Establishing risk-based preventive controls enables you to apply a proactive and systematic approach to your food safety program through the establishment of preventive controls designed to protect your food, and the consumer, from biological, chemical (including radiological), and physical hazards. This document is directed to those persons (you) who are subject to the PCHF requirements of part 117. See 21 CFR 117.5 for a list and description of these exemptions. Part 117 includes several complete or partial exemptions from the PCHF requirements. The PCHF requirements implement the provisions of the FDA Food Safety Modernization Act (FSMA), established in section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Part 117 establishes requirements for current good manufacturing practice for human food (CGMPs), for hazard analysis and risk-based preventive controls for human food (PCHF), and related requirements. In 21 Code of Federal Regulations (CFR) part 117 (part 117), we have established our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food.” We published the final rule establishing part 117 in the Federal Register of Septem(80 FR 55908). Center for Food Safety and Applied Nutrition
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