“Unexposed packaged food” means packaged food that is not exposed to the environment (see 21 CFR § 117.3). A food does not have to be packaged for a retail consumer (e.g., boxes of crackers or packages of chips) to be an unexposed packaged food. For example, an ingredient that will be used as a direct additive in food may be packaged in such a way that it meets the definition of “unexposed packaged food.” Unexposed packaged food is protected from outside bacteria by its packaging. See also the discussion in Response 170 regarding produce packed in “vented crates,” which is not “unexposed packaged food.” (See Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, Response 170; 80 Fed. Reg. 55908 at 55970 (CGMP & PC Rule)).
