Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 112</CFR> <DEPDOC>[Docket No. FDA-2021-N-0471]</DEPDOC> <RIN>RIN 0910-AI49</RIN> <SUBJECT>Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration is issuing a final rule to amend the agricultural water provisions of the produce safety regulation. This rule replaces the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with a regulatory approach that incorporates recent science and Food and Drug Administration outbreak investigation findings to achieve improved public health protections as compared to the earlier requirements. The rule requires systems-based assessments, with required testing in certain circumstances, that focus on key risk factors for contamination by pre-harvest agricultural water and will enable farms to implement effective preventive measures. The rule requires farms to take timely action based on risk and includes a new requirement for expedited mitigation for certain hazards. The requirements are adaptable to future scientific advancements and provide sufficient flexibility to be practicable for all sizes and types of farms to implement across the wide variety of agricultural water systems, uses, and practices. These revisions to the produce safety regulation will more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective July 5, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> For access to the docket to read background documents or comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">With regard to the final rule:</E> Samir Assar, Director, Division of Produce Safety, Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS-317) 5001 Campus Dr., College Park, MD 20740, 240-402-1636, email: <E T="03">samir.assar@hhs.fda.gov</E> . <E T="03">With regard to the information collection:</E> Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, <E T="03">PRAStaff@fda.hhs.gov</E> . </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose and Coverage of the Final Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Final Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Table of Abbreviations/Commonly Used Acronyms in This Document</FP> <FP SOURCE="FP-2">III. Background</FP> <FP SOURCE="FP1-2">A. FDA Food Safety Modernization Act</FP> <FP SOURCE="FP1-2">B. 2015 Produce Safety Final Rule</FP> <FP SOURCE="FP1-2">C. New Information Since Issuance of the 2015 Produce Safety Final Rule</FP> <FP SOURCE="FP1-2">D. 2021 Agricultural Water Proposed Rule</FP> <FP SOURCE="FP1-2">E. 2022 Supplemental Proposed Rule</FP> <FP SOURCE="FP1-2">F. Public Comments</FP> <FP SOURCE="FP1-2">G. General Overview of Changes in the Final Rule</FP> <FP SOURCE="FP-2">IV. Legal Authority</FP> <FP SOURCE="FP-2">V. Comments on the Proposed Rule and FDA Response</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. General Comments on the Proposed Rule</FP> <FP SOURCE="FP1-2">C. Definitions (§ 112.3)</FP> <FP SOURCE="FP1-2">D. General Comments Regarding Pre-Harvest Agricultural Water Assessments (§ 112.43)</FP> <FP SOURCE="FP1-2">E. Exemptions From Agricultural Water Assessments (§ 112.43(b))</FP> <FP SOURCE="FP1-2">F. Elements of an Agricultural Water Assessment (§ 112.43(a))</FP> <FP SOURCE="FP1-2">G. Outcomes (§ 112.43(c))</FP> <FP SOURCE="FP1-2">H. Testing as Part of an Assessment (§ 112.43(d))</FP> <FP SOURCE="FP1-2">I. Reassessment (§ 112.43(e))</FP> <FP SOURCE="FP1-2">J. Corrective and Mitigation Measures (§ 112.45)</FP> <FP SOURCE="FP1-2">K. Treatment of Agricultural Water</FP> <FP SOURCE="FP1-2">L. Records Relating to Agricultural Water (§ 112.50)</FP> <FP SOURCE="FP-2">VI. Effective and Compliance Dates</FP> <FP SOURCE="FP-2">VII. Economic Analysis of Impacts</FP> <FP SOURCE="FP-2">VIII. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">IX. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">X. Federalism</FP> <FP SOURCE="FP-2">XI. Consultation and Coordination With Indian Tribal Governments</FP> <FP SOURCE="FP-2">XII. References</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose and Coverage of the Final Rule</HD> In this final rule, the Food and Drug Administration (FDA, the Agency, or we) is amending the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” rule (2015 produce safety final rule), which was established in accordance with the FDA Food Safety Modernization Act (FSMA) and sets forth science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables for human consumption. This rule revises certain provisions in the 2015 produce safety final rule applicable to agricultural water  <SU>1</SU> <FTREF/> for covered produce other than sprouts, using a direct application method during growing activities (commonly referred to as “pre-harvest agricultural water”  <SU>2</SU> <FTREF/> ). It establishes a regulatory framework of systems-based assessments and risk-tiered outcomes through which farms subject to the 2015 produce safety final rule (covered farms) are required to identify known and potential hazards and implement effective preventive measures within specific timeframes based on risk. <FTNT> <SU>1</SU>  “Agricultural water” is defined at 21 CFR 112.3 as water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food-contact surfaces, including water used in growing activities (including irrigation water applied using direct water application methods, water used for preparing crop sprays, and water used for growing sprouts) and in harvesting, packing, and holding activities (including water used for washing or cooling harvested produce and water used for preventing dehydration of covered produce). Related to this definition is our definition of “direct water application method,” which means agricultural water used in a manner whereby the water is intended to, or is likely to, contact covered produce or food-contact surfaces during use of the water. If a specific use of water does not fit within the definition of agricultural water, then the requirements in subpart E do not apply to that specific use of water. See 80 FR 74354 at 74429. </FTNT> <FTNT> <SU>2</SU>  The 2015 produce safety final rule refers to pre-harvest agricultural water used during sprout production as “sprout irrigation water.” </FTNT> The written assessments focus on agricultural water systems, including sources, and agricultural water practices that are key determinants of contamination risks associated with agricultural water, together with crop characteristics and environmental conditions that can impact the survival of pathogens. The assessments include a requirement to test pre-harvest agricultural water in certain circumstances—that is, when doing so would not delay action most critical to protect public health and would further inform the farm's determination as to whether measures are reasonably necessary. Moreover, the assessments are designed for use in diverse circumstances and require covered farms to evaluate a broad range of factors that impact pre-harvest agricultural water quality, providing results that are tailored to address hazards unique to their respective operations. This approach will be feasible to implement across the wide variety of agricultural water systems, practices, and uses, and it is adaptable to future advancements in agricultural water quality science. Farms must use the information evaluated to make a written determination on the outcomes of their assessments. The outcomes are based on risk, and include the actions farms must take within a specific timeframe to ensure that their pre-harvest agricultural water is safe and is of adequate sanitary quality for the intended use(s). Within this framework for risk-tiered outcomes is a new expedited mitigation requirement relating to the impacts of certain adjacent and nearby land uses on pre-harvest agricultural water. These amendments to the 2015 produce safety final rule are supported by scientific literature published since FDA promulgated the 2015 produce safety final rule and findings from FDA's outbreak investigations since FDA promulgated the 2015 produce safety final rule. These amendments are also supported by information and insights shared by an array of stakeholders through a variety of means since FDA promulgated the 2015 produce safety final rule (including through meetings, educational farm visits, and listening sessions), as well as information shared through the notice-and-comment process for this rulemaking. Feedback shared by stakeholders included informat ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 538k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━