Mitigation Strategies to Protect Food Against Intentional Adulteration
The FSMA "food defense" rule requiring registered food facilities to protect against intentional adulteration aimed at causing wide-scale public-health harm. Facilities must conduct a vulnerability assessment, identify actionable process steps, implement mitigation strategies, and maintain a written food-defense plan.
Registered domestic and foreign food facilities — protection of food against intentional adulteration intended to cause wide-scale harm.
- 01Conduct a vulnerability assessment to identify actionable process steps
- 02Implement and monitor mitigation strategies at those steps
- 03Prepare and maintain a written food-defense plan
- 04Train personnel and keep food-defense records
Finalised under FSMA in 2016 with compliance dates from 2019; the first US regulation mandating food-defense planning.
21 CFR Part 121: frequently asked questions
Quick answers to common questions about 21 CFR Part 121.
What is 21 CFR Part 121?
21 CFR Part 121 — Mitigation Strategies to Protect Food Against Intentional Adulteration — is a regulation issued by the Food and Drug Administration (United States). The FSMA "food defense" rule requiring registered food facilities to protect against intentional adulteration aimed at causing wide-scale public-health harm. Facilities must conduct a vulnerability assessment, identify actionable process steps, implement mitigation strategies, and maintain a written food-defense plan.
Who does 21 CFR Part 121 apply to?
Registered domestic and foreign food facilities — protection of food against intentional adulteration intended to cause wide-scale harm.
What are the key requirements of 21 CFR Part 121?
FDA 21 CFR Part 121 requires, among other things: Conduct a vulnerability assessment to identify actionable process steps; Implement and monitor mitigation strategies at those steps; Prepare and maintain a written food-defense plan; Train personnel and keep food-defense records.
When was 21 CFR Part 121 last updated?
The current version of 21 CFR Part 121 dates from July 2016. Finalised under FSMA in 2016 with compliance dates from 2019; the first US regulation mandating food-defense planning.
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When 21 CFR Part 121 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.