{"abstract":"The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in two fundamental ways. First, we are modernizing the long-standing current good manufacturing practice requirements. Second, we are adding requirements for domestic and foreign facilities that are subject to our regulation for Registration of Food Facilities to establish and implement hazard analysis and risk- based preventive controls for human food. We also are revising certain definitions in our regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided for \"farms\" and, in so doing, to clarify which domestic and foreign facilities are subject to the requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action as part of our announced initiative to revisit the current good manufacturing practice requirements since they were last revised in 1986 and to implement new statutory provisions in the FDA Food Safety Modernization Act. The rule is intended to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system.","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/2015/09/17/2015-21920.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 55908","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective November 16, 2015, except for the amendment to part 110 in instruction 13, which is effective September 17, 2018 and paragraph (2) of the definition of \"qualified auditor\" in Sec. 117.3, and Sec. Sec. 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2) and 117.475(c)(13). FDA will publish a document in the Federal Register announcing the effective dates of paragraph (2) of the definition of \"qualified auditor\" in Sec. 117.3, and Sec. Sec. 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2), and 117.475(c)(13). See section LVI for the compliance dates.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0920"],"dockets":[],"document_number":"2015-21920","effective_on":"2015-11-16","end_page":56168,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/09/17/2015-21920.xml","html_url":"https://www.federalregister.gov/documents/2015/09/17/2015-21920/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/2015-21920?publication_date=2015-09-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-09-17/2015-21920/mods.xml","not_received_for_publication":null,"page_length":261,"page_views":{"count":116082,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-09-17/pdf/2015-21920.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-21920.pdf?1441889121","publication_date":"2015-09-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/09/17/2015-21920.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"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":"2015-10-07T06:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":55908,"subtype":null,"title":"Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","toc_doc":"Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","toc_subject":null,"topics":["Administrative practice and procedure","Beverages","Beverages","Computer technology","Cosmetics","Drugs","Exports","Fish","Food additives","Food grades and standards","Food labeling","Food packaging","Foods","Fruit juices","Imports","Infants and children","Labeling","Laboratories","Nutrition","Packaging and containers","Prescription drugs","Radiation protection","Reporting and recordkeeping requirements","Seafood","Signs and symbols","Vegetable juices","Warehouses"],"type":"Rule","volume":80}