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 2015-10-15 article Part III Rules and Regulations D09002ee1c7f71eae D09002ee1c7f71f66 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 or we) is adding regulations for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. These regulations will, for the first time, establish requirements for the current good manufacturing practice (CGMP) for food for animals. In addition, we are adding requirements for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. We are taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to humans and animals and to implement new statutory provisions in the FDA Food Safety Modernization Act (FSMA). The rule is intended to build an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system. 80 FR 56170 https://www.govinfo.gov/app/details/FR-2015-09-17/2015-21921 2015-21921 fr17se15-20 RIN 0910-AG10 4164-01-P Docket No. FDA-2011-N-0922 https://www.govinfo.gov/app/details/FR-2015-09-17/2015-21921 https://www.govinfo.gov/content/pkg/FR-2015-09-17/html/2015-21921.htm https://www.govinfo.gov/content/pkg/FR-2015-09-17/pdf/2015-21921.pdf Administrative Practice and Procedure Computer Technology Reporting and Recordkeeping Requirements Food Packaging Foods Animal Drugs Animal Feeds Cancer Labeling Packaging and Containers Polychlorinated Biphenyls (Pcb's) Animal Foods Radiation Protection 187 p. 56170 56356 80 FR 56170 Title 21 Part 117 21 CFR Part 117 Title 21 Part 11 21 CFR Part 11 Title 21 Part 16 21 CFR Part 16 Title 21 Part 500 21 CFR Part 500 Title 21 Part 507 21 CFR Part 507 Title 21 Part 579 21 CFR Part 579 RIN 0910-AG10 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Federal Register Vol. 80, Issue RULE 2015-21921 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2015-11-16 Docket No. FDA-2011-N-0922 4164-01-P 2015-21921 Final rule.

The Food and Drug Administration (FDA or we) is adding regulations for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. These regulations will, for the first time, establish requirements for the current good manufacturing practice (CGMP) for food for animals. In addition, we are adding requirements for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. We are taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to humans and animals and to implement new statutory provisions in the FDA Food Safety Modernization Act (FSMA). The rule is intended to build an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system.

This rule is effective November 16, 2015, except for paragraph (2) of the definition of "qualified auditor" in Sec. 507.3, and Sec. Sec. 507.12(a)(1)(ii), 507.105(a)(2), 507.105(c), 507.110(d)(2)(ii), 507.130(d), 507.135(d), 507.175(c)(2), and 507.175(c)(13). FDA will publish a document in the Federal Register announcing the effective dates of paragraph (2) of the definition of "qualified auditor" in Sec. 507.3, Sec. Sec. 507.12(a)(1)(ii), 507.105(a)(2), 507.105(c), 507.110(d)(2)(ii), 507.130(d), 507.135(d), 507.175(c)(2), and 507.175(c)(13). Certain provisions have later compliance dates as discussed in section LIII "Effective and Compliance Dates." Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246, email: jenny.murphy@fda.hhs.gov. Administrative Practice and Procedure Computer Technology Reporting and Recordkeeping Requirements Food Packaging Foods Animal Drugs Animal Feeds Cancer Labeling Packaging and Containers Polychlorinated Biphenyls (Pcb's) Animal Foods Radiation Protection Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals , jenny.murphy@fda.hhs.gov Dictionary.com ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_23e.pdf http://dictionary.reference.com/browse/solely http://ndb.nal.usda.gov/ http://www.codexalimentarius.org/input/download/standards/11022/CXG_069e.pdf http://www.fao.org/docrep/012/i1379e/i1379e00.htm http://www.fda.gov http://www.fda.gov/ http://www.fda.gov/aboutfda/centersoffices/officeoffoods/cfsan/cfsanfoiaelectronicreadingroom/ucm329370.htm http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/default.htm2015 http://www.fda.gov/downloads/Food/ComplianceEnforcement/RFR/UCM349856.pdf http://www.fda.gov/downloads/Food/ComplianceEnforcement/RFR/UCM395684.pdf http://www.fda.gov/downloads/Food/ComplianceEnforcement/UCM291297.pdf http://www.fda.gov/downloads/Food/ComplianceEnforcement/UCM301013.pdf http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM436593.pdf http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM213214.pdf http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/UCM373333.pdf http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/CurrentGoodManufacturingPracticesCGMPs/ucm207458.htm http://www.fda.gov/food/guidanceregulation/fsma/ucm284406.htm http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm http://www.fda.gov/food/guidanceregulation/fsma/ucm432576.htm http://www.fda.gov/Food/GuidanceRegulation/FSMA/UCM436592.pdf http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/RFR/ucm180761.htm http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/salmonella/ucm295271.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm445428.htm http://www.fda.gov/Food/InternationalInteragencyCoordination/ucm367400.htm http://www.fda.gov/food/newsevents/constituentupdates/ucm430492.htm http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm http://www.fda.gov/furls http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074693.htm http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074694.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm http://www.fda.gov/pcafrule http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2010/ucm214996.htm http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm http://www.fda.gov/Safety/Recalls/ucm266082.htm http://www.fda.gov/safety/recalls/ucm312988.htm http://www.fda.gov/Safety/Recalls/ucm333676.htm http://www.fda.gov/Safety/Recalls/ucm397362.htm http://www.fda.gov/Safety/Recalls/ucm399978.htm http://www.fda.gov/Safety/Recalls/ucm403829.htm http://www.fda.gov/Safety/Recalls/ucm424607.htm http://www.fda.gov/Safety/Recalls/ucm431432.htm http://www.fda.gov/Safety/Recalls/ucm438183.htm http://www.fda.gov/Safety/Recalls/ucm449841.htm http://www.fsis.usda.gov/shared/PDF/HACCP_Systems_Validation.pdf http://www.merriam-webster.com/dictionary/include http://www.mygfsi.com/images/mygfsi/gfsifiles/gfsi_guidance/GFSI_Guidance_Document_Over.pdf http://www.regulations.gov https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_48 https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.pdf https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm Merriam-Webster.com Vol. 80, no. 180 Office of the Federal Register, National Archives and Records Administration 2015-09-17 continuing daily deposited born digital 659 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-09-17 P0b002ee18dbb04ce 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr17se15 https://www.govinfo.gov/app/details/FR-2015-09-17 https://www.govinfo.gov/content/pkg/FR-2015-09-17/pdf/FR-2015-09-17.pdf https://www.govinfo.gov/content/pkg/FR-2015-09-17/xml/FR-2015-09-17.xml fdlp 55715 56364 DGPO 2015-10-15 2024-06-02 FR-2015-09-17 machine generated eng FR FR-2015-09-17 80 180