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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
These stakeholders indicated that they find the alternatives in the final rule for the use of a different microbial water quality criterion or criteria and/
or testing frequency for untreated surface water sources to be unworkable.
While data sharing is one way that implementation challenges associated with sampling could be reduced, some stakeholders noted that it may be difficult to implement due to the requirements that water samples be representative of the particular use of the water and collected as close in time as practicable, but prior to, harvest.
Some stakeholders noted implementation challenges with establishing long-term MWQPs for farms that grow rotational crops or on leased land, as they may not be using or have access to the same water source over multiple years.
Based on stakeholder feedback received as of March 2017, FDA
publicly announced that we were considering how we might simplify the microbial quality and testing requirements for agricultural water while still protecting public health and that we intended to work with stakeholders as these efforts progressed Ref. 1.
As FDA subject matter experts continued stakeholder engagement activities, they gained additional feedback that was consistent with earlier messages that the pre-harvest requirements in subpart E were complex and challenging to implement, as they were:
Inflexible, by imposing a one-sizefits-all approach that is difficult to implement across the wide variety of sources, uses, and practices covered by the rule;
Too complicated to understand and implement, such as the calculation of the GM and STV; and Difficult to implement because covered farms with multiple pre-harvest agricultural water sources are required to establish individual microbial quality profiles for each agricultural water source.
After receiving consistent feedback from numerous stakeholders expressing concern about complexity and challenges with implementation of certain agricultural water requirements, in the Federal Register of September 13, 2017 82 FR 42963, FDA proposed to extend the compliance dates for subpart E for covered produce other than sprouts. FDA took that action based on feedback we received from numerous stakeholders raising issues regarding the practicality of some of these provisions in particular the testing requirements for pre-harvest agricultural water. The
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additional time allotted by extending the Subpart E compliance dates for covered produce other than sprouts was intended to allow consideration of approaches to address these issues, as well as to identify opportunities to enhance the flexibility of these requirements beyond those reflected in the final rule.
As part of the continuing stakeholder engagement on agricultural water, in October 2017, FDA participated in a collaborative forum, sponsored by The Pew Charitable Trusts and the Robert Wood Johnson Foundation, where participants discussed ideas for how to amend the agricultural water requirements within the rules current framework to address near-term challenges, as well as, and potentially in combination with, ideas for frameworks that could improve public health outcomes long term and allow for the incorporation of new scientific knowledge and learnings as they become available. At the invitation of the sponsor, farms, academia, food industry trade associations, consumer groups, and other State and Federal partners also attended.
Forum participants identified several possible alternatives for pre-harvest agricultural water, including: 1
Retaining the microbial water quality criteria and testing requirements for agricultural water used during growing activities and issuing companion guidance to recommend alternative approaches that would satisfy the regulation; 2 replacing the existing quantitative requirements with a qualitative standard and issuing companion guidance to recommend alternative approaches that would satisfy the regulation; 3 adopting private industry standards in guidance as a short term measure while research continues on analytes and appropriate numerical thresholds; and 4
performing a multiyear quantitative microbial risk assessment to identify index and/or indicator organisms that can be used to characterize risk associated with agricultural water across a variety of conditions. Forum participants identified advantages and disadvantages of each proposed approach and also identified other areas for further consideration by FDA, including qualitative standards, data sharing, and the need for additional guidance Ref. 2.
Implementation challenges with the agricultural water requirements in subpart E were also the focus of a 2-day Agricultural Water Summit, convened by the Produce Safety Alliance in February 2018, to discuss implementation challenges and explore
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possible approaches that would be practical to implement while protecting public health Ref. 3. FDA subject matter experts joined more than 350
other participants at the summit, including farmers and other produce industry members, researchers, extension educators, and State and Federal regulators. Additionally, approximately 200 people from eight different countries viewed the summit proceedings via webcast and had the opportunity to provide comments. The meeting was open to registration by the general public.
The summit included presentations and discussions on addressing food safety hazards in the growing environment. Participants discussed the complexities associated with farm environments. For example, participants noted that difficulties can arise due to variability in the following factors: 1
Agricultural water source quality, including how it arrives and moves throughout the farm; 2 the methods of water application to the crop; 3
commodity characteristics that influence vulnerability to contamination; and 4 regional climatic effects. Participants identified agricultural water assessments as a promising approach for science-based management decisions that could take those factors into account. Participants also recognized that farmers would need additional educational tools to conduct this type of assessment Ref. 3.
FDA produce safety experts continued farm visits into 2018 to gather additional feedback and perspectives from stakeholders, in addition to the information and insights from the Agricultural Water Summit and the Collaborative Forum. Joined on these visits by representatives from the produce industry, academia, and government agencies, FDA visited nearly 100 farms in 2018, during which we observed a wide variety of water sources, distribution systems, and practices among farms of all sizes. As part of the farm visits, FDA often participated in listening sessions with farmers to learn about their water use practices, how they currently manage water quality, and their perspectives on how best to achieve public health protections related to agricultural water in a way that would be practicable and workable across a variety of operations Ref. 4.
Throughout the produce safety rule outreach and education efforts, FDA
also continued to engage with a broad range of stakeholders, including consumer protection groups, through coalition meetings, while also collaborating with State regulatory
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