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
For most companies, the compliance date is July of 2019. Smaller companies have more time.