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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]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
 
PART 112STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
 

Subpart M - Sprouts

Sec. 112.141 What commodities are subject to this subpart?

The requirements of this subpart apply to growing, harvesting, packing, and holding of all sprouts, except soil- or substrate-grown sprouts harvested without their roots.

Sec. 112.142 What requirements apply to seeds or beans used to grow sprouts?

In addition to the requirements of this part, all of the following requirements apply to seeds or beans used to grow sprouts.

(a) You must take measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into or onto seeds or beans that you will use for sprouting.

(b) Except as provided in paragraph (c) of this section, if you know or have reason to believe that a lot of seeds or beans may be contaminated with a pathogen (either because it has been associated with foodborne illness; or based on microbial test results, including a positive finding of a pathogen in tests required under § 112.144(b)), you must:

(1) Discontinue use of all seeds or beans from that lot for sprout production and ensure that sprouts grown from that lot of seeds or beans do not enter commerce; and

(2) Report the information (association with illness and/or findings of microbial testing) to the seed grower, distributor, supplier, or other entity from whom you received the seeds or beans.

(c) If your reason to believe that a lot of seeds or beans may be contaminated was based only on microbial test results:

(1) You are not required to take the steps set forth in paragraph (b)(1) of this section if you treat your lot of seeds or beans with a process that is reasonably certain to achieve destruction or elimination in the seeds or beans of the most resistant microorganisms of public health significance that are likely to occur in the seeds or beans; or

(2) You are not required to take the steps set forth in paragraphs (b)(1) and (2) of this section if you later reasonably determine, through appropriate followup actions, that the lot of seeds or beans is not the source of contamination (e.g., the lot of seeds or beans is not the source of a pathogen found in spent sprout irrigation water or sprouts).

(d) You must visually examine seeds and beans, and packaging used to ship seeds or beans, for signs of potential contamination with known or reasonably foreseeable hazards.

(e) You must either:

(1) Treat seeds or beans that will be used to grow sprouts using a scientifically valid method to reduce microorganisms of public health significance; or

(2) Rely on prior treatment of seeds or beans conducted by a grower, distributor, or supplier of the seeds or beans (whether to fulfill this requirement completely or for the purpose of considering such prior treatment when applying appropriate additional treatment of the seeds or beans at the covered farm immediately before sprouting), provided that you obtain documentation (such as a Certificate of Conformance) from the grower, distributor, or supplier that:

(i) The prior treatment was conducted using a scientifically valid method to reduce microorganisms of public health significance; and

(ii) The treated seeds or beans were handled and packaged following the treatment in a manner that minimizes the potential for contamination.

Sec. 112.143 What measures must I take for growing, harvesting, packing, and holding sprouts?

You must take all of the following measures for growing, harvesting, packing, and holding sprouts:

(a) You must grow, harvest, pack, and hold sprouts in a fully-enclosed building.

(b) Any food contact surfaces you use to grow, harvest, pack, or hold sprouts must be cleaned and sanitized before contact with sprouts or seeds or beans used to grow sprouts.

(c) You must conduct testing during growing, harvesting, packing, and holding sprouts, as specified in § 112.144.

(d) You must establish and implement a written environmental monitoring plan as specified in § 112.145.

(e) You must take certain actions if you detect Listeria species or L. monocytogenes in the growing, harvesting, packing, or holding environment, as specified in § 112.146.

(f) You must establish and implement a written sampling plan to test spent sprout irrigation water or sprouts for pathogens as specified in § 112.147.

(g) You must take certain actions if the samples of spent sprout irrigation water or sprouts test positive for a pathogen as specified in § 112.148.

Sec. 112.144 What testing must I do during growing, harvesting, packing, and holding sprouts?

All of the following testing must be done during growing, harvesting, packing, and holding sprouts:

(a) You must test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes in accordance with the requirements of § 112.145.

(b) You must either:

(1) Test spent sprout irrigation water from each production batch of sprouts for E. coli O157:H7, Salmonella species, and any pathogens meeting the criteria in paragraph (c) of this section, in accordance with the requirements of § 112.147; or

(2) If testing spent sprout irrigation water is not practicable (for example, soil-grown sprouts harvested with roots or for hydroponically grown sprouts that use very little water), test each production batch of sprouts at the in-process stage (i.e., while sprouts are still growing) for E. coli O157:H7, Salmonella species, and any pathogens meeting the criteria in paragraph (c) of this section, in accordance with the requirements of § 112.147.

(c) In addition to E. coli O157:H7 and Salmonella species, you must conduct tests as provided in paragraph (b) of this section for additional pathogens when the following conditions are met:

(1) Testing for the pathogen is reasonably necessary to minimize the risk of serious adverse health consequences or death from use of, or exposure to, sprouts; and

(2) A scientifically valid test method for the pathogen is available to detect the pathogen in spent sprout irrigation water (or sprouts).

Sec. 112.145 What requirements apply to testing the environment for Listeria species or L. monocytogenes?

All of the following testing requirements apply for the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes.

(a) You must establish and implement a written environmental monitoring plan that is designed to identify L. monocytogenes if it is present in the growing, harvesting, packing, or holding environment.

(b) Your written environmental monitoring plan must be directed to sampling and testing for either Listeria species or L. monocytogenes.

(c) Your written environmental monitoring plan must include a sampling plan that specifies:

(1) What you will test collected samples for (i.e., Listeria species or L. monocytogenes );

(2) How often you will collect environmental samples, which must be no less than monthly, and at what point during production you will collect the samples; and

(3) Sample collection sites; the number and location of sampling sites must be sufficient to determine whether measures are effective and must include appropriate food contact surfaces and non-food-contact surfaces of equipment, and other surfaces within the growing, harvesting, packing, and holding environment.

(d) You must aseptically collect environmental samples and test them for Listeria species or L. monocytogenes using a method as set forth in § 112.152.

(e) Your written environmental monitoring plan must include a corrective action plan that, at a minimum, requires you to take the actions in § 112.146, and details when and how you will accomplish those actions, if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes.

Sec. 112.146 What actions must I take if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes?

You must, at a minimum, take the following actions if you detect Listeria species or L. monocytogenes in the growing, harvesting, packing, or holding environment:

(a) Conduct additional testing of surfaces and areas surrounding the area where Listeria species or L. monocytogenes was detected to evaluate the extent of the problem, including the potential for Listeria species or L. monocytogenes to have become established in a niche;

(b) Clean and sanitize the affected surfaces and surrounding areas;

(c) Conduct additional sampling and testing to determine whether the Listeria species or L. monocytogenes has been eliminated;

(d) Conduct finished product testing when appropriate;

(e) Perform any other actions necessary to prevent recurrence of the contamination; and

(f) Take appropriate action to prevent any food that is adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act from entering into commerce.

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).

Sec. 112.148 What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen?

You must, at a minimum, take the following 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):

(a) Take appropriate action to prevent any food that is adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act from entering into commerce;

(b) Take the steps required in § 112.142(b) with respect to the lot of seeds or beans used to grow the affected production batch of sprouts (except as allowed under § 112.142(c));

(c) Clean and sanitize the affected surfaces and surrounding areas; and

(d) Perform any other actions necessary to prevent reoccurrence of the contamination.

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.

Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.
Source: 80 FR 74547, Nov. 27, 2015, unless otherwise noted.

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