The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117; 80 Fed. Reg. 55908) (CGMP & PC rule) creates requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. In general, if a facility manufactures, processes, packs, or holds food for human consumption in the United States and has to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic Act (see 21 CFR Part 1, subpart H), the facility is subject to the preventive controls requirements in the CGMP & PC rule, unless subject to an exemption. Note that an establishment may also be subject to the Current Good Manufacturing Practice (CGMP) requirements in subpart B; those requirements are not dependent on whether a facility is required to register.
Subparts C (Requirements for Hazard Analysis and Risk-Based Preventive Controls) and G (Requirements for a Supply-Chain Program) of CGMP & PC rule do not apply to a facility solely engaged in the storage of unexposed packaged food (see 21 CFR § 117.7(a)).
To qualify for the exemption, the facility storing the unexposed packaged food must be solely engaged in the storage of unexposed packaged food. For example, the exemption in § 117.7 would not apply to a facility that stores but also processes food (see CGMP & PC rule, Response 212; 80 Fed. Reg. 55908 at 55985). Also note that unexposed packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens is subject to the modified requirements in 21 CFR § 117.206.
