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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: 21CFR121.140]



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. 121.140 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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