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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 29, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 2]
[CITE: 21CFR121.150]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION

PART 121 -- MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION

Subpart C - Food Defense Measures

Sec. 121.150 Food defense verification.

(a) Food defense verification activities. Food defense verification activities must include, as appropriate to the nature of the mitigation strategy and its role in the facility's food defense system:

(1) Verification that food defense monitoring is being conducted as required by § 121.138 (and in accordance with § 121.140);

(2) Verification that appropriate decisions about food defense corrective actions are being made as required by § 121.138 (and in accordance with § 121.145);

(3) Verification that mitigation strategies are properly implemented and are significantly minimizing or preventing the significant vulnerabilities. To do so, you must conduct activities that include the following, as appropriate to the facility, the food, and the nature of the mitigation strategy and its role in the facility's food defense system:

(i) Review of the food defense monitoring and food defense corrective actions records within appropriate timeframes to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food defense plan, the mitigation strategies are properly implemented, and appropriate decisions were made about food defense corrective actions; and

(ii) Other activities appropriate for verification of proper implementation of mitigation strategies; and

(4) Verification of reanalysis in accordance with § 121.157.

(b) Written procedures. You must establish and implement written procedures, including the frequency for which they are to be performed, for verification activities conducted according to § 121.150(a)(3)(ii).

(c) Documentation. All verification activities conducted in accordance with this section must be documented in records.

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