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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
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amendments to the produce safety regulation, if finalized, will help prevent the spread of communicable diseases associated with contaminated produce.
V. Need for Regulatory Action and Proposed Regulatory Approach We are proposing to amend subpart E
of the produce safety regulation based on stakeholder feedback, new information we have gathered since issuance of the 2015 final rule, and findings from FDA investigations of produce-related outbreaks.
As described in section III.C., numerous stakeholders have provided feedback to FDA about the complexity and challenges of implementing the preharvest microbial quality criteria and testing requirements in subpart E for pre-harvest agricultural water for covered produce other than sprouts.
Stakeholders shared their input and concerns during FDAs outreach and education efforts on the 2015 produce safety final rule, at the 2018 Agricultural Water Summit, and at meetings convened by others. Stakeholders also expressed concerns about these preharvest agricultural water testing requirements in comments submitted to other dockets, including for the compliance date extension rulemaking 84 FR 9706. See section III.C. of this document. The feedback has been consistent in its message about the implementation challenges of the preharvest agricultural water testing requirements and has come from individual growers and industry organizations that encompass various growing regions, farm sizes, and commodities.
FDA investigations of recent producerelated outbreaks have highlighted the role of pre-harvest agricultural water as a potential contributing factor in the introduction and spread of contamination to produce. Section III.D.
discusses new information and findings from several recent investigations of the potential routes of contamination of preharvest agricultural water associated with activities conducted on lands adjacent and nearby to farms identified during traceback investigations and the agricultural water systems used by those farms.
This proposed rule would amend the agricultural water provisions of the produce safety regulation to replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce other than sprouts that covered farms have found to be complex and challenging to implement, with provisions for comprehensive assessments of pre-

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harvest agricultural water systems, practices, and on-farm conditions. The proposed agricultural water assessments would provide additional flexibility to covered farms, using a systems-based approach that would be feasible to implement across the wide variety of pre-harvest agricultural water systems, uses, and farm operations and would be adaptable as scientific understanding of agricultural water quality expands in the future. We also are proposing to require expedited mitigation for hazards related to certain activities associated with adjacent and nearby lands in light of findings from several recent produce outbreak investigations. These proposed revisions to the produce safety regulation, if finalized, would set forth requirements for comprehensive preharvest agricultural water assessments and mitigation measures that 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 these hazards.
We developed this approach to preharvest agricultural water by considering public health objectives while recognizing that each covered farmwhether foreign or domestichas a unique combination of agricultural water sources, growing practices, current and previous uses of the farmland, and adjacent and nearby land uses, among other factors. Cognizant of the practical implementation challenges we identified, we sought to identify an approach that: 1 Is workable for covered farms of all sizes, both foreign and domestic; 2 provides sufficient specificity, while offering adequate flexibility, so that covered farms can understand what requirements apply and how to implement them to prevent produce contamination; 3 meets the public health objectives of the Agency and the relevant requirements set forth in the FD&C Act; and 4 enables FDA
to verify compliance.
After evaluating relevant information gathered since publication of the final rule, and based on FDAs expertise and experience, we considered four options.
A. Option A: Additional Guidance on Subpart E
We considered the option of issuing additional guidance with more reference material, examples, and explanations for covered farms, while maintaining the existing pre-harvest agricultural water testing requirements in the produce safety regulation.

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In particular, we contemplated issuing additional guidance to describe circumstances in which covered farms might satisfy the pre-harvest sampling and testing requirements through shared data with other covered farms.
Discussions at a collaborative forum Ref. 2 and the Agricultural Water Summit Ref. 3, stakeholder comments and information gathered from farm visits and other stakeholder outreach described in section III.C. revealed several limitations with this option.
There are currently few if any agricultural water data-sharing arrangements between covered farms, and such arrangements likely would be time-intensive and impractical to establish. For example, the diversity of agricultural water sources, distribution systems, and possible impacts from lands adjacent to and nearby each covered farm would make it difficult for many covered farms to rely on shared data to satisfy the requirement for samples adequately representative of their agricultural water at the time of application.
Moreover, some stakeholders indicated that guidance alone could not overcome difficulties with using alternative microbial quality criteria or criterion or alternative sampling frequency provisions of the produce safety regulation. Other stakeholders pointed out that, under 112.171, the produce safety regulation only allows States, Federally recognized tribes, or countries from which food is imported into the United States to request a variance from FDA to use an alternative approach to the requirements set forth in the produce safety regulation.
In light of the foregoing, we concluded that issuing additional guidance as described above would not adequately address the practical implementation issues associated with the pre-harvest agricultural testing requirements in the produce safety regulation.
B. Option B: Risk Assessment/Research Followed by Rulemaking Based on comments and dialogue at collaborative fora and other stakeholder engagement activities, as described in section III.C., we considered whether to conduct another risk assessment, followed by a rulemaking to revise the pre-harvest agricultural water testing requirements. For example, we could perform a multiyear quantitative microbial risk assessment to identify index and/or indicator organisms to characterize risk associated with agricultural water across a variety of conditions, followed by rulemaking on pre-harvest agricultural water testing.

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