{"abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of two guidance documents that will help sprout operations subject to FDA's final rule entitled \"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption\" (the Produce Safety Rule) understand the topics covered in the Produce Safety Rule pertaining to personnel qualifications, training, and hygienic practices; equipment, tools, and buildings; and sampling and testing of spent sprout irrigation water (or in-process sprouts). FDA is issuing a draft guidance entitled, \"Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption,\" which revises a currently issued draft guidance entitled \"Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations\" (January 23, 2017) (the January 2017 draft guidance). In addition, FDA is announcing the availability of a final guidance entitled \"Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption,\" which finalizes portions of the January 2017 draft guidance with additional clarifications in response to comments.","action":"Notification of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2023/09/29/2023-21294.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"112","title":21}],"citation":"88 FR 67157","comment_url":"http://www.regulations.gov/commenton/FDA_FRDOC_0001-12463","comments_close_on":"2024-03-27","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft revised guidance by March 27, 2024 to ensure that FDA considers your comment on the draft revised guidance before we begin work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-0175"],"dockets":[{"supporting_documents":[{"title":"Reference 41 - Environmental Protection Agency. 2003. “Cross-Connection Control Manual.” Accessed September 20, 2023. RE Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption","document_id":"FDA-2017-D-0175-0144"},{"title":"Reference 5 -  Gubernot, D., et al. “Memorandum to the File: 2015-2016 Sprout and Sprout-Derived Product Related Outbreak Data, July 2016.” Food and Drug Administration. RE Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption","document_id":"FDA-2017-D-0175-0124"},{"title":"Reference 63-2004_WHO_Laboratory Biosafety Manual re Guidance for Industry on Compliance with and Implementation of the Standards for Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption for Sprout Operations","document_id":"FDA-2017-D-0175-0072"},{"title":"Reference 62-FDA_2014_Liquid Chemical Sterilization re Guidance for Industry on Compliance with and Implementation of the Standards for Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption for Sprout Operations","document_id":"FDA-2017-D-0175-0071"},{"title":"Reference 61-Buchanan_2000_Acquisition of Microbiological Data to Enhabce_JFP re Guidance for Industry on Compliance with and Implementation of the Standards for Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption for Sprout Operati","document_id":"FDA-2017-D-0175-0070"},{"title":"Reference 60-Carpentier_2011_Persistence of Listeria monocytogenes in food industry equipment and premises re Guidance for Industry on Compliance with and Implementation of the Standards for Growing, Harvesting, Packing, and Holding of Sprouts for Human C","document_id":"FDA-2017-D-0175-0069"},{"title":"Reference 55-Lado_2007_Characteristics of LM important to food processors re Guidance for Industry on Compliance with and Implementation of the Standards for Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption for Sprout Operations","document_id":"FDA-2017-D-0175-0064"},{"title":"Reference 54-ICMSF_1996_Chapter 8 Listeria monocytogenes re Guidance for Industry on Compliance with and Implementation of the Standards for Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption for Sprout Operations","document_id":"FDA-2017-D-0175-0063"},{"title":"Reference 52-Weller_2015_Irrigation Is Significantly Associated with an Increased Prevalence of LM in Produce Production re Guidance for Industry on Compliance with and Implementation of the Standards for Growing, Harvesting, Packing, and Holding of Sprou","document_id":"FDA-2017-D-0175-0061"},{"title":"Reference 49-FDA_Recalls Listeria mono in Sprouts_RES Database re Guidance for Industry on Compliance with and Implementation of the Standards for Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption for Sprout Operations","document_id":"FDA-2017-D-0175-0056"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2023-09-29T12:56:47.910-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-D-0175-0117","allow_late_comments":null,"id":"FDA-2017-D-0175-0117","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":223,"id":"FDA-2017-D-0175","title":"Compliance with and Implementation of the Standards for Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption for Sprout Operations: Guidance for Industry "},{"supporting_documents":[{"title":"Guidance: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements","document_id":"FDA_FRDOC_0001-12016"},{"title":"Meetings: Patient-Focused Drug Development for Long COVID","document_id":"FDA_FRDOC_0001-12015"}],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2023-09-29","updated_at":"2023-10-06T01:01:41.341-04:00","comment_url":"https://www.regulations.gov/commenton/FDA_FRDOC_0001-12463","allow_late_comments":null,"id":"FDA_FRDOC_0001-12463","comment_end_date":"2024-03-28","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA_FRDOC_0001","title":"Recently Posted FDA Rules and Notices."}],"document_number":"2023-21294","effective_on":null,"end_page":67159,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/09/29/2023-21294.xml","html_url":"https://www.federalregister.gov/documents/2023/09/29/2023-21294/draft-guidance-for-industry-standards-for-the-growing-harvesting-packing-and-holding-of-sprouts-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-21294?publication_date=2023-09-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-09-29/2023-21294/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":380,"last_updated":"2026-07-26 14:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-29/pdf/2023-21294.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-21294.pdf?1695905153","publication_date":"2023-09-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/09/29/2023-21294.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Guidance: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements","document_id":"FDA_FRDOC_0001-12016"},{"title":"Meetings: Patient-Focused Drug Development for Long COVID","document_id":"FDA_FRDOC_0001-12015"}],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA_FRDOC_0001","supporting_documents_count":0,"docket_id":"FDA_FRDOC_0001","document_id":"FDA_FRDOC_0001-12463","regulation_id_number":null,"title":"Recently Posted FDA Rules and Notices.","checked_regulationsdotgov_at":"2023-10-07T01:00:09Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA_FRDOC_0001-12463","significant":null,"signing_date":null,"start_page":67157,"subtype":null,"title":"Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption; and Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption; Availability","toc_doc":"Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption","toc_subject":"Guidance:\n","topics":[],"type":"Proposed Rule","volume":88}