Minds → Food Safety → What preventive controls must a facility identify and implement under 21 CFR 117.135? Answer in under 100 words.

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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.

Last verified: 2026-08-26 · Sources checked: 1/1 resolving · Next scheduled review: 2026-11-24

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 · as of 2026-08-26

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