{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the agricultural water provisions of the produce safety regulation that covered farms have found complex and challenging to implement. This proposal would replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with provisions for systems-based agricultural water assessments that are designed to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices, while also being adaptable to future advancements in agricultural water quality science and achieving improved public health protections. Additionally, we are proposing to require expedited mitigation for hazards related to certain activities associated with adjacent and nearby lands, in light of findings from several recent produce outbreak investigations. These proposed revisions to the produce safety regulation, if finalized, would more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.","action":"Notice of proposed rulemaking.","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/2021/12/06/2021-26127.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"112","title":21}],"citation":"86 FR 69120","comment_url":null,"comments_close_on":"2022-04-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by April 5, 2022. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 5, 2022 (see the \"Paperwork Reduction Act of 1995\" section of this document).","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":135,"comment_start_date":"2021-12-06","updated_at":"2023-02-28T12:36:24.838-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0471-0001","allow_late_comments":null,"id":"FDA-2021-N-0471-0001","comment_end_date":"2022-04-06","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":"2021-26127","effective_on":null,"end_page":69155,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/12/06/2021-26127.xml","html_url":"https://www.federalregister.gov/documents/2021/12/06/2021-26127/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/2021-26127?publication_date=2021-12-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-12-06/2021-26127/mods.xml","not_received_for_publication":null,"page_length":36,"page_views":{"count":11059,"last_updated":"2026-07-26 14:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-12-06/pdf/2021-26127.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-26127.pdf?1638461725","publication_date":"2021-12-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/12/06/2021-26127.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. No. 94151PA7","document_id":"FDA-2021-N-0471-0054"}],"comments_count":135,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-0471","supporting_documents_count":229,"docket_id":"FDA-2021-N-0471","document_id":"FDA-2021-N-0471-0001","regulation_id_number":null,"title":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water","checked_regulationsdotgov_at":"2024-06-28T18:00:16Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":69120,"subtype":null,"title":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water","toc_doc":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water","toc_subject":null,"topics":["Dietary foods","Food grades and standards","Foods","Fruits","Incorporation by reference","Packaging and containers","Reporting and recordkeeping requirements","Safety","Vegetables"],"type":"Proposed Rule","volume":86}