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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: 21CFR121.4]



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 A - General Provisions

Sec. 121.4 Qualifications of individuals who perform activities under subpart C of this part.

(a) Applicability. You must ensure that each individual who performs activities required under subpart C of this part is a qualified individual as that term is defined in § 121.3.

(b) Qualifications of individuals assigned to an actionable process step. Each individual assigned to an actionable process step (including temporary and seasonal personnel) or in the supervision thereof must:

(1) Be a qualified individual as that term is defined in § 121.3 - i.e., have the appropriate education, training, or experience (or a combination thereof) necessary to properly implement the mitigation strategy or combination of mitigation strategies at the actionable process step; and

(2) Receive training in food defense awareness.

(c) Qualifications of individuals for certain activities described in paragraph (c)(3) of this section. Each individual assigned to certain activities described in paragraph (c)(3) of this section must:

(1) Be a qualified individual as that term is defined in § 121.3 - i.e., have the appropriate education, training, or experience (or a combination thereof) necessary to properly perform the activities; and

(2) Have successfully completed training for the specific function at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum. This individual may be, but is not required to be, an employee of the facility.

(3) One or more qualified individuals must do or oversee:

(i) The preparation of the food defense plan as required in § 121.126;

(ii) The conduct of a vulnerability assessment as required in § 121.130;

(iii) The identification and explanation of the mitigation strategies as required in § 121.135; and

(iv) Reanalysis as required in § 121.157.

(d) Additional qualifications of supervisory personnel. Responsibility for ensuring compliance by individuals with the requirements of this part must be clearly assigned to supervisory personnel with a combination of education, training, and experience necessary to supervise the activities under this subpart.

(e) Records. Training required by paragraphs (b)(2) and (c)(2) of this section must be documented in records, and must:

(1) Include the date of training, the type of training, and the persons trained; and

(2) Be established and maintained in accordance with the requirements of subpart D of this part.

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