| Page Range | 19007-19192 | |
| FR Document |
| Page and Subject | |
|---|---|
| 80 FR 19189 - National Public Health Week, 2015 | |
| 80 FR 19099 - In the Matter of AuraSound, Inc., C2C CrowdFunding, Inc., Convenience TV Inc., Global Security Agency Inc., and NewMarket Technology, Inc., Order of Suspension of Trading | |
| 80 FR 19096 - In the Matter of Chatter Box Call Center Ltd., Euro Group of Companies, Inc., and Golden Century Resources Limited; Order of Suspension of Trading | |
| 80 FR 19097 - In the Matter of China Education International, Inc., Delta Entertainment Group Inc., and Gulf United Energy, Inc.; Order of Suspension of Trading | |
| 80 FR 19096 - Temporary Emergency Committee of the Board of Governors; Sunshine Act Meeting | |
| 80 FR 19070 - Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Notice of Final Results of Changed Circumstances Review | |
| 80 FR 19073 - Certain Cased Pencils From the People's Republic of China: Final Results of Antidumping Duty Changed Circumstances Review | |
| 80 FR 19110 - Notice of Intent To Rule on Request To Release Airport Property at the Former Stapleton International Airport, Denver, Colorado | |
| 80 FR 19109 - Notice of Intent To Rule on Request To Release Airport Property at the Former Stapleton International Airport, Denver, Colorado | |
| 80 FR 19106 - Notice of Intent to Rule on Request to Release Airport Property at the Former Stapleton International Airport, Denver, Colorado | |
| 80 FR 19085 - Announcement of the Board of Directors for the National Environmental Education Foundation | |
| 80 FR 19084 - Pesticide Product Registration; Receipt of Applications for New Active Ingredients | |
| 80 FR 19072 - Purified Carboxymethylcellulose From Finland; Preliminary Results of Antidumping Duty Administrative Review; 2013-2014 | |
| 80 FR 19069 - Solid Urea From the Russian Federation: Preliminary Results of Antidumping Duty Administrative Review; 2013-2014 | |
| 80 FR 19105 - Notice of Intent To Rule on Request To Release Airport Property at the Former Stapleton International Airport, Denver, Colorado | |
| 80 FR 19034 - Fisheries off West Coast States; Pacific Coast Groundfish Fishery; Trawl Rationalization Program; Midwater Trawl Fishery Season Date Change | |
| 80 FR 19079 - Proposed Consent Decree, Clean Air Act Citizen Suit | |
| 80 FR 19075 - Mid-Atlantic Fishery Management Council (MAFMC); Fisheries of the Northeastern United States; Public Meeting | |
| 80 FR 19093 - Zion Solutions, LLC; Zion Nuclear Power Station, Unit Nos. 1 and 2 | |
| 80 FR 19076 - 36(b)(1) Arms Sales Notification | |
| 80 FR 19102 - Agency Information Collection Activities: Proposed Request and Comment Request | |
| 80 FR 19059 - 2015 Rates Charged for AMS Services | |
| 80 FR 19092 - Tetrahydrofurfuryl Alcohol From China: Determination | |
| 80 FR 19059 - National Organic Standards Board (NOSB): Call for Nominations | |
| 80 FR 19105 - Notice of Public Meeting of the President's Emergency Plan for AIDS Relief (PEPFAR) Scientific Advisory Board | |
| 80 FR 19087 - Food and Drug Administration Science Forum 2015; Public Workshop | |
| 80 FR 19109 - Petition for Exemption; Summary of Petition Received | |
| 80 FR 19065 - Agency Information Collection Activities; Proposed Collection; Comment Request; Supplemental Nutrition Assistance Program, Request for Administrative Review; Food Retailers and Wholesalers | |
| 80 FR 19086 - Agency Information Collection Activities; Submission for OMB Review; Comment Request | |
| 80 FR 19090 - Proposed Collection; 60-Day Comment Request: United States and Global Human Influenza Surveillance in at-Risk Settings | |
| 80 FR 19114 - Pipeline Safety: Potential for Damage to Pipeline Facilities Caused by Flooding, River Scour, and River Channel Migration | |
| 80 FR 19116 - Notice of Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits Filed Under Subpart B (formerly Subpart Q) During the Week Ending March 28, 2015. | |
| 80 FR 19092 - Proposed Information Collection: Use of iNaturalist by the National Park Service To Record Natural History Observations | |
| 80 FR 19068 - Notice of National Advisory Council on Innovation and Entrepreneurship Meeting | |
| 80 FR 19091 - Notice of Public Meeting; Western Montana Resource Advisory Council | |
| 80 FR 19112 - Notice of Final Federal Agency Actions on Proposed Highway in Texas | |
| 80 FR 19087 - Agency Forms Undergoing Paperwork Reduction Act Review; Withdrawal | |
| 80 FR 19111 - Notice of Intent to Prepare a Tier I Environmental Impact Statement: Dane County, Wisconsin | |
| 80 FR 19105 - Social Security Ruling, SSR 15-1p; Titles II and XVI: Evaluating Cases Involving Interstitial Cystitis (IC); Correction | |
| 80 FR 19065 - Information Collection; National Woodland Owner Survey | |
| 80 FR 19088 - Center for Scientific Review; Notice of Closed Meetings | |
| 80 FR 19089 - National Institute on Aging; Notice of Closed Meetings | |
| 80 FR 19088 - National Cancer Institute; Notice of Closed Meetings | |
| 80 FR 19090 - National Cancer Institute Amended; Notice of Meeting | |
| 80 FR 19089 - National Eye Institute; Notice of Meeting | |
| 80 FR 19067 - Information Collection; Understanding Value Trade-offs Regarding Fire Hazard Reduction Programs in the Wildland-Urban Interface | |
| 80 FR 19111 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Aircraft Registration Renewal | |
| 80 FR 19108 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Aviation Insurance | |
| 80 FR 19108 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Certification of Airports | |
| 80 FR 19107 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Survey of Airman Satisfaction With Aeromedical Certification Services | |
| 80 FR 19107 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Pilot Certification and Qualification Requirements for Air Carrier Operations | |
| 80 FR 19113 - Pipeline Safety: Public Workshop on Pipeline Safety Management Systems | |
| 80 FR 19097 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 4.3, Record of Written Complaints | |
| 80 FR 19099 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding Rule 4758 | |
| 80 FR 19102 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Withdrawal of a Proposed Rule Change, as Modified by Partial Amendment No. 1 and Partial Amendment No. 2, Amending Rule 13-Equities and Related Rules Governing Order Types and Modifiers | |
| 80 FR 19096 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Withdrawal of a Proposed Rule Change, as Modified by Partial Amendment No. 1, Amending Rule 13 and Related Rules Governing Order Types and Modifiers | |
| 80 FR 19108 - Research, Engineering and Development Advisory Committee; Meeting | |
| 80 FR 19092 - Submission for OMB Review; Comment Request | |
| 80 FR 19090 - Notice of Public Meeting on the Proposed Revised Guidelines for Implementing Executive Order 11988, Floodplain Management, as Revised Through the Federal Flood Risk Management Standard | |
| 80 FR 19094 - Privacy Act of 1974; Computer Matching Program | |
| 80 FR 19068 - Notice of Public Meeting of the Mississippi Advisory Committee for a Meeting To Hear Testimony on Civil Rights Concerns Relating to Distribution of Federal Child Care Subsidies in Mississippi | |
| 80 FR 19075 - Proposed Information Collection; Comment Request; Permitting, Vessel Identification, and Reporting Requirements for the Pelagic Squid Jig Fishery in the Western Pacific Region | |
| 80 FR 19074 - Proposed Information Collection; Comment Request; Pacific Islands Region Coral Reef Ecosystems Permit Form | |
| 80 FR 19050 - Endangered and Threatened Wildlife and Plants; 4(d) Rule for the Georgetown Salamander | |
| 80 FR 19078 - Combined Notice of Filings #1 | |
| 80 FR 19064 - Agency Information Collection Activities: Proposed Collection; Comment Request-School Breakfast Program | |
| 80 FR 19037 - Modification of Significant New Uses of Certain Chemical Substances | |
| 80 FR 19056 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources in the Gulf of Mexico and Atlantic Region; Framework Amendment | |
| 80 FR 19080 - Inquiry To Learn Whether Businesses Assert Business Confidentiality Claims Regarding Waste Import and Export | |
| 80 FR 19159 - Amendments to Registration of Food Facilities | |
| 80 FR 19007 - Changes to Existing Conservation Program Regulations | |
| 80 FR 19020 - Approval and Promulgation of Implementation Plans; New Mexico; Transportation Conformity and Conformity of General Federal Actions | |
| 80 FR 19020 - Revisions to the California State Implementation Plan; San Joaquin Valley Unified Air Pollution Control District; Quantification of Emission Reductions From Incentive Programs | |
| 80 FR 19009 - Airworthiness Directives; Airbus Airplanes | |
| 80 FR 19017 - Airworthiness Directives; Cessna Aircraft Company Airplanes | |
| 80 FR 19013 - Airworthiness Directives; Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Airplanes | |
| 80 FR 19117 - Deepwater Ports |
Agricultural Marketing Service
Food and Nutrition Service
Forest Service
Natural Resources Conservation Service
Economic Development Administration
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Land Management Bureau
National Park Service
Federal Aviation Administration
Federal Highway Administration
Pipeline and Hazardous Materials Safety Administration
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.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Natural Resources Conservation Service (NRCS) and the Commodity Credit Corporation (CCC), United States Department of Agriculture (USDA).
Final rule.
The Agricultural Act of 2014 (the 2014 Act) made several nondiscretionary changes to NRCS conservation programs. These conservation programs have existing regulations that required adjustments. These adjustments include addressing the required review of operating procedures of the State Technical Committee, adding reference of the Regional Conservation Partnership Program (RCPP) to the Watershed Protection and Flood Prevention Act program regulations, adding reference of RCPP to the Healthy Forests Reserve Program (HFRP), expanding the definition of “acreage owned by Indian Tribes” under HFRP, revising and simplifying the Regional Equity provision, and adjusting the Agricultural Management Assistance (AMA) Program to correspond with changes to payment provisions under the Environmental Quality Incentives Program (EQIP). Additionally, the Secretary of Agriculture delegated to NRCS administrative responsibility for implementing the Voluntary Public Access and Habitat Incentive Program (VPA-HIP), and internal NRCS administrative changes warrant updating the appropriate delegated official in the Technical Service Provider (TSP) provision. NRCS published an interim rule with a request for comments on August 1, 2014, to implement changes to these NRCS conservation program regulations that were either necessitated by enactment of the 2014 Act, or required to implement administrative streamlining improvements and clarifications. NRCS received six comments on the interim rule. In this document, NRCS issues a final rule to make permanent these changes and to incorporate two minor mandatory changes in two of the affected parts.
This rule is effective April 9, 2015.
Leslie Deavers, NRCS Farm Bill Coordinator, USDA, NRCS, Post Office Box 2890, Washington, DC 20013-2890; telephone: (202) 720-4531; fax: (202) 720-2998; email:
Persons with disabilities who require alternate means for communication (Braille, large print, audio tape, etc.) should contact the USDA Technology and Accessible Resources Give Employment Today (TARGET) Center at: (202) 720-2600 (voice and TDD).
This rule contains no Federal mandates, as defined under Title II of the UMRA, for State, local, and Tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of UMRA.
• NRCS amended 7 CFR 610.24 to update the list of Title XII programs to which the State Technical Committee Rule applies.
• NRCS amended HFRP regulation at 7 CFR 625.2 to adjust the regulatory definition of “acreage owned by Indian Tribes” to conform with the new statutory definition of the term in Section 502(e)(3) of the Healthy Forests Restoration Act, as amended by section 8203 of the 2014 Act.
• NRCS amended HFRP and the Watershed Operations regulation at 7 CFR part 622 to incorporate their status as programs used in the implementation of RCPP.
• NRCS updated subpart C of the TSP rule at 7 CFR part 652 to designate the Deputy Chief for Programs as the decertification official for TSPs.
• NRCS removed the regional equity rule, formerly at 7 CFR part 662, from the Code of Federal Regulations.
• NRCS amended the rule for VPA-HIP at 7 CFR part 1455 to reflect the transfer of the program's administration from the Administrator of the Farm Service Agency (FSA) to the Chief of NRCS.
• NRCS amended the rule governing the AMA Program (7 CFR part 1465) to maintain consistency with the EQIP program.
NRCS solicited comments on the interim final rule for 60 days ending September 30, 2014. Six comments were received on the rule. Overall, the commenters supported the changes made by the interim rule. This final rule makes only technical and clarifying changes to language adopted in the interim rule, and adds one additional mandatory change to reflect a change made by the 2014 Act to EWPP implementation of floodplain easements.
Additional Clarification Added to VPA-HIP (7 CFR part 1455): VPA-HIP is authorized by section 1240R of the 1985 Act. VPA-HIP provides, within funding limits, grants to State and Tribal governments to encourage owners and operators of privately held farm, ranch,
Discussion of EWPP (7 CFR part 624): NRCS purchases floodplain easements to restore, protect, maintain, and enhance the functions of the floodplain; conserve natural values including fish and wildlife habitat, water quality, flood water retention, ground water recharge, and open space; reduce long-term Federal disaster assistance; and safeguard lives and property from floods, drought, and the products of erosion. Section 382 of the Federal Agriculture Improvement and Reform Act of 1996 amended EWPP, 16 U.S.C. 2203, to authorize the purchase of floodplain easements (FPE) as an emergency measure on lands that qualify for EWPP assistance. EWPP FPEs are administered under 7 CFR part 624.
Prior to the 2014 Act, the EWPP-FPE statute did not address modification or termination of FPEs; therefore the regulations at 7 CFR part 624 specified that FPEs could not be modified or terminated. Section 2206 of the 2014 Act provided such authority, and NRCS is removing this prohibition from EWPP regulations.
Soil conservation, State Technical Committees, Technical assistance, and Water resources.
Watershed projects, Watershed protection, and Flood prevention.
Disaster assistance, Floodplain easement, Flooding, Imminent threat, Natural disaster, and Watershed impairment.
Administrative practice and procedure, Agriculture, and Soil conservation.
NRCS, Soil conservation, and Technical assistance.
Administrative practice and procedure, Agriculture, and Soil conservation.
Agriculture, Animals, Environmental protection, Fishing, Forests and forest products, Grant programs, Hunting, Indians, Indians-land, Natural resources, Recreation and recreation areas, Rural areas, State and local governments, and Wildlife.
Conservation contract, Conservation plan, Conservation practices, and Soil and water conservation.
Accordingly, the interim rule amending 7 CFR parts 610, 622, 625, 652, 662, 1455, and 1465 which was published at 79 FR 44635 on August 1, 2014, is adopted as a final rule with the following changes:
Sec. 216, Pub. L. 81-516, 33 U.S.C. 701b-1; Sec. 403, Pub. L. 95-334, as amended, 16 U.S.C. 2203; 5 U.S.C. 301.
(c) The Chief of NRCS may modify or terminate an easement if, pursuant to 16 U.S.C. 2203(b), the Chief determines the modification or termination is in the public interest and will address a compelling public need for which there is no practicable alternative.
15 U.S.C. 714b and 714c; 16 U.S.C. 3839.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Airbus Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R, B4-622R, F4-605R, F4-622R, and C4-605R Variant F airplanes; and Model A310-203, -204, -221, -222, -304, -322, -324, and -325 airplanes. This AD was prompted by a report of inner skin disbonding damage on a rudder. This AD requires repetitive ultrasonic inspections for disbonding of certain rudders; an elasticity of laminate
This AD becomes effective May 14, 2015.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of May 14, 2015.
You may examine the AD docket on the Internet at
For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R, B4-622R, F4-605R, F4-622R, and C4-605R Variant F airplanes; and Model A310-203, -204, -221, -222, -304, -322, -324, and -325 airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2013-0039, dated February 26, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R, B4-622R, F4-605R, F4-622R, and C4-605R Variant F airplanes; and Model A310-203, -204, -221, -222, -304, -322, -324, and -325 airplanes. The MCAI states:
One A310 operator found substantial inner skin disbonding damage on a rudder that was previously inspected in accordance with the instructions of Airbus Service Bulletin (SB) A310-55-2044. The results of the subsequent investigation revealed that the most probable cause of this damage was a blunt impact with no visible damage from outside during the rudder handling. Damage like this might grow with pressure variation during ground-air-ground cycles, and tests performed with other rudders showed a rapid propagation of damage during artificial pressure cycling.
This condition, if not detected and corrected, could affect the structural integrity of the rudder.
To address this potential unsafe condition, Airbus issued Alert Operators Transmission (AOT) A55W002-12 [dated December 13, 2012], pending Aircraft Maintenance Manual (AMM) 27-21-21 PB401 revision to update rudder handling procedures.
For the reasons described above, this [EASA] AD requires ultrasonic test (UT) inspections of the affected rudders to detect signs of disbonding and, depending on findings, accomplishment of applicable corrective action(s).
Required actions also include an elasticity of laminate checker inspection to detect external and internal disbonding, and a woodpecker or tap test inspection to detect external disbonding. You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (79 FR 11355, February 28, 2014) and the FAA's response to each comment.
Airbus requested that we revise paragraph (g) of the NPRM (79 FR 11355, February 28, 2014) to mirror the language in Airbus Alert Operators Transmission (AOT) A55W002-12, dated December 13, 2012, which takes into account whether or not the rudder has been removed and/or installed since the last inspection. Airbus stated that the removal/installation process is linked to the risk of the unseen damage occurring to the rudder. Airbus suggested revised language for a requirement to determine if the rudder has been removed or installed since the last inspection.
In addition, FedEx requested that we revise paragraph (c) or (g) of the NPRM (79 FR 11355, February 28, 2014) to state that, if the installed rudder has been inspected (and not removed) per AD 2008-11-05, Amendment 39-15527 (73 FR 29423, May 21, 2008), since its installation, no further inspection will be required since the unsafe condition would be alleviated.
UPS, FedEx, and Airbus requested that we revise the NPRM (79 FR 11355, February 28, 2014) to eliminate unnecessary AD tracking requirements. UPS noted that the identified risk only exists in cases where the rudder has been changed since inspection under AD 2008-11-05, Amendment 39-15527 (73 FR 29423, May 21, 2008). UPS further stated that the NPRM does not refer to AD 2008-11-05, even though the repetitive ultrasonic inspections to detect disbonding in the NPRM are identical to the requirements of paragraph (f)(2) of AD 2008-11-05. Also, UPS stated that the airplane maintenance manual (AMM) has been updated as of June 1, 2013, to include the same ultrasonic inspection specified in both AD 2008-11-05 and the NPRM. UPS suggested revised wording for the NPRM.
We concur with the requests to limit the airplanes subject to the requirements of paragraph (g) of this AD. This AD does relate to AD 2008-11-05 (73 FR 29423, dated May 21, 2008), in that the ultrasonic inspections are required in both ADs. This AD requires the ultrasonic inspections for only certain airplanes. Therefore, we have added a new paragraph (h)(2) in this AD. Paragraph (h)(2) of this AD specifies that, for airplanes on which it can be conclusively determined that the most recent inspection specified in Airbus Service Bulletin A310-55-2044 or Airbus Service Bulletin A300-55-6043 was done on the airplane; or the rudder was not removed for any reason since doing the most recent inspection specified in Airbus Service Bulletin A310-55-2044 or Airbus Service Bulletin A300-55-6043; no further action is necessary, except as specified in paragraphs (j) and (k) of this AD.
We have also re-designated paragraphs (h), (h)(1), and (h)(2) of the NPRM as paragraphs (h)(1), (h)(1)(i), and (h)(1)(ii) of this AD, respectively.
UPS requested that we revise the NPRM (79 FR 11355, February 28, 2014)
We concur with the commenter's request to remove from this AD the requirement that repair approvals must specifically refer to this AD. Since late 2006, we have included a standard paragraph titled “Airworthy Product” in all MCAI ADs in which the FAA develops an AD based on a foreign authority's AD. The MCAI or referenced service information in an FAA AD often directs the owner/operator to contact the manufacturer for corrective actions, such as a repair. Briefly, the Airworthy Product paragraph allowed owners/operators to use corrective actions provided by the manufacturer if those actions were FAA-approved. In addition, the paragraph stated that any actions approved by the State of Design Authority (or its delegated agent) are considered to be FAA-approved.
In the NPRM (79 FR 11355, February 28, 2014), we proposed to prevent the use of repairs that were not specifically developed to correct the unsafe condition, by requiring that the repair approval provided by the State of Design Authority or its delegated agent specifically refer to this FAA AD. This change was intended to clarify the method of compliance and to provide operators with better visibility of repairs that are specifically developed and approved to correct the unsafe condition. In addition, we proposed to change the phrase “its delegated agent” to include “the Design Approval Holder (DAH) with a State of Design Authority's design organization approval (DOA)” to refer to a DAH authorized to approve required repairs for the AD.
In its comments to the NPRM (79 FR 11355, February 28, 2014), UPS stated the following: “The proposed wording, being specific to repairs, eliminates the interpretation that Airbus messages or other approved EASA documents are acceptable for approving minor deviations (corrective actions) needed during accomplishment of a[n AD] mandated Airbus service bulletin.”
This comment has made the FAA aware that some operators have misunderstood or misinterpreted the Airworthy Product paragraph to allow the owner/operator to use messages provided by the manufacturer as approval of deviations during the accomplishment of an AD-mandated action. The Airworthy Product paragraph does not approve messages or other information provided by the manufacturer for deviations to the requirements of the AD-mandated actions. The Airworthy Product paragraph only addresses the requirement to contact the manufacturer for corrective actions for the identified unsafe condition and does not cover deviations from other AD requirements. However, deviations to AD-required actions are addressed in 14 CFR 39.17, and anyone may request the approval for an alternative method of compliance to the AD-required actions using the procedures found in 14 CFR 39.19.
To address this misunderstanding and misinterpretation of the Airworthy Product paragraph, we have changed that paragraph and retitled it “Contacting the Manufacturer.” This paragraph now clarifies that for any requirement in this AD to obtain corrective actions from a manufacturer, the actions must be accomplished using a method approved by the FAA, EASA, or Airbus's EASA DOA.
The Contacting the Manufacturer paragraph also clarifies that, if approved by the DOA, the approval must include the DOA-authorized signature. The DOA signature indicates that the data and information contained in the document are EASA-approved, which is also FAA-approved. Messages and other information provided by the manufacturer that do not contain the DOA-authorized signature approval are not EASA-approved, unless EASA directly approves the manufacturer's message or other information.
This clarification does not remove flexibility afforded previously by the Airworthy Product paragraph. Consistent with long-standing FAA policy, such flexibility was never intended for required actions. This is also consistent with the recommendation of the AD Implementation Aviation Rulemaking Committee to increase flexibility in complying with ADs by identifying those actions in manufacturers' service instructions that are “Required for Compliance” with ADs. We continue to work with manufacturers to implement this recommendation. But once we determine that an action is required, any deviation from the requirement must be approved as an alternative method of compliance.
Other commenters to another NPRM having Directorate Identifier 2012-NM-101-AD (78 FR 78285, December 26, 2013) pointed out that in many cases the foreign manufacturer's service bulletin and the foreign authority's MCAI may have been issued some time before the FAA AD. Therefore, the DOA may have provided U.S. operators with an approved repair, developed with full awareness of the unsafe condition, before the FAA AD is issued. Under these circumstances, to comply with the FAA AD, the operator would be required to go back to the manufacturer's DOA and obtain a new approval document, adding time and expense to the compliance process with no safety benefit.
Based on these comments, we removed the requirement from this AD that the DAH-provided repair specifically refer to this AD. Before adopting such a requirement in the future, the FAA will coordinate with affected DAHs and verify they are prepared to implement means to ensure that their repair approvals consider the unsafe condition addressed in an AD. Any such requirements will be adopted through the normal AD rulemaking process, including notice-and-comment procedures, when appropriate.
We have also decided not to include a generic reference to either the “delegated agent” or the “DAH with State of Design Authority design organization approval,” but instead we will provide the specific delegation approval granted by the State of Design Authority for the DAH.
In paragraph (g) of this AD, for airplanes on which the part number or serial number cannot be determined, we have revised the compliance time of “before further flight” to “within 3 months after the effective date of this AD.” This clarification corresponds to the compliance time in the MCAI. We have determined that extending the compliance time will provide an acceptable level of safety.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM (79 FR 11355, February 28, 2014) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 11355, February 28, 2014).
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
Airbus has issued AOT A55W002-12, dated December 13, 2012, including Inspection Flowchart. The service information describes, among other actions, procedures for an ultrasonic inspection along the Z-profile of the rudder side panel. This service information is reasonably available; see
We estimate that this AD affects 89 airplanes of U.S. registry. We also estimate that it would take about 10 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $75,650, or $850 per product.
We have received no definitive data that would enable us to provide a cost estimate for the on-condition actions specified in this AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will 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.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective May 14, 2015.
None.
This AD applies to the airplanes identified in paragraphs (c)(1) and (c)(2) of this AD, except airplanes on which modification 08827 has been embodied in production.
(1) Airbus Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R, B4-622R, F4-605R, F4-622R, and C4-605R Variant F airplanes, certificated in any category, all manufacturer serial numbers.
(2) Airbus Model A310-203, -204, -221, -222, -304, -322, -324, and -325 airplanes, certificated in any category, all manufacturer serial numbers.
Air Transport Association (ATA) of America Code 55; Stabilizers.
This AD was prompted by a report of inner skin disbonding damage on a rudder. We are issuing this AD to detect and correct rudder disbonding, which could affect the structural integrity of the rudder.
Comply with this AD within the compliance times specified, unless already done.
Within 3 months after the effective date of this AD, identify the rudder assembly part number (P/N) and serial number (S/N), in accordance with Airbus Alert Operators Transmission (AOT) A55W002-12, dated December 13, 2012, including Inspection Flowchart. If the part number or serial number cannot be determined, within 3 months after the effective date of this AD, identify the part number and serial number, in accordance with a method approved by either the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
(1) Except as provided by paragraph (h)(2) of this AD, if a rudder assembly part number starting with A55471500 is found during the inspection required by paragraph (g) of this AD, before further flight, do an ultrasonic (UT) inspection for damage (
(i) Do an elasticity of laminate checker inspection to detect external and internal disbonding of the rudder side panel along the Z-profile and in the booster area.
(ii) Do a woodpecker or tap test inspection to detect external disbonding of the rudder side panel along the Z-profile and in the booster area.
(2) For airplanes on which it can be conclusively determined that the most recent inspection specified in Airbus Service Bulletin A310-55-2044 or Airbus Service Bulletin A300-55-6043 was done on the airplane; or the rudder was not removed for any reason since doing the most recent inspection specified in Airbus Service Bulletin A310-55-2044 or Airbus Service Bulletin A300-55-6043: No further action is required by this AD, except as specified in paragraphs (j) and (k) of this AD.
(1) If any disbonding is confirmed during any inspection required by paragraphs (h)(1)(i) and (h)(1)(ii) of this AD, before further flight, repair as specified in paragraphs (i)(1)(i) and (i)(1)(ii) of this AD, as applicable.
(i) If disbonding is less than or equal to 50 millimeters (mm) in width and less than or equal to 150 mm in length, before further flight, vent the core, using a method approved by either the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA. Within 100 flight cycles after the UT inspection specified in paragraph (h) of this AD is done, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA.
(ii) If disbonding is greater than 50 mm in width or greater than 150 mm in length, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA.
(2) If liquid ingress is confirmed during any inspection required by paragraphs (h)(1)(i) and (h)(1)(ii) of this AD, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA.
If any rudder has been inspected as specified in Airbus Service Bulletin A300-55-6043, Revision 01, dated December 3, 2007; or A310-55-2044, Revision 01, dated December 3, 2007; as applicable; and has been removed and re-installed on any airplane after this inspection, that rudder must be re-inspected as required by paragraph (g) of this AD; and all applicable actions required by paragraphs (h) and (i) of this AD must be done.
As of the effective date of this AD, no person may install, on any airplane, a rudder assembly having a part number starting with A55471500, unless it has been inspected as required by paragraph (h) of this AD, and all applicable actions required by paragraph (i) of this AD have been done.
The following provisions also apply to this AD:
(1)
(2)
Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2013-0039, dated February 26, 2013, for related information. This MCAI may be found in the AD docket on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Alert Operators Transmission (AOT) A55W002-12, dated December 13, 2012, including Inspection Flowchart. The inspection flowchart attached to this AOT is referred to in the AOT as “Appendix 1”; however, the flowchart page does not identify itself as an appendix. While the inspection flowchart page does specify the AOT document number, it does not specify a revision level or an issue date.
(ii) Reserved.
(3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are superseding Airworthiness Directive (AD) 2011-09-03 for all Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 382, 382B, 382E, 382F, and 382G airplanes. AD 2011-09-03 required repetitive eddy current inspections to detect cracks in the center wing upper and lower rainbow fittings, and corrective actions if necessary; and repetitive replacement of rainbow fittings, which would extend the repetitive interval for the next inspection. This new AD requires reduced intervals for inspections of the upper rainbow fittings. This AD was prompted by analysis of in-service cracking, which has shown that a reduction in the inspection intervals is necessary for the upper rainbow fittings. We are issuing this AD to detect and correct fatigue cracking of the upper and lower rainbow fittings on the center wings, which could grow large and lead to the failure of the fitting and a catastrophic failure of the center wing.
This AD is effective May 14, 2015.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of May 14, 2015.
The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of May 26, 2011 (76 FR 22311, April 21, 2011).
For service information identified in this AD, contact Lockheed Martin Corporation/Lockheed Martin Aeronautics Company, Airworthiness
You may examine the AD docket on the Internet at
Carl Gray, Aerospace Engineer, Airframe Branch, ACE-117A, FAA, Atlanta Aircraft Certification Office (ACO), 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-5554; fax: 404-474-5606; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011). AD 2011-09-03 applied to all Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 382, 382B, 382E, 382F, and 382G airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (79 FR 55675, September 17, 2014) or on the determination of the cost to the public.
We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM (79 FR 55675, September 17, 2014) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 55675, September 17, 2014).
We reviewed Lockheed Martin Aeronautics Company Service Bulletin 382-57-82, Revision 6, including Appendixes A, B, and C, dated July 11, 2013. The service information describes procedures for repetitive eddy current inspections of the upper and lower rainbow fittings of the center wing; repetitive replacement of the upper and lower rainbow fittings; and related investigative and corrective actions. This service information is reasonably available; see
We estimate that this AD affects 14 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
This AD reduces the compliance times for the upper rainbow fitting inspections and adds no additional economic burden.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States,
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective May 14, 2015.
This AD replaces AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011).
This AD applies to all Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 382, 382B, 382E, 382F, and 382G airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by an analysis of in-service cracking that has shown that the rainbow fittings are susceptible to multiple site fatigue damage. We are issuing this AD to detect and correct fatigue cracking of the upper and lower rainbow fittings on the center wings, which could grow large and lead to the failure of the fitting and a catastrophic failure of the center wing.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011), with revised service information. Except as required by paragraph (m) of this AD, at the later of the times specified in paragraphs (g)(1) and (g)(2) of this AD: Do eddy current inspections to detect cracking of the center wing upper and lower rainbow fittings on the left and right side of the airplane. Do the actions in accordance with the Accomplishment Instructions of Lockheed Service Bulletin 382-57-82, Revision 4, including Appendixes A and B, dated May 20, 2009; or Lockheed Martin Aeronautics Company Service Bulletin 382-57-82, Revision 6, including Appendixes A and B, dated July 11, 2013. If any crack is found during the inspections required by this paragraph, before further flight, do the actions required by paragraph (k) of this AD. Doing the requirements of paragraph (m) of this AD terminates the requirements of this paragraph for the affected upper rainbow fitting only. As of the effective date of this AD, only use Lockheed Martin Aeronautics Company Service Bulletin 382-57-82, Revision 6, including Appendixes A and B, dated July 11, 2013, for accomplishing the actions specified in this paragraph.
(1) Before the accumulation of 15,000 total flight hours on the rainbow fitting.
(2) Within 365 days or 600 flight hours on the rainbow fitting after May 26, 2011, (the effective date of AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011)), whichever occurs first.
This paragraph restates the requirements of paragraph (h) of AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011), with a new exception. Except as required by paragraph (n) of this AD, repeat the inspection required by paragraph (g) of this AD at intervals not to exceed 3,600 flight hours on the center wing, until the rainbow fitting has accumulated 30,000 total flight hours. If any crack is found during the inspections required by this paragraph, before further flight, do the actions required by paragraph (k) of this AD. Doing the requirements of paragraph (n) of this AD terminates the requirements of this paragraph for the affected upper rainbow fitting only.
This paragraph restates the requirements of paragraph (i) of AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011), with revised service information. Before the accumulation of 30,000 flight hours on the rainbow fitting, or within 600 flight hours after May 26, 2011, (the effective date of AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011)), whichever occurs later: Replace the rainbow fitting with a new rainbow fitting, do all related investigative actions, and do all applicable corrective actions, in accordance with paragraph 2.C. of the Accomplishment Instructions of Lockheed Service Bulletin 382-57-82, Revision 4, including Appendix C, dated May 20, 2009, except as required by paragraph (l) of this AD; or Lockheed Martin Aeronautics Company Service Bulletin 382-57-82, Revision 6, including Appendix C, dated July 11, 2013, except as required by paragraph (l) of this AD. Replace the rainbow fitting thereafter at intervals not to exceed 30,000 flight hours. As of the effective date of this AD, only use Lockheed Martin Aeronautics Company Service Bulletin 382-57-82, Revision 6, including Appendix C, dated July 11, 2013, for accomplishing the actions specified in this paragraph.
This paragraph restates the requirements of paragraph (j) of AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011), with a new exception. For upper and lower rainbow fittings replaced in accordance with paragraph (i) or (k) of this AD: Except as required by paragraph (o) of this AD, do the eddy current inspections specified in paragraph (g) of this AD within 15,000 flight hours after doing the replacement and repeat the eddy current inspections specified in paragraph (h) of this AD thereafter at intervals not to exceed 3,600 flight hours until the rainbow fittings are replaced in accordance with paragraph (i) or (k) of this AD. Doing the requirements of paragraph (o) of this AD terminates the requirements of this paragraph for the affected upper rainbow fitting only.
This paragraph restates the requirements of paragraph (k) of AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011), with revised service information and revised references to inspection paragraphs. If, during any inspection required by paragraph (g), (h), (m), or (n) of this AD, any crack is detected in the rainbow fitting, before further flight, replace the rainbow fitting with a new rainbow fitting, do all related investigative actions, and do all applicable corrective actions, in accordance with Paragraph 2.C. of the Accomplishment Instructions of Lockheed Service Bulletin 382-57-82, Revision 4, including Appendix C, dated May 20, 2009, except as provided by paragraph (l) of this AD; or Lockheed Martin Aeronautics Company Service Bulletin 382-57-82, Revision 6, including Appendix C, dated July 11, 2013, except as required by paragraph (l) of this AD. As of the effective date of this AD, only use Lockheed Martin Aeronautics Company Service Bulletin 382-57-82, Revision 6, including Appendix C, dated July 11, 2013, for accomplishing the actions specified in this paragraph.
This paragraph restates the requirements of paragraph (l) of AD 2011-09-03, Amendment
At the applicable compliance time specified in paragraphs (m)(1) and (m)(2) of this AD, do eddy current inspections to detect cracking of the center wing upper rainbow fittings on the left and right side of the airplane. Do the actions in accordance with the Accomplishment Instructions of Lockheed Martin Aeronautics Company Service Bulletin 382-57-82, Revision 6, including Appendixes A and B, dated July 11, 2013. If any crack is found during the inspections required by this paragraph, before further flight, do the actions required by paragraph (k) of this AD. Doing the requirements of this paragraph terminates the requirements of paragraph (g) of this AD for that upper rainbow fitting only. Repeat the inspection thereafter at the interval required by paragraph (n) of this AD.
(1) For upper rainbow fittings that have accumulated less than 10,000 total flight hours as of the effective date of this AD, the compliance time is at the later of the times in paragraphs (m)(1)(i) and (m)(1)(ii) of this AD.
(i) Before the accumulation of 10,000 total flight hours.
(ii) Within 365 days or 600 flight hours after the effective date of this AD, whichever occurs first.
(2) For upper rainbow fittings that have accumulated 10,000 total flight hours or more, but less than 15,000 total flight hours as of the effective date of this AD, the compliance time is the earlier of the times specified in paragraphs (m)(2)(i) and (m)(2)(ii) of this AD.
(i) Within 365 days or 600 flight hours after the effective date of this AD, whichever occurs first.
(ii) Before the accumulation of 15,000 total flight hours on the rainbow fitting.
For upper rainbow fittings on which the requirements of paragraph (g), (h), or (m) of this AD were done, do the next inspection at the earlier of the times required in paragraphs (n)(1) and (n)(2) of this AD. Thereafter, repeat the inspection required by paragraph (m) of this AD at intervals not to exceed 2,500 flight hours until the upper rainbow fitting has accumulated 30,000 total flight hours. If any crack is found during the inspections required by this paragraph, before further flight, do the actions required by paragraph (k) of this AD. Doing an inspection required by this paragraph terminates the requirements of paragraph (h) of this AD for the affected upper rainbow fitting only.
(1) Within 3,600 flight hours since the last inspection done in accordance with paragraph (g), (h), or (m) of this AD, whichever occurs latest.
(2) At the later of the times specified in paragraphs (n)(2)(i) and (n)(2)(ii) of this AD.
(i) Within 2,500 flight hours after the last inspection done in accordance with paragraph (g), (h), or (m) of this AD, whichever occurs latest.
(ii) Within 365 days or 600 flight hours after the effective date of this AD, whichever occurs first.
For upper rainbow fittings replaced in accordance with paragraph (i) or (k) of this AD, do the inspection required by paragraph (m) of this AD at the earlier of the compliance times required in paragraph (o)(1) and (o)(2) of this AD. Repeat the inspection thereafter at intervals not to exceed 2,500 flight hours. Doing the inspections required by this paragraph terminates the requirements of paragraph (j) of this AD for the affected upper rainbow fitting only.
(1) At the later of the times in paragraphs (o)(1)(i) and (o)(1)(ii) of this AD. (i) Within 10,000 total flight hours on the upper rainbow fitting.
(ii) Within 365 days or 600 flight hours after the effective date of this AD, whichever occurs first.
(2) Within 15,000 total flight hours on the upper rainbow fitting.
The service information identified in paragraphs (p)(1)(i), (p)(1)(ii), (p)(1)(iii), (p)(2), and (p)(3) is not incorporated by reference in this AD.
(1) This paragraph provides credit for actions required by paragraphs (g), (h), (i), (j), and (k) of this AD, if those actions were performed before the effective date of this AD using the service information identified in paragraphs (p)(1)(i), (p)(1)(ii), and (p)(1)(iii) of this AD.
(i) Lockheed Service Bulletin 382-57-82, including Appendixes A and B, dated December 7, 2004.
(ii) Lockheed Service Bulletin 382-57-82, Revision 1, including Appendixes A and B, dated February 24, 2005.
(iii) Lockheed Service Bulletin 382-57-82, Revision 2, including Appendixes A and B, dated February 15, 2007.
(2) This paragraph restates paragraph (m) of AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011). This paragraph provides credit for actions required by paragraphs (g), (h), (i), (j), and (k) of this AD, if those actions were performed before May 26, 2011 (the effective date of AD 2011-09-03), using Lockheed Service Bulletin 382-57-82, Revision 3, including Appendixes A, B, and C, dated April 25, 2008.
(3) This paragraph provides credit for actions required by paragraphs (g), (h), (i), (j), (k), (m), (n), and (o) of this AD, if those actions were performed before the effective date of this AD using Lockheed Service Bulletin 382-57-82, Revision 5, including Appendixes A, B, and C, dated August 12, 2010.
(1) The Manager, Atlanta ACO, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (r)(2) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) AMOCs approved for AD 2011-09-03, Amendment 39-16665 (76 FR 22311, April 21, 2011), are approved as AMOCs for the corresponding provisions of this AD.
(1) For more information about this AD, contact Carl Gray, Aerospace Engineer, Airframe Branch, ACE-117A, FAA, Atlanta Aircraft Certification Office (ACO), 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-5554; fax: 404-474-5606; email:
(2) For information about AMOCs, contact Hal Horsbough, Aerospace Engineer, Airframe Branch, ACE-117A, FAA, Atlanta Aircraft Certification Office (ACO), 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-5554; fax: 404-474-5606; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(3) The following service information was approved for IBR on May 14, 2015.
(i) Lockheed Martin Aeronautics Company Service Bulletin 382-57-82, Revision 6, including Appendixes A, B, and C, dated July 11, 2013.
(ii) Reserved.
(4) The following service information was approved for IBR on May 26, 2011 (76 FR 22311, April 21, 2011).
(i) Lockheed Service Bulletin 382-57-82, Revision 4, including Appendixes A, B, and C, dated May 20, 2009.
(ii) Reserved.
(5) For service information identified in this AD, contact Lockheed Martin Corporation/Lockheed Martin Aeronautics Company, Airworthiness Office, Dept. 6A0M,
(6) You may view this service information at FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(7) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for certain Cessna Aircraft Company (Cessna) Model 402C and 414A airplanes. This AD requires repetitively inspecting the engine mount beams for cracks and contacting Cessna for FAA-approved corrective action if cracks are found. This AD also requires sending an inspection report to the FAA and to Cessna. This AD was prompted by reports of cracks found across the engine mount beams. We are issuing this AD to correct the unsafe condition on these products.
This AD is effective April 24, 2015.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of April 24, 2015.
We must receive comments on this AD by May 26, 2015.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this AD, contact Cessna Aircraft Company, Customer service, P.O. Box 7706, Wichita, KS 67277; telephone: (316) 517-5800; fax: (316) 517-7271; email:
You may examine the AD docket on the Internet at
Gary Park, Aerospace Engineer, Wichita Aircraft Certification Office, FAA, 1801 S. Airport Road, Room 100, Wichita, Kansas 67209; phone: (316) 946-4123; fax: (316) 946-4107; email:
We received reports of cracks found on the engine mount beams of certain Cessna Aircraft Company (Cessna) Model 402C airplanes. The cracks found run across the beam and extend beyond the doubler located under the aft engine mount and aft of the forward engine mount. Investigation revealed that the cause of the cracks is fatigue.
The engine beam mounts of the Cessna Model 402C airplanes are the same type design as that of the Cessna Model 414A airplanes.
This condition, if not detected and corrected, could result in failure of an engine mount beam and could lead to engine separation with consequent loss of power and loss of control. We are issuing this AD to correct the unsafe condition on these products.
We reviewed Cessna Aircraft Company Multi-engine Service Letter No. MEL-54-01, dated March 20, 2015, including the undated Attachment, “Inspection Results Form.” The Cessna Aircraft Company Multi-engine Service Letter describes procedures for inspecting the engine mount beams for cracks and reporting the inspection results to Cessna. This information is reasonably available at
We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This AD requires repetitively inspecting the engine mount beams for cracks and contacting Cessna for an FAA-approved corrective action if cracks are found. This AD also requires sending the inspection results to the FAA and to Cessna.
Cessna Aircraft Company Multi-engine Service Letter No. MEL-54-01, dated March 20, 2015, including the undated Attachment, “Inspection Results Form,” specifies reporting the inspection results to Cessna. In this AD, we also require that the inspection results be reported to the FAA.
An unsafe condition exists that requires the immediate adoption of this
This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We estimate that this AD affects 555 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We have no way of knowing the extent of cracks that may be found during the required inspections. Therefore, we have no way of determining the cost of the corrective action.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591. ATTN: Information Collection Clearance Officer, AES-200.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will 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.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective April 24, 2015.
None.
This AD applies to Cessna Aircraft Company Model 402C airplanes, serial numbers 402C0001 through 402C1020, and Model 414A airplanes, serial numbers 414A0001 through 414A1212, certificated in any category.
Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 54, Nacelles/Pylons.
This AD was prompted by reports of cracks found on the engine mount beams. We are issuing this AD to prevent failure of the engine mount beams, which could lead to engine separation with consequent loss of power and loss of control.
Comply with this AD within the compliance times specified, unless already done.
At the compliance times specified in paragraphs (g)(1) through (g)(4) of this AD, inspect each engine mount beam using radiographic (x-ray), eddy current, and visual methods following the Accomplishment Instructions in Cessna Aircraft Company Multi-engine Service Letter No. MEL-54-01, dated March 20, 2015. If total hours time-in-service (TIS) on an engine mount beam is unknown, use the airplane's total hours TIS.
(1) For each engine mount beam that has accumulated less than 20,000 hours TIS, initially inspect at whichever of the following that occurs later and repetitively thereafter at intervals not to exceed 200 hours TIS as long as no cracks are found:
(i) At or before the accumulation of 15,000 hours TIS on each engine beam; or
(ii) Within the next 100 hours TIS after the effective date of this AD or within the next 90 days after the effective date of this AD, whichever occurs first.
(2) For each engine mount beam that has accumulated 20,000 hours TIS but no more than 24,999 hours TIS, initially inspect at whichever of the following that occurs first and repetitively thereafter at intervals not to exceed 200 hours TIS as long as no cracks are found:
(i) Within the next 75 hours TIS after the effective date of this AD; or
(ii) Within the next 60 days after the effective date of this AD.
(3) For each engine mount beam that has accumulated 25,000 hours TIS but no more than 30,000 hours TIS, initially inspect at whichever of the following that occurs first and repetitively thereafter at intervals not to exceed 200 hours TIS as long as no cracks are found:
(i) Within the next 50 hours TIS after the effective date of this AD; or
(ii) Within the next 45 days after the effective date of this AD.
(4) For each engine mount beam that has accumulated more than 30,000 hours TIS, initially inspect at whichever of the following that occurs first and repetitively thereafter at intervals not to exceed 200 hours TIS as long as no cracks are found:
(i) Within the next 25 hours TIS after the effective date of this AD; or
(ii) Within the next 30 days after the effective date of this AD.
If any cracks are found during any inspection required in paragraphs (g)(1) through (g)(4) of this AD, before further flight, contact Cessna Aircraft Company at the address specified in paragraph (m)(3) of this AD for an FAA-approved corrective action developed specifically for this AD.
Within 10 days after each inspection required in paragraphs (g)(1) through (g)(4) of this AD or within 10 days after the effective date of this AD, whichever occurs later, using the undated Attachment, “Inspection Results Form,” to Cessna Aircraft Company Multi-engine Service Letter No. MEL-54-01, dated March 20, 2015, report the results to the FAA, Wichita Aircraft Certification Office (ACO) at the address specified in paragraph (l) of this AD. Report the result of each inspection to the FAA, Wichita ACO, for one year after the date of the initial inspection required in paragraphs (g)(1) through (g)(4) of this AD. Also report the results of the initial inspection to Cessna at the address specified in paragraph (m)(3) of this AD.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 5 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn: Information Collection Clearance Officer, AES-200.
(1) The Manager, Wichita ACO, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (l) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
Gary Park, Aerospace Engineer, Wichita ACO, FAA, 1801 S. Airport Road, Room 100, Wichita, Kansas 67209; phone: (316) 946-4123; fax: (316) 946-4107; continued operational safety email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Cessna Aircraft Company Multi-engine Service Letter No. MEL-54-01, dated March 20, 2015, including the undated Attachment, “Inspection Results Form.”
(ii) Reserved.
(3) For Cessna Aircraft Company service information identified in this AD, contact Cessna Aircraft Company, Customer service, P.O. Box 7706, Wichita, KS 67277; telephone: (316) 517-5800; fax: (316) 517-7271; email:
(4) You may view this service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the Internet at
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Environmental Protection Agency (EPA).
Withdrawal of direct final rule.
On February 10, 2015, the Environmental Protection Agency (EPA) published a direct final rule approving revisions to the New Mexico State Implementation Plan (SIP). These revisions amend the State transportation conformity provisions and remove the State general conformity provisions from the SIP, as allowed by the 2005 amendments to the Clean Air Act (CAA). The direct final rule was published without prior proposal because EPA anticipated no adverse comments. EPA stated in the direct final rule that if EPA received relevant, adverse comments by March 12, 2015, EPA would publish a timely withdrawal in the
The direct final rule published on February 10, 2015 (80 FR 7341), is withdrawn effective April 8, 2015.
Mr. Jeffrey Riley (6PD-L), Air Planning Section, telephone (214) 665-8542, fax (214) 665-6762, email:
On February 10, 2015, EPA published a direct final rule approving revisions to the New Mexico SIP. These revisions amend the State transportation conformity provisions and remove the State general conformity provisions from the SIP, as allowed by the 2005 amendments to the CAA. The direct final rule was published without prior proposal because EPA anticipated no adverse comments. EPA stated in the direct final rule that if relevant, adverse comments were received by March 12, 2015, EPA would publish a timely withdrawal in the
Environmental protection, Air pollution control, Carbon Monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxides, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Accordingly, the amendments to 40 CFR 52.1620 published in the
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing a limited approval and limited disapproval of a revision to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD) portion of the California State Implementation Plan (SIP). This regulation establishes requirements and procedures for the District's quantification of emission reductions achieved through incentive funding programs implemented in the San Joaquin Valley. The effect of this action would be to make these requirements and procedures federally enforceable as part of the California SIP. Under authority of the Clean Air Act (CAA or the Act), this action simultaneously approves the local rule and directs California to correct rule deficiencies.
This rule will be effective on May 11, 2015.
EPA has established docket number EPA-R09-OAR-2013-0754 for this action. Generally, documents in the docket for this action are available electronically at
Idalia Pérez, EPA Region IX, (415) 972-3248,
On May 19, 2014 (79 FR 28650), EPA proposed to fully approve the following rule, which the California Air Resources Board (CARB) submitted for incorporation into the California SIP.
We proposed to fully approve Rule 9610 based on a proposed conclusion that the rule satisfied the applicable CAA requirements. We noted, however, that section 6.2 of the rule contained an incorrect statutory reference and inaccurately described the statutory obligations of the U.S. Department of Agriculture's Natural Resources Conservation Service (NRCS) with respect to disclosure of information concerning implementation of the Environmental Quality Incentives Program (EQIP).
Based on additional evaluation of this rule and in response to public comments, we continue to believe that Rule 9610 largely satisfies the applicable CAA requirements but find that the deficiencies in section 6.2 of the rule, as described in our proposed rule, necessitate a limited disapproval. We provide our rationale for this limited disapproval in our responses to comments below.
EPA's proposed rule provided a 30-day public comment period. During this period, we received comments from the following entities:
1. Paul Cort, Earthjustice; letter dated June 18, 2014.
2. Seyed Sadredin, SJVUAPCD; letter dated June 17, 2014.
We summarize these comments and provide our responses below.
As we explained in our proposal, Rule 9610 contains key provisions designed to establish a regulatory framework for the District's quantification of emission reductions achieved through incentive programs and to provide opportunities for EPA, CARB, and the public to review and comment on the District's evaluations on an annual basis.
As we also stated in the proposed rule, nothing in Rule 9610 supplants the applicable requirements of the CAA, and EPA will review each SIP submittal developed pursuant to Rule 9610 and EPA guidance on a case-by-case basis, following notice-and-comment rulemaking, to determine whether the applicable requirements of the Act are met.
Given that the District's stated purpose in adopting Rule 9610 was to establish an administrative mechanism for crediting emission reductions achieved through incentive programs toward SIP requirements, EPA discussed in the proposed rule “the extent to which the requirements and procedures contained in the rule
Section 110 of the CAA requires each state to submit to EPA for approval a “plan which provides for implementation, maintenance, and enforcement” of each primary and secondary NAAQS, and EPA is required to approve a SIP submittal that relates to these purposes and satisfies the applicable federal requirements.
We expect the District to address the applicable requirements of the CAA in each individual SIP submittal that relies on incentive programs, and our recommendations in both the proposal and today's final rule are intended to provide the District with general guidance on how these requirements, as interpreted in EPA guidance, apply to future SIP submittals developed pursuant to Rule 9610 and the requirements of the Act. To the extent our action on Rule 9610 and the related public process provide a forum for EPA and the public to comment on the statutory requirements that the District must address in future SIP submittals that rely on incentive programs, we view this as an important step toward clarifying the applicable CAA requirements and ensuring transparency in SIP actions going forward. In any case, as EPA stated in the proposed rule, EPA will review each SIP submittal developed pursuant to Rule 9610 (including the necessary evaluation of the applicable incentive program guidelines) on a case-by-case basis, following notice-and-comment rulemaking, to determine whether the applicable requirements of the Act are met.
As we explained in the proposed rule and further in the Proposal TSD, Rule 9610 does not represent all of the CAA requirements applicable to SIPs that rely on incentive programs for emission reduction credit (
We continue to believe, however, that the definitions of the terms “quantifiable,” “surplus,” “enforceable” and “permanent” in Rule 9610 generally represent the four fundamental “integrity elements” defined in EPA guidance for discretionary EIPs and other innovative emission reduction programs, provided the District interprets these terms consistent with our interpretations in this rulemaking, which are the bases for our limited approval of the rule.
Nonetheless, the commenter raises a number of important concerns regarding the adequacy of Rule 9610 as a legal framework for quantifying SIP emission reduction credit for incentive programs, and in an effort both to respond to these comments and to provide the District with specific guidance on the requirements of the Act that each SIP must satisfy, we respond below (in Response 3.a through Response 3.j) to each of these concerns.
Section 2.27 states that “emission reductions are surplus when they are not otherwise required by any federal, state, or local regulation, or other legal mandate, and are in excess of the baseline emission inventories underlying a SIP attainment demonstration.” First, we understand that “any federal, state, or local regulation, or other legal mandate” would include: (1) Any federal rule designed to reduce emissions of a criteria pollutant or its precursors (
Read in its entirety, section 2.27 provides that only those emission reductions that are
One component of EPA's various policy recommendations that the definition of “surplus” in section 2.27 does not explicitly address is the recommendation concerning the remaining useful life of the vehicle, engine, or equipment being replaced.
In our proposed rule and Proposal TSD, we compared the Rule 9610 definition of “enforceable” with EPA's recommended enforceability factors for voluntary and other nontraditional emission reduction measures, and we found the Rule 9610 definition to be generally consistent with EPA's recommendations.
Earthjustice asserts generally that “[a] state cannot claim SIP credit from control measures that shield pollution sources from independent enforcement actions.” But nothing in Rule 9610 shields pollution sources from independent enforcement actions and Earthjustice does not identify any provision that does so. As further explained in Response 3.d., the CAA authorizes EPA and citizens to enforce requirements of an “applicable implementation plan”
We understand that Earthjustice may have intended to argue that Rule 9610 would encourage
Nothing in Rule 9610 undermines the ability of EPA or citizens to bring enforcement actions to assure compliance with SIP requirements, nor does the rule contain or authorize the District to develop any “director discretion” or “affirmative defense” provision that will apply to SIP requirements. To the contrary, section 7.0 of Rule 9610 requires that the District maintain responsibility for ensuring that SIP emission reductions occur through an “enforceable commitment,” which becomes federally enforceable by EPA and citizens upon approval into the SIP under CAA section 110(k).
As we noted previously, following the State's submittal of a specific air quality plan or measure that relies on incentive programs for necessary emission reductions, EPA will evaluate that plan or measure to determine whether it satisfies the enforceability requirements of the Act. We provide these responses to the commenter's concerns only as a preliminary explanation of the enforceability requirements that future SIPs developed through the Rule 9610 process must satisfy, and we encourage the commenter and the public at large
Under longstanding guidance, EPA has recommended presumptive limits (sometimes referred to as “caps”) on the amounts of emission reductions from certain voluntary and other nontraditional measures that may be credited in a SIP. Specifically, for voluntary mobile source emission reduction programs (VMEPs),
Importantly, EPA has consistently stated that SIP credit may be allowed for a voluntary or other nontraditional measure only where the State submits enforceable mechanisms to ensure that the emission reductions necessary to meet applicable CAA requirements are achieved—
Should California submit a SIP that relies on incentive programs to satisfy a CAA requirement, EPA intends to evaluate the submittal to determine whether the necessary emission reductions may be enforced by EPA and citizens through an enforceable State/District commitment. Additionally, should such a SIP rely on incentive-based emission reductions in amounts that exceed EPA's presumptive limits, as discussed in EPA's longstanding guidance, EPA intends to evaluate the SIP submittal to determine whether the State and/or District have provided a clear and convincing justification for such higher amounts.
Second, Earthjustice's claim that Rule 9610 “would only require that violations be defined through contracts” which “can only be enforced by the parties to the contract” overlooks an important provision in the rule that requires the District to provide a mechanism for EPA and citizen enforcement in
Finally, with respect to Earthjustice's claim that EPA's proposal provides “no explanation of how this requirement is met or why it does not apply,” it appears that Earthjustice is referring to
To the extent the commenter disagrees with EPA's interpretations of the Act, we encourage the commenter to submit comments on the SIP rulemakings through which EPA takes final action on air quality plans or measures that rely on incentive program emission reductions. Nothing in our approval of Rule 9610 today deprives the public of these opportunities to comment on these future SIP actions.
One significant exception to the general enforceability provisions in Rule 9610 is the provision in section 6.2 that categorically prohibits public disclosure of records related to NRCS's implementation of the EQIP program. As explained in our proposed rule (
With respect to any future SIP submittal that relies on emission reductions achieved through EQIP to satisfy a CAA requirement, we expect that the annual reports certified by NRCS, as described in the March 2014 Addendum signed by NRCS, EPA, CARB and the District,
With respect to the 2013 Annual Demonstration Report, we provided suggestions for future reports in the Proposal TSD.
We continue to believe that Rule 9610 generally ensures that citizens will have access to all emissions-related information obtained by the District from sources participating in incentive programs, with one significant exception in section 6.2 of the rule. As we explained in the proposed rule, section 6.1 of Rule 9610 specifically requires the District to keep and maintain “[a]ll documents created and/or used in implementing the requirements of Section 4.0” of the rule and to make these documents available for public review consistent with the requirements of the California Public Records Act and related requirements.
Finally, we disagree with the commenter's claim that EPA lacks authority to collect information relevant to source compliance with the contracts issued by the District. Rule 9610 requires the District to maintain, with respect to all projects that the District relies upon for SIP emission reduction credit, reports submitted by grantees and records of all inspections and enforcement actions, among other things.
We expect an enforceable commitment that obligates the District to comply with adequate monitoring and recordkeeping requirements would ensure that emission reductions can be independently verified. In any case, EPA will review each submitted SIP commitment on a case-by-case basis to determine whether the commitment is legally and practically enforceable by EPA and citizens, in accordance with the requirements of the Act.
In any case, we are not approving any State or District commitments in today's action and therefore do not have reason to evaluate this SIP submittal in accordance with EPA's policy criteria for approving enforceable commitments. As EPA stated in the proposed rule, EPA will review each SIP submittal developed pursuant to Rule 9610 on a case-by-case basis, following notice-and-comment rulemaking, to determine whether the applicable requirements of the Act are met.
We agree, however, with Earthjustice's suggestion that EPA, the State, the District and interested stakeholders should work together toward the development of air quality plans and measures that satisfy CAA requirements as applied to discretionary incentive programs and other nontraditional emission reduction measures. We look forward to the public's continued involvement, both during the State and local rulemaking processes through which the District and ARB adopt these plans and during the EPA rulemakings through which EPA takes final action on these plan submittals under section 110 of the CAA.
EPA supports and encourages the continuing efforts by CARB, the District, and NRCS to make voluntary economic incentive programs an effective part of the SJV's strategy for clean air. We commit to continue our work with these agencies to develop reliable methods for documenting and verifying the emission reductions achieved through these programs and to ensure that future air
Under CAA sections 110(k)(3) and 301(a) of the Act and for the reasons set forth above and in our May 19, 2014 proposed rule, EPA is finalizing a limited approval and limited disapproval of Rule 9610 as submitted June 26, 2013. We are finalizing a limited approval of the submitted rule because we continue to believe that the rule improves the SIP and is largely consistent with the applicable CAA requirements. This action incorporates the submitted rule, including those provisions identified as deficient, into the SJV portion of the federally-enforceable California SIP.
We are finalizing a limited disapproval of Rule 9610 because section 6.2 of the rule incorrectly describes NRCS's statutory obligations with respect to disclosure of information concerning the EQIP program and creates a potential conflict with the requirements of the CAA concerning public availability of emission data. Our reasons for disapproving the rule on these bases are explained in the proposed rule and further in our responses to comments above.
This limited disapproval does not trigger any sanctions clocks under CAA section 179(a) because Rule 9610 was not submitted to address a requirement of part D, title I of the Act or in response to a finding of substantial inadequacy as described in CAA section 110(k)(5) (
Note that the submitted rule has been adopted by the SJVUAPCD, and EPA's final limited disapproval does not prevent the local agency from enforcing it. The limited disapproval also does not prevent any portion of the rule from being incorporated by reference into the federally enforceable SIP as discussed in a July 9, 1992 EPA memo found at:
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the SJVUPACD rule described in the amendments to 40 CFR 52 set forth below. EPA has made, and will continue to make, these documents available electronically through
The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.
This rule will not have a significant impact on a substantial number of small entities because SIP approvals and limited approvals/limited disapprovals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because this limited approval/limited disapproval action does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.
Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of State action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds.
Under sections 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, or tribal governments in the aggregate; or to the private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.
EPA has determined that the limited approval/limited disapproval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.
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, as specified in Executive Order 13132, because it merely approves a State rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.
Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, 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. Thus, Executive Order 13175 does not apply to this rule.
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045, because it approves a State rule implementing a Federal standard.
This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.
Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.
The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.
Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA lacks the discretionary authority to address environmental justice in this rulemaking.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 8, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.
Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(455) New and amended regulations for the following APCDs were submitted on June 26, 2013.
(i) Incorporation by reference.
(A) San Joaquin Valley Unified Air Pollution Control District.
(
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
This action implements revisions to the Pacific Coast Groundfish Trawl Rationalization Program affecting the limited entry midwater trawl fisheries managed under the Pacific Coast Groundfish Fishery Management Plan (FMP). This action revises the primary season-opening date for the Shorebased Individual Fishing Quota (IFQ) Program midwater trawl fishery (targeting both whiting and non-whiting species) to May 15 north of 40°30′ N. lat. to the U.S./Canada border. This moves the season a month earlier for waters off the coasts of Washington and Oregon, and a month and half later for waters off the coast of northern California (north of 40°30′ N. lat.). This action increases consistency in the season start date along the coast and between the shorebased and at-sea midwater trawl fleets.
Effective May 15, 2015.
NMFS prepared a Final Regulatory Flexibility Analysis (FRFA), which is summarized in the Classification section of this final rule. NMFS also prepared an Initial Regulatory Flexibility Analysis (IRFA) for the proposed rule. Copies of the IRFA, FRFA and the Small Entity Compliance Guide are available from William W. Stelle, Jr., Regional Administrator, West Coast Region, NMFS, 7600 Sand Point Way NE., Seattle, WA 98115-0070; or by phone at 206-526-6150. Copies of the Small Entity Compliance Guide are available on the West Coast Region'sWeb site at
Jamie Goen, 206-526-4656,
Since implementing the trawl rationalization program in 2011, the Pacific Fishery Management Council (Council) and NMFS have been working to implement additional regulatory changes to further improve the trawl rationalization program and respond to industry requests. Changing the midwater trawl fishery season date will further increase consistency in the season start date along the coast and between the shorebased and at-sea midwater trawl fleets. This action revises the primary season-opening date for the Shorebased IFQ Program midwater trawl fishery (targeting both whiting and non-whiting species) to May 15 north of 40°30′ N. lat. to the U.S./Canada border. This moves the season a month earlier for waters off the coasts of Washington and Oregon, and a month and half later for waters off the coast of northern California (north of 40°30′ N. lat.).
NMFS published a proposed rule for this action on February 17, 2015 (80 FR 8280). The preamble to the proposed rule provided more background and information on the history of season date changes in the groundfish midwater trawl fisheries, as well as expected impacts. The preamble to the proposed rule also described the re-emerging midwater trawl fishery targeting groundfish species other than Pacific whiting (non-whiting midwater trawl). The season date change in this action applies to all midwater trawling in the Shorebased IFQ Program, whether targeting whiting or non-whiting groundfish species.
The comment period on the proposed rule ended March 19, 2015. NMFS received one comment letter (with three separate comments) on the proposed rule from a fishing industry organization.
There are no changes to the regulatory text from the proposed rule.
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Fishery Conservation and Management Act (MSA), the NMFS Assistant
The Council prepared an environmental assessment (EA) for this action and the NMFS Assistant Administrator concluded in a “Finding of No Significant Impact” that there will be no significant impact on the human environment as a result of this rule. The EA is available on the Council's Web site at
This final rule has been determined to be not significant for purposes of Executive Order 12866.
A final regulatory flexibility analysis (FRFA) was prepared and incorporates the initial regulatory flexibility analysis (IRFA). A summary of the significant issues raised by the public comments in response to the IRFA, and NMFS' responses to those comments, and a summary of the analyses completed to support the action are addressed below. NMFS also prepared a Regulatory Impact Review (RIR) for this action. A copy of the RIR/FRFA is available from NMFS (see
The SBA has established size criteria for all major industry sectors in the United States, including fish harvesting and fish processing businesses. A business involved in fish harvesting is a small business if it is independently owned and operated and not dominant in its field of operation (including its affiliates) and if it has combined annual receipts not in excess of $20.5 million for all its affiliated operations worldwide. For marinas and charter/party boats, a small business is one with annual receipts not in excess of $7.5 million. For purposes of rulemaking, NMFS is also applying the $20.5 million standard to catcher/processors (C/Ps) because they are involved in the commercial harvest of finfish. A seafood processor is a small business if it is independently owned and operated, not dominant in its field of operation, and employs 500 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide. A wholesale business servicing the fishing industry is a small business if it employs 100 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide. A small organization is any nonprofit enterprise that is independently owned and operated and is not dominant in its field. A small governmental jurisdiction is a government of a city, county, town, township, village, school district, or special district with a population of less than 50,000.
This action revises the primary season opening date for the Shorebased IFQ Program midwater trawl fishery (targeting both whiting and non-whiting species) to May 15 north of 40°30′ N. lat. to the U.S./Canada border. This moves the season a month earlier for waters off the coasts of Washington and Oregon (from June 15 to May 15), and a month and half later for waters off the cost of northern California (north of 40°30′ N. lat.) (from April 1 to May 15), increasing consistency in the season start date along the coast and between the shorebased and at-sea midwater trawl fleets.
NMFS did not receive any public comments directly related to the IRFA. One public comment did indicate that the change should result in greater revenue to the local fishing communities.
This rule affects shorebased midwater trawlers in the trawl rationalization program and the processors that receive their product. During the 2011 to 2014 period, 30 midwater trawl vessels delivered to 10 shoreside processing plants in this fishery. Some vessels share common ownership, other vessels are owned by processing companies, and some companies own multiple processing plants. After accounting for these relationships, there are 26 entities that have participated in the fishery, 22 of which are small entities, based on NMFS' review of available information.
There are no significant alternatives that accomplish the stated objectives of applicable statutes and that minimize the impact of the rule on small entities. Most entities affected by this rule are small entities (22 out of 26). An earlier shorebased season will increase the choices available for the Northern fishery (off Oregon and Washington), providing an opportunity to improve business decisions and potential profits from the fishery. For the Central Area fishery, there would be a contraction in flexibility to harvest from April 1 to May 15. Reducing the season in the Central fishery may have a chilling effect on the potential growth in the fishery. However, data for 2011 through 2014 shows that no midwater trawl gear harvest occurred in this area under the IFQ program.
There are no new Federal reporting and recordkeeping requirements associated with this action. There are no relevant Federal rules that may duplicate, overlap, or conflict with this action.
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a small entity compliance guide (the guide) was prepared. Copies of this final rule are available from the West Coast Regional Office, and the guide will be included in a public notice sent to all members of the groundfish email group. To sign-up for the groundfish email group, click on the “subscribe” link on the following Web site:
NMFS issued Biological Opinions under the Endangered Species Act (ESA) on August 10, 1990, November 26, 1991, August 28, 1992, September 27, 1993, May 14, 1996, and December 15, 1999, pertaining to the effects of the Groundfish FMP fisheries on Chinook salmon (Puget Sound, Snake River spring/summer, Snake River fall, upper Columbia River spring, lower Columbia River, upper Willamette River, Sacramento River winter, Central Valley spring, California coastal), coho salmon (Central California coastal, southern Oregon/northern California coastal), chum salmon (Hood Canal summer, Columbia River), sockeye salmon (Snake River, Ozette Lake), and steelhead (upper, middle and lower Columbia River, Snake River Basin, upper Willamette River, central California coast, California Central Valley, south/central California, northern California, southern California). These biological opinions have concluded that implementation of the FMP is not expected to jeopardize the continued existence of any endangered or threatened species under the jurisdiction of NMFS, or result in the destruction or adverse modification of critical habitat.
NMFS issued a Supplemental Biological Opinion on March 11, 2006, concluding that neither the higher observed bycatch of Chinook in the 2005 whiting fishery nor new data regarding salmon bycatch in the groundfish bottom trawl fishery
NMFS has reinitiated section 7 consultation on the Pacific Coast Groundfish FMP with respect to its effects on listed salmonids. In the event the consultation identifies either reasonable and prudent alternatives to address jeopardy concerns, or reasonable and prudent measures to minimize incidental take, NMFS would coordinate with the Council to put additional alternatives or measures into place, as required. After reviewing the available information, NMFS has concluded that, consistent with sections 7(a)(2) and 7(d) of the ESA, this action will not jeopardize any listed species, would not adversely modify any designated critical habitat, and will not result in any irreversible or irretrievable commitment of resources that would have the effect of foreclosing the formulation or implementation of any reasonable and prudent alternative measures.
On December 7, 2012, NMFS completed a biological opinion concluding that the groundfish fishery is not likely to jeopardize non-salmonid marine species, including listed eulachon, the southern distinct population segment (DPS) of green sturgeon, humpback whales, the eastern DPS of Steller sea lions, and leatherback sea turtles. The opinion also concluded that the fishery is not likely to adversely modify critical habitat for green sturgeon and leatherback sea turtles. An analysis included in the same document as the opinion concludes that the fishery is not likely to adversely affect green sea turtles, olive ridley sea turtles, loggerhead sea turtles, sei whales, North Pacific right whales, blue whales, fin whales, sperm whales, Southern Resident killer whales, Guadalupe fur seals, or the critical habitat for Steller sea lions. Since that biological opinion, the eastern DPS of Steller sea lions was delisted on November 4, 2013 (78 FR 66140); however, this delisting did not change the designated critical habitat for the eastern DPS of Steller sea lions. On January 21, 2013, NMFS informally consulted on the fishery's effects on eulachon to consider whether the 2012 opinion should be reconsidered for eulachon in light of new information from the 2011 fishery and the proposed chafing gear modifications. NMFS determined that information about bycatch of eulachon in 2011 and chafing gear regulations did not change the effects that were analyzed in the December 7, 2012, biological opinion, or provide any other basis to reinitiate consultation.
On November 21, 2012, the U.S. Fish and Wildlife Service (FWS) issued a biological opinion concluding that the groundfish fishery will not jeopardize the continued existence of the short-tailed albatross. The FWS also concurred that the fishery is not likely to adversely affect the marbled murrelet, California least tern, southern sea otter, bull trout, nor bull trout critical habitat.
West Coast pot fisheries for sablefish are considered Category II fisheries under the Marine Mammal Protection Act (MMPA), indicating occasional interactions. All other West Coast groundfish fisheries, including the trawl fishery, are considered Category III fisheries under the MMPA, indicating a remote likelihood of or no known serious injuries or mortalities to marine mammals. MMPA section 101(a)(5)(E) requires that NMFS authorize the taking of ESA-listed marine mammals incidental to U.S. commercial fisheries if it makes the requisite findings, including a finding that the incidental mortality and serious injury from commercial fisheries will have a negligible impact on the affected species or stock. As noted above, NMFS concluded in its biological opinion for the 2012 groundfish fisheries that these fisheries were not likely to jeopardize Steller sea lions or humpback whales. The eastern distinct population segment of Steller sea lions was delisted under the ESA on November 4, 2013 (78 FR 66140). On September 4, 2013, based on its negligible impact determination dated August 28, 2013, NMFS issued a permit for a period of 3 years to authorize the incidental taking of humpback whales by the sablefish pot fishery (78 FR 54553).
Fisheries, Fishing, and Indian fisheries.
For the reasons stated in the preamble, 50 CFR part 660 is amended as follows:
16 U.S.C. 1801
(b) * * *
(2) * * *
(iii) * * *
(C)
(
(
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to amend the significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 24 chemical substances which were the subject of premanufacture notices (PMNs). This action would amend the SNURs to allow certain uses without requiring a significant new use notice (SNUN), and would extend SNUN requirements to certain additional uses. EPA is proposing these amendments based on review of new data as described for each chemical substance. This action would requires persons who intend to manufacture (including import) or process any of these 24 chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
Comments must be received on or before May 11, 2015.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2014-0649, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. 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:
• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110),
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to a modified SNUR must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export the chemical substance that is the subject of a final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
1.
2.
EPA is proposing amendments to the SNURs for 24 chemical substances in 40 CFR part 721 subpart E. This proposed action would require persons who intend to manufacture or process these chemical substances for an activity that is designated as a significant new use by these amended rules to notify EPA at least 90 days before commencing that activity. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs.
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors, listed in Unit III. of this document. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use. Persons who must report are described in § 721.5.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the
Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the 24 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substance, likely human exposures and environmental releases associated with possible uses, taking into consideration the four bulleted TSCA section 5(a)(2) factors listed in this unit.
EPA is proposing to amend the significant new use and recordkeeping requirements for 24 chemical substances in 40 CFR part 721 Subpart E. In this unit, EPA provides the following information for each chemical substance:
• PMN number and SNUN number.
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS) number (if assigned for non-confidential chemical identities).
•
• Basis for the Proposed Amendment.
• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VII. for more information).
• CFR citation assigned in the regulatory text section of this rule.
1. Workers to use personal protective equipment to prevent dermal exposure.
2. Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the Material Safety Data Sheet (MSDS).
3. Not manufacture the substance in the United States.
4. Not use the substance in consumer products.
5. Limit the percent concentration of the substance to 10% or less in final products whose use involves an application method that generates a vapor, mist, or aerosol, except for commercial/professional inkjet printing in a commercial (excluding retail) print shop.
The proposed SNUR designates as a significant new use the absence of these protective measures when using the substance for any use other than as described in the PMN.
A SNUR was issued for this chemical substance on January 5, 2000. The SNUR designated as a “significant new use” the absence of the protective measures required in the consent order.
Subsequent to issuance of the SNUR, the PMN submitter completed the following studies under the terms of the TSCA section 5(e) consent order: An
Based on these new data, concerns remained for possible effects to the liver, testes, kidney, and blood from dermal exposure. However, EPA no longer had substantial human health concerns for mutagenicity and neurotoxicity. In addition, Agency concerns for carcinogenicity by inhalation were reduced, but were further mitigated by retaining the original consent order prohibition of industrial processing and use in a non-enclosed process and any use application methods that generate a vapor, mist, or aerosol form of the PMN substance.
In addition, to account for data received on analogous substances since the initial PMN was submitted and to address Agency environmental concerns, a re-review of the environmental toxicity profile for the chemical substance was conducted. The results of this evaluation indicated a low concern for chronic aquatic toxicity. Therefore, EPA could no longer make a “may present unreasonable risk” finding for releases of the PMN substance to surface waters. As a result of this review, EPA issued a modified TSCA section 5(e) consent order which became effective on May 9, 2006. The modified order removed requirements for respiratory protection, waived further required trigger testing, removed the restriction on domestic manufacture, and removed waste disposal restrictions. Pursuant to § 721.185(a)(5), the Agency examined new information and reexamined the test data and other information supporting its finding under section 5(e)(1)(A)(ii)(I) of TSCA, and concluded that a rational basis no longer existed to support findings that certain activities involving the substance may present an unreasonable risk of injury to human health and the environment required under section 5(e)(1)(A) of TSCA.
To protect against the remaining potential risks, the modified consent order:
• Requires the use of dermal personal protective equipment (including gloves demonstrated to be impervious).
• Requires establishment of a hazard communication program.
• Prohibits processing and use activities in non-enclosed processes.
• Prohibits the use of the chemical substance involving an application method that generates a vapor, mist, or aerosol.
On June 27, 2008, the Agency received a SNUN, S-08-7, for the subject chemical substance. The significant new use identified in the notice was release to water for the generic (non-confidential) use of “contained use in energy production”. The 90-day review period for the SNUN expired on October 2, 2008 with EPA not taking action on the “significant new use” of release of the substance to water.
On May 13, 2011, EPA issued a modified SNUR based on and consistent with the provisions in the underlying modified consent order which no longer included release to water as a significant new use. In addition, EPA included, in the regulatory text, clarifying language for those forms of the PMN substance which are exempt from the provisions of the proposed SNUR. The SNUR does not apply to quantities of the PMN substance after it has been completely reacted (cured) because the PMN substance will no longer exist.
On October 21, 2013, EPA received a second SNUN, S-14-1, for the subject chemical substance. The significant new use identified in the notice was processing and use in a non-enclosed process as a monomer for use in ultraviolet ink jet applications. The 90-day review period for the SNUN expired on March 13, 2014, with EPA not taking action on the significant new use of processing and use in a non-enclosed process as a monomer for use in ultraviolet ink jet applications. When evaluating this new use, EPA also evaluated potential environmental releases. Based on a new review of test data on the chemical substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 100 ppb of the chemical substance in surface waters. As described in the PMN and SNUNs, releases of the substance are not expected to result in surface water concentrations that exceed 100 ppb. EPA has determined, however, that any use of the substance resulting in surface waters concentrations exceeding 100 ppb may result in significant adverse environmental effects. Based on this information, the chemical substance meets the concern criteria at § 721.170 (b)(4)(i). The proposed SNUR designates as a “significant new use” the absence of the protective measures required in the modified consent order, any water releases during manufacturing, processing, and use that exceed 100
Claimed confidential (PMN P-97-297/298/299 and SNUN S-03-11/12/13).
EPA had evaluated the results of a combined biodegradation and aquatic toxicity test for P-10-486 during PMN review. The test was submitted as part of the PMN submissions. During the review, EPA accepted the data as valid for purposes of ascertaining the environmental fate of the PMN substances (the overall rate of ready biodegradation), but not for purposes of determining potential environmental toxicity of the transformation products to aquatic organisms. Subsequent to issuance of the SNUR, and based on discussions with the Company and other PMN submitters, EPA re-evaluated the data and determined that the data could be used to evaluate the aquatic toxicity of the PMN transformation products. The combined biodegradation/ecological toxicity testing demonstrated that, subsequent to the biodegradation portion of the combined study, no further ecologically toxic substances remained from the P-10-486 parent substance. EPA also believes the results of the test data for P-10-486 apply to the structurally analogous P-10-487 substance. Based on this evaluation EPA did not find that the PMN substances present an unreasonable risk to the environment or human health or will be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities based on activities described in the PMN. As a result EPA revoked the consent order. EPA has determined, however, that other uses of the substances may cause significant adverse environmental effects. Based on this information, the chemical substances meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii). Based on these findings EPA is proposing to modify the SNUR to require notification of any use of the substances without disposal by incineration or injection into a Class I or II waste disposal well; release to water without prior biological treatment (activated sludge or equivalent) plus clarification; or non-industrial use.
Pursuant to § 721.185 and as described in Unit IV, this proposed rule includes 23 chemical substances where EPA determined, based on new information, there is no need to require additional notice from persons who propose to engage in identical or similar activities, or a rational basis no longer exists for the findings that activities involving the substance may present an unreasonable risk of injury to human health or the environment required under section 5(e)(1)(A) of the Act.
This proposed rule also includes a chemical substance, P-01-781, where EPA is modifying the chemical identity information.
To establish a significant “new” use, EPA must determine that the use is not ongoing. EPA solicits comments on whether any of the uses proposed as significant new uses are ongoing. As discussed in the
Thus, any persons who begin commercial manufacture or processing activities with the chemical substances that are not currently a significant new use under the current rule but which would be regulated as a “significant new use” if this proposed rule is finalized, must cease any such activity as of the effective date of the rule if and when finalized. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under § 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities.
EPA recognizes that TSCA section 5 does not require the development of any particular test data before submission of a SNUN. The two exceptions are:
1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and
The recommended testing specified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance. However, SNUNs submitted without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
• Human exposure and environmental release that may result from the significant new use of the chemical substances.
• Potential benefits of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR 720.40. E-PMN software is available electronically at
EPA evaluated the potential costs of SNUN requirements for potential manufacturers and processors of the chemical substances in the proposed rule. The Agency's complete Economic Analysis is available in the docket under docket ID number EPA-HQ-OPPT-2014-0649.
This proposed action would modify SNURs for 24 chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled
According to PRA, 44 U.S.C. 3501
The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601
1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
2. The SNUN submitted by any small entity would not cost significantly more than $8,300.
A copy of that certification is available in the docket for this rule.
This proposed rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit IX. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:
• A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
• Submission of the SNUN would not cost any small entity significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this final rule. As such, EPA has determined that this rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204,
This action would not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled “
This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “
This action is not subject to Executive Order 13045, entitled “
This action is not subject to Executive Order 13211, entitled “
In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Therefore, it is proposed that 40 CFR part 721 be amended as follows:
15 U.S.C. 2604, 2607, and 2625(c).
The revisions read as follows:
(a)
(2) * * *
(i)
The revisions and addition read as follows:
(a)
(2) * * *
(i)
(3) The significant new uses for any use other than the use described in P-00-618:
(i)
(ii)
(iii)
(b) * * *
(1)
The revisions read as follows:
(a)
(2) * * *
(i)
(b) * * *
(1)
The revisions read as follows:
(a) * * *. (1) The chemical substance identified as D-Glucuronic acid, polymer with 6-deoxy-L-mannose and D-glucose, acetate, calcium magnesium potassium sodium salt (PMN P-00-7; SNUN S-05-1; SNUN S-06-4; SNUN S-07-03; and SNUN S-07-5; CAS No. 125005-87-0) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(2) * * *
(i)
The revisions and additions read as follows:
(a) * * * (1) The chemical substance identified as 2-Propen-1-one, 1-(4-morpholinyl)- (PMN P-95-169; SNUN S-08-7; and SNUN S-14-1; CAS No. 5117-12-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the chemical substance after it has been completely reacted (cured) because 2-Propen-1-one, 1-(4-morpholinyl)- will no longer exist.
(2) * * *
(iii)
(iv)
(b) * * *
(1)
The revisions read as follows:
(a) * * * (1) The chemical substance identified as oxirane, 2,2′-(1,6-hexanediylbis(oxymethylene))bis- (PMN P-88-2179; PMN P-89-539; and SNUN S-08-3; CAS No. 16096-31-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) * * *
(iii)
The revisions read as follows:
(a) * * * (1) The chemical substance identified as pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro (PMN P-95-638, SNUN P-97-79, and SNUN S-06-8; CAS No. 138495-42-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) * * *
(i)
The revisions read as follows:
(a) * * * (1) The chemical substance identified generically as a phenol—biphenyl polymer condensate (PMN P-00-1220 and S-07-2) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(2) * * *
(i)
The revisions read as follows:
(a) * * * (1) The chemical substance identified as propane,1,1,1,2,2,3,3-heptafluoro-3-methoxy- (PMN P-01-320; SNUN S-04-2; and SNUN 11-1; CAS No. 375-03-1) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(2) * * *
(i)
(a) * * * (1) The chemical substance identified as silane, triethoxy[3-oxiranylmethoxy)propyl]- (PMN P-01-781; CAS No. 2602-34-8) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
The revisions read as follows:
(a) * * * (1) The chemical substance identified generically as siloxanes and silicones, aminoalkyl, fluorooctyl, hydroxy-terminated salt (PMN P-00-1132 and SNUN S-11-5) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(2) * * *
(i)
The revisions read as follows:
(a) * * * (1) The chemical substances identified as benzenesulfonic acid, mono C-
(2) * * *
(i)
The revisions read as follows:
(a)
(2) * * *
(i)
(A) Manufactured by other than the method described in premanufacture notice P-90-226 and significant new use notices P-96-1408, S-08-6, S-09-4, and S-13-49.
(B) Manufactured producing respirable, acicular fibers with an average aspect ratio of greater than 5. The average aspect ratio is defined as the ratio of average length to average diameter.
(ii) [Reserved]
(b) * * *
(1)
The revisions read as follows:
(a) * * * (1) The chemical substance identified as 1,3-Dimethyl-2-imidazolidinone (PMN P-93-1649, SNUN S-04-3 and S-11-3; CAS No. 80-73-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) * * *
(iii)
The revisions read as follows:
(a) * * *
(2) * * *
(ii)
(b) * * *
(1)
The revisions read as follows:
(a) * * *
(1) The chemical substance identified as 1-propene, 2,3,3,3-tetrafluoro- (PMN P-07-601 and SNUN S-14-11; CAS No. 754-12-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) * * *
(i)
(A) Use other than as a refrigerant: In motor vehicle air conditioning systems in new passenger cars and vehicles (
(B) Section 721.80(m) (commercial use other than: In passenger cars and vehicles in which the original charging of motor vehicle air conditioning systems with the PMN substance was done by the motor vehicle original equipment manufacturer (OEM), in stationary refrigeration, or in stationary air conditioning).
(C) Section 721.80(o) (use in consumer products other than products used to recharge the motor vehicle air conditioning systems in passenger cars and vehicles in which the original charging of motor vehicle air conditioning systems with the PMN substance was done by the motor vehicle OEM).
The revisions read as follows:
(a) * * *
(2) * * *
(i)
(ii) Disposal. Requirements as specified in § 721.85. A significant new of the substances is any method of disposal of a waste stream containing the PMN substances other than by incineration or by injection into a Class I or II waste disposal well.
(iii)
(ii) Disposal. Requirements as specified in § 721.85. A significant new of the substances is any method of disposal of a waste stream containing the PMN substances other than by incineration or by injection into a Class I or II waste disposal well.
(iii)
(b) * * *
(1)
The revisions read as follows:
(a) * * *
(2) * * *
(i)
(ii)
(iii)
(b) * * *
(1)
The revisions read as follows:
(a) * * *
(1) The chemical substances identified generically as partially fluorinated alcohol substituted glycols (PMNs P-10-58, P-10-59, P-10-60, and P-10-184) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) * * *
(i)
Fish and Wildlife Service, Interior.
Revised proposed rule.
We, the U.S. Fish and Wildlife Service, are amending our proposed rule under authority of section 4(d) of the Endangered Species Act of 1973, as amended (Act), that provides measures that are necessary and advisable to provide for the conservation of the Georgetown salamander (
We will consider comments received or postmarked on or before May 11, 2015. Comments submitted electronically using the Federal eRulemaking Portal (see Public Comments, below) must be received by 11:59 p.m. Eastern Time on the closing date.
(1)
(2)
We request that you send comments only by one of the methods described above. We will post all comments on
Adam Zerrenner, Field Supervisor, U.S. Fish and Wildlife Service, Austin Ecological Services Field Office, 10711 Burnet Rd, Suite 200, Austin, TX 78758; telephone 512-490-0057; facsimile 512-490-0974. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.
We intend that any final action resulting from this proposal will be as accurate and as effective as possible. Therefore, we request comments or suggestions on this revised proposed rule. We particularly seek comments concerning:
(1) Whether the measures outlined in this revised proposed rule are necessary and advisable for the conservation and management of the Georgetown salamander;
(2) The effectiveness of the adaptive management component incorporated within the measures outlined in this revised proposed rule; and
(3) Additional provisions the Service may wish to consider for a rule issued under section 4(d) of the Act (16 U.S.C. 1531
We will consider all comments and information received during our preparation of a final rule. Accordingly, the final rule may differ from this proposal.
You may submit your comments and materials concerning this proposed rule by one of the methods listed in
If you submit information via
Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on
On August 22, 2012, we published a proposed rule to list the Georgetown salamander (
The Georgetown salamander is entirely aquatic and depends on water from the Edwards Aquifer in sufficient quantity and quality to meet its life-history requirements for survival, growth, and reproduction. Degradation of habitat, in the form of reduced water quality and quantity and disturbance of spring sites, is the main threat to this species. For more information on the Georgetown salamander and its habitat, please refer to the February 24, 2014, final listing determination (79 FR 10236).
The Act does not specify particular prohibitions, or exceptions to those prohibitions, for threatened species. Instead, under section 4(d) of the Act, the Secretary of the Interior has the discretion to issue such regulations as she deems necessary and advisable to provide for the conservation of such species. The Secretary also has the discretion to prohibit by regulation, with respect to any threatened wildlife species, any act prohibited under section 9(a)(1) of the Act. Exercising this discretion, the Service developed general prohibitions (50 CFR 17.31) and exceptions to those prohibitions (50 CFR 17.32) under the Act that apply to most threatened wildlife species. Alternately, for other threatened species, under the authority of section 4(d) of the Act, the Service may develop specific prohibitions and exceptions that are tailored to the specific conservation needs of the species. In such cases, some of the prohibitions and authorizations under 50 CFR 17.31 and 17.32 may be appropriate for the species and incorporated into a rule under section 4(d) of the Act. However, these rules, known as 4(d) rules, will also include provisions that are tailored to the specific conservation needs of the threatened species and may be more or less restrictive than the general provisions at 50 CFR 17.31.
Under section 4(d) of the Act, the Secretary may publish a rule that modifies the standard protections for threatened species and that contains prohibitions tailored to the conservation of the species and that are determined to be necessary and advisable. Under this revised proposed 4(d) rule, the Service would provide that all of the prohibitions under 50 CFR 17.31 and 17.32 are necessary and advisable and, therefore, apply to the Georgetown salamander, except as noted below. This revised proposed 4(d) rule would not remove or alter in any way the consultation requirements under section 7 of the Act.
On December 20, 2013, the City Council of Georgetown, Texas, approved the Edwards Aquifer Recharge Zone Water Quality Ordinance (Ordinance No. 2013-59). In the February 24, 2014, proposed 4(d) rule (79 FR 10077), the Service proposed that take incidental to activities that are conducted consistent with the conservation measures contained in the ordinance would not be prohibited under the Act. Since we published the proposed 4(d) rule, the City of Georgetown has incorporated, and expanded upon, the ordinance in their Unified Development Code (UDC), which is the primary tool to regulate land development in Georgetown. This revised proposed rule provides greater clarity around the activities that are proposed to be covered.
For activities outside of habitat occupied by the Georgetown salamander, we propose that take of Georgetown salamanders that is incidental to regulated activities that are conducted consistent with the water quality regulations contained in chapter 11.07 of the City of Georgetown Unified Development Code (UDC 11.07) (
When a property owner submits a development application for a regulated activity on a tract of land located over the Edwards Aquifer Recharge Zone, that individual is required to submit a geologic assessment. The geologic assessment identifies and describes all springs and streams on any subject property, and the UDC establishes buffer zones around identified springs and streams. For springs, the buffer encompasses 50 meters (164 feet) extending from the approximate center of the spring outlet that is identified in a geologic assessment. For streams, the boundaries of the buffer must coincide with either the boundaries of the Federal Emergency Management Agency 1 percent floodplain or a calculated 1 percent floodplain, whichever is smaller. Thus, these stream buffers may vary depending on the size of the stream, but they may be no smaller than 200 feet (61 meters) wide with at least 75 feet (23 meters) from the centerline of the stream. Section 11.07.003 of the UDC states that no “regulated activities” may be conducted within the spring and stream buffers. “Regulated activities” are defined in Title 30, Texas Administrative Code section 213.3(28) as any construction-related or post-construction activities on the Recharge Zone of the Edwards Aquifer having the potential for polluting the Edwards Aquifer and hydrologically connected surface streams. More specific details on spring and stream buffers can be found in sections 11.07.003A. and B. of the UDC.
In addition to the establishment of these spring and stream buffers, the UDC outlines water quality best management practices designed to minimize sediment runoff, increase the removal of total suspended solids, prevent an increase in flow rates, and ensure spill containment for new or expanded roadways. These regulations in chapter 11.07 of the UDC are designed to reduce water quality degradation that may occur as a result of development. By reducing further water quality degradation that may result from development, these protective measures are also expected to minimize habitat degradation to the Georgetown salamander.
The UDC also outlines exemptions from the requirement to prepare a geologic assessment, the process by which a landowner may request a variance to the spring and stream buffer requirements, and exemptions to the spring and stream buffer requirements of section 11.07.003. Small (less than 5 acres (2 hectares)) single-family and two-family residential developments are exempt from submitting a geologic assessment; however, these developments are required to implement UDC water quality measures. Property owners may request a variance from the spring or stream buffer requirements. For unoccupied habitat, variances will be considered by the City of Georgetown's Planning and Zoning Commission. Properties with a site occupied by the Georgetown salamander are exempt from the spring and stream buffer requirements in chapter 11.07. Rather, UDC Appendix A outlines voluntary conservation measures to be implemented when undertaking regulated activities that occur on a tract of land with an occupied site, or within 984 feet (300 meters) of an occupied site.
For activities involving habitat occupied by the Georgetown salamander, we propose that take of the Georgetown salamander that is incidental to regulated activities that are conducted consistent with the voluntary guidelines described in Appendix A of the UDC will not be prohibited under the Act. Similar to chapter 11.07 of the UDC, the guidelines in Appendix A establish stream and spring buffers and allowable activities within those buffers; however, the measures described in Appendix A create larger, more protective buffers than those that appear in chapter 11 for unoccupied sites. First, Appendix A establishes a “No-Disturbance Zone” in the stream or waterway that a spring drains directly into; this zone extends 264 feet (80 meters) upstream and downstream from the approximate center the spring outlet of an occupied site and is bounded by the top of the bank. No regulated activities may occur within the “No-Disturbance Zone.” In addition, Appendix A establishes a “Minimal-Disturbance Zone” for the subsurface area that drains to the spring(s) at an occupied site; this zone consists of the area within 984 feet (300 meters) of the approximate center of the spring outlet of an occupied site, except those areas within the “No-Disturbance Zone.” Most regulated activities are also prohibited in the “Minimal-Disturbance Zone,” but single-family developments; limited parks and open space development; and wastewater infrastructure will be allowed. For additional details on the buffers around occupied sites and prohibited actions, please refer to the UDC Appendix A to Chapter 11.
Section 11.07.008 of the UDC also establishes an Adaptive Management Working Group (Working Group) that is responsible for reviewing data on a regular basis and making recommendations for specific changes in the management directions related to the voluntary conservation measures for occupied sites in Appendix A. Adaptive management of preservation of the Georgetown salamander is one of the duties tasked to the Working Group. Therefore, the guidelines described in Appendix A may change over time. Appendix A also indicates that the Working Group is authorized to hear and make recommendations to the Service regarding variances from the voluntary guidelines on a case-by-case basis and as long as the proposed variance will achieve the same level or greater level of water quality benefits and conservation objectives to the Georgetown salamander. The Working Group will also develop an annual report regarding the preservation of the Georgetown salamander, continuous monitoring of the Georgetown salamander, assessment of research priorities, and the effectiveness of the water quality regulations and guidelines. Copies of the UDC 11.07 and Appendix A are available at
Section 4(d) of the Act states that “the Secretary shall issue such regulations as [s]he deems necessary and advisable to provide for the conservation” of species listed as threatened species. Conservation is defined in the Act to mean “to use and the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to [the Act] are no longer necessary.”
The courts have recognized the extent of the Secretary's discretion under this standard to develop rules that are appropriate for the conservation of a species. For example, the Secretary may find that it is necessary and advisable not to include a taking prohibition, or to include a limited taking prohibition. See
Section 9 prohibitions make it illegal for any person subject to the jurisdiction of the United States to take (including harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or attempt any of these), import or export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any wildlife species listed as an endangered species, without written authorization. It also is illegal under section 9(a)(1) of the Act to possess, sell, deliver, carry, transport, or ship any such wildlife that is taken illegally. Prohibited actions consistent with section 9 of the Act are outlined for threatened wildlife in 50 CFR 17.31(a) and (b). For the Georgetown salamander, the Service has determined that a 4(d) rule tailored to its specific conservation needs is appropriate. This revised proposed 4(d) rule proposes that all prohibitions in 50 CFR 17.31(a) and (b) will apply to the Georgetown salamander, except as described below.
Under this revised proposed 4(d) rule, incidental take of the Georgetown salamander will not be considered a violation of section 9 of the Act if the take occurs on privately owned, State, or County land and from regulated activities that are conducted consistent with the water quality protection measures contained in chapter 11.07 and Appendix A of the City of Georgetown Unified Development Code. This revised proposed 4(d) rule refers to the definition of “regulated activities” in Title 30, Texas Administrative Code section 213.3(28), which are any construction related or post-construction activities on the recharge zone of the Edwards Aquifer having the potential for polluting the Edwards Aquifer and hydrologically connected surface streams. Our rationale for including this provision is explained in the paragraphs that follow.
The local community in the City of Georgetown and Williamson County has expressed a desire to design and implement a local solution to conserving the natural resources in their county, including water quality and the Georgetown salamander (City of Georgetown Resolution No. 082812-N). Because impervious cover levels within most of the springsheds known to be occupied by the Georgetown salamander are still relatively low, a window of opportunity exists to design and implement measures to protect water quality and, therefore, conserve the salamander. The City and County's approach for accomplishing this conservation goal includes both regulatory and non-regulatory actions, as described below. Regulatory actions include passage of the Edwards Aquifer Recharge Zone Water Quality Ordinance (Ordinance No. 2013-59) by the Georgetown City Council on December 20, 2013, and the revisions to their UDC (chapter 11.07) finalized on February 24, 2015. Their approach also includes nonregulatory actions, such as the technical guidance provided in Appendix A of the UDC, which outlines additional conservation measures to protect water quality and to avoid direct destruction of occupied sites.
Habitat modification, in the form of degraded water quality and quantity and disturbance of spring sites, is the primary threat to the Georgetown salamander. The conservation measures in both chapter 11.07 and Appendix A of the UDC provide a variety of water quality protection measures, such as the creation of buffers around springs and streams where regulated activities are prohibited, designed to lessen impacts to the water quality of springs and streams in the Edwards Aquifer Recharge Zone. Although the UDC addresses water quality, regulating water quantity and groundwater withdrawal is outside the scope of the UDC. The UDC is applied throughout the watersheds that contain the Georgetown salamander. This watershed-level approach works to avoid incremental environmental degradation that may go unnoticed on a small, individual project scale. Through this revised proposed 4(d) rule, we could achieve a greater level of conservation for the Georgetown salamander than we could without it because it encourages implementation of the water quality protective measures that are likely to limit habitat degradation for Georgetown salamanders. The majority of salamanders occur within 164 feet (50 meters) of a spring outlet; this coincides with the spring and stream buffers for unoccupied sites. We also believe the salamander populations exist through underground conduits that may extend 984 feet (300 meters) around cave or spring points; this area coincides with the size of the “Minimal-Disturbance” Zones for occupied sites. By limiting development activities within these respective areas, the measures in the UDC 11.07 and Appendix A are expected to limit water quality degradation in these areas that may provide suitable surface or subsurface habitat for the Georgetown salamander regardless of occupancy. In addition, although the areas that provide recharge and the source water for specific areas occupied by the salamander have not been precisely delineated, this watershed-level approach makes it likely that these unknown recharge areas are covered under the UDC. This is because the UDC requires buffers around all springs and streams where regulated activities are prohibited; thus, water quality impacts are expected to be limited.
This watershed-level approach also includes an adaptive management component that will allow the Adaptive Management Working Group (Working Group) to evaluate the response of salamander populations to management actions and quickly respond and recommend adjustments, if necessary, to management strategies to protect water quality consistent with conserving the Georgetown salamander. The UDC formalizes the Working Group with representatives from the City of Georgetown, Williamson County, Texas Commission on Environmental Quality, Texas Parks and Wildlife Department, university scientists, private real estate developers, and the U.S. Fish and Wildlife Service. The role of the Working Group is to:
• Review scientific information to understand the latest science on watershed management practices and the conservation of the Georgetown salamander;
• Recommend support for additional Georgetown salamander scientific studies and oversee a long-term monitoring program to ensure that salamander abundance at monitored locations are stable or improving;
• Conduct and evaluate water quality trend analysis as part of its long-term monitoring program to ensure water quality conditions do not decline and, in turn, result in impacts to salamander abundance; and
• Make recommendations for changes to the UDC Appendix A for occupied sites if scientific and monitoring information indicates that water quality and salamander protection measures need changes to minimize impacts to salamander populations and to attain the goal of species conservation.
While a window of opportunity exists to design and implement conservation measures to conserve the Georgetown salamander, human population levels and development are expected to increase rapidly in Williamson County (Texas State Data Center 2012, pp. 166-167). Therefore, the success of the local community's efforts will depend on this robust adaptive management program designed to monitor and quickly assess the effectiveness of the identified conservation measures and strategies in attaining the goal of species' conservation, and to respond quickly and adapt the measures and strategies as needed to attain the goal. The adaptive management approach will ensure that the water quality protective measures are serving their intended purpose of conserving the Georgetown salamander, thereby providing for the conservation of the species. Adaptive management measures related to UDC 11.07 and Appendix A that are agreed upon by the Working Group and consistent with the goal of preserving the Georgetown salamander would be covered under this revised proposed 4(d) rule.
By not prohibiting incidental take resulting from regulated activities conducted in accordance with the UDC 11.07 and Appendix A, the Service is supporting and encouraging a local solution to conservation of the Georgetown salamander. This revised proposed 4(d) rule would provide the Service the opportunity to work cooperatively, in partnership with the local community and State agencies, on conservation of the Georgetown salamander and the ecosystems on which it depends. Leveraging our conservation capacity with that of the State, local governments, and the conservation community at large may make it possible to attain biological outcomes larger than those we could attain ourselves due to the watershed-scale protection the UDC requires. Further, these local partners are better able to design solutions that minimize socioeconomic impacts, thereby encouraging participation in measures that will protect water quality and conserve the Georgetown salamander. In addition, by not prohibiting incidental take resulting from regulated activities conducted in accordance with UDC 11.07 and Appendix A, the Service is providing a streamlining mechanism for compliance with the Act for those project proponents who comply with the protective measures in the UDC 11.07 and Appendix A and, thus, would be covered by this revised 4(d) rule. Developers who comply with these protective measures outlined in this proposed rule can implement their projects without any potential delay from seeking incidental take coverage from the Service, while also minimizing water quality degradation; this simple approach makes streamlined compliance more enticing for project proponents and is likely to result in increased implementation of water quality protective measures that benefit salamanders than would occur otherwise.
Based on the rationale explained above, the provisions included in this revised proposed 4(d) rule are necessary and advisable to provide for the conservation of the Georgetown salamander. If an activity that may affect the species is not regulated by UDC 11.07 or is not in accordance with the UDC 11.07 and Appendix A, or a person or entity is not in compliance with all terms and conditions of the UDC 11.07 and Appendix A, and the activity would result in an act that would be otherwise prohibited under 50 CFR 17.31, then provisions of 50 CFR 17.31 and 17.32 for threatened species will apply. In such circumstances, the prohibitions of 50 CFR 17.31 would be in effect, and authorization under 50 CFR 17.32 would be required.
In addition, nothing in this revised proposed 4(d) rule affects in any way other provisions of the Act such as the designation of critical habitat under section 4, recovery planning provisions of section 4(f), and consultation requirements under section 7.
The Service is conducting a National Environment Policy Act (NEPA; 42 U.S.C. 4321
In accordance with our joint policy published in the
Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this rule is not significant.
Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this revised proposed 4(d) rule in a manner consistent with these requirements.
Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601
On February 24, 2014 (79 FR 10236), we published the final determination to list the Georgetown salamander as a threatened species. That rule became effective on March 26, 2014. As a result, the Georgetown salamander is currently covered by the full protections of the Act, including the full section 9 prohibitions that make it illegal for any person subject to the jurisdiction of the United States to take (including harass, harm, pursue, shoot, wound, kill, trap, capture, or collect; or attempt any of these), import or export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any wildlife species listed as an endangered species, without written authorization. It also is illegal under section 9(a)(1) of the Act to possess, sell, deliver, carry, transport, or ship any such wildlife that is taken illegally. Prohibited actions consistent with section 9 of the Act are outlined for threatened species in 50 CFR 17.31(a) and (b). This revised proposed 4(d) rule proposes that all prohibitions in 50 CFR 17.31(a) and (b) will apply to the Georgetown salamander, except regulated activities that are conducted consistent with the water quality protective measures contained in Chapter 11.07 and Appendix A of the Unified Development Code, which would result in a less restrictive regulation under the Act, as it pertains to the Georgetown salamander, than would otherwise exist. For the above reasons, we certify that if promulgated, the revised proposed rule would not have a significant economic impact on a substantial number of small entities. Therefore, an initial regulatory flexibility analysis is not required.
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
(a) This proposed rule would not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or Tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or [T]ribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and [T]ribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or Tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; AFDC work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”
(b) This revised proposed 4(d) rule proposes that all prohibitions in 50 CFR 17.31(a) and (b) will apply to the Georgetown salamander, except activities that are conducted consistent with the water quality protection measures contained in Chapter 11.07 and Appendix A of the Unified Development Code, which would result in a less restrictive regulation under the Act, as it pertains to the Georgetown salamander, than would otherwise exist. As a result, we do not believe that this rule would significantly or uniquely affect small governments. Therefore, a Small Government Agency Plan is not required.
In accordance with Executive Order 12630, this proposed rule would not have significant takings implications. We have determined that the rule has no potential takings of private property implications as defined by this Executive Order because this revised proposed 4(d0 rule would result in a less-restrictive regulation under the Endangered Species Act than would otherwise exist. A takings implication assessment is not required.
In accordance with Executive Order 13132, this revised proposed rule does not have significant Federalism effects. A federalism summary impact statement is not required. This proposed rule would not have substantial direct effects on the State, on the relationship between the Federal Government and the State, or on the distribution of power and responsibilities among the various levels of government.
In accordance with Executive Order 12988, the Office of the Solicitor has determined that this revised proposed rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.
Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking actions that significantly affect energy supply, distribution, and use. For reasons discussed within this proposed rule, we believe that the rule would not have any effect on energy supplies, distribution, and use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.
We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(a) Be logically organized;
(b) Use the active voice to address readers directly;
(c) Use clear language rather than jargon;
(d) Be divided into short sections and sentences; and
(e) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
This rule does not contain any new collections of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. This rule will 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.
We have prepared a draft environmental assessment, as defined under the authority of the National Environmental Policy Act of 1969. For information on how to obtain a copy of the draft environmental assessment, see
In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes. We determined that there are no known tribal lands within the range of the Georgetown salamander.
The primary authors of this proposed rule are the staff members of the Austin Ecological Services Field Office (see
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we propose to further amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as proposed to be amended at 79 FR 10077 (February 24, 2014) as set forth below:
16 U.S.C. 1361-1407; 1531-1544; 4201-4245; unless otherwise noted.
(e) * * *
(2)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes to implement management measures described in Framework Amendment 2 to the Fishery Management Plan (FMP) for the Coastal Migratory Pelagic (CMP) Resources in the Gulf of Mexico and Atlantic Region (Framework Amendment 2), as prepared and submitted by the South Atlantic and Gulf of Mexico Fishery Management Councils (Councils). If implemented, this proposed rule would remove the unlimited commercial trip limit for Spanish mackerel in Federal waters off the east coast of Florida on weekdays beginning December 1 of each year. Since the trip limit system has been in place, fishery conditions and regulations have changed. This proposed rule intends to modify the current trip limit system to better fit the current fishery conditions and catch limits for Atlantic migratory group Spanish mackerel in the southern zone, while increasing social and economic benefits of the CMP fishery.
NMFS must receive written comments on the proposed rule by May 11, 2015.
You may submit comments on the proposed rule, identified by “NOAA-NMFS-2014-0136” by any of the following methods:
•
•
Framework Amendment 2 to the FMP, which includes an environmental assessment and a regulatory impact review, is available from
Karla Gore, NMFS Southeast Regional
The CMP fishery of the South Atlantic and Gulf of Mexico (Gulf) includes Spanish mackerel and is managed under the FMP. The FMP was prepared by the Councils and implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
The Magnuson-Stevens Act requires that NMFS and regional fishery management councils prevent overfishing and achieve, on a continuing basis, the optimum yield from federally managed fish stocks. These mandates are intended to ensure that fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, and protecting marine ecosystems. To further this goal, the Magnuson-Stevens Act requires fishery managers to minimize bycatch and bycatch mortality to the extent practicable.
This proposed rule would modify the commercial trip limit system for Atlantic migratory group Spanish mackerel. Since the current trip limit regime has been in place, changes in fishery conditions, such as an increase of the commercial annual catch limit (ACL), have necessitated modifications to some elements of the current trip limit system.
Currently, the commercial trip limit for Atlantic migratory group Spanish mackerel in Federal waters off the eastern coast of Florida is 3,500 lb (1,588 kg) from the start of the fishing year on March 1 through November 30. Starting December 1, there is no trip limit on weekdays, and the trip limit is 1,500 lb (680 kg) on weekends. There is no trip limit on weekdays until 75 percent of the adjusted quota (set at 250,000 lb (113,400 kg) below the commercial ACL (adjusted quota)) is landed, after which the trip limit is 1,500 lb (680 kg) every day. When 100 percent of the adjusted quota is reached, the trip limit is reduced to 500 lb (227 kg) until the end of the fishing year or until the full quota is met or projected to be met. The adjusted quota provides a buffer to help prevent the commercial sector from exceeding the commercial ACL. North of a line extending offshore from the state boundary of Georgia and Florida, the trip limit in Federal waters is 3,500 lb (1,588 kg) year-round.
The lack of a commercial trip limit for Atlantic migratory group Spanish mackerel in Federal waters off the eastern coast of Florida on weekdays beginning December 1 may contribute to early closures. Therefore, this proposed rule would establish a trip limit of 3,500 lb (1,588 kg) for Spanish mackerel in Federal waters offshore of South Carolina, Georgia, and eastern Florida, which is the area recently established by the final rule implementing Amendment 20B to the FMP as the southern zone (80 FR 4216, January 27, 2015). When 75 percent of the adjusted southern zone quota (2,417,330 lb (1,096,482 kg)) is met or projected to be met, the trip limit would be reduced to 1,500 lb (680 kg). When 100 percent of the adjusted southern zone quota is met or projected to be met, the trip limit would be reduced to 500 lb (227 kg) until the end of the fishing year or until the southern zone commercial quota is met or projected to be met, at which time the commercial sector in the southern zone would be closed to harvest of Spanish mackerel. The modified system of trip limits described above would remove the unlimited weekday trip limit to control harvest more effectively.
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the FMP, other provisions of the Magnuson-Stevens Act, and other applicable laws, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if implemented, would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is as follows:
The objective of this proposed rule is to respond to changing fishery characteristics for the Atlantic migratory group Spanish mackerel component of the CMP fishery, reduce the complexity of the commercial trip limit system for this component, and increase social and economic benefits while ensuring resource protection. The Magnuson-Stevens Act provides the statutory basis for this proposed rule.
If implemented, NMFS expects this proposed rule to directly affect all commercial fishing vessels that harvest Atlantic migratory group Spanish mackerel. A Federal commercial permit is required to harvest Spanish mackerel in the Atlantic exclusive economic zone (EEZ) in excess of the bag limit and to sell these species. On May 6, 2014, 1,729 vessels possessed a valid Federal commercial Spanish mackerel permit. A valid permit is a permit that has not expired and may be actively fished. Because the Federal commercial Spanish mackerel permit is an open access permit, expired permits are not renewed; if a permit expires before renewal, a new permit would be issued (if applied for) instead of renewal of the expired permit. The Federal commercial Spanish mackerel permit allows fishermen to harvest commercial quantities of Atlantic and Gulf migratory group Spanish mackerel in the Atlantic and the Gulf EEZ. Over the 2007-2008 through 2011-2012 fishing years (March through February), an average of 387 vessels per year recorded harvests of Atlantic migratory group Spanish mackerel. More recent data on vessel identification and harvest revenues from all fishing activity by these vessels are not available. Therefore, NMFS expects this proposed rule would affect an estimated 387 commercial fishing vessels per year.
NMFS has not identified any other small entities that this proposed rule would be expected to directly affect.
The SBA has established size criteria for all major industry sectors in the U.S., including commercial fish harvesters. A business involved in commercial fish harvesting is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $20.5 million (NAICS code 114111, finfish fishing) for all its affiliated operations worldwide. The estimated average annual gross revenue from all fishing activity by a commercial vessel that harvests Atlantic migratory group Spanish mackerel is approximately $32,100 (2013 dollars). Because the average annual revenue estimate provided above is significantly less than the SBA revenue threshold for this sector, all commercial vessels expected to be directly affected by this proposed rule are believed to be small business entities.
This proposed rule would not require any new reporting, record-keeping, or other compliance requirements associated with reporting or record-keeping that may require professional skills.
If implemented, NMFS expects the effects of this proposed rule to range from no economic effects to a small
Based on data from the 2003-2004 through 2012-2013 fishing years,
Annual catch limit, Fisheries, Fishing, Gulf of Mexico, Quotas, South Atlantic, Spanish mackerel.
For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:
16 U.S.C. 1801
(b) * * *
(1)
(i) Northern zone. Spanish mackerel in or from the EEZ may not be possessed on board or landed in a day from a vessel for which a permit for Spanish mackerel has been issued, as required under § 622.370(a)(3), in amounts exceeding 3,500 lb (1,588 kg).
(ii) Southern zone. Spanish mackerel in or from the EEZ may not be possessed on board or landed in a day from a vessel for which a permit for Spanish mackerel has been issued, as required under § 622.370(a)(3)—
(A) From March 1 until 75 percent of the adjusted quota for the southern zone has been reached or is projected to be reached, in amounts exceeding 3,500 lb (1,588 kg).
(B) After 75 percent of the adjusted quota for the southern zone has been reached or is projected to be reached, in amounts exceeding 1,500 lb (680 kg).
(C) After 100 percent of the adjusted quota for the southern zone has been reached or is projected to be reached, and until the end of the fishing year or the southern zone's quota has been reached or projected to be reached, in amounts exceeding 500 lb (227 kg). See § 622.384(e) for limitations regarding Atlantic migratory group Spanish mackerel after the southern zone's quota is reached.
(2) For the purpose of paragraph (b)(1)(ii) of this section, the adjusted quota for the southern zone is 2,417,330 lb (1,096,482 kg). The adjusted quota for the southern zone is the quota for the Atlantic migratory group Spanish mackerel southern zone reduced by an amount calculated to allow continued harvest of Atlantic migratory group Spanish mackerel at the rate of 500 lb (227 kg) per vessel per day for the remainder of the fishing year after the adjusted quota is reached. Total commercial harvest in the southern zone is still subject to the southern zone quota and accountability measures. By filing a notification with the Office of the Federal Register, the Assistant Administrator will announce when 75 percent and 100 percent of the adjusted quota are reached or is projected to be reached.
Agricultural Marketing Service, USDA.
Notice; call for nominations.
The National Organic Standards Board (NOSB) was established to assist in the development of standards for substances to be used in organic production and to advise the Secretary on the implementation of the Organic Foods Production Act of 1990 (OFPA). Through this Notice, The USDA is requesting nominations to fill five (5) upcoming vacancies on the NOSB. The positions are as follows: Farmers/growers (2), consumer/public interest advocates (2), and a USDA Accredited Certifying Agent (1). The Secretary of Agriculture will appoint one person to each of these five positions to serve a 5-year term of office that will commence on January 24, 2016, and end January 23, 2021.
Written nominations must be postmarked on or before May 15, 2015.
Nomination applications are to be mailed to Rita Meade, USDA-AMS-NOP, 1400 Independence Avenue SW., Room 2648-S., Ag Stop 0268, Washington, DC 20250; or electronically sent via Email to:
Michelle Arsenault, (202) 720-0081; Email:
The OFPA of 1990, as amended (7 U.S.C. Section 6501
The NOSB is composed of 15 members; including 4 organic producers, 2 organic handlers, a retailer, 3 environmentalists/resource conservationists, 3 public/consumer representatives, a scientist, and a certifying agent. Through this Notice, USDA is seeking nominations to fill the following five (5) positions: Farmers/growers (2), consumer/public interest advocates (2), and a USDA Accredited Certifying Agent (1). As per the OFPA, individuals seeking appointment to the NOSB at this time must: Own or operate an organic farming operation; represent public interest or consumer interest groups; and/or be a certifying agent as identified under section 6515 of this title.
Selection criteria include such factors as: Understanding of organic principles and practical experience in the organic community; demonstrated experience in the development of public policy such as participation on public or private advisory boards, boards of directors or other comparable organizations; participation in standards development or involvement in educational outreach activities; a commitment to the integrity of the organic food and fiber industry; the ability to evaluate technical information and to fully participate in Board deliberation and recommendations; and the willingness to commit the time and energy necessary to assume Board duties; demonstrated experience and interest in organic production; organic certification; support of consumer and public interest organizations; demonstrated experience with respect to agricultural products produced and handled on certified organic farms; and such other factors as may be appropriate for specific positions.
To nominate yourself or someone else, please submit: A resume, a cover letter, and a Form AD-755, which can be accessed at:
If USDA receives a request under the Freedom of Information Act (FOIA) (5 U.S.C. 552), for records relating to NOSB nominations, your application materials may be released to the requester. Prior to the release of the information, personally identifiable information protected by the FIOA Privacy Act will be redacted.
Nominations are open to all individuals without regard to race, color, religion, gender, national origin, age, mental or physical disability, marital status, or sexual orientation. To ensure that the recommendations of the NOSB take into account the needs of the diverse groups that are served by the Department, membership on the NOSB shall include, to the extent practicable, individuals with demonstrated ability to represent minorities, women, and persons with disabilities.
The information collection requirements concerning the nomination process have been previously cleared by the Office of Management and Budget (OMB) under OMB Control No. 0505-0001.
Agricultural Marketing Service, USDA.
Notice.
The Agricultural Marketing Service (AMS) is announcing the 2015
April 10, 2015.
Sonia Jimenez, AMS, U.S. Department of Agriculture, Room 3069-S, 1400 Independence Ave. SW., Washington, DC 20250; telephone (202) 720-5115, fax (202) 720-8477; email
The Agricultural Marketing Act of 1946, as amended, (AMA)(7 U.S.C. 1621-1627), provides for the collection of fees to cover costs of various inspection, grading, certification or auditing services covering many agricultural commodities and products. The AMA also provides for the recovery of costs incurred in providing laboratory services. The Cotton Statistics and Estimates Act (7 U.S.C. 471-476) and the U.S. Cotton Standards Act (7 U.S.C. 51-65) provide for classification of cotton and development of cotton standards materials necessary for cotton classification. The Cotton Futures Act (7 U.S.C. 15b) provides for futures certification services and the Tobacco Inspection Act (7 U.S.C. 511-511s) provides for tobacco inspection and grading. These Acts also provide for the recovery of costs associated with these services.
On November 13, 2014, The Department of Agriculture (Department) published in the
This notice announces the fee rates for voluntary grading, inspection, certification, auditing and laboratory services for a variety of agricultural commodities including meat and poultry, fruits and vegetables, eggs, dairy products, and cotton and tobacco on a per-hour rate and, in some instances, the equivalent per-unit cost. The per-unit cost is provided to facilitate understanding of the costs associated with the service to the industries that historically used unit-cost basis for payment. The fee rates will be effective at the beginning of the fiscal year, crop year, or as required by specific laws (June 1 for cotton programs).
The rates reflect direct and indirect costs of providing services. Direct costs include the cost of salaries, employee benefits, and if applicable, travel and some operating costs. Indirect or overhead costs include the cost of Program and Agency activities supporting the services provided to the industry.
These services include the grading, inspection or certification of quality factors in accordance with established U.S. Grade Standards; audits or accreditation according to International Organization for Standardization (ISO) standards and/or Hazard Analysis and Critical Control Point (HACCP) principles; and other marketing claims. The quality grades serve as a basis for market prices and reflect the value of agricultural commodities to both producers and consumers. AMS' grading and quality verification and certification, audit and accreditation, plant process and equipment verification, and laboratory approval services are voluntary tools paid by the users on a fee-for-service basis. The agriculture industry can use these tools to promote and communicate the quality of agricultural commodities to consumers. Laboratory services are provided for analytic testing, including but not limited to chemical, microbiological, biomolecular, and physical analyses. AMS is required by statute to recover the costs associated with these services.
As required by the Cotton Statistics and Estimates Act (7 U.S.C. 471-476), consultations regarding the establishment of the fee for cotton classification with U.S. cotton industry representatives were held between January 2014 and the present. Representatives of all segments of the cotton industry, including producers, ginners, bale storage facility operators, merchants, cooperatives, and textile manufacturers were informed of the fees during various industry-sponsored forums.
AMS calculated the rate for services, per hour per program employee using the following formulas (a per-unit base is included for programs that charge services based on a per-unit base):
(1)
(2)
(3)
All rates are per-hour except when a per-unit cost is noted. The specific amounts in each rate calculation are available upon request from the specific AMS program.
7 U.S.C. 15b; 7 U.S.C. 473a-b; 7 U.S.C. 55 and 61; 7 U.S.C. 51-65; 7 U.S.C. 471-476; 7 U.S.C. 511, 511s; and 7 U.S.C. 1621-1627.
Food and Nutrition Service (FNS), USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this information collection. This collection is a revision of a currently approved collection which FNS employs to determine public participation in the School Breakfast Program.
Written comments must be received on or before June 8, 2015.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments may be sent to: Lynn Rodgers-Kuperman, Branch Chief, Program Monitoring, Child Nutrition Programs, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 636, Alexandria, VA 22302-1594. Comments may also be submitted via fax to the attention of Lynn Rodgers-Kuperman at 703-305-2879 or via email to
All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.
Requests for additional information or copies of this information collection should be directed to Lynn Rodgers at 703-305-2595.
See the table below for estimated total annual burden for each type of respondent.
Food and Nutrition Service, FNS, USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This is a revision of a currently approved collection for SNAP, Request for Administrative Review.
Written comments must be received on or before June 8, 2015.
Comments are invited on (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to 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.
Comments may be sent to: Shanta Swezy, Branch Chief, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 418, Alexandria, Virginia 22302. Comments may also be submitted via fax to the attention of Shanta Swezy at (703) 305-1863 or via email to
All responses to this notice will be summarized and included in the request for Office and Management and Budget approval. All comments will be a matter of public record.
Requests for additional information should be directed to Shanta Swezy, (703) 305-2238.
Forest Service, USDA.
Notice; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the reinstatement with change for the information collection, National Woodland Owner Survey (NWOS).
Comments must be received in writing on or June 8, 2015 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Comments concerning this notice should be addressed to Brett Butler, USDA Forest Service, Northern Research Station, 160 Holdsworth Way, Amherst, MA 01003.
Comments also may be submitted via facsimile to 413-545-1860 or by email to
Comments submitted in response to this notice may be made available to the public through relevant Web sites and upon request. For this reason, please do
The public may inspect the draft supporting statement and/or comments received at Northern Research Station during normal business hours. Visitors are encouraged to call ahead to 413-545-1387 to facilitate entry to the building. The public may request an electronic copy of the draft supporting statement and/or any comments received be sent via return email. Requests should be emailed to
Brett Butler, by phone at 413-545-1387. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.
• Who owns and manages the forest and other wooded lands of the United States;
• Why they own/manage it;
• How they have used it; and
• How they intend to use it.
The Forest Service's direction and authority to conduct the NWOS is from the Forest and Range Land Renewable Resources Planning Act of 1974 and the Forest and Range Land Renewable Resources Act of 1978. These Acts assign responsibility for the inventory and assessment of forest and related renewable resources to the Forest Service. Additionally, the importance of an ownership survey in this inventory and assessment process is highlighted in section 253(c) of the Agricultural Research, Extension, and Education Reform Act of 1998 and the recommendations of the Second Blue Ribbon Panel on the Forest Inventory and Analysis program (FIA).
Previous iterations of the NWOS were conducted in 1978, 1993, 2002-2006, and 2011-2013. Approval for the last iteration of the NWOS expired on August 31, 2013. As planned, approval for the information collection was allowed to lapse after 2013 to permit a full assessment of the program that has now been completed. If reinstated, the NWOS will operate for another 3-year cycle.
Information will be collected related to:
• The characteristics of the land holdings;
• Attitudes and perceptions of the owners and managers;
• Resource uses and management activities; and
• Where applicable, landowner demographics.
Separate survey instruments are being developed for families and individuals, corporate, and public ownerships. In addition, the owners in urban areas will be sent a different survey instrument. For the families and individuals, the dominant ownership group of forest and other wooded land, a subset of ownerships will be sent survey instruments addressing the following topics, in addition to the core questions from the base survey instrument:
• Climate change;
• Wildfires;
• Invasive species;
• Land owner values; and
• Decision making.
The NWOS provides widely cited benchmarks for the number, extent, and characteristics of owners of forest and other wooded land in the United States. These results have been used to assess the sustainability of forest resources at national, regional, and State levels; to implement and assess forest-land owner assistance programs; and to answer a variety of questions with topics ranging from fragmentation to the economics of timber production. This is the only effort to collect in-depth information about owners of forest and other wooded land at the national scale. It provides longitudinal data to track ownership trends and broad spatial data to allow for comparisons across regions of the country.
The respondents will be a statistically selected group of individuals, families, American Indian tribes, partnerships, corporations, nonprofit organizations, and other private groups that own forest and other wooded land in the United States in addition to a statistically selected group of Federal, State, and local government agencies that manage forest and other wooded land. A well distributed, random set of sampling points has been established across the country. At each point, remotely sensed data, such as aerial photographs or satellite imagery, will be used to identify forested/wooded points. For the forested/wooded points, public records will be used to identify the owners on record—the names and addresses of the landowners we will contact. The number of owners of forest and other wooded land to be contacted in each State will be a function of the number of owners of forest and other wooded land and the sampling intensity.
The NWOS will utilize a mixed-mode survey technique involving cognitive interviews, focus groups, self-administered questionnaires, and telephone interviews. Cognitive interviews will be used to test the questionnaires. Focus groups will be used to provide more in-depth understanding of the responses and to explore new areas of inquiry.
The implementation of the self-administered survey will involve up to four contacts. First, a pre-notice postcard will be sent to all potential respondents describing this information collection and why the information is being collected. Second, a questionnaire with a cover letter and pre-paid return envelope will be sent to the potential respondents. The cover letter will reiterate the purpose of this information collection and provide the respondents with all legally required information. Third, a reminder will be mailed to thank the respondents and encourage the non-respondents to reply. Those who have yet to respond will be sent a new questionnaire, cover letter, and pre-paid return envelope. Telephone interviews will be used for follow-up with non-respondents. For corporations and public agencies, the primary survey instrument will be electronic, and for all other owners, the primary survey instrument will be paper forms with the
Forest Service researchers will coordinate all components of this information collection. Forest Service personnel with assistance provided by contractors and cooperators, such as university researchers, will conduct the mail portion of the survey, cognitive interviews, and focus groups. The U.S. Department of Agriculture, National Agricultural Statistics Service will conduct the telephone follow-ups. Data will be compiled and edited by Forest Service personnel with assistance provided by contractors and cooperators as appropriate. Forest Service researchers and cooperators will analyze the collected data. National, regional, and State-level results will be distributed through print and/or electronic media.
This information collection will generate scientifically-based, statically-reliable, up-to-date information about the owners of forest and other wooded land in the United States. The results of these efforts will provide more reliable information on this important and dynamic segment of the United States population; thus facilitating more complete assessments of the country's forest and other wooded land resources and improved planning and implementation of forestry programs on state, regional, and national levels.
Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request toward Office of Management and Budget approval.
Forest Service, USDA.
Notice; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with no revision of a currently approved information collection, Understanding Value Trade-offs regarding Fire Hazard Reduction Programs in the Wildland-Urban Interface.
Comments must be received in writing on or before June 8, 2015 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Comments concerning this notice should be addressed to José Sánchez, USDA Forest Service, Pacific Southwest Research Station, 4955 Canyon Crest Drive, Riverside, California 92507.
Comments may also be submitted via facsimile to 951-680-1501, or by email to
The public may inspect comments received at the Pacific Southwest Research Station, during normal business hours. Visitors are encouraged to call ahead to facilitate entry to the building.
José Sánchez, by phone at 951-680-1560. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.
A random sample of residents are contacted via random-digit dialed telephone calls and asked to participate in the research study and type of questionnaire (paper or online versions). Those agreeing to participate then answer a minimal set of questions to determine pre-existing knowledge of fuels reduction treatments and provide a mailing address, as well as agreeing to a date and time for an in-depth interview related to the mail questionnaire or to provide email address where to send them a link for an online questionnaire. After completion of the in-depth interview or online questionnaire, no further contact with the participants will occur.
A university research-survey center collects the information for mail/online questionnaires. A Forest Service researcher and collaborators at a cooperating university analyze the data collected. Both researchers are experienced in applied economic non-market valuation research and survey research methods.
The Forest Service, Bureau of Land Management, Bureau of Indian Affairs, National Park Service, Fish and Wildlife Service, as well as many State agencies
At present the Forest Service, Bureau of Land Management, Bureau of Indian Affairs, National Park Service, Fish & Wildlife Service, and many State agencies with fire protection responsibilities continue an ambitious and costly fuels reduction program for fire risk reduction and will benefit from public opinion on which treatments are most effective or desirable.
Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request toward Office of Management and Budget approval.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Mississippi Advisory Committee (Committee) will hold a meeting on Wednesday, April 29, 2015, at 1:30 p.m. CST for the purpose of hearing testimony on civil rights concerns relating to potential disparities in the distribution of federal child care subsidies in Mississippi on the basis of race or color. The committee previously approved a project proposal on the topic in February and plan to hold the public meeting and gather more testimony on the topic May 13, 2015, in Jackson, MS. The testimony heard during this meeting will be preliminary testimony primarily from academics and national experts to provide background to the Committee on the issues.
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-359-3627, conference ID: 5121265. Any interested member of the public may call this number and listen to the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Member of the public are also invited and welcomed to make statements at the end of the conference call. In addition, members of the public may submit written comments; the comments must be received in the regional office by May 29, 2015. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Administrative Assistant, Carolyn Allen at
Records and documents discussed during the meeting for public viewing prior to the meeting and will be available at
The meeting will be held on Wednesday, April 29, 2015, at 1:30 p.m. CST.
Economic Development Administration, Commerce.
Notice of an Open Meeting.
The National Advisory Council on Innovation and
Wednesday, April 29, 2015, Time: 2:00-3:00 p.m. EDT.
N/A, Teleconference, Dial-In: 1-877-950-4778, Passcode: 4423486.
The Council was chartered on November 10, 2009 to advise the Secretary of Commerce on matters related to innovation and entrepreneurship in the United States. NACIE's overarching focus is recommending transformational policies to the Secretary that will help U.S. communities, businesses, and the workforce become more globally competitive. The Council operates as an independent entity within the Office of Innovation and Entrepreneurship (OIE), which is housed within the U.S. Commerce Department's Economic Development Administration. NACIE members are a diverse and dynamic group of successful entrepreneurs, innovators, and investors, as well as leaders from nonprofit organizations and academia.
The purpose of this meeting is to discuss the Council's planned work initiatives in three focus areas: workforce/talent, entrepreneurship, and innovation. The final agenda will be posted on the NACIE Web site at
Julie Lenzer Kirk, Office of Innovation and Entrepreneurship, Room 70003, 1401 Constitution Avenue NW., Washington, DC 20230; email:
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on solid urea from the Russian Federation (Russia). The period of review (POR) is July 1, 2013, through June 30, 2014. The review covers one producer/exporter of the subject merchandise, MCC EuroChem (EuroChem). We preliminarily find that EuroChem has not sold subject merchandise at less than normal value during the POR. Interested parties are invited to comment on these preliminary results.
Michael Romani or Minoo Hatten, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0198 or (202) 482-1690, respectively.
The merchandise subject to the order is solid urea. The product is currently classified under the Harmonized Tariff Schedules of the United States (HTSUS) item number 3102.10.00.00. While the HTSUS subheading is provided for convenience and customs purposes, the written description is dispositive. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.
The Department conducted this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). Constructed export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions,
As a result of this review, we preliminarily determine that a weighted-average dumping margin of 0.00 percent exists for EuroChem for the period July 1, 2013, through June 30, 2014.
We intend to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Pursuant to 19 CFR 351.309(c), interested parties may submit cases briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically
The Department intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act.
Upon completion of the administrative review, the Department shall determine and U.S. Customs and Border Protection (CBP) shall assess antidumping duties on all appropriate entries. If EuroChem's weighted-average dumping margin is above
The Department clarified its “automatic assessment” regulation on May 6, 2003.
We intend to issue instructions to CBP 15 days after publication of the final results of this review.
The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of solid urea from Russia entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for EuroChem will be the rate established in the final results of this administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation but the manufacturer is, the cash deposit rate will be the rate established for the manufacturer of the merchandise for the most recently completed segment of this proceeding; (4) the cash deposit rate for all other manufacturers or exporters will continue to be 64.93 percent.
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Commerce.
On November 21, 2014, the Department of Commerce (the Department) published the preliminary results of the changed circumstances review (CCR) of the antidumping duty (AD) order on tapered roller bearings and parts thereof, finished and unfinished (TRBs), from the People's Republic of China (PRC).
Stephen Banea, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0656.
On June 15, 1987, the Department published in the
Effective August 1, 2012, the majority shareholder of SGBC merged with AB SKF (SKF) and, as a result of the merger, SGBC became part of the SKF Group. On February 13, 2013, SGBC/SKF requested that the Department conduct a CCR pursuant to 19 CFR 351.221(c)(3)(ii) to determine whether it is the successor-in-interest to SGBC as it existed prior to its affiliation with SKF, and on June 28, 2013, the Department published in the
On November 21, 2014, the Department published in the
On December 12, 2014, SGBC/SKF and Stemco LP (Stemco), a U.S. manufacturer and importer of TRBs from the PRC, submitted case briefs. On December 19, 2014, SGBC/SKF submitted a rebuttal brief. On January 16, 2015, the Department held a public hearing at the request of Stemco. On January 29, 2015, we extended the final results in this CCR to no later than April 1, 2015.
Imports covered by the order are shipments of tapered roller bearings and parts thereof, finished and unfinished, from the People's Republic of China; flange, take up cartridge, and hanger units incorporating tapered roller bearings; and tapered roller housings (except pillow blocks) incorporating tapered rollers, with or without spindles, whether or not for automotive use. These products are currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) item numbers 8482.20.00, 8482.91.0050, 8482.99.15, 8482.99.45, 8483.20.40, 8483.20.80, 8483.30.80, 8483.90.20, 8483.90.30, 8483.90.80, 8708.70.6060, 8708.99.2300, 8708.99.4850, 8708.99.6890, 8708.99.8115 and, 8708.99.8180. Although the HTSUS item numbers are provided for convenience and customs purposes, the written description of the scope of the order is dispositive.
All issues raised in the case and rebuttal briefs by parties to this CCR are addressed in the Issues and Decision Memorandum,
The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's AD and Countervailing Duty (CVD) Centralized Electronic Service System (ACCESS).
In the
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or
This notice is issued and published in accordance with sections 751(b)(1) and 777(i) of the Tariff Act of 1930, as amended, and 19 CFR 351.216 and 351.221(c)(3).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
In response to a request from Ashland Specialty Ingredients, a division of Hercules Inc., (Petitioner), and CP Kelco Oy (CP Kelco), the Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on purified carboxymethylcellulose (CMC) from Finland. The period of review (POR) is July 1, 2013, through June 30, 2014. The review covers one respondent, CP Kelco. We preliminarily find that sales of the subject merchandise by CP Kelco have not been made at prices below normal value (NV) during the POR. We invite interested parties to comment on these preliminary results.
Michael J. Heaney or Robert James, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4475 or (202) 482-0649, respectively.
The merchandise covered by the order is all purified CMC, sometimes also referred to as purified sodium CMC, polyanionic cellulose, or cellulose gum, which is a white to off-white, non-toxic, odorless, biodegradable powder, comprising sodium CMC that has been refined and purified to a minimum assay of 90 percent. The merchandise subject to the order is classified in the Harmonized Tariff Schedule of the United States at subheading 3912.31.00.
The Department is conducting this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). Export price and constructed export price are calculated in accordance with section 772 of the Act. NV is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions,
As a result of this review, we preliminarily determine the following weighted-average dumping margin for the period July 1, 2013, through June 30, 2014.
The Department intends to disclose to interested parties the calculations performed in connection with these preliminary results within five days of the date of publication of this notice.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically filed document must be received successfully in its entirety by the Departments electronic records system, ACCESS, by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice.
The Department intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any
Upon completion of the administrative review, the Department shall determine and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries. If CP Kelco's weighted-average dumping margin is above
The Department clarified its “automatic assessment” regulation on May 6, 2003.
We intend to issue instructions to CBP 15 days after publication of the final results of this review.
The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for CP Kelco Oy will be the rate established in the final results of this administrative review except if the rate is
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Commerce.
On February 26, 2015, the Department of Commerce (the Department) published the notice of initiation and the preliminary results of the changed circumstances review (CCR) of the antidumping duty order on certain cased pencils (pencils) from the People's Republic of China (PRC), in which the Department preliminarily determined that Beijing FILA Dixon Stationery Co., Ltd.
Sergio Balbontin, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6478.
On December 28, 1994, the Department published the
On November 27, 2014, Beijing Dixon requsted that the Department conduct a CCR pursuant to section 751(b)(1) of the Tariff Act of 1930, as amended (the Act), 19 CFR 351.216(b), and 19 CFR 351.221, to determine whether it is the successor-in-interest to Beijing Dixon for purposes of the Order.
The merchandise subject to the order includes pencils from the PRC. Pencils are currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheading 9609.1010. Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description is dispositive.
Because no interested parties submitted comments on the Department's
As explained in the
As a result of this determination, the Department finds that entries of subject merchandise exported by Beijing Dixon as currently structured should receive the same antidumping duty treatment with respect to cased pencils as its predecessor-in-interest. Accordingly, the Department will continue to instruct U.S. Customs and Border Protection to liquidate entries for Beijing Dixon without regard to antidumping duties.
This notice also serves as a reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested.
These final results of administrative review are issued and published in accordance with sections 751(b)(1) and 777(i) of the Act and 19 CFR 351.216(e).
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before June 8, 2015.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Walter Ikehara, (808) 725-5175 or
This request is for extension of a current information collection.
National Marine Fisheries Service (NMFS) requires, as codified under 50 CFR part 665, any person (1) fishing for, taking, retaining, or using a vessel to fish for Western Pacific coral reef ecosystem management unit species in the designated low-use Marine Protected Areas, (2) fishing for any of these species using gear not specifically allowed in the regulations, or (3) fishing for, taking, or retaining any Potentially Harvested Coral Reef Taxa in the coral reef ecosystem regulatory area, to obtain and carry a permit. A receiving vessel owner must also have a transshipment permit for at-sea transshipment of coral reef ecosystem management unit species. The permit application form provides basic information about the permit applicant, vessel, fishing gear and method, target species, projected fishing effort,
Information is submitted to NMFS, in the form of paper permit application forms.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Mid-Atlantic Fishery Management Council's (Council) River Herring and Shad (RH/S) Advisory Panel (AP) will meet to develop recommendations for the 2016-18 RH/S Cap on the Atlantic mackerel fishery and provide general input on RH/S conservation.
The meeting will be Friday, April 24, 2015 at 10:30 a.m.
The meeting will be held via webinar, but anyone can also attend at the Council office address (see below). The webinar link is:
Christopher M. Moore, Ph.D. Executive Director, Mid-Atlantic Fishery Management Council; telephone: (302) 526-5255. The Council's Web site,
The Council's River Herring and Shad (RH/S) Advisory Panel (AP) will meet to develop recommendations for the 2016-18 RH/S Cap on the Atlantic mackerel fishery and provide general input on RH/S conservation. There will also be time for public questions and comments. The Council will utilize the input from the RH/S AP at the June 2015 Council meeting when setting the 2016-18 RH/S Cap on the Atlantic mackerel fishery and discussing RH/S conservation.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before June 8, 2015.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Walter Ikehara, (808) 725-5175 or
This request is for extension of a currently approved information collection.
Federal regulations at Title 50, Part 665, of the Code of Federal Regulations require that owners of vessels fishing for, or landing, pelagic squid in the western Pacific region obtain a permit from NOAA Fisheries Service (NMFS). In addition, the regulations require vessel operators to report fishing activity and harvest on daily logbooks and mark their vessels for identification.
The information collected is used to identify participants in the fishery,
Vessel owners must identify their vessels to assist in aerial and at-sea enforcement of fishing regulations.
Respondents have a choice of either electronic or paper forms. Methods of submittal include email of electronic forms, and mail and facsimile transmission of paper forms.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Defense Security Cooperation Agency, DoD.
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 15-12 with attached transmittal, policy justification, and Sensitivity of Technology.
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
* as defined in Section 47(6) of the Arms Export Control Act
The Republic of Korea (ROK) has requested a possible sale of 400 AGM-114R1 Hellfire II Semi-Active Laser Missiles with containers, 100 ATM-114Q Air Training Missiles, and 12 M36E8 Hellfire II Captive Air Training Missiles. The estimated cost is $81 million.
This proposed sale will contribute to the foreign policy and national security objectives of the United States by meeting the legitimate security and defense needs of an ally and partner nation. The ROK is one of the major political and economic powers in East Asia and the Western Pacific and a key partner of the United States in ensuring peace and stability in that region. It is vital to the U.S. national interest to assist our Korean ally in developing and maintaining a strong and ready self-defense capability.
The ROK intends to use these Hellfire missiles to supplement its existing missile capability and current weapon inventory. This sale will contribute to the ROK's force modernization goals and enhance interoperability with U.S. forces. The ROK will use this enhanced capability to strengthen its homeland defense and deter regional threats. The ROK is capable of absorbing and maintaining these missiles in its inventory.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractor will be Lockheed Martin Corporation in Orlando, Florida. There are no known offset agreements in connection with this potential sale.
Implementation of this proposed sale will not require any additional U.S. Government or U.S. contractor personnel in Korea.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The AGM-114R Hellfire II Air-to-Ground Missile with container is 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 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.
2. The ATM-114Q Air Training Missile with mass stimulant warhead replicates the shape, aerodynamic properties, weight, center-of-gravity, and moment-of-inertia properties of a Hellfire II missile. The practice missile can be launched in a training environment simulating a tactical engagement without destroying the target. 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 maintenance, or training is Confidential.
3. The M36E8 Captive Air Training Missile (CATM) consists of a functional guidance section coupled to an inert missile bus and is used for flight training but cannot be launched. The missile has an operational semi-active laser seeker that can search for and lock-on to laser-designated targets. The CATM functions as a tactical missile (without launch capability) during captive carry on the aircraft, making it suitable for training the aircrew in simulated Hellfire missile target acquisition and lock. 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.
4. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures or equivalent systems which might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
5. A determination has been made that the recipient country can provide 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.
6. All defense articles and services listed in this transmittal have been authorized for release and export to the Republic of Korea.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following land acquisition reports:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA)
Notice of Proposed Consent Decree; Request for Public Comment
In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), notice is hereby given of a proposed consent decree to address a lawsuit filed by Bill Green (“Plaintiff”):
Written comments on the proposed consent decree must be received by May 11, 2015.
Submit your comments, identified by Docket ID number EPA-HQ-OGC-2015-0253, online at
Jonathan Skinner-Thompson, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone: (202) 564-0291; email address:
This proposed consent decree would resolve a lawsuit filed by Plaintiff seeking to compel the Administrator to take actions under CAA section 505(b)(2). Under the terms of the proposed consent decree, EPA would agree to sign a response to the petitions by May 29, 2015. The proposed consent decree also provides for the possibility that circumstances beyond EPA's reasonable control could delay compliance with the May 29, 2015 deadline, and provides a framework for extending that deadline. In addition, the proposed consent decree also enumerates Plaintiff's right to seek costs of litigation, including reasonable attorneys' fees, and provides that payment of those costs will constitute a full and complete settlement of all of Plaintiff's costs in connection with this litigation.
For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed consent decree from persons who are not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should be withdrawn, the terms of the consent decree will be affirmed.
The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2015-0253) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.
An electronic version of the public docket is available through
It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at
You may submit comments as provided in the
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
Use of the
Environmental Protection Agency (EPA).
Notice; request for comment.
The Environmental Protection Agency (EPA) receives from time to time Freedom of Information Act (FOIA) requests for documentation received or issued by EPA or data contained in EPA database systems pertaining to the export and import of Resource Conservation and Recovery Act (RCRA) hazardous waste from/to the United States, the export of cathode ray tubes (CRTs) and spent lead acid batteries (SLABs) from the United States, and the export and import of RCRA universal
Comments must be received on or before May 11, 2015. The period for submission of comments may be extended if, before the comments are due, you make a request for an extension of the comment period and it is approved by the EPA legal office. Except in extraordinary circumstances, the EPA legal office will not approve such an extension without the consent of any person whose request for release of the information under the FOIA is pending.
Submit your comments, identified by Docket ID No. EPA-HQ-OECA-2015-0002, by one of the following methods:
•
•
•
The
Eva Kreisler, International Compliance Assurance Division, Office of Federal Activities, Office of Enforcement and Compliance Assurance, Environmental Protection Agency, Mailcode: 2254A, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-8186; email address:
Today's notice relates to any documents or data in the following areas: (1) Export of Resource Conservation and Recovery Act (RCRA) hazardous waste, during calendar year 2014 or before, under 40 CFR part 262, subparts E and H; (2) import of RCRA hazardous waste, during calendar year 2014 or before, under 40 CFR part 262, subparts F and H; (3) transit of RCRA hazardous waste, during calendar year 2014 or before, under 40 CFR part 262, subpart H, through the United States and foreign countries; (4) export of cathode ray tubes, during calendar year 2014 or before, under 40 CFR part 261, subpart E; (5) exports of non-crushed spent lead acid batteries with intact casings, during calendar year 2014 or before, under 40 CFR part 266 subpart G; (6) export and import of RCRA universal waste, during calendar year 2014 or before, under 40 CFR part 273, subparts B, C, D, and F; (7) submissions from transporters, during calendar year 2014 or before, under 40 CFR part 263, or from treatment, storage or disposal facilities under 40 CFR parts 264 and 265, related to exports or imports of hazardous waste which occurred during calendar year 2014 or before, including receiving facility notices under 40 CFR 264.12(a)(1) and 265.12(a)(1) and import consent documentation under 40 CFR 264.71(a)3) and 265.71(a)(3).
EPA has previously published notices similar to this one in the
Specifically, EPA receives FOIA requests from time to time for documentation or data related to
Certain businesses, however, do not meet the definition of “affected business,” and are not covered by today's notice. They consist of any business that actually submitted information responsive to a FOIA request, under the authority of 40 CFR parts 260 through 266 and 268, and did not assert a claim of business confidentiality covering any of that information at the time of submission. As set forth in the RCRA regulations at 40 CFR 260.2(b), “if no such [business confidentiality] claim accompanies the information when it is received by EPA, it may be made available to the public without further notice to the person submitting it.” Thus, for purposes of this notice and as a general matter under 40 CFR 260.2(b), a business that submitted to EPA the documents at issue, pursuant to applicable regulatory requirements, and that failed to assert a claim as to information that pertains to it at the time of submission, cannot later make a business confidentiality claim.
In addition, EPA may develop its own documents and organize into its database systems information that was originally contained in documents from submitting businesses relating to exports and imports of hazardous waste. If a submitting business fails to assert a CBI claim for the documents it submits to EPA at the time of submission, not only does it waive its right to claim CBI for those documents, but it also waives its right to claim CBI for information in EPA's documents or databases that is based on or derived from the documents that were originally submitted by that business.
In accordance with 40 CFR 2.204(c) and (e), this notice inquires whether any affected business asserts a claim that any of the requested information constitutes CBI, and affords such business an opportunity to comment to EPA on the issue. This notice also informs affected businesses that, if a claim is made, EPA would determine under 40 CFR part 2, subpart B, whether any of the requested information is entitled to business confidential treatment.
EPA's FOIA regulations at 40 CFR 2.204(c)(1) require an EPA office that is responsible for responding to a FOIA request for the release of business information (“EPA office”) to determine which businesses, if any, are affected businesses. “Affected business” is defined at 40 CFR 2.201(d) as: With reference to an item of business information, a business which has asserted (and not waived or withdrawn) a business confidentiality claim covering the information, or a business which could be expected to make such a claim if it were aware that disclosure of the information to the public was proposed.
This notice encompasses two distinct steps in the process of communication with affected businesses prior to EPA's making a final determination concerning the business confidentiality of the information at issue: The preliminary inquiry and the notice of opportunity to comment.
Section 2.204(c)(2)(i) provides, in relevant part: If the examination conducted under paragraph (c)(1) of § 2.204 discloses the existence of any business which, although it has not asserted a claim, might be expected to assert a claim if it knew EPA proposed
Sections 2.204(d)(1)(i) and 2.204(e)(1) of title 40 of the Code of Federal Regulations require that written notice be provided to businesses that have made claims of business confidentiality for any of the information at issue, stating that EPA is determining under 40 CFR part 2, subpart B, whether the information is entitled to business confidential treatment, and affording each business an opportunity to comment as to the reasons why it believes that the information deserves business confidential treatment.
Section 2.204(e)(1) of title 40 of the Code of Federal Regulations requires that this type of notice be furnished by certified mail (return receipt requested), by personal delivery, or by other means which allows verification of the fact and date of receipt. EPA, however, has determined that in the present circumstances the use of a
All responses to this notice must be in the English language.
In accordance with 40 CFR 2.204(e)(1) and 2.205(d)(1), EPA will construe your failure to furnish timely comments in response to this notice as a waiver of your business's claim(s) of business confidentiality for any information in the types of documents identified in this notice.
If you believe that any of the information contained in the types of documents which are described in this notice and which are currently, or may become, subject to FOIA requests, is entitled to business confidential treatment, please specify which portions of the information you consider business confidential. Information not specifically identified as subject to a business confidentiality claim may be disclosed to the requestor without further notice to you.
For each item or class of information that you identify as being subject to your claim, please answer the following questions, giving as much detail as possible:
1. For what period of time do you request that the information be maintained as business confidential,
2. Information submitted to EPA becomes stale over time. Why should the information you claim as business confidential be protected for the time period specified in your answer to question no. 1?
3. What measures have you taken to protect the information claimed as business confidential? Have you disclosed the information to anyone other than a governmental body or someone who is bound by an agreement not to disclose the information further? If so, why should the information still be considered business confidential?
4. Is the information contained in any publicly available material such as the Internet, publicly available data bases, promotional publications, annual reports, or articles? Is there any means by which a member of the public could obtain access to the information? Is the information of a kind that you would customarily not release to the public?
5. Has any governmental body made a determination as to the business confidentiality of the information? If so, please attach a copy of the determination.
6. For each category of information claimed as business confidential, explain with specificity why and how release of the information is likely to cause substantial harm to your competitive position. Explain the specific nature of those harmful effects, why they should be viewed as substantial, and the causal relationship between disclosure and such harmful effects. How could your competitors make use of this information to your detriment?
7. Do you assert that the information is submitted on a voluntary or a mandatory basis? Please explain the reason for your assertion. If the business asserts that the information is voluntarily submitted information, please explain whether and why disclosure of the information would tend to lessen the availability to EPA of similar information in the future.
8. Any other issue you deem relevant.
Please note that you bear the burden of substantiating your business confidentiality claim. Conclusory allegations will be given little or no weight in the determination. If you wish to claim any of the information in your response as business confidential, you must mark the response “BUSINESS CONFIDENTIAL” or with a similar designation, and must bracket all text so claimed. Information so designated will be disclosed by EPA only to the extent allowed by, and by means of, the procedures set forth in, 40 CFR part 2, subpart B. If you fail to claim the information as business confidential, it may be made available to the requestor without further notice to you.
1. Submitting CBI. Do not submit this information to EPA through
2. Tips for Preparing Your Comments. When submitting comments, remember to:
• Identify the notice by docket number and other identifying information (subject heading,
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Describe any assumptions and provide any technical information and/or data that you used.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Make sure to submit your comments by the comment period deadline identified.
Environmental Protection Agency (EPA).
Notice.
EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Comments must be received on or before May 11, 2015.
Submit your comments, identified by docket identification (ID) number and the File Symbol of interest as shown in the body of this document, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Jennifer Mclain, Antimicrobials Division (AD) (7510P), 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).
1.
2.
EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.
1.
2.
3.
4.
5.
6.
7.
7 U.S.C. 136
Environmental Protection Agency; Office of External Affairs and Environmental Education.
Notice.
The National Environmental Education and Training Foundation (doing business as The National Environmental Education Foundation or NEEF) was created by Section 10 of Public Law 101-619, the National Environmental Education Act of 1990. It is a private 501(c)(3) non-profit organization established to promote and support education and training as necessary tools to further environmental protection and sustainable, environmentally sound development. It provides the common ground upon which leaders from business and industry, all levels of government, public interest groups, and others can work cooperatively to expand the reach of environmental education and training programs beyond the traditional classroom. The Foundation promotes innovative environmental education and training programs such as environmental education for medical healthcare providers and broadcast meteorologists; it also develops partnerships with government and other organizations to administer projects that promote the development of an environmentally literal public. The Administrator of the U.S. Environmental Protection Agency, as required by the terms of the Act, announces the following appointment to the National Environmental Education Foundation Board of Directors. The appointee is Ms. Jeniffer Harper-Taylor, president of the Siemens Foundation, where she leads one of the nation's preeminent nonprofit organizations dedicated to STEM education.
For information regarding this Notice of Appointment, please contact Mr. Brian Bond, Senior Advisor to the Administrator for Public Engagement, U.S. EPA 1200 Pennsylvania Ave. NW., Washington, DC 20460. General information concerning NEEF can be found on their Web site at:
This appointee will join the current Board members which include:
• Decker Anstrom (NEEF Chairman) Former U.S. Ambassador, Retired Chairman, The Weather Channel Companies.
• Diane Wood (NEEF Secretary) President, National Environmental Education Foundation.
• Carlos Alcazar, Founder and Chairman, Culture ONE World.
• Megan Reilly Cayten, Co-Founder and Chief Executive Officer, Catrinka, LLC.
• David M. Kiser, Vice President, Environment, Health, Safety and Sustainability, International Paper.
• Wonya Lucas, President, Lucas Strategic Consulting.
• Shannon Schuyler, Principal, Corporate Responsibility Leader, PricewaterhouseCoopers (PwC).
• Jacqueline M. Thomas, Vice President of Corporate Responsibility, Toyota Motor Sales USA Inc.
• Raul Perea-Henze, MD, MPH, Managing Director, HORUS Advisors, Washington, DC.
• George Basile, Ph.D., Professor, School of Sustainability, Arizona State University, Tempe, AZ.
The Foundation is a charitable and nonprofit corporation whose income is exempt from tax, and donations to which are tax deductible to the same extent as those organizations listed pursuant to section 501(c) of the Internal Revenue Code of 1986. The Foundation is not an agency or establishment of the United States. The purposes of the Foundation are—
(A) subject to the limitation contained in the final sentence of subsection (d) herein, to encourage, accept, leverage, and administer private gifts for the benefit of, or in connection with, the environmental education and training activities and services of the United States Environmental Protection Agency;
(B) to conduct such other environmental education activities as will further the development of an environmentally conscious and responsible public, a well-trained and environmentally literate workforce, and an environmentally advanced educational system;
(C) to participate with foreign entities and individuals in the conduct and coordination of activities that will further opportunities for environmental education and training to address environmental issues and problems involving the United States and Canada or Mexico.
The Foundation develops, supports, and/or operates programs and projects to educate and train educational and environmental professionals, and to assist them in the development and delivery of environmental education and training programs and studies.
The Foundation has a governing Board of Directors (hereafter referred to in this section as `the Board'), which consists of 13 directors, each of whom shall be knowledgeable or experienced in the environment, education and/or training. The Board oversees the activities of the Foundation and assures that the activities of the Foundation are consistent with the environmental and education goals and policies of the Environmental Protection Agency and with the intents and purposes of the Act. The membership of the Board, to the extent practicable, represents diverse points of view relating to environmental education and training. Members of the Board are appointed by the Administrator of the Environmental Protection Agency.
Within 90 days of the date of the enactment of the National Environmental Education Act, and as appropriate thereafter, the Administrator will publish in the
As President of the Siemens Foundation, Ms. Harper-Taylor leads one of the nation's preeminent nonprofit organizations dedicated to STEM education. During more than a decade of service she has impacted students, teachers and schools on a national scale, introducing tens of thousands of young people to opportunities in STEM. Today she oversees an annual investment of more than $7 million in innovative education programs that support, recognize and encourage the scientists and engineers of tomorrow.
Ms. Harper-Taylor joined Siemens in 1999 as a university recruitment manager. She then joined the Siemens Foundation as Program Manager in March 2000, subsequently serving as Program Director and Vice President before being named President in March 2010. Throughout her tenure she has spearheaded partnerships with such education leaders as the College Board, Discovery Education, the National Science Teachers Association and Oak Ridge Associated Universities to broaden the reach and impact of the Foundation's programs.
Ms. Harper-Taylor is a charter member of the Advisory Board for the Association of Public and Land-grant Universities (APLU) Office for Access and the Advancement of Public Black Universities. She also serves on The Conference Board's Contributions Council, a group dedicated to advancing the practice of corporate philanthropy. Previously, she served as the Diversity Council Chairperson for Siemens Corporation, USA.
Born and raised in Atlanta, Georgia, Ms. Harper-Taylor has played an active role in various community organizations in her hometown, including the Atlanta chapter of Big Brothers and Big Sisters and membership in the NAACP and Urban League. She takes pride in the legacy of Historically Black Colleges and Universities as a graduate of Southern University, Baton Rouge, Louisiana, where she earned her Bachelor's degree.
Federal Trade Commission (FTC or Commission).
Notice and request for comment.
In compliance with the Paperwork Reduction Act (PRA) of 1995, the FTC is seeking public comments on its request to OMB to extend for three years the current PRA clearances for information collection requirements contained in the rules and regulations under the Fur Products Labeling Act (“Fur Rules”), 16 CFR 301. This clearance expires on April 30, 2015.
Comments must be received by May 11, 2015.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Requests for copies of the collection of information and supporting documentation should be addressed to Robert M. Frisby, 202-326-2098, or Lemuel Dowdy, 202-326-2981, Attorneys, Division of Enforcement, Bureau of Consumer Protection, 600 Pennsylvania Ave. NW., Room CC-9528, Washington, DC 20580.
On January 27, 2015, the Commission sought comment on the information collection requirements in the Fur Rules. 80 FR 4264. No comments were received. As required by OMB regulations, 5 CFR part 1320, the FTC is providing this second opportunity for public comment.
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before May 11, 2015. Write “Fur Rules: FTC File No. P074201” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you are required to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential only if the FTC General Counsel grants your request in accordance with the law and the public interest.
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comment online, or to send it to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Fur Rules: FTC File No. P074201” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before May 11, 2015. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at
Comments on the information collection requirements subject to review under the PRA should also be submitted to OMB. If sent by U.S. mail, address comments to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead should be sent by facsimile to (202) 395-5167.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice withdrawal.
Due to an information collection request oversight, the Centers for Disease Control and Prevention (CDC) requests immediate publication withdrawal of the 30-Day
The 30-day FRN published on March 25, 2015 at 80 FR 15791 is withdrawn as of April 9, 2015.
For further information call (404) 639-7570 or mail comments to CDC, Leroy A. Richardson, 1600 Clifton Road, MS D-74, Atlanta, GA 30333 or send an email to
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA) is announcing a public workshop entitled “FDA Science Forum 2015.” The purpose of the public workshop is to highlight science conducted at the FDA by showcasing how scientific research informs regulatory decision making and to provide a forum for developing collaborations within FDA and with external organizations. The focus of the forum will be the eight FDA Regulatory Science priority areas
There is no registration fee for the public workshop. Early registration is recommended because seating is limited. There will be no onsite registration.
If you need special accommodations due to a disability, please contact Leslie Wheelock (see
Each session of the FDA Science Forum will have an expert in the area and presentations by FDA staff.
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/contract proposals 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.
Information is also available on the Institute's/Center's home page:
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
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Eye Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
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.
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 Institute of Allergy and Infectious Diseases (NIAID), 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 on 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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.
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Diane Post, Program Officer, Respiratory Diseases Branch, NIAID, NIH 5601 Fishers Lane, Bethesda, MD or call non-toll-free number at 240-627-3348 or email your request, including your address to:
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours for the entire 3 year request are 1,500.
Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, April 30, 2015 08:00 a.m. to April 30, 2015, 06:00 p.m., Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814 which was published in the
The meeting notice is amended to change the meeting title from NCI Omnibus R03 & R21 SEP-12 to Exploratory/Developmental Research Grant Program-Omnibus SEP-12. The meeting is closed to the public.
Federal Emergency Management Agency, DHS.
Notice.
This notice is to announce a public meeting to solicit public input on the proposed “Revised Guidelines for Implementing Executive Order 11988, Floodplain Management.”
The public meeting will be held in Seattle, WA on April 14, 2015, from 1:00 p.m. Pacific Time (PT) to 3:30 p.m. PT.
The public meeting will be held in Seattle, WA, at the University of Washington Medicine at South Lake Union, Administrative Building C, Orin Smith Auditorium, 850 Republican Street, Seattle, WA 98109.
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, please contact the person listed in the
Due to space constraints of the facility, seating will be limited to 100 participants for the meeting. To reserve a seat in advance for this meeting, please provide a request via email or mail with the contact information of the participant (including name, mailing address, and email address), the meeting(s) to be attended, and include the subject/attention line (or on the envelope if by mail): Reservation Request for FFRMS Meeting. Advance reservations are preferred three (3) business days prior to the meeting to ensure processing, but will be accepted until seating capacity is reached. Unregistered participants will be accepted after all participants with reservations have been accommodated and will be admitted on a first-come, first-serve basis, provided the person capacity is not exceeded. To submit reservations, please email:
To facilitate public participation, members of the public are invited to provide written comments on the issues to be considered at the public meeting. Comments may be submitted by one of the following methods:
•
•
Bradley Garner, 202-646-3901 or
On January 30, 2015, the President signed Executive Order 13690, directing FEMA, on behalf of the Mitigation Framework Leadership Group, to publish for public comment draft revised Floodplain Management Guidelines to provide guidance to agencies on the implementation of Executive Order 11988, as amended, consistent with a new Federal Flood Risk Management Standard. These draft revised Guidelines were developed by the Mitigation Framework Leadership Group in consultation with the Federal Interagency Floodplain Management Task Force. FEMA is publishing this Notice on behalf of the Mitigation Framework Leadership Group, which is chaired by FEMA, to solicit and consider public input on the draft revised Guidelines at a public meeting.
Background information about these topics is available on the FFRMS Web site at
The meeting is exempt from the Federal Advisory Committee Act (FACA), as the Mitigation Framework Leadership Group is an intergovernmental committee and falls under the intergovernmental committee exception to FACA, 41 CFR 102-3.40(g).
Executive Order 11988, as amended; Executive Order 13690.
Bureau of Land Management, Interior.
Notice of Public Meeting.
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Western Montana Resource Advisory Council (RAC) will meet as indicated below.
The Western Montana Resource Advisory Council meeting will be held May 19, 2015 in Missoula, Montana. The meeting will begin at 9:00 a.m. with a 30-minute public comment period starting at 11:30 a.m. and will adjourn at 3:00 p.m.
BLM's Missoula Field Office, 3255 Fort Missoula Road, Missoula, MT.
David Abrams, Western Montana Resource Advisory Council Coordinator, Butte Field Office, 106 North Parkmont, Butte, MT 59701, 406-533-7617,
This 15-member council advises the Secretary of the Interior through the BLM on a variety of management issues associated with public land management in Montana. During this meeting the council will discuss several topics, including an update on the BLM's Greater Sage-Grouse Planning Strategy, a report from the RAC's Timber Harvest Subgroup, and reports from the BLM's Butte, Missoula and Dillon field offices. All RAC meetings are open to the public. The public may present written comments to the RAC. Each formal RAC meeting will also have time allocated for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited.
43 CFR 1784.4-2.
National Park Service, Interior.
Notice; request for comments.
We (National Park Service) will ask the Office of Management and Budget (OMB) to approve a new information collection (IC) that will be used by the public to collect and record natural history observations at selected NPS parks and sponsored events. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other federal agencies to take this opportunity to comment on this IC. A federal 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.
To ensure that your comments on this IC are considered, we must receive them on or before June 8, 2015.
Direct all written comments on this IC to Phadrea Ponds, Information Collection Coordinator, National Park Service, 1201 Oakridge Drive, Fort Collins, CO 80525 (mail); or
Margaret Beer, National Park Service Inventory and Monitoring Division, 1201 Oakridge Drive, Suite 150, Fort Collins, CO 80525 (mail);
The NPS is in the process of developing a partnership with the California Academy of Sciences to use its iNaturalist web-based and mobile applications to digitally record natural history observations during selected NPS parks and sponsored events. This information will be recorded by park visitor participants to help verify and substantiate the presence of wildlife and plant species in over 300 NPS units. Because the parks have no formal mechanism for visitors to contribute natural history observations to our current listings, we are requesting to use iNaturalist as a platform to submit observations that can be used by NPS.
We invite comments concerning this information collection on:
• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;
• The accuracy of our estimate of the burden for this collection of information;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• Ways to minimize the burden of the collection of information on respondents.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this IC. 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.
On the basis of the record
The Commission instituted this review on November 3, 2014 (79 FR 65241) and determined on February 6, 2015 that it would conduct an expedited review (80 FR 10162, February 25, 2015).
The Commission completed and filed its determination in this review on April 6, 2015. The views of the Commission are contained in USITC Publication 4524 (April 2015), entitled
By order of the Commission.
National Endowment for the Humanities.
Notice.
The National Endowment for the Humanities (NEH) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval as required by the provisions of the Paperwork Reduction Act of 1995.
Comments on this information collection must be submitted on or before May 11, 2015.
Mail comments to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the National Endowment for the Humanities, Office of Management and Budget, Room 10235, Washington, DC 20503; (202) 395-7316.
Mr. Joel Schwartz, Chief Guidelines Officer, 400 7th Street SW., Washington, DC 20506; (202) 606-8473;
The Office of Management and Budget (OMB) is particularly interested in comments which: (1) 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; (2) 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; (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, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Copies of this ICR, with applicable supporting documentation, may be obtained by calling Joel Schwartz at (202-606-8473) or may be requested by email to
Nuclear Regulatory Commission.
Environmental assessment and finding of no significant impact; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an environmental assessment and finding of no significant impact regarding exemptions from specific emergency planning requirements for license nos. DPR-39 and DPR-48, issued to Zion
The environmental assessment and finding of no significant impact referenced in this document is available on April 9, 2015.
Please refer to Docket ID NRC-2015-0087 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
John Hickman, Division of Decommissioning, Uranium Recovery, and Waste Programs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-00001. Telephone: 301-415-3017; email:
The NRC is considering issuance of exemptions from specific emergency planning (EP) requirements of part 50 of Title 10 of the Code of Federal Regulations (10 CFR) for license nos. DPR-39 and DPR-48, issued to Zion
On November 23, 2011, the NRC issued a Final Rule modifying or adding EP requirements in § 50.47, § 50.54, and appendix E of 10 CFR part 50 (76
The proposed action would exempt ZNPS, a 10 CFR part 50 licensee, from certain 10 CFR part 50 EP requirements because ZNPS is a permanently shut-down nuclear facility.
The proposed action is in accordance with the licensee's application dated June 20, 2012, (ADAMS Accession No. ML12173A316).
ZNPS was shut down on February 21, 1997, and is currently in a permanently shut-down and defueled condition. In a letter dated May 4, 1998, the NRC acknowledged that pursuant to 10 CFR 50.82(a)(2), the 10 CFR part 50 licenses for ZNPS, Units 1 and 2 no longer authorize operation of the reactors, or emplacement or retention of fuel in the reactor vessels. Active decommissioning is currently underway.
The licensee claims that the proposed action is needed because the Final Rule imposed requirements on ZNPS that are not necessary to meet the underlying purpose of the regulations in view of the greatly reduced offsite radiological consequences associated with the current plant status as permanently shut down. The EP program at this facility met the EP requirements in 10 CFR part 50 that were in effect before December 23, 2011, subject to any license amendments or exemptions modifying the EP requirements for the licensee. Thus, compliance with the EP requirements in effect before the effective date of the EP Final Rule demonstrated reasonable assurance that adequate protective measures could be taken in the event of a radiological emergency.
The NRC staff evaluated the environmental impacts of the proposed action and concludes that exempting the facility from the emergency planning requirements will not have any adverse environmental impacts. With respect to radiological impacts, the NRC has determined that no credible events at ZNPS would result in doses to the public beyond the owner controlled area boundary that would exceed the U.S. Environmental Protection Agency Protective Actions Guides at the site boundary. The proposed action is wholly procedural and administrative in nature. As such, the proposed action will not: Significantly increase the probability or consequences of radiological accidents, result in any changes to the types of effluents that may be released offsite, and result in any significant increase in occupational or public radiation exposure. Therefore, there are no significant radiological environmental impacts associated with the proposed action.
With regard to potential non-radiological impacts, the proposed action does not involve any construction activities, renovation of buildings or structures, ground disturbing activities or other alteration to land. The proposed action will not change the site activities and therefore will not result in any changes to the workforce or vehicular traffic. Furthermore, the proposed action is not a type of activity that has the potential to cause effects on historic properties or cultural resources, including traditional cultural properties. In addition the proposed action will not result in any change to non-radiological plant effluents and thus, will have no impact on either air or water quality. As the proposed action is wholly procedural and administrative in nature, the NRC staff has determined that the proposed action will have no effect on listed species or critical habitat. Therefore, there are no significant non-radiological environmental impacts associated with the proposed action.
Accordingly, the NRC staff concludes that there are no significant environmental impacts associated with the proposed action.
As an alternative to the proposed action, the NRC staff considered denial of the proposed action (
The NRC staff has concluded that the proposed action will not significantly impact the quality of the human environment, and that the proposed action is the preferred alternative.
The NRC contacted the Illinois Emergency Management Agency concerning this request. There were no comments, concerns or objections from the State official.
The NRC staff has prepared this EA as part of its review of the proposed action. On the basis of this EA, the NRC finds that there are no significant environmental impacts from the proposed action, and that preparation of an environmental impact statement is not warranted. Accordingly, the NRC has determined that a Finding of No Significant Impact (FONSI) is appropriate. In accordance with 10 CFR 51.32(a)(4), this FONSI incorporates the EA set forth in this notice by reference.
For the Nuclear Regulatory Commission.
Office of Personnel Management.
Notice—computer matching between the Office of Personnel Management and the Social Security Administration (Computer Matching Agreement 1018).
In accordance with the Privacy Act of 1974 (5 U.S.C. 552a), as amended by the Computer Matching and Privacy Protection Act of 1988 (Pub. L. 100-503), Office of Management and
OPM will file a report of the subject matching program with the Committee on Homeland Security and Governmental Affairs of the Senate, the Committee on Oversight and Government Reform of the House of Representatives and the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). The matching program will begin May 11, 2015 or 40 days after the date of OPM's submission of the letters to Congress and OMB, whichever is later. The matching program will continue for 18 months from the beginning date and may be extended an additional 12 months thereafter. Subsequent matches will run until one of the parties advises the other in writing of its intention to reevaluate, modify and/or terminate the agreement.
Send comments to Deon Mason, Chief, Business Services, Retirement Services, Office of Personnel Management, Room 3316-G, 1900 E Street NW., Washington, DC 20415.
Bernard A. Wells III on 202-606-2730
The Privacy Act (5 U.S.C. 552a), as amended, establishes the conditions under which computer matching involving the Federal government could be performed and adding certain protections for individuals applying for and receiving Federal benefits. Section 7201 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) further amended the Privacy Act regarding protections for such individuals.
The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records are matched with other Federal, State, or local government records. Among other things, it requires Federal agencies involved in computer matching programs to:
(1) Negotiate written agreements with the other agency for agencies participating in the matching programs;
(2) Obtain the approval of the match agreement by the Data Integrity Boards (DIB) of the participating Federal agencies;
(3) Furnish detailed reports about matching programs to Congress and OMB;
(4) Notify applicants and beneficiaries that their records are subject to matching;
(5) Verify match findings before reducing, suspending, termination or denying an individual's benefits or payments.
We have taken action to ensure that all of OPM's computer matching programs comply with the requirements of the Privacy Act, as amended.
OPM and SSA.
The purpose of this agreement is to establish the conditions under which SSA agrees to disclose tax return and/or Social Security benefit information to OPM. The SSA records will be used in redetermining and recomputing the benefits of certain annuitants and survivors whose computations are based, in part, on military service performed after December 1956 under the Civil Service Retirement System (CSRS) and certain annuitants and survivors whose annuity computation under the Federal Employees Retirement System (FERS) have a CSRS component.
Chapters 83 and 84 of title 5 of the United States Code provide the basis for computing annuities under CSRS and FERS, respectively, and require release of information by SSA to OPM in order to administer data exchanges involving military service performed by an individual after December 31, 1956. The CSRS requirement is codified at section 8332(j) of title 5 of the United States Code; the FERS requirement is codified at section 8422(e)(4) of title 5 of the United States Code. The responsibilities of SSA and OPM with respect to information obtained pursuant to this agreement are also in accordance with the following: the Privacy Act (5 U.S.C. 552a), as amended; section 307 of the Omnibus Budget Reconciliation Act of 1982 (Pub. L. 97-253), codified at section 8332 Note of title 5 of the United States Code; section 1306(a) of title 42 of the United States Code; and section 6103(1)(11) of title 26 of the United States Code.
SSA will disclose data from its MBR file (60-0090, Master Beneficiary Record, SSA/OEEAS) and MEF file (60-0059, Earnings Recording and Self-Employment Income System, SSA/OEEAS) and manually-extracted military wage information from SSA's “1086” microfilm file when required (71 FR 1796, January 11, 2006). OPM will provide SSA with an electronic finder file from the OPM system of records published as OPM/Central-1 (Civil Service Retirement and Insurance Records) on October 8, 1999 (64 FR 54930), as amended on March 20, 2008 (73 FR 15013). The system of records involved have routine uses permitting the disclosures needed to conduct this match.
The Privacy Act (5 U.S.C. 552a(o)(1)(G)) requires that each matching agreement specify procedures for ensuring the administrative, technical and physical security of the records matched and the results of such programs.
All Federal agencies are subject to: The Federal Information Security Management Act of 2002 (FISMA) (44 U.S.C. 3541
FISMA requirements apply to all Federal contractors and organizations or sources that possess or use Federal information, or that operate, use, or have access to Federal information systems on behalf of an agency. OPM will be responsible for oversight and compliance of their contractors and agents. Both OPM and SSA reserve the right to conduct onsite inspection to monitor compliance with FISMA regulations.
The matching program shall become effective upon the signing of the agreement by both parties to the agreement and approval of the agreement by the Data Integrity Boards of the respective agencies, but no sooner than 40 days after notice of this matching program is sent to Congress and the Office of Management and Budget or 30 days after publication of this notice in the
March 24, 2015, at 4 p.m.
Washington, DC, via Teleconference.
1. Strategic Issues.
2. Financial Matters.
3. Pricing.
The General Counsel of the United States Postal Service has certified that the meeting was properly closed under the Government in the Sunshine Act.
Requests for information about the meeting should be addressed to the Secretary of the Board, Julie S. Moore, at 202-268-4800.
March 27, 2015, at 3 p.m.
Washington DC, via Teleconference.
Committee Votes to Close March 27, 2015, Meeting: By telephone vote on March 27, 2015, members of the Temporary Emergency Committee of the Board of Governors of the United States Postal Service met and voted unanimously to close to public observation its meeting held in Washington, DC, via teleconference. The Committee determined that no earlier public notice was possible.
1. Strategic Issues.
2. Financial Matters.
3. Pricing.
The General Counsel of the United States Postal Service has certified that the meeting was properly closed under the Government in the Sunshine Act.
Requests for information about the meeting should be addressed to the Secretary of the Board, Julie S. Moore, at 202-268-4800.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Chatter Box Call Center Ltd. because it has not filed any periodic reports since the period ended December 31, 2011.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Euro Group of Companies, Inc. because it has not filed any periodic reports since the period ended June 30, 2011.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Golden Century Resources Limited because it has not filed any periodic reports since the period ended March 31, 2012.
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed companies. Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in the securities of the above-listed companies is suspended for the period from 9:30 a.m. EDT on April 7, 2015, through 11:59 p.m. EDT on April 20, 2015.
By the Commission.
On November 14, 2014, New York Stock Exchange LLC (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of China Education International, Inc. because it has not filed any periodic reports since the period ended September 30, 2012.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Delta Entertainment Group Inc. because it has not filed any periodic reports since the period ended September 30, 2012.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Gulf United Energy, Inc. because it has not filed any periodic reports since the period ended September 30, 2012.
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed companies. Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in the securities of the above-listed companies is suspended for the period from 9:30 a.m. EDT on April 7, 2015, through 11:59 p.m. EDT on April 20, 2015.
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend Rule 4.3, Record of Written Complaints. The text of the proposed rule change is below. Proposed new language is in italics; proposed deletions are in brackets.
(a) Each Member shall keep and preserve for a period of not less than [five]
(b) (No change).
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 II.A., II.B., and II.C. below, of the most significant aspects of such statements.
The Exchange filed a proposal to amend Rule 4.3, Record of Written Complaints, to conform with the rules of the Financial Industry Regulatory Authority, Inc. (“FINRA”) for purposes of an agreement between the Exchange and FINRA, as well as to conform Exchange Rule 4.3 with the rules of the EDGX Exchange, Inc. (“EDGX”) and the EDGA Exchange, Inc. (“EDGA”).
Pursuant to Rule 17d-2 under the Act,
The 17d-2 Agreement included a certification by the Exchange that states that the requirements contained in certain Exchange rules are identical to, or substantially similar to, certain FINRA rules that have been identified as comparable. To conform to comparable FINRA rules for purposes of the 17d-2 Agreement, the Exchange proposes to amend Rule 4.3, Record of Written Complaints, to align with FINRA Rule 4513.
Exchange Rule 4.3 currently requires that members of the Exchange (“Members”) keep and preserve written customer complaints
The Exchange, therefore, proposes to decrease the record retention requirements under Rule 4.3 from five to four years. The Exchange believes that amending the record retention requirements for customer complaints to align with FINRA Rule 4513 would help to avoid confusion among Members that are also members of FINRA, EDGA, or EDGX. The Exchange further believes that aligning the Exchange's rules with FINRA Rule 4513 would account for FINRA's four-year routine examination cycle for certain members, which FINRA conducts on the Exchange's behalf under the 17d-2 Agreement ensuring consistent regulation of Members that are also members of FINRA.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act
The Exchange 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 because the proposed change would apply to all Members equally.
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)(ii) 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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the
All submissions should refer to File No. SR-BYX-2015-20 and should be submitted on or before April 30, 2015.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of AuraSound, Inc. because it has not filed any periodic reports since the period ended December 31, 2011.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of C2C CrowdFunding, Inc. because it has not filed any periodic reports since the period ended September 30, 2012.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Convenience TV Inc. because it has not filed any periodic reports since the period ended September 30, 2012.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Global Security Agency Inc. because it has not filed any periodic reports since the period ended September 30, 2012.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of NewMarket Technology, Inc. because it has not filed any periodic reports since the period ended June 30, 2011.
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed companies. Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in the securities of the above-listed companies is suspended for the period from 9:30 a.m. EDT on April 7, 2015, through 11:59 p.m. EDT on April 20, 2015.
By the Commission.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 4758 (Order Routing) to (a) explain the treatment of a DOT or DOTI order designated to participate in the closing only; (b) explain the treatment of a LIST order designated to participate in the closing only; and (c) explain the treatment of a LIST order in the after-hours market.
The text of the proposed rule change is available 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.
The purpose of this proposed rule change is to amend subsection (a)(1)(A) of Rule 4758 to: (a) Explain the treatment of a DOT or DOTI order designated to participate in the closing only; (b) explain the treatment of a LIST order designated to participate in the closing only; and (c) explain the treatment of a LIST order in the after-hours market. The Exchange also proposes to make technical changes to further explain the language of the rule.
NASDAQ offers its members optional routing functionality that allows them to use NASDAQ's facilities to access liquidity available on other trading venues. The functionality includes a range of defined routing algorithms—known as strategies—that determine the destinations and pattern of routing. The particular pattern of routing to other venues associated with a particular strategy is referred to in Rule 4758 as the “System routing table.” All routing is designed to be conducted in a manner consistent with the requirements of Regulation NMS.
NASDAQ currently offers a set of strategies designed to allow market participants to route orders to the primary market on which a security is listed. NASDAQ is proposing minor
First, NASDAQ is proposing to modify the language of subsection (a)(1)(A) of Rule 4758 to make it clear that a DOT order may be designated to participate in the opening only or in the closing only, with different outcomes. Currently, an order entered before the open (or close) that is designated as opening only (or closing only) will likely be cancelled by the destination market after the open (or close) in accordance with its terms and therefore will not return to NASDAQ, even if not executed in full. Similarly, if NASDAQ receives a DOT order after the security has opened (or closed) and the order has been designated to participate in the opening only (or closing only), the order will nevertheless be routed to NYSE or NYSE MKT (which would be expected to reject the order based on its designation as opening only or closing only).
Second, NASDAQ is proposing similar changes to the DOTI routing strategy in subsection (a)(1)(A) of Rule 4758 to make it clear that a DOTI order may be designated to participate in the opening only but not in the closing only under certain circumstances. Currently, DOTI is a routing option for orders that the entering firm wishes to direct to the NYSE or NYSE MKT without them returning to the NASDAQ Market Center. DOTI orders check the System for available shares and then are sent to destinations on the System routing table before being sent to NYSE or NYSE MKT, as appropriate. Alternatively, the member entering the order may opt to have it check the System and then be sent directly to NYSE or NYSE MKT, without routing to destinations on the System routing table.
Third, NASDAQ is proposing similar changes to the LIST routing strategy in subsection (a)(1)(A) of Rule 4758 to make it clear how a LIST order designated to participate in the closing only will be handled. Currently, LIST is a routing option designed to allow orders to participate in the opening and/or closing process of the primary listing market for a security, and to follow additional routing logic as described below. A LIST order received before the security has opened on its primary listing market will be routed to the primary listing market for participation in that market's opening process. After the security has opened on its primary listing market, unexecuted shares will be returned to the NASDAQ system; the order would be returned only to the extent that the order has not been designated opening only and has not
By way of housekeeping, the Exchange also proposes additional explanatory language in respect of LIST orders. First, where currently Rule 4758(a)(1)(A)(x) states that two minutes before market close, all LIST orders on the book “will route” to the security's primary listing market for participation in its closing process, the Exchange proposes to say “will begin routing” in recognition of the fact that the sheer volume of orders will not allow all orders to route at exactly the same time. Second, where currently Rule 4758(a)(1)(A)(x) states that after the security has closed on the primary listing market, a LIST order that has not been designated as “a closing only order” and that has not been fully executed, rejected, or cancelled by the market to which it was routed will be returned to the NASDAQ System, the Exchange proposes to state “a closing only or MDAY order” in recognition of the time in force of a MDAY order.
The Exchange believes that these proposed explanatory changes are non-controversial and are consistent with the Act.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder, including the requirements of Section 6(b) of the Act.
NASDAQ believes that the changes will make clear to market participants that they may not designate DOT and DOTI orders to participate in the closing only of a primary listing venue under certain circumstances. In addition, NASDAQ proposes to clearly explain to market participants how orders designated to participate in the closing only and are entered at 3:45 p.m. Eastern Time or later (or in the case of an early closing, are entered 15 minutes prior to the close or later) will be handled. Collectively, the changes discussed in the proposal facilitate transactions in securities and perfect the mechanism of a free and open market and a national market system by providing NASDAQ members with greater explanation regarding the routing of their orders. The Exchange believes the changes make clear the language to Rule 4758 and make it easier to follow, and should serve to minimize any potential confusion regarding its application. The majority of the changes are explanatory, and some are technical in nature.
As noted, the Exchange believes that the changes proposed are explanatory and non-controversial in nature.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will have any impact on competition.
Written comments were neither solicited nor 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
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 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.
On October 31, 2014, NYSE MKT LLC (“NYSE MKT” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On February 26, 2014, the Exchange withdrew the proposal SR-NYSEMKT-2014-95.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions and extensions of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
I. The information collections below are pending at SSA. SSA will submit them to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than June 8, 2015. Individuals can obtain copies of the collection instruments by writing to the above email address.
1. Disability Report-Adult—20 CFR 404.1512 and 416.912—0960-0579. State Disability Determination Services (DDS) use the SSA-3368 and its electronic versions to determine if adult disability applicants' impairments are severe, and, if so, how the impairments affect the applicants' ability to work. This determination dictates whether the DDSs and SSA will find the applicant disabled and entitled to Supplement Security Income (SSI) payments. The respondents are applicants for Title II disability benefits or Title XVI SSI payments.
Type of Request: Revision of an OMB-approved information collection.
2. Representative Payment Policies Regulation—20 CFR 404.2011(a)(1), 404.2025, 416.611(a)(1), 416.625—0960-0679. Per 20 CFR 404.2011 and 20 CFR 416.611 of the Code of Federal Regulations, if SSA determines it may cause substantial harm for Title II or Title XVI recipients to receive their payments directly, recipients may dispute that decision. To do so, recipients provide SSA with information the agency uses to re-evaluate its determination. In addition, our regulations state that after SSA selects a representative payee to receive benefits on a recipient's behalf, the payees provide SSA with information on their continuing relationship and responsibility for the recipients, and explain how they use the recipients' payments. Sections 20 CFR 404.2025 and 20 CFR 416.625 of the Code of Federal Regulations provide a process to follow up with the representative payee to verify payee performance. The respondents are Title II and Title XVI recipients, and their representative payees.
Type of Request: Extension of an OMB-approved information collection.
II. SSA submitted the information collections below to OMB for clearance. Your comments regarding the information collections would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than May 11, 2015. Individuals can obtain copies of the OMB clearance packages by writing to
1. Certification by Religious Group—20 CFR 404.1075—0960-0093. SSA is responsible for determining whether religious groups meet the qualifications exempting certain members and sects from payment of Self-Employment Contribution Act taxes under the Internal Revenue Code, Section 1402(g). SSA sends Form SSA-1458, Certification by Religious Group, to a group's authorized spokesperson to complete and verify organizational members meet or continue to meet the criteria for exemption. The respondents are spokespersons for religious groups or sects.
Type of Request: Revision of an OMB-approved information collection.
2. Request for Reconsideration—Disability Cessation—20 CFR 404.909, 416.1409—0960-0349. When SSA determines that claimants' disabilities ceased or are no longer sufficiently disabling, these claimants may ask SSA to reconsider that determination. SSA uses Form SSA-789-U4 to arrange for a hearing or to prepare a decision based on the evidence of record. Specifically, claimants or their representatives use Form SSA-789-U4 to: (1) ask SSA to
Type of Request: Revision of an OMB-approved information collection.
3. Prohibition of Payment of SSI Benefits to Fugitive Felons and Parole/Probation Violators—20 CFR 416.708(o)—0960-0617. Section 1611(e)(4) of the Social Security Act precludes eligibility for SSI payments for certain fugitives and probation/parole violators. Regulations at 20 CFR 416.708(o) require individuals applying for or receiving SSI to report to SSA that: (1) They are fleeing to avoid prosecution for a crime; (2) they are fleeing to avoid custody or confinement after conviction of a crime; or (3) they are violating a condition of probation or parole. SSA uses the information we receive to deny eligibility, or suspend recipients' SSI payments. The respondents are SSI applicants and recipients, or representative payees of SSI applicants and recipients, who are reporting their status as a fugitive felon or probation/parole violator.
Type of Request: Extension of an OMB-approved information collection.
4. Identifying Information for Possible Direct Payment of Authorized Fees—0960-0730. SSA collects information from claimants' appointed representatives on Form SSA-1695 to: (1) Process and facilitate direct payment of authorized fees; (2) issue a Form 1099-MISC, if applicable; and (3) establish a link between each claim for benefits and the data we collect on the SSA-1699 for our appointed representative database. The respondents are attorneys and other individuals who represent claimants for benefits before SSA.
Type of Request: Revision of an OMB approved information collection.
5. Request for Business Entity Taxpayer Information—0960-0731. Law firms or other business entities must complete Form SSA-1694, Request for Business Entity Taxpayer Information, if they wish to serve as appointed representatives and receive direct payment of fees from SSA. SSA uses the information to issue a Form 1099-MISC. SSA also uses the information to allow business entities to designate individuals to serve as entity administrators authorized to perform certain administrative duties on their behalf, such as providing bank account information, maintaining entity information, and updating individual affiliations. Respondents are law firms or other business entities with attorneys or other qualified individuals as partners or employees who represent claimants before SSA.
Type of Request: Revision of an OMB-approved information collection.
6. Request to Pay Civil Monetary by Installment Agreement—20 CFR 498—0960-0776. When SSA imposes a civil monetary penalty (CMP) on individuals for various fraudulent conduct related to SSA-administrated programs, those individuals may request to pay the CMP through benefit withholding, or an installment agreement. To negotiate a monthly payment amount, fair to both the individual and the agency, SSA needs financial information from the individual. The agency uses Form SSA-640 to obtain the information necessary to determine a monthly installment
Type of Request: Revision of an OMB-approved information collection.
Social Security Administration.
Notice of Social Security Ruling; Correction.
The Social Security Administration published a document in the
In accordance with the Federal Advisory Committee Act (FACA), the PEPFAR Scientific Advisory Board hereinafter referred to as “the Board”, will meet as indicated below.
The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) Scientific Advisory Board will meet on Thursday, April 30th via teleconference. The meeting will be from 9 a.m. ET until approximately 10:30 a.m. ET and is open to the public (please see teleconference phone number below). The meeting will be hosted by the Office of the U.S. Global AIDS Coordinator, Ambassador Deborah L. Birx, who leads implementation of the President's Emergency Plan for AIDS Relief (PEPFAR). The PEPFAR Scientific Advisory Board serves the Global AIDS Coordinator in a solely advisory capacity concerning scientific, implementation, and policy issues related to the global response to HIV/AIDS. These issues will be of concern as they influence the priorities and direction of PEPFAR evaluation and research, the content of national and international strategies and implementation, and the role of PEPFAR in the international discourse regarding appropriate and resourced responses. The April 30th teleconference will act as an introduction to PEPFAR programs, the goals of the Board, and provide an overview and forum for discussion of PEPFAR 3.0, (
To RSVP, please contact the Office of the U.S. Global AIDS Coordinator: email (
For further information about the meeting, please contact Dr. Julia MacKenzie, Senior Technical Advisor and Designated Federal Officer, Office of the U.S. Global AIDS Coordinator at (202) 663-1079 or
Federal Aviation Administration (FAA), DOT.
Notice of request to release airport property.
The FAA proposes to rule and invite public comment on the release of land at the former Stapleton International Airport (SIA) under the provisions of Section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21), now 49 U.S.C. 47107(h)(2).
Comments must be received on or before May 11, 2015.
Comments on this application may be mailed or delivered to the FAA at the following address: Mr. John P. Bauer, Manager, Federal Aviation Administration, Northwest Mountain Region, Airports Division, Denver Airports District Office, 26805 E. 68th Avenue, Suite 224, Denver, Colorado 80249-6361.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Mr. Greg Holt, Stapleton Redevelopment Program Manager, Denver International Airport, at the following address: Mr. Greg Holt, Stapleton Redevelopment Program Manager, Denver International Airport, 8500 Pena Boulevard, Ninth Floor, Room 9870, Denver, Colorado 80249-6340.
Mr. Marc Miller, Colorado Engineer/Compliance Specialist, Federal Aviation Administration, Northwest Mountain Region, Denver Airports District Office, 26805 E. 68th Avenue, Suite 224, Denver, Colorado 80249-6361.
The request to release property may be reviewed, by appointment, in person at this same location.
The FAA invites public comment on the request to release property at the former
The Airport and Airway Safety and Capacity Expansion Act of 1987, Public Law 100-223, 101 Stat. 1529, Section 313(a), gave the Secretary of Transportation the authorization, subject to the provisions of Section 4 of the Act of October 1, 1949 (63 Stat. 700; 50 U.S.C. App. 1622c), to grant Stapleton International Airport release from any of the terms, conditions, reservations, or restrictions contained in each deed of conveyance under which the United States conveyed property to the City and County of Denver, Colorado, on which any portion of Stapleton International Airport is located. This included property conveyed under Section 16 of the Federal Airport Act (60 Stat. 179).
On April 3, 2015, the FAA determined that the request to release property at the former Stapleton International Airport submitted by the City and County of Denver meets the procedural requirements of the Federal Aviation Administration.
The following is a brief overview of the request:
The City and County of Denver is proposing the release from the terms, conditions, reservations and restrictions on 73.310 acres of property identified as SIA Section 10 (Eastern Portion) at the former Stapleton International Airport. This parcel was conveyed from the United States of America to the City and County of Denver to be used for aviation development on October 29, 1969. Denver voters endorsed the plan to build a new airport, to be called Denver International Airport. Stapleton International Airport closed on February 28, 1995, when Denver International Airport opened, and the FAA transferred all City and County of Denver's grant obligations in connection with Stapleton International Airport to the development and operation of Denver International Airport. The Stapleton property has slowly been redeveloped over the past 20 years for homes, businesses, roads, parks, and open space, in accordance with zoning, plats, and general development plans approved by the City and County of Denver. The sale of this property will be based on an appraisal conducted in January 2000 which was approved by the FAA in April 2000. The City and County of Denver will treat all proceeds as airport revenue and will be used exclusively in connection with Denver International Airport, specifically for the payment of debt.
Any person may inspect, by appointment, the request in person at the FAA office listed above under
In addition, any person may, upon appointment and request, inspect the application, notice and other documents germane to the application in person at the Denver International Airport.
Federal Aviation Administration (FAA), DOT.
Notice of request to release airport property.
The FAA proposes to rule and invite public comment on the release of land at the former Stapleton International Airport (SIA) under the provisions of Section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21), now 49 U.S.C. 47107(h)(2).
Comments must be received on or before May 11, 2015.
Comments on this application may be mailed or delivered to the FAA at the following address: Mr. John P. Bauer, Manager, Federal Aviation Administration, Northwest Mountain Region, Airports Division, Denver Airports District Office, 26805 E. 68th Avenue, Suite 224, Denver, Colorado 80249-6361.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Mr. Greg Holt, Stapleton Redevelopment Program Manager, Denver International Airport, at the following address: Mr. Greg Holt, Stapleton Redevelopment Program Manager, Denver International Airport, 8500 Pena Boulevard, Ninth Floor, Room 9870, Denver, Colorado 80249-6340.
Mr. Marc Miller, Colorado Engineer/Compliance Specialist, Federal Aviation Administration, Northwest Mountain Region, Denver Airports District Office, 26805 E. 68th Avenue, Suite 224, Denver, Colorado 80249-6361.
The request to release property may be reviewed, by appointment, in person at this same location.
The FAA invites public comment on the request to release property at the former Stapleton International Airport under the provisions of the AIR 21 (49 U.S.C. 47107(h)(2)).
The Airport and Airway Safety and Capacity Expansion Act of 1987, Public Law 100-223, 101 Stat. 1529, Section 313(a), gave the Secretary of Transportation the authorization, subject to the provisions of Section 4 of the Act of October 1, 1949 (63 Stat. 700; 50 U.S.C. App. 1622c), to grant Stapleton International Airport release from any of the terms, conditions, reservations, or restrictions contained in each deed of conveyance under which the United States conveyed property to the City and County of Denver, Colorado, on which any portion of Stapleton International Airport is located. This included property conveyed under Section 16 of the Federal Airport Act (60 Stat. 179).
On April 3, 2015, the FAA determined that the request to release property at the former Stapleton International Airport submitted by the City and County of Denver meets the procedural requirements of the Federal Aviation Administration.
The following is a brief overview of the request:
The City and County of Denver is proposing the release from the terms, conditions, reservations and restrictions on the remaining property identified in Section 15 (68.931 acres) and Section 22 (150.708 acres) at the former Stapleton International Airport. These parcels were conveyed from the United States of America to the City and County of Denver to be used for aviation development on November 22, 1957, February 26, 1960, and July 18, 1963. In May 1989, Denver voters endorsed the plan to build a new airport, to be called Denver International Airport. Stapleton International Airport closed on February 28, 1995, when Denver International Airport opened, and the FAA transferred all City and County of Denver's grant obligations in connection with Stapleton International Airport to the development and operation of Denver International Airport. The Stapleton property has slowly been redeveloped over the past 20 years for homes, businesses, roads, parks, and open space, in accordance with zoning, plats, and general development plans approved by the City and County of Denver. The sale of this property will be based on an appraisal conducted in January 2000 which was approved by the FAA in April 2000. The City and County of Denver will treat all proceeds as airport revenue and will be used
Any person may inspect, by appointment, the request in person at the FAA office listed above under
In addition, any person may, upon appointment and request, inspect the application, notice and other documents germane to the application in person at the Denver International Airport.
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. FAA aviation safety inspectors review Airline Transport Pilot (ATP) Certification Training Program (CTP) submittals to determine that the program complies with the applicable requirements of 14 CFR 61.156.
Written comments should be submitted by June 8, 2015.
Send comments to the FAA at the following address: Ronda Thompson, Room 300, Federal Aviation Administration, ASP-110, 950 L'Enfant Plaza SW., Washington, DC 20024.
Ronda Thompson at (202) 267-1416, or by email at:
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. This survey assesses airman opinion of key dimensions of service quality of aeromedical certification services.
Written comments should be submitted by June 8, 2015.
Send comments to the FAA at the following address: Ronda Thompson, Room 300, Federal Aviation Administration, ASP-110, 950 L'Enfant Plaza SW., Washington, DC 20024.
Ronda Thompson at (202) 267-1416, or by email at:
Pursuant to section 10(A) (2) of the Federal Advisory Committee Act (Pub. L. 92-463; 5 U.S.C. App. 2), notice is hereby given of a meeting of the FAA Research, Engineering and Development (R,E&D) Advisory Committee.
Federal Aviation Administration.
Notice of Meeting.
Research, Engineering & Development Advisory Committee
April 22, 2015—9:30 a.m. to 4:00 p.m.
Issued in Washington, DC on March 25, 2015.
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. 14 CFR part 139 establishes certification requirements for airports serving scheduled air carrier operations in aircraft with 10-30 seats. These requirements result in information collections from respondents.
Written comments should be submitted by June 8, 2015.
Send comments to the FAA at the following address: Ronda Thompson, Room 300, Federal Aviation Administration, ASP-110, 950 L'Enfant Plaza SW., Washington, DC 20024.
Ronda Thompson at (202) 267-1416, or by email at:
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The
Written comments should be submitted by May 11, 2015.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the attention of the Desk Officer, Department of Transportation/FAA, and sent via electronic mail to
Ronda Thompson at (202) 267-1416, or by email at:
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before April 29, 2015.
You may send comments identified by Docket Number, FAA-2015-0194 using any of the following methods:
•
•
•
•
Sandra Long, ARM-200, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591, email
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice of request to release airport property.
The FAA proposes to rule and invite public comment on the release of land at the former Stapleton International Airport (SIA) under the provisions of Section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21), now 49 U.S.C. 47107(h)(2).
Comments must be received on or before May 11, 2015.
Comments on this application may be mailed or delivered
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Mr. Greg Holt, Stapleton Redevelopment Program Manager, Denver International Airport, at the following address: Mr. Greg Holt, Stapleton Redevelopment Program Manager, Denver International Airport, 8500 Pena Boulevard, Ninth Floor, Room 9870, Denver, Colorado 80249-6340.
Mr. Marc Miller, Colorado Engineer/Compliance Specialist, Federal Aviation Administration, Northwest Mountain Region, Denver Airports District Office, 26805 E. 68th Avenue, Suite 224, Denver, Colorado 80249-6361.
The request to release property may be reviewed, by appointment, in person at this same location.
The FAA invites public comment on the request to release property at the former Stapleton International Airport under the provisions of the AIR 21 (49 U.S.C. 47107(h)(2)).
The Airport and Airway Safety and Capacity Expansion Act of 1987, Public Law 100-223, 101 Stat. 1529, Section 313(a), gave the Secretary of Transportation the authorization, subject to the provisions of Section 4 of the Act of October 1, 1949 (63 Stat. 700; 50 U.S.C. App. 1622c), to grant Stapleton International Airport release from any of the terms, conditions, reservations, or restrictions contained in each deed of conveyance under which the United States conveyed property to the City and County of Denver, Colorado, on which any portion of Stapleton International Airport is located. This included property conveyed under Section 16 of the Federal Airport Act (60 Stat. 179).
On April 3, 2015, the FAA determined that the request to release property at the former Stapleton International Airport submitted by the City and County of Denver meets the procedural requirements of the Federal Aviation Administration.
The following is a brief overview of the request:
The City and County of Denver is proposing the release from the terms, conditions, reservations and restrictions on 10.479 acres of property identified as SIA Section 10 (Northwest Corner) at the former Stapleton International Airport. This parcel was conveyed from the United States of America to the City and County of Denver to be used for aviation development on October 29, 1969. Denver voters endorsed the plan to build a new airport, to be called Denver International Airport. Stapleton International Airport closed on February 28, 1995, when Denver International Airport opened, and the FAA transferred all of City and County of Denver's grant obligations in connection with Stapleton International Airport to the development and operation of Denver International Airport. The Stapleton property has slowly been redeveloped over the past 20 years for homes, businesses, roads, parks, and open space, in accordance with zoning, plats, and general development plans approved by the City and County of Denver. The sale of this property will be based on an appraisal conducted in January 2000 which was approved by the FAA in April 2000. The City and County of Denver will treat all proceeds as airport revenue and will be used exclusively in connection with Denver International Airport, specifically for the payment of debt.
Any person may inspect, by appointment, the request in person at the FAA office listed above under
In addition, any person may, upon appointment and request, inspect the application, notice and other documents germane to the application in person at the Denver International Airport.
Federal Aviation Administration (FAA), DOT.
Notice of request to release airport property.
The FAA proposes to rule and invite public comment on the release of land at the former Stapleton International Airport (SIA) under the provisions of Section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21), now 49 U.S.C. 47107(h)(2).
Comments must be received on or before May 11, 2015.
Comments on this application may be mailed or delivered to the FAA at the following address: Mr. John P. Bauer, Manager, Federal Aviation Administration, Northwest Mountain Region, Airports Division, Denver Airports District Office, 26805 E. 68th Avenue, Suite 224, Denver, Colorado 80249-6361.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Mr. Greg Holt, Stapleton Redevelopment Program Manager, Denver International Airport, at the following address: Mr. Greg Holt, Stapleton Redevelopment Program Manager, Denver International Airport, 8500 Pena Boulevard, Ninth Floor, Room 9870, Denver, Colorado 80249-6340.
Mr. Marc Miller, Colorado Engineer/Compliance Specialist, Federal Aviation Administration, Northwest Mountain Region, Denver Airports District Office, 26805 E. 68th Avenue, Suite 224, Denver, Colorado 80249-6361.
The request to release property may be reviewed, by appointment, in person at this same location.
The FAA invites public comment on the request to release property at the former Stapleton International Airport under the provisions of the AIR 21 (49 U.S.C. 47107(h)(2)).
The Airport and Airway Safety and Capacity Expansion Act of 1987, Public Law 100-223, 101 Stat. 1529, Section 313(a), gave the Secretary of Transportation the authorization, subject to the provisions of Section 4 of the Act of October 1, 1949 (63 Stat. 700; 50 U.S.C. App. 1622c), to grant Stapleton International Airport release from any of the terms, conditions, reservations, or restrictions contained in each deed of conveyance under which the United States conveyed property to the City and County of Denver, Colorado, on which any portion of Stapleton International Airport is located. This included property conveyed under Section 16 of the Federal Airport Act (60 Stat. 179).
On April 3, 2015, the FAA determined that the request to release property at the former Stapleton International Airport submitted by the City and County of Denver meets the procedural requirements of the Federal Aviation Administration.
The following is a brief overview of the request:
The City and County of Denver is proposing the release from the terms,
Any person may inspect, by appointment, the request in person at the FAA office listed above under
In addition, any person may, upon appointment and request, inspect the application, notice and other documents germane to the application in person at the Denver International Airport.
Federal Aviation Administration (FAA), DOT
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The
Written comments should be submitted by May 11, 2015.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the attention of the Desk Officer, Department of Transportation/FAA, and sent via electronic mail to
Ronda Thompson at (202) 267-1416, or by email at:
Federal Highway Administration (FHWA), Wisconsin Department of Transportation (WisDOT).
Federal Notice of Intent to Prepare a Tier 1 Environmental Impact Statement (Tier 1 EIS).
The FHWA is issuing this revised notice to advise the public that FHWA and WisDOT will be preparing a Tier 1 EIS for proposed transportation improvements in the United States Highway (US) 51 corridor in Dane County, Wisconsin generally between Interstate 39/90 east of the City of Stoughton and US 12/18 (Madison South Beltline Highway). The previous Notice of Intent was to prepare an Environmental Impact Statement and was published in the
Mr. Johnny Gerbitz, Field Operations Engineer, Federal Highway Administration, City Center West, 525 Junction Road, Suite 8000, Madison, Wisconsin, 53717-2157, Telephone: (608) 829-7500.
A needs assessment was conducted for the project corridor in 2004 followed by initiation of the environmental review process for an environmental impact statement (EIS). The EIS review process examined factors contributing to the need for improvements within the US 51 study corridor (long-term planning and corridor preservation, safety,
The FHWA, in cooperation with the Wisconsin Department of Transportation (WisDOT), will prepare a Tier 1 EIS for proposed improvements to address safety, operational and capacity concerns on approximately 18 miles of US 51 between Interstate 39/90, east of the City of Stoughton, to US 12/18 (Madison South Beltline Highway), north of the Village of McFarland. The study will also examine a bypass of Stoughton, as well as potential operational improvements on existing US 51 in Stoughton. As alternatives to capacity improvements on US 51, the study will consider improvements on highways other than US 51 that might address the needs of travelers between the southeast portion of Dane County and the Madison Urban area. The Tier 1 EIS will evaluate the social, economic, and environmental impacts of the alternatives within the existing US 51 highway corridor, and other full build improvements on other regional highway corridors. The objective of this project is to address existing and future transportation demand and safety concerns as identified in the US 51 Needs Assessment Report. The Tier 1 EIS will be prepared in accordance with 23 U.S.C. 139, 23 CFR 771, and 40 CFR 1500-1508. Completion of the Tier 1 EIS and the Record of Decision (ROD) is expected in 2018.
Public involvement is a critical component of the National Environmental Policy Act (NEPA) and will occur throughout the development of the draft and final Tier 1 EIS. All environmental documents will be made available for review by federal and state resource agencies and the public. Specific efforts to encourage involvement by, and solicit comments from, minority and low-income populations in the project study area will be made, with public involvement meetings held throughout the environmental document process. Public notice will be given as to the time and place of public involvement meetings. A public hearing will be held after the completion of the Draft Tier 1 EIS.
Inquiries related to this study can be sent to
Projects receiving Federal funds must comply with Title VI of the Civil Rights Act, and Executive Order 12898 “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations.” Federal law prohibits discrimination on the basis of race, color, age, sex, or country of national origin in the implementation of this project. It is also Federal policy to identify and address any disproportionately high and adverse effects of federal projects on the health or environment of minority and low-income populations to the greatest extent practicable and permitted by law.
Federal Highway Administration (FHWA), DOT
Notice of Limitation on Claims for Judicial Review of Actions by FHWA and Other Federal Agencies
This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. § 139(l)(1). The actions relate to a proposed highway project, Trinity Parkway from Interstate Highway 35 East (IH35E)/State Highway (SH) 183 to U.S. 175/SH 310 in the County of Dallas, State of Texas. Those actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. § 139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before September 8, 2015. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Mr. Achille Alonzi, Division Administrator, Texas Division, Federal Highway Administration, 300 E. 8th Street, Room 826, Austin, Texas 78701; 8:00 a.m. to 5:00 p.m. (central daylight time) Monday through Friday, 512-536-5902; email:
Notice is hereby given that the FHWA and other Federal agencies have taken final agency actions by issuing licenses, permits, and approvals for the following highway project in the State of Texas: The Trinity Parkway (Texas Department of Transportation CSJ 0918-45-121) would consist of a limited-access toll facility on new location in the City of Dallas, extending from the IH 35E/SH 183 interchange (northern terminus) to the US 175/SH 310 interchange (southern terminus), a distance of approximately nine miles. The facility would ultimately consist of six mixed-flow tolled mainlanes, local street interchanges, and interchanges at the northern terminus, southern terminus, Woodall Rodgers Freeway, and IH 45. The primary purpose for the Trinity Parkway is to manage congestion on existing highways through the downtown Dallas area. Trinity Parkway would help manage congestion on IH 35E (Lower Stemmons and South R.L. Thornton Freeways), IH 30, and other major transportation facilities within the Trinity Parkway project area to improve mobility and safety, and thereby increase accessibility to businesses and public facilities.
The actions by the Federal agencies, and the laws under which such actions were taken, are described in the Final Environmental Impact Statement (FEIS) for the project, approved on March 7, 2014, in the FHWA Record of Decision (ROD) issued on April 2, 2015, and in other documents in the FHWA administrative record. The FEIS, ROD, and other documents in the FHWA administrative record file are available by contacting the FHWA at the address provided above. The FHWA FEIS and ROD can be viewed and downloaded from the project Web site at:
This notice does not apply to the U.S. Army Corps of Engineering (U.S.A.C.E.) permitting process for this project, because no U.S.A.C.E. permits have been issued the project to date. This notice applies to all Federal agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1. General: National Environmental Policy Act (NEPA) [42 U.S.C. 4321-4375]; Federal-Aid Highway Act [23 U.S.C. 109].
2. Air: Clean Air Act [42 U.S.C. 7401-7671(q)]
3. Land: Uniform Relocation and Real Property Acquisition Policies Act of 1970 [42 U.S.C. 4601-4655]; Section 4(f) of the Department of Transportation Act of 1966 [Pub. L. No. 111-212, Section 405 (a)(b)].
4. Wildlife: Endangered Species Act [16 U.S.C. 1531-1544]; Migratory Bird Treaty Act [16 U.S.C. 703-712]; Bald and Golden Eagle Protection Act of 1940 [16 U.S.C. 668]; Fish and Wildlife Coordination Act [16 U.S.C. 661-666(c)].
5. Social and Economic: Civil Rights Act of 1964 [42 U.S.C. 2000(d)-2000(d)(1)]; Section 504 of the Americans with Disability Act; Farmland Protection Policy Act (FPPA) [7 U.S.C. 4201-4209].
6. Wetlands and Water Resources: Clean Water Act [33 U.S.C. 1251-1342 (Sections 303(d), 305(b), and 402)]; Section 9 of the Rivers and Harbors Act of 1899 [33 U.S.C. 401], as modified by the General Bridge Act of 1946 [33 U.S.C. 525]; Wild and Scenic Rivers Act [16 U.S.C. 1271-1287]; Safe Drinking Water Act of 1996 [42 U.S.C. 300(f)-300(j)(6)]; Section 6(f) of the Land and Water Conservation Fund (LWCF) Act [16 U.S.C. 460l-4
7. Executive Orders: E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 13112 Invasive Species; E.O. 12898 Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 13166 Improving Access to Services for Persons with Limited English Proficiency (LEP).
23 U.S.C. § 139(l)(1)
Pipeline and Hazardous Materials Safety Administration, DOT.
Notice of public meeting.
This notice is announcing a one-day public workshop to discuss the recent Pipeline Safety Management Systems (SMS) national consensus standard. The meeting will include participation from all major pipeline sectors, state and Federal regulators, and public safety advocates. This workshop will detail the development process of the SMS standard. The workshop will also emphasize the core elements of the standard including: Leadership and management commitment; risk management; emergency preparedness and response; competence awareness and training; management review and continuous commitment, and the critical role of safety culture.
The public workshop will held on Wednesday, April 22, 2015, from 8:00 a.m. to 4:30 p.m. EST. Written comments must be received by June 8, 2015.
The workshop will be held at the Westin Galleria, 5060 West Alabama Street, Houston, TX 77056. Hotel reservations can be made under the room block “PHMSA—Pipeline Safety Management SystemWorkshop/”.
The meeting agenda and any additional information will be published on the PHMSA home page Web site at (
Comments: Members of the public may also submit written comments either before or after the workshop. Comments should reference Docket No. PHMSA-2014-0014. Comments may be submitted in the following ways:
•
•
•
Comments will be posted without changes or edits to
Anyone may search the electronic form of all comments received for any of our dockets. You may review DOT's complete Privacy Act Statement in the
For information on facilities or services for individuals with disabilities, or to request special assistance at the meeting, please contact Nancy White, Office of Pipeline Safety, at 202-366-1419 or by email at
Ms. Nancy White, Office of Pipeline Safety, at 202-366-1419 or by email at
The details on this meeting, including the location, times and agenda items, will be available on the meeting page (
Presentations will be available online at the meeting page and also be posted in the E-Gov Web site:
49 U.S.C. Chapter 601 and 49 CFR 1.97.
Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT.
Notice; Issuance of Advisory Bulletin.
PHMSA is issuing this updated advisory bulletin to all owners and operators of gas and hazardous liquid pipelines to communicate the potential for damage to pipeline facilities caused by severe flooding. This advisory includes actions that operators should consider taking to ensure the integrity of pipelines in the event of flooding, river scour, and river channel migration.
Operators of pipelines subject to regulation by PHMSA should contact the appropriate PHMSA Region Office. The PHMSA Region Offices and their contact information are as follows:
• Central Region: 816-329-3800, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, South Dakota, and Wisconsin
• Eastern Region: 609-989-2171, Connecticut, Delaware, District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, Virginia, and West Virginia
• Southern Region: 404-832-1147, Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, Puerto Rico, South Carolina, and Tennessee
• Southwest Region: 713-272-2859, Arkansas, Louisiana, New Mexico, Oklahoma, and Texas
• Western Region: 720-963-3160, Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, Oregon, Utah, Washington, and Wyoming
Intrastate pipeline operators should contact the appropriate state pipeline safety authority. A list of state pipeline safety authorities is provided at:
Section 192.613(a) of the Pipeline Safety Regulations (49 CFR parts 190-199) states that “[e]ach operator shall have a procedure for continuing surveillance of its facilities to determine and take appropriate action concerning changes in class location, failures, leakage history, corrosion, substantial changes in cathodic protection requirements, and other unusual operating and maintenance conditions.” Section 192.613(b) further states that “[i]f a segment of pipeline is determined to be in unsatisfactory condition but no immediate hazard exists, the operator shall initiate a program to recondition or phase out the segment involved, or, if the segment cannot be reconditioned or phased out, reduce the maximum allowable operating pressure in accordance with § 192.619(a) and (b).”
Likewise, § 195.401(b)(1) of the Pipeline Safety Regulations states that “[w]henever an operator discovers any condition that could adversely affect the safe operation of its pipeline system, it must correct the condition within a reasonable time. However, if the condition is of such a nature that it presents an immediate hazard to persons or property, the operator may not operate the affected part of the system until it has corrected the unsafe condition.” Section 195.401(b)(2) further states that “[w]hen an operator discovers a condition on a pipeline covered under [the integrity management requirements in] § 195.452, the operator must correct the condition as prescribed in § 195.452(h).” Severe flooding, river scour, and river channel migration are the types of unusual operating conditions that can adversely affect the safe operation of a pipeline and require corrective action under §§ 192.613(a) and 195.401(b).
In addition, Part 194 requires operators of onshore oil pipelines to “include procedures and a list of resources for responding, to the maximum extent practicable, to a worst case discharge and to a substantial threat of such a discharge” under § 194.107(a). Per § 194.115, the operator must “identify, and ensure, by contract or other approved means, the resources necessary to remove, to the maximum extent practicable, a worst case discharge and to mitigate or prevent a substantial threat of a worst case discharge”.
Furthermore, an operator must take additional preventative and mitigative measures beyond those already required in Parts 192, 194, and 195 to prevent a pipeline failure and to mitigate the consequences of a pipeline failure per §§ 192.935, 194.107(a) and 195.452(i). An operator must base the additional measures on the threats the operator has identified for each pipeline segment. If an operator determines outside force damage (
PHMSA has released five Advisory Bulletins on this subject, with the earliest issued July 29, 1993, (ADB-93-03), and the most recent on July 27, 2011, (ADB-11-04; 76 FR 44985). Each of these bulletins followed an event that involved severe flooding that affected pipelines in the areas of rising waters. Four of the more notable events are briefly described below:
On August 13, 2011, Enterprise Products Operating, LLC discovered a release of 28,350 gallons (675 barrels) of natural gasoline in the Missouri River in Iowa. The rupture, according to the metallurgical report, was the result of fatigue crack growth driven by vibrations in the pipe from vortex shedding.
On July 1, 2011, ExxonMobil Pipeline Company experienced a pipeline failure near Laurel, Montana, resulting in the release of 63,000 gallons (1,500 barrels) of crude oil into the Yellowstone River. According to the results of PHMSA's accident investigation, the rupture was caused by channel migration and river bottom scour, leaving a large span of the pipeline exposed to prolonged current forces and debris washing downstream in the river. Those external forces damaged the exposed pipeline.
On July 15, 2011, NuStar Pipeline Operating Partnership, L.P. reported a 4,200 gallon (100 barrels) anhydrous ammonia spill in the Missouri River in Nebraska requiring extensive environmental response and causing supply disruption. The 6-inch-diameter pipeline was exposed by scouring during extreme flooding.
On January 17, 2015, a breach in the Bridger Pipeline Company's Poplar system resulted in another spill into the Yellowstone River near the town of Glendive, Montana, releasing an estimated 28,434 gallons (677 barrels) of crude oil into the river and impacting local water supplies. Preliminary information indicates over 100 feet of pipeline was exposed on the river bottom, and a release point was near a girth weld.
As shown in these events, river bottom scour and channel migration may occur due to seasonal flooding, increased stream velocities, and man-made and natural river bank restrictions. River scour and channel migration may damage a pipeline as a result of additional stresses imposed on the pipe by undermining underlying support soils, exposing the pipeline to lateral water forces and impact from waterborne debris. Lateral water forces may cause excessive bending loads that lead to pipeline failures, and possible impact forces from debris in the river or harmonic vibrations from water rapidly passing over pipelines can also increase the potential for pipeline failures.
Additionally, the safety of valves, regulators, relief sets, pressure sensors, and other facilities normally above ground or above water can be jeopardized when covered by water. Not only can these facilities become inoperable when submerged, but they are also at a greater risk of damage by outside forces, floating debris, river currents, and craft operating on the water. Boaters involved in rescue operations, emergency support functions, sightseeing, and other activities are generally not aware of the seriousness of an incident that could result from their craft damaging a pipeline facility that is unseen beneath the surface of the water. Depending on the size of the craft and the pipeline facility struck, significant pipeline damage may result.
Although accidents at river crossings account for less than one percent of the total number of pipeline accidents, the consequences of a release in water can be much more severe because of the threats to drinking water supplies and the environment. Unlike hazardous liquid releases on land where it can be easier to respond to and contain spills, swift-moving river currents will carry hazardous liquids further downstream, potentially impacting much larger geographical areas and more communities. Product releases in rivers can create difficult, costly, and lengthy spill response and remediation scenarios and activities for operators, communities, and local, state, and Federal responders.
To: Owners and Operators of Gas and Hazardous Liquid Pipeline Systems.
Subject: Potential for Damage to Pipeline Facilities Caused by Severe Flooding.
Advisory: Severe flooding can adversely affect the safe operation of a pipeline. Operators need to direct their resources in a manner that will enable them to determine and mitigate the potential effects of flooding on their pipeline systems in accordance with applicable regulations. Operators are urged to take the following actions to prevent and mitigate damage to pipeline facilities and ensure public and environmental safety in areas affected by flooding:
1. Utilize experts in river flow, such as hydrologists or fluvial geomorphologists, to evaluate a river's potential for scour or channel migration at each pipeline river crossing.
2. Evaluate each pipeline crossing a river to determine the pipeline's installation method and determine if that method (and the pipeline's current condition) is sufficient to withstand the risks posed by anticipated flood conditions, river scour, or river channel migration. In areas prone to these conditions and risks, consider installing pipelines using horizontal directional drilling to help place pipelines below elevations of maximum scour and outside the limits of lateral channel migration.
3. Determine the maximum flow or flooding conditions at rivers where pipeline integrity is at risk in the event of flooding (
4. Evaluate the accessibility of pipeline facilities and components that may be in jeopardy, such as valve settings, which are needed to isolate water crossings or other sections of pipelines.
5. Extend regulator vents and relief stacks above the level of anticipated flooding as appropriate.
6. Coordinate with emergency and spill responders on pipeline locations, crossing conditions, and the commodities transported. Provide maps and other relevant information to such responders so they can develop appropriate response strategies.
7. Coordinate with other pipeline operators in flood areas and establish emergency response centers to act as a liaison for pipeline problems and solutions.
8. Deploy personnel so that they will be in position to shut down, isolate, contain, or perform any other emergency action on an affected pipeline.
9. Determine if facilities that are normally above ground (
10. Perform frequent patrols, including appropriate overflights, to evaluate right-of-way conditions at water crossings during flooding and after waters subside. Report any flooding, either localized or systemic, to integrity staff to determine if pipeline crossings may have been damaged or would be in imminent jeopardy from future flooding.
11. Have open communications with local and state officials to address their concerns regarding observed pipeline exposures, localized flooding, ice dams, debris dams, and extensive bank erosion that may affect the integrity of pipeline crossings.
12. Following floods, and when safe river access is first available, determine if flooding has exposed or undermined pipelines because of new river channel profiles. This is best done by a depth of cover survey.
13. Where appropriate, surveys of underwater pipe should include the use of visual inspection by divers or instrumented detection. Pipelines in recently flooded lands adjacent to rivers should also be evaluated to determine the remaining depth of cover. You should share information gathered by these surveys with affected landowners. Agricultural agencies may help to inform farmers of potential hazards from reduced cover over pipelines.
14. Ensure that line markers are still in place or are replaced in a timely manner. Notify contractors, highway departments, and others involved in post-flood restoration activities of the presence of pipelines and the risks posed by reduced cover.
If a pipeline has suffered damage or is shut-in as a precautionary measure due to flooding, the operator should advise the appropriate PHMSA regional office or state pipeline safety authority before returning the line to service, increasing its operating pressure, or otherwise changing its operating status. Furthermore, reporting a Safety-Related Condition as prescribed in §§ 191.23 and 195.55 may also be required.
49 U.S.C. Chapter 601 and 49 CFR 1.97
The following Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier. Permits were filed under Subpart B (formerly Subpart Q) of the Department of Transportation's Procedural Regulations (See 14 CFR 302. 201 et. seq.). The due date for Answers, Conforming Applications, or Motions to Modify Scope are set forth below for each application. Following the Answer period DOT may process the application by expedited procedures. Such procedures may consist of the adoption of a show-cause order, a tentative order, or in appropriate cases a final order without further proceedings.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes revisions to its regulations for the licensing, construction, design, equipment, and operation of deepwater ports, which are offshore fixed or floating structures, other than vessels, used as ports or terminals for the import or export of oil and natural gas. The proposed revisions would provide additional information, clarify existing regulations, provide additional regulatory flexibility, and add new requirements to ensure safety. The proposed rule would not affect the license to operate of any existing deepwater port, nor would it result in the licensing of any new deepwater port. This proposed rule furthers the Coast Guard's maritime safety and stewardship missions.
Comments and related material must either be submitted to our online docket via
You may submit comments identified by docket number USCG-2012-0061 using any one of the following methods:
(1)
(2)
(3)
(4)
To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the
If you have questions on this proposed rule, call or email Mr. Kevin Tone, Deepwater Ports Standards Division (CG-OES-4), Coast Guard; telephone 202-372-1441, 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 (USCG-2012-0061), 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. We recommend that you include your name and a mailing address, an email address, or a phone number in the body of your document so that we can contact you if we have questions regarding your submission.
To submit your comment online, go to
We will consider all comments and material received during the comment period and may change this proposed rule based on your comments.
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 to the docket using one of the methods specified under
The purpose of this rulemaking is to revise existing Coast Guard regulations for deepwater ports. A deepwater port is a fixed or floating manmade structure, or a group of structures, other than a vessel, located beyond State seaward boundaries and used or intended for use as a port or terminal for the transportation, storage, and further handling of oil or natural gas for transportation to or from any State.
The legal basis of this rulemaking is 33 U.S.C. 1504(a) and (b), which require the Secretary of Transportation to issue regulations to implement the Deepwater Port Act of 1974, as amended (DWPA).
This NPRM proposes numerous small revisions to a complex regulatory scheme. Collectively, these revisions will provide applicants with additional information and clarity, additional regulatory flexibility, and new requirements to ensure safety. Above all, the revisions should help applicants assemble more complete applications, to help them meet the Coast Guard's regulatory requirements within the strict time limitations mandated by the DWPA and without costly suspensions of the licensing process. The proposed rule would not affect the license to operate of any existing deepwater port, nor would it result in the licensing of any new deepwater port.
This NPRM would impose no new regulatory costs and should help future license applicants receive more efficient, faster processing of their applications. Some proposed revisions may give applicants more flexibility than they have under current regulations. Finally, some applicants may benefit from proposed revisions that would facilitate the licensing of export deepwater ports.
Deepwater ports are oil or natural gas import or export facilities,
Since our most recent substantive revision of subchapter NN,
This proposed rule draws on the lessons we have learned about efficiencies in the license application review process and in building and operating safe and efficient deepwater ports. In developing this proposed rule, we have consulted with MARAD and other Federal agencies that work with us on deepwater port issues, and we will continue this consultation as we develop a final rule.
This proposed rule would primarily clarify existing requirements or provide more information about how those requirements intersect with the requirements of other Federal agencies and State governments that have roles in the licensing and operation of deepwater ports. The intent of this proposed rule is to reduce the number of times the “clock is stopped” pursuant to our regulations, thereby reducing the time needed to reach decisions on applications. Although we propose a few new requirements, they are likely to impose no new regulatory costs because they track with industry's current behavior. We also propose several changes that should provide industry with additional regulatory flexibility. Our proposals would apply to any applications received after the effective date of the final rule. The rule would not affect the license to operate any existing deepwater port, nor would they result in the licensing of any new deepwater port.
The proposed rule aligns with directives in several Executive Orders (E.O.s). Section 3(a)(1) of E.O. 12988
The changes we propose for part 148 focus on providing deepwater port license applicants with clearer information about the information we require, so that applicants will be less likely to encounter “stopped clocks.” We propose reorganizing part 149, which addresses the complex process of designing, constructing, and equipping deepwater ports. Other changes in part 149 would clarify its requirements or adapt terminology to the reality that no two deepwater ports use identical design elements. Most of the procedural changes we propose would affect the deepwater port operations requirements in part 150. In addition to clarifying part 150's requirements and providing more information, we propose changes (in line with current industry practice) that would ensure that future deepwater ports continue to meet acceptable levels of safety.
Table 1 lists each section that we propose adding or amending, and briefly explains our rationale for the proposal. It omits the nonsubstantive redesignation of specific sections as part of the reorganization of part 149, which we discuss in the table, and the nonsubstantive insertion of “but not limited to” in lists, to emphasize their non-exclusive nature.
The Coast Guard developed this proposed rule after considering the statutes and E.O.s related to rulemaking that are discussed in this part.
Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This notice of proposed rulemaking has been designated a “significant regulatory action” although not economically significant, under section 3(f) of E.O. 12866. Accordingly, the notice of proposed rulemaking has been reviewed by the Office of Management and Budget (OMB).
The Coast Guard proposes revisions to its regulations for the licensing, construction, design, equipment, and operation of deepwater ports, which are offshore fixed or floating structures, other than vessels, used as ports or terminals for the import or export of oil and natural gas. The proposed revisions would provide additional information, clarify existing regulations, provide additional regulatory flexibility, and add new requirements to ensure safety.
One objective of the proposed rule is to ensure that adequate information is submitted with a deepwater port application. Through the experience of processing past applications, Coast Guard and other Federal agencies have identified additional, specific types of information that are necessary to ensure a timely review of, and decision on, deepwater port applications. For past applications, this additional information has been requested during the review process, causing delays in the review and approval of applications. Specifying that the additional information is required at the beginning of the process will not increase the application process burden, but is expected to result in more efficient and timely reviews of any future applications.
Further, the proposed rule codifies various technical and operational requirements. During the application review process, and after the actual construction and operation of new deepwater ports, the Coast Guard gained additional insight into the technical and operational requirements that will help ensure operations are conducted efficiently and in a manner that furthers safety, security, and environmental protection. These technical and operational requirements are currently standard industry practice or are existing requirements (
Table 2 below provides a summary of the final rule's costs and benefits.
One oil deepwater port began operation before 2006. Since 2006, the Coast Guard has processed, or is processing, eight deepwater port applications to site, construct, and operate deepwater ports. After review of those applications, two LNG deepwater ports have been constructed, one has been issued a license to construct, and one has initial approval through a favorable ROD from MARAD. The applicants for the other four applications have withdrawn their applications. The population of currently operating deepwater ports is three: the one pre-2006 oil port and two LNG ports.
The potential number of additional deepwater port applications over the next 10 years is dependent on changing market conditions and economic forces. The existing deepwater ports were built when the forecasts for imports of LNG to the United States, such as those made by the Energy Information Administration (EIA), were predicting high levels of LNG imports. With recent changes in the natural gas and oil markets, EIA now projects continued decline in LNG imports and increasing volumes of LNG exports.
Table 3 details numerous proposed changes in the regulation with an assessment of the cost impacts of the change. These changes fall into the following categories:
• May result in possible time or cost savings as they allow for greater flexibility in complying with existing requirements.
• Clarify information to be submitted with the deepwater port application. These information requirements do not result in additional costs to industry as this information has been required under existing 33 CFR 148.107 in the past during application processing and review. Based on experience with each of the previous applicant reviews, the Coast Guard has consistently requested this information at some point in the processing of the application. The proposed regulatory changes clarify that the information is required up front to allow for the more timely review of the application, thus saving the applicant the time and expense of additional submissions.
• Implementation may be optional.
• Clarify the Coast Guard's existing need for certain additional information that it specifies during the license process and which the license applicant provides; the intended impact of the clarification is to notify the applicant that, in the interest of expeditious processing of the application, this information should be provided up front. As the information is already being provided, there is no new cost impact.
• May be administrative and would not result in costs. Many of these changes clarify the relationship between various Federal agencies with responsibility for deepwater ports application, licensing, and review. These types of changes do not impose any behavioral changes by applicants of deepwater ports. These changes are labeled “Administrative,” described as clarifications, and will have no cost impact. Other “Administrative” proposed changes reword definitions or delete outdated references.
• Proposed § 148.8 allows an applicant to nominate a CE during the application processing phase. Currently, an applicant nominates a CE later in the application process. By allowing the nomination earlier, we believe that the applicants will have potential cost savings by identifying potential problems or challenges earlier in the process rather than later, when more work has been done on the application.
• Proposed § 148.105 allows for equivalent means of certifying the accuracy of maps. Applicants have experienced delays when certified geologists were not available to certify the accuracy of maps. The Coast Guard had no alternative but to stop the clock, often delaying application processing by several months. The intent of this proposed revision is to permit the use of specialists who do not possess a professional certification, but are able to provide proof of equivalent technical expertise and experience, to certify work studies and reports required to satisfactorily process a deepwater port application. Allowing certifications by technical personnel possessing alternate credentialing will help to eliminate extensive delays in projects, waiting for expertise that is limited and in high demand. Also, proposed § 148.105 allows for the use of data older than 5 years under certain conditions. Use of older data could result in potential cost savings due to the avoidance of gathering new data.
• Proposed § 148.214 allows for resubmission of a modified application without incurring a fee. Under the existing process, an application can be re-submitted after modification, but the applicant must pay the filing fee.
• Proposed § 149.51 allows foreign-national engineers to submit design and construction plans on behalf of the licensee. The potential cost savings come from the flexibility of allowing the applicant to contract services from a larger pool of engineers. The applicant
• Proposed § 149.52 allows for adoption of classification society standards. Many maritime companies rely on classification standards to satisfy insurance, safety management system (SMS), and other requirements. The Coast Guard's adoption of classification society standards eliminates the potential for duplicate effort. The Coast Guard recognizes that work already completed by a classification society can be used in the application process. An example is the APL submerged turret loading buoy system to import natural gas. The first natural gas deepwater port was Gulf Gateway, which used the APL submerged turret loading buoy system. There were no existing classification standards that addressed these types of ports or their components. Classification societies (American Bureau of Shipping (ABS) and Det Norske Veritas (DNV)) had to develop standards as the post-licensing review and approval process was taking place. Additional review on the part of the Coast Guard to grant equivalency approvals for some major port components and systems (emergency alarms, shutoffs, etc.) caused some delays in schedule. The classification societies have developed a highly detailed body of information on the submerged turret loading buoy-type deepwater ports, as well as practical experience with the actual deepwater port operations. This information, adopted as classification society standards, will improve and expedite the post-licensing engineering review and approval process.
• Proposed § 150.435 authorizes continuation of cargo transfer operations during an electrical storm. The potential cost savings derives from the ability to continue safe operations during certain electrical storms in accordance with the deepwater port's plans. The LNG port operators have stated that they cannot shut down operations during electrical storms as this will lead to potentially hazardous situations due to static electricity build-up.
The benefits of the proposed rule are summarized below. See Table 4 for more detailed marginal benefit analysis.
The main purpose of the revisions to 33 CFR part 148 in this proposed rule is to clarify the deepwater port application process. The roles of the Coast Guard, MARAD, BOEM, and other Federal agencies would be further clarified to insure applicants better understand the application process. The
The benefits for 33 CFR part 148 would come from incorporating lessons learned from the history of deepwater port applications. The Coast Guard frequently finds that applications cannot be fully processed without time-consuming delays to obtain additional data from applicants. The result may require the Coast Guard to “stop the clock” on the application review process. This proposed rule will likely reduce the periods when the “clock is stopped,” and expedite the application process.
The proposed changes in 33 CFR part 149 are mainly technical and administrative in nature to clarify the review and approval process. The proposed changes would allow for increased flexibility in the review and approval process and for certifying entities.
The proposed changes to part 150 of Title 33 would consolidate operational requirements and codify current industry practice to improve understanding of, and compliance with, good operational practices.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this final rule will have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and government jurisdictions with populations of less than 50,000.
There are three entities that operate existing deepwater ports. LOOP is owned by a consortium of three multinational energy corporations. The owners/operators of LOOP are not small; therefore, LOOP exceeds the threshold for a small entity. Gulf Gateway and Northeast Gateway are wholly owned by the second entity, which exceeds the threshold for a small entity. The deepwater port Neptune LNG is wholly owned by the third entity, which exceeds the threshold for a small entity. The applicants of the five applications that were withdrawn also exceed the threshold for a small entity. We assume that any new deepwater port will not be a small entity given the history and requirements for a new deepwater port. The North American Industry Classification System (NAICS) codes and size standards for these entities are found in Table 5.
Therefore the Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment to the Docket Management Facility at the address under
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996,
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).
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995
This proposed rule comprises deepwater port application, operation, and oversight procedures. The Coast Guard expects fewer than ten entities in the natural gas industry would be affected by this rule within any 12-month period because there are only four deepwater ports currently in operation, and the Coast Guard does not expect to receive ten or more applications in any future year because it has received only eight applications in the last five years combined. Thus, we expect to receive less than 10 applications per year; less than 10 submissions of design, construction, and equipment modification per year; and less than 10 proposals to amend approved Operation Manuals per year. Consequently, the number of respondents is less than the threshold of ten respondents per 12-month period for collection of information requirements under the PRA.
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
Congress conferred rulemaking authority on the Secretary of Transportation to promulgate regulations to carry out the provisions of the DWPA. Relating to deepwater port licenses, 33 U.S.C. 1504(a) states that the Secretary “shall . . . issue regulations to carry out the purposes and provisions of [the DWPA] . . . Such regulations shall pertain to, but need not be limited to, application, issuance, transfer, renewal, suspension, and termination of licenses.” As noted above, when the Coast Guard was transferred to DHS, certain authorities and functions that were delegated to the Coast Guard while operating as a part of the Department of Transportation remained with the Coast Guard after its transfer to DHS. As such, the Coast Guard retained its delegated authority to establish the regulatory framework governing the application and licensing process of deepwater ports. Although Congress specifically provided for affected States to play a role in the licensing process of deepwater ports, the authorities exercised by the Coast Guard in this rulemaking do not involve those delineated State roles or responsibilities as they establish the licensing procedures themselves. Congress made clear in the language of the DWPA that the authority to establish licensing procedures was reserved to the Coast Guard and States may not regulate within this category. Therefore, the proposed rule is consistent with the principles of federalism and preemption requirements in Executive Order 13132.
Additionally, the Coast Guard was granted the authority by Congress, through delegation, to issue regulations to improve safety in deepwater ports. 33 U.S.C. 1509(b) states that the Secretary “shall issue and enforce regulations with respect to lights and other warning devices, safety equipment, and other matters relating to the promotion of safety of life and property in any deepwater port and the waters adjacent thereto.” As this proposed rule revises provisions regarding the construction, design, equipment, and operation of deepwater ports, it falls within the scope of authority Congress granted exclusively to the Secretary. This authority has been delegated to the Coast Guard and is exercised in this rulemaking, and the States may not regulate within these categories of construction, design, equipment and operation for deepwater ports. Therefore, the proposed rule is consistent with the principles of federalism and preemption requirements in Executive Order 13132.
While it is well settled that States may not regulate in categories in which Congress intended the Coast Guard to be the sole source of authority to issue regulations, the Coast Guard recognizes the key role that State and local governments may have in making regulatory determinations. Additionally, for rules with federalism implications and preemptive effect, Executive Order 13132 specifically directs agencies to consult with State and local governments during the rulemaking process. If you believe this proposed rule has implications for federalism under Executive Order 13132, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995
This proposed rule would not cause a taking of private property or otherwise have taking implications under E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this proposed rule under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. This proposed rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This proposed rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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.
We have analyzed this proposed rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order. Though it is a “significant regulatory action” under E.O. 12866, it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under E.O. 13211.
The National Technology Transfer and Advancement Act
This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this proposed rule under DHS Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969,
Administrative practice and procedure, Environmental protection, Harbors, Petroleum.
Fire prevention, Harbors, Marine Safety, Navigation (water), Occupational safety and health, Oil pollution.
Harbors, Incorporation by reference, Marine safety, Navigation (water), Occupational safety and health, Oil pollution, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR parts 148, 149, and 150 as follows:
33 U.S.C. 1504; Department of Homeland Security Delegation No. 0170.1 (75).
(a) Under delegations from the Secretary of Homeland Security and the Secretary of Transportation, the Coast Guard and MARAD coordinate with each other in processing applications for the issuance, transfer, or amendment of a license for the construction and operation of a deepwater port.
(b) The Coast Guard is responsible for compliance with the National Environmental Policy Act (NEPA), including, but not limited to, preparation of the appropriate environmental documents (Environmental Impact Statement, Environmental Assessment, and/or a State-required Environmental Impact Report) for each deepwater port license application. The Coast Guard also has authority over certain matters relating to navigation safety and security, engineering and safety standards and deepwater port inspections.
(c) MARAD is responsible for issuing the Record of Decision to announce whether a license application is approved, approved with conditions, or denied, and for issuing, revoking, and reinstating deepwater port licenses. MARAD also has authority over the approval of fees charged by Adjacent Coastal States, and certain matters relating to international policy, civil actions, and suspension or termination of licenses.
(d) The Secretary of Transportation has delegated to the Administrator of the Pipeline Hazardous Materials and Safety Administration (PHMSA) the authority to carry out the functions vested in the Secretary under section 21 of the Deepwater Port Act relating to the safe construction, operation, and maintenance of pipelines associated with deepwater ports.
(e) The Secretary of the Interior is responsible for determining the fair market rental value of the subsoil and seabed of the Outer Continental Shelf of the United States to be used by the deepwater port, including, but not limited to, the fair market rental value of the right-of-way necessary for the pipeline segment of the port located on such subsoil and seabed. Any proposed subsuface storage of oil and gas in the submerged lands of the Outer Continental Shelf is also subject to the review and approval of the Secretary of the Interior. In order to minimize potential impacts to existing facilities and protect the development potential of nearby oil, gas, and mineral resources, Bureau of Ocean Energy Management (BOEM) should also be involved in the site selection process.
(f) The Environmental Protection Agency (EPA), U.S. Army Corps of Engineers, and other Federal agencies are designated as cooperating agencies and support the Coast Guard and MARAD in the review and evaluation of deepwater port license applications.
The additions and revisions read as follows;
As used in this subchapter:
(2) Includes all components and equipment, including pipelines, pumping stations, service platforms, buoys, mooring lines, and similar facilities, to the extent that they are located seaward of the high water mark;
(3) Includes, in the case of natural gas, all components and equipment, including pipelines, pumping or compressor stations, service platforms, buoys, mooring lines, and similar facilities which are proposed and/or approved for construction and operation as part of the deepwater port, to the extent that they are located seaward of the high water mark and do not include interconnecting facilities; and
(4) Must be considered a “new source” for purposes of the Clean Air Act, as amended (codified at 42 U.S.C. 7401
The addition reads as follows:
(a) * * * Applicants may, with Commandant (CG-5P) approval, nominate a CE before the Maritime Administration issues a Record of Decision.
The revisions and additions read as follows:
(g) * * *
(1) * * *
(i) Annual financial statements, audited by an independent certified public accountant, for the previous 3 years, including, but not limited to, an income statement, balance sheet, and cash flow statement with footnote disclosures prepared according to U.S. Generally Accepted Accounting Principles; provided, however, that MARAD, in consultation with the Commandant (CG-5P), may waive this requirement upon finding:
(2) * * *
(iii) A preliminary estimate of the cost of removing all of the deepwater port marine components, including pipelines that lie beneath the seabed. The licensee of a deepwater port is responsible for the costs associated with removal of all deepwater port components. Should a license be granted, MARAD will require a bond, guarantee, or other financial instrument to cover the complete cost of decommissioning as a condition of the license.
(i) * * *
(1) Evidence, to the extent available, that the requirements of 33 U.S.C. 1341(a)(1) will be satisfied. If complete information is not available by the time MARAD must either approve or deny the application under 33 U.S.C. 1504(i)(1), the license for the deepwater port will be conditioned upon the applicant demonstrating that the requirements of 33 U.S.C. 1341(a)(1) will be satisfied.
(j)
(i) The statement: “The proposed activity complies with the enforceable policies of [NAME OF AFFECTED STATE]'s approved management program and will be conducted in a manner consistent with such program.”; and
(ii) A copy of the environmental evaluation required by § 148.105(z) of this part; and
(2) At the time of submitting the application, the applicant must also furnish to the appropriate agency of each State where the proposal may affect a coastal use or resource, a copy of the certification requesting concurrence with the consistency certification. Complete procedures for providing data for the consistency certification are specified at 15 CFR part 930, subpart D.
(k)
(m) * * *
(1) * * *
(i) Fixed and floating structures and associated components seaward of the high water mark;
(iii) Proposed anchorage and mooring areas, including areas associated with construction and pipelaying operations;
(2) A reconnaissance hydrographic survey of the proposed marine site. This survey should provide data on the water depth, cultural resources, and a general characterization of the sea bottom. A requirement to submit a reconnaissance hydrographic survey of the final marine site will be imposed as a condition in the license. The applicant may submit existing data, gathered within the previous 5 years (or within a longer timeframe if approved by the Commandant (CG-5P)), but it must be supplemented by field data for the specific locations in which a high degree of variability exists;
(3) Meteorological/oceanographic (“MetOcean”) data. This should include prevailing winds, currents, waves and storms in the vicinity of the proposed marine site; and
(4) Vessel traffic data. At least one year of vessel traffic data from the most recent year's data, if available, in the vicinity of the proposed marine site.
(n)
(s) * * *
(6) * * *
(iv) Any associated equipment, including equipment for oil or natural gas regasification, throughput measuring, leak detection, emergency shutdown, and the alarm system.
(t)
(y)
(z)
(ff)
(a) The Commandant (CG-5P), in coordination with MARAD, may require the applicant, or the applicant's affiliates, to file as a supplement to the application any analysis, explanation, or other information the Commandant (CG-5P) deems necessary to process the application.
(b) The Commandant (CG-5P), in coordination with MARAD, may require the applicant, or the applicant's affiliates, to make available for Coast Guard or MARAD examination, under oath or for interview, persons having, or believed to have, necessary information.
(c) If information under paragraph (a) or (b) of this section is required, the Commandant (CG-5P), with input from the applicant, will determine if that required supplemental information can be provided in a timeframe necessary to meet the Act's timeline for processing the application. If the information under paragraph (a) or (b) cannot be provided in that timeframe, the Commandant (CG-5P), in consultation with MARAD, may suspend the timeline for processing the application until the Commandant (CG-5P) receives that information and deems it to be adequate.
(d) The deadline for the Administrator's review of an application under the Act is extended for a period of time equal to the total number of days of all suspensions made under paragraph (c) of this section.
(e) If information under paragraph (a) or (b) of this section is required, and the Commandant (CG-5P) determines that reasonable progress is not being made to supply that information, the Commandant (CG-5P) may recommend to MARAD to either suspend processing of the application indefinitely or to treat the application as withdrawn in accordance with § 148.283 of this part.
(a) Each Federal agency with jurisdiction over any aspect of ownership, construction, or operation of deepwater ports; and
(a) If at any time before MARAD approves or denies an application, the information in it changes, becomes incomplete, or becomes inaccurate, the applicant must promptly submit the changes, additional information, or necessary corrections in the manner set forth in § 148.115 of this part.
(b) The Coast Guard may determine that the change or required information is of such magnitude that it warrants submission of an amended or, in some cases, a completely revised application. The Commandant (CG-5P), in consultation with MARAD, will determine if the change is of such a magnitude as to require reopening of the scoping process or otherwise warrant the opportunity for additional public comment on the proposed action.
With the approval of MARAD, in consultation with the Commandant (CG-5P), an applicant may resubmit a previously withdrawn application in accordance with subpart B of this part. The Commandant (CG-5P) may waive such subpart B requirements as the Commandant (CG-5P) deems appropriate. Where the application was previously denied, or withdrawn due to concerns raised by either MARAD or the governor of an Adjacent Coastal State, the resubmission must be accompanied by a memorandum in which the applicant shows clearly how the application has been revised to address those reasons for denial or concerns.
(b) * * *
(1) Be submitted in writing to MARAD within 14 days after the date of publication of the notice of application in the
(c) Upon receipt of a request, MARAD will send a copy of the State's request to the Administrator of the National Oceanic and Atmospheric Administration (NOAA) and ask for the Administrator's recommendations within an amount of time that will allow MARAD, in consultation with the Commandant (CG-5P), 45 days from receipt of the request to determine the matter.
(d) If after receiving NOAA's recommendations, MARAD determines that the State should be considered an Adjacent Coastal State, MARAD, in consultation with the Commandant (CG-5P), will so designate it. If MARAD, in consultation with the Commandant (CG-5P), denies the request, he or she will notify the requesting State's Governor of the denial.
After all public meetings under § 148.222 of this part are concluded, MARAD, in consultation with the Commandant (CG-5P), will consider whether there are one or more specific and material factual issues that may be resolved by a formal evidentiary hearing. If it is determined that a formal
(a) In 33 U.S.C. 1504, the Act provides strict timelines for action on a license application, which, if closely observed, can lead to action in just under 1 year. The Coast Guard, with the concurrence of MARAD, may suspend the timeline if an applicant fails to provide timely information or requests additional time to comply with a request, as described in § 148.107 of this part.
(b) The timeline for action on a license application includes publishing a notice of application. A notice of application is published after it has been determined that the application contains sufficient material for processing the application. The Coast Guard and MARAD must conduct a public hearing in each Adjacent Coastal State within 240 days of publishing the notice.
(c) After the final environmental impact statement is published, MARAD will hold a final public hearing in each Adjacent Coastal State. MARAD issues a Record of Decision (ROD) approving or denying a license application within 90 days after the final public hearing. Actual issuance of a license may not take place until certain conditions imposed by the ROD have been met. Those conditions may include how the applicant must address design, construction, installation, testing, operations, and decommissioning of the deepwater port, or meet the requirements of other agencies.
(d) Approvals or disapprovals of the application from the governors of Adjacent Coastal States will be accepted by MARAD only within the 45-day period after the close of the final public hearing on the application, and not before the final public hearing. If the governor fails to transmit his or her approval or disapproval to MARAD not later than 45 days after the last public hearing, such approval will be conclusively presumed.
(a) The Commandant (CG-5P) may recommend to MARAD that an application be treated as withdrawn before the application is approved or denied if—
(1) The application is withdrawn before MARAD approves it; or
(2) The application is incomplete, and the applicant does not respond to a request by the Commandant (CG-5P) for further information, as per § 148.107 of this part.
(b) The Commandant (CG-5P) and MARAD will provide joint written notice to the applicant of an action taken under this section.
The OPA 90 limits of liability for deepwater ports are set forth in 33 CFR 138.230(b). The limits of liability in that section are adjusted periodically for significant increases in the Consumer Price Index, in accordance with 33 U.S.C. 2704(d)(4) and the procedures in 33 CFR 138.240. The limits of liability may also be adjusted under 33 U.S.C. 2704(d)(2) and the procedures in § 148.605 of this subpart.
(a) Upon an applicant's or licensee's request, the Coast Guard may lower the generally applicable OPA 90 limit of liability for deepwater ports in 33 CFR 138.230(b)(1). The Coast Guard may do so under 33 U.S.C. 2704(d)(2) on a port by-port-basis, after evaluating a spill risk analysis and an economic analysis. Adjustments to a deepwater port's limit of liability are established by a rulemaking that allows for public notice and comment, and if approved, will be codified at 33 CFR 138.230(b)(2).
(b) The limit of liability of a deepwater port will not be reduced to less than $50 million, and may be increased following a reduction, as the Coast Guard deems appropriate, if the design, construction, or operation of the deepwater port changes, or if oil spill incidents related to the deepwater port, or to deepwater ports generally, indicate that a higher limit is needed.
(c) Requests to adjust the limit of liability for a deepwater port under this subpart must be submitted to the Commandant (CG-5P). Requests to adjust the limits of liability may be submitted with a license application or upon receipt of a license from MARAD to construct and operate the proposed deepwater port. If the request for adjustment is submitted with the license application, no action will be taken on the request until MARAD issues a license to construct and operate the proposed deepwater port.
(d) Requests to adjust the limit of liability under this subpart must include a risk analysis of the deepwater port to determine its maximum probable oil discharge and an economic analysis to determine the OPA 90 responsible party removal costs and OPA 90 removal costs and damages for which the responsible party is liable under 33 U.S.C. 2702 that could result from such a spill.
(1) The risk analysis must, as applicable, consider the following factors:
(i) Deepwater port oil handling, storage, transfer, and transportation capacity and practices.
(ii) Type of oil handled.
(iii) Physical layout and condition of the deepwater port.
(iv) On-site oil spill response capability.
(v) Oil spill history of the deepwater port.
(vi) The pipeline oil leak detection system.
(vii) Section-by-section pipeline analysis of credible oil spill scenarios.
(viii) Other oil spills for which the deepwater port might be solely or jointly liable (such as tanker spills).
(2) The economic analysis must, as applicable, consider the following factors for the maximum credible spill:
(i) Spill trajectories.
(ii) Potential responsible party removal costs.
(iii) Potential removal costs and damages for which the responsible party is liable under 33 U.S.C. 2702.
The revisions and additions read as follows:
(b) The environmental evaluation will be applied to the phases of construction, operation, and decommissioning of the proposed action and alternatives. Alternatives must consider alternate siting of the deepwater port as well as different technologies and pipeline routes. The evaluation will assess:
(1) * * *
(ix) Marine, coastal, and migratory birds; and
(x) Marine mammals and fisheries.
In constructing and operating a deepwater port, the deepwater port must comply with all applicable Federal, State, and tribal environmental statutes and Executive Orders (E.O.s). For the purposes of information only, a non-exhaustive list of Federal environmental statutes and E.O.s is available online via a Coast Guard Web site:
33 U.S.C. 1504; Department of Homeland Security Delegation No. 0170.1 (75).
Definitions applicable to this part appear in 33 CFR 148.5.
The addition reads as follows:
(d) The appropriateness of the design of a deepwater port, or its components, may be shown by its compliance with standards generally used within the offshore industry that are at least equivalent to rules established by any recognized classification society as defined in 46 CFR 8.100. Based on the design, complexity, and location of a deepwater port, the Commandant (CG-5P) will determine, in coordination with the applicant or licensee, as appropriate, the components to be included in classification society certification or classification certificate. This coordination should start early in the process, especially in the case of manned fixed or floating structures.
(a) Alterations and modifications affecting the design and construction of a deepwater port must be submitted to the Commandant (CG-5P) for review and approval if—
(1) A license has not yet been issued; or
(2) A license has been issued but the deepwater port has not commenced operations; or
(3) The alterations and modifications are deemed a major conversion; or
(4) The alterations or modifications substantially change the manner in which the deepwater port operates or are not in accordance with a condition of the license.
(b) All other alterations and modifications to the deepwater port must be submitted to the Sector Commander, or MSU Commander with COTP and OCMI authority for review and approval.
(c) Approval for alterations and modifications proposed after a license has been issued will be contingent upon whether the proposed changes will affect the way the deepwater port operates, or any conditions imposed in the license.
(d) The licensee is not authorized to proceed with alterations prior to approval from the Commandant (CG-5P) for the conditions outlined in paragraph (a) and for approval by the cognizant Sector Commander, or MSU Commander with COTP and OCMI authority as required in paragraph (b) of this section.
(e) During the review and approval process of a proposed alteration or modification, the Commandant (CG-5P) may consult with the Marine Safety Center and cooperating Federal agencies possessing relevant technical expertise.
(a) The Coast Guard is responsible for ensuring that all aspects of a deepwater port are in compliance with appropriate standards and requirements. The Coast Guard review of a proposed deepwater port ends at, and includes, the last downstream valve of the pipeline end manifold (PLEM) for each single point mooring-oil transfer system (SPM-OTS) or single point mooring-natural gas transfer system (SPM-NGTS) (last downstream valve prior to connecting to a pipeline). The main gas transmission lines to shore or to offshore pipeline infrastructure, and the flowlines or gathering lines connecting multiple SPM-OTSs or SPM-NGTSs, fall under the jurisdiction of PHMSA.
(b) The Commandant (CG-5P) will coordinate the review and approval for operations for the Coast Guard and other Federal and State agencies as necessary.
(c) Depending on project complexity, construction, and installation timing, the Commandant (CG-5P) will determine, with input from the licensee, when the review process should be initiated and when the certifying entity (CE), if used, should be nominated, approved and engaged. The CE may also be the classification society being used as described in 33 CFR 149.52(d).
(d) Final approval to commence commissioning and operations of the deepwater port will come from the Commandant (CG-5P). This approval may contain additional conditions that must be satisfied once the deepwater port is operational. Once Commandant (CG-5P) has granted the deepwater port clearance to operate, the Sector Commander, or MSU Commander with COTP and OCMI authority will exercise day to day oversight.
(a) A certifying entity (CE), contracted by the licensee but under the direction of and acting for the Coast Guard, may assist in the review and verification of each phase (
(1)
(2)
(3)
(b) The licensee must provide to the Commandant (CG-5P), and to a CE, if used, the design basis and lists of drawings, plans, calculations, analyses, procedures, and correspondence as determined in the review.
(c) If a CE is used, key responsibilities for the CE include, but are not limited to—
(1) Recommendation of approval, disapproval, or approval with proposed changes of the applicant's design basis;
(2) Development of an action plan for each phase;
(3) Providing selected drawings and plan reviews;
(4) Inspections and oversight;
(5) Interim reports and recommendations; and
(6) A final report and recommendation for Coast Guard approval or disapproval.
(d) The CE may also be used to assist in the review of such areas as—
(1) A maintenance and inspection program;
(2) System safety, including interoperability, reliability, safety integrity levels, and LNG carrier compatibility;
(3) Specific, higher-risk components and operations; and
(4) Pipeline design, installation and operations manual (The applicant must coordinate the review and approval of the pipeline appendix to the operations manual with PHMSA).
(e) At the option of the licensee, the CE may continue to support the review and approval process for a deepwater port through to its decommissioning.
Survival craft and rescue boats must satisfy the requirements of 46 CFR
(a) Except for boathooks, the survival equipment required by 46 CFR 108.575(b) must be securely stowed in the lifeboat.
(b) Each lifeboat must have a list of the survival equipment it is required to carry. The list must be posted in the lifeboat.
(c) Except as provided in § 149.205(b) of this part, each inflatable or rigid liferaft, boarded from a deck that is more than 4.5 meters (14.75 feet) above the water, must be davit-launched or served by a marine evacuation system approved under approval series 160.175.
(d) The launching equipment must be arranged so that a loaded liferaft does not have to be lifted before it is lowered.
(e) Not more than two liferafts may be launched from the same set of launching equipment.
(f) The operator must arrange survival craft so that they are—
(1) Readily accessible in an emergency;
(2) Accessible for inspection, maintenance, and testing;
(3) In locations clear of overboard discharge piping or openings, and of obstructions below; and
(4) Located so that survival craft with an aggregate capacity to accommodate all persons authorized to be berthed are readily accessible from the personnel berthing area.
(g) The operator may use an onboard crane to launch a rescue boat if the crane's launching system meets the requirements of this section.
Unless approval from the Sector Commander, or MSU Commander with COTP and OCMI authority, is requested and granted pursuant to § 149.303 of this part and as permitted under § 149.303, § 149.315(c) or (d), § 149.319(a)(1), or § 149.320 of this part, all required firefighting and fire protection equipment on a deepwater port must be approved by the Commandant (CG-ENG). Firefighting and fire protection equipment that exceeds required equipment must also be approved by the Commandant (CG-ENG).
33 U.S.C. 1231, 1321(j)(1)(C), (j)(5), (j)(6), (m)(2); 33 U.S.C. 1509(a); E.O. 12777, sec. 2; E.O. 13286, sec. 34, 68 FR 10619; Department of Homeland Security Delegation No. 0170.1(70), (73), (75), (80).
(b) The operations manual is reviewed and approved by the Commandant (CG-5P), in coordination with the local Sector Commander, or MSU Commander, with COTP and OCMI authority, as meeting the requirements of the Act and this subchapter.
(c) The manual must be readily available on the deepwater port for use by personnel.
(d) The licensee must ensure that all personnel are trained and follow the procedures in the manual while at the deepwater port.
(e) Every 5 years from the date of approval of the operations manual (unless a longer timeframe is approved by the Commandant (CG-5P)), a deepwater port operator must re-submit the operations manual to the Commandant (CG-5P) to be re-reviewed and re-approved.
The additions and revisions read as follows:
(o) A certificate of adequacy (COA) that certifies a deepwater port meets the requirements for reception facilities as required under 33 CFR part 158, or a waiver of a COA.
(y)
(i) Access controls for goods and materials and access controls for personnel that require positive and verifiable identification;
(ii) Monitoring and alerting of vessels that approach or enter the deepwater port's security zone;
(iii) Risk identification and procedures for detecting and deterring terrorist or subversive activity, such as security lighting and remotely-alarmed restricted areas;
(iv) Internal and external notification and response requirements in the event of a perceived threat or an attack on the deepwater port;
(v) Designation of the deepwater port security officer (DPSO);
(vi) Required security training and drills for all personnel; and
(vii) The scalability of actions and procedures for the various levels of threat.
(2)
(ii) If there is a change in ownership or operations of the deepwater port, or if there have been modifications to the deepwater port, the deepwater port security plan must be audited including but not limited to physical structure, emergency response procedures, security measures, or operations.
(iii) Auditing the deepwater port security plan, as a result of modifications to the deepwater port, may be limited to those sections of the deepwater port security plan affected by the deepwater port modifications.
(iv) Unless impracticable due to the size and nature of the company or the deepwater port, personnel conducting internal audits of the security measures specified in the deepwater port security plan or evaluating its implementation must—
(A) Have knowledge of methods of conducting audits and inspections, and control and monitoring techniques;
(B) Not have regularly assigned security duties; and
(C) Be independent of any security measures being audited.
(v) If the results of an audit require an amendment of the deepwater port security plan, the DPSO must submit the proposed amendment to the cognizant Sector Commander, or MSU Commander with COTP and OCMI authority, with copy to the Commandant (CG-5P), for review and approval no later than 30 days after completion of the audit.
(3)
(bb)
(1)
(i) Monitoring must commence shortly before project construction in the vicinity of the construction sites and other potentially impacted areas and continue throughout the construction phase.
(ii) During project operations, a continuous monitoring program designed to ensure coverage of seasonal variations must be undertaken.
(2)
(i) The re-examination must include, but not be limited to, a detailed analysis of the results of the environmental monitoring program to identify trends and impacts that result from the deepwater port's operations.
(ii) The re-examination must be submitted for review and approval to the Commandant (CG-5P) and MARAD not later than 60 days before the 5 year period ends.
(cc)
The revisions and addition read as follows:
(c) * * *
(1) If the Sector Commander, or MSU Commander with COTP and OCMI authority determines that the proposed amendments are inadequate, the Sector Commander, or MSU Commander with COTP and OCMI authority, will return them to the licensee for revision.
(2) If the Sector Commander, or MSU Commander with COTP and OCMI authority, decides that a proposed amendment is adequate, the amendment will go into effect 60 days after the Sector Commander, or MSU Commander with COTP and OCMI authority, notifies the licensee, with copy to the Commandant (CG-5P). The Commandant (CG-5P) will notify MARAD, and PHMSA as appropriate, prior to a significant amendment going into effect.
(e) If the Sector Commander, or MSU Commander with COTP and OCMI authority, finds that a particular situation requires immediate action to prevent a spill or discharge, or to protect the safety of life and property, he or she may issue an amendment effective on the date that the licensee receives it. The Sector Commander, or MSU Commander with COTP and OCMI authority, must include a brief statement of the reasons for the immediate amendment. The licensee may petition the District Commander for review, but the petition does not delay the effective date of the amendment.
(f) Other Federal agencies may propose amendments to the operations manual by submitting them to the Coast Guard's Office of Operating and Environmental Standards (CG-OES), which will coordinate with the Sector Commander, or MSU Commander with COTP and OCMI authority, to have the licensee implement requested amendments.
(a) Proposed amendments to an approved operations manual must be submitted to the Sector Commander, or MSU Commander with COTP and OCMI authority, in whose area of responsibility the deepwater port is located, with copy to the Commandant (CG-5P). The Commandant (CG-5P) will notify MARAD prior to approval of proposed significant amendments to the operations manual to ensure approval accords with the conditions of the deepwater port's license. If the proposed changes are not consistent with the requirements of any license condition, the environmental impact analysis, or any other Federal or State license or approval, the Commandant (CG-5P) must notify the Sector Commander, or MSU Commander with COTP and OCMI authority of this inconsistency immediately. Sector Commander, or MSU Commander with COTP and OCMI authority approval of the proposed changes will be withheld until the identified inconsistencies are resolved.
(b) The licensee may propose an amendment to the operations manual—
(1) By submitting to the Sector Commander, or to the MSU Commander with COTP and OCMI authority, in writing, the amendments and reasons for the amendments, not less than 30 days before the requested effective date of the amendment; or
(2) If the amendment is needed immediately, by submitting the amendment, and reasons why the amendment is needed immediately, to the Sector Commander, or to the MSU Commander with COTP and OCMI authority in writing.
(c) The Sector Commander, or MSU Commander with COTP and OCMI authority, in coordination with the Commandant (CG-5P), must respond to a proposed amendment by notifying the licensee of his or her decision, in writing, before the requested date of the amendment. If the request is disapproved, the Sector Commander, or MSU Commander with COTP and OCMI authority must include the reasons for disapproval in the notice. If the request is for an immediate amendment, the Sector Commander, or the MSU Commander with COTP and OCMI authority must respond as soon as possible.
(a) An Adjacent Coastal State connected by pipeline to the deepwater port may petition the cognizant Sector Commander, or MSU Commander with COTP and OCMI authority, with copy to the Commandant (CG-5P), to amend deepwater port operations. The petition must include sufficient information to allow the Sector Commander, or MSU Commander with COTP and OCMI authority to reach a decision concerning the proposed amendment.
(b) After the Sector Commander, or MSU Commander with COTP and OCMI
(c) After reviewing the petition and comments and considering the costs and benefits involved, the Sector Commander, or MSU Commander with COTP and OCMI authority, in coordination with the Commandant (CG-5P), may approve the petition if the proposed amendment will provide equivalent or improved protection and safety. The Adjacent Coastal State may petition the Commandant (CG-5P) to review the decision. Petitions must be made in writing and presented to the Sector Commander, or MSU Commander with COTP and OCMI authority for forwarding to the Commandant (CG-5P) via the District Commander.
(a) If, because of a particular situation, the licensee needs to deviate from the operations manual, the licensee must submit a written request to the Sector Commander, or MSU Commander with COTP and OCMI authority explaining why the deviation is necessary and what alternative is proposed. If the Sector Commander, or MSU Commander with COTP and OCMI authority determines that the deviation would ensure equivalent or greater protection and safety, the Sector Commander, or MSU Commander with COTP and OCMI authority will authorize the deviation and notify the licensee in writing.
(b) In an emergency, any person may deviate from any requirement in this subchapter, or any procedure in the operations manual, to ensure the safety of life, property, or the environment. Each deviation must be reported to the Sector Commander, or to the MSU Commander with COTP and OCMI authority at the earliest possible time.
(a) Under direction of the Sector Commander, or MSU Commander, with COTP and OCMI authority, marine inspectors may inspect deepwater ports to determine whether the requirements of this subchapter are met. A marine inspector may conduct an inspection, with or without advance notice, at any time the Sector Commander or MSU Commander deems necessary.
(b) During an inspection, Coast Guard marine inspectors may be accompanied by representatives of other Federal agencies.
(a) The operator of each deepwater port must ensure that the deepwater port is regularly inspected to determine whether the facility is in compliance with the requirements of the approved operations manual, the license, and any classification society certifications. To this end, a deepwater port operator may propose to the Sector Commander, or to the MSU Commander, with COTP and OCMI authority, to implement a self-inspection program. Prior to the initiation of a self-inspection program, and before commencement of operations, the owner or operator must submit a proposal describing the self-inspection plan to the Sector Commander, or to the MSU Commander, with COTP and OCMI authority for acceptance. The plan must address all applicable requirements outlined in parts 149 and 150 of this subchapter. Any proposed program must include inspection intervals not to exceed 12 months between inspections. The inspection may be conducted up to 2 months after its due date, but will be valid for only the 12 months following that due date.
(b) The operator must record and submit the results of the annual self-inspection to the Sector Commander, or to the MSU Commander with COTP and OCMI authority, within 30 days of completing the inspection. The report must include a description of any failure, and the scope of repairs made to components or equipment, in accordance with the requirements in subpart I of this part, other than primary lifesaving, firefighting, or transfer equipment, which are inspected and repaired in accordance with subpart F.
(c) The Sector Commander, or the MSU Commander with COTP and OCMI authority, must validate the results of each inspection. If the Sector Commander, or the MSU Commander with COTP and OCMI authority, determines that the deepwater port is not operating in conformity with its operations manual or license, the Sector Commander, or the MSU Commander with COTP and OCMI authority, must direct appropriate corrective action to the deepwater port operator, and the Sector Commander, or the MSU Commander with COTP and OCMI authority, must notify the Commandant (CG-5P). After receipt of the notification, if the Commandant (CG-5P) concurs that a possible violation of a license condition is indicated, Commandant (CG-5P) will notify MARAD for consideration of what, if any, action on the license should be taken.
The operator must notify the Sector Commander, or the MSU Commander with COTP and OCMI authority, of scheduled Federal and State agency inspections. The operator must retain the record of results of any Federal or State agency inspection and make those records available for review upon receiving a request by the Sector Commander, or by the MSU Commander with COTP and OCMI authority, or his or her designated representative. The Coast Guard may participate in any inspection undertaken by another Federal or State agency with jurisdiction.
(a) * * *
(b) If the activity is not listed in table 150.380(a) of this section, or otherwise provided for in this subpart, the permission of the Sector Commander, or MSU Commander with COTP and OCMI authority, is required before operating in the safety zone or other ship's routing measure.
(a) Oil pollution incidents involving a deepwater port are reported according to part 153, subpart B, of this chapter.
(b) In each notification made under paragraph (a) of this section, the person in charge of the deepwater port involved in the incident must provide his or her name and telephone number, or radio call sign, and, to the extent known, the—
(1) Location, date, and time of the incident;
(2) Quantity of oil involved;
(3) Cause of the incident;
(4) Name or other identification of the vessel or offshore facility involved;
(5) Size and color of any slick or sheen and the direction of its movement;
(6) Observed on-scene weather conditions, including wind speed and direction, height and direction of seas, and any tidal or current influence present;
(7) Actions taken or contemplated to secure the source or contain and remove or otherwise control the discharged oil;
(8) Extent of any injuries or other damages incurred as a result of the incident;
(9) Observed damage to living natural resources; and
(10) Any other information deemed relevant by the reporting party or requested by the person receiving the notification.
(c) The person giving notification of an incident must not delay notification to gather all required information and
Food and Drug Administration, HHS.
Notice of proposed rulemaking.
The Food and Drug Administration (FDA or we) is proposing to amend its regulation for registration of food facilities that requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA. This proposed rule would amend and update FDA's registration regulations and is part of our implementation of the FDA Food Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities. Moreover, a number of provisions in FSMA apply only to facilities required to register, including hazard analysis and risk-based preventive controls and mandatory recall authority. The proposed amendments will further enhance FDA's capabilities with respect to responding to food safety issues, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.
Submit either electronic or written comments on the proposed rule by June 8, 2015. Submit comments on the information collection issues under the Paperwork Reduction Act of 1995 by May 11, 2015, (see the “Paperwork Reduction Act of 1995” section of this document).
You may submit comments by any of the following methods, except that comments on the information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the “Paperwork Reduction Act of 1995” section of this document).
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
Submit written submissions in the following ways:
• Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
This proposed regulation would implement certain provisions in section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d), as amended by section 102 of the FDA Food Safety Modernization Act (FSMA), that relate to registration of food facilities. In addition, this proposed regulation would amend and update FDA's registration regulations to further enhance FDA's capabilities with respect to responding to food-related emergencies, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.
Section 102 of FSMA amends section 415 of the FD&C Act by requiring that certain additional information be included in registrations. More specifically, section 102(a)(1)(A) of FSMA amends section 415 to provide that registrations for domestic food facilities are required to contain the email address for the contact person of the facility, and registrations for foreign food facilities are required to contain the email address of the U.S. agent for the facility. Further, section 102(a)(3) of FSMA amends section 415 to provide that food facilities required to register with FDA must renew their registrations with FDA every 2 years, between October 1 and December 31 of each even-numbered year, by submitting registration renewals to FDA. Also, section 102(b)(1)(A) of FSMA provides that all food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. These FSMA amendments were self-implementing and became effective upon enactment of FSMA. These FSMA amendments are being included in this proposed rule to codify the provisions in the food facility registration regulations in 21 CFR part 1, subpart H.
In addition, section 102(b) of FSMA authorizes FDA to require that all food facility registrations be submitted to FDA in an electronic format; however, such requirement cannot take effect before the date that is 5 years after the date of enactment of FSMA (
Section 102(c) of FSMA also directs FDA to amend the definition of the term “retail food establishment” in § 1.227(b)(11) of title 21, Code of Federal Regulations to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include: (1) The sale of food products or food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a community supported agriculture program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary. We are proposing to implement these provisions in this proposed rule.
Lastly, we are proposing changes to improve the utility of the food facility registration database. We are proposing, among other things, to: (1) Require
Costs of meeting the proposed requirements of this rule will be incurred by both FDA and food facilities that are required to register. Table 1 presents estimated costs associated with the provisions in this proposed rule. Estimated one-time costs to domestic and foreign facilities are about $22 million. Annualized costs are calculated using a discount rate of 7 percent and 3 percent over 20 years. Total annualized costs to food facilities, which include annualized one-time costs and annualized recurring costs, are approximately $5 million and $6 million. Annualized recurring costs to FDA are approximately $1 million, using both discount rates. We expect that the benefits of the proposed rule would include aiding FDA's ability to deter and limit the effects of foodborne outbreaks and other food-related emergencies. Although we are unable to quantify these and other benefits, we discuss the expected benefits qualitatively in the preliminary regulatory impact analysis (PRIA).
After the events of September 11, 2001, highlighted the need to enhance the security of the infrastructure of the United States, including the food supply, Congress responded by enacting the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188), which was signed into law on June 12, 2002. The Bioterrorism Act included a provision in Title III (Protecting Safety and Security of Food and Drug Supply), Subtitle A—Protection of Food Supply, section 305, which required the Secretary of Health and Human Services (the Secretary) to develop a regulation to require domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States to register with FDA by December 12, 2003. The provision created section 415 and amended sections 301 and 801 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 331 and 381). Section 415 of the FD&C Act, as added by the Bioterrorism Act, generally requires food facilities to register with FDA by submitting certain information to the Agency and updating such information as necessary. Section 301(dd) of the FD&C Act provides that failure to register in accordance with section 415 of the FD&C Act is a prohibited act. Section 801(l) of the FD&C Act, as added by the Bioterrorism Act, generally provides that an article of food imported or offered for import into the United States from a foreign facility for which a registration has not been submitted to FDA under section 415 shall be held at the port of entry for the article.
The Secretary and the Department of Treasury (Treasury) jointly issued a proposed rule for food facility registration (2003 proposed rule) in the
• The owner, operator, or agent in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in
• The owner, operator, or agent in charge of a facility that is required to register may authorize an individual to register the facility on its behalf.
• Facilities covered under the interim final rule had to be registered by December 12, 2003.
• A foreign facility is exempt from registering if food from the facility undergoes further manufacturing/processing (including packaging) by another facility outside the United States. The foreign facility is not exempt from registration if the further manufacturing/processing (including packaging) activities of the subsequent facility are limited to affixing a label to a package or other de minimis activity.
• The following domestic and foreign facilities are also excluded from the registration requirement: Farms; retail food establishments; restaurants; nonprofit food establishments in which food is prepared for, or served directly to, the consumer; certain fishing vessels not engaged in processing; and facilities regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601,
• Registrants must use Form FDA 3537 to register. This form is available either on the Internet or via mail or phone request. Registrants must use Form FDA 3537(a) to cancel their registrations.
• FDA strongly encourages electronic registration, which is quicker and more convenient for both facilities and FDA than registration by mail.
• To register electronically, a registrant may visit
• Regardless of the method of submission (paper or electronic), each registration must include the names, full addresses, and phone numbers for the facility, its parent company (if applicable), and the owner, operator and agent in charge; for a foreign facility, the name, address, and phone number, and, if no emergency contact is designated, the emergency contact phone number of the foreign facility's U.S. agent; for a domestic facility, an emergency contact phone number; all trade names the facility uses; applicable food product categories as identified in § 170.3 (21 CFR 170.3); and a statement certifying that the information submitted is true and accurate and, if the individual submitting the registration is not the owner, operator, or agent in charge of the facility, a statement in which the individual certifies that he/she is authorized to submit the registration.
• No registration fee is required.
• Updates to registration information or cancellation of registration must be submitted within 60 calendar days of any change to any of the required information previously submitted, except a change of the owner.
• If a facility has a new owner, the former owner must cancel the facility's registration within 60 calendar days of the change and the new owner must re-register the facility.
• Failure of a domestic or foreign facility to register, update, or cancel its registration in accordance with the regulation is a prohibited act under section 301(dd) of the FD&C Act.
• FDA will cancel a registration if the Agency independently verifies that the facility is no longer in business or has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration, or if FDA determines that the registration is for a facility that does not exist.
• The disposition of food imported or offered for import from an unregistered foreign facility is governed by the procedures set out in subpart I of part 1 (21 CFR part 1) (Prior Notice of Imported Food).
• Assignment of a registration number to a facility means that the facility is registered with FDA. Assignment of a registration number does not in any way convey FDA's approval or endorsement of a facility or its products.
• The list of registered facilities and registration documents submitted are not subject to public disclosure under 5 U.S.C. 552 (the Freedom of Information Act). Information derived from this list or these documents is also not subject to such disclosure to the extent that it discloses the identity or location of a specific registered facility.
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the food supply. Section 102 of FSMA, entitled Registration of Food Facilities, amends section 415 of the FD&C Act regarding requirements for food facility registration along with other sections of the FD&C Act involving food facility registration. Further, other sections of FSMA include amendments that apply to facilities that are required to register under section 415 of the FD&C Act.
Section 102 of FSMA includes a number of amendments to food facility registration requirements or sections of the FD&C Act involving food facility registration. First, section 102 of FSMA amends section 415 by requiring that certain additional information be included in registrations. More specifically, section 102(a)(1)(A) of FSMA amends section 415 to provide that registrations for domestic food facilities are required to contain the email address for the contact person of the facility, and registrations for foreign food facilities are required to contain the email address of the U.S. agent for the facility. Also, section 102(b)(1)(A) of FSMA provides that all food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. These FSMA amendments were self-implementing and became effective upon enactment of FSMA. These FSMA amendments are being included in this proposed rule to codify the provisions in the registration of food facilities regulations in 21 CFR part 1, subpart H.
Second, section 102 of FSMA amends section 415 with respect to updating food product category information required in food facility registrations. Before FSMA was enacted, section 415(a)(2) of the FD&C Act, as added by section 305 of the Bioterrorism Act, provided in relevant part that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in § 170.3) of food manufactured, processed, packed, or held at such facility. On July 17, 2003, FDA issued a guidance document stating that FDA had determined that the inclusion of food product categories in food facility registrations was necessary for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency (see 68 FR 42415). Section 102(a)(1)(B) of FSMA amends section 415(a)(2) of the FD&C Act with respect to food product category information by authorizing FDA to determine other food product categories, including those not
Third, section 102(a)(3) of FSMA amends section 415 to provide that food facilities required to register with FDA must renew their registrations with FDA every 2 years, between October 1 and December 31 of each even-numbered year, by submitting registration renewals to FDA. Further, section 102(a)(3) of FSMA directs FDA to provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility.
Fourth, section 102(b) of FSMA amends section 415(b) of the FD&C Act by adding new provisions authorizing FDA to suspend the registration of a food facility in certain circumstances. Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that created, caused, or was otherwise responsible for such reasonable probability; or knew of, or had reason to know of, such reasonable probability and packed, received, or held such food. Under section 415(b)(4) of the FD&C Act, as amended by section 102(b) of FSMA, if the registration of a food facility is suspended, no person can import or export, or offer to import or export, food from the facility into the United States, or otherwise introduce food from the facility into interstate or intrastate commerce in the United States. Under section 301(d) of the FD&C Act, as amended by section 102(b) of FSMA, the introduction or delivery for introduction into interstate commerce of an article of food in violation of section 415 is a prohibited act. Further, section 801(l) of the FD&C Act, as amended by section 102(b) of FSMA, provides, in relevant part, that an article of food being imported or offered for import into the United States that is from a foreign facility for which a registration has been suspended under section 415 must be held at the port of entry for the article of food, and may not be delivered to the importer, owner, or consignee of the article. FDA intends to address the suspension of registration provisions in section 102(b) of FSMA in a separate rulemaking.
Section 102(b) of FSMA also authorizes FDA to require that all food facility registrations be submitted to FDA in an electronic format; however, such requirement cannot take effect before the date that is 5 years after the date of enactment of FSMA (
Lastly, section 102(c) of FSMA directs FDA to amend the definition of the term “retail food establishment” in § 1.227(b)(11) of title 21, Code of Federal Regulations to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include: (1) The sale of food products or food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a community supported agriculture program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary. As discussed more fully in the paragraphs that follow, we are proposing to implement these provisions in this proposed rule.
In addition to amending section 415 of the FD&C Act and the other related sections of the FD&C Act as discussed in the preceding section, FSMA also amended the FD&C Act such that section 415 functions in connection with other food safety provisions. For instance, FSMA added section 418 of the FD&C Act (21 U.S.C. 350g), which establishes certain preventive control requirements for food facilities that are required to register under section 415. In general, section 418(a) requires the owner, operator, or agent in charge of a “facility” to evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. The term “facility” is defined in section 418(
In addition, section 201(a) of FSMA created section 421 of the FD&C Act (21 U.S.C. 350j), which also ties to section 415. In particular, section 421 requires the Agency to identify high-risk “facilities” and mandates more frequent inspections for domestic high-risk “facilities” than for domestic non-high-risk facilities. Section 421 also includes an inspection mandate for foreign facilities. For the purposes of section 421, the term “facility” refers to facilities that are required to register under section 415. (See section 421(e)). In addition, section 306 of FSMA added section 807(a)(1) of the FD&C Act (21 U.S.C. 384c(a)(1)), which provides that FDA may enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered under section 415.
FSMA also created section 423 of the FD&C Act (21 U.S.C. 350
Further, section 107 of FSMA amended the FD&C Act to provide FDA with the authority to collect fees related to reinspections of facilities required to register under section 415 of the FD&C Act. Specifically, section 107 of FSMA
FSMA is not the only act in which Congress has linked food facility registration to specific food safety requirements. The Food and Drug Administration Amendments Act of 2007 (FDAAA) also tied food safety requirements to food facility registration. FDAAA amended the FD&C Act by creating section 417, which generally requires a “responsible party” to submit a report to FDA through the Reportable Food Registry after determining that an article of food is a reportable food as defined in section 417(a)(2) and further defined in section 201(ff) of the FD&C Act (21 U.S.C. 321(ff))). As stated previously, section 417 of the FD&C Act defines the term “responsible party” as a person that submits the registration under section 415(a) of the FD&C Act for a food facility that is required to register under section 415(a) of the FD&C Act, at which such article of food is manufactured, processed, packed, or held. (See section 417(a)(1) of the FD&C Act.)
As a result of these links between food facility registration and additional requirements in the FD&C Act, food facility registration now serves additional functions to those originally identified in the food facility registration regulations issued in 2003 and finalized in 2005 (68 FR 58894; 70 FR 57505). More specifically, the interim final rule noted that food facility registration would help FDA act quickly in responding to a threatened or actual bioterrorist attack on the U.S. food supply or to other food-related emergencies (68 FR 58894 at 58895). It also noted that registration would provide FDA with information about food facilities that would help FDA and other authorities determine the source and cause of an outbreak of foodborne illness, while also enabling FDA to notify more quickly the facilities that might be affected by the outbreak (68 FR 58894 at 58895). While food facility registration continues to serve all of those functions, with the passage of FSMA and FDAAA, food facility registration now also serves to determine the applicability of provisions in other sections of the FD&C Act, including sections 417, 418, 421, 423, 743, 807, and 808 of the FD&C Act. Thus, food facility registration now relates to many more food safety requirements than when the system was first implemented in 2003.
Section 103(c)(1)(A) of FSMA, regarding Hazard Analysis and Risk-Based Preventive Controls, requires that the Secretary publish a notice of proposed rulemaking in the
We are issuing this proposed rule under the FD&C Act, FSMA, and the Bioterrorism Act. We are proposing to codify the requirements of section 102 of FSMA that were self-implementing and effective upon enactment of FSMA, as discussed previously, in the Registration of Food Facilities Regulation (part 1, subpart H). In addition, we are proposing to implement other requirements of section 102 of FSMA, as discussed previously, including mandatory electronic registration submissions beginning in 2016 and amendments to the retail food establishment definition. Lastly, we are proposing other changes to improve the utility of the food facility registration database.
FDA's legal authority to implement requirements of section 102 of FSMA derives from section 102 of FSMA and sections 415, 301(dd), 801(l), and 701(a) of the FD&C Act. As discussed previously, section 415 of the FD&C Act requires food facilities that manufacture/process, pack, or hold food for consumption in the United States to register with FDA by submitting certain information to the Agency and updating such information as necessary. Section 415(a)(2) of the FD&C Act, as amended by section 102 of FSMA, requires, in relevant part, food facility registrations to include additional information, including the email addresses of contact persons for domestic facilities and U.S. agents for foreign facilities; an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act; and updated food product category information, if determined necessary and appropriate by FDA. Further, section 415(a)(3) of the FD&C Act, as amended by section 102 of FSMA, requires, in relevant part, food facilities required to register to renew their registrations with FDA between October 1 and December 1 of each even-numbered year, and directs FDA to provide for an abbreviated registration renewal process for registrants that have not had any changes to registration information since the registrant submitted the preceding registration or registration renewal for the facility involved. Section 301(dd) of the FD&C Act provides that failure to register in accordance with section 415 of the FD&C is a prohibited act. Section 801(l) of the FD&C Act provides that an article of food being imported or offered for import into the United States that is from a foreign facility for which a registration has not been submitted to FDA under section 415 (or for which a registration has been suspended under such section) must be held at the port of entry for the article of food, and may not be delivered to the importer, owner, or consignee of the article until the foreign facility is so registered. Section 701(a) of the FD&C Act authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act. As discussed previously, section 102(c) of FSMA also directs FDA to amend the definition of the term “retail food establishment” in FDA's Registration of Food Facilities Regulation at § 1.227(b)(11).
As discussed in detail in the paragraphs that follow, FDA is proposing additional required data elements in food facility registrations to provide for more efficient and effective communications during a public health emergency and to provide FDA information that we can use to focus
This proposed rule would revise FDA's current regulations in part 1, subpart H, regarding registration of food facilities in two fundamental ways. First, it would add new provisions to the current regulations to implement certain provisions of section 102 of FSMA or otherwise codify amendments of section 102 of FSMA that were self-implementing and effective upon enactment of FSMA, as discussed previously. Second, we are proposing changes to improve the utility of the food facility registration database. We are proposing to do this by proposing, among other things, to: (1) Require certain additional data elements in food facility registrations; (2) employ additional measures to verify certain information submitted in registrations; and (3) take additional steps to ensure that our registration database is up to date by identifying additional circumstances under which FDA will cancel registrations. The following description of the proposed rule describes both new provisions and changes to the existing regulations in part 1, subpart H.
Under section 415 of the FD&C Act and FDA's registration regulation (21 CFR 1.226(c)), a retail food establishment is not required to register with FDA. A “retail food establishment” is defined in current § 1.227(b)(11) to mean an establishment that sells food products directly to consumers as its primary function. Under current § 1.227(b)(11), a retail food establishment may manufacture/process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufacturers/processes, packs, or holds, directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The definition of retail food establishment also provides that the term “consumers” does not include businesses, and a “retail food establishment” includes grocery stores, convenience stores, and vending machine locations.
Section 102(c) of FSMA directs FDA to amend the definition of “retail food establishment” to clarify that, in determining the primary function of an establishment, the sale of food directly to consumers by such establishment includes: (1) The sale of food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a community supported agriculture program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.
The proposed amendment to the retail food establishment definition addresses off-farm sales by an establishment located on a farm. How these off-farm sales relate to an establishment's status as a retail food establishment is significant because if manufacturing/processing activities on a farm are part of a retail food establishment, they do not trigger the requirement to register. Otherwise, unless all food used in such activities is consumed on that farm or another farm under the same ownership, the manufacturing/processing operation is required to register (see § 1.227(b)(3)(ii)). If all sales from an on-farm manufacturing/processing operation must be made on-farm for that operation to qualify as a retail food establishment, then an on-farm establishment that sells processed food at a direct sales platform such as a farmer's market could not qualify as a retail food establishment and would be required to register. To prevent this, proposed § 1.227(b)(11) clarifies that all sales by an on-farm establishment do not have to be on the farm by specifically addressing how off-farm sales directly to consumers are to be counted in determining whether the on-farm establishment is a retail food establishment.
FDA is proposing that a farmers' market is a location where one or more local farmers assemble to sell from their farms directly to consumers. FDA is proposing that a roadside stand is a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers. These definitions are based on definitions found in 7 CFR 249.2, with modifications to more specifically describe foods sold by on-farm establishments at direct sales
Section 102(c) of FSMA provides that for the purposes of the retail food establishment definition, “the term `community supported agriculture program' has the same meaning given the term `community supported agriculture (CSA) program' in section 249.2 of title 7, Code of Federal Regulations (or any successor regulation).” Under 7 CFR 249.2, a “community supported agriculture (CSA) program” means “a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. State agencies may purchase shares or subscribe to a community supported agriculture program on behalf of individual SFMNP [Senior Farmers' Market Nutrition Program] participants.” Accordingly, we are proposing that the term “community supported agriculture program” in proposed § 1.227(b)(11) have the same meaning used for the term in 7 CFR 249.2. We note that, under proposed § 1.227(b)(11)(ii), a CSA program would include CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers.
d.
Further, proposed § 1.227(b)(11) provides for considering certain off-farm sales directly to consumers when determining an on-farm establishment's primary function, but does not provide for considering off-farm sales to businesses in the primary function calculation. In doing so, the proposal reflected section 102(c) of FSMA, which addresses only sales to consumers. We request comment on whether, in addition to implementing the specific clarification in section 102(c), we should provide that off-farm sales to businesses also be considered in determining the primary function of an on-farm establishment.
In addition, proposed § 1.227(b)(11) provides for, in determining the primary function of an on-farm establishment, considering the off-farm sales of “food” directly to consumers, which would include both food that has been manufactured/processed and food that has not (raw agricultural commodities). FDA requests comment on whether, in light of the reference to “other than where the food was manufactured or processed” in section 102(c)(1)(A) of FSMA or for other reasons, only the sale of processed foods off the farm should be considered in determining the primary function of an establishment located on a farm.
Section 415(a)(3) of the FD&C Act, as amended by section 102(a) of FSMA, requires that during the period beginning on October 1 and ending on December 31 of each even-numbered year, a registrant that has submitted a registration to FDA under section 415(a)(1) of the FD&C Act must submit to FDA a renewal registration containing the information described in section 415(a)(2) of the FD&C Act. This requirement went into effect upon enactment of FSMA. Food facilities were required to renew their registrations with FDA after the enactment of FSMA during the 2012 registration renewal period.
Proposed § 1.230(b) would require the owner, operator, or agent in charge of a facility to submit a registration renewal to FDA containing the information required under § 1.232 every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year. Under proposed § 1.230(b), the owner, operator, or agent in charge of a facility may authorize an individual to renew the facility's registration on its behalf. As discussed in section III.B.12.b, we are proposing to replace “the owner, operator, or agent in charge of a facility” with “you” throughout the regulation because “you” is defined in the regulation under current § 1.227(b)(14) to mean the owner, operator, or agent in charge of a facility that manufactures/processes, packs, or holds food for consumption in the United States.
Section 415(a)(3) of the FD&C Act, as amended by section 102(a)(3) of FSMA, directs FDA to provide for an abbreviated registration renewal process for any registrant that has not had any changes to its registration information since the registrant submitted the preceding registration or registration renewal for the facility. Proposed § 1.230(c) would provide for an abbreviated registration renewal process for registrations that do not have any changes to the information required under § 1.232 since the registrant submitted the preceding registration or registration renewal for the facility to FDA. The abbreviated registration renewal process would require a registrant to confirm that no changes have been made to the information required in the registration since the registrant submitted the preceding registration or registration renewal, confirm that FDA will be permitted to
Proposed § 1.230(b) would codify in FDA's registration regulation the biennial registration renewal requirement of section 415(a)(3) of the FD&C Act (as added by section 102(a)(3) of FSMA), which is already in effect. Proposed § 1.230(c) would implement the provision of section 415(a)(3) of the FD&C Act providing for an abbreviated registration renewal process for registrants that have not had any changes to required registration information since such registrations submitted the preceding registration or registration renewal for the facility involved. The abbreviated registration renewal process was not available for the 2012 registration renewal period because section 102(a) of FSMA established new registration data elements, meaning all registrants would have had changes to their registration information since such registrations were previously submitted or updated.
Section 415(b)(5)(B) of the FD&C Act, as added by section 102(b) of FSMA, provides that FDA may require that registration under section 415 be submitted to FDA in an electronic format. However, section 415(b)(5)(B) specifies that such requirement may not take effect before the date that is 5 years after the date of enactment of FSMA, which is January 4, 2016. Proposed § 1.231(a)(2) would provide that beginning January 4, 2016, electronic registration will be mandatory, unless a waiver has been granted for the registrant. In addition, proposed § 1.231(a)(2) would require mandatory electronic registration renewals beginning in the 2016 registration renewal period. Proposed § 1.231(b) would also provide that beginning January 4, 2016, registration or registration renewals by mail or fax would no longer be permitted, unless a waiver has been granted for the registrant. Such waivers are further discussed in section III.B.11.
FDA tentatively concludes that mandatory electronic submission of registration and registration renewals would provide a number of advantages over submission of registration and registration renewals on the FDA paper form, including the following:
• The mandatory electronic system would improve the timeliness and accuracy of submissions.
• The electronic transmission of information would be easier and more efficient for both industry and FDA than the use of paper forms. For example, a registrant would receive onscreen feedback if the information submitted was not complete, reducing errors and time and cost of communicating with FDA. Similarly, electronic transmission of the information would reduce significantly the time and cost associated with processing paper forms and communicating with industry concerning errors on those forms.
• Information search and retrieval time would be reduced, allowing quicker access to the information in the database.
• FDA has strongly encouraged electronic registration for the benefit of both FDA and the registrant. FDA tentatively concludes that the majority of facilities, both in the United States and abroad, have access to the Internet, either within their facilities or parent companies or through public libraries, copy centers, schools, or Internet cafes, as well as through a foreign facility's U.S. agent if the facility makes such arrangements. If the U.S. agent does not have Internet access onsite, the agent may register the facility electronically from a local library or other public facility that offers Internet access.
• FDA is able to accept electronic registrations from anywhere in the world where the Internet is available 24 hours a day, 7 days a week.
• Electronic registration also enables a facility to be registered more quickly than if registering by mail. Registration by mail can take several weeks to several months, depending on the efficiency of the mail system, the number of paper registrations that FDA would need to enter manually into the system, whether the Agency would have to return an incomplete or illegible form to a registrant, and because FDA would have to subsequently mail the registration number and receipt of registration to the registrant.
We are seeking comments on the proposed requirements for mandatory electronic registration and registration renewals to begin in the year 2016. We are also requesting comments and data on the number of facilities, if any, that believe they would be unable to register or renew their registrations electronically, and the reasons for such belief, such as, no access to the Internet or for religious beliefs. In addition, as further discussed in section III.B.11, we are seeking comments on our proposal to allow for a waiver from the requirement for mandatory registration and registration renewals beginning in 2016.
Section 415(a)(2) of the FD&C Act, as amended by section 102(a) of FSMA, requires, among other things, that a registration for a domestic facility contain the email address for the contact person of the facility. This requirement went into effect upon enactment of FSMA. Proposed § 1.232(b)(1) would require the email address for the contact person of a domestic facility be included in the registration. Proposed § 1.232(b)(1) would codify in FDA's registration regulation the requirement of section 415(a)(2) of the FD&C Act that a registration for a domestic facility contain the email address for the contact person of the facility.
FDA has received questions from some registrants related to the requirement that a registration for a domestic facility include the email address for the contact person of the facility. Specifically, some registrants have indicated that they are unable to obtain email addresses or otherwise use computers or similar electronic devices because of their religious beliefs. While section 415(a)(2) of the FD&C Act requires a registration for a domestic food facility to include the email address for the contact person of the facility, such contact person is not required to be the owner, operator, or agent in charge. Accordingly, a registrant can provide the email address of a third-party contact person in a registration (to be used for email communications between FDA and the facility), meaning that the registrant would not be required to obtain an email address or otherwise use a computer or similar electronic device within this context.
As further discussed throughout this document, it is critical that FDA be able to contact facilities in a quick manner in the event of a threatened or actual terrorist attack, an outbreak of foodborne illness, or other food-related emergency. Moreover, section 415(a)(2) of the FD&C Act, as amended by FSMA, specifically requires domestic facilities to submit the email addresses of contact persons in food facility registrations. For these reasons, FDA tentatively concludes that all registrations for
Section 415(a)(2) of the FD&C Act, as amended by section 102(a) of FSMA, requires, among other things, that a registration for a foreign facility contain the email address of the U.S. agent for the foreign facility. This requirement went into effect upon enactment of FSMA. Proposed § 1.232(c)(1) would require that a registration for a foreign facility include the email address of the foreign facility's U.S. agent in addition to the U.S. agent's name, full address, and phone number. Proposed § 1.232(c)(1) would therefore codify in FDA's registration regulation the requirement of section 415(a)(2) of the FD&C Act that a registration for a foreign facility contain the email address of the foreign facility's U.S. agent.
Section 415(a)(2) of the FD&C Act, as amended by section 102(b) of FSMA, also requires, among other things, that food facility registrations contain an assurance that the Secretary (and by delegation, FDA) will be permitted to inspect such facility at the times and in the manner permitted by the FD&C Act. This requirement went into effect upon enactment of FSMA. Proposed § 1.232(a)(9) would codify such requirement in FDA's registration regulations. Specifically, proposed § 1.232(a)(9) would require a food facility registration to include a statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.
Currently, § 1.241 specifies the consequences of failing to register, update, or cancel a food facility registration. As described in current § 1.241(a), the failure of an owner, operator, or agent in charge of a food facility to register its facility, to update required elements of its facility's registration, or to cancel its registration in accordance with part 1, subpart H is a prohibited action under section 301(dd) of the FD&C Act. Accordingly, as further described in current § 1.241(a), the consequences of failing to register, update, or cancel a food facility registration include civil injunction proceedings under section 302 of the FD&C Act (21 U.S.C. 332), criminal penalties under section 303 of the FD&C Act (21 U.S.C. 333), and debarment of a person who has been convicted of a felony relating to importation of food into the United States under section 306 of the FD&C Act (21 U.S.C. 335a).
Proposed § 1.241(a) would amend current § 1.241(a) by adding the failure to renew a food facility registration among the list of actions related to food facility registration that could subject a person to the consequences specified in § 1.241(a). As discussed in section II, section 415(a)(3) of the FD&C Act, as amended by section 102(a) of FSMA, requires registrants to renew their facility registrations with FDA every other year. This requirement went into effect upon enactment of FSMA. Further, section 301(dd) of the FD&C Act provides that the failure to register in accordance with section 415 is a prohibited act. On June 2, 2014, FDA issued a guidance entitled “Compliance Policy Guide Sec. 100.250 Food Facility Registration—Human and Animal Food” stating that FDA will consider a registration to be expired if the registration is not renewed, as required by section 415(a)(3) of the FD&C Act, and the failure of a food facility to renew its registration with FDA, as required by section 415(a)(3) of the FD&C Act, means that the facility has failed to register in accordance with section 415 of the FD&C Act and thereby has committed a prohibited act under section 301(dd) of the FD&C Act (Ref. 1).
Accordingly, in addition to proposing to amend § 1.241(a), we are proposing to add proposed § 1.241(b) to specify that FDA will consider a registration for a food facility to be expired if the registration is not renewed, as required by § 1.230(b), and FDA will consider a food facility with an expired registration to have failed to register in accordance with section 415 of the FD&C Act. In addition, as discussed more fully in section III.B.10, under proposed § 1.241(c), FDA would cancel a registration that is expired for failure to renew if the facility has failed to renew its registration in accordance with proposed § 1.230(b).
Section 415(a)(1)(B) of the FD&C Act provides in relevant part that the registration of a foreign food facility must include the name of the U.S. agent for the facility. Currently, § 1.227(b)(13) defines a U.S. agent, in relevant part, as a person (as defined in section 201(e) of the FD&C Act) residing or maintaining a place of business in the United States whom a foreign facility designates as its agent for purposes of food facility registration. In addition, § 1.227(b)(13)(i) currently provides that the U.S. agent acts as a communications link between FDA and the foreign facility for both routine and emergency situations and that FDA will contact the U.S. agent when an emergency occurs, unless the registration specifies another emergency contact (see also 68 FR 58894 at 58915). Further, § 1.227(b)(13)(ii) currently provides that FDA will treat representations by the U.S. agent as those of the foreign facility, and will consider information or documents provided to the U.S. agent the equivalent of providing the information or documents to the foreign facility.
Section 107 of FSMA amended the FD&C Act to provide U.S. agents with an additional role. Specifically, section 107 of FSMA added section 743(a)(1)(A) of the FD&C Act, which provides FDA with the authority to assess and collect fees from the U.S. agent for each foreign facility subject to reinspection to cover reinspection-related costs.
In order to further enable U.S. agents to serve their intended role, we are proposing to amend § 1.227(b)(13)(ii). Specifically, we are proposing to add that the U.S. agent of a foreign facility may view the information submitted in the foreign facility's registration. Making registration information available to U.S. agents would allow agents to obtain the most current information contained in FDA's registration database. U.S. agents could use such information to be in contact with foreign facilities, thereby enabling U.S. agents to more efficiently and effectively function as communications links between foreign food facilities and FDA. (See § 1.227(b)(13)(i) (establishing that a U.S. agent “acts as a communications link between FDA and the foreign facility for both emergency and routine communications”).) Further, U.S. agents could use such information to better represent foreign facilities when
In proposing to make information submitted in a foreign facility's registration available to the U.S. agent for that facility, we have considered FDA's regulations governing public information (21 CFR part 20) among other factors. Section 20.21 (21 CFR 20.21) provides that any record of FDA that is disclosed in an authorized manner to any member of the public is available for disclosure to all members of the public (subject to certain exceptions). If U.S. agents had the same status as any member of the public, making registration information available to U.S. agents for review likely would constitute disclosure to the public and obligate FDA to make the same records available to any person who requests them under the Freedom of Information Act (FOIA). FDA tentatively concludes, however, that U.S. agents for foreign facilities do not have the same status as any member of the public within the context of registration for such facilities. Indeed, FDA's current registration regulations establish that U.S. agents function as stand-ins for foreign facilities with respect to communications and information sharing. Specifically, FDA's regulations establish that a U.S. agent “acts as a communications link between FDA and the foreign facility for both emergency and routine communications.” (§ 1.227(b)(13)(i).) Further, FDA's regulations establish that “information or documents provided to the U.S. agent [are] the equivalent of providing the information or documents to the foreign facility.” (§ 1.227(b)(13)(ii).) Put another way, making information or documents available to a U.S. agent has the same status as making information or documents available to a foreign facility. Thus, making registration information available for review to U.S. agents is the equivalent to making that information available for review to the U.S. agent's foreign facility. FDA tentatively concludes, therefore, that the requirement for uniform access in § 20.21 would not be triggered by FDA's proposed amendment to § 1.227(b)(13)(ii). FDA invites comments on this tentative conclusion.
For this same reason, FDA also tentatively concludes that making foreign facilities' registration information available to U.S. agents is consistent with the disclosure provision in section 415(a)(5) of the FD&C Act. That provision of the FD&C Act provides, in relevant part, that FDA's list of registered food facilities and registration documents submitted to FDA under section 415 shall not be subject to disclosure under FOIA. That provision also provides that information derived from such list shall not be subject to disclosure under FOIA to the extent that it discloses the identity or location of a specific registered person. Because § 1.227(b)(13)(ii) establishes that “information or documents provided to the U.S. agent [are] the equivalent of providing the information or documents to the foreign facility,” FDA's proposal to allow U.S. agents to view a foreign facility's registration information would not result in any disclosures. That is, allowing U.S. agents to view foreign facilities' registration information is the equivalent to allowing foreign facilities to view that information. Accordingly, FDA tentatively concludes that its proposal to amend § 1.227(b)(13)(ii) is consistent with the disclosure provision in section 415(a)(5) of the FD&C Act.
Proposed § 1.231(a)(5) and (b)(7) would provide that after a foreign facility completes its registration or updates its U.S. agent information as part of registration renewal, FDA will email the person identified as the U.S. agent for the foreign facility, using the email address for the person identified as the U.S. agent in the facility's registration, to verify that the person has agreed to serve as the facility's U.S. agent. FDA would not confirm the foreign facility's registration or registration renewal until that person confirms that the person agreed to serve as the U.S. agent for the foreign facility. In addition, with respect to initial registrations, FDA will not provide the facility with a registration number until that person confirms that the person agreed to serve as the U.S. agent for the foreign facility. Proposed § 1.231(a)(5) would apply this verification requirement to electronic registrations, and proposed § 1.231(b)(7) would apply this requirement to registrations submitted by mail or fax. Under proposed § 1.234(c)(2) and (d)(5), this verification step would also take place when foreign facilities update U.S. agent information. Those proposed provisions provide that when updating U.S. agent information, FDA will email the person identified as the U.S. agent for the foreign facility, using the email address for the person identified as the U.S. agent in the facility's registration, to verify that the person has agreed to serve as the U.S. agent. Under proposed § 1.234(c)(2) and (d)(5), FDA would not provide an update confirmation until that person confirms that the person agreed to serve as the U.S. agent for the foreign facility. Proposed § 1.234(c)(2) would apply this verification requirement to electronic updates, and proposed § 1.234(d)(5) would apply this requirement to updates submitted by mail or fax.
We are proposing this verification step for three reasons. First, we have learned that in some cases persons identified as U.S. agents in foreign food facility registrations were unaware that they had been so identified, and had not in fact agreed to serve as U.S. agents. Adding a verification step would help ensure that FDA's registration database is accurate and up to date. Second, the verification step would allow FDA to more efficiently enforce section 743 of the FD&C Act. As stated elsewhere in this proposed rule, section 743(a)(1)(A) of the FD&C Act authorizes FDA to assess and collect fees from the U.S. agent for each foreign facility subject to reinspection to cover reinspection-related costs. Verifying that individuals identified as U.S. agents in foreign facilities' registrations have actually agreed to serve as U.S. agents for those facilities would help ensure that FDA is assessing and collecting foreign facility reinspection fees from the appropriate individuals and allow for efficient enforcement of section 743 of the FD&C Act. Third, section 305(d) of the Bioterrorism Act (Pub. L. 107-188) directs FDA, in relevant part, to ensure adequate authentication protocols are used to enable identification of the registrant and validation of the registration data, as appropriate, for registrations submitted to FDA electronically. FDA tentatively concludes that a verification step for U.S. agent information would serve as an authentication protocol and help validate registration data concerning U.S. agents, including in those registrations submitted electronically.
We seek comments on these proposed provisions, including on whether the proposed email verification step will be effective in preventing the unauthorized listing of persons as U.S. agents. Further, we seek comment on the effectiveness of this proposed email verification step in connection with two
Proposed § 1.232(a)(2) would require the D-U-N-S® number of a domestic and foreign facility be included in the facility's registration. This requirement would function in connection with proposed § 1.231(a)(3) and (b)(5), which provide that after a facility completes its registration or updates its D-U-N-S® number as part of registration renewal, FDA will verify the accuracy of the food facility's D-U-N-S® number and will also verify that the facility-specific address associated with the D-U-N-S® number is the same address associated with the facility's registration. Under proposed § 1.231(a)(3) and (b)(5), FDA would not confirm a food facility's registration or registration renewal until FDA verifies the accuracy of its D-U-N-S® number and verifies that the facility-specific address associated with the D-U-N-S® number is the same address associated with the facility's registration. With respect to initial registrations, proposed § 1.231(a)(3) and (b)(5) would also provide that FDA would not provide a facility with a registration number until FDA verifies the accuracy of its D-U-N-S® number and verifies that the facility-specific address associated with the D-U-N-S® number is the same address associated with the facility's registration. Proposed § 1.231(a)(3) would apply this verification requirement to electronic registrations, and proposed § 1.231(b)(5) would apply this requirement to registrations submitted by mail or fax. The requirement to submit D-U-N-S® numbers would also function in connection with proposed § 1.234(c)(2) and (d)(5), which provide that FDA will perform the same verification step after facilities complete their registration updates. Under proposed § 1.234(c)(2) and (d)(5), FDA would not provide an update confirmation until FDA verifies the accuracy of the food facility's D-U-N-S® number and also verifies that the facility-specific address associated with the D-U-N-S® number is the same address associated with the facility's registration. Proposed § 1.234(c)(2) would apply this verification requirement to electronic updates, and proposed § 1.234(d)(5) would apply this requirement to updates submitted by mail or fax.
Dun & Bradstreet assigns and maintains a database of the D-U-N-S® numbers, which serve as unique identifiers (codes) of business entities. A D-U-N-S® number is a unique nine-digit sequence provided by Dun & Bradstreet that can be specific for each site. The site-specific number is a widely recognized business identification tool and serves as a useful resource for FDA in identifying and verifying certain business information submitted by a user. Upon application, each physical location of a business entity may be assigned a distinct site-specific nine-digit D-U-N-S® number. D-U-N-S® Numbers are proprietary to and controlled by Dun & Bradstreet (D&B).
If a food facility has not obtained a D-U-N-S® number, it may obtain one for no cost directly from Dun & Bradstreet (
FDA's tentative decision to require and verify D-U-N-S® numbers is grounded in the statutory objective of efficiently enforcing the food safety and other requirements of the FD&C Act. By requiring D-U-N-S® numbers of facilities, FDA would be able to verify the facility-specific address information associated with those numbers. Such verification would increase the accuracy of FDA's food facility registration database. As a consequence, FDA investigators would have access to more accurate food facility information, and would therefore be able to more efficiently identify and locate food facilities for inspection. As a result, FDA would be able to more efficiently conduct inspections under section 704 to enforce the food safety and other requirements of the FD&C Act.
FDA's tentative decision to require D-U-N-S® numbers in food facility registration is also consistent with FDA's mandate under section 415(a)(5) of the FD&C Act to compile and maintain an up-to-date list of registered food facilities, as well as the requirement in section 415(a)(2) of the FD&C Act that registrants submit information necessary to notify FDA of the name and address of each facility at which the registrant conducts business. Indeed, the verification that D-U-N-S® numbers provides would help ensure that the food facility list is up to date and contains accurate information concerning the addresses of food facilities. Moreover, an up-to-date list that includes information necessary to notify FDA of the name and address of food facilities would aid FDA in efficiently responding to a terrorist threat or other food-related emergency. Finally, FDA's tentative decision to require D-U-N-S® numbers is consistent with the direction contained in section 305(d) of the Bioterrorism Act (Pub. L. 107-188) to ensure adequate authentication protocols to enable identification of the registrant and validation of the registration data for registrations submitted to FDA electronically. FDA tentatively concludes that verifying information in connection with a D-U-N-S® number for a food facility would provide FDA with a protocol to enable FDA to identify food facilities and verify certain registration information for those facilities. We are seeking comment on these proposed provisions.
In addition to requesting comment on the proposals related to requiring facility-specific D-U-N-S® numbers, we request comment on whether FDA should require use of a different facility identifier and, if so, what that identifier should be. If you recommend that FDA use a different identifier, we request comment on whether FDA should verify that identifier and whether FDA should verify facility-specific address information in connection with that identifier. We also request comment on whether FDA should also require that the registrations of foreign facilities also include a D-U-N-S® number or other identifier for the facility's U.S. agent. To the extent FDA does pursue a D-U-N-S® number requirement, we seek comment on whether, as with the D-U-N-S® number for food facilities, FDA
We are requesting comment related to requiring D-U-N-S® numbers and other identifiers for U.S. agents because FDA has encountered instances in which foreign food facilities have included invalid U.S. agent information in their registrations. We are considering whether to require D-U-N-S® numbers or other identifiers for U.S. agents and verify the information associated with such numbers in order to increase the accuracy and reliability of the U.S. agent information. We also believe that more accurate U.S. agent information would allow FDA to more efficiently enforce section 743 of the FD&C Act, which authorizes FDA to assess and collect fees from the U.S. agent for each foreign facility subject to reinspection to cover reinspection-related costs. In addition, and as noted elsewhere in this proposed rule, section 305(d) of the Bioterrorism Act (Pub. L. 107-188) directs FDA, in relevant part, to ensure adequate authentication protocols are used to enable identification of the registrant and validation of the registration data, as appropriate, for registrations submitted to FDA electronically. FDA believes that requiring D-U-N-S® numbers or other identifiers and verifying information associated with such numbers could serve as an authentication protocol and help validate registration data concerning U.S. agents, including in those registrations submitted electronically. We seek comment on whether the D-U-N-S® numbers or other identifiers for U.S. agents and verification of such numbers and related information would, in fact, increase the accuracy and reliability of the U.S. agent information. We also seek comment on any burdens that requiring D-U-N-S® numbers or other identifiers for U.S. agents would entail, both for foreign facilities and any persons registered as U.S. agents.
The only individuals permitted to register a facility are the owner, operator, or the agent in charge of the facility or an individual authorized to register the facility on behalf of the owner, operator, or agent in charge. (Section 415(a)(1) of the FD&C Act; §§ 1.225 and 1.232 (21 CFR 1.225 and 1.232).) Currently, § 1.232(i) provides that if the individual submitting the registration form is not the owner, operator, or agent in charge of the facility, the registration must include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, and telephone number, the individual who authorized submission of the registration. We are proposing to recodify this provision at § 1.232(a)(10), and also to add the email address of the individual who authorized submission of the registration to the list of required information identifying the individual who authorized submission of such registrations. Proposed § 1.230(b) would apply this requirement to registration renewals. Thus, for registrations and registration renewals submitted by an individual who is not the owner, operator, or agent in charge, such submissions would be required to include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, email address, and telephone number, the individual who authorized submission of the registration. In addition, proposed § 1.234(a) would provide that updates not submitted by the owner, operator, or agent in charge of the facility must include the email address of the owner, operator, or agent in charge who authorized submission of the update, and proposed § 1.235(b)(5) would provide this same email address requirement for cancellations not submitted by the owner, operator, or agent in charge of the facility.
These requirements would function in connection with proposed §§ 1.231(a)(4) and (b)(6), 1.234(c)(3) and (d)(6), and 1.235(c)(3) and (d)(6), which provide a verification step for electronic registrations and registration renewals, mail/fax registrations and registration renewals, electronic updates, mail/fax updates, electronic cancellations, and mail/fax cancellations not submitted by the owner, operator or agent in charge of the facility. Specifically, these proposals provide that after completion of such submissions, FDA will email the individual identified as the owner, operator, or agent in charge who authorized the submission to verify that the individual in fact authorized the submission on behalf of the facility. Under proposed § 1.231(a)(4) and (b)(6), FDA would not confirm the registration or provide a registration number until that individual confirms that he or she authorized the registration. With respect to registration renewals, proposed § 1.231(a)(4) and (b)(6) provide that FDA would not provide a confirmation of the registration renewal until the individual confirms that he or she authorized the registration renewal. Under proposed § 1.234(c)(3) and (d)(6), FDA would not confirm a registration update until the individual identified as the owner, operator, or agent in charge who authorized the update confirms that he or she in fact authorized the update on behalf of the facility. And under proposed § 1.235(c)(3) and (d)(6), FDA would not confirm a registration cancellation until the individual identified as the owner, operator, or agent in charge who authorized the update confirms that he or she in fact authorized the cancellation on behalf of the facility. Proposed § 1.231(a)(4) would apply this verification requirement to electronic registrations and registration renewals; proposed § 1.231(b)(6) would apply the verification requirement to registration and registration renewals submitted by mail or fax; proposed § 1.234(c)(3) would apply the verification requirement to electronic updates; proposed § 1.234(d)(6) would apply the verification requirement to updates submitted by mail or fax; proposed § 1.235(c)(3) would apply the verification requirement to electronic cancellations; and proposed § 1.235(d)(6) would apply the verification requirement to cancellations submitted by mail or fax.
We are proposing this email requirement and verification step to address a problem with unauthorized third party registration submissions that FDA has encountered in the course of implementing food facility registration. In some cases, this has resulted in duplicate registrations for foreign food facilities. In other cases, registrations
We seek comment on these proposed provisions, including on whether the proposed email verification step will be effective in preventing the unauthorized submission of registrations, registration renewals, updates, and cancellations. We also seek comment on whether we should require any alternative or additional checks to ensure that the individual registering a facility is authorized to do so by the owner, operator, and agent in charge. For instance, should FDA require that owners, operators, or agents in charge create some type of authorization documentation to provide documentation for the fact that the owner, operator or agent in charge has authorized the individual to make a registration submission? If so, should such documentation be required to be submitted to FDA or maintained at the facility? Should such documentation include a letter signed by the owner, operator, or agent in charge authorizing the individual to make a registration submission? Are there other types of documentation that would provide another check that is necessary to ensure that the owner, operator, or agent in charge in fact provided authorization?
We are proposing this requirement in addition to the requirements in §§ 1.232(a)(10), 1.230(b), 1.234(a), and 1.235(b)(5) discussed earlier in this document with respect to registrations, registration renewals, updates, and cancellations submitted by individuals other than the owner, operator, or agent in charge of the facility. For such submissions, we are proposing in §§ 1.232(a)(10), 1.230(b), 1.234(a), and 1.235(b)(5) to require the email address of the owner, operator, or agent in charge who authorized such submissions. We realize that in some cases the owner, operator, or agent in charge email address in proposed § 1.232(a)(6) may be the same email address as the email address for the owner, operator, or agent in charge who authorized third party registration submissions in proposed §§ 1.232(a)(10), 1.230(b), 1.234(a), and 1.235(b)(5). In some cases, however, the email addresses might differ.
We are seeking comments on this proposed provision. Further, we are seeking comments on whether a waiver for this proposed requirement should be available in limited circumstances such as when and if the religious beliefs of an owner, operator or agent in charge prevent that individual from obtaining an email address. We are also seeking comments on how a food facility should request such a waiver, including whether such waivers should be requested in writing.
FDA believes that information regarding activity type is necessary to assist the Agency in using its limited resources efficiently, including with regard to inspectional oversight. Among other purposes, food facility registration was designed to provide FDA with a complete list of foreign and domestic facilities that manufacture/process, pack, or hold food for consumption into the United States. In the approximately 10 years since food facility registration was originally implemented, the list of facilities has helped FDA accomplish one of its most important regulatory activities: Scheduling and planning inspections of establishments in which foods are manufactured/processed, packed, or held under section 704 of the FD&C Act. Specifically, FDA has used the food facility registration list to identify food facilities for inspection.
Although the creation of food facility registration has led to improvements in FDA's ability to identify food facilities for inspection, the limited nature of the information provided through food facility registration has meant that the information has not functioned as the most efficient tool for planning inspections. For instance, registrants have not been required to provide the Agency with such basic information as whether a facility manufactures/processes or holds foods, or both. The difference between manufacturing/processing and holding is important. FDA might prepare for inspections of manufacturing/processing and holding facilities quite differently, and might assign different personnel for the different types of inspections. With information about activity type, however, the Agency would be better able to prepare investigators for inspections and assign appropriate investigators. This would provide for more efficient use of the Agency's limited inspectional resources, as sending appropriate, well-prepared investigators helps ensure that inspections are thorough and meaningful. Requiring information regarding activity type would therefore allow for the more efficient use of FDA's inspectional authority under section 704.
The activity type requirement would serve additional purposes as well. Information about a facility's activity type would provide FDA with important information regarding a facility's role in the U.S. food supply system. This would allow FDA to better assess the facility's potential impact in cases of bioterrorist incidents or other food-related emergencies. Better information about a facility's impact would assist FDA in using its limited resources efficiently during such incidents, for instance helping the Agency identify manufacturers/processors that may receive contaminated ingredients or frozen storage facilities impacted by power outages. The improved information would also allow FDA to communicate more quickly and efficiently on various non-emergency issues, such as new regulatory requirements or policies.
In addition, the activity type information would aid FDA in implementing FSMA's mandate to determine inspectional frequency based on safety risks. Specifically, section 201(a) of FSMA created section 421 of the FD&C Act, which requires the Agency to identify high-risk facilities and mandates more frequent inspections for domestic high-risk facilities than for domestic non-high-risk facilities. For the purposes of section 421, the term “facility” refers to facilities that are required to register under section 415. (See section 421(e).) Section 421(a)(1) sets forth the factors for FDA to use in identifying high-risk facilities, which include “[a]ny . . . criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.” (Section 421(a)(1)(F).) Among the criteria the Agency has deemed necessary and appropriate for this purpose are type of activity conducted at the facility (manufacturer/processor, packer/repacker, etc.). Because section 421's risk-based inspection mandate applies to facilities registered under section 415, and because the Agency has identified information about the type of activity conducted at a facility as an important factor to consider when identifying high-risk facilities under section 421, FDA tentatively concludes that the proposed activity type requirement for registration would allow the Agency to more efficiently enforce section 421.
For all of these reasons, FDA tentatively concludes that section 415 of the FD&C Act, along with sections 421, 701(a), and 704, authorize FDA to require the submission of the activity type information specified in this proposed rulemaking.
Although proposed § 1.232(a)(8) lists the specific activity types that food facilities must select, the proposed provision does not define those activity types. FDA is requesting comments on whether it should define the specified activity types in FDA's food facility registration regulations. To the extent that FDA does define the activity types, FDA anticipates that the Agency would model the activity type definitions from the definitions for establishment types contained in the Agency's Field Management Directive (Ref. 2), while also modifying the Field Management Directive definitions to reflect the nature of activities conducted by registered food facilities and the information required on other parts of the food facility registration form. FDA tentatively concludes that modeling the activity type definitions from the Field Management Directive definitions would allow for the efficient use of FDA inspectional resources. FDA investigators are already familiar with the Field Management Directive, and consistency between the food facility registration and Field Management Directive definitions would minimize confusion about the nature of activities performed at food facilities. FDA's tentative definitions for food facility activity types for food facilities that are required to register under section 415 of the FD&C Act are as follows:
• Ambient human food storage warehouse/holding facility: A facility that holds or stores food for human consumption at ambient air temperatures (approximately 21 °C/70 °F). Examples include storage tanks and grain elevators.
• Refrigerated human food warehouse/holding facility: A facility that holds or stores food products for human consumption at refrigerated temperatures (approximately 4 °C/40 °F-0 °C/32 °F).
• Frozen human food warehouse/holding facility: A facility that holds or stores food for human consumption at frozen temperatures (approximately0 °C/32 °F or below).
• Interstate conveyance caterer/catering point: A facility that prepares complete or partial meals or drinks from raw or partially processed materials for service to passengers or crew aboard an interstate conveyance or for consumption by these groups at a location other than where prepared.
• Contract Sterilizer: A facility that performs sterilization or irradiation of foods or components of foods.
• Labeler/Relabeler: A facility that affixes the original labeling to a food product or changes in any way the labeling on a food product without affecting the product or its container.
• Manufacturer/Processor: A non-farm facility that makes food from one or more ingredients, or synthesizes, prepares, treats, modifies, or manipulates food, including food crops or ingredients. For purposes of this activity type option, examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, or packaging.
• Farm Mixed-Type Facility: An establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition in § 1.227, but also conducts activities that require the establishment to be registered.
• Packer/Repacker: A facility that packs a food product or products into different containers without making any change in the form of the product.
• Salvage Operator (Reconditioner): A facility that deals in the resale and reconditioning of damaged foods.
• Animal food warehouse/holding facility (
FDA requests comment on whether the above definitions provide sufficient information for food facilities to select from the activity type options. To the extent that the definitions do not provide sufficient information, FDA requests comment on how the activity type definitions should be amended. In addition to seeking comment on whether and how to define the above activity types, FDA seeks comment on whether the activity types listed in proposed § 1.232(a)(8) encompass the full range of activities conducted by registered food facilities and whether they are otherwise appropriate. FDA selected the list of activity types in proposed § 1.232(a)(8) because that list largely reflects the optional activity types on current Form FDA 3537. At the same time, we are proposing several modifications to the current optional list of activity types. The modifications are designed to help FDA communicate more quickly with food facilities in the case of food-related emergencies, as well as to more accurately reflect the types of activities conducted at human and animal food facilities. Such modifications include dividing the optional activity type of “warehouse/holding facility” for facilities that hold food for human consumption into three subcategories. Those three subcategories would be “ambient human food temperature warehouse/holding facility,” “refrigerated human food warehouse/holding facility,” and “frozen human food warehouse/holding facility.” These additional subcategories would enable FDA to more quickly alert facilities potentially affected by an emergency food incident if FDA receives information indicating the type of facility affected. For example, if FDA receives information indicating that refrigerated or frozen warehouses/holding facilities could be affected by power outages, FDA would be able to communicate with such facilities about the incident. For animal food warehouse/holding facilities, however, FDA is not proposing to modify the activity types (that are currently optional) on current Form FDA 3537. FDA has tentatively concluded that the nature of animal food warehouse/holding facilities differs from human food warehouse/holding facilities, and that the current list of activity types—which has only one option for warehouse/holding—sufficiently enables FDA to respond quickly in the case of emergencies related to animal food. Indeed, animal food warehouse/holding facilities typically hold or store animal food at ambient temperature, negating the need for FDA to have information about the temperature storage conditions at animal food facilities.
In addition, FDA is proposing to add a “farm mixed-type facility” activity type option. FDA is proposing to add this activity type option in order to help the Agency efficiently inspect farm mixed-type facilities. The expertise required to inspect such facilities may differ from the expertise required to inspect non-farm manufacturing/processing facilities. Information about whether a facility is a farm mixed-type facility would therefore allow FDA to identify appropriate investigators to conduct such inspections.
Another change FDA is proposing to make from the optional activity types on current Form FDA 3537 is to eliminate the “commissary” activity type option. FDA is proposing this change because the Agency has tentatively concluded that the other activity type options listed in proposed § 1.232(a)(8)(i) through (a)(8)(xi) sufficiently address the types of activities conducted by facilities that identify as commissaries and that are required to register under section 415 of the FD&C Act.
Finally, FDA seeks comment on whether low-acid and acidified food processing should be treated as activity types, or whether there should be food product category options related to low-acid canned foods and acidified foods, or both. Currently, low-acid food and acidified food processing are optional activity types on current Form FDA 3537. In addition, FDA identified low-acid canned food products and acidified foods as food product categories in the October 2012 guidance the Agency issued concerning food product categories. (See “Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories.”) As a result of the October 2012 guidance, low-acid foods and acidified foods have been listed on Form FDA 3537 as food product categories, while also being included as optional activity types. FDA recognizes that it may be confusing and redundant for there to be both food product categories and activity type categories related to low-acid canned foods and acidified foods. FDA also recognizes that the food product categories for low-acid canned foods and acidified foods may be broad in certain circumstances and may encompass a number of foods for which there may also be other applicable food categories. For example, a low-acid food might also be a baby food, which is another food product category option. And an acidified food might also be a fruit or fruit product, which is also another food product category option. A facility that manufactures/processes, packs, or holds low-acid food that is a baby food or an acidified food that is fruit or fruit product might therefore be confused about which food product categories to select. Accordingly, FDA seeks comment on whether low-acid and acidified foods should be included in only one portion of Form FDA 3537. We further seek comment on whether to include these products in the activity type section or the food product category section of Form FDA 3537. We also seek comment on all aspects of our proposal related to requiring food facilities to identify the type of activity conducted at the facility for each food product category identified.
Proposed § 1.232(a)(7) would retain the requirement in current § 1.232(g) that food facilities provide information regarding food product categories, but would change that requirement to be consistent with the changes FDA has made to food product categories in response to the FSMA amendments.
Section 415(a)(2) of the FD&C Act, as added by section 305 of the Bioterrorism Act, provided in relevant part that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in § 170.3) of food manufactured, processed, packed, or held at such facility. On July 17, 2003, FDA issued a guidance document stating that FDA had determined that the inclusion of food product categories in food facility registrations was necessary for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency (see 68 FR 42415). On October 10, 2003, FDA issued an interim final rule that also required facilities to submit registrations to FDA containing information regarding applicable food product categories as identified in § 170.3. Specifically, current § 1.232(g) provides that food facility registrations include applicable food product categories as defined in § 170.3, unless facilities check either “most/all human food product categories,” according to § 1.233(j), or “none of the above mandatory categories” because a facility manufactures/processes, packs, or holds a food that is not identified in § 170.3. On October 3, 2005, FDA issued a final rule for food facility registration, which generally confirmed the interim final rule (70 FR 57505).
As discussed previously, section 102 of FSMA amends section 415(a)(2) of the FD&C Act, to now provide, in relevant part, that, when determined necessary by FDA “through guidance,” a registrant is required to submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in § 170.3 or any other food categories, as determined appropriate by FDA, including by guidance) of any food manufactured, processed, packed, or held at such facility. In October 2012, FDA issued a guidance document entitled “Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories” (Ref. 3). This guidance document represents FDA's conclusion on the necessity of food product categories in food facility registrations and identifies additional food product categories, as provided by section 415(a)(2) of the FD&C Act. In the guidance document, FDA explained that because of Congress's explicit statutory authorization to effectuate a binding requirement based on findings in a guidance, the document is not subject to the usual restrictions in FDA's good guidance practice (GGP) regulations, such as the requirements that guidances not establish legally enforceable responsibilities and that they prominently display a statement of the document's nonbinding effect (21 CFR 10.115(d) and (i)).
Proposed § 1.232(a)(7) would be consistent with FDA's October 2012 guidance and the FSMA amendments. Specifically, the proposed provision would require that a food facility registration include applicable food product categories of any food manufactured/processed, packed, or held at the facility, as identified on Form FDA 3537. FDA intends to address any further amendments of the food product categories contained on FDA Form 3537, if necessary and appropriate, through updates to the guidance document “Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories.” We are seeking comments on this proposed provision.
Proposed § 1.233 would provide that FDA encourages, but does not require, registrants to submit items that are indicated as optional on the Form FDA 3537. This proposed amendment would remove the list of optional items currently codified in § 1.233. We are proposing this change for two reasons. First, we are proposing elsewhere in this document to convert several of the optional items in current § 1.233 into required items in proposed § 1.232. Second, we believe FDA recommendations for optional items to include in food facility registrations are better addressed in guidance documents that follow our GGP regulations in 21 CFR 10.115. We are seeking comments on this proposed amendment.
Proposed § 1.231(a)(6) would require a food facility to immediately update any previously submitted registration information that was incorrect at the time of submission of an electronic registration or registration renewal. This proposal is consistent with the current requirement in § 1.231(b)(6) for registrations submitted by mail or fax, as well as with the current requirement in § 1.231(c)(10) for registrations submitted by CD-ROM. Under current § 1.231(b)(6) and (c)(10), any information that was incorrect at the time of submission of a registration submitted by mail or fax or CD-ROM must be immediately updated. Under the proposed rule, § 1.231(b)(6) would be recodified as § 1.231(b)(9). (Current § 1.231(c)(10) would not be recodified, as FDA is proposing to no longer allow registration submissions to be submitted by CD-ROM.) That requirement would also apply to registration renewals submitted by mail or fax, as we are proposing for all of the requirements in § 1.231(b) to apply to both registrations and registration renewals submitted by mail or fax.
We are proposing to require the immediate update of incorrect information submitted in electronic
Proposed § 1.234(a) and § 1.235(a) would shorten the time period for a food facility to update or cancel its registration from 60 calendar days to 30 calendar days. Specifically, proposed § 1.234(a) would require facilities to update their registration information, previously submitted under § 1.232, within 30 calendar days, replacing the 60-calendar-day requirement in current § 1.234(a). Proposed § 1.234(a) would not amend the other requirements in current § 1.234(a). For instance, it would not amend the requirement that such updates occur when there is any change to any of the information previously submitted under § 1.232 (
We are proposing to shorten the time period for updates and cancellations because we have learned over the past 10 years of food facility registration that: (1) We need registration information to be accurate and (2) for such information to be accurate, it needs to be more timely. For instance, we need to know as soon as possible when vital contact information has changed and when a facility has changed the food products it manufactures/processes, packs, or holds. We also need to know as soon as possible when a facility ceases operations or has been sold to a new owner. This information is important in both scheduling inspections and in responding to actual or threatened terrorist attacks and other food-related emergencies. Furthermore, the proposed timeframe is consistent with FDA's requirement under section 415(a)(5) of the FD&C Act to maintain an up-to-date list of facilities that are registered, as well as with registrants' obligation under section 415(a)(2) of the FD&C Act to notify FDA “in a timely manner” of changes to registration information. For these reasons, we tentatively conclude that the expedited receipt of updates to registration information and cancellations would help promote the efficient enforcement of section 415 of the FD&C Act.
Currently, § 1.241(b) provides that FDA will cancel a registration if FDA independently verifies that the facility is no longer in business or has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration, or if FDA determines that the registration is for a facility that does not exist. Proposed § 1.241(c) would amend the regulation by also providing that FDA will cancel a registration if the Agency independently verifies that the facility is not required to register, if information about the facility's address was not updated in a timely manner in accordance with § 1.234(a), or if the registration was submitted to the Agency by a person not authorized to submit the registration under § 1.225. Proposed § 1.241(c) would further amend the regulation by also providing that FDA will cancel a registration if the facility's registration has expired because the facility has failed to renew the registration in accordance with § 1.230(b).
FDA is proposing to cancel registrations in these additional circumstances based on our experiences with invalid registrations during the approximately 10 years we have spent administering food facility registration, as well as to improve the utility of the food facility registration database and to make registration cancellations more consistent with the FSMA amendments. Examples of such invalid registrations have included instances in which an importer has registered a foreign food facility and listed himself as the U.S. agent as well as the owner, operator, or agent in charge for the facility without the facility's authorization. There have also been instances in which other third parties have created duplicate registrations for foreign food facilities, without authorization from the foreign facilities. Such registrations do not comply with food facility registration requirements and undermine the main objectives of food facility registration. The only individuals permitted to register a facility are the owner, operator, or the agent in charge of the facility or an individual authorized to register the facility on behalf of the owner, operator, or agent in charge. (Section 415 (a)(2) of the FD&C Act; §§ 1.225 and 1.232.) Registration information submitted to FDA must be true and accurate. (§ 1.232(i).) Where a registration is submitted to the Agency by an unauthorized person, the registration is not submitted in accordance with section 415 of the FD&C Act and FDA's registration regulations. Further, such registrations are less likely to be accurate or complete because unauthorized persons generally do not have access to a facility's information. Registrations containing false, inaccurate, or incomplete information hinder the Agency's ability to act quickly in responding to a threatened or actual terrorist attack on the U.S. food supply or other food-related emergency. Moreover, such registrations could hinder the Agency's
As to our proposal to cancel registrations when a facility has failed to renew its registration in accordance with § 1.230(b), this proposal is designed to respond to the FSMA amendments. As discussed elsewhere in this document, FSMA amended section 415 of the FD&C Act to require food facilities that are required to register with FDA to renew their registrations with FDA every other year. Cancelling the registrations of facilities that have failed to do so would allow FDA to efficiently enforce the renewal requirement. It would also allow FDA to efficiently implement its obligation under section 415(a)(5) of the FD&C Act to maintain an up-to-date list of facilities that are registered—as would the proposals to cancel registrations for facilities that are not required to register and registrations submitted to the Agency by unauthorized officials. A registration database that includes unnecessary, un-updated, or unauthorized entries would not be an up-to-date list of food facilities required to register with FDA under section 415 of the FD&C Act.
As to our proposal to cancel registrations when information about the facility's address was not updated in a timely manner in accordance with proposed § 1.234(a), this proposal is designed to assist FDA in using its limited inspectional resources efficiently. Inaccurate address information makes it difficult for FDA investigators to efficiently inspect food facilities, as investigators may invest time traveling to a particular address location only to find that the facility is not located there. FDA tentatively concludes that canceling registrations where a food facility has failed to update its address information in a timely manner in accordance with proposed § 1.234(a) would increase the accuracy of the address information contained in FDA's food facility registration database, and would therefore enable FDA investigators to more efficiently locate food facilities for inspection. FDA also tentatively concludes that such cancellations would allow FDA to efficiently implement its obligation under section 415(a)(5) to maintain an up-to-date list of facilities that are registered and would be consistent with the requirement in section 415(a)(2) of the FD&C Act that facilities notify FDA in a “timely manner” as to changes in their registration information, including their address information. We have also tentatively concluded that canceling registrations where a facility has failed to update its address information would supplement the requirement in FSMA that food facilities participate in biennial registration. Biennial registration renewal serves as a general mechanism to ensure all registrations are accurate and up to date, while cancellations based on failure to update allow FDA to respond to specific facilities that have failed to update address information. In addition, in enacting biennial registration renewal, Congress did not eliminate the requirement in section 415(a)(2) of the FD&C Act that registrants provide updates to their registration information in a “timely manner.” Instead, Congress added biennial renewal as a supplemental requirement. Thus, biennial renewal and the proposal to cancel registrations based on un-updated address information would both operate to improve the accuracy of FDA's food facility registration database, but would provide different mechanisms for doing so.
Proposed § 1.241(c) would maintain the requirement in current § 1.241(b) that FDA will cancel registrations in the specified circumstances if the Agency “independently verifies” those circumstances. Specifically, proposed § 1.241(c) would provide that FDA will cancel registrations if it “independently verifies” that the facility is no longer in business or has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration, or if FDA determines that the registration is for a facility that does not exist, is not required to register, or where the information about the facility's address was not updated in a timely manner in accordance with § 1.234(a) or the registration was submitted by a person not authorized to submit the registration under § 1.225. In maintaining the “independently verif[y]” requirement, we realize that each potential cancellation is likely to present unique facts, and thus may require the Agency to take an individualized approach in independently verifying the circumstances that merit registration cancellation. Nevertheless, we believe that in many cases it would be appropriate for us to send notices to facilities facing potential cancellation indicating our intent to cancel their registrations and the basis for such cancellations. We anticipate that we would send such notices prior to canceling registrations. We also anticipate that, when appropriate, if the circumstances meriting possible cancellation are corrected within 30 days after notice is provided, we would not cancel the registration. We anticipate that it would not be appropriate to provide the 30-day window for corrective action if the basis for cancellation is an expired registration due to failure to renew a registration in accordance with § 1.230(b). In such circumstances, we anticipate that a facility would have already received notice of its obligation to renew its registration, and therefore would have already have had the amount of time specified in section 415(a)(3) of the FD&C Act—the period beginning on October 1 and ending on December 31 of each even-numbered year—to renew its registration. Accordingly, when a facility's registration has expired due to failure to renew, we do not anticipate that FDA would need to provide the facility with additional time to take corrective action prior to canceling that facility's registration. We further anticipate that if facilities do not respond within 30 days, or if corrective action is otherwise not taken within that time period, we would determine that we conducted an independent verification and would then cancel the registration. If a facility believes its registration was cancelled in error, the facility would be able to contact the FDA Industry Systems Help Desk via telephone at 1-800-216-7331 or 301-575-0156.
Finally, proposed § 1.241(c) would maintain the requirement in current § 1.241(b) that if FDA cancels a facility's registration, FDA will mail a confirmation of the cancellation to the facility at the address provided in the facility's registration.
We are seeking comments on proposed § 1.241(c), as well as the Agency's approach to independently verifying the circumstances that may merit registration cancellation.
As discussed previously, section 415(b)(5)(B) of the FD&C Act, as added by section 102(b) of FSMA, provides that FDA may require that registrations under section 415 be submitted to FDA in an electronic format. Section 415(b)(5)(B) specifies that such requirement may not take effect before the date that is 5 years after the date of enactment of FSMA, which is January 4, 2016. Proposed § 1.231(a)(2) would provide that beginning January 4, 2016,
In addition, proposed § 1.230(a) would retain the provision in current § 1.230(a) that owners, operators and agents in charge may authorize an individual to register the facility on their behalf. Currently, registrations submitted by such authorized individuals must include a statement from such individuals certifying that the information submitted is truthful and accurate and the individual is authorized to submit the registrations on the facility's behalf, and the individual must identify by name, address, and telephone number the individual who authorized submission of the registration. (21 CFR 1.232(i).) The certification statement also states that anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties under 18 U.S.C. 1001. (Under the proposed rule, this certification provision would be recodified at § 1.232(a)(10)). Further, as discussed in section III.B.4., for registrations submitted by individuals other than the owner, operator, or agent in charge, we are proposing to add the email address to the information required for identifying the individual who authorized submission of the registration on behalf of the facility. In addition, we are proposing that FDA will email the individual identified as the owner, operator, or agent in charge who authorized submission of the registration to verify that the individual in fact authorized submission of the registration on behalf of the facility. Further, we are proposing that FDA will not confirm the registration or provide a registration number until that individual confirms that he or she authorized the registration submission.
We are requesting comments on whether we should issue a future guidance document to provide for the creation of a U.S. Agent Voluntary Identification System (VIS or the system), or otherwise create such a system. As currently envisioned, the system would be designed to ensure the accuracy of U.S. agent information and enable U.S. agents to independently identify the facility or facilities for which the agent has agreed to serve. Specifically, the system would allow a U.S. agent to directly provide FDA with the agent's contact information (that is, the same contact information required for foreign food facility registration) and the name of the facility or facilities for which the agent has agreed to serve. Currently, FDA only receives U.S. agent contact information through foreign food facility registrations, many of which are submitted and updated by the facility, rather than the U.S. agent for the facility. The new system would allow agents to provide information about themselves, including their name, mailing address, phone number, email address, and emergency contact phone number, as well as the name of the facility or facilities for which the agent agrees to serve. After a U.S. agent has provided such information to FDA through the system, the Agency would provide the U.S. agent with an
As we envision the voluntary system, U.S. agents would have discretion as to whom they provide their U.S. agent identification numbers. Because U.S. agents would be notified any time a foreign facility registers with FDA using their U.S. agent identification numbers, U.S. agents would have the opportunity to contact FDA in the event the U.S. agent is falsely identified in a food facility registration. U.S. agents would also have the ability to directly update or correct their contact information themselves. If we implement the voluntary U.S. agent verification system, we anticipate that we would also create update requirements that would mirror the update requirements for food facility registration (
We are seeking comment on creating this voluntary system because we find merit in the notion that a system that allows U.S. agents to provide their own contact information is likely to increase the accuracy of U.S. agent contact information and reduce the number of unauthorized and/or fraudulent U.S. agent listings.
If we pursue this system, we would follow our Good Guidance Practice regulations in 21 CFR 10.115. We are seeking comments on the proposed U.S. Agent Voluntary Identification System.
FDA has examined the impacts of this proposed 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). FDA has developed a PRIA that presents the benefits and costs of this proposed rule (Ref. 4). FDA believes that the proposed rule will not be a significant regulatory action as defined by Executive Order 12866.
For interested persons, the detailed PRIA (Ref. 4) is available at
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. We expect compliance costs generated by this proposed rule to be small. Nevertheless, we are unsure whether this proposed rule would have a significant economic impact on a substantial number of small entities and have analyzed various regulatory options to examine the impact on small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $141 million, using the most current (2013) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.
The analyses that FDA has performed in order to examine the impacts of this proposed 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), are available to the public in the docket for this proposed rule (Ref. 4).
This proposed 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 (the PRA) (44 U.S.C. 3501-3520). A description of these provisions is given in the
FDA invites comment on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions,
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended section 415 of the FD&C Act to require, among other things, that registrants for food facilities renew registrations biennially (section 415(a)(3) of the FD&C Act). FSMA also amended section 415 of the FD&C Act to require that food facility registrations include the email address for the contact person of a domestic facility and the email address of the United States agent for a foreign facility, as well as an assurance that FDA will be permitted to inspect the facility (section 415(a)(2) of the FD&C Act). These requirements went into effect upon enactment of FSMA. In addition, section 415(a)(2) of the FD&C Act, as amended by FSMA, also provides that, when determined necessary by FDA “through guidance,” a food facility is required to submit to FDA information about the general food category of a food manufactured, processed, packed, or held at such facility, as determined appropriate by FDA, including by guidance. FDA issued a guidance document entitled “Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories” in October 2012.
To comply with the statutory deadline under the provisions of FSMA, FDA initially obtained a 6-month OMB approval of these self-implementing FSMA reporting burdens under the emergency processing provisions of the PRA, and subsequently obtained a 3-year approval of these requirements under the same assigned OMB control number 0910-0502. OMB extended the approval for an additional 3 years in 2013. The current expiration date of the information collection is August 31, 2016.
The proposed rule would require food facilities to submit additional registration information to FDA with initial registrations, updates, and biennial renewals. The proposed rule would make the submission of the following currently optional information mandatory: (1) Preferred mailing address; (2) email address for the owner, operator, or agent in charge; (3) type of activity conducted at the facility; and (4) email address of the emergency contact of a domestic facility. In addition, the proposed rule would require food facilities to submit a D-U-N-S Number and, for registrations submitted by individuals other than the owner, operator, or agent in charge, the email address for the owner, operator, or agent in charge who authorized the registration submission on behalf of the facility. The proposed rule would also require mandatory electronic registration submissions beginning in 2016, which we estimate would cause some food facilities to submit a request for a waiver from that requirement. Finally, the proposed rule would establish a verification procedure for registration submissions made by individuals other than the owner, operator, or agent in charge, as well as a verification procedure for U.S. Agents.
Registration is one of several tools implemented under the Bioterrorism Act that enables FDA to act quickly in responding to a threatened or actual terrorist attack on the U.S. food supply or other food-related emergency by giving FDA information about facilities that manufacture/process, pack, or hold food for consumption in the United States. Further, in the event of an outbreak of foodborne illness, such information helps FDA determine the source and cause of the event. In addition, registration information enables FDA to quickly notify food facilities that might be affected by an outbreak, terrorist attack, threat, or other emergency. The proposed amendments will further enhance FDA's capabilities with respect to responding to food safety issues, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.
The currently approved reporting burden for food facility registration under OMB control number 0910-0502 is 468,117 hours. The estimated reporting burden for food facility registration under the proposed rule is 413,153 hours, a decrease of 54,964 hours. This decrease is due in large part to a reduction in the number of registered food facilities, which we believe is reflective of the fact that the 2012 biennial registration renewal cycle appears to have had the effect of removing many out-of-date registrations from the registration system. We are proposing to make additional changes to the currently approved reporting burden as well. Since obtaining the FSMA-related emergency OMB approval and subsequent 3-year approval, we have refined our estimates for the time required to comply with the self-implementing FSMA provisions. As we explain in detail in the preliminary economic impact analysis, this is in part because we no longer assume that it will take domestic and foreign facilities different amounts of time to comply with the provisions of the proposed rule. It is also in part because the option to submit abbreviated registration renewals did not previously exist and in part because we have revised additional assumptions.
FDA revises its estimate of the one-time burden of the FSMA-related provisions of the proposed rule on registered facilities as follows:
To determine the number of facilities in table 2, we assume that some of the participants in the 2012 biennial registration renewal cycle were new registrants. We do not consider those new registrations in estimating the total burden associated with the FSMA requirements. FDA used the the Small Business Administraiton's (SBA's) estimate that 12 percent of all businesses are new. Although SBA's estimate does not necessarily mean that 12 percent of all food facilities are new, we nevertheless find the SBA's estimate sufficiently relevant to apply to food facilities. We therefore estimate that 12 percent of currently registered food facilities were not registered at the time of the 2012 registration renewal cycle. As such, we estimate that 88 percent of currently registered food facilities, or 172,274 facilities, were registered in 2012.
Using our updated estimates for the time required to comply with the self-implementing FSMA provisions, we now estimate that the requirement for an email address for a domestic facility's contact person and a foreign facility's U.S. Agent will take 1 minute. We also now estimate that the assurance statement required by FSMA will take 5 minutes to provide and that the post-FSMA changes to food product categories will not result in any additional burden for facilities.
We also estimate the one-time burden from the new data elements in the proposed rule. We estimate that the average burden per response would be increased by the new data elements in the proposed rule. FDA believes that the new information will be readily available to the firms. We estimate that entering the four additional pieces of information that are currently optional would require, on average, an additional minute for each new data element per response. The four additional pieces of information that are currently optional are: (1) Preferred mailing address; (2) email address for the owner, operator, or agent in charge; (3) type of activity or type of storage conducted at the facility; and (4) email address of the emergency contact of a domestic facility. In addition, we estimate that entering a D-U-N-S® Number would require, on average, an additional minute per response. Thus, we estimate that these five proposed new data elements will require a total of 5 additional minutes. We estimate that the submission of the FSMA data elements and proposed new data elements would jointly increase the one-time burden from those activities by a total of 11 minutes (0.18 hour). The estimated one-time burden for currently registered facilities is therefore 172,274 facilities × 0.18 hours = 31,584 hours.
FDA estimates the annual burden of the proposed rule's revision of this information collection as follows:
The currently approved annual reporting burden for food facility registration under OMB control number 0910-0502 is 468,117 hours. The estimated reporting burden for food facility registration under the proposed rule is 332,971 hours, a decrease of 135,146 hours. This decrease is due to the recently reduced number of active registrations in the food facility registration database.
Our estimates of the number of facilities that will submit new facility registrations are based on estimates by SBA that 12 percent of all businesses each year are new. As such, we estimate that 12 percent of registrations (or 23,500 registrations) are from new facilities entering the market. We are proposing to make additional changes to the currently approved reporting burden as well. As discussed previously, FDA obtained a 6-month emergency OMB approval of the self-implementing FSMA reporting burdens, and subsequently obtained a 3-year approval of these requirements. As described in the preliminary economic impact analysis, we estimate that 68,518 respondents will file updates, a decrease from the estimated number of 118,530 respondents reported in the 2013 request for extension, and we estimate that 97,883 respondents will file biennial renewals, a decrease from the
Prior to FSMA, FDA estimated that the average burden associated with new domestic and foreign facility registrations was a respective 2.5 and 8.5 hours. (See 75 FR 30033, May 28, 2010.) We expect that the proposed rule would add an additional 11 minutes to that burden as a result of the proposed new data elements. Based on estimates by SBA that 12 percent of all businesses are new, we estimate that all new facilities each year will be equal to 12 percent of the total number of registered facilities. Thus, we estimate that each year there will be 9,795 new domestic and 13,697 new foreign facility registrations, and that the average burden for those new registrations will be of 2.7 hours (2.5 hours plus 11 minutes) for new domestic facility registrations and 8.7 hours (8.5 hours plus 11 minutes) for new foreign facility registrations, as reported in table 28, rows 1 and 2) (p. 64 of Ref. 4).
The proposed rule would also shorten the time period for updates from 60 calendar days to 30 calendar days. The average burden per response for updates would increase from 1.2 hours to 1.54 hours (difference of 0.34 hours, or about 20 minutes), as reported in table 28, row 3 (p. 64 of Ref. 4).
This proposed rule would also establish an abbreviated renewal process, which modifies our previous estimate that on average it would take 0.5 hours per renewal. With the option for an abbreviated renewal process, we estimate that half the facilities will take 15 minutes per renewal using the abbreviated renewal process and that half of facilities will take 30 minutes. This alters our previous estimate of 0.5 hours to submit a renewal to an average of 0.38 hours (23 minutes) to submit a renewal, as reported in table 28, row 5 (p. 64 of Ref. 4). This estimate takes into account that some registered firms would be able to take advantage of the abbreviated renewal process, while other firms would take more time to prepare and submit the renewal, as discussed in the preliminary economic impact analysis. We have not changed our estimate of the average burden per response for cancellations because the proposed rule does not add new data elements for cancellations.
If the rule is finalized as proposed, it would mandate the electronic submission of food facility registrations, while also allowing respondents to submit a request for waiver of the requirement to electronically submit their registration. As described in the preliminary economic impact analysis, we estimate that, on average, 1,061 facilities will seek a waiver each year. We also estimate that it would take a respondent 10 minutes to prepare the proposed waiver request submission and attach it to their paper Form FDA 3537 registration submission. Thus, the total annual burden of submitting waiver requests is estimated to be 180 hours (1,061 × 0.17 hours), as reported in table 28, row 6 (p. 64 of Ref. 4).
If the rule is finalized as proposed, it would establish a verification procedure for registrations submitted by individuals other than the owner, operator, or agent-in-charge (third party registrations), as well as a verification procedure for U.S. Agents. To verify third-party registrations, FDA would send an email to the owner, operator, or agent in charge with a link allowing the owner, operator, or agent in charge to either confirm or deny that he or she authorized the registration submission on behalf of the facility. In connection with requiring his verification process, the proposed rule would add email address to the list of required information identifying the individual who authorized submission of registrations submitted by individuals other than the owner, operator, or agent in charge. As described in the preliminary economic impact analysis, we estimate that it would take an owner, operator, or agent in charge 15 minutes (0.25 hour) to participate in FDA's verification procedure. This estimate includes the time required to enter the email address of the owner, operator, or agent in charge who authorized the submission. We further estimate that 82,513 registrations would be affected once every other year, or 41,257 annually. Thus, the total annual burden of these verifications is estimated to be 10,314 hours (41,257 × 0.25 hour = 10,314 hours), as reported in table 28, row 7 (p. 64 of Ref. 4).
To verify the U.S. Agent, FDA would send an email to the U.S. Agent at the email address provided by the registrant. The email address would include a link that would connect the U.S. Agent to FDA's food facility registration module, allowing the U.S. Agent to either accept or decline assignment with the facility. If the U.S. Agent accepts the assignment, FDA would also email the facility of the U.S. Agent's acceptance. If, however, a U.S. Agent declines the assignment, the issuance of the registration number could be delayed. We estimate that the burden that will result from the verification procedure would be about 30 minutes (0.5 hours). We also estimate that 114,139 registrations would be affected once every 2 years, or 57,070 facility registrations annually. Thus, the total annual burden of these verifications is estimated to be 28,535 hours (57,070 × 0.5 hour = 28,535 hours), as reported in table 28, row 8 (p. 64 of Ref. 4).
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. Interested persons are requested to send comments regarding information collection to the Office of Information and Regulatory Affairs, OMB.
To ensure that comments on 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
We have 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.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule, if finalized, would 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, we tentatively conclude that the proposed 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.
We invite public comment on the matters specified in this document as well as any other matters concerning this proposed rule that are of interest.
The following references have been placed on display in the Division of Dockets Management (see
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 1 be amended as follows:
15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 350j, 352, 355, 360b, 362, 371, 374, 379j-31, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264; Pub. L. 107-188, 116 Stat. 594, 668-69.
(b) * * *
(11)
(i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers' market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);
(ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and
(iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.
(13)
(i) The U.S. agent acts as a communications link between FDA and the foreign facility for both emergency and routine communications. The U.S. agent will be the person FDA contacts when an emergency occurs, unless the registration specifies another emergency contact.
(ii) FDA will treat representations by the U.S. agent as those of the foreign facility, and will consider information or documents provided to the U.S. agent the equivalent of providing the information or documents to the foreign facility. FDA will consider the U.S. agent the equivalent of the registrant for purposes of sharing information and communications. The U.S. agent of a foreign facility may view the information submitted in the foreign facility's registration.
(iii) Having a single U.S. agent for the purposes of this subpart does not preclude facilities from having multiple agents (such as foreign suppliers) for other business purposes. A firm's commercial business in the United States need not be conducted through the U.S. agent designated for purposes of this subpart.
(a)
(b)
(c)
(a)
(2) Beginning on January 4, 2016, you must submit your registration or registration renewal to FDA electronically, unless you have been granted a waiver under § 1.245.
(3) After you complete your electronic registration, FDA will verify the accuracy of your facility's Data Universal Numbering System (D-U-N-S® number) and will also verify that the facility-specific address associated with the D-U-N-S® number is the same address associated with your registration. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility's D-U-N-S® number and verifies that the facility-specific address associated with the D-U-N-S® number is the same address associated with your registration. With respect to electronic registration renewals, after you complete your electronic registration renewal, FDA will provide you with an electronic confirmation of your registration renewal. When you update your facility's D-U-N-S® number as part of your electronic registration renewal, FDA will verify the accuracy of your facility's D-U-N-S® number and will also verify that the facility-specific address associated with the D-U-N-S® number is the same address associated with your registration. FDA will not provide you with an electronic confirmation of your registration renewal until FDA verifies the accuracy of your D-U-N-S® number and verifies that the facility-specific address associated with the D-U-N-S® number is the same address associated with your registration.
(4) For electronic registrations not submitted by the owner, operator, or agent in charge of the facility, after completion of the electronic registration, FDA will email the individual identified as the owner, operator, or agent in charge who authorized submission of the registration to verify that the individual in fact authorized submission of the registration on behalf of the facility. FDA will not confirm the registration or provide a registration number until that individual confirms that he or she authorized the registration submission. With respect to electronic registration renewals, after completion of the electronic registration renewal, FDA will provide an electronic confirmation of the registration renewal. For electronic registration renewals not submitted by the owner, operator, or agent in charge of the facility, FDA will email the individual identified as the owner, operator, or agent in charge who authorized submission of the registration renewal to verify that the individual in fact authorized submission of the registration renewal on behalf of the facility. FDA will not provide an electronic confirmation of the registration renewal until that individual confirms that he or she authorized the registration renewal.
(5) For a foreign facility, after you complete your electronic registration, FDA will email the person identified as the U.S. agent for your foreign facility, using the email address for the person identified as your U.S. agent, to verify that the person has agreed to serve as your U.S. agent. FDA will not confirm your registration or provide you with a registration number until that person confirms that the person agreed to serve as your U.S. agent. With respect to electronic registration renewals, after you complete your electronic registration renewal, FDA will provide you with an electronic confirmation of your registration renewal. When you update information about your U.S. agent as part of your electronic registration renewal, FDA will email the person identified as the U.S. agent for your foreign facility, using the email address for the person identified as your U.S. agent, to verify that the person has agreed to serve as your U.S. agent. FDA will not provide you with an electronic confirmation of your registration renewal until that person confirms that the person agreed to serve as your U.S. agent.
(6) If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration as specified in § 1.234.
(7) You will be considered registered once FDA electronically transmits your confirmation and registration number.
(b)
(1) You must register or renew a registration (including abbreviated registration renewals) using Form FDA 3537. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy. (HFS-681), College Park, MD 20993, or by requesting the form by phone at 1-800-216-7331 or 301-575-0156.
(2) When you receive the form, you must fill it out completely and legibly and either mail it to the address in paragraph (b)(1) of this section or fax it to 301-436-2804.
(3) If any required information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a registration form for revision, FDA will use the means by which the form was received by the Agency (
(4) FDA will enter complete and legible mailed and faxed registration submissions into its registration system, as soon as practicable, in the order FDA receives them.
(5) After you complete your registration, FDA will verify the accuracy of your facility's D-U-N-S® number and will also verify that the
(6) For registrations not submitted by the owner, operator, or agent in charge of the facility, after completion of the registration by mail or fax, FDA will email the individual identified as the owner, operator, or agent in charge who authorized submission of the registration to verify that the individual in fact authorized submission of the registration on behalf of the facility. FDA will not confirm the registration or provide a registration number until that individual confirms that he or she authorized the registration submission. With respect to registration renewals, after completion of the registration renewal by mail or fax, FDA will provide a confirmation of the registration renewal. For registration renewals not submitted by the owner, operator, or agent in charge of the facility, FDA will email the individual identified as the owner, operator or agent in charge who authorized submission of the registration renewal to verify that the individual in fact authorized the submission of the registration renewal on behalf of the facility. FDA will not provide a confirmation of the registration renewal until that individual confirms that he or she authorized the registration renewal.
(7) For a foreign facility, after you complete your registration by mail or fax, FDA will email the person identified as the U.S. agent for your foreign facility, using the email address for the person identified as the U.S. agent in your registration, to verify that the person has agreed to serve as your U.S. agent. FDA will not confirm your registration or provide you with a registration number until that person confirms that the person agreed to serve as your U.S. agent. With respect to registration renewals, after you complete your registration renewal by mail or fax, FDA will provide you with a confirmation of your registration renewal. When you update information about your U.S. agent as part of your registration renewal, FDA will email the person identified as the U.S. agent for your foreign facility, using the email address for the person identified as your U.S. agent, to verify that the person has agreed to serve as your U.S. agent. FDA will not provide you with a confirmation of your registration renewal until that person confirms that the person agreed to serve as your U.S. agent.
(8) FDA will mail or fax a copy of the registration as entered, confirmation of registration, and your registration number. When responding to a registration submission, FDA will use the means by which the registration was received by the Agency (
(9) If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration as specified in § 1.234.
(10) Your facility is considered registered once FDA enters your facility's registration data into the registration system and the system generates a registration number.
(c)
(d)
(a) For a domestic and foreign facility, the following information is required:
(1) The name, full address, and phone number of the facility;
(2) The D-U-N-S® number of the facility;
(3) The preferred mailing address, if different from that of the facility;
(4) The name, full address, and phone number of the parent company, if the facility is a subsidiary of the parent company;
(5) All trade names the facility uses;
(6) The name, full address, phone number, and email address of the owner, operator, or agent in charge of the facility;
(7) The applicable food product categories of any food manufactured/processed, packed, or held at the facility as identified on Form FDA 3537;
(8) The type of activity conducted at the facility for each food product category identified. You may select more than one activity type for each food product category identified. The activity type options are as follows:
(i) Ambient human food storage warehouse/holding facility;
(ii) Refrigerated human food warehouse/holding facility;
(iii) Frozen human food warehouse/holding facility;
(iv) Interstate conveyance caterer/catering point;
(v) Contract Sterilizer;
(vi) Labeler/Relabeler;
(vii) Manufacturer/Processor;
(viii) Farm Mixed-Type Facility;
(ix) Packer/Repacker;
(x) Salvage Operator (Reconditioner);
(xi) Animal food warehouse/holding facility;
(xii) Other Activity.
(9) A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug, and Cosmetic Act;
(10) A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate. If the individual submitting the form is not the owner, operator, or agent in charge of the facility, the registration must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, email address and telephone number, the individual who authorized submission of the registration. Each registration must include the name of the individual registering the facility submitting the registration, and the individual's signature (for the paper option).
(b) For a domestic facility, the following additional information is required:
(1) The email address for the contact person of the facility;
(2) An emergency contact phone number and email address if different from the email address for the contact person in paragraph (b)(1) of this section.
(c) For a foreign facility, the following additional information is required:
(1) The name, full address, phone number, and email address of the foreign facility's U.S. agent;
(2) An emergency contact phone number and email address.
Yes. FDA encourages, but does not require, you to submit items that are indicated as optional on the Form FDA 3537 that you submit.
(a)
(b)
(c)
(2) After you complete your electronic update, FDA will provide you with an electronic confirmation of your update. When updating D-U-N-S® number information, FDA will verify the accuracy of your facility's D-U-N-S® number and will also verify that the facility-specific address associated with the D-U-N-S® number is the same address associated with your registration. FDA will not provide you with an electronic confirmation of your registration update until FDA verifies the accuracy of your facility's D-U-N-S® number and verifies that the facility-specific address associated with the D-U-N-S® number is the same address associated with your registration. For foreign facilities, when updating information about your U.S. agent, FDA will email the person identified as the U.S. agent for your foreign facility, using the email address for the person identified as your U.S. agent, to verify that the person has agreed to serve as your U.S. agent. FDA will not provide you with an electronic confirmation of your registration update until that person confirms that the person agreed to serve as your U.S. agent.
(3) For electronic updates not submitted by the owner, operator, or agent in charge of the facility, after completion of the electronic update, FDA will email the individual identified as the owner, operator, or agent in charge who authorized submission of the update to verify that the individual in fact authorized submission of the update on behalf of the facility. FDA will not confirm the update to the registration until that individual confirms that he or she authorized the update.
(4) Your registration will be considered updated once FDA transmits your update confirmation, unless notified otherwise.
(d)
(1) You must update your registration using Form FDA 3537. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy. (HFS-681), College Park, MD 20993 or by requesting the form by phone at 1-800-216-7331 or 301-575-0156.
(2) When you receive the form, you must legibly fill out the sections of the form reflecting your updated information and either mail it to the address in paragraph (d)(1) of this section or fax it to 301-436-2804.
(3) If the information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a registration form for revision, FDA will use the means by which the registration was received by the Agency (
(4) FDA will enter complete and legible updates into its registration system as soon as practicable, in the order FDA receives them.
(5) FDA will then mail to the address or fax to the fax number on the registration form a copy of the update as entered and confirmation of the update. When responding to an update submission, FDA will use the means by which the form was received by the Agency (
(6) For registration updates not submitted by the owner, operator, or agent in charge of the facility, after completion of the registration update by mail or fax, FDA will email the individual identified as the owner, operator, or agent in charge who authorized submission of the registration update to verify that the individual in fact authorized submission of the update on behalf of the facility. FDA will not confirm the registration update until that individual confirms that he or she authorized the update.
(7) If any update information you previously submitted was incorrect at the time of submission, you must immediately resubmit your update.
(8) Your registration will be considered updated once FDA enters your facility's update data into the registration system and the system generates an update confirmation.
(a)
(b)
(1) The facility's registration number;
(2) Whether the facility is domestic or foreign;
(3) The facility name and address;
(4) The name, address, and email address (if available) of the individual submitting the cancellation;
(5) For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, the email address of the owner, operator, or agent in charge who authorized submission of the registration cancellation; and
(6) A statement certifying that the information submitted is true and accurate, and that the person submitting the cancellation is authorized by the facility to cancel its registration.
(c)
(2) Once you complete your electronic cancellation, FDA will automatically provide you with an electronic confirmation of your cancellation.
(3) For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, after completion of the registration cancellation, FDA will email the individual identified as the owner, operator, or agent in charge who authorized submission of the registration cancellation to verify that the individual in fact authorized submission of the registration cancellation on behalf of the facility. FDA will not confirm the registration cancellation until that individual confirms that he or she authorized the registration cancellation.
(4) Your registration will be considered cancelled once FDA transmits your cancellation confirmation.
(d)
(1) You must cancel your registration using Form FDA 3537a. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy. (HFS-681), College Park, MD 20993 or by requesting the form by phone at 1-800-216-7331 or 301-575-0156.
(2) When you receive the form, you must completely and legibly fill out the form and either mail it to the address in paragraph (d)(1) of this section or fax it to 301-436-2804.
(3) If the information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a cancellation form for revision, FDA will use the means by which the cancellation was received by the Agency (
(4) FDA will enter complete and legible mailed and faxed cancellations into its registration system as soon as practicable, in the order FDA receives them.
(5) FDA will mail to the address or fax to the fax number on the cancellation form a copy of the cancellation as entered and confirmation of the cancellation. When responding to a cancellation, FDA will use the means by which the form was received by the Agency (
(6) For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, after completion of the registration cancellation by mail or fax, FDA will email the individual identified as the owner, operator, or agent in charge who authorized submission of the registration cancellation to verify that the individual in fact authorized submission of the registration cancellation on behalf of the facility. FDA will not confirm the registration cancellation until that individual confirms that he or she authorized the registration cancellation.
(7) If any information you previously submitted was incorrect at the time of submission, you must immediately resubmit your cancellation.
(8) Your registration will be considered cancelled once FDA enters your facility's cancellation data into the registration system and the system generates a confirmation.
(e)
(a) Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) prohibits the doing of certain acts or causing such acts to be done. Under section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332), the United States can bring a civil action in Federal court to enjoin a person who commits a prohibited act. Under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), the United States can bring a criminal action in Federal court to prosecute a person who is responsible for the commission of a prohibited act. Under section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a), FDA can seek debarment of any person who has been convicted of a felony relating to importation of food into the United States. Failure of an owner, operator, or agent in charge of a domestic or foreign facility to register its facility, renew the registration of its facility, update required elements of its facility's registration, or cancel its registration in accordance with the requirements of this subpart is a prohibited act under section 301(dd) of the Federal Food, Drug, and Cosmetic Act.
(b) FDA will consider a registration for a food facility to be expired if the registration is not renewed, as required by § 1.230(b). Thus, if you previously submitted a registration to FDA, but do not submit a registration renewal to FDA during the period beginning on October 1 and ending on December 31 of each even-numbered year, FDA will consider the registration for the facility to be expired. FDA will consider a food facility with an expired registration to have failed to register in accordance with section 415 of the Federal Food, Drug, and Cosmetic Act.
(c) FDA will cancel a registration if FDA independently verifies that the facility is no longer in business or has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration, or if FDA determines that the registration is for a facility that does not exist, is not required to register, or where the information about the facility's address was not updated in a timely manner in accordance with § 1.234(a) or the registration was submitted by a person not authorized to submit the registration under § 1.225. Also, FDA will cancel a registration if the facility's registration has expired because the facility has failed to renew its registration in accordance with § 1.230(b). If FDA cancels a facility's registration, FDA will mail a confirmation of the cancellation to the facility at the address provided in the facility's registration.
(d) If an article of food is imported or offered for import into the United States and a foreign facility that manufactured/processed, packed, or held that article of food has not registered in accordance with this subpart, the disposition of the article of food shall be governed by the procedures set out in subpart I of this part.
Under § 1.231(a)(2) and (b), beginning January 4, 2016, you must submit your registration or registration renewal to FDA electronically unless FDA grants a waiver from such requirement. To request a waiver from such requirement, you must submit a written request to FDA that explains why it is not reasonable for you to submit your registration or registration renewal to FDA electronically. You must submit your request to: U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy. (HFS-681), College Park, MD 20993.
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |