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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: 21CFR121.126]



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. 121.126 Food defense plan.

(a) Requirement for a food defense plan. You must prepare, or have prepared, and implement a written food defense plan.

(b) Contents of a food defense plan. The written food defense plan must include:

(1) The written vulnerability assessment, including required explanations, to identify significant vulnerabilities and actionable process steps as required by § 121.130(c);

(2) The written mitigation strategies, including required explanations, as required by § 121.135(b);

(3) The written procedures for the food defense monitoring of the implementation of the mitigation strategies as required by § 121.140(a);

(4) The written procedures for food defense corrective actions as required by § 121.145(a)(1); and

(5) The written procedures for food defense verification as required by § 121.150(b).

(c) Records. The food defense plan required by this section is a record that is subject to the requirements of subpart D of this part.

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