and repeated decompressions. Although several investigators have identified physiological adaptations that may protect marine mammals against nitrogen gas supersaturation (alveolar collapse and elective circulation; Kooyman
Zimmer and Tyack (2007) modeled nitrogen tension and bubble growth in several tissue compartments for several hypothetical dive profiles and concluded that repetitive shallow dives (defined as a dive where depth does not exceed the depth of alveolar collapse, approximately 72 m for
If marine mammals respond to a Navy vessel that is transmitting active sonar in the same way that they might respond to a predator, their probability of flight responses should increase when they perceive that Navy vessels are approaching them directly, because a direct approach may convey detection and intent to capture (Burger and Gochfeld, 1981, 1990; Cooper, 1997, 1998). The probability of flight responses should also increase as received levels of active sonar increase (and the ship is, therefore, closer) and as ship speeds increase (that is, as approach speeds increase). For example, the probability of flight responses in Dall's sheep (
Despite the many theories involving bubble formation (both as a direct cause of injury (see Acoustically Mediated Bubble Growth Section) and an indirect cause of stranding (See Behaviorally Mediated Bubble Growth Section), Southall
Underwater explosive detonations send a shock wave and sound energy through the water and can release gaseous by-products, create an oscillating bubble, or cause a plume of water to shoot up from the water surface. The shock wave and accompanying noise are of most concern to marine animals. Depending on the intensity of the shock wave and size, location, and depth of the animal, an animal can be injured, killed, suffer non-lethal physical effects, experience hearing related effects with or without behavioral responses, or exhibit temporary behavioral responses or tolerance from hearing the blast sound. Generally, exposures to higher levels of impulse and pressure levels would result in greater impacts to an individual animal.
Injuries resulting from a shock wave take place at boundaries between tissues of different densities. Different velocities are imparted to tissues of different densities, and this can lead to their physical disruption. Blast effects are greatest at the gas-liquid interface (Landsberg, 2000). Gas-containing organs, particularly the lungs and gastrointestinal tract, are especially susceptible (Goertner, 1982; Hill, 1978; Yelverton
Because the ears are the most sensitive to pressure, they are the organs most susceptible to injury (Ketten, 2000). Sound-related damage associated with sound energy from detonations can be theoretically distinct from injury from the shock wave, particularly farther from the explosion. If a noise is audible to an animal, it has the potential to damage the animal's hearing by causing decreased sensitivity (Ketten, 1995). Sound-related trauma can be lethal or sublethal. Lethal impacts are those that result in immediate death or serious debilitation in or near an intense source and are not, technically, pure acoustic trauma (Ketten, 1995). Sublethal impacts include hearing loss, which is caused by exposures to perceptible sounds. Severe damage (from the shock wave) to the ears includes tympanic membrane rupture, fracture of the ossicles, damage to the cochlea, hemorrhage, and cerebrospinal fluid leakage into the middle ear. Moderate injury implies partial hearing loss due to tympanic membrane rupture and blood in the middle ear. Permanent hearing loss also can occur when the hair cells are damaged by one very loud event, as well as by prolonged exposure to a loud noise or chronic exposure to noise. The level of impact from blasts depends on both an animal's location and, at outer zones, on its sensitivity to the residual noise (Ketten, 1995).
There have been fewer studies addressing the behavioral effects of explosives on marine mammals compared to MFAS/HFAS. However, though the nature of the sound waves emitted from an explosion are different (in shape and rise time) from MFAS/HFAS, NMFS still anticipates the same sorts of behavioral responses to result from repeated explosive detonations (a smaller range of likely less severe responses (
Baleen whales have shown a variety of responses to impulse sound sources, including avoidance, reduced surface intervals, altered swimming behavior, and changes in vocalization rates (Richardson
Gray whales migrating along the U.S. west coast showed avoidance responses to seismic vessels by 10 percent of animals at 164 dB re 1 μPa, and by 90 percent of animals at 190 dB re 1 μPa, with similar results for whales in the Bering Sea (Malme 1986, 1988). In contrast, noise from seismic surveys was not found to impact feeding behavior or exhalation rates while resting or diving in western gray whales off the coast of Russia (Yazvenko
Humpback whales showed avoidance behavior at ranges of 5-8 km from a seismic array during observational studies and controlled exposure experiments in western Australia (McCauley, 1998; Todd
Seismic pulses at average received levels of 131 dB re 1 micropascal squared second (μPa
Madsen
A review of behavioral reactions by pinnipeds to impulse noise can be found in Richardson
Commercial and Navy ship strikes of cetaceans can cause major wounds, which may lead to the death of the animal. An animal at the surface could be struck directly by a vessel, a surfacing animal could hit the bottom of a vessel, or an animal just below the surface could be cut by a vessel's propeller. The severity of injuries typically depends on the size and speed of the vessel (Knowlton and Kraus, 2001; Laist
An examination of all known ship strikes from all shipping sources (civilian and military) indicates vessel speed is a principal factor in whether a vessel strike results in death (Knowlton and Kraus, 2001; Laist
Jensen and Silber (2003) detailed 292 records of known or probable ship strikes of all large whale species from 1975 to 2002. Of these, vessel speed at the time of collision was reported for 58 cases. Of these cases, 39 (or 67 percent) resulted in serious injury or death (19 of those resulted in serious injury as determined by blood in the water, propeller gashes or severed tailstock, and fractured skull, jaw, vertebrae, hemorrhaging, massive bruising or other injuries noted during necropsy and 20 resulted in death). Operating speeds of vessels that struck various species of large whales ranged from 2 to 51 knots. The majority (79 percent) of these strikes occurred at speeds of 13 knots or greater. The average speed that resulted in serious injury or death was 18.6 knots. Pace and Silber (2005) found that the probability of death or serious injury increased rapidly with increasing vessel speed. Specifically, the predicted probability of serious injury or death increased from 45 to 75 percent as vessel speed increased from 10 to 14 knots, and exceeded 90 percent at 17 knots. Higher speeds during collisions result in greater force of impact and also appear to increase the chance of severe injuries or death. While modeling studies have suggested that hydrodynamic forces pulling whales toward the vessel hull increase with increasing speed (Clyne, 1999; Knowlton
The Jensen and Silber (2003) report notes that the database represents a minimum number of collisions, because the vast majority probably goes undetected or unreported. In contrast, Navy vessels are likely to detect any strike that does occur, and they are required to report all ship strikes involving marine mammals. Overall, the percentages of Navy traffic relative to overall large shipping traffic are very small (on the order of 2 percent).
There are no records of any Navy vessel strikes to marine mammals during training or testing activities in the NWTT Study Area. There has been only one whale strike in the Pacific Northwest by the Navy since such records have been kept (June 1994-present). In August 2012, a San Diego homeported DDG (destroyer) at-sea about 35 nm west of Coos Bay, Oregon struck a whale (believed to be a minke) while transiting to San Diego from Seattle. There have been Navy strikes of large whales in areas outside the Study Area, such as Hawaii and Southern California. However, these areas differ significantly from the Study Area given that both Hawaii and Southern
Other efforts have been undertaken to investigate the impact from vessels (both whale-watching and general vessel traffic noise) and demonstrated impacts do occur (Bain, 2002; Erbe, 2002; Lusseau, 2009; Williams
The Navy's proposed training and testing activities could potentially affect marine mammal habitat through the introduction of sound into the water column, impacts to the prey species of marine mammals, bottom disturbance, or changes in water quality. Each of these components was considered in the January 2014 NWTT DEIS/OEIS and was determined by the Navy to have no effect on marine mammal habitat. Based on the information below and the supporting information included in the January 2014 NWTT DEIS/OEIS, NMFS has preliminarily determined that the proposed training and testing activities would not have adverse or long-term impacts on marine mammal habitat.
The southern resident killer whale (in the inshore area) is the only ESA-listed marine mammal species with designated critical habitat located in the Study Area. The majority of the Navy's proposed training and testing activities would, however, not occur in the southern resident killer whale's designated critical habitat (NMFS, 2006). For all substressors that would occur within the critical habitat, those training and testing activities are not expected to impact the identified primary constituent elements of that habitat and therefore would have no effect on that critical habitat. Effects to designated critical habitat will be fully analyzed in the Navy's and NMFS' internal ESA Section 7 consultations for NWTT.
Unless the sound source or explosive detonation is stationary and/or continuous over a long duration in one area, the effects of the introduction of sound into the environment are generally considered to have a less severe impact on marine mammal habitat than the physical alteration of the habitat. Acoustic exposures are not expected to result in long-term physical alteration of the water column or bottom topography, as the occurrences are of limited duration and are intermittent in time. Surface vessels associated with the activities are present in limited duration and are intermittent as they move relatively rapidly through any given area. Most of the high-explosive military expended materials would detonate at or near the water surface. Only bottom-laid explosives are likely to affect bottom substrate; habitat used for underwater detonations and seafloor device placement would primarily be soft-bottom sediment. Once on the seafloor, military expended material would likely be colonized by benthic organisms because the materials would serve as anchor points in the shifting bottom substrates, similar to a reef. The surface area of bottom substrate affected would make up a very small percentage of the total training area available in the NWTT Study Area.
Marine invertebrates in the Study Area inhabit coastal waters and benthic habitats, including salt marshes, kelp forests, soft sediments, canyons, and the continental shelf. Salt marsh invertebrates include oysters, crabs, and worms that are important prey for birds and small mammals. Mudflats provide habitat for substantial amounts of crustaceans, bivalves, and worms. The sandy intertidal area is dominated by species that are highly mobile and can burrow. One of the most abundant invertebrates found in the near shore areas of the Study Area on soft sediments are geoduck clams (
All marine invertebrate taxonomic groups are represented in the NWTT Study Area. Major invertebrate phyla (taxonomic range)—those with greater than 1,000 species and the general zones they inhabit in the Study Area are described in Chapter 3 of the January 2014 NWTT DEIS/OEIS.
Very little is known about sound detection and use of sound by aquatic invertebrates (Budelmann 2010; Montgomery
Both behavioral and auditory brainstem response studies suggest that crustaceans may sense sounds up to three kilohertz (kHz), but best sensitivity is likely below 200 Hz (Lovell
Little information is available on the potential impacts on marine invertebrates of exposure to sonar, explosions, and other sound-producing activities. It is expected that most marine invertebrates would not sense mid- or high-frequency sounds, distant sounds, or aircraft noise transmitted through the air-water interface. Most marine invertebrates would not be close enough to intense sound sources, such as some sonars, to potentially experience impacts to sensory structures. Any marine invertebrate capable of sensing sound may alter its behavior if exposed to non-impulsive sound, although it is unknown if responses to non-impulsive sounds occur. Continuous noise, such as from vessels, may contribute to masking of relevant environmental sounds, such as reef noise. Because the distance over which most marine invertebrates are expected to detect any sounds is limited and vessels would be in transit, any sound exposures with the potential to cause masking or behavioral responses would be brief and long-term impacts are not expected. Although non-impulsive underwater sounds produced during training and testing activities may briefly impact individuals, intermittent exposures to non-impulsive sounds are not expected to impact survival, growth, recruitment, or reproduction of widespread marine invertebrate populations.
Most detonations would occur greater than 3 nm from shore. As water depth increases away from shore, benthic invertebrates would be less likely to be impacted by detonations at or near the surface. In addition, detonations near the surface would release a portion of their explosive energy into the air, reducing the explosive impacts in the water. Some marine invertebrates may be sensitive to the low-frequency component of impulsive sound, and they may exhibit startle reactions or temporary changes in swim speed in response to an impulsive exposure. Because exposures are brief, limited in number, and spread over a large area, no long-term impacts due to startle reactions or short-term behavioral changes are expected. Although individual marine invertebrates may be injured or killed during an explosion or pile driving, no long-term impacts on the survival, growth, recruitment, or reproduction of marine invertebrate populations are expected.
The distribution and abundance of fishes depends greatly on the physical and biological factors of the marine ecosystem, such as salinity, temperature, dissolved oxygen, population dynamics, predator and prey interaction oscillations, seasonal movements, reproduction and life cycles, and recruitment success (Helfman
There are 17 major taxonomic groups of marine fishes within the NWTT Study Area. Detailed information on taxa presence, distribution, and characteristics are provided in Chapter 3 of the January 2014 NWTT DEIS/OEIS.
All fish have two sensory systems to detect sound in the water: The inner ear, which functions very much like the inner ear in other vertebrates, and the lateral line, which consists of a series of receptors along the fish's body (Popper, 2008). The inner ear generally detects relatively higher-frequency sounds, while the lateral line detects water motion at low frequencies (below a few hundred Hz) (Hastings and Popper, 2005a). Although hearing capability data only exist for fewer than 100 of the 32,000 fish species, current data suggest that most species of fish detect sounds from 50 to 1,000 Hz, with few fish hearing sounds above 4 kHz (Popper, 2008). It is believed that most fish have their best hearing sensitivity from 100 to 400 Hz (Popper, 2003b). Additionally, some clupeids (shad in the subfamily Alosinae) possess ultrasonic hearing (
Potential direct injuries from non-impulsive sound sources, such as sonar, are unlikely because of the relatively lower peak pressures and slower rise times than potentially injurious sources such as explosives. Non-impulsive sources also lack the strong shock waves associated with an explosion. Therefore, direct injury is not likely to occur from exposure to non-impulsive sources such as sonar, vessel noise, or subsonic aircraft noise. Only a few fish species are able to detect high-frequency sonar and could have behavioral reactions or experience auditory masking during these activities. These effects are expected to be transient and long-term consequences for the population are not expected. MFAS is unlikely to impact fish species because most species are unable to detect sounds in this frequency range and vessels operating MFAS would be transiting an area (not stationary). While a large number of fish species may be able to detect low-frequency sonar and other active acoustic sources, low-frequency active usage is rare and mostly conducted in deeper waters. Overall effects to fish from would be localized and infrequent.
Physical effects from pressure waves generated by underwater sounds (
Marine mammals may be temporarily displaced from areas where Navy training and testing is occurring, but the area should be utilized again after the activities have ceased. Avoidance of an area can help the animal avoid further acoustic effects by avoiding or reducing further exposure. The intermittent or short duration of many activities should prevent animals from being exposed to stressors on a continuous basis. In areas of repeated and frequent acoustic disturbance, some animals may habituate or learn to tolerate the new baseline or fluctuations in noise level. While some animals may not return to an area, or may begin using an area differently due to training and testing activities, most animals are expected to return to their usual locations and behavior.
Other sources that may affect marine mammal habitat were considered in the January 2014 NWTT DEIS/OEIS and potentially include the introduction of fuel, debris, ordnance, and chemical residues into the water column. The majority of high-order explosions would occur at or above the surface of the ocean, and would have no impacts on sediments and minimal impacts on water quality. While disturbance or strike from an item falling through the water column is possible, it is unlikely because (1) objects sink slowly, (2) most projectiles are fired at targets (and hit those targets), and (3) animals are generally widely dispersed throughout the water column and over the NWTT Study Area. Chemical, physical, or biological changes in sediment or water quality would not be detectable. In the event of an ordnance failure, the energetic materials it contained would remain mostly intact. The explosive materials in failed ordnance items and metal components from training and testing would leach slowly and would quickly disperse in the water column. Chemicals from other explosives would not be introduced into the water column in large amounts and all torpedoes would be recovered following training and testing activities, reducing the potential for chemical concentrations to reach levels that can affect sediment quality, water quality, or benthic habitats.
In order to issue an incidental take authorization under section 101(a)(5)(A) of the MMPA, NMFS must set forth the “permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.” NMFS' duty under this “least practicable adverse impact” standard is to prescribe mitigation reasonably designed to minimize, to the extent practicable, any adverse population-level impacts, as well as habitat impacts. While population-level impacts can be minimized by reducing impacts on individual marine mammals, not all takes translate to population-level impacts. NMFS' primary objective under the “least practicable adverse impact” standard is to design mitigation targeting those impacts on individual marine mammals that are most likely to lead to adverse population-level effects.
The NDAA of 2004 amended the MMPA as it relates to military-readiness activities and the ITA process such that “least practicable adverse impact” shall include consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the “military readiness activity.” The training and testing activities described in the LOA application are considered military readiness activities.
NMFS reviewed the proposed activities and the proposed mitigation measures as described in the LOA application to determine if they would result in the least practicable adverse effect on marine mammals, which includes a careful balancing of the likely benefit of any particular measure to the marine mammals with the likely effect of that measure on personnel safety, practicality of implementation, and impact on the effectiveness of the “military-readiness activity.” Included below are the mitigation measures the Navy proposed in their LOA application. NMFS worked with the Navy to develop these proposed measures, and they are informed by years of experience and monitoring. In addition, the adaptive management process (see Adaptive management) and annual meetings between NMFS and the Navy allows NMFS to consider new information from different sources to determine (with input from the Navy regarding practicability) on an annual or biennial basis if mitigation measures should be refined or modified.
The Navy's proposed mitigation measures are modifications to the proposed activities that are implemented for the sole purpose of reducing a specific potential environmental impact on a particular resource. These do not include standard operating procedures, which are established for reasons other than environmental benefit. Most of the following proposed mitigation measures are currently, or were previously, implemented as a result of past environmental compliance documents. The Navy's overall approach to assessing potential mitigation measures is based on two principles: (1) Mitigation measures will be effective at reducing potential impacts on the resource, and (2) from a military perspective, the mitigation measures are practicable, executable, and safety and readiness will not be impacted.
The use of Lookouts is a critical component of Navy procedural measures and implementation of mitigation zones. Navy Lookouts are highly qualified and experienced observers of the marine environment. Their duties require that they report all objects sighted in the water to the Officer of the Deck (OOD) (
The Navy would have two types of Lookouts for the purposes of conducting visual observations: (1) Those positioned on surface ships, and (2)
Due to manning and space restrictions on aircraft, small boats, and some Navy ships, Lookouts for these platforms may be supplemented by the aircraft crew or pilot, boat crew, range site personnel, or shore-side personnel. Lookouts positioned in minimally manned platforms may be responsible for tasks in addition to observing the air or surface of the water (
The procedural measures described below primarily consist of having Lookouts during specific training and testing activities.
All personnel standing watch on the bridge, Commanding Officers, Executive Officers, maritime patrol aircraft aircrews, anti‐submarine warfare helicopter crews, civilian equivalents, and Lookouts will successfully complete the United States Navy Marine Species Awareness Training prior to standing watch or serving as a Lookout. Additional details on the Navy's Marine Species Awareness Training can be found in the NWTT Draft EIS/OEIS.
The Navy proposes to use one or more Lookouts during the training and testing activities provided in Table 10. Additional details on Lookout procedures and implementation are provided in Chapter 11 of the LOA application (
The Navy proposes to use mitigation zones to reduce the potential impacts to marine mammals from training and testing activities. Mitigation zones are measured as the radius from a source and represent a distance that the Navy would monitor. Mitigation zones are applied to acoustic stressors (
Most of the current mitigation zones for activities that involve the use of impulsive and non-impulsive sources were originally designed to reduce the potential for onset of TTS. The Navy updated their acoustic propagation modeling to incorporate new hearing threshold metrics (
As a result of the updates to the acoustic propagation modeling, in some cases the ranges to onset of TTS effects are much larger than previous model outputs. Due to the ineffectiveness and unacceptable operational impacts associated with mitigating these large areas, the Navy is unable to mitigate for onset of TTS for every activity. For the NWTT analysis, the Navy developed each recommended mitigation zone to avoid or reduce the potential for onset of the lowest level of injury, PTS, out to the predicted maximum range. In some cases where the ranges to effects are smaller than previous models estimated, the mitigation zones were adjusted accordingly to provide consistency across the measures. Mitigating to the predicted maximum range to PTS consequently also mitigates to the predicted maximum range to onset mortality (1 percent mortality), onset slight lung injury, and onset slight gastrointestinal tract injury, since the maximum range to effects for these criteria are shorter than for PTS. Furthermore, in most cases, the predicted maximum range to PTS also consequently covers the predicted average range to TTS. Table 11 summarizes the predicted average range to TTS, average range to PTS, maximum range to PTS, and recommended mitigation zone for each activity category, based on the Navy's acoustic propagation modeling results. The predicted ranges are based on local environmental conditions and are unique to the NWTT Study Area.
The Navy's proposed mitigation zones are based on the longest range for all the
There are no low-frequency active sonar training activities proposed in the Study Area. The Navy is proposing to (1) continue implementing the current measures for mid-frequency active sonar, (2) clarify the conditions needed to recommence an activity after a sighting, and (3) implement mitigation measures for pinnipeds and for pierside sonar testing in the vicinity of hauled out pinnipeds.
Activities that involve the use of hull-mounted mid-frequency active sonar (including pierside) will use Lookouts for visual observation from a ship immediately before and during the activity. Mitigation zones for these activities involve powering down the sonar by 6 dB when a marine mammal is sighted within 1,000 yd. (920 m) of the sonar dome, and by an additional 4 dB when sighted within 500 yd. (460 m) from the source, for a total reduction of 10 dB. Active transmissions will cease if a marine mammal is sighted within 200 yd. (180 m). Active transmission will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, (3) the mitigation zone has been clear from any additional sightings for a period of 30 minutes, (4) the ship has transited more than 2,000 yd. (1.8 km) beyond the location of the last sighting, or (5) the Lookout concludes that dolphins are deliberately closing in on the ship to ride the ship's bow wave (and there are no other marine mammal sightings within the mitigation zone). Active transmission may resume when dolphins are bow riding because they are out of the main transmission axis of the active sonar while in the shallow-wave area of the ship bow.
For pinnipeds, the Navy proposes a 100 yd. (90 m) mitigation zone for activities that involve the use of hull-mounted mid-frequency active sonar. The pinniped mitigation zone does not apply for pierside testing in the vicinity of pinnipeds hauled out on man-made structures and vessels. Within Puget Sound there are several locations where pinnipeds use Navy structures (
There are no current hull-mounted mid-frequency active sonar testing activities in the Study Area, and no mitigation procedures. However, the Navy's Proposed Action includes newly assessed hull-mounted mid-frequency active sonar testing activities. For testing activities, the recommended measures are provided below.
Activities that involve the use of low-frequency active sonar (including pierside) will use Lookouts for visual observation immediately before and during the event. If a marine mammal is sighted within 200 yd. (180 m) of the sound source, active transmissions will cease. Active transmission will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, (3) the mitigation zone has been clear from any additional sightings for a period of 30 minutes, or (4) the sound source has transited more than 2,000 yd. (1.8 km) beyond the location of the last sighting.
Activities that involve the use of hull-mounted mid-frequency active sonar (including pierside and shore-based testing) will follow the mitigation measures described above for Low-Frequency and Hull-Mounted Mid-Frequency Active Sonar Training.
For pinnipeds, the Navy proposes a 100 yd. mitigation zone. The pinniped mitigation zone does not apply for pierside testing in the vicinity of pinnipeds hauled out on man-made structures and vessels.
Non-hull-mounted mid-frequency active sonar training activities include the use of aircraft deployed sonobuoys and helicopter dipping sonar. The Navy is proposing to: (1) Continue implementing the current mitigation measures for activities currently being executed, such as dipping sonar activities; (2) extend the implementation of its current mitigation to all other activities in this category; and (3) clarify the conditions needed to recommence an activity after a sighting.
Mitigation will include visual observation from a vessel or aircraft (with the exception of platforms operating at high altitudes) immediately before and during active transmission within a mitigation zone of 200 yd. (180 m) from the active sonar source. For activities involving helicopter deployed dipping sonar, visual observation will commence 10 minutes before the first deployment of active dipping sonar. Helicopter dipping and sonobuoy deployment will not begin if concentrations of floating vegetation (kelp paddies), are observed in the mitigation zone. If the source can be turned off during the activity, active transmission will cease if a marine mammal is sighted within the mitigation zone. Active transmission will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, (3) the mitigation zone has been clear from any additional sightings for a period of 10 minutes for an aircraft-deployed source, (4) the mitigation zone has been clear from any additional sightings for a period of 30 minutes for a vessel-deployed source, (5) the vessel or aircraft has repositioned itself more than 400 yd. (370 m) away from the location of the last sighting, or (6) the vessel concludes that dolphins are deliberately closing in to ride the vessel's bow wave (and there are no other marine mammal sightings within the mitigation zone).
Mitigation measures for high-frequency active sonar sources currently exist only for testing activities conducted in the Inland Waters of Puget Sound and in the Western Behm Canal, Alaska. These activities include the use of unmanned vehicles, non-explosive torpedoes, and similar systems. Currently, the mitigation measures for testing activities using high frequency and non-hull-mounted mid-frequency sources are the same as those currently in place for testing activities with low frequency sources.
For the proposed action, the Navy is proposing that testing activities with high frequency and non-hull-mounted mid-frequency sources employ the proposed mitigation measures described above for training.
For pinnipeds, the Navy proposes a 100 yd. (90 m) mitigation zone during testing. The pinniped mitigation zone does not apply for pierside or shore-based testing in the vicinity of pinnipeds hauled out on man-made structures and vessels. Within Puget Sound there are several locations where pinnipeds use Navy structures (
The Navy's proposed action does not include Improved Extended Echo Ranging sonobuoy training activities.
The Navy is proposing to (1) modify the mitigation measures currently implemented for this activity by reducing the marine mammal mitigation zone from 1,000 yd. (920 m) to 600 yd. (550 m), (2) clarify the conditions needed to recommence an activity after a sighting, and (3) adopt the marine mammal mitigation zone size for floating vegetation for ease of implementation. The recommended measures are provided below.
Mitigation will include pre-testing aerial observation and passive acoustic monitoring, which will begin 30 minutes before the first source/receiver pair detonation and continue throughout the duration of the test. The pre-testing aerial observation will include the time it takes to deploy the sonobuoy pattern (deployment is conducted by aircraft dropping sonobuoys in the water). Improved Extended Echo Ranging sonobuoys will not be deployed if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone around the intended deployment location. Explosive detonations will cease if a marine mammal or sea turtle is sighted within the mitigation zone. Detonations will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, or (3) the mitigation zone has been clear from any additional sightings for a period of 30 minutes.
Passive acoustic monitoring would be conducted with Navy assets, such as sonobuoys, already participating in the activity. These assets would only detect vocalizing marine mammals within the frequency bands monitored by Navy personnel. Passive acoustic detections would provide only limited range and bearing to detected animals, and therefore cannot provide locations of these animals. Passive acoustic detections would be reported to Lookouts posted in aircraft and on vessels in order to increase vigilance of their visual surveillance.
The Navy is proposing to add the following recommended measures. Mitigation will include pre-exercise aerial monitoring during deployment within a mitigation zone of 350 yd. (320 m) around an explosive SUS buoy. Explosive SUS buoys will not be deployed if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone (around the intended deployment location). SUS deployment will cease if a marine mammal or sea turtle is sighted within the mitigation zone. Deployment will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, or (3) the mitigation zone has been clear from any additional sightings for a period of 10 minutes.
Passive acoustic monitoring will also be conducted with Navy assets, such as sonobuoys, already participating in the activity. These assets would only detect vocalizing marine mammals within the frequency bands monitored by Navy personnel. Passive acoustic detections would not provide range or bearing to detected animals, and therefore cannot provide locations of these animals. Passive acoustic detections would be reported to Lookouts posted in aircraft in order to increase vigilance of their visual surveillance.
The Navy's proposed mitigation measures for testing activities are consistent with Navy training mitigation measures described above.
Mine countermeasure and neutralization activities in the Study Area involve the use of diver-placed charges that typically occur close to shore. When these activities are conducted using a positive control firing device, the detonation is controlled by the personnel conducting the activity and is not authorized until the area is clear at the time of detonation.
Currently, the Navy employs the following mitigation zone procedures during mine countermeasure and neutralization activities using positive control firing devices:
• Mitigation Zone—The exclusion zone for marine mammals shall extend in a 700 yd. (640 m) arc radius around the detonation site for charges >0.5-2.5 lb. NEW.
• Pre-Exercise Surveys—For Demolition and Mine Countermeasures Operations, pre-exercise surveys shall be conducted within 30 minutes prior to the commencement of the scheduled explosive event. The survey may be conducted from the surface, by divers, or from the air, and personnel shall be alert to the presence of any marine mammal. Should such an animal be present within the survey area, the explosive event shall not be started until the animal voluntarily leaves the area. The Navy will ensure the mitigation zone is clear of marine mammals for a full 30 minutes prior to initiating the explosive event. Personnel will record any marine mammal observations during the exercise as well as measures taken if species are detected within the exclusion zone.
• Post-Exercise Surveys—Surveys within the same radius shall also be conducted within 30 minutes after the completion of the explosive event.
For activities involving positive control diver-placed charges, the Navy is proposing to (1) modify the currently implemented mitigation measures for this activity involving >0.5-2.5 lb. NEW detonation by changing the mitigation zone from 700 yd. (640 m) to 400 yd. (366 m), (2) clarify the conditions needed to recommence an activity after a sighting, and (3) add a requirement to observe for floating vegetation. The recommended measures for activities involving positive control diver-placed activities are provided below.
The Navy is proposing to use the 400 yd. (366 m) mitigation zones for marine mammals described above during activities involving positive control diver-placed charges involving >0.5-2.5 lb. NEW. Visual observation will be conducted by two small boats, each with a minimum of one surveyor.
Explosive detonations will cease if a marine mammal is sighted in the water portion of the mitigation zone (
The Navy's proposed action does not include mine countermeasure and neutralization testing activities.
The Navy is proposing to (1) continue implementing the current mitigation measures for this activity, (2) clarify the conditions needed to recommence an activity after a sighting, and (3) add a requirement to visually observe for kelp paddies.
Mitigation will include visual observation from a vessel or aircraft immediately before and during the exercise within a mitigation zone of 200 yd. (180 m) around the intended impact location. Vessels will observe the mitigation zone from the firing position. When aircraft are firing, the aircrew will maintain visual watch of the mitigation zone during the activity. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, (3) the mitigation zone has been clear from any additional sightings for a period of 10 minutes for a firing aircraft, (4) the mitigation zone has been clear from any additional sightings for a period of 30 minutes for a firing ship, or (5) the intended target location has been repositioned more than 400 yd. (370 m) away from the location of the last sighting.
The Navy's proposed action does not include gunnery testing activities.
There are currently no existing mitigation measures unique to large-caliber explosive gunnery exercises in the Study Area. The Navy is proposing to adopt mitigation measures in place at other Navy training ranges outside of the Study Area.
For all explosive and non-explosive large-caliber gunnery exercises conducted from a ship, mitigation will include visual observation immediately before and during the exercise within a mitigation zone of 70 yd. (46 m) within 30 degrees on either side of the gun target line on the firing side. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, (3) the mitigation zone has been clear from any additional sightings for a period of 30 minutes, or (4) the vessel has repositioned itself more than 140 yd. (128 m) away from the location of the last sighting.
The Navy is proposing to (1) implement new mitigation zone measures for this activity, (2) describe conditions needed to recommence an activity after a sighting, and (3) implement a requirement to visually observe for kelp paddies. The recommended measures are provided below.
Mitigation will include visual observation from a ship immediately before and during the exercise within a mitigation zone of 600 yd. (550 m) around the intended impact location. Ships will observe the mitigation zone from the firing position. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, or (3) the mitigation zone has been clear from any additional sightings for a period of 30 minutes.
Currently, the Navy employs a mitigation zone of 1,800 yd. (1.6 km) for all missile exercises. Because the Navy is not proposing to use missiles with less than a 251 lb. NEW warhead in the Study Area, separate mitigation procedures for this exercise have not been developed. Should the need arise to conduct training using missiles in this category, the Navy proposes that mitigation procedures be followed as described below for the larger category of missiles (Missile Exercises 251-500 Pound Net Explosive Weight [Surface Target]).
The Navy's proposed action does not include missile testing activities.
Current mitigation measures apply to all missile exercises, regardless of the warhead size. The Navy proposes to add a mitigation zone that applies only to missiles with a NEW of 251-500 lb. The recommended measures are provided below.
When aircraft are involved in the missile firing, mitigation will include visual observation by the aircrew prior to commencement of the activity within a mitigation zone of 2,000 yd. (1.8 km) around the intended impact location. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, or (3) the mitigation zone has been clear from any additional sightings for a period of 10 minutes or 30 minutes (depending on aircraft type).
The Navy's proposed action does not include missile testing activities.
Currently, the Navy employs the following mitigation zone procedures during bombing exercises:
• Ordnance shall not be targeted to impact within 1,000 yd. (920 m) of known or observed floating kelp or marine mammals.
• A 1,000 yd. (920 m) radius mitigation zone shall be established around the intended target.
• The exercise will be conducted only if marine mammals are not visible within the mitigation zone.
The Navy is proposing to (1) maintain the existing mitigation zone to be used for non-explosive bombing activities, (2) revise the mitigation zone procedures to account for predicted ranges to impacts to marine species when high explosive bombs are used, (3) clarify the conditions needed to recommence an activity after a sighting, and (4) add a requirement to visually observe for kelp paddies.
Mitigation will include visual observation from the aircraft
The Navy's proposed action does not include bomb testing activities.
The Navy does not include training with explosive torpedoes in the proposed action.
The Navy is proposing to (1) establish mitigation measures for this activity that include a mitigation zone of 2,100 yd. (1.9 km), (2) establish the conditions needed to recommence an activity after a sighting, and (3) establish a requirement to visually observe for kelp paddies. The recommended measures are provided below.
Mitigation will include visual observation by aircraft (with the exception of platforms operating at high altitudes) immediately before, during, and after the event within a mitigation zone of 2,100 yd. (1.9 km) around the intended impact location. The event will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will cease if a marine mammal or sea turtle is sighted within the mitigation zone. Firing will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, or (3) the mitigation zone has been clear from any additional sightings for a period of 10 minutes or 30 minutes (depending on aircraft type).
In addition to visual observation, passive acoustic monitoring will be conducted with Navy assets, such as passive ships sonar systems or sonobuoys, already participating in the activity. Passive acoustic observation would be accomplished through the use of remote acoustic sensors or expendable sonobuoys, or via passive acoustic sensors on submarines when they participate in the proposed action. These assets would only detect vocalizing marine mammals within the frequency bands monitored by Navy personnel. Passive acoustic detections would not provide range or bearing to detected animals, and therefore cannot provide locations of these animals. Passive acoustic detections would be reported to the Lookout posted in the aircraft in order to increase vigilance of the visual surveillance; and to the person in control of the activity for their consideration in determining when the mitigation zone is determined free of visible marine mammals.
The Navy and U.S. Coast Guard are proposing to adopt measures currently used during Navy gunnery exercises in other ranges outside of the Study Area. For all explosive and non-explosive large-caliber gunnery exercises conducted from a ship, mitigation will include visual observation immediately before and during the exercise within a mitigation zone of 70 yd. (46 m) within 30 degrees on either side of the gun target line on the firing side. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, (3) the mitigation zone has been clear from any additional sightings for a period of 30 minutes, or (4) the vessel has repositioned itself more than 140 yd. (128 m) away from the location of the last sighting.
The Navy's proposed action does not include gun testing activities.
The Navy's current measures to mitigate potential impacts to marine mammals from vessel and in-water device strikes during training activities are provided below:
• Naval vessels shall maneuver to keep at least 500 yd. (460 m) away from any observed whale in the vessel's path and avoid approaching whales head-on. These requirements do not apply if a vessel's safety is threatened, such as when change of course will create an imminent and serious threat to a person, vessel, or aircraft, and to the extent vessels are restricted in their ability to maneuver. Restricted maneuverability includes, but is not limited to, situations when vessels are engaged in dredging, submerged activities, launching and recovering aircraft or landing craft, minesweeping activities, replenishment while underway and towing activities that severely restrict a vessel's ability to deviate course.
• Vessels will take reasonable steps to alert other vessels in the vicinity of the whale. Given rapid swimming speeds and maneuverability of many dolphin species, naval vessels would maintain normal course and speed on sighting dolphins unless some condition indicated a need for the vessel to maneuver.
The Navy is proposing to continue to use the 500 yd. (460 m) mitigation zone currently established for whales, and to implement a 200 yd. (180 m) mitigation zone for all other marine mammals. Vessels will avoid approaching marine mammals head on and will maneuver to maintain a mitigation zone of 500 yd. (460 m) around observed whales and 200 yd. (180 m) around all other marine mammals (except bow-riding dolphins), providing it is safe to do so.
The Navy's current measures to mitigate potential impacts to marine mammals from vessel and in-water device strikes during testing activities are provided below:
• Range activities shall be conducted in such a way as to ensure marine mammals are not harassed or harmed by human-caused events.
• Visual surveillance shall be accomplished just prior to all in-water exercises. This surveillance shall ensure that no marine mammals are visible within the boundaries of the area within which the test unit is expected to be operating. Surveillance shall include, as a minimum, monitoring from all participating surface craft and, where available, adjacent shore sites.
• The Navy shall postpone activities until cetaceans (whales, dolphins, and porpoises) leave the activity area. When cetaceans have been sighted in an area, all range participants increase vigilance and take reasonable and practicable actions to avoid collisions and activities that may result in close interaction of naval assets and marine mammals. Actions may include changing speed or
• Range craft shall not approach within 100 yd. (90 m) of marine mammals and shall be followed to the extent practicable considering human and vessel safety priorities. All Navy vessels and aircraft, including helicopters, are expected to comply with this directive. This includes marine mammals “hauled-out” on islands, rocks, and other areas such as buoys.
The Navy is proposing to incorporate the training mitigation measures described above during testing activities involving surface ships, and for all other testing activities to continue using the mitigation measures currently implemented, revised to exclude pinnipeds during test body retrieval and to include the exception for bow-riding dolphins as described above under Training. During test body retrieval, the activity cannot be relocated away from marine mammals active in the area, or significantly delayed without risking loss of the test body, so the activity must proceed even if pinnipeds are present in the immediate vicinity. However, the retrieval vessel is a range craft and risks to marine mammals are very low.
The Navy is proposing to adopt measures currently used in other ranges outside of the Study Area during activities involving towed in-water devices. The Navy will ensure that towed in-water devices being towed from manned platforms avoid coming within a mitigation zone of 250 yd. (230 m) around any observed marine mammal, providing it is safe to do so.
The Navy's proposed mitigation measures for testing activities from manned platforms are consistent with Navy training mitigation measures described above. During testing in which in-water devices are towed by unmanned platforms, a manned escort vessel will be included and one Lookout will be employed.
Currently, the Navy employs the same mitigation measures for non-explosive gunnery exercises as described above for explosive Gunnery Exercises—Small-, Medium-, and Large-Caliber Using a Surface Target.
The Navy is proposing to (1) continue using the mitigation measures currently implemented for this activity, and (2) clarify the conditions needed to recommence an activity after a sighting. The recommended measures are provided below.
Mitigation will include visual observation from a vessel or aircraft immediately before and during the exercise within a mitigation zone of 200 yd. (180 m) around the intended impact location. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, (3) the mitigation zone has been clear from any additional sightings for a period of 10 minutes for a firing aircraft, (4) the mitigation zone has been clear from any additional sightings for a period of 30 minutes for a firing ship, or (5) the intended target location has been repositioned more than 400 yd. (370 m) away from the location of the last sighting.
The Navy's proposed action does not include gunnery testing activities.
The Navy is proposing to continue using the mitigation measures currently implemented for this activity. The recommended measure includes clarification of a post-sighting activity recommencement criterion.
Mitigation will include visual observation from the aircraft immediately before the exercise and during target approach within a mitigation zone of 1,000 yd. (920 m) around the intended impact location. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Bombing will cease if a marine mammal is sighted within the mitigation zone. Bombing will recommence if any one of the following conditions is met: (1) The animal is observed exiting the mitigation zone, (2) the animal is thought to have exited the mitigation zone based on its course and speed, or (3) the mitigation zone has been clear from any additional sightings for a period of 10 minutes.
The Navy's proposed action does not include bomb testing activities.
Already incorporated into the Navy's and NMFS' analysis of affects to marine mammals, has been consideration of emergent science regarding locations where cetaceans are known to engage in specific activities (
The Navy and NMFS have supported and will continue to support the Cetacean and Sound Mapping project, including providing representation on the Cetacean Density and Distribution Mapping Working Group (CetMap) developing the BIAs. The final products, including U.S. West Coast BIAs, from this mapping effort were completed and published in March 2015 (Aquatic Mammals, 2015; Calambokidis
NMFS Office of Protected Resources routinely considers available information about marine mammal habitat use to inform discussions with applicants regarding potential spatio-temporal limitations on their activities that might help effect the least practicable adverse impact on species or stocks and their habitat. BIAs are useful tools for planning and impact assessments and are being provided to the public via this Web site:
During the April 2014 annual adaptive management meeting in Washington, DC, NMFS and the Navy discussed the BIAs that might overlap with portions of the NWTT Study Area, what Navy activities take place in these areas (in the context of what their effects on marine mammals might be or whether additional mitigation is necessary), and what measures could be implemented to reduce impacts in these areas (in the context of their potential to reduce marine mammal impacts and their practicability). Upon request by NMFS the Navy preparing a draft assessment of these BIAs, including the degree of spatial overlap as well as an assessment of potential impacts or lack of impacts for each BIA. The Navy preliminarily determined that the degree of overlap between Navy activities within the Study Area and regional BIAs is relatively small (10 percent) geographically. Further, a review of the BIAs for humpback whales and gray whales against areas where most acoustic activities are conducted in the Study Area (especially those that involve ASW hull-mounted sonar, sonobuoys, and use of explosive munitions) identified that there is no spatial overlap. The Navy preliminarily concluded that any potential impacts from training and testing activities on a given area are infrequent, spatially and temporally variable, and biologically insignificant since the activities are unlikely to significantly affect the marine mammal activities for which the BIAs were designated. The Navy also concluded that additional mitigations other than those already described in the January 2014 NWTT DEIS/OEIS and LOA application would not be further protective nor offer addition protection to marine mammals beyond what is already proposed. NMFS is currently reviewing the Navy's draft assessment, the outcome of which will be discussed in the final rule.
As we learn more about marine mammal density, distribution, and habitat use (and the BIAs are updated), NMFS and the Navy will continue to reevaluate appropriate time-area measures through the Adaptive Management process outlined in these regulations.
NMFS and the Navy developed a Stranding Response Plan for the NWTRC in 2010 and the NUWC Keyport Range Complex in 2011 as part of the incidental take authorization process for those complexes. The Stranding Response Plan is specifically intended to outline the applicable requirements in the event that a marine mammal stranding is reported in the complexes during a major training exercise. NMFS considers all plausible causes within the course of a stranding investigation and this plan in no way presumes that any strandings in a Navy range complex are related to, or caused by, Navy training and testing activities, absent a determination made during investigation. The plan is designed to address mitigation, monitoring, and compliance. The Navy is currently working with NMFS to refine this plan for the NWTT Study Area. The current Stranding Response Plans for the NWTRC and NUWC Keyport Range Complex are available for review here:
NMFS has carefully evaluated the Navy's proposed mitigation measures—many of which were developed with NMFS' input during the first phase of Navy Training and Testing authorizations—and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable adverse impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another: The manner in which, and the degree to which, the successful implementation of the mitigation measures is expected to reduce the likelihood and/or magnitude of adverse impacts to marine mammal species and stocks and their habitat; the proven or likely efficacy of the measures; and the practicability of the suite of measures for applicant implementation, including consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to accomplishing one or more of the general goals listed below:
a. Avoid or minimize injury or death of marine mammals wherever possible (goals b, c, and d may contribute to this goal).
b. Reduce the number of marine mammals (total number or number at biologically important time or location) exposed to received levels of MFAS/HFAS, underwater detonations, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing harassment takes only).
c. Reduce the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of MFAS/HFAS, underwater detonations, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing harassment takes only).
d. Reduce the intensity of exposures (either total number or number at biologically important time or location) to received levels of MFAS/HFAS, underwater detonations, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).
e. Avoid or minimize adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.
f. For monitoring directly related to mitigation—increase the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation (shut-down zone, etc.).
Based on our evaluation of the Navy's proposed measures, as well as other measures considered by NMFS, NMFS has determined preliminarily that the Navy's proposed mitigation measures (especially when the adaptive management component is taken into
The proposed rule comment period provides the public an opportunity to submit recommendations, views, and/or concerns regarding this action and the proposed mitigation measures. While NMFS has determined preliminarily that the Navy's proposed mitigation measures would effect the least practicable adverse impact on the affected species or stocks and their habitat, NMFS will consider all public comments to help inform our final decision. Consequently, the proposed mitigation measures may be refined, modified, removed, or added to prior to the issuance of the final rule based on public comments received, and where appropriate, further analysis of any additional mitigation measures.
Section 101(a)(5)(A) of the MMPA states that in order to issue an ITA for an activity, NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for LOAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present.
The Navy's ICMP is intended to coordinate monitoring efforts across all regions and to allocate the most appropriate level and type of effort for each range complex based on a set of standardized objectives, and in acknowledgement of regional expertise and resource availability. The ICMP is designed to be flexible, scalable, and adaptable through the adaptive management and strategic planning processes to periodically assess progress and reevaluate objectives. Although the ICMP does not specify actual monitoring field work or projects, it does establish top-level goals that have been developed in coordination with NMFS. As the ICMP is implemented, detailed and specific studies will be developed which support the Navy's top-level monitoring goals. In essence, the ICMP directs that monitoring activities relating to the effects of Navy training and testing activities on marine species should be designed to contribute towards one or more of the following top-level goals:
• An increase in our understanding of the likely occurrence of marine mammals and/or ESA-listed marine species in the vicinity of the action (
• An increase in our understanding of the nature, scope, or context of the likely exposure of marine mammals and/or ESA-listed species to any of the potential stressor(s) associated with the action (
• An increase in our understanding of how individual marine mammals or ESA-listed marine species respond (behaviorally or physiologically) to the specific stressors associated with the action (in specific contexts, where possible,
• An increase in our understanding of how anticipated individual responses to individual stressors or anticipated combinations of stressors may impact either: (1) The long-term fitness and survival of an individual; or (2) the population, species, or stock (
• An increase in our understanding of the effectiveness of mitigation and monitoring measures;
• A better understanding and record of the manner in which the authorized entity complies with the ITA and Incidental Take Statement;
• An increase in the probability of detecting marine mammals (through improved technology or methods), both specifically within the safety zone (thus allowing for more effective implementation of the mitigation) and in general, to better achieve the above goals; and
• A reduction in the adverse impact of activities to the least practicable level, as defined in the MMPA.
Monitoring would address the ICMP top-level goals through a collection of specific regional and ocean basin studies based on scientific objectives. Quantitative metrics of monitoring effort (
The Navy also developed the Strategic Planning Process for Marine Species Monitoring, which establishes the guidelines and processes necessary to develop, evaluate, and fund individual projects based on objective scientific study questions. The process uses an underlying framework designed around top-level goals, a conceptual framework incorporating a progression of knowledge, and in consultation with a Scientific Advisory Group and other regional experts. The Strategic Planning Process for Marine Species Monitoring would be used to set intermediate scientific objectives, identify potential species of interest at a regional scale, and evaluate and select specific monitoring projects to fund or continue supporting for a given fiscal year. This process would also address relative investments to different range complexes based on goals across all range complexes, and monitoring would leverage multiple techniques for data acquisition and analysis whenever possible. The Strategic Planning Process for Marine Species Monitoring is also available online (
NMFS has received multiple years' worth of annual exercise and monitoring reports addressing active sonar use and explosive detonations within the NWTT and other Navy range complexes. The data and information contained in these reports have been considered in developing mitigation and
1. The Navy has shown significant initiative in developing its marine species monitoring program and made considerable progress toward reaching goals and objectives of the ICMP.
2. Observation data from watchstanders aboard navy vessels is generally useful to indicate the presence or absence of marine mammals within the mitigation zones (and sometimes beyond) and to document the implementation of mitigation measures, but does not provide useful species-specific information or behavioral data.
3. Data gathered by experienced marine mammal observers can provide very valuable information at a level of detail not possible with watchstanders.
4. Though it is by no means conclusive, it is worth noting that no instances of obvious behavioral disturbance have been observed by Navy watchstanders or experienced marine mammal observers conducting visual monitoring.
5. Visual surveys generally provide suitable data for addressing questions of distribution and abundance of marine mammals, but are much less effective at providing information on movements and behavior, with a few notable exceptions where sightings are most frequent.
6. Passive acoustics and animal tagging have significant potential for applications addressing animal movements and behavioral response to Navy training activities, but require a longer time horizon and heavy investment in analysis to produce relevant results.
This following section includes a summary of Navy-funded compliance monitoring in the NWTRC since 2010 and in the NUWC Keyport Range Complex since 2011. Additional Navy-funded monitoring outside of and in addition to the Navy's commitments to NMFS is provided later in the section. The monitoring years are shown in Table 12.
As part of previous monitoring within the Pacific Northwest, the Navy funded deployment of two passive acoustic devices along the central coast of Washington State from 2011 to 2013. Results from this effort are summarized in the Navy's annual NWTRC monitoring reports for 2011, 2012, and 2013 (U.S. Department of the Navy, 2011; Širović
The Navy purchased 10 satellite tracking tags in Year 1, suitable for deployment by a suite of marine species within the offshore waters of the NWTRC. The tags used were the Andrews-style LIMPET (Low Impact Minimally Percutaneous External Transmitter), in either the location-only Spot5 configuration or the location/dive data Mk10-A configuration (Wildlife Computers, Redmond, Washington) (Schorr
The Navy purchased these satellite tracking tags as part of the NWTRC monitoring from 2010 to 2013. The tags were deployed opportunistically during field efforts associated with a 3-year collaborative field project addressing marine mammal distribution and habitat use off Oregon and Washington (Schorr
Annual results from this effort are summarized in the Navy's NWTRC Monitoring Reports for 2011, 2012, and 2013 (U.S. Department of the Navy, 2011a, 2012a, and 2013d) and collectively in Schorr
In 2012, the Navy funded a multi-year satellite tracking study of Pacific Coast Feeding Group gray whales (U.S. Department of the Navy, 2013d). Tags were attached to 11 gray whales near Crescent City, California, in fall 2012 (Mate, 2013). Good track histories were received from nine of the 11 tags which confirmed an exclusive near shore (< 15 km) distribution and movement along the California, Oregon, and Washington coast. Additional tag deployments on gray whales have occurred since the Mate (2013) report. These will be described in the NWTRC Year 4 Annual Monitoring Report in 2014.
Satellite tagging efforts are also funded for 2014-2018 along the U.S. west coast and include fin and blue whales. Longer term tags (up to 1 year) will allow for an assessment of animal occurrence, movement patterns, and residence time at areas within and outside of Navy at-sea ranges, including the NWTRC.
The Navy has conducted two annual underwater detonation training events in the NWTRC at the Floral Point site in Hood Canal. In 2012, the event was monitored by marine mammal and seabird observers, and acoustic measurements were also recorded. The observers were positioned aboard small Navy craft that followed a closely spaced transect pattern in nearshore waters. In 2013, a similar monitoring effort occurred, but two beach observers were added to the monitoring team in order to provide a training opportunity. The beach observers are not required under the permits. The entire area to be monitored can be seen via the small craft vessels and as a result of the tightly spaced transect observation pattern. Pre-event and post-event surveys were also conducted. Harbor seals were the only marine mammal species seen either before or after the training event, and no marine mammals were in the exclusion zone during the detonations.
Annual monitoring surveys were undertaken in 2011, 2012, and 2013 in the DBRC portion of the Keyport Range Complex. These surveys included both visual and passive acoustic monitoring during concurrent mid-frequency active sonar and high-frequency active sonar tests. In addition to Navy Lookouts, Navy marine mammal observers were positioned aboard range vessels and at a high elevation observation point on land to monitor the events. A pre-event and post-event survey was also conducted. Species seen included harbor seals, California sea lions, and harbor porpoise. In total over all years, there were 262 sightings representing 420 individuals seen during the visual surveys, which may include repeat sightings of the same individuals. No marine mammals were detected using the bottom-moored passive acoustic monitoring array in any year. Discussion and results from these efforts are summarized in the Navy's Keyport Range Complex Annual Monitoring Reports for 2011, 2012, and 2013 (U.S. Department of the Navy, 2012c, 2012d, and 2013e).
Additional marine mammal studies are being funded or conducted by the Navy outside of and in addition to the Navy's commitments to NMFS for the NWTRC and the NUWC Keyport Range Complex. A variety of field survey methodologies are being utilized in order to better determine marine mammal presence, seasonality, abundance, distribution, habitat use, and density in these areas. The following studies either have been conducted or are underway during the 2010-2014 period:
• Naval Base Pinniped Haulout Surveys (2010-2014): Biologists located at NAVBASE Kitsap, Bangor, Bremerton, the Manchester Fuel Depot, and Naval Station Everett have been conducting year-round counts of sea lions hauled out on site-specific structures such as the floating security fences, submarines, or other opportunistic haulouts such as the large floating dock near Manchester. These counts are typically conducted weekly and involve identifying the sea lions to species and documenting branded animals. This information has shown seasonal use of the haulouts at each site, as well as trends in the number of animals by species using the haulouts at each site. In the case of Bangor, there are no haulout areas used by adult harbor seals, despite the adults being seen daily in the water, year-round. The only exception to this would be during pupping season when one wave screen (floating dock) is used temporarily by adult females to give birth. In late fall 2013, there were sightings of individual harbor seal pups using opportunistic manmade structures as temporary haulouts. These sightings include one harbor seal pup using a partially submerged ladder rung as a haulout and place to nurse; another pup resting on a floating oil boom; a third pup resting on a large piece of chain hanging in the water; a fourth pup managing to get aboard a submarine and haul out next to the California sea lions; and a fifth, older juvenile resting on the outer pontoon of the floating security fence. Harbor seals have not been seen hauled out at Bremerton or at the floating dock near Manchester. Harbor seals do haul out on the log rafts near Naval Station Everett.
• Marine Mammal Surveys in Hood Canal and Dabob Bay (2011-2012): The Navy conducted an opportunistic marine mammal vessel-based line transect density survey in Hood Canal and Dabob Bay during September and October 2011 and again in October 2012. In Hood Canal, the surveys followed a double saw-tooth pattern to achieve uniform coverage of the entire NAVBASE Kitsap, Bangor waterfront. Transects generally covered the area from Hazel Point on the south end of the Toandos Peninsula to Thorndyke Bay. Surveys in the adjacent Dabob Bay followed a slightly different pattern and generally followed more closely to the shoreline while completing a circular route through the Bay. These surveys had a dual purpose of collecting marine mammal and marbled murrelet (bird species) data, and near-shore surveys tended to yield more marbled murrelet sightings. During surveys, the survey vessels traveled at a speed of approximately five knots when transiting along the transect lines. Two observers recorded sightings of marine mammals both in the water and hauled out. Marine mammal sightings data included species identification, Global Positioning System animal locations relative to vessel position, and detailed behavioral notes. Data from the line
• Aerial Surveys of Pinniped Haulout Sites in Pacific Northwest Inland Waters (2013-2014): Navy-funded aerial surveys of pinniped haulout sites in the inland waters of Washington State were initiated in March 2013 (Jeffries, 2013b) and continued until March 2014 (1-year study design). The objectives of this effort were to provide estimates of seasonal abundance, identify seasonal distribution patterns, and collect data to determine seal and sea lion densities. Aerial surveys being conducted under this effort represent the first pinniped assessments to be done in the region over all four seasons, and will therefore provide much-needed information about seasonal variation of harbor seal, northern elephant seal, California sea lion, and Steller sea lion distribution and abundance in the inland waters of Washington. In addition, this effort will update the Atlas of Seal and Seal Lion Haulout Sites in Washington (inland waters region) (Jeffries
• Aerial Surveys of Marine Mammals in Pacific Northwest Inland Waters (2013-2014): Navy-funded aerial line-transect density surveys in the inland waters of Washington State were initiated in August 2013 (Smultea and Bacon, 2013). Surveys are planned to continue quarterly (every season) through 2014. These surveys were designed in cooperation with NMFS in order to estimate density and abundance of species with sufficient sightings, document distribution and habitat use, and describe behaviors seen. Smultea and Bacon (2013) reported a total of 779 sightings composed of an estimated 1,716 individual marine mammals representing four species: Harbor seal, harbor porpoise, California sea lion, and Risso's dolphins. Eighty-seven percent of sightings were of harbor seals, while harbor porpoise were the second-most frequent sighting (9 percent), followed by California sea lions; a pair of Risso's dolphins were seen twice.
• Tagging and Behavioral Monitoring of Sea Lions in the Pacific Northwest in Proximity to Navy Facilities (2013-2015): In an Interagency Agreement between the Navy and the NMFS Alaska Fisheries Science Center, the Navy has funded a sea lion satellite tagging study beginning in 2013 through 2015. Tagging is anticipated to occur in early 2014 with monitoring and data analysis extending into 2015. There are significant scientific data gaps in identifying the location of local foraging areas and percentage of time hauled out for pinniped species near Puget Sound Navy facilities. Data collected from this project will directly tie into Navy's future Phase III marine mammal density modeling for training and testing activities at-sea, and within Puget Sound. In particular, integration of improved haulout percentages will lower over-predictive modeled takes which currently, due to lack of regional data, assume all pinniped species are always in-water for purposes of model assessment of takes. Numbers of animals observed hauled out can be corrected into a population estimate by applying an estimate of the proportion of satellite-tagged-animals that are hauled out at the time of the census. Satellite-linked dive recorders can be used to assess location of foraging activity and describe the diving behavior, as well as record when the animal is hauled out.
Based on NMFS-Navy meetings in June and October 2011, future Navy compliance monitoring, including pending NWTT monitoring, will address ICMP top-level goals through a series of regional and ocean basin study questions with a prioritization and funding focus on species of interest as identified for each range complex. The ICMP will also address relative investments to different range complexes based on goals across all range complexes, and monitoring will leverage multiple techniques for data acquisition and analysis whenever possible.
Within the NWTT area, the Navy's initial recommendation for species of interest includes blue whale, fin whale, humpback whale, Southern Resident killer whale (offshore portion of their annual movements), and beaked whales. Navy monitoring for NWTT under this LOA authorization and concurrently in other areas of the Pacific Ocean will therefore be structured to address region-specific species-specific study questions that will be outlined in the final NWTT Monitoring Project Table in consultation with NMFS.
As an early start to NWTT monitoring, in July 2014 the Navy provided funding ($209,000) to NMFS' Northwest Fisheries Science Center to jointly participate in a new NWTT-specific study: Modeling the distribution of southern resident killer whales in the Pacific Northwest. The goal of this new study is to provide a more scientific understanding of endangered southern resident killer whale winter distribution off the Pacific Northwest coast. While the end project will work to develop a Bayesian space-state model for predicting the offshore winter occurrence, the project will actually consist of analysis of existing NMFS data (passive acoustic detections, satellite tag tracks) as well as new data collection from fall 2014 through spring 2015. Details of the study can be found at:
• Identification and classification of marine mammal detections from acoustic recorders.
• Acquisition and field deployment of satellite-linked transmitters (n=4) to track and determine southern resident killer whales movements.
• Deployment of autonomous underwater acoustic recorders in and adjacent to the coastal and shelf/slope waters of Washington State. Navy funding will allow 10 additional recorders to be purchased and deployed along with four NMFS recorders for a total of 14 deployed recorders.
• Estimation of the probability of Southern Resident killer whale detection on acoustic recorders.
• Development of the state-space occurrence models.
• Development of predicative maps of the seasonal annual occurrence of southern resident killer whales.
• Development a cost efficient strategy for the deployment of acoustic recorders in and adjacent to Pacific Northwest Navy ranges.
• Reporting.
The U.S. Navy is one of the world's leading organizations in assessing the effects of human activities the marine environment, including marine mammals. From 2004 through 2013, the Navy has funded over $240M specifically for marine mammal research. Navy scientists work cooperatively with other government researchers and scientists, universities, industry, and non-governmental conservation organizations in collecting, evaluating, and modeling information
ONR's current Marine Mammals and Biology Program thrusts include, but are not limited to: (1) Monitoring and detection research; (2) integrated ecosystem research including sensor and tag development; (3) effects of sound on marine life (such as hearing, behavioral response studies, physiology [diving and stress], and PCAD); and (4) models and databases for environmental compliance.
To manage some of the Navy's marine mammal research programmatic elements, OPNAV N45 developed in 2011 a new Living Marine Resources (LMR) Research and Development Program (
• Providing science-based information to support Navy environmental effects assessments for research, development, acquisition, testing, and evaluation as well as Fleet at-sea training, exercises, maintenance, and support activities.
• Improving knowledge of the status and trends of marine species of concern and the ecosystems of which they are a part.
• Developing the scientific basis for the criteria and thresholds to measure the effects of Navy-generated sound.
• Improving understanding of underwater sound and sound field characterization unique to assessing the biological consequences resulting from underwater sound (as opposed to tactical applications of underwater sound or propagation loss modeling for military communications or tactical applications).
• Developing technologies and methods to monitor and, where possible, mitigate biologically significant consequences to living marine resources resulting from naval activities, emphasizing those consequences that are most likely to be biologically significant.
The integration between the Navy's new LMR research and development program and related range complex monitoring will continue and improve during the applicable period of the rulemaking with results presented in NWTT annual monitoring reports.
The final regulations governing the take of marine mammals incidental to Navy training and testing activities in the NWTT Study Area would contain an adaptive management component carried over from previous authorizations. Although better than 5 years ago, our understanding of the effects of Navy training and testing activities (
The reporting requirements associated with this proposed rule are designed to provide NMFS with monitoring data from the previous year to allow NMFS to consider whether any changes are appropriate. NMFS and the Navy would meet to discuss the monitoring reports, Navy R&D developments, and current science and whether mitigation or monitoring modifications are appropriate. The use of adaptive management allows NMFS to consider new information from different sources to determine (with input from the Navy regarding practicability) on an annual or biennial basis if mitigation or monitoring measures should be modified (including additions or deletions). Mitigation measures could be modified if new data suggests that such modifications would have a reasonable likelihood of reducing adverse effects to marine mammals and if the measures are practicable.
The following are some of the possible sources of applicable data to be considered through the adaptive management process: (1) Results from monitoring and exercises reports, as required by MMPA authorizations; (2) compiled results of Navy funded R&D studies; (3) results from specific stranding investigations; (4) results from general marine mammal and sound research; and (5) any information which reveals that marine mammals may have been taken in a manner, extent, or number not authorized by these regulations or subsequent LOAs.
In order to issue an ITA for an activity, section 101(a)(5)(A) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such
Navy personnel would ensure that NMFS (the appropriate Regional Stranding Coordinator) is notified immediately (or as soon as clearance procedures allow) if an injured or dead marine mammal is found during or shortly after, and in the vicinity of, any Navy training exercise utilizing MFAS, HFAS, or underwater explosive detonations. The Navy would provide NMFS with species identification or a description of the animal(s), the condition of the animal(s) (including carcass condition if the animal is dead), location, time of first discovery, observed behaviors (if alive), and photographs or video (if available).
In the event that an injured, stranded, or dead marine mammal is found by the Navy that is not in the vicinity of, or during or shortly after MFAS, HFAS, or underwater explosive detonations, the Navy will report the same information as listed above as soon as operationally feasible and clearance procedures allow.
The Navy shall submit an annual report of the NWTT Monitoring Plan describing the implementation and results of the NWTT Monitoring Plan from the previous calendar year. Data collection methods will be standardized across range complexes and study areas to allow for comparison in different geographic locations. Although additional information will be gathered, the protected species observers collecting marine mammal data pursuant to the NWTT Monitoring Plan shall, at a minimum, provide the same marine mammal observation data required in § 218.145. The report shall be submitted either 90 days after the calendar year, or 90 days after the conclusion of the monitoring year to be determined by the Adaptive Management process.
The NWTT Monitoring Plan Report may be provided to NMFS within a larger report that includes the required Monitoring Plan reports from multiple range complexes and study areas (the multi-Range Complex Annual Monitoring Report). Such a report would describe progress of knowledge made with respect to monitoring plan study questions across all Navy ranges associated with the ICMP. Similar study questions shall be treated together so that progress on each topic shall be summarized across all Navy ranges. The report need not include analyses and content that does not provide direct assessment of cumulative progress on the monitoring plan study questions.
The Navy shall submit preliminary reports detailing the status of authorized sound sources within 21 days after the anniversary of the date of issuance of the LOA. The Navy shall submit detailed reports 3 months after the anniversary of the date of issuance of the LOA. The detailed annual reports shall describe the level of training and testing conducted during the reporting period, and a summary of sound sources used (total annual hours or quantity [per the LOA] of each bin of sonar or other non-impulsive source; total annual number of each type of explosive exercises; total annual expended/detonated rounds [missiles, bombs, etc.] for each explosive bin; and improved Extended Echo-Ranging System (IEER)/sonobuoy summary, including total number of IEER events conducted in the Study Area, total expended/detonated rounds (buoys), and total number of self-scuttled IEER rounds. The analysis in the detailed reports will be based on the accumulation of data from the current year's report and data collected from previous reports.
This report will be included as part of the 2020 annual exercise or testing report. This report will provide the annual totals for each sound source bin with a comparison to the annual allowance and the 5-year total for each sound source bin with a comparison to the 5-year allowance. Additionally, if there were any changes to the sound source allowance, this report will include a discussion of why the change was made and include the analysis to support how the change did or did not result in a change in the SEIS and final rule determinations. The report will be submitted 3 months after the expiration of the rule. NMFS will submit comments on the draft close-out report, if any, within 3 months of receipt. The report will be considered final after the Navy has addressed NMFS' comments, or 3 months after the submittal of the draft if NMFS does not provide comments.
In the potential effects section, NMFS' analysis identified the lethal responses, physical trauma, sensory impairment (PTS, TTS, and acoustic masking), physiological responses (particular stress responses), and behavioral responses that could potentially result from exposure to MFAS/HFAS or underwater explosive detonations. In this section, the potential effects to marine mammals from MFAS/HFAS and underwater detonation of explosives will be related to the MMPA regulatory definitions of Level A and Level B harassment and attempt to quantify the effects that might occur from the proposed training and testing activities in the Study Area.
As mentioned previously, behavioral responses are context-dependent, complex, and influenced to varying degrees by a number of factors other than just received level. For example, an animal may respond differently to a sound emanating from a ship that is moving towards the animal than it would to an identical received level coming from a vessel that is moving away, or to a ship traveling at a different speed or at a different distance from the animal. At greater distances, though, the nature of vessel movements could also potentially not have any effect on the animal's response to the sound. In any case, a full description of the suite of factors that elicited a behavioral response would require a mention of the vicinity, speed and movement of the vessel, or other factors. So, while sound sources and the received levels are the primary focus of the analysis and those that are laid out quantitatively in the regulatory text, it is with the understanding that other factors related to the training are sometimes contributing to the behavioral responses of marine mammals, although they cannot be quantified.
As mentioned previously, with respect to military readiness activities, section 3(18)(B) of the MMPA defines “harassment” as: “(i) any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild [Level A
Of the potential effects that were described earlier in this document, the following are the types of effects that fall into the Level B harassment category:
As the statutory definition is currently applied, a wide range of behavioral reactions may qualify as Level B harassment under the MMPA, including but not limited to avoidance of the sound source, temporary changes in vocalizations or dive patters, temporary avoidance of an area, or temporary disruption of feeding, migrating, or reproductive behaviors. The estimates calculated by the Navy using the acoustic thresholds do not differentiate between the different types of potential behavioral reactions. Nor do the estimates provide information regarding the potential fitness or other biological consequences of the reactions on the affected individuals. We therefore consider the available scientific evidence to determine the likely nature of the modeled behavioral responses and the potential fitness consequences for affected individuals
Of the potential effects that were described earlier, following are the types of effects that can fall into the Level A harassment category (unless they further rise to the level of serious injury or mortality):
There is considerable disagreement among scientists as to the likelihood of this phenomenon (Piantadosi and Thalmann, 2004; Evans and Miller, 2003). Although it has been argued that traumas from recent beaked whale strandings are consistent with gas emboli and bubble-induced tissue separations (Jepson
For the purposes of an MMPA authorization, three types of take are identified: Level B harassment; Level A harassment; and mortality (or serious injury leading to mortality). The categories of marine mammal responses (physiological and behavioral) that fall into the two harassment categories were described in the previous section.
Because the physiological and behavioral responses of the majority of the marine mammals exposed to non-impulse and impulse sounds cannot be easily detected or measured, and because NMFS must authorize take prior to the impacts to marine mammals, a method is needed to estimate the number of individuals that will be taken, pursuant to the MMPA, based on the proposed action. To this end, NMFS developed acoustic thresholds that estimate at what received level (when exposed to non-impulse or impulse sounds) Level B harassment and Level A harassment of marine mammals would occur. The acoustic thresholds for non-impulse and impulse sounds are discussed below.
TTS is a physiological effect that has been studied and quantified in laboratory conditions. Because data exist to support an estimate of the received levels at which marine mammals will incur TTS, NMFS uses an acoustic criteria to estimate the number of marine mammals that might sustain TTS. TTS is a subset of Level B harassment (along with sub-TTS behavioral harassment) and the Navy is not specifically required to estimate those numbers; however, the more specifically the affected marine mammal responses can be estimated, the better the analysis.
PTS data do not currently exist for marine mammals and are unlikely to be obtained due to ethical concerns. However, PTS levels for these animals may be estimated using TTS data from marine mammals and relationships between TTS and PTS that have been determined through study of terrestrial mammals.
We note here that behaviorally mediated injuries (such as those that have been hypothesized as the cause of some beaked whale strandings) could potentially occur in response to received levels lower than those believed to directly result in tissue damage. As mentioned previously, data to support a quantitative estimate of these potential effects (for which the exact mechanism is not known and in which factors other than received level may play a significant role) do not exist. However, based on the number of years (more than 60) and number of hours of MFAS per year that the U.S. (and other countries) has operated compared to the reported (and verified) cases of associated marine mammal strandings, NMFS believes that the probability of these types of injuries is very low. Tables 13 and 14 provide a summary of non-impulsive and impulsive thresholds to TTS and PTS for marine mammals. A detailed explanation of how these thresholds were derived is provided in the NWTT DEIS/OEIS Criteria and Thresholds Technical Report (Finneran and Jenkins, 2012) and summarized in Chapter 6 of the LOA application (
As the statutory definition is currently applied, a wide range of behavioral reactions may qualify as Level B harassment under the MMPA, including but not limited to avoidance of the sound source, temporary changes in vocalizations or dive patters, temporary avoidance of an area, or temporary disruption of feeding, migrating, or reproductive behaviors. The estimates calculated by the Navy using the acoustic thresholds do not differentiate between the different types of potential behavioral reactions. Nor do the estimates provide information regarding the potential fitness or other biological consequences of the reactions on the affected individuals. We therefore consider the available scientific evidence to determine the likely nature of the modeled behavioral responses and the potential fitness consequences for affected individuals.
Unlike step functions, acoustic risk continuum functions (which are also called “exposure-response functions” or “dose-response functions” in other risk assessment contexts) allow for probability of a response that NMFS would classify as harassment to occur over a range of possible received levels (instead of one number) and assume that the probability of a response depends first on the “dose” (in this case, the received level of sound) and that the probability of a response increases as the “dose” increases. In January 2009, NMFS issued three final rules governing the incidental take of marine mammals (within Navy's Hawaii Range, Southern California Training and Testing Range, and Atlantic Fleet Active Sonar Training complexes) that used a risk continuum to estimate the percent of marine mammals exposed to various levels of MFAS that would respond in a manner NMFS considers harassment.
The Navy and NMFS have previously used acoustic risk functions to estimate the probable responses of marine mammals to acoustic exposures for other training and research programs. Examples of previous application include the Navy EISs on the Surveillance Towed Array Sensor System Low Frequency Active (SURTASS LFA) sonar (U.S. Department of the Navy, 2001c); the North Pacific Acoustic Laboratory experiments conducted off the Island of Kauai (Office of Naval Research, 2001), and the Supplemental EIS for SURTASS LFA sonar (U.S. Department of the Navy, 2007d). As discussed earlier, factors other than received level (such as distance from or bearing to the sound source, context of animal at time of exposure) can affect the way that marine mammals respond; however, data to support a quantitative analysis of those (and other factors) do not currently exist. It is also worth specifically noting that while context is very important in marine mammal response, given otherwise equivalent context, the severity of a marine mammal behavioral response is also expected to increase with received level (Houser and Moore, 2014). NMFS will continue to modify these criteria as new data become available and can be appropriately and effectively incorporated.
The particular acoustic risk functions developed by NMFS and the Navy (see Figures 1 and 2 of the LOA application) estimate the probability of behavioral responses to MFAS/HFAS (interpreted as the percentage of the exposed population) that NMFS would classify as harassment for the purposes of the MMPA given exposure to specific received levels of MFAS/HFAS. The mathematical function (below) underlying this curve is a cumulative probability distribution adapted from a solution in Feller (1968) and was also used in predicting risk for the Navy's SURTASS LFA MMPA authorization as well.
Detailed information on the above equation and its parameters is available in the January 2014 NWTT DEIS/OEIS and previous Navy documents listed above.
The harbor porpoise and beaked whales have unique criteria based on specific data that show these animals to be especially sensitive to sound. Harbor porpoise and beaked whale non-impulsive behavioral criteria are used unweighted—without weighting the received level before comparing it to the threshold (see Finneran and Jenkins, 2012).
It has been speculated for some time that beaked whales might have unusual sensitivities to sonar sound due to their likelihood of stranding in conjunction with mid-frequency sonar use, even in areas where other species were more abundant (D'Amico
Since the development of the criterion, analysis of the data the 2010 and 2011 field seasons of the southern California Behavioral Responses Study have been published. The study, DeRuiter
The information currently available regarding harbor porpoises suggests a very low threshold level of response for both captive and wild animals. Threshold levels at which both captive (Kastelein
Since impulse events can be quite short, it may be possible to accumulate multiple received impulses at sound pressure levels considerably above the energy-based criterion and still not be considered a behavioral take. The Navy treats all individual received impulses as if they were one second long for the purposes of calculating cumulative sound exposure level for multiple impulse events. For example, five air gun impulses, each 0.1 second long, received at a Type II weighted sound pressure level of 167 dB SPL would equal a 164 dB sound exposure level, and would not be predicted as leading to a significant behavioral response (take) in MF or HF cetaceans. However, if the five 0.1 second pulses are treated as a 5 second exposure, it would yield an adjusted SEL of approximately 169 dB, exceeding the behavioral threshold of 167 dB SEL. For impulses associated with explosions that have durations of a few microseconds, this assumption greatly overestimates effects based on sound exposure level metrics such as TTS and PTS and behavioral responses. Appropriate weighting values will be applied to the received impulse in one-third octave bands and the energy summed to produce a total weighted sound exposure level value. For impulsive behavioral criteria, the Navy's weighting functions (detailed in Chapter 6 of the LOA application) are applied to the received sound level before being compared to the threshold.
A quantitative analysis of impacts on a species requires data on the abundance and distribution of the species population in the potentially impacted area. The most appropriate unit of metric for this type of analysis is density, which is described as the number of animals present per unit area.
There is no single source of density data for every area, species, and season because of the fiscal costs, resources, and effort involved in NMFS providing enough survey coverage to sufficiently estimate density. Therefore, to characterize the marine species density for large areas such as the Study Area, the Navy needed to compile data from multiple sources. Each data source may use different methods to estimate density, of which, uncertainty in the estimate can be directly related to the method applied. To develop a database of marine species density estimates, the Navy, in consultation with NMFS experts, adopted a protocol to select the best available data sources (including habitat-based density models, line-transect analyses, and peer-reviewed published studies) based on species, area, and season (see the Navy's Pacific Marine Species Density Database Technical Report; U.S. Department of the Navy, 2014b). The resulting Geographic Information System (GIS) database includes one single spatial and seasonal density value for every marine mammal present within the Study Area.
The Navy Marine Species Density Database includes a compilation of the best available density data from several primary sources and published works
For most cetacean species, abundance is estimated using line-transect methods that employ a standard equation to derive densities based on sighting data collected from systematic ship or aerial surveys. More recently, habitat-based density models have been used effectively to model cetacean density as a function of environmental variables (
Methods used to estimate pinniped at-sea density are generally quite different than those described above for cetaceans. Pinniped abundance is generally estimated via shore counts of animals at known rookeries and haulout sites. For example, for species such as the California sea lion, population estimates are based on counts of pups at the breeding sites (Carretta
Density estimates for each species in the Study Area, and the sources for these estimates, are provided in Chapter 6 of the LOA application and in the Navy's Pacific Marine Species Density Database Technical Report (U.S. Department of the Navy, 2014b).
The Navy performed a quantitative analysis to estimate the number of marine mammals that could be affected by acoustic sources or explosives used during Navy training and testing activities. Inputs to the quantitative analysis include marine mammal density estimates; marine mammal depth occurrence distributions; oceanographic and environmental data; marine mammal hearing data; and criteria and thresholds for levels of potential effects. The quantitative analysis consists of computer modeled estimates and a post-model analysis to determine the number of potential harassments. The model calculates sound energy propagation from sonar, other active acoustic sources, and explosives during naval activities; the sound or impulse received by animat (virtual representation of an animal) dosimeters representing marine mammals distributed in the area around the modeled activity; and whether the sound or impulse received by a marine mammal exceeds the thresholds for effects. The model estimates are then further analyzed and adjusted to consider animal avoidance (
Various computer models and mathematical equations can be used to predict how energy spreads from a sound source (
More complex computer models build upon basic modeling by factoring in additional variables in an effort to be more accurate by accounting for such things as variable bathymetry and an animal's likely presence at various depths.
The Navy has developed new software tools, up to date marine mammal density data, and other oceanographic data for the quantification of estimated acoustic impacts to marine mammal impacts from Navy activities. This new approach is the resulting evolution of the basic model previously used by the Navy and reflects a more complex modeling approach as described below. The new model, NAEMO, is the standard model now used by the Navy to estimate the potential acoustic effects of Navy training and testing activities on marine mammals. Although this more complex computer modeling approach accounts
The incorporation of mitigation factors for the reduction of predicted effects used a conservative approach (erring on the side of overestimating the number of effects) since reductions as a result of implemented mitigation were only applied to those events having a very high likelihood of detecting marine mammals. It is important to note that there are additional protections offered by mitigation procedures which will further reduce effects to marine mammals, but these are not considered in the quantitative adjustment of the model predicted effects.
The steps of the quantitative analysis of acoustic effects, the values and assumptions that went into the Navy's model, and the resulting ranges to effects are detailed in Chapter 6 (Section 6.5) of the LOA application (
While there are past and current reports of Guadalupe fur seal strandings in the Pacific Northwest, NMFS does not have at-sea Guadalupe fur seal sightings from which to derive a density estimate. For the NWTT DEIS/OEIS, the Navy elected to take a subset of Northern fur seal modeled exposures as a surrogate for Guadalupe fur seals. Essentially, a fraction of the northern fur seal modeled exposures from the Navy's acoustic effects analysis were used for Guadalupe fur seals exposures based on a comparative ratio of expected occurrence offshore in the NWTT Study Area for northern fur seals and Guadalupe fur seals (based on NMFS stranding records). Northern fur seal at-sea densities described in the Navy's Pacific Marine Species Density Database Technical Report (U.S. Department of the Navy, 2014b) were derived as a single NWTT Study Area wide layer (0.106 animals/km
This initial analysis, however, was done without consideration of the likely differences in biological at-sea distributions of both northern fur seals and Guadalupe fur seals. Northern fur seals have a documented highly pelagic distribution through the offshore waters of the Study Area where the majority of Navy training would occur (Davis
The Navy, therefore, has proposed to modify the Guadalupe fur seal take number in the NWTT Final EIS/OEIS and has revised the LOA application to account for species-specific biological differences in at-sea distributions within the NWTT Study Area. This would limit Guadalupe fur seal exposures as compared to the process described above, as well as more realistically reflect impacts from offshore Navy training and testing events. The first step in this reanalysis was an examination of the exact Navy events modeled in NAEMO that generated exposures for Northern fur seals. The Navy then analyzed the potential for co-occurrence of the activities resulting in exposures with the Guadalupe fur seal's distribution to determine if the currently predicted exposures should be modified. For training, the Navy asserted that TRACKEX events typically conducted >50 nm from shore in the NWTT Study Area would have limited to no co-occurrence with Guadalupe fur seals, and would not result in training related MMPA exposures. TRACKEX events account for 82 percent of exposures under the NWTT DEIS/OEIS preferred alternative (Table 16). The remaining 18 percent of exposures were from offshore submarine sonar maintenance and offshore surface ship sonar maintenance. While these events would also likely be further offshore, the Navy cannot totally exclude such events from at-sea co-occurring with the Guadalupe fur seal. For testing, the Navy asserts that countermeasure testing and littoral combat ship (LCS) mission package testing-ASW typically conducted >50 nm from shore in the NWTT Study Area would have limited to no co-occurrence with Guadalupe fur seals and would not result in testing MMPA exposures. Countermeasure testing and LCS mission package testing-ASW events account for 92 percent of exposures under the NWTT EIS/OEIS preferred alternative (Table 16). The remaining 8 percent of exposures were from various testing activities with the majority (5.6 percent) from ASW-guided missile destroyer (DDG)-attack submarine (SSN) testing which the Navy cannot totally exclude from at-sea co-occurrence with the Guadalupe fur seal.
Based on the results of this analysis, the Navy is modifying current NWTT EIS/OEIS take tables and has revised the LOA application to account for a percentage decrease in Guadalupe fur seal take requests. For this proposed rulemaking, the Guadalupe fur seal Level B behavioral take request for training has changed from “37” to “7” (Table 18) and for testing has changed from “27” to “3” (Table 21).
For harbor seals in the inland waters portion of the Study Area, there was a change to the Washington Inland Waters stock in 2014 subsequent to the presentation of the January 2014 NWTT DEIS/OEIS to the public. Based on DNA evidence, the single Inland Waters stock was broken up into three new stocks, designated the Hood Canal, the Washington Northern Inland Waters, and the Southern Puget Sound stocks (Carretta
As a result of the changes to the harbor seal abundance and haulout assumptions for the Hood Canal stock, for this proposed rulemaking the harbor seal Level B behavioral take request has increased by an additional 417 takes for training (Table 18) and an additional 52,970 takes (Table 21) for testing. The Level A take request has increased an additional 4 takes for training (Table 18) and an additional 61 takes for testing (Table 21).
The January 2014 NWTT DEIS/OEIS considered all training and testing activities proposed to occur in the Study Area that have the potential to result in the MMPA defined take of marine mammals. The potential stressors associated with these activities included the following:
• Acoustic (sonar and other active non-impulse sources, explosives, swimmer defense airguns, weapons firing, launch and impact noise, vessel noise, aircraft noise);
• Energy (electromagnetic devices);
• Physical disturbance or strikes (vessels, in-water devices, military expended materials, seafloor devices);
• Entanglement (fiber optic cables, guidance wires, parachutes);
• Ingestion (munitions, military expended materials other than munitions); and
• Secondary stressors (sediments and water quality).
NMFS has determined that two stressors could potentially result in the incidental taking of marine mammals from training and testing activities within the Study Area: (1) Non-impulsive stressors (sonar and other active acoustic sources) and (2) impulsive stressors (explosives). Non-impulsive and impulsive stressors have the potential to result in incidental takes of marine mammals by harassment, injury, or mortality. NMFS also considered the potential for vessel strikes to impact marine mammals, and that assessment is presented below.
A detailed analysis of effects due to marine mammal exposures to impulsive and non-impulsive sources in the Study Area is presented in Chapter 6 of the LOA application. Based on the model and post-model analysis described in Chapter 6 of the LOA application, Table 17 summarizes the Navy's final take request for training activities for a year (a 12-month period) and the summation over a 5-year period (annual events occurring five times and the non-annual event occurring three times). The Civilian Port Defense exercise is a non-
Table 18 provides the Navy's take request for training activities by species from the acoustic effects modeling estimates. The numbers provided in the annual columns are the totals for a maximum year (
There has never been a vessel strike to marine mammals during any training activities in the Study Area. A detailed analysis of strike data is contained in Section 6.7 (Estimated Take of Large Whales by Navy Vessel Strike) of the LOA application. The Navy does not anticipate vessel strikes to marine mammals within the Study Area, nor were takes by injury or mortality resulting from vessel strike predicted in the Navy's analysis. Therefore, takes by injury or mortality resulting from vessel strikes are not authorized by NMFS in this proposed rule. However, the Navy has proposed measures (see Proposed Mitigation) to mitigate potential impacts to marine mammals from vessel strikes during training activities in the Study Area.
A detailed analysis of effects due to marine mammal exposures to impulsive and non-impulsive sources in the Study Area is presented in Chapter 6 of the LOA application. Based on the model and post-model analysis described in Chapter 6 of the LOA application, Table 20 summarizes the Navy's final take request for testing activities for an annual (12-month) period and the summation over a 5-year period. There are no non-annual testing events.
Table 21 summarizes the Navy's take request for testing activities by species. There are no non-annual testing events. Derivation of these values is described in more detail within Chapter 6 of the LOA application. There are no mortalities predicted for any testing activities based on the analysis of impulsive and non-impulsive sources.
There has never been a vessel strike to marine mammals during any testing activities in the Study Area. A detailed analysis of strike data is contained in Section 6.7 (Estimated Take of Large Whales by Navy Vessel Strike) of the LOA application. Testing activities involving vessel movement could mainly occur in the Inland Waters and in Western Behm Canal with some additional testing activities in the offshore region. The majority of vessels used in the Inland Waters and Western Behm Canal are smaller vessels, which are less likely to be involved in a whale strike. The Navy's proposed actions would not result in any appreciable changes in locations or frequency of vessel activity, and there have been no whale strikes during any previous testing activities in the Study Area. The manner in which the Navy has tested would remain consistent with the range of variability observed over the last decade so the Navy does not anticipate vessel strikes would occur within the Study Area during testing events. Further, takes by injury or mortality resulting from vessel strike were not predicted in the Navy's analysis. As such, NMFS is not authorizing take by injury or mortality resulting from vessel strike this proposed rule. However, the Navy has proposed measures (see Proposed Mitigation) to mitigate potential impacts to marine mammals from vessel strikes during testing activities in the Study Area.
Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
The Navy's specified activities have been described based on best estimates of the maximum amount of sonar and other acoustic source use or detonations that the Navy would conduct. There may be some flexibility in that the exact number of hours, items, or detonations may vary from year to year, but take totals are not authorized to exceed the 5-year totals indicated in Tables 17-21. However, it is also worth noting here that while models that incorporate realistic environmental, operational, and biological parameters are the best way to satisfy our need to quantify takes, and are very useful in our analysis (especially where subsets of takes can be pared with factors associated with differential expected levels of severity or duration), due to the inherent variability and uncertainty in model inputs, modeled take estimates are never expected to represent the exact number of animals that will actually be taken, but rather can provide (depending on nature of model) a decent relative understanding of the portion of a population that might be affected and/or the number of repeat takes of individuals on subsequent days that might occur.
The Navy's take request is based on their model and post-model analysis. Generally speaking, and especially with other factors being equal, the Navy and NMFS anticipate more severe effects from takes resulting from exposure to higher received levels (though this is in no way a strictly linear relationship throughout species, individuals, or circumstances) and less severe effects from takes resulting from exposure to lower received levels. The requested number of Level B takes does not equate to the number of individual animals the Navy expects to harass (which is lower), but rather to the instances of take (
It is important to note that, while NMFS does not expect that all of the requested and authorized takes (as shown in Tables 17-21 and based on the acoustic analysis) will actually occur, we nevertheless base our analysis and NID on the maximum number of takes requested and authorized (
As discussed previously in this document, marine mammals can respond to MFAS/HFAS in many different ways, a subset of which qualifies as harassment (see Behavioral Harassment Section). One thing that the Level B harassment take estimates do not take into account is the fact that most marine mammals will likely avoid strong sound sources to one extent or another. Although an animal that avoids the sound source will likely still be taken in some instances (such as if the avoidance results in a missed opportunity to feed, interruption of reproductive behaviors, etc.), in other cases avoidance may result in fewer instances of take than were estimated or in the takes resulting from exposure to a lower received level than was estimated, which could result in a less severe response. For MFAS/HFAS, the Navy provided information (Table 22) estimating the percentage of behavioral harassment that would occur within the 6-dB bins (without considering mitigation or avoidance). As mentioned above, an animal's exposure to a higher received level is more likely to result in a behavioral response that is more likely to adversely affect the health of the animal. As illustrated below, the majority (about 73 percent, at least for hull-mounted sonar, which is responsible for most of the sonar takes) of calculated takes from MFAS result from exposures between 156 dB and 162 dB. Less than 0.5 percent of the takes are expected to result from exposures above 174 dB.
Specifically, given a range of behavioral responses that may be classified as Level B harassment, to the degree that higher received levels are expected to result in more severe behavioral responses, only a small percentage of the anticipated Level B harassment from Navy activities might necessarily be expected to potentially result in more severe responses, especially when the distance from the source at which the levels below are received is considered (see Table 22). Marine mammals are able to discern the distance of a given sound source, and given other equal factors (including received level), they have been reported to respond more to sounds that are closer (DeRuiter
Although the Navy has been monitoring the effects of MFAS/HFAS on marine mammals since 2006, and research on the effects of MFAS is advancing, our understanding of exactly how marine mammals in the Study Area will respond to MFAS/HFAS is still growing. The Navy has submitted reports from more than 60 major exercises across Navy range complexes that indicate no behavioral disturbance was observed. One cannot conclude from these results that marine mammals were not harassed from MFAS/HFAS, as a portion of animals within the area of concern were not seen (especially those more cryptic, deep-diving species, such as beaked whales or
As noted previously, many animals perform vital functions, such as feeding, resting, traveling, and socializing on a diel cycle (24-hour cycle). Behavioral reactions to noise exposure (when taking place in a biologically important context, such as disruption of critical life functions, displacement, or avoidance of important habitat) are more likely to be significant if they last more than one diel cycle or recur on subsequent days (Southall
Durations for non-impulsive activities utilizing tactical sonar sources vary and are fully described in Appendix A of the January 2014 DEIS/OEIS. ASW training and testing exercises using MFAS/HFAS generally last for 2-16 hours, and may have intervals of non-activity in between. Because of the need to train in a large variety of situations, the Navy does not typically conduct successive MTEs or other ASW exercises in the same locations. Given the average length of ASW exercises (times of continuous sonar use) and typical vessel speed, combined with the fact that the majority of the cetaceans in the Study Area would not likely remain in an area for successive days, it is unlikely that an animal would be exposed to MFAS/HFAS at levels likely to result in a substantive response that would then be carried on for more than one day or on successive days. There are no MTEs proposed for NWTT activities.
Most planned explosive exercises are of a short duration (1-6 hours). Although explosive exercises may sometimes be conducted in the same general areas repeatedly, because of their short duration and the fact that they are in the open ocean and animals can easily move away, it is similarly unlikely that animals would be exposed for long, continuous amounts of time.
As mentioned previously, TTS can last from a few minutes to days, be of varying degree, and occur across various frequency bandwidths, all of which determine the severity of the impacts on the affected individual, which can range from minor to more severe. The TTS sustained by an animal is primarily classified by three characteristics:
1. Frequency—Available data (of mid-frequency hearing specialists exposed to mid- or high-frequency sounds; Southall
2. Degree of the shift (
3. Duration of TTS (recovery time)—In the TTS laboratory studies, some using exposures of almost an hour in duration or up to 217 SEL, almost all individuals recovered within 1 day (or less, often in minutes), although in one study (Finneran
Based on the range of degree and duration of TTS reportedly induced by exposures to non-pulse sounds of energy higher than that to which free-swimming marine mammals in the field are likely to be exposed during MFAS/HFAS training exercises in the Study Area, it is unlikely that marine mammals would ever sustain a TTS
Masking only occurs during the time of the signal (and potential secondary arrivals of indirect rays), versus TTS, which continues beyond the duration of the signal. Standard MFAS nominally pings every 50 seconds for hull-mounted sources. For the sources for which we know the pulse length, most are significantly shorter than hull-mounted active sonar, on the order of several microseconds to tens of microseconds. For hull-mounted active sonar, though some of the vocalizations that marine mammals make are less than one second long, there is only a 1 in 50 chance that they would occur exactly when the ping was received, and when vocalizations are longer than one second, only parts of them are masked. Alternately, when the pulses are only several microseconds long, the majority of most animals' vocalizations would not be masked. Masking effects from MFAS/HFAS are expected to be minimal. If masking or communication impairment were to occur briefly, it would be in the frequency range of MFAS, which overlaps with some marine mammal vocalizations; however, it would likely not mask the entirety of any particular vocalization, communication series, or other critical auditory cue, because the signal length, frequency, and duty cycle of the MFAS/HFAS signal does not perfectly mimic the characteristics of any marine mammal's vocalizations.
NMFS believes that many marine mammals would deliberately avoid exposing themselves to the received levels of active sonar necessary to induce injury by moving away from or at least modifying their path to avoid a close approach. Additionally, in the unlikely event that an animal approaches the sonar vessel at a close distance, NMFS believes that the mitigation measures (
If a marine mammal is able to approach a surface vessel within the distance necessary to incur PTS, the likely speed of the vessel (nominal 10-15 knots) would make it very difficult for the animal to remain in range long enough to accumulate enough energy to result in more than a mild case of PTS. As mentioned previously and in relation to TTS, the likely consequences to the health of an individual that incurs PTS can range from mild to more serious, depending upon the degree of PTS and the frequency band it is in, and many animals are able to compensate for the shift, although it may include energetic costs.
As discussed previously, marine mammals (especially beaked whales) could potentially respond to MFAS at a received level lower than the injury threshold in a manner that indirectly results in the animals stranding. The exact mechanism of this potential response, behavioral or physiological, is not known. When naval exercises have been associated with strandings in the past, it has typically been when three or more vessels are operating simultaneously, in the presence of a strong surface duct, and in areas of constricted channels, semi-enclosed areas, and/or steep bathymetry. A combination of these environmental and operational parameters is not present in the NWTT action. When this is combined with consideration of the number of hours of active sonar training that will be conducted and the nature of the exercises—which do not typically include the use of multiple hull-mounted sonar sources—we believe that the probability is small that this will occur. Furthermore, given that there has never been a stranding in the Study Area associated with sonar use and based on the number of occurrences where strandings have been definitively associated with military sonar versus the number of hours of active sonar training that have been conducted, we believe that the probability is small that this will occur as a result of the Navy's proposed training and testing activities. Lastly, an active sonar shutdown protocol for strandings involving live animals milling in the water minimizes the chances that these types of events turn into mortalities.
As stated previously, there have been no recorded Navy vessel strikes of any marine mammals during training or testing in the NWTT Study Area to date, nor were takes by injury or mortality resulting from vessel strike predicted in the Navy's acoustic effects analysis.
In the discussions below, the “acoustic analysis” refers to the Navy's model results and post-model analysis. The Navy performed a quantitative analysis to estimate the number of marine mammals that could be harassed by acoustic sources or explosives used during Navy training and testing activities. Inputs to the quantitative analysis included marine mammal density estimates; marine mammal depth occurrence distributions; oceanographic and environmental data; marine mammal hearing data; and criteria and thresholds for levels of potential effects. Marine mammal densities used in the model may overestimate actual densities when species data is limited and for species with seasonal migrations (
Although this more complex computer modeling approach accounts for various environmental factors affecting acoustic propagation, the current software tools do not consider the likelihood that a marine mammal would attempt to avoid repeated exposures to a sound or avoid an area of intense activity where a training or testing event may be focused. Additionally, the software tools do not consider the implementation of mitigation (
It is important to note that adjustments to take estimates as a result of implemented mitigation were only applied to those events having a very high likelihood of detecting marine mammals. It is also important to note that the Navy's take estimates represent the total number of takes and not the number of individuals taken, as a single individual may be taken multiple times over the course of a year. NMFS provided input to the Navy on this process and the Navy's qualitative analysis is described in detail in Chapter 6 of their LOA application. (
Predicted harassment of marine mammals from sonar and other active acoustic sources and explosions during annual training and testing activities are shown in Tables 18-21. The acoustic analysis predicts the majority of marine mammal species in the Study Area would not be exposed to explosive (impulse) sources associated with training and testing activities, which would exceed the current impact thresholds (Table 4). Only harbor porpoise, Dall's porpoise, and Northern elephant seal are predicted to have exposures that would exceed the current impact thresholds for explosives, as presented in the following subsections.
The analysis below may in some cases (
These exposure estimates represent a limited number of takes relative to population estimates for all mysticete stocks in the Study Area (Table 9). When the numbers of behavioral takes are compared to the estimated stock abundance and if one assumes that each take happens to a separate animal, less than 20 percent of each of these stocks would be behaviorally harassed during the course of a year. More likely, fewer individuals would be taken, but a subset would be taken more than one time per year.
Level B harassment takes are anticipated to be in the form of TTS and behavioral reactions and no injurious takes of humpback, blue, fin, or sei whales from sonar and other active acoustic stressors or explosives are expected. The majority of acoustic effects to mysticetes from sonar and other active sound sources during training activities would be primarily from anti-submarine warfare events involving surface ships and hull mounted sonar. Most Level B harassments to mysticetes from sonar would result from received levels less than 158 dB SPL. Recovery from a threshold shift (TTS) can take a few minutes to a few days (
Specific to U.S. Navy systems using low frequency sound, studies were undertaken in 1997-98 pursuant to the Navy's Low Frequency Sound Scientific Research Program. These studies found only short-term responses to low frequency sound by mysticetes (fin, blue, and humpback), including changes in vocal activity and avoidance of the source vessel (Clark, 2001; Miller
Specific to mid-frequency sounds, studies by Melcón
High-frequency systems are not within mysticetes' ideal hearing range and it is unlikely that they would cause a significant behavioral reaction resulting in takes.
Overall, the number of predicted behavioral reactions is low and occasional behavioral reactions are unlikely to cause long-term consequences for individual animals or populations. The implementation of mitigation and the sightability of mysticetes (due to their large size) reduces the potential for a significant behavioral reaction or a threshold shift to occur. Furthermore, there is no designated critical habitat for mysticetes in the NWTT Study Area. There are also no known specific breeding or calving areas for mysticete species within the Study Area. Some biologically-important mysticete feeding and migration areas (Northern Puget Sound Feeding Area for gray whales; Northbound Migration Phase A for gray whales; Northbound Migration Phase B for gray whales; Potential Presence Migration Area for gray whales; Northern Washington Feeding Area for humpback whales; Stonewall and Heceta Bank Feeding Area for humpback whales; Cape Blanco and Orford Reef Feeding Area for gray whale; and Point St. George Feeding Area for gray whales) may overlap slightly with the Study Area. However, a review of the BIAs for humpback whales and gray whales against areas where most acoustic activities are conducted in the Study Area (especially those that involve ASW hull-mounted sonar, sonobuoys, and use of explosive munitions) identified that there is no spatial overlap. The overall risk to species in these areas has been preliminarily determined to be low or biologically insignificant, in part due to the generally infrequent, temporally and spatially variable, and extreme offshore nature of sonar-related activities and sound propagation relative to the more coastally distributed biologically important areas; the probability that propagated receive levels within these areas would be relatively low in terms of behavioral criteria (Debich
There has never been a vessel strike to a whale during any active training or testing activities in the Study Area. A detailed analysis of strike data is contained in Chapter 6 (Section 6.7, Estimated Take of Large Whales by Navy Vessel Strike) of the LOA application. The Navy and NMFS do not anticipate vessel strikes to any marine mammals during training or testing activities within the Study Area, nor were takes by injury or mortality resulting from vessel strike predicted in the Navy's analysis. Therefore, NMFS is not authorizing mysticete takes (by injury or mortality) from vessel strikes during the 5-year period of the NWTT regulations.
The majority of Level B takes are expected to be in the form of mild responses. Relative to the population size (stock abundance estimates are shown in Table 9), this activity is anticipated to result only in a limited number of Level B harassment takes. When the number of behavioral takes is compared to the estimated stock abundance and if one assumes that each take happens to a separate animal, less than 17 percent of the California/Oregon/Washington stock would be behaviorally harassed during the course of a year. More likely, fewer individuals would be taken, but a subset would be taken more than one time per year. Overall, the number of predicted behavioral reactions are unlikely to cause long-term consequences for individual animals or populations. The NWTT activities are not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for sperm whales. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of sperm whales. Sperm whales are listed as depleted under the MMPA and endangered under the ESA; however, there is no designated critical habitat in the Study Area.
There has never been a vessel strike to a sperm whale during any active training or testing activities in the Study Area. A detailed analysis of strike data is contained in Chapter 6 (Section 6.7, Estimated Take of Large Whales by Navy Vessel Strike) of the LOA application. The Navy and NMFS do not anticipate vessel strikes to any marine mammals during training or testing activities within the Study Area, nor were takes by injury or mortality resulting from vessel strikes predicted in the Navy's analysis. Therefore, NMFS is not authorizing sperm whale takes (by injury or mortality) from vessel strikes during the 5-year period of the NWTT regulations.
Acoustic analysis (factoring in the post-model correction for avoidance and mitigation) also predicted that 47 Dall's porpoises and 45 harbor porpoises might be exposed to sound levels likely to result in PTS or injury (Level A harassment) from mainly sonar and other active acoustic stressors, and explosives. In the case of all explosive exercises, it is worth noting that the amount of explosive and acoustic energy entering the water, and therefore the effects on marine mammals, may be overestimated, as many explosions actually occur upon impact with above-water targets. However, sources such as these were modeled as exploding at 1-meter depth. Furthermore, in the case of all explosive exercises, the exclusion zones are considerably larger than the estimated distance at which an animal would be exposed to injurious sounds or pressure waves.
Animals that do experience hearing loss (TTS or PTS) may have reduced ability to detect relevant sounds such as predators, prey, or social vocalizations. Some porpoise vocalizations might overlap with the MFAS/HFAS TTS frequency range (2-20 kHz). It is worth noting that TTS in the range induced by MFAS/HFAS would reduce sensitivity in the band that killer whales (a potential predator) click and echolocate in. Recovery from a threshold shift (TTS; partial hearing loss) can take a few minutes to a few days, depending on the exposure duration, sound exposure level, and the magnitude of the initial shift, with larger threshold shifts and longer exposure durations requiring longer recovery times (Finneran
Harbor porpoises have been observed to be especially sensitive to human activity (Tyack
Stock abundance estimates for Dall's and harbor porpoises are shown in Table 9. When the numbers of takes for Dall's porpoise are compared to the estimated stock abundances and if one assumes that each take happens to a separate animal, approximately 30 percent of the Alaska stock and less than 2 percent of the California/Oregon/Washington stock would be harassed (behaviorally) during the course of a year. More likely, fewer individuals are harassed, but a subset are harassed more than one time during the course of the year. The number of harbor porpoises—in particular, Northern Oregon/Washington Coast and Northern California/Southern Oregon stocks—behaviorally harassed by exposure to MFAS/HFAS in the Study Area is higher than the other species (and, in fact, suggests that every member of the stock could potentially be taken by Level B harassment multiple times, although it is more likely that fewer individuals are harassed but a subset are harassed more than one time during the course of the year) because of the low Level B harassment threshold (we assume for the purpose of estimating take that all harbor porpoises exposed to 120 dB or higher MFAS/HFAS will be taken by Level B behavioral harassment), which essentially makes the ensonified area of effects significantly larger than for the other species. However, the fact that the threshold is a step function and not a curve (and assuming uniform density) means that the vast majority of the takes occur in the very lowest levels that exceed the threshold (it is estimated that approximately 80 percent of the takes are from exposures to 120 dB to 126 dB), which means that anticipated behavioral effects are not expected to be severe (
The harbor porpoise is a common species in the nearshore coastal waters of the Study Area year-round (Barlow, 1988; Green
Considering the information above, the predicted effects to Dall's and harbor porpoises are unlikely to cause long-term consequences for individual animals or the population. The NWTT activities are not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for Dall's and harbor porpoises. Pacific stocks of Dall's and harbor porpoises are not listed as depleted under the MMPA. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of porpoises.
Recovery from a threshold shift (TTS; partial hearing loss) can take a few minutes to a few days, depending on the exposure duration, sound exposure level, and the magnitude of the initial shift, with larger threshold shifts and longer exposure durations requiring longer recovery times (Finneran
Some
Research and observations on
The predicted effects to
Behavioral responses can range from a mild orienting response, or a shifting of attention, to flight and panic (Richardson, 1995; Nowacek, 2007; Southall
It has been speculated for some time that beaked whales might have unusual sensitivities to sonar sound due to their likelihood of stranding in conjunction with mid-frequency sonar use. Research and observations show that if beaked whales are exposed to sonar or other active acoustic sources they may startle, break off feeding dives, and avoid the area of the sound source to levels of 157 dB re 1 μPa, or below (McCarthy
Based on the findings above, it is clear that the Navy's long-term ongoing use of sonar and other active acoustic sources has not precluded beaked whales from also continuing to inhabit those areas. In summary, based on the best available science, the Navy and NMFS believe that beaked whales that exhibit a significant TTS or behavioral reaction due to sonar and other active acoustic testing activities would generally not have long-term consequences for individuals or populations. Claridge (2013) speculates that sonar use in a Bahamas range could have “a possible population-level effect” on beaked whales based on lower abundance in comparison to control sites. However, the study suffers from several shortcomings and incorrectly assumes that the Navy range and control sites were identical. The author also acknowledged that “information currently available cannot provide a quantitative answer to whether frequent sonar use at [the Bahamas range] is causing stress to resident beaked whales,” and cautioned that the outcome of ongoing studies “is a critical component to understanding if there are population-level effects.” Moore and Barlow (2013) have noted a decline in beaked whale populations in a broad area of the Pacific Ocean area out to 300 nm from the coast and extending from the Canadian-U.S. border to the tip of Baja Mexico. There are scientific caveats and limitations to the data used for that analysis, as well as oceanographic and species assemblage changes on the U.S. Pacific coast not thoroughly addressed. Interestingly, however, in the small portion of that area overlapping the Navy's SOCAL Range Complex, long-term residency by individual Cuvier's beaked whales and higher densities provide indications that the proposed decline noted elsewhere is not apparent where for decades the Navy has been intensively training and testing with sonar and other systems.
NMFS also considered New
No beaked whales are predicted in the acoustic analysis to be exposed to sound levels associated with PTS, other injury, or mortality. After decades of the Navy conducting similar activities in the NWTT Study Area without incident, NMFS does not expect strandings, injury, or mortality of beaked whales to occur as a result of training and testing activities. Additionally, through the MMPA process (which allows for adaptive management), NMFS and the Navy will determine the appropriate way to proceed in the event that a causal relationship were to be found between Navy activities and a future stranding.
The NWTT training and testing activities are not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for beaked whales. Although no areas of specific importance for reproduction or feeding of beaked whales have been identified in the Study Area, beaked whales are generally found in deep waters over the continental slope, oceanic seamounts, and areas with submarine escarpments (very seldom over the continental shelf). None of the Pacific stocks for beaked whales species found in the Study Area are depleted under the MMPA. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of beaked whales.
All of these takes are anticipated to be in the form of behavioral harassment (TTS and behavioral reaction) and no injurious takes of delphinids from sonar and other active acoustic stressors or explosives are requested or proposed for authorization. Further, the majority of takes are anticipated to be by behavioral harassment in the form of mild responses. Behavioral responses can range from a mild orienting response, or a shifting of attention, to flight and panic (Richardson, 1995; Nowacek, 2007; Southall
The predicted effects to delphinids are unlikely to cause long-term consequences for individual animals or populations. The NWTT activities are not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for delphinids. Pacific stocks of delphinid species found in the Study Area are not depleted under the MMPA. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of delphinid species.
All of these takes are anticipated to be in the form of behavioral harassment (TTS and behavioral reaction) and no injurious takes of killer whales from sonar and other active acoustic stressors or explosives are requested or proposed for authorization. Further, the majority of takes are anticipated to be by behavioral harassment in the form of
The southern resident killer whale is the only ESA-listed marine mammal species with designated critical habitat located in the NWTT Study Area (NMFS, 2006). The majority of the Navy's proposed training and testing activities would, however, not occur in the southern resident killer whale's designated critical habitat (NMFS, 2006). For all substressors that would occur within the critical habitat, those training and testing activities are not expected to impact the identified primary constituent elements of that habitat and therefore would have no effect on that critical habitat. Furthermore, the majority of testing events would occur in Hood Canal, where southern resident killer whales are not believed to be present, while the majority of training activities would occur in the offshore portions of the Study Area where they are only present briefly during their annual migration period. Effects to designated critical habitat will be fully analyzed in the Navy's and NMFS' internal ESA Section 7 consultations for NWTT.
The whale's size and detectability makes it unlikely that these animals would be exposed to the higher energy or pressure expected to result in more severe effects. As stated above, the vocalizations of killer whales fall directly into the frequency range in which TTS would be incurred from the MFAS sources used during ASW exercises; however, the Navy is conducting ASW exercises mainly in the Offshore Area while killer whales are predominantly situated in the Inland Waters Area. Both behavioral and auditory brainstem response techniques indicate killer whales can hear a frequency range of 1 to 100 kHz and are most sensitive at 20 kHz. This is one the lowest maximum-sensitivity frequencies known among toothed whales (Szymanski
The NWTT training and testing activities are generally not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for killer whales. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of killer whale species and will therefore not result in population-level impacts.
Research has demonstrated that for pinnipeds, as for other mammals, recovery from a hearing threshold shift (
Research and observations show that pinnipeds in the water may be tolerant of anthropogenic noise and activity (a review of behavioral reactions by pinnipeds to impulsive and non-impulsive noise can be found in Richardson
Thus, even repeated Level B harassment of some small subset of the overall stock is unlikely to result in any significant realized decrease in fitness to those individuals, and would not result in any adverse impact to the stock as a whole. Evidence from areas where the Navy extensively trains and tests provides some indication of the possible consequences resulting from those proposed activities. In the confined waters of Washington State's Hood Canal where the Navy has been training and intensively testing for decades and harbor seals are present year-round, the population level has remained stable suggesting the area's carrying capacity may have been reached (Jeffries
Generally speaking, pinniped stocks in the Study Area are thought to be stable or increasing. Abundance estimates for pinniped stocks in the Study Area are shown in Table 9. Relative to population size, training and testing activities are anticipated to result only in a limited number of takes for the majority of pinniped species. When the numbers of takes are compared to the estimated stock abundances and if one assumes that each take happens to a separate animal, less than 2 percent of each Steller sea lion, California sea lion, northern fur seal, and northern elephant seal stock would be harassed (behaviorally) during the course of a year. More likely, fewer individuals are harassed, but a subset are harassed more than one time during the course of the year. Takes of depleted (as defined under the MMPA) stocks of northern fur seals (Eastern Pacific) and Guadalupe fur seals (Mexoco) represent only 0.7 percent and 0.07 percent of their respective stock.
NMFS has determined that the Level A and Level B harassment exposures to the Hood Canal stock of harbor seals are not biologically significant to the population because (1) the vast majority of the exposures are within the non-injurious TTS or behavioral effects zones and none of the estimated exposures result in mortality; (2) the majority of predicted harbor seal exposures result from testing activities which are generally of an intermittent or short duration and should prevent animals from being exposed to stressors on a continuous basis; (3) there are no indications that the historically occurring activities resulting in these behavioral harassment exposures are having any effect on this population's survival by altering behavior patterns such as breeding, nursing, feeding, or sheltering; (4) the population has been stable and likely at carrying capacity (Jeffries
The Guadalupe fur seal is the only ESA-listed pinniped species found within the NWTT Study Area. Guadalupe fur seals are considered “seasonally migrant” and are present within the offshore portion of the Study Area during the warm season (summer and early autumn) and during that portion of the year may be exposed to sonar and other active acoustic sources associated with training and testing activities. Predicted Level B takes of Guadalupe fur seals in the Study Area represent a negligible percentage of the San Miguel Island stock. Furthermore, critical habitat has not been designated for Guadalupe fur seals.
We believe that factors described above, as well as the available body of evidence from past Navy activities in the Study Area, demonstrate that the potential effects of the specified activity will have only short-term effects on individuals. The NWTT training and testing activities are not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for pinnipeds. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of pinniped species and will therefore not result in population-level impacts.
The best assessment of long-term consequences from training and testing activities will be to monitor the populations over time within a given Navy range complex. A U.S. workshop on Marine Mammals and Sound (Fitch
Since 2006 across all Navy Range Complexes (in the Atlantic, Gulf of Mexico, and the Pacific), there have been more than 80 reports; Major Exercise Reports, Annual Exercise Reports, and Monitoring Reports. For the Pacific since 2011, there have been 29 monitoring and exercise reports (as shown in Table 6-1 of the LOA application) submitted to NMFS to further research goals aimed at understanding the Navy's impact on the environment as it carries out its mission to train and test.
In addition to this multi-year record of reports from across the Navy, there have also been ongoing Behavioral Response Study research efforts (in
Based on the findings from surveys in Puget Sound and research efforts and monitoring before, during, and after training and testing events across the Navy since 2006, NMFS' assessment is that it is unlikely there would be impacts to populations of marine mammals having any long-term consequences as a result of the proposed continuation of training and testing in the ocean areas historically used by the Navy, including the Study Area. This assessment of likelihood is based on four indicators from areas in the Pacific where Navy training and testing has been ongoing for decades: (1) Evidence suggesting or documenting increases in the numbers of marine mammals present (Calambokidis and Barlow, 2004; Calambokidis
To summarize, while the evidence covers most marine mammal taxonomic suborders, it is limited to a few species and only suggestive of the general viability of those species in intensively used Navy training and testing areas. There is no direct evidence that routine Navy training and testing spanning decades has negatively impacted marine mammal populations at any Navy Range Complex. Although there have been a few strandings associated with use of sonar in other locations (see U.S. Department of the Navy, 2013b), Ketten (2012) has recently summarized, “to date, there has been no demonstrable evidence of acute, traumatic, disruptive, or profound auditory damage in any marine mammal as the result of anthropogenic noise exposures, including sonar.” Therefore, based on the best available science (Barlow
Training and testing activities proposed in the NWTT Study Area would result in Level B and Level A takes, as summarized in Tables 17-21. Based on best available science, as summarized in this proposed rule and in the January 2014 DEIS/OEIS (Section 3.4.4.1), NMFS concludes that exposures to marine mammal species and stocks due to NWTT activities would result in only short-term (temporary and short in duration) and relatively infrequent effects to most individuals exposed, and not of the type or severity that would be expected to be additive for the generally small portion of the stocks and species likely to be exposed. Marine mammal takes from Navy activities are not expected to impact annual rates of recruitment or survival and will therefore not result in population-level impacts for the following reasons:
• Most acoustic exposures (greater than 99 percent) are within the non-injurious TTS or behavioral effects zones (Level B harassment consisting of generally temporary modifications in behavior) and none of the estimated exposures result in mortality.
• Although the numbers presented in Tables 17-21 represent estimated harassment under the MMPA, as described above, they are conservative estimates of harassment, primarily by behavioral disturbance, and made without taking into consideration
• Additionally, the protective measures described in the Proposed Mitigation section above are designed to reduce sound exposure and explosive effects on marine mammals to levels below those that may cause physiological effects (injury) and to achieve the least practicable adverse effect on marine mammal species or stocks.
• Range complexes where intensive training and testing have been occurring for decades have populations of multiple species with strong site fidelity (including highly sensitive resident beaked whales at some locations) and increases in the number of some species.
• Years of monitoring of Navy-wide activities (since 2006) have documented hundreds of thousands of marine mammals on the range complexes and there are only two instances of overt behavioral change that have been observed.
• Years of monitoring of Navy-wide activities on the range complexes have documented no demonstrable instances of injury to marine mammals as a direct result of non-impulsive acoustic sources.
• In at least three decades of the same type of activities, only one instance of injury to marine mammals (March 4, 2011; three long-beaked common dolphin off Southern California) has occurred as a known result of training or testing using an impulsive source (underwater explosion). Of note, the time-delay firing underwater explosive training activity implicated in the March 4 incident is not proposed for the training activities in the NWTT Study Area.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat and dependent upon the implementation of the mitigation and monitoring measures, NMFS preliminarily finds that the total taking from Navy training and testing exercises in the NWTT Study Area will have a negligible impact on the affected species or stocks. NMFS has proposed regulations for these exercises that prescribe the means of effecting the least practicable adverse impact on marine mammals and their habitat and set forth requirements pertaining to the monitoring and reporting of that taking.
There are no relevant subsistence uses of marine mammals implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
There are nine marine mammal species under NMFS jurisdiction that are listed as endangered or threatened under the ESA with confirmed or possible occurrence in the NWTT Study Area: North Pacific right whale, blue whale, humpback whale, fin whale, sei whale, gray whale (Western North Pacific stock), sperm whale, killer whale (Eastern North Pacific Southern Resident stock), and Guadalupe fur seal. The Navy will consult with NMFS pursuant to section 7 of the ESA, and NMFS will also consult internally on the issuance of LOAs under section 101(a)(5)(A) of the MMPA for NWTT activities. Consultation will be concluded prior to a determination on the issuance of the final rule and an LOA.
NMFS is a cooperating agency on the Navy's NWTT DEIS/OEIS, which was prepared and released to the public in January 2014. Upon completion, the Final EIS/OEIS (FEIS/OEIS) will be made available for public review and posted on NMFS' Web site:
Some Navy NWTT activities will occur within the Olympic Coast National Marine Sanctuary (OCNMS). Federal agency actions that are likely to injure sanctuary resources are subject to consultation with the NOAA Office of National Marine Sanctuaries (ONMS) under section 304(d) of the National Marine Sanctuaries Act (NMSA). The Navy analyzed potential impacts to sanctuary resources and has provided the analysis in the January 2014 NWTT DEIS/OEIS. Where the Navy either proposes new military activities or proposes to modify existing military activities that are otherwise exempted by individual sanctuary regulations at 15 CFR part 922 in a way that the modified activities would adversely impact sanctuary resources and qualities, the Navy will initiate consultation with ONMS.
NMFS is currently consulting with ONMS on the issuance of regulations and LOAs for NWTT activities. Consultation will be concluded prior to a determination on the issuance of the final rule and an LOA.
The Office of Management and Budget has determined that this proposed rule is not significant for purposes of Executive Order 12866.
Pursuant to the Regulatory Flexibility Act (RFA), the Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The RFA requires federal agencies to prepare an analysis of a rule's impact on small entities whenever the agency is required to publish a notice of proposed rulemaking. However, a federal agency may certify, pursuant to 5 U.S.C. 605 (b), that the action will not have a significant economic impact on a substantial number of small entities. The Navy is the sole entity that would be affected by this rulemaking, and the Navy is not a small governmental jurisdiction, small organization, or small business, as defined by the RFA. Any requirements imposed by an LOA issued pursuant to these regulations, and any monitoring or reporting requirements imposed by these regulations, would be applicable only to the Navy. NMFS does not expect the issuance of these regulations or the associated LOAs to result in any impacts to small entities pursuant to the RFA. Because this action, if adopted, would directly affect the Navy and not a small entity, NMFS concludes the action would not result in a significant economic impact on a substantial number of small entities.
Exports, Fish, Imports, Incidental take, Indians, Labeling, Marine mammals, Navy, Penalties, Reporting and recordkeeping requirements, Seafood, Sonar, Transportation.
For reasons set forth in the preamble, 50 CFR part 218 is proposed to be amended as follows:
16 U.S.C. 1361
(f) * * *
(1) * * *
(ii) * * *
(F) Individual marine mammal sighting information for each sighting when mitigation occurred during each MTE.
(f) * * *
(1) * * *
(ii) * * *
(F) Individual marine mammal sighting information for each sighting when mitigation occurred during each MTE.
(f) * * *
(1) * * *
(ii) Individual marine mammal sighting information for each sighting in each exercise when mitigation occurred.
(a) Regulations in this subpart apply only to the U.S. Navy for the taking of marine mammals that occurs in the area outlined in paragraph (b) of this section and that occurs incidental to the activities described in paragraph (c) of this section.
(b) The taking of marine mammals by the Navy is only authorized if it occurs within the NWTT Study Area, which is composed of established maritime operating and warning areas in the eastern North Pacific Ocean region, including areas of the Strait of Juan de Fuca, Puget Sound, and Western Behm Canal in southeastern Alaska. The Study Area includes air and water space within and outside Washington state waters, and outside state waters of Oregon and Northern California. The Study Area includes four existing range complexes and facilities: The Northwest Training Range Complex (NWTRC), the Keyport Range Complex, Carr Inlet Operations Area, and SEAFAC. In addition to these range complexes, the Study Area also includes Navy pierside locations where sonar maintenance and testing occurs as part of overhaul, modernization, maintenance and repair activities at NAVBASE Kitsap, Bremerton; NAVBASE Kitsap, Bangor; and Naval Station Everett.
(c) The taking of marine mammals by the Navy is only authorized if it occurs incidental to the following activities within the designated amounts of use:
(1) Sonar and other Active Sources Used During Training:
(i) Mid-frequency (MF) Source Classes:
(A) MF1—an average of 166 hours per year.
(B) MF3—an average of 70 hours per year.
(C) MF4—an average of 4 hours per year.
(D) MF5—an average of 896 items per year.
(E) MF11—an average of 16 hours per year.
(ii) High-frequency (HF) Source Classes:
(A) HF1—an average of 48 hours per year.
(B) HF4—an average of 384 hours per year.
(C) HF6—an average of 192 items per year.
(iii) Anti-Submarine Warfare (ASW) Source Classes:
(A) ASW2—an average of 720 items per year per year.
(B) ASW3—an average of 78 hours per year.
(2) Sonar and other Active Sources Used During Testing:
(i) Low-frequency (LF) Source Classes:
(A) LF4—an average of 110 hours per year.
(B) LF5—an average of 71 hours per year.
(ii) Mid-frequency (MF):
(A) MF3—an average of 161 hours per year.
(B) MF4—an average of 10 hours per year.
(C) MF5—an average of 273 items per year.
(D) MF6—an average of 12 items per year.
(E) MF8—an average of 40 hours per year.
(F) MF9—an average of 1,183 hours per year.
(G) MF10—an average of 1,156 hours per year.
(H) MF11—an average of 34 hours per year.
(I) MF12—an average of 24 hours per year.
(iii) High-frequency (HF) and Very High-frequency (VHF):
(A) HF1—an average of 161 hours per year.
(B) HF3—an average of 145 hours per year.
(C) HF5—an average of 360 hours per year.
(D) HF6—an average of 2,099 hours per year.
(iv) VHF:
(A) VHF2—an average of 35 hours per year.
(v) ASW:
(A) ASW1—an average of 16 hours per year.
(B) ASW2—an average of 64 hours per year.
(C) ASW2—an average of 170 items per year.
(D) ASW3—an average of 444 hours per year.
(E) ASW4—an average of 1,182 items per year.
(vi) Acoustic Modems (M):
(A) M3—an average of 1,519 hours per year.
(vii) Torpedoes (TORP):
(A) TORP1—an average of 315 items per year.
(B) TORP2—an average of 299 items per year.
(viii) Swimmer Detection Sonar (SD):
(A) SD1—an average of 757 hours per year.
(ix) Synthetic Aperture Sonar (SAS):
(A) SAS2—an average of 798 hours per year.
(3) Impulsive Source Detonations During Training:
(i) Explosive Classes:
(A) E1 (0.1 to 0.25 pound [lb] NEW)—an average of 48 detonations per year.
(B) E3 (>0.5 to 2.5 lb NEW)—an average of 6 detonations per year.
(C) E5 (>5 to 10 lb NEW)—an average of 80 detonations per year.
(D) E10 (>250 to 500 lb NEW)—an average of 4 detonations per year.
(E) E12 (>650 to 1,000 lb NEW)—an average of 10 detonations per year.
(ii) [Reserved].
(4) Impulsive Source Detonations During Testing:
(i) Explosive Classes:
(A) E3 (>0.5 to 2.5 lb NEW)—an average of 72 detonations per year.
(B) E4 (>2.5 to 5 lb NEW)—an average of 70 detonations per year.
(C) E8 (>60 to 100 lb NEW)—an average of 3 detonations per year.
(ii) [Reserved]
Regulations in this subpart are effective June 2, 2015 through June 2, 2020.
(a) Under Letters of Authorization (LOAs) issued pursuant to § 218.147, the Holder of LOA may incidentally, but not intentionally, take marine mammals within the area described in § 218.140, provided the activity is in compliance with all terms, conditions, and requirements of these regulations and the appropriate LOA.
(b) The activities identified in § 218.140(c) must be conducted in a manner that minimizes, to the greatest extent practicable, any adverse impacts on marine mammals and their habitat.
(c) The incidental take of marine mammals under the activities identified in § 218.140(c) is limited to the following species, by the identified method of take and the indicated number of times:
(1) Level B Harassment for all Training Activities:
(i) Mysticetes:
(A) Blue whale (Balaenoptera musculus)—25 (an average of 5 per year).
(B) Fin whale (Balaenoptera physalus)—125 (an average of 25 per year).
(C) Gray whale (Eschrichtius robustus)—30 (an average of 6 per year).
(D) Humpback whale (Megaptera novaeangliae)—60 (an average of 12 per year).
(E) Minke whale (Balaenoptera acutorostrata)—90 (an average of 18 per year).
(ii) Odontocetes:
(A) Baird's beaked whale (Berardius bairdii)—2,955 (an average of 591 per year).
(B) Mesoplodont beaked whale Mesoplodon spp.)—7,085 (an average of 1,417 per year).
(C) Cuvier's beaked whale Ziphius cavirostris—1,765 (an average of 353 per year).
(D) Dall's porpoise Phocoenoidea dalli—18,188 (an average of 3,732 per year).
(E) Harbor porpoise Phocoena phocoena—441,984 (an average of 88,932 per year).
(F) Killer whale Orcinus orca—110 (an average of 24 per year).
(G) Kogia spp.—365 (an average of 73 per year).
(H) Northern right whale dolphin Lissodelphis borealis—6,660 (an average of 1,332 per year).
(I) Pacific white-sided dolphin Lagenorhynchus obliquidens—17,408 (an average of 3,482 per year).
(J) Risso's dolphin Grampus griseus—3,285 (an average of 657 per year).
(K) Short-beaked common dolphin Delphinus delphis—3,670 (an average of 734 per year).
(L) Sperm whale Physeter macrocephalus—405 (an average of 81 per year).
(M) Striped dolphin Stenella coerulealba—110 (an average of 22 per year).
(iii) Pinnipeds:
(A) California sea lion Zalophus californianus—4,038 (an average of 814 per year).
(B) Steller sea lion Eumetopias jubatus—1,986 (an average of 404 per year).
(C) Guadalupe fur seal Arctocephalus townsendi—35 (an average of 7 per year).
(D) Harbor seal Phoca vitulina—4,161 (an average of 832 per year).
(E) Northern elephant seal Mirounga angustirostris—6,353 (an average of 1,271 per year).
(F) Northern fur seal Callorhinus ursinus—12,660 (an average of 2,532 per year).
(2) Level A Harassment for all Training Activities:
(i) Mysticetes:
(A) [Reserved]
(B) [Reserved]
(ii) Odontocetes:
(A) Dall's porpoise (Phocoenoidea dalli)—20 (an average of 4 per year).
(B) Harbor porpoise (Phocoena phocoena)—5 (an average of 1 per year).
(iii) Pinnipeds:
(A) Harbor seal (Phoca vitulina)—30 (an average of 6 per year).
(B) [Reserved]
(3) Level B Harassment for all Testing Activities:
(i) Mysticetes:
(A) Blue whale (Balaenoptera musculus)—30 (an average of 6 per year).
(B) Fin whale (Balaenoptera physalus)—180 (an average of 36 per year).
(C) Gray whale (Eschrichtius robustus)—55 (an average of 11 per year).
(D) Humpback whale (Megaptera novaeangliae)—225 (an average of 45 per year).
(E) Minke whale (Balaenoptera acutorostrata)—90 (an average of 18 per year).
(F) Sei whale (Balaenoptera borealis)—10 (an average of 2 per year).
(ii) Odontocetes:
(A) Baird's beaked whale (Berardius bairdii)—870 (an average of 174 per year).
(B) Mesoplodont beaked whale (Mesoplodon spp.)—1,845 (an average of 369 per year).
(C) Cuvier's beaked whale (Ziphius cavirostris)—530 (an average of 106 per year).
(D) Dall's porpoise (Phocoenoidea dalli)—56,695 (an average of 11,339 per year).
(E) Harbor porpoise (Phocoena phocoena)—246,465 (an average of 49,293 per year).
(F) Killer whale (Orcinus orca)—1, 130 (an average of 226 per year).
(G) Kogia spp.—530 (an average of 106 per year).
(H) Northern right whale dolphin (Lissodelphis borealis)—10 (an average of 2,038 per year).
(I) Pacific white-sided dolphin (Lagenorhynchus obliquidens)—24,360 (an average of 4,872 per year).
(J) Risso's dolphin (Grampus griseus)—5,770 (an average of 1,154 per year).
(K) Short-beaked common dolphin (Delphinus delphis)—8,140 (an average of 1,628 per year).
(L) Sperm whale (Physeter macrocephalus)—390 (an average of 78 per year).
(M) Striped dolphin (Stenella coerulealba)—70 (an average of 14 per year).
(iii) Pinnipeds:
(A) California sea lion (Zalophus californianus)—10,365 (an average of 2,073 per year).
(B) Steller sea lion (Eumetopias jubatus)—2,520 (an average of 504 per year).
(C) Guadalupe fur seal (Arctocephalus townsendi)—15 (an average of 3 per year).
(D) Harbor seal (Phoca vitulina)—312,690 (an average of 62,538 per year).
(E) Northern elephant seal (Mirounga angustirostris)—6,625 (an average of 1,325 per year).
(F) Northern fur seal (Callorhinus ursinus)—9,285 (an average of 1,857 per year).
(4) Level A Harassment for all Testing Activities:
(i) Mysticetes:
(A) [Reserved]
(B) [Reserved]
(ii) Odontocetes:
(A) Kogia spp.—5 (an average of 1 per year).
(B) Dall' porpoise (Phocoenoidea dalli)—215 (an average of 43 per year).
(C) Harbor porpoise (Phocoena phocoena)—220 (an average of 44 per year).
(iii) Pinnipeds:
(A) Harbor seal (Phoca vitulina)—430 (an average of 86 per year).(B) Northern elephant seal (Mirounga angustirostris)—10 (an average of 2 per year).
(C) [Reserved]
Notwithstanding takings contemplated in § 218.142 and authorized by an LOA issued under §§ 216.106 and 218.147 of this chapter, no person in connection with the activities described in § 218.140 may:
(a) Take any marine mammal not specified in § 218.142(c);
(b) Take any marine mammal specified in § 218.142(c) other than by incidental take as specified in § 218.142(c);
(c) Take a marine mammal specified in § 218.142(c) if such taking results in more than a negligible impact on the species or stocks of such marine mammal; or
(d) Violate, or fail to comply with, the terms, conditions, and requirements of these regulations or an LOA issued under §§ 216.106 and 218.147.
(a) When conducting training and testing activities, as identified in § 218.140, the mitigation measures
(1)
(i) Lookouts positioned on surface ships will be dedicated solely to diligent observation of the air and surface of the water. Their observation objectives will include, but are not limited to, detecting the presence of biological resources and recreational or fishing boats, observing mitigation zones, and monitoring for vessel and personnel safety concerns.
(ii) Lookouts positioned ashore, in aircraft or on boats will, to the maximum extent practicable and consistent with aircraft and boat safety and training and testing requirements, comply with the observation objectives described in paragraph (a)(1)(i) of this section.
(iii) Lookout measures for non-impulsive sound:
(A) With the exception of vessels less than 65 ft (20 m) in length and the Littoral Combat Ship (and similar vessels which are minimally manned), ships using low-frequency or hull-mounted mid-frequency active sonar sources associated with anti-submarine warfare and mine warfare activities at sea will have two Lookouts at the forward position of the vessel. For the purposes of this rule, low-frequency active sonar does not include surface towed array surveillance system low-frequency active sonar.
(B) While using low-frequency or hull-mounted mid-frequency active sonar sources associated with anti-submarine warfare and mine warfare activities at sea, vessels less than 65 ft (20 m) in length and the Littoral Combat Ship (and similar vessels which are minimally manned) will have one Lookout at the forward position of the vessel due to space and manning restrictions.
(C) Ships conducting active sonar activities while moored or at anchor (including pierside or shore-based testing or maintenance) will maintain one Lookout.
(D) Small boats, range craft, minimally manned vessels, or aircraft conducting hull-mounted mid-frequency testing will employ one Lookout.
(E) Ships or aircraft conducting non-hull-mounted mid-frequency active sonar, such as helicopter dipping sonar systems, will maintain one Lookout.
(F) Surface ships or aircraft conducting high-frequency or non-hull-mounted mid-frequency active sonar activities associated with anti-submarine warfare and mine warfare activities at sea will have one Lookout.
(iv) Lookout measures for explosives and impulsive sound:
(A) Aircraft conducting improved extended echo ranging sonobuoy activities will have one Lookout.
(B) Aircraft conducting explosive sonobuoy activities using >0.5 to 2.5-lb net explosive weight (NEW) will have one Lookout.
(C) General mine countermeasure and neutralization activities involving positive control diver placed charges using >0.5 to 2.5 lb NEW will have a total of two Lookouts (one Lookout positioned in each of the two support vessels). All divers placing the charges on mines will support the Lookouts while performing their regular duties. The divers and Lookouts will report all marine mammal sightings to their dive support vessel.
(D) Surface vessels or aircraft conducting small- and medium-caliber gunnery exercises will have one Lookout. Towing vessels, if applicable, will also maintain one Lookout.
(E) Aircraft conducting missile exercises against a surface target will have one Lookout.
(F) Aircraft conducting explosive bombing exercises will have one Lookout and any surface vessels involved will have trained Lookouts.
(G) During explosive torpedo testing from aircraft one Lookout will be used and positioned in an aircraft. During explosive torpedo testing from a surface ship the Lookout procedures implemented for hull-mounted mid-frequency active sonar activities will be used.
(H) Ships conducting explosive and non-explosive large-caliber gunnery exercises will have one Lookout. This may be the same Lookout used for small, medium, and large-caliber gunnery exercises using a surface target when that activity is conducted from a ship against a surface target.
(v) Lookout measures for physical strike and disturbance:
(A) While underway, surface ships will have at least one Lookout.
(B) During activities using towed in-water devices towed from a manned platform, one Lookout will be used. During activities in which in-water devices are towed by unmanned platforms, a manned escort vessel will be included and one Lookout will be employed.
(C) Activities involving non-explosive practice munitions (
(D) During non-explosive bombing exercises one Lookout will be positioned in an aircraft and trained Lookouts will be positioned in any surface vessels involved.
(2)
(i) Mitigation zones will be measured as the radius from a source and represent a distance to be monitored.
(ii) Visual detections of marine mammals (or sea turtles) within a mitigation zone will be communicated immediately to a watch station for information dissemination and appropriate action.
(iii) Mitigation zones for non-impulsive sound:
(A) The Navy shall ensure that hull-mounted mid-frequency active sonar transmission levels are limited to at least 6 dB below normal operating levels if any detected marine mammals (or sea turtles) are within 1,000 yd. (914 m) of the sonar dome (the bow).
(B) The Navy shall ensure that hull-mounted mid-frequency active sonar transmissions are limited to at least 10 dB below the equipment's normal operating level if any detected marine mammals (or sea turtles) are within 500 yd. (457 m) of the sonar dome.
(C) The Navy shall ensure that hull-mounted mid-frequency active sonar transmissions are ceased if any detected cetaceans (or sea turtles) are within 200 yd. (180 m) and pinnipeds are within 100 yd. (90 m) of the sonar dome. Transmissions will not resume until the marine mammal has been observed exiting the mitigation zone, is thought to have exited the mitigation zone based on its course and speed, has not been detected for 30 minutes, the vessel has transited more than 2,000 yd. beyond the location of the last detection, or the Lookout concludes that dolphins are deliberately closing in on the ship to ride the ship's bow wave (and there are no other marine mammal sightings within the mitigation zone). Active transmission may resume when dolphins are bow riding because they are out of the main transmission axis of the active sonar while in the shallow-wave area of the ship bow. The pinniped mitigation zone does not apply for pierside or shore-based testing in the vicinity of pinnipeds hauled out on man-made structures and vessels.
(D) The Navy shall ensure that low-frequency active sonar transmission levels are ceased if any detected cetaceans (or sea turtles) are within 200 yd. (180 m) and pinnipeds are within 100 yd. (90 m) of the source. Transmissions will not resume until the marine mammal has been observed
(E) The Navy shall ensure that high-frequency and non-hull-mounted mid-frequency active sonar transmission levels are ceased if any detected cetaceans are within 200 yd. (180 m) and pinnipeds are within 100 yd. (90 m) of the source. Transmissions will not resume until the marine mammal has been observed exiting the mitigation zone, is thought to have exited the mitigation zone based on its course and speed, the mitigation zone has been clear from any additional sightings for a period of 10 minutes for an aircraft-deployed source, the mitigation zone has been clear from any additional sightings for a period of 30 minutes for a vessel-deployed source, the vessel or aircraft has repositioned itself more than 400 yd. (370 m) away from the location of the last sighting, or the vessel concludes that dolphins are deliberately closing in to ride the vessel's bow wave (and there are no other marine mammal sightings within the mitigation zone). The pinniped mitigation zone does not apply for pierside or shore-based testing in the vicinity of pinnipeds hauled out on man-made structures and vessels.
(iv) Mitigation zones for explosive and impulsive sound:
(A) For activities using IEERs, explosive detonations will cease if a marine mammal, sea turtle, or concentrations of floating vegetation are sighted within a 600-yd. (550 m) mitigation zone. Detonations will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 30 minutes.
(B) A mitigation zone with a radius of 350 yd. (320 m) shall be established for explosive signal underwater sonobuoys using >0.5 to 2.5 lb net explosive weight. Detonations will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 10 minutes.
(C) A mitigation zone with a radius of 400 yd. (366 m) shall be established for mine countermeasures and neutralization activities using positive control firing devices. Explosive detonations will cease if a marine mammal is sighted in the water portion of the mitigation zone (
(D) A mitigation zone with a radius of 200 yd. (180 m) shall be established for small- and medium-caliber gunnery exercises with a surface target. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, the mitigation zone has been clear from any additional sightings for a period of 10 minutes for a firing aircraft, the mitigation zone has been clear from any additional sightings for a period of 30 minutes for a firing ship, or the intended target location has been repositioned more than 400 yd. (370 m) away from the location of the last sighting.
(E) A mitigation zone with a radius of 600 yd. (550 m) shall be established for large-caliber gunnery exercises with a surface target. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 30 minutes.
(F) The Navy is not proposing to use missiles with less than a 251 lb NEW warhead in the NWTT Study Area. However, should the need arise to conduct training activities using missiles in this category, a mitigation zone with a radius of 2,000 yd. (1.8 km) shall be established for missile exercises with up to 250 lb net explosive weight and a surface target. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 10 minutes or 30 minutes (depending on aircraft type).
(G) A mitigation zone with a radius of 2,000 yd. (1.8 km) shall be established for missile exercises with 251 to 500 lb NEW using a surface target. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 10 minutes or 30 minutes (depending on aircraft type).
(H) A mitigation zone with a radius of 2,500 yd. (2.3 km) around the intended impact location for explosive bombs shall be established for bombing exercises. Bombing will cease if a marine mammal is sighted within the mitigation zone. Bombing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 10 minutes.
(I) A mitigation zone with a radius of 2,100 yd. (1.9 km) shall be established for torpedo (explosive) testing. Firing will cease if a marine mammal, sea turtle, or concentrations of floating vegetation are sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 10 minutes or 30 minutes (depending on aircraft type).
(iii) Mitigation zones for vessels and in-water devices:
(A) A mitigation zone of 500 yd. (460 m) for observed whales and 200 yd (183 m) for all other marine mammals (except bow riding dolphins) shall be established for all vessel movement during training activities, providing it is safe to do so. During testing activities, all range craft (vessels and aircraft, including helicopters) shall not approach within 100 yd. (90 m) of marine mammals.
(B) A mitigation zone of 250 yd. (230 m) shall be established for all towed in-water devices, providing it is safe to do so.
(vi) Mitigation zones for non-explosive practice munitions:
(A) A mitigation zone of 200 yd. (180 m) shall be established for small, medium, and large caliber gunnery exercises using a surface target. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and
(B) A mitigation zone of 1,000 yd. (920 m) shall be established for bombing exercises. Bombing will cease if a marine mammal is sighted within the mitigation zone. Bombing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 10 minutes.
(a) The Navy is required to cooperate with the NMFS, and any other Federal, state or local agency monitoring the impacts of the activity on marine mammals.
(b) General Notification of Injured or Dead Marine Mammals—Navy personnel shall ensure that NMFS is notified immediately (or as soon as clearance procedures allow) if an injured, stranded, or dead marine mammal is found during or shortly after, and in the vicinity of, any Navy training exercise utilizing MFAS, HFAS, or underwater explosive detonations. The Navy will provide NMFS with species or description of the animal(s), the condition of the animal(s) (including carcass condition if the animal is dead), location, time of first discovery, observed behaviors (if alive), and photo or video (if available). In the event that an injured, stranded, or dead marine mammal is found by the Navy that is not in the vicinity of, or during or shortly after, MFAS, HFAS, or underwater explosive detonations, the Navy will report the same information as listed above as soon as operationally feasible and clearance procedures allow.
(c) General Notification of Ship Strike—In the event of a ship strike by any Navy vessel, at any time or place, the Navy shall do the following:
(1) Immediately report to NMFS the species identification (if known), location (lat/long) of the animal (or the strike if the animal has disappeared), and whether the animal is alive or dead (or unknown)
(2) Report to NMFS as soon as operationally feasible the size and length of animal, an estimate of the injury status (ex., dead, injured but alive, injured and moving, unknown, etc.), vessel class/type and operational status.
(3) Report to NMFS the vessel length, speed, and heading as soon as feasible.
(4) Provide NMFS a photo or video, if equipment is available
(d) Event Communication Plan—The Navy shall develop a communication plan that will include all of the communication protocols (phone trees, etc.) and associated contact information required for NMFS and the Navy to carry out the necessary expeditious communication required in the event of a stranding or ship strike, including as described in the proposed notification measures above.
(e) The Navy must conduct all monitoring and/or research required under the Letter of Authorization including abiding by the NWTT Monitoring Plan (
(f) Annual NWTT Monitoring Plan Report—The Navy shall submit an annual report of the NWTT Monitoring Plan describing the implementation and results of the NWTT Monitoring Plan from the previous calendar year. Data collection methods will be standardized across range complexes and study areas to allow for comparison in different geographic locations. Although additional information will be gathered, the protected species observers collecting marine mammal data pursuant to the NWTT Monitoring Plan shall, at a minimum, provide the same marine mammal observation data required in § 218.145. The report shall be submitted either 90 days after the calendar year, or 90 days after the conclusion of the monitoring year to be determined by the Adaptive Management process.
The NWTT Monitoring Plan may be provided to NMFS within a larger report that includes the required Monitoring Plan reports from multiple range complexes and study areas (the multi-Range Complex Annual Monitoring Report). Such a report would describe progress of knowledge made with respect to monitoring plan study questions across all Navy ranges associated with the ICMP. Similar study questions shall be treated together so that progress on each topic shall be summarized across all Navy ranges. The report need not include analyses and content that does not provide direct assessment of cumulative progress on the monitoring plan study questions.
(g) Annual NWTT Exercise and Testing Reports—The Navy shall submit preliminary reports detailing the status of authorized sound sources within 21 days after the anniversary of the date of issuance of the LOA. The Navy shall submit detailed reports 3 months after the anniversary of the date of issuance of the LOA. The detailed annual reports shall describe the level of training and testing conducted during the reporting period, and a summary of sound sources used (total annual hours or quantity [per the LOA] of each bin of sonar or other non-impulsive source; total annual number of each type of explosive exercises; total annual expended/detonated rounds [missiles, bombs, etc.] for each explosive bin; and improved Extended Echo-Ranging System (IEER)/sonobuoy summary, including total number of IEER events conducted in the Study Area, total expended/detonated rounds (buoys), and total number of self-scuttled IEER rounds. The analysis in the detailed reports will be based on the accumulation of data from the current year's report and data collected from previous reports.
(h) 5-year Close-out Exercise and Testing Report—This report will be included as part of the 2020 annual exercise or testing report. This report will provide the annual totals for each sound source bin with a comparison to the annual allowance and the 5-year total for each sound source bin with a comparison to the 5-year allowance. Additionally, if there were any changes to the sound source allowance, this report will include a discussion of why the change was made and include the analysis to support how the change did or did not result in a change in the SEIS and final rule determinations. The report will be submitted 3 months after the expiration of the rule. NMFS will submit comments on the draft close-out report, if any, within 3 months of receipt. The report will be considered final after the Navy has addressed NMFS' comments, or 3 months after the submittal of the draft if NMFS does not provide comments.
To incidentally take marine mammals pursuant to the regulations in this subpart, the U.S. citizen (as defined by § 216.106) conducting the activity identified in § 218.140(c) (the U.S. Navy) must apply for and obtain either an initial LOA in accordance with § 218.147 or a renewal under § 218.148.
(a) An LOA, unless suspended or revoked, will be valid for a period of time not to exceed the period of validity of this subpart.
(b) Each LOA will set forth:
(1) Permissible methods of incidental taking;
(2) Means of effecting the least practicable adverse impact on the species, its habitat, and on the availability of the species for subsistence uses (
(3) Requirements for mitigation, monitoring and reporting.
(c) Issuance and renewal of the LOA will be based on a determination that the total number of marine mammals taken by the activity as a whole will have no more than a negligible impact on the affected species or stock of marine mammal(s).
(a) A Letter of Authorization issued under §§ 216.106 and 218.147 of this chapter for the activity identified in § 218.140(c) will be renewed or modified upon request of the applicant, provided that:
(1) The proposed specified activity and mitigation, monitoring, and reporting measures, as well as the anticipated impacts, are the same as those described and analyzed for these regulations (excluding changes made pursuant to the adaptive management provision of this chapter), and;
(2) NMFS determines that the mitigation, monitoring, and reporting measures required by the previous LOA under these regulations were implemented.
(b) For LOA modification or renewal requests by the applicant that include changes to the activity or the mitigation, monitoring, or reporting (excluding changes made pursuant to the adaptive management provision of this chapter) that do not change the findings made for the regulations or result in no more than a minor change in the total estimated number of takes (or distribution by species or years), NMFS may publish a notice of proposed LOA in the
(c) An LOA issued under § 216.106 and § 218.147 of this chapter for the activity identified in § 218.144 of this chapter may be modified by NMFS under the following circumstances:
(1) Adaptive Management—NMFS may modify (including augment) the existing mitigation, monitoring, or reporting measures (after consulting with the Navy regarding the practicability of the modifications) if doing so creates a reasonable likelihood of more effectively accomplishing the goals of the mitigation and monitoring set forth in the preamble for these regulations.
(i) Possible sources of data that could contribute to the decision to modify the mitigation, monitoring, and reporting measures in an LOA:
(A) Results from Navy's monitoring from the previous year(s);
(B) Results from other marine mammal and/or sound research or studies; or
(C) Any information that reveals marine mammals may have been taken in a manner, extent, or number not authorized by these regulations or subsequent LOAs.
(ii) If, through adaptive management, the modifications to the mitigation, monitoring, or reporting measures are substantial, NMFS would publish a notice of proposed LOA in the
(2) Emergencies—If NMFS determines that an emergency exists that poses a significant risk to the well-being of the species or stocks of marine mammals specified in § 218.142(c), an LOA may be modified without prior notification and an opportunity for public comment. Notification would be published in the
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Collection | Federal Register | |
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