{"abstract":"The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled \"Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements.\" This final rule affirms the IFR's change to FDA's records access as required by the FDA Food Safety Modernization Act (FSMA). Prior to the passage of FSMA, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) provided the Secretary (by delegation FDA) with access to records relating to food that FDA reasonably believes to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to include records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR.","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/2014/04/04/2014-07550.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21}],"citation":"79 FR 18799","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This final rule is effective April 4, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2002-N-0153 (Formerly Docket No. 2002N-0277)"],"dockets":[],"document_number":"2014-07550","effective_on":"2014-04-04","end_page":18802,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/04/04/2014-07550.xml","html_url":"https://www.federalregister.gov/documents/2014/04/04/2014-07550/establishment-maintenance-and-availability-of-records-amendment-to-record-availability-requirements","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-07550?publication_date=2014-04-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-04-04/2014-07550/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":15456,"last_updated":"2026-10-25 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-04-04/pdf/2014-07550.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-07550.pdf?1396529393","publication_date":"2014-04-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/04/04/2014-07550.txt","regulation_id_number_info":{"0910-AG73":{"issue":"201310","html_url":"https://www.federalregister.gov/regulations/0910-AG73/establishment-maintenance-and-availability-of-records-amendment-to-record-availability-requirements","title":"Establishment, Maintenance, and Availability of Records:  Amendment to Record Availability Requirements","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201310&RIN=0910-AG73&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG73"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Supporting Statement","document_id":"FDA-2002-N-0153-0111"},{"title":"Supporting Statement","document_id":"FDA-2002-N-0153-0110"},{"title":"Supporting Statement","document_id":"FDA-2002-N-0153-0109"},{"title":"Establishment & Maintenance of Records Under The Public Health Security & Bioterrorism Preparedness & Response Act of 2002 (Table of Tabs)","document_id":"FDA-2002-N-0153-0041"},{"title":"Tab 16 [R. T. I. International \"Survey of Manufacturing Practices In The Dietary Supplement Industry (Continued)\"]","document_id":"FDA-2002-N-0153-0040"},{"title":"Tab 6 - [U. S. Department of Labor \"National Compensation Survey: Occupation Wages In The United Sates, 2000\"]","document_id":"FDA-2002-N-0153-0039"},{"title":"Tab 16 - [R. T. I. International \"Survey of Manufacturing Practices In The Dietary Supplement Industry\"]","document_id":"FDA-2002-N-0153-0038"},{"title":"Tab 32 - [Infectious Disease Society of America \"Bacterial Contamination of Animal Feed & It's Relationship To Human Foodborne Illness\"]","document_id":"FDA-2002-N-0153-0037"},{"title":"Tab 31 - [S. B. A. \"Small Business By The Numbers\"]","document_id":"FDA-2002-N-0153-0036"},{"title":"Tab 30 - [The New Journal of Medicine \"An Outbreak In 1996 of Cyclosporiasis Associated with Imported Raspberries\"]","document_id":"FDA-2002-N-0153-0035"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2002-N-0153","supporting_documents_count":37,"docket_id":"FDA-2002-N-0153","regulation_id_number":null,"title":"Bioterrorism; Establishment & Maintenance of Records","checked_regulationsdotgov_at":"2014-04-24T08:03:33Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":18799,"subtype":null,"title":"Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements","toc_doc":"Establishment, Maintenance, and Availability of Records","toc_subject":"Record Availability Requirements:","topics":["Cosmetics","Drugs","Exports","Food labeling","Imports","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":79}