21 CFR § 112.45 - What measures must I take for agricultural water to reduce the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards?
(a) Discontinue use(s). 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(s) in growing, harvesting, packing, or holding covered produce as required under § 112.41, and/or if your agricultural water used as sprout irrigation water or for harvesting, packing, or holding activities does not meet the requirements in § 112.44(a) (including the microbial quality criterion), you must immediately discontinue such use(s). 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 § 112.46.
(b) Implement mitigation measures.
(1) You must implement any mitigation measures that 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. Such measures must be implemented as soon as practicable and no later than 1 year after the date of your agricultural water assessment or reassessment (as required by § 112.43), except that mitigation measures for known or reasonably foreseeable hazards related to animal activity, the application of biological soil amendments of animal origin, or the presence of untreated or improperly treated human waste on adjacent or nearby lands must be implemented promptly, and no later than the same growing season as such assessment or reassessment. Mitigation measures include:
(i) Making necessary changes (for example, repairs) to address any conditions that are reasonably likely to introduce such known or reasonably foreseeable hazards into or onto the covered produce or food contact surfaces;
(ii) Increasing the time interval between the last direct application of agricultural water and harvest of the covered produce to allow for microbial die-off, provided you have scientifically valid supporting data and information;
(iii) Increasing the time interval between harvest and the end of storage to allow for microbial die-off, and/or conducting other activities during or after harvest to allow for microbial die-off or removal, provided you have scientifically valid supporting data and information;
(iv) Changing the method of water application to reduce the likelihood of contamination of the covered produce (such as by changing from overhead spray to subsurface drip irrigation of certain crops);
(v) Treating the water in accordance with § 112.46; and
(vi) Taking an alternative mitigation measure, provided that you satisfy the requirements of § 112.12.
(2) If you fail to implement appropriate mitigation measures in accordance with paragraph (b)(1) of this section, or if you determine that your mitigation measures were not effective to reduce the potential for contamination of the covered produce or food contact surfaces with known or reasonably foreseeable hazards, you must discontinue use of the agricultural water until you have implemented mitigation measures adequate to reduce the potential for such contamination, consistent with § 112.41.