The overall framework of section 418 of the FD&C Act is directed to a facility. For example, section 418(b) of the FD&C Act provides in part that “[t]he owner, operator, or agent in charge of a facility must identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility” (emphasis added) (see the discussion of the facility-based nature of the food safety plan in the 2013 proposed rule; 78 Fed. Reg. 3646 at 3732). Thus, the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117; 80 Fed. Reg. 55908) establishes a requirement for every facility to have its own written food safety plan (see 21 CFR § 117.126). Even if a corporation makes or holds similar products at separate facilities, it is unlikely that the separate facilities have exactly the same equipment and layout. Procedural instructions must be tailored to the equipment being used, and the layout of a facility including processing lines, technologies, and raw materials utilized as they will affect the approach to applying preventive controls such as allergen controls (see CGMP & PC rule, Comment/Response 371).
