United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2015-11-26 article Part II Rules and Regulations D09002ee1c7f6d97c D09002ee1c7f6daa6 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is adopting a regulation on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The regulation requires importers to verify that food they import into the United States is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA). The regulation will help ensure the safety of imported food. 80 FR 74226 https://www.govinfo.gov/app/details/FR-2015-11-27/2015-28158 2015-28158 fr27no15-19 RIN 0910-AG64 4164-01-P Docket No. FDA-2011-N-0143 https://www.govinfo.gov/app/details/FR-2015-11-27/2015-28158 https://www.govinfo.gov/content/pkg/FR-2015-11-27/html/2015-28158.htm https://www.govinfo.gov/content/pkg/FR-2015-11-27/pdf/2015-28158.pdf Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements Administrative Practice and Procedure Computer Technology Dietary Foods Foods Packaging and Containers 127 p. 74226 74352 80 FR 74226 Title 21 Part 11 21 CFR Part 11 Title 21 Part 111 21 CFR Part 111 Title 21 Part 1 21 CFR Part 1 RIN 0910-AG64 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Federal Register Vol. 80, Issue RULE 2015-28158 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-01-26 Docket No. FDA-2011-N-0143 4164-01-P 2015-28158 Final rule.

The Food and Drug Administration (FDA) is adopting a regulation on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The regulation requires importers to verify that food they import into the United States is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA). The regulation will help ensure the safety of imported food.

This rule is effective January 26, 2016. For the applicable compliance dates, see "Effective and Compliance Dates" in the Supplementary Information section of this document. Brian Pendleton, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4614; or Domenic Veneziano, Office of Enforcement and Import Operations (ELEM-3108), Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, 301-796-6673. Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements Administrative Practice and Procedure Computer Technology Dietary Foods Foods Packaging and Containers Foreign Supplier Verification Programs for Importers of Food for Humans and Animals , http://codexalimentarius.org/download/standards/32/CXS_001e.pdf http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:165:0001:0141:EN:PDF http://fda.gov/food/internationalinteragencycoordination/ucm367400.htm http://www.codexalimentarius.net/download/standards/10075/CXG_047e.pdf http://www.codexalimentarius.org/download/standards/23/CXP_001e.pdf http://www.fas.org.sgp/crs/misc/R43358.pdf http://www.fda.gov http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM341440.pdf http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/UCM373333.pdf http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/RFR/ucm180761.htm http://www.fda.gov/food/internationalinteragencycoordination/ucm367400.htm http://www.fda.gov/fsvprule http://www.regulations.gov http://www.usp.org/food-ingredients/food-fraud-database http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.htm http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm www.regulations.gov Vol. 80, no. 228 Office of the Federal Register, National Archives and Records Administration 2015-11-27 continuing daily deposited born digital 740 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-11-27 P0b002ee18e039191 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr27no15 https://www.govinfo.gov/app/details/FR-2015-11-27 https://www.govinfo.gov/content/pkg/FR-2015-11-27/pdf/FR-2015-11-27.pdf https://www.govinfo.gov/content/pkg/FR-2015-11-27/xml/FR-2015-11-27.xml fdlp 73943 74672 DGPO 2015-11-26 2024-06-02 FR-2015-11-27 machine generated eng FR FR-2015-11-27 80 228