---
title: "What preventive controls must a facility identify and implement under 21 CFR 117.135? Answer in under 100 words."
canonical: https://www.m-i-n-d.ai/minds/food-safety/preventive-controls-must-facility-identify-implement-under-21-cfr-117-135
jurisdiction: "US Federal · FDA"
last_verified: 2026-08-26
license: CC BY 4.0 — https://creativecommons.org/licenses/by/4.0/
attribution: "Source: MIND (m-i-n-d.ai)"
---

# What preventive controls must a facility identify and implement under 21 CFR 117.135? Answer in under 100 words.

Under 21 CFR 117.135, a facility must identify and implement preventive controls that significantly minimize or prevent hazards requiring a preventive control. These controls must be written and include, as appropriate, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan as specified in § 117.139.

## Details / How it works

Under 21 CFR 117.135, the owner, operator, or agent in charge of a food facility must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented. The food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w). Preventive controls must be written and include controls at critical control points (CCPs) and other controls appropriate for food safety.

## Numbers & thresholds

| Preventive Control Type | Required Components |
|-------------------------|---------------------|
| Process Controls | Parameters (e.g., heat processing, acidifying, irradiating, refrigerating) with maximum/minimum values to control hazards |
| Food Allergen Controls | Procedures to prevent allergen cross-contact and ensure proper labeling to avoid misbranding |
| Sanitation Controls | Procedures for cleanliness of food-contact surfaces and prevention of allergen cross-contact and cross-contamination |
| Supply-Chain Controls | Supply-chain program as required by subpart G |
| Recall Plan | Plan as required by § 117.139 |
| Other Controls | Additional procedures, practices, and processes (e.g., hygiene training, CGMPs) as necessary

## Exceptions & edge cases

Preventive controls are required only as appropriate to the facility and the food. The regulation specifies that controls must be identified and implemented to significantly minimize or prevent hazards requiring a preventive control, but does not mandate specific controls for every facility. Other controls may include hygiene training and other current good manufacturing practices as needed to satisfy the requirements.

## Sources

- [1] U.S. National Archives, Electronic Code of Federal Regulations — 21 CFR 117.135 — Preventive Controls · https://www.ecfr.gov/current/title-21/section-117.135 · as of 2026-08-26