The Food Defense Plan is required as part of FSMA.
The rule requires a written food defense plan for all covered facilities unless an exemption applies (21 CFR 121.5). The written plan must include (21 CFR 121.126):
- 1. A vulnerability assessment to identify significant vulnerabilities and actionable process steps, and associated explanations
- Mitigation strategies and associated explanations
- Procedures for food defense monitoring
- Procedures for food defense corrective actions
- Procedures for food defense verification
- The rule requires training for certain personnel. See “EDUCATION, TRAINING, AND QUALIFICATIONS” section (21 CFR 121.4)
- The rule requires covered facilities to maintain the food defense plan as a record as well as records for training, food defense monitoring, food defense corrective actions, and food defense verification. (21 CFR 121.126(c), 121.140(c), 121.145(b), and 121.150(c))
- The rule requires reanalysis of the food defense plan. (21 CFR 121.157)
For most companies, the compliance date is July of 2019. Smaller companies have more time.
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