21CFR117美国食品良好生产规范、危害分析和基于风险的

Vol. 80No. 180Part IIThursday,September 17, 2024Department of Health and Human ServicesFood and Drug Administration21 CFR Parts 1, 11, 16, 106, 110,et al.Current Good Manufacturing Practice, Hazard Analysis, and Risk-BasedPreventive Controls for Human Food; Final RuleVerDate Sep<11>202417:48 Sep 16, 2024Jkt 235001PO 00000Frm 00001Fmt 4717Sfmt 4717E:\FR\FM\17SER2.SGM17SER2 tkelley on DSK3SPTVN1PROD with RULES255908Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2024 / Rules and RegulationsDEPARTMENT OF HEALTH ANDHUMAN SERVICESFood and Drug Administration21 CFR Parts 1, 11, 16, 106, 110, 114,117, 120, 123, 129, 179, and 211[Docket No. FDA–2024–N–0920]Current Good Manufacturing Practice,Hazard Analysis, and Risk-BasedPreventive Controls for Human FoodAGENCY: Food and Drug Administration,HHS.ACTION: Final rule.SUMMARY: The Food and DrugAdministration (FDA or we) isamending our regulation for CurrentGood Manufacturing Practice InManufacturing, Packing, or HoldingHuman Food in two fundamental ways.First, we are modernizing the long-standing current good manufacturingpractice requirements. Second, we areadding requirements for domestic andforeign facilities that are subject to ourregulation for Registration of FoodFacilities to establish and implementhazard analysis and risk-basedpreventive controls for human food. Wealso are revising certain definitions inour regulation for Registration of FoodFacilities to clarify the scope of theexemption from registrationrequirements provided for ‘‘farms’’ and,in so doing, to clarify which domesticand foreign facilities are subject to therequirements for hazard analysis andrisk-based preventive controls forhuman food. We are taking this actionas part of our announced initiative torevisit the curren...