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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
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which potential hazards are introduced into a water system intermittently, such that a covered farm is able to compare data to further refine its assessments of whether measures under 112.45 are reasonably necessary to reduce the potential for contamination of nonsprout covered produce or food contact surfaces with known or reasonably foreseeable hazards associated with preharvest agricultural water.
d. Records relating to analytes, sampling frequencies, and pre-harvest water quality criteria. If a covered farm tests its water under 112.43d for generic E. coli using the sampling frequencies and pre-harvest microbial water quality criteria outlined in the 2015 produce safety final rule, the covered farm could document its use of such sampling frequencies and microbial criteria in meeting the requirements of proposed 112.50b4, as we have already determined these sampling frequencies and microbial criteria to be scientifically valid and appropriate for purposes of proposed 112.45b.
Under proposed 112.50b34, a covered farm that tests its pre-harvest agricultural water using a scientifically valid indicator organism other than generic E. coli, or an index organism or other analyte would be required to maintain records under proposed 112.50 of the scientific data or information used to support its selection of other indicator organism, index organism, or other analyte, as well scientifically valid and appropriate sampling frequency and microbial criterion or criteria being applied. See also section VI.G. regarding proposed records requirements.
Such data and information could be developed by the covered farm, available in the scientific literature, or available to the farm through a third party. Such scientific support could be derived from the science underlying commodity-specific or other guidance or recommendations, including those developed by industry, academia, trade associations, or other stakeholders.
16. Proposed 112.43eReassessment Under proposed 112.43e, a covered farm would conduct an agricultural water assessment, at a minimum, each year that the farm applies pre-harvest agricultural water to non-sprout covered produce. A covered farm also would conduct a reassessment whenever a significant change occurs in its agricultural water systems, agricultural water practices, crop characteristics, environmental conditions, or other relevant factors that would impact hazard identification or a risk
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management determination as described in 112.43c. For example, a change from an untreated ground water source to an untreated surface water source would be a significant change that would require a reassessment under proposed 112.43e. The reassessment would evaluate the impacts of those changes on the factors in proposed 112.43a1 through 5, any new hazards identified, and the outcome and determination under proposed 112.43c.
Agricultural water assessments are the primary tool that covered farms would use under this proposed rule for hazard identification and risk management for their pre-harvest agricultural water used for non-sprout covered produce.
Specifically, covered farms would use the outcomes of their pre-harvest agricultural water assessments proposed 112.43, together with the results of any inspections and maintenance performed proposed 112.42, in determining whether measures proposed 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 pre-harvest agricultural water.
The proposed requirements for an agricultural water assessment align with domestic produce safety standards, such as the USDA Harmonized GAP Plus+
Standard, section F4.1 Ref. 70, and international standards, such as the Codex Code Section 3.2.1.1 Ref. 62, which recommends the periodic assessment of agricultural water for suitability for use.
For the foregoing reasons, we have tentatively concluded that it would be reasonable and appropriate to require covered farms to conduct a written preharvest agricultural water assessments annually, and whenever significant changes would impact the hazard identification or risk management determination relating to pre-harvest agricultural water for non-sprout covered produce.
F. Mitigation Measures Proposed 112.45
Proposed 112.45 would establish requirements for implementing corrective and mitigation measures for pre-harvest, harvest, and post-harvest agricultural water that are reasonably necessary to reduce the potential for contamination of non-sprout covered produce or food contact surfaces with known or reasonably foreseeable hazards associated with agricultural water for covered produce. This
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provision is supplemented by proposed 112.42, which would require covered farms to conduct routine maintenance of agricultural water systems to the extent of their control including, for example, taking steps to prevent pooled water from contaminating covered produce.
We are proposing to retain the requirement from 112.45a of the produce safety regulation to immediately discontinue use of any agricultural water that is not safe or not of adequate sanitary quality for its intended uses, until the covered farm implements effective corrective measures and the agricultural water meets the requirements of 112.41. We also propose to retain the requirement, from 112.45a of the produce safety regulation, to discontinue use of harvest or post-harvest water that does not meet the microbial water quality criterion in 112.44a until effective corrective measures are implemented.
Under this proposed rule, a covered farm would make a determination under 112.43c, based on the outcome of its agricultural water assessment, as to whether mitigation measures would be 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 its pre-harvest agricultural water. A covered farm would be required to implement mitigation measures under proposed 112.45b as soon as practicable and no later than one year after the date of the agricultural water assessment or reassessment as required by proposed 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 its assessment. See the discussions of adjacent and nearby land uses and outcomes in section VI.E.
Under proposed 112.45b, mitigation measures include:
Making necessary changes such as repairs to address any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces;
Increasing the time interval between the last direct application of agricultural water and harvest of the covered produce to allow for microbial die-off with a minimum interval of 4
days between application and harvest, except as supported by test results
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