{"abstract":"The Food and Drug Administration (FDA or we) is proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food. In that 2013 proposed rule, we proposed to amend the CGMP requirements to modernize them and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also proposed to revise certain definitions in our current regulation for Registration of Food Facilities to clarify the scope of an exemption from registration requirements for \"farms\" and, in so doing, to clarify which domestic and foreign facilities would be subject to the proposed requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action because the extensive input we have received from public comments has led to significant changes in our current thinking on certain key provisions of these proposed rules. We are reopening the comment period only with respect to specific issues identified in this proposed rule.","action":"Proposed rule; supplemental 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/2014/09/29/2014-22446.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21},{"chapter":null,"citation_url":null,"part":16,"title":21},{"chapter":null,"citation_url":null,"part":117,"title":21}],"citation":"79 FR 58524","comment_url":null,"comments_close_on":"2014-12-15","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by December 15, 2014 Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 15, 2014 (see the \"Paperwork Reduction Act of 1995\" section of this document).","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0920"],"dockets":[],"document_number":"2014-22446","effective_on":null,"end_page":58572,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/09/29/2014-22446.xml","html_url":"https://www.federalregister.gov/documents/2014/09/29/2014-22446/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-human","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-22446?publication_date=2014-09-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-09-29/2014-22446/mods.xml","not_received_for_publication":null,"page_length":49,"page_views":{"count":10862,"last_updated":"2026-07-26 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-09-29/pdf/2014-22446.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-22446.pdf?1411130541","publication_date":"2014-09-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/09/29/2014-22446.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":"2014-12-16T05:00:41Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":58524,"subtype":null,"title":"Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food","toc_doc":"Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls","toc_subject":"Human Foods:","topics":["Administrative practice and procedure","Cosmetics","Drugs","Exports","Food labeling","Food packaging","Foods","Imports","Labeling","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":79}