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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 Jul 20, 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: 21CFR112.150]



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

PART 112 -- STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

Subpart M - Sprouts

Sec. 112.150 Under this subpart, what requirements apply regarding records?

(a) You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part.

(b) You must establish and keep the following records:

(1) Documentation of your treatment of seeds or beans to reduce microorganisms of public health significance in the seeds or beans, at your farm; or alternatively, documentation (such as a Certificate of Conformance) from your seed supplier that seeds or beans are treated to reduce microorganisms of public health significance and are appropriately handled and packaged following the treatment, in accordance with the requirements of § 112.142(e);

(2) Your written environmental monitoring plan in accordance with the requirements of § 112.145;

(3) Your written sampling plan for each production batch of sprouts in accordance with the requirements of § 112.147(a) and (c);

(4) Documentation of the results of all analytical tests conducted for purposes of compliance with this subpart;

(5) Any analytical methods you use in lieu of the methods that are incorporated by reference in §§ 112.152 and 112.153; and

(6) Documentation of actions you take in accordance with §§ 112.142(b) and (c), 112.146, and 112.148.

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