{"abstract":"The Food and Drug Administration (FDA or we) is issuing this final rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. FDA is issuing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA).","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/2016/05/27/2016-12373.html","cfr_references":[{"chapter":null,"citation_url":null,"part":11,"title":21},{"chapter":null,"citation_url":null,"part":121,"title":21}],"citation":"81 FR 34166","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective July 26, 2016. See section VIII for compliance dates.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1425"],"dockets":[],"document_number":"2016-12373","effective_on":"2016-07-26","end_page":34223,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/05/27/2016-12373.xml","html_url":"https://www.federalregister.gov/documents/2016/05/27/2016-12373/mitigation-strategies-to-protect-food-against-intentional-adulteration","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-12373?publication_date=2016-05-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-05-27/2016-12373/mods.xml","not_received_for_publication":null,"page_length":58,"page_views":{"count":40399,"last_updated":"2026-07-27 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-05-27/pdf/2016-12373.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-12373.pdf?1464266755","publication_date":"2016-05-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/05/27/2016-12373.txt","regulation_id_number_info":{"0910-AG63":{"issue":"201604","html_url":"https://www.federalregister.gov/regulations/0910-AG63/focused-mitigation-strategies-to-protect-food-against-intentional-adulteration","title":"Focused Mitigation Strategies To Protect Food Against Intentional Adulteration","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0910-AG63&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AG63"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals","document_id":"FDA-2013-N-1425-0200"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Focused Mitigation Strategies To Protect Food Against Intentional Adulteration","document_id":"FDA-2013-N-1425-0186"},{"title":"Mitigation Strategies To Protect Food Against Intentional Adulteration: What You Need To Know About the Food and Drug Administration Regulation: Small Entity Compliance Guide; Availability","document_id":"FDA-2013-N-1425-0185"},{"title":"Reference 14-15. Food Defense Guidance re Mitigation Strategies to Protect Food Against Intentional Adulteration","document_id":"FDA-2013-N-1425-0183"},{"title":"Reference 14-16. National Industry-Specific Occupational Employment and Wage Estimates re Mitigation Strategies to Protect Food Against Intentional Adulteration","document_id":"FDA-2013-N-1425-0182"},{"title":"Reference 15. Memo detailing an evaluation of the potential for wide-scale public health harm resulting from intentional adulteration of mineral oil re Mitigation Strategies to Protect Food Against Intentional Adulteration","document_id":"FDA-2013-N-1425-0180"},{"title":"Reference 17. Tribal Summary Impact Statement re Mitigation Strategies to Protect Food Against Intentional Adulteration","document_id":"FDA-2013-N-1425-0178"},{"title":"Reference 18-1. Categorical Exclusion Memo for the Proposed Rule Focused Mitigation Strategies to Protect Food Against Intentional Adulteration re Mitigation Strategies to Protect Food Against Intentional Adulteration","document_id":"FDA-2013-N-1425-0176"},{"title":"Reference 3-1. Analysis of Results for FDA Food Defense Vulnerability Assessments and Identification of Activity Types re Mitigation Strategies to Protect Food Against Intentional Adulteration","document_id":"FDA-2013-N-1425-0171"},{"title":"Reference 5. Food Defense in the Age of Domestic Terrorism re Mitigation Strategies to Protect Food Against Intentional Adulteration","document_id":"FDA-2013-N-1425-0169"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG63/focused-mitigation-strategies-to-protect-food-against-intentional-adulteration","title":"Focused Mitigation Strategies To Protect Food Against Intentional Adulteration"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-1425","supporting_documents_count":70,"docket_id":"FDA-2013-N-1425","regulation_id_number":"0910-AG63","title":"Focused Mitigation Strategies to Protect Food Against Intentional Adulteration","checked_regulationsdotgov_at":"2016-06-16T06:00:14Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":34166,"subtype":null,"title":"Mitigation Strategies To Protect Food Against Intentional Adulteration","toc_doc":"Mitigation Strategies to Protect Food Against Intentional Adulteration","toc_subject":null,"topics":["Administrative practice and procedure","Computer technology","Food packaging","Foods","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}