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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
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Alternatively, we could issue guidance on pre-harvest agricultural water based on industry standards while research is conducted to develop sufficient scientific information on other analytes and appropriate numerical thresholds, followed by rulemaking to revise the pre-harvest agricultural water testing requirements. This is different than Option A, which would involve additional guidance on the 2015
produce safety final rule testing requirements.
Having reviewed the conclusions of the QAR Ref. 11 and the 2019 IFSAC
report Ref. 25, and considered FDAs experience with investigations of produce-related outbreaks, we concluded that it is not necessary for FDA to conduct an additional risk assessment or issue guidance based on industry standards before conducting rulemaking to establish new pre-harvest agricultural water standards to minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce, and provide reasonable assurances that the produce is not adulterated on account of those hazards.
C. Option C: Retaining the Pre-Harvest Agricultural Water Requirements for Covered Produce Other Than Sprouts Another option would be to allow the existing testing requirements for preharvest agricultural water for non-sprout covered produce to go into effect after expiration of the compliance date extension 84 FR 9706.
When contemplating this option, we considered repeated stakeholder feedback that the testing requirements for pre-harvest agricultural water for non-sprout covered produce are difficult to understand and challenging to implement in a workable manner given the diversity of uses and sources of such water. We also considered additional information, gathered during recent outbreak investigations, on the variety of factors that impact on pre-harvest agricultural water for non-sprout covered produce.
Although we continue to believe that the existing rule with mandated testing frequency and water standards would, if implemented, result in overall improved agricultural water quality and improved public health, we understand that if confusion and infeasibility undermine successful implementation of the preharvest agricultural water requirements for non-sprout covered produce, then the desired public health improvements are not likely to result. Thus, we have sought an alternative means to achieve
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improved public health protections in this area.
In light of the foregoing, we concluded that retention of the subpart E pre-harvest requirements, as applicable to non-sprout covered produce, would not adequately address these issues in a timely manner.
D. Option D: Rulemaking To Revise Certain Provisions of the Produce Safety Regulation As another option, we considered whether to engage in rulemaking to revise the pre-harvest agricultural water testing requirements for non-sprout covered produce.
In evaluating this option, we considered proceedings of the Agricultural Water Summit Ref. 3, which included discussions and presentations on addressing hazards in the growing environment. In addition to discussing the feasibility of implementing the pre-harvest water quality profile and testing requirements of the produce safety regulation, Summit participants discussed the utility of pre-harvest agricultural water assessments given the diverse farm environments.
Summit participants identified several complex factors associated with agricultural water, including the variability in water source quality such as how it arrives and moves throughout the farm; the method of water application to the crop; commodity characteristics that influence vulnerability to contamination; and regional climatic effects. After several presentations and lengthy discussions of issues, Summit participants identified agricultural water assessments as a promising approach for science-based management decisions that could take the complexities of each farm into account. Similar themes emerged during discussions at the Collaborative Food Safety Forum Ref. 2 and in stakeholder feedback on the final rule, as described in section III.C.
In light of the findings of our QAR
Ref. 11, stakeholder feedback, and new findings and information we have gathered since publication of the 2015
produce safety regulation as described in section III., we have concluded that the most appropriate regulatory approach is to undertake rulemaking.
We acknowledge that the identified implementation challenges of the preharvest agricultural water testing requirements for non-sprout covered produce could prevent full realization of our intended public health objectives.
The proposed rule provides for comprehensive assessments of preharvest agricultural water for non-sprout
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covered produce that would be feasible to implement across a wide variety of pre-harvest agricultural water systems, uses, and farm operations and are adaptable as our scientific understanding of agricultural water quality expands over time. The proposed rule also would provide for expedited mitigation for certain hazards related to animal activity and other activities on adjacent and nearby lands in light of findings of FDA
investigations.
The proposal sets forth procedures, processes, and practices to minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce, and to provide reasonable assurances that the produce is not adulterated on account of those hazards.
If finalized, the proposed rule would more comprehensively address the potential for pre-harvest agricultural water to serve as a route of contamination of non-sprout covered produce, by using a systems-based, preventive approach that is sufficiently flexible to accommodate a wide range of agricultural water sources, uses, and practices and would be adaptable to future advancements in agricultural water quality science.
VI. Description of the Proposed Rule We are proposing to amend the produce safety regulation to address concerns about the practical challenges of implementing the pre-harvest agricultural water microbial water quality criteria and testing requirements by providing additional flexibility while continuing to protect the public health.
If finalized, the proposed rule would replace those pre-harvest agricultural water microbial criteria and testing requirements for non-sprout covered produce with requirements for preharvest agricultural water assessments that covered farms would use to determine appropriate measures for ensuring that their pre-harvest agricultural water is safe and of adequate sanitary quality under 112.41. We also are proposing to enhance risk-based mitigation measures for pre-harvest agricultural water, including expedited mitigation measures to address known or reasonably foreseeable hazards in agricultural water systems due to animal activity, biological soil amendments of animal origin BSAAOs, or human waste related to adjacent or nearby land uses. This proposed rule would add relevant definitions in subpart A and a requirement in subpart O for
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