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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules partners to prepare for produce safety rule implementation. FDA heard frequent and consistent concerns from covered farms and produce industry trade associations about the complexity and implementation challenges of certain subpart E requirements, which was reinforced in their comment submissions. In the face of widespread and steady concerns, including new concerns that were not expressed in response to the produce safety proposed rule, FDA concluded that it was in the publics interest to institute a delay to allow for further collaboration with an array of stakeholders and pursuit of solutions to achieve the shared goal of improved produce safety in a way that is more workable for covered farms.
Accordingly, in the Federal Register of March 18, 2019 84 FR 9706, FDA
extended the compliance dates for subpart E for non-sprout covered produce, as follows: January 26, 2024, for very small farms; January 26, 2023, for small farms; and January 26, 2022, for all other farms covered by the produce safety regulation. FDA noted that ignoring the widespread concerns raised about complexity and serious questions about how the requirements can be implemented in practical ways on farms would be likely to reduce the estimated public health benefits of the agricultural water provision of the 2015
final rule 84 FR 9706 at 9710. We recognized that farms that cannot understand the requirements and determine how to implement the requirements are not likely to be realizing full food safety measures, which led us to conclude that further collaboration with stakeholders was necessary to understand the source of the complexity and develop a more workable solution for pre-harvest agricultural water that would increase produce safety.
In the compliance date extension final rule 84 FR 9706 at 9710, we also reiterated our commitment to ensuring that the produce safety rule addresses the risks associated with agricultural water and emphasized that produce remains subject to the other applicable provisions of the produce safety regulation and the FD&C Act notwithstanding the extension. We recommended that farms should continue to use good agricultural practices to help maintain and protect the quality of their water sources.
Stakeholders including covered farms, consumer protection groups, and state governments submitted various comments addressing the underlying subpart E requirements applicable to non-sprout covered produce in response to the compliance date extension
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proposed rule. FDA responded to comments on in the compliance date extension final rule 84 FR 9706. While substantive issues were outside the narrow scope of the compliance date extension rulemaking, we considered those comments in developing this proposed rule. Stakeholders also submitted comments on the underlying subpart E requirements to Docket No.
FDA2017N5094, Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements 82 FR 42503
September 8, 2017. Although this docket was established as part of the implementation of two Executive Orders E.O. that have since been revoked see E.O. 13992 Revocation of Certain Executive Orders Concerning Federal Regulation, we consider the comments submitted to this docket on the underlying requirements of subpart E Refs. 510 as relevant to the purposes of this rulemaking.
Some comments indicate that stakeholder concerns on the agricultural water requirements were already addressed during rulemaking for the produce safety rule and argue that further action to consider stakeholder concerns is therefore unnecessary.
These comments note that stakeholders were given the opportunity to provide comment on pre-harvest agricultural water testing requirements when the notice of proposed rulemaking NPRM
issued in 2013, and again when the supplemental NPRM issued in 2014.
However, the feedback we received after the 2015 produce safety final rule was published about the complexity and the implementation challenges posed by the pre-harvest testing requirements was new and in addition to the comments on the proposed rule 84 FR 9706 at 9710.
Some comments encouraged FDA to withdraw the proposed compliance date extension and focus on implementation, noting the public health benefits of the produce safety regulation and concluding that an extension would harm consumers more than it would help. As previously indicated, FDA
decided to pursue a rigorous stakeholder engagement plan to consider the practical implementation of the agricultural water requirements and how to best achieve the important public health objectives of the rule.
Other comments indicate that certain agricultural water requirements in the 2015 produce safety final rule are too complex, overly prescriptive, and not practical to implement, urging FDA to reconsider the one-size-fits-all approach of the produce safety regulations that they state is not riskbased or adaptable based on future
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research. Some comments suggest that the pre-harvest agricultural water testing requirements in subpart E should be reduced to one annual test per source to be consistent with industry practice and some State requirements. Some comments cite concerns related to allowable testing methods, use of historical data and data sharing, the applicability of recreational water quality criteria to pre-harvest agricultural water, and considerations about crop rotations and short growing seasons. Some comments point out that certain areas where produce is grown lack nearby laboratories capable of testing water samples. Other comments assert that the produce safety regulation requires covered farms to hire a consultant or third party to test their water. Still other comments cite concerns about how the standards relate to foreign farms, in particular for covered farms located in foreign countries with a systems recognition arrangement with FDA.
Various comments indicate that a more flexible approach that incorporates region-, commodity-, and practicespecific information would be useful in addressing the diversity of agricultural water sources. These comments recommend taking into account practices and lessons learned under third-party auditing standards. Other comments assert that FDA should recognize the risk-based approaches that different commodity groups and different industry sectors are already using. Some comments suggest that FDA
perform a multiyear quantitative microbial risk assessment for agricultural water to better understand the associated risks, while other comments propose building additional flexibility into the testing requirements to allow for future scientific advancements, such as the use of metagenomics. Still others cite a need for ongoing education, training, outreach, and guidance on a variety of agricultural water-related issues and recommend that FDA involve a variety of stakeholders, including the States, in any outreach and guidance efforts. We considered these comments in developing this proposed rule.
D. Recent Outbreaks For more than a decade, FDA has conducted investigations of produce outbreaks to learn what factors may have contributed to the outbreaks of foodborne illness or food contamination events. These investigations also known as environmental assessments, or EAs are performed in collaboration with regulatory partners following initial outbreak response activities and
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