21 CFR 117.136 - Circumstances in Which a Preventive Control Is Not Required

What it says

Where a facility identifies a hazard requiring a preventive control but the food will be processed further by another party that will control the hazard, section 117.136 sets out the circumstances in which the facility does not need to apply its own control. The facility must disclose in documents that accompany the food, in line with the practice of the trade, that the food is not processed to control the identified hazard, and must obtain written assurance from the customer, renewed annually, about how the hazard will be controlled.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision lets a facility rely on a downstream customer to control a hazard, but only in the specific circumstances the rule lists and only with the right documentation.
• The disclosure has to travel with the food, for example on labels or accompanying documents, so shipping and labeling procedures need to include it.
• The written assurance from the customer is not a one-time document. It has to be renewed every year, which makes it a recurring task in customer management.

What FDA inspectors look for

• Whether the facility can show which hazards it passes on to customers and which circumstance it relies on in each case.
• Whether the required disclosure appears on the documents that accompany the food.
• Whether a current written assurance is on file for each customer the facility relies on.

Related regulations