{"abstract":"To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce.","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/2015/11/27/2015-28159.html","cfr_references":[{"chapter":null,"citation_url":null,"part":11,"title":21},{"chapter":null,"citation_url":null,"part":16,"title":21},{"chapter":null,"citation_url":null,"part":112,"title":21}],"citation":"80 FR 74354","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective January 26, 2016. The effective date of Sec. Sec. 117.5(k)(2), 117.8, 117.405(c), 117.410(d)(2)(ii), 117.430(d), and 117.475(c)(13) published September 17, 2015 (80 FR 55908), is January 26, 2016. The effective date of Sec. Sec. 507.12(a)(1)(ii), 507.105(c), 507.110(d)(2)(ii), 507.130(d), and 507.175(c)(13) published September 17, 2015 (80 FR 56170), is January 26, 2016. See section XXIV of this document for the compliance dates. The incorporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register as of January 26, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0921"],"dockets":[],"document_number":"2015-28159","effective_on":"2016-01-26","end_page":74568,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/11/27/2015-28159.xml","html_url":"https://www.federalregister.gov/documents/2015/11/27/2015-28159/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-28159?publication_date=2015-11-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-11-27/2015-28159/mods.xml","not_received_for_publication":null,"page_length":215,"page_views":{"count":86576,"last_updated":"2026-07-25 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-11-27/pdf/2015-28159.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-28159.pdf?1447422325","publication_date":"2015-11-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/11/27/2015-28159.txt","regulation_id_number_info":{"0910-AG35":{"issue":"201510","html_url":"https://www.federalregister.gov/regulations/0910-AG35/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption-","title":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201510&RIN=0910-AG35&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AG35"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference  2 Produce Ag Water compliance extension PRIA Sept 2017 re Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E","document_id":"FDA-2011-N-0921-19147"},{"title":"QAR _Reference 75_EFSA-2011-Scientific Opinion on the Risk Posed by STEC and Other Pathogenic Bacteria in Seeds-EFSA Journal 9(11)1-101 re Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","document_id":"FDA-2011-N-0921-18900"},{"title":"QAR _Reference 29_Buchholz-2012-Transfer of O157H7 from equipment surfaces to fresh-cut leafy greens during processing-JFP 75(11)1920-1929 re Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","document_id":"FDA-2011-N-0921-18854"},{"title":"QAR _Reference 9_Barak-2007-The Role of Cellulose and O-Antigen Capsule in the Colonization of Plants by Salmonella enterica-MOLEC PLAT MICROBE INT re Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","document_id":"FDA-2011-N-0921-18834"},{"title":"Reference 232_Johanson_2015_Review of Lit on Methods for Seed Treatment_Memo re Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","document_id":"FDA-2011-N-0921-18792"},{"title":"Reference 218_FDA_Recalls Listeria mono in Sprouts_RES Database re Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","document_id":"FDA-2011-N-0921-18778"},{"title":"Reference 150_FDA_2015_Final Record of Decision (ROD) for Produce Rule re Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","document_id":"FDA-2011-N-0921-18709"},{"title":"Reference 140_FDA_Determining Regulatory Authority_Web re Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","document_id":"FDA-2011-N-0921-18699"},{"title":"Reference 134_FDA_2014_ESA Section 7 No effects determination_Memo re Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","document_id":"FDA-2011-N-0921-18693"},{"title":"Reference 131_National Pesticide_State Pesticide Regulatory Agencies_Web re Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","document_id":"FDA-2011-N-0921-18690"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG35/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption-","title":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption "},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0921","supporting_documents_count":655,"docket_id":"FDA-2011-N-0921","regulation_id_number":"0910-AG35","title":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","checked_regulationsdotgov_at":"2015-12-17T06:00:14Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":74354,"subtype":null,"title":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","toc_doc":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","toc_subject":null,"topics":["Administrative practice and procedure","Computer technology","Foods","Incorporation by reference","Packaging and containers","Reporting and recordkeeping requirements","Safety"],"type":"Rule","volume":80}