{"abstract":"The Food and Drug Administration (FDA or we) is clarifying the compliance date that we provided for certain food establishments subject to a final rule that published in the Federal Register of September 17, 2015. Among other things, that final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. We are taking this action in response to requests for clarification of the compliance date for facilities that manufacture, process, pack, or hold grade \"A\" milk or milk products and that are regulated under the National Conference on Interstate Milk Shipments (NCIMS) system.","action":"Final rule; clarification of compliance date for certain food establishments.","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/2015/11/18/2015-29340.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21},{"chapter":null,"citation_url":null,"part":11,"title":21},{"chapter":null,"citation_url":null,"part":16,"title":21},{"chapter":null,"citation_url":null,"part":106,"title":21},{"chapter":null,"citation_url":null,"part":110,"title":21},{"chapter":null,"citation_url":null,"part":114,"title":21},{"chapter":null,"citation_url":null,"part":117,"title":21},{"chapter":null,"citation_url":null,"part":120,"title":21},{"chapter":null,"citation_url":null,"part":123,"title":21},{"chapter":null,"citation_url":null,"part":129,"title":21},{"chapter":null,"citation_url":null,"part":179,"title":21},{"chapter":null,"citation_url":null,"part":211,"title":21}],"citation":"80 FR 71934","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The compliance date under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (published on September 17, 2015 at 80 FR 55908) for grade \"A\" milk and milk products covered by NCIMS under the PMO is September 17, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0920"],"dockets":[],"document_number":"2015-29340","effective_on":null,"end_page":71936,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/11/18/2015-29340.xml","html_url":"https://www.federalregister.gov/documents/2015/11/18/2015-29340/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-human","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-29340?publication_date=2015-11-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-11-18/2015-29340/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":26350,"last_updated":"2026-10-24 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-11-18/pdf/2015-29340.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-29340.pdf?1447767926","publication_date":"2015-11-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/11/18/2015-29340.txt","regulation_id_number_info":{"0910-AG36":{"issue":"201504","html_url":"https://www.federalregister.gov/regulations/0910-AG36/current-good-manufacturing-and-hazard-analysis-and-risk-based-preventive-controls-for-human-food-","title":"Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food\n","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201504&RIN=0910-AG36&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AG36"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 6 Standards for the Growing Harvesting and Holding of Produce RIA re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","document_id":"FDA-2011-N-0920-2060"},{"title":"Reference 5 Part 117 FSMA Final Rulemaking for CGMP and HAPC for Human Food RIA re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","document_id":"FDA-2011-N-0920-2059"},{"title":"Reference 4 Society of Plastics Letter May 3 2016 re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","document_id":"FDA-2011-N-0920-2058"},{"title":"Reference 3 Califonia Cotton Ginners Association Letter May 20 2016 re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","document_id":"FDA-2011-N-0920-2057"},{"title":"Reference 99-Final Rule-World Trade Organization 1994-The WTO Agreement on the Application of Sanitary and Phytosanitary Measures re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2044"},{"title":"Reference 97-Final Rule-FDA 2013-Information for Foreign Governments_Frequently Asked Questions on Systems Recognition re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2042"},{"title":"Reference 93-Final Rule-FDA 2012-Letter to Sunland Inc concerning Suspension of Food Facility Registration_Notice of Opportunity for Hearing re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2038"},{"title":"Reference 89-Final Rule-FDA 2008-Guidance for industry_Guide to minimize microbial hazards of fresh-cut fruits and vegetables re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2034"},{"title":"Reference 88-Final Rule-FDA 1995-Memorandum_Configuration of HACCP Plans re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2033"},{"title":"Reference 80-Final Rule-US Department of Health and Human Services 2015-Employers and Health Information in the Workplace HIPAA Privacy Rule re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2029"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG36/current-good-manufacturing-and-hazard-analysis-and-risk-based-preventive-controls-for-human-food-","title":"Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food\n"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0920","supporting_documents_count":105,"docket_id":"FDA-2011-N-0920","regulation_id_number":"0910-AG36","title":"Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food","checked_regulationsdotgov_at":"2015-12-08T06:00:11Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":71934,"subtype":null,"title":"Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments","toc_doc":"Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments","toc_subject":null,"topics":[],"type":"Rule","volume":80}