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e-CFR data is current as of March 5, 2021

Title 21Chapter ISubchapter BPart 121Subpart C → §121.140


Title 21: Food and Drugs
PART 121—MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION
Subpart C—Food Defense Measures


§121.140   Food defense monitoring.

As appropriate to the nature of the mitigation strategy and its role in the facility's food defense system:

(a) Written procedures. You must establish and implement written procedures, including the frequency with which they are to be performed, for food defense monitoring of the mitigation strategies.

(b) Food defense monitoring. You must monitor the mitigation strategies with adequate frequency to provide assurances that they are consistently performed.

(c) Records—(1) Requirement to document food defense monitoring. You must document the monitoring of mitigation strategies in accordance with this section in records that are subject to verification in accordance with §121.150(a)(1) and records review in accordance with §121.150(a)(3)(i).

(2) Exception records. Records may be affirmative records demonstrating the mitigation strategy is functioning as intended. Exception records demonstrating the mitigation strategy is not functioning as intended may be adequate in some circumstances.

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