The Intentional Adulteration rule does not include exemptions for seafood, juice, LACF, or dietary supplements. The IA rule applies to the owner, operator or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act unless subject to an exemption (see 21 CFR 121.5). The rule requires covered facilities to prepare, or have prepared, and implement a written food defense plan that includes a written
1. Vulnerability assessment, including required explanations, to identify significant vulnerabilities and actionable process steps;
2. Mitigation strategies including required explanations;
3. Procedures for the food defense monitoring of the implementation of the mitigation strategies;
4. Procedures for food defense corrective actions; and
5. Procedures for food defense verification (see 21 CFR 121.126
