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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 April 1 2020.

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2020]
[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 E - Agricultural Water

Sec. 112.41 What requirements apply to the quality of agricultural water?

All agricultural water must be safe and of adequate sanitary quality for its intended use.

Sec. 112.42 What requirements apply to my agricultural water sources, water distribution system, and pooling of water?

(a) At the beginning of a growing season, as appropriate, but at least once annually, you must inspect all of your agricultural water systems, to the extent they are under your control (including water sources, water distribution systems, facilities, and equipment), to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces in light of your covered produce, practices, and conditions, including consideration of the following:

(1) The nature of each agricultural water source (for example, ground water or surface water);

(2) The extent of your control over each agricultural water source;

(3) The degree of protection of each agricultural water source;

(4) Use of adjacent and nearby land; and

(5) The likelihood of introduction of known or reasonably foreseeable hazards to agricultural water by another user of agricultural water before the water reaches your covered farm.

(b) You must adequately maintain all agricultural water distribution systems to the extent they are under your control as necessary and appropriate to prevent the water distribution system from being a source of contamination to covered produce, food contact surfaces, areas used for a covered activity, or water sources, including by regularly inspecting and adequately storing all equipment used in the system.

(c) You must adequately maintain all agricultural water sources to the extent they are under your control (such as wells). Such maintenance includes regularly inspecting each source to identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces; correcting any significant deficiencies (e.g., repairs to well cap, well casing, sanitary seals, piping tanks and treatment equipment, and control of cross-connections); and keeping the source free of debris, trash, domesticated animals, and other possible sources of contamination of covered produce to the extent practicable and appropriate under the circumstances.

(d) As necessary and appropriate, you must implement measures reasonably necessary to reduce the potential for contamination of covered produce with known or reasonably foreseeable hazards as a result of contact of covered produce with pooled water. For example, such measures may include using protective barriers or staking to keep covered produce from touching the ground or using an alternative irrigation method.

Sec. 112.43 What requirements apply to treating agricultural water?

(a) When agricultural water is treated in accordance with § 112.45:

(1) Any method you use to treat agricultural water (such as with physical treatment, including using a pesticide device as defined by the U.S. Environmental Protection Agency (EPA); EPA-registered antimicrobial pesticide product; or other suitable method) must be effective to make the water safe and of adequate sanitary quality for its intended use and/or meet the relevant microbial quality criteria in § 112.44, as applicable.

(2) You must deliver any treatment of agricultural water in a manner to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use and/or consistently meets the relevant microbial quality criteria in § 112.44, as applicable.

(b) You must monitor any treatment of agricultural water at a frequency adequate to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use and/or consistently meets the relevant microbial quality criteria in § 112.44, as applicable.

Sec. 112.44 What specific microbial quality criteria apply to agricultural water used for certain intended uses?

(a) When you use agricultural water for any one or more of these following purposes, you must ensure there is no detectable generic Escherichia coli (E. coli ) in 100 milliliters (mL) of agricultural water, and you must not use untreated surface water for any of these purposes:

(1) Used as sprout irrigation water;

(2) Applied in any manner that directly contacts covered produce during or after harvest activities (for example, water that is applied to covered produce for washing or cooling activities, and water that is applied to harvested crops to prevent dehydration before cooling), including when used to make ice that directly contacts covered produce during or after harvest activities;

(3) Used to contact food contact surfaces, or to make ice that will contact food contact surfaces; and

(4) Used for washing hands during and after harvest activities.

(b) When you use agricultural water during growing activities for covered produce (other than sprouts) using a direct water application method, the following criteria apply (unless you establish and use alternative criteria in accordance with § 112.49):

(1) A geometric mean (GM) of your agricultural water samples of 126 or less colony forming units (CFU) of generic E. coli per 100 mL of water (GM is a measure of the central tendency of your water quality distribution); and

(2) A statistical threshold value (STV) of your agricultural water samples of 410 or less CFU of generic E. coli per 100 mL of water (STV is a measure of variability of your water quality distribution, derived as a model-based calculation approximating the 90th percentile using the lognormal distribution).

Sec. 112.45 What measures must I take if my agricultural water does not meet the requirements of 112.41 or 112.44?

(a) If you have determined or have reason to believe that your agricultural water is not safe or of adequate sanitary quality for its intended use as required under § 112.41 and/or if your agricultural water does not meet the microbial quality criterion for the specified purposes as required under § 112.44(a), you must immediately discontinue that use(s), and before you may use the water source and/or distribution system again for the intended use(s), you must either:

(1) Re-inspect the entire affected agricultural water system to the extent it is under your control, identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces, make necessary changes, and take adequate measures to determine if your changes were effective and, as applicable, adequately ensure that your agricultural water meets the microbial quality criterion in § 112.44(a); or

(2) Treat the water in accordance with the requirements of § 112.43.

(b) If you have determined that your agricultural water does not meet the microbial quality criteria (or any alternative microbial quality criteria, if applicable) required under § 112.44(b), as soon as practicable and no later than the following year, you must discontinue that use, unless you either:

(1) Apply a time interval(s) (in days) and/or a (calculated) log reduction by:

(i) Applying a time interval between last irrigation and harvest using either:

(A) A microbial die-off rate of 0.5 log per day to achieve a (calculated) log reduction of your geometric mean (GM) and statistical threshold value (STV) to meet the microbial quality criteria in § 112.44(b) (or any alternative microbial criteria, if applicable), but no greater than a maximum time interval of 4 consecutive days; or

(B) An alternative microbial die-off rate and any accompanying maximum time interval, in accordance with § 112.49; and/or

(ii) Applying a time interval between harvest and end of storage using an appropriate microbial die-off rate between harvest and end of storage, and/or applying a (calculated) log reduction using appropriate microbial removal rates during activities such as commercial washing, to meet the microbial quality criteria in § 112.44(b) (or any alternative microbial criteria, if applicable), and any accompanying maximum time interval or log reduction, provided you have adequate supporting scientific data and information;

(2) Re-inspect the entire affected agricultural water system to the extent it is under your control, identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces, make necessary changes, and take adequate measures to determine if your changes were effective and adequately ensure that your agricultural water meets the microbial quality criteria in § 112.44(b) (or any alternative microbial criteria, if applicable); or

(3) Treat the water in accordance with the requirements of § 112.43.

Sec. 112.46 How often must I test agricultural water that is subject to the requirements of 112.44?

(a) There is no requirement to test any agricultural water that is subject to the requirements of § 112.44 when:

(1) You receive water from a Public Water System, as defined under the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, that furnishes water that meets the microbial requirements under those regulations or under the regulations of a State (as defined in 40 CFR 141.2) approved to administer the SDWA public water supply program, and you have Public Water System results or certificates of compliance that demonstrate that the water meets that requirement;

(2) You receive water from a public water supply that furnishes water that meets the microbial quality requirement described in § 112.44(a), and you have public water system results or certificates of compliance that demonstrate that the water meets that requirement; or

(3) You treat water in accordance with the requirements of § 112.43.

(b) Except as provided in paragraph (a) of this section, you must take the following steps for each source of water used for purposes that are subject to the requirements of § 112.44(b):

(1) Conduct an initial survey to develop a microbial water quality profile of the agricultural water source.

(i) The initial survey must be conducted:

(A) For an untreated surface water source, by taking a minimum total of 20 samples of agricultural water (or an alternative testing frequency that you establish and use, in accordance with § 112.49) over a minimum period of 2 years, but not greater than 4 years.

(B) For an untreated ground water source, by taking a minimum total of four samples of agricultural water during the growing season or over a period of 1 year.

(ii) The samples of agricultural water must be representative of your use of the water and must be collected as close in time as practicable to, but prior to, harvest. The microbial water quality profile initially consists of the geometric mean (GM) and the statistical threshold value (STV) of generic Escherichia coli (E. coli) (colony forming units (CFU) per 100 milliliter (mL)) calculated using this data set. You must determine the appropriate way(s) in which the water may be used based on your microbial water quality profile in accordance with § 112.45(b).

(iii) You must update the microbial water quality profile annually as required under paragraph (b)(2) of this section, and otherwise required under paragraph (b)(3) of this section.

(2) Conduct an annual survey to update the microbial water quality profile of your agricultural water.

(i) After the initial survey described in paragraph (b)(1)(i) of this section, you must test the water annually to update your existing microbial water quality profile to confirm that the way(s) in which the water is used continues to be appropriate. You must analyze:

(A) For an untreated surface water source, a minimum number of five samples per year (or an alternative testing frequency that you establish and use, in accordance with § 112.49).

(B) For an untreated ground water source, a minimum of one sample per year.

(ii) The samples of agricultural water must be representative of your use of the water and must be collected as close in time as practicable to, but prior to, harvest.

(iii) To update the microbial water quality profile, you must calculate revised GM and STV values using your current annual survey data, combined with your most recent initial or annual survey data from within the previous 4 years, to make up a rolling data set of:

(A) At least 20 samples for untreated surface water sources; and

(B) At least 4 samples for untreated ground water sources.

(iv) You must modify your water use, as appropriate, based on the revised GM and STV values in your updated microbial water quality profile in accordance with § 112.45(b).

(3) If you have determined or have reason to believe that your microbial water quality profile no longer represents the quality of your water (for example, if there are significant changes in adjacent land use that are reasonably likely to adversely affect the quality of your water source), you must develop a new microbial water quality profile reflective of the time period at which you believe your microbial water quality profile changed.

(i) To develop a new microbial water quality profile, you must calculate new GM and STV values using your current annual survey data (if taken after the time of the change), combined with new data, to make up a data set of:

(A) At least 20 samples for untreated surface water sources; and

(B) At least 4 samples for untreated ground water sources.

(ii) You must modify your water use based on the new GM and STV values in your new microbial water quality profile in accordance with § 112.45(b).

(c) If you use untreated ground water for the purposes that are subject to the requirements of § 112.44(a), you must initially test the microbial quality of each source of the untreated ground water at least four times during the growing season or over a period of 1 year, using a minimum total of four samples collected to be representative of the intended use(s). Based on these results, you must determine whether the water can be used for that purpose, in accordance with § 112.45(a). If your four initial sample results meet the microbial quality criteria of § 112.44(a), you may test once annually thereafter, using a minimum of one sample collected to be representative of the intended use(s). You must resume testing at least four times per growing season or year if any annual test fails to meet the microbial quality criteria in § 112.44(a).

Sec. 112.47 Who must perform the tests required under 112.46 and what methods must be used?

(a) You may meet the requirements related to agricultural water testing required under § 112.46 using:

(1) Test results from your agricultural water source(s) performed by you, or by a person or entity acting on your behalf; or

(2) Data collected by a third party or parties, provided the water source(s) sampled by the third party or parties adequately represent your agricultural water source(s) and all other applicable requirements of this part are met.

(b) Agricultural water samples must be aseptically collected and tested using a method as set forth in § 112.151.

Sec. 112.48 What measures must I take for water that I use during harvest, packing, and holding activities for covered produce?

(a) You must manage the water as necessary, including by establishing and following water-change schedules for re-circulated water, to maintain its safety and adequate sanitary quality and minimize the potential for contamination of covered produce and food contact surfaces with known or reasonably foreseeable hazards (for example, hazards that may be introduced into the water from soil adhering to the covered produce).

(b) You must visually monitor the quality of water that you use during harvest, packing, and holding activities for covered produce (for example, water used for washing covered produce in dump tanks, flumes, or wash tanks, and water used for cooling covered produce in hydrocoolers) for buildup of organic material (such as soil and plant debris).

(c) You must maintain and monitor the temperature of water at a temperature that is appropriate for the commodity and operation (considering the time and depth of submersion) and is adequate to minimize the potential for infiltration of microorganisms of public health significance into covered produce.

Sec. 112.49 What alternatives may I establish and use in lieu of the requirements of this subpart?

Provided you satisfy the requirements of § 112.12, you may establish and use one or more of the following alternatives:

(a) An alternative microbial quality criterion (or criteria) using an appropriate indicator of fecal contamination, in lieu of the microbial quality criteria in § 112.44(b);

(b) An alternative microbial die-off rate and an accompanying maximum time interval, in lieu of the microbial die-off rate and maximum time interval in § 112.45(b)(1)(i);

(c) An alternative minimum number of samples used in the initial survey for an untreated surface water source, in lieu of the minimum number of samples required under § 112.46(b)(1)(i)(A); and

(d) An alternative minimum number of samples used in the annual survey for an untreated surface water source, in lieu of the minimum number of samples required under § 112.46(b)(2)(i)(A).

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).

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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