21 CFR § 121.135 - Mitigation strategies for actionable process steps.

---
identifier: "/us/cfr/t21/s121.135"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 121.135 - Mitigation strategies for actionable process steps."
title_number: 21
title_name: "Food and Drugs"
section_number: "121.135"
section_name: "Mitigation strategies for actionable process steps."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "121"
part_name: "MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 342, 350g, 350(i), 371, 374."
regulatory_source: "81 FR 34219, May 27, 2016, unless otherwise noted."
cfr_part: "121"
---


# 121.135 Mitigation strategies for actionable process steps.

(a) You must identify and implement mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act. For each mitigation strategy implemented at each actionable process step, you must include a written explanation of how the mitigation strategy sufficiently minimizes or prevents the significant vulnerability associated with the actionable process step.

(b) Mitigation strategies and accompanying explanations must be written.