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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules 4. Proposed 112.47
As clarifying edits, we would:
In 112.47a of the produce safety regulation, replace 112.46 with 112.43c4ii and 112.44 and In 112.47b of the produce safety regulation, replace method as set forth in 112.151 with method set forth in 112.151, as applicable.
5. Proposed 112.48
As part of our reorganization of subpart E, we would move the requirements in 112.48 of the produce safety regulation to proposed 112.44d, which would contain other requirements applicable to harvest and post-harvest uses of agricultural water, and reserve 112.48.
6. Proposed 112.49
As part of our reorganization of subpart E, we would remove and reserve 112.49 of the produce safety regulation that allows for various alternatives based on the pre-harvest agricultural water quality profile and testing requirements that we propose to remove from subpart E.

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VII. Online Tool We recognize that covered farms would likely benefit from resources to assist them in complying with the proposed requirements, if finalized. As such, we are developing an online tool that would assist farms in developing the pre-harvest agricultural water assessments described in this proposed rule. We plan to provide additional information about this online tool in the near future.
VIII. Proposed Effective and Compliance Dates We are proposing that a final rule based on this proposed rule be effective 60 days after the date of publication of the final rule.
Covered farms currently are required to comply with the subpart E preharvest, harvest, and post-harvest agricultural water requirements for covered produce other than sprouts beginning on January 26, 2024, for very small farms; January 26, 2023, for small farms; and January 26, 2022, for all other covered farms 84 FR 9706. We intend to exercise enforcement discretion for these subpart E
requirements while pursuing a targeted compliance date rulemaking, with the goal of completing the rulemaking as quickly as possible.
In the meantime, covered farms other than sprout operations, for which compliance dates have already passed should focus their attention good agricultural practices to maintain and
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protect the quality of their water sources Ref. 32. We note that produce remains subject to the other applicable provisions of the produce safety regulation and the applicable provisions of the FD&C Act.
IX. Preliminary Economic Analysis of Impacts We have examined the impacts of the proposed rule under E.O. 12866, E.O.
13563, the Regulatory Flexibility Act 5
U.S.C. 601612, and the Unfunded Mandates Reform Act of 1995 Pub. L.
1044. E.O.s 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety, and other advantages;
distributive impacts; and equity. This proposed rule has been designated a significant regulatory action as defined by E.O. 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities.
Because we estimate that annualized costs will not be larger than 3 percent of revenue for any covered farms, we anticipate that the proposed rule will not have a significant economic impact on a substantial number of small entities. If the proposed rule is finalized, we may, if appropriate, certify that the final rule does not have a significant impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 section 202a requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more adjusted annually for inflation in any one year. The current threshold after adjustment for inflation is $158 million, using the most current 2020 Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
We have developed a comprehensive Preliminary Economic Analysis of Impacts PRIA that assesses the impacts of the proposed rule Ref. 79. We estimate costs of the proposed rule resulting from reading the rule, conducting pre-harvest agricultural water assessments, conducting mitigation measures when reasonably necessary based on the outcomes of the
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pre-harvest agricultural water assessments, and recordkeeping as a result of the pre-harvest agricultural water assessments. We estimate cost savings of the proposed rule resulting from pre-harvest agricultural water testing and corrective measure provisions in the 2015 final rule that would be replaced by the proposed provisions for pre-harvest agricultural water assessments and mitigation measures. Our primary estimates of annualized net costs are approximately $11.3 million at a 3 percent discount rate over 10 years and approximately $11.2 million at a 7 percent discount rate over 10 years.
We estimate benefits of the proposed rule resulting from the dollar burden of foodborne illnesses averted, and we estimate forgone benefits of the proposed rule resulting from foodborne illnesses not averted due to the current pre-harvest agricultural water testing provisions. Our primary estimates of annualized net benefits are approximately $9.9 million at a 3
percent discount rate and approximately $9.6 million at a 7 percent discount rate.
We discuss qualitative benefits of the proposed rule stemming from increased flexibility for covered farms to comprehensively evaluate their agricultural water systems. These changes to pre-harvest agricultural water provisions are being proposed, in part, to address practical implementation challenges of the current pre-harvest agricultural water testing requirements.
The full preliminary analysis of economic impacts is available in the docket for this proposed rule and at https www.fda.gov/about-fda/reports/
economic-impact-analyses-fdaregulations.
X. Analysis of Environmental Impact The Agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The Agencys finding of no significant impact and the evidence supporting that finding may be seen in the Dockets Management Staff see ADDRESSES between 9 a.m. and 4 p.m., Monday through Friday Refs. 8081.
Under FDAs regulations implementing the National Environmental Policy Act 21 CFR part 25, an action of this type would require an EA under 21 CFR
25.31aa an abbreviated EA under 21
CFR 25.31ab.

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