{"abstract":"The Food and Drug Administration (FDA or we) is adopting regulations to provide for accreditation of third-party certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications, under the FDA Food Safety Modernization Act (FSMA). These certifications will be required for participation in the voluntary qualified importer program (VQIP) established under the Federal Food, Drug, and Cosmetic Act (FD&C Act). In addition, when the Agency has determined that an imported food is subject to certification under FSMA, the Agency may require a certification under this rule as a condition for admitting the food into the United States. FDA also expects that these regulations will increase efficiency by reducing the number of redundant food safety audits.","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/2015/11/27/2015-28160.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}],"citation":"80 FR 74570","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective January 26, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0146"],"dockets":[],"document_number":"2015-28160","effective_on":"2016-01-26","end_page":74667,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/11/27/2015-28160.xml","html_url":"https://www.federalregister.gov/documents/2015/11/27/2015-28160/accreditation-of-third-party-certification-bodies-to-conduct-food-safety-audits-and-to-issue","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-28160?publication_date=2015-11-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-11-27/2015-28160/mods.xml","not_received_for_publication":null,"page_length":98,"page_views":{"count":13150,"last_updated":"2026-07-27 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-11-27/pdf/2015-28160.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-28160.pdf?1447422322","publication_date":"2015-11-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/11/27/2015-28160.txt","regulation_id_number_info":{"0910-AG66":{"issue":"201510","html_url":"https://www.federalregister.gov/regulations/0910-AG66/accreditation-of-third-party-auditors-certification-bodies-to-conduct-food-safety-audits-and-to-issu","title":"Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications\n","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201510&RIN=0910-AG66&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG66"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 03 Regulatory Impact Analysis for Third-Party Final Rule re Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for User Fee Program","document_id":"FDA-2011-N-0146-0245"},{"title":"Reference 02 Preliminary Regulatory Impact Analysis for Third-Party Proposed Rule re Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for User Fee Program","document_id":"FDA-2011-N-0146-0244"},{"title":"Reference 01 ISO IEC 17011-2004_copyright re Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for User Fee Program","document_id":"FDA-2011-N-0146-0243"},{"title":"List of References re Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for User Fee Program","document_id":"FDA-2011-N-0146-0242"},{"title":"Reference 25: FDA, “Tribal Summary Impact Statement: Final Rule on Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Iss","document_id":"FDA-2011-N-0146-0218"},{"title":"Reference 24: International Organization for Standardization, “ISO/TS 22003:2013 Food Safety Management Systems--Requirements for Bodies Providing Audit and Certification of Food Safety Management Systems,” re Accreditation of Third-Party Certification Bo","document_id":"FDA-2011-N-0146-0217"},{"title":"Reference 23: Safe Quality Food Institute, “SQF Code, Edition 7.2: A HACCP-Based Supplier Assurance Code for the Food Industry,” July 2014 re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications","document_id":"FDA-2011-N-0146-0216"},{"title":"Reference 21: International Organization for Standardization/International Electrotechnical Commission, “ISO 22000:2005 Food Safety Management Systems--Requirements for Any Organization in the Food Chain,” re Accreditation of Third-Party Certification Bod","document_id":"FDA-2011-N-0146-0215"},{"title":"Reference 19: Danish Accreditation Fund, “DANAK Home” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications","document_id":"FDA-2011-N-0146-0214"},{"title":"Reference 18: United Kingdom Accreditation Service, “About UKAS,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications","document_id":"FDA-2011-N-0146-0213"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG66/accreditation-of-third-party-auditors-certification-bodies-to-conduct-food-safety-audits-and-to-issu","title":"Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications\n"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0146","supporting_documents_count":29,"docket_id":"FDA-2011-N-0146","regulation_id_number":"0910-AG66","title":"Accreditation of Third-Party Auditors","checked_regulationsdotgov_at":"2015-12-17T06:00:14Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":74570,"subtype":null,"title":"Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications","toc_doc":"Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications","toc_subject":null,"topics":["Administrative practice and procedure","Computer technology","Cosmetics","Drugs","Exports","Food labeling","Imports","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":80}