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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: 21CFR112.147]



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. 112.147 What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens?

All of the following requirements apply for collecting and testing samples of spent sprout irrigation water or sprouts for pathogens as required in § 112.144(b):

(a) You must establish and implement a written sampling plan that identifies the number and location of samples (of spent sprout irrigation water or sprouts) to be collected for each production batch of sprouts to ensure that the collected samples are representative of the production batch when testing for contamination.

(b) In accordance with the written sampling plan required under paragraph (a) of this section, you must aseptically collect samples of spent sprout irrigation water or sprouts, and test the collected samples for pathogens using a method as set forth in § 112.153. You must not allow the production batch of sprouts to enter into commerce unless the results of the testing of spent sprout irrigation water or sprouts are negative for E. coli O157:H7, Salmonella species, and, if applicable, a pathogen meeting the criteria in § 112.144(c).

(c) Your written sampling plan must include a corrective action plan that at a minimum, requires you to take the actions in § 112.148, and details when and how you will accomplish those actions, if the samples of spent sprout irrigation water or sprouts test positive for E. coli O157:H7, Salmonella species, or a pathogen meeting the criteria in § 112.144(c).

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