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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules 5 Other relevant factors, including, if applicable, the results of any testing conducted pursuant to paragraph d of this section.
b Exemptions. You do not need to prepare a written agricultural water assessment for water that you directly apply during growing activities for covered produce other than sprouts, if you can demonstrate that the water:
1 Meets the requirements in 112.44a, including the microbial quality criterion, and if untreated ground water, also meets the testing requirements in 112.44b, 112.47, and 112.151;
2 Meets the requirements in 112.44c for water from a Public Water System or public water supply; or 3 Is treated in accordance with 112.46.
c Outcomes. Based on your evaluation under paragraph a of this section, you must determine whether measures under 112.45 are reasonably necessary to reduce the potential for contamination of covered produce other than sprouts or food contact surfaces with known or reasonably foreseeable hazards associated with your agricultural water used in growing covered produce other than sprouts.
You must record your determination in the assessment, and you must take necessary and appropriate action, as follows:
1 If your agricultural water is not safe or is not of adequate sanitary quality for its intended uses, as required under 112.41, you must discontinue use of the water and take corrective measures under 112.45a before resuming such uses;
2 If you have identified a condition that is reasonably likely to introduce a known or reasonably foreseeable hazard and is related to animal activity, application of a biological soil amendment of animal origin, or the presence of untreated or improperly treated human waste on adjacent or nearby lands, you must implement any mitigation measures under 112.45b promptly, and no later than the same growing season as the assessment;
3 If you have identified no conditions that are reasonably likely to introduce a known or reasonably foreseeable hazard for which measures under 112.45 are reasonably necessary to reduce the potential for contamination of covered produce other than sprouts or food contact surfaces, you must:
i Regularly inspect and adequately maintain your agricultural water systems under 112.42; and ii Reassess your agricultural water annually and whenever a significant
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change occurs such as a change in the manner or timing of water application that increases the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto covered produce or food contact surfaces; and 4 If your agricultural water does not meet the criteria in paragraph c1, 2, or 3 of this section, you must either:
i Implement mitigation measures under 112.45b as soon as practicable and no later than 1 year after the date of the agricultural water assessment as required by this section; or ii Test the water pursuant to paragraph d of this section, consider the results as part of your assessment, and take appropriate action under paragraph c1, 2, or 3, or c4i of this section.
d Testing for assessment purposes.
In conducting testing to be used as part of your assessment under paragraph a5 of this section, you must use scientifically valid collection and testing methods and procedures, including:
1 Any sampling conducted for purposes of paragraph c4ii of this section must be collected aseptically immediately prior to or during the growing season and must be representative of the water you use in growing covered produce other than sprouts.
2 The samples must be tested for generic Escherichia coli E. coli as an indicator of fecal contamination or for another scientifically valid indicator organism, index organism, or other analyte.
3 The frequency of testing samples and any microbial criteria applied must be scientifically valid and appropriate to assist in determining, in conjunction with other data and information evaluated under paragraph a of this section, whether measures under 112.45 are reasonably necessary to reduce the potential for contamination of covered produce other than sprouts or food contact surfaces with known or reasonably foreseeable hazards associated with your agricultural water used in growing covered produce other than sprouts.
e Reassessment. You must conduct an agricultural water assessment and take appropriate action under paragraph c of this section:
1 At least once annually when you apply agricultural water to covered produce other than sprouts during growing activities; and 2 Whenever a significant change occurs in your agricultural water systems including changes relating to animal activity, the application of biological soil amendments of animal
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origin, or the presence of untreated or improperly treated human waste associated with adjacent or nearby land uses, agricultural water practices, crop characteristics, environmental conditions, or other relevant factors that make it reasonably likely that a known or reasonably foreseeable hazard will be introduced into or onto covered produce other than sprouts or food contact surfaces through direct application of agricultural water during growing activities. Your reassessment must evaluate any factors and conditions that are affected by such change.
112.44 What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?

a Microbial quality criterion. When you use agricultural water for any one or more of the 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 Used during or after harvest activities in a manner that directly contacts covered produce for example, water that is applied to covered produce for washing or cooling activities, water that is applied to harvested crops to prevent dehydration before cooling, and water that is 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 Untreated ground water. You must test any untreated ground water used as sprout irrigation water or for harvesting, packing, holding covered produce to determine if it meets the microbial quality criterion in paragraph a of this section, as follows:
1 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 aseptically and representative of the intended uses. Based on these results, you must determine whether the water can be used for the intended purposes, in accordance with 112.45a.
2 If your four initial sample results meet the microbial quality criterion, you may test once annually thereafter, using a minimum of one sample collected aseptically and representative of the intended uses.
3 If any annual test fails to meet the microbial quality criterion, you must:

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