{"abstract":"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.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/05/06/2024-09153.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"112","title":21}],"citation":"89 FR 37448","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective July 5, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0471"],"dockets":[{"supporting_documents":[{"title":"Reference 78 Weller 2017 Survival E. coli Lettuce Field Conditions encountered in the northeastern United States","document_id":"FDA-2021-N-0471-0093"},{"title":"Reference 64 Park 2012 Risk Factors Microbial Contamination Fruits and Vegetables preharvest level","document_id":"FDA-2021-N-0471-0088"},{"title":"Reference 51 Renter 2002 Enterohemorrhagic E. coli O157-H7 bovine production","document_id":"FDA-2021-N-0471-0081"},{"title":"Reference 26 Richardson 2017 Updated scheme for categorizing foods implicated in outbreaks","document_id":"FDA-2021-N-0471-0067"},{"title":"PRIA Reference 14 Minor 2015 Per Case and Totale Annual Costs of Foodborne Illness in the US","document_id":"FDA-2021-N-0471-0064"},{"title":"Reference 80 FDA 2021 Environmental Assessment for Proposed Rule","document_id":"FDA-2021-N-0471-0061"},{"title":"Reference 77 Chhetri 2019 Attachment strength and on-farm die-off rate of Escherichia coli on watermelon surfaces","document_id":"FDA-2021-N-0471-0060"},{"title":"Reference 74 Bowers 2015 Memo to File Minimum Sample Size for Surveys of Water Quality","document_id":"FDA-2021-N-0471-0057"},{"title":"Reference 73 EPA 2018 2017 Five-Year Review of 2012 RWQC","document_id":"FDA-2021-N-0471-0056"},{"title":"Reference 71 Blackburn 2020 Memorandum-Revised Protocol Review for Reg. No. 94151PA7","document_id":"FDA-2021-N-0471-0054"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-05-06","updated_at":"2024-09-03T16:57:47.710-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0471-0302","allow_late_comments":false,"id":"FDA-2021-N-0471-0302","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":229,"id":"FDA-2021-N-0471","title":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water"}],"document_number":"2024-09153","effective_on":"2024-07-05","end_page":37519,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/05/06/2024-09153.xml","html_url":"https://www.federalregister.gov/documents/2024/05/06/2024-09153/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption-relating","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-09153?publication_date=2024-05-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-05-06/2024-09153/mods.xml","not_received_for_publication":null,"page_length":72,"page_views":{"count":3414,"last_updated":"2026-05-30 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-09153.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09153.pdf?1714662913","publication_date":"2024-05-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/05/06/2024-09153.txt","regulation_id_number_info":{"0910-AI49":{"issue":"202310","html_url":"https://www.federalregister.gov/regulations/0910-AI49/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption-relating-t","title":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AI49&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AI49"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 78 Weller 2017 Survival E. coli Lettuce Field Conditions encountered in the northeastern United States","document_id":"FDA-2021-N-0471-0093"},{"title":"Reference 64 Park 2012 Risk Factors Microbial Contamination Fruits and Vegetables preharvest level","document_id":"FDA-2021-N-0471-0088"},{"title":"Reference 51 Renter 2002 Enterohemorrhagic E. coli O157-H7 bovine production","document_id":"FDA-2021-N-0471-0081"},{"title":"Reference 26 Richardson 2017 Updated scheme for categorizing foods implicated in outbreaks","document_id":"FDA-2021-N-0471-0067"},{"title":"PRIA Reference 14 Minor 2015 Per Case and Totale Annual Costs of Foodborne Illness in the US","document_id":"FDA-2021-N-0471-0064"},{"title":"Reference 80 FDA 2021 Environmental Assessment for Proposed Rule","document_id":"FDA-2021-N-0471-0061"},{"title":"Reference 77 Chhetri 2019 Attachment strength and on-farm die-off rate of Escherichia coli on watermelon surfaces","document_id":"FDA-2021-N-0471-0060"},{"title":"Reference 74 Bowers 2015 Memo to File Minimum Sample Size for Surveys of Water Quality","document_id":"FDA-2021-N-0471-0057"},{"title":"Reference 73 EPA 2018 2017 Five-Year Review of 2012 RWQC","document_id":"FDA-2021-N-0471-0056"},{"title":"Reference 71 Blackburn 2020 Memorandum-Revised Protocol Review for Reg. 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