| Page Range | 19857-20218 | |
| FR Document |
| Page and Subject | |
|---|---|
| 81 FR 20217 - Continuation of the National Emergency With Respect to Somalia | |
| 81 FR 20215 - World Autism Awareness Day, 2016 | |
| 81 FR 20213 - National Public Health Week, 2016 | |
| 81 FR 20211 - National Donate Life Month, 2016 | |
| 81 FR 20046 - In the Matter of Go EZ Corp.; Order of Suspension of Trading | |
| 81 FR 19967 - Request for Nominations of Candidates to the EPA's Clean Air Scientific Advisory Committee (CASAC) and the EPA Science Advisory Board (SAB) | |
| 81 FR 19994 - Notice of Availability of the Proposed Notice of Sale for Western Gulf of Mexico Planning Area Outer Continental Shelf Oil and Gas Lease Sale 248 | |
| 81 FR 20049 - Twenty-Sixth Meeting: RTCA Special Committee (216) Aeronautical Systems Security | |
| 81 FR 20047 - Thirty-First Meeting: RTCA Special Committee (213) Enhanced Flight Visions Systems/Synthetic Vision Systems (EFVS/SVS)(Joint With EUROCAE WG-79) | |
| 81 FR 20048 - Noise Exposure Map Notice for LA/Ontario International Airport, Ontario, California | |
| 81 FR 19953 - Agency Information Collection Activities: Information Collection; Comment Request-Report of Disqualification From Participation-Institutions and Responsible Principals/Individuals (FNS-843) and Report of Disqualification From Participation-Individually Disqualified Responsible Principal/Individual or Day Care Home Provider (FNS-844) | |
| 81 FR 19861 - Change of Newark Liberty International Airport (EWR) Designation | |
| 81 FR 19982 - National Advisory Council on Migrant Health; Notice of Meeting | |
| 81 FR 19978 - Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal | |
| 81 FR 19998 - Operator Licensing Examination Standards for Power Reactors | |
| 81 FR 19978 - Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice | |
| 81 FR 19931 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher Vessels Using Trawl Gear in the Bering Sea and Aleutian Islands Management Area | |
| 81 FR 19999 - Virgil C. Summer Nuclear Station, Units 2 and 3; South Carolina Electric and Gas; Reconciliation of Tier 1 Valve Differences | |
| 81 FR 19954 - Steel Wire Garment Hangers From Taiwan: Rescission of Antidumping Duty Administrative Review | |
| 81 FR 19955 - National Construction Safety Team Advisory Committee Meeting | |
| 81 FR 19954 - Certain Biaxial Integral Geogrid Products From the People's Republic of China: Notice of Postponement of Preliminary Determination in the Countervailing Duty Investigation | |
| 81 FR 19863 - Public Access to Information | |
| 81 FR 19975 - Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice | |
| 81 FR 19939 - Special Local Regulation; Bucksport/Southeastern Drag Boat Summer Championships, Atlantic Intracoastal Waterway; Bucksport, SC | |
| 81 FR 19887 - Health Care for Certain Children of Vietnam Veterans and Certain Korea Veterans-Covered Birth Defects and Spina Bifida | |
| 81 FR 19857 - Privacy Act of 1974: Implementation of Exemptions; Department of Homeland Security/ALL-030 Use of the Terrorist Screening Database System of Records | |
| 81 FR 19988 - Privacy Act of 1974: Department of Homeland Security/ALL-030 Use of the Terrorist Screening Database System of Records | |
| 81 FR 19932 - Privacy Act of 1974; Implementation of Exemptions; Department of Homeland Security/U.S. Customs and Border Protection-014 Regulatory Audit Archive System (RAAS) System of Records | |
| 81 FR 19985 - Privacy Act of 1974; Department of Homeland Security, U.S. Customs and Border Protection, DHS/CBP-014 Regulatory Audit Archive System (RAAS) System of Records | |
| 81 FR 19956 - The Benefits, Challenges, and Potential Roles for the Government in Fostering the Advancement of the Internet of Things | |
| 81 FR 19942 - Special Local Regulation; Bucksport/Southeastern Drag Boat Summer Extravaganza, Atlantic Intracoastal Waterway; Bucksport, SC | |
| 81 FR 19974 - Notice of Agreements Filed | |
| 81 FR 19997 - Agency Information Collection Activities; Comment Extension, Establishing Paid Sick Leave for Federal Contractors | |
| 81 FR 19944 - Radio Broadcasting Services; Raymond, Washington | |
| 81 FR 19996 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Application for Prevailing Wage Determination | |
| 81 FR 19994 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; National Medical Support Notice-Part B | |
| 81 FR 19995 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Petition Requirements and Investigative Data Collection: Trade Act of 1974, as Amended | |
| 81 FR 19981 - Statement of Organization, Functions and Delegations of Authority | |
| 81 FR 19979 - National Vaccine Injury Compensation Program; List of Petitions Received | |
| 81 FR 19983 - Meeting of the Presidential Advisory Council on HIV/AIDS | |
| 81 FR 19960 - Privacy Act of 1974; System of Records | |
| 81 FR 20003 - New Postal Product | |
| 81 FR 20001 - New Postal Product | |
| 81 FR 20000 - New Postal Product | |
| 81 FR 19992 - Notice of Filing of Plats of Survey; Colorado | |
| 81 FR 19962 - Notice of Filing of Self-Certification of Coal Capability Under the Powerplant and Industrial Fuel Use Act | |
| 81 FR 20053 - JLG Industries, Inc., Grant of Petition for Decision of Inconsequential Noncompliance | |
| 81 FR 20002 - New Postal Product | |
| 81 FR 19994 - Meeting of the Compact Council for the National Crime Prevention and Privacy Compact | |
| 81 FR 19877 - Rights-of-Way on Indian Land | |
| 81 FR 19963 - Notice of the Stakeholder Meeting To Receive Input on the U.S. Department of Energy (DOE) Outyear Marine and Hydrokinetic Program Strategy | |
| 81 FR 19991 - Notice of Public Meetings, Southwest Resource Advisory Council | |
| 81 FR 19983 - Prospective Grant of an Exclusive Patent License for Commercialization: Boron Neutron Capture Therapy for Brain Tumors | |
| 81 FR 19984 - Prospective Grant of an Exclusive Patent License for Commercialization: Boron Neutron Capture Therapy for Skin Cancer | |
| 81 FR 19971 - Notice of Termination: 10342 Sunshine State Community Bank, Port Orange, Florida | |
| 81 FR 19971 - Notice to All Interested Parties of the Termination of the Receivership of 10259, Metro Bank of Dade County; Miami, Florida | |
| 81 FR 19971 - Notice to All Interested Parties of the Termination of the Receivership of 10084, First Piedmont Bank; Winder, Georgia | |
| 81 FR 20055 - Tax Design Challenge; Requirements and Procedures; Correction | |
| 81 FR 19963 - Combined Notice of Filings #1 | |
| 81 FR 19965 - White Pine Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 19965 - Innovative Solar 46, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 19965 - Michigan South Central Power Agency; Notice of Filing | |
| 81 FR 19966 - Transcontinental Gas Pipe Line Company, LLC; Notice of Availability of the Environmental Assessment for the Proposed Dalton Expansion Project | |
| 81 FR 19878 - Burundi Sanctions Regulations | |
| 81 FR 19951 - Notice of Intent To Request New Information Collection | |
| 81 FR 19962 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Teacher Incentive Fund (TIF) Application (1894-0001) | |
| 81 FR 19961 - Proposed Collection; Comment Request | |
| 81 FR 19896 - Unlicensed-National Information Infrastructure, Order on Reconsideration | |
| 81 FR 19970 - FCC To Hold Open Commission Meeting, Thursday, March 31, 2016 | |
| 81 FR 19969 - Schedule Change and Deletion of Consent Agenda Items From March 31, 2016 Open Meeting | |
| 81 FR 19990 - Proposed Information Collection; Captive Wildlife Safety Act | |
| 81 FR 19976 - Inorganic Arsenic in Rice Cereals for Infants: Action Level; Draft Guidance for Industry; Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice Products Risk Assessment: Report; Availability | |
| 81 FR 20030 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule Change, as Modified by Amendment No. 2, Amending Its Rules Relating to Pre-Opening Indications and Opening Procedures To Promote Greater Efficiency and Transparency at the Open of Trading on the Exchange | |
| 81 FR 20049 - Notice of Proposed Policy Statement on the Implementation of the Phased Increase in Domestic Content Under the Buy America Waiver for Rolling Stock | |
| 81 FR 20051 - Notice of Proposed Public Interest Waiver of Buy America Domestic Content Requirements for Rolling Stock Procurements In Limited Circumstances | |
| 81 FR 20007 - Advisors Asset Management, Inc. and AAM ETF Trust; Notice of Application | |
| 81 FR 20004 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing of Proposed Rule Change Related to Market Wide Risk Protection | |
| 81 FR 20021 - Self-Regulatory Organizations; ISE Gemini, LLC; Notice of Filing of Proposed Rule Change Related to Market Wide Risk Protection | |
| 81 FR 20016 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Granting Approval of Proposed Rule Change, as Modified by Amendment Nos. 1, 2, and 3 Thereto, To List and Trade Shares of the Elkhorn S&P GSCI Dynamic Roll Commodity ETF of Elkhorn ETF Trust | |
| 81 FR 20024 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Adopting Requirements for the Collection and Transmission of Data Pursuant to Appendices B and C of the Regulation NMS Plan To Implement a Tick Size Pilot Program | |
| 81 FR 20040 - Self-Regulatory Organizations; National Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt Exchange Rule 11.26 To Implement the Regulation NMS Plan To Implement a Tick Size Pilot Program | |
| 81 FR 19902 - Federal Motor Vehicle Safety Standards; Occupant Crash Protection | |
| 81 FR 19944 - Federal Motor Vehicle Safety Standards; Occupant Crash Protection | |
| 81 FR 20055 - Solicitation of Nominations for Appointment to the Advisory Committee on Cemeteries and Memorials | |
| 81 FR 19956 - Taking and Importing of Marine Mammals | |
| 81 FR 20054 - Proposed Collection; Comment Request for Form 8582-CR | |
| 81 FR 19993 - National Register of Historic Places; Notification of Pending Nominations and Related Actions | |
| 81 FR 19992 - National Register of Historic Places; Notification of Pending Nominations and Related Actions | |
| 81 FR 19971 - Agency Information Collection Activities: Proposed Collection Renewals; Comment Request (3064-0001, -0174, -0188 & -0191) | |
| 81 FR 19974 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 81 FR 20046 - Public Hearing | |
| 81 FR 19860 - Amendment of Class D Airspace for Bartow, FL | |
| 81 FR 19858 - Establishment of Class D and Class E Airspace, and Amendment of Class E Airspace; Lake City, FL | |
| 81 FR 19923 - Endangered and Threatened Wildlife and Plants; U.S. Captive-Bred Inter-subspecific Crossed or Generic Tigers | |
| 81 FR 19904 - Accounting and Reporting of Business Combinations, Security Investments, Comprehensive Income, Derivative Instruments, and Hedging Activities | |
| 81 FR 19934 - Disaster Assistance Loan Program; Disaster Loan Mitigation, Contractor Malfeasance and Secured Threshold | |
| 81 FR 19884 - Safety Zone; Lower Mississippi River Mile 95.7 to 96.7; New Orleans, LA | |
| 81 FR 19936 - Labeling and Advertising of Home Insulation | |
| 81 FR 19891 - Hexythiazox; Pesticide Tolerances | |
| 81 FR 20058 - Endangered and Threatened Wildlife and Plants; Final Rule To List Eleven Distinct Population Segments of the Green Sea Turtle (Chelonia mydas) as Endangered or Threatened and Revision of Current Listings Under the Endangered Species Act | |
| 81 FR 19933 - Supplemental Nutrition Assistance Program Promotion; Correction | |
| 81 FR 20092 - Sanitary Transportation of Human and Animal Food | |
| 81 FR 20172 - National Emission Standards for Hazardous Air Pollutants From Coal- and Oil-Fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units; Technical Correction |
Economic Research Service
Food and Nutrition Service
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Army Department
Energy Efficiency and Renewable Energy Office
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
National Park Service
Ocean Energy Management Bureau
Federal Bureau of Investigation
Wage and Hour Division
Federal Aviation Administration
Federal Transit Administration
National Highway Traffic Safety Administration
Foreign Assets Control Office
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, 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.
Privacy Office, Department of Homeland Security.
Final rule.
The Department of Homeland Security (DHS) is issuing a final rule to amend its regulations to exempt portions of an existing system of records titled, “Department of Homeland Security/ALL-030 Use of the Terrorist Screening Database System of Records” from certain provisions of the Privacy Act. Specifically, the Department exempts portions of the “Department of Homeland Security/ALL-030 Use of the Terrorist Screening Database System of Records” from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.
This final rule is effective April 6, 2016.
Karen L. Neuman, (202) 343-1717, Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.
The Department of Homeland Security (DHS) published a notice of proposed rulemaking in the
DHS received three comments. Two comments were from private individuals who complemented DHS for this update. DHS received an identical comment from a public interest research center on the SORN and NPRM. The commenter raised concerns regarding the number of exemptions taken by DHS, particularly exemptions related to access and accounting for disclosures. Specifically, the commenter questioned the need to exempt records once an investigation was complete.
In response, DHS emphasizes that the Terrorist Screening Database (TSDB) belongs to the Department of Justice (DOJ)/Federal Bureau of Investigation (FBI). DHS does not change or alter these records. All records within the DHS/ALL-030 Use of the Terrorist Screening Database System of Records are collected and disseminated by the DOJ/FBI and are covered by the DOJ/FBI-019, “Terrorist Screening Records Center System,” 72 FR 77846 (Dec. 14, 2011). Because DHS does not make any changes to the records obtained from DOJ/FBI, the same exemptions outlined in the DOJ/FBI SORN, and reasons provided in its implementing regulations for use of such exemptions at 28 CFR 16.96, transfer and apply. For instance, disclosing this information to individuals who have been misidentified as known or suspected terrorists due to a close name similarity, and of which the investigation has been completed, could reveal the Government's investigative interest in a terrorist suspect for an ongoing investigation, because it could make known the name of the individual who actually is the subject of the Government's interest. Similarly, providing any type of notice to a misidentified known or suspected terrorist due to a close name similarity could alert the actual known or suspected terrorist of the Government's investigative interest in that individual. Further, amendment of these records would impose an impossible administrative burden by requiring investigations, analyses, and reports to be continuously reinvestigated and revised. DHS is not taking any new exemptions as a result of the expansion to the categories of individuals in the TSDB. As noted in the NPRM, permitting access and amendment to watchlist records could disclose sensitive information that could be detrimental to national security. Release of the accounting of disclosures could reveal the details of watchlist matching measures, as well as capabilities and vulnerabilities of the watchlist matching process, the release of which could permit an individual to evade future detection and thereby impede efforts to ensure national security.
However, DHS does agree that some of the exemptions proposed in the NPRM are unnecessary. With the publication of this Final Rule, DHS is removing the exemption from subsections 5 U.S.C. 552a(e)(4)(G), (e)(4)(H), and (e)(4)(I) (Agency Requirements) and (f) (Agency Rules), because DHS has already established requirements, rules, or procedures with respect to individual access and will review each request for access on a case-by-case basis. Concurrent with this Final Rule, DHS is republishing the DHS/ALL-030 Use of the Terrorist Screening Database System of Records to reflect this change.
Freedom of information, Privacy.
For the reasons stated in the preamble, DHS amends chapter I of title 6, Code of Federal Regulations, as follows:
Pub. L. 107-296, 116 Stat. 2135; (6 U.S.C. 101
(a) From subsection (c)(3) and (4) (Accounting for Disclosures) because release of the accounting of disclosures could alert the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS as well as the recipient agency. Disclosure of the accounting would therefore present a serious impediment to law enforcement efforts and/or efforts to preserve national security. Disclosure of the accounting would also permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension, which would undermine the entire investigative process.
(b) From subsection (d) (Access to Records) because access to the records contained in this system of records could inform the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS or another agency. Access to the records could permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension. Amendment of the records could interfere with ongoing investigations and law enforcement activities and would impose an unreasonable administrative burden by requiring investigations to be continually reinvestigated. In addition, permitting access and amendment to such information could disclose security-sensitive information that could be detrimental to homeland security.
(c) From subsection (e)(1) (Relevancy and Necessity of Information) because in the course of investigations into potential violations of Federal law, the accuracy of information obtained or introduced occasionally may be unclear, or the information may not be strictly relevant or necessary to a specific investigation. In the interests of effective law enforcement, it is appropriate to retain all information that may aid in establishing patterns of unlawful activity.
(d) From subsection (e)(2) (Collection of Information from Individuals) because requiring that information be collected from the subject of an investigation would alert the subject to the nature or existence of the investigation, thereby interfering with that investigation and related law enforcement activities.
(e) From subsection (e)(3) (Notice to Subjects) because providing such detailed information could impede law enforcement by compromising the existence of a confidential investigation or reveal the identity of witnesses or confidential informants.
(f) From subsection (e)(5) (Collection of Information) because with the collection of information for law enforcement purposes, it is impossible to determine in advance what information is accurate, relevant, timely, and complete. Compliance with subsection (e)(5) would preclude DHS agents from using their investigative training and exercise of good judgment to both conduct and report on investigations.
(g) From subsection (e)(8) (Notice on Individuals) because compliance would interfere with DHS's ability to obtain, serve, and issue subpoenas, warrants, and other law enforcement mechanisms that may be filed under seal and could result in disclosure of investigative techniques, procedures, and evidence.
(h) From subsection (g) (Civil Remedies) to the extent that the system is exempt from other specific subsections of the Privacy Act.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class D airspace and Class E surface area airspace at Lake City, FL, providing the controlled airspace required for the Air Traffic Control Tower at Lake City Gateway Airport. This action also amends existing Class E airspace by recognizing the airport's name change. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. A minor adjustment is made to the geographic coordinates of the airport.
Effective 0901 UTC, May 26, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class D and Class E airspace, and amends Class E airspace at Lake City Gateway Airport, Lake City, FL.
On January 13, 2016, the FAA published in the
Class D and E airspace designations are published in paragraphs 5000, 6002, and 6005, respectively, of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class D airspace and Class E surface area airspace at Lake City Gateway Airport, Lake City, FL, providing the controlled airspace required to support the Air Traffic Control Tower. Class D airspace extending upward from the surface up to and including 2,500 feet is established within a 4.2 mile radius of the airport. Class E surface area airspace is established within a 4.2 mile radius of the airport. Class E airspace extending upward from 700 feet above the surface is amended by changing the airport's name from Lake City Municipal Airport to Lake City Gateway Airport. Controlled airspace is necessary for IFR operations. The geographic latitude coordinate of the airport is adjusted from “lat. 30°10′56″ N.”, to “lat. 30°10′55″ N.” for the Class D and E airspace areas.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (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); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 2,500 feet within a 4.2-mile radius of Lake City Gateway Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
Within a 4.2-mile radius of Lake City Gateway Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from 700 feet above the surface within a 7-mile radius of Lake City Gateway Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class D Airspace at Bartow Municipal Airport, Bartow, FL, by adjusting the ceiling of the Class D airspace area from 2,600 feet to 1,600 feet above the surface. This change allows the air traffic control tower at Tampa International Airport, Tampa, FL, to carry out Letter of Agreement procedures, already established, between Bartow Air Traffic Control Tower and Tampa Terminal Radar Approach Control (TRACON) for the safety and management of standard instrument approach procedures (SIAPs) and for Instrument Flight Rule (IFR) operations in the area.
Effective 0901 UTC, May 26, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class D airspace at Bartow Municipal Airport, Bartow, FL.
In a review of the airspace, the FAA found the Class D airspace description for Bartow Municipal Airport, Bartow, FL, published in FAA Order 7400.9Z, describes the ceiling as, extending upward from the surface to and including 2,600 feet MSL. The Tampa International Airport Class B airspace area has control of aircraft operating at and above 1,800 feet MSL in the Bartow, FL, Class D airspace area. The FAA is lowering the Class D airspace area to 1,600 feet MSL to avoid the overlap between the two facilities. To avoid confusion on the part of the pilots overflying the Bartow, FL, area, the FAA finds that notice and public procedure under 5 U.S.C 553(b) are impracticable and contrary to the public interest. To be consistent with the FAA's safety mandate when an unsafe condition exists, the FAA finds good cause pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days to promote the safe and efficient handling of air traffic in the area.
Class D airspace designations are published in paragraphs 5000 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class D airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by lowering the Class D ceiling airspace area from 2,600 feet MSL to and including 1,600 feet MSL at Bartow Municipal Airport, Bartow, FL. The Letter of Agreement between Tampa TRACON and Bartow ATCT, established June 3, 2013, states that Tampa TRACON shall control aircraft operating at or above 1,800 feet MSL in the Bartow Airport Class D airspace area. This airspace change eliminates pilot confusion for those aircraft operating above 1,600 feet MSL in the Bartow Airport Class D airspace area.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (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); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 1,600 feet MSL within a 4-mile radius of Bartow Municipal Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
Federal Aviation Administration (FAA), DOT.
Change of Newark Liberty International Airport (EWR) Designation.
This document announces that the FAA will designate Newark Liberty International Airport (EWR) as a Level 2, schedule-facilitated airport under the International Air Transport Association (IATA) Worldwide Slot Guidelines (WSG) effective for the Winter 2016 scheduling season, which begins on October 30, 2016. The FAA has determined this designation is necessary based on an updated demand and capacity analysis of the airport. The current FAA Order designating EWR as a Level 3, slot-controlled airport will expire on October 29, 2016.
This designation takes effect on October 30, 2016.
Requests may be submitted by mail to Slot Administration Office, AGC-220 Office of the Chief Counsel, 800 Independence Ave. SW., Washington, DC 20591; facsimile: 202-267-7277; or by email to:
For questions contact: Susan Pfingstler, System Operations Services, Air Traffic Organization, Federal Aviation Administration, 600 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-6462; email
By Order dated May 21, 2008, the FAA placed temporary limits on scheduled operations at EWR to mitigate congestion and delays at the airport.
Under the EWR Order, the FAA (1) established hourly limits of 81 scheduled operations during the peak period; (2) imposed an 80 percent minimum usage requirement for Operating Authorizations (OAs or slots) with defined exceptions; (3) provided a mechanism for withdrawal of OAs for FAA operational reasons; (4) established procedures to allocate withdrawn, surrendered, or unallocated OAs; and, (5) allowed for trades and leases of OAs for consideration for the duration of the Order.
On January 8, 2015, the Department of Transportation (DOT) and FAA issued the Slot Management and Transparency for LaGuardia Airport, John F. Kennedy International Airport, and Newark Liberty International Airport Notice of Proposed Rulemaking (NPRM).
Based on the FAA's review of operational performance, demand, and capacity discussed in this document, Level 3 slot controls are no longer warranted for EWR. Rather, the FAA will transition EWR to a Level 2, schedule-facilitated airport, starting with the Winter 2016 scheduling season. In addition, the FAA also has updated the performance, demand, and capacity analyses for JFK and LGA and has determined that Level 3 slot-controlled restrictions remain necessary for these airports. Therefore, through separate notices published in the
This document confirms the EWR Order will expire on October 29, 2016. A copy of this document will be placed in Docket FAA-2008-0221. As explained herein, the FAA is designating EWR as a Level 2 airport effective October 30, 2016. As further explained in this document, the FAA has conducted a screening for potential impacts to noise and air emissions as a result of this change in designation at EWR and has determined that the proposed action does not have the potential to cause a significant impact.
The FAA regularly reviews operational performance and demand at the New York City area airports as part of ongoing efforts to improve the efficiency of the air traffic control system. Section 413 of the FAA Modernization and Reform Act, Pub. L. 112-95, 126 Stat. 11 (Feb. 14, 2012), requires the FAA to take actions to ensure that aircraft operations of air carriers do not exceed the hourly
On an annual basis since adopting the 2008 Order, the FAA has performed analyses to compare and contrast operational and performance data for each year subsequent to the peak 2007 summer scheduling season to identify operational and performance trends. Such analyses have consistently placed particular emphasis on the May through August months since this period includes the peak summer demand. The on-time performance and delay metrics at EWR show significant improvements during such peak periods of demand. For example, on-time gate arrivals at EWR have increased by about 11 percentage points when comparing May through August 2015 to the same period in 2007.
The FAA recently modeled the summer 2015 demand against summer 2015 runway capacity and then compared the results to the delay profile that was the basis for the 2008 Order. Operations in 2015 were down by 8 percent, total minutes of arrival delays went from 16,100 to 10,100 for a 37 percent decrease, mean arrival delays decreased from 24.0 minutes to 16.3 minutes, and mean departure delays from 18.0 minutes to 14.2 minutes.
The FAA also reviewed scheduled flights at EWR over the last few years. Scheduled demand was routinely below the 81 hourly scheduling limits in the Order, even during the busiest early morning, afternoon, and evening hours. For example, in the 3 p.m. through 8:59 p.m. local hours, weekday scheduled demand in the May-August period averaged 71 flights per hour in 2011, 74 flights per hour in 2013, and 72 flights per hour in 2015.
In light of the FAA's demand and capacity analysis at EWR, the FAA has determined that EWR does not warrant a Level 3 designation. The FAA's analysis demonstrates that runway capacity exists for additional operations. However, under a Level 3 designation, the FAA must deny requests from carriers to add or retime operations based on allocated slots rather than scheduled and actual operations, provided the carrier satisfies the minimum slot usage requirements. Further, the FAA simply cannot increase the scheduling limits to compensate for slots that are under-scheduled but meet the minimum usage rules, as this would require the FAA to determine that additional capacity exists for operations above the current scheduling limits.
The FAA also considered whether EWR should be re-designated as a Level 1 airport since EWR operated for many years without scheduling limits while nearby JFK and LGA were slot controlled. During this time, EWR provided access to the New York City area and, while delays were high compared to other airports, overall demand was generally consistent with runway capacity. However, there are practical limitations to the number of additional flights that EWR can accept from a runway and airport facilities perspective. Moreover, we expect there will be significant demand for access to EWR, given its location and that the JFK and LGA airports will remain slot-controlled airports. Thus, the FAA has determined that the Level 2 schedule facilitation process and its related principles of voluntary cooperation will best balance the anticipated demand with the practical limitations on the number of additional flights possible at EWR. Following the effective date of the Level 2 designation, the FAA will continue to review whether Level 2 is appropriate or whether other action might be needed. The FAA does not expect to make any airport level changes based on short-term airline schedule plans or resulting delays.
Consistent with existing FAA practice for schedule facilitation at Level 2 airports, under the Level 2 designation at EWR, the FAA will request and review airline schedules for the 6 a.m. to 10:59 p.m. period and either approve the request or work with carriers to achieve schedule adjustments as needed to avoid exceeding the airport's capacity. The success of Level 2 schedule facilitation procedures depends upon a number of factors delineated in the WSG. The FAA will apply the priorities for schedule facilitation outlined in the WSG. In particular, priority will be given to carriers based on actual approved schedules and operations conducted in the previous corresponding season over new demand for the same timings.
Additionally, although there is some runway capacity available at EWR, approval of new or retimed operations must avoid significant scheduled peaking and allow for recovery to avoid causing a consistent level of unacceptable delay, which could necessitate a return to Level 3. The FAA intends, if necessary, to deny schedule submissions that exceed the declared airport runway capacity and to offer alternative times to carriers. The WSG recognizes that some carriers might operate at times without approval from the airport's schedule facilitator. Consistent with the WSG, carriers would not receive historic status for such flights if the airport level changes from Level 2 to Level 3.
Finally, while the FAA is responsible for managing the airport's runway capacity, there are terminal, gate, and other operational factors that may require schedule adjustments. The FAA recognizes that the entry at EWR has been limited by runway slot availability for the last 8 years and new entry and growth by incumbent carriers is expected. The Port Authority of New York and New Jersey (Port Authority) currently reviews schedules for
The FAA conducted an environmental screening for potential impacts to noise and air emissions relative to the change of the EWR designation from Level 3 to Level 2. Based on the screening, the FAA has determined that this action may be categorically excluded from further environmental analysis according to FAA Order 1050.1, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.6.f. Specifically, paragraph 5-6.6.f states that “Regulations, standards, and exemptions (excluding those which if implemented may cause a significant impact on the human environment)” are categorically excluded from further environmental review.
The FAA conducted noise screening of the proposed action using Area Equivalent Method and determined that the action does not have the potential to cause a significant impact on noise levels of noise sensitive areas. In addition, the FAA conducted an analysis of air emissions using Aviation Environmental Design Tool and determined that the action does not have the potential to cause a significant impact on air quality or a violation of Federal, state, tribal, or local air quality standards under the Clean Air Act, 42 U.S.C. §§ 7401-7671q. Therefore, implementation of the airport level change is not expected to result in significant adverse impacts to the human environment. The implementation of this action is not expected to result in any extraordinary circumstances in accordance with FAA Order 1050.1. A copy of the categorical exclusion has been placed in the docket associated with this action.
The FAA will continue to regularly review and monitor performance at EWR, as well as carrier compliance with FAA-approved schedules. The FAA will continue to review data on actual operations, including the number of hourly and daily air traffic operations, runway capacity and utilization, aircraft fleet mix, scheduled and unscheduled demand, on-time performance relative to schedule, the number and duration of flight arrival and departure delays, airfield or other capacity changes, and air traffic control procedures. The FAA will publish a notice in April, 2016 announcing the schedule submission deadline and the declared runway capacity limits for the Winter 2016 scheduling season.
The FAA expects that delays at EWR will increase over current levels as flights are added, but an incremental increase in delays would not necessarily mean the FAA would revert to Level 3. The FAA's objective while working with carriers under the Level 2 process is to appropriately balance and maximize the use of the available runway capacity at EWR while maintaining an acceptable level of delay.
Department of State.
Final rule.
The Department of State (the Department) finalizes its revisions to its regulations implementing the Freedom of Information Act (FOIA) and the Privacy Act. The final rule reflects changes in FOIA and other statutes and consequent changes in the Department's procedures since the last revision of the Department's regulations on this subject.
This rule is effective on May 6, 2016.
Alice Kottmyer, Office of the Legal Adviser, Office of Management, U.S. Department of State,
On July 28, 2015, the Department published a notice of proposed rulemaking (NPRM) to update its FOIA and Privacy Act rules contained in 22 CFR part 171. See 80 FR 44898, and the discussion therein.
This rulemaking responds to public comments and finalizes the rule. The rule is finalized as published in the NPRM, except for minor format edits; modifications, as indicated below, in response to public comments; and the addition of one clause to § 171.24(a), which codifies a longstanding provision of the Privacy Act (5 U.S.C. 552a(c)(3)), and which was inadvertently omitted from the NPRM. Since § 171.24(a) is substantially the same as 5 U.S.C. 552a(c)(3) in the Privacy Act itself, it need not be published for comment.
The Department would like to thank the members of the public who invested time in reviewing the proposed changes to the FOIA and Privacy Act regulations, and for providing very useful feedback.
The first commenter expressed concern about the proposal for the Department to charge a fee of 15 cents per page of duplication. The commenter pointed out that present day photocopying and scanning is relatively cheap, and expressed a belief that the Department's lease arrangements reflect a significantly lesser per page cost than 15 cents; in addition, he stated that other agencies' costs vary and might be lower, and no evidence was provided on how the Department formulated the fee. He stated that some other agencies have lowered duplication costs in their regulations in the last two years to be in line with actual direct costs.
The fee charged for photocopying at the Department is 15 cents per page, which is charged at a standard rate throughout the Department for copying services. This charge is based on the costs calculated by examining paper costs, machinery, and services provided to produce a photocopy. Other agencies and departments charge FOIA duplication fees that range from five cents to twenty cents per page. The Department's duplication fee of fifteen cents per page is in line with what other agencies and departments charge for duplication. For this reason, the Department declines to change the duplication fee as suggested.
This comment expressed the following six points:
1. In proposed § 171.11, Processing requests, the proposed regulations state that a requester “shall be considered to have agreed to pay applicable fees up to $25, unless a fee waiver is granted.” The commenters believe that the Department should follow Department of Justice's regulations and provide that no fees will be assessed if the fees are under $25, which is their approximate cost of collecting fees. Also, they believe the Department should at least limit the presumption to instances in which a fee waiver has not been requested, per the Department of Justice's superseded regulations.
The Department accepts the Justice Department's estimate that the cost to collect fees is approximately $25.00. The Department agrees to revise § 171.14, “Fees to be charged,” to state the current cost of collecting a fee is $25.00; therefore, the Department will process requests without assessing fees up to $25.00. The Department will also revise this section to state that the Department will attempt to notify the requester if fees are estimated to exceed $25.00, including a breakdown of the fees for search, review or duplication, unless the requester has indicated a willingness to pay fees as high as those anticipated.
2. In proposed § 171.11(f), the commenters are concerned that the appeal of expedited processing is submitted to the Director of IPS, the same Director who is responsible for issuing initial determinations on requests. The regulations should clearly state if the Director is receiving the appeals on behalf of the Appeal Review Panel.
The Department's Appeals Review Panel does not review appeals from denials of expedited processing. See 22 CFR 171.13(a). For this reason, the Department will not revise § 171.11(f) as suggested. The Department will revise § 171.11(a) to state that the Division Chief, Requester Liaison Division, in the Office of Information Programs and Services, will issue all initial decisions on whether a request is valid or perfected, and whether to grant or deny requests for a fee waiver and for expedited processing.
3. The acknowledgement letter in subsection (i) should include the receipt date, to assist requesters with determining an agency's statutory response deadline.
The Department will revise § 171.11(e), “Receipt of request”, to include a subsection that states that upon receipt IPS will send an acknowledgement letter to the requester that will identify the date of receipt of the request in the proper component, as identified in § 171.11(a), and the case tracking number. Subsection (i) sets forth the information that is available to a requester by contacting the FOIA Requester Service Center.
4. The Department's proposed consultation procedures in subsection (m) are limited to agencies only. They do not account for consultations that may be required with the Office of the White House Counsel. The commenters believe the regulations should address its FOIA-related consultations with the Office of White House Counsel.
Section 171.11(m) “Referrals and Consultations” states that the Department will refer documents created by another agency to that agency for a release determination. In practice, the implementation of this section turns on the identity of the originator of a document and not on whether the originator works in an agency or department or other governmental entity. The Department will revise subsection (m) as follows: “If the Department determines that Department records retrieved as responsive to the request are of interest to another agency or Federal government office, it may consult with the other agency or office before responding to the request.”
5. Business information. The Department should specify a minimum number of days that submitters will have to provide comments and to file a “reverse-FOIA” lawsuit, respectively. This is preferred over a “reasonable period of time”. The commenters recognize that circumstances might warrant providing one submitter with more time than another. They believe five business days would be considered a “reasonable period of time,” as Executive Order 12600 requires.
The Department declines to revise this subsection as suggested, because providing some flexibility to submitters in seeking input in response to a notice issued under this subsection ensures the best outcome for the requesters, the submitters, and the Department.
6. In § 171.16, Waiver or reduction of fees, the commenters are concerned with the Department responding to fee waiver appeals within “30 working days” from the date of receipt. Unless unusual circumstances exist, an agency must make a determination on a fee waiver appeal within 20 working days. Furthermore, they ask for clarification on who will adjudicate the fee waiver appeals, as it is presumably not the “Director of IPS” who issues fee determinations.
The Department will revise § 171.16(e) to state that the Department must respond to an appeal of a denial of a fee waiver or fee reduction request within 20 working days. The Department's Appeals Review Panel does not review appeals from a denial of a fee waiver. See 22 CFR 171.13(a). The Department will revise § 171.16 (e) to state that the Division Chief of the Requester Liaison Division in IPS will issue all initial decisions on whether to grant or deny requests for a fee waiver and that appeals should be directed to the Director of IPS.
The third public comment was submitted by the National Archives and Records Administration's Office of Government Information Services (OGIS). OGIS suggested adding to the end of § 171.13(d) the following or similar language: “If the requester elects to engage in the mediation services offered by the Office of Government Information Services of the National Archives and Records Administration, the Department of State must actively engage as a partner to the mediation process in an attempt to resolve the dispute.”
The Department understands the importance of resolving disputes between FOIA requesters and Federal agencies, and will revise this subsection as follows: “When the Department of State engages in the mediation services offered by OGIS, it will work in good faith as a partner to the mediation process in an attempt to resolve the dispute. The Department reserves its right to decide on a case-by-case basis whether to enter into formal mediation offered by OGIS.”
This comment, from Cause of Action, suggests that the Department revise its definition of a representative of the news media, following an opinion of the District of Columbia Circuit Court in
Furthermore, Cause of Action raised concern over the “middleman standard” not being included in the Department's regulatory definition. Cause of Action stated that the D.C. Circuit Court “disagreed with the suggestion that a public interest advocacy organization cannot satisfy the statute's distribution criterion because it is `more like a middleman for dissemination to the media than a representative of the media itself '. . . There is no indication that Congress meant to distinguish between those who reach their ultimate audiences directly and those who partner with others to do so.” Cause of Action believes that the final rule should draw a distinction between those that market FOIA information for their direct economic benefit and the Court's direction that “public interest advocacy organizations” can “partner with others” to disseminate their distinct works.
The regulation states that the examples provided regarding who may qualify for news media status are not all-inclusive; therefore, the Department does not believe that providing another non all-inclusive list would help shed light on the process the Department employs.
The Department agrees that this information may be helpful for requesters to understand how IPS analyzes a request for representative in the news media status. For this reason, the Department will add this information to its public FOIA Web site.
In the second comment (regarding the “middleman standard”), the Office of Management and Budget (“OMB”) has policy-making responsibility for issuing fee guidance. For this reason, the Department defers to OMB with regard to this suggestion.
The Department published this rule under the provisions of 5 U.S.C. 553, with a 60-day public comment period.
The Department of State, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and import markets.
The Department has reviewed this regulation in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this regulation.
The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.
The Department has considered this rule in light of these Executive Orders and affirms that this regulation is consistent with the guidance therein. The benefits of this rulemaking for the public include, but are not limited to, providing an up-to-date procedure for requesting information from the Department. The Department is aware of no cost to the public from this rulemaking.
This rule does not impose or revise any reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35.
Administrative practice and procedure, Freedom of information, Privacy.
For the reasons set forth in the preamble, 22 CFR part 171 is revised to read as follows:
22 U.S.C. 2651a; 5 U.S.C. 552, 552a; E.O. 12600 (52 FR 23781); Pub. L. 95-521, 92 Stat. 1824 (codified as amended at 5 U.S.C. app. 101-505); 5 CFR part 2634.
(a) This subpart contains the rules that the Department of State and the Foreign Service Grievance Board (FSGB), an independent body, follow in processing requests for records under the Freedom of Information Act (FOIA), 5 U.S.C. 552, as amended, and the Privacy Act of 1974 (PA), 5 U.S.C. 552a, as amended. Records of the Department shall be made available to the public upon request made in compliance with the access procedures established in this part, except for any records exempt by law from disclosure. Regulations at 22 CFR 172.1 through 172.9 govern,
(b)
(2) For purposes of subparts A, B, C, and D of this part,
Most of the records maintained by the Department pertain to the formulation and execution of U.S. foreign policy. The Department also maintains certain records that pertain to individuals, such as applications for U.S. passports, applications for visas to enter the United States, records on consular assistance given abroad by U.S. Foreign Service posts to U.S citizens and legal permanent residents, and records on Department employees. Further information on the types of records maintained by the Department may be obtained by reviewing the Department's records disposition schedules, which are available on the Department's Web site at
Information that is required to be published in the
(a) Requests for records made in accordance with subparts A, B, and C of this part must be made in writing and may be made by mail addressed to the Office of Information Programs and Services (IPS), U.S. Department of State, State Annex 2 (SA-2), 515 22nd Street, NW., Washington, DC 20522-8100, or by fax to (202) 261-8579, or through the Department's FOIA Web site (
(1) Requests for passport records that are covered under PA System of Records Notice 26, including passport records issued from 1925 to present, should be mailed to U.S. Department of State, Law Enforcement Liaison Division, CA/PPT/S/L/LE, 44132 Mercure Cir, P.O. Box 1227, Sterling, VA 20166. Further guidance on obtaining passport records is available on the Department's Web site:
(2) Requests for records of the Office of Inspector General (OIG) may be submitted to U.S. Department of State, Office of Inspector General, Office of General Counsel, Washington, DC 20520-0308, ATTN: FOIA officer. In addition, FOIA requests seeking OIG records may be submitted via email to
(3) All other requests for other Department records must be submitted to the Office of Information Programs and Services by one of the means noted above. The Office of Information Programs and Services, the Law Enforcement Liaison Division of the Office of Passport Services, and the OIG are the only Department components authorized to accept FOIA requests submitted to the Department.
(4) Providing the specific citation to the statute under which a requester is requesting information will facilitate the processing of the request by the Department. The Department automatically processes requests for information maintained in a PA system of records under both the FOIA and the PA to provide the requester with the greatest degree of access to the requester. Such information may be withheld only if it is exempt from access under both laws; if the information is exempt under only one of the laws, it must be released.
(b) Although no particular format is required, a request must reasonably describe the Department records that are sought. To the extent that requests are specific and include all pertinent details about the requested information, it will be easier for the Department to locate responsive records. For FOIA requests, such details include the subject, timeframe, names of any individuals involved, a contract number (if applicable), and reasons why the requester believes the Department may have records on the subject of the request.
(c) While every effort is made to guarantee the greatest possible access to all requesters regardless of the statute(s) under which the information is requested, the following guidance is provided for the benefit of requesters:
(1) The Freedom of Information Act applies to requests for records concerning the general activities of government and of the Department in particular (see subpart B of this part).
(2) The Privacy Act applies to requests from U.S. citizens or legal permanent resident aliens for records that pertain to them that are maintained by the Department in a system of records retrievable by the individual's name or personal identifier (see subpart C of this part).
(d) As a general matter, information access requests are processed in the order in which they are received. However, if the request is specific and the search can be narrowed, it may be processed more quickly. Additionally, FOIA requests granted expedited processing will be placed in the expedited processing queue (see § 171.11(f) for more information). Multi-tracking of FOIA requests is also used to manage requests (see § 171.11(h)).
The Department ordinarily transfers records designated as historically significant to the National Archives when they are 25 years old. Accordingly, requests for some Department records 25 years old or older should be submitted to the National Archives by mail addressed to Special Access and FOIA Staff (NWCTF), 8601 Adelphi Road, Room 5500, College Park, MD 20740; by fax to (301) 837-1864; or by email to
This subpart contains the rules that the Department follows under the Freedom of Information Act (FOIA), 5 U.S.C. 552, as amended. The rules should be read together with the FOIA, which provides additional information about access to records and contains the specific exemptions that are applicable to withholding information, the Uniform Freedom of Information Fee Schedule and Guidelines published by the Office of Management and Budget (OMB Guidelines), and information located at
(a)
(2) The Division Chief, Requester Liaison Division, in the Office of Information Programs and Services, shall issue all initial decisions on whether a request is valid or perfected, and whether to grant or deny requests for a fee waiver or for expedited processing.
(1)
(2)
(3)
(4)
(i) The need to search for and collect the requested records from Foreign Service posts or Department offices other than IPS;
(ii) The need to search for, collect, and appropriately examine a voluminous amount of distinct records; or
(iii) The need to consult with another agency or other agencies that has/have a substantial interest in the records, or among two or more Department components that have a substantial subject-matter interest therein. In the majority of requests received by the Department unusual circumstances exist due to the need to search in multiple bureaus/offices/posts located around the globe.
(c)
(d)
(e)
(1) The Department may make one request to the requester for clarifying information and toll the 20-day period while waiting for the requester's response; or
(2) If necessary to clarify with the requester issues regarding fees. In either case, the Department's receipt of the information from the requester ends the tolling period.
(f)
(1) Failure to obtain requested information on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual.
(2) The information is urgently needed by an individual primarily engaged in disseminating information in order to inform the public concerning actual or alleged Federal government activity. Requesters must demonstrate that their primary activity involves publishing or otherwise disseminating information to the public in general, not just to a particular segment or group.
(3) Failure to release the information would impair substantial due process rights or harm substantial humanitarian interests.
(4) A request for expedited processing may be made at the time of the initial request for records or at any later time. The request for expedited processing shall set forth with specificity the facts on which the request is based. A notice of the determination whether to grant expedited processing shall be provided to the requester within 10 calendar days of the date of the receipt of the request in the appropriate office (whether IPS, OIG, or PPT). A denial of a request for expedited processing may be appealed to the Director of IPS within 30 calendar days of the date of the Department's letter denying the request. A decision in writing on the appeal will be issued within 10 calendar days of the receipt of the appeal. See § 171.4 for contact information.
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(2) Whenever the Department refers any part of the responsibility for responding to a request to another agency, it shall document the referral, maintain a copy of the record that it refers, and notify the requester of the referral.
(3) Agreements regarding consultations and referrals. The Department may make agreements with other agencies to eliminate the need for consultations or referrals for particular types of records.
(4) The Department will make efforts to handle referrals and consultations according to the date that the referring agency initially received the FOIA request.
(5) The standard referral procedure is not appropriate where disclosure of the identity of the agency to which the referral would be made could harm an interest protected by an applicable exemption, such as the exemptions that protect personal privacy or national security interests. In such instances, the Department will coordinate with the originating agency to seek its views on the disclosability of the record(s).
(n)
(2)
(3)
(i) A third-party requester may receive greater access to requested information by submitting information about the subject of the request that is set forth in paragraph (n)(1) of this section, and providing proof that that third party is deceased or the third party's authorization to the Department to release information about him- or herself to the requester. The third-party authorization: should take one of the following forms:
(ii) A signed and notarized authorization by the third party; or
(iii) A declaration by the third party made in compliance with the requirements set forth in 28 U.S.C. 1746 authorizing disclosure pertaining to the third party to the requester. The third-party authorization or declaration should be dated within six months of the date of the request. In addition, the Department's Certification of Identity form, DS-4240, can be used to provide authorization from a third party.
(iv) Please note that if a requester is seeking information about a third party and the information is located in a PA system of records, the requester should review subpart C of this part. By providing verification of identity and authorization under that subpart, the third party is treated as a first party for processing purposes. Without providing the required information listed in that subpart, the request will still be processed under the FOIA procedures in subpart B of this part.
(4)
(5)
(a)
(1) Business information means commercial or financial or proprietary intellectual information obtained by the Department from a submitter that may be exempt from disclosure as privileged or confidential under Exemption 4 of the FOIA.
(2) Submitter means any person or entity from which the Department obtains business information, directly or indirectly. The term includes corporations, partnerships, and sole proprietorships; state, local, and tribal governments; foreign governments, NGOs and educational institutions.
(b)
(c)
(d)
(1) The information has been designated in good faith by the submitter as information considered exempt from disclosure under Exemption 4; or
(2) The Department has reason to believe that the information may be exempt from disclosure under Exemption 4, but has not yet determined whether the information is protected from disclosure under that exemption or any other applicable exemption.
(e)
(1) The Department determines that the information is exempt from disclosure;
(2) The information lawfully has been published or has been officially made available to the public;
(3) Disclosure of the information is required by statute (other than the FOIA) or by a regulation issued in accordance with the requirements of Executive Order 12600; or
(4) The designation made by the submitter under paragraph (b) of this section appears obviously frivolous, except that, in such a case, the Department shall, within a reasonable time prior to a specified disclosure date, give the submitter written notice of any final decision to disclose the information.
(f)
(g)
(1) A statement of the reason(s) why each of the submitter's disclosure objections was not sustained;
(2) A description of the business information to be disclosed; and
(3) A specified disclosure date, which shall be a reasonable time subsequent to the notice.
(h)
(i)
(a) Any denial, in whole or in part, of a request for Department records under the FOIA may be administratively appealed to the Appeals Review Panel of the Department. This appeal right includes the right to appeal the determination that no records responsive to the request exist in Department files. Appeals must be postmarked within 60 calendar days of the date of the Department's denial letter and sent to: Appeals Officer, Appeals Review Panel, Office of Information Programs and Services, at the address set forth in § 171.4, or faxed to (202) 261-8571. The time limit for a response to an appeal is 20 working days, which may be extended in unusual circumstances, as defined in § 171.11(b). The time limit begins to run on the day the appeal is received by IPS. Appeals from denials of requests for expedited processing and for a fee reduction or waiver must be postmarked within 30 calendar days of the date of the Department's denial letter. See §§ 171.11(f)(4) (expedited processing appeals) and 171.16(e) (fee reduction/waiver appeals) of this subpart. See also § 171.4 for address information.
(b) Requesters may decide to litigate a request that is in the appeal stage. Once a summons and complaint is received by the Department in connection with a particular request, the Department will administratively close any open appeal regarding such request.
(c) Requesters should submit an administrative appeal, to IPS at the above address, of any denial, in whole or in part, of a request for access to FSGB records under the FOIA. IPS will assign a tracking number to the appeal and forward it to the FSGB, which is an independent body, for adjudication.
(d)
(a)
(b)
(1) Direct costs are those costs the Department incurs in searching for, duplicating, and, in the case of commercial use requests, reviewing records in response to a FOIA request. The term does not include overhead expenses.
(2) Search costs are those costs the Department incurs in looking for, identifying, and retrieving material, in paper or electronic form, that is potentially responsive to a request. The Department shall attempt to ensure that searching for material is done in the most efficient and least expensive manner so as to minimize costs for both the Department and the requester. The Department may charge for time spent searching even if it does not locate any responsive record, or if it withholds the record(s) located as entirely exempt from disclosure. Further information on current search fees is available by visiting the FOIA home page at
(3) Duplication costs are those costs the Department incurs in reproducing a requested record in a form appropriate for release in response to a FOIA request.
(4) Review costs are those costs the Department incurs in examining a record to determine whether and to what extent the record is responsive to a FOIA request and the extent to which it may be disclosed to the requester, including the page-by-page or line-by-line review of material within records. It does not include the costs of resolving general legal or policy issues that may be raised by a request.
(5)
(i) A commercial use requester is a person or entity who seeks information for a use or purpose that furthers the commercial, trade, or profit interest of the requester or the person on whose behalf the request is made. In determining whether a requester belongs within this category, the Department will look at the way in which the requester intends to use the information requested. Commercial use requesters will be charged for search time, review time, and duplication in connection with processing their requests.
(ii)
A request from a professor of geology at a university for records relating to soil erosion, written on letterhead of the Department of Geology, would be presumed to be from an educational institution.
A request from the same professor of geology seeking drug information from the Food and Drug Administration in furtherance of a murder mystery he is writing would not be presumed to be an institutional request, regardless of whether it was written on institutional stationery.
(B) A non-commercial scientific institution requester is a person or entity that submits a request on behalf of an institution that is not operated on a “commercial” basis and that is operated solely for the purpose of conducting scientific research, the results of which are not intended to promote any particular product or industry. Non-commercial scientific institution requesters will not be charged for search and review time, and the first 100 pages of duplication will be provided free of charge.
(C) A representative of the news media is any person or entity that gathers information of potential interest to a segment of the public, uses its editorial skills to turn the raw materials into a distinct work, and distributes that work to an audience. The term news means information that is about current events or that would be of current interest to the public. News media include television or radio stations broadcasting to the public at large and publishers of periodicals (but only in those instances when they can qualify as disseminators of “news”) who make their products available to the general public. “Freelance” journalists shall be regarded as working for a news media entity if they can demonstrate a solid basis for expecting publication through that entity, such as by a contract or past publication record. These examples are not all-inclusive. A representative of the news media will not be charged for search and review time, and the first 100 pages of duplication will be provided free of charge.
(iii) All other requesters are persons or entities that do not fall into the requester categories defined above. All other requesters will be provided the first two hours of search time and the first 100 pages of duplication free of charge, and will not be charged for review time.
(c)
(d)
(e)
(f)
(g)
(1) Sending records by special methods such as express mail, overnight courier, etc.
(2) Providing records to a requester in a special format.
(3) Providing duplicate copies of records already produced to the same requester in response to the same request.
(h)
(i)
(a)
(b)
(c)
(1) It estimates or determines that allowable charges that a requester may be required to pay are likely to exceed $250. In such a case, the Department shall notify the requester of the likely cost and obtain satisfactory assurance of full payment where the requester has a history of prompt payment of FOIA fees, or shall, in its discretion, require an advance payment of an amount up to the full estimated charges in the case of requesters with no history of payment; or
(2) A requester has previously failed to pay an assessed fee within 30 days of the date of its billing. In such a case, the Department shall require the requester to pay the full amount previously owed plus any applicable interest and to make an advance payment of the full amount of the estimated fee before the Department begins to process a new or pending request from that requester.
(3) If a requester has failed to pay a fee properly charged by another U.S. government agency in a FOIA case, the Department may require proof that such fee has been paid before processing a new or pending request from that requester.
(4) When the Department acts under paragraph (c)(1) or (2) of this section, the administrative time limits prescribed in the FOIA, 5 U.S.C. 552(a)(6) (
(d)
(e)
(f)
(a) Fees otherwise chargeable in connection with a request for disclosure of a record shall be waived or reduced where the requester seeks a waiver or reduction of fees and the Department determines, in its discretion, that disclosure is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government and is not primarily in the commercial interest of the requester.
(1) In deciding whether disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of operations or activities of the government, the Department shall consider all four of the following factors:
(i) The subject of the request must concern identifiable operations or activities of the Federal Government, with a connection that is direct and clear, not remote or attenuated.
(ii) Disclosure of the requested records must be meaningfully informative about government operations or activities in order to be “likely to contribute” to an increased public understanding of those operations or activities. The disclosure of information that already is in the public domain, in either the same or a substantially identical form, would not contribute to such understanding where nothing new would be added to the public's understanding.
(iii) The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester. A requester's expertise in the subject area as well as the requester's ability and intention to effectively convey information to the public shall be considered. It shall be presumed that a representative of the news media will satisfy this consideration.
(iv) The public's understanding of the subject in question must be enhanced by the disclosure to a significant extent.
(2) In order to determine whether disclosure of the information is not primarily in the commercial interest of the requester, the Department will consider the following factors:
(i) The existence and magnitude of a commercial interest,
(ii) The primary interest in disclosure,
(iii) Requests for purposes of writing a book, an article, or other publication will not be considered a commercial purpose.
(b) The Department may refuse to consider waiver or reduction of fees for requesters from whom unpaid fees remain owed to the Department for another FOIA request.
(c) Where only some of the records to be released satisfy the requirements for a waiver or reduction of fees, a waiver or reduction shall be granted for only those records.
(d) Requests for a waiver or reduction of fees should be made when the request is first submitted to the Department and should address the criteria referenced above. A requester may submit a fee waiver request at a later time so long as the underlying record request is pending or on administrative appeal. When a requester who has committed to pay fees subsequently asks for a waiver of those fees and that waiver is denied, the requester shall be required to pay any costs incurred up to the date the fee waiver request was received.
(e) The Division Chief of the Requester Liaison Division in IPS will issue all initial decisions on whether to grant or deny requests for a fee waiver. A decision to refuse to waive or reduce fees may be appealed to the Director of IPS within 30 calendar days of the date of the Department's refusal letter. See § 171.4 for address information. A decision in writing on the appeal shall be issued within 20 working days of the receipt of the appeal.
The Office of Government Information Services (OGIS) in the National Archives and Records Administration is charged with offering mediation services to resolve disputes between persons making FOIA requests and Federal agencies as a non-exclusive alternative to litigation. Additionally, the FOIA directs the Department's FOIA Public Liaison to assist in the resolution of disputes. The Department will inform
The Department shall preserve all correspondence pertaining to the requests that it receives under this subpart, as well as copies of all requested records, until disposition or destruction is authorized pursuant to title 44 of the United States Code or the General Records Schedule 14 of the National Archives and Records Administration. Records shall not be disposed of or destroyed while they are the subject of a pending request, appeal, or lawsuit under the FOIA.
This subpart contains the rules that the Department follows under the Privacy Act of 1974 (PA), 5 U.S.C. 552a, as amended. These rules should be read together with the text of the statute, which provides additional information about records maintained on individuals. The rules in this subpart apply to all records in systems of records maintained by the Department that are retrieved by an individual's name or personal identifier. They describe the procedures by which individuals may request access to records about themselves, request amendment or correction of those records, and request an accounting of disclosures of those records by the Department. If any records retrieved pursuant to an access request under the PA are found to be exempt from access under that Act, they will be processed for possible disclosure under the Freedom of Information Act (FOIA), 5 U.S.C. 552, as amended. No fees shall be charged for access to or amendment of PA records.
As used in this subpart, the following definitions shall apply:
(a) Individual means a citizen or a legal permanent resident alien (LPR) of the United States.
(b) Maintain includes maintain, collect, use, or disseminate.
(c) Record means any item, collection, or grouping of information about an individual that is maintained by the Department and that contains the individual's name or the identifying number, symbol, or other identifying particular assigned to the individual, such as a finger or voice print or photograph.
(d) System of records means a group of any records under the control of the Department from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to an individual.
(a)
(b)
(c)
(d)
(e)
(1)
(2)
(3)
(f)
(g)
(h)
(a) An individual has the right to request that the Department amend a record pertaining to the individual that the individual believes is not accurate, relevant, timely, or complete.
(b) Requests to amend records must be in writing and mailed or delivered to the Office of Information Programs and Services at the address given in § 171.4, with ATTENTION: PRIVACY ACT AMENDMENT REQUEST written on the envelope. IPS will coordinate the review of the request with the appropriate offices of the Department. The Department will require verification of personal identity as provided in section 171.22(c) before it will initiate action to amend a record. Amendment requests should contain, at a minimum, identifying information needed to locate the record in question, a description of the specific correction requested, and an explanation of why the existing record is not accurate, relevant, timely, or complete. The request must be signed, and the requester's signature must be either notarized or made under penalty of perjury pursuant to 28 U.S.C. 1746. The requester should submit as much pertinent documentation, other information, and explanation as possible to support the request for amendment.
(c) All requests for amendments to records shall be acknowledged within 10 working days.
(d) In reviewing a record in response to a request to amend, the Department shall review the record to determine if it is accurate, relevant, timely, and complete.
(e) If the Department agrees with an individual's request to amend a record, it shall:
(1) Advise the individual in writing of its decision;
(2) Amend the record accordingly; and
(3) If an accounting of disclosure has been made, advise all previous recipients of the record of the amendment and its substance.
(f) If the Department denies an individual's request to amend a record, it shall advise the individual in writing of its decision and the reason for the refusal, and the procedures for the individual to request further review. See § 171.25.
(a) How made. Except where accountings of disclosures are not required to be kept, as set forth in paragraph (b) of this section, or where accountings of disclosures do not need to be provided to a requesting individual pursuant to 5 U.S.C. 552a(c)(3), an individual has a right to request an accounting of any disclosure that the Department has made to another person, organization, or agency of any record about an individual. This accounting shall contain the date, nature, and purpose of each disclosure as well as the name and address of the recipient of the disclosure. Any request for accounting should identify each particular record in question and may be made by writing directly to the Office of Information Programs and Services at the address given in § 171.4.
(b) Where accountings not required. The Department is not required to keep an accounting of disclosures in the case of:
(1) Disclosures made to employees within the Department who have a need for the record in the performance of their duties; and
(2) Disclosures required under the FOIA.
(a) If the Department denies a request for amendment of such records, the requester shall be informed of the reason for the denial and of the right to appeal the denial to the Appeals Review Panel. Any such appeal must be postmarked within 60 working days of the date of the Department's denial letter and sent to: Appeals Officer, Appeals Review Panel, Office of Information Programs and Services, at the address set forth in § 171.4.
(b) Appellants should submit an administrative appeal of any denial, in whole or in part, of a request for access to FSGB records under the PA to IPS at the above address. IPS will assign a tracking number to the appeal and forward it to the FSGB, which is an independent body, for adjudication.
(c) The Appeals Review Panel will decide appeals from denials of PA amendment requests within 30 business days, unless the Panel extends that period for good cause shown, from the date when it is received by the Panel.
(d) Appeals Review Panel Decisions will be made in writing, and appellants will receive notification of the decision. A reversal will result in reprocessing of the request in accordance with that decision. An affirmance will include a brief statement of the reason for the affirmance and will inform the appellant that the decision of the Panel represents the final decision of the Department and of the right to seek judicial review of the Panel's decision, when applicable.
(e) If the Panel's decision is that a record shall be amended in accordance with the appellant's request, the Chairman shall direct the office responsible for the record to amend the
(f) If the Panel's decision is that the amendment request is denied, in addition to the notification required by paragraph (d) of this section, the Chairman shall advise the appellant:
(1) Of the right to file a concise Statement of Disagreement stating the reasons for disagreement with the decision of the Department;
(2) Of the procedures for filing the Statement of Disagreement;
(3) That any Statement of Disagreement that is filed will be made available to anyone to whom the record is subsequently disclosed, together with, at the discretion of the Department, a brief statement by the Department summarizing its reasons for refusing to amend the record;
(4) That prior recipients of the disputed record will be provided a copy of any statement of disagreement, to the extent that an accounting of disclosures was maintained.
(g) If the appellant files a Statement of Disagreement under paragraph (f) of this section, the Department will clearly annotate the record so that the fact that the record is disputed is apparent to anyone who may subsequently access the record. When the disputed record is subsequently disclosed, the Department will note the dispute and provide a copy of the Statement of Disagreement. The Department may also include a brief summary of the reasons for not amending the record. Copies of the Department's statement shall be treated as part of the individual's record for granting access; however, it will not be subject to amendment by an individual under this part.
Systems of records maintained by the Department are authorized to be exempt from certain provisions of the PA under both general and specific exemptions set forth in the Act. In utilizing these exemptions, the Department is exempting only those portions of systems that are necessary for the proper functioning of the Department and that are consistent with the PA. Where compliance would not interfere with or adversely affect the law enforcement process, and/or where it may be appropriate to permit individuals to contest the accuracy of the information collected, the applicable exemption may be waived, either partially or totally, by the Department or the OIG, in the sole discretion of the Department or the OIG, as appropriate. Records exempt under 5 U.S.C. 552a(j) or (k) by the originator of the record remain exempt if subsequently incorporated into any Department system of records, provided the reason for the exemption remains valid and necessary.
(a)
(1) Individuals may not have access to records maintained by the Department that are maintained or originated by the Central Intelligence Agency under 5 U.S.C. 552a(j)(1).
(2) In accordance with 5 U.S.C. 552a(j)(2), individuals may not have access to records maintained or originated by an agency or component thereof that performs as its principal function any activity pertaining to the enforcement of criminal laws, including police efforts to prevent, control, or reduce crime or to apprehend criminals, and the activities of prosecutors, courts, correctional, probation, pardon, or parole authorities, and which consists of:
(i) Information compiled for the purpose of identifying individual criminal offenders and alleged offenders and consisting only of identifying data and notations of arrests, the nature and disposition of criminal charges, sentencing, confinement, release, and parole and probation status;
(ii) Information compiled for the purpose of a criminal investigation, including reports of informants and investigators, and associated with an identifiable individual; or
(iii) Reports identifiable to an individual compiled at any stage of the process of enforcement of the criminal laws from arrest or indictment through release from supervision. The reason for invoking these exemptions is to ensure effective criminal law enforcement processes. Records maintained by the Department in the following systems of records are exempt from all of the provisions of the PA except paragraphs (b), (c)(1) and (2), (e)(4)(A) through (F), (e)(6), (e)(7), (e)(9), (e)(10), and (e)(11), and (i), to the extent to which they meet the criteria of section (j)(2) of 5 U.S.C. 552a. The names of the systems correspond to those published in the
Office of Inspector General Investigation Management System. STATE-53.
Information Access Program Records. STATE-35.
Risk Analysis and Management. STATE-78.
Security Records. STATE-36.
(b)
(1)
Board of Appellate Review Records. STATE-02.
Congressional Correspondence. STATE-43.
Congressional Travel Records. STATE-44.
Coordinator for the Combating of Terrorism Records. STATE-06.
External Research Records. STATE-10.
Extradition Records. STATE-11.
Family Advocacy Case Records. STATE-75.
Foreign Assistance Inspection Records. STATE-48.
Human Resources Records. STATE-31.
Information Access Programs Records. STATE-35.
Intelligence and Research Records. STATE-15.
International Organizations Records. STATE-17.
Law of the Sea Records. STATE-19.
Legal Case Management Records. STATE-21.
Munitions Control Records. STATE-42.
Overseas Citizens Services Records. STATE-05.
Passport Records. STATE-26.
Personality Cross Reference Index to the Secretariat Automated Data Index. STATE-28.
Personality Index to the Central Foreign Policy Records. STATE-29.
Personnel Payroll Records. STATE-30.
Office of Inspector General Investigation Management System. STATE-53.
Records of the Office of the Assistant Legal Adviser for International Claims and Investment Disputes. STATE-54.
Risk Analysis and Management Records. STATE-78.
Rover Records. STATE-41.
Records of Domestic Accounts Receivable. STATE-23.
Records of the Office of White House Liaison. STATE-34.
Refugee Records. STATE-59.
Security Records. STATE-36.
Visa Records. STATE-39.
(2)
Board of Appellate Review Records. STATE-02.
Coordinator for the Combating of Terrorism Records. STATE-06.
Extradition Records. STATE-11.
Family Advocacy Case Records. STATE-75
Foreign Assistance Inspection Records. STATE-48.
Garnishment of Wages Records. STATE-61.
Information Access Program Records. STATE-35.
Intelligence and Research Records. STATE-15.
Munitions Control Records. STATE-42.
Overseas Citizens Services Records. STATE-05.
Passport Records. STATE-26.
Personality Cross Reference Index to the Secretariat Automated Data Index. STATE-28.
Personality Index to the Central Foreign Policy Records. STATE-29.
Office of Inspector General Investigation Management System. STATE-53.
Risk Analysis and Management Records. STATE-78.
Security Records. STATE-36.
Visa Records. STATE-39.
(3)
Extradition Records. STATE-11.
Information Access Programs Records. STATE-35.
Intelligence and Research Records. STATE-15.
Overseas Citizens Services Records. STATE-05.
Passport Records. STATE-26.
Personality Cross-Reference Index to the Secretariat Automated Data Index. STATE-28.
Personality Index to the Central Foreign Policy Records. STATE-29.
Security Records. STATE-36.
Visa Records. STATE-39.
(4)
Foreign Service Institute Records. STATE-14.
Human Resources Records. STATE-31.
Information Access Programs Records. STATE-35.
Overseas Citizens Services Records, STATE-05
Personnel Payroll Records. STATE-30.
Security Records. STATE-36.
(5)
Records Maintained by the Office of Civil Rights. STATE-09.
Foreign Assistance Inspection Records. STATE-48.
Foreign Service Grievance Board Records. STATE-13.
Human Resources Records. STATE-31.
Information Access Programs Records. STATE-35.
Legal Adviser Attorney Employment Application Records. STATE-20.
Overseas Citizens Services Records. STATE-25.
Personality Cross-Reference Index to the Secretariat Automated Data Index. STATE-28.
Office of Inspector General Investigation Management System. STATE-53.
Records of the Office of White House Liaison. STATE-34.
Risk Analysis and Management Records. STATE-78.
Rover Records. STATE-41.
Security Records. STATE-36.
Senior Personnel Appointments Records. STATE-47.
(6)
Foreign Service Institute Records. STATE-14.
Human Resources Records. STATE-31.
Information Access Programs Records. STATE-35.
Records Maintained by the Office of Civil Rights. STATE-09
Security Records. STATE-36.
(7)
Overseas Citizens Services Records. STATE-25.
Human Resources Records. STATE-31.
Information Access Programs Records. STATE-35.
Personality Cross-Reference Index to the Secretariat Automated Data Index. STATE-28.
Personality Index to the Central Foreign Policy Records. STATE-29.
This subpart sets forth the process by which persons may request access to public financial disclosure reports filed with the Department in accordance with sections 101 and 103(l) of the Ethics in Government Act of 1978, 5 U.S.C. app. 101 and 103(l), as amended. The retention, public availability, and improper use of these reports are governed by 5 U.S.C. app. 105 and 5 CFR 2634.603.
Requests for access to public financial disclosure reports filed with the Department should be made by submitting a completed Office of Government Ethics request form, OGE Form 201, to
Bureau of Indian Affairs, Interior.
Final rule; guidance on applicability.
The Bureau of Indian Affairs (BIA) published a final rule on November 19, 2015, governing rights-of-way on Indian land, which stated that procedural provisions of the final rule would apply (with certain exceptions) to rights-of-way granted or submitted to BIA prior to the effective date of the final rule. This document provides guidance on what provisions the Department considers to be “procedural provisions” that are applicable to rights-of-way granted or submitted prior to the effective date of the final rule.
This guidance is effective on April 6, 2016.
Ms. Elizabeth Appel, Director, Office of Regulatory Affairs & Collaborative Action, Office of the Assistant Secretary—Indian Affairs, U.S. Department of the Interior (202) 273-4680;
On November 19, 2015, BIA published a final rule addressing rights-of-way on Indian land and BIA land.
In § 169.7(b), the final rule states that its procedural provisions apply to rights-of-way that were granted prior to the final rule's effective date (with certain exceptions). Likewise, in § 169.7(c)(2), the final rule states that if an application for a right-of-way was pending as of the effective date of the final rule, and the applicant chose not to withdraw and resubmit the application on or after the final rule's effective date, the procedural provisions of the final rule apply (with certain exceptions) once BIA issues the right-of-way grant. In either situation, if the procedural provisions of the final rule conflict with the explicit provisions of the right-of-way grant or statute authorizing the right-of-way document, then the provisions of the right-of-way grant or authorizing statute will apply. In short, if a right-of-way was granted prior to the effective date of the rule, or an application for a right-of-way was pending as of the effective date of the rule, only the procedural provisions of the final rule apply to those grants and the other provisions do not apply to those grants. If an existing right-of-way is amended, assigned, or mortgaged, on or after the effective date of the rule, the final rule's procedural provisions apply to that amendment, assignment, or mortgage. An “existing right-of-way” is a grant issued before the effective date of the final rule, or a grant for which the application was pending on the effective date of the final rule is issued after the effective date of the final rule.
This document provides guidance regarding which provisions BIA considers procedural (and thus applicable to all right-of-way grants, regardless of when issued, and applicable to all amendments, assignments, and mortgages of existing right-of-way grants, unless the procedural provision conflicts with the explicit provisions of the right-of-way grant or authorizing statute).
• § 169.12 How does BIA provide notice to the parties to a right-of-way?
• § 169.13 May decisions under this part be appealed?
• [No procedural provisions]
• § 169.107 Must I obtain tribal or individual Indian landowner consent for a right-of-way across Indian land?
• § 169.109 Whose consent do I need for a right-of-way when there is a life estate on the tract?
• § 169.119 Will BIA notify a grantee when a payment is due for a right-of-way?
• § 169.127 Is a new right-of-way grant required for a new use within or overlapping an existing right-of-way?
• § 169.129 What is required if the location described in the original application and grant differs from the construction location?
• § 169.202 Under what circumstances will a grant of right-of-way be renewed?
• § 169.203 May a right-of-way be renewed multiple times?
• § 169.204 May a grantee amend a right-of-way?
• § 169.205 What is the approval process for an amendment of a right-of-way?
• § 169.206 How will BIA decide whether to approve an amendment of a right-of-way?
• § 169.207 May a grantee assign a right-of-way?
• § 169.208 What is the approval process for an assignment of a right-of-way?
• § 169.209 How will BIA decide whether to approve an assignment of a right-of-way?
• § 169.210 May a grantee mortgage a right-of-way?
• § 169.211 What is the approval process for a mortgage of a right-of-way?
• § 169.212 How will BIA decide whether to approve a mortgage of a right-of-way?
• § 169.301 When will a right-of-way document be effective?
• § 169.302 Must a right-of-way be recorded?
• § 169.303 What happens if BIA denies a right-of-way document?
• § 169.304 What happens if BIA does not meet a deadline for issuing a decision on a right-of-way document?
• § 169.305 Will BIA require an appeal bond for an appeal of a decision on a right-of-way document?
• § 169.402 Who may investigate compliance with a right-of-way?
• § 169.404 What will BIA do about a violation of a right-of-way grant?
• § 169.405 What will BIA do if the grantee does not cure a violation of a right-of-way grant on time?
• § 169.406 Will late payment charges, penalties, or special fees apply to delinquent payments due under a right-of-way grant?
• § 169.407 How will payment rights relating to a right-of-way grant be allocated?
• § 169.408 What is the process for cancelling a right-of-way for non-use or abandonment?
• § 169.409 When will a cancellation of a right-of-way grant be effective?
• § 169.410 What will BIA do if a grantee remains in possession after a right-of-way expires or is terminated or cancelled?
• § 169.411 Will BIA appeal bond regulations apply to cancellation decisions involving right-of-way grants?
• § 169.412 When will BIA issue a decision on an appeal from a right-of-way decision?
• § 169.415 How will BIA conduct compliance and enforcement when there is a life estate on the tract?
All other provisions of the final rule are general statements or apply prospectively only. A chart providing more information on each provision and how it applies can be viewed at:
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is issuing regulations to implement Executive Order 13712 of November 22, 2015 (“Blocking Property of Certain Persons Contributing to the Situation in Burundi”). OFAC intends to supplement this part 554 with a more comprehensive set of regulations, which may include additional interpretive and definitional guidance and additional general licenses and statements of licensing policy.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
This document and additional information concerning OFAC are available from OFAC's Web site (
On November 22, 2015, the President issued Executive Order 13712 (80 FR 73633, November 25, 2015) (E.O. 13712), invoking the authority of,
The Regulations are being published in abbreviated form at this time for the purpose of providing immediate guidance to the public. OFAC intends to supplement this part 554 with a more comprehensive set of regulations, which may include additional interpretive and definitional guidance, and additional general licenses and statements of licensing policy. The appendix to the Regulations will be removed when OFAC supplements this part with a more comprehensive set of regulations.
Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
Administrative practice and procedure, Banking, Banks, Blocking of assets, Brokers, Burundi, Credit, Foreign Trade, Investments, Loans, Securities, Services.
For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control adds part 554 to 31 CFR chapter V to read as follows:
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); Pub. L. 110-96, 121 Stat. 1011 (50 U.S.C. 1705 note); E.O. 13712, 80 FR 73633, November 25, 2015.
This part is separate from, and independent of, the other parts of this chapter, with the exception of part 501 of this chapter, the recordkeeping and reporting requirements and license application and other procedures of which apply to this part. Actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. Differing foreign policy and national security circumstances may result in differing interpretations of similar language among the parts of this chapter. No license or authorization contained in or issued pursuant to those other parts authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to any other provision of law or regulation authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to this part relieves the involved parties from complying with any other applicable laws or regulations.
All transactions prohibited pursuant to Executive Order 13712 of November 22, 2015, are also prohibited pursuant to this part.
(a) Any transfer after the effective date that is in violation of any provision of this part or of any regulation, order, directive, ruling, instruction, or license issued pursuant to this part, and that involves any property or interest in property blocked pursuant to § 554.201, is null and void and shall not be the basis for the assertion or recognition of any interest in or right, remedy, power, or privilege with respect to such property or property interest.
(b) No transfer before the effective date shall be the basis for the assertion or recognition of any right, remedy, power, or privilege with respect to, or any interest in, any property or interest in property blocked pursuant to § 554.201, unless the person who holds or maintains such property, prior to that date, had written notice of the transfer or by any written evidence had recognized such transfer.
(c) Unless otherwise provided, a license or other authorization issued by OFAC before, during, or after a transfer shall validate such transfer or make it enforceable to the same extent that it would be valid or enforceable but for the provisions of this part and any regulation, order, directive, ruling, instruction, or license issued pursuant to this part.
(d) Transfers of property that otherwise would be null and void or unenforceable by virtue of the provisions of this section shall not be deemed to be null and void or unenforceable as to any person with whom such property is or was held or maintained (and as to such person only) in cases in which such person is able to establish to the satisfaction of OFAC each of the following:
(1) Such transfer did not represent a willful violation of the provisions of this part by the person with whom such property is or was held or maintained (and as to such person only);
(2) The person with whom such property is or was held or maintained did not have reasonable cause to know or suspect, in view of all the facts and circumstances known or available to such person, that such transfer required a license or authorization issued pursuant to this part and was not so licensed or authorized, or, if a license or authorization did purport to cover the transfer, that such license or authorization had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained; and
(3) The person with whom such property is or was held or maintained filed with OFAC a report setting forth in full the circumstances relating to such transfer promptly upon discovery that:
(i) Such transfer was in violation of the provisions of this part or any regulation, ruling, instruction, license, or other directive or authorization issued pursuant to this part;
(ii) Such transfer was not licensed or authorized by OFAC; or
(iii) If a license did purport to cover the transfer, such license had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained.
(e) Unless licensed pursuant to this part, any attachment, judgment, decree, lien, execution, garnishment, or other judicial process is null and void with respect to any property and interests in property blocked pursuant to § 554.201.
(a) Except as provided in paragraphs (e) or (f) of this section, or as otherwise directed or authorized by OFAC, any U.S. person holding funds, such as currency, bank deposits, or liquidated financial obligations, subject to § 554.201 shall hold or place such funds in a blocked interest-bearing account located in the United States.
(b)(1) For purposes of this section, the term
(i) In a federally-insured U.S. bank, thrift institution, or credit union, provided the funds are earning interest at rates that are commercially reasonable; or
(ii) With a broker or dealer registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a
(2) Funds held or placed in a blocked account pursuant to paragraph (a) of this section may not be invested in instruments the maturity of which exceeds 180 days.
(c) For purposes of this section, a rate is commercially reasonable if it is the rate currently offered to other depositors on deposits or instruments of comparable size and maturity.
(d) For purposes of this section, if interest is credited to a separate blocked account or subaccount, the name of the account party on each account must be the same.
(e) Blocked funds held in instruments the maturity of which exceeds 180 days at the time the funds become subject to § 554.201 may continue to be held until maturity in the original instrument, provided any interest, earnings, or other proceeds derived therefrom are paid into a blocked interest-bearing account in accordance with paragraphs (a) or (f) of this section.
(f) Blocked funds held in accounts or instruments outside the United States at the time the funds become subject to § 554.201 may continue to be held in the same type of accounts or instruments, provided the funds earn interest at rates that are commercially reasonable.
(g) This section does not create an affirmative obligation for the holder of blocked tangible property, such as chattels or real estate, or of other blocked property, such as debt or equity securities, to sell or liquidate such property. However, OFAC may issue licenses permitting or directing such sales or liquidation in appropriate cases.
(h) Funds subject to this section may not be held, invested, or reinvested in a manner that provides immediate financial or economic benefit or access to any person whose property and interests in property are blocked pursuant to § 554.201, nor may their holder cooperate in or facilitate the pledging or other attempted use as collateral of blocked funds or other assets.
(a) Except as otherwise authorized, and notwithstanding the existence of any rights or obligations conferred or imposed by any international agreement or contract entered into or any license or permit granted prior to the effective date, all expenses incident to the maintenance of physical property blocked pursuant to § 554.201 shall be the responsibility of the owners or operators of such property, which expenses shall not be met from blocked funds.
(b) Property blocked pursuant to § 554.201 may, in the discretion of OFAC, be sold or liquidated and the net proceeds placed in a blocked interest-bearing account in the name of the owner of the property.
The definitions in this subpart apply throughout the entire part.
The terms
The term
(a) With respect to a person listed in the Annex to E.O. 13712 of November 22, 2015, 12:01 a.m. eastern standard time on November 23, 2015; and
(b) With respect to a person whose property and interest in property are otherwise blocked pursuant to § 554.201, the earlier of the date of actual or constructive notice that such person's property and interests in property are blocked.
The term
The term
Except as otherwise provided in this part, the term
(a) Except as otherwise provided in this part, the term
(b) The term
(c) The term
The term
The term
The terms
The term
The term
The term
The term
Unless otherwise specifically provided, any amendment, modification, or revocation of any provision in or appendix to this part or chapter or of any order, regulation, ruling, instruction, or license issued by OFAC does not affect any act done or omitted, or any civil or criminal proceeding commenced or pending, prior to such amendment, modification, or revocation. All penalties, forfeitures, and liabilities under any such order, regulation, ruling, instruction, or license continue and may be enforced as if such amendment, modification, or revocation had not been made.
(a) Whenever a transaction licensed or authorized by or pursuant to this part results in the transfer of property (including any property interest) away from a person whose property and interests in property are blocked pursuant to § 554.201, such property shall no longer be deemed to be property blocked pursuant to § 554.201, unless there exists in the property another interest that is blocked pursuant to § 554.201, the transfer of which has not been effected pursuant to license or other authorization.
(b) Unless otherwise specifically provided in a license or other authorization issued pursuant to this part, if property (including any property interest) is transferred or attempted to be transferred to a person whose property and interests in property are blocked pursuant to § 554.201, such property shall be deemed to be property in which such person has an interest and therefore blocked.
Any transaction ordinarily incident to a licensed transaction and necessary to give effect thereto is also authorized, except:
(a) An ordinarily incident transaction, not explicitly authorized within the terms of the license, by or with a person whose property and interests in property are blocked pursuant to § 554.201; or
(b) An ordinarily incident transaction, not explicitly authorized within the terms of the license, involving a debit to a blocked account or a transfer of blocked property.
A setoff against blocked property (including a blocked account), whether by a U.S. bank or other U.S. person, is a prohibited transfer under § 554.201 if effected after the effective date.
Persons whose property and interests in property are blocked pursuant to § 554.201 have an interest in all property and interests in property of an entity in which such blocked persons own, whether individually or in the aggregate, directly or indirectly, a 50 percent or greater interest. The property and interests in property of such an entity, therefore, are blocked, and such an entity is a person whose property and interests in property are blocked pursuant to § 554.201, regardless of whether the name of the entity is incorporated into OFAC's Specially Designated Nationals and Blocked Persons List (SDN List).
For provisions relating to licensing procedures, see part 501, subpart E of this chapter. Licensing actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. General licenses and statements of licensing policy relating to this part also may be available through the Burundi sanctions page on OFAC's Web site:
OFAC reserves the right to exclude any person, property, transaction, or class thereof from the operation of any license or from the privileges conferred by any license. OFAC also reserves the right to restrict the applicability of any license to particular persons, property, transactions, or classes thereof. Such actions are binding upon actual or constructive notice of the exclusions or restrictions.
Any payment of funds or transfer of credit in which a person whose property and interests in property are blocked pursuant to § 554.201 has any interest that comes within the possession or control of a U.S. financial institution must be blocked in an account on the books of that financial institution. A transfer of funds or credit by a U.S. financial institution between blocked accounts in its branches or offices is authorized, provided that no transfer is made from an account within the United States to an account held outside the United States, and further provided that a transfer from a blocked account may be made only to another blocked account held in the same name.
(a) A U.S. financial institution is authorized to debit any blocked account held at that financial institution in payment or reimbursement for normal service charges owed it by the owner of that blocked account.
(b) As used in this section, the term
(a) The provision of the following legal services to or on behalf of persons whose property and interests in property are blocked pursuant to § 554.201 or any further Executive orders relating to the national emergency declared in Executive Order 13712 of November 22, 2015, is authorized, provided that receipt of payment of professional fees and reimbursement of incurred expenses must be specifically licensed, authorized pursuant to § 554.507, which authorizes certain payments for legal services from funds originating outside the United States, or otherwise authorized pursuant to this part:
(1) Provision of legal advice and counseling on the requirements of and compliance with the laws of the United States or any jurisdiction within the United States, provided that such advice and counseling are not provided to facilitate transactions in violation of this part;
(2) Representation of persons named as defendants in or otherwise made parties to legal, arbitration, or administrative proceedings before any U.S. federal, state, or local court or agency;
(3) Initiation and conduct of legal, arbitration, or administrative proceedings before any U.S. federal, state, or local court or agency;
(4) Representation of persons before any U.S. federal, state, or local court or agency with respect to the imposition, administration, or enforcement of U.S. sanctions against such persons; and
(5) Provision of legal services in any other context in which prevailing U.S. law requires access to legal counsel at public expense.
(b) The provision of any other legal services to persons whose property and interests in property are blocked pursuant to § 554.201 or any further Executive orders relating to the national emergency declared in Executive Order 13712 of November 22, 2015, not otherwise authorized in this part, requires the issuance of a specific license.
(c) Entry into a settlement agreement or the enforcement of any lien, judgment, arbitral award, decree, or other order through execution, garnishment, or other judicial process purporting to transfer or otherwise alter or affect property or interests in property blocked pursuant to § 554.201 or any further Executive orders relating to the national emergency declared in Executive Order 13712 of November 22, 2015, is prohibited unless licensed pursuant to this part.
(a) Receipt of payment of professional fees and reimbursement of incurred expenses for the provision of legal services authorized pursuant to § 554.506(a) to or on behalf of any
(1) A source within the United States;
(2) Any source, wherever located, within the possession or control of a U.S. person; or
(3) Any individual or entity, other than the person on whose behalf the legal services authorized pursuant to § 554.506(a) are to be provided, whose property and interests in property are blocked pursuant to any part of this chapter or any Executive order.
(b)
(i) The individual or entity from whom the funds originated and the amount of funds received; and
(ii) If applicable:
(A) The names of any individuals or entities providing related services to the U.S. person receiving payment in connection with authorized legal services, such as private investigators or expert witnesses;
(B) A general description of the services provided; and
(C) The amount of funds paid in connection with such services.
(2) The reports, which must reference this section, are to be mailed to: Licensing Division, Office of Foreign Assets Control, U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW., Annex, Washington, DC 20220.
The provision and receipt of nonscheduled emergency medical services that are otherwise prohibited by this part or any further Executive orders relating to the national emergency declared in Executive Order 13712 of November 22, 2015, are authorized.
Any action that the Secretary of the Treasury is authorized to take pursuant to Executive Order 13712 of November 22, 2015, and any further Executive orders relating to the national emergency declared therein, may be taken by the Director of OFAC or by any other person to whom the Secretary of the Treasury has delegated authority so to act.
For approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) of information collections relating to recordkeeping and reporting requirements, licensing procedures, and other procedures, see § 501.901 of this chapter. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.
By the authority vested in me as President by the Constitution and the laws of the United States of America, including the International Emergency Economic Powers Act (50 U.S.C. 1701
I, BARACK OBAMA, President of the United States of America, find that the situation in Burundi, which has been marked by the killing of and violence against civilians, unrest, the incitement of imminent violence, and significant political repression, and which threatens the peace, security, and stability of Burundi, constitutes an unusual and extraordinary threat to the national security and foreign policy of the United States, and I hereby declare a national emergency to deal with that threat. I hereby order:
(i) the persons listed in the Annex to this order; and
(ii) any person determined by the Secretary of the Treasury, in consultation with the Secretary of State:
(A) to be responsible for or complicit in, or to have engaged in, directly or indirectly, any of the following in or in relation to Burundi:
(1) actions or policies that threaten the peace, security, or stability of Burundi;
(2) actions or policies that undermine democratic processes or institutions in Burundi;
(3) human rights abuses;
(4) the targeting of women, children, or any civilians through the commission of acts of violence (including killing, maiming, torture, or rape or other sexual violence), abduction, forced displacement, or attacks on schools, hospitals, religious sites, or locations where civilians are seeking refuge, or through other conduct that may constitute a serious abuse or violation of human rights or a violation of international humanitarian law;
(5) actions or policies that prohibit, limit, or penalize the exercise of freedom of expression or freedom of peaceful assembly;
(6) the use or recruitment of children by armed groups or armed forces;
(7) the obstruction of the delivery or distribution of, or access to, humanitarian assistance; or
(8) attacks, attempted attacks, or threats against United Nations missions, international security presences, or other peacekeeping operations;
(B) to be a leader or official of:
(1) an entity, including any government entity or armed group, that has, or whose members have, engaged in any of the activities described in subsection (a)(ii)(A) of this section; or
(2) an entity whose property and interests in property are blocked pursuant to this order;
(C) to have materially assisted, sponsored, or provided financial, material, or
(1) any of the activities described in subsection (a)(ii)(A) of this section; or
(2) any person whose property and interests in property are blocked pursuant to this order; or
(D) to be owned or controlled by, or to have acted or purported to act for or on behalf of, directly or indirectly, any person whose property and interests in property are blocked pursuant to this order.
(b) The prohibitions in subsection (a) of this section apply except to the extent provided by statutes, or in regulations, orders, directives, or licenses that may be issued pursuant to this order, and notwithstanding any contract entered into or any license or permit granted prior to the effective date of this order.
(a) the making of any contribution or provision of funds, goods, or services by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to this order; and
(b) the receipt of any contribution or provision of funds, goods, or services from any such person.
(b) Any conspiracy formed to violate any of the prohibitions set forth in this order is prohibited.
(a) the term “person” means an individual or entity;
(b) the term “entity” means a partnership, association, trust, joint venture, corporation, group, subgroup, or other organization; and
(c) the term “United States person” means any United States citizen, permanent resident alien, entity organized under the laws of the United States or any jurisdiction within the United States (including foreign branches), or any person in the United States.
1. Alain Guillaume Bunyoni [Minister of Public Security; born January 2, 1972]
2. Cyrille Ndayirukiye [Former Defense Minister; born July 8, 1954]
3. Godefroid Niyombare [Major General; born October 18, 1969]
4. Godefroid Bizimana [born April 23, 1968]
Coast Guard, DHS.
Temporary final rule; request for comments.
The Coast Guard is establishing a temporary safety zone from Mile Marker (MM) 95.7 to MM 96.7 above Head of Passes (AHP) on the Lower Mississippi River (LMR) on April 12, 2016. This safety zone is necessary to protect persons and vessels from potential safety hazards associated with fireworks displays on or over navigable waterways. Entry into this zone is prohibited unless specifically authorized by the Captain of the Port New Orleans or a designated representative.
This rule is effective from 6:00 p.m. through 11:00 p.m. on April 12, 2016. Comments and related material must be received by the Coast Guard on or before May 6, 2016.
You may submit comments identified by docket number USCG-2016-0189 using the Federal eRulemaking Portal at
If you have questions on this rule, call or email Lieutenant Commander (LCDR) James Gatz, Sector New Orleans, at (504) 365-2281 or
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard received information about this fireworks display on or about January 27, 2016. Due to the risks associated with an aerial barge-based fireworks display taking place on and over the waterway, a safety zone is needed. It would be impracticable to publish a NPRM because the safety zone must be established on April 12, 2016. This rule provides for a comment period and comments received will be reviewed and analyzed to assist the Coast Guard in future rulemakings establishing similar safety zones. The Coast Guard will notify the public and maritime community that the safety zone will be in effect and of its enforcement periods via broadcast notices to mariners (BNM).
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. On April 12, 2016, a fireworks display will be launched from a barge positioned in the waterway adjacent to Mardi Gras World, an event venue located at MM 96.2 AHP on the Lower Mississippi River, in a high commercial traffic area near a tight river bend. Therefore, the Coast Guard has determined that a safety zone is needed to ensure safe navigation for all those in the vicinity of these fireworks displays.
The Coast Guard is establishing a temporary safety zone on the Lower Mississippi River, for one hour during the evening of April 12, 2016, to occur between 6 and 11 p.m. The safety zone will include the entire width of the Lower Mississippi River in New Orleans, LA from MM 95.7 to MM 96.7 AHP. Entry into this zone is prohibited unless permission has been granted by the COTP New Orleans, or a designated representative.
The COTP New Orleans will inform the public through BNMs of the one-hour enforcement period for the safety zone as well as any changes in the planned schedule. Mariners and other members of the public may also contact Coast Guard Sector New Orleans Command Center to inquire about the status of the safety zone, at (504) 365-2200.
We developed this rule after considering numerous statutes and Executive order related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 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. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. This safety zone will only restrict navigation on the Lower Mississippi River from MM 95.7 to MM 96.7 AHP, for approximately one hour on April 12, 2016. Due to the limited scope and short duration of the safety zone, the impacts on routine navigation are expected to be minimal.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. 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 governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit the safety zone area during the periods of enforcement. The safety zone will not have a significant economic impact on a substantial number of small entities because they are limited in scope and will be in effect for a short period of time. Before the enforcement periods, the Coast Guard COTP will issue maritime advisories widely available to waterway users. Deviation from the safety zone established through this rulemaking may be requested from the appropriate COTP and requests will be considered on a case-by-case basis.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishment of a temporary safety zone for all waters of the Lower Mississippi River from MM 95.7 to MM 96.7 AHP. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) Vessels requiring deviation from this rule must request permission from the COTP New Orleans or a COTP New Orleans designated representative. They may be contacted on VHF-FM Channel 16 or 67, or through Vessel Traffic Service Lower Mississippi River at 504-365-2415.
(3) Persons and vessels permitted to deviate from this safety zone regulation and enter the restricted area must transit at the slowest safe speed and comply with all lawful directions issued by the COTP New Orleans or the designated representative.
(d)
Department of Veterans Affairs.
Final rule.
This rule adopts as final a proposed rule of the Department of Veterans Affairs (VA) to amend its regulations concerning the provision of health care to birth children of Vietnam veterans and veterans of covered service in Korea diagnosed with spina bifida, except for spina bifida occulta, and certain other birth defects. In the proposed rule published on May 15, 2015, VA proposed changes to more clearly define the types of health care VA provides, including day health care and health-related services, which we defined as homemaker or home health aide services that provide assistance with Activities of Daily Living or Instrumental Activities of Daily Living that have therapeutic value. We also proposed changes to the list of health care services that require preauthorization by VA. This final rule addresses comments received from the public and adopts as final the proposed rule, without change.
Karyn Barrett, Director, Program Administration Directorate, Chief Business Office Purchased Care (10NB3), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Ave. NW., Washington, DC 20420, (303) 331-7500. (This is not a toll-free number.)
Chapter 18 of title 38, United States Code, provides for benefits for certain birth children of Vietnam veterans and veterans of covered service in Korea who have been diagnosed with spina bifida, except spina bifida occulta, and certain other birth defects. These benefits include: (1) Monthly monetary allowances for various disability levels; (2) health care; and (3) vocational training and rehabilitation. VA's regulations concerning health care for children authorized under this chapter are published at 38 CFR 17.900 through 17.905.
On May 15, 2015, VA published a proposed rule to more clearly define the types of healthcare VA provides, including day healthcare and health-related services, which VA would define as homemaker or home health aide services that provide assistance with Activities of Daily Living or Instrumental Activities of Daily Living that have therapeutic value; and to make changes to the list of health care services that require preauthorization by VA. (80 FR 27878). The comment period closed on June 14, 2015. We received ten comments, which were all generally supportive. However, the commenters raised several issues regarding beneficiaries covered by this rulemaking, specific services provided, definitions included in the proposed rule, and provision of health care through non-VA care (care in the community). We respond to these comments below and adopt as final the proposed rule, without change.
One commenter stated that children of Vietnam veterans who have spina bifida may have children of their own, and VA should also provide care to grandchildren of Vietnam veterans who have spina bifida. The commenter stated that according to the US National Library of Medicine, spina bifida is likely caused by the interaction of multiple genetic and environmental factors, and that genetic changes in individuals with spina bifida may increase the risk of neural tube defects in the subsequent generation. The commenter stated that if a child with spina bifida can establish that the grandfather was exposed to herbicides during the Vietnam War, that child should also be covered.
Another commenter stated that children of Air Force active duty servicemembers and reservists who were exposed to Agent Orange while flying C-123 aircraft both during the Vietnam War and the post-war period should also be covered. The commenter noted that these servicemembers flew out of air bases in Thailand and Clark Air Base in the Philippine Islands, and some of the airplanes potentially contaminated by Agent Orange remained in service after the war.
In response to the first comment, VA does not have statutory authority to provide health care to grandchildren of Vietnam veterans who may have spina bifida. VA's authority to provide health care to children with spina bifida or other covered birth defects is limited by statute. A “child” covered under this statute is defined at 38 U.S.C. 1831(1) as an individual, regardless of age or marital status, who is the natural child of a Vietnam veteran, and was conceived after the date on which that veteran first entered the Republic of Vietnam during the Vietnam era; or, is the natural child of a veteran of covered service in Korea (as determined for purposes of 38 U.S.C. 1821), and was conceived after the date on which that veteran first entered service described in 38 U.S.C. 1821(c).
With respect to the second comment, VA also does not have the authority to extend benefits under 38 U.S.C. Chapter 18 to children of veterans who did not serve in the Republic of Vietnam during the Vietnam era or who did not have certain service in Korea. “Vietnam veteran” is defined at 38 U.S.C. 1831(2) to mean an individual who performed active military, naval, or air service in the Republic of Vietnam during the Vietnam era, without regard to the characterization of that individual's service. The “Vietnam era” is defined at 38 U.S.C. 1831(3) as ending on May 7, 1975. A veteran of covered service in Korea is any individual, without regard to the characterization of that individual's service, who served in the active military, naval, or air service in or near the Korean demilitarized zone (DMZ), as determined by the Secretary in consultation with the Secretary of Defense, during the period beginning on September 1, 1967, and ending on August 31, 1971; and is determined by VA, in consultation with the Department of Defense, to have been exposed to an herbicide agent during such service in or near the Korean demilitarized zone. 38 U.S.C. 1821(c). To the extent a veteran who flew in a C-123 is also a veteran with covered service defined in 38 U.S.C. 1831(2) and has a child covered by 38 U.S.C. 1831(1), however, the child would be eligible for benefits under Chapter 18.
In further response to the comment regarding reservists and servicemembers who flew in C-123 aircraft, we note that VA does have authority in certain other circumstances to extend benefits to veterans who did not serve in those defined areas or time periods, but may have been exposed to Agent Orange. This authority is unrelated to benefits furnished to eligible children under 38 U.S.C. Chapter 18 but we briefly discuss it here because a recent VA rulemaking is relevant to the second public comment. On June 19, 2015, VA published an interim final rule (80 FR 35248) extending the presumption of herbicide exposure and presumption of service connection to individuals who performed service in the Air Force or Air Force Reserve under circumstances in which the individual concerned regularly and repeatedly operated, maintained, or served onboard C-123
We make no changes based on these comments.
One commenter asked whether the proposed addition of day health care to the list of health care services would require the beneficiary to transfer to a group home. In the proposed rule we defined day health care to mean a therapeutic program prescribed by an approved health care provider that provides necessary medical services, rehabilitation, therapeutic activities, socialization, nutrition, and transportation services in a congregate setting. Day health care services contemplated under this proposal are non-residential and equivalent to adult day health care provided to disabled veterans under 38 CFR 17.111(c)(1). These would not require the beneficiary to relocate to a group home. The essential features are the therapeutic focus of the day health care services and provision of these services in a congregate setting. The addition of day health care to the list of covered health care services augments rather than contracts the options available. Day health care is an alternative care setting that can allow some beneficiaries who require long term care services to remain in their homes rather than be institutionalized in a nursing home. Such beneficiaries typically require support for some, but not all, Activities of Daily Living (ADLs), such as bathing, dressing or feeding. In many cases, a family member may provide the beneficiary with much of their care, but require additional support for some ADLs. By filling these gaps, day health care can allow these beneficiaries to remain in their homes and communities for additional months or even years. Day health care programs can help caregivers to meet their other professional and family obligations, or provide a well-deserved respite, while their loved ones are participating in the program.
Two commenters urged VA to allow payment for homemakers and home health aides to shop for groceries outside of the home. Homemaker and home health aide (H/HHA) services are health-related services. VA provides health-related services, including H/HHA services, to veterans under 38 U.S.C. 1720C. We proposed to provide H/HHA services to spina bifida beneficiaries similar to that provided to veterans, to the extent allowed by law. Under 38 U.S.C. 1720C, VA may provide H/HHA to veterans in “noninstitutional settings.” This includes services performed outside the home, such as grocery shopping and escorting the veteran to necessary appointments. VA may not provide such services to beneficiaries under the Spina Bifida Health Care Benefits Program, health-related services for spina bifida beneficiaries are included as a component of home care. Home care is defined at 38 U.S.C. 1803(c)(3) as outpatient care, habilitative and rehabilitative care, preventive health services, and health-related services furnished to an individual in the individual's home or other place of residence. This definition specifically limits the provision of health-related services under 38 U.S.C. 1803 to those services furnished within the home or other place of residence. Grocery shopping, which is an H/HHA type of health-related service performed outside the home or other place of residence, cannot be provided due to this statutory restriction that applies to the Spina Bifida Health Care Benefits Program, but not to VA's authorities to provide care to veterans.
One commenter supported the proposed rule, but urged us to amend the definition of “other place of residence.” As noted above, home care, including health-related services such as H/HHA services, is provided in the individual's home or other place of residence. We proposed to define other place of residence to include an assisted living facility or residential group home. Assisted living facilities and residential group homes are appropriate for individuals who do not require the level of care provided in a nursing home, and VA believes that providing home care in assisted living facilities and residential group homes will allow individuals to retain a greater level of independence and quality of life, and delay or prevent any need for nursing home care. While VA may provide services to an individual residing in an assisted living facility or residential group home, we do not have the statutory authority to pay for placement in such facility. The types of alternatives to home care that VA may provide under 38 U.S.C. 1803 are nursing home care, hospital care, and respite care. The commenter suggested amending the definition of “other place of residence” to state that “placement in such facility or home is covered to the extent that the facility or home provides covered care or services.” The commenter stated that this would clarify that VA can provide for placement in an assisted living facility or residential group home to the extent that such location provides aspects of care or services covered under 38 U.S.C. 1803. We do not agree. Payment for placement in an assisted living facility or residential group home is distinctly different than providing for care and services rendered in such facility. While VA cannot do the former, we may do the latter to the extent allowed by law. VA believes that the suggested language would lead to confusion as it implies that VA can cover, to some extent, placement in an assisted living facility or residential group home.
One commenter asked for clarification of what long-term care means as that term applies to H/HHA services. Specifically, the commenter asked whether a spina bifida beneficiary would be entitled to receive H/HHA services around the clock and indefinitely. One commenter asked whether there would be a limit on the number of hours of H/HHA services that a beneficiary may receive. As noted above, H/HHA services provided to spina bifida beneficiaries are similar to that provided to veterans, to the extent allowed by law. Under 38 U.S.C. 1720C, VA is authorized to provide veterans with health-related services in a non-institutional setting. The total cost of providing such services or in-kind assistance to any veteran in any fiscal year may not exceed 65 percent of the cost that would have been incurred by VA during that fiscal year if the veteran had been furnished, instead, nursing home care under 38 U.S.C. 1710. See 38 U.S.C. 1720C(d). The same limitation is applied currently to H/HHA services provided to spina bifida beneficiaries and will continue to apply under this
The commenter also requested clarification on what type of health care provider must prescribe H/HHA services. These services must be prescribed by an approved health care provider. Under § 17.900, “approved health care provider” means a health care provider currently approved by the Center for Medicare and Medicaid Services (CMS), Department of Defense TRICARE Program, Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA), Joint Commission, or currently approved for providing health care under a license or certificate issued by a governmental entity with jurisdiction.
The commenter also raised several procedural issues that are beyond the scope of this rulemaking.
We make no changes based on these comments.
One commenter stated that health care should be provided directly by VA health care providers rather than through care in the community. However, children with covered birth defects or spina bifida require specialty care that may not be available in a VA medical center, and requiring the beneficiary to commute to a VA medical facility could impose an undue burden on the caregiver. Here, care in the community ensures that the beneficiary receives necessary specialty medical care in a timely manner, and eliminates the need to travel to the nearest VA medical center to obtain that care.
Based on the rationale set forth in the preamble to the proposed rule and in this preamble, VA is adopting the proposed rule as a final rule, with no changes.
Title 38 of the Code of Federal Regulations, as revised by this final rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507) requires that VA consider the impact of paperwork and other information collection burdens imposed on the public. Under 44 U.S.C. 3507(a), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid Office of Management and Budget (OMB) control number. See also 5 CFR 1320.8(b)(2)(vi).
This final rule will impose the following amended information collection requirements. Preauthorization from VA under 38 CFR 17.902(a) is required for certain services or benefits under §§ 17.900 through 17.905. Information collection under this rule is approved under OMB control number 2900-0219. VA is making a minor modification to this information collection by requiring preauthorization for mental health services only for outpatient mental health services, and only when those services are provided in excess of 23 visits in a calendar year. VA also adds day health care provided as outpatient care and homemaker services to the list of services or benefits that must receive preauthorization. VA anticipates that the decrease in the number of beneficiaries that must request preauthorization for mental health services will be offset by the number of beneficiaries that will request preauthorization for day health care. Therefore, we believe that there will be little, if any, change in the total burden hours as a result of this modification. As required by the 44 U.S.C. 3507(d), VA submitted these information collection amendments to OMB for its review, and the information collection is pending OMB approval. Notice of OMB approval for this information collection will be published in a future
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule will directly affect only individuals and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.
Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”
The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.
There are no Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert D. Snyder, Chief of Staff, Department of Veterans Affairs, approved this document on March 31, 2016, for publication.
Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programs-health, Grant programs-veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans.
For the reasons set out in the preamble, the Department of Veterans Affairs amends 38 CFR part 17 as follows:
38 U.S.C. 501, and as noted in specific sections.
The additions and revision read as follows:
The revisions read as follows:
(a) Preauthorization from VA is required for the following services or benefits under §§ 17.900 through 17.905: Rental or purchase of durable medical equipment with a total rental or purchase price in excess of $300, respectively; day health care provided as outpatient care; dental services; homemaker services; outpatient mental health services in excess of 23 visits in a calendar year; substance abuse treatment; training; transplantation services; and travel (other than mileage at the General Services Administration rate for privately owned automobiles). Authorization will only be given in spina bifida cases where it is demonstrated that the care is medically necessary. In cases of other covered birth defects, authorization will only be given where it is demonstrated that the care is medically necessary and related to the covered birth defects. * * *
The addition reads as follows:
(a)(1) * * * For those services or benefits covered by §§ 17.900 through 17.905 but not covered by CHAMPVA we will use payment methodologies the same or similar to those used for equivalent services or benefits provided to veterans.
Environmental Protection Agency (EPA).
Final rule.
This regulation amends tolerances for residues of hexythiazox in or on citrus and cotton. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective April 6, 2016. Objections and requests for hearings must be received on or before June 6, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The dockets for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0338 and EPA-HQ-OPP-2015-0339, are available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0338 and EPA-HQ-OPP-2015-0339 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before June 6, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0338 and EPA-HQ-OPP-2015-0339, by one of the following methods:
•
•
•
In the
Based upon review of the data supporting the petition, EPA has revoked citrus, dried pulp tolerance as it is covered by the recommended fruit, citrus, group 10-10 tolerance. For citrus oil, EPA revised the tolerance to 25 ppm and for cotton undelinted seed to 0.4
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for hexythiazox including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with hexythiazox follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Hexythiazox has low acute toxicity by oral, dermal and inhalation routes of exposure. It is not a dermal irritant, is negative for dermal sensitization and produces only mild eye irritation. Hexythiazox is associated with toxicity of the liver and adrenals following subchronic and chronic exposure to dogs, rats and mice, with the dog being the most sensitive species. The prenatal developmental studies in rabbits and rats and the two-generation reproduction study in rats showed no indication of increased susceptibility to
Specific information on the studies received and the nature of the adverse effects caused by hexythiazox as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
1.
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ii.
iii.
iv.
2.
Based on the Surface Water Concentration Calculator, the estimated drinking water concentrations (EDWCs) of hexythiazox for chronic exposures for non-cancer assessments are estimated to be 4.3 parts per billion (ppb) for surface water. Since groundwater residues are not expected to exceed surface water residues, surface water residues were used in the dietary risk assessment. Modeled estimates of drinking water
3.
Hexythiazox is currently registered for the following uses that could result in residential exposures: Ornamental plantings, lawns, recreational sites such as campgrounds and golf courses, turf, and fruit and nut trees in residential settings. EPA assessed residential exposure using the following assumptions:
Residential handler exposures are expected to be short-term (1 to 30 days) via either the dermal or inhalation routes of exposures. Intermediate-term exposures are not likely because of the intermittent nature of applications by residential applicators. Since hexythiazox does not pose a significant dermal risk, a quantitative dermal risk assessment was not performed and handler margins of exposure (MOE) were calculated for the inhalation route of exposure only.
Both adults and children may be exposed to hexythiazox residues from contact with treated lawns or treated residential plants. Post-application exposures are expected to be short-term (1 to 30 days) in duration for most exposure scenarios, and intermediate-term (1 to 6 months) in duration for soil ingestion only due to the aerobic soil metabolism half-life for hexythiazox. Adult post-application exposures were not assessed since no quantitative dermal risk assessment is needed for hexythiazox and inhalation exposures are typically negligible in outdoor settings. The exposure assessment for children included incidental oral exposure resulting from transfer of residues from the hands or objects to the mouth, and from incidental ingestion of soil.
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
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i. The toxicity database for hexythiazox is complete.
ii. There is no indication that hexythiazox is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that hexythiazox results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to hexythiazox in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by hexythiazox.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate- and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
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Hexythiazox is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to hexythiazox.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1,300 for children and 9,900 for adults. Because EPA's level of concern for hexythiazox is a MOE of 100 or below, these MOEs are not of concern.
4.
Hexythiazox is currently registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to hexythiazox.
Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 1,500 for children and 9,900 for adults. Because EPA's level of concern for hexythiazox is a MOE of 100 or below, these MOEs are not of concern.
5.
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Adequate enforcement methodology (high performance liquid chromatography method with ultraviolet detection (HPLC/UV)) is available to enforce the tolerance expression. This method is listed in the U.S. EPA Index of Residue Analytical methods under hexythiazox as method AMR-985-87.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has established MRLs for residues of hexythiazox on citrus, fruits but not for cotton. The Codex plant residue definition is for hexythiazox as opposed to the U.S. definition which includes hexythiazox plus metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety. The differences in U.S. and Codex residue definitions prohibits harmonization.
Although the petitioner requested an amended tolerance for citrus, dried pulp at 0.6, the Agency has determined that no such tolerance is necessary because that commodity is covered by the established citrus group 10-10 tolerance. The Agency is revising the tolerance for citrus oil to 25 ppm based on the following: By multiplying the citrus oil processing factor (104X) from the 2006 processing study (D334889, 07/03/2006, T. Bloem) by the highest average field trial (HAFT) residue for lemons (0.243 ppm) from the submitted citrus study since lemons are the citrus crop that produced the highest residues.
As noted in its most recent crop group rulemaking in the
The Agency is amending the tolerance for cotton, undelinted seed at 0.4 ppm based on the available cotton data that reflect a national use at the label specified 35 day pre-harvest internal (PHI) to calculate the 0.4 ppm tolerance.
Therefore, tolerances are amended for residues of hexythiazox and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety, in or on citrus, oil at 25 ppm; fruit, citrus, group 10-10 at 0.6 ppm; cotton, gin byproducts at 15 ppm; cotton, undelinted seed at 0.4 ppm. The current citrus, dried pulp tolerance is revoked because it is unnecessary due to the establishment of the fruit, citrus, group 10-10 tolerance.
This action amends tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The additions and revisions read as follows:
(a)
(c)
Federal Communications Commission.
Final rule.
This document responds to seven petitions for reconsideration of certain rules adopted in the
Effective May 6, 2016.
Aole Wilkins, Office of Engineering and Technology, (202) 418-2406, email:
This is a summary of the Commission's
1. Prior to adoption of the
2. In response to the
3.
4.
5.
6.
7. The Commission believes that the Joint Emissions Proposal best addresses the need for amended rules in the U-NII-3 band. It recognizes that, without further accommodation, point-to-point systems that utilize high gain transmit antennas with full permissible output power may not readily be able to comply with the OOBE limit adopted in the
8. As demonstrated in Ubiquiti's
9. Dedicated Short Range Communications (DSRC) Systems are designed to operate under the FCC provisions for the Intelligent Transportation Systems (ITS) radio service in the 5.85-5.925 GHz band. Prior to the adoption of the
10. In its petition for reconsideration, the Association of Global Automakers, Inc. (Global) requests that the Commission suspend or reverse key decisions made in the
11. The Commission rejects Global's Request and declines to reverse or suspend its decision to consolidate the rules for unlicensed devices operating in the 5.725-5.85 GHz band under one rule section. The Commission finds that DSRC systems will receive greater interference protection under the emission mask adopted in this MO&O than was provided under the old rules. In the
12. Prior to adoption of the
13. EchoStar (ETC) argues that the
14. ETC stated in its petition that while these devices are not usually attached to anything physically, the box can only operate while sitting still and, generally cannot be moved throughout the home without risking a degradation or loss of video service. As such, the box is functionally identical to an indoor access point, and therefore, the interference considerations are the same for both. Thus, ETC claims there is no reason not to permit both types of devices to transmit at a maximum power level of 1 Watt when operating in the U-NII-1 band. Several parties supported ETC's request for a clarification of the rules.
15. The Commission clarifies that in the
16. In response to ETC's recommendation to adopt rules that allow U-NII-1 band indoor set-top boxes or any other type of client devices to operate at 1 Watt, the same power levels as U-NII-1 band access points, the Commission declines to do so. As a point of clarification, the Commission has allowed set-top boxes that serve as access points to operate up to 1 Watt based on the rationale that access points generally remain in one location. However, it has treated client devices as subject to the 250 mW limit because it is generally more difficult to control the location and use of these devices (
17. It is unclear from Echostar's petition that its set top box qualifies as an access point and therefore would be permitted to operate at 1 W. This will depend on the specific characteristics of the device as presented through the equipment authorization process. Echostar and any other entity can, therefore, seek approval, at the time it files for equipment authorization, for a set-top box or other such device to operate up to 1 Watt by making a showing that it serves as an access point. However, the Commission is not convinced of the need to increase the in-band power levels for set-top boxes, and if consumers desire to increase the range between the access point and the set-top boxes, repeaters are widely available at commercially reasonable prices for this purpose. The Commission concludes that 250 mW is adequate for most client device installations. For the aforementioned reasons, the Commission will continue to limit client devices in the U-NII-1 band to operating at conducted power levels up to 250 mW with a maximum PSD level of 11dBm/MHz using a transmit antenna with a maximum gain of 6 dBi. It continues to impose this limit on client devices, and without distinction as to whether devices are located indoors or outdoors.
18. Section 15.205 identifies a number of restricted bands in which low power, non-licensed transmitters are not allowed to place any portion of their fundamental emission because of potential interference to sensitive radio communications such as commercial aviation communications and navigation, radio astronomy, search and rescue operations, and other critical government radio services. Additionally, unwanted emissions from non-licensed transmitters that fall into restricted bands must comply with the general radiated emission limits in Section 15.209. The 5.091-5.15 GHz band falls within the larger 4.5-5.15 GHz restricted band, as specified in Section 15.205(a).
19. The 5.091-5.15 GHz band is allocated to the Aeronautical Mobile Service (AMS) on a primary basis for Federal and non-Federal use, including aeronautical fixed communications; Aeronautical Mobile Telemetry (AMT), restricted to 52 designated flight test areas and additional locations authorized for flight testing on a case-by-case basis; and the Fixed Satellite Service (FSS) limited to feeder links for non-geostationary orbit (NGSO) satellite systems in the Mobile Satellite Service (MSS).
20. The Wireless Internet Service Provider Association (WISPA) et al. supports relaxing the Section 15.205 provisions between 5.091 GHz and 5.15 GHz by 1dB for every dB that the antenna gain exceeds 6 dBi, provided that the antenna is oriented at 30 degrees or less above the horizon. Fastback proposes to change the restricted band at 4.5-5.15 GHz to end at 5.091 GHz, thus allowing higher out of band emissions (up to -17 dBm/MHz) from U-NII-1 devices into the 5.091-5.15 GHz portion. It states that adopting its proposed recommendations would enable an increase in EIRP for U-NII-1 point-to-point links, corresponding to an increased communication range of two hundred and fifty percent.
21. The Commission declines to increase the allowable emissions from U-NII band devices into the restricted band below 5.15 GHz. The restricted bands were created to protect radio communications services that are sensitive to interference and that provide critical benefits to public safety and national security. WISPA and Fastback have not offered any analysis showing that increasing the emissions limit in this restricted band would not create an unacceptable risk of interference in the restricted band. Moreover, to the extent that WISPA and Fastback make their proposals in order to increase the utilization of the U-NII-1 band, the Commission observes that it other rule revisions adopted in this order accomplish this purpose, by removing the restriction to indoor operation and increasing the permitted power level for U-NII-1 devices. The emission limits into the adjacent restricted band from U-NII-1 devices may not provide all of the benefits that some equipment suppliers desire, and some equipment manufacturers may find that they need to reduce power below the level permitted under the rules in order to achieve compliance with the OOBE limit below 5.15 GHz. However, the removal of the indoor restriction and the increase in power permitted in the 5.15-5.25 GHz band provide greater opportunities than were available before. Other parts of the 5 GHz band can accommodate higher powered operation where it may not be possible to achieve the desired power level and compliance with the OOBE limit at 5.15—5.25 GHz.
22. The Commission adopted rules requiring that, 12 months after the effective date of the
23. Motorola Solutions, Inc. (MSI) asks that the Commission reconsider its requirement that the manufacture, marketing, sale and importation into the United States of digitally modulated and hybrid devices certified under Section 15.247 cease operating in the 5.725- 5.850 GHz U-NII-3 band two years after the effective date of the
24. Cisco raises no objection to a short extension of the transition deadlines if manufacturers can make a compelling case that it is not possible to redesign and re-certify equipment with a reasonable effort, but given the central role U-NII-3 equipment has played in causing interference to TDWR, any extension that delays the introduction of enhanced security features should be as brief as possible. MSI clarifies that its petition was not intended to extend the deadline for introduction of enhanced security features to previously certified devices, but to limit the period of time
25. The Commission modifies the dates by which the certification, manufacture, marketing, sale and importation into the United States of U-NII-3 band devices that do not meet the modified emission limits adopted in this Memorandum Opinion and Order must cease. The Commission modifies Section 15.407(b)(4) to permit manufacturers of devices certified before March 2, 2017 with antenna gain greater than 10 dBi to demonstrate compliance with the emission limits in Section 15.247(d), but manufacturing, marketing, sale and importing of devices certified under this alternative must cease by March 2, 2018. The Commission further modify Section 15.407(b)(4) to permit manufacturers of devices certified before March 2, 2018 with an antenna gain of 10 dBi or less to demonstrate compliance with the emission limits in Section 15.247(d), but manufacturing, marketing, sale and importing of devices certified under this alternative must cease before March 2, 2020. The Commission has already issued two orders that have provided a 10-month extension that permitted manufacturers to continue to certify devices under the old rules until March 2, 2016. Here, the Commission does not further extend the transition provisions in Section 15.37(h) allowing certification and marketing under the old rules, but rather implement a phased implementation of only the out-of-band limits in Section 15.407.
26. The Commission understands Cisco's concerns and agrees that manufacturers should be granted an extension of time only if they cannot comply with the modified rules with reasonable effort and that the time extension should not be indefinite. The Commission recognizes that during the years leading up to the rule change, the industry had made a significant investment in the research, design, and development of new product lines. The Commission also recognizes that manufacturers have made a significant effort to design compliant equipment but are not able to reasonably suppress their OOBEs without significantly reducing the in-band power and thereby reducing the range of their devices. The majority of products that are effected, operate with relatively low power and employ antenna gains of less than 10dBi. The Commission understands that the typical design cycle for enterprise and home routers can last two to three years and that there is no simple solution for manufacturers to swiftly redesign compliant products before the transition period deadlines. Therefore, the Commission will provide a slightly longer transition period for devices that operate a 10 dBi or lower antenna. The Commission notes that these devices tend to present a lower risk of harmful interference because they are typically lower powered and are installed indoor. The Commission recognizes that in theory, harmful interference could occur from an enterprise or home access point, however it has not observed this in practice. In practice, harmful interference to the TDWR was typically caused by long-range devices that were unlawfully modified and typically operated with antenna gains of 15 dBi and above. The devices that employ higher gain antennas are typically operated by service providers for the purposes of wireless back haul and are installed in outdoor environments. The Commission therefore concludes that in the case of devices that employ an antenna with a gain of 10 dBi or less, appropriate deadlines are March 2, 2018 for certification, and March 2, 2020 as the cut-off for devices that can be imported or marketed within the United States under the old emission limits.
27. The Commission believes these extensions will give manufacturers and vendors sufficient time to come into compliance with the new emission limits. The Commission does not believe a short extension of the deadlines will represent a significant risk of harmful interference for the TDWR. The new certification and marketing deadlines apply to devices that operate in the U-NII-3 band.
28. The Commission notes that the ultimate purpose of the transition date is to expediently reduce the threat of harmful interference to the TDWR and other radar facilities from devices on the market that were easily and unlawfully modified. However, the Commission recognizes that manufacturers will need additional time to design new product lines that comply with the new rules. Extending the emission limit deadlines will permit manufacturers to plan their research and design activities to comply with the outcome of our actions here. Permitting this extended period will provide economic relief by allowing manufacturers to continue to sell through remaining inventory. The Commission has already provided more time than originally intended to bring these devices into compliance and no further extensions are contemplated.
29.
30. Pursuant to the RFA, the Commission incorporated an Initial Regulatory Flexibility Analysis (IRFA) into the
31. In the
32. The Commission will send a copy of the MO&O, including a copy of this final Regulatory Flexibility Certification,
33.
34.
35. Pursuant to Sections 4(i), 301, 302, 303(e), 303(f), 303(g), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 301, 302a, 303(e), 303(f), 303(g), and 303(r), this
36. Pursuant to Sections 4(i), 302, 303(e) 303(f), 303(g), 303(r), and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 302, 303(e), 303(f), 303(g), 303(r), and 405, the petitions for reconsideration addressed ARE GRANTED, to the extent indicated above, and otherwise ARE DENIED.
37. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, SHALL SEND a copy of this
Communications equipment.
For the reasons discussed in the preamble the Federal Communications Commission amends 47 CFR part 15 as follows:
47 U.S.C. 154, 302a, 303, 304, 307, 336, 544a, and 549.
(a) * * *
(1) * * *
(iv) For client devices in the 5.15-5.25 GHz band, the maximum conducted output power over the frequency band of operation shall not exceed 250 mW provided the maximum antenna gain does not exceed 6 dBi. In addition, the maximum power spectral density shall not exceed 11 dBm in any 1 megahertz band. If transmitting antennas of directional gain greater than 6 dBi are used, both the maximum conducted output power and the maximum power spectral density shall be reduced by the amount in dB that the directional gain of the antenna exceeds 6 dBi.
(b) * * *
(4) For transmitters operating in the 5.725-5.85 GHz band:
(i) All emissions shall be limited to a level of −27 dBm/MHz at 75 MHz or more above or below the band edge increasing linearly to 10 dBm/MHz at 25 MHz above or below the band edge, and from 25 MHz above or below the band edge increasing linearly to a level of 15.6 dBm/MHz at 5 MHz above or below the band edge, and from 5 MHz above or below the band edge increasing linearly to a level of 27 dBm/MHz at the band edge.
(ii) Devices certified before March 2, 2017 with antenna gain greater than 10 dBi may demonstrate compliance with the emission limits in § 15.247(d), but manufacturing, marketing and importing of devices certified under this alternative must cease by March 2, 2018. Devices certified before March 2, 2018 with antenna gain of 10 dBi or less may demonstrate compliance with the emission limits in § 15.247(d), but manufacturing, marketing and importing of devices certified under this
National Highway Traffic Safety Administration (NHTSA), DOT.
Denial of petitions for reconsideration.
This document denies petitions for reconsideration submitted by bus manufacturers IC Bus, LLC (IC Bus), Daimler Trucks North America (Daimler Trucks) and Prevost, concerning a November 25, 2013 final rule requiring seat belts on large buses. IC Bus and Daimler Trucks petitioned to modify the definition of “over-the-road bus” specified in the final rule. NHTSA is denying these petitions because any change to the definition may serve to reduce the standard's applicability, contrary to Congressional and NHTSA intent, and the definition of “over-the-road bus” is sufficiently clear. Prevost petitioned to revise the seat belt anchorage strength requirements for last row seats having no passenger seating behind them. NHTSA is denying this petition primarily because the requested force level reduction may set strength levels below an acceptable level for a dynamic environment.
April 6, 2016.
This document denies petitions for reconsideration of a November 25, 2013 final rule requiring seat belts on large buses (78 FR 70416). We first deny the petitions submitted by bus manufacturers IC Bus and Daimler Trucks to modify the definition of “over-the-road bus” specified in the final rule. These petitions are denied because any change to the definition may serve to reduce the standard's applicability, contrary to Congressional intent and the safety need addressed by the rule, and the current definition of “over-the-road bus” is sufficiently clear as to which buses must be equipped with seat belts. Second, this document denies a petition for reconsideration from bus manufacturer Prevost to revise the seat belt anchorage strength requirements for last row seats having no passenger seating behind them. This petition is denied because, as explained in the 2013 final rule, the agency is concerned about the interchangeability of these seats with those equipped with integrated seat belts and the risk that a seat that is certified to a lesser requirement could be moved to a row that has passenger seats behind it. Further, we deny the petition because the requested force level reduction may set strength levels below an acceptable level for a dynamic environment.
On July 6, 2012, President Obama signed the “Moving Ahead for Progress in the 21st Century Act” (MAP-21), which incorporates the “Motorcoach Enhanced Safety Act of 2012” in subtitle G. Section 32703(a) of this legislation calls for prescribing regulations for seat belts at all designated seating positions in “motorcoaches.” Section 32702(6) states that “[t]he term `motorcoach' has the meaning given the term `over-the-road bus' in section 3038(a)(3) of the Transportation Equity Act for the 21st Century (49 U.S.C. 5310 note)” with two specific exceptions.
On November 25, 2013, NHTSA issued a final rule on occupant protection in large buses, fulfilling the statutory mandate in section 32703(a) of MAP-21. The 2013 final rule amended Federal Motor Vehicle Safety Standard (FMVSS) No. 208, “Occupant crash protection,” to require lap/shoulder seat belts for each passenger seating position in all new over-the road buses regardless of gross vehicle weight rating (GVWR). In the final rule, consistent with MAP-21, NHTSA incorporated the term “over-the-road bus” into FMVSS No. 208 and the definition for the term set forth in MAP-21. Further, finding a safety need to improve occupant protection for passengers on other large buses, the agency also required seat belts in new buses, other than over-the road buses, with a GVWR greater than 11,793 kilograms (kg) (26,000 pounds (lb)).
In response to the November 25, 2013 final rule, the agency received petitions for reconsideration requesting the agency further define the term “over-the road bus” with dimensional specificity and/or with other bus attributes. IC Bus stated that the current definition of over-the-road bus is ambiguous and the terms “elevated passenger deck” and “baggage compartment” are undefined and subject to interpretation. IC Bus petitioned the agency to—
• modify the definition such that “over the road bus means a bus characterized by an elevated passenger deck to accommodate a baggage compartment underneath, except a school bus,” and
• define the term “elevated passenger deck” based on physical attributes of the bus such as passenger compartment floor height as measured from the ground (scaled for different GVWR) or define a passenger compartment floor height requirement with respect to some specific vehicle reference point.
Daimler Trucks also petitioned the agency to modify the definition of over-the road bus to include objective dimensional criteria for the elevated passenger deck, such as floor height from the ground (variable for different GVWR), and also to define baggage compartment in terms of volume per seating position.
The petitioners did not provide information supporting the requested action. They made broad suggestions as to how the definition of over-the-road bus might be quantified, but specific criteria and supporting data were lacking in the submissions. The petitioners did not provide data on the floor height or luggage compartment volume for any bus body type. They did not discuss what floor height or luggage compartment volume should be used to distinguish an over-the-road bus from
NHTSA has limited discretion regarding the “motorcoach” definition and the application of the November 2013 final rule. Section 32702(6) of MAP-21 precisely defines the meaning of the term “motorcoach,” incorporating the “over-the-road bus” definition used in 49 U.S.C. 5310 note (which the petitioners seek to change). Further, section 32703(a) requires the Secretary to “prescribe regulations requiring safety belts to be installed in motorcoaches at each designated seating position.” We note that buses are built for different purposes to different specifications, with varying floor height, floor length, compartment sizes, etc. Adding dimensional limits to the bus attributes as the petitioners suggest would reduce the number of vehicles fitting under the definition, which in turn would reduce the number of buses that would be required to have seat belts. The agency is concerned that such a reduction in the number of buses subject to the seat belt requirement would be contrary to Congress's intent to enhance the safety of buses used for passenger transport for compensation.
Additionally, NHTSA does not believe that the requested action is needed to clarify the application of the seat belt requirement. The applicability of the requirement is quite clear. As previously discussed, all buses with a GVWR greater than 11,793 kg (26,000 lb) must have seat belts.
We believe that a bus manufacturer can determine whether the vehicle they manufacture must have seat belts, based on the vehicle's GVWR and whether the bus has a luggage compartment under any part of the passenger deck. A bus that does not fit the definition is one without a luggage-carrying compartment under any part of the passenger deck.
Based on the above, the agency declines the petitioners' request to modify the definition of over-the-road bus.
As part of the motorcoach seat belt requirements, the agency specified that the seat belt assembly anchorages must meet the requirements of FMVSS No. 210, “Seat belt assembly anchorages,” to ensure effective occupant restraint and to reduce the likelihood of their failure. Further, the rule required that the seat belt anchorages must be integrated to the seat structure, except for the belt anchorages in the last row of the coach (if there is no wheelchair position or side emergency door behind these seats) and in the driver seating position. For the excluded seats in the last row, the final rule provided manufacturers the option of either having an integrated seat belt or attaching the seat belt anchorages to the bus side or back structure, as such placement would not impede ingress or egress of passengers in the coach.
In response to the final rule, Prevost petitioned asking for reduced “seat retention” requirements for last row seats where there is no possibility of any passengers being behind them. Prevost is concerned that “the very last seats are secured over a thin metal bulkhead which did not require being very rigid when there were no seat belts”
The agency has carefully considered the petitioner's request to reduce the seat belt anchorage forces for the subject seats. We are denying the request for the reasons explained below.
We first note that Prevost's petition is essentially a repeat of the comments it made to the notice of proposed rulemaking (NPRM)
We are unable to agree to Prevost's suggestion that the strength requirements be adjusted (reduced) for seats where there are no other seats behind it (and therefore no unbelted passengers seated behind it). We are aware that some operators of covered buses have changed the passenger seating configuration from that set by the factory or have removed and reinstalled seats. If “weaker” seats are moved after the factory installation to a position that had a passenger seat behind it, the weaker seat would not provide the performance required by FMVSS No. 210. Furthermore, this final rule provides some of the flexibility Prevost seeks. Under this final rule, seats with no other seats behind them are not required to have the lap/shoulder belt anchorages attached to the seat structure. For these seats, the lap/shoulder belt anchorages can be attached directly to the vehicle structure. (78 FR at 70455)
Consistent with our final rule response, we remain concerned about the interchangeability of the seats with integrated seat belts, particularly in consideration of the long life of these vehicles (20+ years) and subsequent sales to operators that may need to reconfigure seating. If the operator moved the reduced-strength seat to a position that had a passenger seat behind it, the moved seat will not have the characteristics needed to withstand the loading from the aft passengers. If the reduced-strength seat were in a position that had a storage space behind it, loose items may create forward loading in a crash, similarly to rear occupant loading. The petitioner did not address this point. Similarly, no information or analysis was provided to suggest a value by which the seat belt anchorage strength requirement should be reduced.
The agency is not convinced of the merits of lowering the strength requirement per se. NHTSA conducted a full scale 48 kilometers per hour (km/h) (30 miles per hour) crash test of a 2000 Model Year MCI 102EL3 Renaissance motorcoach (capacity of 54 passengers seats). Post-test examination of the bus
In addition, data indicate that the last row of seats may be subject to loading unique to the rear of the bus. The vehicle accelerometer data from the full scale crash test were suggestive of forward flexing and dynamic rebound near the rear wall of the passenger compartment, compared to the front of the passenger compartment.
In its petition, Prevost states that reducing the strength requirement of FMVSS No. 210 for last row seats would result in a weight reduction and fuel savings. The agency is not convinced that there would be a significant weight reduction or fuel savings. Prevost did not provide information substantiating its claims, such as data on the thickness changes to the metal bulkhead (for example) required to secure seat belts designed to comply with the FMVSS No. 210 requirements compared to current designs.
Further, the final rule permits—rather than requires—manufacturers to attach the seat belts to the vehicle structure for last-row seats. In the final rule, NHTSA stated that “[l]ap/shoulder belt equipped seats that meet the requirements of FMVSS No. 210 are available in the U.S. that are equivalent in weight to the European seats.” (78 FR at 70460.) We concluded that, depending on the efficiency of the structural design, there would be little or no weight penalty associated with the structural changes needed to meet FMVSS No. 210. Thus, the petitioner could use the integrated seat belt design for the last row seats if attaching the belt to the bus rear wall is problematic. Regardless, we emphasize that the petitioners have not shown that there will be a weight penalty for seat belt anchorages integrated into the vehicle structure. The increased flexibility of attachment to the vehicle rather than the seat has expanded the opportunity for efficient, innovative and practicable designs for manufacturers choosing to attach the belts to the vehicle structure.
For the reasons stated above, NHTSA hereby denies all petitions for reconsideration of the November 25, 2013 final rule amending FMVSS No. 208.
49 U.S.C. 322, 30111, 30115, 30117 and 30166; delegation of authority at 49 CFR 1.95.
Surface Transportation Board.
Final rule.
The Surface Transportation Board (STB or Board) is adopting final rules that update the accounting and reporting requirements in its Uniform System of Accounts (USOA) for Class I Railroads so that they are more consistent with current generally accepted accounting principles (GAAP). The Board is also revising the schedules and instructions for the Annual Report for Class I Railroads (R-1 or Form R-1) to better meet regulatory requirements and industry needs.
This rule is effective on May 6, 2016.
Pedro Ramirez at (202) 245-0333. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.
The Interstate Commerce Act, as amended by the ICC Termination Act of 1995 (ICCTA), Public Law 104-88, 109 Stat. 803, authorizes the Board, in 49 U.S.C. 11142, to prescribe a uniform accounting system for rail carriers subject to our jurisdiction and, in 49 U.S.C. 11161, to maintain cost accounting rules for rail carriers.
In a notice of proposed rulemaking served on July 8, 2015 (NPR), the Board proposed to make a number of changes to the USOA. First, the Board noted that the existing USOA does not specifically address the proper accounting and reporting for changes in the fair value of certain security investments, derivative instruments, and hedging activities, nor does it contain specific accounts to record amounts related to items of Other Comprehensive Income or provide a format to display comprehensive income in the Form R-1. Without specific instructions and accounts for recording and reporting these transactions and events, inconsistent and incomplete accounting would result. Thus, the Board proposed to amend its USOA and Form R-1 to account for those types of transactions and events. Specifically, the Board proposed updating the USOA to provide for: (1) Fair value presentation of certain security investments, derivative instruments, and hedging activities; and (2) presentation of comprehensive income and components of other comprehensive income.
The Board proposed these revisions based on the GAAP promulgated by the Financial Accounting Standards Board (FASB)
Second, the Board proposed revising the USOA to reflect current accounting practices for business combinations by removing existing instructions for the pooling-of-interest method of accounting and replacing those instructions with the acquisition accounting method. This method of accounting has been standard practice in the accounting industry for some time, and the Board has already agreed that the acquisition method better reflects the investment made in an acquired entity and has affirmed the use of this treatment.
Finally, the Board proposed revising the Form R-1 to include new accounts and a new reporting schedule and eliminating 15 schedules that the Board no longer uses.
The proposed rules were published in the
The Board has reviewed the issues raised in AAR's comments and addresses them below, along with any revisions made in response. The final rules in full are below.
In the NPR, the Board proposed to amend its USOA and Form R-1 by adding new general instructions and accounts to recognize changes in the fair value of certain security investments, items of other comprehensive income, derivative instruments, and hedging activities. Additionally, the Board proposed revising its USOA to reflect current accounting practices for business combinations by removing existing instructions for the pooling-of-interest method of accounting and requiring only the acquisition accounting methodology. The Board also sought comment on its proposal to revise the Form R-1 to include the new accounts and a new reporting schedule.
No comments were filed in opposition to these proposals. Thus, the Board adopts such proposals here in the final rules. These changes will improve completeness and consistency of accounting and reporting. The addition of the proposed new accounts and related reporting requirements to the Form R-1 will reduce regulatory uncertainty as to the proper accounting and reporting for these items and minimize regulatory burden by reducing the potential differences in the manner in which certain amounts are reported to shareholders and to the Board. Finally, the reporting of derivative instruments and hedging activities by regulated carriers will assist the Board in its overall monitoring effort as well as its ability to assess railroad industry growth and financial stability.
The Board stated in the NPR that it had examined the current Form R-1 and determined that 15 of the 47 schedules were no longer used by the Board to perform regulatory and oversight functions. The Board, therefore, proposed to eliminate the following 15 schedules:
In its comments, AAR states that it supports the Board's proposal to eliminate these schedules from the Form R-1, with the exception of Schedule 702, Miles of Road at Close of Year-By States and Territories (Single Track). According to AAR, Schedule 702 should be retained because this schedule is used to calculate state tax rates in the Revenue Shortfall Allocation Method.
We agree with AAR that Schedule 702 should be retained. The Form R-1 report, filed annually by Class I railroads, includes the mileage necessary to weight average state tax rates that are utilized in the Revenue Shortfall Allocation methodology.
In addition to the schedules proposed for elimination in the NPR, AAR requests, consistent with its comments previously filed in
The Board will not adopt AAR's proposals to eliminate these other schedules. Schedule 220, Retained Earnings, will be retained because it is a significant financial disclosure for stakeholders interested in changes in the retained earnings account during the reporting period and gives important insight into the rail carrier's financial performance. Schedule 342, Accumulated Depreciation—Improvements to Road and Equipment Leased from Others, will be retained because it is used in the Board's Uniform Rail Costing System (URCS) and review of depreciation studies. In addition, eliminating Schedule 342 would limit the Board's ability to collect
AAR further suggests, consistent with its comments in
While the Board will not adopt AAR's suggestions that the Board make certain other changes to either conform Form R-1 schedules to GAAP or otherwise harmonize Form R-1 reporting requirements, the Board will provide clarifying instructions with respect to one of AAR's proposals.
First, we will not adopt AAR's requested changes to Schedule 210, Results of Operations. Although AAR's proposal would simplify the reporting presentation in the Form R-1, the Board's current practice of presenting premiums and discounts of funded debt separately is preferable because it allows for transparent financial reporting by showing both interest income and expense.
Additionally, AAR's suggestion that the Board combine owned and capitalized leases in Schedule 415 (Supporting Schedule—Equipment) will not be adopted because this change would limit the Board's ability to collect sufficient detail for R-1 reporting regarding railroads' implementation of the updated GAAP standards for leases. This change would also require a modification in how Schedule 415 is inputted in URCS. In addition, although AAR suggests that lines pertaining to “Machinery” be eliminated in Schedule 415 because, according to AAR, such data is not in or supported by Schedule 410 (Equipment Accounts), the Board will not do so because Schedule 415, Lines 38-40 reconcile to Schedule 410, Lines 203, 222, and 306.
In Schedule 755 (Railroad Operating Statistics), the Board will retain Line 89-Caboose Miles. While reporting carriers have been reducing the use of cabooses over time, a level of use still exists. Further, removing Line 89 would eliminate an operating statistic from the URCS calculation.
While AAR suggests adding a separate line for “Shop Machinery” in Schedule 412 (Way and Structures) to reconcile the amortization expenses and depreciation for road accounts required in Schedules 412 (Way and Structures) and 335 (Accumulated Depreciation—Road and Equipment Owned and Used), the Board notes that Schedule 412 reports a railroad's fixed roadway facilities; “Shop Machinery” does not fall into such a category, but should be recorded in equipment accounts. The Board, however, will clarify instruction 4 in Schedule 412 to read as follows: “Amortization adjustment of each road property type which is included in column (b) shall be repeated in column (d) as a debit or credit to the appropriate line item. The net adjustment on line 29 shall equal the adjustment reported on line 29 of Schedule 335, excluding Account 44, Shop Machinery.”
In sum, the final rules will eliminate the schedules previously identified in the NPR except for Schedule 702, Miles of Road at Close of Year-By States and Territories (Single Track), as discussed above. The Board will also clarify R-1 Schedule 412 instruction 4 as it pertains to the treatment of Shop Machinery.
As noted in the NPR, ASC 805 Business Combinations requires the use of the acquisition method of accounting for all business combinations. While this method of accounting has been standard practice in the accounting industry for some time, and the Board has already agreed that the acquisition method better reflects the investment made in an acquired entity and has affirmed the use of this treatment, the USOA has not been updated to incorporate the method.
In connection with that proposal, the Board specifically sought comment on the application of Instruction 2-15, paragraph (d) with respect to use of the pooling of interest method for transactions involving the acquisition and merger of property of subsidiaries in INSTRUCTIONS FOR PROPERTY ACCOUNTS. No comments were submitted regarding the treatment or application of Instruction 2-15, paragraph (d). Therefore, we will update Instruction 2-15, paragraph (d) to reflect the use of the acquisition accounting methodology and remove any reference or instruction pertaining to the pooling-of-interest methodology.
In response to the NPR, AAR also suggests that the Board adopt ASC 410, Asset Retirement and Environmental Obligations, which addresses financial accounting and reporting for obligations associated with the retirement of tangible long-lived assets and the associated asset retirement costs. AAR, however, does not explain why it believes ASC 410 should be adopted. The Board has already determined in an Accounting Series Circular served on June 11, 2003, and sent to all accounting officers of Class I railroads, that the Board would not adopt Financial Accounting Standard (FAS) 143, Accounting for Asset Retirement
As noted above, 49 U.S.C. 11142 and 11161 require the Board to conform its accounting rules to GAAP “[t]o the maximum extent practicable.” Therefore, in keeping with this requirement, the Board will conduct a periodic review of its accounting standards not less than every five years.
In the NPR the Board sought comments pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501-3549, and Office of Management and Budget (OMB) regulations at 5 CFR 1320.11, regarding: (1) Whether the revisions to the collection of information proposed here are necessary for the proper performance of the functions of the Board, including whether the collection has practical utility; (2) the accuracy of the Board's burden assessment; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burdens of the collections of information on the respondents, including the use of automated collection techniques or other forms of information technology, when appropriate. Comments regarding the necessity, utility, and clarity of the information collection were received and are addressed above. No comments concerning the Board's burden estimates were received.
The proposed collection was submitted to OMB for review as required under the PRA, 44 U.S.C. 3507(d), and 5 CFR 1320.11. OMB withheld approval pending submission of the final rule. We are today submitting the collection contained in this final rule to OMB for approval. Once approval is received, we will post a copy of the revised Form R-1 on the Board's Web site. Unless renewed, OMB approval of this collection expires three years after the date that OMB approves the collection.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, generally requires a description and analysis of new rules that would have a significant economic impact on a substantial number of small entities. In drafting a rule, an agency is required to: (1) Assess the effect that its regulation will have on small entities; (2) analyze effective alternatives that may minimize a regulation's impact; and (3) make the analysis available for public comment. 5 U.S.C. 601-604. Under § 605(b), an agency is not required to perform an initial or final regulatory flexibility analysis if it certifies that the proposed or final rules will not have a “significant impact on a substantial number of small entities.”
Because the goal of the RFA is to reduce the cost to small entities of complying with federal regulations, the RFA requires an agency to perform a regulatory flexibility analysis of small entity impacts only when a rule directly regulates those entities. In other words, the impact must be a direct impact on small entities “whose conduct is circumscribed or mandated” by the proposed rule.
The rule changes adopted here will not have a significant economic impact upon a substantial number of small entities, within the meaning of the RFA. The reporting requirements are applicable only to entities that are required to file Form R-1 reports,
49 U.S.C. 11142 and 11164.
Railroads, Uniform System of Accounts.
1. The final rules set forth below are adopted and will be effective on May 6, 2016. Notice of the rules adopted here will be published in the
2. This decision is effective on the date of service.
By the Board, Chairman Elliott, Vice Chairman Miller, and Commissioner Begeman.
For the reasons set forth in the preamble, the Surface Transportation Board is amending part 1201 of title 49, chapter X, of the Code of Federal Regulations as follows:
49 U.S.C. 11142 and 11164.
(ii) * * *
16. * * *
(c)
1-19
(b) Supporting records will be maintained for account 799 so that the company can readily identify the cumulative amount of Other Comprehensive Income for each item included in this account.
(c) When an item of Other Comprehensive Income enters into the determination of earnings in the current or subsequent periods, a reclassification adjustment will be recorded in account 799 to avoid double counting of when
1-20
(1) The derivative instrument has one or more underlyings and a notional amount or payment provision. Those terms determine the amount of the settlement or settlements, and, in some cases, whether or not a settlement is required.
(2) The derivative instrument requires no initial net investment or an initial net investment that is smaller than would be required for other types of contracts that would be expected to have similar responses to changes in market factors.
(3) The derivative instrument's terms require or permit net settlement; the derivative instrument can readily be settled net by a means outside the contract; or the derivative instrument's terms provide for delivery of an asset that puts the recipient in a position not substantially different from net settlement.
(b) The accounting for the changes in the fair value of derivative instruments depends upon their intended use and designation. Changes in the fair value of derivative instruments not designated as fair value or cash flow hedges will be recorded in account 713.5,
(c) A derivative instrument may be specifically designated as a fair-value or cash-flow hedge. A hedge may be used to manage risk to price, interest rates, or foreign currency transactions. An entity will maintain documentation of the hedge relationship at the inception of the hedge that details the risk management objective and strategy for undertaking the hedge, the nature of the risk being hedged, and how hedge effectiveness will be determined.
(d) If the carrier designates the derivative instrument as a fair-value hedge against exposure to changes in the fair value of a recognized asset, liability, or a firm commitment, it will record the change in fair value of the derivative instrument designated as a fair-value hedge to account 713.6,
(e) If the carrier designates the derivative instrument as a cash-flow hedge against exposure to variable cash flows of a probable forecasted transaction, it will record changes in the fair value of the derivative instrument in account 713.6,
The revisions read as follows:
2-15 * * * (a) When a railway or portion thereof constituting an operating unit or system is acquired in a business combination, that business combination shall be recorded in the accounts in the manner stated hereunder.
(b) Purchase:
(1) The amount includable in account 731, Road and equipment property, shall be the cost at the date of acquisition to the purchaser of the transportation property acquired. The cost assigned the property, as well as other assets acquired, shall be the amount of the cost consideration given. Where property and other assets are acquired for other than cash, including liabilities assumed and shares of stock issued, cost shall be determined by either the fair value of the consideration given or the fair value of the assets acquired, whichever is more clearly evident. In addition to any liabilities assumed, provision shall be made for such estimated liabilities as may be necessary.
(2) When the costs of individual units or classes of transportation property are not specified in the agreement, the cost assigned such property shall be apportioned among the appropriate primary accounts using the percentage relationship between the fair values for each class of property acquired and the total of such values.
(c) Merger of subsidiaries:
The acquisition and merger of property of subsidiaries controlled through ownership of the majority shares of voting stock is to be accounted for using the acquisition accounting methodology.
5-2 * * *
(a) * * *
(2) Account 702,
(3) For the purpose of determining net ledger value, the marketable equity securities in account 702 shall be considered the current portfolio and the marketable equity securities in accounts 721 and 722 (combined) shall be considered the noncurrent portfolio.
(4) Carriers will categorize their security investments as held-to-maturity, trading, or available-for-sale. Unrealized holding gains and losses on trading type investment securities will be recorded in account 551,
(a) * * *
Unrealized holding gains and losses on trading type investment securities.
The additions read as follows:
* * * This account shall also include unrealized holding gains and losses on trading and available-for-sale types of security investments.
This account shall include the amounts paid for derivative instruments, and the change in the fair value of all derivative instrument assets not designated as cash-flow or fair-value hedges. Account 551,
(a) This account shall include the amounts paid for derivative instruments, and the change in the fair value of derivative instrument assets designated by the carrier as cash-flow or fair-value hedges.
(b) When a carrier designates a derivative instrument asset as a cash-flow hedge, it will record the change in the fair value of the derivative instrument in this account with a concurrent charge to account 799.1,
(c) When a carrier designates a derivative instrument as a fair-value hedge, it will record the change in the fair value of the derivative instrument in this account with a concurrent charge to a sub-account of the asset or liability that carries the item being hedged. The ineffective portion of the fair-value hedge will be charged to the same income or expense account that would have been used if the hedged item had been disposed of or otherwise settled.
The additions read as follows:
(b) * * * This account shall also include unrealized holding gains and losses on trading and available-for-sale types of security investments. The cash value of life insurance policies on the lives of employees and officers to the extent that the carrier is the beneficiary of such policies shall also be included in this account.
(a) * * * This account shall also include unrealized holding gains and losses on trading and available-for-sale types of security investments.
This account shall also include unrealized holding gains and losses on trading and available-for-sale types of security investments.
The addition reads as follows:
(a) * * * This account shall also include unrealized holding gains and losses on trading and available-for-sale types of security investments. Include also the offsetting entry to the recording of amortization of discount or premium on interest bearing investments.
This account shall include the change in the fair value of all derivative instrument liabilities not designated as cash-flow or fair-value hedges. Account 551,
(a) This account shall include the change in the fair value of derivative instrument liabilities designated by the carrier as cash-flow or fair-value hedges.
(b) A carrier will record the change in the fair value of a derivative instrument liability related to a cash-flow hedge in this account, with a concurrent charge to account 799.1,
(c) A carrier will record the change in the fair value of a derivative instrument liability related to a fair-value hedge in this account, with a concurrent charge to a sub-account of the asset or liability
The addition reads as follows:
(a) This account shall include revenues, expenses, gains, and losses that are properly includable in Other Comprehensive Income during the period. Examples of items of Other Comprehensive Income include foreign currency items, minimum pension liability adjustments, unrealized gains and losses on certain investments in debt and equity securities, and cash-flow hedges. Records supporting the entries to this account shall be maintained so that the carrier can furnish the amount of Other Comprehensive Income for each item included in this account.
(b) This account shall also be debited or credited, as appropriate, with amounts of accumulated Other Comprehensive Income that have been included in the determination of net income during the period and in accumulated Other Comprehensive Income in prior periods. Separate records for each category of items will be maintained to identify the amount of the reclassification adjustments from accumulated Other Comprehensive Income to earnings made during the period.
The classified form of general balance sheet statement is designed to show the financial condition of the accounting company at any specified date.
The following appendix will not appear in the Code of Federal Regulations.
Fish and Wildlife Service, Interior.
Final rule.
We, the U.S. Fish and Wildlife Service (Service), are amending the regulations that implement the Endangered Species Act (Act) by removing inter-subspecific crossed or generic tiger
This rule becomes effective on May 6, 2016.
The supplementary materials for this rule, including the public comments received, are available at
Timothy J. Van Norman, Chief, Branch of Permits, Division of Management Authority, U.S. Fish and Wildlife Service, 5275 Leesburg Pike, MS-IA, Falls Church, VA 22041-3803; telephone 703-358-2104; fax 703-358-2281. If you use a telecommunications devise for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800-877-8339.
To prevent the extinction of wildlife and plants, the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
In 1979, the Service published the Captive-bred Wildlife (CBW) regulations (44 FR 54002, September 17, 1979) to reduce Federal permitting requirements and facilitate captive breeding of endangered and threatened species under certain conditions. These conditions include:
(1) A person may become registered with the Service to conduct otherwise prohibited activities when the activities can be shown to enhance the propagation or survival of the species;
(2) Interstate commerce is authorized only when both the buyer and seller are registered for the same species;
(3) The registration is only for live, mainly nonnative endangered or threatened wildlife that was born in captivity in the United States (although the Service may determine that a native species is eligible for the registration; to date, the only native species granted eligibility under the registration is the Laysan duck
(4) Registration does not authorize activities with non-living wildlife, a provision that is intended to discourage the propagation of endangered or threatened wildlife for consumptive markets; and
(5) The registrants are required to maintain written records of authorized activities and report them annually to the Service. The CBW registration has provided zoological institutions and breeding operations the ability to move animals quickly between registered institutions for breeding purposes.
In 1993, the Service amended the CBW regulations at 50 CFR 17.21(g) (58 FR 68323, December 27, 1993) to eliminate public education through exhibition of living wildlife as the sole justification for the issuance of a CBW registration. That decision was based on the Service's belief that the scope of the CBW system should be revised to relate more closely to its original intent,
In 1998, the Service amended the CBW regulations (63 FR 48634, September 11, 1998) to delete the requirement to obtain a CBW registration for holders of inter-subspecific crossed or generic tigers (
On August 22, 2011, the Service proposed to amend the CBW regulations that implement the Act by removing inter-subspecific crossed or generic tigers from paragraph (g)(6) of 50 CFR 17.21 (76 FR 52297). The public was provided with a 30-day comment period to submit their views and comments on the proposed rule. However, due to the large volume of comments, the Service published a notice on September 21, 2011 (76 FR 58455), extending the comment period for an additional 30 days. This comment period ended on October 21, 2011. Since that time, the Service has received no new substantive information that would affect this rule.
The wild tiger was once abundant throughout Asia. At the end of the 19th century, an estimated 100,000 tigers occurred in the wild (Nowak 1999, p. 828), but by the late 1990s, the estimated population had declined to 5,000-7,000 animals (Seidensticker et al. 1999, p. xvii). Today's population in the wild is thought to be 3,000-5,000 individuals, according to the IUCN (International Union for Conservation of Nature) Red List estimate (Chundawat et al. 2010, unpaginated), with no more than 2,500 mature breeding adults (Williamson and Henry 2008, pp. 7, 43). The once-abundant tiger now lives in small, fragmented groups, mostly in protected forests, refuges, and national parks (FWS 2010a, p. 1). The species occupies only about 7 percent of its original range, and in the past decade, the species' range has decreased by as much as 41 percent (Dinerstein et al. 2007, p. 508).
For many years, the international community has expressed concern about the status of tigers in the wild and the risk that captive tigers, if used for consumptive purposes, may sustain the demand for tiger parts, which would ultimately have a detrimental effect on the survival of the species in the wild. An estimated 5,000 captive tigers occur on China's commercial tiger farms, where tigers are being bred intensively and produce more than 800 animals each year (Williamson and Henry 2008, p. 40). Tiger body parts, such as organs, bones, and pelts, are in demand not only in China, but also on the global black market. Organs and bones are used in traditional medicines, which are purchased by consumers who believe the parts convey strength, health, and virility.
Current regulations under the ESA prohibit the taking of any tiger, including generic tigers, and there is no clear evidence that the U.S. captive tiger population has played a role in illegal international trade. However, in 2005, Werner (p. 24) estimated that 4,692 tigers were held in captivity in the United States. Approximately 264 tigers were held in institutions registered with the Association of Zoos and Aquariums (AZA), 1,179 in wildlife sanctuaries, 2,120 in institutions registered by the U.S. Department of Agriculture (USDA), and 1,120 in private hands. In 2008, Williamson and Henry stated that as many as 5,000 tigers are in captivity in the United States, but cautioned that, given the current State and Federal legal framework that regulates U.S. captive tigers, the exact size of the population is unknown (Williamson and Henry 2008).
The tiger is a species of global concern, is classified as endangered in the IUCN Red List (IUCN 2010), and is protected by a number of U.S. laws and treaties. It is listed as endangered under the Act. Section 3 of the Act defines an “endangered species” as “any species which is in danger of extinction throughout all or a significant portion of its range.” The listing is at the species level and, thus, includes all subspecies of tiger (including those that are of unknown subspecies, referred to as “generic” tigers) and inter-subspecific crosses.
The species is also protected by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). Under this treaty, 178 member countries (Parties) work together to ensure that international trade in protected species is not detrimental to the survival of wild populations. The United States and all the tiger range countries are Parties to CITES. The tiger is listed in Appendix I, which includes species threatened with extinction whose trade is permitted only under exceptional circumstances, and which generally precludes commercial trade. The United States has a long history of working within CITES to promote tiger conservation and has been a leader in supporting strong actions within CITES for tigers, including strict controls on captive-bred animals. In 2007 at the 14th meeting of the Conference of the Parties to CITES (CoP14), we were closely involved in drafting Decision 14.69, which calls on countries with intensive commercial breeding operations of tigers to implement measures to restrict the captive population to a level supportive only to conserving wild tigers, and for tigers not to be bred for trade in their parts and products. Although the decision was primarily directed at large commercial breeding operations such as those found in China, we are aware of the large number of captive tigers in the United States and the need to be vigilant in monitoring these tigers as well.
The tiger is afforded additional protection under the Captive Wildlife Safety Act (CWSA) and the Rhinoceros and Tiger Conservation Act (RTCA, 16 U.S.C. 5301
The RTCA is another powerful tool in combating the international trade in products containing tiger parts. It prohibits the sale, import, and export of products intended for human use and containing, or labeled or advertised as
The World Wildlife Fund, TRAFFIC North America, other nongovernmental organizations (NGOs), and the public have expressed concerns about the potential role U.S. captive tigers may play, or could potentially play, in the trade in tiger parts. In July 2008, TRAFFIC published a report titled,
In our proposed rule (August 22, 2011; 76 FR 52297), we asked interested parties to submit comments or suggestions regarding the proposal to eliminate inter-subspecific crossed or generic tigers from the regulation at 50 CFR 17.21(g). The original comment period for the proposed rule lasted for 30 days, ending September 21, 2011. The comment period was extended, however, on September 21, 2011 (76 FR 58455), to allow for an additional 30 days to accommodate the large number of commenters. The extended comment period ended on October 21, 2011. We received 15,199 individual comments during the two comment periods. The vast majority of the comments (approximately 15,000) either supported the proposed rule as written or stated that it was not strong enough to address captive breeding of inter-subspecific crossed or generic tigers. We received 109 comments from individuals or organizations that opposed the proposed rule. The remaining 79 comments were either irrelevant to the proposed rule or indecipherable.
However, this change in regulations would not directly result in the control of breeding of inter-specific crossed or generic tigers. The Act does not regulate intrastate activities that do not result in a take or the noncommercial interstate movement of a listed species. The only intrastate activity that the Act regulates is the take (
It is also possible that, with this change in the CBW regulations and the potentially lower demand for tigers within the United States, individuals or facilities that currently hold inter-subspecific crossed or generic tigers will move their animals to sanctuaries or other zoo facilities, causing these facilities to become overcrowded. We do not believe that such movement will become a significant problem at most zoos and sanctuaries, which generally maintain a high standard of care and, in any case, are required by the Animal Welfare Act and other Federal and State laws and regulations to provide humane treatment for animals. A need may arise, however, for greater coordination between nongovernmental organizations, zoos, and sanctuaries to ensure that all inter-subspecific crossed or generic tigers that end up in sanctuaries or zoos receive adequate housing and care.
When we issue a permit or other authorization under the Act for otherwise prohibited activities, we do have the authority to conduct periodic inspections or otherwise have oversight of permitted activities. This authority, however, does not extend to activities outside the scope of the Act or for activities that are not regulated by the Act. Therefore, we do not have the ability to conduct regular inspections of breeding operations that do not require authorization from us. This type of inspection may be possible in some cases under the Animal Welfare Act, which is implemented by the USDA, but is outside the scope of this regulation. However, if we have evidence of illegal activity, we have the authority to carry out criminal investigations of any facility, whether or not it is permitted.
While we could require microchipping of tigers at a facility that has obtained a permit or other authorization from the Service, we cannot require the microchipping of all tigers within the United States. Microchipping some tigers may give us the ability to track the movement of live animals that are involved in interstate commerce (an otherwise prohibited activity), but we would not be able to track live tigers that do not fall under our jurisdiction. Further, microchipping is unlikely to assist us in investigating the illegal movement of tiger parts within the United States. We also do not have the authority or the resources to monitor and record the birth, death, or transfer of all tigers in the United States. Microchipping a portion of the captive tigers in the United States for tracking purposes might give us a limited picture of the movement and ownership of these animals in the United States, but we do not believe that any limited benefits would outweigh the cost and administrative burden of microchipping and tracking these animals.
We strongly encourage and support programs established by tiger range countries to control and ultimately eliminate poaching of wild tigers. We have been able to fund a variety of anti-poaching programs through various grant programs, including grants under the RTCA. We have also been actively involved in efforts through CITES to assist range countries in monitoring and controlling illegal trade in tigers. We do not have any authority, however, to establish stricter regulations regarding poaching in other countries.
The Act does not regulate intrastate activities other than take, such as ownership and breeding, nor does it regulate noncommercial interstate transfers of listed species (
It should also be noted that the requirement to show that authorizing an otherwise prohibited activity, such as interstate commerce, could be met through an individual or institution, or a group of individuals or institutions together, working to provide a benefit to the species in the wild. For example, if one or more zoological institutions were purchasing inter-subspecific crossed or generic tigers for educational and display purposes, they could provide support (
On December 27, 1993, the Service published a final rule (58 FR 68323) that eliminated public education through exhibition of living wildlife as the sole justification for issuing a CBW registration under § 17.21(g). As one commenter correctly pointed out, the Service made the statement in the 1998 final rule exempting inter-subspecific crossed or generic tigers from the CBW registration process (63 FR 48638) that inter-subspecific crossed or generic tigers should not be used to enhance the propagation of the species, but could be used for exhibition in a manner designed to educate the public about the ecological role and conservation needs of the species. While individuals are not precluded from continuing to provide educational opportunities to the public through the display of inter-subspecific crossed or generic tigers, an educational purpose alone is not enough to support CBW registration per the 1993 rule. The basis for excluding education as the sole justification for a CBW registration was discussed in the final rule on that issue (58 FR 68323) and is outside the scope of this rulemaking.
Since pure and generic tigers would be treated the same in regards to permits issued under 50 CFR 17.22 (
We are amending the CBW regulations that implement the Act by removing inter-subspecific crossed or generic tiger
We are changing the regulations to ensure that we maintain stricter control over the commercial movement and sale of captive tigers in the United States. As stated in the comment section, we do not believe that breeding inter-subspecific crossed or generic tigers, in and of itself, provides a conservation benefit for the long-term survival of the species. Inter-subspecific tiger crosses and animals of unknown genetic ancestry could not be used for maintaining genetic viability and distinctness of specific tiger subspecies. Tigers of unknown or mixed genetic origin are typically not maintained in a manner to ensure that inbreeding or other inappropriate matings of animals do not occur. By exempting inter-subspecific crossed or generic tigers from the CBW registration process in 1998, we had inadvertently suggested that the breeding of these tigers, in and of itself, qualifies as conservation. By removing the exemption, we reinforce the value of conservation breeding of individual tiger subspecies through the CBW program.
As stated in the proposed rule, we are unaware of any evidence that tiger parts are entering into trade from the captive U.S. population of tigers. However, we recognize that the use of tiger parts and products, including in traditional medicine, poses a significant threat to wild tiger populations. The United States has worked vigorously with other CITES countries to encourage not only the adoption of measures to protect wild tiger populations from poaching and illegal trade, but also the implementation of measures to ensure that breeding of tigers in captivity supports conservation goals and that tigers are not bred for trade in parts and products. While we do not have
The previous CBW exemption also created enforcement difficulties. Specifically, law enforcement cases have hinged on whether activities the Service has identified as illegal were actually exempted under the current regulations. By removing the exemption, persons engaged in otherwise prohibited activities will need to obtain a permit or register under the CBW program, giving the Service greater ability to bring enforcement cases for violations involving tigers.
It should be stressed, however, that removing the exemption for inter-subspecific crossed or generic tigers would not result in regulations by the Service of ownership, intrastate commerce, or noncommercial movement of these tigers across State lines, as long as they are not killed or harmed. These activities are not prohibited by the Act, and we have no authority to prohibit or otherwise regulate them.
Finally, we reorganized paragraph (g)(6), redesignating subparagraphs to make the section clearer. With the exception of removing inter-subspecific crossed or generic tigers, the text is essentially the same as it previously appeared in 50 CFR 17.21(g)(6).
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 rule in a manner consistent with these requirements.
The U.S. Small Business Administration (SBA) defines a small business as one with annual revenue or employment that meets or is below an established size standard. We expect that the majority of the entities involved in taking, exporting, re-importing, and selling in interstate or foreign commerce of inter-subspecific crossed or generic tigers would be considered small as defined by the SBA.
Currently, businesses conducting activities with inter-subspecific crossed or generic tigers are exempt from registration under the CBW regulations, if the activities are consistent with the purposes of the ESA and CBW program. This rule would require businesses that are otherwise carrying out these activities to apply for authorization under the Act and pay an application fee of $100 for a one-time interstate commerce permit or $200 to register under the CBW program (valid for 5 years).
Currently, there is no Federal or State mechanism in place that tracks or monitors the extent of business activities involving generic tigers. With the exemption from registration by facilities that are conducting activities in compliance with the current CBW regulations, FWS does not have data on how many businesses are involved in the interstate commerce of generic tigers, the number of businesses for which an interstate commerce permit or registration in the CBW program will be a viable option, and the economic impacts if prospective applicants are unable to either secure an interstate commerce permit or registration in the CBW program. While the U.S. Department of Agriculture regulates some aspects of holding large cats like tigers, their authority does not extend to all facilities that maintain tigers. As such, there is not a centralized database or collection of data that would identify the number of facilities within the United States. While some State governments may monitor or even regulate some aspects of holding tigers, either pure-bred or generic, there is not a universal approach that would render any significant data on those facilities that hold tigers throughout the United States. Nonetheless, based on the comments received during the public comment period, FWS anticipates that the number of affected small businesses is small and either registration in the CBW program or an interstate commerce permit will be a viable option at a modest expense. Therefore, the regulatory change is not major in scope and will create only a modest financial or paperwork burden on the affected members of the public.
We, therefore, certify that this rule would not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601
a. Would not have an annual effect on the economy of $100 million or more. This rule removes the inter-subspecific crossed or generic tigers from the exemption to register under the CBW regulations. Individuals and captive-breeding operations would need to obtain endangered species permits or other authorization to engage in certain otherwise prohibited activities. This rule would not have a negative effect on the economy. It will affect all businesses, whether large or small, the same. There is not a disproportionate share of benefits for small or large businesses.
b. Would not cause a major increase in costs or prices for consumers;
c. Would not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.
a. This rule would not significantly or uniquely affect small governments. A Small Government Agency Plan is not required.
b. This rule would not produce a Federal requirement of $100 million or greater in any year and is not a “significant regulatory action” under the Unfunded Mandates Reform Act.
A complete list of references cited in this rulemaking is available on the Internet at
Endangered and threatened species, Exports, Imports, Reporting, and recordkeeping requirements, Transportation.
For the reasons given in the preamble, we are amending part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as follows:
16 U.S.C. 1361-1407; 1531-1544; 4201-4245; unless otherwise noted.
(g) * * *
(6)
(A) The bar-tailed pheasant
(B) Parakeets of the species
(C) The Laysan duck
(D) The white-winged wood duck
(ii)
(A) The purpose of the activity is to enhance the propagation or survival of the affected exempted species.
(B) Such activity does not involve interstate or foreign commerce, in the course of a commercial activity, with respect to nonliving wildlife.
(C) Each specimen to be reimported is uniquely identified by a band, tattoo, or other means that was reported in writing to an official of the Service at a
(D) No specimens of the taxa in paragraph (g)(6)(i) of this section that were taken from the wild may be imported for breeding purposes absent a definitive showing that the need for new bloodlines can be met only by wild specimens, that suitable foreign-bred, captive individuals are unavailable, and that wild populations can sustain limited taking. In addition, an import permit must be issued under § 17.22.
(E) Any permanent exports of such specimens meet the requirements of paragraph (g)(4) of this section.
(F) Each person claiming the benefit of the exception in paragraph (g)(1) of this section must maintain accurate written records of activities, including births, deaths, and transfers of specimens, and make those records accessible to Service agents for inspection at reasonable hours as set forth in §§ 13.46 and 13.47 of this chapter.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using trawl gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the B season apportionment of the 2016 Pacific cod total allowable catch allocated to trawl catcher vessels in the BSAI.
Effective 1200 hours, Alaska local time (A.l.t.), April 4, 2016, through 1200 hours, A.l.t., June 10, 2016.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The B season apportionment of the 2016 Pacific cod total allowable catch (TAC) allocated to trawl catcher vessels in the BSAI is 5,460 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).
In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the B season apportionment of the 2016 Pacific cod TAC allocated to trawl catcher vessels in the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 5,000 mt and is setting aside the remaining 460 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using trawl gear in the BSAI.
After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for Pacific cod by catcher vessels using trawl gear in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 31, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Privacy Office, Department of Homeland Security.
Notice of proposed rulemaking.
The Department of Homeland Security is giving concurrent notice of an updated and reissued system of records pursuant to the Privacy Act of 1974 for the “Department of Homeland Security/U.S. Customs and Border Protection-014 Regulatory Audit Archive System of Records” and this proposed rulemaking. This system of records will continue to manage audits that are part of DHS/CBP's continuing oversight of customs brokers, importers, and other parties engaged in international trade activities, that are the subject of a regulatory audit or are identified in and related to the scope of an audit report.
In this proposed rulemaking, the Department proposes to reduce the number of exemptions of the system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.
Comments must be received on or before May 6, 2016.
You may submit comments, identified by docket number DHS-2016-0026 by one of the following methods:
•
•
•
For general questions, please contact: John Connors, (202) 344-1610, Privacy Officer, U.S. Customs and Border Protection, Privacy and Diversity Office, 1300 Pennsylvania Avenue NW., Washington, DC 20229. For privacy questions, please contact: Karen L. Neuman, (202) 343-1717, Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS)/U.S. Customs and Border Protection (CBP) is giving notice of a proposed rule to accompany an updated system of records notice titled, “DHS/CBP-014 Regulatory Audit Archive System (RAAS) System of Records.”
DHS/CBP conducts regulatory audits in support of its oversight of customs brokers licensed by DHS/CBP pursuant to 19 U.S.C. 1641 to act as agents for importers in the entry of merchandise and payment of duties and fees. This system of records covers records about importers and other parties engaged in international trade activities that are the subject of a regulatory audit or are identified in and related to the scope of an audit report.
Concurrent with this NPRM, elsewhere in the
DHS/CBP is clarifying the authorities section to include updated and more narrowly tailored authorities to permit the collection of EIN or SSN. 19 CFR 24.5 and 19 CFR 149.3 require that DHS/CBP collect Federal Taxpayer Identifying Numbers in association with services resulting in issuance of a bill or refund check upon adjustment of a cash collection or to document entities that are liable for payment of all duties and responsible for meeting all statutory or regulatory requirements incurred as a result of importation. Individuals or entities that do not have a SSN may submit an EIN in lieu of the SSN for merchandise entry purposes.
DHS/CBP is making non-substantive edits to the Routine Uses A-G to align with previously published Departmental SORNs. This notice also includes non-substantive changes to simplify the formatting and texts of the previously published notice.
Consistent with DHS's information sharing mission, information stored in DHS/CBP-014 RAAS may be shared with other DHS Components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, DHS/CBP may share information with appropriate Federal, State, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice.
DHS/CBP previously published a Final Rule in the
The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.
The Privacy Act allows government agencies to exempt certain records from the access and amendment provisions. If an agency claims an exemption, however, it must issue a Notice of Proposed Rulemaking to make clear to the public the reasons why a particular exemption is claimed.
DHS is revising the previously claimed exemptions from certain requirements of the Privacy Act for DHS/CBP-014 Regulatory Audit Archive System (RAAS) System of Records. DHS/CBP is not requesting an exemption with respect to information maintained in the system as it relates to data submitted by or on behalf of a subject of an audit. The Privacy Act requires DHS to maintain an accounting of the disclosures made pursuant to all routines uses. Disclosing the fact that a law enforcement or intelligence agency has sought particular records may affect ongoing law enforcement activity. Therefore, pursuant to 5 U.S.C. 552a(k)(2), DHS will claim exemption from sec. (c)(3) of the Privacy Act of 1974, as amended, as is necessary and appropriate to protect this information.
Some information in DHS/CBP-014 Regulatory Audit Archive System (RAAS) System of Records relates to official DHS law enforcement activities. These exemptions are needed to protect information relating to DHS law enforcement activities from disclosure to subjects or others related to these activities. Specifically, the exemptions are required to preclude subjects of these activities from frustrating these processes; to avoid disclosure of activity techniques; to protect the identities and physical safety of confidential informants and law enforcement personnel; to ensure DHS's ability to obtain information from third parties and other sources; to protect the privacy of third parties; and to safeguard classified information. Disclosure of information to the subject of the inquiry could also permit the subject to avoid detection or apprehension.
The exemption proposed here is a standard law enforcement exemption exercised by a large number of Federal law enforcement agencies. In appropriate circumstances, when compliance would not appear to interfere with or adversely affect the law enforcement purposes of this system and the overall law enforcement process, the applicable exemptions may be waived on a case-by-case basis.
A system of records notice for DHS/CBP-014 Regulatory Audit Archive System (RAAS) System of Records is also published in this issue of the
Freedom of information, Privacy.
For the reasons stated in the preamble, DHS proposes to amend chapter I of title 6, Code of Federal Regulations, as follows:
Pub. L. 107-296, 116 Stat. 2135; (6 U.S.C. 101
25. The Department of Homeland Security/U.S. Customs and Border Protection-014 Regulatory Audit Archive System (RAAS) System of Records consists of electronic and paper records and will be used by DHS and its Components. The DHS/CBP-014 RAAS System of Records is a repository of information held by DHS in connection with its several and varied missions and functions, including, but not limited to: The enforcement of civil and criminal laws; investigations, inquiries, and proceedings there under. The DHS/CBP-014 RAAS System of Records contains information that is collected by, on behalf of, in support of, or in cooperation with DHS and its Components and may contain personally identifiable information collected by other Federal, State, local, tribal, foreign, or international government agencies. The Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(k)(2), has exempted this system from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3). Exemptions from these particular subsections are justified, on a case-by-case basis to be determined at the time a request is made, for the following reasons:
(a) From subsec. (c)(3) (Accounting for Disclosures) because release of the accounting of disclosures could alert the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS as well as the recipient agency. Disclosure of the accounting would therefore present a serious impediment to law enforcement efforts and/or efforts to preserve national security. Disclosure of the accounting would also permit the individual who is the subject of a record to impede the investigation, to
(b) tamper with witnesses or evidence, and to avoid detection or apprehension, which would undermine the entire investigative process.
Food and Nutrition Service (FNS), USDA.
Proposed rule; correction.
This document contains a correction to the proposed rule published in the
To be assured of consideration, written comments must be received on or before May 13, 2016.
Mary Rose Conroy, Branch Chief, Program Development Division, Program Design Branch, Food and Nutrition Services, U.S. Department of Agriculture, 3101 Park Center Drive, Room 810, Alexandria, VA 22302, or by phone at (703) 305-2803, or by email at
In proposed rule FR Doc. 2016-05583, beginning on page 13290 in the issue of March 14, 2016, make the following correction in the Summary section. On page 13290 the Summary section is revised to read as follows:
Section 4018 also prohibits any entity that receives funds under the FNA from compensating any person engaged in outreach or recruitment activities based on the number of individuals who apply to receive SNAP benefits. Lastly, Section 4018 modifies Section 16(a)(4) of the FNA to prohibit the Federal government from paying administrative costs associated with recruitment activities designed to persuade an individual to apply for program benefits or that promote the program through television, radio, or billboard advertisements.
This proposed rule would also impact the Food Distribution Program on Indian Reservations (FDPIR) and The Emergency Food Assistance Program (TEFAP), both of which receive funding and/or foods authorized under the FNA.
U.S. Small Business Administration.
Proposed rule.
The U.S. Small Business Administration (SBA) proposes to amend its disaster loan program regulations in response to changes made to the Small Business Act (the Act) by the Recovery Improvements for Small Entities After Disaster Act of 2015 (the RISE Act). The first change would expand the definition of a mitigating measure to include the construction of a safe room or similar storm shelter designed to protect property and occupants. The second change would allow for an increase of the unsecured threshold for physical damage loans for non-major disasters. The third change would allow SBA to increase loan amounts to address contractor malfeasance. In addition, SBA proposes to make several technical corrections to conform certain regulatory provisions to existing statutory authority and remove an obsolete reference in part 123.
Comments must be received on or before June 6, 2016.
You may submit comments, identified by RIN 3245-AG78, by any of the following methods: (1) Federal Rulemaking Portal:
SBA will post all comments to this proposed rule on
Jerome Edwards, Office of Disaster Assistance 202-205-6734 or
Section 7(b) of the Small Business Act, 15 U.S.C. 636(b), authorizes SBA to make direct loans to homeowners, renters, businesses, and non-profit organizations that have been adversely affected by a disaster. After a declared disaster, SBA makes loans of up to $200,000 to homeowners and renters (plus up to $40,000 for personal property) and loans of up to $2 million to businesses of all sizes and non-profit organizations to assist with any uninsured and otherwise uncompensated physical losses sustained during the disaster. In addition to loans for the repair or replacement of damaged physical property, SBA also offers working capital loans, known as Economic Injury Disaster Loans (EIDLs), to small businesses, small agricultural cooperatives, and most private non-profit organizations that have suffered economic injury caused by a disaster. The maximum loan amount is $2 million for physical and economic injuries combined. SBA may waive this $2 million limit if a business is a major source of employment.
The Recovery Improvements for Small Entities After Disaster Act of 2015, Public Law 114-88, 129 Stat. 686 (November 25, 2015), amended certain terms and conditions of SBA's Disaster Assistance program. As discussed below, this rulemaking proposes to implement three of those amendments, as set out in sections 1102, 2102 and 2107 of the RISE Act. SBA also proposes to make several minor technical amendments to the program regulations that, among other things, would ensure consistency between the program's regulatory and statutory authorities.
Section 1102 of the RISE Act, Use of Physical Damage Disaster Loans to Construct Safe Rooms, expanded the definition of mitigation to include “construction of a safe room or similar storm shelter designed to protect property and occupants from tornadoes or other natural disasters, if such safe room or similar storm shelter is constructed in accordance with applicable standards issued by the Federal Emergency Management Agency.” This change allows SBA to include a safe room or storm shelter as a mitigating measure; therefore, SBA proposes to amend 13 CFR 123.21 to reflect this change in the definition of a
Section 2102 of the RISE Act, Collateral Requirements for Disaster Loans, increased SBA's unsecured loan limits for all disaster loans for a period of three years. In 2014, SBA published an Interim Final Rule, Disaster Assistance Loan Program; Disaster Loan Credit and Collateral Requirements (79 FR 22859, April 25, 2014), to raise the unsecured limit to $25,000 for economic injury loans for all disasters and for physical damage loans for major disasters. The unsecured limit for physical damage loans for non-major disasters continued to be $14,000, in accordance with the Small Business Act. Section 2102 of the RISE Act expanded on these previous changes by increasing the unsecured limit to $25,000 to include physical damage loans for non-major disasters for a period of three years, until November 25, 2018. Therefore, SBA proposes to amend 13 CFR 123.11 to reflect a $25,000 unsecured threshold for all disaster declarations. After November 25, 2018, the unsecured limit for physical damage loans for non-major disasters would revert back to $14,000, unless Congress makes the increase permanent.
Section 2107 of the RISE Act, Contractor Malfeasance, expanded SBA's ability to provide disaster assistance by expressly allowing for supplemental assistance for malfeasance by a contractor or other person and defining what constitutes malfeasance. Prior to implementation of the RISE Act, SBA provided assistance only for malfeasance by contractors, not malfeasance by any “other person” in connection with the loan, and did not allow for increases in the loan amount beyond the regulatory limit of $200,000 for repair or replacement of damaged property. The RISE Act gave SBA authority to increase a disaster loan when a contractor or other person engages in malfeasance in connection with repairs to, rehabilitation of, or replacement of property for which SBA made a disaster loan and the malfeasance results in substantial economic damage or substantial risks to health or safety. SBA proposes to revise 13 CFR 123.18, 123.20, and 123.105 to include details on what constitutes malfeasance, provide guidance on when borrowers are eligible to apply for loan increases due to malfeasance, and allow home loan borrowers to increase their loans up to an additional $200,000 for malfeasance. For business loans, the total maximum loan amount, including any increase for malfeasance, remains $2,000,000.
The proposed changes made as a result of the RISE Act apply to all eligible recipients of SBA disaster loans for disasters declared on or after the effective date of the RISE Act, November 25, 2015.
In addition to the changes proposed as a result of the RISE Act, SBA is also proposing to make several technical corrections. SBA proposes to change the phrase “sudden physical event” to “sudden event” in 13 CFR 123.2 to conform the regulation to SBA's statutory definition of “disaster” in 15 U.S.C. 632(k). SBA proposes to revise 13 CFR 123.3 to remove the reference to “emergency” declarations in § 123.3(a)(1) in order to conform the regulations to SBA's statutory authority. SBA proposes this change to clarify that SBA disaster assistance is not automatically authorized when the President declares an emergency; such assistance may be available, however, if SBA declares a disaster under its own authority. Finally, SBA proposes to revise 13 CFR 123.13(a) to remove the reference to an expired OMB control number.
SBA invites comments from interested members of the public on all changes proposed in this rule. These comments must be received on or before the close of the comment period noted in the
The Office of Management and Budget (OMB) has determined that this proposed rule does not constitute a significant regulatory action under Executive Order 12866. This is not a major rule under the Congressional Review Act, 5 U.S.C. 800.
This action meets applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. This action does not have preemptive or retroactive effect.
For the purposes of Executive Order 13132, this proposed rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, SBA determined that this proposed rule has no federalism implications warranting preparation of a federalism assessment.
Executive Order 13563 reaffirms the principles of Executive Order 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. Executive Order 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 proposed rule in a manner consistent with these requirements and are affording the public 60 days to participate and provide comments.
For purpose of the Paperwork Reduction Act, 44 U.S.C. Ch. 35, SBA has determined that this proposed rule would not impose any new reporting or recordkeeping requirements.
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601, requires administrative agencies to consider the effect of their actions on small entities, including small businesses. According to the RFA, when an agency issues a rule, the agency must prepare an analysis to determine whether the impact of the rule will have a significant economic impact on a substantial number of small entities. However, the RFA allows an agency to certify a rule in lieu of preparing an analysis if the rulemaking is not expected to have a significant impact on a substantial number of small entities. This proposed rule conforms to
Disaster assistance, Loan programs-business, Reporting and recordkeeping requirements, Small businesses.
For reasons set forth in the preamble, SBA proposes to amend 13 CFR part 123 as follows:
15 U.S.C. 632, 634(b)(6), 636(b), 636(d), 657n; Pub. L. 102-395, 106 Stat. 1828, 1864; Pub. L. 103-75, 107 Stat. 739; and Pub. L. 106-50, 113 Stat. 245.
* * * Sudden events that cause substantial economic injury may be disasters even if they do not cause physical damage to a victim's property. * * *
(a) * * *
(1) The President declares a Major Disaster and authorizes Federal Assistance, including individual assistance (Assistance to Individuals and Households Program).
4. Amend § 123.11 by revising paragraph (a)(2) to read as follows:
(a) * * *
(2)
The revisions and additions read as follows:
(a) Generally, SBA will consider your request for an increase in your loan if you can show that the eligible cost of repair or replacement of damages increased because of events occurring after the loan approval that were beyond your control.* * *
(b) For all disasters occurring on or after November 25, 2015, you may also request an increase in your loan if you suffered substantial economic damage or substantial risks to health or safety as a result of malfeasance in connection with the repair or replacement of real property or business machinery and equipment for which SBA made a disaster loan. See § 123.105 for limits on home loan amounts and § 123.202 for limits on business loan amounts. Malfeasance may include, but is not limited to, nonperformance of all or any portion of the work for which a contractor was paid, work that does not meet acceptable standards, or use of substandard materials.
(a) * * *
(b) For physical disaster loan increases requested under § 123.18(b) as a result of malfeasance, the request must be received not later than two years after the date of final disbursement.
A mitigation measure is something done for the purpose of protecting property and occupants against disaster related damage.* * * Examples of mitigation measures include building retaining walls, sea walls, grading and contouring land, elevating flood prone structures, relocating utilities, constructing a safe room or similar storm shelter (if such safe room or similar storm shelter is constructed in accordance with applicable standards issued by the Federal Emergency Management Agency), or retrofitting structures to protect against high winds, earthquakes, flood, wildfires, or other physical disasters.* * *
The revisions and additions read as follows:
(a) There are limits on how much money you can borrow for particular purposes:
(4) 20 percent of the verified loss (not including refinancing or malfeasance), before deduction of compensation from other sources, up to a maximum of $200,000 for post-disaster mitigation (see § 123.107); and
(5) $200,000 for eligible malfeasance, pursuant to § 123.18.
Federal Trade Commission (“FTC” or “Commission”).
Advance notice of proposed rulemaking; request for public comment.
As part of the Commission's systematic review of all current FTC rules and guides, the Commission requests public comment on the overall costs, benefits, necessity, and regulatory and economic impact of the FTC's “Trade Regulation Rule Concerning the Labeling and Advertising of Home Insulation” (the “R-value Rule” or “Rule”).
Comments must be received on or before June 6, 2016.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Hampton Newsome, (202) 326-2889, Attorney, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Thermal insulation is an important energy-savings product that reduces consumers' heating and cooling costs and increases their home energy efficiency. The Commission promulgated the R-value Rule, found at 16 CFR part 460 (“the current Rule” or “the current R-value Rule”), in 1979 to address the failure of the home insulation marketplace to provide essential pre-purchase information to consumers, primarily an insulation product's “R-value.”
The FTC's current R-value Rule provides substantiation and disclosure requirements for insulation products used in the residential market and prohibits certain claims unless they are true. Specifically, the current Rule requires insulation sellers to disclose the insulation product's R-value and related information for their products based on uniform, industry-adopted test procedures.
The R-value Rule covers all “home insulation products.” Under the current Rule, the term “insulation” includes any product “mainly used to slow down heat flow” from, for example, a heated interior through exterior walls to the outside.
Home insulation falls into two basic categories: “mass” and “reflective.” Mass insulations reduce heat transfer by conduction (through the insulation's mass), convection (air movement within, and through, the air spaces inside the insulation), and radiation. Reflective insulations (primarily aluminum foils) reduce heat transfer when installed facing an airspace. Within these basic categories, home insulation is sold in various types or materials (
The current Rule applies to home insulation manufacturers, professional installers, retailers who sell insulation to consumers for do-it-yourself installation, and new home sellers, including sellers of manufactured housing. It also applies to testing laboratories that conduct R-value tests for home insulation manufacturers or other sellers who base their R-value claims on these test results.
The Commission first issued the current R-value Rule in response to a variety of unfair or deceptive acts or practices in the insulation industry. Specifically, the Commission found that many sellers: (1) Failed to disclose R-values, impeding informed purchasing decisions and misleading consumers who based their purchases on price or thickness alone; (2) exaggerated R-value disclosures and often failed to account for material factors (
The current Rule requires manufacturers and others who sell home insulation to disclose R-value and related information (
The current Rule also requires specific disclosures on manufacturer product labels and fact sheets, installer receipts, and new home seller contracts. For example, insulation labels must display, among other things, the product's R-value and the statement “R means resistance to heat flow. The higher the R-value, the greater the insulating power.”
The Commission reviews its rules and guides periodically to seek information about their costs and benefits, regulatory and economic impact, and general effectiveness in protecting consumers and helping industry avoid deceptive claims. These reviews assist the Commission in identifying rules and guides that warrant modification or rescission. As part of its last review in 2005, the Commission issued several amendments to update and improve the Rule.
With this document, the Commission initiates a new review. The Commission solicits comments on, among other things, the economic impact of, and the continuing need for, the R-value Rule; the Rule's benefits to consumers; and the burdens it places on industry members subject to the requirements, including small businesses.
To aid commenters in submitting information, the Commission has prepared the following specific questions related to the R-value Rule. The Commission seeks comments on these and any other issues related to the Rule's current requirements. In their replies, commenters should provide any available evidence that supports their position.
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(1)
The current Rule addresses this aging process by requiring that R-value tests be performed on specimens that “fully reflect the effect of aging on the product's R-value.” Section 460.5(a)(1) of the Rule accepts the use of the “accelerated aging” procedure in General Services Administration (“GSA”) Purchase Specification HH-I-530A (which was in effect at the time the Commission promulgated the Rule) as a permissible “safe harbor” procedure, but also allows manufacturers to use “another reliable procedure.”
(2)
(3)
(4)
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before June 6, 2016. Write “16 CFR part 460—R-value Rule Review, File No. R811001” 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 have 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 comments online, or send them 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 prefer to file your comment on paper, write “16 CFR part 460—R-value Rule Review, File No. R811001” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex B), 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 B), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
By direction of the Commission.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish a special local regulation on the Atlantic Intracoastal Waterway in Bucksport, South Carolina during the Bucksport/Southeastern Drag Boat Summer Championships, on August 13, and August 14, 2016. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. This proposed rulemaking would prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Charleston or a designated representative. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before May 6, 2016.
You may submit comments identified by docket number USCG-2016-0011 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Lieutenant John Downing, Sector Charleston Office of Waterways Management, Coast Guard; telephone (843) 740-3184, email
On December 27, 2015, the Bucksport Marina notified the Coast Guard that it will sponsor a series of drag boat races from 12 p.m. to 7 p.m. on August 13, and August 14, 2016. The legal basis for the proposed rule is the Coast Guard's Authority to establish special local regulations: 33 U.S.C 1233. The purpose of the proposed rule is to ensure safety of life on the navigable water of the United States during the Bucksport/Lake Murray Drag Boat Spring Nationals, a series of high speed boat races.
The Coast Guard proposes to establish a special local regulation on the Atlantic Intracoastal Waterway in Bucksport, South Carolina during Bucksport/Southeastern Drag Boat Summer Championships, on August 13 and August 14, 2016. Approximately 75 powerboats are anticipated to participate in the races and approximately 35 spectator vessels are expected to attend the event. Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the special local regulation by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders and we discuss the First Amendment rights of protestors.
E.O.s 12866 and 13563 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.
This proposed rule is not a significant regulatory action under section 3(f) of E.O. 12866, Regulatory Planning and Review, as supplemented by E.O. 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of E.O. 12866 or under section 1 of E.O. 13563. The Office of Management and Budget has not reviewed it under those Orders.
The economic impact of this proposed rule is not significant for the following reasons: (1) The special local regulation would be enforced for only seven hours a day over a two day period; (2) although persons and vessels would not be able to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port Charleston or a designated representative, they would be able to operate in the surrounding area during the enforcement periods; (3) persons and vessels would still be able to enter, transit through, anchor in, or remain within the regulated area if authorized by the Captain of the Port Charleston or a designated representative; and (4) the Coast Guard would provide advance notification of the regulated area to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. 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 governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. We have considered the impact of this proposed rule on small entities. This rule may affect the following entities, some of which may be small entities: the owner or operators of vessels intending to enter, transit through, anchor in, or remain within the regulated area during the enforcement period. For the reasons discussed in Regulatory Planning and Review section above, this rule will not 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 (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 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 proposed rule under that Order and have determined that it is consistent
Also, 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. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(b)
(c)
(2) The Coast Guard will provide notice of the regulated area by Marine Safety Information Bulletins, Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
(d)
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish a special local regulation on the Atlantic Intracoastal Waterway in Bucksport, South Carolina during the Bucksport/Southeastern Drag Boat Summer Extravaganza, on July 9 and July 10, 2016. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. This proposed rulemaking would prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Charleston or a designated representative. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before May 6, 2016.
You may submit comments identified by docket number USCG-2016-0010 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Lieutenant John Downing, Sector Charleston Office of Waterways Management, Coast Guard; telephone (843) 740-3184, email
On December 27, 2015, the Bucksport Marina notified the Coast Guard that it will sponsor a series of drag boat races from 12 p.m. to 7 p.m. on July 9, and July 10, 2016. The legal basis for the proposed rule is the Coast Guard's Authority to establish special local regulations: 33 U.S.C 1233. The purpose of the proposed rule is to ensure safety of life on the navigable water of the United States during the Bucksport/Lake Murray Drag Boat Spring Nationals, a series of high speed boat races.
The Coast Guard proposes to establish a special local regulation on the Atlantic Intracoastal Waterway in Bucksport, South Carolina during the Bucksport/Southeastern Drag Boat Summer Extravaganza, on July 9 and July 10, 2016. Approximately 75 powerboats are anticipated to participate in the races and approximately 35 spectator vessels are expected to attend the event. Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the special local regulation by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders and we discuss the First Amendment rights of protestors.
E.O.s 12866 and 13563 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.
This proposed rule is not a significant regulatory action under section 3(f) of E.O. 12866, Regulatory Planning and Review, as supplemented by E.O. 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of E.O. 12866 or under section 1 of E.O. 13563. The Office of Management and Budget has not reviewed it under those Orders.
The economic impact of this proposed rule is not significant for the following reasons: (1) The special local regulation would be enforced for only seven hours a day over a two-day period; (2) although persons and vessels would not be able to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port Charleston or a designated representative, they would be able to operate in the surrounding area during the enforcement periods; (3) persons and vessels would still be able to enter, transit through, anchor in, or remain within the regulated area if authorized by the Captain of the Port Charleston or a designated representative; and (4) the Coast Guard would provide advance notification of the regulated area to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. 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 governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. We have considered the impact of this proposed rule on small entities. This rule may affect the following entities, some of which may be small entities: The owner or operators of vessels intending to enter, transit through, anchor in, or remain within the regulated area during the enforcement period. For the reasons discussed in Regulatory Planning and Review section above, this rule will not 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 (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 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 proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, 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. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(b)
(c)
(2) The Coast Guard will provide notice of the regulated area by Marine Safety Information Bulletins, Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
(d)
Federal Communications Commission.
Proposed rule.
This document proposes to amend the FM Table of Allotments by allotting Channel 300A at Raymond, Washington, as the community's second or third local service. After the filing of the petition, a change of community application was filed for Station KBSG(FM) from Westport, Washington, to Raymond, Washington. Therefore, if the application is granted prior to the issuance of the
Comments must be filed on or before May 16, 2016, and reply comments on or before May 31, 2016.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554. In addition to filing comments with the FCC, interested parties should serve the rule making petitioner and the counter proponent as follows: Peter Gutmann, Esq., Womble Carlyle Sandridge & Rice, LLP, 1200 19th Street NW., 5th Floor, Washington, DC 20036.
Rolanda F. Smith, Media Bureau, (202) 418-2700.
This is a synopsis of the Commission's
In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
Provisions of the Regulatory Flexibility Act of l980 do not apply to this proceeding.
Members of the public should note that from the time a Notice of Proposed Rule Making is issued until the matter is no longer subject to Commission consideration or court review, all
For information regarding proper filing procedures for comments, see 47 CFR 1.415 and 1.420.
Radio, Radio broadcasting.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 73 as follows:
47 U.S.C. 154, 303, 334, 336, and 339.
National Highway Traffic Safety Administration (NHTSA), DOT.
Denial of petition for rulemaking.
This document denies a rulemaking petition submitted by Mr. James E. Hofferberth on April 1, 2013. His petition includes two requests: (1) To regulate the performance of supplementary automotive restraint systems that are marketed specifically for pregnant women; and (2) to require prominent warning labels in all vehicles with the intent of informing pregnant women that “seat belts could injure or kill their unborn child,” specifically by crushing the unborn baby in a frontal crash. NHTSA is denying the petition to regulate the performance of these systems because the agency does not have sufficient information at this time to state whether there is an additional net safety benefit/disbenefit to be derived from their use or whether one type of device is superior to another. NHTSA is denying the petition for labeling because this would provide advice that, if followed, would threaten the safety of both the mother and the unborn child in a crash.
In a letter dated April 1, 2013, Mr. James E. Hofferberth petitioned NHTSA to regulate the performance of supplementary automotive restraint systems for pregnant women and to also require prominent warning labels in all vehicles with the intent of informing pregnant women that “seat belts could injure or kill their unborn child.” This is the petitioner's second request for rulemaking regarding the safety of seat belts for pregnant women.
In 2005, NHTSA received a petition for rulemaking from this same petitioner, Mr. James E. Hofferberth, requesting that the agency initiate rulemaking to require an advisory placard warning occupants that seat belts should not be worn by pregnant women. On March 23, 2006, NHTSA published a
NHTSA recommends that pregnant women wear their seat belts, as does the American College of Obstetricians and Gynecologists (ACOG).
The safety benefits to pregnant women from wearing seat belts are supported by a research study,
The agency conducted an extensive review in its analysis of the petition. This included a review of technical literature, including a study by the University of Michigan Transportation Research Institute (UMTRI), as well as the papers cited by the petitioner. The agency also conducted a full review of the NHTSA field data repositories for evidence of supplementary automotive restraints causing harm to pregnant women in motor vehicle crashes (MVCs). The agency's findings are provided in the following sections of this notice, and they reaffirm the position stated in the 2006 denial notice.
NHTSA has sponsored research studying and demonstrating the effectiveness of properly adjusted restraint systems for pregnant women from as early as 1971,
More recently, a 2008 paper written by these same researchers at UMTRI
The 57 investigated cases all involved women of at least 20 weeks gestation who were involved in a motor vehicle crash that was not a rollover and who agreed to participate. Natural spontaneous pregnancy loss before 20 weeks of gestation being not uncommon, which made association of fetal loss so early in pregnancy with an MVC questionable, and the difficulty in determining injury causation to occupants during a rollover event
The database created by this study became the largest collection of MVCs involving pregnant women including detailed quantitative information about both the crash event and the outcome for the unborn baby, with a focus on crashes with both positive and negative fetal outcomes. The seat belt usage rate in the database was reported as 72 percent,
To analyze the claims in the petition, the agency studied crashes involving pregnant women in the applicable NHTSA data repositories: Artemis,
NASS CDS started tracking fetal demise in 2006. The sampling is designed in such a way that it is possible to use the data to compute estimates representative of the entire country through application of a multiplier (case weight) to each NASS CDS case.
The weighted estimate of 112,341 pregnant women was derived from 439 unweighted cases. Twenty-four of these 439 cases were coded as involving the death of an unborn child. However, the
Due to the small number of cases involving pregnant women who lost an unborn child after a crash and variation in the NASS CDS case weight factors applied to small numbers,
In order to be consistent with previous research in studying the deaths of unborn babies in frontal crashes, NHTSA aligned the NASS CDS data with that of the 2008 UMTRI study. This eliminated 18 of the 19 cases from the 2006-2011 NASS CDS dataset involving the death of an unborn child: Eight cases
The one NASS CDS case that matched the 2008 UMTRI study criteria was case 2006-78-71. In this case, two vehicles were involved in a head-on collision. The 32 year old driver of the second vehicle, a 1993 Mazda 626 equipped with air bags, was 9 months pregnant and not wearing a seat belt. She was 150 cm tall and weighed 64 kg, with a Body Mass Index (BMI)
This multi-event case from NASS CDS was also the focus of a NHTSA SCI investigation due to the concern that placental abruption was possibly caused by the seat belt. In this case, the vehicle containing the 40 year old pregnant woman, a 2006 Mercedes Benz E350, collided with a 2005 Ford Explorer Sport Trac attempting to make a left-hand turn. Crash reconstruction estimated the pregnant woman's vehicle to have a longitudinal Delta-V of 37 km/h. The Mercedes struck the Ford forward of its center of gravity, causing the Ford to quickly rotate and strike the Mercedes in a side-slap impact. The pregnant woman was seated in the first row passenger seat and was wearing her seat belt, though it is unknown whether the seat belt was worn correctly. She was 165 cm tall and weighed 91 kg at the time of the crash, corresponding to a BMI of 33.4, placing her in the obese category.
The pregnant woman had 11 injuries with AIS scores ranging from 1 to 3. The most critical six were determined to have possibly resulted from contact with the driver and the center console during the side-slap, the most severe being an AIS 3 cerebrum subarachnoid hemorrhage. These injuries did not occur in the uterine area, and they were not directly related to the death of the unborn child. Injury number 7 of 11 was
While the crash was assigned to NHTSA's SCI team, the SCI investigators were not able to conduct interviews or inspect the vehicle until approximately 6 months after the crash. Though it was certain that the pregnant woman had been wearing her seat belt, investigators were not able to conclusively determine whether or not she had been wearing it correctly.
Mr. Hofferberth petitions for two rulemakings. First, he requests that the agency initiate a rulemaking for Supplementary Automotive Restraint Systems for Pregnant Women. Second, the petitioner requests that the agency initiate rulemaking to require the warning of pregnant women that the seat belts could injure or kill their unborn children.
The petitioner, in both his letter and the attached report, states his beliefs that unborn babies are in danger of being crushed by the lap belt portion of a seat belt during a frontal collision and that seat belts are not appropriate for use by pregnant women. He cites research that he asserts shows that the lap belt portion of the restraint system has been implicated in causing specific trauma to the placenta and unborn child in relatively minor vehicular accidents. He also cites other research that he argues shows a high rate of fetal and placental injury and asserts that research shows that the fetus of a pregnant woman is approximately five times more likely to receive serious injury than a 0-1 year old child using a supplementary infant or child restraint riding in the same car.
The petitioner also states that there are many supplementary restraint products on the market for pregnant women, which are not all equally effective and in some cases dangerous. The petitioner presents depictions and makes assertions regarding the effectiveness of several of these restraints, including a restraint which he patented.
Motor vehicle safety standards must be practicable, meet the need for motor vehicle safety, and be stated in objective terms. 49 U.S.C. 30111(a). Petitions for rulemaking are governed by 49 CFR part 552. Pursuant to Part 552, the agency conducts a technical review of the petition, which may consist of an analysis of the material submitted, together with information already in possession of the agency. In deciding whether to grant or deny a petition, the agency considers this technical review as well as appropriate factors, which may include, among others, allocation of agency resources and agency priorities.
The agency's technical review of the petition had several main parts. First, the agency reviewed the petition and the sources it cited before conducting a comprehensive literature review, which included material from the early 1970s through the present. Additionally, the agency, as described above, conducted an updated review of crash data available from the NHTSA field databases, including NASS CDS. The agency considered all of the information contained in the petition, and for the reasons stated below, the agency is denying the petition.
The first part of Mr. Hofferberth's petition asks that NHTSA regulate the performance of supplementary automotive restraint systems for pregnant women. In assessing this aspect of the petition, NHTSA first attempted to quantify the safety problem,
For example, the petitioner asserts that unborn babies are in danger of being crushed by the lap belt portion of a seat belt during a frontal collision and that seat belts are not appropriate for use by pregnant women. However, the comprehensive UMTRI study showed that a pregnant woman's proper use of a seat belt has a positive effect on fetal outcome in a crash: “an 84 percent reduction in risk of adverse fetal outcome is obtained by properly wearing a seatbelt. On the basis of this relative risk and an overall belt use rate of 80 percent, unbelted pregnant occupants sustain an estimated 62 percent of all fetal losses in motor vehicle crashes.” In addition, the amniotic fluid is capable of resisting the forces from the lap portion of a seat belt, and can aid in preventing the belt from penetrating through the unborn baby's body.
Similarly, the petitioner asserts that the lap belt portion of the restraint system causes fetal trauma in relatively minor crashes. However, as discussed above, a study
Additionally, the agency performed an updated review of crash data available from the NHTSA field databases, including NASS CDS. Although the petitioner asserts that
With regard to establishing performance requirements for supplemental restraints, NHTSA does not have sufficient information at this time to state whether there is any additional net safety benefit/disbenefit to be derived from their use or whether one type of device is superior to another. The agency notes that these devices are considered motor vehicle equipment, and manufacturers of these devices are subject to the recall and remedy requirements of the Motor Vehicle Safety Act (49 U.S.C. 30118-30120). To date NHTSA has not seen evidence of these devices causing harm to pregnant women. Artemis, the agency's central repository of data on motor vehicles and motor vehicle equipment defects, does not currently contain entries related to complaints or reported injuries resulting from the use of such devices.
Given the observed correlation between maternal and fetal outcome, the agency believes that improvements in crashworthiness, particularly advancements in occupant restraint systems, will serve to protect pregnant women and their unborn children. NHTSA continues to work towards these improvements through research efforts in the areas of advanced restraints and improvements to the Federal motor vehicle safety standards. The petitioner did not provide any data or testing to support the benefits of supplemental devices or the merits of the proposed test procedure to discriminate between good and bad performance to serve as a basis for such a performance requirement.
The second request in the petition asks that the agency warn pregnant women of the risk from the seat belt through a prominent warning label required in every vehicle. As noted in the
As noted above, the agency conducted an extensive literature review and reviewed all sources cited by the petitioner. It is the agency's view that this literature shows that the most effective way to protect the unborn baby is to protect the pregnant woman. Technical studies were discussed in the preceding sections of this notice of decision. Additionally, the agency is not aware of any serious injuries to pregnant women caused by seat belts in non-impact situations, and the aforementioned 2008 Klinich paper showed that “[c]laims that restraints cause adverse fetal outcomes cannot be substantiated without reliable information on crash severity.”
The agency's field data analysis shows, among other things, that seat belt-caused uterine or placental injuries during crashes are extremely rare (0.1 percent of cases) and that seat belt use dramatically reduces the risk of dying in a crash for both pregnant women and unborn children. Additional information regarding the agency's field data analysis is provided above in section I.C.2.
Accordingly, for the reasons stated above, the petition is denied.
A study showed that despite NHTSA recommending specific seat belt best practices for pregnant women, approximately one quarter of the pregnant women being studied did not follow the recommendation, and nearly two thirds of them had not received the information.
Another recent study supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, of the National Institutes of Health, reported that even though most pregnant women wear seat belts, those who do are not necessarily wearing them correctly. Additionally, this report states that despite ACOG's recommendation that all pregnant women receive prenatal seat belt counseling, not all women receive it. It also suggests that increased educational efforts emphasizing not only the use of seat belts but also their proper placement would be appropriate.
The agency believes that it is very important to convey the importance of proper seat belt use to pregnant women. As indicated by the aforementioned studies, a large percentage of pregnant women are not following the current recommendations; therefore, NHTSA has decided to increase outreach efforts in this area. NHTSA currently posts the agency's official brochure,
After carefully considering the safety need for the requested rulemaking and supporting information and in accordance with 49 CFR part 552, NHTSA hereby denies Mr. James E. Hofferberth's April 1, 2013 petition to regulate the performance of supplementary automotive restraint systems that are marketed specifically for pregnant women and to require prominent warning labels in all vehicles with the intent of informing pregnant women that “seat belts could injure or kill their unborn child.” Research and real-world data show the substantial benefits of seat belt use for both pregnant women and unborn children, and the agency recommends that all pregnant women wear properly adjusted seat belts.
The agency takes the safety of pregnant women very seriously and has already begun to increase awareness and educational efforts related to the proper use of seat belts while continuing to monitor the data trends surrounding this issue.
In accordance with 49 CFR part 552, this concludes the agency's review of the petition.
49 U.S.C. 322, 30111, 30115, 30117, and 30162; delegation of authority at 49 CFR 1.95.
Economic Research Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces the Economic Research Service's intention to request approval for a new information collection for a Pilot Survey on Food Acquisition among American Households.
Written comments must be received by June 6, 2016 to be assured of consideration.
Address all comments concerning this notice to John Kirlin, Food Assistance Branch, Food Economics Division, Economic Research Service, U.S. Department of Agriculture, 1400 Independence Ave. SW., Mailstop 1800, Washington, DC 20250-0002. Comments may also be submitted via email to
John Kirlin,
The U.S. Department of Agriculture collected similar data in 2012-2013 with the National Household Food Acquisition and Purchase Survey (FoodAPS, OMB Control Number 0536-0068). Participating household members in that survey used food booklets and a hand-held scanner to record information about all food acquisitions during a 7-day period. There is evidence in the FoodAPS data of some drop-off in the frequency of reported food acquisitions toward the end of the 7-day reporting periods. FoodAPS was a nationally representative survey with over-sampling of households participating in the Supplemental Nutrition Assistance Program (SNAP) and non-SNAP households with low incomes.
The main objective of the NFS pilot is to test an alternative method of collecting data on the foods acquired by American households that leads to more complete and accurate information about patterns of food acquisitions. Other objectives are to explore the feasibility of expanding the population of interest to include households receiving benefits from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and to collect more complete and accurate information on income. Data will be collected from households in nine states.
The sample will be selected from an address-based sampling frame. A total of 2,154 households from 12 Primary Sampling Units (PSUs) in nine states will receive a letter requesting their participation in the study. The pilot will also test the effectiveness of using WIC and SNAP administrative data at identifying SNAP and WIC participants.
The NFS pilot data collection begins by screening households via an in-person interview to determine eligibility and identifying a primary respondent (person who does the majority of the grocery shopping and cooking for the household) within eligible households. Next, an in-person initial interview is completed with the primary respondent. Then, all members of the household age 11 years and older are asked to access a web-based system daily to report food or drinks obtained during their assigned data collection week. Upon completion of the week-long data collection, a final in-person interview is completed with the primary respondent. To determine measurement error, immediately after the final interview, a follow-up re-interview will be conducted with two household members about their last two reporting days and to probe for missing information.
Food obtained by household members includes food purchased or obtained for free and brought into the home as well as food purchased or acquired for free outside of the home. Information to be collected about each food event will include place name and type, location, date, total cost, and method(s) of payment. Food item information to be collected will include an item descriptor, quantity acquired, unit price, and use of coupons or store loyalty cards that reduce actual cost. Participants also will be asked to upload photos of receipts. Participants will receive reminder email messages or text messages throughout the week if they do not report acquisitions for a day. If needed, households will be provided electronic equipment for the duration of their data collection period to assist them in accessing the web instrument.
Recruited households will receive $50 upon completion of the initial interview. Households will accumulate a $3 per day credit for each eligible household member whose food purchase behavior (including affirmation of no acquisitions) is recorded in the web system for that day, and a bonus of $50 for households whose members record food acquisitions for all 7 days and that complete the final interview. Finally, $5 will be provided to the household if members complete the income questions online.
All data collection instruments will ask only the most pertinent information, and the web-based system will be as respondent- and user-friendly as possible. Responses are voluntary and confidential. The instruments and procedures will be pretested prior to the finalization.
Responses from the National Food Study pilot will be combined for statistical purposes and reported only in aggregate or statistical form. A final report summarizing the findings will include an evaluation on the accuracy of administrative data used to select WIC and SNAP households as well as an
These data will be collected under the authority of 7 U.S.C. 2204(a). ERS will comply with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA)”, 72 FR 33362, June 15, 2007. Respondent information will be protected under the CIPSEA and the 7 U.S.C. 2276.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.
Food and Nutrition Service (FNS), USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and public agencies to comment on a proposed information collection. This collection is an extension, without change, of a currently approved collection for maintaining the National Disqualified List of institutions, day care home providers, and individuals that have been terminated or otherwise disqualified from Child and Adult Care Food Program (CACFP) participation. These federal requirements affect eligibility under the CACFP. The State Agencies are required to enter data as institutions and individuals become disqualified from participating in the CACFP. The collection is the result of a FNS web-based system constructed to update and maintain the list of disqualified institutions and individuals so that no State agency or sponsoring organization may approve any entity on the National Disqualified List to ensure the integrity of the Program.
Written comments must be received on or before June 6, 2016.
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 will 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 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: Sarah Smith-Holmes, Director, Program Monitoring and Operational Support Branch, Child Nutrition Division, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 630, Alexandria, Virginia 22302. Comments will also be accepted through the Federal eRulemaking Portal. Go to
All written comment(s) will be open for public inspection at the office of the Food and Nutrition Service during regular business hours (8:30 a.m. to 5 p.m., Monday through Friday) at 3101 Park Center Drive, Room 640, Alexandria, Virginia 22302.
All responses to this notice will be summarized and included in the request for Office of Management and Budget (OMB) approval, and will become a matter of public record.
Sarah Smith-Holmes (703) 305-2063.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the “Department”) is rescinding the administrative review of the antidumping duty order on steel wire garment hangers from Taiwan for the period of review (“POR”), December 1, 2014, through November 30, 2015.
Kenneth Hawkins, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone 202.482.6491.
On February 9, 2016, based on a timely request for review by Petitioners,
Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review if the party that requested the review withdraws its request within 90 days of the publication of the notice of initiation of the requested review. Petitioners withdrew their request within the 90-day deadline. No other party requested an administrative review of the antidumping duty order. As a result, we are rescinding the administrative review of steel wire garment hangers from Taiwan for the POR.
The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries. Because the Department is rescinding this administrative review in its entirety, the entries to which this administrative review pertained shall be assessed antidumping duties at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions to CBP 15 days after the publication of this notice.
This notice serves as a final 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 the antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a final reminder to parties subject to 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/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Katie Marksberry, AD/CVD Operations, Office V, Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-7906.
On February 8, 2016, the Department of Commerce (“Department”) initiated the countervailing duty investigation of certain biaxial integral geogrid products from the People's Republic of China.
Section 703(b)(1) of the Tariff Act of 1930, as amended (“the Act”), requires the Department to issue the preliminary determination in a countervailing duty investigation within 65 days after the date on which the Department initiated the investigation. However, if the Department concludes that the parties concerned are cooperating, and that the case is extraordinarily complicated such that additional time is necessary to make the preliminary determination, section 703(c)(l)(B) of the Act allows the Department to postpone making the preliminary determination until no later than 130 days after the date on which the administering authority initiated the investigation. We have concluded that the parties concerned are cooperating and that the case is extraordinarily complicated, such that we will need more time to make the preliminary determination. Specifically, the Department finds that the instant case is extraordinarily complicated by reason of the number and complexity of the alleged countervailable subsidy practices, and the need to determine the
Additionally, the Department notes that we issued questionnaires to the respondents in this case on March 1, 2016. The due date for these questionnaires is April 7, 2016, which is only six days before the unextended preliminary determination date. For these reasons we are fully extending the due date until 130 days after the Department's initiation for the preliminary determination. Therefore, the deadline for the completion of the preliminary determination is now June 17, 2016.
This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).
National Institute of Standards and Technology, Department of Commerce.
Notice of open meeting.
The National Construction Safety Team (NCST) Advisory Committee (Committee) will meet on Tuesday, May 3, 2016 from 9:00 a.m. to 5:00 p.m. Eastern Time. The primary purpose of this meeting is to update the Committee on the progress of the implementation of the National Institute of Standards and Technology (NIST) Joplin tornado investigation report's recommendations and receive NIST's response to the Committee's 2015 annual report and recommendations. The agenda may change to accommodate Committee business. The final agenda will be posted on the NIST Web site at
The NCST Advisory Committee will meet on Tuesday, May 3, 2016 from 9:00 a.m. until 5:00 p.m. Eastern Time. The meeting will be open to the public.
The meeting will be held in Building 101 Room C121, NIST, 100 Bureau Drive, Gaithersburg, Maryland 20899. Please note admittance instructions under the
Benjamin Davis, Management and Program Analyst, Community Resilience Program, Engineering Laboratory, NIST, 100 Bureau Drive, Mail Stop 8615, Gaithersburg, Maryland 20899-8604. Mr. Davis' email address is
The Committee was established pursuant to Section 11 of the NCST Act (Pub. L. 107-231), codified at 15 U.S.C. 7301
Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the NCST Advisory Committee will meet on Tuesday, May 3, 2016, from 9:00 a.m. until 5:00 p.m. Eastern Time. The meeting will be open to the public. The meeting will be held in Building 101 Room C121, NIST, 100 Bureau Drive, Gaithersburg, Maryland 20899. The primary purpose of this meeting is to update the Committee on the progress of the implementation of the NIST Joplin tornado investigation report's recommendations, available at
Individuals and representatives of organizations who would like to offer comments and suggestions related to items on the Committee's agenda for this meeting are invited to request a place on the agenda. On May 3, 2016, approximately fifteen minutes will be reserved near the conclusion of the meeting for public comments, and speaking times will be assigned on a first-come, first-served basis. The amount of time per speaker will be determined by the number of requests received, but is likely to be three minutes each. Questions from the public will not be considered during this period. All those wishing to speak must submit their request by email to the attention of Mr. Benjamin Davis,
All visitors to the NIST site are required to pre-register to be admitted. Anyone wishing to attend this meeting must register by 5:00 p.m. Eastern Time, Tuesday, April 26, 2016, in order to attend. Please submit your full name, email address, and phone number to Melissa Banner. Non-U.S. citizens must submit additional information; please contact Ms. Banner. Ms. Banner's email address is
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; new five-year affirmative findings for Ecuador, Guatemala, Mexico, and Spain.
The NMFS Assistant Administrator (Assistant Administrator) has issued new five-year affirmative findings for the Governments of Ecuador, Guatemala, Mexico, and Spain (Hereafter known as “The Nations”) under the Marine Mammal Protection Act (MMPA). These new five-year affirmative findings will allow yellowfin tuna and yellowfin tuna products harvested in the eastern tropical Pacific Ocean (ETP) in compliance with the International Dolphin Conservation Program (IDCP) by The Nations' flagged purse seine vessels or purse seine vessels operating under The Nations' jurisdiction to be imported into the United States. The new five-year affirmative findings were based on reviews of documentary evidence submitted by the Governments of The Nations and obtained from the Inter-American Tropical Tuna Commission (IATTC).
These new five-year affirmative findings are effective for the five-year period of April 1, 2015, through March 31, 2020.
Justin Greenman, West Coast Region, National Marine Fisheries Service, 501 W. Ocean Blvd., Long Beach, CA 90802. Phone: 562-980-3264. Email:
The MMPA, 16 U.S.C. 1361
The affirmative finding process requires that the harvesting nation is meeting its obligations under the IDCP and obligations of membership in the IATTC. Every five years, the government of the harvesting nation must request a new affirmative finding and submit the required documentary evidence directly to the Assistant Administrator. On an annual basis, NMFS reviews the affirmative finding and determines whether the harvesting nation continues to meet the requirements. A nation may provide information related to compliance with IDCP and IATTC measures directly to NMFS on an annual basis or may authorize the IATTC to release the information to NMFS to annually renew an affirmative finding determination without an application from the harvesting nation.
An affirmative finding will be terminated, in consultation with the Secretary of State, if the Assistant Administrator determines that the requirements of 50 CFR 216.24(f) are no longer being met or that a nation is consistently failing to take enforcement actions on violations, thereby diminishing the effectiveness of the IDCP.
As a part of the affirmative finding process set forth in 50 CFR 216.24(f), the Assistant Administrator considered documentary evidence submitted by the Governments of The Nations and obtained from the IATTC and has determined that The Nations have met the MMPA's requirements to receive new five-year affirmative findings.
After consultation with the Department of State, the Assistant Administrator issued new five-year affirmative findings to The Nations, allowing the continued importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by The Nations' flagged purse seine vessels or purse seine vessels operating under The Nations jurisdiction for the five-year period of April 1, 2015, through March 31, 2020.
National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice, request for public comment.
Recognizing the vital importance of the Internet to U.S. innovation, prosperity, education, and civic and cultural life, the Department of Commerce has made it a top priority to encourage growth of the digital economy and ensure that the Internet remains an open platform for innovation. Thus, as part of the Department's Digital Economy Agenda, the National Telecommunications and Information Administration (NTIA) is initiating an inquiry regarding the Internet of Things (IoT) to review the current technological and policy landscape. Through this Notice, NTIA seeks broad input from all interested stakeholders—including the private industry, researchers, academia, and civil society—on the potential benefits and challenges of these technologies and what role, if any, the U.S. Government should play in this area. After analyzing the comments, the Department intends to issue a “green paper” that identifies key issues impacting deployment of these technologies, highlights potential benefits and challenges, and identifies possible roles for the federal government in fostering the advancement of IoT technologies in partnership with the private sector.
Comments are due on or before 5 p.m. Eastern Time on May 23, 2016.
Written comments may be submitted by email to
Travis Hall, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue, NW., Room 4725, Washington, DC 20230; telephone (202) 482-3522; email
Although a number of architectures describing different aspects or various applications of the IoT are being developed, there is no broad consensus on exactly how the concept should be defined or scoped. Consensus has emerged, however, that the number of connected devices is expected to grow exponentially, and the economic impact of those devices will increase dramatically.
However, the IoT also presents challenges,
In recognition of the broad impact that the Internet and digitization are having across the economy, in 2015 the Department created the Digital Economy Leadership Team (DELT). Comprised of senior officials from across the Department, the DELT provides high-level guidance and coordination, leveraging the substantial expertise within the agency to promote initiatives that have a positive impact on the digital economy and society. The DELT currently focuses on the four pillars of the Department's 2015-16 Digital Economy Agenda: promoting a free and open Internet worldwide; promoting trust and confidence online; ensuring
Given the cross-cutting nature of the IoT landscape, the Department of Commerce—through the DELT and IPTF—is able to provide important perspective and expertise on IoT. The mission of the Department is to help establish conditions that will enable the private sector to grow the economy, innovate, and create jobs. The Department also has statutory authority, expertise, and ongoing work streams in numerous areas that are critical to the development of IoT, including: cybersecurity, privacy, cross-border data flows, spectrum, international trade, advanced manufacturing, protection of intellectual property, standards policy, Internet governance, big data, entrepreneurship, and worker skills. For example:
• The Department has long standing technological and policy expertise and experience that it is applying to IoT. The Department's National Institute of Standards and Technology (NIST) has coordinated the development of a draft reference architecture for Cyber-Physical Systems and is conducting a Global City Teams Challenge to foster the development of Smart Cities and promote interoperability. NTIA's spectrum planning and management activities contemplate the growth of IoT and its Institute for Telecommunications Sciences (ITS) has begun testing the possible effects of IoT on spectrum usage. Both NIST and NTIA have been actively engaged with international standards bodies and international organizations on aspects of IoT and other related areas (
• The Economic Development Administration (EDA) provides grants to communities around the country to build up their technology-focused innovation ecosystems in order to grow their local economies and create jobs.
• The U.S. Patent and Trademark Office (USPTO) continues to improve its patent quality, especially in new technological domains, including IoT. USPTO also plays a key role in the alignment of intellectual property policies around the world, so that U.S. inventors of IoT technology can have access to the protections they need to continue innovating and sell their products and services everywhere.
• The International Trade Administration (ITA) is an active promoter of IoT and Smart Cities on the international stage, including participation in the CS Europe Smart Cities Initiative and working with the other Federal agencies to consider innovative financing mechanisms for Smart City projects. ITA hosts roundtables on an ad hoc basis with the private sector and federal partners to discuss Smart Cities and infrastructure financing. In addition, ITA's Office of Textiles and Apparel is holding a Smart Fabrics Summit (
For any response, commenters may wish to consider describing specific goals or actions that the Department of Commerce, or the U.S. Government in general, might take (on its own or in conjunction with the private sector) to achieve those goals; the benefits and costs associated with the action; whether the proposal is agency-specific or interagency; the rationale and evidence to support it; and the roles of other stakeholders.
1. Are the challenges and opportunities arising from IoT similar to those that governments and societies have previously addressed with existing technologies, or are they different, and if so, how?
a. What are the novel technological challenges presented by IoT relative to existing technological infrastructure and devices, if any? What makes them novel?
b. What are the novel policy challenges presented by IoT relative to existing technology policy issues, if any? Why are they novel? Can existing policies and policy approaches address these new challenges, and if not, why?
c. What are the most significant new opportunities and/or benefits created by IoT, be they technological, policy, or economic?
2. The term “Internet of Things” and related concepts have been defined by multiple organizations, including parts of the U.S. Government such as NIST and the FTC, through policy briefs and reference architectures.
3. With respect to current or planned laws, regulations, and/or policies that apply to IoT:
a. Are there examples that, in your view, foster IoT development and deployment, while also providing an appropriate level of protection to workers, consumers, patients, and/or other users of IoT technologies?
b. Are there examples that, in your view, unnecessarily inhibit IoT development and deployment?
4. Are there ways to divide or classify the IoT landscape to improve the precision with which public policy issues are discussed? If so, what are they, and what are the benefits or limitations of using such classifications? Examples of possible classifications of IoT could include: Consumer vs. industrial; public vs. private; device-to-device vs. human interfacing.
5. Please provide information on any current (or concluded) initiatives or research of significance that have examined or made important strides in understanding the IoT policy landscape. Why do you find this work to be significant?
6. What technological issues may hinder the development of IoT, if any?
a. Examples of possible technical issues could include:
b. What can the government do, if anything, to help mitigate these technical issues? Where may government/private sector partnership be beneficial?
7. NIST and NTIA are actively working to develop and understand many of the technical underpinnings for IoT technologies and their applications. What factors should the Department of Commerce and, more generally, the federal government consider when prioritizing their technical activities with regard to IoT and its applications, and why?
8. How will IoT place demands on existing infrastructure architectures, business models, or stability?
9. Are there ways to prepare for or minimize IoT disruptions in these infrastructures? How are these infrastructures planning and evolving to meet the demands of IoT?
10. What role might the government play in bolstering and protecting the availability and resiliency of these infrastructures to support IoT?
11. Should the government quantify and measure the IoT sector? If so, how?
a. As devices manufactured or sold (in value or volume)?
b. As industrial/manufacturing components?
c. As part of the digital economy?
i. In providing services
ii. In the commerce of digital goods
d. In enabling more advanced manufacturing and supply chains?
e. What other metrics would be useful, if any? What new data collection tools might be necessary, if any?
f. How might IoT fit within the existing industry classification systems? What new sector codes are necessary, if any?
12. Should the government measure the economic impact of IoT? If so, how?
a. Are there novel analytical tools that should be applied?
b. Does IoT create unique challenges for impact measurement?
13. What impact will the proliferation of IoT have on industrial practices, for example, advanced manufacturing, supply chains, or agriculture?
a. What will be the benefits, if any?
b. What will be the challenges, if any?
c. What role or actions should the Department of Commerce and, more generally, the federal government take in response to these challenges, if any?
14. What impact (positive or negative) might the growth of IoT have on the U.S. workforce? What are the potential benefits of IoT for employees and/or employers? What role or actions should the government take in response to workforce challenges raised by IoT, if any?
15. What are the main policy issues that affect or are affected by IoT? How should the government address or respond to these issues?
16. How should the government address or respond to cybersecurity concerns about IoT?
a. What are the cybersecurity concerns raised specifically by IoT? How are they different from other cybersecurity concerns?
b. How do these concerns change based on the categorization of IoT applications (
c. What role or actions should the Department of Commerce and, more generally, the federal government take regarding policies, rules, and/or standards with regards to IoT cybersecurity, if any?
17. How should the government address or respond to privacy concerns about IoT?
a. What are the privacy concerns raised specifically by IoT? How are they different from other privacy concerns?
b. Do these concerns change based on the categorization of IoT applications (
c. What role or actions should the Department of Commerce and, more generally, the federal government take regarding policies, rules, and/or standards with regards to privacy and the IoT?
18. Are there other consumer protection issues that are raised specifically by IoT? If so, what are they and how should the government respond to the concerns?
19. In what ways could IoT affect and be affected by questions of economic equity?
a. In what ways could IoT potentially help disadvantaged communities or groups? Rural communities?
b. In what ways might IoT create obstacles for these communities or groups?
c. What effects, if any, will Internet access have on IoT, and what effects, if any, will IoT have on Internet access?
d. What role, if any, should the government play in ensuring that the positive impacts of IoT reach all Americans and keep the negatives from disproportionately impacting disadvantaged communities or groups?
20. What factors should the Department consider in its international engagement in:
a. Standards and specification organizations?
b. Bilateral and multilateral engagement?
c. Industry alliances?
d. Other?
21. What issues, if any, regarding IoT should the Department focus on through international engagement?
22. Are there Internet governance issues now or in the foreseeable future specific to IoT?
23. Are there policies that the government should seek to promote with international partners that would be helpful in the IoT context?
24. What factors can impede the growth of the IoT outside the U. S. (
25. Are there IoT policy areas that could be appropriate for multistakeholder engagement, similar to the NTIA-run processes on privacy and cybersecurity?
26. What role should the Department of Commerce play within the federal government in helping to address the challenges and opportunities of IoT? How can the Department of Commerce best collaborate with stakeholders on IoT matters?
27. How should government and the private sector collaborate to ensure that infrastructure, policy, technology, and investment are working together to best fuel IoT growth and development? Would an overarching strategy, such as those deployed in other countries, be useful in this space? If the answer is yes, what should that strategy entail?
28. What are any additional relevant issues not raised above, and what role, if any, should the Department of Commerce and, more generally, the federal government play in addressing them?
Department of the Army, DoD.
Notice to alter a system of records.
The Department of the Army proposes to alter a system of records, A0600-37b DAPE, entitled “Unfavorable Information Files,” to record Board action and to provide pattern of subsequent unfavorable information. Information filed in the performance portion of the Official Military Personnel File is also used by Department of Army promotion/selection boards when the individual has been afforded due process.
Comments will be accepted on or before May 6, 2016. This proposed action will be effective on the date following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
*
*
Ms. Tracy Rogers, Department of the Army, Privacy Office, U.S. Army Records Management and Declassification Agency, 7701 Telegraph Road, Casey Building, Suite 144, Alexandria, VA 22325-3905 or by calling (703) 428-6185.
The Department of the Army's notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The proposed systems reports, as required by 5 U.S.C. 552a(r) of the Privacy Act, as amended, were submitted on March 28, 2016, to the House Committee on Oversight and Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).
Unfavorable Information Files (December 8, 2000, 65 FR 77002)
Delete entry and replace with “Summary of unfavorable information, copy of letter of notification to individual, individual's response or appeal, summary of consideration of response or appeal, disposition determination, and voting record of Board members. Personal data includes full name, Social Security Number (SSN), DoD ID number, grade/rank, mailing address, email, unit and location at discharge or separation, work and home telephone numbers.”
Delete entry and replace with “10 U.S.C. 3013, Secretary of the Army; Department of Defense Directive 1030.01, Victim and Witness Assistance; DoDI 1030.2, Victim and Witness Assistance Procedures; and Army Regulation 600-37, Unfavorable Information; and E.O. 9397 (SSN), as amended.”
Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, the records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To victims and witnesses of a crime for purposes of providing information, consistent with the requirements of the Victim and Witness Assistance Program, regarding the investigation and disposition of an offense.
The DoD Blanket Routine Uses set forth at the beginning of the Army's compilation of systems of records notices may apply to this system. The complete list of DoD Blanket Routine Uses can be found online at:
Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:
Delete entry and replace with “Paper records and electronic storage media.”
Delete entry and replace with “By individual's full name and SSN/DoD ID Number.”
Delete entry and replace with “Paper records in file cabinets are accessible only to authorized personnel who are properly instructed in the permissible use. The files are not accessible to the public or to persons within the command without an official need to know. File cabinets have locking capabilities and offices are locked during non-work hours. Army Activities and approved users ensure that electronic records collected and used are maintained in controlled areas accessible only to authorized personnel. Access to computerized data is restricted by use of Common Access Cards (CACs) and is accessible only by users with an authorized account. The system and electronic backups are maintained in controlled facilities that employ physical restrictions and safeguards such as security guards, identification badges, key cards, and locks.”
Delete entry and replace with “Individuals seeking to determine if information about themselves is contained in this system should address written inquiries to the Deputy Chief of Staff for Personnel, Department of the Army, 4000 Army Pentagon, Washington, DC 20310-4000.
Inquirer should furnish full name, SSN/DoD ID Number, current address and telephone number, and sufficient details concerning time and place of event to ensure locating pertinent records, and signature.
In addition, the requester must provide a notarized statement or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:
`I declare (or certify, verify, or state) under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on (date). (Signature)'.
If executed within the United States, its territories, possessions, or commonwealths: `I declare (or certify, verify, or state) under penalty of perjury that the foregoing is true and correct. Executed on (date). (Signature)'.”
Delete entry and replace with “Individuals seeking access to information about themselves contained in this system should address written request to the Deputy Chief of Staff for Personnel, Headquarters, Department of the Army, ATTN: DAPE-MPD, 4000 Army Pentagon, Washington, DC 20310-4000.
Inquirer should furnish full name, SSN/DoD ID Number, current address and telephone number, and sufficient details concerning time and place of event to ensure locating pertinent records, and signature.
In addition, the requester must provide a notarized statement or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:
`I declare (or certify, verify, or state) under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on (date). (Signature)'.
If executed within the United States, its territories, possessions, or commonwealths: `I declare (or certify, verify, or state) under penalty of perjury that the foregoing is true and correct. Executed on (date). (Signature)'.”
Delete entry and replace with “The Army's rules for accessing records, and for contesting contents and appealing initial agency determinations are contained in 32 CFR part 505, Army Privacy Program; or may be obtained from the system manager.”
Office of the Under Secretary of Defense for Policy, DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by June 6, 2016.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Leadership and Organizational Development Office, 2400 Defense Pentagon, Room 5B683, ATTN: Dr. James Cully, Washington, DC 20301-2400, or call, at 703.695.7386.
Respondents are defense contractors employed by Office of the Under Secretary of Defense for Policy who provide analytic, administrative, and operations services. The survey is administered to all employees of the Office of Secretary of Defense for Policy as required by the Under Secretary of Defense for Policy to assess the effectiveness and progress of the current human capital strategy. If contractors are not permitted to take the survey then the assessment effectively excludes ~20% of the employee population, diminishing the accuracy of the survey and resulting conclusions.
Office of Innovation and Improvement (OII), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before May 6, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Corinne Sauri, 202-260-2533.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Electricity Delivery and Energy Reliability, DOE.
Notice of Filing.
On March 15, 2016, Middlesex Energy Center, LLC, as owner and operator of a new combined cycle electric powerplant, submitted a coal capability self-certification to the Department of Energy (DOE) pursuant to § 201(d) of the Powerplant and Industrial Fuel Use Act of 1978 (FUA), as amended, and DOE regulations in 10 CFR 501.60, 61. FUA and regulations thereunder require DOE to publish a notice of filing of self-certification in the
Copies of coal capability self-certification filings are available for public inspection, upon request, in the Office of Electricity Delivery and Energy Reliability, Mail Code OE-20, Room 8G-024, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585.
Christopher Lawrence at (202) 586-5260.
Title II of FUA, as amended (42 U.S.C. 8301
The following owner of a proposed new combined cycle electric powerplant has filed a self-certification of coal-capability with DOE pursuant to FUA section 201(d) and in accordance with DOE regulations in 10 CFR 501.60, 61:
OWNER: Middlesex Energy Center, LLC,
CAPACITY: 560 megawatts (MW).
PLANT LOCATION: Borough of Sayreville, Middlesex County, New Jersey.
IN-SERVICE DATE: May 2019.
Wind and Water Power Technologies Office, Office of Energy Efficiency and Renewable Energy, Department of Energy (DOE).
Notice of the Stakeholder Meeting.
The Wind and Water Power Technologies Office within the U.S. DOE intends to hold a Stakeholder Meeting on the request for information (RFI) to receive input for the U.S. DOE Outyear Marine and Hydrokinetic Program Strategy in Washington, DC on April 27, 2016. The RFI is posted on the EERE Exchange Web site:
DOE will host the Stakeholder Meeting from 12:00 p.m. to 5:00 p.m. on Wednesday, April 27, 2016.
The meeting will be held at the Capitol Hilton, 1001 16th St. NW., Washington, DC 20036.
Maggie Yancey, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Ave. SW., Washington, DC 20585. Telephone: (202) 586-4536. For email, please include in the subject line “Further Information,” and in the body of the email: your name, organization, contact information, and your specific question or inquiry.
The event is open to the public based upon space availability. All individuals, including those not able to attend will have the opportunity to submit comments to the RFI until 5:00 p.m. ET April 29, 2016. The RFI is posted on the EERE Exchange Web site:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
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:
This is a supplemental notice in the above-referenced proceeding of Innovative Solar 46, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 20, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on March 30, 2016, Michigan South Central Power Agency (MSCPA) filed a notice of cancellation of Original Sheet 1 which set forth MSCPA's Reactive Support Revenue Requirement for the provision of Reactive Supply and Voltage Control from Generation Sources Services to the Midcontinent Independent System Operator from the Endicott Generating Station, effective June 1, 2016.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
This is a supplemental notice in the above-referenced proceeding of White Pine Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 20, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the Dalton Expansion Project (Project), proposed by Transcontinental Gas Pipe Line, LLC (Transco) in the above-referenced docket. Transco requests authorization to construct and operate about 113 miles of new natural gas pipeline and associated facilities in Coweta, Carroll, Douglas, Paulding, Bartow, Gordon, and Murray Counties, Georgia and a new compressor station in Carroll County, Georgia. Additionally, Transco plans to modify existing facilities along its mainline transmission system in Virginia and North Carolina to accommodate bidirectional flow. Transco has indicated that the Project would provide 448,000 dekatherms per day of incremental firm transportation service to markets in northwest Georgia.
The EA assesses the potential environmental effects of the construction and operation of the Project in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of the proposed project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment.
The proposed Dalton Expansion Project includes the following facilities:
• A new 21,830 horsepower compressor station (Compressor Station 116) in Carroll County, Georgia;
• three new meter stations in Bartow and Murray Counties, Georgia;
• about 7.6 miles of new 30-inch-diameter pipeline in Coweta and Carroll Counties, Georgia;
• 48.2 miles of new 24-inch-diameter pipeline in Carroll, Douglas, Paulding, and Bartow Counties, Georgia;
• 53.5 miles of new 20-inch-diameter pipeline in Bartow, Gordon, and Murray Counties, Georgia;
• 1.5 miles of new 16-inch-diameter pipeline in Murray County, Georgia; and ancillary facilities associated with the new pipeline including mainline valves and pig1 launcher/receiver facilities.
The FERC staff mailed copies of the EA to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; newspapers and libraries in the project area; and parties to this proceeding. In addition, the EA is available for public viewing on the FERC's Web site (
Any person wishing to comment on the EA may do so. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that the Commission has the opportunity to consider your comments prior to making its decision on this project, it is important that we receive your comments in Washington, DC on or before May 2, 2016.
For your convenience, there are three methods you can use to file your comments to the Commission. In all instances, please reference the project docket number (CP15-117-000 with your submission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the eComment feature on the Commission's Web site (
(2) You can also file your comments electronically using the eFiling feature on the Commission's Web site (
(3) You can file a paper copy of your comments by mailing them to the following address:
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214).
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Environmental Protection Agency.
Notice.
The U.S. Environmental Protection Agency (EPA) invites nominations of scientific experts from a diverse range of disciplines to be considered for appointment to the Clean Air Scientific Advisory Committee (CASAC) and the EPA Science Advisory Board (SAB) and five SAB committees described in this notice. Appointments are anticipated to be filled by the start of Fiscal Year 2017 (October 2016).
Nominations should be submitted in time to arrive no later than May 6, 2016.
Nominators unable to submit nominations electronically as described below may submit a paper copy to the Designated Federal Officers (DFO) for the committees, as identified below. General inquiries regarding the work of the CASAC, the SAB or SAB committees also may be directed to the appropriate DFO.
The SAB Staff Office is especially interested in scientists with expertise described above who have knowledge and experience in air quality; agricultural sciences; climate change; drinking water; energy and the environment; water quality; water quantity; water reuse; ecosystem services; community environmental health; sustainability; chemical safety; green chemistry; human health risk assessment; homeland security; and waste and waste management.
For further information about the chartered SAB membership appointment process and schedule, please contact Mr. Thomas Carpenter, DFO, by telephone at (202) 564-4885 or by email at
The SAB Staff Office is also seeking nominations for experts for five SAB committees: The Chemical Assessment Advisory Committee; the Drinking Water Committee; the Environmental Economics Advisory Committee; the
(1) The SAB Chemical Assessment Advisory Committee (CAAC) provides advice through the chartered SAB regarding selected toxicological reviews of environmental chemicals available on EPA's Integrated Risk Information System (IRIS). The SAB Staff Office is seeking nominations of experts with experience in chemical assessments. Members should have expertise in one or more of the following disciplines:
(2) The SAB Drinking Water Committee (DWC) provides advice on the scientific and technical aspects of EPA's national drinking water program. The SAB Staff Office is seeking nominations of experts with experience on drinking water issues. Members should have expertise in one or more of the following disciplines:
(3) The SAB Environmental Economics Advisory Committee (EEAC) provides advice on methods and analyses related to economics, costs, and benefits of EPA environmental programs. The SAB Staff Office is seeking nominations of experts in
(4) The SAB Environmental Engineering Committee (EEC) provides advice on risk management technologies to control and prevent pollution. The SAB Staff Office is seeking nominations of experts to serve on the EEC with demonstrated expertise in the following disciplines:
(5) The Radiation Advisory Committee (RAC) provides advice on radiation protection, radiation science, and radiation risk assessment. The SAB Staff Office is seeking nominations of experts to serve on the RAC with demonstrated expertise in the following disciplines:
As these committees undertake specific advisory activities, the SAB Staff Office will consider two additional criteria for each new activity: absence of financial conflicts of interest and absence of an appearance of a loss of impartiality.
Nominators are asked to identify the specific committee for which nominees are to be considered. The following information should be provided on the nomination form: contact information for the person making the nomination; contact information for the nominee; the disciplinary and specific areas of expertise of the nominee; the nominee's
Candidates invited to serve will be asked to submit the “Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency” (EPA Form 3110-48). This confidential form allows EPA to determine whether there is a statutory conflict between that person's public responsibilities as a Special Government Employee and private interests and activities, or the appearance of a loss of impartiality, as defined by Federal regulation. The form may be viewed and downloaded through the “Ethics Requirements for Advisors” link on the SAB home page at
The order of presentations for the Federal Communications Commission Open Meeting on March 31, 2016 and listed in the Commission's Notice of March 24, 2016, has been changed and is listed below. In addition, the Consent Agenda scheduled for consideration at the Open Meeting has been deleted. Items 1, 3, 4 and 5 from the consent agenda have been adopted by the Commission.
Please note that the time for the open meeting is rescheduled from 10:30 a.m. to 12:00 p.m. The prompt and orderly conduct of the Commission's business requires this change and no earlier announcement was practicable.
The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests
Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live Web page at
For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services, call (703) 993-3100 or go to
The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, March 31, 2016, which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW., Washington, DC.
The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to:
Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live Web page at
For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services, call (703) 993-3100 or go to
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10342, Sunshine State Community Bank, Port Orange, Florida (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Sunshine State Community Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective April 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 32.1, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 32.1, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, 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
Comments must be submitted on or before June 6, 2016.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
Gary Kuiper or Manny Cabeza, at the FDIC address above.
Proposal to renew the following currently-approved collections of information:
1.
2.
3.
The rule also requires a higher-risk mortgage loan creditor to obtain an additional written appraisal, from a different licensed or certified appraiser, at no cost to the borrower, if: The higher-risk mortgage loan will finance the acquisition of the consumer's principal dwelling; the seller acquired the home within 180 days of signing the agreement to sell the property; and the consumer is purchasing the home for a higher price than the seller paid.
The additional written appraisal generally must include the following information: (1) An analysis of the difference in sale prices (
The information collection requirements are needed to protect consumers and promote the safety and soundness of creditors making higher-risk mortgage loans. This information is used by creditors to evaluate real estate collateral in higher-risk mortgage loan transactions and by consumers entering these transactions.
4.
The guidance outlines high-level principles related to safe and sound leveraged lending activities, including underwriting considerations, assessing and documenting enterprise value, risk management expectations for credits awaiting distribution, stress testing expectations and portfolio management, and risk management expectations, all of which will be reviewed during supervisory examinations to assess how well the financial institution is managing its risk. Banks will not be submitting documentation to the FDIC. Rather, FDIC examiners will review this documentation during examinations to assess a bank's management of its risk.
Comments are invited on: (a) Whether the collections of information are
Federal Deposit Insurance Corporation.
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
By Order of the Federal Maritime Commission.
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) 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,
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
National Program of Cancer Registries Cancer Surveillance System (NPCR CSS, OMB No. 0920-0469, exp. 5/31/2016)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
In 2012, the most recent year for which complete information is available, more than 580,000 people died of cancer and more than 1.5 million were diagnosed with cancer. It is estimated that 13.8 million Americans are currently alive with a history of cancer (2). In the U.S., state-based cancer registries are the only method for systematically collecting and reporting population based information about cancer incidence and outcomes such as survival. These data are used to measure the changing incidence and burden of each cancer; identify populations at increased or increasing risk; target preventive measures; and measure the success or failure of cancer control efforts in the U.S.
In 1992, Congress passed the Cancer Registries Amendment Act which established the National Program of Cancer Registries (NPCR). The NPCR provides support for state-based cancer registries that collect, manage and analyze data about cancer cases. The state-based cancer registries report information to CDC through the National Program of Cancer Registries Cancer Surveillance System (NPCR CSS), (OMB No. 0920-0469 5/31/2016). CDC plans to request OMB approval to continue collecting this information for three years. Data definitions will be updated to reflect changes in national standards for cancer diagnosis and coding, but the number of respondents and the burden per respondent will not change.
The NPCR CSS allows CDC to collect, aggregate, evaluate and disseminate cancer incidence data at the national level. The NPCR CSS is the primary source of information for
The NPCR CSS also allows CDC to monitor cancer trends over time, describe geographic variation in cancer incidence throughout the country, and provide incidence data on racial/ethnic populations and rare cancers. These activities and analyses further support CDC's planning and evaluation efforts for state and national cancer control and prevention. In addition, datasets can be made available for secondary analysis.
Respondents are NPCR-supported central cancer registries (CCR) in 45 U.S. states, 2 territories, and the District of Columbia. Thirty-eight CCR submit data elements specified for the Standard NPCR CSS Report. Ten specialized CCR submit data elements specified for the Enhanced NPCR CSS Report, which includes additional information about treatment and follow-up for cases of breast, colorectal, and chronic myeloid leukemia cases diagnosed in 2011. Each CCR is asked to transmit two data files to CDC per year. The first file, submitted in January, is a preliminary report consisting of one year of data for the most recent year of available data. CDC evaluates the preliminary data for completeness and quality and provides a report back to the CCR. The second file, submitted by November, contains cumulative cancer incidence data from the first diagnosis year for which the cancer registry collected data with the assistance of NPCR funds (
All information is transmitted to CDC electronically. Participation is required as a condition of the cooperative agreement with CDC. There are no costs to respondents except their time.
The total estimated annualized burden hours are 192 (152 for the Standard NPCR CSS Report, and 40 for the Enhanced NPCR CSS Report).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This meeting was announced in the
LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417,
In the
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Inorganic Arsenic in Rice Cereals for Infants: Action Level,” a supporting document entitled “Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants” (the supporting document), and a risk assessment report entitled “Arsenic in Rice and Rice Products Risk Assessment: Report” (the risk assessment report). The draft guidance, when finalized, will identify for industry an action level for inorganic arsenic in rice cereals for infants that will help protect public health and is achievable with the use of current good manufacturing practice. It also will describe our intended sampling and enforcement approach. The risk assessment report includes a quantitative component (a mathematical model) that estimates occurrence of lung cancer and bladder cancer from long-term exposure to inorganic arsenic in rice and rice products, and a qualitative component that describes our review and evaluation of the scientific literature of certain non-cancer health risks, in certain susceptible life stages, from inorganic arsenic in rice and rice products.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance, the supporting document, or the risk assessment report by July 5, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance and the supporting document to the Division of Plant Products and Beverages, Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the
Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2378.
Arsenic is present in the environment as a naturally occurring substance or as a result of contamination from human activity. It is found in water, air (
We have focused on rice and rice products because evidence from FDA's Total Diet Study revealed that arsenic levels, although varying, tend to be higher in these foods than in others, and rice products are common in the average American diet. Collectively, our sampling indicates that the presence of inorganic arsenic varies widely among and within different categories of rice grain and products made from rice grain, ranging from <1 to 545 parts per billion (ppb) inorganic arsenic.
We are announcing the availability of three documents: (1) A draft guidance for industry entitled “Inorganic Arsenic in Rice Cereals for Infants: Action Level;” (2) a supporting document referenced in the draft guidance entitled “Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants;” and (3) a risk assessment referenced in the draft guidance entitled “Arsenic in Rice and Rice Products Risk Assessment: Report.”
In the risk assessment report, we provide quantitative estimates of lung and bladder cancer risk presented by long-term exposure to inorganic arsenic in rice and rice products. We qualitatively address certain non-cancer health risks of exposure to inorganic arsenic in rice and rice products during pregnancy, infancy, and early childhood, periods of high susceptibility to those risks. We also used the mathematical cancer risk model to evaluate the impact of potential mitigation options to reduce the risk. We conducted this risk assessment in consultation with other Federal Agencies, including the National Institute of Environmental Health Science, the FDA National Center for Toxicological Research, and the Environmental Protection Agency. External expert peer review of the risk assessment was conducted; the risk assessment report and peer review documents are available online (Refs. 5, 6, and 7).
The draft guidance identifies an action level for inorganic arsenic in rice cereals for infants of 100 micrograms/kilogram (µg/kg) or 100 parts per billion (ppb), and identifies FDA's intended sampling and enforcement approach. The supporting document reviews data on inorganic arsenic levels in rice cereals for infants, health effects, and achievability, and explains FDA's rationale for identifying an action level for inorganic arsenic in rice cereals for infants of 100 µg/kg.
We conclude that the 100 µg/kg action level will help protect the public health and is achievable with the use of current good manufacturing practice, but we especially welcome comments and information bearing on the achievability and public health benefits and risks of 100 µg/kg, as compared with other potential action levels (including no action level). If the guidance is finalized consistent with the draft, we intend to consider the action level of 100 µg/kg or 100 ppb inorganic arsenic, in addition to other factors, when considering whether to bring enforcement action in a particular case.
We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the draft guidance and the supporting document at either
The following references are on display in the Division of Dockets Management (see
1. U.S. Food and Drug Administration, “Total Diet Study,” 2016, (
2. U.S. Food and Drug Administration, “Toxic Elements in Food and Foodware and Radionuclides in Food Program,” 2016, (
3. U.S. Food and Drug Administration, “Analytical Results from Inorganic Arsenic in Rice and Rice Products Sampling,” 2013, (
4. U.S. Food and Drug Administration, “Analytical Results from Inorganic Arsenic in Rice Cereals for Infants, Non-rice Infant Cereal and Other Foods Commonly Eaten by Infants and Toddlers,” 2016, (
5. U.S. Food and Drug Administration, “Arsenic in Rice and Rice Products Risk Assessment: Report,” 2016, (
6. U.S. Food and Drug Administration, “External Peer Review Report. Arsenic in Rice and Rice Products Risk Assessment: Draft Report, Addendum, and Model,” 2015, (
7. U.S. Food and Drug Administration, “FDA's Response to External Peer Review on FDA's Arsenic in Rice and Rice Products Risk Assessment: Draft Report (July 2015), Addendum to FDA's Arsenic in Rice and Rice Products Risk Assessment, and Arsenic in Rice and Rice Products Risk Assessment Cancer Model,” 2016, (
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This meeting was announced in the
LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533,
In the
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Food and Drug Administration, HHS.
Notice; renewal of advisory committee.
The Food and Drug Administration (FDA) is announcing the renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Bone, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 23, 2018.
Authority for the Bone, Reproductive and Urologic Drugs Advisory Committee will expire on March 23, 2018, unless the Commissioner formally determines that renewal is in the public interest.
Kalyani Bhatt, Division of Advisory Committee and Consultant Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, email:
Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Bone, Reproductive and Urologic Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drug products for use in the practice of osteoporosis and metabolic bone disease, obstetrics, gynecology, urology and related specialties, and makes appropriate recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of osteoporosis and metabolic bone disease, obstetrics, gynecology, urology, pediatrics, epidemiology, or statistics and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.
Further information regarding the most recent charter and other information can be found at
This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at
Health Resources and Services Administration, HHS.
Notice.
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place NW., Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, MD 20857; (301) 443-6593, or visit our Web site at:
The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10
A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the
Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:
1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and
2. Any allegation in a petition that the petitioner either:
a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or
b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.
This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 81 FR 10874-10875 dated March 2, 2016).
This notice reflects organizational changes in the Health Resources and Services Administration (HRSA), Office of Federal Assistance Management (RJ). Specifically, this notice: (1) Establishes the Office of Operations and Management (RJA); (2) establishes the Office of Data and Organizational Management (RJB); and (3) updates the functional statement for the Office of Federal Assistance Management (RJ) in its entirety.
The Office of Federal Assistance Management (OFAM) through strategic direction and collaborative efforts provides leadership in the awarding and oversight of federal funds and related activities that advance the HRSA mission.
Delete the organization for the Office of Federal Assistance Management in its entirety and replace with the following:
The Office of Federal Assistance Management (RJ) is headed by the Associate Administrator, who reports directly to the Administrator, Health Resources and Services Administration. The Office of Federal Assistance Management includes the following components:
(1) Office of the Associate Administrator (RJ);
(2) Office of Operations Management (RJA);
(3) Office of Data and Organizational Management (RJB);
(4) Division of Financial Integrity (RJ1);
(5) Division of Grants Policy (RJ2);
(6) Division of Grants Management Operations (RJ3); and
(7) Division of Independent Review (RJ4).
This notice reflects organizational changes in the Health Resources and Services Administration (HRSA), Office of Federal Assistance Management (RJ). Specifically, this notice: (1) Establishes the Office of Operations and Management (RJA); (2) establishes the Office of Data and Organizational Management (RJB); and (3) updates the functional statement for the Office of Federal Assistance Management (RJ) in its entirety.
Delete the function for the Office of Federal Assistance Management, and replace in its entirety.
The Office of Federal Assistance Management (OFAM) provides national leadership in the administration and assurance of the financial integrity of HRSA's programs and provides oversight over HRSA activities to ensure that HRSA's resources are being properly used and protected. Provides leadership, direction, and coordination to all phases of grants policy, administration, and independent review of Competitive grant applications. Specifically: (1) Serves as the Administrator's principal source for grants policy and financial integrity of HRSA programs; (2) exercises oversight over the Agency's business processes related to assistance programs; (3) facilitates, plans, directs, and coordinates the administration of HRSA grant policies and operations; (4) directs and carries out the independent review of grant applications for all of HRSA's programs; (5) exercises the responsibility within HRSA for grant and cooperative agreement receipt, award, and post-award processes; and (6) plans, directs plus manages the electronic systems and business operations that enable staff to perform their day-to-day work.
Plans, directs and coordinates OFAM-wide administrative management activities. Specifically: (1) Serves as the principal source for administrative operations advice and assistance; (2) provides guidance and coordinates personnel activities for OFAM; (3) provides organization and management analysis, coordinating the allocation of personnel resources, developing policies and procedures for internal operations, interpreting and implementing OFAM management policies and procedures and systems; (4) develops and coordinates OFAM administrative delegations of authority activities (5) lead, plan, and coordinate all OFAM budgetary activities, such as contracts, procurements and inter-agency agreements, as well as, provides guidance and support to OFAM leadership in these areas; (6) provides OFAM-wide support services such as travel coordination, supply management, equipment utilization, printing, property management, space management, records management, and management reports; (7) coordinates OFAM administrative management activities with other components within HRSA and HHS, and with other Federal agencies, as appropriate; and (8) provides overall support for OFAM's continuity of operations and emergency support.
The Office of Data and Organizational Management provides strategic management and direction for OFAM-wide efforts addressing organizational and staff development, communication and outreach, business operations and data analysis and evaluation. Specifically: (1) Develops and manages
The Division of Financial Integrity: (1) Coordinates Agency-wide efforts addressing HHS's Program Integrity Initiative/Enterprise Risk Management; (2) serves as the Agency's focal point for resolving audit findings on HRSA programs resulting from the Single Audits and special reviews; (3) conducts financial and compliance reviews of non-federal entities use of HRSA funds; (4) conducts the pre-award financial assessment of HRSA non-federal entities; (5) conducts the pre-award and post-award review of grant applicant's and non-federal entities financial soundness and management including accounting systems for managing federal grants; (6) conducts ad hoc studies and reviews related to the financial integrity of the HRSA business processes related to assistance programs; (7) serves as the Agency's liaison with the Office of Inspector General for issues related to HRSA programs; (8) coordinates non-federal entities appeal actions for the Department on HRSA decisions related to HRSA programs; (9) coordinates the preparation of informational reports on high risk non-federal entities; (10) coordinates contractor audit/financial assessment assignments; (11) responds to data requests; (12) serves as the HRSA liaison with the Department on the Single Audit Compliance Supplement update; (13) conducts internal audits; and (14) serves as the outreach to HRSA staff and non-federal entities to increase monitoring efforts for non-federal entities.
The Division of Grants Policy (DGP) analyzes, develops and implements HRSA's federal assistance award policy in compliance with statutes, regulations, Government-wide administrative requirements and Departmental policy. The DGP recommends internal procedures to ensure consistent and effective stewardship of taxpayer dollars.
The Division of Grants Management Operations exercises responsibility within HRSA for all business aspects of grant and cooperative agreement award and post-award processes, and participates in the planning, development, and implementation of policies and procedures for grants and other federal financial assistance mechanisms. Specifically: (1) Plans, directs and carries out the grants officer functions for all of HRSA's grant programs as well as awarding official functions for various scholarship, loan, and loan repayment assistance programs; (2) participates in the planning, development, and implementation of policies and procedures for grants and cooperative agreements; (3) provides assistance and technical consultation to program offices and grantees in the application of laws, regulations, policies, and guidelines relative to the Agency's grant and cooperative agreement programs; (4) develops standard operating procedures, methods, and materials for the administration of the Agency's grants programs; (5) establishes standards and guides for grants management operations; (6) reviews grantee financial status reports and prepares reports and analyses on the grantee's use of funds; (7) provides technical assistance to applicants and grantees on financial and administrative aspects of grant projects; (8) provides data and analyses as necessary for budget planning, hearings, operational planning, and management decisions; (9) participates in the development of program guidance and instructions for grant competitions; (10) oversees contracts in support of receipt of applications, records management, and grant closeout operations; and (11) supports post-award monitoring and closeout by analyzing payment management system data and working with grants and program office staff.
The Division of Independent Review is responsible for the management and oversight of HRSA's independent review of grant and cooperative agreement applications for funding. Specifically: (1) Plans, directs, and carries out HRSA's independent review of applications for grants and cooperative agreement funding, and assures that the process is fair, open, and competitive; (2) develops, implements, and maintains policies and procedures necessary to carry out the Agency's independent review/peer review processes; (3) provides technical assistance to independent reviewers ensuring that reviewers are aware of and comply with appropriate administrative policies and regulations; (4) provides technical advice and guidance to the Agency regarding the independent review processes; (5) coordinates and assures the development of program policies and rules relating to HRSA's extramural grant activities; and (6) provides HRSA's Offices and Bureaus with the final disposition of all reviewed applications.
All delegations of authority and re-delegations of authority made to HRSA officials that were in effect immediately prior to this reorganization, and that are consistent with this reorganization, shall continue in effect pending further re-delegation.
This reorganization is effective upon date of signature.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting:
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 at least 10 days prior to the meeting.
Esther Paul, MBBS, MA, MPH., Office of Policy and Program Development, Bureau of Primary Health Care, Health Resources and Services Administration, 5600 Fishers Lane, 16N38B, Maryland 20857; Phone number: (301) 594-4496.
Office of the Secretary, Office of the Assistant Secretary for Health, Department of Health and Human Services.
Notice.
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding a meeting to continue discussions and possibly develop recommendations regarding People Living with HIV/AIDS. During this meeting, PACHA members will have discussions regarding Health System Transformations, community approaches to implementing the Updated National HIV/AIDS Strategy, and a panel making the case for food as medicine. The meeting will be open to the public.
The meeting will be held on May 24, 2016, from 9:00 a.m. to approximately 5:00 p.m. (ET) and May 25, 2016, from 9:00 a.m. to approximately 12:00 p.m. (ET).
200 Independence Avenue SW., Washington, DC 20201 in the Penthouse (eighth floor), Room 800.
Ms. Caroline Talev, Public Health Analyst, Presidential Advisory Council on HIV/AIDS, Department of Health and Human Services, 200 Independence Avenue SW., Room 443H, Hubert H. Humphrey Building, Washington, DC 20201; (202) 205-1178 or
PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996. In a memorandum, dated July 13, 2010, and under Executive Order 13703, dated July 30, 2015, the President gave certain authorities to the PACHA for implementation of the National HIV/AIDS Strategy for the United States (Strategy). PACHA is currently operating under the authority given in Executive Order 13708, dated September 30, 2015.
PACHA provides advice, information, and recommendations to the Secretary regarding programs, policies, and research to promote effective treatment, prevention, and cure of HIV disease and AIDS, including considering common co-morbidities of those infected with HIV as needed, to promote effective HIV prevention and treatment and quality services to persons living with HIV disease and AIDS.
Substantial progress has been made in addressing the domestic HIV epidemic since the Strategy was released in July 2010. Under Executive order 13703, the National HIV/AIDS Strategy for the United States: Updated to 2020 (Updated Strategy) was released. PACHA shall contribute to the federal effort to improve HIV prevention and care.
The functions of the Council are solely advisory in nature.
The Council consists of not more than 25 members. Council members are selected from prominent community leaders with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. Council members are appointed by the Secretary or designee, in consultation with the White House Office on National AIDS Policy. The agenda for the upcoming meeting will be posted on the AIDS.gov Web site at
Public attendance at the meeting is limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify Caroline Talev at
National Institutes of Health, HHS.
Notice.
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in: HHS Ref. No. E-135-2015/0, U.S. Provisional Patent Application No. 62/155,085, filed April 30, 2015, entitled “Boron Mimics Of Amino Acids And Uses Thereof,” to Beijing Lanyears Communication
The contemplated exclusive license may be limited to boron neutron capture therapy for brain tumors.
Only written comments and/or applications for a license that are received by NIH at the address indicated below on or before April 21, 2016 will be considered.
Requests for a copy of any unpublished patent application, inquiries, objections to this notice, comments and other requests relating to the contemplated license should be directed to: Michael Shmilovich, Esq., CLP, Senior Licensing and Patent Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479, phone number 301-435-5019, or
The invention pertains to boramino acid compounds that can be used as imaging agents for positron emission tomography of cancer or for boron neutron capture therapy. Mimetics created by substituting the carboxylate group (-COO-) of an amino acid with trifluoroborate (-BF3-) are metabolically stable and allow for the use of fluorine-18 (
The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within fifteen (15) days from the date of this published notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
National Institutes of Health, HHS.
Notice.
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in: HHS Ref. No. E-135-2015/0, U.S. Provisional Patent Application No. 62/155,085, filed April 30, 2015, entitled “Boron Mimics Of Amino Acids And Uses Thereof,” to Beijing Lanyears Communication Technology, Ltd., a company formed under the laws of the People's Republic of China and having its principle place of business in Beijing, China.
The contemplated exclusive license may be limited to boron neutron capture therapy for skin cancer.
Only written comments and/or applications for a license that are received by NIH at the address indicated below on or before April 21, 2016 will be considered.
Requests for a copy of any unpublished patent application, inquiries, objections to this notice, comments and other requests relating to the contemplated license should be directed to: Michael Shmilovich, Esq., CLP, Senior Licensing and Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479, phone number 301-435-5019, or
The invention pertains to boramino acid compounds that can be used as imaging agents for positron emission tomography of cancer or for boron neutron capture therapy. Mimetics created by substituting the carboxylate group (-COO-) of an amino acid with trifluoroborate (-BF3-) are metabolically stable and allow for the use of fluorine-18 (
The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within fifteen (15) days from the date of this published notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Privacy Office, Department of Homeland Security.
Notice of Privacy Act System of Records.
In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to update and reissue a current DHS system of records titled, “DHS/U.S. Customs and Border Protection (CBP)-014 Regulatory Audit Archive System (RAAS) System of Records” (73 FR 77807, December 19, 2008). This system of records allows DHS/CBP to collect and maintain records on individuals subject to regulatory audits of customs brokers, importers, and other parties involved in international trade activities. CBP is updating this system of records notice to reflect changes to its authorities, category of records, and routine uses. Specifically, these changes include expanding the category of records to permit the collection of Employer Identification Numbers (EINs) or Social Security numbers (SSNs), also known as a Federal Taxpayer Identifying Number, and business records associated with the audit from customs brokers, importers, and other parties via merchandise entry documentation. CBP is clarifying the authorities section to include updated and more narrowly tailored authorities to permit the collection of EIN or SSN. CBP is making non-substantive edits to the Routine Uses A-G to align with previously published Departmental Systems of Records Notices (SORNs). Lastly, this notice includes non-substantive changes to simplify the formatting and text of the previously published notice.
Additionally, DHS is issuing a Notice of Proposed Rulemaking to reduce the current exemptions for this system of records from certain provisions of the Privacy Act elsewhere in the
Submit comments on or before May 6, 2016. This updated system will be effective May 6, 2016.
You may submit comments, identified by docket number DHS-2016-0027 by one of the following methods:
•
•
•
For general questions, please contact: John Connors, (202) 344-1610, Privacy Officer, U.S. Customs and Border Protection, Privacy and Diversity Office, 1300 Pennsylvania Ave. NW., Washington, DC 20229. For privacy questions, please contact: Karen L. Neuman, (202) 343-1717, Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS)/U.S. Customs and Border Protection (CBP) proposes to update and reissue a current DHS system of records titled, “DHS/CBP-014 Regulatory Audit Archive System (RAAS) System of Records.”
DHS/CBP conducts regulatory audits in support of its oversight of customs brokers licensed by DHS/CBP pursuant to 19 U.S.C. 1641 to act as agents for importers in the entry of merchandise and payment of duties and fees. This system of records covers records about importers and other parties engaged in international trade activities that are the subject of a regulatory audit or are identified in and related to the scope of an audit report.
As a result of a biennial review of this SORN, DHS/CBP is updating the categories of records to include the collection of EINs or SSNs, also known as Federal Taxpayer Identifying Number, pursuant to 19 CFR 24.5, 19 CFR 149.3, and E.O. 9397,
DHS/CBP is clarifying the authorities section to include updated and more narrowly tailored authorities to permit the collection of EIN or SSN. 19 CFR 24.5 and 19 CFR 149.3 require that DHS/CBP collect Federal Taxpayer Identifying Numbers in association with services resulting in issuance of a bill or refund check upon adjustment of a cash collection or to document entities that are liable for payment of all duties and
DHS/CBP is making non-substantive edits to the Routine Uses A-G to align with previously published Departmental SORNs. This notice also includes non-substantive changes to simplify the formatting and texts of the previously published notice.
Consistent with DHS's information sharing mission, information stored in DHS/CBP-014 RAAS may be shared with other DHS Components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, DHS/CBP may share information with appropriate Federal, State, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice.
Additionally, DHS is issuing a Notice of Proposed Rulemaking to reduce the current exemptions for this system of records from certain provisions of the Privacy Act elsewhere in the
The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.
Below is the description of the DHS/CBP-014 Regulatory Audit Archive System (RAAS) System of Records.
In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.
Department of Homeland Security (DHS)/U.S. Customs and Border Protection (CBP)-014.
DHS/CBP-014 Regulatory Audit Archive System (RAAS).
Unclassified.
Records are maintained in the Regulatory Audit Management Information System (RAMIS) located at the U.S. Customs and Border Protection Headquarters in Washington, DC and field offices.
Categories of individuals covered by this system include importers and other parties engaged in international trade activities that are the subject of a regulatory audit or are identified in and related to the scope of an audit report.
Categories of individuals covered by this system include:
• Individual's name, including names of officers of customs broker firms or other business entities engaged in international trade and identified as a subject of an audit or related to the scope of an audit;
• Importer of Record (IR) Number;
• Dun and Bradstreet, Inc. DUN numbers;
• Business records associated with the audit;
• Email address;
• Phone number;
• Employer Identification Number (EIN) or Social Security number (SSN), also known as Federal Taxpayer Identifying Number;
• Audit reports of subject accounts and records;
• Correspondence with the subject of the audits and related parties:
• Congressional inquiries concerning customs brokers or other audit subjects and disposition made of such inquiries; and
• License and permit numbers and dates issued and district or port covered.
6 U.S.C. 115(a)(1) and 213(b)(2); 19 U.S.C. ch. 4; 19 U.S.C. 1508, 1509, 1592, and 1641; 19 CFR parts 24.5, 111, 143, 149.3, 163; 31 U.S.C. 3729; and E.O. 9397,
The purpose of this system is to collect and maintain records on the regulatory audits of customs brokers, licensed by CBP pursuant to 19 U.S.C. 1641, to act as agents for importers in the entry of merchandise and payment of duties and fees, and other persons or business entities engaged in international trade.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
A. To the Department of Justice (DOJ), including Offices of the U.S. Attorneys, or other Federal agency conducting litigation or in proceedings before any court, adjudicative, or administrative body, when it is relevant or necessary to the litigation and one of the following is a party to the litigation or has an interest in such litigation:
1. DHS or any Component thereof;
2. Any employee or former employee of DHS in his/her official capacity;
3. Any employee or former employee of DHS in his/her individual capacity when DOJ or DHS has agreed to represent the employee; or
4. The United States or any agency thereof.
B. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual to whom the record pertains.
C. To the National Archives and Records Administration (NARA) or General Services Administration pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
D. To an agency or organization for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.
E. To appropriate agencies, entities, and persons when:
1. DHS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised;
2. DHS has determined that as a result of the suspected or confirmed compromise, there is a risk of identity theft or fraud, harm to economic or property interests, harm to an individual, or harm to the security or
3. The disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with DHS's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
F. To contractors and their agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for DHS, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to DHS officers and employees.
G. To an appropriate Federal, State, tribal, local, international, or foreign law enforcement agency or other appropriate authority charged with investigating or prosecuting a violation or enforcing or implementing a law, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.
H. To an appropriate Federal, State, local, tribal, foreign, or international agency, if the information is relevant and necessary to a requesting agency's decision concerning the hiring or retention of an individual, or issuance of a security clearance, license, contract, grant, or other benefit, or if the information is relevant and necessary to a DHS decision concerning the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuance of a license, grant or other benefit and disclosure is appropriate to the proper performance of the official duties of the person making the request.
I. To a court, magistrate, or administrative tribunal in the course of presenting evidence, including disclosures to opposing counsel or witnesses in the course of civil discovery, litigation, or settlement negotiations or in connection with criminal law proceedings or in response to a subpoena from a court of competent jurisdiction.
J. To the news media and the public, with the approval of the Chief Privacy Officer in consultation with counsel, when there exists a legitimate public interest in the disclosure of the information, when disclosure is necessary to preserve confidence in the integrity of DHS, or when disclosure is necessary to demonstrate the accountability of DHS's officers, employees, or individuals covered by the system, except to the extent the Chief Privacy Officer determines that release of the specific information in the context of a particular case would constitute an unwarranted invasion of personal privacy.
None.
DHS/CBP stores records in this system electronically or on paper in secure facilities in a locked drawer behind a locked door. The records may be stored on magnetic disc, tape, and digital media.
DHS/CBP may retrieve records by name or other (alphanumeric) personal identifier.
DHS/CBP safeguards records in this system according in accordance with applicable rules and policies, including all applicable DHS automated systems security and access policies. DHS/CBP has imposed strict controls to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.
DHS/CBP maintains regulatory audit records in accordance with N1-36-86-1 approved by NARA on November 9, 1989. CBP maintains regulatory reports and company findings on-site for one year and then transfers the records to the Federal Records Center (FRC), which destroys the records after ten (10) years. CBP maintains regulatory audit subject records on-site for one year and transfers the files to the FRC, which destroys the records after three years.
Executive Director, Regulatory Audit, U.S. Customs and Border Protection, 1717 H Street—6th Floor, Washington, DC 20229.
Individuals seeking notification of and access to any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the DHS Chief Freedom of Information Act (FOIA) Officer or CBP's FOIA Officer, whose contact information can be found at
When seeking records about yourself from this system of records or any other Departmental system of records, your request must conform with the Privacy Act regulations set forth in 6 CFR part 5. You must first verify your identity, meaning that you must provide your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the Chief Privacy Officer and Chief Freedom of Information Act Office at
• Explain why you believe the Department would have information on you;
• Identify which Component(s) of the Department you believe may have the information about you;
• Specify when you believe the records would have been created; and
• Provide any other information that will help the FOIA staff determine which DHS Component agency may have responsive records.
If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his/her agreement for you to access his or her records.
Without the above information, the Component(s) may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.
See “Notification procedure” above.
See “Notification procedure” above.
The information contained in this system of records originates in connection with customs broker audits and audits of other persons engaged in international commerce conducted by the regulatory audit staffs. The audits may be supplemented with information furnished by the Office of the Chief Counsel or its field offices, Office of International Trade—Regulations and Rulings, and the Office of Investigations, U.S. Immigration and Customs Enforcement. These audits include examination of records pertaining to brokers and importers (including their clients), and other persons engaged in international trade activities.
DHS/CBP is not requesting an exemption with respect to information maintained in the system as it relates to data submitted by or on behalf of a subject of an audit. Information in the system may be shared pursuant to the exceptions under the Privacy Act (5 U.S.C. 552a(b)) and the above routine uses. The Privacy Act requires DHS to maintain an accounting of the disclosures made pursuant to all routines uses. Disclosing the fact that a law enforcement or intelligence agency has sought particular records may affect ongoing law enforcement activity. Therefore, pursuant to 5 U.S.C. 552a(k)(2), DHS will claim exemption from sec. (c)(3) of the Privacy Act of 1974, as amended, as is necessary and appropriate to protect this information.
Privacy Office, Department of Homeland Security.
Notice of Privacy Act System of Records.
In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to update and reissue a current Department-wide system of records titled, “Department of Homeland Security (DHS)/ALL-030 Use of the Terrorist Screening Database (TSDB) System of Records,” 76 FR 39408, July 6, 2011. This system of records allows DHS to maintain a synchronized copy of the Department of Justice's (DOJ) Federal Bureau of Investigation's (FBI) Terrorist Screening Database (TSDB), which includes categories of individuals covered by DOJ/FBI-019, “Terrorist Screening Records Center System,” 72 FR 77846 (Dec. 14, 2011). DHS maintains a synchronized copy to automate and simplify the transmission of information in the Terrorist Screening Database to DHS and its Components. With this updated notice, DHS is reducing the number of claimed exemptions, pursuant to a concurrently published Final Rule elsewhere in the
DHS is issuing a new Final Rule concurrently with this notice. The existing Final Rule for Privacy Act exemptions will continue to apply until the new Final Rule is published. This updated system will be included in DHS's inventory of record systems.
Submit comments on or before May 6, 2016. This updated system will be effective May 6, 2016.
You may submit comments, identified by docket number DHS-2016-0024 by one of the following methods:
•
•
•
For general questions and privacy issues please contact: Karen L. Neuman (202-343-1717), Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.
In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to update and reissue a current Department-wide system of records titled, “Department of Homeland Security (DHS)/ALL-030 Use of the Terrorist Screening Database (TSDB) System of Records,” 76 FR 39408, July 6, 2011. This system of records allows DHS to maintain a synchronized copy of the Department of Justice's (DOJ) Federal Bureau of Investigation's (FBI) Terrorist Screening Database (TSDB), which includes categories of individuals covered by DOJ/FBI-019, “Terrorist Screening Records Center System,” 72 FR 77846 (Dec. 14, 2011). DHS maintains a synchronized copy to automate and simplify the transmission of information in the Terrorist Screening Database to DHS and its Components. With this updated notice, DHS is reducing the number of claimed exemptions, pursuant to a concurrently published Final Rule elsewhere in the
DHS is issuing a new Final Rule concurrently with this notice. The existing Final Rule for Privacy Act exemptions, 75 FR 55335 (Dec. 29, 2011) will continue to apply until the new Final Rule is published. This updated system will be included in DHS's inventory of record systems.
The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information
Below is the description of the DHS/ALL-030 Use of the Terrorist Screening Database (TSDB) System of Records.
In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.
Department of Homeland Security (DHS)/ALL-030
DHS/ALL-030 Use of the Terrorist Screening Database (TSDB) System of Records
Unclassified.
Records are maintained at DHS and Component Headquarters in Washington, DC and field offices.
Categories of individuals covered by this system include:
(a) Individuals known or suspected to be or have been engaged in conduct constituting, in preparation for, in aid of, or related to terrorism (“known or suspected terrorists”);
(b) Individuals who are foreign nationals or lawful permanent resident aliens and who are excludable from the United States based on their familial relationship, association, or connection with a known or suspected terrorist as described in sec. 212(a)(3)(B) of the Immigration and Nationality Act of 1952 (“INA exceptions”);
(c) Individuals who were officially detained during military operations, but not as Enemy Prisoners of War, and who have been identified to pose an actual or possible threat to national security (“military detainees”); and
(d) Individuals known or suspected to be or have been engaged in conduct constituting, in aid of, or related to transnational organized crime, thereby posing a possible threat to national security (“transnational organized crime actors”).
Categories of records in this system include:
1. Identifying biographic information, such as name, date of birth, place of birth, passport or driver's license information, and other available identifying particulars used to compare the identity of an individual being screened with a subject in the TSDB;
2. Biometric information, such as photographs, fingerprints, or iris images, and associated biographic and contextual information;
3. References to or information from other government law enforcement and intelligence databases, or other relevant databases that may contain terrorism or national security information, such as unique identification numbers used in other systems;
4. Information collected and compiled to maintain an audit trail of the activity of authorized users of WLS information systems; and
5. System-generated information, including metadata, archived records and record histories from WLS.
Homeland Security Act of 2002, Pub. L. 107-296, 116 Stat. 2135; The Tariff Act of 1930, Pub. L. 71-361, 46 Stat. 741, as amended; The Immigration and Nationality Act; 49 U.S.C. 114, 5103a, 40113, ch. 49 and 46105; Homeland Security Presidential Directive/HSPD-6, “Integration and Use of Screening Information to Protect Against Terrorism” (Sept. 16, 2003); Homeland Security Presidential Directive/HSPD-11, “Comprehensive Terrorist-Related Screening Procedures” (Aug. 27, 2004); National Security Presidential Directive/NSPD-59/Homeland Security Presidential Directive/HSPD-24, “Biometrics for Identification and Screening to Enhance National Security” (June 5, 2008); E.O. 13388, “Further Strengthening the Sharing of Terrorism Information to Protect Americans,” 70 FR 62023 (Oct. 25, 2005); Intelligence Reform and Terrorism Prevention Act of 2004, Pub. L. 108-458, 118 Stat 3638; National Security Act of 1947, Pub. L. 235, 61 Stat. 495, as amended; and 28 U.S.C. 533.
DHS and its Components collect, use, maintain, and disseminate information in the DHS Watchlist Service (WLS) to facilitate DHS mission-related functions, such as counterterrorism, law enforcement, border security, and inspection activities. The TSDB data, which includes personally identifiable information (PII), is necessary for DHS to effectively and efficiently assess the risk or threat posed by a person for the conduct of its mission.
The Federal Bureau of Investigation's (FBI's) Terrorist Screening Center (TSC) provides a near real time, synchronized version of the TSDB to DHS in order to improve the timeliness and governance of watchlist data exchanged between the FBI's TSC and DHS and its Component systems that currently use TSDB data.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
A. To the Department of Justice (DOJ)/FBI/TSC in order to receive confirmations that the information has been appropriately transferred and any other information related to the reconciliation process so that DHS is able to maintain a synchronized copy of the TSDB.
DHS will share information contained in this system to Components internal to DHS pursuant to subsec. 552a(b)(1) of the Privacy Act, and subsequently may be shared externally outside DHS at the programmatic level pursuant to routine uses described in the following published system of records notices:
(1) DHS/TSA-002 Transportation Security Threat Assessment System (T-STAS), 79 FR 46862, Aug. 11, 2014;
(2) DHS/TSA-019 Secure Flight Records, 80 FR 223, Jan. 5, 2015;
(3) DHS/CBP-011 TECS, 73 FR 77778, Dec. 19, 2008;
(4) DHS/CBP-006, Customs and Border Protection Automated Targeting System, 77 FR 30297, May 22, 2012;
(5) DHS/US-VISIT-004, DHS Automated Biometric Identification System (IDENT), 72 FR 31080, June 5, 2007;
(6) DHS/IA-001, Office of Intelligence and Analysis (I&A) Enterprise Records System, 73 FR 28128, May 15, 2008;
(7) DHS/ICE-009, ICE External Investigations, 75 FR 404, Jan. 5, 2010; and
(8) DHS/USCIS-006 Fraud Detection and National Security Records, 77 FR 47411, Aug. 8, 2012.
None.
DHS stores records in this system electronically or on paper in secure facilities in a locked drawer behind a locked door. The records are stored on servers, magnetic disc, tape, digital media, and CD-ROM.
DHS may retrieve records by name or other personal identifier.
DHS safeguards records in this system in accordance with applicable rules and policies, including all applicable DHS automated systems security and access policies. Strict controls have been imposed to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.
The WLS maintains a near real-time feed of the TSDB, and does not retain historical copies of the TSDB. The WLS is synchronized with the TSDB. When the FBI/TSC adds, modifies, or deletes data from TSDB, WLS duplicates these functions almost simultaneously, and that information is then passed to DHS and its authorized Component systems. DHS does not manipulate the data within TSDB feed received by WLS. The authorized DHS Component that is screening individuals will maintain, separate from WLS, a record of a match or possible match with TSDB and DHS will retain this information in accordance with the DHS Component specific SORNs identified in this notice.
Executive Director, Passenger Systems Program Directorate, Office of Information and Technology, U.S. Customs and Border Protection, 7400 Fullerton Rd, Springfield, VA 22153.
The Secretary of Homeland Security has exempted this system from the notification, access, and amendment procedures of the Privacy Act because it is a law enforcement system. However, DHS and its Components will consider individual requests to determine whether or not information may be released. Thus, individuals seeking notification of and access to any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the Headquarters or component Freedom of Information Act (FOIA) Officer, whose contact information can be found at
When seeking records about yourself from this system of records or any other Departmental system of records, your request must conform with the Privacy Act regulations set forth in 6 CFR part 5. You must first verify your identity, meaning that you must provide your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the Chief Privacy Officer and Chief FOIA Officer at
• Explain why you believe the Department would have information on you;
• Identify which Component(s) of the Department you believe may have the information about you;
• Specify when you believe the records would have been created; and
• Provide any other information that will help the FOIA staff determine which DHS component agency may have responsive records.
If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his/her agreement for you to access his or her records.
Without the above information, the Component(s) may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.
In addition, if individuals are uncertain what agency handles the information, they may seek redress through the DHS Traveler Inquiry Redress Program (DHS TRIP), 72 FR 2294, Jan. 18, 2007. Individuals who believe they have been improperly denied entry, refused boarding for transportation, or identified for additional screening by DHS may submit a redress request through DHS TRIP. The DHS TRIP is a single point of contact for individuals who have inquiries or seek resolution regarding difficulties they experienced during their travel screening at transportation hubs such as airports and train stations or crossing U.S. borders. Redress requests should be sent to: DHS Traveler Redress Inquiry Program, 601 South 12th Street, TSA-901, Arlington, VA 20598 or online at
See “Notification procedure” above.
See “Notification procedure” above.
Records are received from the FBI's Terrorist Screening Center, specifically records covered by DOJ/FBI-019, “Terrorist Screening Records Center System,” 72 FR 77846 (Dec. 14, 2011).
The Secretary of Homeland Security has exempted this system from the following provisions of the Privacy Act, subject to the limitations set forth in 5 U.S.C. 552a(c)(3) and (c)(4); (d); (e)(1), (e)(2), (e)(3), (e)(5), (e)(8); and (g) pursuant to 5 U.S.C. 552a(j)(2).
Fish and Wildlife Service, Interior.
Notice; request for comments.
We (U.S. Fish and Wildlife Service) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. 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. This IC is scheduled to expire on August 31, 2016. We 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 we are able to consider your comments on this IC, we must receive them by June 6, 2016.
Send your comments on the IC to the Information Collection Clearance Officer, U.S. Fish and Wildlife Service, MS BPHC, 5275
To request additional information about this IC, contact Hope Grey at
There is no requirement for wildlife sanctuaries to submit applications to qualify for the accredited wildlife sanctuary exemption. Wildlife sanctuaries themselves will determine if they qualify. To qualify, they must meet all of the following criteria:
• Approval by the United States Internal Revenue Service (IRS) as a corporation that is exempt from taxation under section 501(a) of the Internal Revenue Code of 1986, which is described in sections 501(c)(3) and 170(b)(1)(A)(vi) of that code.
• No engagement in commercial trade in the prohibited wildlife species, including offspring, parts, and products.
• No propagation of the prohibited wildlife species.
• No direct contact between the public and the prohibited wildlife species.
The basis for this information collection is the recordkeeping requirement that we place on accredited wildlife sanctuaries. We require accredited wildlife sanctuaries to maintain complete and accurate records of any possession, transportation, acquisition, disposition, importation, or exportation of the prohibited wildlife species as defined in the CWSA (50 CFR 14, subpart K). Records must be up to date and include: (1) Names and addresses of persons to or from whom any prohibited wildlife species has been acquired, imported, exported, purchased, sold, or otherwise transferred; and (2) dates of these transactions. Accredited wildlife sanctuaries must:
• Maintain these records for 5 years.
• Make these records accessible to Service officials for inspection at reasonable hours.
• Copy these records for Service officials, if requested.
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.
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Southwest Resource Advisory Council (RAC) is scheduled to meet as indicated below.
The Southwest RAC meeting will be held on June 10, 2016, in Mancos, Colorado.
The Southwest RAC meeting will be held June 10 at the Mancos Community Building, 130 Grand Ave., Mancos, CO 81328. The meeting will begin at 9 a.m. and adjourn at approximately 4 p.m. A public comment period regarding matters on the agenda will be held at 11:30 a.m.
Shannon Borders, Public Affairs Specialist, 970-240-5300; 2505 S. Townsend Ave., Montrose, CO 81401. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, seven days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The Southwest RAC advises the Secretary of the Interior, through the BLM, on a variety of public land issues in Colorado. Topics of discussion for all Southwest RAC meetings may include field manager and working group reports, recreation, fire management, land use planning, invasive species management, energy and minerals management, travel management, wilderness, land exchange proposals, cultural resource management and other issues as appropriate. These meetings are open to the public. The public may present written comments to the RACs. Each formal RAC meeting will also have time, as identified above, allocated for hearing public comments. Depending on the number of people wishing to comment and time available, the time
Bureau of Land Management, Interior.
Notice of Filing of Plats of Survey; Colorado.
The Bureau of Land Management (BLM) Colorado State Office is publishing this notice to inform the public of the intent to officially file the survey plats listed below and afford a proper period of time to protest this action prior to the plat filing. During this time, the plats will be available for review in the BLM Colorado State Office.
Unless there are protests of this action, the filing of the plats described in this notice will happen on May 6, 2016.
BLM Colorado State Office, Cadastral Survey, 2850 Youngfield Street, Lakewood, CO 80215-7093.
Randy Bloom, Chief Cadastral Surveyor for Colorado, (303) 239-3856.
Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, seven days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The plat and field notes of the dependent resurvey in Township 27 South, Range 55 West, Sixth Principal Meridian, Colorado, were accepted on December 9, 2015.
The plat and field notes of the dependent resurvey and survey in Township 13 South, Range 69 West, Sixth Principal Meridian, Colorado, were accepted on January 7, 2016.
The field notes of the remonumentation of certain corners in Township 51 North, Range 8 East, New Mexico Principal Meridian, Colorado, were accepted on January 19, 2016.
The plat and field notes of the dependent resurvey and survey in Township 34 North, Range 4 West, South of the Ute Line, New Mexico Principal Meridian, Colorado, were accepted on February 11, 2016.
The plat, in 2 sheets, and field notes of the dependent resurvey and survey in Township 34 North, Range 5 West, South of the Ute Line, New Mexico Principal Meridian, Colorado, were accepted on February 11, 2016.
The plat and field notes of the dependent resurvey survey and survey in Township 36 North, Range 11 East, New Mexico Principal Meridian, Colorado, were accepted on March 9, 2016.
The plat, in 2 sheets, incorporating the field notes of the dependent resurvey and survey of Fractional Township 36 North, Range 12 East, New Mexico Principal Meridian, Colorado, was accepted on March 9, 2016.
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before February 20, 2016, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by April 21, 2016.
Comments may be sent via U.S. Postal Service to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service, 1201 Eye St. NW., 8th floor, Washington, DC 20005; or by fax, 202-371-6447.
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before February 20, 2016. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
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.
60.13 of 36 CFR part 60.
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before March 12, 2016, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by April 21, 2016.
Comments may be sent via U.S. Postal Service to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service, 1201 Eye St. NW., 8th floor, Washington, DC 20005; or by fax, 202-371-6447.
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before March 12, 2016. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
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.
60.13 of 36 CFR part 60.
Bureau of Ocean Energy Management (BOEM), Interior.
Notice of availability of the Proposed Notice of Sale for Western Planning Area Lease Sale 248.
BOEM announces the availability of the Proposed Notice of Sale (NOS) for the proposed Western Planning Area (WPA) Outer Continental Shelf (OCS) Oil and Gas Lease Sale 248 (WPA Sale 248). This Notice is published pursuant to 30 CFR 556.29(c) as a matter of information to the public. With regard to oil and gas leasing on the OCS, the Secretary of the Interior, pursuant to section 19 of the OCS Lands Act, provides affected States the opportunity to review the Proposed NOS. The Proposed NOS sets forth the proposed terms and conditions of the sale, including minimum bids, royalty rates, and rental rates.
Affected States may comment on the size, timing, and location of proposed WPA Sale 248 within 60 days following their receipt of the Proposed NOS. The Final NOS will be published in the
The Proposed NOS for WPA Sale 248 and Proposed NOS Package containing information essential to potential bidders may be obtained from the Public Information Unit, Gulf of Mexico Region, Bureau of Ocean Energy Management, 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123-2394. Telephone: (504) 736-2519. The Proposed NOS and Proposed NOS Package also are available on BOEM's Web site at
Federal Bureau of Investigation, DOJ.
Meeting notice.
The purpose of this notice is to announce a meeting of the National Crime Prevention and Privacy Compact Council (Council) created by the National Crime Prevention and Privacy Compact Act of 1998 (Compact). Thus far, the Federal Government and 30 states are parties to the Compact which governs the exchange of criminal history records for licensing, employment, and similar purposes. The Compact also provides a legal framework for the establishment of a cooperative federal-state system to exchange such records.
The United States Attorney General appointed 15 persons from state and federal agencies to serve on the Council. The Council will prescribe system rules and procedures for the effective and proper operation of the Interstate Identification Index system for noncriminal justice purposes.
Matters for discussion are expected to include:
The meeting will be open to the public on a first-come, first-seated basis. Any member of the public wishing to file a written statement with the Council or wishing to address this session of the Council should notify the Federal Bureau Of Investigation (FBI) Compact Officer, Mr. Gary S. Barron at (304) 625-2803, at least 24 hours prior to the start of the session. The notification should contain the individual's name and corporate designation, consumer affiliation, or government designation, along with a short statement describing the topic to be addressed and the time needed for the presentation. Individuals will ordinarily be allowed up to 15 minutes to present a topic.
The meeting will take place at the Westin Convention Center, 1000 Penn Avenue, Pittsburgh, Pennsylvania, telephone 412-560-6353.
Inquiries may be addressed to Mr. Gary S. Barron, FBI Compact Officer, Module D3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306, telephone (304) 625-2803, facsimile (304) 625-2868.
Notice.
The Department of Labor (DOL) is submitting the Employee Benefits Security Administration sponsored information collection request (ICR) titled, “National Medical Support Notice—Part B,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before May 6, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-EBSA, Office of Management and Budget,
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
44 U.S.C. 3507(a)(1)(D).
This ICR seeks to extend PRA authority for the National Medical Support Notice—Part B information collection. Employee Retirement Income Security Act (ERISA) section 609(a), 29 U.S.C. 1169(a), and regulations 29 CFR 2590.609-2 establish a National Medical Support Notice to provide group health benefits coverage pursuant to Qualified Medical Child Support Orders. Part B, Medical Support Notice to Plan Administrator, is a notice from an employer to a benefits plan administrator to implement coverage of children under ERISA covered group health plans.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Notice.
The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, “Petition Requirements and Investigative Data Collection: Trade Act of 1974, as Amended,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before May 6, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
44 U.S.C. 3507(a)(1)(D).
This ICR seeks to extend PRA authority for the Petition Requirements and Investigative Data Collection: Trade Act of 1974, as Amended information collection. Trade Act of 1974 section 221(a), as amended by the Trade and Globalization Adjustment Assistance Act of 2009 (19 U.S.C. 2271), authorizes the Secretary of Labor and the Governor of each State to
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Notice.
The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, “Application for Prevailing Wage Determination,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before May 6, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Contact Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
44 U.S.C. 3507(a)(1)(D).
This ICR seeks to extend PRA authority for the Application for Prevailing Wage Determination, Form ETA-9141, information collection. The information collected via Form ETA-9141 is the basis for the Secretary's determination of the wage an employer must pay in order protect against an adverse effect on U.S. workers' wages by the employment of a foreign worker. The Immigration and Nationality Act authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Wage and Hour Division, Department of Labor.
Notice.
This document extends the period for filing comments on the Paperwork Reduction Act and Information Collections ONLY, related to Establishing Paid Sick Leave for Federal Contractors. RIN 1235-AA13, until April 25, 2016. The Notice of Proposed Rulemaking (NPRM), and associated Information Collections were published in the
The agency must receive comments on or before April 25, 2016. The period for public comments on the Paperwork Reduction Act and Information Collections, which was set to close on April 12, 2016, will be extended to April 25, 2016. Comments must be received by 11:59 p.m. on April 25, 2016. This notice does not extend the comment period on the NPRM; comments on the NPRM must still be submitted no later than April 12, 2016.
You may submit comments identified by Control Number 1235-AA13, by either one of the following methods:
Comments on the Paperwork Reduction Act and Information Collections affected by this Rulemaking can also continue to be submitted through Regulations.gov, but only through April 12, 2016.
Robert Waterman, Compliance Specialist, Division of Regulations, Legislation and Interpretation, Wage and Hour Division, U.S. Department of Labor, Room S-3510, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-0406 (this is not a toll-free number). Copies of the NPRM may be obtained in alternative formats (large print, braille, audio tape, or disc) upon request by calling (202) 693-0023. TTY/TDD callers may dial toll-free (877) 889-5627 to obtain information or request materials in alternative formats.
Questions of interpretation or enforcement of regulations issued by this agency or referenced in this document may be directed to Amy DeBisschop, Director, Government Contracts Branch at (202) 693-0064.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95). 44 U.S.C. 3056(c)(2)(A). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial
Currently, the Wage and Hour Division is soliciting comments concerning its analysis that the Department's proposed rule, published on February 25, 2016 at 81 FR 9592, if finalized as proposed, would create a slight paperwork burden associated with ICR 1235-0021 but would not create a paperwork burden on the regulated community of the information collection provisions contained in ICR 1235-0018. Additionally, the Department seeks comments on its analysis that this NPRM, if finalized as proposed, would create a new paperwork burden on the regulated community as described in the new information collection provisions contained in ICR 1235-0NEW. While much of the information provided to OMB in support of the information collection request appears in the preamble, interested parties may obtain a copy of the full supporting statements for ICR 1235-0018, ICR 1235-0021, and ICR 1235-0NEW by sending a written request to the email address or mail address shown in the
Nuclear Regulatory Commission.
Draft NUREG; additional changes and reopen comment period.
On February 5, 2016, the U.S. Nuclear Regulatory Commission (NRC) published draft NUREG-1021, Revision 11, “Operator Licensing Examination Standards for Power Reactors” for public comment. The public comment period was originally scheduled to close on March 21, 2016. On March 3, 2016, the comment period was extended to April 5, 2016. On March 18, 2016, the NRC posted three updated sections of Examination Standards (ES) in NUREG-1021 that reflect three additional changes that the NRC proposes to incorporate into Revision 11. The public comment period closed on April 5, 2016. The NRC has decided to reopen the public comment period to allow more time for members of the public to develop and submit comments on Revision 11.
The extended public comment period that ended on April 5, 2016 has been reopened for comments requested in the document published on March 3, 2016 (81 FR 11302), including comments on the additional sections of NUREG-1021 posted on March 18, 2016. Comments should be filed no later than May 6, 2016. Comments received after this date will be considered if it is practical to do so, but the NRC staff is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Maurin Scheetz, telephone: 301-415-2758; email:
Please refer to Docket ID NRC-2016-0006 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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Please include Docket ID NRC-2016-0006 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
On February 5, 2016 (81 FR 6301), the NRC published draft NUREG-1021, Revision 11, “Operator Licensing Examination Standards for Power Reactors” for public comment. The comment period was extended on March 3, 2016 (81 FR 11302). The extended public comment period closed on April 5, 2016. The NRC has decided
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Exemption and combined license amendment; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption from certain Tier 1 information in the generic design control document (DCD) and issuing License Amendment No. 31 to combined licenses (COL), NPF-93 and NPF-94. The COLs were issued to South Carolina Electric and Gas (SCE&G) and South Carolina Public Service Authority (Santee Cooper) (the licensee), for construction and operation of the Virgil C. Summer Nuclear Station (VCSNS), Units 2 and 3 located in Fairfield County, South Carolina. The granting of the exemption allows the changes to Tier 1 information and promotes consistency with the VCSNS updated final safety analysis report (UFSAR) Tier 2 information. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
April 6, 2016.
Please refer to Docket ID NRC-2008-0441 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this action by the following methods:
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Billy Gleaves, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5848; email:
The NRC is granting an exemption from Section III.B of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the
Part of the justification for granting the exemption was provided by the review of the amendment. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemption met all applicable regulatory criteria set forth in 10 CFR 50.12, 10 CFR 52.7, and 10 CFR 52.63(b)(1) of appendix D to 10 CFR part
Identical exemption documents (except as needed to reflect the unique unit numbers and license numbers) were issued to the licensee for VCSNS Units 2 and 3 (COLs NPF-93 and NPF-94). These documents can be found in ADAMS under Accession Nos. ML15204A442 and ML15204A445, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-93 and NPF-94 are available in ADAMS under Accession Nos. ML15204A416 and ML15204A426, respectively. A summary of the amendment documents is provided in Section III of this document.
Reproduced below is the exemption issued to VCSNS Units 2 and 3. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC in order to grant the exemption:
1. In a letter dated February 7, 2013, and supplemented by the letters dated July 19, 2013, November 21, 2013, February 6, 2014, February 20, 2014, May 12, 2014, September 22, 2014, and November 19, 2014, South Carolina Electric & Gas Company (licensee) requested from the Nuclear Regulatory Commission (NRC/Commission) an exemption to allow departures from Tier 1 information in the certified design control document (DCD) incorporated by reference in title 10 of the
For the reasons set forth in Section 3.1 of the NRC staff's safety evaluation, which can be found in ADAMS under Accession No. ML15204A476, the Commission finds that:
A. The exemption is authorized by law;
B. the exemption presents no undue risk to public health and safety;
C. the exemption is consistent with the common defense and security;
D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;
E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and
F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.
2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 and COL Appendix C, Tables 2.1.2-1. 2.2.1-1, 2.2.2-1, 2.2.3-1, 2.2.3-3, 2.2.5-1, 2.3.2-1, 2.3.2-3, and 2.3.6-1, as described in the licensee's request dated February 7, 2013, and supplemented by the letters dated July 19, 2013, November 21, 2013, February 6, 2014, February 20, 2014, May 12, 2014, September 22, 2014, and November 19, 2014. This exemption is related to, and necessary for the granting of License Amendment No. 31, which is being issued concurrently with this exemption.
3. As explained in Section 5.0 of the NRC staff's safety evaluation (ADAMS Accession No. ML15204A476), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.
4. This exemption is effective as of the date of its issuance.
By letter dated February 7, 2013, as supplemented, the licensee requested that the NRC amend the COLs for VCSNS Units 2 and 3, COLs NPF-93 and NPF-94. The licensee request and supplements are listed in Section I, above.
The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendments.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.
Using the reasons set forth in the combined safety evaluation, the staff granted the exemption and issued the amendment that the licensee requested on September 3, 2015. The exemption and amendment were issued to the licensee on September 3, 2015 as part of a package of documents (ADAMS Accession No. ML15204A391).
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of First-Class Package Service Contract 50 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-117 and CP2016-148 to consider the Request pertaining to the proposed First-Class Package Service Contract 50 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 8, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Jennaca D. Upperman to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-117 and CP2016-148 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Jennaca D. Upperman is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than April 8, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning notice to enter into an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On March 31, 2016, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2016-143 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 8, 2016. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Natalie R. Ward to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2016-143 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Natalie R. Ward is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than April 8, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of First-Class Package Service Contract 49 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add First-Class Package Service Contract 49 to the competitive product list.
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-116 and CP2016-147 to consider the Request pertaining to the proposed First-Class Package Service Contract 49 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 8, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-116 and CP2016-147 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than April 8, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 204 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add Priority Mail Contract 204 to the competitive product list.
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-114 and CP2016-145 to consider the Request pertaining to the proposed Priority Mail Contract 204 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 8, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-114 and CP2016-145 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than April 8, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 205 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add Priority Mail Contract 205 to the competitive product list.
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-115 and CP2016-146 to consider the Request pertaining to the proposed Priority Mail Contract 205 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 8, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Kenneth R. Moeller to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-115 and CP2016-146 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than April 8, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning notice to enter into an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On March 31, 2016, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2016-142 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 8, 2016. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Katalin K. Clendenin to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2016-142 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Katalin K. Clendenin is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than April 8, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning notice to enter into an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On March 31, 2016, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2016-144 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 8, 2016. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Jennaca D. Upperman to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2016-144 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Jennaca D. Upperman is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than April 8, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to introduce new activity based order protections as described in more detail below. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the self-regulatory organization 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 self-regulatory organization has prepared summaries, set forth in sections A, B and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to introduce new risk protections for orders designed to aid members in their risk management by supplementing current price reasonability checks with activity based order protections.
Pursuant to the proposed Market Wide Risk Protection rule, the Exchange's trading system (the “System”) will maintain one or more counting programs on behalf of each member that will count the number of orders entered, and the number of contracts traded on ISE or, if chosen by the member,
Members will have discretion to establish the applicable time period for each of the counts maintained under the Market Wide Risk Protection, provided that the selected period must be within minimum and maximum parameters established by the Exchange and announced via circular.
The Exchange proposes to use separate counts for regular orders, complex options orders, and complex orders with a stock component as members may want to have different risk settings for these instruments. In order to fully protect members, however, if the Market Wide Risk Protection is triggered based on any count, the triggered action will be taken across the entire market. In particular, if the Market Wide Risk Protection is triggered, action will be taken with respect to all products traded in both simple and complex instruments, and across ISE or, if applicable, ISE and ISE Gemini. Contracts executed on the agency and contra-side of a two-sided crossing order will be counted separately for the Order Execution Rate Protection. In addition, the contract execution count for complex orders will be the sum of the number of contracts executed with respect to each leg. Complex instruments that contain a stock component will not be included as part of the complex order execution count as the Order Execution Rate Protection is based exclusively on options contracts executed, and therefore does not apply to orders that have both stock and options components.
The System will trigger the Market Wide Risk Protection when the counting program has determined that the member has either (1) entered during the specified time period a number of orders exceeding its designated allowable order rate, or (2) executed during the specified time period a number of contracts exceeding its designated allowable contract execution rate. In particular, after a member enters an order, or a member's order is executed, the System will look back over the specified time period to determine whether the member has exceeded the threshold that it has set for the total number of orders entered or the total number of contracts traded, as applicable. If the member's threshold has been exceeded in either simple or complex instruments, the Market Wide Risk Protection will be triggered and the System will automatically reject all subsequent incoming orders entered by the member on ISE or, if applicable, across both ISE and ISE Gemini.
The Exchange believes that the proposed Market Wide Risk Protection will assist members in better managing their risk when trading on the [sic] ISE. In particular, the proposed rule change provides functionality that allows members to set risk management thresholds for the number of orders entered or contracts executed on the Exchange during a specified period. This is similar to how other options exchanges have implemented activity-based risk management protections,
The examples below illustrate how the Market Wide Risk Protection would work both for order entry and order execution protections:
Broker Dealer 1 (“BD1”) designates an allowable order rate of 499 orders/1 second in simple instruments, 299 orders/1 second in complex options orders, and 199 orders/1 second in complex orders with a stock component.
Market Wide Risk Protection is triggered on ISE, and, if applicable, ISE Gemini
BD1 designates an allowable execution rate of 15,000 contracts/2 seconds in simple instruments and 10,000 contracts/2 seconds in complex options orders.
Market Wide Risk Protection is triggered on ISE, and, if applicable, ISE Gemini
The Exchange believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.
The Exchange believes that the proposed rule change would assist with the maintenance of a fair and orderly market by establishing new activity based risk protections for orders. The Exchange currently offers a risk protection mechanism for market maker quotes that removes the member's quotes if a specified number of curtailment events occur during a set time period (“Market Wide Speed Bump”).
The proposed Market Wide Risk Protection is similar to risk management functionality provided by other options exchanges, including, for example, the MIAX Options Exchange (“MIAX”), which recently received Commission approval for its “Risk Protection Monitor” for orders.
The Exchange also believes that it is consistent with the protection of investors and the public interest to offer the Market Wide Risk Protection to members across both ISE and ISE Gemini as this will permit members to more effectively manage their risk simultaneously on both markets if desired. The Exchange already offers cross market risk protections for market makers [sic] quotes,
In accordance with Section 6(b)(8) of the Act,
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.
Within 45 days of the publication date of this notice or within such longer period (1) as the Commission may designate up to 45 days of such date if it finds such longer period to be appropriate and publishes its reasons for so finding or (2) as to which the self-regulatory organization consents, the Commission will:
(a) By order approve or disapprove such proposed rule change; or
(b) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to 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.
Securities and Exchange Commission (“Commission”).
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and 12(d)(1)(B) of the Act.
Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549; Applicants: Scott I. Coyler, Advisors Asset Management, Inc., 18925 Base Camp Road, Suite 203, Monument, Colorado 80132.
Deepak T. Pai, Senior Counsel, at (202) 551-6876, or Mary Kay Frech, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. The Trust is a business trust organized under the laws of the Commonwealth of Massachusetts and intends to register under the Act as an open-end management investment company with multiple series. Each series for which the Trust seeks the requested order will operate as an exchange traded fund (“ETF”).
2. The Initial Adviser is registered as an investment adviser under the Investment Advisers Act of 1940 (the “Advisers Act”) and will be the investment adviser to the Funds (defined below). Any other Adviser (defined below) also will be registered as an investment adviser under the Advisers Act. The Adviser may enter into sub-advisory agreements with one or more investment advisers to act as sub-advisers to particular Funds (each, a “Sub-Adviser”). Any Sub-Adviser will either be registered under the Advisers Act or will not be required to register thereunder.
3. The Trust will enter into a distribution agreement with one or more distributors. Each distributor for a Fund will be a broker-dealer (“Broker”) registered under the Securities Exchange Act of 1934 (“Exchange Act”) and will act as distributor and principal underwriter (“Distributor”) for one or more of the Funds. No Distributor will be affiliated with any national securities exchange, as defined in section 2(a)(26) of the Act (“Exchange”). The Distributor for each Fund will comply with the terms and conditions of the requested order.
4. Applicants request that the order apply to the initial series of the Trust described in the application (“Initial Fund”) and any additional series of the Trust, and any other open-end management investment company or series thereof, that may be created in the future (“Future Funds” and together with the Initial Fund, “Funds”), each of which will operate as an ETF and will track a specified index comprised of domestic or foreign equity and/or fixed income securities, or a blend of domestic and/or foreign equity and fixed income securities (each, an “Underlying Index”). Any Fund will (a) be advised by the Initial Adviser or an entity controlling, controlled by, or under common control with the Initial Adviser (each such entity and any successor thereto, an “Adviser”)
5. Each Fund will hold certain securities, currencies, other assets, and other investment positions (“Portfolio Holdings”) selected to correspond generally to the performance of its Underlying Index. The Underlying Indexes will be comprised of equity and/or fixed income securities issued by one or more of the following categories of issuers: (i) Domestic issuers and (ii) non-domestic issuers meeting the requirements for trading in U.S. markets. Other Funds will be based on Underlying Indexes that will be comprised of foreign and domestic, or solely foreign, equity and/or fixed income securities (“Foreign Funds”).
6. Applicants represent that each Fund will invest at least 80% of its assets (excluding securities lending collateral) in the component securities of its respective Underlying Index (“Component Securities”) and TBA Transactions,
7. The Trust may offer Funds that seek to track Underlying Indexes constructed using 130/30 investment strategies (“130/30 Funds”) or other long/short investment strategies (“Long/Short Funds”). Each Long/Short Fund will establish (i) exposures equal to approximately 100% of the long positions specified by the Long/Short Index
8. A Fund will utilize either a replication or representative sampling strategy to track its Underlying Index. A Fund using a replication strategy will invest in the Component Securities of its Underlying Index in the same approximate proportions as in such Underlying Index. A Fund using a representative sampling strategy will hold some, but not necessarily all of the Component Securities of its Underlying Index. Applicants state that a Fund using a representative sampling strategy will not be expected to track the performance of its Underlying Index with the same degree of accuracy as would an investment vehicle that invested in every Component Security of the Underlying Index with the same weighting as the Underlying Index. Applicants expect that each Fund will have an annual tracking error relative to the performance of its Underlying Index of less than 5%.
9. Each Fund will be entitled to use its Underlying Index pursuant to either a licensing agreement with the entity that compiles, creates, sponsors or maintains the Underlying Index (each, an “Index Provider”) or a sub-licensing arrangement with the Adviser, which will have a licensing agreement with such Index Provider.
10. Applicants recognize that Self-Indexing Funds could raise concerns regarding the ability of the Affiliated Index Provider to manipulate the Underlying Index to the benefit or detriment of the Self-Indexing Fund. Applicants further recognize the potential for conflicts that may arise with respect to the personal trading activity of personnel of the Affiliated Index Provider who have knowledge of changes to an Underlying Index prior to the time that information is publicly disseminated.
11. Applicants propose that each Self-Indexing Fund will post on its Web site, on each day the Fund is open, including any day when it satisfies redemption requests as required by section 22(e) of the Act (a “Business Day”), before commencement of trading of Shares on the Listing Exchange, the identities and quantities of the Portfolio Holdings that will form the basis for the Fund's calculation of its NAV at the end of the Business Day. Applicants believe that requiring Self-Indexing Funds to maintain full portfolio transparency will also provide an additional mechanism for addressing any such potential conflicts of interest.
12. In addition, applicants do not believe the potential for conflicts of interest raised by the Adviser's use of the Underlying Indexes in connection with the management of the Self Indexing Funds and the Affiliated Accounts will be substantially different from the potential conflicts presented by an adviser managing two or more registered funds. Both the Act and the Advisers Act contain various protections to address conflicts of interest where an adviser is managing two or more registered funds and these protections will also help address these conflicts with respect to the Self-Indexing Funds.
13. The Adviser and any Sub-Adviser have adopted or will adopt, pursuant to Rule 206(4)-7 under the Advisers Act, written policies and procedures designed to prevent violations of the Advisers Act and the rules thereunder. These include policies and procedures designed to minimize potential conflicts of interest among the Self-Indexing Funds and the Affiliated Accounts, such as cross trading policies, as well as those designed to ensure the equitable allocation of portfolio transactions and brokerage commissions. In addition, the Initial Adviser has adopted or will adopt policies and procedures as required under section 204A of the Advisers Act, which are reasonably designed in light of the nature of its business to prevent the misuse, in violation of the Advisers Act or the Exchange Act or the rules thereunder, of material non-public information by the Initial Adviser or an associated person (“Inside Information Policy”). Any other Adviser or Sub-Adviser will be required to adopt and maintain a similar Inside Information Policy. In accordance with the Code of Ethics
14. To the extent the Self-Indexing Funds transact with an Affiliated Person of the Adviser or Sub-Adviser, such transactions will comply with the Act, the rules thereunder and the terms and conditions of the requested order. In this regard, each Self-Indexing Fund's board of directors or trustees (“Board”) will periodically review the Self-Indexing Fund's use of an Affiliated Index Provider. Subject to the approval of the Self-Indexing Fund's Board, the Adviser, Affiliated Persons of the Adviser (“Adviser Affiliates”) and Affiliated Persons of any Sub-Adviser (“Sub-Adviser Affiliates”) may be authorized to provide custody, fund accounting and administration and transfer agency services to the Self-Indexing Funds. Any services provided by the Adviser, Adviser Affiliates, Sub-Adviser and Sub-Adviser Affiliates will be performed in accordance with the provisions of the Act, the rules under the Act and any relevant guidelines from the staff of the Commission.
15. The Shares of each Fund will be purchased and redeemed in Creation Units and generally on an in-kind basis. Except where the purchase or redemption will include cash under the limited circumstances specified below, purchasers will be required to purchase Creation Units by making an in-kind deposit of specified instruments (“Deposit Instruments”), and shareholders redeeming their Shares will receive an in-kind transfer of specified instruments (“Redemption Instruments”).
16. Purchases and redemptions of Creation Units may be made in whole or in part on a cash basis, rather than in kind, solely under the following circumstances: (a) To the extent there is a Cash Amount; (b) if, on a given Business Day, the Fund announces before the open of trading that all purchases, all redemptions or all purchases and redemptions on that day will be made entirely in cash; (c) if, upon receiving a purchase or redemption order from an Authorized Participant, the Fund determines to require the purchase or redemption, as applicable, to be made entirely in cash;
17. Creation Units will consist of specified large aggregations of Shares (
18. Each Business Day, before the open of trading on the Exchange on which Shares are primarily listed (“Listing Exchange”), each Fund will cause to be published through the NSCC the names and quantities of the instruments comprising the Deposit Instruments and the Redemption Instruments, as well as the estimated Cash Amount (if any), for that day. The list of Deposit Instruments and Redemption Instruments will apply until a new list is announced on the following Business Day, and there will be no intra-day changes to the list except to correct errors in the published list. Each Listing Exchange will disseminate, every 15 seconds during regular Exchange trading hours, through the facilities of the Consolidated Tape Association, an amount for each Fund stated on a per individual Share basis representing the sum of (i) the estimated Cash Amount and (ii) the current value of the Deposit Instruments.
19. Transaction expenses, including operational processing and brokerage costs, will be incurred by a Fund when investors purchase or redeem Creation Units in-kind and such costs have the potential to dilute the interests of the Fund's existing shareholders. Each Fund will impose purchase or redemption transaction fees (“Transaction Fees”) in connection with effecting such purchases or redemptions of Creation Units. In all cases, such Transaction Fees will be limited in accordance with requirements of the Commission applicable to management investment companies offering redeemable securities. Since the Transaction Fees are intended to defray the transaction expenses as well as to prevent possible shareholder dilution resulting from the purchase or redemption of Creation Units, the Transaction Fees will be borne only by such purchasers or redeemers.
20. Shares of each Fund will be listed and traded individually on an Exchange. It is expected that one or more member firms of an Exchange will be designated to act as a market maker (each, a “Market Maker”) and maintain a market for Shares trading on the Exchange. Prices of Shares trading on an Exchange will be based on the current bid/offer market. Transactions involving the sale of Shares on an Exchange will be subject to customary brokerage commissions and charges.
21. Applicants expect that purchasers of Creation Units will include institutional investors and arbitrageurs. Market Makers, acting in their roles to provide a fair and orderly secondary market for the Shares, may from time to time find it appropriate to purchase or redeem Creation Units. Applicants expect that secondary market purchasers of Shares will include both institutional and retail investors.
22. Shares will not be individually redeemable, and owners of Shares may acquire those Shares from the Fund, or tender such Shares for redemption to the Fund, in Creation Units only. To redeem, an investor must accumulate enough Shares to constitute a Creation Unit. Redemption requests must be placed through an Authorized Participant. A redeeming investor will pay a Transaction Fee, calculated in the same manner as a Transaction Fee payable in connection with purchases of Creation Units.
23. Neither the Trust nor any Fund will be advertised or marketed or otherwise held out as a traditional open-end investment company or a “mutual fund.” Instead, each such Fund will be marketed as an “ETF.” All marketing materials that describe the features or method of obtaining, buying or selling Creation Units, or Shares traded on an Exchange, or refer to redeemability, will prominently disclose that Shares are not individually redeemable and will disclose that the owners of Shares may acquire those Shares from the Fund or tender such Shares for redemption to the Fund in Creation Units only. The Funds will provide copies of their annual and semi-annual shareholder reports to DTC Participants for distribution to beneficial owners of Shares.
1. Applicants request an order under section 6(c) of the Act for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and (B) of the Act, and under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act.
2. Section 6(c) of the Act provides that the Commission may exempt any person, security or transaction, or any class of persons, securities or transactions, from any provision of the Act, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 17(b) of the Act authorizes the Commission to exempt a proposed transaction from section 17(a) of the Act if evidence establishes that the terms of the transaction, including the consideration to be paid or received, are reasonable and fair and do not involve overreaching on the part of any person concerned, and the proposed transaction is consistent with the policies of the registered investment company and the general provisions of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities or transactions, from any provisions of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors.
3. Section 5(a)(1) of the Act defines an “open-end company” as a management investment company that is offering for
4. Section 22(d) of the Act, among other things, prohibits a dealer from selling a redeemable security that is currently being offered to the public by or through an underwriter, except at a current public offering price described in the prospectus. Rule 22c-1 under the Act generally requires that a dealer selling, redeeming or repurchasing a redeemable security do so only at a price based on its NAV. Applicants state that secondary market trading in Shares will take place at negotiated prices, not at a current offering price described in a Fund's prospectus, and not at a price based on NAV. Thus, purchases and sales of Shares in the secondary market will not comply with section 22(d) of the Act and rule 22c-1 under the Act. Applicants request an exemption under section 6(c) from these provisions.
5. Applicants assert that the concerns sought to be addressed by section 22(d) of the Act and rule 22c-1 under the Act with respect to pricing are equally satisfied by the proposed method of pricing Shares. Applicants maintain that while there is little legislative history regarding section 22(d), its provisions, as well as those of rule 22c-1, appear to have been designed to (a) prevent dilution caused by certain riskless-trading schemes by principal underwriters and contract dealers, (b) prevent unjust discrimination or preferential treatment among buyers, and (c) ensure an orderly distribution of investment company shares by eliminating price competition from dealers offering shares at less than the published sales price and repurchasing shares at more than the published redemption price.
6. Applicants believe that none of these purposes will be thwarted by permitting Shares to trade in the secondary market at negotiated prices. Applicants state that (a) secondary market trading in Shares does not involve a Fund as a party and will not result in dilution of an investment in Shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in Shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants contend that the price at which Shares trade will be disciplined by arbitrage opportunities created by the option continually to purchase or redeem Shares in Creation Units, which should help prevent Shares from trading at a material discount or premium in relation to their NAV.
7. Section 22(e) of the Act generally prohibits a registered investment company from suspending the right of redemption or postponing the date of payment of redemption proceeds for more than seven days after the tender of a security for redemption. Applicants state that settlement of redemptions for Foreign Funds will be contingent not only on the settlement cycle of the United States market, but also on current delivery cycles in local markets for underlying foreign securities held by a Foreign Fund. Applicants state that the delivery cycles currently practicable for transferring Redemption Instruments to redeeming investors, coupled with local market holiday schedules, may require a delivery process of up to fifteen (15) calendar days.
8. Applicants believe that Congress adopted section 22(e) to prevent unreasonable, undisclosed or unforeseen delays in the actual payment of redemption proceeds. Applicants propose that allowing redemption payments for Creation Units of a Foreign Fund to be made within fifteen calendar days would not be inconsistent with the spirit and intent of section 22(e). Applicants suggest that a redemption payment occurring within fifteen calendar days following a redemption request would adequately afford investor protection.
9. Applicants are not seeking relief from section 22(e) with respect to Foreign Funds that do not effect creations and redemptions of Creation Units in-kind.
10. Section 12(d)(1)(A) of the Act prohibits a registered investment company from acquiring securities of an investment company if such securities represent more than 3% of the total outstanding voting stock of the acquired company, more than 5% of the total assets of the acquiring company, or, together with the securities of any other investment companies, more than 10% of the total assets of the acquiring company. Section 12(d)(1)(B) of the Act prohibits a registered open-end investment company, its principal underwriter and any other broker-dealer from knowingly selling the investment company's shares to another investment company if the sale will cause the acquiring company to own more than 3% of the acquired company's voting stock, or if the sale will cause more than 10% of the acquired company's voting stock to be owned by investment companies generally.
11. Applicants request an exemption to permit registered management investment companies and UITs that are not advised or sponsored by the Adviser, and not part of the same “group of investment companies,” as defined in section 12(d)(1)(G)(ii) of the Act as the Underlying Funds (such management investment companies are referred to as “Investing Management Companies,” such UITs are referred to as “Investing Trusts,” and Investing Management Companies and Investing Trusts are collectively referred to as “Funds of Funds”)
12. Each Investing Management Company will be advised by an investment adviser within the meaning of section 2(a)(20)(A) of the Act (the “Fund of Funds Adviser”) and may be sub-advised by investment advisers within the meaning of section 2(a)(20)(B) of the Act (each, a “Fund of Funds Sub-Adviser”). Any investment adviser to an Investing Management Company will be registered under the Advisers Act. Each Investing Trust will be sponsored by a sponsor (“Sponsor”).
13. Applicants submit that the proposed conditions to the requested relief adequately address the concerns underlying the limits in sections 12(d)(1)(A) and (B), which include concerns about undue influence by a fund of funds over underlying funds, excessive layering of fees and overly complex fund structures. Applicants believe that the requested exemption is consistent with the public interest and the protection of investors.
14. Applicants believe that neither a Fund of Funds nor a Fund of Funds Affiliate would be able to exert undue influence over an Underlying Fund.
15. Applicants propose other conditions to limit the potential for undue influence over the Underlying Funds, including that no Fund of Funds or Fund of Funds Affiliate (except to the extent it is acting in its capacity as an investment adviser to an Underlying Fund) will cause an Underlying Fund to purchase a security in an offering of securities during the existence of an underwriting or selling syndicate of which a principal underwriter is an Underwriting Affiliate (“Affiliated Underwriting”). An “Underwriting Affiliate” is a principal underwriter in any underwriting or selling syndicate that is an officer, director, member of an advisory board, Fund of Funds Adviser, Fund of Funds Sub-Adviser, employee or Sponsor of the Fund of Funds, or a person of which any such officer, director, member of an advisory board, Fund of Funds Adviser or Fund of Funds Sub-Adviser, employee or Sponsor is an affiliated person (except that any person whose relationship to the Underlying Fund is covered by section 10(f) of the Act is not an Underwriting Affiliate).
16. Applicants do not believe that the proposed arrangement will involve excessive layering of fees. The board of directors or trustees of any Investing Management Company, including a majority of the directors or trustees who are not “interested persons” within the meaning of section 2(a)(19) of the Act (“disinterested directors or trustees”), will find that the advisory fees charged under the contract are based on services provided that will be in addition to, rather than duplicative of, services provided under the advisory contract of any Underlying Fund in which the Investing Management Company may invest. In addition, under condition B.5., a Fund of Funds Adviser, or a Fund of Funds' trustee or Sponsor, as applicable, will waive fees otherwise payable to it by the Fund of Funds in an amount at least equal to any compensation (including fees received pursuant to any plan adopted by a Fund under rule 12b-1 under the Act) received from an Underlying Fund by the Fund of Funds Adviser, trustee or Sponsor or an affiliated person of the Fund of Funds Adviser, trustee or Sponsor, other than any advisory fees paid to the Fund of Funds Adviser, trustee or Sponsor or its affiliated person by an Underlying Fund, in connection with the investment by the Fund of Funds in the Underlying Fund. Applicants state that any sales charges and/or service fees charged with respect to shares of a Fund of Funds will not exceed the limits applicable to a fund of funds as set forth in NASD Conduct Rule 2830.
17. Applicants submit that the proposed arrangement will not create an overly complex fund structure. Applicants note that no Underlying Fund will acquire securities of any investment company or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in section 12(d)(1)(A) of the Act, except to the extent permitted by exemptive relief from the Commission permitting the Underlying Fund to purchase shares of other investment companies for short-term cash management purposes. To ensure a Fund of Funds is aware of the terms and conditions of the requested order, the Fund of Funds will enter into an agreement with the Underlying Fund (“FOF Participation Agreement”). The FOF Participation Agreement will include an acknowledgement from the Fund of Funds that it may rely on the order only to invest in the Underlying Funds and not in any other investment company.
18. Applicants also note that an Underlying Fund may choose to reject a direct purchase of Underlying Fund Shares in Creation Units by a Fund of Funds. To the extent that a Fund of Funds purchases Underlying Fund Shares in the secondary market, an Underlying Fund would still retain its ability to reject any initial investment by a Fund of Funds in excess of the limits of section 12(d)(1)(A) by declining to enter into a FOF Participation Agreement with the Fund of Funds.
19. Sections 17(a)(1) and (2) of the Act generally prohibit an affiliated person of a registered investment company, or an affiliated person of such a person, from selling any security to or purchasing any security from the company. Section 2(a)(3) of the Act defines “affiliated person” of another person to include (a) any person directly or indirectly
20. Applicants request an exemption from sections 17(a)(1) and 17(a)(2) of the Act pursuant to sections 6(c) and 17(b) of the Act to permit persons that are Affiliated Persons of the Funds, or Second-Tier Affiliates of the Funds, solely by virtue of one or more of the following: (a) holding 5% or more, or in excess of 25%, of the outstanding Shares of one or more Funds; (b) an affiliation with a person with an ownership interest described in (a); or (c) holding 5% or more, or more than 25%, of the shares of one or more Affiliated Funds, to effectuate purchases and redemptions “in-kind.”
21. Applicants assert that no useful purpose would be served by prohibiting such affiliated persons from making “in-kind” purchases or “in-kind” redemptions of Shares of a Fund in Creation Units. Both the deposit procedures for “in-kind” purchases of Creation Units and the redemption procedures for “in-kind” redemptions of Creation Units will be effected in exactly the same manner for all purchases and redemptions, regardless of size or number. There will be no discrimination between purchasers or redeemers. Deposit Instruments and Redemption Instruments for each Fund will be valued in the identical manner as those Portfolio Holdings currently held by such Fund and the valuation of the Deposit Instruments and Redemption Instruments will be made in an identical manner regardless of the identity of the purchaser or redeemer. Applicants do not believe that “in-kind” purchases and redemptions will result in abusive self-dealing or overreaching, but rather assert that such procedures will be implemented consistently with each Fund's objectives and with the general purposes of the Act. Applicants believe that “in-kind” purchases and redemptions will be made on terms reasonable to applicants and any affiliated persons because they will be valued pursuant to verifiable objective standards. The method of valuing Portfolio Holdings held by a Fund is identical to that used for calculating “in-kind” purchase or redemption values and therefore creates no opportunity for affiliated persons or Second-Tier Affiliates of applicants to effect a transaction detrimental to the other holders of Shares of that Fund. Similarly, applicants submit that, by using the same standards for valuing Portfolio Holdings held by a Fund as are used for calculating “in-kind” redemptions or purchases, the Fund will ensure that its NAV will not be adversely affected by such securities transactions. Applicants also note that the ability to take deposits and make redemptions “in-kind” will help each Fund to track closely its Underlying Index and therefore aid in achieving the Fund's objectives.
22. Applicants also seek relief under sections 6(c) and 17(b) from section 17(a) to permit an Underlying Fund that is an affiliated person, or an affiliated person of an affiliated person, of a Fund of Funds to sell its Underlying Fund Shares to and redeem its Underlying Fund Shares from a Fund of Funds, and to engage in the accompanying in-kind transactions with the Fund of Funds.
Applicants agree that any order of the Commission granting the requested relief will be subject to the following conditions:
1. The requested relief to permit ETF operations will expire on the effective date of any Commission rule under the Act that provides relief permitting the operation of index-based ETFs.
2. As long as a Fund operates in reliance on the requested order, the Shares of such Fund will be listed on an Exchange.
3. Neither the Trust nor any Fund will be advertised or marketed as an open-end investment company or a mutual fund. Any advertising material that describes the purchase or sale of Creation Units or refers to redeemability will prominently disclose that Shares are not individually redeemable and that owners of Shares may acquire those Shares from the Fund and tender those Shares for redemption to a Fund in Creation Units only.
4. The Web site, which is and will be publicly accessible at no charge, will contain, on a per Share basis for each Fund, the prior Business Day's NAV and the market closing price or the midpoint of the bid/ask spread at the time of the calculation of such NAV (“Bid/Ask Price”), and a calculation of the premium or discount of the market closing price or Bid/Ask Price against such NAV.
5. Each Self-Indexing Fund, Long/Short Fund and 130/30 Fund will post on the Web site on each Business Day, before commencement of trading of Shares on the Exchange, the Fund's Portfolio Holdings.
6. No Adviser or any Sub-Adviser to a Self-Indexing Fund, directly or indirectly, will cause any Authorized Participant (or any investor on whose behalf an Authorized Participant may transact with the Self-Indexing Fund) to acquire any Deposit Instrument for a Self-Indexing Fund through a transaction in which the Self-Indexing Fund could not engage directly.
1. The members of a Fund of Funds' Advisory Group will not control (individually or in the aggregate) an Underlying Fund within the meaning of section 2(a)(9) of the Act. The members of a Fund of Funds' Sub-Advisory Group will not control (individually or in the aggregate) an Underlying Fund within the meaning of section 2(a)(9) of the Act. If, as a result of a decrease in the outstanding voting securities of an Underlying Fund, the Fund of Funds' Advisory Group or the Fund of Funds' Sub-Advisory Group, each in the aggregate, becomes a holder of more than 25 percent of the outstanding voting securities of an Underlying Fund, it will vote its Underlying Fund Shares of the Underlying Fund in the same proportion as the vote of all other holders of the Underlying Fund's Shares. This condition does not apply to the Fund of Funds' Sub-Advisory Group with respect to an Underlying Fund for which the Fund of Funds' Sub-Adviser or a person controlling, controlled by or under common control with the Fund of Funds' Sub-Adviser acts as the investment adviser within the meaning of section 2(a)(20)(A) of the Act.
2. No Fund of Funds or Fund of Funds Affiliate will cause any existing or potential investment by the Fund of Funds in an Underlying Fund to influence the terms of any services or transactions between the Fund of Funds or Fund of Funds Affiliate and the Underlying Fund or an Underlying Fund Affiliate.
3. The board of directors or trustees of an Investing Management Company, including a majority of the disinterested directors or trustees, will adopt procedures reasonably designed to ensure that the Fund of Funds Adviser and Fund of Funds Sub-Adviser are conducting the investment program of the Investing Management Company without taking into account any consideration received by the Investing Management Company or a Fund of Funds Affiliate from an Underlying Fund or Underlying Fund Affiliate in connection with any services or transactions.
4. Once an investment by a Fund of Funds in Underlying Fund Shares exceeds the limits in section 12(d)(1)(A)(i) of the Act, the Board of the Underlying Fund, including a majority of the directors or trustees who are not “interested persons” within the meaning of section 2(a)(19) of the Act (“non-interested Board members”), will determine that any consideration paid by the Underlying Fund to the Fund of Funds or a Fund of Funds Affiliate in connection with any services or transactions: (i) is fair and reasonable in relation to the nature and quality of the services and benefits received by the Underlying Fund; (ii) is within the range of consideration that the Underlying Fund would be required to pay to another unaffiliated entity in connection with the same services or transactions; and (iii) does not involve overreaching on the part of any person concerned. This condition does not apply with respect to any services or transactions between an Underlying Fund and its investment adviser(s), or any person controlling, controlled by or under common control with such investment adviser(s).
5. The Fund of Funds Adviser, or trustee or Sponsor of an Investing Trust, as applicable, will waive fees otherwise payable to it by the Fund of Funds in an amount at least equal to any compensation (including fees received pursuant to any plan adopted by an Underlying Fund under rule 12b-l under the Act) received from an Underlying Fund by the Fund of Funds Adviser, or trustee or Sponsor of the Investing Trust, or an affiliated person of the Fund of Funds Adviser, or trustee or Sponsor of the Investing Trust, other than any advisory fees paid to the Fund of Funds Adviser, or trustee or Sponsor of an Investing Trust, or its affiliated person by the Underlying Fund, in connection with the investment by the Fund of Funds in the Underlying Fund. Any Fund of Funds Sub-Adviser will waive fees otherwise payable to the Fund of Funds Sub-Adviser, directly or indirectly, by the Investing Management Company in an amount at least equal to any compensation received from an Underlying Fund by the Fund of Funds Sub-Adviser, or an affiliated person of the Fund of Funds Sub-Adviser, other than any advisory fees paid to the Fund of Funds Sub-Adviser or its affiliated person by the Underlying Fund, in connection with the investment by the Investing Management Company in the Underlying Fund made at the direction of the Fund of Funds Sub-Adviser. In the event that the Fund of Funds Sub-Adviser waives fees, the benefit of the waiver will be passed through to the Investing Management Company.
6. No Fund of Funds or Fund of Funds Affiliate (except to the extent it is acting in its capacity as an investment adviser to an Underlying Fund) will cause an Underlying Fund to purchase a security in any Affiliated Underwriting.
7. The Board of an Underlying Fund, including a majority of the non-interested Board members, will adopt procedures reasonably designed to monitor any purchases of securities by the Underlying Fund in an Affiliated Underwriting, once an investment by a Fund of Funds in the securities of the Underlying Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, including any purchases made directly from an Underwriting Affiliate. The Board of the Underlying Fund will review these purchases periodically, but no less frequently than annually, to determine whether the purchases were influenced by the investment by the Fund of Funds in the Underlying Fund. The Board of the Underlying Fund will consider, among other things: (i) Whether the purchases were consistent with the investment objectives and policies of the Underlying Fund; (ii) how the performance of securities purchased in an Affiliated Underwriting compares to the performance of comparable securities purchased during a comparable period of time in underwritings other than Affiliated Underwritings or to a benchmark such as a comparable market index; and (iii) whether the amount of securities purchased by the Underlying Fund in Affiliated Underwritings and the amount purchased directly from an Underwriting Affiliate have changed significantly from prior years. The Board will take any appropriate actions based on its review, including, if appropriate, the institution of procedures designed to ensure that purchases of securities in Affiliated Underwritings are in the best interest of shareholders of the Underlying Fund.
8. Each Underlying Fund will maintain and preserve permanently in an easily accessible place a written copy of the procedures described in the preceding condition, and any modifications to such procedures, and will maintain and preserve for a period of not less than six years from the end of the fiscal year in which any purchase in an Affiliated Underwriting occurred, the first two years in an easily accessible place, a written record of each purchase of securities in Affiliated Underwritings once an investment by a Fund of Funds in the securities of the Underlying Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, setting forth from whom the securities were acquired, the identity of the underwriting syndicate's members, the terms of the purchase, and the information or materials upon which the determinations of the Board of the Underlying Fund were made.
9. Before investing in an Underlying Fund in excess of the limit in section 12(d)(1)(A), a Fund of Funds and the Trust will execute a FOF Participation Agreement stating, without limitation, that their respective boards of directors or trustees and their investment advisers, or trustee and Sponsor, as applicable, understand the terms and conditions of the order, and agree to fulfill their responsibilities under the order. At the time of its investment in Underlying Fund Shares in excess of the limit in section 12(d)(1)(A)(i), a Fund of Funds will notify the Underlying Fund of the investment. At such time, the Fund of Funds will also transmit to the Underlying Fund a list of the names of each Fund of Funds Affiliate and Underwriting Affiliate. The Fund of Funds will notify the Underlying Fund of any changes to the list of the names as soon as reasonably practicable after a change occurs. The Underlying Fund and the Fund of Funds will maintain and preserve a copy of the order, the FOF Participation Agreement, and the list with any updated information for the duration of the investment and for a period of not less than six years thereafter, the first two years in an easily accessible place.
10. Before approving any advisory contract under section 15 of the Act, the board of directors or trustees of each Investing Management Company including a majority of the disinterested directors or trustees, will find that the advisory fees charged under such contract are based on services provided that will be in addition to, rather than duplicative of, the services provided under the advisory contract(s) of any Underlying Fund in which the Investing Management Company may invest. These findings and their basis will be fully recorded in the minute books of the appropriate Investing Management Company.
11. Any sales charges and/or service fees charged with respect to shares of a Fund of Funds will not exceed the limits applicable to a fund of funds as set forth in NASD Conduct Rule 2830.
12. No Underlying Fund will acquire securities of an investment company or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in section 12(d)(1)(A) of the Act, except to the extent the Underlying Fund acquires securities of another investment company pursuant to exemptive relief from the Commission permitting the Underlying Fund to acquire securities of one or more investment companies for short-term cash management purposes.
For the Commission, by the Division of Investment Management, under delegated authority.
On December 18, 2015, BATS Exchange, Inc. (“Exchange” or “BATS”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade the Shares of the Fund pursuant to BATS Rule 14.11(i), which governs the listing and trading of Managed Fund Shares on the Exchange. The Shares will be offered by the Trust, which was established as a Massachusetts business trust on December 12, 2013.
According to the Exchange, the Fund's investment objective will be to provide total return which exceeds that of the S&P GSCI Dynamic Roll Index (“Benchmark”)
The Fund will be an actively managed fund that seeks to achieve its investment objective by investing, under normal market conditions,
The Fund's Commodities investments, in part, will be comprised of exchange-traded futures contracts on commodities that comprise the Benchmark. Although the Fund, through the Subsidiary, will generally hold many of the futures contracts included in the Benchmark, the Fund and the Subsidiary will be actively managed and will not be obligated to invest in all of (or to limit investments solely to) such futures contracts. In addition, with respect to investments in exchange-traded futures contracts, the Fund and the Subsidiary will not be obligated to invest in the same amount or proportion as the Benchmark, or be obligated to track the performance of the Benchmark. In addition to exchange-traded futures contracts, the Fund's Commodities investments will also be comprised of the following: centrally cleared and non-centrally cleared swaps on commodities; exchange-traded options on futures contracts that provide exposure to the investment returns of the commodities markets; and exchange-traded commodity-linked instruments, without investing directly in physical commodities.
The Fund will invest in Commodities through investments in the Subsidiary and will not invest directly in physical commodities. The Fund's investment in the Subsidiary may not exceed 25% of the Fund's total assets. In addition to Commodities, the Fund's assets will be invested in: (1) short-term, investment grade fixed income securities, including only the following instruments: U.S. government and agency securities,
The Fund's investment in the Subsidiary will be designed to help the Fund achieve exposure to commodity returns in a manner consistent with the federal tax requirements applicable to the Fund and other regulated investment companies. The Fund intends to qualify for, and to elect to be treated as, a separate regulated investment company under Subchapter M of the Internal Revenue Code.
The Subsidiary will generally seek to make investments in Commodities, and its portfolio will be managed by the Adviser or a Sub-Adviser.
The Fund's investment in the Subsidiary is intended to provide the Fund with exposure to commodity markets within the limits of current federal income tax laws applicable to investment companies such as the Fund, which limit the ability of investment companies to invest directly in the derivative instruments. The Subsidiary will have the same investment objective as the Fund, but unlike the Fund, it may invest without limitation in Commodities. The Subsidiary's investments will provide the Fund with exposure to domestic and international markets.
The Commodity Futures Trading Commission (“CFTC”) has adopted substantial amendments to CFTC Rule 4.5 relating to the permissible exemptions and conditions for reliance on exemptions from registration as a commodity pool operator. As a result of the instruments that will be indirectly held by the Fund, the Adviser will register as a commodity pool operator and will also become a member of the National Futures Association (“NFA”). Any Sub-Adviser will register as a commodity pool operator or commodity trading adviser, as required by CFTC regulations. The Fund and the Subsidiary will be subject to regulation by the CFTC and NFA and additional disclosure, reporting, and recordkeeping rules imposed upon commodity pools.
While the Fund will be permitted to borrow as permitted under the 1940 Act, the Fund's investments will not be used to seek performance that is the multiple or inverse multiple (
The Subsidiary's shares will be offered only to the Fund, and the Fund will not sell shares of the Subsidiary to other investors. The Fund and the Subsidiary will not invest in any non-U.S. equity securities (other than shares of the Subsidiary). The Fund will not purchase securities of open-end or closed-end investment companies, except in compliance with the 1940 Act or any applicable exemptive relief. In addition, the Exchange represents that, with respect to the futures contracts and exchange-traded options on futures contracts in which the Subsidiary invests, not more than 10% of the weight (to be calculated as the value of the contract divided by the total absolute notional value of the Subsidiary's futures and options contracts) of the futures and options contracts held by the Subsidiary, in the aggregate, shall consist of instruments whose principal trading market is a market from which the Exchange may not obtain information regarding trading in the futures contracts and exchange-traded options on futures contracts by virtue of: (a) Its membership in the Intermarket Surveillance Group (“ISG”); or (b) a comprehensive surveillance sharing agreement.
The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), including securities deemed illiquid by the Adviser.
The Commission has carefully reviewed the proposed rule change and finds that it is consistent with the requirements of Section 6 of the Act
The Commission also finds that the proposal is consistent with Section 11A(a)(1)(C)(iii) of the Act,
The Commission further believes that the proposal to list and trade the Shares is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. The Commission notes that the Exchange will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily, and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time.
The Exchange further represents that the Shares are deemed to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. In support of this proposal, the Exchange has made representations, including:
(1) The Shares will be subject to BATS Rule 14.11(i), which sets forth the initial and continued listing criteria applicable to Managed Fund Shares.
(2) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.
(3) The Exchange believes that its surveillance procedures are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. Trading of the Shares through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Managed Fund Shares.
(4) The Exchange will communicate as needed regarding trading in the Shares and in the exchange-traded Commodities and exchange-traded investment companies not included within the definition of Commodities (together, “Exchange Traded Instruments”) held by the Fund and the Subsidiary with other markets and other entities that are members of ISG and may obtain trading information regarding trading in the Shares and in the Exchange Traded Instruments held by the Fund and the Subsidiary from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares and in the Exchange Traded Instruments held by the Fund and the Subsidiary from markets and other entities that are members of ISG, which includes securities and futures exchanges, or with which the Exchange has in place a comprehensive surveillance sharing agreement. The Exchange also will be able to access, as needed, trade information for certain fixed income securities held by the Fund reported to FINRA's TRACE.
(5) With respect to the futures contracts and exchange-traded options on futures contracts in which the Subsidiary invests, not more than 10% of the weight (to be calculated as the value of the contract divided by the total absolute notional value of the Subsidiary's futures and options contracts) of the futures and options contracts held by the Subsidiary, in the aggregate, shall consist of instruments whose principal trading market is a market from which the Exchange may not obtain information regarding trading in the futures contracts and exchange-
(6) Prior to the commencement of trading, the Exchange will inform its members in an Information Circular (“Circular”) of the special characteristics and risks associated with trading the Shares. Specifically, the Circular will discuss the following: (a) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (b) BATS Rule 3.7, which imposes suitability obligations on Exchange members with respect to recommending transactions in the Shares to customers; (c) how information regarding the IIV and the Disclosed Portfolio is disseminated; (d) the risks involved in trading the Shares during the Pre-Opening
(7) For initial and continued listing, the Fund and the Subsidiary must be in compliance with Rule 10A-3 under the Act.
(8) The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), including securities deemed illiquid by the Adviser under the 1940 Act.
(9) The Fund will invest in Commodities through investments in the Subsidiary and will not invest directly in physical commodities. The Fund's investment in the Subsidiary may not exceed 25% of the Fund's total assets. The Fund and the Subsidiary will not invest in any non-U.S. equity securities (other than shares of the Subsidiary).
(10) Investments in non-centrally cleared swaps (through the Subsidiary) will not represent more than 20% of the Fund's net assets.
(11) At least 75% of corporate debt obligations will have a minimum principal amount outstanding of $100 million or more. In addition, the exchange-traded investment companies and commodity-linked instruments in which the Fund invests will be listed and traded in the U.S. on registered exchanges.
(12) While the Fund will be permitted to borrow as permitted under the 1940 Act, the Fund's investments will not be used to seek performance that is the multiple or inverse multiple (
(13) A minimum of 100,000 Shares will be outstanding at the commencement of trading on the Exchange.
The Exchange represents that all statements and representations made in the filing regarding (a) the description of the portfolio, (b) limitations on portfolio holdings or reference assets, or (c) the applicability of Exchange rules and surveillance procedures constitute continued listing requirements for listing the Shares on the Exchange. In addition, the issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will surveil for compliance with the continued listing requirements. If the Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under Exchange Rule 14.12. This approval order is based on all of the Exchange's representations and description of the Fund, including those set forth above and in the Notice. The Commission notes that the Fund and the Shares must comply with the requirements of BATS Rule 14.11(i), including those set forth in this proposed rule change, to be listed and traded on the Exchange on an initial and continuing basis.
For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment Nos. 1, 2, and 3 thereto, is consistent with Section 6(b)(5) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to introduce new activity based order protections as described in more detail below. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the self-regulatory organization 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 self-regulatory organization has prepared summaries, set forth in sections A, B and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to introduce new risk protections for orders designed to aid members in their risk management by supplementing current price
Pursuant to the proposed Market Wide Risk Protection rule, the Exchange's trading system (the “System”) will maintain one or more counting programs on behalf of each member that will count the number of orders entered, and the number of contracts traded on ISE Gemini or, if chosen by the member,
Members will have discretion to establish the applicable time period for each of the counts maintained under the Market Wide Risk Protection, provided that the selected period must be within minimum and maximum parameters established by the Exchange and announced via circular.
The System will trigger the Market Wide Risk Protection when the counting program has determined that the member has either (1) entered during the specified time period a number of orders exceeding its designated allowable order rate, or (2) executed during the specified time period a number of contracts exceeding its designated allowable contract execution rate. In particular, after a member enters an order, or a member's order is executed, the System will look back over the specified time period to determine whether the member has exceeded the threshold that it has set for the total number of orders entered or the total number of contracts traded, as applicable. If the member's threshold has been exceeded, the Market Wide Risk Protection will be triggered and the System will automatically reject all subsequent incoming orders entered by the member on ISE Gemini or, if applicable, across both ISE Gemini and ISE.
The Exchange believes that the proposed Market Wide Risk Protection will assist members in better managing their risk when trading on ISE Gemini. In particular, the proposed rule change provides functionality that allows members to set risk management thresholds for the number of orders entered or contracts executed on the Exchange during a specified period. This is similar to how other options exchanges have implemented activity-based risk management protections,
The examples below illustrate how the Market Wide Risk Protection would work both for order entry and order execution protections:
Broker Dealer 1 (“BD1”) designates an allowable order rate of 499 orders/1 second.
Market Wide Risk Protection is triggered on ISE Gemini, and, if applicable, ISE
BD1 designates an allowable execution rate of 15,000 contracts/2 seconds.
Market Wide Risk Protection is triggered on ISE Gemini, and, if applicable, ISE
The Exchange believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.
The Exchange believes that the proposed rule change would assist with the maintenance of a fair and orderly market by establishing new activity based risk protections for orders. The Exchange currently offers a risk protection mechanism for market maker quotes that removes the member's quotes if a specified number of curtailment events occur during a set time period (“Market Wide Speed Bump”).
The proposed Market Wide Risk Protection is similar to risk management functionality provided by other options exchanges, including, for example, the MIAX Options Exchange (“MIAX”), which recently received Commission approval for its “Risk Protection Monitor” for orders.
The Exchange also believes that it is consistent with the protection of investors and the public interest to offer the Market Wide Risk Protection to members across both ISE Gemini and ISE as this will permit members to more effectively manage their risk simultaneously on both markets if desired. The Exchange already offers cross market risk protections for market makers [sic] quotes,
In accordance with Section 6(b)(8) of the Act,
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.
Within 45 days of the publication date of this notice or within such longer period (1) as the Commission may designate up to 45 days of such date if it finds such longer period to be appropriate and publishes its reasons for so finding or (2) as to which the self-regulatory organization consents, the Commission will:
(a) by order approve or disapprove such proposed rule change; or
(b) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to adopt requirements for the collection and transmission of data pursuant to Appendices B and C of the Regulation NMS Plan to Implement a Tick Size Pilot Program (“Plan”). The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization 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 those 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 parts of such statements.
On August 25, 2014, NYSE Group, Inc., on behalf of the Exchange, New York Stock Exchange LLC, NYSE MKT LLC, the Bats BZX Exchange, Inc. f/k/a BATS Exchange, Inc. (“BZX”), BATS BYX Exchange, Inc. f/k/a BATS Y-Exchange, Inc. (“BYX”), Bats EDGA Exchange, Inc., Bats EDGX Exchange, Inc., Chicago Stock Exchange, Inc., Financial Industry Regulatory Authority, Inc. (“FINRA”), NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC, and the Nasdaq Stock Market LLC (collectively “Participants”), filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stocks of small-capitalization companies. Each Participant is required to comply, and to enforce compliance by its members, as applicable, with the provisions of the Plan. As is described more fully below, the proposed rules would require ETP Holders
The term ETP is defined in NYSE Arca Equities Rule 1.1(m) to mean an equity trading permit issued by NYSE Arca Equities for effecting approved securities transactions on NYSE Arca Equities' trading facilities.
The Pilot will include stocks of companies with $3 billion or less in market capitalization, an average daily trading volume of one million shares or less, and a volume weighted average price of at least $2.00 for every trading day. The Pilot will consist of a control group of approximately 1400 Pilot Securities and three test groups with 400 Pilot Securities in each (selected by a stratified random sampling process).
In approving the Plan, the Commission noted that the Trading Center data reporting requirements would facilitate an analysis of the effects of the Pilot on liquidity (
The Plan contains requirements for collecting and transmitting data to the Commission and to the public.
Appendix B.II of the Plan (Market and Marketable Limit Order Data) requires Trading Centers to submit information relating to market orders and marketable limit orders, including the time of order receipt, order type, the order size, the National Best Bid and National Best Offer (“NBBO”) quoted price, the NBBO quoted depth, the average execution price-share-weighted average, and the average execution time-share-weighted average.
The Plan requires Appendix B.I and B.II data to be submitted by Participants that operate a Trading Center, and by members of the Participants that operate Trading Centers. The Plan provides that each Participant that is the Designated Examining Authority (“DEA”) for a member of the Participant that operates a Trading Center shall collect such data in a pipe delimited format, beginning six months prior to the Pilot Period and ending six months after the end of the Pilot Period. The Plan also requires the Participant, operating as DEA, to transmit this information to the SEC within 30 calendar days following month end.
The Exchange is proposing new Rule 7.46(b) to set forth the requirements for the collection and transmission of data pursuant to Appendices B and C of the Plan. Proposed Rule 7.46(b) is substantially similar to the proposed
Proposed Rule 7.46(b)(1) requires that an ETP Holder that operates a Trading Center shall establish, maintain and enforce written policies and procedures that are reasonably designed to comply with the data collection and transmission requirements of Items I and II to Appendix B of the Plan, and an ETP Holder that is a Market Maker shall establish, maintain and enforce written policies and procedures that are reasonably designed to comply with the data collection and transmission requirements of Item IV of Appendix B of the Plan and Item I of Appendix C of the Plan.
Proposed Rule 7.46(b)(2) provides that the Exchange shall collect and transmit to the SEC the data described in Items I and II of Appendix B of the Plan relating to trading activity in Pre-Pilot Data Collection Securities
Appendix B.IV (Daily Market Maker Participation Statistics) requires a Participant to collect data related to Market Maker participation from each Market Maker
The Exchange understands that some ETP Holders may utilize a DEA that is not a Participant to the Plan and that their DEA would not be subject to the Plan's data collection requirements. In such case, a DEA that is not a Participant of the Plan would not be required to collect the required data and may not establish procedures for which ETP Holders it acts a DEA for to report the data required under subparagraphs (b)(3)(A) of Rule 7.46 and in accordance with Item IV of Appendix B of the Plan. Therefore, the Exchange proposes to adopt subparagraph (b)(3)(B) to Rule 7.46 to require an ETP Holder that is a Market Maker whose DEA is not a Participant to the Plan to transmit the data collected pursuant to paragraph (3)(A) of Rule 7.46(b) to FINRA, which is a Participant to the Plan and is to collect data relating to Item IV of Appendix B of the Plan on behalf of the Participants. For Market Makers for which it is the DEA, FINRA issued a Market Maker Transaction Data Technical Specification to collect data on Pre-Pilot Data Collection Securities and Pilot Securities from Trading Centers to comply with the Plan's data collection requirements.
Proposed Rule 7.46(b)(3)(C) provides that the Exchange shall transmit the data collected by the DEA or FINRA pursuant to Rule 7.46(b)(3)(A) and (B) above relating to Market Maker activity on a Trading Center operated by the Exchange to the SEC in a pipe delimited format within 30 calendar days following month end. The Exchange shall also make such data publicly available on the Exchange Web site on a monthly basis at no charge and shall not identify the Trading Center that generated the data.
Appendix C.I (Market Maker Profitability) requires a Participant to collect data related to Market Maker profitability from each Market Maker for which it is the DEA. Specifically, the Participant is required to collect the total number of shares of orders executed by the Market Maker; the raw Market Maker realized trading profits, and the raw Market Maker unrealized trading profits. Data shall be collected for dates starting six months prior to the Pilot Period through six months after the end of the Pilot Period. This data shall be collected on a monthly basis, to be provided in a pipe delimited format to the Participant, as DEA, within 30 calendar days following month end. Appendix C.II (Aggregated Market Maker Profitability) requires the Participant, as DEA, to aggregate the Appendix C.I data, and to categorize this data by security as well as by the control group and each Test Group. That aggregated data shall contain information relating to total raw Market Maker realized trading profits, volume-weighted average of raw Market Maker realized trading profits, the total raw Market Maker unrealized trading profits, and the volume-weighted average of Market Maker unrealized trading profits.
The Exchange is therefore proposing Rule 7.46(b)(4) to set forth the requirements for the collection and transmission of data pursuant to Appendix C.I of the Plan. Proposed Rule 7.46(b)(4)(A) requires that an ETP Holder that is a Market Maker shall
For the same reasons set forth above for subparagraph (b)(3)(B) to Rule 7.46, the Exchange proposes to adopt subparagraph (b)(4)(B) to Rule 7.46 to require an ETP Holder that is a Market Maker whose DEA is not a Participant to the Plan to transmit the data collected pursuant to paragraph (4)(A) of Rule 7.46(b) to FINRA. As stated above, FINRA is a Participant to the Plan and is to collect data relating to Item I of Appendix C of the Plan on behalf of the Participants. For Market Makers for which it is the DEA, FINRA issued a Market Maker Transaction Data Technical Specification to collect data on Pre-Pilot Data Collection Securities and Pilot Securities from Trading Centers to comply with the Plan's data collection requirements.
The Exchange is also adopting a rule setting forth the manner in which Market Maker participation will be calculated. Item III of Appendix B of the Plan requires each Participant that is a national securities exchange to collect daily Market Maker registration statistics categorized by security, including the following information: (i) Ticker symbol; (ii) the Participant exchange; (iii) number of registered market makers; and (iv) the number of other registered liquidity providers. Therefore, the Exchange proposes to adopt Rule 7.46(b)(5) providing that the Exchange shall collect and transmit to the SEC the data described in Item III of Appendix B of the Plan relating to daily Market Maker registration statistics in a pipe delimited format within 30 calendar days following month end for: (i) Transactions in each Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period; and (ii) transactions in each Pilot Security for the period beginning on the first day of the Pilot Period through six months after the end of the Pilot Period.
The Exchange is also proposing, through
The Exchange and the other Participants have determined that it is appropriate to create a new flag for reporting orders that are affected by the Limit-Up Limit-Down bands. Accordingly, a Trading Center shall report a value of “Y” to their DEA when the ability of an order to execute has been affected by the Limit-Up Limit-Down bands in effect at the time of order receipt. A Trading Center shall report a value of “N” to their DEA when the ability of an order to execute has not been affected by the Limit-Up Limit-Down bands in effect at the time of order receipt.
The Exchange is proposing
The Exchange is proposing
The Exchange is proposing
Finally, the Exchange is proposing
The proposed rule change will be effective on April 4, 2016.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant of the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. The Exchange believes that this proposal is in furtherance of the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act because the proposal implements and clarifies the requirements of the Plan and applies specific obligations to ETP Holders in furtherance of compliance with the Plan.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant of the Plan. The Exchange also notes that the data collection requirements for ETP Holders that operate Trading Centers will apply equally to all such ETP Holders, as will the data collection requirements for Market Makers.
No written comments were solicited or received with respect to the proposed rule change.
Because the 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) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under 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 necessary or appropriate in the public interest, for the protection of investors, or 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 change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend its rules relating to pre-opening indications and opening procedures to promote greater efficiency and transparency at the open of trading on the Exchange. This Amendment No. 2 supersedes the original filing in its entirety. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization 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 those 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 parts of such statements.
The Exchange proposes to amend its rules relating to pre-opening indications and opening procedures to promote greater efficiency and transparency at the open of trading on the Exchange. In particular, the Exchange proposes to:
• Make changes to the rules related to the pre-opening indication process by:
○ Amending Rules 15 and 123D to consolidate the requirements for publication of pre-open indications in a single rule (Rule 15);
○ changing the conditions in which a Designated Market Maker (“DMM”) is required to publish a pre-opening indication in a security to an anticipated 5% move from a security's reference price and, during extreme market-wide volatility, an anticipated 10% from a security's reference price; and
○ providing for the CEO of the Exchange to temporarily suspend the requirement to publish pre-opening indications.
• Make changes to Rule 123D related to the opening process by:
○ Incorporating all procedures relating to openings, other than pre-opening indications, in Rule 123D; and
○ Specifying that DMMs may effect an opening of a security electronically within specified percentage and volume parameters, which would be doubled during extreme market-wide volatility; and
○ providing for the CEO of the Exchange to temporarily suspend price and volume limitations for a DMM
• Delete Rule 48
• Make conforming changes to Rules 80C, 124 and 9217.
The Exchange believes that the proposed changes will enhance transparency regarding the Exchange's opening process by specifying new parameters for how the opening at the Exchange would be effectuated on trading days experiencing extreme market-wide volatility, which would include both additional information before the open through the use of new parameters for pre-opening indications and expanded ability for DMMs to effectuate an opening electronically. The proposed rule changes are designed to preserve the Exchange's existing model, which values human touch when opening securities with significant price or volume disparity, while at the same time promoting automated measures to have as many securities open as close to 9:30 a.m. as feasible, even during extreme market-wide volatility.
The Exchange's current pre-opening procedures are outlined in Rules 15 (Pre-Opening Indications), 48 (Exemptive Relief—Extreme Market Volatility Condition), and 123D (Openings and Halts in Trading).
Rule 15(a) provides that if the opening transaction in a security will be at a price that represents a change of more than the “applicable price change” specified in the Rule,
A Rule 15 Indication is published on the Exchange's proprietary data feeds only and includes the security and the price range within which the DMM anticipates the opening transaction will occur, and would include any orally-represented Floor broker interest for the open. The applicable price ranges for determining whether to publish a Rule 15 Indication are based on five different price buckets and are expressed in dollar and percentage parameters:
Rule 123D also mandates that pre-opening indications be published if the opening price would result in a significant price change from the previous close or if the opening is delayed past 10:00 a.m. Eastern Time (“Rule 123D Mandatory Indication”). The DMM is responsible for publishing the Rule 123D Mandatory Indication and, when determining the price range for the indication, takes into consideration Floor broker interest that has been orally entered and what, at a given time, the DMM anticipates the dealer participation in the opening transaction would be. Rule 123D Mandatory Indications are published to the Consolidated Tape and proprietary data feeds. The applicable price ranges for determining whether an opening price would be a “significant” price change requiring a Rule 123D Mandatory Indication are based on three price buckets and are expressed in a mixture of dollar (1 point = one dollar) and percentage parameters:
Rule 48 provides that a “qualified Exchange officer”
Finally, Rule 123D, which in addition to setting forth requirements for certain pre-opening indications, also specifies procedures relating to openings, including that it is the responsibility of each DMM to ensure that securities open as close to the opening bell as possible and that securities can be opened on a trade or a quote. The rule further provides that openings may be effectuated manually or electronically.
The Exchange proposes to amend Rules 15, 48, and 123D to introduce greater efficiency and transparency into its opening process by, among other things, consolidating its rules regarding pre-opening indications into a single rule (Rule 15), introducing a new, single percentage parameter for the publication of pre-opening indications that would double on volatile trading days, and consolidating opening procedures into Rule 123D, including specifying parameters of when a DMM may effect an opening electronically, and consolidating the procedures of Rule 48 into Rules 15 and 123D, as applicable. The Exchange also proposes conforming changes to Rules 80C, 124 and 9217.
The Exchange proposes to make changes to the pre-opening indication process. The Exchange would consolidate the requirements relating to pre-opening indications into Rule 15(a)-(f). Because the Exchange proposes all new rule text in Rule 15(a)-(f), the Exchange proposes to delete paragraphs (a) and (b) of current Rule 15, re-number Rule 15(c) as Rule 15(g), delete rule text in Rule 123D(b) relating to mandatory indications, and amend the title of Rule 15 to add the phrase “and Opening Order Imbalance Information” so that the rule would be titled “Pre-Opening Indications and Opening Order Imbalance Information.” In amending Rule 15, the Exchange would establish new conditions for when DMMs are required to publish pre-opening indications.
Proposed Rule 15(a), entitled “Pre-Opening Indications,” would provide that a pre-opening indication would include the security and the price range within which the opening price is anticipated to occur. This proposed rule text is based on the last clause of the first sentence of current Rule 15(a), which provides that a pre-opening
Proposed Rule 15(b), entitled “Conditions for Publishing a Pre-Open Indication,” would set forth the conditions in which a DMM is required to publish a pre-opening indication.
• Proposed Rule 15(b)(1) would provide that a DMM will publish a pre-opening indication before a security opens if the opening transaction on the Exchange is anticipated to be at a price that represents a change of more than the “Applicable Price Range,” as defined in proposed Rule 15(d), from a specified “Reference Price,” as defined in proposed Rule 15(c), before the security opens. The procedures for publishing a pre-opening indication would be described in Rule 15(e). This proposed rule text is based on current Rule 15(a), which uses the term “applicable price range” and describes the reference prices used for purposes of current Rule 15(a). The Exchange proposes to define the “Reference Price” and “Applicable Price Range” in proposed Rules 15(c) and (d), described below. The requirement for DMMs to publish pre-opening indications is based on current Rule 15(a), which provides that the DMM shall issue a pre-opening indication if the conditions set forth in the rule are met.
• Proposed Rule 15(b)(2) would specify that when making a determination of what the opening transaction price would be, the DMM will take into consideration all interest eligible to participate in the opening transaction, including electronically-entered orders, the DMM's own interest, and any interest represented orally in the crowd. This proposed rule text would be new and is designed to promote transparency in Exchange rules that all interest eligible to participate in the opening transaction is considered when publishing a pre-opening indication.
• Proposed Rule 15(b)(3) would provide that if a DMM is unable to publish a pre-opening indication for one or more securities due to a systems or technical issue, the Exchange may publish the pre-opening indication. This proposed rule text is based in part on current Rule 15(a), which provides that either the DMM or the Exchange shall publish a pre-opening indication. The Exchange proposes a substantive difference to provide that the Exchange “may” rather than “shall” publish a pre-opening indication. As set forth in current Rule 123D(a)(5), which was added after the applicable rule text in Rule 15(a),
Proposed Rule 15(c), entitled “Reference Price,” would provide in paragraph (1) that the Reference Price for a security (other than an American Depository Receipt (“ADR”)) for purposes of the proposed rule would be:
• The security's last reported sale price on the Exchange (proposed Rule 15(c)(1)(A));
• in the case of an IPO, the security's offering price (proposed Rule 15(c)(1)(B)); or
• the security's last reported sale price on the securities market from which the security is being transferred to the Exchange, on the security's first day of trading on the Exchange (proposed Rule 15(c)(1)(C)).
This proposed rule text is based on current Rule 15(a).
Proposed Rule 15(c)(2) would provide that the Reference Price for ADRs for purposes of the proposed rule would be:
• The closing price of the security underlying the ADR in the primary foreign market in such security when the trading day of the primary foreign market concludes (proposed Rule 15(c)(2)(A)); or
• based on parity with the last sale price of the security underlying the ADR in the primary foreign market for such security when the trading day of the primary foreign market is open for trading at the time of the opening on the Exchange (proposed Rule 15(c)(2)(B)).
This proposed rule text is based on current Rule 15(b), with non-substantive differences for clarity and to use the defined term “Reference Price” in the proposed rule text.
Proposed Rule 15(d) would set forth the Applicable Price Ranges for determining whether a DMM is required to disseminate a pre-opening indication. The Exchange proposes to eliminate the current price buckets in Rules 15 and 123D and instead use a single percentage parameter as the Applicable Price Range for all securities, regardless of price of the security. As proposed, except during extreme market-wide volatility as set forth in proposed Rule 15(d)(2), a DMM would be required to publish a pre-opening indication if a security is expected to open at a price more than 5% away from the Reference Price. The Exchange believes that the proposed 5% parameter applicable to all securities would simplify and streamline the Exchange's rules regarding required pre-opening indications by having a single percentage parameter that would be applied across all securities, rather than having different price buckets and percentage parameter ranges to track. The Exchange further believes that the proposed single percentage parameter would result in a similar number of pre-opening indications as are currently published pursuant to Rule 123D, while at the same time simplifying the process for DMMs.
For example, using trade data for the month of October 2015, which was a month of relative trading stability and volumes, current Rule 123D Mandatory Indication parameters required indications for 15 securities on an average daily basis, which represents approximately 0.46% of the securities traded on the Exchange. Applying the proposed new percentage parameter of 5% to the same October 2015 trade data, DMMs would have been required, on average, to publish 33 pre-opening indications, which represents 1.01% of securities that trade on the Exchange. The Exchange believes that the incremental increase in number of pre-opening indications that would have been published pursuant to the proposed new single percentage parameter would promote transparency
Under current rules, the Exchange may suspend the requirement to publish pre-opening indications if a market-wide extreme market volatility condition is declared under Rule 48. This rule was adopted, in part, because of the manual nature of publishing pre-opening indications, and if DMMs were required to publish Rule 123D Mandatory Indications for multiple securities, it could delay the opening process and result in a large number of securities opening past 9:30 a.m. Eastern Time.
Accordingly, the Exchange proposes to amend its rules to provide that on trading days with extreme market-wide volatility, the Applicable Price Range would be 10%, or double the Applicable Price Range on regular trading days. Specifically, proposed Rule 15(d)(2) would provide that, if as of 9:00 a.m. Eastern Time (“ET”), the E-mini S&P 500 Futures are plus or minus 2% from the prior day's closing price of the E-mini S&P 500 Futures, when reopening trading following a market-wide trading halt under Rule 80B, or if the Exchange determines that it is necessary or appropriate for the maintenance of a fair and order market, a DMM would be required to publish a pre-opening indication in a security if the price of that security is expected to open at a price more than 10% away from the Reference Price. By proposing to specify the conditions in which the Applicable Price Range would be 10%, the Exchange would promote transparency in Exchange rules so that market participants will know when the double-wide percentage parameter would be applied. Because the standard for extreme market-wide volatility would be specified in the rule, the Exchange would not need to provide separate notification on a trading day when the double-wide percentages would be applicable.
By proposing to specify in its rules that the Applicable Price Range would be 10%, rather than 5%, when the market is more volatile, the Exchange would require DMMs to disseminate pre-opening indications in those securities experiencing the greatest price movement. Under current rules, the Exchange's only option when the overall market is volatile is to lift the requirement for pre-opening indications under Rule 48. The Exchange also proposes to use the 10% percentage parameter when reopening securities following a market-wide trading halt under Rule 80B. The Exchange believes that widening the parameters for pre-opening indications following a market-wide trading halt would be appropriate because the reason for the trading halt was market-wide volatility, and thus the reopening of securities would face similar pricing pressure as circumstances when there is pre-opening extreme market-wide volatility. The Exchange also proposes that it would have the authority to use the 10% Applicable Price Range when it is necessary or appropriate for the maintenance of a fair and orderly market. For example, if the E-mini S&P 500 Futures were not plus or minus 2% as of 9:00 a.m., but moved to that level between 9:00 and 9:30, it may be appropriate, for the maintenance of a fair and orderly market, to use widened percentage parameters.
To determine the percentage parameter that would be appropriate for trading days with extreme market-wide volatility, the Exchange reviewed trading data from August 24, 25, and 26, 2015 and assessed how many Rule 123D Mandatory Indications would have been required under current rules, and how many pre-opening indications would have been required if a 5% and 10% percentage parameter were used on those days. Taking for example August 24, 2015, as set forth on Table 1 below, the data show that, had the Exchange not invoked Rule 48 lifting the requirement to publish Rule 123D Mandatory Indications, there would have been 638 securities (19% of securities) for which DMMs would have been required to publish Rule 123D Mandatory Indications. As set forth in Table 2 below, a 5% percentage parameter would have required 1,460 pre-opening indications (44% of securities) on August 24, 2015, more than twice as many as under the current parameters. As noted above, the Exchange believes that this would be too many pre-opening indications for DMMs to process on a trading day without impacting their ability to timely open their assigned securities.
By contrast, as set forth in Table 2 below, a 10% percentage parameter would have required pre-opening indications in 278 securities (8.4% of securities) on August 24, 2015. While this number is still higher than the number of pre-opening indications that would have been published on an average trading day in October using the 5% percentage parameter (see above), the Exchange believes that it strikes the appropriate balance between providing additional pre-opening information to investors and enabling the DMM's to timely open their assigned securities. As set forth in more detail in Tables 1 and 2 below, August 24 represents an outlier, even for days when there has been extreme market-wide volatility. For other days in 2015 when the Exchange declared an extreme market-wide volatility under Rule 48, as set forth in Tables 1 and 2 below, applying a 10% parameter would not materially change the number of pre-opening indications being published.
Proposed Rule 15(e), entitled “Procedures for publishing a pre-opening indication,” would set forth proposed procedures a DMM would use when publishing a pre-opening indication. As discussed below, these procedures are based on existing procedures currently set forth in Rule 123D, with specified differences.
Proposed Rule 15(e)(1) would provide that publication of pre-opening indications requires the supervision and approval of a Floor Governor.
Proposed Rule 15(e)(2) would provide that a pre-opening indication must be updated if the opening transaction would be at a price outside of a published pre-opening indication. Proposed Rule 15(e)(3) would further require that if a pre-opening indication is a spread wider than $1.00, the DMM should undertake best efforts to publish an updated pre-opening indication of $1.00 or less before opening the security, as may be appropriate for the specific security. Proposed Rules 15(e)(2) and (e)(3) are based, in part, on the second and third bullet points following the ninth paragraph of Rule 123D(b),
Proposed Rule 15(e)(4) would provide that, after publication of a pre-opening indication, the DMM must wait for the following minimum specified periods before opening a security:
• Proposed Rule 15(e)(4)(A) would provide that, when using the 5% Applicable Price Range specified in proposed Rule 15(d)(1), a minimum of three minutes must elapse between publication of the first indication and a security's opening. The rule would further provide that, if more than one indication has been published, a security may be opened one minute after the last published indication provided that at least three minutes have elapsed from the dissemination of the first indication. These first two sentences of proposed Rule 15(e)(4)(A) are based on rule text set forth in the twelfth and thirteenth paragraphs of current Rule 123D(b). Proposed Rule 15(e)(4)(A) would further provide that the DMM may open a security less than the required wait times after the publication of a pre-opening indication if the imbalance is paired off at a price within the Applicable Price Range. This proposed exception to the three-minute waiting requirement is new and is because the Exchange believes that, if equilibrium in price has been reached at a price within the Applicable Price Range,
• Proposed Rule 15(e)(4)(B) would provide that, when using the 10% Applicable Price Range specified in Proposed Rule 15(d)(2), a minimum of one minute must elapse between publication of the first indication and a security's opening and that if more than one indication has been published, a security may be opened without waiting any additional time. As discussed above, proposed Rule 15(d)(2) would provide for new percentage parameters for trading days with extreme market-wide volatility. Based on the analysis of trade data for August 24, 2015, even with the new percentage parameters, there is the potential for 278 pre-opening indications to be required on an extremely volatile trading day. Because these pre-opening indications would be manually published by the DMM, the Exchange believes that eliminating additional wait times would enable the
Proposed Rule 15(e)(5) would provide that, if trading is halted for a non-regulatory order imbalance, a pre-opening indication must be published as soon as practicable after the security is halted. This proposed rule text is based on the first sentence of the third bulleted paragraph following the ninth paragraph in Rule 123D(b), with a proposed substantive difference that a pre-opening indication should be published “as soon as practicable,” rather than “immediately,” after a security is halted. The Exchange believes that the proposed approach provides for more flexibility for the DMM to assess the order imbalance and publish a pre-opening indication that takes into consideration all applicable factors.
Proposed Rule 15(e)(6) would set forth the requirements for pre-opening indications when reopening a security following a trading pause under Rule 80C.
Proposed Rule 15(f), entitled “Temporary Suspension of Pre-Opening Indications,” would provide in proposed Rule 15(f)(1) that if the CEO of the Exchange determines that a Floor-wide event is likely to impact the ability of DMMs to arrange for a fair and orderly opening or reopening and that absent such relief, operation of the Exchange is likely to be impaired, the CEO of the Exchange may temporarily suspend the requirement to publish pre-opening indications under Rule 15 prior to opening or reopening a security following a market-wide trading halt.
Proposed Rule 15(f) is based in part on Rule 48, which provides that a qualified Exchange officer may declare an extreme market volatility condition and temporarily suspend the requirements for pre-opening indications.
Proposed Rule 15(f)(2), which is based on Rule 48(c)(1)(A), would specify the range of factors that the CEO of the Exchange would be required to consider in making any determination to temporarily suspend the requirement for pre-opening indications.
Because the Exchange has added new subsections to Rule 15, the Exchange proposes to renumber Rule 15(c) as Rule 15(g) and to add a header to this subsection of rule entitled “Opening Order Imbalance Information.” In addition to re-designating the rule from Rule 15(c) to Rule 15(g), the Exchange proposes non-substantive differences to re-number the subsections of proposed Rule 15(g) to use the same numbering convention as proposed for proposed Rule 15(a)-(f), delete the phrase “the provisions of” in proposed Rule 15(g)(2)(B), and remove the reference to subparagraph (b) by deleting the phrase “or (b).”
The Exchange also proposes a substantive difference to change Rule 15(c)(3)(iii) (re-numbered as proposed Rule 15(g)(3)(C)) to increase the frequency with which the Exchange disseminates Order Imbalance Information
Finally, the Exchange proposes to add new Supplementary Material .10 to Rule 15 providing that, unless otherwise specified in the proposed Rule,
As noted above, the process for publishing either Rule 15 Indications or Rule 123D Mandatory Indications is manual, and is generally followed by the DMM effecting the opening of a security manually rather than electronically. Consistent with this approach, the Exchange currently systemically blocks DMMs from opening a security electronically if the opening price would be outside of price parameters that are based on the price buckets and applicable price ranges specified in Rule 15(a). The Exchange similarly blocks DMMs from electronically opening a security if size of the opening transaction would be a significant volume, which similarly would indicate the potential need for manual oversight of the opening process.
Because the DMM is not obligated to open a security electronically, the Exchange has not historically specified in its rules the parameters for when the DMM may effect an opening electronically.
In specifying parameters for when a DMM may effectuate an opening electronically, the Exchange proposes to adopt parameters and requirements that would be structured similarly to the proposed parameters for new Rule 15 pre-opening indications, as discussed above. To effect this change, the Exchange proposes new subsection numbering to Rule 123D(a)(1) to break out the third and fourth sentences of current Rule 123D(a)(1) to be proposed Rules 123D(a)(1)(A) and (B).
The Exchange proposes to set forth the parameters for when a DMM may effect an opening electronically in new proposed Rules 123D(a)(1)(B)(i) and (ii):
• Proposed Rule 123D(a)(1)(B)(i) would provide that except under the conditions set forth in Rule 123D(a)(1)(B)(ii), a DMM may not effect an opening electronically if the opening transaction would be at a price more than 4% away from the Official Closing Price, as defined in Rule 123C(1)(e), or the matched volume for the opening transaction would be more than (a) 150,000 shares for securities with an average opening volume of 100,000 shares or fewer in the previous calendar quarter; or (b) 500,000 shares for securities with an average opening volume of over 100,000 shares in the previous calendar quarter. For purposes of this Rule, the calendar quarters will be based on a January 1 to December 31 calendar year.
• Proposed Rule 123D(a)(1)(B)(ii) would provide that if as of 9:00 a.m. ET, the E-mini S&P 500 Futures are plus or minus 2% from the prior day's closing price of the E-mini S&P 500 Futures, or if the Exchange determines that it is necessary or appropriate for the maintenance of a fair and order market, a DMM could effect an opening electronically if the opening transaction would be at a price of up to 8% away from the Official Closing Price, as defined in Proposed Rule 123C(1)(e), without any volume limitations.
Similar to the new Applicable Price Ranges for pre-opening indications proposed in Rule 15(d) above, the Exchange proposes to use a single percentage parameter for all securities, regardless of price. The Exchange also proposes to double those percentage parameters on days with extreme market-wide volatility, and would use the same standard for determining whether there is market-wide volatility as is proposed in Rule 15(d)(2), described above. Because the Exchange continues to believe that, if a pre-opening indication has been published, a security is better served if a DMM effects a manual opening, the Exchange proposes to apply percentage parameters to DMM automated openings that are tighter than the requirements for publishing a pre-opening indication. In other words, if a pre-opening indication would be required under proposed Rule 15, the DMM would not be permitted to effect an opening electronically. To achieve this goal, the Exchange proposes that the percentage parameter on a regular trading day for DMM automated opens should be one percent lower than the percentage parameter for pre-opening indications on a regular trading day. And as with pre-opening indications, on a day with extreme market-wide volatility, the applicable percentage would be doubled.
The Exchange believes that the proposed conditions for when a DMM may effect an opening electronically would reduce the number of manual openings and enable more securities to open closer to 9:30 a.m. ET, both on regular trading days and on extremely volatile trading days such as August 24, 2015.
Tables 3 through 5 below illustrate how many securities would not be eligible for a DMM to effect an opening electronically when applying the current and proposed percentage and volume parameters to trade data from October 2015 and trade data from August 24, 2015.
For example, as set forth in Table 3, using current price parameters and a 100,000 share volume parameter, in October 2015, 94 securities (13.4% of securities) on average each day were not eligible to be opened by the DMM electronically. As demonstrated in Table 4, using the proposed 4% price and tiered volume parameters, a comparable 47 securities (1.7% of securities) on average in October would not have been eligible to be opened by the DMM electronically.
With respect to the proposed volume parameters, the Exchange believes that having a parameter tied to higher-than-average opening volume in a security would better reflect whether opening electronically would be appropriate. For example, as the data show in Table 4, there were 74 securities averaging daily opening volume over 100,000 shares in the previous quarter (3Q15) and three of those securities had opening volume of over 500,000 shares on an average daily basis in October. The Exchange believes that if a security has a higher-than-average opening volume on a quarterly basis without any corresponding price dislocation, then the volume of shares trading on the opening for such securities is not representative of any volatility for that security, but rather, is a regular state of affairs that does not require a high-touch opening managed by a DMM on the trading Floor. Rather, such securities would benefit from being available for the DMM to open electronically in order to promote a fair and orderly opening at or near the open of trading.
As with pre-opening indications, the Exchange proposes to double the percentage parameter on trading days with extreme market-wide volatility and eliminate the volume parameter. As illustrated in Table 5, doubling the percentage parameter and eliminating the volume parameters would allow DMMs to open most securities electronically even during extreme market-wide volatility. As trade data from August 24, 2015 set forth in Table 3 illustrates, the current percentage parameters restricted DMMs from opening 1,753 securities electronically, which represents 58.4% of securities.
The Exchange also proposes to add a new paragraph (c) to Rule 123D entitled “Temporary Suspension of DMM Automated Opening Limitations or Floor Official Approval.” Similar to proposed Rule 15(f), if the CEO of the Exchange determines that a Floor-wide event it likely to have an impact on the ability of DMMs to arrange for a fair and orderly opening or reopening following a market-wide trading halt at the Exchange and that, absent relief, the operation of the Exchange is likely to be impaired, the CEO of the Exchange may temporarily suspend the prohibition on a DMM opening a security electronically if the opening transaction would be more than the price or volume parameters specified in proposed Rule 123D(a)(1)(B). This would be a new suspension authority that relates to the proposed new price and volume parameters for when a DMM may open a security electronically. The Exchange believes that having this temporary suspension authority would be appropriate for situations if the DMM is unable to open a security manually, either due to unavailability of 11 Wall Street facilities or because of systems or technical issues with Floor-based tools for manually opening a security.
Proposed Rule 123D(c) would also provide that if the CEO of the Exchange
Proposed Rule 123D(c)(2)-(3) are nearly identical to proposed Rule 15(f)(1)-(3), as described in greater detail above, with changes only to address that this proposed rule relates to the temporary suspension of the requirements for specified paragraphs of Rule 123D. Proposed Rule 123D(c)(2)-(3) is based on the same provisions of Rule 48 that proposed Rule 15(f)(2)-(4) is based on, which is discussed in greater detail above.
The miscellaneous and technical amendments proposed to Rule 123D are as follows:
• The Exchange proposes to amend Rule 123D(a)(5) (Pre-Opening Information) to change the citation to Rule 15(c) to 15(g) based on the proposed changes to Rule 15, described above, and delete the word “either” and the references to Rule 123D.
• The Exchange proposes to delete the phrase “Halts in Trading” from the heading of Rule 123D(b).
• Also in Rule 123D(b), the Exchange proposes to delete the text relating to the dissemination of mandatory indications beginning with the sentence “If an unusual situation exists, such as a large order imbalance, tape indications should be disseminated, including multiple indications if appropriate with the supervision of a Floor Official” through and including the sentence “An Executive Floor Governor or Floor Governor should be consulted in any case where there is not complete agreement among the Floor Officials participating in the discussion.” This rule text all pertains to Rule 123D Mandatory indications, which, as discussed above, would be governed by proposed Rule 15.
• The Exchange proposes to add a new heading (c) entitled “Halts in Trading” before the sentence “Once trading has commenced, trading may only be halted with the approval of a Floor Governor or two Floor Officials” in current Rule 123D(b) and change current headings (c) (Equipment Changeover) and (d) of Rule 123D to (d) and (e), respectively.
• Finally, in current Rule 123D(c) (Proposed Rule 123D(e)), to reflect that all information relating to pre-opening indications, including the Applicable Price Ranges and Reference Prices, are now described in Rule 15, the Exchange proposes to delete the phrase “a significant order imbalance (one which would result in a price change from the last sale of one point or more for stocks under $10, the lesser of 10% or three points for $10—$99.99 and five points if $100 or more—unless a Floor Governor deems circumstances warrant a lower parameter) develops” and add the phrase “a pre-opening indication would be required to be published” in its place.
The Exchange proposes to delete Rule 48 in its entirety. As discussed above, the Exchange is proposing changes to Rules 15 and 123D that it believes will allow DMMs to publish pre-opening indications in a manageable number of securities, even on days of high volatility, which would promote transparency regarding opening prices at the Exchange. In addition, and as described above, the Exchange is incorporating into Rules 15 and 123D authority for the CEO of the Exchange to temporarily suspend the requirement to publish pre-opening indications, the pricing and volume limitations for a DMM to open a security electronically, and for a DMM to obtain Floor Official approval under Rule 123D(b) when opening or reopening a security, if the CEO of the Exchange determines that such relief is necessary to the ability of DMMs to open the securities and to the operation of the Exchange. Accordingly, the Exchange believes that the Rule 48 is no longer necessary.
The Exchange proposes conforming amendments Rule 80C(b)(2), which governs a Trading Pause under the LULD Plan.
First, Rule 80C(b)(2) requires that the Exchange re-open the security in a manner similar to the procedures set forth in Rule 123D following a Trading Pause (as defined therein). The Exchange proposes to add a reference to Rule 15 to Rule 80C(b)(2), so that the requirement to re-open would be in a manner similar to Rules 15 and 123D.
Second, the Exchange proposes to delete subdivision (A) of Rule 80C(b)(2) in its entirety and mark the deleted text as “Reserved.” As noted above, the requirements for reopening a security following a trading pause set forth in Rule 80C would be codified in proposed Rule 15(d)(6).
The Exchange proposes to amend subsection (c)(1) of Rule 124 (Midday Auction), describing the reopening process for the Midday Auction in the same manner as in Rule 123D for reopenings, by adding “pre-opening” before the word “indication” in four places and deleting the reference “to the Consolidated Tape” in the first sentence.
The Exchange also proposes to amend Rule 9217, which sets forth the list of rules under which a member organization or covered person may be subject to a fine under a minor rule violation plan as set forth in Rule 9216(b). Rule 9217 permits a summary fine for violations of Rule 123D requirements for DMMs relating to openings, reopenings, delayed openings, trading halts, and tape indications. The Exchange proposes to delete the clause “tape indications” to reflect elimination of mandatory indications from Rule 123D. The Exchange believes this proposed change would add transparency and clarity to the Exchange's rules.
Because of the technology changes associated with the proposed rule
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that streamlining and consolidating pre-opening indications into a single rule (Rule 15) from two (Rules 15 and 123D) would remove impediments to and perfect the mechanism of a free and open market because it would set forth in a single rule the requirements for pre-opening indications, thereby promoting transparency by using consistent terminology for rules governing equities trading and ensuring that members, regulators, and the public can more easily navigate the Exchange's rulebook.
The Exchange believes that adopting new single-wide (5% change) and double-wide (10% change if S&P 500 futures move 2%) percentage parameters for the publication of pre-opening indications would remove impediments to and perfect the mechanism of a free and open market by requiring issuance of more pre-opening indications than currently during times of market stress, thereby increasing the amount of information available in the pre-market and improving the quality of price discovery at the opening. The proposed rule therefore promotes just and equitable principles of trade because it would expand the amount of pre-opening information available to the marketplace, thereby promoting transparency. For the same reasons, the proposal is also designed to protect investors as well as the public interest.
The Exchange believes that amending Rule 123D to specify when a DMM may effect an opening electronically would remove impediments to and perfect the mechanism of a free and open market by promoting transparency in Exchange rules regarding under what circumstances a DMM may effect an opening electronically. The Exchange believes that the proposed parameters for when a DMM may open a security electronically, which would be 4% on regular trading days and doubled to 8% in times of market stress, would remove impediments to and perfect the mechanism of a free and open market by reducing the number of manual openings and enabling more securities to open closer to 9:30 a.m. ET on extremely volatile trading days, thereby providing customers and the investing public with greater certainty of a timely open in circumstances of extreme market stress. The Exchange further believes that the proposal would advance the efficiency and transparency of the opening process, thereby fostering accurate price discovery at the open of trading. For the same reasons, the proposal is also designed to protect investors as well as the public interest.
The Exchange believes that deleting Rule 48 and moving the applicable provisions to Rules 15 and 123D would remove impediments to and perfect the mechanism of a free and open market by reducing reliance on Rule 48 during extremely volatile trading days. Rather, as proposed, the need for the CEO of the Exchange to temporarily suspend either pre-opening indications or the need for prior Floor Official approval before opening or reopening a security would be under more narrow circumstances of when a Floor-wide event would impair the Exchange's ability to conduct a fair and orderly open or reopening. As discussed above, the proposed amendments to Rule 15 and 123D to provide for parameters on days with extreme market-wide volatility would obviate the need for the current Rule 48 ability to lift the requirements for pre-opening indications or prior Floor Official approval during extreme market-wide volatility. The Exchange further believes that the proposal would advance the efficiency and transparency of the opening process, thereby fostering accurate price discovery at the open of trading. For the same reasons, the proposal is also designed to protect investors as well as the public interest.
The Exchange believes that making corresponding conforming changes to Rules 80C, 124 and 9217 would remove impediments to and perfects the mechanism of a free and open market by reducing potential confusion and adding transparency and clarity to the Exchange's rules, thereby ensuring that members, regulators and the public can more easily navigate and understand the Exchange's rulebook.
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 proposed rule change is not intended to address competitive issues but rather promote greater efficiency and transparency at the open of trading on the Exchange.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
The Exchange filed a proposal to adopt Exchange Rule 11.26 to implement the Regulation NMS Plan to Implement a Tick Size Pilot Program (the “Plan”). Specifically, the Exchange has proposed Rule 11.26(b) to set forth the requirements for the collection and transmission of data pursuant to Appendices B and C of the Plan. The proposed rule change is substantially similar to proposed rule changes recently approved or published by the Commission for the Bats BZX Exchange, Inc. f/k/a BATS Exchange, Inc. (“BZX”) to adopt BZX Rule 11.27(b) which also sets forth requirements for the collection and transmission of data pursuant to Appendices B and C of the Plan.
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
On August 25, 2014, NYSE Group, Inc., on behalf of BZX, Chicago Stock Exchange, Inc., Bats EDGA Exchange, Inc., Bats EDGX Exchange, Inc., Financial Industry Regulatory Authority, Inc. (“FINRA”), NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC, the Nasdaq Stock Market LLC, New York Stock Exchange LLC (“NYSE”), NYSE MKT LLC, and NYSE Arca, Inc. (collectively “Participants”), filed with the Commission, pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stocks of small-capitalization companies. Each Participant is required to comply, and to enforce compliance by its member organizations, as applicable, with the provisions of the Plan. As is described more fully below, the proposed rules would require ETP Holders
The Pilot will include stocks of companies with $3 billion or less in market capitalization, an average daily trading volume of one million shares or less, and a volume weighted average price of at least $2.00 for every trading day. The Pilot will consist of a control group of approximately 1,400 Pilot Securities and three test groups with 400 Pilot Securities in each (selected by a stratified random sampling process).
In approving the Plan, the Commission noted that the Trading Center data reporting requirements would facilitate an analysis of the effects of the Pilot on liquidity (
The Plan contains requirements for collecting and transmitting data to the Commission and to the public.
Appendix B.II of the Plan (Market and Marketable Limit Order Data) requires Trading Centers to submit information relating to market orders and marketable limit orders, including the time of order receipt, order type, the order size, the National Best Bid and National Best Offer (“NBBO”) quoted price, the NBBO quoted depth, the average execution price-share-weighted average, and the average execution time-share-weighted average.
The Plan requires Appendix B.I and B.II data to be submitted by Participants that operate a Trading Center, and by members of the Participants that operate Trading Centers. The Plan provides that each Participant that is the Designated Examining Authority (“DEA”) for a member of the Participant that operates a Trading Center shall collect such data in a pipe delimited format, beginning six months prior to the Pilot Period and ending six months after the end of the Pilot Period. The Plan also requires the Participant, operating as DEA, to transmit this information to the SEC within 30 calendar days following month end.
The Exchange is therefore proposing Rule 11.26(b) to set forth the requirements for the collection and transmission of data pursuant to Appendices B and C of the Plan. Proposed Rule 11.26(b) is substantially similar to proposed rule changes by BZX that were recently approved or published by the Commission to adopt BZX Rule 11.27(b) which also sets forth requirements for the collection and transmission of data pursuant to Appendices B and C of the Plan.
Proposed Rule 11.26(b)(1) requires that an ETP Holder that operates a Trading Center shall establish, maintain and enforce written policies and procedures that are reasonably designed to comply with the data collection and transmission requirements of Items I and II to Appendix B of the Plan, and an ETP Holder that is a Market Maker
Proposed Rule 11.26(b)(2) provides that the Exchange shall collect and transmit to the SEC the data described in Items I and II of Appendix B of the Plan relating to trading activity in Pre-Pilot Securities and Pilot Securities on a Trading Center operated by the Exchange. The Exchange shall transmit such data to the SEC in a pipe delimited format, on a disaggregated basis by Trading Center, within 30 calendar days following month end for: (i) Each Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period; and (ii) each Pilot Security for the
Appendix B.IV (Daily Market Maker Participation Statistics) requires a Participant to collect data related to Market Maker participation from each Market Maker engaging in trading activity on a Trading Center operated by the Participant. The Exchange is therefore proposing Rule 11.26(b)(3) to gather data about a Market Maker's participation in Pilot Securities and Pre-Pilot Data Collection Securities. Proposed Rule 11.26(b)(3)(A) provides that an ETP Holder that is a Market Maker shall collect and transmit to its DEA data relating to Item IV of Appendix B of the Plan with respect to activity conducted on any Trading Center in Pilot Securities and Pre-Pilot Data Collection Securities in furtherance of its status as a registered Market Maker, including a Trading Center that executes trades otherwise than on a national securities exchange, for transactions that have settled or reached settlement date. The proposed rule requires Market Makers to transmit such data in a format required by their DEA, by 12:00 p.m. EST on T + 4 for: (i) Transactions in each Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period; and (ii) for transactions in each Pilot Security for the period beginning on the first day of the Pilot Period through six months after the end of the Pilot Period.
The Exchange understands that some ETP Holders may have a DEA that is not a Participant to the Plan and that such non-Participant DEA would not be subject to the Plan's data collection requirements. In such case, a DEA that is not a Participant of the Plan would not be required to collect the required data and may not establish procedures for those ETP Holders for which it acts as DEA to report the data required under subparagraphs (b)(3)(A) of Rule 11.26 and in accordance with Item IV of Appendix B of the Plan. Therefore, the Exchange proposes to adopt subparagraph (b)(3)(B) to Rule 11.26 to require an ETP Holder that is a Market Maker whose DEA is not a Participant to the Plan to transmit the data collected pursuant to paragraph (3)(A) of Rule 11.26(b) to FINRA, which is a Participant to the Plan and will collect data relating to Item IV of Appendix B of the Plan on behalf of the Participants. For Market Makers for which it is the DEA, FINRA issued a Market Maker Transaction Data Technical Specification to collect data on Pre-Pilot Data Collection Securities and Pilot Securities from Trading Centers to comply with the Plan's data collection requirements.
Proposed Rule 11.26(b)(3)(C) provides that the Exchange shall transmit the data collected by the DEA or FINRA pursuant to Rule 11.26(b)(3)(A) and (B) above relating to Market Maker activity on a Trading Center operated by the Exchange to the SEC in a pipe delimited format within 30 calendar days following month end. The Exchange shall also make such data publicly available on the Exchange Web site on a monthly basis at no charge and shall not identify the Trading Center that generated the data.
Appendix C.I (Market Maker Profitability) requires a Participant to collect data related to Market Maker profitability from each Market Maker for which it is the DEA. Specifically, the Participant is required to collect the total number of shares of orders executed by the Market Maker; the raw Market Maker realized trading profits, and the raw Market Maker unrealized trading profits. Data shall be collected for dates starting six months prior to the Pilot Period through six months after the end of the Pilot Period. This data shall be collected on a monthly basis, to be provided in a pipe delimited format to the Participant, as DEA, within 30 calendar days following month end. Appendix C.II (Aggregated Market Maker Profitability) requires the Participant, as DEA, to aggregate the Appendix C.I data, and to categorize this data by security as well as by the control group and each Test Group. That aggregated data shall contain information relating to total raw Market Maker realized trading profits, volume-weighted average of raw Market Maker realized trading profits, the total raw Market Maker unrealized trading profits, and the volume-weighted average of Market Maker unrealized trading profits.
The Exchange is therefore proposing Rule 11.26(b)(4) to set forth the requirements for the collection and transmission of data pursuant to Appendix C.I of the Plan. Proposed Rule 11.26(b)(4)(A) requires that an ETP Holder that is a Market Maker shall collect and transmit to its DEA the data described in Item I of Appendix C of the Plan with respect to executions in Pilot Securities that have settled or reached settlement date that were executed on any Trading Center. The proposed rule also requires ETP Holders to provide such data in a format required by its their DEA by 12 p.m. EST on T + 4 for executions during and outside of Regular Trading Hours in each: (i) Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period; and (ii) Pilot Security for the period beginning on the first day of the Pilot Period through six months after the end of the Pilot Period.
For the same reasons set forth above for subparagraph (b)(3)(B) to Rule 11.26, the Exchange proposes to adopt subparagraph (b)(4)(B) to Rule 11.26 to require an ETP Holder that is a Market Maker whose DEA is not a Participant to the Plan to transmit the data collected pursuant to paragraph (4)(A) of Rule 11.26(b) to FINRA. As stated above, FINRA is a Participant to the Plan and is to collect data relating to Item I of Appendix C of the Plan on behalf of the Participants. For Market Makers for which it is the DEA, FINRA issued a Market Maker Transaction Data Technical Specification to collect data on Pre-Pilot Data Collection Securities and Pilot Securities from Trading Centers to comply with the Plan's data collection requirements.
The Exchange is also adopting a rule describing the manner in which Market Maker participation will be calculated. Item III of Appendix B of the Plan requires each Participant that is a national securities exchange to collect daily Market Maker registration statistics categorized by security, including the following information: (i) Ticker symbol; (ii) the Participant exchange; (iii) number of registered market makers; and (iv) the number of other registered liquidity providers. Therefore, the Exchange proposes to adopt Rule 11.26(b)(5) providing that the Exchange shall collect and transmit to the SEC the data described in Item III of Appendix B of the Plan relating to daily Market Maker registration statistics in a pipe delimited format within 30 calendar days following month end for: (i) Transactions in each Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period; and (ii) transactions in each Pilot Security for the period beginning on the first day of the Pilot Period through six months after the end of the Pilot Period. The Exchange notes that, as of the date
The Exchange is also proposing, through Interpretations and Policies, to clarify other aspects of the data collection requirements.
Interpretations and Policies .03 requires that ETP Holders populate a field to identify to their DEA whether an order is affected by the bands in place pursuant to the National Market System Plan to Address Extraordinary Market Volatility.
The Exchange and the other Participants have determined that it is appropriate to create a new flag for reporting orders that are affected by the Limit-Up Limit-Down bands. Accordingly, a Trading Center shall report a value of “Y” to their DEA when the ability of an order to execute has been affected by the Limit-Up Limit-Down bands in effect at the time of order receipt. A Trading Center shall report a value of “N” to their DEA when the ability of an order to execute has not been affected by the Limit-Up Limit-Down bands in effect at the time of order receipt.
Interpretations and Policies .03 also requires, for securities that may trade in a foreign market, that the Participant indicate whether the order was handled domestically, or routed to a foreign venue. Accordingly, the Participant will indicate, for purposes of Appendix B.I, whether the order was: (1) Fully executed domestically, or (2) fully or partially executed on a foreign market. For purposes of Appendix B.II, the Participant will classify all orders in securities that may trade in a foreign market Pilot and Pre-Pilot Securities as: (1) Directed to a domestic venue for execution; (2) may only be directed to a foreign venue for execution; or (3) was fully or partially directed to a foreign venue at the discretion of the member. The Exchange believes that this proposed flag will better identify orders in securities that may trade in a foreign market, as such orders that were routed to foreign venues would not be subject to the Plan's quoting and trading requirements, and could otherwise compromise the integrity of the data.
Interpretations and Policies .04 relates to the time ranges specified in Appendix B.I.a(14), B.I.a(15), B.I.a(21) and B.I.a(22).
Interpretations and Policies .05 relates to the relevant measurement for purposes of Appendix B.I.a(31)-(33) reporting. Currently, the Plan states that this data shall be reported as of the time of order execution. The Exchange and the other Participants believe that this information should more properly be captured at the time of order receipt as evaluating share-weighted average prices at the time of order receipt is more consistent with the goal of observing the effect of the Pilot on the liquidity of Pilot Securities. The Exchange is therefore proposing to make this change through Interpretations and
Interpretations and Policies .06 addresses the status of not-held and auction orders for purposes of Appendix B.I reporting. Currently, Appendix B.I sets forth eight categories of orders, including market orders, marketable limit orders, and inside-the-quote resting limit orders, for which daily market quality statistics must be reported. Currently, Appendix B.I does not provide a category for not held orders, clean cross orders, auction orders, or orders received when the NBBO is crossed. The Exchange and the other Participants have determined that it is appropriate to include separate categories for these orders types for purposes of Appendix B reporting. The Exchange is therefore proposing Interpretations and Policies .06 to provide that not held orders shall be included as an order type for purposes of Appendix B reporting, and shall be assigned the number (18). Clean cross orders shall be included as an order type for purposes of Appendix B reporting, and shall be assigned the number (19); auction orders shall be included an as order type for purposes of Appendix B reporting, and shall be assigned the number (20);
The Exchange is proposing Interpretations and Policies .07 to clarify the scope of the Plan as it relates to ETP Holders that only execute orders limited purposes. Specifically, the Exchange and the other Participants believe that an ETP Holder that only executes orders otherwise than on a national securities exchange for the purpose of: (1) Correcting a bona fide error related to the execution of a customer order; (2) purchasing a security from a customer at a nominal price solely for purposes of liquidating the customer's position; or (3) completing the fractional share portion of an order
The Exchange is proposing Interpretations and Policies .08 to clarify that, for purposes of the Plan, Trading Centers must begin the data collection required pursuant to Appendix B.I.a(1) through B.II.(y) of the Plan and Item I of Appendix C of the Plan on April 4, 2016. While the Exchange or the ETP Holder's DEA will provide the information required by Appendix B and C of the Plan during the Pilot Period, the requirement that the Exchange or their DEA provide information to the SEC within 30 days following month end and make such data publicly available on its Web site pursuant to Appendix B and C shall commence six months prior to the beginning of the Pilot Period.
The Exchange is proposing Interpretations and Policies .09 to address the requirement in Appendix C.I(b) of the Plan that the calculation of raw Market Maker realized trading profits utilize a last in, first out (“LIFO”)-like method to determine which share prices shall be used in that calculation. The Exchange and the other Participants believe that it is more appropriate to utilize a methodology that yields LIFO-like results, rather than utilizing a LIFO-like method, and the Exchange is therefore proposing Interpretations and Policies .09 to make this change.
Finally, the Exchange is proposing Interpretations and Policies .10 to address the securities that will be used for data collection purposes prior to the commencement of the Pilot. The Exchange and the other Participants have determined that it is appropriate to collect data for a group of securities that is larger, and using different quantitative thresholds, than the group of securities that will be Pilot Securities. The Exchange is therefore proposing Interpretations and Policies .10 to define “Pre-Pilot Data Collection Securities” as the securities designated by the Participants for purposes of the data collection requirements described in Items I, II and IV of Appendix B and Item I of Appendix C of the Plan for the period beginning six months prior to the Pilot Period and ending on the trading day immediately preceding the Pilot Period. The Participants shall compile
The proposed rule change will be effective on April 4, 2016.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant of the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. The Exchange believes that this proposal is in furtherance of the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act because the proposal implements and clarifies the requirements of the Plan and applies specific obligations to ETP Holders in furtherance of compliance with the Plan.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the data collection requirements for ETP Holders that operate Trading Centers will apply equally to all such ETP Holders, as will the data collection requirements for Market Makers.
The Exchange has neither solicited nor received comments on the proposed rule change.
Because the 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) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under 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 necessary or appropriate in the public interest, for the protection of investors, or 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 change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Go EZ Corp. (“GEZC”) (CIK No. 314197) because of questions regarding the accuracy and adequacy of publicly disseminated information in press releases and public filings concerning, among other things, GEZC's business prospects, operations, and control. GEZC is a Delaware corporation whose principal place of business is listed as 6782 Collins Ave., Miami Beach, Florida. GEZC's common stock is quoted on OTC Link operated by OTC Markets Group, Inc. under the ticker symbol GEZC.
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 company.
Susquehanna River Basin Commission.
Notice.
The Susquehanna River Basin Commission will hold a public hearing on May 4, 2016, in Grantville, Pennsylvania. At this public hearing, the Commission will hear testimony on the projects listed in the
The public hearing will convene on May 4, 2016, at 7:00 p.m. The public hearing will end at 9:00 p.m. or at the conclusion of public testimony, whichever is sooner. The deadline for the submission of written comments is May 16, 2016.
The public hearing will be conducted at the East Hanover Township Municipal Building, Main Hall, 8848 Jonestown Road, Grantville, PA 17028 (parking lot entry off of Manada Gap Road; see
Jason Oyler, General Counsel, telephone: (717) 238-0423, ext. 1312; fax: (717) 238-2436.
Information concerning the applications for these projects is available at the SRBC Water Resource Portal at
The public hearing will cover a proposed guidance for expiring project approvals and a proposed guidance for terminating review of a project application as well as proposed amendments to its Regulatory Program Fee Schedule and the
1. Project Sponsor and Facility: Black Bear Waters, LLC (Lycoming Creek), Lewis Township, Lycoming County, Pa. Application for renewal of surface water withdrawal of up to 0.900 mgd (peak day) (Docket No. 20120303).
2. Project Sponsor and Facility: Blossburg Municipal Authority, Bloss Township, Tioga County, Pa. Application for renewal of groundwater withdrawal of up to 0.288 mgd (30-day average) from Route 15 Well (Docket No. 20120304).
3. Project Sponsor and Facility: Cabot Oil & Gas Corporation (Martins Creek), Harford Township, Susquehanna County, Pa. Application for surface water withdrawal of up to 0.500 mgd (peak day).
4. Project Sponsor and Facility: Todd and Gemma Campbell (Susquehanna River), Athens Township, Bradford County, Pa. Application for renewal of surface water withdrawal of up to 0.999 mgd (peak day) (Docket No. 20120609).
5. Project Sponsor and Facility: Elizabethtown Area Water Authority, Elizabethtown Borough, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.201 mgd (30-day average) from Well 1.
6. Project Sponsor and Facility: Elizabethtown Area Water Authority, Elizabethtown Borough, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.106 mgd (30-day average) from Well 3.
7. Project Sponsor and Facility: Elizabethtown Area Water Authority, Elizabethtown Borough, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.130 mgd (30-day average) from Well 4.
8. Project Sponsor and Facility: Elizabethtown Area Water Authority, Mount Joy Township, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.187 mgd (30-day average) from Well 8.
9. Project Sponsor and Facility: Elizabethtown Area Water Authority, Mount Joy Township, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.216 mgd (30-day average) from Well 9.
10. Project Sponsor and Facility: EQT Production Company (Pine Creek), Porter Township, Lycoming County, Pa. Application for surface water withdrawal of up to 1.000 mgd (peak day).
11. Project Sponsor: Exelon Generation Company, LLC. Project Facility: Muddy Run Pumped Storage Project, Drumore and Martic Townships, Lancaster County, Pa. Application for an existing hydroelectric facility.
12. Project Sponsor and Facility: Manbel Devco I, LP, Manheim Township, Lancaster County, Pa. Application for groundwater withdrawal of up to 4.320 mgd (30-day average) from the Belmont Quarry.
13. Project Sponsor and Facility: Mount Joy Borough Authority, East Donegal Township, Lancaster County, Pa. Modification to increase withdrawal limit from Well 1 by an additional 0.073 mgd (30-day average), for a total Well 1 withdrawal limit of 1.300 mgd (30-day average) (Docket No. 20110617).
14. Project Sponsor: New Enterprise Stone & Lime Co., Inc. Project Facility: Burkholder Quarry, Earl Township, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.005 mgd (30-day average) from Sump 4.
15. Project Sponsor: New Enterprise Stone & Lime Co., Inc. Project Facility: Burkholder Quarry, Earl Township, Lancaster County, Pa. Modification to increase consumptive water use by an additional 0.099 mgd (peak day), for a total consumptive water use of up to 0.249 mgd (peak day) and to add an additional new source (Sump 4) (Docket No. 20040307).
16. Project Sponsor and Facility: Renovo Energy Center LLC (West Branch Susquehanna River), Renovo Borough, Clinton County, Pa. Application for surface water withdrawal of up to 0.612 mgd (peak day).
17. Project Sponsor and Facility: Renovo Energy Center LLC, Renovo Borough, Clinton County, Pa. Application for consumptive water use of up to 0.217 mgd (peak day).
18. Project Sponsor: SUEZ Water Pennsylvania Inc. Project Facility: Newberry Operation, Newberry Township, York County, Pa. Application for groundwater withdrawal of up to 0.108 mgd (30-day average) from the Coppersmith Well.
19. Project Sponsor: SUEZ Water Pennsylvania Inc. Project Facility: Newberry Operation, Newberry Township, York County, Pa. Application for groundwater withdrawal of up to 0.200 mgd (30-day average) from Conley 1 Well.
20. Project Sponsor and Facility: Sugar Hollow Trout Park and Hatchery, Eaton Township, Wyoming County, Pa. Application for renewal of groundwater withdrawal of up to 0.864 mgd (30-day average) from Wells 1, 2, and 3 (the Hatchery Wellfield) (Docket No. 20100913).
21. Project Sponsor and Facility: Tioga Downs Racetrack, LLC, Town of Nichols, Tioga County, N.Y. Application for groundwater withdrawal of up to 0.099 mgd (30-day average) from the Racetrack Well.
22. Project Sponsor and Facility: Tioga Downs Racetrack, LLC, Town of Nichols, Tioga County, N.Y. Application for consumptive water use of up to 0.099 mgd (peak day).
Interested parties may appear at the hearing to offer comments to the Commission on any project or proposal listed above. The presiding officer reserves the right to limit oral statements in the interest of time and to otherwise control the course of the hearing. Rules of conduct will be posted on the Commission's Web site,
Public Law 91-575, 84 Stat. 1509
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Notice of Thirty-First RTCA Special Committee 213 Meeting.
The FAA is issuing this notice to advise the public of the Thirty-First RTCA Special Committee 213 meeting.
The meeting will be held May 10-12, 2016 from 8:30 a.m.-5:00 p.m.
The meeting will be held at Thales, 3 Rue Toussaint Catros, 33185 Le Haillan, Bordeaux, France, Tel: (202) 330-0662.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of RTCA Special Committee 213. The agenda will include the following:
Federal Aviation Administration, (FAA), DOT.
Notice
The Federal Aviation Administration (FAA) announces its determination that the noise exposure maps submitted by Los Angeles World Airports, for LA/Ontario International Airport under the provisions of 49 U.S.C. 47501
The effective date of the FAA's determination on the noise exposure maps is April 6, 2016 and applicable March 29, 2016.
Victor Globa, Environmental Protection Specialist, Federal Aviation Administration, Los Angeles Airports District Office, Mailing Address: P.O. Box 92007, Los Angeles, California 90009-2007. Street Address: 15000 Aviation Boulevard, Hawthorne, California 90261. Telephone: 310/725-3637.
This notice announces that the FAA finds that the noise exposure maps submitted for LA/Ontario International Airport are in compliance with applicable requirements of Title 14, Code of Federal Regulations (CFR) Part 150 (hereinafter referred to as “Part 150”), effective March 29, 2016. Under 49 U.S.C. Section 47503 of the Aviation Safety and Noise Abatement Act (hereinafter referred to as “the Act”), an airport operator may submit to the FAA noise exposure maps which meet applicable regulations and which depict non-compatible land uses as of the date of submission of such maps, a description of projected aircraft operations, and the ways in which such operations will affect such maps. The Act requires such maps to be developed in consultation with interested and affected parties in the local community, government agencies, and persons using the airport. An airport operator who has submitted noise exposure maps that are found by FAA to be in compliance with the requirements of Part 150, promulgated pursuant to the Act, may submit a noise compatibility program for FAA approval which sets forth the measures the operator has taken or proposes to take to reduce existing non-compatible uses and prevent the introduction of additional non-compatible uses.
The FAA has completed its review of the noise exposure maps and accompanying documentation submitted by Los Angeles World Airports. The documentation that constitutes the “Noise Exposure Maps” as defined in Section 150.7 of part 150 includes: Figure 13, Existing Conditions (2015) Noise Exposure Map; and Figure 14, Forecast Conditions (2020) Noise Exposure Map. The Noise Exposure Maps contain current and forecast information including the depiction of: The airport and its boundary; the runway configurations; land uses such as residential, commercial, industrial, and open space/recreational land use; locations of noise sensitive public buildings (such as schools, hospitals, and historic properties on or eligible for the National Register of Historic Places); and the Community Noise Equivalent Level (CNEL) 65, 70, and 75 decibel airport noise contours resulting from existing and forecast airport operations. The frequency of airport operations is described in Section 2.1.2 of the Noise Exposure Map Update report. Flight tracks associated with LA/Ontario International Airport are depicted in Figures 8 through 11. The LA/Ontario International Airport noise monitoring system is described in Appendix B, Program Element 6.5, and monitoring locations are shown on Exhibits 8, 9, 12, 13, 14 and 15 of the Noise Exposure Map Update report. Estimates of the number of people residing within the CNEL contours is located in Section 3.2.2 of the Noise Exposure Map Update report. The FAA has determined that these noise exposure maps and accompanying documentation are in compliance with applicable requirements. This determination is applicable on March 29, 2016.
FAA's determination on an airport operator's noise exposure maps is limited to a finding that the maps were developed in accordance with the procedures contained in Appendix A of part 150. Such determination does not constitute approval of the applicant's data, information or plans, or a commitment to approve a noise compatibility program or to fund the implementation of that program. If questions arise concerning the precise relationship of specific properties to noise exposure contours depicted on a noise exposure map submitted under Section 47503 of the Act, it should be noted that the FAA is not involved in any way in determining the relative locations of specific properties with regard to the depicted noise contours, or in interpreting the noise exposure maps to resolve questions concerning, for example, which properties should be covered by the provisions of Section 47506 of the Act. These functions are inseparable from the ultimate land use control and planning responsibilities of local government. These local responsibilities are not changed in any way under Part 150 or through FAA's review of noise exposure maps. Therefore, the responsibility for the detailed overlaying of noise exposure contours onto the map depicting properties on the surface rests exclusively with the airport operator that submitted those maps, or with those public agencies and planning agencies with which consultation is required under Section 47503 of the Act. The FAA has relied on the certification by the airport operator, under Section 150.21 of Part 150, that the statutorily required consultation has been accomplished.
Copies of the full noise exposure map documentation and of the FAA's evaluation of the maps are available for examination at the following locations:
Questions may be directed to the individual named above under the heading
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of Twenty-Sixth RTCA Special Committee 216 Meeting.
The FAA is issuing this notice to advise the public of the Twenty-Sixth RTCA Special Committee 216 meeting.
The meeting will be held May 3-5, 2016 from 9:00 a.m.-5:00 p.m.
The meeting will be held at RTCA, Inc., 1150 18th Street NW., Suite 910, Washington, DC 20036, Tel: (202) 330-0662.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of RTCA Special Committee 216. The agenda will include the following:
Federal Transit Administration, DOT.
Notice of proposed policy statement and request for comments.
This notice proposes a statement of policy regarding the implementation of the phased increase in domestic content for rolling stock under the Federal Transit Administration's (FTA) Buy America statute, as amended by the Fixing America's Surface Transportation (FAST) Act. The FAST Act was signed into law on December 4, 2015, with an effective date of October 1, 2015. FTA seeks comments from all interested parties. After consideration of the comments, FTA will issue a second
Comments must be received by May 6, 2016. Late-filed comments will be considered to the extent practicable.
Please submit your comments by one of the following means, identifying your submissions by docket number FTA-2016-0019:
1.
2.
3.
4.
Cecelia Comito, Assistant Chief Counsel, Office of the Chief Counsel, phone: (202) 366-2217 or email,
The purpose of this notice is to propose a statement of policy that will clarify how to apply FTA's Buy America requirements to procurements for rolling stock with delivery dates or options in FY2018 through FY2020 and beyond. The FAST Act amended the rolling stock waiver in 49 U.S.C. 5323(j)(2)(C) to provide for a phased increase in the domestic content of rolling stock for FY2018-FY2019 and FY2020 and beyond:
(j) Buy America.
(1) In general. The Secretary may obligate an amount that may be appropriated to carry out this chapter for a project only if the steel, iron, and manufactured goods used in the project are produced in the United States.
(2) Waiver. The Secretary may waive paragraph (1) of this subsection if the Secretary finds that:
(C) when procuring rolling stock (including train control, communication, traction power equipment, and rolling stock prototypes) under this chapter
(i) the cost of components and subcomponents produced in the United States
(I) for fiscal years 2016 and 2017, is more than 60 percent of the cost of all components of the rolling stock;
(II) for fiscal years 2018 and 2019, is more than 65 percent of the cost of all components of the rolling stock; and
(III) for fiscal years 2020 and each fiscal year thereafter, is more than 70 percent of the cost of all components of the rolling stock; and
(ii) final assembly of the rolling stock has occurred in the United States . . .
Recipients may enter into rolling stock contracts under 49 U.S.C. 5325(e) for up to five years for buses and seven years for railcars. In FTA Circular 4220.1F, “Third Party Contracting Guidance,” FTA interpreted these five- and seven-year periods as covering the recipient's “material requirements” for rolling stock and replacement needs from the first day when the contract becomes effective to its “material requirements” at the end of the fifth or seventh year, as applicable. FTA has not required that “the recipient must obtain delivery, acceptance, or even fabrication in five or seven years. Instead it means only that FTA limits a contract to purchasing no more than the recipient's material requirements for rolling stock or replacement parts for five or seven years based on the effective date of the contract.”
Recipients have asked FTA to provide specific guidance on the applicability of the FAST Act's new Buy America provisions to contracts entered into before or after October 1, 2015, the effective date of the FAST Act.
FTA's Buy America requirements focus on two points in time: (1) “When
The FAST Act amendments do not apply to contracts entered into before the effective date of the FAST Act,
Therefore, for purchase orders placed against State purchasing schedules before October 1, 2015, for the delivery of rolling stock in FY2018 and beyond, the increased domestic content requirements will not apply. For purchase orders placed against State schedules on or after October 1, 2015, for rolling stock that will be delivered in FY 2016 and 2017, the domestic content requirement must exceed 60%. For purchase orders placed against State schedules for rolling stock that will be delivered in FY 2018 and 2019, the domestic content must exceed 65%, and for purchase orders placed against State schedules for rolling stock that will be delivered in FY 2020 and beyond, the domestic content must exceed 70%.
FTA believes that this interpretation is consistent with the plain language of the statute, Congress' directive to increase the domestic content for vehicles produced in FY2018 or later, and principles of statutory construction.
Thus, for FY2018 and 2019, for a component to be of domestic content, more than 65 percent of the subcomponents of that component, by cost, must be of domestic origin, and for FY2020 and beyond, more than 70 percent of the subcomponents of the component must be of domestic content. The requirement that manufacture of the component take place in the United States still applies. Additionally, if a
Under 49 U.S.C. 5323(j)(2)(A), the Administrator may waive the Buy America requirements if the Administrator finds that applying the Buy America requirements would be inconsistent with the public interest. “In determining whether the conditions exist to grant a public interest waiver, the Administrator will consider all appropriate factors on a case-by-case basis . . . When granting a public interest waiver, the Administrator shall issue a detailed written statement justifying why the waiver is in the public interest. The Administrator shall publish this justification in the
In a separate notice published in today's
Recipients or vendors may apply to FTA for individual public interest waivers for contracts entered into after December 4, 2015, and others that do not fall within the scope of a general public interest waiver. A request for a public interest waiver should set forth the detailed justification for the proposed waiver, including information about the history of the procurement and the burden on the recipient and/or the industry in complying with the FAST Act. Public interest waivers should be narrowly tailored and FTA will not generally look favorably on waivers that provide for contracts that include the exercise of options for vehicles that will be delivered beyond FY2020. FTA will act expeditiously on public interest waiver requests that provide the information requested.
FTA seeks comment from all interested parties on the above policy statement. After consideration of the comments, FTA will publish a second notice in the
Federal Transit Administration, DOT.
Notice of proposed general public interest waiver and request for comments.
The purpose of this notice is to articulate the Federal Transit Administration's (FTA) justification for waiving its Buy America requirements for rolling stock under certain limited circumstances because application of the increased domestic content requirements is inconsistent with public policy. The Fixing America's Surface Transportation (FAST) Act amended FTA's Buy America statute to include a phased increase in domestic content for rolling stock. The FAST Act was signed into law on December 4, 2015, but included an effective date of October 1, 2015. FTA proposes a public interest waiver for the following categories of contracts: (1) For contracts entered into between the FAST Act's effective date and date of enactment (
Comments must be received by April 13, 2016. Late-filed comments will be considered to the extent practicable.
Please submit your comments by one of the following means, identifying your submissions by docket number FTA-2016-0020:
1.
2.
3.
4.
Cecelia Comito, Assistant Chief Counsel, Office of the Chief Counsel, phone: (202) 366-2217 or email,
The FAST Act, FTA's current authorizing legislation, amended the rolling stock waiver in 49 U.S.C. 5323(j)(2)(C) to provide for a phased increase in the domestic content for rolling stock for FY2018-FY2019 and FY2020 and beyond. As amended by the FAST Act, the domestic content for rolling stock increases over time from the current rate of “more than 60 percent” to “more than 70 percent” in FY2020 and beyond:
(j) Buy America.
(1) In general. The Secretary may obligate an amount that may be appropriated to carry out this chapter for a project only if the steel, iron, and manufactured goods used in the project are produced in the United States.
(2) Waiver. The Secretary may waive paragraph (1) of this subsection if the Secretary finds that:
(C) when procuring rolling stock (including train control, communication, traction power equipment, and rolling stock prototypes) under this chapter
(i) the cost of components and subcomponents produced in the United States
(I) for fiscal years 2016 and 2017, is more than 60 percent of the cost of all components of the rolling stock;
(II) for fiscal years 2018 and 2019, is more than 65 percent of the cost of all components of the rolling stock; and
(III) for fiscal years 2020 and each fiscal year thereafter, is more than 70 percent of the cost of all components of the rolling stock; and
(ii) final assembly of the rolling stock has occurred in the United States . . .
In a separate notice published in today's
With certain exceptions, FTA's “Buy America” requirements prevent FTA from obligating an amount that may be appropriated to carry out its program for a project unless “the steel, iron, and manufactured goods used in the project are produced in the United States.” 49 U.S.C. 5323(j)(1). One such exception is where applying the Buy America requirements “would be inconsistent with the public interest.” 49 U.S.C. 5323(j)(2)(A). After considering all appropriate factors on a case-by-case basis, 49 CFR 661.7(b), if FTA determines that the conditions exist to grant a public interest waiver, FTA will issue a detailed written statement justifying why the waiver is in the public interest, and will publish this justification in the
Recipients who entered into rolling stock contracts prior to December 4, 2015, were required under existing Buy America law to procure vehicles with a domestic content of more than 60 percent, regardless of when the vehicle was delivered. Because rolling stock frequently cannot be delivered in a short time frame, recipients may enter into multi-year contracts for rolling stock, allowing for contracts up to five years for buses and up to seven years for railcars. 49 U.S.C. 5325(e). Thus, under existing law at the time of contracting, recipients were not prohibited from entering into contracts for vehicles that would be delivered in FY2018 and beyond.
Although the FAST Act was signed into law on December 4, 2015, Congress included an effective date of October 1, 2015. Application of the FAST Act's retroactive effective date to rolling stock contracts entered into between October 1, 2015 and December 4, 2015, would result in rendering those contracts ineligible for FTA funds for vehicles delivered in FY2018 and beyond. Without a waiver, recipients most likely would be required to cancel those contracts, and start the procurement process again.
“The inquiry into whether a statute operates retroactively demands a “commonsense, functional judgment about `whether the new provision attaches new legal consequences to events completed before its enactment.' ”
Retroactive application of the FAST Act's increase in domestic content to contracts entered into between October 1, 2015 and December 4, 2015 would be inconsistent with the public interest. As noted in the FTA's
Depending on the complexity of the procurement, the time intervals typically required to accomplish rolling stock contract awards might include:
• One year advance planning before Request for Proposals (RFP) for the engineering services;
• Four months from RFP to award of the engineering services;
• Two years to prepare technical specifications;
• Three months from completion of specifications to system RFP;
• Six months from system RFP to award; and
• Three years for system construction.
The planning and design processes can change this schedule significantly.
All of this planning and work by the recipient is at tremendous cost to the recipient, and therefore, to the public, both in terms of money and the delayed acquisition of new transit vehicles. Additionally, preparation of a proposal or bid in response to a solicitation for vehicles is both time-consuming and costly for the manufacturers.
Application of the FAST Act's increased domestic content requirements to rolling stock procurements for which recipients have advertised solicitations for bids or requests for proposals prior to December 4, 2015 will be particularly burdensome for both the recipient and the manufacturer. FTA proposes a public interest waiver under these circumstances. These procurements are underway and a change in the domestic content will require recipients to amend their solicitations and specifications in order to include the FAST Act's
Accordingly, FTA proposes a public interest waiver for the following categories of contracts: (1) For contracts entered into between the FAST Act's effective date and date of enactment (
This public interest waiver is limited to the parties to the contract only. Recipients who are not direct parties to the contract, however, may not exercise options (a/k/a “piggybacking”) on such contracts and take advantage of the lower domestic content requirement. The assignment of options to a third party results in the third party and the vendor entering into a new contract after the effective date of the FAST Act, and therefore, the increased domestic content requirements for FY2018 and beyond will apply to vehicles delivered in those years.
Recipients or vendors may apply to FTA for individual public interest waivers for contracts entered into after December 4, 2015, and others that do not fall within the scope of this general public interest waiver. A request for a public interest waiver should set forth the detailed justification for the proposed waiver, including information about the history of the procurement and the burden on the recipient and/or the industry in complying with the FAST Act. Public interest waivers should be narrowly tailored and FTA will not generally look favorably on waivers that provide for contracts that include the exercise of options for vehicles that will be delivered beyond FY2020. FTA will act expeditiously on public interest waiver requests that provide the information requested.
FTA seeks comment from all interested parties on the above public interest waiver. After consideration of the comments, FTA will publish a second notice in the
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Grant of petition.
JLG Industries, Inc. (JLG) has determined that certain JLG Triple-L utility trailers do not fully comply with paragraph S4.3.5 of Federal Motor Vehicle Safety Standard (FMVSS) No. 110,
For further information on this decision contact Stuart Seigel, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), Telephone (202) 366-5287, facsimile (202) 366-5930.
Pursuant to 49 U.S.C. 30118(d) and 30120(h) and the rule implementing those provisions at 49 CFR part 556, JLG submitted a petition for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
Notice of receipt of JLG's petition was published, with a 30-day public comment period, on November 21, 2014, in the
Affected are approximately 2,940 JLG Triple-L utility trailers with a GVWR of less than 10,000 lbs. that were manufactured between August 2005 and July 2014.
JLG explains that the noncompliance is that the tire and loading information placard does not contain the words “The weight of the cargo should never exceed XXX kilograms or XXX pounds” as required by paragraph S4.3.5 of FMVSS No. 110.
Paragraph S4.3.5 of FMVSS No. 110 requires in pertinent part:
S4.3.5
JLG stated its belief that the subject noncompliance is inconsequential to motor vehicle safety for the following reasons:
(A) With regard to trailers JLG states that there is no need to account for passenger weight when considering cargo weight because there are no designated seating positions on the trailer and all of the weight capacity is designated towards cargo. JLG also believes that providing the maximum load capacity for the trailer therefore provides the same information as providing the maximum weight of the cargo.
(B) Although the Tire and Loading Information labels on the subject trailers do not contain the statement set forth in S4.3.5, the same information is provided on a separate label in the vicinity of the Tire and Loading Information label. That label states that the “Max Load Capacity xxxx lbs” and further instructs the operator to “center load on deck.” It also draws attention to the maximum carrying load of the trailer and ensures that drivers loading the trailer are aware of the maximum load capacity the trailer can carry—the precise
JLG has additionally informed NHTSA that it has corrected the noncompliance so that all future production trailer Tire and Loading Information labels will comply with FMVSS No. 110.
In summation, JLG believes that the described noncompliance of the subject trailers is inconsequential to motor vehicle safety, and that its petition, to exempt JLG from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120 should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the subject trailers that JLG no longer controlled at the time it determined that the noncompliance existed. However, the granting of this petition does not relieve vehicle distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant trailers under their control after JLG notified them that the subject noncompliance existed.
49 U.S.C. 30118, 30120: Delegations of authority at 49 CFR 1.95 and 501.8.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8582-CR, Passive Activity Credit Limitations.
Written comments should be received on or before June 6, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Allan Hopkins, at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service, Treasury.
Notice; correction.
The Internal Revenue Service published a document in the
Christopher Daggett, 503-330-6311 or Michael Lin, 202-317-6381.
In the
(1) Must register to participate in the Challenge under the rules promulgated by the Internal Revenue Service.
(2) Must comply with all the requirements under this section.
(3) Must be at least 18 years old at the time of submission.
(4) In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States.
(5) Shall not be a Federal entity or Federal employee acting within the scope of their employment.
(6) Shall not be an employee of the Internal Revenue Service or the Mortgage Bankers Association (“the Cosponsor”).
(7) Shall not be affiliated with any judge on the review panel. In the case of a private entity, this means that no judge currently serves as a director, officer, or employee of the entity. In the case of a private individual, the individual shall not have a close family or professional relationship with any judge.
(8) Federal grantees may not use Federal funds to develop Challenge applications unless consistent with the purpose of their grant award.
(9) Federal contractors may not use Federal funds from a contract to develop Challenge applications or to fund efforts in support of a Challenge submission.
Notice.
The Department of Veterans Affairs (VA), National Cemetery Administration (NCA), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Cemeteries and Memorials (herein-after in this section referred to as “the Committee”). The Committee was established pursuant to 38 U.S.C. 2401 to advise the Secretary of VA with respect to the administration of VA national cemeteries, soldiers' lots and plots, which are the responsibility of the Secretary, the erection of appropriate memorials and the adequacy of Federal burial benefits.
Nominations of qualified candidates are being sought to fill upcoming vacancies on the Committee. Nominations for membership on the Committee must be received no later than 5:00 p.m. EST on May 31, 2016.
All nominations should be mailed to National Cemetery Administration, Department of Veterans Affairs, 810 Vermont Avenue NW. (43A2), Washington, DC 20420, or faxed to (202) 632-7910.
Mr. Michael Nacincik, National Cemetery Administration, Department of Veterans Affairs, 810 Vermont Avenue NW. (43A2), Washington, DC 20420, telephone (202) 632-8013. A copy of Committee charter and list of the current membership can be obtained by contacting Mr. Nacincik or by accessing the Web site managed by NCA at:
The Advisory Committee on Cemeteries and Memorials (ACCM) was established pursuant to 38 U.S.C. 2401 to advise the Secretary of VA with respect to the administration of VA national cemeteries, soldiers' lots and plots, which are the responsibility of the Secretary, the erection of appropriate memorials and the adequacy of Federal burial benefits. The Committee responsibilities include:
(1) Advising the Secretary on VA's administration of burial benefits and the selection of cemetery sites, the erection of appropriate memorials, and the adequacy of Federal burial benefits;
(2) Providing to the Secretary and Congress periodic reports outlining recommendations, concerns, and observations on VA's delivery of these benefits and services to Veterans;
(3) Meeting with VA officials, Veteran Service Organizations, and other stakeholders to assess the Department's efforts in providing burial benefits and outreach on these benefits to Veterans and their dependents;
(4) Undertaking assignments to conduct research and assess existing burial and memorial programs; to examine potential revisions or expansion of burial and memorial programs and services; and to provide advice and recommendations to the Secretary based on this research.
NCA is requesting nominations for upcoming vacancies on the Committee. The Committee is composed of up to twelve members and several ex-officio members.
The members of the Committee are appointed by the Secretary of Veteran Affairs from the general public, including but not limited to:
(1) Veterans or other individuals who are recognized authorities in fields pertinent to the needs of Veterans;
(2) Veterans who have experience in a military theater of operations;
(3) Recently separated service members;
(4) Officials from Government, non-Government organizations (NGOs) and industry partners in the provision of memorial benefits and services, and outreach information to VA beneficiaries.
The Secretary shall determine the number, terms of service, and pay and allowances of members of the Committee appointed by the Secretary, except that a term of service of any such member may not exceed three years. The Secretary may reappoint any such member for additional terms of service.
To the extent possible, the Secretary seeks members who have diverse professional and personal qualifications,
(1) A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (
(2) The nominee's contact information, including name, mailing address, telephone numbers, and email address;
(3) The nominee's curriculum vitae; and
(4) A summary of the nominee's experience and qualifications relative to the membership considerations described above.
Individuals selected for appointment to the Committee shall be invited to serve a two-year term. Committee members will receive a stipend for attending Committee meetings, including per diem and reimbursement for travel expenses incurred. The Department makes every effort to ensure that the membership of VA federal advisory committees is diverse in terms of points of view represented and the committee's capabilities. Appointments to this Committee shall be made without discrimination because of a person's race, color, religion, sex, sexual orientation, gender identify, national origin, age, disability, or genetic information. Nominations must state that the nominee is willing to serve as a member of the Committee and appears to have no conflict of interest that would preclude membership. An ethics review is conducted for each selected nominee.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce; United States Fish and Wildlife Service (USFWS), Interior.
Final rule.
NMFS and USFWS issue a final rule to list 11 distinct population segments (DPSs) of the green sea turtle (
This final rule is effective May 6, 2016.
Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Room 13535, Silver Spring, MD 20910; or U.S. Fish and Wildlife Service, North Florida Ecological Services Office, 7915 Baymeadows Way, Suite 200, Jacksonville, FL 32256. The final rule, list of references, and other materials relating to this determination can be found at:
Jennifer Schultz, NMFS (ph. 301-427-8443, email
On July 28, 1978, NMFS and USFWS, collectively referred to as the Services, listed the green turtle under the ESA (43 FR 32800). Pursuant to the authority that the statute provided, and prior to the current statutory definition of “species” that includes DPSs, we listed the species as threatened, except for the Florida and Mexican Pacific coast breeding populations, which we listed as endangered. We published recovery plans for U.S. Atlantic (NMFS and USFWS, 1991) and U.S. Pacific (including the East Pacific; 63 FR 28359, May 22, 1998; NMFS and USFWS, 1998) populations of the green turtle (
On February 16, 2012, we received a petition from the Association of Hawaiian Civic Clubs to identify the Hawaiian green turtle population as a DPS and “delist” it. On August 1, 2012, NMFS, with USFWS concurrence, determined that the petition presented substantial information indicating that the petitioned action may be warranted (77 FR 45571). Our 5-year review (NMFS and USFWS, 2007) also recommended a review of the status of the species, in light of significant new information since its listing and in accordance with our DPS joint policy (61 FR 4722, February 7, 1996). We convened a Status Review Team, green turtle and ESA experts within the Services, who conducted a comprehensive status review of the species and published their findings as the “Status Review of the Green Turtle (
On March 23, 2015, we published the 12-month finding on the petition and proposed rule (80 FR 15271). We proposed to remove the existing ESA listings from 1978 and, in their place, list three endangered (Mediterranean, Central West Pacific, and Central South Pacific) and eight threatened (North Atlantic, South Atlantic, Southwest Indian, North Indian, East Indian-West Pacific, Southwest Pacific, Central North Pacific, and East Pacific) DPSs. We opened a 90-day comment period on the proposed rule and extended this comment period three times until September 25, 2015, for a total of 187 days (
Section 4(a)(1) of the ESA requires us to determine by regulation whether “any species is an endangered species or a threatened species because of any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence” (16 U.S.C. 1533(a)(1); hereafter, the section 4(a)(1) factors). Section 3 of the ESA defines a “species” as “any subspecies of fish or wildlife or plants, and any DPS of any species of vertebrate fish or wildlife which interbreeds when mature” (16 U.S.C. 1532(16)). Section 3 of the ESA further defines an “endangered species” as “any species which is in danger of extinction throughout all or a significant portion of its range” and a “threatened species” as one “which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range” (16 U.S.C. 1532(6), (20)). The U.S. District Court for the District of Columbia noted that Congress included “a temporal element to the distinction between the categories of endangered and threatened species.”
The ESA does not define “distinct population segment,” but our 1996 joint policy identifies three elements that must be considered when identifying a DPS: (1) The discreteness of the population segment in relation to the remainder of the species to which it belongs; (2) the significance of the population segment to the species to which it belongs; and (3) the population segment's conservation status (
As we described more fully in the proposed rule, to identify potential DPSs, the Status Review Team members gathered the best available scientific and commercial data on green turtles. They evaluated the discreteness and significance of population segments. For each potential DPS, they described the demographic parameters that influence population persistence (
We reviewed the Status Review Report and concluded that it provided the best available scientific and commercial data on the identification of DPSs, demographic parameters, and section 4(a)(1) factors, with two exceptions. First, in evaluating the extinction risk of a DPS, we cannot assume the retention of ESA protections, which would no longer apply if a DPS was not listed under the ESA. Second, the critical risk threshold (
To make the listing determinations, we used the best available scientific and commercial data on the green turtle, which are summarized in the Status Review Report and incorporated herein. We applied information from the Status Review Report on the identification of DPSs, demographic parameters, and section 4(a)(1) factors, but we did not apply the critical risk threshold. Instead, we directly evaluated the section 4(a)(1) factors in the context of the demographic parameters and considered the potential loss of ESA protections that would result if we did not list a DPS as threatened or endangered under the ESA. After considering conservation efforts by States and foreign nations to protect the DPS, as required under section 4(b)(1)(A), we proposed listing determinations based on the statutory definitions of endangered and threatened species (80 FR 15271, March 23, 2015). To make our final listing determinations, we reviewed all information provided during the 6-month public comment period and additional scientific and commercial data that became available since the publication of the proposed rule. However, this additional information merely supplemented, and did not differ significantly from, the information presented in the proposed rule. We received no significant new information that would cause us to change our listing determinations. With this rule, we finalize our proposed listing determinations.
We solicited comments on the proposed rule from all interested parties (80 FR 15271, March 23, 2015). Specifically, we requested information regarding: (1) Historical and current population status and trends; (2) historical and current distribution; (3) migratory movements and behavior; (4) genetic population structure; (5) current or planned activities that may adversely affect green turtles; (6) conservation efforts to protect green turtles; and (7) our extinction risk analysis and findings. We considered all comments received, which included 905 comments from the public, government agencies, the scientific community, industry, and environmental organizations. The majority of comments (over 800) expressed support for the proposed listings. Some commenters requested that all DPSs be listed as endangered, and some commenters disagreed with the proposed status of one or more DPSs. We summarize all comments below by first addressing topics that apply to multiple DPSs; we then address comments specific to a particular DPS.
Though the term “distinct population segment” may be used generally in the scientific literature, our use of the term throughout the proposed and final rules refers to the legal term, “distinct population segment,” as used specifically in the statute and our binding policy, which we promulgated after reviewing public comment (16 U.S.C. 1532 (16); 61 FR 4722, February 7, 1996). The Status Review Team considered other potential DPSs, including 17 regional management units identified by Wallace
Our DPS policy requires a DPS be “discrete” and “significant” (61 FR 4722, February 7, 1996). To evaluate discreteness, the Status Review Team considered tagging and telemetry, morphology, oceanographic and ecological features, and genetic data. The genetic data included previously published studies of biparentally (nuclear DNA) and maternally (mtDNA) inherited neutral genetic markers (Seminoff
The Status Review Team also considered the significance of the population segment to the species. Each DPS was determined to be significant because of its unique ecological setting or because its loss would result in a significant gap in the range of the species. In addition, some DPSs differed markedly from others in their genetic characteristics, likely due to exposure to different selective pressures and generations of reproductive isolation.
We reviewed, considered, and incorporated as appropriate scientific and commercial data that were not previously included in the Status Review Report or proposed rule; however, this additional information did not change our identification of any DPS. Scientific or commercial data that become available after the publication of this rule will be reviewed at a later date as appropriate (
We used information from the Status Review Report on the demographic parameters and section 4(a)(1) factors to make our listing determinations. The
Regarding our treatment of uncertainty, it is important to note that the best available scientific and commercial data are not required to be free from uncertainty. We identified uncertainties in the demographic parameters and section 4(a)(1) factors throughout the proposed rule. Nevertheless, we did not base any listing determination solely on uncertain demographic parameters or section 4(a)(1) factors.
The estimates of total nester abundance and trends were based on quantitative surveys at nesting beaches; however, qualitative data on nesting sites were provided for each DPS. To evaluate the demographic parameters, the Status Review Team did not rely on qualitative estimates of abundance at foraging habitats or other areas. Such areas often include many juvenile turtles, which are characterized by lower survival rates relative to adults (Halley
The ESA requires us to determine whether any species is endangered or threatened because of any one or a combination of the section 4(a)(1) factors, including disease or predation (16 U.S.C. 1533 (a)(1)(C)). It does not distinguish between native or non-native predators; however, we included this information where available. FP is a disease that causes tumors in sea turtles. In 2015, NMFS hosted the International Summit on Fibropapillomatosis of Marine Turtles: Global Status, Trends, and Population Impacts. NMFS (in progress) summarized the current state of FP knowledge and concluded that FP has population level impacts because it generally results in reduced survivorship; however, some turtles recover from FP (Hirama, 2001; Hirama and Ehrhart, 2007). Therefore, we included FP in our analyses of section 4(a)(1) factors and considered the best available data on the incidence and expression of the disease for each DPS.
We considered the inadequacy of existing regulatory mechanisms for each DPS. For some DPSs, this included identification of inadequate harassment and pollution laws, due to lack of implementation and enforcement.
We evaluated other natural or manmade factors that affect the DPSs' continued existence. Plastics and other discarded materials (
In summary, we considered each of the section 4(a)(1) factors for each DPS, including disease or predation, the inadequacy of existing regulatory mechanisms, and other natural or manmade factors. The information provided on FP, predation, harassment, pollution, plastics, UMEs, and snorkelers does not represent significant new information and does not change our proposed listing determinations.
The ESA exempts from prohibition the take and import of endangered and threatened species for subsistence purposes by Alaskan Natives and non-native permanent residents of Alaskan native villages (16 U.S.C. 1539(e)); however, those provisions are specific to Alaskan Natives and permanent residents of Alaskan native villages. They provide no basis for authorizing take in any other context. The statute contains no other exceptions for cultural or subsistence take. Modifications to the statute to recognize additional exemptions are beyond our authority.
With respect to the longstanding regulatory provisions extending the section 9 prohibitions to threatened species of sea turtles, modifications to the existing protective regulations are beyond the scope of this rule. The scope of this rule is limited to the identification of green turtle DPSs and the determination of their listing statuses based on the best available scientific and commercial data. We have not undertaken to review or otherwise modify the protective regulations, which remain in effect as noted in the proposed rule.
In addition to the ESA, the Inter-American Convention for the Protection and Conservation of Sea Turtles (2001) prohibits the intentional capture, retention, or killing of, and domestic trade in, sea turtles, their eggs, parts, or products. The United States is a Contracting Party to, and is therefore bound by, the treaty and required to apply the prohibitions to all persons subject to U.S. jurisdiction. The treaty does not identify exceptions for cultural take. Currently, U.S. obligations under the treaty are not implemented through separate legislation or regulations, as sea turtles are already protected under the ESA.
Historically, the harvest of green turtles and their eggs resulted in overexploitation, one of the major factors cited in the original listings of green turtles under the ESA (43 FR 32800, July 28, 1978). Green turtle populations are vulnerable to overexploitation due to slow growth rates, late sexual maturity, and complex migratory life histories (Bjorndal
The Intergovernmental Panel on Climate Change (IPCC) was established by the United Nations Environmental Programme and World Meteorological Organization to assess climate change and its potential environmental and socio-economic impacts. The Fifth Assessment Report (IPCC, 2014) summarizes the best available scientific knowledge relevant to climate change, considering different greenhouse gas concentration pathways (
• The global mean surface temperature is likely to increase 2.6 °C to 4.8 °C by 2100;
• Ocean acidification is likely to increase 100 to 109 percent by 2100;
• Global mean sea level will likely rise 0.45 to 0.82 m by 2100; sea level will very likely rise in at least 95 percent of the ocean area; approximately 70 percent of coastlines are projected to experience a sea level rise of within 20 percent of the global mean; and
• There is high confidence that warming, ocean acidification, and sea level rise will continue to increase for centuries beyond 2100.
Based on the above information, we do not agree with the commenters who state that climate change and its resulting impacts are not likely to occur. The IPCC provides conservative estimates of the effects of climate change. For example, its estimates of sea level rise represent the mean sea level rise that is likely to occur; under Pathway 8.5, the maximum is 0.98 m, and there is a 17 percent risk of exceeding that maximum (IPCC, 2014). In addition, studies published since the Fifth Assessment Report identify the potential for higher rates of sea level rise due to the destabilization of West Antarctic ice sheets (Joughin
Regarding the comment on limitations and uncertainties in climate change science, the IPCC uses qualitative descriptions of likelihood and confidence. In the Fifth Assessment Report, the term “high confidence” refers to the authors' judgments about the validity of findings as determined through evaluation of evidence and agreement; the term “likely” refers to a 66 to 100 percent likelihood of an outcome (IPCC, 2010). In our review of the Fifth Assessment Report, we focused on and applied outcomes and findings that were “likely” to occur and with “high confidence” findings. For example, the IPCC reports with high confidence that a large fraction of species faces increased extinction risk due to climate change during and beyond the 21st century, especially as climate change interacts with other stressors (IPCC, 2014). This conclusion is based on observational evidence that lower rates of natural climate change caused significant ecosystem shifts and species extinctions during the past millions of years, and the current changes are occurring at a faster rate over less time. The IPCC also reports with high confidence that marine organisms will face progressively lower oxygen levels and higher rates of ocean acidification and that coastal systems and low-lying areas are at risk from sea level rise (IPCC, 2014).
We agree with commenters that climate change and its impacts are a threat to green turtles. Species with high fecundity and low juvenile survival, such as sea turtles, are the most vulnerable to climate change and elevated levels of environmental variability (Cavallo
Some commenters stated that sea turtles would respond to climate change via adaptation or behavioral changes. Adaptation by natural selection occurs when individuals with one heritable trait survive and reproduce (passing that trait onto their offspring) at a higher rate than individuals with other heritable traits. It occurs over many generations, and one green turtle generation is approximately 30 years (Seminoff
We agree that in response to climate change, green turtles may alter their behavior; for example, nesting females may use beaches with higher elevation or cooler sands (Santos
Our consideration of climate change includes efforts to limit future emissions and mitigate the impacts of climate change. After the publication of the proposed rule, 195 nations adopted the landmark Paris Agreement at the Twenty-First Conference of the Parties to the United Nations Framework Convention on Climate Change (the 2015 Paris Climate Conference, or COP 21). The Agreement will be open for signature for one year beginning on April 22, 2016, and will come into effect when ratified by 55 nations, representing 55% of global greenhouse gas emissions. Article 2.1 of the Agreement states that it “aims to strengthen the global response to the threat of climate change, in the context of sustainable development and efforts to eradicate poverty, including by . . . [h]olding the increase in the global average temperature to well below 2 °C above pre-industrial levels and to pursue efforts to limit the temperature increase to 1.5 °C above pre-industrial levels. . . .” (UNFCCC, Dec. 12, 2015, Article 2.1(a),
One study assessed possible mitigation measures, which included shading or sprinkling nests with water to reduce temperatures (Jourdan and Fuentes, 2015); however, the effectiveness of such strategies to address climate change impacts has yet to be determined and is likely to be dependent on conservation resources and site-specific characteristics.
Therefore, based on the best available scientific and commercial data, we conclude that the effects of climate change present a threat to all green turtle DPSs. While this threat alone does not put any DPS in danger of extinction, climate change together with other threats places some DPSs in danger of extinction (
Regarding the comment on the number of nesting survey locations, for each DPS we compiled the best available scientific and commercial data including peer-reviewed scientific publications, government reports, and verified unpublished data on green turtle biology and threats. The Status Review Team and two post-doctoral researchers evaluated over 600 publications on green turtles for the Status Review Report, which was peer-reviewed by 15 scientists. To further ensure that the listing determinations are based on the best available data, we requested additional information and allowed over 6 months for response (80 FR 15271, March 23, 2015). We did not receive any new information on nesting sites in the Central West or Central South Pacific DPSs. We did not receive any information that changed the listing determination for any DPS.
Regarding the request for an extension, the ESA provides that if we find that there is substantial disagreement regarding the sufficiency or accuracy of the available data relevant to the determination, we may delay the publication of the final rule
We do not agree with commenters who state that the North Atlantic DPS is endangered or should not be listed under the ESA. The North Atlantic DPS is not presently in danger of extinction because of its high nesting abundance, increasing trends, connectivity, and spatial diversity, which provide some resilience against the section 4(a)(1) factors. However, the DPS is likely to become endangered within the foreseeable future throughout all or a significant portion of its range due to the following threats: habitat degradation, harvest of turtles and eggs, disease and predation, bycatch, channel dredging, marine debris, cold stunning, and climate change. Removing ESA protections would further increase the likelihood of endangerment. The large abundance and increasing trend of nesting females are a direct result of ESA protections and State, local, and foreign protections, which are influenced by the ESA status. If we did not list the DPS under the ESA, the important protections, financial resources, and conservation benefits associated with the ESA would not continue. Further, without listing under the ESA, it is possible that some State,
Regarding the comment on turtles from the Florida breeding population, the change in status (from endangered to threatened) will not reduce protections afforded under the ESA. Threatened and endangered sea turtles receive similar protections under the ESA because longstanding protective regulations apply the prohibitions of section 9 of the statute (which automatically apply to endangered species) to threatened sea turtle species (50 CFR 17.42(b)(1); 50 CFR 223.205). As discussed in the proposed rule and in a prior response, those regulations are not affected by this listing determination rulemaking and remain in effect for threatened DPSs, such as the North Atlantic DPS. One minor change for turtles from the Florida breeding population is that, under the USFWS and FWC section 6(c)(1) agreement, any authorized employee or agent of the FWC may, when acting in the course of official duties, take or issue a conservation permit authorizing take of a green turtle for purposes consistent with the ESA and provisions of the section 6(c)(1) agreement.
We find that the purported petition fails to constitute a valid petition for three additional reasons. First, were the Services to process comments on a proposed rule as petitions seeking to determine the status of the species already the subject of the proposed rule, it would create a circular and redundant process. When a petition is filed, the Services must make a 90-day finding to the maximum extent practicable, and if that initial finding is positive, it triggers a status review and ultimately a 12-month determination (50 CFR 424.14(b)(3)). If the relevant status review has already been conducted and a proposed rule to determine the status of the affected species is available for comment, there is nothing more that processing a new petition at that time could accomplish. Second, API's letter can be read as attempting to petition the Services to delist the North Atlantic DPS before the rule to list it as such has become a final agency action. To the extent that was the commenter's intent, such a preemptive petition is improper as it does not seek an action that can be presently taken. Finally, we note that our regulations require that every petition clearly identify itself as such (50 CFR 424.14(a)), a requirement not clearly met where the document is self-described as a comment letter filed within the context of an ongoing, docketed proceeding.
Regarding the comments on FP, the disease results in internal and/or external tumors that may grow large enough to hamper swimming, vision, feeding, and potential escape from predators. We acknowledge the increasing distribution and incidence of FP, particularly in Florida. The threat is likely to increase, given the continuing, and possibly increasing, human impacts to, and eutrophication of, coastal marine ecosystems that may promote this disease (NMFS, in progress). However, FP is not always lethal, and photographic evidence from Florida shows that the tumors on some green turtles go into regression (Hirama, 2001; Hirama and Ehrhart, 2007; NMFS, in progress).
Regarding the comments on habitat destruction and protection, we considered habitat modification and destruction impacts to the extent they are known and based on the best available data, including qualitative information (
Regarding the comment on poaching, as explained in more detail in the Status Review Report, the harvest of turtles and eggs remains legal in several countries within the range of the North Atlantic DPS. Turtles are legally and illegally harvested in foraging areas. Eggs are harvested at many nesting beaches.
Regarding the comment on the
Numerous other natural and manmade factors affect the continued existence of this DPS. Regulatory mechanisms contained within international instruments are inconsistent and likely to be insufficient. While some regulatory mechanisms should address direct and incidental take for this DPS, it is unclear to what extent such measures are implemented and effective. The species is conservation-dependent and positive population trends are likely to be curtailed or reversed without alternate mechanisms in place to continue existing conservation efforts and protections afforded under the ESA. We conclude that the North Atlantic DPS is threatened by the above section 4(a)(1) factors.
The 1991 Recovery Plan was written prior to the identification of the DPS and only applies to the U.S. population of the Atlantic green turtle (whereas the North Atlantic DPS includes foreign populations and does not include turtles nesting in the U.S. Virgin Islands). The 1991 Recovery Plan identifies recovery criteria (NMFS and USFWS, 1991); however, these criteria apply to delisting, not to changes in listing status (
To make our listing determination, we evaluated the section 4(a)(1) factors in the context of the demographic parameters for this DPS (
Regarding the suggestion to combine the North and South Atlantic DPSs, the best available scientific and commercial data support the identification of the North and South Atlantic DPSs. Genetic, tagging, tracking, and modeling studies support the discreteness of the North and South Atlantic DPSs (Baudouin
Regarding the suggestion to rename the South Atlantic DPS, the vast majority of the range of the South Atlantic DPS lies in the South Atlantic Ocean. We find that the nomenclature appropriately distinguishes this DPS from the North Atlantic DPS and is consistent with the terminology used to name all DPSs.
The Status Review Team considered the BIOT, which includes the seven atolls of the Chagos Archipelago, where sea turtle nesting is common (Mortimer and Day, 1999). The estimated total nester abundance of 1,800 nesting females (Seminoff
Regarding the comments on development and human population size, threats to nesting beaches include construction (and associated lighting), military activities, public use of beaches, and beach driving (NMFS and USFWS, 1998; CNMI Coastal Resources Management Office, 2011; Palacios, 2012; Wusstig, 2012). Coastal erosion has been identified as a high risk in the CNMI due to the existence of concentrated human population centers near erosion-prone zones; it is likely to be exacerbated by sea level rise (CNMI Coastal Resources Management Office, 2011). In Guam, turtle densities are highest where there are healthy coral reefs and seagrass beds, low human densities, and marine protected areas (Martin
Regarding the comments on sea level rise, sea level changes have occurred throughout the history of the species (
We conclude that the Central West Pacific DPS is endangered by a combination of section 4(a)(1) factors.
Regarding the comments on data, to make our proposed listing determination, we evaluated the best available scientific and commercial data, which included information from several surveys (NMFS and USFWS, 1998; Bureau of Marine Resources, 2005; Barr, 2006; Palau Bureau of Marine Resources, 2008; Trevor, 2009; Maison
Regarding the suggestion to list the DPS as threatened, based on the best available scientific and commercial data, we find the species to be in danger of extinction throughout all or a portion of its range as a result of the present and threatened modification of its habitat, poaching of turtles and eggs, disease and predation, fisheries bycatch, marine debris, and climate change. Regulatory mechanisms and conservation efforts are inadequate to remove the impact of these threats, and the DPS has little resilience to such threats due to its low nesting abundance and limited nesting site diversity.
Regarding the comment on naturally low abundance and the possibility of additional nesting sites, the low nesting abundance is likely a result of previous and continued harvest of turtles and eggs (Groombridge and Luxmoore, 1989). We are not aware of any additional nesting data for the northern islands and did not receive any information on additional nesting sites during the 6-month public comment period.
Regarding the information requests and concerns over the endangered status, upon publication of the proposed rule, we notified other nations and requested their comments. We intend to update the recovery plans in the future after the DPS listings are finalized; however, we do not have an anticipated completion date for such plans at this time. The updated listings will allow for more specialized protection of each DPS. The endangered status of the Central West Pacific DPS will highlight it as a conservation priority among green turtle DPSs. We do not agree that the endangered status will increase the extinction risk and hinder recovery. Past ESA protections have led to improving trends in the Central West Pacific (Martin
Regarding the comment on the impacts of the change in status, the new listings will allow for more specialized protection of each DPS. The endangered status of the Central South Pacific DPS will highlight it as a conservation priority among green turtle DPSs. This may encourage conservation actions in other nations. The status change for turtles in American Samoa is unlikely to result in additional implementation burdens because of longstanding regulations protecting threatened species in a manner similar to endangered species (50 CFR 17.42(b)(1); 50 CFR 223.205).
Regarding the comments on surveys and assessments, for the Central South Pacific DPS, the best available scientific and commercial data are summarized in the Status Review Report and include, but are not limited to, unpublished nesting and in-water surveys data in American Samoa collected by NMFS and the Department of Marine and Wildlife Resources of American Samoa. In the proposed rule, we requested all data on nesting locations, abundance, trends, and threats, to ensure the identification and application of the best available data; however, we did not receive additional information for this DPS. We conclude that the data identified in the Status Review Report and applied in the proposed and final rule represent the best available scientific and commercial data and are sufficient to make a listing determination on the Central South Pacific DPS.
Regarding the comments on weighting data, to determine the status of the DPS, we analyzed the best available data on the section 4(a)(1) factors in the context of demographic parameters, including nesting abundance and trends. Nesting abundance was not weighted to potential available habitat or survey efforts because such data are not available. Instead, the Status Review Team provides two estimates of total abundance of nesting females. The first estimate of approximately 2,900 nesting females was based on 37 quantified nesting sites (Seminoff
Regarding the comments on the composition of the DPS, turtles nesting in American Samoa and French Polynesia commonly exhibit haplotypes from Clade III, which are uncommon in other DPSs; satellite tagging data indicate that these turtles share foraging habitat in Fiji, French Polynesia, and American Samoa (Seminoff
We considered the increasing nesting trend, along with the small nesting population size and limited spatial structure, during our evaluation of the demographic factors. We concluded that these demographic parameters do not demonstrate adequate resilience against the threats of habitat loss and modification, disease and predation, inadequate regulatory mechanisms, bycatch, marine debris, boating activities, climate change, and limited nesting site diversity (
Regarding the comment on the destruction or modification of habitat at Johnston Atoll, previous military activities, including nuclear testing and chemical weapons incineration, polluted the beaches and surrounding marine ecosystem (
Regarding the comment on destruction or modification of habitat by vessel groundings, such incidents damage foraging habitat and reef-associated organisms (
Regarding the comment on loss of habitat at Whale-Skate Island, the disappearance of Whale-Skate Island at French Frigate Shoals (FFS) was due to
Regarding the comment that little can be done to protect nesting beaches without halting or reversing all development, our listing determination is based on whether the species meets the definition of threatened or endangered, not whether activities could be performed. Nevertheless, we note that less drastic measures (such as minimizing impacts of artificial lighting, construction, vehicular and pedestrian traffic, and pollution on beaches during nesting seasons) are effective for protecting nesting beaches.
Regarding the comments on predation, introduced species, such as mongoose, rats, dogs, feral pigs, and cats, prey on eggs and hatchlings at some nesting beaches in the MHI. Although hatchlings at Moomomi may have no significant land predators, they are likely to encounter predators at sea, including sea birds, sharks, and other large fish.
Regarding the comments on FP, we agree with the commenters who identified FP as a threat to the DPS. In a study of 3,732 green turtle strandings in Hawai'i between 1982 and 2003, FP was the most common cause of stranding (28 percent) and had a specific mortality rate of 88 percent (Chaloupka
Regarding the comments on bycatch and the inadequacy of existing regulatory mechanisms, after FP, fishing line and gillnet entanglement are the leading cause of stranding and mortality of green turtles in Hawai'i (Work
Regarding the comment on natural disasters, since 1950, more than 50 hurricanes, tropical storms, and tropical depressions have affected Hawai'i. We expect climate change to increase the frequency and intensity of such events (IPCC, 2014). Storm events during the nesting season are likely to disrupt green turtle nesting activity and hatchling production by flooding or exposing nests and altering thermal conditions (Van Houtan and Bass, 2007), resulting in reduced cohort abundance. These events can also degrade turtle nesting habitat by reducing or eliminating sandy beaches and creating barriers to adult and hatchling movements. A single event is unlikely to result in large-scale losses over multiple nesting seasons; however, the increased frequency of such events combined with the effects of sea level rise increase the likelihood of this scenario (Baker
Regarding the comment on stochasticities, irregular, random, and stochastic events, such as those described above, increase the extinction risk of small populations (Schaffer, 1981; Wright and Hubbell, 1983; Lande
Baker
Using a simulation model, Tiwari
Reynolds
It must be noted that these studies used a passive, inundation or “bathtub” model, which is conservative and does not consider storm surges or the projected increases in storm intensity and frequency (Hawkes
These considerations appear to be important in Hawai'i, where historical shoreline changes (
The MHI may also be exposed to “coastal squeeze,”
In addition to sea level rise, we considered the effects of increased temperatures (including nest failure and skewed sex ratios), ocean acidification, and the impact of sea level rise on the movement of hatchlings, oceanic juveniles, and adults. Hawkes
Prior to the identification and proposed listing of the Central North Pacific DPS, the Services published the Recovery Plan for U.S. Pacific Populations of the Green Turtle (
There have been numerous studies on carrying capacity in the Hawaiian green turtle population, focusing on foraging, nesting site, and overall carrying capacity (
One study has also considered nesting carrying capacity. Tiwari
Other studies considered overall carrying capacity (Balazs and Chaloupka, 2004a; 2006; Chaloupka and Balazs, 2007; Snover
Finally, since the original consideration of carrying capacity in 2004, the abundance of nesting females at East Island has continued to increase from an estimated average of 338 nesting females (2000-2003) to an estimated average of 464 nesting females (2009-2012; Humburg and Balazs, 2014). Had carrying capacity been reached in 2004, we would have expected nesting abundance and population growth rates to level off or decrease by now.
Kittinger
In summary, we conclude that historically the DPS was significantly more abundant and has not yet reached foraging, nesting, or overall carrying capacity.
Unlike the ESA, the Red List is not a statute and is not a legally binding or regulatory instrument. It does not include legally binding requirements, prohibitions, or guidance for the protection of threatened (
Thus, the ESA and Red List are inherently different. To the extent that the information described within Red List is relevant to our determination, we do not agree that the DPS “is approaching full recovery to pre-exploitation levels” (IUCN, 2012). The IUCN cites the modeling study by Chaloupka and Balazs (2007), which has been refuted by more recent and complete data (Balazs
We agree with the IUCN's identification of the following threats to the DPS: Restricted location (
Green turtles are selective foragers that target specific species (Balazs, 1980). Only two of these species (
Conservation efforts have led to increasing abundance at numerous nesting sites throughout the range of the DPS. In addition to the increasing trends at Michoacán, we found stable to slightly increasing nesting trends at Galápagos nesting beaches, which host the second largest nesting aggregation of the DPS (Seminoff
We make the following changes from the proposed rule:
• We change the boundaries of the ranges for the North and South Atlantic DPSs because all islands of the U.S. Virgin Islands (not just St. Croix) should be included in the range of the South Atlantic DPS, as indicated by genetic and other data presented in the Status Review Report.
• In the proposed rule, we erroneously listed the California and Oregon border as 41° N.; we remove the reference to the California and Oregon border, however, 41° N. remains the northern boundary for the range of the East Pacific DPS.
• We corrected typographical errors in the listing tables and throughout the preamble, including correcting the citation to the existing critical habitat designation for the North Atlantic DPS, at 50 CFR 226.208.
• We include information on the National Colombia Programme for Conservation of Marine and Continental Turtles in our consideration of conservation efforts for the South Atlantic and East Pacific DPSs.
• We indicate that the BIOT, located within the range of the Southwest Indian DPS, protects green turtles and their habitat; however, conservation efforts are not sufficient to adequately reduce all threats (Mortimer and Day, 1999).
• We reviewed, and incorporate as appropriate, scientific data from references that were not included in the Status Review Report and proposed rule. We include the following references, which together with previously cited references, represent the best available scientific and commercial data; however, these new references do not present significant new findings that change any of our proposed listing determinations: Benaka
The comments that we received on the proposed rule did not change our conclusions regarding the identification of DPSs. We reviewed relevant and recently available scientific data that were not included in the Status Review Report and proposed rule (Carreras
In summary, we applied our joint DPS policy (61 FR 4722, February 7, 1996) to identify 11 discrete and significant DPSs: North Atlantic, Mediterranean, South Atlantic, Southwest Indian, North Indian, East Indian-West Pacific, Central West Pacific, Southwest Pacific, Central South Pacific, Central North Pacific, and East Pacific (Figure 1).
The comments that we received on the North Atlantic DPS and additional information that became available since the publication of the proposed rule did not change our conclusions regarding its listing determination. Therefore, we incorporate herein all information on the North Atlantic DPS provided in the Status Review Report and proposed rule, with the following exceptions: The boundary of the DPS (which was changed to exclude all islands of the U.S. Virgin Islands), and the application of the critical risk threshold from the Status Review Report (which, as we explained in the proposed rule, does not directly correlate with the ESA definitions of “endangered” and “threatened”). The following represents a brief summary of that information.
The range of the DPS extends from the boundary of South and Central America, north along the coast to include Panama, Costa Rica, Nicaragua, Honduras, Belize, Mexico, and the United States. It extends due east across the Atlantic Ocean at 48° N. and follows the coast south to include the northern portion of the Islamic Republic of Mauritania (Mauritania) on the African continent to 19° N. It extends west at 19° N. to the Caribbean basin to 65.1° W., then due south to 14° N., 65.1° W., then due west to 14° N., 77° W., and due south to 7.5° N., 77° W., the boundary of South and Central America. It includes Puerto Rico, the Bahamas, Cuba, Turks and Caicos Islands, Republic of Haiti, Dominican Republic, Cayman Islands, and Jamaica. The North Atlantic DPS includes the Florida breeding population, which was originally listed as endangered under the ESA (43 FR 32800, July 28, 1978).
The DPS exhibits high nesting abundance, with an estimated total nester abundance of 167,424 females at 73 nesting sites. More than 100,000 females nest at Tortuguero, Costa Rica, and more than 10,000 females nest at Quintana Roo, Mexico. Nesting data indicate long-term increases at all major nesting sites. There is little genetic substructure within the DPS, and turtles from multiple nesting beaches share common foraging areas. Nesting is geographically widespread and occurs at a diversity of mainland and insular sites.
Nesting beaches are degraded by coastal development, coastal armoring, beachfront lighting, erosion, sand extraction, and vehicle and pedestrian traffic. Foraging habitat is degraded by pollution (including oil spills, agricultural and residential runoff, and sewage), propeller scarring, anchor damage, dredging, sand mining, marina construction, and beach nourishment. The harvest of green turtles and eggs remains legal in several countries (
Conservation efforts include bycatch reduction measures, nesting beach acquisitions, and nest protection programs to reduce harvest and predation. Numerous initiatives, such as the Colombia National Programme for the Conservation of Marine and Continental Turtles, promote education, conservation, and outreach. The recovery of the DPS is dependent on ESA protections and those provided by local, State, and foreign laws, some of which may have been triggered by the original ESA listing. Though ESA protections would be lost if the DPS were not listed under the ESA, it is unclear whether local, State, and foreign laws would remain in place.
The high nesting abundance, increasing trends, connectivity, and spatial diversity provide the DPS with some resilience against current threats (
For the above reasons, we list the North Atlantic DPS as a threatened species under the ESA.
The comments that we received on the Mediterranean DPS and additional information that became available since the publication of the proposed rule did not change our conclusions regarding its listing determination. Therefore, we incorporate herein all information on the Mediterranean DPS provided in the Status Review Report and proposed rule, with the exception of the application of the critical risk threshold from the Status Review Report, which does not directly correlate with the ESA definitions of “endangered” and “threatened,” as explained in the proposed rule. The following represents a brief summary of that information.
The range of the DPS includes the Mediterranean Sea (excluding the Black Sea), with the Strait of Gibraltar as its western boundary.
The DPS exhibits low abundance, with an estimated total nester abundance of 404 to 992 females at 32 sites. The DPS is severely depleted relative to historical levels; however, five of seven nesting sites indicate slightly increasing trends. Connectivity is high (
Nesting habitat is destroyed or modified by coastal development, construction, beachfront lighting, sand extraction, beach erosion, vehicular and pedestrian traffic, and beach pollution. Fishing and pollution result in the destruction and modification of foraging habitat. The harvest of turtles and eggs contributed to the historical decline of this DPS and continues in several areas. Numerous species prey on eggs and hatchlings. Many international and national regulatory mechanisms exist; however, fisheries bycatch and tourism impacts are poorly regulated. Fisheries bycatch results in substantial mortality and is a major threat to the DPS. Vessel activity and strikes result in mortality, injury, and abandoned nesting attempts. Marine debris is a major concern. Climate change is likely to alter thermal sand characteristics; in some areas, hatchling sex ratios are already highly female biased (up to 95 percent).
Conservation efforts include protection of nesting beaches, removal of marine debris, and establishment of marine protected areas. In a recent study, Ullmann and Stachowitsch (2015) identified 49 stranding response (
As a result of low nesting abundance (concentrated primarily in one area), weak population growth rates, and low diversity of nesting sites, the DPS has little resilience to threats, which include: Habitat loss and degradation, overexploitation, predation, inadequate regulatory mechanisms, fisheries bycatch, vessel traffic, marine debris, and climate change. Although they are beneficial, the conservation efforts do not adequately reduce threats. We conclude that the Mediterranean DPS is in danger of extinction throughout all or a significant portion of its range.
For the above reasons, we list the Mediterranean DPS as an endangered species under the ESA.
The comments that we received on the South Atlantic DPS and additional information that became available since the publication of the proposed rule did not change our conclusions regarding its listing determination. Therefore, we incorporate herein all information on the South Atlantic DPS provided in the Status Review Report and proposed rule, with the following exceptions: the boundary of the DPS (which was changed to include all islands of the U.S. Virgin Islands), and the application of the critical risk threshold from the Status Review Report (which, as we
The range of the South Atlantic DPS begins at the border of Panama and Colombia at 7.5° N., 77° W., heads due north to 14° N., 77° W., then east to 14° N., 65.1° W., then north to 19° N., 65.1° W., and along 19° N. latitude to Mauritania in Africa, to include the U.S. Virgin Islands in the Caribbean. It extends along the coast of Africa to South Africa, with the southern border being 40° S. latitude.
The DPS exhibits high nesting abundance, with an estimated total nester abundance of 63,332 females. Two nesting sites have greater than 10,000 nesting females: Poilão, Guinea-Bissau and Ascension Island, UK (Weber
Nesting habitat is destroyed or modified by coastal development and construction, placement of erosion control structures and other barriers to nesting, beachfront lighting (
Most nations in South America, the Caribbean, and Africa have national legislation or programs sponsored by state governments, local communities, academic institutions, and organizations to protect sea turtles and their nesting and foraging habitats. Conservation efforts at the primary nesting beaches, such as Ascension Island, include legal prohibitions as well as extensive monitoring, outreach, and research (
As a result of the high population abundance, increasing nesting trend, and diverse nesting sites, the DPS is somewhat resilient to current threats, which include: Habitat loss and degradation, overexploitation, disease and predation, inadequate regulatory mechanisms, fisheries bycatch, marine debris, oil exploration and extraction, and climate change. The conservation efforts vary in consistency and efficacy throughout the range of the DPS and do not adequately mitigate all threats. We conclude that the DPS is not presently in danger of extinction throughout all or a significant portion of its range. Listing is warranted because numerous threats remain, some of which are likely to increase within the foreseeable future; the loss of ESA protections would further exacerbate all threats. We conclude that the DPS is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.
For the above reasons, we list the South Atlantic DPS as a threatened species under the ESA.
The comments that we received on the Southwest Indian DPS did not change our conclusions regarding its listing determination. Therefore, we incorporate herein all information on the Southwest Indian DPS provided in the Status Review Report and proposed rule, with the exception of the application of the critical risk threshold from the Status Review Report, which does not directly correlate with the ESA definitions of “endangered” and “threatened,” as explained in the proposed rule. The following represents a brief summary of that information.
The range of the Southwest Indian DPS has as its western boundary the shores of continental Africa from the equator, just north of the Kenya-Somalia border, south to the Cape of Good Hope (South Africa), and extends south from there along 19° E. longitude to 40° S., 19° E. Its southern boundary extends along 40° S. latitude from 19° E. to 84° E., and its eastern boundary runs along 84° E. longitude from 40° S. latitude to the equator. Its northern boundary extends along the equator from 84° E. to the continent of Africa just north of the Kenya-Somalia border.
The DPS exhibits high abundance, with an estimated total nester abundance of 91,059 females at 15 nesting sites (four of which host more than 10,000 females). Nesting data at these mostly protected beaches indicate increasing trends. Within the DPS, there is a moderate degree of genetic substructure (
Nesting beaches are threatened by increased tourism and artificial lighting. Foraging habitats are degraded by development of the coastline, dredging, land-fill, sedimentation, and sand extraction. Legal and illegal harvest of turtles and eggs persists throughout the DPS. Poaching of nesting females has led to declines at some beaches, and foraging turtles are heavily poached in several areas. Existing regulatory mechanisms to address poaching and bycatch are often inadequately implemented and/or enforced, as demonstrated by the high level of illegal harvest and bycatch within this DPS. The DPS is threatened by bycatch in demersal and pelagic longlines, trawls, gill nets, and purse seines (
Several regional initiatives have promoted conservation, management, research and education throughout the range of the DPS. Other multinational programs and national laws protect sea turtles. For example, Mortimer and Day (1999) state that green turtles and nesting habitat in the Chagos Archipelago are well protected by the BIOT administration (Mortimer and Day, 1999) and a large marine protected area (Hays
The high nesting abundance, increasing nesting trends, and spatial and genetic diversity of the DPS provide some resilience to threats, which include: Habitat loss and degradation, overexploitation of eggs and turtles, inadequate regulatory mechanisms, fisheries bycatch, and climate change. Despite many beneficial conservation efforts, poaching and bycatch remain major threats. We conclude that the DPS is not presently in danger of extinction throughout all or a significant portion of its range. Listing is warranted because of the high levels of harvest and bycatch, in the context of increasing impacts from climate change, are likely to overwhelm the resilience of the DPS. We conclude that the DPS is likely to become endangered within the foreseeable future throughout all or a significant portion of its range.
For the above reasons, we list the Southwest Indian DPS as a threatened species under the ESA.
We did not receive comments on the North Indian DPS, and there are no changes to our proposed listing determination. Therefore, we incorporate herein all information on the North Indian DPS provided in the Status Review Report and proposed rule, with the exception of the application of the critical risk threshold from the Status Review Report, which does not directly correlate with the ESA definitions of “endangered” and “threatened,” as explained in the proposed rule. The following represents a brief summary of that information.
The range of the North Indian DPS begins at the border of Somalia and Kenya north into the Gulf of Aden, Red Sea, Persian Gulf and east to the Gulf of Mannar off the southern tip of India and includes a major portion of India's southeastern coast up to Andra Pradesh. The southern and eastern boundaries are the equator (0°) and 84° E., respectively, which intersect in the southeast corner of the range of the DPS. It is bordered by the following countries (following the water bodies from west to east): Somalia, Djibouti, Eritrea, Sudan, Egypt, Israel, Jordan, Saudi Arabia, Yemen, Oman, United Arab Emirates, Qatar, Bahrain, Kuwait, Iraq, the Islamic Republic of Iran, Pakistan, India, and Sri Lanka.
The DPS exhibits high abundance, with an estimated total nester abundance of 55,243 females at 38 nesting sites. Two sites host greater than 10,000 nesting females: Ras Sharma, Yemen, and Ras Al Hadd, Oman. Nesting trends are increasing at Ras Al Hadd but possibly declining at other sites. Nesting is moderately dispersed, though concentrated in the northern and western region of the range.
Nesting beaches are degraded by light pollution and uncontrolled particulate emissions that prevent the emergence of hatchlings from their nests at some beaches. Marine habitat is degraded as a result of trawling, dredging, siltation, land reclamation, and pollution. The legal and illegal harvest of turtles and eggs persists at several nesting beaches. Predation of eggs and hatchlings is a major threat at some nesting beaches. Though numerous international and national regulatory mechanisms apply to the DPS, many are inadequate due to limited implementation and enforcement. Sea turtle bycatch in gill nets, trawls, and longline fisheries is a significant cause of mortality. Vessel strikes are a large and increasing threat. Beach driving causes hatchling turtles to be caught in ruts, struck, or run over. Marine debris entangles and is ingested by turtles. Sea level rise and the increased frequency and intensity of storm events, as a result of climate change, are likely to cause severe erosion to nesting beaches.
There are several multinational and national programs underway to protect and conserve the DPS. Most focus on protecting the nesting beaches.
The high abundance and broadly distributed nesting beaches of the DPS provide some resilience to threats; however, nesting is relatively concentrated and declining at some beaches. The DPS is threatened by the following factors: habitat loss and degradation, harvest of turtles and eggs, predation, inadequate regulatory mechanisms, fisheries bycatch, marine debris, beach driving, boat strikes, and climate change. While conservation efforts for the North Indian DPS are extensive and expanding, they remain inadequate to ensure the long-term viability of the population. We conclude that the DPS is not presently in danger of extinction throughout all or a significant portion of its range. Listing is warranted because resilience is limited and several of the existing threats are likely to increase. Therefore, the DPS is likely to become endangered within the foreseeable future throughout all or a significant portion of its range.
For the above reasons, we list the North Indian DPS as a threatened species under the ESA.
The comments that we received on the East Indian-West Pacific DPS did not change our conclusions regarding its listing determination. Therefore, we incorporate herein all information on the East Indian-West Pacific DPS provided in the Status Review Report and proposed rule, with the exception of the application of the critical risk threshold from the Status Review Report, which does not directly correlate with the ESA definitions of “endangered” and “threatened,” as explained in the proposed rule. The following represents a brief summary of that information.
The western boundary for the range of the East Indian-West Pacific DPS is 84° E. longitude from 40° S. to where it coincides with India near Odisha, northeast along the shoreline and into the West Pacific Ocean to include Taiwan extending east at 41° N. to 146° E. longitude, south and west to 4.5° N., 129° E., then south and east to West Papua in Indonesia and the Torres Straits in Australia. The southern boundary is 40° S. latitude, encompassing the Gulf of Carpentaria.
The DPS exhibits high abundance, with an estimated total nester abundance of 77,009 females at 50 nesting sites. The largest nesting site (Wellesley Group in northern Australia) supports approximately 25,000 nesting females. Declines occur at several nesting sites, though others appear to be stable or increasing. There is complex and significant spatial substructure, but some mixing of turtles occurs at foraging areas. Nesting and foraging areas are widespread throughout the range of the DPS, providing some resilience through habitat diversity.
The majority of nesting beaches are degraded due to tourism, coastal development, artificial lighting, sand mining, oil and gas production, and marine debris. Foraging habitat is degraded due to siltation, sewage, pollution (
There are several conservation programs throughout the range of the DPS. Sanctuaries and parks protect some nesting beaches, and some marine protected areas have been established. There are bycatch reduction efforts in some areas. Several programs conduct monitoring, education, outreach, and enforcement.
The high nesting abundance and spatial diversity of nesting and foraging locations provide the DPS with some resilience against current threats; however, nesting trends at several sites are declining. The DPS is threatened by all section 4(a)(1) factors: Habitat loss and degradation, overexploitation, disease and predation, inadequate regulatory mechanisms, fisheries bycatch, marine debris, and climate change. Though beneficial, the conservation efforts do not adequately reduce threats. We conclude that the East Indian-West Pacific DPS is not presently in danger of extinction throughout all or a significant portion of its range. Listing is warranted because current and increasing threats are likely to exacerbate population declines, especially in the context of climate change. For these reasons, the DPS is likely to become endangered within the foreseeable future throughout all or a significant portion of its range.
For the above reasons, we list the East Indian-West Pacific DPS as a threatened species under the ESA.
The comments that we received on the Central West Pacific DPS did not change our conclusions regarding its listing determination. Therefore, we incorporate herein all information on the Central West Pacific DPS provided in the Status Review Report and proposed rule, with the exception of the application of the critical risk threshold from the Status Review Report, which does not directly correlate with the ESA definitions of “endangered” and “threatened,” as explained in the proposed rule. The following represents a brief summary of that information.
The range of the Central West Pacific DPS has a northern boundary of 41° N. latitude and is bounded by 41° N., 169° E. in the northeast corner, going southeast to 9° N., 175° W., then southwest to 13° S., 171° E., west and slightly north to the eastern tip of Papua New Guinea, along the northern shore of the Island of New Guinea to West Papua in Indonesia, northwest to 4.5° N., 129° E. then to West Papua in Indonesia, then north to 41° N., 146° E. It encompasses the Republic of Palau, Federated States of Micronesia, New Guinea, Solomon Islands, Marshall Islands, Guam, CNMI, and the Ogasawara Islands of Japan.
The DPS exhibits low nesting abundance, with an estimated total nester abundance of 6,518 females at 50 nesting sites. Nesting data indicate increasing trends at one site but decreasing trends at others. There is significant genetic substructure and limited connectivity among four independent stocks. Nesting is relatively widespread but occurs only on islands and atolls (
Nesting habitat is degraded by coastal development and construction, placement of barriers to nesting, beachfront lighting, tourism, vehicular and pedestrian traffic, sand extraction, beach erosion, beach pollution, removal of native vegetation, and the presence of non-native vegetation. Destruction and modification of marine habitat occurs as a result of coastal construction, tourism, sedimentation, pollution, sewage, runoff, military activities, dredging, destructive fishing methods, and boat anchoring. The harvest of turtles and eggs is a large and persistent threat throughout the range of the DPS. Predation is a significant threat in some areas. Though there are some existing regulatory mechanisms to reduce the harvest of turtles and eggs and to prevent or reduce bycatch, implementation and enforcement are inadequate. Turtles are incidentally caught in longline, pole and line, and purse seine fisheries. Marine debris results in the mortality of sea turtles through ingestion and entanglement. Temperature increases, as a result of climate change, are the greatest long-term threat to atoll morphology in nations throughout the range of the DPS. Sea level rise is likely to reduce available nesting habitat. The increased frequency and intensity of storm events are likely to cause beach erosion and nest inundation, as demonstrated in a recent study by Summers
Conservation efforts include programs to protect turtles, establish protected areas, and reduce beach pollution. A recent study demonstrates that turtle densities have increased by an order of
The low nesting abundance, limited connectivity, and low nesting diversity provide the DPS with little resilience against current threats. Though nesting trends are increasing in some areas, they are decreasing in others. The DPS is vulnerable to the following section 4(a)(1) factors: Habitat modification and destruction, overexploitation, predation, fisheries bycatch, marine debris, and climate change. Conservation efforts do not adequately reduce such threats; ESA and additional protections are essential to the continued existence of the DPS. We conclude that the DPS is in danger of extinction throughout all or a significant portion of its range.
For the above reasons, we list the Central West Pacific DPS as an endangered species under the ESA.
We did not receive comments on the Southwest Pacific DPS and made no changes to our proposed listing determination. Therefore, we incorporate herein all information on the Southwest Pacific DPS provided in the Status Review Report and proposed rule, with the exception of the application of the critical risk threshold from the Status Review Report, which does not directly correlate with the ESA definitions of “endangered” and “threatened,” as explained in the proposed rule. The following represents a brief summary of that information.
The range of the Southwest Pacific DPS extends from the western boundary of Torres Strait, to the eastern tip of Papua New Guinea and out to the offshore coordinate of 13° S., 171° E.; the eastern boundary runs from this point southeast to 40° S., 176° E.; the southern boundary runs along 40° S. from 142° E. to 176° E.; and the western boundary runs from 40° S., 142° E. north to the Australian coast then follows the coast northward to the Torres Strait.
The DPS exhibits high nesting abundance, with an estimated total nester abundance of 83,058 females at 12 aggregated nesting sites. Three sites (all in Australia) host more than 10,000 nesting females: Raine Island, Moulter Cay, and the Capricorn and Bunker Group. Nesting data indicate slightly increasing trends. There are four regional genetic stocks, though mixing occurs at foraging areas. Nesting and foraging areas are widely dispersed.
Nesting habitat has been degraded by beach erosion, artificial lighting, pollution, removal of native vegetation, and planting of non-native vegetation. Threats to foraging habitat include destructive fishing practices, channel dredging, and marine pollution. Harvest of turtles and eggs is substantial and occurs in many areas. Several species prey on eggs and hatchlings. Existing regulatory mechanisms inadequately address the incidental take of turtles, and many are not enforced at the local level. Incidental capture in artisanal and commercial fisheries (
Conservation efforts for the DPS have resulted in take prohibitions, implementation of bycatch reduction devices, improvement of shark control devices, and safer dredging practices. Most nesting occurs on protected beaches, and the habitat off the largest nesting site falls within a marine protected area.
The high nesting abundance, slightly increasing trends, and spatial diversity provide the DPS with some resilience against current threats, which include: Habitat loss and degradation, overexploitation, disease and predation, inadequate regulatory mechanisms, fisheries bycatch, boat strikes, marine debris, port dredging, and climate change. Though beneficial, the conservation efforts are not sufficient to reduce all threats. We conclude that the DPS is not presently in danger of extinction throughout all or a significant portion of its range. Listing is warranted because of several continuing and increasing threats, as summarized above. As a result of such threats, we conclude that the DPS is likely to become endangered within the foreseeable future throughout all or a significant portion of its range.
For the above reasons, we list the Southwest Pacific DPS as a threatened species under the ESA.
The comments that we received on the Central South Pacific DPS did not change our conclusions regarding its listing determination. Therefore, we incorporate herein all information on the Central South Pacific DPS provided in the Status Review Report and proposed rule, with the exception of the application of the critical risk threshold from the Status Review Report, which does not directly correlate with the ESA definitions of “endangered” and “threatened,” as explained in the proposed rule. The following represents a brief summary of that information.
The range of the DPS extends north and east of New Zealand to include a longitudinal expanse of 7,500 km, from Easter Island, Chile in the east to Fiji in the west, and encompasses American Samoa, French Polynesia, Cook Islands, Fiji, Kiribati, Tokelau, Tonga, and Tuvalu. Its open ocean polygonal boundary endpoints are (clockwise from the northwest-most extent): 9° N., 175° W. to 9° N., 125° W. to 40° S., 96° W. to 40° S., 176° E., to 13° S., 171° E., and back to 9° N., 175° W.
The DPS exhibits low nesting abundance, with an estimated total nester abundance of 2,677 to 3,600 nesting females at 59 nesting sites. There is a negative nesting trend at the most abundant nesting site but increasing trends at less abundant nesting beaches. There are at least two genetic stocks within the DPS. Nesting is geographically broad, but there is little diversity of nesting sites, with most nesting occurring on low-lying coral atolls or oceanic islands.
Some nesting beaches are degraded by coastal erosion, development, construction, sand extraction, artificial lighting, proximity to road traffic, and natural disasters, such as tsunamis. Marine habitat is degraded by runoff, sedimentation, dredging, ship groundings, natural disasters, and pollution (
Conservation efforts throughout the region, such as establishment of protected areas and national legislation to protect turtles, provide some benefits to the DPS. The remoteness of some areas appears to provide the most conservation protection against certain threats, such as poaching.
The low nesting abundance, decreasing nesting trends at the largest nesting site, and low nesting diversity provide the DPS with little resilience against current threats. Though nesting trends are increasing at some less abundant nesting beaches, such trends provide little additional resilience to the DPS. Therefore, the DPS is vulnerable to the following section 4(a)(1) factors: Habitat loss and degradation, overexploitation, predation, inadequate regulatory mechanisms, fisheries bycatch, marine debris, and climate change. Conservation efforts do not adequately reduce such threats; ESA and additional protections are essential to the continued existence of the DPS. We conclude that the DPS is in danger of extinction throughout all or a significant portion of its range.
For the above reasons, we list the Central South Pacific DPS as an endangered species under the ESA.
The comments that we received on the Central North Pacific DPS did not change our conclusions regarding its listing determination. Therefore, we incorporate herein all information on the Central North Pacific DPS provided in the Status Review Report and proposed rule, with the exception of the application of the critical risk threshold from the Status Review Report, which does not directly correlate with the ESA definitions of “endangered” and “threatened,” as explained in the proposed rule. The following represents a brief summary of that information.
The range of the Central North Pacific DPS includes the Hawaiian Archipelago and Johnston Atoll. It is bounded by a four-sided polygon with open ocean extents reaching to 41° N., 169° E. in the northwest corner, 41° N., 143° W. in the northeast, 9° N., 125° W. in southeast, and 9° N., 175° W. in the southwest.
The DPS exhibits low nesting abundance, with an estimated total nester abundance of 3,846 nesting females at 13 nesting sites. The most recent published study on this DPS estimates the total nester abundance at roughly 4,000 nesting females (Balazs
In the MHI, nesting and basking habitats are degraded by coastal development and construction, vehicular and pedestrian traffic, beach pollution, tourism, and other human related activities. Foraging habitat is degraded by coastal development, marina construction, siltation, pollution, sewage, military activities, vessel traffic, and vessel groundings. As stated in a recent study, FP continues to cause the majority of green turtle strandings in Hawai'i (Work
Overall, State and Federal conservation efforts have been successful in countering some threats. Important State initiatives include the regulation of gill net fishing and the distribution of barbless circle hooks.
Though the low nesting abundance and extremely limited nesting diversity render the DPS vulnerable to several threats, the increasing nesting trend at FFS provides some resilience. The DPS is threatened by the following section 4(a)(1) factors: Present and threatened habitat loss and degradation, disease and predation, inadequate regulatory mechanisms, fisheries bycatch, marine debris, vessel activities, limited spatial diversity, and climate change. Though beneficial, the conservation efforts are not sufficient to reduce all threats. We conclude that the DPS is not presently in danger of extinction throughout all or a significant portion of its range. Listing is warranted because of numerous continuing and increasing threats, which would be further exacerbated if ESA protections were lost. We conclude that the DPS is likely to become endangered within the foreseeable future throughout all or a significant portion of its range.
For the above reasons, we list the Central North Pacific DPS as a threatened species under the ESA.
The comments that we received on the East Pacific DPS did not change our conclusions regarding its listing determination. Therefore, we incorporate herein all information on the East Pacific DPS provided in the Status Review Report and proposed
The range of the DPS extends from 41° N. southward along the Pacific coast of the Americas to central Chile (40° S.) and westward to 142° W. and 96° W., respectively. The offshore boundary of this DPS is a straight line between these two coordinates. The East Pacific DPS includes the Mexican Pacific coast breeding population, which was originally listed as endangered (43 FR 32800, July 28, 1978).
The DPS exhibits an estimated total nester abundance of 20,112 females at 39 nesting sites. The largest nesting aggregation (Colola, Michoacán, Mexico) hosts more than 10,000 nesting females. Nesting data indicate increasing trends in recent decades. Within the DPS, there is additional substructure, and four regional genetic stocks have been identified; however, stocks mix at foraging areas. Nesting occurs at both insular and continental sites, providing some spatial diversity.
Some nesting beaches are degraded by coastal development, tourism, and pedestrian traffic. Some foraging areas exhibit high levels of contaminants and reduced seagrass communities. As described by Senko
Conservation initiatives include broad regional efforts and national programs, such as the National Programme for the Conservation of Marine and Continental Turtles in Colombia, which provides education, conservation, and outreach plans. Marine reserves protect green turtles and their foraging habitat.
The increasing trends and spatial diversity provide the DPS with some resilience against current threats; the nesting abundance, though not high, may be large enough to avoid depensation and other risks associated with small population size. The DPS is threatened by the following section 4(a)(1) factors: Habitat loss and degradation, overexploitation, inadequate regulatory mechanisms, fisheries bycatch, marine debris, boat strikes, red tide poisoning, and climate change. Though beneficial, conservation efforts are not sufficient to adequately reduce threats. We conclude that the DPS is not presently in danger of extinction throughout all or a significant portion of its range. Listing is warranted because significant threats (
For the above reasons, we list the East Pacific DPS as a threatened species under the ESA.
We reviewed the best available scientific and commercial information, including the information in the Status Review Report, the comments of peer reviewers, public comments, and information that has become available since the publication of the proposed rule. We identified 11 green turtle DPSs: North Atlantic, Mediterranean, South Atlantic, Southwest Indian, North Indian, East Indian-West Pacific, Central West Pacific, Southwest Pacific, Central South Pacific, Central North Pacific, and East Pacific. For each DPS, we reviewed the demographic parameters and section 4(a)(1) factors, performed an extinction risk analysis, and considered conservation efforts. We determined that the Mediterranean, Central West Pacific, and Central South Pacific DPSs are endangered species, and the following DPSs are threatened species: North Atlantic, South Atlantic, Southwest Indian, North Indian, East Indian-West Pacific, Southwest Pacific, Central North Pacific, and East Pacific. We hereby replace the original listings for the species and breeding populations in Florida and the Pacific coast of Mexico with listings of the 11 threatened or endangered DPSs.
Under the ESA and our implementing regulations, a species may warrant listing if it is endangered or threatened throughout all or a significant portion of its range. See the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (79 FR 37577, July 1, 2014). Under that policy, we only need to consider whether listing may be appropriate on the basis of the “significant portion of its range” language if the rangewide analysis does not lead to a threatened or endangered listing determination. Because we have determined that each green turtle DPS is either threatened or endangered throughout all of its range, no portion of its range can be “significant” for purposes of the definitions of “endangered species” and “threatened species.”
Conservation benefits for species listed as endangered or threatened under the ESA include: Recovery plans and actions (16 U.S.C. 1533(f)); designation of critical habitat if prudent and determinable (16 U.S.C. 1533(a)(3)(A)(i)); the requirement that Federal agencies consult with the Services to ensure that their actions are not likely to jeopardize species or result in adverse modification or destruction of critical habitat, should it be designated (16 U.S.C. 1536(a)(2)); and prohibitions against take and certain other activities (16 U.S.C. 1538). In addition, recognition of the species' status through listing promotes conservation actions by Federal and State agencies, foreign entities, conservation organizations, and individuals.
Section 7(a)(2) of the ESA requires Federal agencies to consult with the relevant Service(s) to insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of listed species or result in
Section 3 of the ESA defines critical habitat as: (1) The specific areas within the geographical area occupied by a species, at the time it is listed in accordance [with the ESA], on which are found those physical or biological features (a) essential to the conservation of the species and (b) that may require special management considerations or protection; and (2) specific areas outside the geographical area occupied by a species at the time it is listed in accordance [with the ESA] upon a determination by the Services that such areas are essential for the conservation of the species (16 U.S.C. 1532(5)). Section 4(a)(3)(A) requires us to designate critical habitat to the maximum extent prudent and determinable and concurrently with a listing determination (16 U.S.C. 1533(a)(3)(A)(i)), unless as described in section 4(b)(6)(C), critical habitat is not then determinable, in which case we may take an additional year to publish the final critical habitat determination (16 U.S.C. 1533(b)(6)(C)(ii)). The implementing regulations state that critical habitat shall not be designated within foreign countries or in other areas outside of U.S. jurisdiction (50 CFR 424.12 (h)). The ranges of six DPSs occur within U.S. jurisdiction: North Atlantic, South Atlantic, East Pacific, Central North Pacific, Central South Pacific, and Central West Pacific. We are currently evaluating the areas that contain physical and biological features that are essential to the DPSs and may require special management considerations or protection, but critical habitat is not determinable at this time. Therefore, we will propose critical habitat in a future rulemaking. As discussed in the proposed rule, designated critical habitat, in waters surrounding Culebra Island, Puerto Rico, from the mean high water line seaward to 3 nautical miles (5.6 km; 63 FR 46693, September 2, 1998), remains in effect for the North Atlantic DPS.
All prohibitions in section 9(a)(1) of the ESA (16 U.S.C. 1538(a)(1)) apply automatically under the statute to the three endangered DPSs: Mediterranean, Central West Pacific and Central South Pacific. These include prohibitions against importing, exporting, engaging in foreign or interstate commerce, or “taking” of the species. “Take” is defined under the ESA as “to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct” (16 U.S.C. 1532(19)). These prohibitions apply to any “person” (as defined by the ESA) subject to the jurisdiction of the United States, including within the United States, its territorial seas, or on the high seas. Certain exceptions apply to employees of the Services, other Federal land management agencies, and State conservation agencies. In addition, longstanding requirements for fishing activities to protect endangered sea turtles apply to these DPSs (50 CFR 224.104) and are not affected by this rule.
Section 4(d) of the ESA authorizes us to issue regulations that we deem necessary and advisable to provide for the conservation of threatened species (16 U.S.C. 1533(d)). As discussed in the proposed rule, the longstanding protective regulations (50 CFR 17.42(b), 223.205, 223.206, and 223.207) remain in effect and continue to apply section 9 prohibitions to threatened species of sea turtles, which include the North Atlantic, South Atlantic, Southwest Indian, North Indian, East Indian-West Pacific, Southwest Pacific, Central North Pacific, and East Pacific DPSs. The specific content of those provisions is beyond the scope of this rulemaking and is unaffected by this rulemaking.
Pursuant to section 10 of the ESA, we may issue permits to carry out activities otherwise prohibited by section 9 for scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities (16 U.S.C. 1539(a)(1)). For threatened species, we may also issue permits for education and zoological exhibition (50 CFR 17.32(a)(1); 50 CFR 223.206(a)(1)).
On July 1, 1994, we published a policy (59 FR 34272) that requires us to identify, to the maximum extent practicable at the time a species is listed, those activities that would or would not likely constitute a violation of section 9 of the ESA. The intent of this policy is to increase public awareness of the effect of a listing on proposed and ongoing activities within a species' range. Activities likely to violate section 9 include, but are not limited to: (1) Importation or exportation of any part of a green turtle or green turtle eggs; (2) directed take of green turtles, including fishing for, capturing, handling, or possessing green turtles, eggs, or parts; (3) sale of green turtles, eggs, or parts in interstate commerce; (4) modification or degradation of green turtle habitat, including nesting beaches, beaches used for basking, and developmental, foraging habitat, and migratory habitat that actually kills or injures green turtles (
Activities not likely to violate section 9 of the ESA may include: Take authorized by and carried out in accordance with the terms and conditions of an ESA section 10(a)(1)(A) permit; and continued possession of parts that were in possession at the time of the original listing (
In December 2004, the Office of Management and Budget (OMB) issued a Final Information Quality Bulletin for
A complete list of the references is available at:
The 1982 amendments to section 4(b)(1)(A) of the ESA restrict the information that may be considered when assessing species for listing. Based on this limitation of criteria for a listing decision and the opinion in
As noted in the Conference Report on the 1982 amendments to the ESA, economic impacts cannot be considered when assessing the status of a species. Therefore, the economic analysis requirements of the Regulatory Flexibility Act are not applicable to the listing process. In addition, this final rule is exempt from review under Executive Order 12866. This final rule does not contain a collection-of-information requirement for the purposes of the Paperwork Reduction Act.
In accordance with Executive Order 13132, we determined that this final rule does not have significant Federalism effects and that a Federalism assessment is not required.
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Endangered and threatened species, Exports, Imports, Transportation.
For the reasons set out in the preamble, 50 CFR parts 17, 223, and 224 are amended as follows:
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.
(h) * * *
16 U.S.C. 1531-1543; subpart B, § 223.201-202 also issued under 16 U.S.C. 1361
(e) * * *
16 U.S.C. 1531-1543 and 16 U.S.C. 1361
(h) * * *
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. This action is part of our larger effort to focus on prevention of food safety problems throughout the food chain and is part of our implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the Food Safety Modernization Act of 2011 (FSMA).
This rule is effective June 6, 2016. See section V for the compliance dates.
Michael Kashtock, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2022.
This rule is part of FDA's implementation of the 2005 SFTA and the FSMA. These statutes require us to issue regulations requiring shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. This rule creates new requirements for the sanitary transportation of human and animal food by motor vehicle and rail vehicle to ensure that transportation practices do not create food safety risks. Practices that create such risk include failure to properly refrigerate food requiring temperature control for food safety, the inadequate cleaning of vehicles between loads, and the failure to otherwise properly protect food during transportation. This rule builds on current safe food transportation best practices and is focused on ensuring that persons engaged in the transportation of food that is at the greatest risk for contamination during transportation follow appropriate sanitary transportation practices. The rule is flexible to allow the transportation industry to continue to use industry best practices concerning cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment to ensure that food is transported under the conditions and controls necessary to prevent adulteration linked to food safety.
As required by the 2005 SFTA, this final rule addresses the sanitary transportation of food (human and animal food) by establishing criteria and definitions that apply in determining whether food is adulterated because it has been transported or offered for transport by a shipper, loader, carrier by motor vehicle or rail vehicle, or receiver engaged in the transportation of food under conditions that are not in compliance with the sanitary food transportation regulations. This rule defines transportation as “any movement of food in commerce by motor vehicle or rail vehicle” and establishes requirements for sanitary transportation practices applicable to shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in food transportation operations addressing:
• Vehicles and transportation equipment;
• Transportation operations;
• Training;
• Records; and
• Waivers.
This rule allows the transportation industry to continue to use best practices,
We made several revisions to this final rule, in response to comments that we received regarding the proposed rule, to affirm that the use of current sanitary food transportation best practices as described in these comments,
As discussed in detail in later sections of the rule, we made several major revisions to the provisions of this rule mainly in response to comments that focus the rule more narrowly on food safety and are consistent with existing safe transportation best practices. These major revisions include the following:
• We have simplified the definitions for parties covered by the rule to make them all activity based and added a definition for “loader” as a new party covered by the rule, based on comments indicating that this was a relevant segment of the transportation industry that we had not previously identified.
• We have amended the definition of “transportation operations” such that additional transportation activities are not covered by the rule, including transport of food completely enclosed by a container, except food that requires temperature control for safety (broadens proposed exclusion for transport of shelf stable food completely enclosed by a container), food contact substances, and human food byproducts transported for use as animal food without further processing.
• We changed the provisions of the rule to focus on food safety concerns and not additionally adulteration as a result of spoilage or quality defects. Therefore, we have replaced language indicating that the goal of the rule is prevention of both food safety and non-safety concerns with language indicating that the goal is prevention of food becoming “unsafe,
• We have removed prescriptive requirements for temperature monitoring devices and continuous monitoring of temperature during transport and replaced these provisions with a more flexible approach which allows the shipper and carrier to agree to a temperature monitoring mechanism for shipments of food that require temperature control for safety. We have also removed the provision requiring the carrier to demonstrate temperature control to the receiver for every shipment requiring temperature control. In this final rule, the demonstration must only be made if the shipper or receiver requests it, which is consistent with industry best practices and would likely only be done in situations in which it is suspected that there has been a material failure of temperature control.
• We have revised this rule to require that if a person subject to this rule becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the person must take appropriate action, to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual, that the temperature deviation or other condition did not render the food unsafe.
• We have revised the requirements of this final rule to make it clear that its requirements account for the fact that the intended use of the vehicle or equipment with respect to the type of food that is being transported,
• Finally, we have revised the rule to primarily place the responsibility for determinations about appropriate transportation operations (
This final rule implements requirements addressing the sanitary transportation of human and animal food. It establishes requirements for sanitary transportation practices applicable to shippers, carriers by motor vehicle and rail vehicle, loaders, and receivers. Specifically, these finalized requirements address design and maintenance of vehicles and transportation equipment; sanitary practices during transportation operations that apply to shippers, receivers, loaders, and carriers; training of carrier employees; and records related to, for example, training, and written procedures. As shown in table 1, the total annualized costs are estimated to be approximately $113 million per year, estimated with a 3 percent discount rate, and $117 million per year, estimated at 7 percent when discounted over 10 years. We do not have sufficient data to fully quantify the benefits of this regulation.
FSMA (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, is intended to allow FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables us to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law contains important new tools to better ensure the safety of imported foods and encourages
We also issued a supplemental notice of proposed rulemaking for the rules listed in table 3 and requested comments on specific issues identified in each supplemental notice of proposed rulemaking.
We finalized five of the foundational rulemakings listed in table 4 in September and November 2015.
As FDA finalizes these seven foundational rulemakings, we are putting in place a modern, risk-based framework for food safety, based on the most recent science, that focuses efforts where the hazards are reasonably likely to occur, and that is flexible and practical given our current knowledge of food safety practices. To achieve this, FDA has engaged in a significant amount of outreach to the stakeholder community to find the right balance between flexibility and accountability in these regulations.
After FSMA was enacted in 2011, we have been involved in approximately 600 stakeholder engagements on FSMA and the proposed rules, including public meetings, Webinars, listening sessions, farm tours, and extensive presentations and meetings with various
Due to illness outbreaks involving human food and animal food that became contaminated during transportation (Refs. 4 and 5), and incidents and reports of insanitary transportation practices (Refs. 6 to 11), there have been concerns over the past few decades about the need to ensure that food is transported in the United States in a sanitary manner (Ref. 12). Press accounts in the late 1980s of trucks carrying food from the Midwest to both the East and West Coasts and returning with garbage for Midwest landfills caused concern that food products could become contaminated and unfit for human consumption if irresponsible vehicle operators failed to properly clean vehicles that had been previously used to haul waste or other nonfood materials (Refs. 13 to 15). Congress responded to these concerns by passing the Sanitary Food Transportation Act of 1990 (1990 SFTA) (Pub. L. 101-500), which directed the Department of Transportation (DOT) to establish regulations to prevent food or food additives transported in certain types of bulk vehicles from being contaminated by nonfood products that were simultaneously or previously transported in those vehicles. Following the passage of the 1990 SFTA it became clear that potential sources of food contamination during transport were not just limited to nonfood products. Most notably, a 1994 outbreak of salmonellosis occurred in which ice cream mix became contaminated during transport in tanker trucks that had previously hauled raw liquid eggs. That outbreak affected an estimated 224,000 persons nationwide (Ref. 4). In 2005, Congress reallocated authority for food transportation safety to FDA, DOT, and USDA by passing the 2005 SFTA, a broader food transportation safety law than the 1990 SFTA. The focus of the 2005 SFTA was not limited only to preventing food contamination from nonfood sources during transportation.
The 2005 SFTA directed us to establish regulations prescribing sanitary transportation practices to be followed by shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food. Section 111(a) of FSMA also directed FDA to issue these sanitary transportation regulations. In April of 2010, we issued guidance to provide the industry with broadly applicable recommendations for controls to prevent food safety problems during transport while we worked toward implementing the 2005 SFTA (Ref. 16). We also published a
We subsequently published a proposed rule in the
In brief, we proposed to address the sanitary transportation of food for humans and animals by establishing definitions and criteria that would apply to determine whether food is adulterated because it has been transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, or receiver under conditions that are not in compliance with the sanitary food transportation regulations. We proposed to define transportation as any movement of food in commerce by motor vehicle or rail vehicle. We proposed to establish requirements for sanitary transportation practices applicable to shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in food transportation operations. Specifically, we proposed to establish requirements for:
• Vehicles and transportation equipment;
• Transportation operations;
• Training;
• Records; and
• Waivers.
The proposed rule would allow the transportation industry to continue to use best practices concerning cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment that it has developed to ensure that food is transported under the conditions and controls necessary to prevent contamination and other safety hazards.
We received about 240 submissions in response to the proposed rule. We received comments from individuals, industry and trade associations, consumer and advocacy groups, academia, law firms, professional organizations, Federal and State, tribal and foreign government agencies and other organizations. In this document, we describe these comments, respond to them, and explain any revisions we made to the proposed rule in response to those comments. In addition, we held three public meetings to discuss the proposed rule. The meetings took place on February 27, 2014, in Chicago, IL; March 13, 2014, in Anaheim, CA; and March 20, 2014, in Washington, DC.
Some comments address issues that are outside the scope of this rule. For example, a comment suggests that we undertake a comprehensive examination of transportation that occurs by ship or barge within, into, or out of the United States to provide Congress with sufficient information to reevaluate our safe food transportation statutory authority (see responses to Comment 9 and Comment 30). Another comment states that this rule should identify the parties who are responsible for paying attorney's fees in cases where claims are made for damage that occurs during truck or rail transport of food. We do not discuss these types of comments in this document.
We are issuing this rule under authority of the 2005 SFTA and as directed by section 111(a) of FSMA.
The 2005 SFTA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in part, by creating a new section, 416 of the FD&C Act (21 U.S.C. 350e). Section 416(b) of the FD&C Act directs us to issue regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons
In addition, the 2005 SFTA created new section 402(i) in the FD&C Act (21 U.S.C. 342(i)) which provides that food that is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with the regulations issued under section 416 is adulterated. Also, new section 301(hh) in the FD&C Act (21 U.S.C. 331(hh)) prohibits the failure by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food to comply with the regulations issued under section 416. The 2005 SFTA also amended section 703 of the FD&C Act (21 U.S.C. 373) by adding section 703(b), which provides that a shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to section 416 shall, on request of an officer or employee designated by FDA, permit the officer or employee, at reasonable times, to have access to and to copy all records that are required to be kept under the regulations issued under section 416.
FDA's authority for this rule is also derived from sections 402(a)(1), (2), and (4) and 701(a) of the FD&C Act (21 U.S.C. 371(a)). Section 402(a)(1) of the FD&C Act provides, in part, that a food is adulterated if it bears or contains any added poisonous or deleterious substance, which may render it injurious to health. Section 402(a)(2) of the FD&C Act provides that a food is adulterated if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity (RAC) or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of 21 U.S.C. 346; if it bears or contains a pesticide chemical residue that is unsafe within the meaning of 21 U.S.C 346a(a); or if it is or if it bears or contains (1) any food additive that is unsafe within the meaning of 21 U.S.C. 348; or (2) a new animal drug (or conversion product thereof) that is unsafe within the meaning of 21 U.S.C. 360b. Section 402(a)(4) of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. This rule includes requirements that are necessary to prevent food from becoming unsafe,
(Comment 1) We stated in the proposed rule that the goal of this rulemaking is to ensure that transportation practices do not create food safety risks and that this rule builds on current food transport industry best practices. The rule is focused on ensuring that persons engaged in the transportation of food that is at the greatest risk for contamination during transportation follow appropriate sanitary transportation practices. This rule allows the food transportation industry to continue to use best practices concerning the cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment that it has developed to ensure that food is transported under the conditions and controls necessary to prevent contamination and other safety hazards.
Several comments support our intent to provide shippers, loaders, carriers and receivers with the flexibility to continue to utilize appropriate sanitary transportation industry best practices. A comment states that this approach allows companies to tailor their practices, as appropriate and necessary, based on the nature of the food and the transportation conveyance used, and to adopt new practices when there are advances in technology. Other comments agree with many aspects of the proposed rule, but conclude that some aspects need further refinement to reflect current industry best practices.
On the other hand, one comment states that this rulemaking is not necessary and that the food transportation industry, instead, should be given the flexibility to meet the standards placed upon it by the shippers without undue interference, or rules and regulations, that hinder the safe and efficient movement of human and animal food. One comment states that there are no systemic food safety issues related to the sanitary transport of food and that, therefore, this rulemaking is unnecessary.
(Response 1) As stated in the proposed rule, the SFTA requires FDA to issue regulations requiring shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. We have met this mandate, in part, by incorporating current best practices into this rule to the extent that we believe they are effective in achieving the goal of this rule. We disagree with the comments that stated this rule is unnecessary because Congress found that there was an adequate need to mandate that FDA issue these regulations in the 2005 SFTA and FSMA.
(Comment 2) Several comments express concern that the proposed rule applies the same requirements to human food and animal food. Many of these comments state that we should issue a separate rule for the sanitary transportation of animal food that is appropriately risk-based and specific to the types of ingredients and manufacturing processes used for animal food. Other comments state that we should distinguish between sanitary transportation requirements for animal food and human food in this rule to allow it to be reasonable and practical for the animal food industry.
(Response 2) We agree that this rule should more clearly recognize that sanitary transportation practices may differ for different types of food being transported to avoid confusion in its
(Comment 3) One comment states that there are two distinct animal food industries, the pet food industry, which employs standards and practices equivalent or close to those used for human food, and the animal feed industry, for which product is not normally handled with the same equipment used for human food transportation operations. This comment encourages us to recognize the significant difference between the purpose and function of these two “markets” for animal food, so that livestock feed transportation is not held to the same standards as pet food transportation. A related comment encourages us not to establish a pet food standard for all animal food and stated that the final rule should not require significant conversion of equipment used in animal feed sourcing and transport operations to pet food standards which necessitate the use of stainless steel equipment.
(Response 3) We agree that sanitary transportation practices for pet food differ from those for animal feed. The revisions we have made to this rule in § 1.906 and § 1.908, as explained in our response to Comment 2, will allow practices employed for the transport of pet food and animal feed to be appropriately tailored to the unique needs of those operations. This rule, therefore, will not necessitate the conversion of equipment used in animal feed operations to meet standards for pet food.
(Comment 4) Some comments suggest that produce safety could be improved by establishing general requirements under the FSMA produce safety rule for the transportation of produce after it leaves the farm, if the farm assumes the role of either the shipper or the carrier. These comments suggest that these FSMA produce safety requirements should be similar to the practices outlined in the proposed rule for the transport of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control. These comments also state that, by covering produce under a transportation provision in the FSMA produce safety rule, enforcement for sanitary transportation practices would be performed by Agencies already tasked with implementing the produce safety rule. One comment states that regulating the transportation of produce in this manner would provide a single source for compliance requirements and would likely reduce the possibility that any requirements might be overlooked.
(Response 4) The produce safety rule establishes science-based minimum standards for the safe production and harvesting of fruits and vegetables to minimize the risk of serious adverse health consequences or death, focusing on the most important routes of on-farm contamination of produce with biological hazards. By contrast this rule requires persons engaged in the transportation of all foods, including fresh fruits and vegetables, to use sanitary transportation practices in their operations to ensure that food is transported under conditions that prevent it from becoming unsafe. The sanitary transportation practices required by this rule are not limited to those that address potential contamination of food with biological hazards, they also apply to other forms of contamination,
(Comment 5) One comment expresses concern that this rule's requirements would apply uniformly across the entire U.S. food transportation sector, despite the fact that current railroad industry best practices have resulted in very few reported cases of foodborne illnesses directly attributable to rail carriers. Another comment asserts that we should defer issuing this rule as it applies to railroads. It states that, in view of the absence of reported incidents of insanitary food rail transportation and the existing rail industry practices to prevent such incidents, applying the rule to the rail industry is not necessary at this time.
(Response 5) The 2005 SFTA directs us to issue regulations that require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. We are issuing this rule as directed by Congress. It is unlikely carriers who have successfully employed best practices for food transportation, whether they be motor or rail carriers, will need to alter their transportation practices significantly to comply with this rule, although we acknowledge that there are new costs associated with training and recordkeeping.
(Comment 6) One comment identifies smaller box trucks making local deliveries as a particular sanitary food transport problem. The comment states that most of the instances where food transportation problems were found in the 2007 Interstate Food Transportation Assessment Project study (Ref. 6) involved smaller box trucks as discussed in the proposed rule (79 FR 7006 at 7008). The comment suggests that FDA develop an enforcement plan focused on smaller box trucks engaged in local food delivery operations.
(Response 6) As we implement this rule, we will work with our partners,
(Comment 7) One comment states that the provisions of this rule are not specific and so broad based that they should be viewed only as non-binding recommendations. It further asserts that the only way we can protect the food supply is by implementing enforceable laws like the Sanitary Food Transportation Act of 1990 and that DOT already has a system in place in which vehicles are inspected wherein they could use an F (signifying food vehicle) on the inspection sticker of the trucks and trailers that transport food.
(Response 7) We reject this interpretation of this rule. The provisions of this rule are not guidance nor are they recommendations. Many of the requirements established in this rule address broadly applicable procedures and practices intended to provide flexibility for shippers, loaders, carriers, and receivers to comply with the requirements in a way that is most suitable for their practices, as many are already implementing the industry best practices on which the rule is based. Furthermore, Congress enacted the 2005
(Comment 8) Several of the comments express a preference for the farm definition in the proposed transportation rule over the definitions in other FSMA proposed rules because it does not limit the facility's activities to the packing and holding of a farm's own food. These comments recommend that we apply the sanitary transportation rule's farm definition throughout all of the FSMA rules. Conversely, another comment suggests that we use different definitions for entities such as “farms” in the various FSMA rules, allowing us to take a customized approach to each specific rule.
(Response 8) We agree that using a definition of the term “farm” in this rule that, to the extent practicable, is aligned with this term as defined in other FDA regulations, including the regulations we have established under FSMA, would be functionally efficient for us and for stakeholders. We explained in the proposed rule that we tentatively defined the term “farm” differently than it was defined in 21 CFR 1.227(b)(3), which is used to establish which facilities are required to register under section 415 of the FD&C Act (21 U.S.C. 350d), because 21 CFR 1.227(b)(3) applies only to facilities that pack or hold food if the food used in such activities is grown, raised, or consumed on that farm or a farm under the same ownership. We had tentatively concluded that the sanitary transportation practices that would be required by our proposed rule would not be necessary to prevent RACs from becoming adulterated during transportation by farms, regardless of whether the farms are conducting transportation operations for RACs that were grown, raised, or consumed on the same farm or on another farm under different ownership. We therefore tentatively concluded to use a different definition of the term “farm” for purposes of this rulemaking.
In the FSMA preventive controls for human food final rule (80 FR 55908 at 55925), we revised our definition of the term “farm” in 21 CFR 1.227 to clarify the types of activities that are included as part of the definition of the term “facility” and to clarify the scope of the exemption from the registration requirement for “farms” established in section 415 of the FD&C Act. This revised definition no longer requires that farms that pack or hold food only carry out these activities for food that was grown, raised, or consumed on that farm or a farm under the same management. This revised definition now governs the applicability of the provision in this final rule that excludes transportation operations performed by farms from coverage under this rule. We, therefore, have aligned this rule with the revised definition of the term “farm” in 21 CFR 1.227 by revising 21 CFR 1.904 to state that this term has the new meaning contained in 21 CFR 1.227. This action also aligns the definition in this rule with this term as defined in other FSMA rules,
(Comment 9) One comment urges us to create a party with the same responsibilities as the “importer” in the FSMA Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) rule who would be responsible for verifying that the practices of foreign suppliers are in compliance with our regulations. The comment states that this person would be responsible for verifying the safe transportation of imported products before and after the products arrive in the United States. The comment explains that in the preamble to the FSVP proposed rule, we stated that the person responsible for verifying the safety of the foreign supplier “has a direct financial interest in the food and is most likely to have knowledge and control over the product's supply chain.” The comment asserts that for imported food, the safety of the food transport is inextricably linked with the safety of the supply chain, starting with the foreign supplier. The comment further states that the person with a direct financial interest in the food product is the party most likely to have the knowledge and control necessary to ensure not just the safety of the foreign supplier, but also the safety of the transportation after the food arrives in the United States. The comment argues that there should be consistency between these two rules for imported products.
(Response 9) The 2005 SFTA direct us to issue regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food in the United States to use prescribed sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. It does not direct us to establish requirements for the transport of food destined for the United States before it reaches the United States. Shipments of food destined for consumption in the United States remain subject to the provisions of the FD&C Act, including the adulteration provisions.
(Comment 10) One comment states that the treatment of small businesses in the FSMA rules is not consistent. The comment states that modified requirements, compliance dates, and exemptions have been based on annual sales throughout the FSMA proposed rules, but the annual sales metrics have not been consistent,
(Response 10) The only provisions of this final rule that are related to the business size or business volume are the number of employees threshold for businesses, other than carriers by motor vehicle, in the definition of a “small business,” the annual receipts threshold for carriers by motor vehicle in the definition of a “small business,” and the annual revenue threshold in the definition of a “non-covered business.”
With respect to the number of employees threshold for businesses that are not carriers by motor vehicle, as explained in the proposed rule (79 FR 7006 at 7014) and the discussion of this definition in section IV.C. of this final rule, this provision is based upon the size based standard (expressed in terms of numbers of employees) that has been established by the U.S. Small Business Administration under 13 CFR 121.201 for most food manufacturers. This provision of the “small business” definition incorporates the same size based standard as we included in the preventive controls final rules for human and animal food.
With respect to the annual receipts threshold for small businesses that are motor carriers, as explained in the proposed rule (79 FR 7006 at 7014) and the discussion of this definition in section IV.C. of this final rule, this provision is based upon the size based standard of the U.S. Small Business Administration for truck transportation firms in 13 CFR 121.201. This provision of the “small business” definition is unique to this rule and has no relation to other FSMA rules, because only this rule establishes requirements for carriers.
With respect to the annual revenue threshold in the definition of a “non-covered business,” as we state in our response to Comment 62, we proposed
(Comment 11) One comment states that we did not address the issue of routine security measures, such as the use of truck seals, in the proposed transportation rule and other proposed FSMA rules. The comment states that these measures provide a benefit in transportation similar to that of underlying prerequisite programs in the context of a food manufacturer's hazard analysis and critical control point (HACCP) system. The comment further states that these measures need to be addressed by the FSMA rules to ensure that potential contamination risks (that do not rise to the level of the massive, catastrophic threats that are the subject of the proposed FSMA intentional adulteration rule) are addressed.
(Response 11) This suggestion is outside the scope of this rulemaking. We agree that persons engaged in food transportation should consider the use of routine security measures. We have issued guidance on this subject: “FDA Guidance on Food Security Preventive Measures for Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations, and Fluid Milk Processors;” and “FDA Guidance on Food Security Preventive Measures for Food Producers, Processors, and Transporters” (Refs. 17 and 18). However, the purpose of this rule is to establish sanitary transportation practices to be used by shippers, carriers by motor vehicle and rail vehicle, receivers, and other persons engaged in food transportation to ensure that food is not rendered adulterated during transportation, which is distinct from the issue of the security of food transportation. FDA will be addressing food defense concerns in its upcoming final rulemaking on Intentional Adulteration; however, to the extent that certain food defense issues are not covered in the FSMA rulemakings, and it becomes apparent as we implement the rules that there are food defense concerns that would benefit from additional regulation, we will consider initiating such rulemakings in the future.
(Comment 12) Several comments note that FDA lacks jurisdiction over meat, poultry, and egg products within meat, poultry, and egg product establishments that are subject to USDA regulation and inspection by USDA's Food Safety and Inspection Service (FSIS) under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601
In addition to the FDA-USDA jurisdictional issue, some comments state that a new layer of FDA sanitary food transportation regulation is unnecessarily duplicative with respect to the meat and poultry industries because meat and poultry establishments are already subject to FSIS regulations that address the transportation of meat and poultry products (see, 9 CFR part 325 and 9 CFR part 381, subpart S), as well as by guidance issued by USDA. These comments also state that FSIS's existing meat and poultry safety regulations and oversight activities are adequate and sufficiently robust, and are based on established industry best practices. Another comment suggests that we should dispense with any unnecessarily duplicative sanitary food transportation regulation of meat, poultry, and egg products by issuing a waiver, as provided for under this rule, or by establishing a Memorandum of Understanding (MOU) with FSIS that provides for FSIS to regulate transportation of these products from FSIS-regulated facilities.
(Response 12) We agree that FDA lacks jurisdiction for meat, poultry, and egg product activities that occur within meat, poultry, and egg product processing facilities regulated exclusively by USDA. We have consulted with USDA and modified § 1.900(b) in this rule by adding a third category of persons exempt from the requirements of this subpart. In this final rule, § 1.900(b)(3) excludes shippers, loaders, receivers, or carriers when they are engaged in transportation operations of food while the food is located in food facilities as defined in § 1.227, that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the FMIA, the PPIA, or the EPIA. However, there are dual jurisdiction establishments that prepare, pack, hold, or otherwise handle both foods regulated by USDA and foods regulated by FDA. In the case of dual jurisdiction establishments, FDA would inspect in accordance with its existing MOU with USDA (Ref. 19).
In addition, we did not tentatively conclude in the proposed rule that USDA guidance on the safe transportation and distribution of meat, poultry, and egg products is not adequate to ensure their safety. Rather, we stated that FSIS does not have requirements that directly address transportation operations for these foods once they leave FSIS-inspected facilities. However, FSIS has regulations that require that FSIS-regulated establishments to address sanitation during transportation,
(Comment 13) One comment opposes applying the sanitary food transportation rule to shell eggs on the grounds that the transportation of shell eggs is already regulated by FDA under 21 CFR part 118, and that the transportation of egg products is already regulated by USDA under requirements established under the EPIA. The comment further states that most shell egg producers also are subject to additional transportation safeguards either because of customers' proprietary specifications or customers' requests that the egg producers participate in voluntary quality-assurance programs, such as the Safe Quality Food (SQF-2000) standards or the United Egg Producer's 5-Star Egg Safety Program.
(Response 13) We disagree with this comment. The transportation requirements in 21 CFR part 118 address only the ambient temperature of vehicles used to transport shell eggs and do not include requirements for the design, condition, and sanitation of the vehicles or specific procedures to
With regard to customers' specifications and quality assurance programs, many types of foods are subject to customers' transportation specifications and quality assurance programs. However, we cannot rely on them, exclusively and under all circumstances, to keep food safe during transportation because they vary in effectiveness and are not uniformly administered. This rule establishes uniform, nationwide requirements for the sanitary transportation of food, including shell eggs. To the extent that transportation practices are covered under egg quality assurance programs, these egg producers should find it easier to comply with our requirements.
(Comment 14) A few comments ask us to amend this rule to clarify that under section 116(a) of the FSMA, a facility engaged in the manufacturing, processing, packing, or holding of beverage alcohol products is exempt from this rulemaking. The comments also suggest that we should exempt the transport of all bulk or packaged beverage alcohol products from this rule, including the transport of ingredients and the co-products or by-products of beverage alcohol manufacture. The comments state that the language of section 116 of FSMA specifies which sections of the statute apply to a facility engaged in the manufacturing, processing, packing, or holding of one or more beverage alcohol products, and note that unless a rule falls under sections 102, 206, 207, 302, 304, 402, 403 or 404 of FSMA, Congress does not intend for it to apply to a facility engaged in manufacturing, processing, packing, or holding beverage alcohol products. The comments further assert that because section 111(a) of the FSMA, which directs us to issue this rule, is not one of the listed sections, a facility that is exempt under section 116 should also be exempt from the sanitary food transportation rule. Some of the comments also state that we should exempt the transport of alcoholic beverage products, as well as any oversight of their production facilities, from this rule to avoid duplicative regulatory schemes implemented by both FDA and the U.S. Tax and Trade Bureau (TTB).
(Response 14) There is nothing in FSMA that indicates that transportation operations for beverage alcohol should be exempt from the requirements of this rule. Section 111(a) of the FSMA only creates a deadline for the implementation of the 2005 SFTA final rule, and nothing in the FSMA otherwise addresses the 2005 SFTA. Therefore, it seems that, based on a plain reading of the statute, transportation operations for beverage alcohol can be covered by this rule. In addition, we are not aware of TTB regulatory requirements that would duplicate the requirements of this rule. However, this final rule, as provided under the revised definition of “transportation operations” in § 1.904, does not apply to the transportation of food fully enclosed by a container that does not require temperature control to prevent it from becoming unsafe. This provision essentially excludes packaged beverage alcohol products from coverage under this rule.
(Comment 15) One comment asks that we consider issues regarding the rejection of produce shipments under this rule that are also subject to the Perishable Agricultural Commodities Act (PACA). The comment states that under the PACA, sellers and buyers must legally ship and accept the quantity and quality of produce specified in their contracts, and receivers must accept produce that is damaged and decayed, up to a certain percentage, depending on the product's grade standards. The comment contemplates a situation where a receiver would be required to accept shipments under the PACA, but, according to the comment, might be required to reject them under this rule for deviation from quality standards set by the shipper.
(Response 15) This rule does not require a receiver to reject a shipment that is transported under conditions that deviate from those specified by the shipper to the carrier and loader in accordance with § 1.908(b)(1). As explained in our response to Comment 129, the rule establishes requirements for shippers, loaders, carriers, and receivers in § 1.908(a)(6) that precludes the sale or distribution of any food subject to this rule where there is an indication of a material failure of temperature control or other conditions during transportation that may render the food unsafe, unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe. Contrary to the comment's assertions, this rule does not address the disposition of any produce delivered to a receiver that might deviate from quality standards set by a shipper.
(Comment 16) Several comments asserted that, to reflect common industry practice, we should explicitly recognize that companies that bear legal responsibility for compliance with this rule may contractually assign specific tasks,
(Response 16) We acknowledge that industry practice is to alter, by contract, the tasks assigned to shippers, loaders, carriers, and receivers in this rule. Therefore, we also explicitly recognize that companies that bear legal responsibility for compliance with this rule may contractually assign specific tasks,
The duty to comply with the provisions in this rule can be reassigned via contract among parties covered by this rule (
(Comment 17) One comment states that the application of this rule to both intrastate and interstate shipments would create consistent expectations among parties engaged in food transportation. Furthermore, the comment suggests that we consider addressing in this rule a common practice among the parties engaged in food transportation whereby they engage in a separate contract for the transportation of food, as authorized by 49 U.S.C. 14101(b). The comment states that because there is currently no standard transportation contract, parties are free to agree to any and all terms that they choose, and the various State laws apply to those terms. Further, the comment asked whether parties can shift responsibilities, agree to terms more or less onerous, and change the meaning of this rule by contract. The comment states that we should clarify whether the rule cannot be modified by contract or specify what parts can be modified. The comment also states that leaving these questions unsettled in the final rule might result in numerous State contract claims related to this rule.
(Response 17) We agree that the application of this rule to both intrastate and interstate shipments would create consistent expectations among parties engaged in food transportation.
Further, we acknowledge that under the provisions of 49 U.S.C. 14101(b), carriers by motor vehicle may “expressly waive any and all rights and remedies under [that] part for transportation covered [by a contract between that carrier and a shipper].” However, the purpose of this rule is not to address the ability of parties to contract under that provision. The purpose of this rule is to ensure that shippers, loaders, carriers, and receivers use practices that ensure the sanitary transportation of human and animal food. Therefore, as discussed in the previous comment, the roles being played by the particular parties involved in the transportation of food can be shifted among the parties within the contractual relationship However, entities covered by this rule cannot, via contract or otherwise, either change the meaning of the rule or establish sanitary transportation requirements that are less onerous than those contained in this rule.
(Comment 18) One comment states that intrastate activities should be exempt from the requirements of this rule. It asserts that the paperwork burden required by this rule would be onerous for local bulk animal feed facilities and that complying with this rule would make it difficult for these types of facilities to remain in business. The comment further states that the intrastate transportation of commercial animal feed historically has presented little to no risk to humans and animals.
(Response 18) We disagree that intrastate transportation activities should be exempt from this rule. As we noted in the proposed rule, section 416(b) of the FD&C Act directs us to create regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated. The scope of section 416(b) is not limited to interstate commerce. We are sensitive to the concerns voiced by this comment about the burden this rule might impose upon small facilities. As we discuss in sections IV.E.2 and 5, we have revised the requirements regarding the exchange of information between shippers and carriers (§ 1.908(b) and (e)), which in many cases will reduce or eliminate paperwork burdens imposed on parties subject to this rule, including facilities engaged exclusively in the intrastate shipment of bulk animal feed. In addition, feed facilities engaged in intrastate transportation operations are not subject to this rule if they are a “non-covered business” as defined in this rule. This final rule establishes appropriate requirements for such facilities and will not impose undue cost or paperwork burdens. Since the rule has its basis in industry best practices, many persons should be in substantial compliance with its provisions and should not find compliance burdensome. Accordingly, this comment does not persuade us that it would be appropriate or in keeping with the purpose of this statute to exclude intrastate activities from the scope of this rule.
(Comment 19) We received many comments regarding the enforcement of this rule. The comments cover a broad range of topics, such as: The need for clarification of the roles of various Agencies including DOT and State and local regulatory authorities in enforcing the rule; FDA's need to establish enforcement partnerships with other Agencies; how variations in the applicability of this rule (
(Response 19) The Secretary of Transportation, in consultation with the Secretary of Health and Human Services and the Secretary of Agriculture, is required by section 5701(a)(1) of the 2005 SFTA to establish procedures for transportation safety inspections to identify suspected incidents of contamination or adulteration of: Food in violation of regulations issued under section 416 of the FD&C Act; carcasses, parts of carcasses, meat, meat food products, or animals subject to detention under section 402 of the FMIA (21 U.S.C. 672) and the DOT's food transportation safety inspection requirements that appear at 49 U.S.C. 5701; and poultry products and poultry subject to detention under section 19 of the PPIA (21 U.S.C. 467a). The 2005 SFTA further states in section 5701(b) that the Secretary of Transportation shall promptly notify the Secretary of Health and Human Services or the Secretary of Agriculture, as applicable, of any instances of potential food contamination or adulteration of a food identified during DOT transportation safety inspections. We note that DOT and USDA have jointly produced a training video, entitled “Considerations for the Safe Transportation of Food Video,” that is available via the Department of Homeland Security at the University of Tennessee Knoxville's Web site:
We intend to allocate our resources for the enforcement of this rule by following up on information that DOT provides us or by initiating inspections and investigations. These comments raise issues that we will consider when developing enforcement strategies. The details of our prospective enforcement strategies, however, are beyond the scope of this rulemaking; however we believe that the impact of our enforcement activities upon international trade will be minimal since this rule allows the transportation industry to continue to use existing practices that have proven to be effective for the safe transportation of food. We know that we will need to address staffing and training needs, and we will seek to establish partnerships with other Federal Agencies and with State, local, and tribal governments to implement this rule. We also will communicate with the public, including with regulated industry, as appropriate, throughout the process of developing and implementing our enforcement efforts for this rule.
We received several comments asking us to include provisions in this final rule for food transportation operations that are conducted under the ownership or operational control of a single corporate/legal entity,
(Comment 20) Several comments state that intra-corporate transportation operations should be completely and expressly exempt from this final rule. Some of these comments suggest that we should define the term intra-corporate/intra-company in § 1.904 of the final rule and exempt these types of activities from the definition of “transportation operations” as that term is defined in § 1.904. Some of the comments ask us to exempt intra-corporate transportation operations by issuing a waiver as provided for under §§ 1.914 and 1.916 of this final rule. Most of these comments assert that intra-corporate shipments typically are conducted in accordance with integrated, intra-corporate Standard Operating Procedures (SOPs) and good sanitary food transportation practices and therefore should be exempt from the final rule. Some of the comments argue that food transportation operations that are predominantly, but not entirely intra-corporate, for example, in which a shipper and a receiver share a common corporate ownership, but in which the loader or carrier might be an independent, third-party entity operating under a contract with the shipper, also should be entirely and expressly exempt from this final rule.
Some of these comments assert that we should exempt intra-corporate food shipments from this rule because we contemplated exempting similarly situated entities under our FSMA FSVP proposed rule (78 FR 45730 at 45743). Two comments argue that exempting all intra-corporate food transportation operations from this rule is warranted because intra-corporate transfers would be addressed under the FSMA preventive controls rules for human and animal food. These comments assert that subjecting intra-corporate shipments to additional regulation and recordkeeping requirements under this sanitary food transportation rule therefore would be unnecessary and redundant.
One of the comments observes that the SFTA of 2005 and § 1.904 of the proposed rule define the term “transportation” to mean “any movement in commerce by motor vehicle or rail vehicle.” The comment asserts that intra-corporate food shipments therefore should be exempt from this rule because, for example, food shipped between facilities owned, leased, or operated by the same corporate entity “does not enter the stream of commerce.”
(Response 20) We decline to establish a blanket exemption from all of this rule's requirements for food transportation operations that are conducted between shippers, loaders, carriers, and/or receivers that are part of the same corporate/legal entity either by revising the definition of “transportation operations” in the final rule, by issuing a waiver for intra-corporate shipments, or by any other mechanism. We conclude that the fact that shippers, loaders, carriers, and/or receivers may be operating within a unified corporate/legal entity or sanitary food transportation system does not necessarily ensure that all of the involved parties are operating in compliance with the portions of section 402 of the FD&C Act that are relevant to this rulemaking. While we acknowledge that parties involved in intra-corporate food transportation operations can lessen their recordkeeping burden by adopting a unified, company-wide approach to sanitary food transportation operations,
In the FSVP final rule, we declined to establish “an exemption from the FSVP requirements for food that an importer obtains from a foreign supplier that is part of the same corporate structure as the importer,” and we further declined “to establish an exemption from the FSVP requirements where the foreign supplier and importer may otherwise be affiliated, and where the foreign supplier and importer are part of the same company-wide `approach' to food safety” (80 FR 74225 at 74255-56).
We also decline to exempt intra-corporate food transportation operations from this rule on the grounds that such activities will be covered by the requirements of the preventive controls rules for human and animal food. The primary purpose of the preventive controls rules is to establish modern science- and risk-based preventive controls requirements for the manufacturing, processing, packing, or holding of human and animal food. Although facilities under the preventive controls rules may identify refrigeration during transport as a preventive control, for example, the preventive controls rule, unlike this final rule, does not directly regulate carriers. We also note that SFTA was signed into law in 2005 and FSMA was signed into law in 2011. If Congress had intended for FSMA's preventive controls rules to supplant the sanitary food transportation statutory requirements set forth in SFTA under any circumstances, including but not limited to intra-corporate food shipments, Congress presumably would have stated so explicitly in FSMA's statutory language.
Finally, we also decline to completely exempt intra-corporate food transportation operations from this final rule on the commenter's theory that food shipments between shippers, loaders, carriers, and/or receivers that share a common corporate ownership do not fall within the rule's definition of “transportation” because such food shipments do not enter the stream of commerce. Although not explicitly stated in the comment that asserts this theory, the comment appears to suggest that the shipment of food between entities that operate under a common corporate ownership or control does not enter into the stream of “commerce” presumably because the food is not being offered for sale between the parties involved in the transportation operations. We conclude that this interpretation of the 2005 SFTA's statutory definition and the parallel definition of “transportation” in § 1.904 of this final rule is incorrect. The 2005 SFTA does not define the term “in commerce” and therefore does not explicitly limit the scope of the rule, for example, only to those transportation operations that involve the shipment of food that is offered for sale.
(Comment 21) We received several comments asking us to apply modified requirements regarding this rule's information sharing and recordkeeping provisions to shippers, loaders, carriers, and/or receivers engaged in intra-corporate food transportation operations. These comments state, for example, that to require a shipper under this rule that owns its own carrier fleet to provide to the carrier, in writing, all necessary sanitary requirements for the carrier's vehicles and transportation equipment would be redundant and serve no purpose because the information sharing required by this rule, under these circumstances, would presumably already be established by written intra-corporate food transportation SOPs.
Some of these comments assert that a precedent for exempting intra-corporate food shipments from the information sharing and recordkeeping provisions of this rule can be found in the recordkeeping final rule that we issued under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), at 21 CFR part 1, subpart J.
(Response 21) We agree with these comments and have revised the regulatory text accordingly. Section 1.908(a)(5) of this final rule stipulates that as an alternative to meeting this rule's applicable requirements, shippers, receivers, loaders, and carriers that are under the ownership or operational control of a single legal entity may conduct transportation operations in conformance with common, integrated, written procedures that ensure the sanitary transportation of food consistent with the rule. Section 1.908(a)(5) also states that these written procedures are subject to the records requirements of this rule in § 1.912, which are discussed in section IV.G of this document.
Finally, as we already mentioned earlier in this document, some of the comments invoked the Bioterrorism Act recordkeeping rule as a precedent for granting the revised information sharing and recordkeeping requirements of this rule for intra-corporate food transportation operations. As we explained in the preamble to the Bioterrorism Act recordkeeping rule, “intra-corporate” interactions, for purposes of the implementation of that rule, are limited to interactions between entities that are part of a “vertically integrated company,” for example, a food manufacturer that owns its own suppliers, carriers, distributors, and food retail outlets and, therefore, never releases the food to persons outside of its vertically controlled production path (69 FR 71562 at 71568-71569, December 9, 2004).
The definition of a vertically integrated company as used in the Bioterrorism Act recordkeeping rule is narrower in scope than the definition of “intra-corporate” in this rule. As we explain in our February 2012 guidance to industry entitled “Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)” (Ref. 20), two corporate entities that have the same controlling corporate parent are not always part of a vertically integrated company. They may be legally distinct persons, for example, and therefore would not be exempt from the Bioterrorism Act rule's recordkeeping requirements. Similarly, two corporate subsidiaries that are legally distinct persons, but that are managed operationally as a single entity, would not be exempt from the Bioterrorism Act recordkeeping rule. We conclude that the information exchange and recordkeeping provisions set forth in § 1.908(a)(5) of this final rule are appropriate because shippers, carriers, receivers, and loaders operating under the control of a single legal entity can effectively use common integrated written procedures that prescribe sanitary food transportation practices. Accordingly, the provisions set forth in § 1.908(a)(5) of this rule will not be strictly limited to vertically integrated companies, like the Bioterrorism Act's recordkeeping rule.
(Comment 22) One comment asks us to exempt from this final rule's information exchange and recordkeeping requirements food transportation operations that involve shipments of food from centralized charitable food distribution centers that act as shippers, and sometimes also carriers, to member food banks that are separate legal entities, but are closely affiliated with the shippers. The comment also asks us to exempt shipments between food banks. This comment asserts that these types of operations are similar to intra-corporate food transportation operations and, therefore, adherence to this rule's information exchange and recordkeeping requirements should not be required because internal written SOPs are sufficient for ensuring the sanitary transportation of food between these types of entities.
(Response 22) We decline to exempt food transportation operations that involve shipments from centralized charitable food distribution centers to food banks, as well, as food shipments between food banks, from this rule's information exchange and recordkeeping requirements. The commenter describes itself as being a national, domestic hunger relief charity that acts as a shipper to distribute food to and through a network of 200 member community food banks. The comment also states that the individual food banks that form the network “are separate legal entities,” but are “closely affiliated with the national organization.” We decline to exempt these types of transportation operations from this rule because we do not believe that they are comparable to intra-corporate food transportation operations in which shippers, loaders, carriers, and/or receivers operate under the ownership or operational control of a single corporate/legal entity. The commenter and its network of independent food banks are “affiliated” only in the sense that they cooperate closely to advance their shared mission of delivering food assistance to people in need.
However, we have made revisions in this final rule that may lessen the information sharing and corresponding records requirements for organizations such as the ones described by this comment. As we note in our response to Comment 124, we have revised the information sharing provisions in § 1.908(b)(1) to only require one-time notification to the carrier and when necessary, to the loader, by the shipper, unless the design requirements and cleaning procedures required for sanitary transport change because of the type of food being transported. In addition, as we note in our response to Comment 129 and Comment 134, we have revised § 1.908(b)(2) to recognize that the specification of pre-cooling and operating temperature parameters by the shipper to the carrier, and to the loader, may not be necessary for transportation operations conducted during winter in cold areas or for short distance transportation of food in appropriate circumstances.
We requested comments in the preamble to the proposed rule in response to our tentative decision not to identify and include, in this rulemaking, specific nonfood products that, under all circumstances, may adulterate food subsequently hauled in bulk or non-bulk vehicles. We also requested comment on our tentative conclusion that issuing guidance instead, regarding how some transportation practices may affect the potential for nonfood products to adulterate food products, and would be helpful to the transportation industry.
(Comment 23) Many comments support our decision not to issue lists of nonfood items that may adulterate food if transported simultaneously with food in a non-bulk vehicle, or prior to the transport of food in a bulk vehicle. Several comments agree with our tentative conclusion that issuing guidance regarding how specific transportation practices may affect the potential for nonfood products to adulterate food products would be helpful to the transportation industry. One comment states that the oilseed industry already uses lists of acceptable and unacceptable previous cargos to prevent the adulteration of edible oils during transport and encourages us to incorporate these lists as reference documents in this rulemaking or to establish corresponding guidance documents.
(Response 23) Based upon these comments, we affirm our decision not to include lists of nonfood items that may adulterate food if transported simultaneously with food in a non-bulk vehicle, or prior to the transport of food in a bulk vehicle, as part of this rulemaking. However, we will consider the utility of using such lists as references in any guidance we may issue on this subject in the future.
(Comment 24) Several comments express the need for guidance documents related to this rule. These comments state that guidance will be important for explaining our expectations (
(Response 24) We agree that guidance are important for helping stakeholders to understand the application of this rule to their operations. As we note elsewhere in this document, we may issue future guidance, as resources allow, regarding issues such as the granting of waivers, transportation activities performed by farms, and how transportation practices may affect the potential for the adulteration of food products by nonfood products during transportation operations. We will consider whether guidance on these or other matters would be useful to clarify measures that entities engaged in the transportation of food may take to comply with this rule. We would not include requirements in any guidance because under our good guidance practices regulation (21 CFR 10.115), guidance documents do not establish legally enforceable rights or responsibilities.
(Comment 25) A comment addressing the transportation of RACs by farms agrees with our tentative conclusion in the proposed rule that the sanitary transportation practices that would be required by this rule are not necessary to prevent RACs from becoming adulterated during transportation by farms. However, to minimize the potential for adulteration, this commenter recommends that we develop a guidance document on good transportation practices, as well as user-friendly education materials. The comment suggests that such guidance should stress the importance of cleanout procedures in non-dedicated farm transportation conveyances and equipment used to haul RACs and other products, and provide sample clean-out procedures for such conveyances. The comment also suggests that the guidance could encourage farms that transport RACs to inform receivers about the previous load hauled in the conveyance.
(Response 25) We discussed the exemption of transportation activities for RACs performed by farms from this rule in the proposed rule (79 FR 7006 at 7016) and noted that the diversity of farms and their transportation operations pose challenges in developing mandatory requirements via rulemaking that would be broadly suitable and meaningful for this sector of the food transportation industry. As we discuss in Comment 79, we have revised this final rule to provide that all transportation activities performed by a farm are not subject to this rule. However, we agree that issuing a guidance document on farm transportation operations may be useful in setting forth good transportation practices, given the diverse practices that occur within this sector. We, therefore, intend to consider establishing such guidance and will consider the role that we might be able to play in promoting educational and training activities to address this issue.
(Comment 26) Some comments expressed concern with the preemption provision of the 2005 SFTA and its potential impact on any State with existing transportation requirements. One comment stated that this rule should be flexible enough to permit State laws to stay in effect if the State law is stronger and its enforcement is superior to what is being achieved under this rule. Some of these comments asserted that the statutory exclusions in the coverage of the 2005 SFTA,
(Response 26) As we stated in the proposed rule (79 FR 7006 at 7032), the 2005 SFTA includes an express preemption provision at section 416(e) of the FD&C Act, which provides that a requirement of a State or political subdivision of a State that concerns the transportation of food is preempted if: (1) Complying with the requirement of the State or political subdivision and with a requirement of section 416, or with a regulation issued under section 416, is not possible; or (2) the requirement of the State or political subdivision as applied or enforced is an obstacle to accomplishing and carrying out section 416 or a regulation issued under section 416. Section 416(e) of the FD&C Act further provides that the express preemption provision applies to transportation that occurs on or after the effective date of regulations issued under section 416. This express preemption provision applies to the requirements of this final rule upon their becoming effective. Nonetheless, a State law, including unified State laws, should States wish to adopt such laws, concerning the sanitary transportation of food by motor vehicle or rail vehicle, is not preempted if such laws do not fall under either section 416(e)(1) or (2) of the FD&C Act. Furthermore, it is highly unlikely that any State law addressing transportation operations not subject to the 2005 SFTA,
(Comment 27) Some comments urge us to affirm that this rule does not preempt related State laws when they are “in addition to” Federal regulation and do not present an obstacle to advancing the purposes of SFTA. The comments further state that we should construe the preemption clause in the SFTA of 2005 narrowly and that we should work in tandem with State authorities by treating this regulation as a floor, and not a ceiling, for State public health measures such that States wishing to enact sanitary food transportation requirements that are more rigorous than those imposed by this rule will be permitted to do so. These comments state that there are two ways that a Federal authority can block State regulation—either by “conflict (or obstacle) preemption” or by “field preemption”—and the comment stated that the language in the SFTA is an example of the former. Conflict preemption only applies when a person or entity cannot satisfy both Federal and State law, and where State law is an obstacle to Federal goals.
(Response 27) Under section 416(e) of the FD&C Act, this rule does not preempt State laws or laws of a political subdivision regarding sanitary transportation of human and animal food unless complying with those laws and this law is impossible, or the requirement of the State or political subdivision as applied or enforced is an obstacle to carrying out this law. Section 416(e) of the FD&C Act further provides that the express preemption provision applies to transportation that occurs on or after the effective date of regulations issued under section 416.
We agree with the commenters that conflict preemption could apply to any State laws governing sanitary food transportation that would make it impossible to simultaneously comply with this rule. In addition, another aspect of conflict preemption could apply under a “frustration of purpose” or “obstacle” theory, whereby a State law requiring sanitary transportation practices would be preempted to the extent the State law frustrates the purpose of, or presents an obstacle to accomplishing the purpose of, this rule. Whether a State requirement is preempted by Federal law depends on specific factual situations. Therefore, although some State requirements may be preempted by Federal law, this law does not prevent States from developing sanitary transportation regulations at the State or local level.
(Comment 28) Some comments ask us to publish a revised proposed rule or an interim rule before proceeding to a final rule because of anticipated, significant changes resulting from comments that we received in response to the proposed rule, as well as potentially significant changes in the other, interrelated FSMA rules. One comment states that because the FSMA rules are dependent on one another, all proposed FSMA rules should be issued concurrently so that a concurrent evaluation and comment period may be conducted. Some comments state that re-proposal and a second opportunity for public comment also is warranted because implementation of the sanitary transportation rule will require the complex coordination of efforts among multiple Federal Agencies.
(Response 28) We considered these comments requesting that we issue a supplemental proposal. This final rule includes numerous revisions to the proposed rule. These revisions, however, better achieve our stated objective in the proposed rule to align the provisions of this rule with current safe food transportation practices and to allow industry to continue to use existing practices that have proven to be effective. The revisions we made to this rule are also a logical outgrowth from the proposed rule and are supported by comments that we received in response to the proposed rule. Therefore, we have determined that issuing a supplemental proposal of the rule is not necessary.
We also do not believe that we need to issue a supplemental proposal because implementation will require complex coordination among multiple Federal Agencies. We have sufficiently addressed in our responses to Comment 12 and Comment 13 the application of this rule to food that is subject to the regulatory authority of USDA. In addition, while section 5701 of the 2005 SFTA directs DOT to establish procedures for transportation safety inspections for the purpose of identifying suspected incidents of contamination or adulteration of food during transport in violation of this rule, we do not consider any coordination that we must do with DOT on enforcement to be particularly complex, such that it would have benefited from an additional opportunity for public comment. Therefore, we have determined that issuing a supplemental proposal to consider further aspects of this rule that are relevant to our interactions and relationships with other Federal Agencies is not necessary.
With regard to the suggestion that we should re-issue all seven of the FSMA foundational proposed rules simultaneously for comment, we agree that this might have been helpful to commenters. However, given our deadlines under a consent decree for the seven rules (Ref. 21), this was not possible. We also believe that stakeholders were given adequate opportunity to comment on the
(Comment 29) One comment states that in line with the requirements of Executive Order 13563, the Office of Management and Budget's (OMB's) implementation memo for that Executive order (Ref. 22), and OMB's 2013 Report to Congress (Ref. 23), it is clear that FDA should incorporate specific plans for retrospective review and ex post evaluation into the text of its final rule. The comment also suggests that given the uncertainty of the underlying data used to formulate the provisions of this rule, we commit to measuring the actual effects of the regulation and use the data we collect during the implementation of the rule to annually review whether the standards are having their desired effects.
(Response 29) We disagree. As discussed in the Final Regulatory Impact Analysis for this rule (Ref. 24), we have examined the impacts of the proposed rule under Executive Orders 13563 and 12866, in relevant part. Section 6 of Executive Order 13563 addresses retrospective analysis of existing rules by agencies, but the Executive order does not require that agencies include retrospective review plans in the codified text. FDA is committed to reviewing its rules to ensure their implementation is effective.
(Comment 30) One comment expresses concern about gaps in FDA's authority to regulate different types of food transport conveyances under the 2005 SFTA. The comment notes that the statute specifically limits our regulatory authority to the transportation of food by motor carriers and rail vehicles, excluding transportation by barge or ship and by air. The comment asserts that these omissions create critical weaknesses in the sanitary food transportation system because significant amounts of animal feed grain are transported by barge or ship within the United States and because highly perishable food products are frequently transported by aircraft. Another comment recommends that we explicitly state in this rulemaking that these additional conveyances are excluded and provide a rationale for their exclusion.
(Response 30) The 2005 SFTA, as passed by Congress and signed into law by the President of the United States, expressly mandates that FDA issue regulations to “require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices . . . to ensure that food is not transported under conditions that may render the food adulterated” (21 U.S.C. 350e(b)). We do not believe that we need to issue any confirmatory statements or rationales in response to these comments because the relevant 2005 SFTA statutory language is plain and clear on its face. The 2005 SFTA does not mandate that we issue regulations applicable to the sanitary transportation of food by any other conveyances, including barges or ships and aircraft. However, if we find that there is a public health need for us to regulate air and barge or ship transportation, we will consider whether we want to pursue covering these routes under a non-SFTA authority in the future.
We stated in the proposed rule (79 FR 7006 at 7029-7030) that we had tentatively determined that it would be appropriate to waive the applicable requirements of this rule, if finalized as proposed, with respect to the following classes of persons:
• Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety Program, only when engaged in transportation operations involving Grade A milk and milk products; and
• Food establishments,
We stated our intent to separately publish in the
However, we did receive comments requesting that we modify or expand the scope of these waivers beyond that which we discussed in the proposed rule. While we intend to publish waivers in the
(Comment 31) We received comments that we should acknowledge Tribal food codes in addition to state and local food codes in our discussion of waivers and that we should refer to Tribal governments in this final rule in every instance in which we mention State or foreign governments.
(Response 31) We acknowledge that tribal authorities, as well as state and local government agencies, can issue permits to food establishments under their relevant regulatory authority. In light of comments, throughout this final rule we explicitly recognize Tribal governments as partners we intend to work with in the implementation of this rule,
In table 5 we outline the revisions we have made to § 1.900 in finalizing this rulemaking. Following the table we respond to comments about these provisions.
(Comment 32) One comment expresses concern about whether the responsibilities that apply to persons subject to this rule would apply to a specific, individual person rather than to an entity. The comment notes that we indicated in the proposed rule that the intent of the rule is to establish accountability at the individual level for ensuring that transportation operations comply with the rule's requirements. However, the commenter asserts that it is not appropriate to place all responsibility onto a single individual. The comment supports having a qualified individual supervise and provide general oversight, but requests confirmation that the term “person” used in this rule refers to legal persons—including corporations.
(Response 32) The statement that this comment references from the proposed rule (79 FR 7006 at 7018) addresses the proposed requirement in § 1.908(a)(2) that responsibility for ensuring that transportation operations are carried out in compliance with all requirements of this rule must be assigned to competent supervisory personnel. That specific requirement does designate an individual as being responsible for this requirement, but we did not state that the intent of the rule is to establish accountability at the individual level for compliance with all requirements of the rule. The term “person” as used in this rule will include “individuals, partnerships, corporations, and associations.”
(Comment 33) One comment asked us to affirm that, for cheese exported to the United States under “freight on board” (FOB) contracts, the shipper is not responsible under this rule once the goods are delivered to a warehouse in the United States. FOB contracts specify that, once the goods have been turned over to the transporting company, the purchaser assumes the risk of loss as defined by the Agreement on International Commercial Terms.
(Response 33) The responsibilities of a shipper under this rule are not affected by the type of shipping arrangement,
(Comment 34) One comment asked whether the term “other persons” engaged in transportation might include governmental customs agencies that might withhold or load products during the agencies' custom processing operations for more time than considered to be usual in transport to their final destination. The commenter expresses concern that such a delay might potentially create food safety issues.
(Response 34) The 2005 SFTA authorizes us by regulation to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. Generally, governmental customs officials are not engaged in food transportation operations and typically would not be subject to this rulemaking. Their role in inspecting food does not bring them within the scope of what this rule is intended to cover.
(Comment 35) A few comments asked us to address responsibility under this rule in a few situations involving international shipments into the United States. One comment, for example, asked if a rail bulk container travels from Canada to a U.S. rail yard and then is transferred to a new train, is the person or entity that initiated the shipment in Canada the shipper, or is the shipper the person that transferred the bulk container at the U.S. rail yard for further transport in the United States? Another comment asks us to identify the carrier for a closed container that is shipped into the United States by ocean-going vessel and then is transferred, unopened, at the U.S. port of entry onto a truck. Finally, one comment asks us who would be held responsible under this rule if a refrigerated container is shipped from China to the United States via ocean-going vessel and then is transferred, unopened, at the U.S. port of entry onto a truck, and upon receipt, the U.S. receiver discovers evidence of temperature abuse.
(Response 35) In the first example, the shipper for any segment of transportation of the bulk container,
(Comment 36) One comment asks us to consider situations that include several different transportation legs in determining how parties are defined, or whether specific responsibilities assigned on the basis of the roles the persons involved in transportation operations play are even necessary. For example, corn grain is harvested and (1) taken in a semi-trailer by a farmer to the grain elevator, where it is (2) loaded in a rail car and transported to the Mississippi River, and (3) loaded in a barge for additional transport. Upon arrival, the grain is offloaded into a railcar and is then sent to a feed mill for mixing into hog feed. The comment seeks clarification on the applicability of the regulation if not all parties are subject to this rule,
(Response 36) In this example, the initial transportation operation would not be subject to this rule because it involves the transportation of food by a farm. In the example described in this comment, the grain elevator would be the receiver. The second segment of transit is subject to this rule because the transportation operation is by rail vehicle and the shipper, loader, carrier and receiver would be the persons who meet the definitions of these entities in this rule. These may not be separate persons,
We acknowledge that situations may occur where not all parties involved in a transportation operation are subject to this rule,
(Comment 37) A comment expressed concern with the shipper requirements because shipments originating abroad and destined for interior locations in the United States are arranged in the country of origin and the shippers in under-developed countries are not always accessible or easy to connect with, and may not be equipped to communicate with foreign companies and governments. There would be no U.S. shipper in this circumstance and it is unclear how the U.S. carrier and receiver would comply with reporting requirements related to the shipper.
(Response 37) International shipments such as those described in this comment can present difficulties for U.S. firms subject to this rule when it may be necessary to investigate the history of a shipment because, in addition to the circumstances described by the comment, a segment of the shipment,
(Comment 38) One comment states that this rule should also apply to entities that transfer a product from one mode of transportation to another (trans-loaders). It is common, particularly for feed ingredients, to have the cargo trans-loaded from a railcar to a truck. The comment recommends that FDA clarify the situations in which trans-loaders are to be considered shippers, carriers, or receivers because a trans-loader may be a separate (sub-contracted) entity.
(Response 38) An entity that only transfers food cargo from one mode of transportation to another,
(Comment 39) One comment asks who acts as the shipper when a single container is shipped using multiple modes of transportation. A container, for example, may start its transit on a truck and then be transferred to a rail car and remain sealed until it reaches its final destination. The comment states that in such instances, the entity that initiated the shipment initially should be considered the “shipper” throughout the voyage and not an entity that transfers the container between conveyances. The comment states that if the second entity were considered to be the shipper, it might have to open the container to inspect it for cleanliness before the container continues in transit, which could impact the safety of the shipment because this would mean breaking the container's seal.
(Response 39) Under this rule, the shipper is the person who arranges for the transportation of food by the carrier. If, in the example given in this comment, a single person arranges for the shipment of the food via multiple modes of transportation, that person is the shipper throughout all stages of transport. The commenter's interpretation, that if another person becomes a subsequent shipper of a sealed container, that person would have to open the container and inspect it before shipment, is incorrect. Nothing in this rule would require the second shipper to open and inspect the sealed container.
We are adding text for clarity to § 1.900(b)(2) to specify that “food that is
(Comment 40) We received a comment asking us to clarify what actions food transporters must take to assure compliance when their food product is intended exclusively for export markets. Another comment states that many commodities intended for export are shipped in standard ocean containers (known in the industry as forty-foot equivalent units (FEUs) and twenty-foot equivalent units (TEUs)), which are owned or leased by steamship lines. This means that the shipper, carrier, and receiver, as identified in the proposed rule, do not own the ocean-going container, which often travels on a truck or rail chassis before reaching a U.S. port for export. The comment asserts that this complicates the relationships and documentation required in the proposed rule between the shipper and the container holder for exports.
(Response 40) The 2005 SFTA states that we must, by regulation, require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated. Further, the statute defines “transportation” as any movement in commerce by motor vehicle or rail vehicle. Thus, persons engaged in the transportation of food that is intended for export are subject to all applicable requirements of this rule when the food is in transit by motor vehicle or rail vehicle to the land-based U.S. border point of export or a port facility. For example, the loader for a truck transportation segment moving the food to a vessel port facility is subject to the rule because it is loading a motor vehicle. The loader for the trans-oceanic ship transport segment is not subject to the rule because the rule does not cover transportation operations for water borne transportation. However, the operations of the second loader are still subject to section 402(a)(4) of the FD&C Act, which prohibits the holding of food under insanitary conditions whereby it may be rendered injurious to health or may become contaminated with filth.
We recognize that under typical practices in the industry, ocean containers are likely to be inspected and otherwise prepared for transportation by the person who loads the container,
(Comment 41) Another comment asks us to include an exemption for human and animal food originating in the United States but bound for export from the requirements of this rule. The comment notes that the proposed rule would not apply to transportation operations for food that is imported but is not “consumed or distributed” in the United States because it is exclusively destined for subsequent export. The comment states that food that originates in the United States and is bound for export travels by vehicle or rail car to reach U.S. ports of exit and, like food that is transshipped through the United States to another country or food that is imported for export, it is neither consumed nor distributed until it reaches foreign soil. The comment therefore recommends that we exempt food that originates in the United States, but that is bound for export, from this rule by including under § 1.900(b) the provision: “Human and animal food that moves under Customs and Border Protection (CBP) export reporting procedures including Automated Export System (AES) and is therefore neither consumed nor distributed in the United States.” The comment asserts that requiring that the shipments of the food comply with CBP export reporting and documentation procedures ensures that cargo bound for export will not be diverted into the U.S. food supply for domestic consumption.
(Response 41) We decline to exempt persons engaged in the transportation of human and animal food originating in the United States and bound for export from the requirements of this rule, because food that originates in the United States and is bound for export is handled in a fundamentally different manner than food that is transshipped through the United States to another country, for example from Mexico for delivery to Canada, or food that is imported for future export in accordance with section 801(d)(3) of the FD&C Act, and that is neither consumed nor distributed in the United States. In the cases of import for export and transshipment, legally enforceable mechanisms exist that ensure that the food will not be diverted for consumption or distribution in the United States.
With respect to food that is transshipped through the United States to another country, CBP regulations in 19 CFR 18.10, “Kinds of Entry,” list the various entries and withdrawals that may be made for merchandise transported in bond. One kind of entry is the transportation and exportation (T&E) entry. A party that transships merchandise in bond through the United States must submit T&E documentation with the CBP and the CBP supervises the shipment of the merchandise through the United States, as well as the intact export of the goods to foreign destinations.
Similarly, under section 801(d)(3) of the FD&C Act, parties which import certain articles that are intended exclusively for further processing or incorporation into another product and for subsequent, mandatory export because the articles cannot be distributed or used in the United States must provide FDA with certain information at the time of initial importation. These articles include food subject to this rule, specifically, food additives, color additives and dietary supplements. These parties must provide, among other things, a statement that confirms their intent to further process such articles or incorporate such articles into a product for purposes of subsequent export, and must provide us with the identities of the entities in the chain of possession of the imported articles while the articles are in the United States. Importers also must provide us with certificates of analysis, as necessary, to identify the article of food. In addition, at the time of initial importation and before delivery to the importer, initial owner, or consignee, a bond must be executed providing for liquidated damages in the event of default, in accordance with CBP requirements. The initial owner or consignee of the article also must maintain records of the use and/or destruction of such imports and must submit the records or a report to FDA upon request. The initial owner or consignee also must destroy any article or portion thereof that is not used in an exported product.
The AES system, on the other hand, collects Electronic Export Information (EEI), formerly known as Shipper's Export Declaration (or any successor document) from persons exporting
However, AES is not specifically designed to function as a legally enforceable mechanism to ensure that food bound for export is not diverted into the domestic supply chain and consumed in the United States. The AES system does not become operative until food arrives at a point of export. Therefore, if a shipper states that any given food shipment that originates in the United States is destined for export and transports the food without complying with the requirements of this rule, but subsequently decides to divert the food for purposes of domestic consumption or distribution, neither we nor the CBP would have any way of knowing that the food had been diverted for domestic consumption, perhaps after being transported under insanitary conditions. In addition, unlike food transshipped through the United States and food imported exclusively for subsequent export, food that originates in the United States and is intended for export, whether it is diverted for domestic consumption or is actually exported, is not transported under a bond. Accordingly, we do not agree that a basis comparable to that for food transshipped through the U.S., or food imported for export, exists for exempting persons engaged in the transportation of human and animal food that originates in the United States but is bound for export from the requirements of this rule as suggested by this comment.
(Comment 42) One comment states that, when cargo is deemed to be adulterated, one of the primary salvage markets may be destinations outside of the United States. The comment observes that this rule appears not to apply to food outside of the United States and argues that, if that is the case, we should clarify that it should not apply to food that is shipped outside of the United States to a destination that was not the original, intended primary market.
(Response 42) If the product has already been offered for sale in the United States and is found to be adulterated, it cannot be legally exported for sale in markets outside the United States. (See
(Comment 43) A comment requests that we address the safe disposal of contaminated foods from a rejected delivery and the sanitization of trailers carrying such cargo. The comment states that when a delivery is rejected, the responsibility for and costs associated with safely disposing of the shipment is often placed on truckers, in some cases with little or no instructions from the shipper. Consequently, according to the comment, drivers who need to dispose of contaminated cargo sometimes simply dump it, give it away to the public, or sell it. The comment states that FDA should explore, in this or a separate rulemaking, the development of rules governing such rejections. The comment further suggests that we should address when rule violations can serve as the basis for the rejection of a delivery and/or a cargo insurance claim, acceptable methods of disposing of contaminated food products after rejection, and the apportionment of disposal costs among parties involved in the transportation of rejected cargoes.
(Response 43) This rule addresses the sanitary transportation of human and animal food to prevent practices that may create food safety risks. We recognize the burdens and uncertainties that may arise when a load is rejected. However, the basis on which a load may be rejected, and the disposition of and costs associated with the disposal of rejected loads of food, are beyond the scope of this rule. We do not agree that we should explore the development of rules to govern rejections and/or cargo insurance claims, or rejected product disposal issues, because they often involve purely economic considerations about food shipments, which do not fall within our jurisdiction. Also, issues of liability are similarly subject to Federal laws that we do not have the authority to administer. We note, however, that if a food shipment is rejected because it is adulterated, the person responsible for that food cannot distribute or offer it for sale. Further, the carrier of a rejected food shipment must ensure that the motor or rail vehicle used to transport the rejected load complies with the vehicle and equipment provisions of § 1.906 before it is used again to transport food.
The only change we made in the proposed provisions in § 1.902(a) and (b), which specify that the criteria and definitions in part 1, subpart O apply in determining whether food is adulterated within the meaning of section 402(i) of the FD&C Act and that failure to comply with the requirements of part 1, subpart O is a prohibited act, was to add “loaders” to the list of covered entities in both paragraphs.
(Comment 44) One comment asks us to replace the term “in compliance” throughout the final rule with the term “in conformance.”
(Response 44) We decline this request. We have used the phrase “in compliance” in § 1.902(a) of this rule consistent with the language of section 7202(a) of the 2005 SFTA, which amends the FD&C Act by adding section 416 to the FD&C Act to provide that a food shall be deemed to be adulterated “[i]f it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section 416.”
(Comment 45) Several comments express concern about food being considered adulterated under this rule simply because of the failure of a carrier to adhere to a shipper's specified conditions during transport, such as maintaining a specified temperature, regardless of whether the food is actually unsafe. In particular, these comments speak to concerns about the impact the rule, as proposed, would have on the cargo claims process governed by the “Carmack Amendment” found in 49 U.S.C. 14706. Under this provision of Federal law, a shipper or receiver seeking to recover money for cargo loss or damage from a carrier must show that the cargo is actually lost or damaged. The mere possibility of damage through “potential” exposure is not sufficient to prove an actual loss. One comment states that this rule is problematic because it directly links failure to
(Response 45) We decline to make the specific change requested, but we have made other revisions to this rule that address the commenter's concerns. We have revised the provisions of this rule, for example, that address instances in which a carrier might not meet a shipper's specifications for temperature control during transportation. An inconsequential failure by a carrier to meet the shipper's temperature control specifications will not necessarily create a per se presumption that the affected food has become adulterated. However, as we discuss in our response to Comment 129, under this rule, in § 1.908(a)(6), if a person subject to this rule becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the person must take appropriate action to ensure that the food is not sold or otherwise distributed, unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe. Failure to take such action may render the food adulterated.
We also have revised this rule in §§ 1.906 and 1.908, as we discuss in our response to Comment 89, to clearly state that the requirements for transportation equipment and transportation operations are intended to prevent food from becoming unsafe during transportation. This revision, in addition to others, makes it clear that under this rule we will apply section 402 of the FD&C Act, as it addresses food safety, to determine whether food has become adulterated during transport. Persons engaged in transportation operations should not expect that we will apply a different standard or different criteria for evaluating compliance with this rule. Therefore, we do not anticipate that this rule will have a significant impact on the cargo claims process.
(Comment 46) Some comments state that there are other common occurrences that they believe could unnecessarily result in a presumption of adulteration under the proposed rule. These commenters express concern that the proposed rule can be interpreted broadly enough to create potential issues if broken seals or evidence of tampering create a presumption of adulteration, absent any evidence of actual threats to the public health.
(Response 46) We have made revisions to this rule that address the concerns of these comments. As we stated in our response to the previous comment, when assessing transportation equipment and transportation operations, we will apply the food safety provisions of section 402 of the FD&C Act as the standard for determining whether food has become adulterated during transport. Persons engaged in transportation operations should not expect that we will apply a different standard or different criteria for evaluating compliance with this rule. A broken cargo seal or any evidence of food cargo tampering would not necessarily create a per se presumption of adulteration. However, we advise persons engaged in transportation operations that, if such situations should arise, they should carefully evaluate the facts and circumstances of each incident, on a case-by-case basis, to determine whether the safety of the food cargo may have been compromised.
(Comment 47) Some comments asked that we clarify, in certain particulars, the interpretation of “conditions not in compliance” in section 402(i) in the FD&C Act, the statutory adulteration provision added to the FD&C Act by the 2005 SFTA. Under that provision, a food is adulterated if it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations issued under section 416 of the FD&C Act,
(Response 47) Under section 402(i) of the FD&C Act, “a food shall be deemed adulterated if it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section 416.” Section 416(b) of the FD&C Act mandates that the Secretary create regulations requiring that food carriers use sanitary transportation practices. Section 416(c)(1)(E) of the FD&C Act states “the regulations under section (b) shall—(1) prescribe such practices as the Secretary determines to be appropriate relating to— . . . (E) recordkeeping . . .” The way that the statute is structured implies that lack of or incomplete records in section 416(c)(1)(E) of the FD&C Act would lead to the food being adulterated under section 402(i) of the FD&C Act. The establishment of records requirements under this rule is consistent with the statutory purpose of the 2005 SFTA. It is clear from the statute and the legislative history that Congress intended recordkeeping to be one of the requirements for maintaining sanitary food transportation practices (See section 416 of the FD&C Act and S. Rep. No. 109-120, at 46 (2005) (Ref. 25)).
Furthermore, the Senate report (S. Rep. No. 109-120, at 46 (2005)) (Ref 25) expresses Congress' intention to grant FDA authority to deem food adulterated on recordkeeping grounds. That report states that SFTA “would amend section 402 of the Federal Food, Drug, and Cosmetic Act . . . to provide that food is adulterated if transported in violation of safe transportation practices prescribed in the new section 416 of the FD&C Act.”
In the seafood HACCP final rule (60 FR 65096 at 65100) we noted that in
Thus, the necessary conditions for compliance with these regulations encompass all of the requirements in this final rule, including those that may not appear to directly affect the safety of the food, such as training and records. The SFTA of 2005 does not differentiate between physical conditions indicating food safety risk and requirements, such as training and recordkeeping.
However, we recognize the concerns expressed by these comments and do not believe that the SFTA of 2005 changes the way we enforce our regulations. Before initiating enforcement action, we will consider all circumstances surrounding the deviation(s),
(Comment 48) One comment states that the rule does not address the obligations of carriers if shelf stable food is compromised during transit or while on a dock or being loaded onto a trailer. The comment states that when a shipment is damaged in transit, or during loading or unloading, the carrier will frequently transport the shipment of damaged goods to a location of the shipper's choice. The commenter asks us, if the carrier is only qualified to handle shelf stable food, can the carrier continue to handle the shelf stable food with compromised packaging? The comment also asks whether the carrier would be required to hire another carrier who has chosen to comply with the record keeping and training requirements of the proposed rule to handle the return of such shipments.
(Response 48) We would have no concerns about the carrier transporting the damaged goods to a location specified by the shipper because, under § 1.908(a)(6), an evaluation must be performed before further distribution to determine whether the food has been rendered unsafe.
We proposed to establish several definitions in § 1.904. In table 6, we describe revisions to the proposed definitions and following the table we respond to comments related to these provisions. We did not make changes to the definitions of adequate, animal food, bulk vehicle, cross-contact, food not completely enclosed by a container, pest, transportation, and vehicle.
We proposed to define the term “adequate” to mean that which is needed to accomplish the intended purpose in keeping with good public health practice. We are finalizing this definition as proposed.
(Comment 49) One comment states that the term “adequate” is not suitable for a rule intended to achieve compliance with best transportation practices focused on reducing the risks of the adulteration of food products. The comment suggests that instead we should use the term “to guarantee,” which the comment defines as meaning “to ensure and protect from any risk or need,” to avoid ambiguity that might cause confusion and result in public health hazards.
(Response 49) We decline this request. The term “adequate” is a long-standing term that we defined in its current form when we first established Current Good Manufacturing Practices (cGMP) requirements for manufacturing, packing and holding food in 1969 (see 34 FR 6977 at 6978, “ `Adequate' means that which is needed to accomplish the intended purpose in keeping with good public health practice.”). The requirements established in this rule address broadly applicable procedures and practices and our use of the term “adequate” is intended to provide flexibility for shippers, loaders, carriers, and receivers to comply with the requirements in a way that is most suitable for their practices. We are not aware that the term has caused confusion in its use with the cGMPs and the comment does not provide any examples of how our use of the term “adequate” may create confusion that might result in public health hazards.
We proposed to define the term “animal food” to mean food for animals other than man, including pet food, animal feed, and associated raw materials and ingredients. We are finalizing this definition as proposed.
(Comment 50) A few comments state that raw materials should not be included in this definition because processing these materials into feed ingredients and finished animal food products after they have been transported to processing facilities removes many, if not all, of the hazards that may be associated with the transportation of the raw materials. One of the comments also notes that the Association of American Feed Control Officials (AAFCO) Model Regulations exempt raw materials (such as meat scraps) from regulation because they are not suitable for use in animal feed without further processing.
(Response 50) We decline to change the definition of animal food. While the transportation of raw materials for animal feed manufacture may not require the same degree of sanitary control as the transport of finished animal feed, there may be circumstances in which processing the raw materials may not remove all health hazards,
We proposed to define the term “bulk vehicle” to mean a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, hopper bin, or any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the interior surfaces of the vehicle. We are finalizing this definition as proposed.
(Comment 51) One comment asks us to add terms such as “gondola” to the examples included in this definition in the interests of clarity.
(Response 51) We decline to change the definition based on this request. We are using the definition of “bulk vehicle” in this rule exactly as it appears in the 2005 SFTA and as incorporated into section 416 of the FD&C Act. However, we note that the list of examples included in the definition is not intended to be comprehensive or all inclusive with respect to the types of vehicles that are bulk vehicles. We define the term to include “any other vehicles in which food is shipped in bulk, with the food coming into direct contact with the vehicle.”
(Comment 52) Some comments state that in several respects, our definition of bulk vehicle is overly broad in scope. According to one commenter, the term “hopper bin,” for example, can be inferred to mean a grain hopper bottom storage bin that is part of a storage facility, and not a piece of transportation equipment. The comment requests that we delete the term “hopper bin” from this definition. Another comment asks us to explicitly exclude vehicles used to transport fruit and vegetable RACs from the definition because many RACs are thermally processed with a kill step or are cooked by the consumer before being consumed.
(Response 52) We decline these requests. A hopper bin constructed as part of a facility and used for storage would not be considered transportation equipment and therefore would not be subject to this rule. A hopper bin on a truck or other conveyance subject to this rule, however, is a piece of transportation equipment and therefore is subject to this rule. We also note that while some RACs that are transported in a bulk vehicle may undergo a kill step process or cooking before being consumed, there may be circumstances in which controls,
We proposed to define the term “carrier” to mean a person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food. The definition also specified that the carrier is responsible for all functions assigned to a carrier in this subpart even if they are performed by other persons, such as a driver that is employed or contracted by a trucking firm, and that a carrier may also be a receiver or a shipper if the person also performs the functions of those respective persons as defined in this subpart. In the final rule, as explained in the discussion of § 1.908(a)(1), we have added a general provision to that section about the multiple roles that can be played by a single entity to replace the separate provisions we had included in the proposed definitions of “carrier,” “shipper” and “receiver”. We are finalizing the definition for “carrier” to mean a person who physically moves food in commerce and clarifying that a carrier does not include any person who transports food while operating as a parcel delivery service. We explain these changes in the responses to the next 3 comments.
(Comment 53) Some comments oppose defining the term “carrier” to mean a person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food. These commenters express concern that this definition would result in the inappropriate and unworkable application of this rule's requirements to railroad operators for the following reasons.
• Railroad operators in many cases do not own or lease the railcars they transport, are not responsible for their storage when they are stored in private facilities, and exercise no control over the cars other than to inspect them for mechanical soundness during the transportation process.
• The shipper or loader is generally responsible for inspecting a railcar to ensure that it is suitable for the particular food cargo, regardless of who owns the car.
• Railroad operators do not have the ability to ensure that the shipper's sanitary and temperature control requirements are met before or during transportation when, as is common in freight railroad transport, other parties,
• Railroad operators generally do not clean the cars they provide and do not maintain documented cleaning procedures.
• The use of railcars in interchange service, in which railroads convey freight cars from other companies over their lines would likely mean that the railroad operator would not be able to provide information about the identity of a bulk vehicle's previous cargoes and its most recent cleaning if requested by the shipper.
The commenters note that for the stated reasons, railroad operators cannot meet requirements of this rule assigned to carriers under proposed §§ 1.906 and 1.908.
These comments also contrast rail carrier and motor carrier food transportation operations, noting that motor carriers generally own the vehicles they provide for transport and are directly involved in transportation operations, such as the loading and unloading of the trailers that they haul, and therefore can comply with requirements assigned to the carrier in §§ 1.906 and 1.908 of the proposed rule.
Finally, one comment asks us to establish separate definitions for motor and rail carriers which would assign appropriate responsibilities for each of the two distinct types of carriers. Another comment asks us to establish a definition specific to railroad carriers in this final rule, which would simply define a “railroad carrier” as a person providing railroad transportation services.
(Response 53) We carefully considered these comments and we agree that our proposed definition of the term “carrier,” when combined with the structure of the proposed requirements at § 1.908, which detail the required interrelationships between carriers, shippers and receivers, would establish requirements that some persons subject to the definition,
We recognize that, in practice, the person who assumes responsibility for functions assigned to a carrier under § 1.908 of the proposed rule is identified by mutual agreement between the shipper and that person,
For these reasons, we have revised the definition of carrier to mean a person who physically moves food by rail or motor vehicle in commerce in the United States. We have removed from the definition the proposed sentence that assigned duties to the carrier, because of the consequences of such assignment, especially relative to rail carriers, as discussed in this document, and because, upon further consideration, we view such language to be inappropriate for a definition. We have also removed from the definition the proposed sentence that stated that a carrier may also be a receiver or a shipper if the person also performs the functions of those respective persons. While we affirm that this statement is valid, we have consolidated this and similar statements in the proposed definitions of shippers and receivers in the regulatory text at § 1.908(a)(1).
(Comment 54) A few comments urge us to consider that home grocery delivery services may originate from locations other than food
(Response 54) Home grocery delivery operations at food distribution centers are generally permitted by States as retail establishments and, therefore, would be included in a waiver of certain transportation operations performed by such retail food establishments. We stated in the proposed rule (79 FR 7006 at 7029-7030) that we had tentatively determined that it would be appropriate to waive the applicable requirements of this rule, if finalized as proposed, with respect to retail food establishments holding valid permits, only when engaged in transportation operations as receivers, or as shippers and carriers in operations in which food is relinquished to consumers after transportation from the establishment. As we stated in section III.E., we intend to publish a waiver in the
(Comment 55) A participant in one of the public meetings we held on the proposed rule asked whether this rule applies to food shipped by the U.S. Postal Service or by private small parcel carriers. One submitted comment states that the impact of the rule would be significant and costly if it is applied to small-parcel common carriers, and therefore asks us to affirmatively state that small-parcel common carriers will be excluded from the definition of “carrier.” The comment notes that small-parcel common carriers handle millions of packages per day containing a broad range of goods, including clothing, shoes, food products, electronics products, and books. The comment asserts that requiring these carriers to understand the unique shipping requirements for every product that they transport would be unduly burdensome and nearly impossible to accomplish. The comment further argues that if FDA requires that small-parcel common carriers meet the requirements imposed on dedicated food carriers, some common parcel carriers, especially large-scale common carriers, will respond by simply excluding all food shipments from their operations. According to the commenter, this result would likely reduce the availability of some of the most cost-effective transportation channels for certain food shippers, even where there have been no demonstrated food safety risks associated with their food product delivery operations. Finally, the commenter suggests that the more appropriate way to ensure food safety under these circumstances would be to require the shipper of any small parcel to ensure that the selected method of transportation is appropriate for the food product at issue.
(Response 55) We agree that it is not appropriate to subject the operations of the U. S. Postal Service or private delivery services delivering parcels to consumers to this rule, given that these carriers transport a broad range of items and do not offer transportation services tailored to the transportation of food products. We, therefore, have added a provision to the definition of the term “carrier” in § 1.904 of this final rule stating that the term does not include any person who transports food while operating as a parcel delivery service. Our expectation is that the person shipping the package would ensure that the selected method and circumstances of transportation are appropriate for the food product at issue, including food that is delivered by small-parcel common carriers.
We proposed to define the term “cross-contact” to mean the unintentional incorporation of a food allergen as defined in section 201(qq) of the FD&C Act into food, except animal food. We did not receive any comments on this definition and are finalizing it as proposed.
We proposed to define the term “farm” to mean a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. The proposed definition of “farm” included facilities that pack or hold food, regardless of whether all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership. We are revising the definition of “farm” in this rule to be consistent with the definition of “farm” used in other FSMA rulemakings. We discuss our considerations of the comments we received on the definition of “farm” in the response to Comment 55 and, additionally, in our response to Comment 8.
(Comment 56) Several comments that address provisions of the proposed definition of “farm” suggest that the definition include terms such as a “facility,” or an “establishment,” or a “place.” Other comments suggest that the definition should include consideration of the locations and the numbers of the structures that constitute a farm.
(Response 56) As we explained in our response to Comment 8, we have revised the definition of the term “farm” in this final rule to align it with the revised definition of the term in 21 CFR 1.227, which was recently established in the FSMA preventive control for human food final rule (80 FR 55908 at 55925). The comments that we received for this rulemaking address provisions of the farm definition that have already been addressed in the rulemaking for preventive controls for human food. Therefore, there is no need for us to address these issues further in this rulemaking.
We included the definition of the term “food” in the proposed rule just as the term is defined in section 201(f) (21 U.S.C. 321(f)) of the FD&C Act. We have deleted this definition from this final rule, however, because § 1.904 of the rule clearly states that “[t]he definitions and interpretations of terms in section 201 of the [FD&C Act] are applicable to such terms when used” in this rule. Food includes animal food and food also food subject to the FMIA, the PPIA, and the EPIA.
(Comment 57) One comment asks us to explicitly exclude food contact shipping and storage equipment from the rule's definition of “food.” The comment also asks us to clarify that empty food contact shipping and storage equipment will be regulated exclusively as “transportation equipment” under this rule. Finally, the comment asks us to clarify that equipment suppliers, including food contact equipment suppliers, are not shippers, carriers or receivers of “food.”
(Response 57) The definition of “food” given in section 201(f) of the FD&C Act applies to this term as used in this rule. Under section 201(f), the term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. Shipping and storage equipment that is meant to contact food is not food and would be regulated exclusively as “transportation equipment” under this rule. Therefore, persons involved in the transportation of such equipment are not shippers, carriers or receivers of
(Comment 58) A few comments ask us to exclude food contact substances as defined in section 409(h)(6) of the FD&C Act from the scope of this rule by excluding them from the definition of “food.” One of the comments notes that we excluded food contact substances from the definition of “food” in the food facility registration regulations in 21 CFR 1.227(b)(4). It further states that requiring manufacturers, shippers, receivers, and carriers of food contact substances to comply with the sanitary transportation requirements would impose a significant burden with respect to the transportation of products that present a very low food safety risk and for which any risk is already effectively managed.
(Response 58) We partially agree with these comments. In the 1990 SFTA, Congress included food additives along with other substances defined in the FD&C Act in designating the scope of the regulations that it directed DOT to issue. We take this to mean that Congress recognized that food could be made unsafe as a result of insanitary food additive transportation practices. Food contact substances are “food additives” and are also “food” as defined in the FD&C Act. In the absence of language in the 2005 SFTA that explicitly excludes food contact substances from regulation as food, we would not agree with the comment's view that food contact substances should not be considered to be “food” within the meaning of this rule.
However, section 416(c)(1) of the 2005 SFTA states that we shall prescribe sanitary transportation practices that we determine to be appropriate in issuing this rule. We, therefore, are revising the definition of transportation operations to exclude food contact substances as defined in section 409(h)(6) of the FD&C Act. Factors inherent to the transportation and downstream handling of food contact substances, described in this section, would strongly support that there is little risk of food products becoming adulterated because of insanitary food contact substance transportation practices. We agree, as one comment notes, that food contact substances are protected during transportation with additional outer packaging. In addition, the pathogenic microorganisms that are deleterious to conventional foods are not known to be a risk for food contact substances. We also note that the handling and processing that these substances undergo during the manufacturing of finished food contact articles, such as curing, drying, and extrusion, often involve very high temperatures, creating conditions under which there is little possibility that any microorganisms that might be present would survive. The nature of finished food contact articles also ensures that the risk of microbial contamination is very low. We, therefore, have determined that requirements under this rulemaking for the sanitary transportation of food contact substances are not necessary.
We proposed to define the term “food not completely enclosed by a container” to mean any “food that is placed into a container in such a manner that it is partially open to the surrounding environment.” We stated in the proposed rule that examples of such containers would include an open wooden basket or crate, an open cardboard box, a vented cardboard box with a top, or a vented plastic bag, but would not include food transported in a bulk vehicles. We are finalizing this definition as proposed.
(Comment 59) One comment objects to our proposed inclusion of food packaged in vented cardboard cartons with tops as an example of “food not completely enclosed by a container.” Several comments disagree that the use of vented cartons by the tree fruit industry poses a measurable risk of contamination to fruit during transportation. One comment observes that vented cardboard cartons with tops are a commonly used for cooling fruit and contribute to the maintenance of fruit quality. According to the comments, vented cartons bearing fruit are stacked on pallets before being placed in refrigerated trucks by forklifts, and they are removed the same way and without ever coming into direct contact with the trucks' interior surfaces. The comments also assert that it is rare for loads of fruit packaged this way to be transported with any other food products, further reducing the risk of cross-contamination or adulteration. Finally, the comments also assert that no evidence of any threat to food safety has emerged over the many decades that the tree fruit industry has used these types of cartons for packaging and transportation.
(Response 59) We agree that when sanitary transportation practices are followed in the transportation of tree fruit, there should be no significant risk of contamination of the product. However, we decline the request to exclude vented cardboard cartons from the definition of “food not completely enclosed by a container.” The purpose of this rulemaking is to prescribe sanitary transportation practices to ensure that food does not become unsafe during transportation. We have determined that it is necessary to establish requirements related to the transportation of foods not completely enclosed by a container, including food transported in vented cardboard cartons with tops, because food, including tree fruits, packaged this way could be susceptible to environmental contamination, for example, if a vehicle used for transport is not in appropriate sanitary condition for the transportation operation.
(Comment 60) One comment states that it is unclear what we mean by a “completely enclosed container” as it relates to storage practices during loading and transportation operations. The comment asks whether this means food must be enclosed by a cardboard box or a plastic wrapped pallet, or whether food must be enclosed by a moisture impervious container such as ones made out of heavy plastic, glass or metal. The commenter states that it has seen “extreme examples of cross contamination, such as raw poultry on ice, stored above fresh produce with bloody ice falling into the produce.” The commenter asks us to provide clearer language.
(Response 60) We consider a “completely enclosed container” to be one that physically separates the food from the environment and functionally protects the food from environmental contamination during transportation. We would not consider items such as pallet wrap, which have the primary purpose of facilitating the handling of pallets, to be food containers. We provided examples of such containers in the proposed rule (79 FR 7006 at 7015),
“Full-time equivalent employee” is a new term in this rule and is used to represent the number of employees of a business entity for the purpose of determining whether the business is a small business. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (
We are adding the term “loader” to this rule and specifying that it means a person that loads food onto a motor car or rail vehicle used during transportation operations. We are adding this term in response to comments that indicated that there were certain functions assigned in the proposed rule that were typically performed by a segment of the transportation industry known as loaders and so we have added this function to the rule.
We proposed to define the term “microorganisms” to mean yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and to include species that have public health significance. We proposed to define the term “undesirable microorganisms” to include those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated. We have removed this term as explained in the response to Comment 61.
(Comment 61) One comment states that although these definitions are familiar from the existing food cGMP regulations at 21 CFR part 110 (which have been revised in the preventive controls for human food final rule and are now in 21 CFR part 117, subpart B), they provide little assistance for purposes of identifying foods that can support the rapid growth of undesirable microorganisms in the absence of temperature controls. Other comments state that we should clarify that microorganisms that have only the potential to cause spoilage, without posing food safety risks, should not be excluded from these definitions of microorganisms.
(Response 61) We included a definition for the term “microorganisms” in the proposed rule that was to be applied to requirements in proposed §§ 1.906 and 1.908 that addressed measures necessary to prevent conditions that could lead to the rapid growth of undesirable microorganisms in food because of the use of insanitary transportation equipment and transportation practices. As we explained in our response to Comment 89, we have revised the language in these sections of this final rule to no longer refer to the term “undesirable microorganisms.” As a result of this revision, there is no longer a need to include a definition for the term “microorganisms.”
We proposed to define the term “non-covered business” to mean a shipper, receiver, or carrier engaged in transportation operations that has less than $500,000 in total annual sales. We have changed the annual sales qualifier in this provision to an annual revenue qualifier because under this rule, this definition applies to firms,
(Comment 62) We received a large number of comments regarding this proposed provision. Most of them oppose granting any kind of size-based exclusion. Several themes emerge from the comments that we received opposing the inclusion of a size-based exclusion in this rule. Many of the comments ask us to create a “very small” category of businesses which would be subject to fewer requirements than other firms. Some of these comments state that the proposed exclusion provision leaves the most problematic group of transporters, operators of small box trucks, uncovered by this rule, citing the findings that we discussed in the proposed rule (79 FR 7006 at 7024), of the 2007 Interstate Food Transportation Assessment Project (Ref. 6). Some comments expressed the view that that all members of the food supply chain, regardless of size, must share responsibility in ensuring food safety. Some comments criticize the proposed exclusion for lacking a statutory basis, for not being risk-based, or for lacking merit and being unnecessary. One comment opposes the proposed exclusion on the grounds that we have failed to explain why the proposed rule's requirements would be prohibitive for those firms capable of qualifying for the exemption. Other commenters state that we should not grant any exclusions because the proposed requirements are similar to food cGMPs, which we impose on almost all food processors.
(Response 62) We articulated our reasons in the proposed rule (79 FR 7006 at 7014) for excluding certain businesses,
To further expand upon our thinking, we note that the preventive controls rules exempted “qualified facilities” as defined by the FSMA, from the requirement for hazard analysis and risk-based preventive controls and instead established very limited requirements (essentially statutorily mandated attestations by the firm to FDA) specific to this category of
Therefore we are retaining the exclusion for non-covered businesses from the requirements of this rule. However, to further promote the application of sanitary transportation practices throughout the industry, we will also consider establishing guidance for transportation activities carried out by non-covered businesses.
(Comment 63) Some comments are concerned about possible unintended consequences potentially associated with size-based exclusions, including confusion that could result when a covered firm attempts to do business with a non-covered firm, or the exit of small firms from the food transportation industry because shippers may discontinue doing business with carriers that are not subject to the rule. One comment opposed to the proposed provision expresses the view that small shippers, loaders, carriers, and receivers excluded from the rule based on size still could be penalized if the food they are transporting becomes adulterated because any party that introduces or receives an adulterated food product in interstate commerce may be held legally responsible.
(Response 63) Firms engaged in food transportation, including those exempt from this rule, must comply with all of the generally applicable requirements of the FD&C Act, including those that prohibit the holding of food under insanitary conditions whereby the food may become contaminated with filth or be rendered injurious to health. While differing requirements have the potential to affect business relationships among firms and their interactions with regulatory agencies, we believe that agencies and the marketplace can adapt appropriately, and that firms will not be unduly inconvenienced by them. Furthermore, if firms that are not covered by this rule because of their size voluntarily chose to meet the rule's requirements, for example, for competitive business purposes, there are resources, such as FDA and industry issued guidance on sanitary food transportation and training in sanitary food transportation practices, available to them.
(Comment 64) One comment states that the proposed exclusion may have the unintended consequence of motivating food transportation firms to create subsidiary companies for the purpose of dispersing their annual sales so that each newly created, related company would have less than $500,000 in annual sales, and therefore qualify for the exclusion.
(Response 64) In the proposed rule (79 FR 7006 at 7014) and in the responses to the previous comments, we articulated our reasons for excluding a “non-covered business” from the requirements of this rule. We cannot discount the possibility that some firms might form separate businesses to bring their disaggregated annual sales below the threshold for a non-covered business, but this is not likely to be a common occurrence and such separation may not be advantageous for business reasons. Therefore, we do not believe that the possibility poses a reasonable basis upon which to modify this provision of the rule.
(Comment 65) Among comments that we received in support of the proposed exclusion for non-covered businesses, some support keeping the provision at its proposed threshold of $500,000 in total annual sales. Another comment supports lowering the annual revenues threshold to $10,000, while a few support increasing it to $1,000,000. One comment supports the exclusion, but suggests defining a non-covered business exclusively as one that employs fewer than 500 people, regardless of annual revenues. According to this comment, annual revenues can vary from firm to firm, depending on the food products involved, for example, the differences between the prices of commodity items and premium or gourmet items. This comment proposes using a threshold of $1,000,000, consistent with the highest threshold in the proposed preventive controls for human food rule, in the event we decline to define a non-covered business in terms of the number of people employed. Another comment supports an increase in the threshold without explicitly suggesting a new one. Finally, one comment supporting the exclusion provision asks us to explicitly state that it would extend to foreign firms engaged in food transportation activities.
(Response 65) We explain our reason for retaining the exclusion of non-covered businesses from the requirements of this rule in our response to Comment 62. We are retaining the threshold for a non-covered business as a total annual revenues based threshold at the $500,000 level as proposed; however, we are allowing for adjustment for inflation and for basing the calculated value on average annual revenues, calculated on a rolling basis, during the 3 preceding years. We estimate that removing firms below this threshold from coverage by the rule would result in about 5 percent of food shipments not being covered by this rule
To define a non-covered business as one not exceeding $10,000 in total annual sales, as one comment suggests, would not be consistent with our stated purpose of extending comparable treatment to firms subject to this rule and similarly situated firms subject to the FSMA preventive controls rules. A $10,000 total annual sales limit corresponds to a business of much smaller size than one that could be a “qualified facility” as defined in the preventive controls rules and such a threshold would likely result in 100 percent of food shipments being covered by the rule.
We considered changing the total annual sales limit for a non-covered business to $1,000,000, which would be consistent with the definition of very small business in the Human Food Preventive Controls rule (the Animal Food Preventive Controls rule defined very small business as less than $2,500,000), but chose not to do so because it would result in about 10 percent of food shipments not being covered by this rule. While selecting a value of $1,000,000 for this rule would be more consistent with the Preventive Controls rules, which we believe to be a desirable endpoint, the percentage of food shipment not covered by this rule at that threshold would be vastly different than the less than 0.6 percent of food not covered by the Preventive Controls rules. We weighed the cost to this category of small businesses against the risk of adulteration, and determined that excluding 5 percent of shipments from coverage by this rule was more appropriate, because it would expose less food to any potential risk arising from non-coverage by this rule.
We decline to establish the threshold for a non-covered business in terms of fewer than 500 people employed, because that threshold is the basis of the definition of a “small business” under this rule, which is a covered business category.
(Comment 66) One comment asks us to add an additional exclusion for food establishments that sell to qualified end users, as defined by the FSMA preventive controls rules, as a separate category within the definition of “non-covered business,” or as a separate exclusion, rather than requiring this category of businesses to undergo the waiver process provided for in this rule. The comment states that such an exclusion would follow FSMA's mandate for the preventive controls rules and produce safety rule to be flexible, and scale- and supply-chain appropriate. The comment states that this mandate includes content requirements for the preventive controls rules and the produce safety rule to provide sufficient flexibility to be practicable for all sizes and types of businesses and facilities, and to provide modified requirements for small and mid-sized farmers and facilities engaged primarily in selling food through direct-to-consumer supply chains.
(Response 66) The Preventive Controls rules for human and animal food provide for modified requirements for qualified facilities. Qualified facilities are defined in those rules to mean a facility that is a very small business (
As explained in our response to previous comments, we have attempted to make consistent, to the extent possible, the size-based “exemption” from this and the Preventive Controls rules. Because we did not “exempt” from the preventive controls rules (
Nevertheless, we stated in the proposed rule (79 FR 7006 at 7029-7030) that we had tentatively determined that it would be appropriate to waive the applicable requirements of this rule, if finalized as proposed, with respect to retail food establishments holding valid permits, only when engaged in transportation operations as receivers, or as shippers and carriers in operations in which food is relinquished to consumers after transportation from the establishment. As we stated in section III.E., we intend to publish a waiver in the
In the proposed rule we defined “person” to mean individuals, partnerships, corporations, and associations. We have deleted this definition from this final rule, however, because § 1.904 of the rule clearly states that the definitions and interpretations of terms in section 201 of the FD&C Act are applicable to such terms when used in this rule. We did not receive any comments on our definition of the term “person.”
We proposed to define the term “pest” to mean any objectionable animals or insects including birds, rodents, flies, and larvae. We are finalizing this definition as proposed.
(Comment 67) One comment states that, while the utmost care is taken to ensure that natural pests of tree fruit are eliminated during the packing process, the presence of naturally occurring plant pests in tree fruit is not an indication of contamination and, if found, should not be cause for concluding that the tree fruit is adulterated.
(Response 67) There is no provision in this rule by which we would automatically regard the presence of naturally occurring plant pests in tree fruit as grounds for determining that the food is unsafe. We do not intend to establish a standard for the adulteration of tree fruit because of the presence of naturally occurring pests. As we discuss in response to Comment 89, we have revised the provisions of the proposed rule that incorporated the adulteration provisions of the FD&C Act in addressing transportation equipment and operations. As we explained, we did this to avoid misinterpretation of this rule and to clarify that this rule only requires that transportation operations, including the use of transportation vehicles and equipment, must be conducted under conditions and controls necessary to prevent the food from becoming unsafe,
We proposed to define “receiver” to mean any person who receives food after transportation, whether or not that person represents the final point of receipt of the food. We further clarified in the proposed definition that the receiver may also be a carrier or a shipper and that a receiver does not include an individual consumer or a person who holds food on behalf of an individual consumer and who is not also a party to the transaction and not in the business of distributing food. In the final rule, as explained in the discussion of § 1.908(a)(1), we have added a general provision about the multiple roles that can be played by a single entity to replace the separate provisions we had included in the proposed definitions of “carrier,” “shipper” and “receiver.” We have also removed the specificity about the consumer or someone acting on his or her behalf because it was inappropriate for a definition, but we affirm that these entities are not subject to this definition. We did not receive any comments on our proposed definition of “receiver.”
We proposed to define the term “shelf stable” to mean a food that can be stored under ambient temperature and humidity conditions and, if the package integrity is maintained, will not spoil or become unsafe throughout its storage life. Examples of shelf stable food include canned juices, vegetables, and meat, bottled water, and dry food items
While some non-shelf-stable foods that are completely enclosed by a container and do not require temperature control for safety,
(Comment 68) One comment states that we should clarify the definition of “shelf stable food” so that it clearly applies to all shelf stable foods, including food ingredients such as flavoring substances and compounded flavors. The comment states that our proposed definition for “shelf stable foods” may be construed too narrowly because the examples we provided in the proposed language imply that the “shelf stable food” definition applies only to finished food products like canned juice, canned vegetables, or bottled water. The commenter voiced the view that it is unclear from the proposed rule whether we intend for that list to be exhaustive or exclusive. The comment asks us to ensure that the definition clearly applies to all foods, including food ingredients that meet the “shelf stable food” definition. Another comment recommends that we include examples of animal food, such as packaged animal food, in the definition of shelf stable food.
(Response 68) We agree with these comments and affirm that food “completely enclosed by a container,” as expressed in the definition of “transportation operations” encompasses food ingredients as well as finished food products for humans and animals. We are not including examples of such foods because this category of food is extremely broad, making any such list limited relative to the whole, and we believe that the revised definition describes the types of foods encompassed by this exclusion in an understandable manner.
(Comment 69) Some comments state that shippers and carriers need more clarity on which food shipments are shelf stable. One comment states that the proposed definition provides a broad description of what constitutes shelf stable food but does not contemplate the diverse characteristics of food items, such as shelf-lives, packaging, and handling requirements that shippers and carriers will need to consider when determining whether food is shelf stable. The comment, for example, asks: How long the shelf-life of an item must be before it is considered shelf stable; whether packaging susceptible to humidity or humidity abuse would be considered to be fully enclosed,
(Response 69) The shipper of the food, who often is also its manufacturer, would be the person who would be expected to know whether a food falls within the scope of the exclusion from the definition of “transportation operations” applicable to food completely enclosed by a container and that does not require temperature control for safety. We would expect that the shipper would take the steps required under this rule with respect to the transportation of any food that falls within the scope of this definition. This rule does not require the shipper to inform the carrier that a shipment of food is not subject to this rule because it is excluded from the scope of this definition.
In addressing the other questions raised by these comments we can state: (1) The requirements applicable to any food subject to this rule apply during transportation to all receivers that are subject to this rule, not just food bound for retail outlets; (2) In general, we would consider boxes with flaps sealed by tape to be a container that completely encloses the food; (3) The transportation of frozen food is not subject to this rule. As we stated in the proposed rule for preventive controls for human food (78 FR 3646 at 3774), the temperature and time required for a frozen food to become unsafe if not maintained in the frozen state would result in significant quality issues for the food before posing any safety risk, and as we discuss elsewhere in this final rule, we have narrowed the focus of this rule to adulteration linked to food safety; (4) There are packages which physically separate food from its surrounding environment that, nonetheless, allow for oxygen and atmospheric moisture exchange (
We proposed to define the term “shipper” to mean a person who initiates a shipment of food by motor vehicle or rail vehicle. We further clarified in the proposed definition that the shipper would be responsible for all functions assigned to a shipper in this subpart, even if they are performed by other persons, such as a person who only holds food and physically transfers it onto a vehicle arranged for by the shipper, and that a shipper may also be a carrier or a receiver if the shipper also performs those functions as defined in this subpart. We are finalizing a simplified definition of “shipper” to mean a person who arranges for the
(Comment 70) Several comments oppose defining a shipper as the person who “initiates” transportation. One comment states that the term is unnecessarily broad and would create confusion about who is subject to the shipper requirements. Another comment states that the meaning of the proposed definition is unclear because shipments of food can be initiated by many different types of persons during the transportation process, such as manufacturers, distributors, brokers (parties who arrange for the transportation of food held by other parties), and retailers. Another comment states that the shipper definition should describe the person who performs an activity directly related to the transportation process.
Several comments suggest changes to the proposed “shipper” definition. Some stated that the shipper should be the person who physically loads or orders the loading of a motor vehicle trailer or railcar. Some comments state that the shipper should be the manufacturer of the food because that person is most knowledgeable about all relevant factors concerning sanitary transportation of the food. One comment states that the shipper should be the person who decides to ship a food product and sets the transportation process in motion.
Other comments state that the shipper should be the person who owns the food at the time of shipment. One of these comments notes that product owners can best meet the responsibilities assigned to a shipper under the proposed rule even when another party arranges for the transportation of the shipment. The comment states that it is common industry practice for owners of the product to provide third-party logistics providers with instructions for the conditions required for shipments. Several comments advocating these revisions state that their suggested changes would clarify which entities in the transportation chain must meet this rule's requirements for shippers.
Other comments state that the shipper definition should not place shipper responsibilities on persons such as brokers because they lack knowledge about food safety and sanitary food transportation practices. One comment stated that third-party logistics providers, such as distribution centers, should not be subject to the shipper definition. The comment states that, although third-party logistics providers arrange for the transportation of food, they lack knowledge about food safety and rely on product owners to provide that information in establishing sanitary transportation conditions.
One comment stated that brokers are nowhere near the location where a shipment of food is being loaded into a motor vehicle trailer or railcar and, therefore, it is impossible for them to carry out duties assigned to a shipper, such as visually inspecting a vehicle prior to loading. A related comment asserts that facilities that hold the food for which shipment is arranged by an offsite shipper should be responsible for proper storage, handling, and loading or unloading of the food in accordance with FDA and customer requirements. Another comment addressed concerns that under the proposed shipper definition, shipper responsibilities would fall upon receivers who purchase food under a FOB contract in which title to the food passes at the seller's location, even though the receiver would not be present at the time of loading, and therefore could not meet this rule's shipper requirements. The comment states that the entity that physically loads the goods, instead of the receiver, is in the best position to meet a shipper's obligations, such as maintaining written procedures and records, and inspecting vehicles and transportation equipment prior to loading.
(Response 70) We agree that our proposed definition for a shipper,
We first considered which person would be best suited to perform those functions, which involve specifying to the carrier all necessary sanitary requirements for the carrier's vehicle and transportation equipment to ensure that the vehicle is in appropriate sanitary condition, and specifying temperature control parameters to the carrier if the food requires temperature control during transportation. Inasmuch as these functions involve communicating important information to the carrier about operating conditions during transportation, we have determined that the appropriate person to perform these functions is the person who makes the transportation arrangements with the carrier because this person communicates directly with the carrier and can directly provide the carrier with the information required by this rule. While the owner or the manufacturer of the food, or the person who loads the food onto a vehicle, may possess this information, we do not regard these persons as best suited to bear responsibility for providing information to the carrier if neither of these persons actually makes the transportation arrangements with the carrier.
We also considered whether a shipper would need to be knowledgeable about food safety and sanitary transportation practices to perform functions that involve communication with a carrier before transportation occurs. While we agree that persons such as brokers, who arrange for transportation of food held by other parties, likely do not possess the degree of knowledge about food safety that a food manufacturer would, we also agree that current industry practices demonstrate that these persons,
We have determined, therefore, that the person who arranges for the transportation of food by a carrier is best suited to perform the functions of a shipper that take place before transportation occurs and that the person can be someone who only arranges for the transportation of food, for example, a broker, as long as they have, or obtain, the necessary food safety information. We have incorporated these provisions into the revised definition of the term “shipper” in § 1.904.
We also considered the second function assigned to the shipper in our
Therefore, we have determined that the shipper should not be responsible for the functions that person would have been assigned under § 1.908(b)(2) and (4) of the proposed rule involving inspection of vehicles and transportation equipment that take place prior to loading. We are defining an additional term, the “loader” as described previously in this section to designate the person who will be responsible for those functions under this rule under § 1.908(c), which has been redesignated in this final rule as “Requirements applicable to loaders engaged in transportation operations.”
We proposed to define the term “small business” to mean a business subject to § 1.900(a) that employs fewer than 500 persons, except that for carriers by motor vehicle that are not also shippers and/or receivers, this term would mean a business subject to § 1.900(a) that has less than $25,500,000 in annual receipts. In the final rule, we have revised the threshold for motor vehicle carriers to $27,500,000, consistent with the recent change made by the Small Business Administration in the size based standard for trucking firms in 13 CFR part 122.201. We have revised this final rule to base the calculation for “small business” on “full-time equivalent employees.” We used the same approach to calculate full-time equivalent employees for the purpose of this rule as we used to calculate full-time equivalent employees in the preventive controls rules (
(Comment 71) One comment states that the proposed definition of a small business is overly broad and would unduly delay the timeframe for compliance with this rule for the majority of the carriers.
(Response 71) We do not agree that our proposed definition is overly broad. As we explained in the proposed rule (79 FR 7006 at 7014), our proposed definition for a small business was based upon the applicable size-based standards issued by the U.S. Small Business Administration (SBA) under 13 CFR part 121. We believe that allowing businesses that are formally classified “small” by the SBA additional time to come into compliance with the requirements of this rule is appropriate. We also believe that small businesses that are able to come into compliance before their compliance date would do so and use that fact for promotional purposes with prospective customer's,
(Comment 72) A comment stated that we should exempt Class II and Class III railroads (these classifications generally relate to short line and regional railroads respectively) with fewer than 400,000 labor hours from the requirements of this rule. The comment states that the 400,000 labor hours standard has been used by DOT from time to time as the standard for exempting small railroad carriers from regulatory requirements. The comment states that railroads are extremely capital intensive as they pay for their right of way and, typically, small business railroads invest much of their revenue into ties and track structure, equipment maintenance and inspections. The comment further states that shifting the responsibility for the sanitation of railcars carrying food products to the small railroad will be burdensome because these entities currently do not clean or sanitize cars or maintain facilities for such operations. Further, the comment states that it is difficult for railroads to know the storage condition of railcars, and that they cannot be reasonably held accountable for the storage conditions of cars in many circumstances of use.
(Response 72) As discussed in our response to Comment 53, we have revised the definition of the term “carrier” in this final rule, in part, because our proposed definition would have established requirements that railroad operators, typically, cannot meet. We stated that under the revised definition of the term “carrier” in this final rule, a railroad operator only bears responsibilities under this rule when it has agreed to do so in a written contract with the shipper. We believe that this revision addresses the concerns of this comment.
We proposed to define the term “time/temperature control for safety (TCS) food” to mean a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation. As we explained in our response to Comment 111, we have not retained this definition in the final rule. We, therefore, do not need to address comments that we received that suggest revisions or clarifications to the proposed definition.
We proposed to define “transportation” to mean any movement of food in commerce by motor vehicle or rail vehicle. We did not receive any comment on our proposed definition and are finalizing it as proposed.
We proposed to define the term “transportation equipment” to mean equipment used in food transportation operations, other than vehicles, for example, bulk and non-bulk containers, bins, totes, pallets, pumps, fittings,
(Comment 73) One comment asks us to revise the proposed definition of “transportation equipment” to clarify that it encompasses only such equipment exclusively associated with a transportation conveyance. The comment states that the proposed definition is overly broad, and could be interpreted to include structures and equipment normally associated with storage, load-out, and receiving procedures (such as loading bins, spouting and other equipment located within a shipper's or receiver's facility), and not strictly to equipment that directly facilitates transportation activities. The comment suggests that we use the following revised definition: “Transportation equipment means equipment used in food transportation operations, other than vehicles,
(Response 73) We decline this request. The definition of “transportation equipment” already specifies that such equipment is used in transportation operations. While some types of equipment used in food transportation, such as hopper bins, may also be constructed as part of a facility, as we state in our response to Comment 52, we would not consider a hopper bin, that is constructed as part of a facility and that is used for storage of materials (but not the movement of food), to be transportation equipment. Therefore, it would not be subject to this rule.
We proposed to define the term “transportation operations” to mean all activities associated with food transportation that may affect the sanitary condition of food including cleaning, inspecting, maintaining, loading and unloading, and operating vehicles and transportation equipment. We further proposed that transportation operations do not include any activities associated with the transportation of shelf stable food that is completely enclosed by a container, compressed food gases, or live food animals and that all transportation activities involving raw agricultural commodities (RACs) that are performed by a farm are also excluded from the definition of the term “transportation operations.” We are finalizing the definition of “transportation operations” as proposed with some additions. As we discuss in section IV.C., concerning our proposed definition of “shelf stable,” which we have not retained in the final rule, we have amended the definition of “transportation operations” to specify that this term does not include activities associated with transport of a food completely enclosed by a container except a food that requires temperature control for safety. We have also added that transportation operations do not include activities associated with transport of food contact substances as defined in section 409(h)(6) of the FD&C Act, human food byproducts transported for use as animal food without further processing, or live food animals except molluscan shellfish. Finally, we have revised the exclusion for transportation activities performed by a farm to all transportation activities performed by a farm, not just those related to the transport of RACs. We explain our consideration of comments and our reasons for the revisions in our responses to the next 12 comments.
(Comment 74) A few comments ask us to consider excluding, or granting a waiver for, the transportation of food additives and substances that are generally recognized as safe (GRAS), and their precursors, from the proposed requirements of this rule. One comment states that these substances always undergo further inspection, testing, and processing steps, which minimizes the possibility that they could render the food ingredient, or the food that the ingredient is eventually incorporated into, adulterated. One comment states that exemption or waiving is appropriate because the production and supply chain for these substances includes controls to prevent contamination during production, packaging and transport, and is often certified by third parties. One comment urges us to apply this rule's provisions for prior cargo disclosures, protections from allergen cross-contact, and recordkeeping to these substances. The comment expresses the view however that a shipper should be exempted from even these requirements if it can demonstrate that its food additives and GRAS substances have not been transported in containers that have come into contact with any of the seven major food allergens, either because these products are not comingled with other foods or because the carrier does not transport any other food items.
(Response 74) We decline these requests. We acknowledge that food additives, GRAS substances, and their precursors may undergo further inspection, testing, and processing that minimizes the possibility that they could render food adulterated, or that they may be subject to controls and third-party certification that address protection of the substance during transportation. However, this is a broad group of substances with diverse packaging and transportation practices (
(Comment 75) One comment asks us to consider excluding shippers and carriers who transport byproducts from a processing facility,
(Response 75) We have partially accommodated this request in this final rule by excluding from the definition of transportation operations, “human food byproducts transported for use as animal food without further processing.” The intent of this new language is to exclude from the definition human food byproducts that are not further processed into a manufactured animal feed. Most commonly, we expect that these byproducts move directly from the human food manufacturer to the farm, where they are fed directly to livestock, often by spreading on the ground. We do not intend to exclude from the definition of transportation operations human food byproducts that are transported to a business to be used as an ingredient in a manufactured animal food, or to be further processed in some
With respect to transportation of human food byproducts for further processing into animal feed, we decline the request to remove such operations from the definition of transportation operations because we have determined that this final rule's recordkeeping and inspection requirements as applied to the transportation of such products are not burdensome and are appropriate for these types of transportation operations. The requirements we are establishing in this rule require that transportation operations be conducted so as to prevent food from becoming adulterated during transportation. We do not envision, for example, that carriers who transport spent grain materials to animal feed manufacturing facilities would have to clean or inspect their vehicles any more frequently under this final rule than what is already typically being done to facilitate safe transportation. However, if carriers haul intervening loads of fertilizer, for example, they would need to clean their vehicles before transporting spent grain intended for use as animal feed. In addition, as we explained in our response to Comment 149 and Comment 160, in § 1.908(e)(4) and (e)(5) of this final rule, we have revised the proposed previous load and cleaning reporting requirements for bulk carriers in a manner that will reduce, and in some cases eliminate, recordkeeping requirements for these carriers.
(Comment 76) Several comments support our proposed provision that would exclude the transport of live animals from the definition of “transportation operations.” One comment disagrees with our tentative conclusion that sanitary transportation practices are not necessary to prevent live food animals from becoming adulterated during transportation and our proposal, therefore, to exclude their transport from the scope of this rule. This comment suggests that transportation during hot and cold weather, as well as long-distance transport, causes stress in the animals, resulting in increased shedding of pathogenic microorganisms in the manure of the animals being transported. The commenter asserts that these pathogenic microbes may be spread from one animal to another via physical contact in transportation vehicles, possibly resulting in a higher percentage of animals arriving at slaughter facilities with high levels of pathogenic microbes on their hides or feathers. The comment asserts that the more animals that arrive at slaughter with pathogens on their hides or feathers, the more likely that the mitigations applied by the slaughter facilities will be ineffective. The commenter further asserts that FSIS inspection at slaughter facilities is inadequate to mitigate this increase in risk and, therefore, asks us to require the cleaning of transportation vehicles with disinfectants between animal loads to mitigate the risk.
(Response 76) We disagree with this comment. We recognize that the stress of transportation may increase the shedding of pathogenic bacteria in the manure of animals during transport, but we are not aware of scientific information that establishes that this leads directly to an increased level of pathogenic bacteria in food products originating from animals coming from FSIS-inspected slaughter facilities that could be controlled by establishing requirements through this rulemaking. The slaughter facilities handling the processing of these animals, as well as the regulatory agencies responsible for oversight of the facilities, such as the FSIS, are aware of these issues and the procedures they use to process these animals have been developed with this risk in mind. Slaughter operations at facilities subject to FSIS jurisdiction, for example, are already subject to requirements intended to minimize the risk of adulteration posed by the presence of contaminants on the external surfaces of live food animals.
(Comment 77) One comment asks us to apply this rule's waiver provisions to determine whether to waive requirements for the transport of live food animals. The comment further asserts that we should use the waiver procedure, in part, to provide for an additional opportunity for public comment with respect to the risks that may be associated with the transportation of live food producing animals.
(Response 77) We disagree. Section 416(d)(1)(A-B) of the FD&C Act provides us with the authority to waive any requirement of this rule with respect to any class of persons, vehicles, food, or nonfood products, if we determine that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health, and will not be contrary to the public interest (21 U.S.C. 350e(d)(1)(A-B)). As we discussed in the proposed rule (79 FR 7006 at 7015), we are not aware of food safety concerns related to the transportation of live food animals intended for slaughter that could be addressed through this rule's sanitary transportation requirements. Furthermore, we also address specific concerns the commenter raised about this issue in our response to Comment 76, and explain why we have concluded that establishing requirements through this rulemaking to address those concerns is not necessary. The prerequisite condition for considering whether we should waive the requirements of this rule for the transportation of live food animals therefore does not exist,
(Comment 78) One comment on our proposed definition of “transportation operations” notes that the exclusion of live food animals from the definition possibly conflicts with our own guidance under the National Shellfish Sanitation Program (Ref. 26). It stated that some states, operating under FDA guidance, require temperature control during the transport of raw molluscan shellfish between the harvest area and the first receiver (also known as the “dealer”). Participants made similar comments during the public meetings that we held on this proposed rule.
(Response 78) We agree that temperature control is necessary to ensure the sanitary transportation of molluscan shellfish (
(Comment 79) Many comments support the exclusion of transportation activities for RACs performed by farms and voice the view that the exemption should be retained in our final rule. Several comments advocate for limiting
(Response 79) We are not aware of food safety concerns related to the transportation of RACs by farms that could be addressed through the sanitary transportation practices set forth in this rule, as we stated in the proposed rule (79 FR 7006 at 7016). We also stated in the proposed rule that we are not aware of instances in which insanitary conditions or practices, for example, improper temperature control, improper equipment construction, or inadequate equipment cleaning involving the transportation of RACs by farms have contributed to foodborne illnesses. We further stated that we recognize the diversity of farms and their transportation operations, including the size of the operation, the nature of the crop(s) being transported (
Upon further consideration, we have also concluded that the exclusion from the transportation operations definition related to transportation activities performed by farms should not be limited to RACs. We are aware that farms ship and receive food items that are not RACs (
Section 416(d)(1)(A) and (B) of the FD&C Act provides us with the authority to waive any requirement of this rule with respect to any class of persons, vehicles, food, or nonfood products, if we determine that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health, and will not be contrary to the public interest. As we discussed in the proposed rule with respect to the transportation of RACs (79 FR 7006 at 7016), and are affirming herein, and as we discussed previously in this response with respect to other types of food transported by farms, we are not aware of food safety concerns related to transportation activities performed by farms that could be addressed through the sanitary transportation practices set forth in this rule. Accordingly, the prerequisite condition for considering whether we should waive the requirements of this rule for transportation activities performed by farms does not exist,
(Comment 80) One comment asserts that if transportation activities for RACs performed by a farm are excluded from this rule, we should clarify that a carrier would not be held responsible for any contamination that may have occurred before the RACs were loaded into the carrier's vehicle.
(Response 80) Under this final rule, as revised, transportation activities for any food, including RACs, performed by farms, while not subject to the requirements of the rule, are still subject to the adulteration and other applicable provisions of the FD&C Act and our applicable implementing regulations. A farm that acts as a carrier, for example, that transports RACs and that is excluded from this rule, is still subject to section 402(a)(4) of the FD&C Act, which prohibits the holding of food under insanitary conditions whereby it may be rendered injurious to health or may become contaminated with filth.
(Comment 81) One comment asks us to clarify whether fruit transported to a processing facility falls under the proposed exclusion for the transportation of RACs performed by a farm.
(Response 81) Transportation activities for RACs, including fruit, to processing facilities are excluded from coverage under this rule, only if the activity is performed by a farm as defined in this rule. However, farms subject to the produce safety rule will be required to take steps to address the transportation of covered produce under that rule. Section 112.125 of the produce safety rule requires that equipment subject to that rule that is used to transport covered produce must be adequately clean before use in transporting covered produce and adequate for use in transporting covered produce.
(Comment 82) One comment asks us to clarify whether this rule applies to dairy farmers who transport bulk animal feed in their own vehicles from a facility to their own farm. A second comment asks us to clarify whether almond hulls and shells are eligible for the rule's RACs transported by farms exemption.
(Response 82) As we discuss in Comment 79, we have revised this final rule to provide that all transportation activities performed by a farm, and not solely those activities involving the transportation of RACs, are not subject to this rule.
(Comment 83) Some comments ask us to clarify whether this rule applies to non-farm carriers who transport RACs on farms or from farms to processing facilities where additional sanitation procedures or microbial kill steps occur, for example, when fruit RACs are processed at the receiving facility into canned fruit. Some comments argue that RACs that are moved on a farm or from a farm to a processing facility should not be subject to the requirements of this rule, regardless of who owns and operates the vehicles and transportation equipment.
(Response 83) Non-farm carriers, unless they are non-covered businesses, engaged in transportation operations, as defined by this rule for RACs, are subject to this rule regardless of whether the RACs are intended to be further processed. While the RACs in question may be further processed, there may be circumstances in which controls, for example, a specific vehicle cleaning procedure, are necessary to ensure that sanitary transportation practices are followed. We have added provisions to § 1.908(a)(3) of this rule to provide sufficient flexibility to allow persons engaged in the transport of food intended for further processing to use sanitary transportation practices that are appropriate for their circumstances. The movement of RACs on a farm that have not entered commerce is not subject to this rule because such on-farm movement is not considered to be transportation, as defined in this rule.
(Comment 84) One comment agrees that transportation of a shelf stable food that is completely enclosed by a container should be excluded from coverage under this rule, as we proposed. It states that, in addition, the exclusion should be extended to those same materials shipped in dedicated bulk containers, so long as the containers meet the criteria for sanitary food transportation.
(Response 84) We wish to make it clear that this comment addresses transportation equipment and not vehicles. We agree with this comment provided that the shelf stable food as packaged within the equipment,
(Comment 85) Several comments ask us to delete the word “solely” from the language in the definition of transportation operations excluding activities associated with the transportation of shelf stable foods from this definition. One comment states that the term “solely” is confusing and appears to suggest that shelf stable food should be shipped in separate loads apart from non‐food items and other covered food items.
(Response 85) We agree that the word “solely,” as used in the proposed definition of “transportation operations,” may be confusing and we have concluded upon further consideration that it is not necessary. We, therefore, have removed the term “solely” from the definition of transportation operations.
We proposed to define the term “vehicle” to mean a land conveyance that is motorized,
(Comment 86) One comment asserts that the definition of “vehicle” as any “land conveyance that is motorized” and the use of the term “motor vehicle” are excessively broad and could be misinterpreted to include a wide range of motorized vehicles, including automobiles. The comment also notes that there are instances in which railcars, trucks, and trailers can be used to store food products. This comment asks us to narrow this definition to read: “Vehicle means a truck or railcar, which is used in transportation operations and not to hold food.”
(Response 86) We decline to make the suggested change. The definition of vehicle is intentionally broad and could include automobiles. We do agree that sometimes railcars, trucks, and trailers can be used to store food products, and we will incorporate that possibility into our implementation of this rule. A truck or trailer used for the permanent or semi-permanent storage of ingredients or finished food products is not within the scope of this rule and could be considered as part of a facility and regulated under another of our applicable regulations,
In table 7 we outline the revisions we have made to § 1.906 in finalizing this rulemaking. Following the table we respond to comments about these provisions and describe the changes we have made to the provisions in finalizing the rule.
We proposed to require that vehicles and equipment used in transportation operations must be so designed and of such material and workmanship as to be suitable and adequately cleanable for their intended use, to prevent the food they transport from becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during transportation operations. Consistent with a decision to more narrowly focus this rule on adulteration linked to food safety as explained in responses to comments below, we have finalized this provision to require that vehicles and equipment used in transportation operations must be so designed and of such material and workmanship as to be suitable and adequately cleanable for their intended use to prevent the food they transport from becoming unsafe,
(Comment 87) A comment from a non-profit organization that develops and updates equipment standards and processing practices asks us to include a provision in the final rule stating that vehicles and transportation equipment that have been fabricated in conformance with its standards and/or operated in accordance with its practices, and have been maintained in a sanitary manner, will be deemed to have met the minimum requirements of this rule.
(Response 87) We are not making this suggested revision. It is the responsibility of the persons subject to this rule to determine whether the vehicles and transportation equipment that they use or offer for use in food transportation operations meet the requirements of this rule.
(Comment 88) A few comments state that this regulation should not preclude
(Response 88) Similar to statements we made in the produce safety rule (80 FR 74353) and final human food preventive controls regulation (80 FR 55908) about wooden bins, we are not precluding the use of transportation vehicles and equipment constructed of wood under this rule. However, where the intended use of the vehicle or equipment is such that food would be in direct contact with the wooden surface of transportation vehicles or equipment, we expect that such vehicles or equipment would be used only to the extent they are cleanable and unlikely to support conditions that may make the food unsafe (see Comment 95).
(Comment 89) Several comments address provisions of this rule for transportation equipment used in operations involving food materials destined for animal consumption. One comment asserts that the provisions in proposed 1.906(a), (b), and (e), do not seem to consider the transportation of materials that are already in a condition not suitable for consumption without further processing, such as viscera, offal, and other byproducts from the chicken slaughtering process. The comment notes that firms transport these materials to facilities where they will be further processed and treated to recondition the materials to make them suitable for animal consumption. Although the transportation conveyances used to transport these materials to processing facilities may, in fact, allow the growth of microorganisms during transport, the subsequent treatment process accounts for this and effectively renders the materials suitable for animal consumption. A similar comment states requiring transportation conveyances for animal food to be free of “filthy, putrid, or decomposed substances” should not apply to unprocessed raw materials destined for rendering. These materials include offal and trimmings from animal slaughter, dead animals, and spoiled or outdated meat from retail food establishments. They are transported by renderers in specialized equipment to prevent leakage and spills, but requirements related to refrigeration, microbial contamination, decomposition, and adulteration during transportation are not germane to these raw materials destined for further processing and hazard control. Another comment asks us to revise the rule to state explicitly that vehicles and transportation equipment must be designed, maintained, and stored in appropriate sanitary condition “for their intended use.” According to this comment, doing so would clarify that different sanitary food transportation requirements can be applied to vehicles and transportation equipment, depending on the intended uses of the vehicles and equipment, while still making it clear that appropriate precautions must be followed in all circumstances. The commenter notes, for example, that although byproduct materials do not need to be transported under conditions that prevent them from becoming decomposed because they already are in this condition at the start of transportation, it would not be appropriate to transport these materials in a container that previously held a chemical contaminant that will not be eliminated through further processing if the container was not adequately cleaned before use.
(Response 89) We agree that in the proposed rule, we applied language from section 402 of the FD&C Act identifying circumstances under which food is adulterated in an overly broad manner so as to suggest, unintentionally, that any food in transport that exhibits any cited criteria of section 402 is adulterated, regardless of the nature of the food or its intended use. We understand how a reader might interpret proposed §§ 1.906 and 1.908 to mean that vehicles must be maintained and operated to always preclude food from becoming filthy, putrid, decomposed or otherwise unfit for food during transport, and that all food, including, for example, materials destined for rendering, that become filthy, putrid, decomposed or otherwise unfit for food as the result of transportation operations are adulterated. We, therefore, have revised § 1.906(a), (b), and (d), and § 1.908(a) to state that the relevant requirements for transportation vehicles, equipment and operations take the intended use of a vehicle or equipment into account and that the intent of these requirements is to prevent food from becoming unsafe,
We also recognize that provisions in §§ 1.906 and 1.908 of the proposed rule that refer to the need, under certain circumstances, for temperature control of food during transport to prevent the “rapid growth of undesirable microorganisms” are used without appropriate consideration of the intended use of the food,
As we discuss in our response to Comment 130, regarding revisions we have made to proposed § 1.908(a)(3), we are also clarifying that, under this rule, the consideration of the type of food and its stage in the relevant production cycle are relevant in determining the necessary sanitary conditions and controls for any given transportation operation.
(Comment 90) One comment asks us to exempt equipment used for transporting fruit and vegetable culls, for deposit into pastures as food for grazing animals, from the bulk vehicle requirements of this rule. It notes that Florida fresh citrus packinghouses often
(Response 90) As we discuss in Comment 75, we have added a provision to this final rule excluding human food byproducts transported for use as animal food without further processing from coverage by this rule. Therefore, transportation operations for fruit and vegetable culls, for deposit into pastures as food for grazing animals, are not subject to this rule.
We do not agree that the other types of vehicles described in these comments, or the transportation operations in which they are used, should be exempt from this rule. The requirements we are establishing for vehicles and transportation equipment, as we explained in our response to the previous comment, require that vehicles and transportation equipment be designed, maintained, and stored to prevent food from becoming adulterated during transportation under the vehicles' intended uses. These requirements are not burdensome and are appropriate even for vehicles used in operations where the risk of food adulteration is low.
Finally, we note in response to the comment that bagged animal feed and bagged animal feed ingredients are exempt from this rule. These items fall outside of the scope of “transportation operations” (as defined in § 1.904) that are subject to the rule because they are food completely enclosed by a container that does not require temperature control for safety.
(Comment 91) A few comments ask us to address the appropriate sanitary conditions for the use of wood pallets. One comment observes that wood is a porous material and therefore is vulnerable to water absorption and potential contamination, but asserts that as long as the food is in appropriate containers and does not come into direct contact with wood pallet surfaces, the opportunity for contamination is slight. Another comment asserts that the pallet conditions that we described as being insanitary in the proposed rule are too restrictive for animal feed transport and allow an FDA inspector too much subjectivity in determining whether a pallet is fit for its intended use.
(Response 91) Pallets need to be maintained so that they do not pose a risk of contaminating food during transportation or of compromising the integrity of the food containers that are supported by the pallet. For example, where the intended use of the pallet is such that food would be in direct contact with the wooden surface of the pallet, we expect that pallets would be used only to the extent they are cleanable and unlikely to support conditions that may make the food unsafe. (See Comment 88). In addition, pallets should not have jagged edges that protrude into the carrying surface in a way that could damage the product being shipped,
(Comment 92) One comment asks us to amend the rule to allow railcars currently in use to remain in use until they are retired from service. The comment states that the absence of recent food safety incidents involving the rail transportation of food demonstrates that the design of railcars currently used in food transportation operations is adequate.
(Response 92) There are no provisions in this rule that would require a railcar currently in use to be removed from service, as long as its condition permits the safe transport of food in accordance with established industry practices. If a railcar is in a condition not suitable for such use, we would expect that the railcar provider would take that car out of service for refurbishment or that the shipper would refuse to use the car if it is offered for food transport.
(Comment 93) A few comments state that the term “adequately cleanable” used in proposed § 1.906(a) is vague. One comment asserts that it fails to provide any discernable benefit to food transporters in preventing food contamination.
(Response 93) As we state in our response to Comment 49, the term “adequate” is a long-standing term that we defined in its current form when we first established cGMP requirements for the manufacturing, packing, and holding of human food. We are using the terms “adequate” and “adequately cleanable” to provide flexibility for shippers, loaders, carriers, and receivers to comply with the requirements of this rule in a way that is both effective for purposes of preventing the adulteration of food during transport and most suitable for their particular operations.
(Comment 94) One comment states that we should recognize that not all transportation equipment needs to be cleaned before being used. The comment observes that cleaning wooden pallets can do more harm than good if proper precautions are not followed to prevent mold growth from moisture. The commenter notes that while it may be appropriate to expect water-based cleaning of certain types of transportation equipment, like hoses, for example, between every use, these kinds of cleaning practices should not be used for wooden pallets. The comment states that a visual inspection of pallets for cleanliness and suitability is sufficient to demonstrate that the pallets are acceptable for use and that the “adequately cleanable” standard for pallets should focus on the dry removal of debris like dust and dirt, when necessary.
(Response 94) We agree that there are circumstances under which some transportation equipment would not need to be cleaned before each use and that pallets that are adequately clean for their intended use do not necessarily need to be cleaned after each use. However, when the cleaning of vehicles and transportation equipment is necessary for a transportation operation to meet the requirements of this rule, we would expect that appropriate cleaning practices will be followed. We address our principal concerns about the use of pallets in our response to Comment 91.
We proposed to require that vehicles and transportation equipment be maintained in such a sanitary condition as to prevent the food they transport from becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during transportation operations. Consistent with a decision to more narrowly focus this rule on
(Comment 95) One comment states that this rule should explicitly distinguish between the terms “sanitize” and “clean” with respect to the intended use of the food being transported. The comment states that human food should be transported using equipment and vehicles that have been “sanitized” to prevent illness while a “clean” vessel is acceptable for the transport of animal feed.
(Response 95) We did not define the terms “sanitize” or “clean” in the proposed rule and we decline the commenter's suggestion that we do so in this final rule. Section 1.906(b) states that vehicles and transportation equipment must be maintained in a “sanitary condition.” We do not consider “sanitary condition” to be synonymous with “sanitize.” We consider “sanitary condition” to be a state of cleanliness. The term “sanitize” is associated with the reduction of potentially harmful microorganisms. Section 1.906(b) further states that the requisite sanitary conditions of vehicles and transportation equipment are to be determined by the “intended use” of the vehicles and equipment in order “to prevent the food they transport from becoming unsafe during transportation operations.” Accordingly, as we state in our response to Comment 2, we recognize that the applicable sanitary transportation practices may vary depending on the types of food that are being transported. More stringent practices, for example, that might be necessary to ensure the sanitary transportation of one type of food,
(Comment 96) One comment states that proposed § 1.906(b)'s requirement that vehicles and transportation equipment, such as hoses and pumps, be maintained in a “sanitary” condition is too ambiguous. The comment asks what it means for vehicles and equipment to be clean or sanitary, how we expect firms to meet this regulatory requirement, and what other types of transportation equipment we anticipate will be subject to this provision. The comment asserts that under certain circumstances, animal feed for livestock can still be protected from becoming unsafe even if the equipment used to transport it is not sanitary, clean, or washed out prior to shipment. The comment states, for example, that a firm can use dedicated equipment, product sequencing, and equipment flushing with water or another appropriate fluid followed by blowing the lines clear. Another comment states that railway hopper cars and semi-trailers used for transporting feed ingredients are not always dedicated to a single ingredient, but rather frequently are also used to haul RACs. This comment notes that, as a matter of current industry practice, cleaning between feed ingredient and RAC loads is minimal because there is an assumption that minor co-mingling of different plant materials does not result in adulteration or otherwise present health hazards.
(Response 96) We are requiring in § 1.906(b) that vehicles and transportation equipment must be maintained in such a sanitary condition for their intended use as to prevent food from becoming unsafe during transportation operations. We are not prescribing, in this rule, methods (such as washouts) for the cleaning and maintenance of vehicles and equipment, nor are we establishing required intervals for cleaning operations. Firms may employ any cleaning procedures and intervals that meet the requirements of this rule.
(Comment 97) One comment states that the term “sanitary” as used in proposed § 1.906(b), and throughout the rule, is misleading because its general meaning infers a standard that exceeds the common understanding of the term “clean.” The comment states that transportation equipment and containers for animal feed for livestock do not need to be “sanitary,” but clean enough so as to prevent adulteration of the feed. The comment suggests that we delete the word “sanitary” from the rule except when we refer to the transportation requirements for human or pet food.
(Response 97) We decline to remove, or otherwise limit the use of, the word “sanitary” from this rule. We have not defined this term to mean “beyond clean” and our use of this term in the rule is not ambiguous. As we note in our response to Comment 95, we consider the term “sanitary” to be a state of cleanliness and we do not consider the term “sanitary” to mean that vehicles and transportation equipment necessarily must be “sanitized” to ensure that food is not rendered unsafe during transportation operations. We use the word “sanitary” in §§ 1.906 and 1.908 as it would apply to the conditions and controls employed for transportation operations, vehicles, and equipment to ensure that food will not be rendered unsafe during transportation. This is consistent with our responsibilities under section 7202 of the 2005 SFTA, which states that we shall, by regulation, require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food unsafe.
Finally, as we also state in our response to Comment 2, we agree that this rule should more clearly recognize that sanitary transportation practices may differ depending on the types of food being transported, for example, human food versus animal food. Our response to that comment discusses revisions we have made to §§ 1.906 and 1.908 to clarify this point.
(Comment 98) One comment asks us to acknowledge that polymerized oil residues that form on the interior steel surfaces of rail tanker cars during the repeated hauling of edible oils for processing into feed ingredients do not adulterate the oil. The comment notes that these residues only present food quality concerns and are removed by filtration and further processing.
(Response 98) We agree. Residues that may form during edible oil transportation operations as described in the comment, which we would expect to be removed during further processing steps, are constituents of the oil which are not toxic by nature and do not make the food unsafe.
We proposed to require that vehicles and transportation equipment that are used in transportation operations for food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation must be designed, maintained, and equipped, to maintain the food under temperature conditions that will prevent the rapid growth of undesirable microorganisms. Consistent with a decision to more narrowly focus this rule on adulteration linked to food safety and to add flexibility with regard to the approach to monitoring
(Comment 99) Several comments ask that we acknowledge that means other than refrigerated vehicles can be used to keep food adequately cold during transport. These include the use of ice, dry ice, insulated coolers, and cooler totes. Another comment asks us to clarify that firms are not required to purchase cold foods from vendors with refrigerated vehicles, that is, the comment seeks clarification that firms can purchase cold foods from vendors who use means other than refrigerated vehicles for purposes of maintaining necessary temperature control of food products during transport.
(Response 99) There is no requirement in this rule that foods subject to temperature control requirements must be transported in refrigerated vehicles or must be purchased from vendors with refrigerated vehicles. The use of the alternative methods described in this comment for keeping food cold during transport are acceptable under this rule if the vehicles, for example, catering trucks and commissary delivery vehicles, equipment, and transportation operations comply with the requirements of §§ 1.906 and 1.908.
We proposed to require that each freezer and mechanically refrigerated cold storage compartment in vehicles or equipment used in transportation operations for food that can support the rapid growth of microorganisms in the absence of temperature control during transportation must be equipped with an indicating thermometer, temperature measuring device, or temperature recording device to show the temperature accurately within the compartment. We have removed § 1.906(d) as proposed from the rule.
(Comment 100) A few comments address this proposed requirement. A participant at one of the public meetings we held on the proposed rule stated that we should require a temperature recording device for all transport vehicles that use refrigeration. One submitted comment states that it should not apply to a carrier if the shipper has provided its own device or relies on measures such as ice packs to maintain adequate temperature control. Another comment asks us to explicitly permit the use of hand-held temperature recording devices as an alternative to devices installed in or on a cold storage cooler. A few comments assert that low cost, time-temperature indicators are generally adequate for temperature monitoring purposes and that we should not require the use of expensive installed recording devices. A comment from the seafood industry states that ensuring continuous temperature control during the entire transit time requires the use of time-temperature recording devices (or the effective use of ice or other cooling media) and that indicating thermometers and temperature measuring devices are inadequate because they do not provide continuous documentation of temperature readings.
(Response 100) We agree that there are a number of effective methods for monitoring temperature control during food transportation, some of which do not require the permanent installation of a device in the compartment. We reconsidered this proposed provision and have determined that persons subject to this rule should be able to use any effective means to monitor temperature control, such as those suggested by the comments, and that it is not necessary to retain this proposed requirement. Therefore, we have removed this provision from this final rule.
(Comment 101) One comment also states that the proposed rule did not discuss the need for temperature indicating devices to be checked for accuracy and calibration.
(Response 101) As we stated in our response to Comment 100, we have removed the requirement that vehicles and transportation equipment be equipped with a temperature indicating device from this final rule. Therefore, there is no need to establish temperature measuring equipment calibration requirements in this final rule.
We proposed to require that vehicles and transportation equipment must be stored in a manner as to prevent the vehicles or transportation equipment from harboring pests or becoming contaminated in any other manner that could result in food for which they will be used becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during transportation operations. Consistent with a decision to more narrowly focus this rule on adulteration linked to food safety as explained in responses to comments that follow (particularly see Comment 89), in this final rule we are requiring that vehicles and transportation equipment must be stored in a manner that prevents it from harboring pests or becoming contaminated in any other manner that could result in food for which it will be used becoming unsafe during transportation operations. In the final rule, this provision is redesignated § 1.906(d) consistent with the removal of proposed § 1.906(d).
(Comment 102) One comment notes that some end-users store pallets used in transportation operations out-of-doors prior to use. The comment argues that end-users' pallet storage practices are just as, if not more, important for food safety than the programs and processes followed by pallet manufacturers and that pallets must be stored in an area with adequate light and airflow to prevent the formation of mold on the pallets.
(Response 102) We have established requirements for the storage of transportation vehicles and equipment, including pallets, in § 1.906(d). The outdoor storage of pallets is permissible if the pallets meet the requirements of this section when they are used in transportation operations,
(Comment 103) One comment states that railroad carriers shouldn't be responsible for how a railcar is stored at a third-party facility and asks us to clarify that the current industry practice of storing railcars on spur tracks and in rail yards is acceptable.
(Response 103) We agree that the storage of railcars on spur tracks and in rail yards is acceptable if such storage meets the requirements of this rule (
In table 8, we describe revisions to proposed § 1.908 and following the table we respond to comments related to these provisions.
We set forth in proposed § 1.908(a) general provisions and requirements applicable to transportation operations.
(Comment 104) We received many comments expressing concern that the proposed rule did not sufficiently recognize that practices for the transportation of raw materials may differ from those for finished food products, and that practices for the transportation of animal feed may differ from those used to transport pet food and finished human food.
(Response 104) We agree with the comments and have added new § 1.908(a)(4) to make it clear that the type of food
(Comment 105) One comment expresses concern about the potential for cross contamination during the transportation of RACs. The comment states that the cross utilization of any equipment, including transportation vehicles, should be conducted in a manner that does not subject RACs to contamination and that equipment used to transport any food products that are minimally processed and consumed raw should be subject to sanitary requirements tailored to ensure the safety of the products.
(Response 105) We agree that cross utilization of vehicles and equipment should not subject any food, including RACs, to cross contamination during transport. The provisions of § 1.906 require the design, maintenance and storage of vehicles and transportation equipment, to be such that they will not cause food to become unsafe during transportation operations. In addition, § 1.908(a)(3), which in part addresses the proper use of vehicles and equipment in transportation operations, requires that all transportation operations must be conducted under such conditions and controls necessary to prevent the food from becoming unsafe.
As previously discussed in the sections of this document related to the definitions of carrier, shippers and receivers, we have removed from these definitions the proposed sentence in each definition that stated that a party may serve in more than one capacity under this rule,
(Comment 106) One comment asserts that the requirements of this rule appear to duplicate warehousing and distribution requirements that appear in the FSMA preventive controls for human food rule, which require that food storage and transportation must be conducted under conditions that will protect against cross-contact and biological, chemical, physical, and radiological contamination of food, as well as against deterioration of the food and its container.
(Response 106) The preventive controls rule for human food requirements in 21 CFR 117.93 provide broad good manufacturing practice (GMP) standards for warehousing and transportation-related activities that occur within the context of warehousing and distribution operations of facilities engaged in the manufacturing, packing, and holding of human food. This rule is intended to be complimentary to those and other provisions of the Preventive Controls rules for human and animal food and establishes more detailed requirements for shippers, loaders, receivers, and carriers to use sanitary transportation practices to ensure that food is transported under conditions that will prevent it from becoming unsafe. This is FDA's only rule that addresses the transportation of food in an integrated manner from beginning to end by establishing the interactions that must occur between shippers, loaders, carriers, and receivers to ensure that sanitary food transportation practices are used by the food industry. It is also the only rule to which carriers are directly subject. Accordingly, this rule is not redundant, as asserted by this comment, because it expands on the transportation-related requirements contained in the GMPs.
(Comment 107) A few comments question the appropriateness of using the terms “under such conditions and controls necessary to prevent the food from becoming . . . decomposed or otherwise unfit for food” to describe requirements for transportation
(Response 107) We acknowledge in our response to Comment 89 that we applied the language from section 402 of the FD&C Act in an overly broad manner in the proposed rule, so as to suggest, unintentionally, that any food in transport that is undergoing a natural process,
(Comment 108) One comment encourages us to ensure that time/temperature control provisions of this final rule will complement related provisions contained in our seafood HACCP regulation.
(Response 108) Our intent in drafting this final rule is to make it compatible with the seafood HACCP rule, which does not include requirements applicable to carriers. Under the seafood HACCP regulation, receivers are required to ensure that transportation was performed under appropriate temperature control, where such control is necessary for the safety of the food. To accomplish this, receivers of seafood often request temperature monitoring information from the carrier upon receipt. As we discuss in our response to Comment 129, this rule should assist receivers of seafood products by requiring that, upon their request, carriers must provide the operating temperature specified by the shipper and demonstrate that it has maintained temperature conditions during the transportation operation consistent with that operating temperature.
We proposed to require that persons take effective measures, such as segregation or isolation, to prevent raw foods and nonfood items from contaminating other food products that might be shipped in the same load during transportation operations.
(Comment 109) One comment addressing proposed § 1.908(a)(3)(i) asserts that current industry practices ensure the adequate separation of ready-to-eat food items from raw foods and nonfood items through the use of packaging and impermeable barriers. The comment also states that our
(Response 109) The 2005 SFTA mandates that we issue regulations to require that shippers, carriers, receivers and other persons engaged in the transportation of food use sanitary transportation practices to ensure that food does not become adulterated during transportation. We agree that both packaging, and segregation or isolation can be effective means of protecting food from contamination by raw foods or nonfood items in the same load. Therefore, we have revised proposed § 1.908(a)(3)(i) to include packaging as one of the examples of such preventive measures during transportation operations.
We proposed to require that persons engaged in transportation operations take effective measures such as segregation, isolation, or other preventive measures such as hand washing, to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination and cross-contact during transportation operations.
(Comment 110) One comment addressing proposed § 1.908(a)(3)(ii) asserts that persons who handle animal feed or raw feed ingredients without using gloves or washing their hands are not going to contaminate or adulterate food while engaged in loading, unloading, or transportation activities. The comment, therefore, asks us to exempt persons who handle animal feed from this provision.
(Response 110) This provision does not require that persons who handle animal feed or raw feed ingredients always wear gloves and/or wash their hands. These measures are provided only as examples of steps persons may take to meet the requirements of this rule. As proposed, § 1.908(a)(3)(ii) provides persons engaged in food transportation the flexibility to determine for themselves which measures are necessary to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination and cross-contact during transportation operations. For this reason, we have not modified this section.
We proposed to require persons engaged in the transportation of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation to follow transportation practices, including attention to temperature conditions, to prevent the food from becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source.
(Comment 111) Several comments ask us to reconsider including temperature control requirements for non-TCS foods that require temperature control only for purposes of preventing spoilage and not for purposes of ensuring food safety.
One comment states that because there are no potential safety hazards associated with such non-TCS foods, strict transportation temperature control requirements are not warranted. One comment observes that we proposed to exempt facilities that hold completely packaged refrigerated food from the requirements of the proposed FSMA preventive controls rule for human food, with the exception of facilities that hold TCS food. Under the preventive controls rule, facilities that hold such TCS food are only subject to preventive controls requirements to provide appropriate temperature control for such food. The comment asserts that we should not impose more stringent requirements on the transportation of food than we require for the holding of food under the preventive controls rule. The comment asserts that this rule, therefore, should not apply transportation requirements for temperature control to non-TCS foods that require temperature control
One comment acknowledges that the language of the 2005 SFTA is somewhat different from the language FSMA in that it directs us to issue regulations that are meant to ensure that food is not transported under conditions that may render the food adulterated. The comment further notes that adulteration is broadly defined by the FD&C Act and can encompass issues such as food spoilage in addition to the narrower issue of food safety. However, this comment states that such considerations are already addressed by the FD&C Act's adulteration provisions in section 402, and notes that FDA has the discretion to implement the provisions of the 2005 SFTA in a manner consistent with a risk-based framework focused more narrowly on food safety risks.
Another comment states that while the temperature control provisions of this rule should not address non-TCS foods, it does not object to the inclusion of references in § 1.906 to the prevention of the rapid growth of undesirable microorganisms (which would include microorganisms that cause spoilage) with respect to the design and maintenance of vehicles and transportation equipment, and in § 1.908 with respect to conditions for loading and unloading food, because these provisions do not relate to the maintenance of temperature control during transportation.
(Response 111) We agree with the comments and explain in our response to Comment 89 that we have revised this rule to require temperature control only for foods that require temperature control for safety. Conversely, the temperature control requirements do not apply to food that is transported under temperature control for other reasons, for example, for marketability purposes, or to prevent spoilage of the food. In particular, we agree with the comment that stated that nonsafety considerations are already adequately addressed by the FD&C Act's adulteration provisions in section 402, and that we have the discretion to implement the provisions of the 2005 SFTA in a manner consistent with a risk-based framework focused more narrowly on food safety hazards.
We also have reconsidered whether to define a descriptive category for the type of food (
The temperature control requirements of this rule apply to any food that requires temperature control for safety during transport, and foods in the latter category, though not subject to the temperature control requirements of this rule, are still subject to the adulteration provisions and other applicable provisions of the FD&C Act and applicable implementing regulations.
(Comment 112) One comment asks us to rewrite the temperature control provisions of this rule to clarify the requirements applicable to TCS and non-TCS foods. Other comments recommend that we establish temperatures for use by shippers in crafting instructions to be given to carriers, to prevent discrepancies in temperature control recommendations among shippers. Some comments also suggest that we should provide guidance to the transportation industry for temperature control that would include extensive lists of TCS and non-TCS foods. One of these comments states that clarifying temperature controlled food requirements and providing such guidance would have the added benefit of assisting regulators tasked with the responsibility of enforcing this rule. One comment asks us to establish a maximum transportation temperature of 45 degrees Fahrenheit for TCS foods.
(Response 112) We decline these requests. As we explain in our response to the preceding comment, we have removed the term “Time/Temperature Control for Safety (TCS) Food” from the definitions section of this final rule in § 1.904, and we have removed from this final rule the descriptive categories “TCS and non-TCS,” which appeared in § 1.908(b)(3) of the proposed rule. We have replaced the definition with the concept of “foods that require refrigeration for safety.”
Because of the vast diversity of human and animal food types, FDA does not have the resources to compile exhaustive lists of foods that require or do not require temperature control for refrigeration nor a list of the appropriate temperature controls for foods. Such a task is made even more daunting because similar foods produced by different manufacturers may have different temperature control requirements, because of differences in formulation. We expect shippers of food to be aware of whether the foods that they are shipping require refrigeration for safety, either because they are the manufacturer of the food or are otherwise knowledgeable about the food safety attributes of the food, or because they have obtained such information from the manufacturer or another knowledgeable person. The Preventive Controls rules for human and animal food require the manufacturer of a food to consider the transportation needs of foods that they manufacture when they develop their food safety plans.
Furthermore, as we explain in our response to Comment 129, we are no longer requiring shippers to specify temperatures to carriers that would be regarded as critical limits for food safety purposes. In many circumstances, the shipper is required to specify an operating temperature to the carrier, and the food is not necessarily unsafe or otherwise adulterated if that temperature is exceeded during transportation. Operating temperatures are generally set to allow for refrigeration compartment temperature fluctuations due to normal activities such as defrosting and opening and closing doors. They also are often set to minimize product deterioration, which is usually a more restrictive requirement than food safety. Regulatory limits for operating temperatures would need to integrate all of these factors for the diversity of foods and operations on the market. We will consider establishing guidance in the future for operating temperatures for the transportation of foods that require temperature control, should the need arise.
We disagree with the suggestion that we should establish a maximum transportation temperature of 45 degrees Fahrenheit for TCS foods. As we explain in our response to Comment 129, we have established requirements, as revised in this final rule, that would preclude the sale or distribution of any food that upon receipt presents an indication of a possible temperature control material failure during transport, unless it can be determined that the temperature deviation has not rendered the food unsafe. We conclude that this is an appropriate science-based approach to apply when assessing whether a potentially significant temperature deviation has occurred during transport because it provides for consideration of all significant factors,
(Comment 113) We requested comment in the proposed rule regarding whether, unlike the proposed regulation, the final regulation should apply to the transportation by farms of TCS RACs, which require time/temperature control for food safety purposes,
(Response 113) As we discuss in our response to Comment 111, we have removed the term “Time/Temperature Control for Safety (TCS) Food” from the definitions section of this final rule in § 1.904, and we have removed from this final rule the descriptive categories “TCS and non-TCS,” which appeared in § 1.908(b)(3) of the proposed rule. Nonetheless, we received no comments that provided any information that changed our tentative conclusion to exclude from coverage TCS RACs when they are being transported by farms. Consequently, we have made no change in that regard. However, when such a RAC is being transported by a person other than a farm, it is subject to the applicable provisions of §§ 1.906 and 1.908 of this rule that require transportation temperature control when it is necessary to prevent the food from becoming unsafe.
(Comment 114) One comment asks us to acknowledge that fresh whole apples, pears, and cherries are transported under temperature control exclusively for quality purposes. The comment also asks us to acknowledge that we regard these fruits as being comparable to bananas, which we stated in the proposed rule are not subject to proposed § 1.908(a)(3)(iii) because there is no risk they will become adulterated if they are transported under conditions that are not temperature controlled. Another comment asks us to provide more examples of foods that would not be subject to proposed § 1.908(a)(3)(iii), and suggests that these additional examples should include potatoes intended for processing into potato chips and chocolate and dairy based seasoning ingredients. The comment also asks us to train FDA inspectors to understand the circumstances under which foods would or would not require temperature control under this rule. Another comment asks us to exclude nuts, which are sometimes refrigerated during transport for quality purposes, from the scope of proposed § 1.908(a)(3)(iii).
(Response 114) This rule only requires temperature control during transportation when it is necessary to prevent the food from becoming unsafe. This rule does not establish requirements for the use of temperature control during food transportation for any other purpose, such as for marketability purposes, or to preclude the spoilage of food subject to this rule. We will ensure that our inspectors understand which factors generally distinguish foods that require temperature control to prevent the food from becoming unsafe from other foods that are transported under temperature control for quality purposes. As discussed earlier in this document, shippers are responsible for determining whether a food is subject to the temperature control provisions of this rule, because they require temperature control for safety. Whole, fresh apples, cherries, pears and potatoes are all examples of foods that generally do not require temperature control for safety. As we state in our response to Comment 112, we do not have the resources to provide an exhaustive list of foods that are transported under temperature control only for marketability purposes.
(Comment 115) One comment asserts that the temperature control provisions of this rule do not apply to the transportation of refined fats and oils. The comment notes that the presence of temperature specifications in transportation documents such as bills of lading is related to quality and performance attributes of the refined fats or oils, and therefore should not serve as a basis for extending this rule's temperature control provisions to the transportation of refined fats and oils. The comment also notes that refined fats and oils are manufactured in closed systems and that the final product does not support the growth of undesirable microorganisms.
(Response 115) We recognize that there may be occasions where temperature control is necessary for maintaining certain product attributes such as product quality, but not to prevent the food from becoming unsafe, as is the case, generally, for refined fats and oils. If temperature control is not required to prevent the food from becoming unsafe during transportation, the temperature control provisions of this rule do not apply to those transportation operations.
We proposed to require that the shipper must specify to the carrier, in writing, all necessary sanitary requirements for the carrier's vehicle and transportation equipment, including any specific design requirements and cleaning procedures to ensure that the vehicle is in appropriate sanitary condition for the transportation of the food,
(Comment 116) One comment states that proposed § 1.908(b)(1) should be revised so that it would apply only to requirements for the carrier's vehicle and transportation equipment that exceed the carrier's basic obligation to provide vehicles and transportation equipment that are clean, appropriate, and in safe condition for transportation of the food intended to be shipped.
(Response 116) As we state in our response to Comment 119, we are aware that written information sharing between shippers and carriers currently is a routine part of the working relationship between these entities. We are retaining § 1.908(b)(1) to ensure that all necessary requirements for the preparation of a vehicle or transportation equipment are communicated to carriers. However, this provision allows the shipper to use reasonable judgment in deciding what information must be communicated to a carrier to meet the requirements of this rule. We understand that a shipper could reasonably determine that it is not necessary to specify any procedures that are commonly understood by carriers such as those described by the comment.
We have, however, modified this provision in several ways. First, because we have added a definition of loader, in response to comments that urged that we account for activities performed by the person loading a vehicle when that person is not also the shipper, receiver or carrier (see Comment 70). We recognize that there will be times when the shipper must provide instructions to the loader in addition to the carrier,
(Comment 117) One comment states that while obtaining written specifications from a shipper about vehicle and equipment sanitation, cleanliness procedures, and temperature requirements is an industry best practice, it is not always feasible or practical. The comment asserts that there is no evidence to suggest that shipper specifications communicated verbally to the carrier instead of in writing create a higher food safety risk.
(Response 117) We continue to assert that written specifications are consistent with industry best practice and are necessary to avoid confusion about the responsibilities of the various parties engaged in transportation operations. Such records are also valuable to assist FDA and other regulatory agencies in their verification role.
(Comment 118) One comment singles out proposed § 1.908(b)(1) as an example of a requirement for which we should afford firms flexibility and latitude to vary the content and level of detail contained in written specifications. The comment states that flexibility is needed, for example, to account for variations in the type of food type being transported, packaging, equipment, the transportation environment, and the shipper's experience with the carrier.
(Response 118) We acknowledge that numerous, variable factors can affect the types of procedures that are required to prepare a vehicle or equipment to be offered to a shipper. For example, the nature of the previous cargo transported in a tanker truck might affect the type of cleaning procedure that would need to be followed to prepare the tanker truck for its next cargo. We would expect that these types of factors will affect the content and degree of detail contained in written specifications that shippers would provide to carriers and loaders under § 1.908(b)(1). Nevertheless, the shipper must provide specifications to the carrier, and loader as necessary, that are adequate to enable them to ensure that the vehicle or transportation equipment is in appropriate sanitary condition for the transportation of the food,
(Comment 119) One comment asserts that the food transportation industry already has proven its ability to manage successfully information sharing between shippers and carriers through, for example, contractual agreements. The comment also asserts that proposed § 1.908(b)(1) will only add an additional, unnecessary layer of recordkeeping that will not add to the goal of feed safety, and that § 1.908(b)(1) seems unnecessary, given that we require carriers to inspect transportation vehicles prior to loading. Finally, the comment states that we should provide clarification regarding how frequently information must be shared between shippers and carriers if we decide to retain this provision.
(Response 119) As this comment observes, written information sharing between shippers and carriers engaged in food transportation already is a part of the routine working relationship between these entities. We do not envision that § 1.908(b)(1) would require additional information sharing above and beyond that which routinely occurs and is necessary for purposes of enabling a carrier to offer a vehicle or transportation equipment in appropriate sanitary condition for the transportation of the food. Furthermore, the requirement in proposed § 1.908(b)(2), that a vehicle or transportation equipment be inspected prior to loading prescribed cargoes, is a verification step that also reflects existing best practice and does not obviate the need for shippers to provide specifications to carriers that are adequate to enable a carrier to offer a vehicle or transportation equipment in appropriate sanitary condition for the transportation of the food. Therefore, we are retaining this requirement.
However, as we note in our response to Comment 124, we have added language to § 1.908(b)(1) stating that a one-time notification by a shipper to a carrier, and, when necessary, to a loader, shall be sufficient, unless there is a factor,
(Comment 120) A comment observes that a shipment may change hands many times during transit as it is transferred between carriers. The comment notes that in these instances, the shipper is not in contact with all of the subsequent carriers that may be involved and, therefore, would not be in a position to ensure its original requirements are met from start to finish. Therefore, the commenter argues that the original carrier, which has initial responsibility for ensuring that the food is handled in accordance with the shipper's requirements, should be responsible for transferring that responsibility to the next carrier down the line. The comment also states that, although an overseas shipper is in the best position to know the transportation conditions appropriate for a given food shipment when it is initiated, the shipment could change hands after it arrives in the United States and the sequential carriers, therefore, should bear responsibility for ensuring that the food is handled in accordance with the shipper's requirements.
(Response 120) This rule would require that the shipper meet the requirements of § 1.908(b)(1) for all
(Comment 121) A comment addressing vehicle cleaning procedures states that with the exception of food-grade tanker trucks, there are no industry standards or protocols for cleaning and sanitizing vehicles that transport food. The comment opines that, other than general statements regarding the need to supply vehicles and transportation equipment that prevent food from becoming adulterated, the rule seems to allow shippers and carriers to agree upon the required cleaning practices. The comment also offers the view that the flexibility provided for by the rule may not be adequate, given the lack of any industry standards or vehicle and equipment cleaning best practices. Finally, the comment notes that if we elect to impose vehicle and equipment cleaning standards, we must recognize that there are a limited number of vehicle washout facilities available to the transportation industry, and that they vary in the type of services they are capable of providing.
(Response 121) The commenter is correct that this rule provides flexibility to shippers and carriers to determine the appropriate protocols for cleaning transportation vehicles and equipment to comply with the requirements of this rule. In general, we do not expect that the requirements of this rule will necessitate a change in the procedures for vehicle and equipment cleaning. Nonetheless, § 1.908(b)(1) will require that these procedures be communicated to the carrier in writing. However, as we stated in response to Comment 116, this provision allows the shipper to use reasonable judgment in deciding what information must be communicated to a carrier to meet the requirements of this rule. We understand that a shipper could reasonably determine that it is not necessary to specify any procedures that are commonly understood by carriers,
We are not establishing vehicle cleaning standards in this rulemaking. This rule provides flexibility to shippers and carriers to determine the appropriate protocols for cleaning transportation vehicles and equipment to comply with the requirements of this rule. We will consider issuing guidance on this subject in the future should the need arise.
(Comment 122) One comment asserts that the proposed rule lacks sufficient flexibility to ensure that it can be implemented effectively by the food transportation industry. According to the comment, shippers are not always sufficiently knowledgeable to be able to specify “all necessary sanitary requirements for the carrier's vehicle and transportation equipment.” The comment also observes that shippers, carriers, and receivers typically work together to establish sanitary requirements that are appropriate for each particular type of food shipment.
(Response 122) Persons responsible for complying with this rule may work with any other persons covered by this rule or third-party experts, for assistance in developing their specifications. For example, a shipper that is not the manufacturer may consult with the manufacturer or with a third-party expert.
(Comment 123) One comment states that the design and construction of tanker trucks varies across the transportation industry and that variations can occur even within a given vehicle manufacturer's model lines. According to this comment, a preparatory procedure that is suitable and adequate for one tanker, therefore, may not necessarily be suitable and adequate for a differently designed or constructed tanker, and only an individual carrier has the best knowledge of the characteristics of its particular tanker.
(Response 123) In order to prescribe the appropriate sanitary conditions for shipment of a bulk cargo, the shipper must have knowledge of the safety requirements of the food, as well as the construction of the vehicle and transportation equipment. We expect that the shipper will either have that knowledge based on prior training or experience, or will obtain information from someone with the necessary expertise. In the case of knowledge about the construction of tankers, it may well be that the shipper's best source of information will be from the carrier. An exchange of information between the carrier and the shipper, leading to a written specification from the shipper to the carrier, is fully consistent with the intent and language of § 1.908(b)(1).
(Comment 124) One comment asks us to confirm that a shipper's written communication required by proposed § 1.908(b)(1) can be executed for a particular commodity for the duration of its agreement with each carrier rather than just for each particular product load. A second comment suggests that this requirement should specify that one-time notifications will be sufficient unless the design requirements and cleaning procedures required by the shipper change because of changes in the types of food being transported, in which case the shipper would be required to supply the carrier with a new written notification.
(Response 124) We agree with both commenters. Therefore we have added the language to § 1.908(b)(1) in this final rule that states that one-time notification shall be sufficient unless a factor,
We proposed to require that a shipper must visually inspect the vehicle or the transportation equipment provided by a carrier for cleanliness before loading food that is not completely enclosed by a container onto a vehicle or into transportation equipment provided by the carrier. We proposed that the shipper would have to determine that the vehicle or transportation equipment is in appropriate sanitary condition for the transport of the food, for example, that it is free of visible evidence of pest infestation and of debris, of previous cargo, or of dirt that could cause the food to become adulterated (revisions to the proposed provision are discussed in Comment 89). As we previously discuss in several sections of this document, responsibility for the pre-loading inspection no longer resides with the shipper, as we had initially proposed. Rather, in this final rule, the loader now bears this responsibility under § 1.908(c)(1).
(Comment 125) One comment states that proposed § 1.908(b)(2) is inapplicable to bulk liquid tanker shipments because personnel do not enter the cavity of a tanker after it has been cleaned and made ready for loading. The comment recommends that we modify this requirement to make it goal-based by requiring the shipper to determine that the vehicle or transportation equipment is in sanitary
(Response 125) We agree that the pre-loading inspection requirement in this final rule should specify the inspection's objective without restricting it to a specific method,
(Comment 126) One comment states that checking for the physical condition of a vehicle during the pre-load inspection, for example, checking for holes in the floor, walls and ceiling and the presence of off-odors and stains that might constitute residual evidence of a chemical spill or pooled water, is not specifically included in proposed § 1.908(b)(2). The comment recommends that we expand the scope of the pre-loading inspection to include these items.
(Response 126) We agree that in certain circumstances,
(Comment 127) A comment states that, during the transport of animal feed, the carrier's driver often performs loading functions without having a shipper's employee present. The comment notes that this practice is established through contract stipulations between the shipper and carrier. The shipper may also choose to inspect the truck, depending on the feed to be loaded and customer requirements. The comment further states that, as a practical matter, a bulk trailer is often inspected after delivering a load to ensure that all the feed was delivered and that it is ready for loading the next load. The commenter asserts that this practice and verification of the last load delivered, in addition to contract requirements, sufficiently ensures the safety of the feed.
(Response 127) This comment describes a situation where the carrier is also the loader. The practices described by the comment are consistent with the provisions of the final rule. In § 1.908(c), this rule requires loaders, in this case also the carrier, to take actions before loading food not completely enclosed by a container onto a vehicle or into transportation equipment to determine that the vehicle or transportation equipment is in appropriate sanitary condition for the transport of the food. In this case, where a dedicated bulk truck is repeatedly used for the same cargo that does not require refrigeration for safety,
(Comment 128) A few comments address proposed § 1.908(b)(2) within the context of partial load shipments, which are also known as less-than-truckload (LTL) shipments. LTL shipments are those in which additional loads are subsequently added to a partially loaded truck. These comments state that the shipper of a partial load will likely be present only for the loading of its own shipment, but not for subsequent loads, and therefore cannot “visually inspect the vehicle . . . for cleanliness” or ensure “that the vehicle . . . is in appropriate sanitary condition” for subsequent loads. One of these comments states that the rule must also account for cross-docking situations in which cargo is transferred from the original vehicle to another vehicle or mode of transport. In cross-docking transfers, employees of neither the shipper nor receiver will be present during loading into the subsequent vehicle, and the subsequent vehicle may even be from another carrier.
(Response 128) Under this final rule, the loader, and not the shipper or receiver, is responsible for performing the inspection upon loading as required by § 1.908(c)(1). This requirement would apply to the loader for each sequential loading of a vehicle that makes multiple stops to pick up partial loads. This also applies to the loader for a trans-loading (cross docking) operation, as we discuss in our response to Comment 38.
We proposed to require that a shipper of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control, whether a TCS food or a non-TCS food, must specify in writing to the carrier, except to a carrier who transports the food in a thermally insulated tank, the temperature conditions needed during the transportation operation, including the pre-cooling phase, to ensure that the carrier will maintain the proper temperature and meet the requirements of § 1.908(a)(3). We also proposed to make this information subject to the records requirements in § 1.912(a) of this rule.
(Comment 129) A large number of comments oppose our proposed provisions in § 1.908(b) and (d) for shippers and carriers engaged in the transportation of temperature controlled foods. These comments urge us to incorporate provisions into this rule that would allow for the continued use of existing food transportation industry best practices that have proven to be effective. They argued that management of temperature control for foods during transportation is a complex issue because it involves interactions between shippers, carriers and receivers who must address a variety of circumstances that may arise during the transportation of the food. We will first summarize the numerous comments we received on this matter.
• These comments universally oppose any requirement that carriers routinely demonstrate for each delivered load that they have met shipper temperature specifications. They state that confirming the functionality and settings of the refrigerator unit, or the temperature of the compartment upon loading and
• These comments also note that truck trailers often have devices onboard that can continuously record the refrigeration unit temperature that can be reviewed when necessary to investigate potential temperature deviations during transport that could affect food safety. These comments state, however, that this recorded information can be difficult to download and takes considerable time and expense to analyze because the process involves, among other things, identifying the container unit in transit, removing it from service, and delivering it to a facility capable of downloading the data. The comments further state that the cost of just extracting the data can be up to $200 per load and may require the services of a third-party vendor and that additional expense is incurred in analyzing the data. The comments therefore conclude that requiring the routine review of recorded onboard refrigerator temperature data is neither practical nor necessary.
• These comments also argue that the language of proposed § 1.908(d)(2)(i) could be interpreted to require continuous temperature monitoring during food transport and suggest that we may be under the misimpression that the use of continuous monitoring devices is the norm in the refrigerated food transport industry. Some comments state that current best industry practices in many cases can give shippers confidence that appropriate temperatures are maintained during transit, without the use of continuous monitoring devices. One comment urges us to permit other forms of adequate temperature monitoring, such as documented alarm systems or properly documented manual temperature records. Many comments state that the rule should allow the carrier to use any means agreeable to the shipper to demonstrate the carrier's adherence to temperature specifications, such as recording trailer temperature settings when the vehicle is loaded and unloaded or periodic temperature checks during transit. Finally, some of the comments note that with the limited exception of the transportation of highly temperature-sensitive food products, such as vacuum packed seafood, where the shipper or receiver voluntarily may determine that the use of continuous monitoring devices is necessary to ensure product safety, using continuous temperature monitoring and recording devices is not necessary for purposes of ensuring the safety of the food during transport.
• These comments also state that a deviation from the shipper's temperature specifications does not necessarily cause the food to be unsafe. According to the comments, the temperature included in a shipment's bill of lading is the temperature at which the trailer's refrigerator unit needs to be set, but is often lower than the temperature needed to ensure the safety of the food shipment. A food that requires time/temperature control to ensure its safety (TCS food) and needs to be maintained at or below 40 degrees Fahrenheit, for example, may be transported during the winter in cold regions of the country at refrigerator settings very close to 40 degrees because this is adequate to ensure the temperature required for safety is not exceeded given the low outside air temperature. If, however, this food is transported during the summer, the shipper may direct the carrier to set the refrigerated trailer temperature much lower than 40 degrees Fahrenheit (
• Finally, these comments urge us to accord shippers the flexibility to assess the conditions under which the food was transported in determining whether temperature deviations cause the food to be unsafe. The commenters assert that, in many cases, the food may still be fit for its original intended use, notwithstanding any temperature deviations that might have occurred during transit. The comments also assert that in a case where a food may no longer be fit for its original intended use because of temperature deviations, the food may still be fit for an alternative use. A food product that may no longer be fit for its intended use as food for humans because of temperature deviations that might have occurred during transit, for example, might still be safe and fit for use as animal food. The comments argue that automatically deeming food adulterated because there was a temperature deviation during transit, without allowing for an evaluation of whether that deviation affected the safety of the food, would result in significant amounts of food waste without providing any corresponding food safety benefit.
(Response 129) We agree that the provisions we proposed for persons engaged in the transportation of foods that require temperature control for safety should be revised to clearly focus their requirements on functions that ensure that adequate temperature control is provided, and to permit the continued use of established industry best practices that provide for the safe transportation of these foods. In revising these provisions, which are now designated as § 1.908(b)(2) in this final rule, we considered the steps that occur before, during, and after the transportation of foods that require temperature control for safety to ensure the transportation operation is in accord with sanitary transportation practices. Our changes to this final rule involve revisions that affect the responsibilities of shippers (§ 1.908(b)), loaders (§ 1.908(c)), receivers (§ 1.908(d)), and carriers (§ 1.908(e)).
In revising this rule's provisions for foods that require temperature control for safety during transportation, we recognized the fact, expressed in several comments, that the temperature control measures we are establishing in this rule may not be necessary for some
Under conditions of shipment where it is necessary to provide temperature control to ensure that food does not become unsafe during transportation, the shipper must provide written instructions to the carrier and, when necessary (
The comments we received clearly state that this provision, as proposed, may be interpreted to mean that we are requiring the shipper to specify a critical limit for the transport of the food, such that food held in a vehicle that exceeds the specified temperature may be unsafe and, therefore, adulterated. We recognize that under established industry practices, the temperature specification provided to a carrier is often lower than the temperature needed to ensure food safety and that if the ambient temperature in a trailer were to exceed the specified temperature, the food would not necessarily be unsafe. We agree with the comments that ask us to clarify that a deviation from the shipper's temperature specifications does not necessarily and automatically cause the food to be unsafe, and, therefore, adulterated. Therefore, we are revising this provision in § 1.908(b)(2) to require that the shipper specify to the carrier, and, when necessary, to the loader, an operating temperature required for the given transportation operation, including, if necessary, the pre-cooling phase. We are adding a definition for the term “operating temperature” in § 1.904 to state that this term means a temperature sufficient to ensure that under foreseeable circumstances of temperature variation during transport,
We next considered how this rule should address temperature monitoring during transportation and under what conditions data acquired during temperature monitoring should be communicated by a carrier to a receiver or shipper. The comments we received clearly state that under established industry practices, parties involved in food transportation use a wide variety of approaches for monitoring temperature conditions. In some instances, for example, the transportation of some vacuum packaged seafood products, the continuous monitoring of temperature during transportation is necessary to ensure that the food is maintained under safe conditions. In most other instances, the transportation industry relies primarily on means, other than reviewing temperature monitoring information acquired during transit, to establish that adequate temperature control was provided during transportation,
We agree with comments that state that the proposed rule could be interpreted to require continuous temperature monitoring during transit, due in part to the proposed requirement at § 1.908(d)(2)(i) that a carrier must, once the transportation operation is complete, demonstrate to the shipper, and if requested, to the receiver, that it maintained temperature conditions during the transportation operation as specified by the shipper. We affirm that the carrier bears the responsibility for demonstrating, when necessary, that it transported food under appropriate temperature control conditions consistent with those specified by the shipper. However, we have revised this final rule at § 1.908(e)(2) to allow that demonstration to be made by any appropriate means agreeable to the carrier and shipper, such as the carrier presenting recordings of the ambient temperature of a trailer when it was loaded and unloaded, or in the form of time/temperature data recorded during the shipment. This revision also clarifies that we are not requiring that the carrier conduct continuous monitoring of the temperature conditions on a vehicle during transport, but it also recognizes that in some circumstances it may be necessary to ensure the safety of the food and that, in these circumstances, the shipper and carrier may agree to this approach.
We also considered circumstances in which it would be necessary for a carrier to provide information to the shipper about temperature conditions during shipment. We agree with comments that state that requiring a carrier to routinely demonstrate for each delivered load that it had met the shipper's temperature specifications is not necessary for purposes of ensuring food safety and is not consistent with current industry best practice. Therefore, we have revised this rule at § 1.908(e)(2) to provide that the carrier's demonstration must be made only upon request by the shipper or the receiver. This revision clarifies that a carrier is not required to routinely provide this demonstration, but requires such a demonstration when, for example, as explained below, the receiver assesses the food upon receipt and determines that there may have been a material failure of temperature control during the shipment, or when the shipper and receiver have agreed that it is necessary to ensure the safety of the food (
We also considered what measures, if any, should be required after a food transportation operation has been completed. Many of the comments that we received observe that receivers currently routinely check the function and settings of the transportation vehicle's refrigeration unit and conduct visual inspections of the delivered food products for which temperature control is required for signs of temperature abuse. We regard these types of inspections as essential for ensuring that the food was transported in accordance with appropriate sanitary transportation practices and was not rendered unsafe because of inadequate temperature control. Accordingly, we have revised this final rule in § 1.908(d), which now includes requirements applicable to receivers, to provide that upon receipt of food that requires temperature control, a receiver must take steps to determine whether the food was subjected to significant temperature abuse. We also have provided examples of measures a receiver could employ for this purpose, such as determining the food product's temperature, the ambient temperature of the vehicle and its refrigeration unit's temperature settings and conducting a sensory inspection to
We also added a provision to the general requirements of this rule § 1.908(a)(6) that is applicable to circumstances in which temperature abuse of a food may have occurred or another event may have occurred that could have jeopardized the safety of the food (
This provision would, for example, require a receiver of food that requires temperature control for safety, that has performed a check of the vehicle compartment temperature as a way to comply with § 1.908(d), and determined that the temperature is above the operating temperature specified by the shipper, to hold the product until it can make a determination that the temperature deviation did not make the food unsafe. It could make that determination on its own, if it is qualified to do so, or could consult with the carrier, loader, shipper, or a third party to make such a determination or to assist it in making such a determination. Whomever makes such a determination should be qualified by training or experience to make such a determination,
We have included in § 1.908(a)(6) a provision that, if requested by the receiver, the carrier must provide to the receiver the operating temperature specified by the shipper in accordance with § 1.908(b)(2). This is a necessary exchange of information to facilitate the receiving examination provided for in § 1.908(d), when the receiver may not be aware of the operating temperature that the shipper provided to the carrier.
The new provision at § 1.908(a)(6) would also, for example, require the carrier of a food that notices leakage of liquid from boxes of raw poultry onto partially enclosed crates of produce during a stop in transportation to hold the food until the carrier can obtain a determination from a qualified individual,
We agree with the comments that we received that argued that if a food has become unfit for its intended use because of material temperature abuse during transportation, the food may still be fit to an alternative use, such as for animal food. We would judge such circumstances on a case-by-case basis.
We have further modified the provisions of proposed § 1.908(b)(3) (now § 1.908(b)(2)) in several ways. First, because we have added a definition of loader, in response to comments that urged that we account for activities performed by the person loading a vehicle when that person is not also the shipper, receiver or carrier (see Comment 70), we recognize that there will be times when the shipper must provide instructions to the loader in addition to the carrier,
Finally, we have prefaced the requirement with the phrase, “Unless the shipper takes other measures in accordance with paragraph (b)(5) of this section to ensure that adequate temperature control is provided during the transportation of food that requires temperature control for safety.” We have added this language in response to comments from the railroad industry (see Comment 53) that stated that they generally do not have a relationship with shippers whereby the shipper provides them with instructions relative temperature control of the railcar that they are to deliver. Our intent is that the language will establish the requirements of § 1.908(b)(1) as the default arrangement whereby the shipper ensures that the vehicle is operated during transportation at a temperature that prevents the food from becoming unsafe by providing instructions to the carrier and, when necessary, the loader, while also allowing for alternative arrangements (
(Comment 130) Several comments state that the proposed temperature control requirements are excessive and inappropriate for the animal food industry, and ask us to revise and better align them with risk-based practices that are commonly used in that industry. One comment states that refrigeration and temperature control are not relevant to rendering industry ingredients because the high-temperature cooking process of rendering destroys the pathogens contained in the raw materials. Another comment states that maintaining temperature conditions should only be considered when a firm has identified a hazard that needs to be controlled.
(Response 130) We have revised § 1.908(a)(3), as we discussed in our response to Comment 2, to clarify that the type of food involved, for example, animal feed, pet food, human food, and the food's given stage in the production process, for example, whether the food is a raw material, an ingredient, or a finished food product, must be considered when determining the conditions and controls, including temperature controls, that may be necessary to ensure the sanitary transportation of the food. We, therefore, agree that it would not be necessary to provide temperature control during the transportation of ingredients destined for rendering because these materials will eventually be treated with high heat to destroy pathogens. As we have previously stated, we have revised this final rule so that it focuses entirely on food safety issues. For this reason, control of temperature during transportation would not be required by the rule if
(Comment 131) Two comments observe that the proposed rule does not address the issue of how a shipment of food requiring temperature control, for which a material failure of temperature control during transport is suspected, should be handled. One of these comments expresses the view that that the rule should remain silent on this matter. The other comment argues that the issue is beyond the scope of this rule and the matter would be best resolved by a risk assessment to be conducted by the receiver and/or shipper.
(Response 131) As we explained in our response to Comment 129, we have revised § 1.908(a)(6) of this final rule to require that if a person subject to this rule becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the person must take appropriate action, to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual, that the temperature deviation or other condition did not render the food unsafe.
While we agree that it is unnecessary to prescribe the details of the mechanics of how such a determination is made, we do not agree that the actions of a receiver after taking delivery of a food shipment that may have been transported without appropriate temperature control, for example, are beyond the scope of this rule. We are charged under the 2005 SFTA to establish sanitary transportation practices to be used by shippers, carriers by motor vehicle or rail vehicle, receivers and other persons engaged in the transportation of food to ensure that food is not transported under conditions that may render it adulterated.
As we discussed in our response to Comment 129, we revised § 1.908(d) to establish duties for receivers of foods that require temperature control because we have determined that they are essential for ensuring that the food was transported in accordance with appropriate sanitary transportation practices, consistent with industry best practices. The new provisions at § 1.908(a)(6) are an appropriate extension of the provisions at § 1.908(a)(6), in that they ensure that the safety of the food is verified before a suspect food is moved further in commerce.
(Comment 132) A comment asserts that if a shipper is shipping a TCS food product and holds it unrefrigerated on a dock before the food is loaded into a transportation vehicle, the temperature of the product will rise, which will increase the ambient temperature of the refrigerated trailer compartment after the food is loaded, perhaps causing a deviation from the shipper's temperature control specifications. The comment argues that this outcome is completely beyond the carrier's control and that it needs to be taken into account when monitoring the temperature of the transportation vehicle throughout the transport process.
(Response 132) Under § 1.908(a)(3)(iii), persons subject to this rule must ensure that food that requires temperature control to prevent it from becoming adulterated during transportation is transported under adequate temperature control. This requirement also applies to the holding of food on a loading dock. Responsibility for complying with this requirement resides with the loader and not with the carrier. Although this rule does not require the use of temperature controlled loading docks, it does require that the loader handle food that requires refrigeration for safety in such a way that will prevent it from becoming unsafe. This may be accomplished by a loader by, for example, rapidly moving the refrigerated product from its refrigerated storage to a precooled vehicle, or by temporarily holding the refrigerated product in a refrigerated loading dock prior to loading onto a precooled vehicle backed up to the loading dock.
(Comment 133) Several comments ask us to clarify that the written temperature condition specifications that shippers must provide to carriers can appear in existing documents, such as contracts or bills of lading, and that they do not have to be conveyed by shippers to carriers in new, separate, dedicated documents.
(Response 133) We agree. The shipper may meet the requirements of § 1.908(b)(2) by communicating written information to the carrier in the form of existing contracts or bills of lading. Shippers do not need to create new, separate written temperature conditions specification documents for transmittal to carriers.
(Comment 134) Some comments state that the proposed rule can be interpreted to require pre-cooling only when it is necessary to maintain temperature conditions during transport, and ask us to clarify this point. One comment, for example, states that pre-cooling may not be required for transportation during the winter in cold areas or for short distance transportation of food.
(Response 134) We did not intend to suggest in the proposed rule that a shipper must always provide pre-cooling parameters to a carrier for the transportation of foods subject to the temperature control requirements of this rule. We agree that pre-cooling may not be required for transportation operations conducted during winter in cold areas or for short distance transportation of food in appropriate circumstances. Under this rule, the shipper must determine whether pre-cooling a vehicle or transportation equipment by the carrier is necessary for the sanitary transportation of the food being shipped. We have revised § 1.908(b)(2) to clarify this point by specifying that the shipper must provide pre-cooling specifications to the carrier and when necessary, to the loader (
(Comment 135) One comment states that pre-cooling transportation equipment is inadequate without pre-cooling the product. The comment singles out RACs as an example, noting that if the RACs are not adequately pre-cooled prior to transportation, they will cause the temperature of the pre-cooled carrier container to rise above the specified temperature limits, thereby potentially creating conditions for bacterial growth. Another comment asks us to modify the language of this rule to clarify that it does not prevent the loading of harvested RACs directly from the field into pre-cooled trailers provided by carriers. This comment states that although under these circumstances, the temperature in the trailer will increase after is has been loaded, this is still a beneficial practice because it begins decreasing the field heat of RACs as soon as possible. The commenter asks us to allow this practice to continue even though it may not be possible for a carrier operating under these circumstances to meet the proposed requirement that the carrier follow the shipper's temperature controls.
(Response 135) Under § 1.908(a)(3) of this rule, all transportation operations must be conducted under such conditions and controls necessary to prevent the food from becoming unsafe. In addition, it is the shipper's responsibility under § 1.908(b)(2) (revised from proposed § 1.908(b)(3)) to specify to the carrier and, when necessary, the loader, whether pre-cooling a vehicle or transportation
(Comment 136) Some comments ask us to acknowledge that pre-cooling procedures should account for the potential for condensation formation during loading operations. One of these comments states that a transit container should be pre-cooled only if it is connected to a cold storage unit because product temperature and container temperature need to be in equilibrium to prevent hotter air from entering the container when its doors are opened during loading. The entry of hotter air into the container causes condensation, which can create a number of problems, including the formation of ice and structural damage to shipping containers.
(Response 136) Under § 1.908(a)(3) of this rule, all transportation operations, including loading operations, must be conducted under such conditions and controls as necessary to prevent the food from becoming unsafe. It is the shipper's responsibility under § 1.908(b)(2) to specify to the carrier whether pre-cooling a vehicle or transportation equipment is necessary for purposes of complying with this rule. We would expect that, if necessary under the requirements of this rule, the shipper (who is often also the loader), and the loader (if the loader is a different entity), will follow appropriate procedures to address the formation of condensation during the loading of a pre-cooled vehicle.
(Comment 137) One comment expresses the view that the carrier needs to have unambiguous notice that it is being tendered a shipment of food that is not shelf stable and that such notices should be uniform and clearly noted in shipping documents so the carrier can make an informed decisions regarding the handling of the shipment. Another comment recommends that the carrier should be notified in writing when a shipment includes a TCS food.
(Response 137) As we have previously stated, this final rule is focused only on food safety, and we have accordingly revised language that previously referred to “foods that are not shelf stable” to “foods that require refrigeration for safety.” We are using the latter term instead of the term TCS food. We agree that it is imperative that a carrier that takes responsibility for ensuring that a food that requires refrigeration for safety be informed by the shipper the operating temperature of the vehicle that is necessary to safely transport the food. Such disclosure is now required by revised § 1.908(b)(2).
(Comment 138) One comment asserts that thermally insulated tankers should be pre-cooled after a high temperature wash. The comment is concerned that the contents of the tanker would increase in temperature if a tanker is not pre-cooled. The comment suggests removing the exclusion for a carrier who transports food in a thermally insulated tank from the requirement of proposed 1.908(b)(3).
(Response 138) We decline this request. It is our understanding that it is a common industry practice to clean thermally insulated tankers right after unloading products rather than immediately before loading. The practice would allow the tankers to cool down after a hot temperature wash. Even if a product is loaded into a thermally insulated tanker that has just been cleaned with a high temperature wash, considering the small surface to volume ratio, we do not believe that the product temperature would be raised to a degree that is significant with respect to the maintenance of appropriate temperature control.
In addition, thermally insulated tankers are designed and built to limit the degree of temperature increase of a food in a given amount of time. Therefore, we are retaining the exclusion relating to food in a thermally insulated tank from the requirement of 1.908(b)(3).
Many of the previously discussed comments depicted a food transportation system that is highly diverse, with shippers, receivers, loaders, and carriers developing and implementing food safety controls that are tailored to their specific circumstances. These controls take into account the nature of the food (
We acknowledge this diversity and agree that the final rule should be structured to accommodate it. We also agree that the rule should be structured as much as possible so as not to restrict innovation in the relationships between the parties covered by the rule. On the other hand, we are compelled to develop a rule that is not so fluid that it is unenforceable. Especially when things go wrong, it is important to know who is responsible for what functions and to be able to hold them accountable. Even during day to day operations, it is important for the interacting parties to know where they are responsible and the responsibilities of the other parties,
In response to Comment 70, we have explained our thinking relative to the revised definition of shipper, which reads, “a person who arranges for the transportation of food by a carrier or multiple carriers sequentially.” We explained that we have concluded that this is the entity that is in the best position to determine the necessary conditions for safe transportation of food. Further, this is the party that causes the food to move in commerce, and, as a result, we believe, should bear the burden of setting out the safe conditions for that movement and assuring that they are met. As a result of these determinations, we have concluded that the shipper should be charged by this rule with developing and implementing written procedures that address how the safety of the food will be assured relative to the three major focus areas of this rule, to the extent that they apply to the foods that they ship. The three major focus areas are: (1) Assurance that vehicles and equipment used in its transportation operations are in appropriate sanitary condition; (2) assurance that, for bulk cargo, a previous cargo does not make the food unsafe; and (3) assurance that, for foods that require refrigeration for safety, the food is transported under adequate temperature control. It is necessary for these procedures to be in writing in order to facilitate consistent implementation by the shipper, especially with changes in personnel, and to provide for effective enforcement by FDA and other regulatory agencies. We expect that shippers would maintain such written procedures to facilitate their operations.
We recognize that, while the shipper is charged with developing and implementing these procedures, in many scenarios the shipper will need to secure the services of other parties, such as the receiver, loader, or carrier, to accomplish some or all of the measures. We expect that those services will be secured under a written agreement, subject to the records requirements of § 1.912(a). It is necessary for these agreements to be in writing in order to facilitate a consistent understanding of responsibilities and consistent implementation of the provisions by the shipper, carrier, loader and receiver, and to provide for effective enforcement by FDA and other regulatory agencies. Again, it is our understanding, based in part on comments discussed earlier in this document, that such agreements, usually in the form of contracts, are consistent with industry best practice.
Consequently, we have added three new sections to the proposed rule at § 1.908(b)(3) to (5). These new sections require that:
• A shipper must develop and implement written procedures, subject to the records requirements of § 1.912(a), adequate to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food,
• A shipper of food transported in bulk must develop and implement written procedures, subject to the records requirements of § 1.912(a), adequate to ensure that a previous cargo does not make the food unsafe. Measures to ensure the safety of the food may be accomplished by the shipper or by the carrier or another party covered by this rule under a written agreement, subject to the records requirements of § 1.912(a).
• The shipper of food that requires temperature control for safety under the conditions of shipment must develop and implement written procedures subject to the records requirements of § 1.912(a), to ensure that the food is transported under adequate temperature control. Measures to ensure the safety of the food may be accomplished by the shipper or by the carrier or another party covered by this rule under a written agreement, subject to the records requirements of § 1.912(a), and must include measures equivalent to those specified for carriers under § 1.908(e)(1) to (3).
We proposed at § 1.908(b)(5) that the shipper assumes the requirements applicable to the carrier in § 1.908(d)(2)(i) with respect to providing a demonstration to the receiver if the shipper and carrier have agreed in writing under § 1.908(d)(2)(ii) that the shipper is responsible for ensuring that the food was held under acceptable temperature conditions during transportation operations. When the shipper and carrier have established such an agreement, the shipper also assumes the corresponding records requirements of §§ 1.908(d)(6)(ii) and 1.912(b). This provision was proposed to provide flexibility in the manner in which temperature control was assured during transportation, and, in particular, who was responsible for demonstrating to the receiver that such control was maintained. This provision is no longer necessary, and has been deleted from the final rule, because the new provision at § 1.908(b)(5) provides the same kind of flexibility for temperature control assurance, for foods that require refrigeration for safety, as discussed earlier in this document.
We had proposed to establish requirements for shippers and receivers addressing food handling during loading and unloading, in proposed § 1.908(c). As we discuss in this section, we have determined that it is not necessary to include these requirements, as they were proposed, in this final rule. We have redesignated § 1.908(c) in this final rule to specify requirements applicable to loaders engaged in transportation operations, which we discuss in the following section.
(Comment 139) One comment states that we should ensure that receivers have the ability to test a food product before automatically discarding it because the shipper's temperature control specifications were exceeded during transport.
(Response 139) Nothing in this rule requires receivers to discard food if the food was subject to deviations from a shipper's temperature control specifications during transport. We discuss a receiver's responsibilities for handling food that requires temperature control in our response to Comment 129.
(Comment 140) Several comments oppose proposed § 1.908(c)(1) on the grounds that the provision would be unnecessarily burdensome and would not improve food safety or otherwise contribute to the sanitary transportation of food.
One comment states that foods that are shipped without being completely enclosed in packaging, such as RACs, are freely handled by consumers when offered for sale in retail establishments. The comment notes that no rule currently requires consumers to wash their hands prior to the handling these foods and that there is no evidence to suggest that transportation vehicle operators present a greater risk of contaminating food not completely enclosed in packaging than do a food retailer's employees or consumers who also handle these food products prior to consumption. The comment also argues that while our proposed rule compares § 1.908(c)(1) to requirements in the cGMP regulations for human food, particularly 21 CFR 110.10(b), they are
Other comments argue that proposed § 1.908(c)(1) should only apply if the vehicle operator is reasonably expected to come in physical contact with the food. One comment asserts that this proposed requirement lacks supporting scientific data, is unnecessary, is not feasible in many instances, and would appear to be appropriate only if human contact with the food poses a risk that the food will become adulterated or otherwise poses a valid health risk to humans or animals. Another comment recommends that any requirement for hand-washing facilities be risk-based and be linked directly to the effectiveness of hand-washing for purposes of reducing the risk that human handling of food would cause the food to be rendered injurious to health or otherwise adulterated.
Another comment suggests that firms should train drivers with respect to safe handling practices and that we should leave the selection of the sanitary methods for the handling of foods not entirely enclosed by packaging up to the transportation firms. The comment suggests, for example, that vehicle operators may be instructed to use disposable gloves, sanitary wipes, and/or a customer's hand washing facilities depending on the circumstances. One comment expresses concern that this provision would require the installation of additional sinks in virtually all food distribution centers at a great cost to the industry.
(Response 140) After considering these comments, we have decided to remove the provision in proposed § 1.908(c)(1) from this final rule. We have determined that this provision is unnecessary because the specific circumstance that proposed § 1.908(c)(1) would address, vehicle operators handling food not completely enclosed by a container, is already addressed by the broader requirement of § 1.908(a)(3), which requires that all transportation operations be conducted under such conditions and controls necessary to prevent the food from becoming unsafe during transportation operations. In particular, § 1.908(a)(3)(ii) includes hand washing as an example of measures that can be taken to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination and cross-contact during transportation operations. Providing vehicle operators access to hand washing facilities is one method for preventing the contamination of food, but we agree that it may not always be necessary. By removing proposed § 1.908(c)(1) from this rule, we are allowing flexibility for the transportation industry to determine what control measures would be necessary in any given set of circumstances.
Furthermore, we have reached the same conclusion concerning the provision in proposed § 1.908(c)(2), which would have required shippers and receivers of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation, to carry out loading and unloading operations under conditions that would “prevent the food from supporting such microbial growth.” We have removed that provision from this final rule because our expectations for temperature control during loading and unloading operations are set forth in new § 1.908(a)(3)(iii), which requires persons subject to this rule to take effective measures to ensure that food that requires temperature control for safety is transported under adequate temperature control; see Comment 132 and Comment 141.
(Comment 141) One comment states that there are no provisions in the rule to ensure that insanitary conditions have not contaminated the food before a carrier becomes involved. The comment asserts that the rule does not require specifications for conditions that must be maintained on loading and unloading docks, and that carriers are not given an opportunity to inspect and confirm either the condition of the cargo or the facilities where the food is picked-up or delivered.
(Response 141) We disagree with the comment. The requirements of § 1.908(a)(3) and (c), while general in nature, address sanitary transportation practices applicable to the loading and unloading of food. In addition, this rule does not preclude a carrier from establishing agreements with the owner or operator of the facility or loading dock to inspect or confirm the condition of cargo or facilities prior to accepting a load.
As we stated in the previous section, we have redesignated § 1.908(c) in this final rule as, “Requirements applicable to loaders engaged in transportation operations.” The provisions we have included in this section arise from our consideration of comments relevant to loading operations in other sections of this final rule; see Comment 125, Comment 126, Comment 127, Comment 128, and Comment 129.
We have established requirements applicable to receivers engaged in transportation operations in § 1.908(d) of this final rule and have moved the corresponding requirements applicable to carriers (proposed § 1.908(d)) to new § 1.908(e), discussed in the following section. The provisions we have included in new § 1.908(d) arise from our consideration of comments relevant to food that requires temperature control for safety, which we discuss in Comment 129.
As discussed in section IV.E.2, we have concluded that the shipper should be charged by this rule with developing and implementing written procedures that address how the safety of the food will be assured relative to the three major focus areas of this rule, to the extent that they apply to the foods that they ship. The three major focus areas are: (1) Assurance that vehicles and equipment used in its transportation operations are in appropriate sanitary condition; (2) assurance that, for bulk cargo, a previous cargo does not make the food unsafe; and (3) assurance that, for foods that require refrigeration for safety, the food is transported under adequate temperature control. We recognize that, while the shipper is charged with developing and implementing these procedures, in many scenarios the shipper will need to secure the services of other parties, such as carrier, to accomplish some or all of the measures. We expect that those services will be secured under a written agreement, subject to the records requirements of § 1.912. It is our understanding, based in part on comments discussed earlier in this document, that such agreements,
Consequently, we have added three new sections to the proposed rule at § 1.908(b)(3) to (5). These new sections require that:
• A shipper must develop and implement written procedures subject to the records requirements of § 1.912(a), adequate to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food,
• A shipper of food transported in bulk, must develop and implement written procedures subject to the records requirements of § 1.912(a), adequate to ensure that a previous cargo does not make the food unsafe. Measures to ensure the safety of the food may be accomplished by the shipper or by the carrier or another party covered by this rule under a written agreement subject to the records requirements of § 1.912(a).
• The shipper of food that requires temperature control for safety under the conditions of shipment must develop and implement written procedures subject to the records requirements of § 1.912(a), to ensure that the food is transported under adequate temperature control. Measures to ensure the safety of the food may be accomplished by the shipper or by the carrier or another party covered by this rule under a written agreement subject to the records requirements of § 1.912(a) and must include measures equivalent to those specified for carriers under § 1.908(e)(1) to (3).
Consistent with these new provisions in the previous section applicable to requirements for shippers, we have included language at § 1.908(e) (proposed § 1.908(d)) that makes the provisions of that section applicable to a carrier only when the carrier and shipper have a written agreement that the carrier is responsible, in whole or part, for sanitary conditions during the transportation operation. Each provision is applicable only when it is relevant to the provisions of the agreement between the carrier and the shipper. For example, the carrier and the shipper may have a written agreement that states that the carrier is to precool the vehicle and set and monitor operating temperatures in the vehicle, based on instructions from the shipper. In this case, the carrier would be responsible for meeting the requirements of § 1.908(e) that are relevant to temperature control (
We proposed to require that a carrier must supply a vehicle and transportation equipment that meets any requirements specified by the shipper in accordance with § 1.908(b)(1), and is otherwise appropriate to prevent the food from becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during the transportation operation.
We have made the following revision to proposed § 1.908(d)(1) (now § 1.908(e)(1)) for consistency with changes elsewhere in the final rule to focus the rule on food safety only. We have changed the proposed phrase “prevent the food from becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health” to “prevent the food from becoming unsafe.”
(Comment 142) One comment asks us to require LTL carriers to implement written procedures to ensure the compatibility of each food contained within an LTL load and to require that the carrier be able to demonstrate full compliance with each shipper's food transportation specifications upon request.
(Response 142) We decline to make this change. We have assigned responsibility for ensuring that a vehicle onto which food not completely enclosed by a container is loaded is in appropriate sanitary condition, to the loader, giving consideration to specifications provided by the shipper (see Comment 70). Among other factors, the loader is to consider whether the vehicle is in adequate physical condition and whether it is free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe. In the case of an LTL load, we would expect that the loader would check to see if any previously loaded cargo could potentially contaminate food not completely enclosed by a container in a subsequent load. We would also expect that the shipper of food not completely enclosed by a container on an LTL load would generally instruct the loader to inspect (where the loader and the shipper are not the same person), consistent with the shipper's obligations under § 1.908(b)(3).
(Comment 143) Another comment notes that the carrier has the responsibility for providing a container in good mechanical condition and that is reasonably clean of dirt, debris and foul odors. However, the comment states that the shipper should be responsible for any “sanitizing” that might be required for the sanitary transportation of a particular food/beverage or commodity.
(Response 143) We are aware that, depending upon the circumstances and the agreement between the parties, current practice is that either shippers, loaders or carriers may wash and/or sanitize vehicles before they are loaded, or they may contract with a third party to perform that function. We see no public health benefit in changing current practice by mandating that one party or another perform the function. As previously discussed, in new § 1.908(b)(3) we have required that shippers develop and implement written procedures specifying how they will ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food. We would expect such procedures to include cleaning and sanitizing procedures as appropriate to the food and conditions of shipment. However, new § 1.908(b)(3) also provides that the shipper may reach an agreement with the carrier, or another party covered by this rule, to perform this function. If a carrier agrees to perform this function, § 1.908(e)(1) requires that they ensure that the vehicle meets the shippers specifications in that regard.
(Comment 144) One comment states that some jurisdictions prohibit carriers from washing out their truck's trailers because of local water quality regulations designed to protect the environment from contaminated water runoff. The comment further asserts that this rule, therefore, places carriers in the untenable position of having to choose which regulation to follow. The comment asks us to provide clarity regarding the interaction between this rule and state and local regulations that may restrict or prohibit truck washing.
(Response 144) This rule is not intended to preempt state and local requirements regarding water runoff and water quality issues that would affect truck washing. Carriers affected by local requirements that restrict or prohibit truck washing must, even now, determine how to meet any
We proposed to require that a carrier must, once the transportation operation is complete, demonstrate to the shipper and if requested, to the receiver, that it has maintained temperature conditions during the transportation operation consistent with those specified by the shipper in accordance with § 1.908(b)(3). We proposed that these demonstrations may be accomplished by any appropriate means agreeable to the carrier and shipper, such as the carrier presenting printouts of a time/temperature recording device or a log of temperature measurements taken at various times during the shipment. We also proposed that a carrier would not be subject to the requirement of § 1.908(d)(2)(i) if the carrier and shipper agree in writing, before initiation of the transportation operations, that the shipper would be responsible for monitoring the temperature conditions during the transportation operation or otherwise ensuring that the food was held under acceptable temperature conditions during the transportation operation. Finally, we proposed that a carrier must provide the written agreement to the receiver, if requested, and that this written agreement would be subject to the records requirements of § 1.912(b).
Consistent with our discussion concerning the duties of the shipper as a result of the requirements of § 1.908(b)(5), we have removed the provisions of proposed § 1.908(d)(2)(ii), concerning alternative arrangements for the responsibility to provide temperature control information to the shipper and receiver. This provision is no longer needed because new § 1.908(b)(5) and the new language at new § 1.908(e) provide the same flexibility to assign responsibility for this function as was provided by proposed § 1.908(d)(2)(ii).
(Comment 145) One comment asserts that an LTL carrier should have the flexibility to deviate from the temperature specified by the shipper when transporting mixed loads that contain food from more than one shipper. The comment further asserts that we should allow LTL carriers to set temperatures for such mixed loads based on the lowest temperature needed to safely transport TCS foods in any given load, even though this temperature may differ from that specified by any of the other LTL shippers.
(Response 145) We agree with the comment. Our expectation is that, generally, each of the shippers of food that require temperature control for safety in an LTL load would provide an operating temperature to the carrier. These temperatures represent temperatures that will ensure that the food does not become unsafe during transportation. In most cases, they will also assure marketability and quality preservation, as desired by the shipper. With regards to the requirements of this regulation, if a carrier who has accepted responsibility for temperature control during transit selects the coldest temperature of those provided by the shippers they will be meeting their responsibility under § 1.908(e)(2). However, we note that there may be times when a shipper does not want their product to be exposed to excessively cold temperatures for quality reasons. In this case, the shipper would be well advised to so instruct the carrier. We would consider such instructions to be outside the scope of this regulation as they do not impact food safety.
(Comment 146) Another comment asks us to develop and require carriers to adhere to air and product temperature-monitoring standards to meet the requirements specified by the shipper under proposed § 1.908(b)(3). The comment asserts that these requirements should include adequate and sanitary representative sampling methods, address appropriate temperature measurement device placement, and consider the effects of load configurations and other contributing factors on temperature control during transportation. The comment asks us to consider the potential need for shippers to require both air and product temperature monitoring and recommends that any requirements related to verification of product temperatures should be incorporated in a manner that would not involve undue or burdensome costs.
(Response 146) We do not agree. We think these types of detailed provisions are better for guidance than for regulations. Because of the diversity of transportation operations, including the variety of foods transported, we have concluded that shippers need to be given considerable latitude to develop temperature controls for their operations, as long as they do, in fact, serve to prevent the food from becoming unsafe during transportation. Some of the recommendations contained in the comment,
We proposed to require that, before offering a vehicle or transportation equipment with an auxiliary refrigeration unit for use for the transportation of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control, a carrier must precool each mechanically refrigerated freezer and cold storage compartment as specified by the shipper in accordance with paragraph (b)(3) of this section.
We have made the following revisions to proposed § 1.908(d)(3) (now § 1.908(e)(3)) for consistency with changes elsewhere in the final rule to focus the rule on food safety only. We have changed the proposed phrase “food that can support the rapid growth of undesirable microorganisms in the absence of temperature control” to “food that requires temperature control for safety.” We have also removed the word “freezer,” because we believe that the pre-cooling of freezer vehicles is a step taken to preserve product quality and marketability and not to prevent the food from becoming unsafe.
We proposed to require that a carrier that offers a bulk vehicle for food transportation must provide information to the shipper that identifies the three previous cargoes transported in the vehicle. We proposed that the shipper and carrier would be able to agree in writing that the carrier would provide information identifying fewer than three
Consistent with our discussion concerning the duties of the shipper as a result of the requirements of § 1.908(b)(4), we have removed the provisions of proposed § 1.908(d)(4), concerning alternative arrangements for the responsibility to provide previous cleaning information to the shipper. This provision is no longer needed because new § 1.908(b)(4) and the new language at new § 1.908(e) provide the same flexibility to assign responsibility for this function as was provided by proposed § 1.908(d)(4).
(Comment 147) A few comments support this proposed provision. One comment notes that the proposed requirement is an existing common industry practice. Another comment informs us that our proposal is feasible. Another comment expressed the view that requiring identification of the three previous loads hauled is excessive and unnecessary for accomplishing the goal of sanitary food transport.
Several comments state that it is currently common for carriers to provide information about the single previous cargo hauled on a bulk transport vehicle to shippers under procedures already in place and widely accepted within both the human and animal food transportation industries. One of these comments states that for shippers, knowing the immediately previous load hauled in a bulk conveyance and knowing whether appropriate clean-out procedures have been followed, if needed to ensure the conveyance meets the needs of the shipper based upon the type of food to be loaded, is critically important. Another comment states that knowing what type of feed was hauled in a dedicated truck immediately before the present load is useful information when assessing the possibility of the contamination of the present load. Another comment offers the view that the shipper, in accordance with the FSMA preventive controls rules, would maintain written procedures as part of its food safety plan to ensure adequate cleanout of vehicles is performed and documented. According to this commenter, this written plan should suffice in lieu of any additional documentation required to support compliance to this rule.
Another comment states that the request for three previous cargoes is impractical for LTL shipments, where tractors hauling trailers with packaged goods may stop at multiple locations to pick up shipments. Several comments assert that the carrier's release of information regarding multiple previous loads could result in the improper disclosure of sensitive business information because it could involve divulging to a shipper's competitors detailed information regarding the shipper's deliveries to their customers. A related comment asserts that the tracking of three previous cargoes is impractical, and perhaps impossible, because trailers are attached to tractor transportation vehicles on a continually changing basis.
(Response 147) These comments indicate that under current industry practices, in some cases, shippers acquire information from carriers about cargo previously transported in a bulk vehicle and that this information has value to them in ensuring that their cargo will not be at risk of contamination during transportation. In other cases, shippers do not seek to obtain this information and instead rely on other measures to ensure that contamination will not occur, such as guarantees that the carrier will provide a vehicle dedicated to transporting a single type of cargo. Further, we have concluded that such a common practice demonstrates that this provision would not adversely impact businesses because of concerns about the disclosure of sensitive business information.
However, none of the comments supported the need to identify more than the single previous shipment and some suggest that it would be unduly burdensome. We are persuaded by these comments, and, consequently, while we have retained proposed § 1.908(d)(4) (new § 1.908(e)(4)), we have revised it to require the carrier to provide, on request from the shipper (when such function is the subject of a written agreement between the shipper and the carrier as provided for under § 1.908(b)(4)), information about the last previous cargo transported in a bulk vehicle. With respect to LTL shipments, we note that this provision does not apply in circumstances where the vehicle is used to transport packaged goods. This provision only applies to vehicles in which food is shipped in bulk, with the food coming into direct contact with the inner surfaces of the vehicle.
(Comment 148) A comment asks us to exempt vehicles that transport raw materials to rendering operations from the requirement of identifying prior cargoes.
(Response 148) While we recognize that materials destined for rendering will receive a heat treatment to destroy pathogens, we are not exempting carriers from the requirement that they identify the vehicle's previous cargo to the shipper supplying raw materials to a rendering operation because the shipper might wish to determine whether the bulk vehicles carried some previous cargoes that could contaminate the raw material in a way that would not be addressed by the heat processes of the rendering operation (
(Comment 149) Another comment asserts that carriers that offer bulk food vehicles for food transportation already comply with comparable requirements under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and further asserts that compliance with these existing requirements is sufficient to protect food safety during transportation operations.
(Response 149) We disagree. We have not established requirements in any other regulations that carriers must provide information to shippers that identifies previous cargoes transported in bulk vehicles or that describes the most recent cleaning of the vehicle. We are establishing these requirements in this rule pursuant to the objective of this rulemaking, which is to require that persons engaged in the transportation of food use sanitary transportation practices to ensure that food does not become unsafe during transportation. The regulations we have established under the Bioterrorism Act, as they pertain to food transportation, address a different purpose. Those regulations in 21 CFR part 1 address records that must be kept by certain persons, including food transporters, that would be available to FDA to identify the immediate previous sources, and immediate subsequent recipients, of food, in order for FDA to address contamination that presents serious adverse health consequences or death to humans or animals.
(Comment 150) A comment states that if a bulk trailer is offered for loading with a wash ticket, there is little reason to provide information about what was previously hauled therein. This commenter asserts that in many cases a
(Response 150) As we discuss in our response to Comment 149, we revised this rule in § 1.908(e)(4) so that carriers will only have to provide shippers with information about the previous load if the shipper requests the information (in cases where the carrier and shipper have a written agreement requiring the shipper to provide such information). We would not expect that a shipper would request this information under circumstances in which the shipper does not regard it as necessary under the terms of its business relationship with the carrier, for example, when the carrier by contract has agreed to only provide vehicles that have previously hauled compatible ingredients or to present a wash ticket to the shipper when the vehicle is offered.
(Comment 151) Another comment notes that railroads do not maintain information on previous cargoes. The commenter states that there is no industry process to track and identify prior shipments in rail cars that travel throughout the general system of rail transportation in interchange service. Railroads would not have this information for privately owned rail cars and they would not necessarily have the information for their own rail cars that have been in service on other railroads or rail cars that have been placed into pool arrangements. Finally, the commenter asks us to revise this final rule so that a railroad carrier would only be required to provide information to the shipper that identifies the three previous movements when a shipper requests this information, the railroad carrier has access to the information through its ordinary course of business, and the information is not otherwise available to the shipper.
Similar comments state that it can be difficult to obtain last-load hauled information from rail carriers unless the railcars being utilized are owned, leased, or controlled by the shipper, or the shipper is the one who is the consignee/consignor or payer of the freight bill. Currently, no consistent or reliable mechanism exists among rail carriers from which to obtain such information.
One comment states that, given the complexity of the rail transport network and the efficiency and safety of current industry practices, the final rule should exclude rail carriers to avoid imposing needless and onerous burden on railroads. The commenter states that the shipper is uniquely positioned to understand the sanitary needs of the goods it ships and therefore can prevent cross-contamination and inspect and clean railcars prior to loads.
Another comment states that section 11904 of the Interstate Commerce Commission Termination Act (ICCTA) prohibits railroads subject to the Surface Transportation Board (STB's) jurisdiction from disclosing any “information about the nature, kind, quantity, destination, consignee, or routing of property tendered or delivered to that rail carrier for transportation . . . that may be used to the detriment of the shipper or consignee or may disclose improperly, to a competitor, the business transactions of the shipper or consignee.” 49 U.S.C. 11904(a)-(b). The commenter also notes that the statute prohibits other shippers from soliciting or knowingly receiving such information from a railroad. The commenter notes, for example, if loaded railcars are delivered to one shipper in a terminal area and the empty railcars are provided to a second shipper in the same terminal area, disclosing the prior load would inform the second shipper as to the nature of its competitor's previous cargo. The commenter argues that this type of disclosure is prohibited by ICCTA.
(Response 151) We acknowledge that the use of railcars in interchange service as described by these comments would likely make it difficult or impossible for the railcar's provider,
(Comment 152) Another comment notes that contract transportation haulers notify renderers and feed manufacturers about prior loads, including nonfoods and animal feed ingredients such as restricted use proteins (
(Response 152) While the procedures described by the commenter may reflect the practices of most contract haulers handling raw materials for rendering, as we discussed previously, we have revised this rule at § 1.908(b)(4) to require the shipper to develop written procedures adequate to ensure that a previous cargo does not make the food unsafe. These procedures may describe actions that the shipper may take to provide this assurance (
This rule does not address controls for specific food safety hazards, such as the agent that causes transmissible spongiform encephalopathy. As we stated in the proposed rule (79 FR 7006 at 7011), we have established requirements in § 589.2000 (“Animal proteins prohibited in ruminant feed”) and § 589.2001 (“Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy”) addressing cleanout requirements and dedicated equipment requirements for equipment used in the distribution of specified feed ingredients to prevent the contamination of ruminant feed and animal food or feed, respectively.
We proposed to require that a carrier that offers a bulk vehicle for food transportation must provide information to the shipper that describes the most
Consistent with our discussion concerning the duties of the shipper as a result of the requirements of § 1.908(b)(4), we have removed the provisions of proposed § 1.908(d)(5), concerning alternative arrangements for the responsibility to provide previous cleaning information to the shipper. This provision is no longer needed because new § 1.908(b)(4) and the new language at new § 1.908(e) provide the same flexibility to assign responsibility for this function as was provided by proposed § 1.908(d)(5).
(Comment 153) Some comments support the proposed provision. One comment states that all cleanout procedures, including wash out for trailers, should be documented.
(Response 153) We have retained these provisions in this final rule with some modifications as noted in the paragraphs immediately preceding this comment.
(Comment 154) One comment asserts that given the strict procedures currently in place to manage medicated feed transport, we do not need to include a previous vehicle cleaning provision in this rule with respect to the transportation of medicated feed.
(Response 154) Under this rule as we have revised it, the shipper has the prerogative to request from the carrier information describing the bulk vehicle's most recent cleaning when a contract between the shipper and receiver provides for such information exchange. We are retaining this provision to allow the shipper to obtain this information from the carrier if the shipper deems it necessary under these circumstances for the purposes of ensuring that his product does not become unsafe during transportation. Our regulations addressing medicated feed cleanout procedures (21 CFR 225.65 and 225.165) do not provide shippers with access to this type of information from carriers. If, however, a shipper has determined that the provisions of 21 CFR 225.65 or 225.165 adequately address his circumstances, the shipper may choose to not request this information from the carrier.
(Comment 155) Another comment states that providing information to the shipper describing the cleaning of a bulk rail car is beyond the current capabilities of railroad operators. The commenter observes that railroads do not generally clean rail cars and do not track the cleaning of railcars. The commenter states that railroad operators do not have access to cleaning records for rail cars that they do not own that are cleaned by customers on site or at third-party locations. The commenter also states that, even if a railroad owns the railcar, railcar operators routinely enter into contractual arrangements whereby the lessee becomes responsible for cleaning the railcar, and that based on the lack of incidents involving food transported in bulk railcars, there is no reason to impose these burdensome requirements on railroad carriers. The commenter therefore asks us to revise this final rule to require a railroad carrier to provide information to the shipper that describes the most recent cleaning of a bulk vehicle when a shipper requests such information, the railroad carrier has access to the information through its ordinary course of business, and the information is not otherwise available to the shipper.
(Response 155) We acknowledge that the use of railcars in interchange service as described by this these comments would likely make it difficult or impossible for the railcar's provider,
(Comment 156) Another comment asks us to permit companies to use a written single generic guideline for all hired carriers with procedures addressing prior loads and the cleaning of bulk vehicles. The comment states that if a carrier commits to a shipper to use dedicated bulk containers or compatible raw ingredients and products, there should be no need for further procedures unless the shipper and carrier want to specify further details.
(Response 156) A shipper may operate in the manner described in this comment consistent with the requirements of this rule in § 1.908(e)(4) and (5). We acknowledge that an agreement provided to all hired carriers might state circumstances in which the shipper would want to know the identity of the previous cargo and information about the most recent cleaning of a bulk vehicle.
We proposed to require that carriers must provide training to personnel engaged in transportation operations that provides an awareness of potential food safety problems that may occur during food transportation, basic sanitary transportation practices to address those potential problems and the responsibilities of the carrier under this rule. The training must be provided upon hiring and as needed thereafter. We also proposed to require that carriers must establish and maintain records documenting the aforementioned training. Such records must include the date of the training, the type of training, and the person(s) trained. These records are subject to the records requirements of § 1.912(c). In table 9, we describe revisions to proposed § 1.910 and following the table we respond to comments related to these provisions.
(Comment 157) Several comments state that the training requirements should also apply to shippers and receivers who conduct loading and unloading operations in which they contact or handle food.
(Response 157) We do not agree and affirm our tentative conclusion in the proposed rule (79 FR 7006 at 7027) that training needs for shippers and receivers would be most appropriately addressed through the training provisions in our cGMP regulations for human and animal food because these regulations contain provisions related to sanitation focused employee training specifically tailored for entities that would operate as shippers, receivers and loaders under this rule.
(Comment 158) Some comments from the railroad industry state that railroads that do not handle food should not be subject to the training requirements of this rule and that these requirements should instead apply to shippers and receivers who actually contact and handle food shipped by rail.
(Response 158) We have addressed the portion of this comment that relates to training for shippers and receivers in our response to Comment 157. We agree that carriers, including railroads, that do not perform food transportation activities that may affect the sanitary condition of food would not benefit from training related to sanitary food transportation. For this reason, we have modified the carrier training requirement to require such training when the carrier and shipper have agreed in a written contract that the carrier is responsible, in whole or part, for the sanitary conditions during transportation operations. This revision is designed to be consistent with revisions at § 1.908(b)(3), (4), (5), and (e), discussed in the relevant sections of this document, that address when the carrier is made responsible for certain sanitary conditions during food transportation operations under this rule.
(Comment 159) Some comments state that training should be available to State and local regulatory officials.
(Response 159) As we discuss in our response to Comment 19, we are aware of the training needs for regulators and we will seek to establish partnerships with other Federal Agencies, and States and Tribes in implementing this rule which would include addressing these training needs.
(Comment 160) A comment requests more information about what type and amount of training would be sufficient to meet the requirements of this rule. It also states that a one-size-fits-all approach would likely overburden carriers who have little or no contact with food in their operations and likewise be insufficient for carriers whose operations involve a high degree of contact with food. Some comments mention that the content, frequency and length of training should be within the discretion of the carrier. Some comments state that a half-day long training seems unnecessary for this regulation. One comment requests that we provide flexibility in the training requirements for the transportation of chemical food additives and GRAS substances.
(Response 160) Beyond the general requirements stated in § 1.910, we are not prescribing details on aspects of the training such as its frequency, length, and subject matter. Given the diversity of food transportation operations, we do not intend to require that the entire industry use a single training approach. Training may vary in particular aspects,
(Comment 161) Some comments ask that we acknowledge in the final rule that industry training on food and feed safety systems will be acceptable and that we will not require that training be specific to this rule.
(Response 161) If industry training programs not specifically designed to address the requirements of this rule, nonetheless meets the requirements of § 1.910, such training would be acceptable under this rule. However, note that § 1.910 prescribes that the training, among other things, address the responsibilities of the carrier under this rule.
(Comment 162) A comment states that there will not be sufficient time or resources to train “qualified individuals” during the one year implementation period following the publication of the final rule. Some comments request that we establish guidelines for the development of standardized training materials. A comment requests that we develop standardized training programs that can be downloaded from our Web site, similar to the educational materials we have made available for food defense training and education.
(Response 162) The term “qualified individual” was not used in the proposed rule. It is used in this final rule in connection with determinations that food is safe when an indication of a possible material failure of temperature control or other conditions that may render the food unsafe occurs during transportation (§ 1.906(a)(6)). While the Preventive Controls rules for human and animal feed set minimum training requirements for qualified individuals, as that term is used in those regulations, no training or other standards are set in this regulation with regard to qualified individuals.
With regard to training for carriers, small businesses will have 2 years after the publication of the final rule to comply with its requirements. All other businesses subject to this rule will have 1 year. We believe firms will be able to comply with the training requirements of this rule within their allotted timeframes given these size based compliance dates and given the relatively brief and readily accessible
(Comment 163) A comment asks whether we have considered having this training be a requirement to obtain a truck driver's license.
(Response 163) A Commercial Driver's Licenses (CDL) is required to operate a tractor-trailer for commercial use. CDLs are issued by the States and are subject to requirements of DOT's Federal Motor Carrier Safety Administration. FDA has no authority to establish requirements for obtaining a CDL. Further, we believe that a requirement for safe food transportation training for all CDL holders would be unnecessarily burdensome, since many such drivers are not involved in transporting food.
(Comment 164) Some comments express willingness to work with us and other carrier and shipper organizations to develop sanitary food transportation training. Several comments state that the Seafood HACCP Alliance could best serve this purpose since it already has an established history in providing training, and has sufficient stakeholder involvement and the infrastructure in place to design, develop, and deliver training.
(Response 164) We commend the willingness of organizations to partner in developing sanitary food transportation training. Training alliances such as the Seafood HACCP Alliance have effectively functioned for this purpose in the past. We believe that a similarly constituted alliance would be useful for developing and promoting training for sanitary food transportation.
We proposed that shippers and carriers: (1) Must retain all records required under this rule for a period of 12 months beyond a specified date when these records are used in their operations; (2) must retain all training records for a period of 12 months beyond when the person identified in the records continues to perform the duties for which the training was provided; (3) must make these records available to a duly authorized individual promptly upon oral or written request; (4) must keep required records as original records, true copies or as electronic records, which must be kept in accordance with part 11 (21 CFR part 11); and (5) may store specified records offsite after 6 months following the creation of the record, if the records can be retrieved and provided onsite within 24 hours of requests for official review. We also specified that all records required by this rule are subject to the disclosure requirements of part 20 (21 CFR part 20). In table 10, we describe revisions to proposed § 1.912 and following the table we respond to comments related to these provisions.
(Comment 165) Several comments assert that we should exempt sanitary food transportation electronic records from compliance with part 11 and instead should take a more practical and simpler approach to requiring the authentication of electronic records. Some of these comments assert that requiring compliance with part 11 would be overly burdensome and cost-prohibitive and that this requirement is unnecessary because it would not significantly benefit the public health and is disproportionate to the regulatory need. Other comments assert that few, if any, entities engaged in the transportation of food would be able to meet this requirement because of the complexities involved with complying with part 11.
Some comments state complying with part 11 would mean that current electronic records and recordkeeping systems would have to be redesigned and would require the use of specialized and expensive software, which many small shippers, carriers and receivers might not be able to afford. Another comment states that compliance with the electronic records requirements in part 11 would be onerous for operations that currently use a combination of paper and electronic recordkeeping systems and that the effective integration of electronic recordkeeping systems throughout the food transportation chain might not be achievable given the diverse nature of the parties involved in the food transportation system and the different types of electronic systems that are currently used by the industry.
One comment acknowledges the importance of requiring that firms have adequate safeguards in place to ensure that electronic records cannot be altered, but asks us to provide the transportation industry with the flexibility to allow it to continue using, or to begin using, any existing electronic recordkeeping system that accomplishes this goal without mandating complete compliance with the prescriptive requirements in part 11. According to these comments, allowing the transportation industry to use existing electronic recordkeeping systems would enable industry to achieve our stated electronic recordkeeping goals efficiently and cost-effectively. A related comment urges us to provide a clear statement that companies may use any electronic recordkeeping systems as long as they ensure that all records are valid, accurate, and cannot be surreptitiously altered even if those electronic recordkeeping systems do not meet the prescriptive requirements of part 11.
(Response 165) We agree that redesigning large numbers of existing electronic records and recordkeeping systems would create a substantial burden disproportionate to the public health need. Therefore, we are providing in new § 1.912(g) of this final rule that records that are established or maintained to satisfy the requirements of this rule, and that meet the definition of electronic records in § 11.3(b)(6) are exempt from the requirements of part 11. We also are specifying that records that satisfy the requirements of this rule, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11. The rule provides that parties covered by this rule may rely on existing records to satisfy the requirements of this rule, and this rule does not change the status under part 11 of any such records if those records are currently subject to part 11. We are also establishing a conforming change in part 11, as new § 11.1(n), which says that part 11 does not apply to records required to be established or maintained by this rule, and that records that satisfy the requirements of this rule, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11.
Although we are not specifying that part 11 applies, we expect parties covered by this rule to take appropriate measures to ensure that records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
(Comment 166) Some comments assert that the 12 month record retention requirement in proposed § 1.912(a) is unnecessary and burdensome. One comment states that the time and costs required to create and maintain records for this rule will far outweigh the benefits of collecting and storing the information. One comment states that requiring record retention for 12 months beyond the last date of the activity described by the record as set forth in proposed § 1.912(a) is confusing. The comment interprets the language of proposed § 1.912(a) as requiring perpetual record retention activity for persons covered by this rule by continually adding an additional 12 month record retention period beyond the latest requirement. The comment also states that the proposed requirement that carriers retain training records for a period of 12 months beyond when the person identified in such records continues to perform the duties for which the training was provided is confusing, and asks us to restate the requirement more clearly. The comment asks, for example, if a person receives a refresher training course 11 months after the initial training, and then receives another refresher training course 13 months later, all the while continuing to perform the duties for which the training was provided, how long must the original and refresher training records be retained?
(Response 166) We are requiring that records be retained for a period 12 months beyond the last date of the activity described by the record, so that we can review the past practices of a shipper or carrier that may not currently be engaged in food transportation operations. Maintaining such records on
(Comment 167) A few comments commend our “practical approach” of not proposing that carriers or shippers would have to maintain a “roomful of records” documenting conditions for individual shipments. These comments state that while our generally practical approach has been conveyed to the food transportation industry repeatedly at FDA's public meetings, it was not discussed in detail in the preamble to the proposed rule. These comments encourage us to explain our regulatory philosophy in the preamble to this final rule in order to prevent deviations from our public statements in the future and to reinforce our intent. These comments also state that our field inspectors should be trained to understand that this regulation's recordkeeping requirements differ from the requirements under other FSMA regulations and that FDA inspectors should be trained not to ask for transportation records beyond those that are legally required under this final rule. A similar comment states that this rule is silent with respect to the retention of shipment records related to truck inspections, pre-cooling activities, and temperature monitoring, and asks us to make clear that the retention of such records is outside the scope of the rule.
(Response 167) Some of these comments refer to statements that we made in public meetings (Refs. 29 and, 30) in Chicago, IL and College Park, MD regarding the proposed rule.
In the Chicago meeting, for example, we stated: “[A] carrier will have to provide information to shippers if it's a bulk carrier, about prior cargoes in its vehicle. We're not looking for a record of every prior cargo that was transported in every bulk vehicle the carrier operates. What we want to see is an SOP, that's the carrier's record . . . that states how it provides this information to the shipper.” We further stated during the Chicago meeting that: [W]e're not looking for operational records that are going to fill a room up to the ceiling—[for example,] time, temperature, strip chart recordings—for every transportation operation for refrigerated food or cleaning records for every bulk tanker, we're looking for a procedure from the carrier that describes how he will provide this information to the shipper.” Finally, we also said during the Chicago public meeting that: “[W]e've done all that we can to minimize the burden of this recordkeeping requirement, but enable us to verify that this information exchange, which we think is an important part of sanitary transportation practices, is taking place.” We stated during the College Park public meeting that: “[W]e are not looking for carriers to fill up some room with time-temperature strip chart recordings for every load of refrigerated food that they transport and show those records for every operation that they conduct to the FDA. We are looking for the carrier to, in the form of a record, provide FDA [with] records that demonstrate that they do conduct this information exchange with shippers, that they do provide, as a part of their operation, information about the maintenance of temperature control to shippers.” We again emphasized during the College Park public meeting that we “tried to develop this recordkeeping provision in a way that minimizes the burden but recognizes the accountability of the carrier to demonstrate to shippers that they are transporting refrigerated foods or bulk foods under conditions that comply with requirements of the rule.” Accordingly, these comments are correct in observing that the records retention requirements of this rule do not require carriers or shippers to maintain for our examination, records documenting conditions, such as temperature conditions, for individual shipments. Carriers may, however, choose to retain such information to provide to shippers upon request in accordance with § 1.908(e)(2)(i).
These comments also are correct in stating that this rule differs from other FSMA rules because this rule does not require the maintenance of records of ongoing transportation operations in the same way that some other FSMA rules require the retention of specific operating records. This rule, for example, does not mandate that persons covered by this rule must maintain monitoring records as does the FSMA preventive controls rules. We will ensure that our investigators are trained to understand the unique recordkeeping requirements of this rule.
Finally, there are no requirements in this rule concerning the retention of individual shipment records for our examination related to truck inspections, or precooling and temperature monitoring activities. Shippers and carriers, however, may choose to retain such information for business purposes.
(Comment 168) One comment states that the proposed rule requires carriers to demonstrate the temperature conditions that are maintained during transport, but fails to specify how long a carrier must maintain these temperature condition records.
(Response 168) A carrier may, but is not required to, create records of temperature conditions maintained during the transportation of food to provide to a shipper or a receiver upon request pursuant to § 1.908(e)(2)(i). This rule does not establish any retention time requirements for these optional temperature condition records.
(Comment 169) Some comments state that the proposed requirements to store records onsite are contrary to accepted and effective recordkeeping practices. Some of these comments state that companies frequently keep records of food safety activities, as well as transportation, cleaning, and training records at their corporate offices and not at operating facilities and asks us to allow this practice to continue. These comments also state that there is little practical difference between maintaining records onsite at food transportation facilities versus maintaining them offsite, for example, at corporate offices, provided that they can be provided to duly authorized individuals promptly upon an oral or written request, that is, within 24 hours.
(Response 169) We agree with this comment. Therefore, we have revised § 1.912(h) of this final rule to allow offsite storage of all records, except for the written procedures required by § 1.908(e)(6)(i), provided that the records can be retrieved and made available to us within 24 hours of a request for official review. As proposed, we will continue to require that the written procedures required by § 1.908(e)(6)(i) remain onsite as long as the procedures are in use in transportation operations. These written procedures comprise cleaning, sanitizing and inspection procedures for
(Comment 170) A few comments state that it may be difficult for some carriers to promptly provide records, depending on what we mean by the term “promptly.” The comment provided an example of a small carrier such as a motor vehicle owner/driver who might own a single motor vehicle used to transport food, who may not carry required records (
(Response 170) We anticipate that, to the extent feasible, we will carry out records examinations at a carrier's fixed business location. If we were to determine for any reason that it is necessary to request records for examination from a small carrier while the carrier is in transit, we would not necessarily expect the carrier to have the records in its immediate possession, and would provide the carrier with a reasonable amount of time to provide the records. Similarly, if for any reason we were to request records that a carrier maintains at a private residence, we would take into account the circumstances of the of the transportation operation as they may affect the carrier's ability to produce the records promptly.
(Comment 171) One comment states that the records requirements of the proposed rule would be difficult to comply with because the shipper, carrier and receiver roles are not always easily identifiable when food is transported sequentially by more than one person between its point of origin and final destination.
(Response 171) We understand that the sequential shipment of food by multiple persons might involve many persons such as brokers, rail carriers, motor carriers, distributors, etc., and that the roles of these persons may vary from one circumstance to another. Therefore, we have revised this final rule to better define the persons who are subject to the requirements of this rule. As we explained in our response to Comment 70, we have revised the definition of the term “shipper” to clarify the scope of this definition. As we also discussed in our response to Comment 53, we have revised the definition of the term “carrier” to focus it more narrowly on the person who is responsible for the sanitary condition of the vehicle or transportation equipment used to transport food and to exclude from the definition, a person who is solely responsible for the movement of the vehicle or equipment. We believe the clarity we have added to the shipper, loader, carrier and receiver roles will make recordkeeping easier.
(Comment 172) Some comments state that written agreements assigning duties in compliance with this rule to other persons, as discussed in our response to Comment 16, should be subject to the record keeping provisions of this rule.
(Response 172) We agree. As we discussed in our response to Comment 16, we expect that the parties would have a written contract as proof of their agreement. To enable us to determine which party has responsibility to fulfill a duty assigned by this rule, we are establishing in § 1.912(b) that written agreements assigning duties in compliance with this rule are subject to the record keeping provisions of this rule.
(Comment 173) Some comments express concern that this rule's recordkeeping requirements will pose a burden on businesses. One of these comments states that this rule adds to other FDA records requirements. Another comment questioning the necessity of the records requirements of this rule, states that food transportation vehicles are pre-cooled and inspected before they are loaded and if they do not meet the required sanitary standards, they are refused or sent to be washed out and that this information is recorded in the shipping paperwork and can be provided to shippers, receivers, and FDA if necessary. Another comment acknowledges that it is important for a carrier to be able to demonstrate that a process is in place for training, sanitizing and cleaning, but asserts that retaining records that document these activities for one year would not serve any meaningful food transportation safety purpose.
(Response 173) We have made several revisions to this final rule in response to comments that we received on the proposed rule that will lessen the recordkeeping requirements for persons who are subject to the rule (see Comment 129, Comment 149, Comment 165, and Comment 169). Section 7202(b) of the 2005 SFTA requires us to issue a regulation that “require[s] shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated.” Section 7202(c) also states that we must prescribe practices that we deem to be appropriate and necessary relating to, among other things, recordkeeping. As we have explained throughout the preamble to this final rule, we have determined that the records provisions in this final rule are appropriate for this purpose and required of us by our statutory mandate.
(Comment 174) One comment asks us to codify all of the recordkeeping requirements that apply to both the manufacture and transportation of animal feed in one location for ease of accessibility by the animal industry.
(Response 174) We have issued this rule for the sanitary transportation of human and animal food under the 2005 SFTA and the preventive controls rule for animal food under the FSMA, which are two separate grants of statutory authority given to us by Congress. These rules and their records requirements have been codified in distinct parts of Title 21 of the Code of Federal Regulations to reflect these two different authorizing statutes. However, FDA maintains a Web site dedicated to the FSMA, which can be found at
(Comment 175) One comment notes that records that are required by our seafood and juice HACCP rules are exempt from public disclosure under the Freedom of Information Act (FOIA), and asks us to similarly exempt the records required by this final rule from public disclosure. The comment's concern is that the records required by this rule may contain proprietary and confidential information (
(Response 175) We first note that in the rulemaking for the seafood and juice HACCP rules we did not state that records required by these rules are exempt from public disclosure. In this regard, the Agency concluded in the seafood HACCP final rule (60 FR 65096 at 65138), that HACCP plans, as a general rule, meet the definition of trade
We would determine whether records required by this rule that we copy are either publicly disclosable or protected from public release under the FOI Act on a case-by-case basis. We copy records on a case-by-case basis as necessary and appropriate. We primarily intend to copy such records if the preliminary assessment by our investigator during a routine inspection is that regulatory followup may be appropriate (
In table 11, we describe revisions to proposed §§ 1.914 to 1.934 and following the table we respond to comments related to these provisions.
(Comment 176) A comment asks that we clarify how we would waive requirements if we determine that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and that is in the public interest, and how we would communicate these waivers to state agencies.
(Response 176) In §§ 1.924 and 1.928 of the proposed rule, we outlined the processes we will follow when waiving a requirement of this subpart, depending on whether the waiver is granted in response to a submitted petition or on our own initiative. In both cases, we will publish a notice in the
(Comment 177) Some comments support our proposal to include in the final rule a petition process whereby we can grant a waiver from the proposed requirements of this rule. Additionally, a few comments urge us to not make such a petition too onerous or burdensome for individuals, small shippers, and owner/operator carriers and to provide lenience and guidance for such situations.
(Response 177) We agree that we should allow a petition process to grant waivers from the requirements of this rule. In § 1.916 of the proposed rule, we stated that we will consider whether to waive a requirement of this rule on our own initiative or on a petition submitted under 21 CFR 10.30. In proposed § 1.918 we outlined what must be included in the Statement of Grounds in the petition. And in proposed § 1.924 we outlined the process that will apply to a petition requesting a waiver. We do not believe that the petition described in § 10.30, the Statement of Grounds described in § 1.918, or the process described in § 1.924 is onerous or burdensome and, therefore, are retaining the language in these sections in the final rule. We do not plan to publish guidance on the petition itself, since it is explained in detail in 21 CFR 10.30.
(Comment 178) A comment strongly urges that we issue public notice of potential waivers and petitions for waivers in the
(Response 178) We will consider whether to waive a requirement of this subpart in one of two ways: (1) On a petition submitted under 21 CFR 10.30 or (2) on our own initiative. For a filed petition, § 1.924(b) states that we will publish a notice in the
(Comment 179) Some comments recommend that we expedite written responses to waiver petitions and include in the final rule a timeframe for our decision on a petition (
(Response 179) We disagree with these comments. In proposed § 1.924, we stated that the procedures set forth in 21 CFR 10.30 govern our response to a petition requesting a waiver. 21 CFR 10.30 outlines the petition process and states that we will respond to the petitioner within 180 days of receipt of the petition. 21 CFR 10.30 does not address steps to be taken if the 180-day timeframe is missed.
(Comment 180) Some comments request that we establish a waiver application process that resembles the process for granting a variance under the proposed FSMA produce safety regulation and ensures engagement with the applicant. One of the comments suggests that this process provide an avenue for an industry or a person to request a waiver without the involvement of a state or foreign government. These comments also state that the process should include an opportunity to re-obtain a revoked waiver after a period of time to incentivize long-term commitments to food safety improvement.
(Response 180) The process for granting a variance under the FSMA produce safety rule is very similar to the waiver petition process described in §§ 1.914 to 1.934 of this final rule. Both require the submission of a petition under 21 CFR 10.30, and both require that we publish a notice in the
(Comment 181) Some comments request clarification regarding whether a waiver can be revoked in whole or part from the group to which it was granted. A few comments suggest that we develop a policy that would allow us to revoke a waiver from a single “bad actor,” even when the waiver has been granted to an entire industry. The comments state that by doing so, each member of the industry still maintains individual responsibility for ensuring compliance.
(Response 181) We outlined the process we will follow for modification and revocation of waivers in §§ 1.932 and 1.934 of the proposed rule. Specifically, we stated in § 1.932 that we may modify or revoke a waiver if we determine that the waiver could result in the transportation of food under conditions that would be unsafe for human or animal health or that the waiver could be contrary to the public interest. We believe the language in §§ 1.932 and 1.934 is clear and, therefore, are retaining it in the final rule. We do not agree that we should establish a policy for revoking a waiver from a single firm. The Sanitary Food Transportation Act of 2005 states that “the Secretary may waive any requirement under this section, with respect to any class of persons, vehicles, food, or nonfood products . . . .” Since the SFTA gives FDA the authority to issue waivers to cover any class of persons, vehicles, food, or nonfood products, we believe that revocation of a waiver must also cover that same class of persons, vehicles, food, or nonfood products to which it was issued and not a subset thereof. Nonetheless, FDA can take appropriate action against an individual firm, such as described by this comment, if the firm fails to comply with the requirements of this rule.
(Comment 182) A comment urges us to adopt appropriate provisions in the regulation governing waivers to protect against the disclosure of confidential business information of shippers, carriers, and receivers.
(Response 182) We have adopted appropriate provisions in this regulation related to protection of confidential information. Proposed § 1.920 states that we will presume that information submitted in a petition requesting a waiver and comments submitted on such a petition does not contain information exempt from public disclosure under 21 CFR part 20 and would be made public as part of the docket associated with this request. As we stated in the proposed rule, we do not believe that information exempt from disclosure under 21 CFR part 20 is the type of information that we are requiring to be submitted in such a petition or that would be relevant in any comments submitted on such a petition. We will publicly disclose a petition for waiver or comments on such a petition unless information in those documents falls within the exemption for confidential commercial or trade secret information in 21 CFR part 20.
(Comment 183) A few comments suggest that we provide a window of 60 days for industry to come into compliance with the regulation when a waiver is revoked. The comments state that regulators could increase food safety surveillance of the product or industry during this short time.
(Response 183) We disagree with these comments. In proposed § 1.934(a)(2) we stated that we will publish a notice of our determination that a waiver should be revoked in the
We proposed that any final rule based on proposed part 1, subpart O become effective 60 days after its date of publication in the
After considering the following comments addressing the proposed compliance dates for this rule, we are establishing the effective and compliance dates as proposed.
(Comment 184) One comment encourages us to allow a phased-in timeframe for compliance with this rule because companies will need time to develop written protocols and train company personnel. One comment states that it is not reasonable to expect the industry to be in compliance in 1 or 2 years, given the cultural changes required by the proposed regulation. One comment states that the 2-year period for compliance for small businesses seems overly generous because many, if not most, of the requirements of this rule should already be in place under existing rules and regulations. A comment states that it will be difficult to implement phased-in compliance dates because inspectors will not be able to determine a business' size when performing single vehicle inspections. The comment recommends that we establish a single compliance date that is possible for all businesses to meet.
(Response 184) It is our general practice for this type of rulemaking, which does not address a public health emergency or other matter that would require a uniform compliance date for all businesses, to consider business size in establishing timeframes for businesses to come into compliance with the rule. After considering these comments, we are retaining the proposed compliance dates for this rule,
The conforming amendment to part 11 adds a reference to the scope of part 11 that the records required under part 1, subpart O are not subject to part 11. This conforming amendment is effective on June 6, 2016, the same date as the effective date of part 1, subpart O. We are not establishing compliance dates for these conforming amendments. As a practical matter, compliance dates will be determined by the dates for compliance with part 1, subpart O.
In accordance with Executive Order 13175, FDA has consulted with tribal government officials. A Tribal Summary Impact Statement has been prepared that includes a summary of tribal officials' concerns and how FDA has addressed them (Ref. 31). Persons with access to the Internet may obtain the Tribal Summary Impact Statement at
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us 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 effects, distributive impacts, and equity). We believe that this final rule is a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. This final rule defines small business as one subject to this rule employing fewer than 500 full-time equivalent employees except that for carriers by motor vehicle that are not also shippers and/or receivers, this term would mean a business subject to this rule having less than $27,500,000 in annual receipts. The Agency concludes that the final rule will have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “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 $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA expects this final rule to result in a 1-year expenditure that would meet or exceed this amount.
The final analysis conducted in accordance with these Executive orders and statutes is available in the docket for this rulemaking (Ref. 24) and at:
This final rule contains information collection requirements that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) (PRA). A description of these provisions is given in the following paragraphs with an estimate of the annual recordkeeping and reporting burdens. Included in the burden estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
We have concluded that recordkeeping and submissions are necessary for the success of the food transportation operation. Records of actions taken due to each requirement are essential for manufacturers to
In the following paragraphs, we describe and respond to the comments that we received on the PRA for our 2014 proposed rule. We numbered each comment to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value, importance, or the order in which it was received.
(Comment 185) We received many comments regarding the burden of proposed § 1.908(d)(2)(i), which required demonstration of temperature conditions during a shipment. The comments stated that these burdens can include adoption of a method of monitoring and recording temperatures during shipment, purchase of equipment, implementation of those systems, and the costs of downloading data. One comment stated that, although most carriers have temperature data on temperature-controlled shipments, this data is not readily available and easily retrievable without incurring significant costs. Furthermore, as another comment stated, if the proposed requirement were finalized, far more than the 1 percent of industry estimated in the economic analysis would have to incur these costs. Another comment stated that, while “reefer” trailers are generally equipped with thermometers, they do not ordinarily create any kind of permanent printout record to be shown to the receiver. The comment emphasized that any requirement to have this would put unnecessary burdens on industry, particularly small firms. One comment stated that the current practice is for such records to be provided only if there is an indication of a problem (
(Response 185) We acknowledge the lack of data available to us when estimating the cost of this proposed requirement. However, as a result of public comment, this requirement has been amended (final § 1.908(e)(2)(i)) to require this demonstration of temperature conditions only when the carrier has agreed by contract with the shipper to assume this responsibility, and only if requested by the shipper or receiver and in a way agreeable to the shipper and carrier, which can include measurements of ambient temperature. We believe this is aligned with current industry practices and is not estimated to represent new cost to industry.
(Comment 186) One commenter stated that proposed § 1.908(d)(4), requiring carriers offering bulk vehicles for food transportation to provide written documentation to the shipper that identifies the three previous cargoes transported in the vehicle, would be overly burdensome. Another comment stated that the estimated burden of this requirement did not include the cost of implementing industry-wide software changes for railroads, as tracking this information is not current industry practice.
(Response 186) These comments did not provide any data to allow us to calculate this burden, and we acknowledge the simplicity of our assumptions in the estimations of the cost related to this provision. However, in response to comments on the proposed rule, this provision has been amended (final § 1.908(e)(4)) to require carriers to provide information identifying the last previous cargo only when they have agreed by contract with the shipper to assume this responsibility, and
(Comment 187) A commenter stated that proposed § 1.908(d)(5), which required carriers to provide information to shippers describing the most recent cleaning of bulk vehicles, would be beyond the current capabilities of railroads. The comment stated that compliance with this requirement would likely require expensive investments to track this information, as this is not current industry practice.
(Response 187) This comment did not provide any data that would allow us to estimate this burden. However, in response to comments on the proposed rule, this provision has been amended (final § 1.908(e)(5)) to require information describing the most recent cleaning of bulk vehicles only when the carrier has agreed by contract with the shipper to assume this responsibility, and only if requested by the shipper. This provision is believed to be aligned with current industry practice. No new burden is estimated for this information collection.
(Comment 188) One commenter stated that requiring firms to retain records for 1 year would not benefit those along the supply chain and would be unnecessarily burdensome.
(Response 188) This comment does not describe how the 12-month retention requirement would be more burdensome. This final rule reduces the total number of records related to sanitary food transport, which will reduce new burden to industry. Furthermore, the codified provides a wide range of options on how these records must be kept. We estimate that firms will maintain electronic records, which further reduces burden.
(Comment 189) One comment expressed appreciation regarding the ability of industry to diverge from certain proposed requirements, such as those for bulk shipments, by contractual agreement. This comment stated that reflects a practical understanding of the way business is conducted and how flexibility is essential because of the highly complex nature of the transportation chain. This comment went on to state that FDA should permit flexibility to allow businesses to enter into contractual agreements allocating the responsibilities for shippers, carriers, and receivers to other parties.
(Response 189) While this comment did not address the PRA of the proposed rule specifically, it does allow us to estimate that contractual agreements, such as those addressed in § 1.908(b)(3), are common business practice. No additional information collection burden to industry is estimated for such agreements.
FDA estimates the burden of this collection of information as follows:
The total one-time estimated burden imposed by this collection of information is 254,923 hours (228,832 recordkeeping hours + 144 submission hours + 25,947 third-party disclosure hours). The total annual estimated burden imposed by this collection of information is 120,342 hours (120,163 recordkeeping hours + 48 submission hours + 113 third-party disclosure hours). There are no capital costs or operating and maintenance costs associated with this collection of information. FDA estimates that firms will be able to fulfill recordkeeping requirements with existing record systems; that is, FDA estimates that it will not be necessary for firms involved in food transportation to invest in new recordkeeping systems.
One-time burdens are estimated for establishing written procedures regarding integrated transportation operations, written procedures for transportation operations with respect to sanitary condition of vehicles and equipment, previous cargoes, and adequate temperature control; written procedures for cleaning and sanitizing; procedures for use of bulk vehicles; training; notification of operating temperature and written sanitary
First-year and annual burdens related to recordkeeping requirements are presented in table 12. In the economic analysis of this final rule, cost estimations were estimated based on a percentage of, for example, shippers that may have to change behavior as a result of this final rule, or shipments that would have new records associated with them. Calculating percentages of firms or shipments often resulted in fractions; these numbers were rounded to the nearest whole number to be presented in the analysis. Therefore, any discrepancies in table 12 are attributable to rounding.
It is estimated that about 343 recordkeepers will each spend 2 hours (one-time) developing written procedures related to integrated transportation operations, as required by § 1.908(a)(4). Therefore, 343 × 2 = 686 (686.13) one-time hours, as presented in line 1.
The one-time cost of developing written procedures to ensure sanitary condition of vehicles and equipment, as required by § 1.908(b)(3), is estimated at the shipper level. It is estimated that these written procedures are relatively simple and easy to assemble, and that one recordkeeper for about 4,483 firms will spend 0.5 hour adjusting current practices with respect to this requirement. Therefore, 0.5 hours × 4,483 = 2,242 (2,241.69) one-time hours for § 1.908(b)(3), as shown in line 2.
The one-time cost of developing written procedures to ensure that previous cargo does not make food unsafe, as required by § 1.908(b)(4), is estimated at the shipper level. It is estimated that these written procedures are relatively simple and easy to assemble, and that one recordkeeper for about 4,483 firms will spend 0.5 hour adjusting current practices with respect to this requirement. Therefore, 0.5 hours × 4,483 = 2,242 (2,241.69) one-time hours for § 1.908(b)(4), as shown in line 3.
The one-time cost of developing written procedures to ensure that food is transported under adequate temperature control, as required by § 1.908(b)(5), is estimated at the shipper level. It is estimated that these written procedures are relatively simple and easy to assemble, and that one recordkeeper for about 4,483 firms will spend 0.5 hour aligning current practices with this requirement. Therefore, 0.5 hours × 4,483 = 2,242 (2,241.69) one-time hours for § 1.908(b)(5), as shown in line 4.
The one-time cost of development of written procedures related to cleaning and sanitation, as required by § 1.908(e)(6)(i), is estimated at the carrier level. It is estimated that one recordkeeper for about 37,249 firms will spend 2 hours developing written procedures. Therefore, 2 hours × 37,249 = 74,498 (74,498.48) one-time hours for § 1.908(e)(6)(i), as shown in line 5.
The one-time cost of development of written procedures related to bulk vehicles, as required by § 1.908(e)(6)(iii), is estimated at the bulk carrier level. It is estimated that one recordkeeper for about 6,713 firms will spend 2 hours developing written procedures. Therefore, 2 hours × 6,713 = 13,426 (13,426.48) one-time hours for § 1.908(e)(6)(iii), as shown in line 6.
The one-time cost of establishing training records, as required by § 1.910(b), is estimated at the employee level. It is estimated that one recordkeeper will establish a record for about 1,668,698 workers, and this will take 5 minutes (0.08 hours) for each worker. Therefore, 0.08 hour × 1,668,698 = 133,496 (133,495.86) one-time hours for § 1.910(b), as shown in line 7.
The total one-time hourly recordkeeping burden is 228,832 (228,832.02) hours.
The annual cost of training records, as required by final § 1.910(b), is estimated at the worker level. It is estimated that one recordkeeper for each of about 1,502,032 workers will spend 5 minutes (0.08 hour) minutes completing records related to annual training (the time spent training is estimated separately and not included in this PRA analysis). We believe recordkeeping will be very simple and can consist of, for example, printing off a certificate of completion. Therefore, 0.08 hour × 1,502,032 workers = 120,163 (120,162.59) annual hours for § 1.910(b), as shown in line 8. Therefore, the annual hourly recordkeeping burden is 120,163 hours.
The one-time and annual hourly burdens related to submission of waiver petitions (§ 1.914) are presented in table 13. This final rule refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information in § 10.30 have been approved under OMB control number 0910-0183 (General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions).
In the first year, it is estimated that one recordkeeper from each of a total of six firms will each spend 24 hours submitting a waiver petition to FDA (per the estimate for the petition process in § 10.30, approved and estimated under OMB control number 0910-0183 as 24 hours per submission). Therefore, 6 waiver petitions × 24 hours = 144 one-time hours for § 1.914, as shown in line 1. Annually, it is estimated that one recordkeeper from each of a total of two firms will spend 24 hours submitting a waiver petition to FDA. Therefore, 2 waiver petitions × 24 hours = 48 annual hours for § 1.914, as shown in line 2.
The one-time and hourly burdens related to third-party disclosures are presented in table 14. The one-time cost of developing written sanitary specifications necessary for transportation, as required by § 1.908(b)(1), is estimated at the shipper level. It is estimated that one recordkeeper for each of about 10,163 firms will spend 30 minutes developing written sanitary specifications. Therefore, 0.5 hour × 10,163 firms = 5,082 (5,081.57) one-time hours for § 1.908(b)(1), as shown in line 1.
The one-time cost of developing initial notifications of operating temperature, as required by § 1.908(b)(2), is estimated at the shipper level. It is estimated that one recordkeeper for each of about 5,646 firms will spend 30 minutes (0.5 hour) developing these notifications. Therefore, 0.5 hour × 5,646 firms = 2,823 (2,823.13) hours, as shown in line 2.
The one-time cost of establishing records pertaining to disclosure of information, as required by § 1.912(a), is estimated at the firm level. It is estimated that one recordkeeper will establish a record at a total of about 36,084 firms, and this will take 30 minutes (0.5 hour) for each record. Therefore, 0.5 hour × 36,084 = 18,042 (18,041.88) one-time hours for § 1.912(a), as shown in line 3.
The total one-time hourly third-party disclosure burden is 25,947 (25,946.57) hours.
The annual cost of disclosing necessary sanitary specifications, as required by § 1.908(b)(1), is estimated at the firm level. It is estimated that 1 recordkeeper for each of about 226 firms will spend 5 minutes disclosing sanitary specifications. Therefore, 0.08 hour × 226 shipments = 18 (18.07) annual hours for § 1.908(b)(1), as shown in line 4.
The annual cost of disclosing operating temperature conditions, as required by § 1.908(b)(2), is estimated at the shipper level. It is estimated that 1 recordkeeper for each of about 226 firms will spend 30 minutes (0.5 hour) disclosing necessary temperature conditions. Therefore, 0.5 hour × 226 firms = 113 (112.93) annual hours for § 1.908(b)(2), as shown in line 5.
The total annual hourly third-party disclosure burden is 131 (130.99) hours.
The information collection provisions of this final rule have been submitted to OMB for review. Prior to the effective date of this final rule, FDA will publish a notice in the
We have determined, under 21 CFR 25.30(j), that this action is of a type that does not individually or cumulatively have a significant effect on the human environment (Refs. 32 and 33). Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132 on federalism. We have examined the effects of the requirements of this rule on the relationship between the Federal Government and the States. We conclude that Federal preemption of State or local rules that establish requirements for the sanitary transportation of human and animal food such that: (1) Complying with the requirements of the State or political subdivision and with a requirement of section 416 of the FD&C Act, or with this rule, is not possible; or (2) the requirements of the State or political subdivision, as applied or enforced, is an obstacle to accomplishing and carrying out section 416 of the FD&C Act or this rule, is consistent with this Executive order. FDA has not incorporated text in this rule to reflect this preemptive effect because section 416(e) of the FD&C Act expressly provides for this preemption.
Section 3(b) of Executive Order 13132 recognizes that Federal action limiting the policymaking discretion of States is appropriate “where there is constitutional and statutory authority for the action and the national activity is appropriate in light of the presence of a problem of national significance.” The constitutional basis for FDA's authority to regulate food safety is well established. Section 4(a) of Executive Order 13132 expressly contemplates preemption where the exercise of State authority conflicts with the exercise of Federal authority under a Federal statute. Moreover, section 4(b) of Executive Order 13132 authorizes preemption of State law by rulemaking when the exercise of State authority directly conflicts with the exercise of Federal authority under the Federal statute, or there is clear evidence to conclude that Congress intended the Agency to have the authority to preempt State law.
Section 4(e) of the Executive order provides that, “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” As required by the Executive order, FDA provided the States and local governments with an opportunity for appropriate participation in this rulemaking when it sought input from all stakeholders through publication of the proposed rule in the
We received comments on the proposed rule from several State government agencies. Most of these comments addressed matters in this rulemaking other than the issue of preemption of State and local requirements for the sanitary transportation of human and animal food. One comment stated that the preemptive provision of section 416(e)(1) or (2) of the FD&C Act could function to prevent States from developing a unified sanitary transportation regulation that would address all modes of transportation. However, a State law, including unified State laws, should states wish to adopt such laws, concerning the sanitary transportation of food by motor vehicle
The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and recordkeeping requirements.
Administrative practice and procedure, Computer technology, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 1 and 11 are 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, 342i, 343, 350c, 350d, 350e, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 373, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.
(a) Except for non-covered businesses as defined in § 1.904 and as provided for in paragraph (b) of this section, the requirements of this subpart apply to shippers, receivers, loaders, and carriers engaged in transportation operations whether or not the food is being offered for or enters interstate commerce. The requirements of this subpart apply in addition to any other requirements of this chapter that are applicable to the transportation of food,
(b) The requirements of this subpart do not apply to shippers, receivers, loaders, or carriers when they are engaged in transportation operations:
(1) Of food that is transshipped through the United States to another country; or
(2) Of food that is imported for future export, in accordance with section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act, and that is neither consumed nor distributed in the United States; or
(3) Of food when it is located in food facilities as defined in § 1.227 of this chapter, that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601
(a) The criteria and definitions of this subpart apply in determining whether food is adulterated within the meaning of section 402(i) of the Federal Food, Drug, and Cosmetic Act in that the food has been transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, loader, or receiver engaged in transportation operations under conditions that are not in compliance with this subpart.
(b) The failure by a shipper, carrier by motor vehicle or rail vehicle, loader, or receiver engaged in transportation operations to comply with the requirements of this subpart is a prohibited act under section 301(hh) of the Federal Food, Drug, and Cosmetic Act.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. The following definitions also apply:
(a) Vehicles and transportation equipment used in transportation operations must be so designed and of such material and workmanship as to be suitable and adequately cleanable for their intended use to prevent the food they transport from becoming unsafe,
(b) Vehicles and transportation equipment must be maintained in such a sanitary condition for their intended use as to prevent the food they transport from becoming unsafe during transportation operations.
(c) Vehicles and transportation equipment used in transportation operations for food requiring temperature control for safety must be designed, maintained, and equipped as necessary to provide adequate temperature control to prevent the food from becoming unsafe during transportation operations.
(d) Vehicles and transportation equipment must be stored in a manner that prevents it from harboring pests or becoming contaminated in any other manner that could result in food for which it will be used becoming unsafe during transportation operations.
(a)
(2) Responsibility for ensuring that transportation operations are carried out in compliance with all requirements in this subpart must be assigned to competent supervisory personnel.
(3) All transportation operations must be conducted under such conditions and controls necessary to prevent the food from becoming unsafe during transportation operations including:
(i) Taking effective measures such as segregation, isolation, or the use of packaging to protect food from contamination by raw foods and nonfood items in the same load.
(ii) Taking effective measures such as segregation, isolation, or other protective measures, such as hand washing, to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination and cross-contact during transportation operations.
(iii) Taking effective measures to ensure that food that requires temperature control for safety is transported under adequate temperature control.
(4) The type of food,
(5) Shippers, receivers, loaders, and carriers, which are under the ownership or operational control of a single legal entity, as an alternative to meeting the requirements of paragraphs (b), (d), and (e) of this section may conduct transportation operations in conformance with common, integrated written procedures that ensure the sanitary transportation of food consistent with the requirements of this section. The written procedures are subject to the records requirements of § 1.912(e).
(6) If a shipper, loader, receiver, or carrier becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the food shall not be sold or otherwise distributed, and these persons must take appropriate action including, as necessary, communication with other parties to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe.
(b)
(2) Unless the shipper takes other measures in accordance with paragraph (b)(5) of this section to ensure that adequate temperature control is provided during the transportation of food that requires temperature control for safety under the conditions of shipment, a shipper of such food must specify in writing to the carrier, except a carrier who transports the food in a thermally insulated tank, and, when necessary, the loader, an operating temperature for the transportation operation including, if necessary, the pre-cooling phase. One-time notification shall be sufficient unless a factor,
(3) A shipper must develop and implement written procedures, subject to the records requirements of § 1.912(a), adequate to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food,
(4) A shipper of food transported in bulk must develop and implement written procedures, subject to the records requirements of § 1.912(a), adequate to ensure that a previous cargo does not make the food unsafe. Measures to ensure the safety of the food may be accomplished by the shipper or by the carrier or another party covered by this subpart under a written agreement subject to the records requirements of § 1.912(a).
(5) The shipper of food that requires temperature control for safety under the conditions of shipment must develop and implement written procedures, subject to the records requirements of § 1.912(a), to ensure that the food is transported under adequate temperature control. Measures to ensure the safety of the food may be accomplished by the shipper or by the carrier or another party covered by this subpart under a written agreement subject to the records requirements of § 1.912(a) and must include measures equivalent to those specified for carriers under paragraphs (e)(1) through (3) of this section.
(c)
(2) Before loading food that requires temperature control for safety, the loader must verify, considering, as appropriate, specifications provided by the shipper in accordance with paragraph (b)(2) of this section, that each mechanically refrigerated cold storage compartment or container is adequately prepared for the transportation of such food, including that it has been properly pre-cooled, if necessary, and meets other sanitary conditions for food transportation.
(d)
(e)
(1) A carrier must ensure that vehicles and transportation equipment meet the shipper's specifications and are otherwise appropriate to prevent the food from becoming unsafe during the transportation operation.
(2) A carrier must, once the transportation operation is complete and if requested by the receiver, provide the operating temperature specified by the shipper in accordance with paragraph (b)(2) of this section and, if requested by the shipper or receiver, demonstrate that it has maintained temperature conditions during the transportation operation consistent with the operating temperature specified by the shipper in accordance with paragraph (b)(2) of this section. Such demonstration may be accomplished by any appropriate means agreeable to the carrier and shipper, such as the carrier presenting measurements of the ambient temperature upon loading and unloading or time/temperature data taken during the shipment.
(3) Before offering a vehicle or transportation equipment with an auxiliary refrigeration unit for use for the transportation of food that requires temperature control for safety under the conditions of the shipment during transportation, a carrier must pre-cool each mechanically refrigerated cold storage compartment as specified by the shipper in accordance with paragraph (b)(2) of this section.
(4) If requested by the shipper, a carrier that offers a bulk vehicle for food transportation must provide information to the shipper that identifies the previous cargo transported in the vehicle.
(5) If requested by the shipper, a carrier that offers a bulk vehicle for food transportation must provide information to the shipper that describes the most recent cleaning of the bulk vehicle.
(6) A carrier must develop and implement written procedures subject to the records requirements of § 1.912(b) that:
(i) Specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and transportation equipment that the carrier provides for use in the transportation of food to maintain the vehicles and the transportation equipment in appropriate sanitary condition as required by § 1.906(b);
(ii) Describe how it will comply with the provisions for temperature control in paragraph (e)(2) of this section, and;
(iii) Describe how it will comply with the provisions for the use of bulk vehicles in paragraphs (e)(4) and (5) of this section.
(a) When the carrier and shipper have agreed in a written contract that the carrier is responsible, in whole or in part, for the sanitary conditions during transportation operations, the carrier must provide adequate training to personnel engaged in transportation operations that provides an awareness of potential food safety problems that may occur during food transportation, basic sanitary transportation practices to address those potential problems, and the responsibilities of the carrier under this part. The training must be provided upon hiring and as needed thereafter.
(b) Carriers must establish and maintain records documenting the training described in paragraph (a) of this section. Such records must include the date of the training, the type of training, and the person(s) trained. These records are subject to the records requirements of § 1.912(c).
(a) Shippers must retain records:
(1) That demonstrate that they provide specifications and operating temperatures to carriers as required by § 1.908(b)(1) and (2) as a regular part of their transportation operations for a period of 12 months beyond the termination of the agreements with the carriers.
(2) Of written agreements and the written procedures required by § 1.908(b)(3), (4), and (5), for a period of 12 months beyond when the agreements and procedures are in use in their transportation operations.
(b) Carriers must retain records of the written procedures required by § 1.908(e)(6) for a period of 12 months beyond when the agreements and procedures are in use in their transportation operations.
(c) Carriers must retain training records required by § 1.910(b) for a period of 12 months beyond when the person identified in any such records stops performing the duties for which the training was provided.
(d) Any person subject to this subpart must retain any other written agreements assigning tasks in compliance with this subpart for a period of 12 months beyond the termination of the agreements.
(e) Shippers, receivers, loaders, and carriers, which operate under the ownership or control of a single legal entity in accordance with the provisions of § 1.908(a)(5), must retain records of the written procedures for a period of 12 months beyond when the procedures are in use in their transportation operations.
(f) Shippers, receivers, loaders, and carriers must make all records required by this subpart available to a duly authorized individual promptly upon oral or written request.
(g) All records required by this subpart must be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records.
(h) Records that are established or maintained to satisfy the requirements of this subpart and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.
(i) Except for the written procedures required by § 1.908(e)(6)(i), offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. The written procedures required by § 1.908(e)(6)(i) must remain onsite as long as the procedures are in use in transportation operations. Electronic records are considered to be onsite if they are accessible from an onsite location.
(j) All records required by this subpart are subject to the disclosure requirements under part 20 of this chapter.
We will waive any requirement of this subpart with respect to any class of persons, vehicles, food, or nonfood products, when we determine that:
(a) The waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health; and
(b) The waiver will not be contrary to the public interest.
We will consider whether to waive a requirement of this subpart on our own initiative or on the petition submitted under § 10.30 of this chapter by any person who is subject to the requirements of this subpart with respect to any class of persons, vehicles, food, or nonfood products.
In addition to the requirements set forth in § 10.30 of this chapter, the Statement of Grounds in a petition requesting a waiver must:
(a) Describe with particularity the waiver requested, including the persons, vehicles, food, or nonfood product(s) to which the waiver would apply and the requirement(s) of this subpart to which the waiver would apply; and
(b) Present information demonstrating that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and will not be contrary to the public interest.
We will presume that information submitted in a petition requesting a waiver and comments submitted on such a petition does not contain information exempt from public disclosure under part 20 of this chapter and would be made public as part of the docket associated with this request.
The Director or Deputy Directors of the Center for Food Safety and Applied Nutrition (CFSAN) or the Center for Veterinary Medicine (CVM), or the Director, Office of Compliance, CFSAN, or the Director, Office of Surveillance and Compliance, CVM, will respond to a petition requesting a waiver.
(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a petition requesting a waiver.
(b) Under § 10.30(h)(3) of this chapter, we will publish a notice in the
(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing.
(1) If we grant the petition, either in whole or in part, we will publish a notice in the
(2) If we deny the petition (including partial denials), our written response to the petitioner will explain the reason(s) for the denial.
(d) We will make readily accessible to the public, and periodically update, a list of filed petitions requesting waivers, including the status of each petition (for example, pending, granted, or denied).
We may deny a petition requesting a waiver if the petition does not provide the information required under § 1.918 (including the requirements of § 10.30 of this chapter), or if we determine that the waiver could result in the transportation of food under conditions that would be unsafe for human or animal health, or that the waiver could be contrary to the public interest.
If we, on our own initiative, determine that a waiver is appropriate, we will publish a notice in the
Any waiver that we grant will become effective on the date that notice of the waiver is published in the
We may modify or revoke a waiver if we determine that the waiver could result in the transportation of food under conditions that would be unsafe for human or animal health or that the waiver could be contrary to the public interest.
(a) We will provide the following notifications:
(1) We will notify the entity that initially requested the waiver, in writing at the address identified in its petition, if we determine that a waiver granted in response to its petition should be modified or revoked.
(2) We will publish a notice of our determination that a waiver should be modified or revoked in the
(b) We will consider timely written submissions submitted to the public docket from interested parties.
(c) We will publish a notice of our decision in the
21 U.S.C. 321-393; 42 U.S.C. 262.
(n) This part does not apply to records required to be established or maintained by subpart O of part 1 of this chapter. Records that satisfy the requirements of subpart O of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.
Environmental Protection Agency (EPA).
Final rule; technical corrections.
This action finalizes the technical corrections that the Environmental Protection Agency (EPA) proposed on February 17, 2015, to correct and clarify certain text of the EPA's regulations regarding “National Emission Standards for Hazardous Air Pollutants from Coal- and Oil-fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units”. We are also taking final action to remove the rule provision establishing an affirmative defense for malfunction.
The effective date of this rule is April 6, 2016.
For questions about the MATS action: Mr. Jim Eddinger, Energy Strategies Group, Sector Policies and Programs Division (D243-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-5426; fax number (919) 541-5450; email address:
This
Under CAA section 307(b)(1), judicial review of this final rule is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit by June 6, 2016. Under CAA section 307(d)(7)(B), only an objection to this final rule that was raised with reasonable specificity during the period for public comment can be raised during judicial review. Note, under CAA section 307(b)(2), the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings brought by the EPA to enforce these requirements.
The final Clean Air Act (CAA) rules published in the
In the February 17, 2015,
Most of the corrections and clarifications remain the same as presented in the proposed correction document and those changes are being finalized without further discussion. However, the EPA has made some changes in this final rule after consideration of the public comments received on the proposed correction document. The changes are to clarify applicability and implementation issues associated with proposed changes, and the significant changes are discussed below in this preamble. A summary of the comments received and our responses thereto is contained in the document “Summary of Public Comments and Responses: MATS and Utility NSPS Technical Corrections” located in the dockets for these rulemakings.
This section of the preamble summarizes the significant changes made to the proposed corrections and clarifications.
1. Section 63.9984(f) is revised to add “or the EGU's otherwise applicable compliance date established by the EPA or the state.” A commenter stated that the EPA's proposed revision, which was adding “the date that compliance must be demonstrated, as given” in § 63.9984, to the initial compliance requirements in § 63.10005(a) for existing EGUs, does not effectively clarify the date that compliance must be demonstrated due to its reference to § 63.9984 and paragraph (f) of § 63.9984 because § 63.9984(b) specifies a compliance date of April 16, 2015 for existing EGUs. Also, § 63.9984(f), which states the dates by which compliance must be demonstrated, refers to § 63.9984(b). Therefore, we revised § 63.9984(f) because specifying a date for existing EGUs to demonstrate compliance is confusing for existing sources that have been granted a compliance extension.
2. Section 63.10000(n) is added to address comments that noted the proposed technical corrections did not address the permanent conversion to natural gas or biomass consistent with the proposals outlined in the February 17, 2015 preamble. In the preamble (see 80 FR 8447), we stated “The EPA is also proposing that sources that permanently convert to natural gas or biomass after the compliance date are no longer subject to MATS, notwithstanding the coal or oil usage the previous 3 calendar years.” However, we inadvertently did not include the necessary language to address permanent conversions in the proposed regulatory text. For that reason, we are revising paragraph (n) to incorporate the proposed change as outlined in the preamble to the proposed rule.
3. The proposal to revise § 63.10005(b)(1) to change the time period allowed for existing EGUs to use stack test data collected prior to the applicable compliance date has been withdrawn. Several commenters did not support the proposed revision to change the window in which initial compliance can be demonstrated, and said that EGUs should be allowed to demonstrate initial compliance using stack tests conducted on or after April 16, 2014. Commenters said the EPA's proposed change is unfair, renders investments in stack testing useless, and requires companies to perform new, unnecessary initial compliance testing. For these reasons, and because the Agency believes earlier stack tests may be representative under certain circumstances, the EPA is not making the proposed change.
4. Section 63.10006(f) is revised to: (1) Correct the minimum time between annual performance tests (from 370 to 320 calendar days); (2) clarify the minimum time between annual sorbent trap mercury testing for 30-boiler operating day low emitting EGU (LEE) retests (also 320 calendar days); and (3) provide the minimum time between annual sorbent trap mercury testing for 90-boiler operating day LEE retests (230 calendar days). Commenters correctly stated that the 370-day interval for annual tests was a typographical error, as they would expect the interval to be 365 days or less. Commenters expressed concerns that, while the proposed revised § 63.10006(f) specified the time
5. Section 63.10009(b)(1) is revised to clarify group eligibility equations 1a and 1b. The purpose of the group eligibility equations is to provide EGU owners or operators a quick method for demonstrating initial compliance with the emission limits for all units participating in the emission averaging group using the maximum rated heat input or gross output of each unit and the results of the initial compliance demonstrations. Commenters stated that the EPA proposed to drop the double summation in the denominator, which is a correct step. However, the commenters indicated they do not understand what the Agency was thinking with respect to adding the “q
6. Section 63.10009(e), (g), and (j)(2) are revised to require compliance with the weighted average emissions rate at all times following the date that emissions averaging begins. A commenter argued that the EPA must also revise these sections to remove the specifically identified dates (
7. Section 63.10010(h)(6)(i), (i)(5)(i)(A), and (j)(4)(i)(A) and (B) are revised to clarify when monitoring system quality assurance or quality control activities are to be reported. Commenters said § 63.10010(h)(6)(i), (i)(5)(i)(A), and (j)(4)(i)(A) and (B) specify what data from particulate matter (PM) continuous parameter monitoring system (CPMS), PM CEMS, and hazardous air pollutants (HAP) metal CEMS must be excluded from compliance determinations and that the EPA proposed to separate the language regarding deviation reporting that currently appears at the end of these provisions into a separate sentence to “ease readability.” The commenter disagreed that the proposed revision improves readability and said that, to the contrary, by separating out the sentence, the EPA implies that the periods when data are not collected because of monitoring system malfunctions, repairs, required quality assurance or quality control, as well as periods when a monitoring system is out of control, are deviations from monitoring requirements, which they are not. The commenter is incorrectly interpreting the proposed change. Periods when data are not collected because of monitoring system malfunctions are deviations. The required quality assurance or quality control activities that are deviations from monitoring requirements are, as stated in § 63.10010(h)(6)(i), (i)(5)(i)(A), and (j)(4)(i)(A) and (B), those conducted during monitoring systems malfunctions.
8. Section 63.10011(g)(4)(v)(A) is revised to change the proposed language “to the maximum extent practicable” back to the language “to the maximum extent possible” as in the final rule. Commenters said the requirement to use clean fuels “to the maximum extent practicable” does not even address the level of toxic emissions during startup, let alone reduce them to the maximum extent achievable as is required under CAA section 112(d)(2). Commenters said, perhaps most importantly, that the EPA's proposed change impermissibly assumes that existing older boilers and control devices are not capable of being upgraded—despite Congress' mandate in CAA section 112(d)(2)-(3) that emissions standards and work practices reflect what is achievable and actually being achieved by the best-performing sources. Commenters said further, under CAA section 112(d), it is the Administrator's duty to establish standards to achieve the required emissions reductions—not the duty of owners and operators. Commenters said the EPA's purported work practices impermissibly allow operators themselves to determine the standards and their own emission reductions achieved (or not) by the requirements. Commenters said the EPA's proposed change leaves it up to each operator to determine the amount of clean fuel use that represents the “maximum extent practicable,” and leaves it up to each operator to determine what qualifies as a “consideration such as boiler or control device integrity.” Commenters said that even though the requirement for clean fuels states that EGUs must have sufficient clean fuel capacity to engage and operate PM control devices within 1 hour of adding the primary fuel (and even though a separate work practice requires PM controls to be engaged and operated within 1 hour), these requirements do not establish whether and to what point EGUs must actually use clean fuels in startups. These comments primarily concern issues that the EPA did not reopen in the proposed document. Because those issues were not reopened, the EPA did not respond to these comments. We did propose to change § 63.10011(g)(4)(v)(A) as the commenter states. We continue to believe that the use of clean fuels during startup must be maximized to reduce HAP emissions and have reconsidered the proposed change of “possible” to “practicable.” We believe “possible” is a more enforceable standard. The final change to § 63.10011(g)(4)(v)(A) is: “to the maximum extent possible, taking into account considerations such as boiler or control device integrity,
The EPA is not finalizing the proposed change because we have determined that requiring clean fuel use to the maximum extent “possible” is more enforceable than the proposed change to “practicable”, and the Agency believes it is critical that the work practice be enforceable to ensure that sources use as much clean fuel with its inherently low HAP content as possible when a source's controls are not yet fully engaged. At the same time, we believe operators must be able to consider the integrity of the EGU system when determining the clean fuel use that is “possible” for a given unit. We believe the final rule addresses both considerations.
9. Section 63.10030(e)(8)(iii) is added to allow EGU owners or operators the ability to switch between paragraphs 1 and 2 of the startup definition. Commenters requested that switching between paragraphs of the definition of startup not be prohibited. We have no objection to such switching provided certain criteria are met. Just as we had not considered that EGU owners or operators would want to switch between mass per year heat input emission limits and mass per gross output emission limits, but proposed to allow such changes provided certain criteria are met, we did not consider that an owner or operator would want to switch between the startup definitions for the EGU. Given the commenter's specific request and the EPA's conditional approval based on the already existing model given in § 63.10030(e)(7)(iii)(A), § 63.10030(e)(8)(iii) is added to the rule. This new section allows EGU owners or operators the ability to switch between paragraphs 1 and 2 of the startup definition provided, among other things, that the EGUs involved in the switch are identified, that a request is submitted 30 days prior to the anticipated switch, that the request contains certification that all previous plans, such as monitoring and emissions averaging, are revised, that records are maintained, and that the new definition is not used until the next reporting period after receipt of written acknowledgement from the Administrator or the delegated authority of the switch.
10. Section 63.10031(c)(4) is revised to clarify that the “date” of the tune-up is the date the tune-up provisions specified in § 63.10021(e)(6) and (7) are completed. Commenters noted that there will not necessarily be a single date associated with completion of an EGU's tune-ups conducted under § 63.10021(e) and suggested that, related to the possibility of a delayed burner inspection, the Agency make it clear that compliance with all requirements besides the burner inspection must occur by the compliance demonstration date, but that the burner inspection may be delayed, and to revise the provision to recognize that as a result, performance of subsequent inspections and tune-ups may be on a separate 36-month track and some EGUs may have “dates” rather than a “date” for completion of requirements. Regardless of when the burner inspection is conducted, the tune-up is considered to have been conducted on the date the combustion optimization is completed. The purpose of the tune-up is the optimization of the combustion to minimize organic HAP, carbon monoxide, and nitrogen oxides (NO
11. Section 63.10031(c)(7) is added to include the reporting requirements that have been removed from § 63.10030(e)(7)(i). A commenter said that there is no reason to submit Notification of Compliance Status (NOCS) for ongoing 3-year tests that are performed to demonstrate that LEE status is maintained, so the proposed language in § 63.10030(e)(7)(i) should be revised. We agree that not only the ongoing 3-year LEE retests, but also the annual and quarterly LEE retests and annual retests that are performed to establish operating limits, should not be submitted as NOCS. According to the introductory text of § 63.10030(e), the NOCS is required only for reporting initial compliance. Therefore, § 63.10030(e)(7)(i) has been removed and reserved, and the reporting requirements in § 63.10030(e)(7)(i) have been moved to a new place,
12. The definitions of “Coal-fired electric utility steam generating unit,” “Fossil fuel-fired,” “Limited-use liquid oil-fired subcategory,” and “Oil-fired electric utility steam generating unit” in § 63.10042 are further revised to clarify the period of time to be included in determining the source's applicability to the MATS.
One commenter indicated that the proposed rule does not address permanent conversion to natural gas or biomass, nor does it make clear that, after the first 3 years of compliance, EGUs are required to evaluate applicability based on coal or oil usage from the 3 previous calendars years on an annual rolling basis. The commenter said that the EPA's clarifying proposals are not clearly outlined in the proposed revised definitions. The commenter urged the EPA to revise the definition in a manner consistent with the proposals outlined in the preamble. Several commenters indicated the proposed changes do not prevent an EGU from continuing to be subject to MATS for several years after a fuel switch.
We agree that the proposed clarification to the definitions does not make it clear that, after the first 3 years of compliance, an EGU is required to evaluate applicability based on coal or oil usage from the 3 previous calendar years on an annual rolling basis. Thus, we have revised the definitions for “Coal-fired electric utility steam generating unit,” “Oil-fired electric utility steam generating unit,” and “Fossil fuel-fired” to clarify that applicability after the first 3 years of compliance will be based on coal or oil usage from the 3 previous calendar years on an annual rolling basis.
Concerning the permanent fuels switch, the EPA explained above that it has addressed permanent conversions in § 63.10000(n) of the final rule, as discussed in paragraph 2 above.
13. Appendix A is finalized with all proposed revisions with the exception of adding an alternative specification for the relative accuracy test audit (RATA) where commenters provided data to support a different approach using an absolute value criterion. However, due to the current lack of available NIST-traceable elemental Hg gas cylinders, owners or operators of EGUs that have purchased/installed Hg CEMS that lack integrated elemental Hg gas generators may continue to use NIST-traceable oxidized gases for calibration error tests and daily checks until such time that NIST-traceable compressed elemental Hg gas standards are available and traceable with a combined uncertainty
14. Appendix B is finalized with all proposed revisions except those related to sections 10 and 11 regarding recordkeeping and reporting for hydrogen chloride (HCl) CEMS subject to PS 18. Sections 10 and 11 will be addressed in the upcoming MATS Completion of Electronic Reporting Requirements rule. One change has been made that was not proposed. A minor technical correction has been made to section 9.4, requiring the HCl emission rates to be reported to 2 significant figures in scientific notation, which is consistent with the way that the emission standards are presented in Tables 1 and 2.
In finalizing the rule, the EPA is addressing several other technical corrections and clarifications in the regulatory language based on public comments that were received on the February 2015 proposal that the Agency determined were necessary to conform to changes included in the proposed rule, as outlined in Table 2 of this preamble.
The EPA received numerous comments on the affirmative defense to civil penalties for violations caused by malfunctions that the EPA proposed to remove in the current rule. Several commenters supported the removal of the affirmative defense for malfunctions. Other commenters opposed the removal of the affirmative defense provision.
As stated in the February 17, 2015, proposal, the United States Court of Appeals for the District of Columbia Circuit vacated an affirmative defense in one of the EPA's CAA section 112(d) regulations.
This action finalizes certain provisions and makes technical and clarifying corrections, but does not promulgate substantive changes to the February 2012 final MATS (77 FR 9304). Therefore, there are no environmental, energy, or economic impacts associated with this final action. The impacts associated with MATS are discussed in detail in the February 16, 2012, final MATS rule.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations (40 CFR part 63, subpart UUUUU) and has assigned OMB control number 2060-0567. This action is believed to result in no changes to the ICR of the February 2012 final MATS rule, so that the information collection estimate of project cost and hour burden from the final MATS have not been revised.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This action finalizes changes to MATS to correct and clarify implementation issues raised by stakeholders.
This action does not contain an unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This rule promulgates amendments to the February 2012 final MATS, but the amendments are clarifications to existing rule language to aid in implementation. Therefore, the action imposes no enforceable duty on any state, local, or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications, as specified in Executive Order 13175. 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, as specified in Executive Order 13175. This action clarifies certain components of the February 2012 final MATS. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This action does not involve technical standards from those contained in the February 16, 2012, final rule. Therefore, the EPA did not consider the use of any voluntary consensus standards.
The EPA believes the human health or environmental risk addressed by this action will
The environmental justice finding in the February 2012 final MATS remains relevant in this action, which finalizes changes to the rule to correct and clarify implementation issues raised by stakeholders.
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the EPA amends 40 CFR parts 60 and 63 as follows:
42 U.S.C. 7401
(f) For affected facilities for which construction, modification, or reconstruction commenced before May 4, 2011, compliance with the applicable daily average PM emissions limit is determined by calculating the arithmetic average of all hourly emission rates each boiler operating day, except for data obtained during startup, shutdown, or malfunction periods. Daily averages are only calculated for boiler operating days that have non-out-of-control data for at least 18 hours of unit operation during which the standard applies. Instead, all of the non-out-of-control hourly emission rates of the operating day(s) not meeting the minimum 18 hours non-out-of-control data daily average requirement are averaged with all of the non-out-of-control hourly emission rates of the next boiler operating day with 18 hours or more of non-out-of-control PM CEMS data to determine compliance. For affected facilities for which construction or reconstruction commenced after May 3, 2011 that elect to demonstrate compliance using PM CEMS, compliance with the applicable PM emissions limit in § 60.42Da is determined on a 30-boiler operating day rolling average basis by calculating the arithmetic average of all hourly PM emission rates for the 30 successive boiler operating days, except for data obtained during periods of startup and shutdown.
42 U.S.C. 7401
The revisions and addition read as follows:
(a) Any unit designated as a major source stationary combustion turbine subject to subpart YYYY of this part and any unit designated as an area source stationary combustion turbine, other than an integrated gasification combined cycle (IGCC) unit.
(b) Any electric utility steam generating unit that is not a coal- or oil-fired EGU and that meets the definition of a natural gas-fired EGU in § 63.10042.
(c) Any electric utility steam generating unit that has the capability of combusting more than 25 MW of coal or oil but does not meet the definition of a coal- or oil-fired EGU because it did not fire sufficient coal or oil to satisfy the average annual heat input requirement set forth in the definitions for coal-fired and oil-fired EGUs in § 63.10042. Heat input means heat derived from combustion of fuel in an EGU and does not include the heat derived from preheated combustion air, recirculated flue gases or exhaust gases from other sources (such as stationary gas turbines, internal combustion engines, and industrial boilers).
(e) Any electric utility steam generating unit that meets the definition of a natural gas-fired EGU under this subpart and that fires at least 10 percent biomass is an industrial boiler subject to standards established under subpart DDDDD of this part, if it otherwise meets the applicability provisions in that rule.
(c) * * *
(1) Has a system using wet or dry flue gas desulfurization technology and an SO
(2) At all times, you operate the wet or dry flue gas desulfurization technology and the SO
(a) You must be in compliance with the emission limits and operating limits in this subpart. These limits apply to you at all times except during periods of startup and shutdown; however, for coal-fired, liquid oil-fired, or solid oil-derived fuel-fired EGUs, you are required to meet the work practice requirements, items 3 and 4, in Table 3 to this subpart during periods of startup or shutdown.
(c)(1) * * *
(i) For a coal-fired or solid oil-derived fuel-fired EGU or IGCC EGU, you may conduct initial performance testing in accordance with § 63.10005(h), to determine whether the EGU qualifies as a low emitting EGU (LEE) for one or more applicable emission limits, except as otherwise provided in paragraphs (c)(1)(i)(A) and (B) of this section:
(A) Except as provided in paragraph (c)(1)(i)(C) of this section, you may not pursue the LEE option if your coal-fired, IGCC, or solid oil-derived fuel-fired EGU is equipped with a main stack and a bypass stack or bypass duct configuration that allows the effluent to bypass any pollutant control device.
(B) You may not pursue the LEE option for Hg if your coal-fired, solid oil-derived fuel-fired EGU or IGCC EGU is new.
(C) You may pursue the LEE option provided that:
(
(
(2) * * *
(iii) If your existing liquid oil-fired unit does not qualify as a LEE for hydrogen chloride (HCl) or for hydrogen fluoride (HF), you may demonstrate initial and continuous compliance through use of an HCl CEMS, an HF CEMS, or an HCl and HF CEMS, installed and operated in accordance with Appendix B to this rule. As an alternative to HCl CEMS, HF CEMS, or HCl and HF CEMS, you may demonstrate initial and continuous compliance through quarterly performance testing and parametric monitoring for HCl and HF. If you choose to use quarterly testing and parametric monitoring, then you must also develop a site-specific monitoring plan that identifies the CMS you will use to ensure that the operations of the EGU remains consistent with those during the performance test. As another alternative, you may measure or obtain, and keep records of, fuel moisture content; as long as fuel moisture does not exceed 1.0 percent by weight, you need not conduct other HCl or HF monitoring or testing.
(f) Except as provided under paragraph (n) of this section, you are subject to the requirements of this subpart for at least 6 months following the last date you met the definition of an EGU subject to this subpart (
(g) Except as provided under paragraph (n) of this section, if your unit no longer meets the definition of an EGU subject to this subpart you must be in compliance with any newly applicable standards on the date you are no longer subject to this subpart. The date you are no longer subject to this subpart is a date selected by you, that must be at least 6 months from the date that your unit last met the definition of an EGU subject to this subpart or the date you begin combusting solid waste, consistent with § 63.9983(d). Your source must remain in compliance with this subpart until the date you select to cease complying with this subpart or the date you begin combusting solid waste, whichever is earlier.
(i)(1) If you own or operate an EGU subject to this subpart and cease to operate in a manner that causes your unit to meet the definition of an EGU subject to this subpart, you must be in compliance with any newly applicable section 112 or 129 standards on the date you selected consistent with paragraphs (g) and (n) of this section.
(m) Should you choose to rely on paragraph (2) of the definition of “startup” in § 63.10042 for your EGU, on or before the date your EGU is subject to this subpart, you must install, verify, operate, maintain, and quality assure each monitoring system necessary for demonstrating compliance with the work practice standards for PM or non-mercury HAP metals controls during startup periods and shutdown periods required to comply with § 63.10020(e).
(1) You may rely on monitoring system specifications or instructions or manufacturer's specifications when installing, verifying, operating, maintaining, and quality assuring each monitoring system.
(2) You must collect, record, report, and maintain data obtained from these monitoring systems during startup periods and shutdown periods.
(n) If you have permanently converted your EGU from coal or oil to natural gas or biomass after your compliance date (or, if applicable, after your approved extended compliance date), as demonstrated by being subject to a permit provision or physical limitation (including retirement) that prevents you from operating in a manner that would subject you to this subpart, you are no longer subject to this subpart, notwithstanding the coal or oil usage in the previous calendar years. The date on which you are no longer subject to this subpart is the date on which you converted to natural gas or biomass firing; it is also the date on which you must be in compliance with any newly applicable standards.
The revisions and additions read as follows:
(a)
(2) To demonstrate initial compliance using either a CMS that measures HAP concentrations directly (
(i) The CMS performance test must demonstrate compliance with the applicable Hg, HCl, HF, PM, or SO
(ii) You must collect hourly data from auxiliary monitoring systems (
(b) * * *
(4) A record of all parameters needed to convert pollutant concentrations to units of the emission standard (
(6) For performance stack test data that are collected prior to the date that compliance must be demonstrated and are used to demonstrate initial compliance with applicable emissions limits, the interval for subsequent stack tests begins on the date that compliance must be demonstrated.
(d) * * *
(3) For affected EGUs that are either required to or elect to demonstrate initial compliance with the applicable Hg emission limit in Table 1 or 2 of this subpart using Hg CEMS or sorbent trap monitoring systems, initial compliance must be demonstrated no later than the applicable date specified in § 63.9984(f) for existing EGUs and in paragraph (g) of this section for new EGUs. Initial compliance is achieved if the arithmetic average of 30- (or 90-) boiler operating days of quality-assured CEMS (or sorbent trap monitoring system) data, expressed in units of the standard (see section 6.2 of appendix A to this subpart), meets the applicable Hg emission limit in Table 1 or 2 to this subpart.
(4) * * *
(i) You must demonstrate initial compliance no later than the applicable date specified in § 63.9984(f) for existing EGUs and in paragraph (g) of this section for new EGUs.
(f) For an existing EGU without a neural network, a tune-up, following the procedures in § 63.10021(e), must occur within 6 months (180 days) after April 16, 2015. For an existing EGU with a neural network, a tune-up must occur within 18 months (545 days) after April 16, 2016. If a tune-up occurs prior to April 16, 2015, you must keep records showing that the tune-up met all rule requirements.
(h)
(3) For Hg, you must conduct a 30- (or 90-) boiler operating day performance test using Method 30B in appendix A-8 to part 60 of this chapter to determine whether a unit qualifies for LEE status. Locate the Method 30B sampling probe tip at a point within 10 percent of the duct area centered about the duct's centroid at a location that meets Method 1 in appendix A-1 to part 60 of this chapter and conduct at least three nominally equal length test runs over the 30- (or 90-) boiler operating day test period. You may use a pair of sorbent traps to sample the stack gas for a period consistent with that given in section 5.2.1 of appendix A to this subpart. Collect Hg emissions data continuously over the entire test period (except when changing sorbent traps or performing required reference method QA procedures). As an alternative to constant rate sampling per Method 30B, you may use proportional sampling per section 8.2.2 of Performance Specification 12 B in appendix B to part 60 of this chapter.
(i) * * *
(D) Hourly gross output data (megawatts), from facility records.
(iii) Calculate the average Hg concentration, in µg/m
(f)
(i) At least 45 calendar days, measured from the test's end date, must separate performance tests conducted every quarter;
(ii) For annual testing:
(A) At least 320 calendar days, measured from the test's end date, must separate performance tests;
(B) At least 320 calendar days, measured from the test's end date, must separate annual sorbent trap mercury testing for 30-boiler operating day LEE tests;
(C) At least 230 calendar days, measured from the test's end date, must separate annual sorbent trap mercury testing for 90-boiler operating day LEE tests; and
(iii) At least 1,050 calendar days, measured from the test's end date, must separate performance tests conducted every 3 years.
(2) For units demonstrating compliance through quarterly emission testing, you must conduct a performance test in the 4th quarter of a calendar year if your EGU has skipped performance tests in the first 3 quarters of the calendar year.
(3) If your EGU misses a performance test deadline due to being inoperative and if 168 or more boiler operating hours occur in the next test period, you must complete an additional performance test in that period as follows:
(i) At least 15 calendar days must separate two performance tests conducted in the same quarter.
(ii) At least 107 calendar days must separate two performance tests conducted in the same calendar year.
(iii) At least 350 calendar days must separate two performance tests conducted in the same 3 year period.
(f) * * *
(2)
(a) * * *
(2) You may demonstrate compliance by emissions averaging among the existing EGUs in the same subcategory, if your averaged Hg emissions for EGUs in the “unit designed for coal ≥8,300 Btu/lb” subcategory are equal to or less than 1.2 lb/TBtu or 1.3E-2 lb/GWh on a 30-boiler operating day basis or if your averaged emissions of individual, other pollutants from other subcategories of such EGUs are equal to or less than the applicable emissions limit in Table 2 to this subpart, according to the procedures in this section. Note that except for the alternate Hg emissions limit from EGUs in the “unit designed for coal ≥ 8,300 Btu/lb” subcategory, the averaging time for emissions averaging for pollutants is 30 days (rolling daily) using data from CEMS or a combination of data from CEMS and manual performance (LEE) testing. The averaging time for emissions averaging for the alternate Hg limit (equal to or less than 1.0 lb/TBtu or 1.1E-2 lb/GWh) from EGUs in the “unit designed for coal ≥ 8,300 Btu/lb” subcategory is 90-boiler operating days (rolling daily) using data from CEMS, sorbent trap monitoring, or a combination of monitoring data and data from manual performance (LEE) testing. For the purposes of this paragraph, 30- (or 90-) group boiler operating days is defined as a period during which at least one unit in the emissions averaging group operates on each of the 30 or 90 days. You must calculate the weighted average emissions rate for the group in accordance with the procedures in this paragraph using the data from all units in the group including any that operate fewer than 30 (or 90) days during the preceding 30 (or 90) group boiler days.
(i) You may choose to have your EGU emissions averaging group meet either the heat input basis (MMBtu or TBtu, as appropriate for the pollutant) or gross output basis (MWh or GWh, as appropriate for the pollutant).
(b) * * *
(1)
Variables with the similar names share the descriptions for Equation 1a of this section,
(2) Weighted 30-boiler operating day rolling average emissions rate equations for pollutants other than Hg. Use Equation 2a or 2b of this section to calculate the 30 day rolling average emissions daily.
(3) Weighted 90-boiler operating day rolling average emissions rate equations for Hg emissions from EGUs in the “coal-fired unit not low rank virgin coal” subcategory. Use Equation 3a or 3b of this section to calculate the 90-day rolling average emissions daily.
(e) The weighted-average emissions rate from the existing EGUs participating in the emissions averaging option must be in compliance with the limits in Table 2 to this subpart at all times following the date that you begin emissions averaging.
(f) Emissions averaging group eligibility demonstration. You must demonstrate the ability for the EGUs included in the emissions averaging group to demonstrate initial compliance according to paragraph (f)(1) or (2) of this section using the maximum rated heat input or gross output over a 30- (or 90-) boiler operating day period of each EGU and the results of the initial performance tests. For this demonstration and prior to preparing your emissions averaging plan, you must conduct required emissions monitoring for 30- (or 90-) days of boiler operation and any required manual performance testing to calculate maximum weighted average emissions rate in accordance with this section. If, before the start of your initial compliance demonstration, the Administrator becomes aware that you intend to use emissions averaging for that demonstration, or if your initial Notification of Compliance Status (NOCS) indicates that you intend to
(2) If you are not capable of monitoring heat input or gross output, and the EGU generates steam for purposes other than generating electricity, you may use Equation 1b of paragraph (b) of this section as an alternative to using Equation 1a of paragraph (b) of this section to demonstrate that the maximum weighted average emissions rates of filterable PM, HF, SO
(g) You must determine the weighted average emissions rate in units of the applicable emissions limit on a 30 group boiler operating day rolling average basis (or, if applicable, on a 90 group boiler operating day rolling average basis for Hg) according to paragraphs (g)(1) and (2) of this section. The first averaging period ends on the 30th (or, if applicable, 90th for the alternate Hg emission limit) group boiler operating day after the date that you begin emissions averaging.
(1) You must use Equation 2a or 3a of paragraph (b) of this section to calculate the weighted average emissions rate using the actual heat input or gross output for each existing unit participating in the emissions averaging option.
(2) If you are not capable of monitoring heat input or gross output, you may use Equation 2b or 3b of paragraph (b) of this section as an alternative to using Equation 2a of paragraph (b) of this section to calculate the average weighted emission rate using the actual steam generation from the units participating in the emissions averaging option.
(j) * * *
(1) * * *
(ii) The process weighting parameter (heat input, gross output, or steam generated) that will be monitored for each averaging group;
(2) If, as described in paragraph (f) of this section, the Administrator requests you to submit the averaging plan for review and approval, you must receive approval before initiating emissions averaging.
(a) * * *
(4)
(i) Route the exhaust from the bypass through the main stack and its monitoring so that bypass emissions are measured; or
(ii) Install a CEMS only on the main stack and count hours that the bypass stack is in use as hours of deviation from the monitoring requirements.
(f) * * *
(3) Calculate and record a 30-boiler operating day rolling average SO
(4) Use only unadjusted, quality-assured SO
(h) * * *
(6) * * *
(i) Any data collected during periods of monitoring system malfunctions, repairs associated with monitoring system malfunctions, or required monitoring system quality assurance or quality control activities that temporarily interrupt the measurement of output data from the PM CPMS. You must report any monitoring system malfunctions or out of control periods in your annual deviation reports. You must report any monitoring system quality assurance or quality control activities per the requirements of § 63.10031(b);
(ii) Any data collected during periods when the monitoring system is out of control as specified in your site-specific monitoring plan, repairs associated with periods when the monitoring system is out of control, or required monitoring system quality assurance or quality control activities conducted during out-of-control periods. You must report any such periods in your annual deviation report;
(i) * * *
(5) * * *
(i) * * *
(A) Any data collected during periods of monitoring system malfunctions, repairs associated with monitoring system malfunctions, or required monitoring system quality assurance or quality control activities that temporarily interrupt the measurement of emissions (
(B) Any data collected during periods when the monitoring system is out of control as specified in your site-specific monitoring plan, repairs associated with periods when the monitoring system is out of control, or required monitoring system quality assurance or quality control activities conducted during out-of-control periods. You must report any such periods in your annual deviation report;
(j) * * *
(1)(i) Install, calibrate, operate, and maintain your HAP metals CEMS according to your CMS quality control program, as described in § 63.8(d)(2). The reportable measurement output from the HAP metals CEMS must be expressed in units of the applicable emissions limit (
(4) * * *
(i) * * *
(A) Any data collected during periods of monitoring system malfunctions, repairs associated with monitoring
(B) Any data collected during periods when the monitoring system is out of control as specified in your site-specific monitoring plan, repairs associated with periods when the monitoring system is out of control, or required monitoring system quality assurance or quality control activities conducted during out-of-control periods. You must report any monitoring system malfunctions or out of control periods in your annual deviation reports. You must report any monitoring system quality assurance or quality control activities per the requirements of § 63.10031(b);
(l) Should you choose to rely on paragraph (2) of the definition of “startup” in § 63.10042 for your EGU, you must install, verify, operate, maintain, and quality assure each monitoring system necessary for demonstrating compliance with the PM or non-mercury metals work practice standards required to comply with § 63.10020(e).
(1) You shall develop a site-specific monitoring plan for PM or non-mercury metals work practice monitoring during startup periods.
(2) You shall submit the site-specific monitoring plan upon request by the Administrator.
(3) The provisions of the monitoring plan must address the following items:
(i) Monitoring system installation;
(ii) Performance and equipment specifications;
(iii) Schedule for initial and periodic performance evaluations;
(iv) Performance evaluation procedures and acceptance criteria;
(v) On-going operation and maintenance procedures; and
(vi) On-going recordkeeping and reporting procedures.
(4) You may rely on monitoring system specifications or instructions or manufacturer's specifications to address paragraphs (l)(3)(i) through (vi) of this section.
(5) You must operate and maintain the monitoring system according to the site-specific monitoring plan.
(b) If you are subject to an operating limit in Table 4 to this subpart, you demonstrate initial compliance with HAP metals or filterable PM emission limit(s) through performance stack tests and you elect to use a PM CPMS to demonstrate continuous performance, or if, for a liquid oil-fired EGU, and you use quarterly stack testing for HCl and HF plus site-specific parameter monitoring to demonstrate continuous performance, you must also establish a site-specific operating limit, in accordance with § 63.10007 and Table 6 to this subpart. You may use only the parametric data recorded during successful performance tests (
(c)(1) If you use CEMS or sorbent trap monitoring systems to measure a HAP (
(2) For an EGU that uses a CEMS to measure SO
(e) You must submit a Notification of Compliance Status containing the results of the initial compliance demonstration, in accordance with § 63.10030(e).
(g) You must follow the startup or shutdown requirements as established in Table 3 to this subpart for each coal-fired, liquid oil-fired, or solid oil-derived fuel-fired EGU.
(1) You may use the diluent cap and default gross output values, as described in § 63.10007(f), during startup periods or shutdown periods.
(2) You must operate all CMS, collect data, calculate pollutant emission rates, and record data during startup periods or shutdown periods.
(3) You must report the information as required in § 63.10031.
(4) If you choose to use paragraph (2) of the definition of “startup” in § 63.10042 and you find that you are unable to safely engage and operate your particulate matter (PM) control(s) within 1 hour of first firing of coal, residual oil, or solid oil-derived fuel, you may choose to rely on paragraph (1) of definition of “startup” in § 63.10042 or you may submit a request to use an alternative non-opacity emissions standard, as described below.
(i) As mentioned in § 63.6(g)(1), your request will be published in the
(ii) Your request need not address the items contained in § 63.6(g)(2).
(iii) Your request shall provide evidence of a documented manufacturer-identified safety issue.
(iv) Your request shall provide information to document that the PM control device is adequately designed and sized to meet the PM emission limit applicable to the EGU.
(v) In addition, your request shall contain documentation that:
(A) Your EGU is using clean fuels to the maximum extent possible, taking into account considerations such as not compromising boiler or control device integrity, to bring your EGU and PM
(B) You have followed explicitly your EGU manufacturer's procedures to alleviate or prevent the identified safety issue; and
(C) You have identified with specificity the details of your EGU manufacturer's statement of concern.
(vi) Your request shall specify the other work practice standards you will take to limit HAP emissions during startup periods and shutdown periods to ensure a control level consistent with the work practice standards of the final rule.
(vii) You must comply with all other work practice requirements, including but not limited to data collection, recordkeeping, and reporting requirements.
(e) Additional requirements during startup periods or shutdown periods if you choose to rely on paragraph (2) of the definition of “startup” in § 63.10042 for your EGU.
(1) During each period of startup, you must record for each EGU:
(i) The date and time that clean fuels being combusted for the purpose of startup begins;
(ii) The quantity and heat input of clean fuel for each hour of startup;
(iii) The gross output for each hour of startup;
(iv) The date and time that non-clean fuel combustion begins; and
(v) The date and time that clean fuels being combusted for the purpose of startup ends.
(2) During each period of shutdown, you must record for each EGU:
(i) The date and time that clean fuels being combusted for the purpose of shutdown begins;
(ii) The quantity and heat input of clean fuel for each hour of shutdown;
(iii) The gross output for each hour of shutdown;
(iv) The date and time that non-clean fuel combustion ends; and
(v) The date and time that clean fuels being combusted for the purpose of shutdown ends.
(3) For PM or non-mercury HAP metals work practice monitoring during startup periods, you must monitor and collect data according to this section and the site-specific monitoring plan required by § 63.10010(l).
(i) Except for an EGU that uses PM CEMS or PM CPMS to demonstrate compliance with the PM emissions limit, or that has LEE status for filterable PM or total non-Hg HAP metals for non- liquid oil-fired EGUs (or HAP metals emissions for liquid oil-fired EGUs), or individual non-mercury metals CEMS, you must:
(A) Record temperature and combustion air flow or calculated flow as determined from combustion equations of post-combustion (exhaust) gas, as well as amperage of forced draft fan(s), upstream of the filterable PM control devices during each hour of startup.
(B) Record temperature and flow of exhaust gas, as well as amperage of any induced draft fan(s), downstream of the filterable PM control devices during each hour of startup.
(C) For an EGU with an electrostatic precipitator, record the number of fields in service, as well as each field's secondary voltage and secondary current during each hour of startup.
(D) For an EGU with a fabric filter, record the number of compartments in service, as well as the differential pressure across the baghouse during each hour of startup.
(E) For an EGU with a wet scrubber needed for filterable PM control, record the scrubber liquid to flue gas ratio and the pressure drop across the scrubber during each hour of startup.
(ii) [Reserved]
(d) * * *
(3) Must conduct site-specific monitoring using CMS to demonstrate compliance with the site-specific monitoring requirements in Table 7 to this subpart pertaining to HCl and HF emissions from a liquid oil-fired EGU to ensure compliance with the HCl and HF emission limits in Tables 1 and 2 to this subpart, in accordance with the requirements of § 63.10000(c)(2)(iii). The monitoring must meet the general operating requirements provided in § 63.10020.
(e) Conduct periodic performance tune-ups of your EGU(s), as specified in paragraphs (e)(1) through (9) of this section. For your first tune-up, you may perform the burner inspection any time prior to the tune-up or you may delay the first burner inspection until the next scheduled EGU outage provided you meet the requirements of § 63.10005. Subsequently, you must perform an inspection of the burner at least once every 36 calendar months unless your EGU employs neural network combustion optimization during normal operations in which case you must perform an inspection of the burner and combustion controls at least once every 48 calendar months. If your EGU is offline when a deadline to perform the tune-up passes, you shall perform the tune-up work practice requirements within 30 days after the re-start of the affected unit.
(9) Report the dates of the initial and subsequent tune-ups in hard copy, as specified in § 63.10031(f)(5), until April 16, 2017. After April 16, 2017, report the date of all tune-ups electronically, in accordance with § 63.10031(f). The tune-up report date is the date when tune-up requirements in paragraphs (e)(6) and (7) of this section are completed.
(h) * * *
(1) You may use the diluent cap and default gross output values, as described in § 63.10007(f), during startup periods or shutdown periods.
(b) * * *
(2) Determine your operating limit as follows:
The revisions and additions read as follows:
(e) * * *
(1) A description of the affected source(s), including identification of the subcategory of the source, the design capacity of the source, a description of the add-on controls used on the source, description of the fuel(s) burned, including whether the fuel(s) were determined by you or EPA through a
(7) * * *
(i) A summary of the results of the annual performance tests and documentation of any operating limits that were reestablished during this test, if applicable. If you are conducting stack tests once every 3 years consistent with § 63.10005(h)(1)(i), the date of each stack test conducted during the previous 3 years, a comparison of emission level you achieved in each stack test conducted during the previous 3 years to the 50 percent emission limit threshold required in § 63.10006(i), and a statement as to whether there have been any operational changes since the last stack test that could increase emissions.
(iii) For each of your existing EGUs, identification of each emissions limit as specified in Table 2 to this subpart with which you plan to comply.
(A) You may switch from a mass per heat input to a mass per gross output limit (or vice-versa), provided that:
(
(
(
(
(
(B) You begin to use the revised emission limits starting in the next reporting period, after receipt of written acknowledgement from the Administrator of the switch.
(C) From submission of your request until start of the next reporting period after receipt of written acknowledgement from the Administrator of the switch, you demonstrate compliance with both the mass per heat input and mass per gross output emission limits for each pollutant for each EGU or EGU emissions averaging group.
(8) Identification of whether you plan to rely on paragraph (1) or (2) of the definition of “startup” in § 63.10042.
(i) Should you choose to rely on paragraph (2) of the definition of “startup” in § 63.10042 for your EGU, you shall include a report that identifies:
(A) The original EGU installation date;
(B) The original EGU design characteristics, including, but not limited to, fuel mix and PM controls;
(C) Each design PM control device efficiency established during performance testing or while operating in periods other than startup and shutdown periods;
(D) The design PM emission rate from the EGU in terms of pounds PM per MMBtu and pounds PM per hour established during performance testing or while operating in periods other than startup and shutdown periods;
(E) The design time from start of fuel combustion to necessary conditions for each PM control device startup;
(F) Each design PM control device efficiency upon startup of the PM control device, if different from the efficiency provided in paragraph (e)(8)(i)(C) of this section;
(G) Current EGU PM producing characteristics, including, but not limited to, fuel mix and PM controls, if different from the characteristics provided in paragraph (e)(8)(i)(B) of this section;
(H) Current PM control device efficiency from each PM control device, if different from the efficiency provided in paragraph (e)(8)(i)(C) of this section;
(I) Current PM emission rate from the EGU in terms of pounds PM per MMBtu and pounds per hour, if different from the rate provided in paragraph (e)(8)(i)(D) of this section;
(J) Current time from start of fuel combustion to conditions necessary for each PM control device startup, if different from the time provided in paragraph (e)(8)(i)(E) of this section; and
(K) Current PM control device efficiency upon startup of each PM control device, if different from the efficiency provided in paragraph (e)(8)(i)(H) of this section.
(ii) The report shall be prepared, signed, and sealed by a professional engineer licensed in the state where your EGU is located.
(iii) You may switch from paragraph (1) of the definition of “startup” in § 63.10042 to paragraph (2) of the definition of “startup” (or vice-versa), provided that:
(A) You submit a request that identifies for each EGU or EGU emissions averaging group involved in the proposed switch both the current definition of “startup” relied on and the proposed definition you plan to rely on;
(B) Your request arrives to the Administrator at least 30 calendar days prior to the date that the switch is proposed to occur;
(C) You revise and submit all other applicable plans,
(D) You maintain records of all information regarding your choice of the definition of “startup”; and
(E) You begin to use the revised definition of “startup” in the next reporting period after receipt of written acknowledgement from the Administrator of the switch.
(f) You must submit the notifications in § 63.10000(h)(2) and (i)(2) that may apply to you by the dates specified.
(c) The compliance report must contain the information required in paragraphs (c)(1) through (9) of this section.
(4) Include the date of the most recent tune-up for each EGU. The date of the tune-up is the date the tune-up provisions specified in § 63.10021(e)(6) and (7) were completed.
(5) Should you choose to rely on paragraph (2) of the definition of “startup” in § 63.10042 for your EGU, for each instance of startup or shutdown you shall:
(i) Include the maximum clean fuel storage capacity and the maximum hourly heat input that can be provided for each clean fuel determined according to the requirements of § 63.10032(f).
(ii) Include the information required to be monitored, collected, or recorded according to the requirements of § 63.10020(e).
(iii) If you choose to use CEMS to demonstrate compliance with numerical limits, include hourly average CEMS values and hourly average flow values during startup periods or shutdown periods. Use units of milligrams per cubic meter for PM CEMS values, micrograms per cubic meter for Hg CEMS values, and ppmv for HCl, HF, or
(iv) If you choose to use a separate sorbent trap measurement system for startup or shutdown reporting periods, include hourly average mercury concentration values in terms of micrograms per cubic meter.
(v) If you choose to use a PM CPMS, include hourly average operating parameter values in terms of the operating limit, as well as the operating parameter to PM correlation equation.
(6) You must report emergency bypass information annually from EGUs with LEE status.
(7) A summary of the results of the annual performance tests and documentation of any operating limits that were reestablished during the test, if applicable. If you are conducting stack tests once every 3 years to maintain LEE status, consistent with § 63.10006(b), the date of each stack test conducted during the previous 3 years, a comparison of emission level you achieved in each stack test conducted during the previous 3 years to the 50 percent emission limit threshold required in § 63.10005(h)(1)(i), and a statement as to whether there have been any operational changes since the last stack test that could increase emissions.
(8) A certification.
(9) If you have a deviation from any emission limit, work practice standard, or operating limit, you must also submit a brief description of the deviation, the duration of the deviation, emissions point identification, and the cause of the deviation.
(f) Regarding startup periods or shutdown periods:
(1) Should you choose to rely on paragraph (1) of the definition of “startup” in § 63.10042 for your EGU, you must keep records of the occurrence and duration of each startup or shutdown.
(2) Should you choose to rely on paragraph (2) of the definition of “startup” in § 63.10042 for your EGU, you must keep records of:
(i) The determination of the maximum possible clean fuel capacity for each EGU;
(ii) The determination of the maximum possible hourly clean fuel heat input and of the hourly clean fuel heat input for each EGU; and
(iii) The information required in § 63.10020(e).
The revisions and additions read as follows:
3.e.1(D) The %R value for each compound must be reported in the test report and all field measurements corrected with the calculated %R value for that compound using the following equation:
and
3.2.1.2.1
4.1.1.1
4.1.1.3
4.1.1.5
4.1.1.5.2
5.1.2.1 Calibration error tests of the Hg CEMS are required daily, except during unit outages. Use a NIST-traceable elemental Hg gas standard for these calibrations. If your Hg CEMS lacks an integrated elemental Hg gas generator, you may continue to use NIST-traceable oxidized Hg gases for the 7-day calibration error test (or the daily calibration error check) until such time as NIST-traceable compressed elemental Hg gas standards, at appropriate concentration levels, are available from gas vendors. Both a zero-level gas and either a mid-level or high-level gas are required for these calibrations.
5.1.2.3 Perform a single-level system integrity check weekly,
5.2.1 Each sorbent trap monitoring system shall be continuously operated and maintained in accordance with Performance Specification (PS) 12B in appendix B to part 60 of this chapter. The QA/QC criteria for routine operation of the system are summarized in Table 12B-1 of PS 12B. Each pair of sorbent traps may be used to sample the stack gas for up to 15 operating days.
6.2.2.3 The applicable gross output-based Hg emission rate limit in Table 1 or 2 to this subpart must be met on a 30- (or 90-) boiler operating day rolling average basis, except as otherwise provided in § 63.10009(a)(2). Use Equation A-5 of this appendix to calculate the Hg emission rate for each averaging period.
7.1.2.6 The EGUs that constitute an emissions averaging group.
7.1.8.5 If applicable, a code to indicate that the default gross output (as defined in § 63.10042) was used to calculate the Hg emission rate.
The revisions and additions read as follows:
2.1
2.3
2.3.1 PS 15, Sections 2.0, 3.0, 4.0, 5.0, 6.0, and 10.0 of appendix B to part 60 of this chapter; or
2.3.2 PS 18, Sections 3.0, 6.0, and 11.0 of appendix B to part 60 of this chapter.
3.1 If you choose to follow PS 15 of appendix B to part 60 of this chapter, then your HCl and/or HF CEMS must be certified according to PS 15 using the procedures for gas auditing and comparison to a reference method (RM) as specified in sections 3.1.1 and 3.1.2 below.
3.2 If you choose to follow PS 18 of appendix B to part 60 of this chapter, then your HCl CEMS must be certified according to PS 18, sections 7.0, 8.0, 11.0, 12.0, and 13.0.
3.3 Any additional stack gas flow rate, diluent gas, and moisture monitoring system(s) needed to express pollutant concentrations in units of the applicable emissions limit must be certified according to part 75 of this chapter.
On-going QA test requirements for HCl and HF CEMS must be implemented as follows:
5.1 If you choose to follow Performance Specification 15 (PS 15) of appendix B to part 60 of this chapter, then the quality assurance/quality control procedures of PS 15 shall apply as set forth in sections 5.1.1 through 5.1.3 and 5.4.2 of this appendix.
5.1.2 On a quarterly basis, you must conduct a gas audit of the HCl and/or HF CEMS as described in section 3.1.1 of this appendix. For the purposes of this appendix, “quarterly” means once every “QA operating quarter” (as defined in section 3.1.20 of appendix A to this subpart). You have the option to use HCl gas in lieu of HF gas for conducting this audit on an HF CEMS. To the extent practicable, perform consecutive quarterly gas audits at least 30 days apart. The initial quarterly audit is due in the first QA operating quarter following the calendar quarter in which certification testing of the CEMS is successfully completed. Up to three consecutive exemptions from the quarterly audit requirement are allowed for “non-QA operating quarters” (
5.2 If you choose to follow Performance Specification PS 18 of appendix B to part 60 of this chapter, then the quality assurance/quality control procedures in Procedure 6 of appendix F to part 60 of this chapter shall apply. The quarterly and annual QA tests required under Procedure 6 shall be performed, respectively, at the frequencies specified in sections 5.1.2 and 5.1.3 of this appendix.
5.3 Stack gas flow rate, diluent gas, and moisture monitoring systems must meet the applicable on-going QA test requirements of part 75 of this chapter.
5.4
5.4.1
5.4.2
5.4.2.1 For the monitoring systems described in section 5.3 of this appendix, a 168 unit or stack operating hour grace period is available for quarterly linearity checks, and a 720 unit or stack operating hour grace period is available for RATAs, as provided, respectively, in sections 2.2.4 and 2.3.3 of appendix B to part 75 of this chapter.
5.4.2.2 For the purposes of this appendix, if the deadline for a required gas audit/data accuracy assessment or RATA of an HCl CEMS cannot be met due to circumstances beyond the control of the owner or operator:
5.4.2.2.1 A 168 unit or stack operating hour grace period is available in which to perform the gas audit or other quarterly data accuracy assessment; or
5.4.2.2.2 A 720 unit or stack operating hour grace period is available in which to perform the RATA.
5.4.2.3 If a required QA test is performed during a grace period, the deadline for the next test shall be determined as follows:
5.4.2.3.1 For a gas audit or RATA of the monitoring systems described in sections 5.1 and 5.2 of this appendix, determine the deadline for the next gas audit or RATA (as applicable) in accordance with section 2.2.4(b) or 2.3.3(d) of appendix B to part 75 of this chapter; treat a gas audit in the same manner as a linearity check.
5.4.2.3.2 For the gas audit or other quarterly data accuracy assessment of an HCl or HF CEMS, the grace period test only satisfies the audit requirement for the calendar quarter in which the test was originally due. If the calendar quarter in which the grace period audit is performed is a QA operating quarter, an additional gas audit/data accuracy assessment is required for that quarter.
5.4.2.3.3 For the RATA of an HCl or HF CEMS, the next RATA is due within three QA operating quarters after the calendar quarter in which the grace period test is performed.
5.4.3
The owner or operator shall develop and implement a quality assurance/quality control (QA/QC) program for the HCl and/or HF CEMS that are used to provide data under this subpart. At a minimum, the program shall include a written plan that describes in detail (or that refers to separate documents containing) complete, step-by-step procedures and operations for the most important QA/QC activities. Electronic storage of the QA/QC plan is permissible, provided that the information can be made available in hard copy to auditors and inspectors. The QA/QC program requirements for
9.3.2 For gross output-based emission rates, first calculate the HCl or HF mass emission rate (lb/h), using an equation that has the general form of Equation A-2 or A-3 in appendix A to this subpart (as applicable), replacing the value of K with 9.43 × 10
| 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 |