Unknown. Final rule; confirmation of effective date

5,060 words·~23 min read·/register/2020/01/31/2020-01060

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2020-01-31.xml --- 85 21 Friday, January 31, 2020 Contents Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Forest Service Animal Animal and Plant Health Inspection Service NOTICES Environmental Impact Statements; Availability, etc.: Rangeland Grasshopper and Mormon Cricket Suppression Program; Record of Decision, 5611 2020-01835 Import Requirements for the Importation: Unshu Oranges from Japan into the United States, 5612-5615 2020-01981 List of Regions Affected with African Swine Fever:

Addition of the Philippines, 5611-5612 2020-01836 Antitrust Division Antitrust Division NOTICES Changes under the National Cooperative Research and Production Act: Cooperative Research Group on ROS-Industrial Consortium-Americas, 5720 2020-01757 Information Warfare Research Project Consortium, 5706-5707 2020-01819 National Armaments Consortium, 5720-5721 2020-01823 ODPi, Inc., 5720 2020-01751 ODVA, Inc., 5706 2020-01820 Southwest Research Institute—Cooperative Research Group on Mechanical Stratigraphy and Natural Deformation in the Permian Strata of Texas and New Mexico:

Implications for Exploitation of the Permian Basin—Phase 2, 5719-5720 2020-01853 Proposed Final Judgment and Competitive Impact Statement: United States v. ZF Friedrichshafen AG, et al., 5707-5719 2020-01759 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5661-5668 2020-01855 2020-01856 2020-01857 2020-01858 2020-01859 2020-01860 2020-01861 Coast Guard Coast Guard RULES Navigation and Navigable Waters, and Shipping;

Technical, Organizational, and Conforming Amendments for U.S. Coast Guard Field District 1, 5567-5570 2020-01294 PROPOSED RULES Special Local Regulation: Choptank River, Between Trappe and Cambridge, MD, 5608-5610 2020-01772 Commerce Commerce Department See Foreign-Trade Zones Board See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List;

Additions and Deletions, 5637-5638 2020-01800 2020-01808 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Company-Run Annual Stress Test Reporting Template and Documentation for Covered Institutions with Total Consolidated Assets of $250 Billion or More under the Dodd-Frank Wall Street Reform and Consumer Protection Act, 5773-5775 2020-01825 Consumer Product Consumer Product Safety Commission PROPOSED RULES Review of the Safety Standards for Full-Size Baby Cribs and Non-Full-Size Baby Cribs, 5587-5589 2020-01832 Defense Department Defense Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Examination of Records by Comptroller General and Contract Audit, 5659 2020-01841 Payments to Small Business Subcontractors, 5660-5661 2020-01837 Department of Defense Science and Technology Reinvention Laboratory Personnel Demonstration Project, 5639-5641 2020-01854 Meetings: Board of Regents, Uniformed Services University of the Health Sciences, 5641-5642 2020-01830 Drug Drug Enforcement Administration RULES Schedules of Controlled Substances:

Placement of Lasmiditan in Schedule V, 5557-5562 2020-01957 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cash Management Contract URL Collection, 5644 2020-01774 Student Assistance General Provision—Subpart E—Verification Student Aid Application Information, 5642-5643 2020-01773 Student Assistance General Provisions—Subpart J—Approval of Independently Administered Tests, 5643 2020-01775 Applications for New Awards:

Training Program for Federal TRIO Programs, 5644-5648 2020-01813 Energy Department Energy Department See Federal Energy Regulatory Commission NOTICES Energy Conservation Program: Decision and Order Granting a Waiver to Bradford White Corporation from the Department of Energy Consumer Water Heaters Test Procedure, 5648-5652 2020-01847 Decision and Order Granting a Waiver to Signify North America Corp. from the Illuminated Exit Sign Test Procedure, 5652-5655 2020-01848 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans;

Approvals and Promulgations: District of Columbia; Infrastructure Requirements for the 2015 Ozone National Ambient Air Quality Standard, 5570-5572 2020-00885 Massachusetts; Transport State Implementation Plan for the 2015 Ozone Standard, 5572-5574 2020-01113 Extension of Time-Limited Tolerances for Emergency Exemptions (Multiple Chemicals, Various Commodities), 5575-5578 2020-00826 National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Partial Deletion of the Idaho Pole Co.

Superfund Site, 5578-5579 2020-01748 New Source Performance Standards and National Emissions Standards for Hazardous Air Pollutants: Connecticut; Memorandum of Agreement for Delegation of Authority, 5574-5575 2020-01112 NOTICES Cross-Media Electronic Reporting: Authorized Program Revision Approval, Maricopa County, AZ, 5657-5658 2020-01579 Authorized Program Revision Approval, State of Iowa, 5657 2020-01578 Environmental Impact Statements; Availability, etc.: Weekly Receipt, 5658 2020-01831 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives:

Thales AVS France SAS Global Positioning System/Satellite Based Augmentation System Receivers, 5584-5587 2020-01706 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification of Aircraft and Airmen for the Operation of Light-Sport Aircraft, 5768 2020-01766 Meetings: Aviation Rulemaking Advisory Committee, 5768-5769 2020-01916 Federal Emergency Federal Emergency Management Agency NOTICES Disaster Declarations: Mississippi, 5683 2020-01885 Ponca Tribe of Nebraska, 5681 2020-01889 South Dakota, 5680-5681 2020-01886 2020-01887 Tennessee, 5683 2020-01883 Major Disaster Declaration:

Georgia; Amendment No. 7, 5681 2020-01899 Nebraska; Amendment No. 13, 5681-5682 2020-01898 Tennessee; Amendment No. 2, 5680 2020-01897 Request for Applicants for Appointment: National Advisory Council, 5682-5683 2020-01904 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 5655-5657 2020-01866 2020-01867 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statements; Availability, etc.: Cape Fear Crossing in Brunswick and New Hanover Counties, NC, 5769 2020-01864 Federal Maritime Federal Maritime Commission RULES Hearing Procedures Governing the Denial, Revocation, or Suspension of an Ocean Transportation Intermediary License, 5579-5583 2020-00907 Federal Reserve Federal Reserve System NOTICES Change in Bank Control:

Acquisitions of Shares of a Bank or Bank Holding Company, 5658-5659 2020-01868 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Species: Recovery Permit Applications, 5687-5691 2020-01862 Food and Drug Food and Drug Administration RULES Food Additive Regulations: Synthetic Flavoring Agents and Adjuvants; Confirmation of Effective Date, 5555-5557 2020-01060 NOTICES Guidance: Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components, 5668-5670 2020-01815 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 5775 2019-28460 Foreign Trade Foreign-Trade Zones Board NOTICES Authorization of Production Activity:

Eastman Kodak Co., Foreign-Trade Zone 141, Rochester, NY, 5616 2020-01839 Panasonic Solar North America, Foreign-Trade Zone 23, Buffalo, NY, 5615-5616 2020-01840 Expansion of Foreign-Trade Zone 116, Port Arthur, TX, 5616 2020-01838 Forest Forest Service NOTICES Intent to Renew: Land Between the Lakes Advisory Board, 5615 2020-01795 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Examination of Records by Comptroller General and Contract Audit, 5659 2020-01841 Payments to Small Business Subcontractors, 5660-5661 2020-01837 Environmental Assessments;

Availability, etc.: Appraisers Building and U.S. Custom House Limited Scope Repair and Alteration Project in San Francisco, CA, 5660 2020-01585 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration NOTICES Meetings: National Clinical Care Commission, 5671 2020-01871 Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, 5671-5672 2020-01872 Health Resources Health Resources and Services Administration NOTICES Meetings:

CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment, 5670 2020-01809 National Advisory Committee on Rural Health and Human Services, 5670-5671 2020-01810 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S. Citizenship and Immigration Services Housing Housing and Urban Development Department RULES Streamlining and Aligning Formaldehyde Emission Control Standards for Certain Wood Products in Manufactured Home Construction with the Toxic Substance Control Act, 5562-5567 2020-01474 PROPOSED RULES Manufactured Home Construction and Safety Standards, 5589-5608 2020-01473 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Alternative Inspections—Housing Choice Voucher Program, 5684-5685 2020-01878 Project Approval for Single-Family Condominiums, 5686-5687 2020-01880 Section 202 Supportive Housing for the Elderly Application Submission Requirements, 5685-5686 2020-01879 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Youth Conservation Corps Application and Medical History, 5691-5692 2020-01818 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Monosodium Glutamate from the People's Republic of China, 5616-5617 2020-01834 Meetings: Civil Nuclear Trade Advisory Committee, 5617-5618 2020-01805 International Trade Com International Trade Commission NOTICES Institution of Investigation and Scheduling of Hearing:

Seafood Obtained via Illegal, Unreported, and Unregulated Fishing; U.S. Imports and Economic Impact on U.S. Commercial Fisheries, 5704-5705 2020-01799 Investigations; Determinations, Modifications, and Rulings, etc.: Dried Tart Cherries from Turkey, 5705 2020-01822 Meetings; Sunshine Act, 5705 2020-02003 Justice Department Justice Department See Antitrust Division See Drug Enforcement Administration Labor Department Labor Department RULES Nondisplacement of Qualified Workers Under Service Contracts;

Rescission of Regulations, 5567 2020-00948 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Benzene Standard, 5722-5723 2020-01790 Cadmium in Construction Standard, 5723-5724 2020-01789 Lead in General Industry Standard, 5721-5722 2020-01788 Respirable Crystalline Silica Standards for General Industry, Maritime and Construction, 5724-5725 2020-01791 Land Land Management Bureau NOTICES Draft Resource Management Plan Amendment and Draft Environmental Impact Statement for Wild Horse Management in the Bureau of Land Management Rock Springs and Rawlins Field Offices, Wyoming, 5695-5696 2020-01979 Plats of Survey:

Alaska, 5694 2020-01870 Proposed Reinstatement of Terminated Oil and Gas Lease: WYW131627, Wyoming, 5695 2020-01844 WYW180623, Wyoming, 5694-5695 2020-01843 WYW183610, Wyoming, 5692-5693 2020-01842 Record of Decision: United States Gypsum Company Mine Expansion/Modernization Project, Imperial County, CA, 5693-5694 2020-01669 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Examination of Records by Comptroller General and Contract Audit, 5659 2020-01841 Payments to Small Business Subcontractors, 5660-5661 2020-01837 National Highway National Highway Traffic Safety Administration NOTICES Receipt of Petition for Decision:

Nonconforming Model Year 1994 to 1997 Jaguar Daimler Double Six Passenger Cars are Eligible for Importation, 5770-5771 2020-01828 Nonconforming Model Year 2015 A. Smith GT Bentley/Bodex Model: T5 Trailers are Eligible for Importation, 5772-5773 2020-01827 Nonconforming Model Year 2015 Ford Fusion SE Passenger Cars are Eligible for Importation, 5771-5772 2020-01829 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Collection of Grant and Contract Data that may be of Interest to Historically Black Colleges and Universities and Small Businesses, 5674-5675 2020-01863 Early Career Reviewer Program Online Application and Vetting System (Center for Scientific Review), 5677-5678 2020-01798 Meetings: Center for Scientific Review, 5672-5676 2020-01794 2020-01797 National Eye Institute, 5676 2020-01793 National Human Genome Research Institute, 5675 2020-01796 National Toxicology Program Board of Scientific Counselors, 5676-5677 2020-01792 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Taking and Importing Marine Mammals:

U.S. Navy Training and Testing Activities in the Mariana Islands Training and Testing Study Area, 5782-5901 2020-00481 NOTICES Meetings: Mid-Atlantic Fishery Management Council, 5618-5619 2020-01873 Pacific Fishery Management Council, 5618, 5634 2020-01874 2020-01875 Pacific Island Fisheries; Western Pacific Stock Assessment Review, 5633-5634 2020-01777 Takes of Marine Mammals: Incidental to THwaites Offshore Research

(THOR)Project in the Amundsen Sea, Antarctica, 5619-5633 2020-01811 National Park National Park Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Designation as National Recreation Trail or National Water Trail, 5702-5704 2020-01803 Community Harvest Assessments for Alaskan National Parks, Preserves, and Monuments, 5698-5699 2020-01802 Glacier Bay National Park and Preserve Bear Sighting and Encounter Reports, 5696-5698 2020-01974 Land and Water Conservation, 5699-5702 2020-01801 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Environmental Impact Statements; Availability, etc.: Exelon Generation Company, LLC Peach Bottom Atomic Power Station, Units 2 and 3, 5725 2020-01769 Office Special Office of the Special Counsel NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5725-5726 2020-01768 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Deposit of Biological Materials, 5636-5637 2020-01852 Patent Law Treaty, 5634-5635 2020-01850 Patent Term Extension, 5636 2020-01849 Post Allowance and Refiling, 5635-5636 2020-01851 Securities Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 5742, 5746-5747 2020-02017 2020-02018 Self-Regulatory Organizations; Proposed Rule Changes: Cboe BYX Exchange, Inc., 5751-5753 2020-01782 Cboe BZX Exchange, Inc., 5753-5756, 5764-5766 2020-01778 2020-01781 Cboe EDGX Exchange, Inc., 5761-5764 2020-01779 ICE Clear Credit LLC, 5756-5761 2020-01784 LCH SA, 5744-5746 2020-01517 Miami Emerald, LLC, 5726-5728 2020-01787 Miami International Securities Exchange LLC, 5742-5744 2020-01780 The Depository Trust Co., 5728-5730, 5747-5751 2020-01785 2020-01786 The Nasdaq Stock Market LLC, 5730-5742 2020-01783 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Employee Self-Certification and Ability to Perform in Emergencies (ESCAPE) Posts, Pre-Deployment Physical Exam Acknowledgement Form; Correction, 5766 2020-01881 Substance Substance Abuse and Mental Health Services Administration NOTICES Certified Laboratories and Instrumented Initial Testing Facilities: List of Facilities that Meet Minimum Standards to Engage in Urine and Oral Fluid Drug Testing for Federal Agencies, 5678-5680 2020-01776 Surface Transportation Surface Transportation Board NOTICES Amended Lease and Operation Exemption Containing Interchange Commitment: Elkhart and Western Railroad Co.; Norfolk Southern Railway Co., 5767-5768 2020-01807 Lease and Operation Exemption Containing Interchange Commitment: East Penn Railroad, L.L.C.; Norfolk Southern Railway Co., 5766-5767 2020-01826 Lease and Operation Exemption Containing Interchange Commitments: Georgia Southern Railway Co.; The South Western Rail Road Co., Central of Georgia Railroad Co., and Norfolk Southern Railway Co., 5767 2020-01900 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See National Highway Traffic Safety Administration Treasury Treasury Department See Comptroller of the Currency See Foreign Assets Control Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5776-5779 2020-01846 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Bank Enterprise Award Program Application, 5779-5780 2020-01882 U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES New Version of Employment Eligibility Verification Form, 5683-5684 2020-01821 Separate Parts In This Issue Part II Commerce Department, National Oceanic and Atmospheric Administration, 5782-5901 2020-00481 Reader Aids 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 electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. 85 21 Friday, January 31, 2020 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 172 and 177 [Docket No. FDA-2015-F-4317] Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; confirmation of effective date. SUMMARY: The Food and Drug Administration (FDA or we) is responding to the submission styled as an objection submitted by Earthjustice on behalf of Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, and the Natural Resources Defense Council, on the final rule that amended the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. The final rule also amended the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. After reviewing the submission, we have concluded that the submission we received is not an objection and consequently does not provide a basis for modifying the regulations. DATES: Effective date of final rule published in the **Federal Register** of October 9, 2018 (83 FR 50490) confirmed: October 9, 2018. ADDRESSES: For access to the docket to read background documents or comments received, go to *https://www.regulations.gov* and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Mical Honigfort, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1278. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of January 4, 2016 (81 FR 42), we announced the filing of a food additive petition (FAP 5A4810) (“petition”) submitted jointly by the Center for Science in the Public Interest; Natural Resources Defense Council; Center for Food Safety; Consumers Union; Improving Kids' Environment; Center for Environmental Health; Environmental Working Group; Environmental Defense Fund, and Mr. James Huff (collectively, “petitioners”) c/o Thomas Neltner, 1875 Connecticut Ave. NW, Suite 600, Washington, DC 20009. Subsequently, the Breast Cancer Fund (now known as the Breast Cancer Prevention Partners) and WE ACT for Environmental Justice joined as co-petitioners. The petition proposed that we take two separate regulatory actions:

(1)Amend the food additive regulations in § 172.515 *Synthetic flavoring substances and adjuvants* (21 CFR 172.515) to no longer authorize the use of seven listed synthetic flavoring food additives and

(2)to establish zero tolerances in § 172.515 for these additives. As FDA explained in the filing notice (81 FR 42 at 42 through 43) and the final rule (83 FR 50490 at 50491) for this petition, the food additive regulation is not the appropriate section for a “zero tolerance,” and this request is not the proper subject of a food additive petition. A food additive petition must either propose the issuance of a regulation prescribing the conditions under which a food additive may be safely used (see section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(b)(1)), or propose the amendment or repeal of an existing food additive regulation (see section 409(i) of the FD&C Act). As we explained in the final rule, we interpreted the petitioners' request to establish zero tolerances for these additives as a request to issue a regulation prohibiting a substance from human food under part 189 (21 CFR part 189), a request that is not the proper subject of a food additive petition (83 FR 50490 at 50491). Therefore, because the petitioners' request to establish zero tolerances fell outside the scope of a food additive petition, we focused solely on the request in the petition to amend the food additive regulations pertaining to these seven synthetic flavoring food additives. The seven food additives that were the subject of the petition are: 1. Benzophenone (also known as diphenylketone) (CAS No. 119-61-9); 2. Ethyl acrylate (CAS No. 140-88-5); 3. Eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol) (CAS No. 93-15-2); 4. Myrcene (also known as 7-methyl-3-methylene-1,6-octadiene) (CAS No. 123-35-3); 5. Pulegone (also known as p-menth-4(8)-en-3-one) (CAS No. 89-82-7); 6. Pyridine (CAS No. 110-86-1); and 7. Styrene (CAS No. 100-42-5) Related to FAP 5A4810, in the **Federal Register** of June 15, 2016 (81 FR 38984), we announced that we filed a food additive petition (FAP 6A4817) proposing that we amend § 172.515 to no longer provide for the use of styrene as a synthetic flavoring substance and adjuvant in food because the use has been abandoned. We later issued a final rule in the **Federal Register** of October 9, 2018 (83 FR 50487) granting the petition and amending § 172.515 to no longer authorize the use of styrene as a synthetic flavoring substance and adjuvant in food because its use under § 172.515 had been permanently and completely abandoned. Additionally, in the **Federal Register** of October 9, 2018 (83 FR 50490), we published a final rule partially granting FAP 5A4810 to amend the food additive regulations in § 172.515 to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. We also amended the food additive regulation in 21 CFR 177.2600 to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. We denied as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned (83 FR 50490 at 50492 through 50493). As discussed in detail in section III, we explained in the final rule that we declined to act on the petitioners' request to establish a zero tolerance for the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition. The final rule advised that objections and requests for a hearing on the final rule were due by November 8, 2018. II. Objections and Requests for Hearing Section 409(f)(1) of the FD&C Act provides that, within 30 days after publication of an order relating to a food additive regulation, any person adversely affected by such order may file objections, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections. Under 21 CFR 171.110, objections and requests for a hearing are governed by 21 CFR part 12 of FDA's regulations. Under 21 CFR 12.22(a), each objection must meet the following conditions:

(1)Must be submitted on or before the 30th day after the date of publication of the final rule;

(2)must be separately numbered;

(3)must specify with particularity the provision of the regulation or proposed order objected to;

(4)must specifically state each objection on which a hearing is requested; failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection; and

(5)must include a detailed description and analysis of the factual information to be presented in support of the objection if a hearing is requested; failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection. Within the 30-day objection period following publication of the final rule, we received approximately 50 comments concerning the final rule. With the exception of one submission, the comments did not purport to raise objections and did not provide or identify any relevant new evidence. We will not address these comments further. However, we received one submission that stated it was noting several concerns and raising one “objection.” Earthjustice, on behalf of Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, and the Natural Resources Defense Council, wrote to “share our objection and concerns” about the final rule (see Letter from Peter Lehner, Senior Attorney, and Carrie Apfel, Staff Attorney, Earthjustice, to Dockets Management Staff, Food and Drug Administration, dated November 8, 2018). (For the purposes of this document, we will refer to these entities as “parties.”) The submission stated that the parties “applaud[ed] FDA for acknowledging that it `cannot consider these synthetic substances to be safe as a matter of law,'” but indicated that it objected to our “failure to indicate expressly that these substances no longer qualify in any way as `safe' for use in food, which amounts to an arbitrary and unlawful failure to protect the safety of food” (id. at page 1). The submission also noted two concerns about our analyses of the substances (id.). The parties also stated in their submission that they waived their right to a hearing (id.). As discussed in detail in section III, the provision for objections and a hearing under section 409(f) of the FD&C Act does not apply to this “objection.” For the purposes of this document, our use of the term “objection” does not mean that the provision for objections under section 409(f) of the FD&C Act applies. III. Analysis of Objection The submission's “objection” is not subject to the objections and hearing procedure in section 409(f) of the FD&C Act. Therefore, we will not address the arguments detailed in the submission. The submission asserts that FDA's failure to indicate expressly in the final rule that substances found to induce cancer cannot qualify in any way as “safe” for use in food is arbitrary and unlawful (Earthjustice submission at pages 2 through 3). The submission further states that, “To correct this deficiency, FDA must explain that substances found to induce cancer cannot qualify as “safe” for use in food, regardless of whether those substances purport to be food additives, GRAS substances, or both” (id. at page 3). A substance is generally recognized as safe

(GRAS)if there is general recognition, among qualified experts, to be safe under the conditions of its intended use. A substance that is GRAS under the conditions of its intended use is excluded from the statutory definition of food additive under section 201(s) of the FD&C Act (21 U.S.C. 321(s)). Thus, given a substance is, by definition, not a food additive if it is GRAS, whether the status of a substance is GRAS is outside the scope of the food additive petition process and the related provision for objections and public hearing. Section 409(f)(1) of the FD&C Act states that within 30 days after publication of an order made pursuant to section 409(c) or

(d)of the FD&C Act, any person adversely affected by such an order may file objections, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor. In the final rule, we stated that we partially granted the petition and partially denied the petition, completely responding to the food additive petition submitted by the petitioners (83 FR 50490 at 50492). FDA partially granted the petition by amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food based on data provided by the petitioners that demonstrated these additives induce cancer in laboratory animals, and, as a result of this finding in animals, FDA cannot as a matter of law maintain the listing of these synthetic flavoring substances in the food additive regulations (21 U.S.C. 348(c)(3)(A)). We further amended the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food because of evidence that benzophenone causes cancer in animals. FDA denied as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. Further, and most relevant here, FDA denied the petitioners' request to establish zero tolerances for these additives because such a request fell outside the scope of the food additive petition process (83 FR 50490 at 50491). As a result of responding to these two food additive petitions, FDA revoked the uses of all seven synthetic flavoring substances either:

(1)As a matter of law because data demonstrated that six of the seven synthetic flavoring substances have been shown to cause cancer in animals or

(2)based on a determination that the use had been completely and permanently abandoned; we further made clear that the petitioners' “zero tolerance” request was not the proper subject of a food additive petition (83 FR 50487; 83 FR 50490). Thus, when the parties state in their “objection” that FDA's “failure to indicate expressly that these substances no longer qualify in any way as `safe' for use in food.. . . amounts to an arbitrary and unlawful failure to protect the safety of food,” it does not appear the parties have stated with particularity a specific provision of the synthetic flavoring substances order that they deem objectionable. The parties do not object to our determination to revoke the uses of the synthetic flavoring substances, and in fact in their submission, the parties stated they “applaud FDA for acknowledging that it `cannot consider these synthetic flavoring substances to be safe as a matter of law' ” (Earthjustice submission, page 1). Rather, by asserting in their submission that FDA is being arbitrary and unlawful by failing to indicate expressly in the final rule that substances found to induce cancer cannot qualify in any way as “safe” for use in food, we interpret the parties' “objection” to be related to the petitioners' request to establish zero tolerances for these synthetic flavoring additives, a request we declined to act on in the final rule because such a request was not the proper subject of a food additive petition. As explained in the final rule (83 FR 50490 at 50491), a food additive petition must either propose the issuance of a regulation prescribing the conditions under which a food additive may be safely used or propose the amendment or repeal of an existing food additive regulation (sections 409(b)(1) and

(i)of the FD&C Act). We explained in the final rule that we interpreted the request to establish zero tolerances for these flavoring additives as a request to issue a regulation prohibiting a substance from human food under part 189 and that this request fell outside the scope of a food additive petition because it does not propose the issuance of a new food additive regulation or the amendment or repeal of an existing food additive regulation (id.). Consequently, we did not address the zero tolerance request further in the final rule and thus this issue was not considered part of the order by regulation that revoked the uses for these synthetic flavoring additives, pursuant to section 409(c) of the FD&C Act. Therefore, because the parties failed to identify a provision of the order deemed objectionable and have also failed to raise an objection regarding the order made pursuant to section 409(c) or

(d)of the FD&C Act, the provision for objections and public hearing under section 409(f) of the FD&C Act does not apply. 1 1 We note that the parties' submission did not present any argument or evidence that FDA's determination that the petitioners' zero tolerance request was not the proper subject of a food additive petition, and was thus outside the scope of section 409 of the FD&C Act, was erroneous. Finally, even though we do not think the parties' submission legally rises to an objection under 409(f) of the FD&C Act, even if the submission was a properly raised objection, we would deny such an objection because the parties' request amounts to the same outcome as the petitioners' zero tolerance request and such a request falls outside the scope of the food additive petition process. IV. Conclusion After evaluating the submission from Earthjustice et al., we have concluded that the “objection” is not within the scope of the objections and hearing provision under section 409(f) of the FD&C Act. Therefore, we do not address the arguments related to this “objection.” We are confirming October 9, 2018, as the effective date of this regulation. FDA still intends to not enforce applicable requirements of the final rule with regard to food products manufactured (domestically and internationally) prior to October 9, 2020, that contain one or more of these six synthetic flavoring substances, to provide an opportunity for companies to reformulate products prior to enforcing the requirements of this final rule. Dated: January 16, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-01060 Filed 1-30-20; 8:45 am]

Connectionstraces to 6

Traces to 6 documents

CFR

U.S. Code

2 references not yet in our index