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 2013_register executive 2013-07-27 article Part III Proposed Rules D09002ee1c7fb30b2 D09002ee1c7fb31a1 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 proposing to adopt regulations on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections 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 proposing these regulations in accordance with the FDA Food Safety Modernization Act (FSMA). The proposed regulations would help ensure that imported food is produced in a manner consistent with U.S. standards. 78 FR 45730 https://www.govinfo.gov/app/details/FR-2013-07-29/2013-17993 2013-17993 fr29jy13-21 RIN 0910-AG64 4160-01-P Docket No. FDA-2011-N-0143 https://www.govinfo.gov/app/details/FR-2013-07-29/2013-17993 https://www.govinfo.gov/content/pkg/FR-2013-07-29/html/2013-17993.htm https://www.govinfo.gov/content/pkg/FR-2013-07-29/pdf/2013-17993.pdf Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements 50 p. 45730 45779 78 FR 45730 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. 78, Issue PRORULE 2013-17993 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2013-11-26 Docket No. FDA-2011-N-0143 4160-01-P 2013-17993 Proposed rule.

The Food and Drug Administration (FDA) is proposing to adopt regulations on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections 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 proposing these regulations in accordance with the FDA Food Safety Modernization Act (FSMA). The proposed regulations would help ensure that imported food is produced in a manner consistent with U.S. standards.

Submit either electronic or written comments on the proposed rule by November 26, 2013. 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 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals , oira_submission@omb.eop.gov http://ec.europa.eu/world/agreements/downloadFile.do?fullText=yes&treatyTransId=751 http://gmaonline.org/downloads/technical-guidance-and-tools/GMA_SupplyChain2.pdf http://www.cdc.gov/outbreaknet/outbreaks.html http://www.codexalimentarius.net/download/standards/10075/CXG_047e.pdf http://www.codexalimentarius.net/download/standards/23/CXP_001e.pdf http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm315486.htm http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006801.htm http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm331276.htm http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm243781.htm http://www.gao.gov/new.items/d11286.pdf http://www.mygfsi.com/gfsifiles/Overview_GFSI_Guidance_Document_Sixth_Edition_Version_6.2.pdf http://www.regulations.gov http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/t/G/SPS/NUSA2156.DOC Vol. 78, no. 145 Office of the Federal Register, National Archives and Records Administration 2013-07-29 continuing daily deposited born digital 409 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-07-29 P0b002ee185b0d119 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr29jy13 https://www.govinfo.gov/app/details/FR-2013-07-29 https://www.govinfo.gov/content/pkg/FR-2013-07-29/pdf/FR-2013-07-29.pdf https://www.govinfo.gov/content/pkg/FR-2013-07-29/xml/FR-2013-07-29.xml fdlp 45441 45839 DGPO 2013-07-27 2024-06-03 FR-2013-07-29 machine generated eng FR FR-2013-07-29 78 145