Editorial Note on Part 112
Editorial Note: Nomenclature changes to part 112 appear at 81 FR 49896, July 29, 2016.

§ 112.43 What requirements apply to assessing agricultural water used in growing covered produce (other than sprouts)? ( a ) *Elements of an agricultural water assessment.* Based in part on the results of any inspections and maintenance you conducted under § 112.42, at the beginning of the growing season, as appropriate, but at least once annually, you must prepare a written agricultural water assessment for water that you apply to covered produce (other than sprouts) using a direct application method during growing activities. The agricultural water assessment must identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce (other than sprouts) or food contact surfaces, based on an evaluation of the following factors: ( 1 ) Each agricultural water system you use for growing activities for the covered produce, including: ( i ) The location and nature of the water source (for example, whether it is ground water or surface water);
( ii ) The type of water distribution system (for example, open or closed conveyance); and
( iii ) The degree of protection from possible sources of contamination, including by other water users; animal impacts; and adjacent and nearby land uses related to animal activity (for example, grazing or commercial animal feeding operations of any size), application of biological soil amendment(s) of animal origin, or presence of untreated or improperly treated human waste;
( 2 ) Agricultural water practices associated with each agricultural water system, including the type of direct application method (such as foliar spray or drip irrigation of covered produce growing underground) and the time interval between the last direct application of agricultural water and harvest of the covered produce;
( 3 ) Crop characteristics, including the susceptibility of the covered produce to surface adhesion or internalization of hazards;
( 4 ) Environmental conditions, including the frequency of heavy rain or extreme weather events that may impact the agricultural water system (such as by stirring sediments) or covered produce (such as damage to edible leaves) during growing activities, air temperatures, and sun exposure; and
( 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 your water meets the criteria in paragraphs (b)(1) and (2) of this section. ( 1 ) You can demonstrate that the water: ( i ) Meets the requirements in § 112.44(a), including the microbial quality criterion and the prohibition on the use of untreated surface water, and if untreated ground water, also meets the testing requirements in §§ 112.44(b), 112.47, and 112.151;
( ii ) Meets the requirements in § 112.44(c) for water from a public water system or public water supply; or
( iii ) Is treated in accordance with § 112.46.
( 2 ) It is reasonably likely that the quality of water in paragraph (b)(1)(i), (ii), or (iii) of this section will not change prior to the water being used as agricultural water (for example, due to the manner in which the water is held, stored, or conveyed).
( 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 use(s), as required under § 112.41, you must immediately discontinue use of the water and take corrective measures under § 112.45(a) before resuming such use(s);
( 2 ) If you have identified one or more conditions that are reasonably likely to introduce known or reasonably foreseeable hazards and are 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 § 112.45(b) promptly, and no later than the same growing season as the agricultural water assessment;
( 3 ) If you have not identified any 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 system(s) under § 112.42; and
( ii ) Reassess your agricultural water annually and whenever a significant 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 paragraphs (c)(1), (2), or (3) of this section, you must either: ( i ) Implement mitigation measures under § 112.45(b) 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 paragraphs (c)(1), (2), or (3), or (c)(4)(i) of this section.
( d ) *Testing as part of an assessment.* In conducting testing to be used as part of your assessment under paragraph (a)(5) of this section, you must use scientifically valid collection and testing methods and procedures, including: ( 1 ) Any sampling conducted for purposes of paragraph (c)(4)(ii) 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 sample(s) 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 criterion (or 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 system(s) (including changes relating to animal activity, the application of biological soil amendments of animal 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.