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Code · REGISTER · 2020-07-08 · Agricultural Marketing Agricultural Marketing Service RULES National Bioengineered Food Disclosure Standard: Guidance on Validation of a Refining Process and Selecting a Testing Method, 40867 2020-146 · Unknown

Unknown. Notification of guidance

2,520 words·~11 min read·/register/2020/07/08/2020-14643

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-2020-07-08.xml --- 85 131 Wednesday, July 8, 2020 Contents Agricultural Marketing Agricultural Marketing Service RULES National Bioengineered Food Disclosure Standard: Guidance on Validation of a Refining Process and Selecting a Testing Method, 40867 2020-14643 Tart Cherries Grown in the States of Michigan, et al.: Free and Restricted Percentages for the 2019-20 Crop Year, 40867-40873 2020-13125 Agriculture Agriculture Department See Agricultural Marketing Service See Forest Service Army Army Department NOTICES Meetings:
Board of Visitors, United States Military Academy, 41006-41007 2020-14712 Privacy Act; Systems of Records, 41007-41009 2020-14655 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41047-41049 2020-14701 2020-14714 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Family Violence Prevention and Services Program, 41049 2020-14673 Refugee Data Submission System for Formula Funds Allocations, 41049-41050 2020-14674 Civil Rights Civil Rights Commission NOTICES Meetings:
California Advisory Committee, 40963-40964 2020-14637 2020-14636 Florida Advisory Committee, 40965 2020-14634 New York Advisory Committee, 40964-40965 2020-14635 Coast Guard Coast Guard RULES Safety Zones: Amelia River, Fernandina, FL, 40899-40901 2020-14788 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41060-41061 2020-14657 Commerce Commerce Department See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration See National Telecommunications and Information Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Generic Clearance for Challenge and Prize Competition Solicitations, 40965-40966 2020-14644 Commodity Futures Commodity Futures Trading Commission RULES Registration and Compliance Requirements: Commodity Pool Operators and Commodity Trading Advisors: Prohibiting Exemptions Under Regulation 4.13 on Behalf of Persons Subject to Certain Statutory Disqualifications, 40877-40892 2020-12607 Community Living Administration Community Living Administration NOTICES Reallotment of FY 2020 Funds, 41050 2020-14616 Consumer Product Consumer Product Safety Commission RULES Revisions to Safety Standard for Children's Folding Chair and Stools;
Correction, 40877 2020-13349 Revisions to Safety Standard for Portable Bed Rails; Corrections, 40875-40876 2020-13348 Revisions to Safety Standard for Sling Carriers; Corrections, 40876-40877 2020-13350 Safety Standard for Hand-Held Infant Carriers; Correction, 40876 2020-13351 Defense Department Defense Department See Army Department NOTICES Meetings: Medicare-Eligible Retiree Health Care Board of Actuaries, 41009-41010 2020-14727 Drug Drug Enforcement Administration NOTICES Importers of Controlled Substances;
Applications: Galephar Pharmaceutical Research, Inc., 41065 2020-14614 Usona Institute, 41065 2020-14624 Xcelience, 41065-41066 2020-14623 Education Department Education Department See National Assessment Governing Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Loan Discharge Applications, 41012 2020-14682 Applications for New Awards: Technical Assistance on State Data Collection--IDEA Data Management Center, 41012-41020 2020-14072 Energy Department Energy Department See Federal Energy Regulatory Commission See National Nuclear Security Administration NOTICES Change In Control:
Magnolia LNG, LLC, 41020-41021 2020-14648 Meetings: Environmental Management Site-Specific Advisory Board, Northern New Mexico, 41022 2020-14685 Proposed Subsequent Arrangement, 41021-41022 2020-14697 2020-14723 2020-14724 Securing the United States Bulk-Power System, 41023-41026 2020-14668 Environmental Protection Environmental Protection Agency RULES National Emission Standards for Hazardous Air Pollutants: Surface Coating of Automobiles and Light-Duty Trucks; Surface Coating of Miscellaneous Metal Parts and Products;
Surface Coating of Plastic Parts and Products; etc., 41100-41161 2020-05908 National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the DuPage County Landfill/Blackwell Forest Superfund Site, 40906-40908 2020-14588 Safer Affordable Fuel-Efficient Vehicles Rule: Model Years 2021-2026 Passenger Cars and Light Trucks; Correction, 40901-40906 2020-14642 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations:
New Mexico; Repeal of State Regulations for Particulate Matter for Lime Manufacturing Plants, 40951-40958 2020-14360 National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the DuPage County Landfill/Blackwell Forest Superfund Site, 40958-40959 2020-14586 Partial Deletion of the U.S. Smelter and Lead Refinery, Inc. Superfund Site, 40959-40961 2020-14476 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives:
Rolls-Royce Deutschland Ltd and Co KG (Type Certificate Previously Held by Rolls-Royce plc) Turbofan Engines, 40873-40875 2020-14601 NOTICES Meetings: Women in Aviation Advisory Board, 41088-41089 2020-14720 Federal Communications Federal Communications Commission RULES Intercarrier Compensation Regime To Eliminate Access Arbitrage, 40908-40915 2020-13183 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41035-41040 2020-14694 2020-14696 2020-14698 2020-14699 Agency Information Collection Activities;
Proposals, Submissions, and Approvals:, 41036-41037 2020-14695 Federal Energy Federal Energy Regulatory Commission NOTICES Application: ANR Pipeline Co., 41032-41033 2020-14663 Brookfield White-Pine Hydro, LLC, 41029-41030 2020-14665 Great Lakes Gas Transmission Limited Partnership, 41030-41031 2020-14664 Combined Filings, 41027-41028, 41031-41035 2020-14686 2020-14687 2020-14688 Environmental Assessments; Availability, etc.: City and County of Denver, CO, 41028-41029 2020-14666 Meetings:
Impacts of COVID-19 on the Energy Industry, 41032 2020-14667 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statements; Availability, etc.: US 1/MD 201 Project, Prince George's County, MD, 41089 2020-14638 US 301 Waldorf Area Transportation Improvements Project, in Charles and Prince George's Counties, MD, 41089 2020-14639 Federal Mine Federal Mine Safety and Health Review Commission NOTICES Temporary Suspension of In-Person Hearings, 41040 2020-14603 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 41040-41045 2020-14613 Change in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 41045-41046 2020-14622 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 41045 2020-14704 Fish Fish and Wildlife Service NOTICES Endangered Species: Receipt of Recovery Permit Applications, 41062-41063 2020-14654 Food and Drug Food and Drug Administration NOTICES Meetings: Cardiovascular and Renal Drugs Advisory Committee, 41053-41055 2020-14719 Requests for Nominations:
Individuals and Consumer Organizations for Advisory Committees, 41050-41053 2020-14715 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 41096 2020-14660 Forest Forest Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for Non-Timber Forest Products, 40962 2020-14703 Proposed CERCLA Settlement Agreement: Ross Adams Mine Site Cleanup, 40963 2020-14641 General Services General Services Administration NOTICES Meetings:
Chet Holifield Federal Building Draft Environmental Impact Statement, Laguna Niguel, CA, 41046-41047 2020-14710 Health and Human Health and Human Services Department See Centers for Medicare & Medicaid Services See Children and Families Administration See Community Living Administration See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41056-41057 2020-14595 Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: The Maternal, Infant, and Early Childhood Home Visiting Program Pay for Outcomes Supplemental Information Request, 41055-41056 2020-14658 Homeland Homeland Security Department See Coast Guard See U.S. Citizenship and Immigration Services Industry Industry and Security Bureau NOTICES Order Denying Export Privileges: Mahin Mojtahedzadeh, a.k.a. Mahin Toussi Mojtahedzadeh, a.k.a. Mahin Mojtahedzadeh Toussi, 40966-40967 2020-14597 Interior Interior Department See Fish and Wildlife Service See National Park Service Internal Revenue Internal Revenue Service RULES Carryback of Consolidated Net Operating Losses, 40892-40899 2020-14426 PROPOSED RULES Consolidated Net Operating Losses, 40927-40951 2020-14427 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
Electrolytic Manganese Dioxide From the People's Republic of China, 40970 2020-14681 Tetrahydrofurfuryl Alcohol From the People's Republic of China, 40969-40970 2020-14680 Determination of Sales At Less Than Fair Value: Xanthan Gum From the People's Republic of China, 40967-40969 2020-14678 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Silicon Metal From Bosnia and Herzegovina, Iceland, Kazakhstan, and Malaysia, 41063-41065 2020-14625 Justice Department Justice Department See Drug Enforcement Administration Maritime Maritime Administration NOTICES Meetings:
Maritime Transportation System National Advisory Committee; Correction, 41089-41090 2020-14684 Port of Long Beach Pier B On-Dock Rail Support Facility Project, 41090-41092 2020-14716 Millenium Millennium Challenge Corporation NOTICES Charter Renewal: Advisory Council; Call for Nominations, 41066 2020-14662 Assesment National Assessment Governing Board NOTICES Meetings: National Assessment Governing Board, 41010-41011 2020-14702 National Highway National Highway Traffic Safety Administration RULES Safer Affordable Fuel-Efficient Vehicles Rule:
Model Years 2021-2026 Passenger Cars and Light Trucks; Correction, 40901-40906 2020-14642 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 41057-41060 2020-14608 2020-14705 2020-14706 2020-14709 National Cancer Institute, 41058-41059 2020-14609 National Center for Advancing Translational Sciences, 41059 2020-14707 National Institute of Biomedical Imaging and Bioengineering, 41059-41060 2020-14611 National Institute of Diabetes and Digestive and Kidney Diseases, 41057 2020-14708 National Institute on Alcohol Abuse and Alcoholism, 41058 2020-14610 Energy National Nuclear National Nuclear Security Administration NOTICES Proposed Subsequent Arrangement, 41026-41027 2020-14722 National Oceanic National Oceanic and Atmospheric Administration RULES Vessel Monitoring Systems:
Requirements for Type-Approval of Cellular Transceiver Units, 40915-40926 2020-14600 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Alaska Region Pacific Halibut Fisheries; Charter, 40990 2020-14676 Fisheries Greater Atlantic Region Gear Identification Requirements, 40992 2020-14683 Marine Recreational Fishing Expenditure Survey, 40990-40991 2020-14677 West Coast Region Vessel Monitoring System and Pre-Trip Reporting System Requirements, 40991 2020-14679 Endangered Species:
File Nos. 18238, 23639, and 23850, 40971 2020-14670 Meetings: New England Fishery Management Council; Correction, 40990 2020-14700 Takes of Marine Mammals Incidental to Specified Activities: Crowley Kotzebue Dock Upgrade Project in Kotzebue, AK, 40971-40990 2020-14628 Seattle Multimodal Project at Colman Dock in Washington State, 40992-41006 2020-14617 National Park National Park Service NOTICES Requests for Nominations: National Park Service Alaska Region Subsistence Resource Commission Program, 41063 2020-14596 National Science National Science Foundation NOTICES Meetings:
Advisory Committee for Mathematical and Physical Sciences, 41066-41067 2020-14672 National Telecommunications National Telecommunications and Information Administration NOTICES Establishment of the Communications Supply Chain Risk Information Partnership, 41006 2020-14725 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Use of Byproduct Material, 41070-41071 2020-14656 Design Limits, Loading Combinations, Materials, Construction and Testing of Concrete Containments, 41071-41072 2020-14645 Exemption:
Independent Spent Fuel Storage Installation; Yankee Atomic Electric Co., 41067-41070 2020-14651 Regulatory Guide: Leakage Tests on Packages for Shipment of Radioactive Material, 41072-41073 2020-14621 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Hazardous Materials: Applications for New Special Permits, 41092-41096 2020-14618 2020-14619 2020-14620 Presidential Documents Presidential Documents EXECUTIVE ORDERS Monuments to U.S. Heroes; Steps To Build and Rebuild (EO 13934), 41163-41168 2020-14872 Securities Securities and Exchange Commission NOTICES Applications:
Keystone Private Income Fund and Keystone National Group, LLC, 41073-41075 2020-14633 Order Granting Hearing and Scheduling Filing of Statements: Allianz Life Insurance Co. of North America, et al., 41087-41088 2020-14615 Self-Regulatory Organizations; Proposed Rule Changes: ICE Clear Europe, Ltd., 41082-41087 2020-14627 Miami International Securities Exchange, LLC, 41075-41082 2020-14629 2020-14630 2020-14631 Small Business Small Business Administration NOTICES Disaster Declaration:
Louisiana, 41088 2020-14593 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See Maritime Administration See National Highway Traffic Safety Administration See Pipeline and Hazardous Materials Safety Administration Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service NOTICES Interest Rate Paid on Cash Deposited To Secure U.S. Immigration and Customs Enforcement Immigration Bonds, 41097 2020-14602 Multiemployer Pension Plan Application To Reduce Benefits, 41096-41097 2020-14713 U.S.
Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Relief Under Former Section 212(c) of the Immigration and Nationality Act, 41061-41062 2020-14669 U.S. Institute United States Institute of Peace NOTICES Meetings: Board; Virtual, 41097 2020-14726 Separate Parts In This Issue Part II Environmental Protection Agency, 41100-41161 2020-05908 Part III Presidential Documents, 41163-41168 2020-14872 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. 85 131 Wednesday, July 8, 2020 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 66 [Document No. AMS-FTPP-19-0104] National Bioengineered Food Disclosure Standard; Guidance on Validation of a Refining Process and Selecting a Testing Method ACTION:
Notification of guidance. SUMMARY: The Agricultural Marketing Service
(AMS)of the Department of Agriculture
(USDA)posts final guidance to validate a refining process and selects a testing method as it pertains to the National Bioengineered Food Disclosure Standard (Standard). DATES: The guidance documents are available and effective July 7, 2020. ADDRESSES: The final guidance and accompanying question and answer documents can be found at *https://www.ams.usda.gov/rules-regulations/be.* FOR FURTHER INFORMATION CONTACT: Trevor Findley, Deputy Director, Food Disclosure and Labeling Division, Fair Trade Practices Program, Agricultural Marketing Service, U.S. Department of Agriculture, telephone
(202)690-3460, email *trevor.findley@usda.gov.* SUPPLEMENTARY INFORMATION: Background On July 29, 2016, Public Law 114-216 amended the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 *et seq.* ) (amended Act) to require USDA to establish a national, mandatory standard for disclosing any food that is or may be bioengineered. In accordance with the amended Act, USDA published final regulations to implement the Standard on December 21, 2018 (83 FR 65814). The regulations became effective on February 19, 2019, with a mandatory compliance date of January 1, 2022. Foods that do not contain detectable modified genetic material are not bioengineered foods and do not require disclosure under the Standard. Under the definition of *bioengineered food* at 7 CFR 66.1, food does not contain modified genetic material if the genetic material is not detectable pursuant to § 66.9. The recordkeeping requirements for detectability at 7 CFR 66.9 specify, among other things,
(1)the requirements to validate that a refining process renders modified genetic material in a food undetectable and
(2)standards of performance for detectability testing. A refining process is validated through analytical testing that meets the standards described in paragraph
(c)of 7 CFR 66.9. Paragraph
(c)requires that analytical testing meet the following standard:
(1)Laboratory quality assurance must ensure the validity and reliability of test results;
(2)analytical method selection, validation, and verification must ensure that the testing method used is appropriate (fit for purpose) and that the laboratory can successfully perform the testing;
(3)the demonstration of testing validity must ensure consistent accurate analytical performance; and
(4)method performance specifications must ensure analytical tests are sufficiently sensitive for the purposes of the detectability requirements of Part 66. In the preamble to the final regulations, USDA indicated that it would provide instructions to the industry to explain how they can ensure
(1)acceptable validation of refining processes in accordance with AMS standards and
(2)acceptable testing methodology used to satisfy that a food does not contain detectable modified genetic material (83 FR 65843). On December 17, 2019, AMS published a document in the **Federal Register** announcing the publication of a draft Instruction to Ensure Acceptable Validation of Refining Processes (84 FR 68816), with a comment period that closed on January 16, 2020. On January 23, 2020, in response to multiple requests for an extension of the comment period, AMS extended the comment period another 15 days (85 FR 3860). The new comment period closed on February 7, 2020. On February 3, 2020, AMS published a document in the **Federal Register** announcing publication of Draft Instructions on Testing Methods (85 FR 5927), with a comment period that closed on March 4, 2020. This document announces the publication of the final guidance to validate a refining process and to select an acceptable testing method. In addition to these two guidance documents, AMS is publishing two corresponding question and answer documents that respond to a number of questions and comments it received during the public comment periods. These four documents are available on the AMS bioengineered food disclosure website at *https://www.ams.usda.gov/rules-regulations/be.* These final instructions pertain to the requirements of the existing regulations, which can be found at *https://www.federalregister.gov/documents/2018/12/21/2018-27283/national-bioengineered-food-disclosure-standard.* Authority: 7 U.S.C. 1639. Bruce Summers, Administrator, Agricultural Marketing Service. [FR Doc. 2020-14643 Filed 7-7-20; 8:45 am]
Connectionstraces to 3
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  • 7 CFR 66
  • 7 CFR 66.1
  • 7 CFR 66.9
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Notification of guidance
Cite7 CFR 66
Cite7 CFR 66.1
Cite7 CFR 66.9
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