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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: 21CFR112.50]



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 E - Agricultural Water

Sec. 112.50 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) The findings of the inspection of your agricultural water system in accordance with the requirements of § 112.42(a);

(2) Documentation of the results of all analytical tests conducted on agricultural water for purposes of compliance with this subpart;

(3) Scientific data or information you rely on to support the adequacy of a method used to satisfy the requirements of § 112.43(a)(1) and (2);

(4) Documentation of the results of water treatment monitoring under § 112.43(b);

(5) Scientific data or information you rely on to support the microbial die-off or removal rate(s) that you used to determine the time interval (in days) between harvest and end of storage, including other activities such as commercial washing, as applicable, used to achieve the calculated log reduction of generic Escherichia coli (E. coli ), in accordance with § 112.45(b)(1)(ii);

(6) Documentation of actions you take in accordance with § 112.45. With respect to any time interval or (calculated) log reduction applied in accordance with § 112.45(b)(1)(i) and/or (ii), such documentation must include the specific time interval or log reduction applied, how the time interval or log reduction was determined, and the dates of corresponding activities such as the dates of last irrigation and harvest, the dates of harvest and end of storage, and/or the dates of activities such as commercial washing);

(7) Annual documentation of the results or certificates of compliance from a public water system required under § 112.46(a)(1) or (2), if applicable;

(8) Scientific data or information you rely on to support any alternative that you establish and use in accordance with § 112.49; and

(9) Any analytical methods you use in lieu of the method that is incorporated by reference in § 112.151(a).

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