{"abstract":"The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.","action":"Final rule; extension and clarification of compliance dates for certain provisions.","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/2016/08/24/2016-20176.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":111,"title":21},{"chapter":null,"citation_url":null,"part":112,"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},{"chapter":null,"citation_url":null,"part":507,"title":21}],"citation":"81 FR 57784","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This final rule is effective August 24, 2016. See sections III.C, IV.A.2, IV.B, and V through VIII for the extended compliance dates.","disposition_notes":null,"docket_ids":["Docket Nos. FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922, FDA-2011-N-0143"],"dockets":[],"document_number":"2016-20176","effective_on":"2016-08-24","end_page":57796,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/08/24/2016-20176.xml","html_url":"https://www.federalregister.gov/documents/2016/08/24/2016-20176/the-food-and-drug-administration-food-safety-modernization-act-extension-and-clarification-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-20176?publication_date=2016-08-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-08-24/2016-20176/mods.xml","not_received_for_publication":null,"page_length":13,"page_views":{"count":28455,"last_updated":"2026-06-23 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-08-24/pdf/2016-20176.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-20176.pdf?1471956344","publication_date":"2016-08-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/08/24/2016-20176.txt","regulation_id_number_info":{"0910-AG10":{"issue":"201504","html_url":"https://www.federalregister.gov/regulations/0910-AG10/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-food-","title":"Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201504&RIN=0910-AG10&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"},"0910-AG64":{"issue":"201510","html_url":"https://www.federalregister.gov/regulations/0910-AG64/foreign-supplier-verification-program","title":"Foreign Supplier Verification Program","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201510&RIN=0910-AG64&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"},"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"},"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-AG10","0910-AG35","0910-AG36","0910-AG64"],"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":"2016-09-13T06:00:19Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":57784,"subtype":null,"title":"The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","toc_doc":"Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","toc_subject":"Food Safety Modernization Act:","topics":[],"type":"Rule","volume":81}