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Food Defense Guidance Documents & Regulatory Information | FDA

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Protect Food Against Intentional Adulteration</a>&nbsp;(May 2016)</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="336281c3-2ae9-4ce6-bf75-4ebeb6e28d87" href="/regulatory-information/search-fda-guidance-documents/supplemental-draft-guidance-industry-mitigation-strategies-protect-food-against-intentional" title="Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration">Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration</a>&nbsp;(February 2020)</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1cbd3c5f-8a35-4eed-9928-f84d0deb497c" href="/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-mitigation-strategies-protect-food-against-intentional-adulteration" title="Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional 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data-entity-uuid="cdc564d6-8193-4bc8-a4b2-56d6b10acf86" href="/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-mitigation-strategies-protect-food-against-intentional-adulteration" title="Small Entity Compliance Guide: Mitigation Strategies to Protect Food Against Intentional Adulteration">Small Entity Compliance Guidance: Mitigation Strategies to Protect Food Against Intentional Adulteration</a>&nbsp;(August 2017)</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c65da1fa-4c35-4928-914b-f96fbb1bded8" href="/regulatory-information/search-fda-guidance-documents/guidance-industry-food-security-preventive-measures-guidance-dairy-farms-bulk-milk-transporters-bulk" title="Guidance for Industry: Food Security Preventive Measures Guidance for Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors">Preventive Measures Guidance - Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors</a>&nbsp;(October 2007)&nbsp;Available in multiple languages.</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4a3f06af-dca9-451a-a6b0-1d648edcbc54" href="/regulatory-information/search-fda-guidance-documents/guidance-industry-food-security-preventive-measures-guidance-retail-food-stores-and-food-service" title="Guidance for Industry: Food Security Preventive Measures Guidance for Retail Food Stores and Food Service Establishments">Preventive Measures Guidance - Retail Food Stores and Food Service Establishments</a> (October 2007)</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c2e345b9-5427-409f-acd0-15d9baccea3c" href="/regulatory-information/search-fda-guidance-documents/guidance-industry-notice-growers-food-manufacturers-food-warehouse-managers-and-transporters-food" title="Guidance for Industry: Notice to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles">Guidance for Industry: Notice to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles</a> (November 2005)</li> </ul> <h2><a name="general"></a>General &amp; Related Information</h2> <p><strong>Importers &amp; Prior Notice of Imported Foods</strong></p> <ul> <li>See&nbsp;<a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7e730e17-2d48-414c-8a34-da8a087974d7" href="/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/imports-exports-guidance-documents-regulatory-information" target title="Imports &amp; Exports Guidance Documents &amp; Regulatory Information">Imports &amp; Exports Guidance Documents &amp; Regulatory Information</a></li> <li>View More on <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7a98ab97-0946-4f25-ac3b-89fb3b9d15e0" href="/food/food-imports-exports/importing-food-products-united-states" target title="Importing Food Products into the United States">Importing Food Products into the United States</a></li> </ul> <p><strong>Registration</strong></p> <ul> <li>See <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="6260d7f5-e50f-4c8e-bcb0-aa7c0fbb2866" href="/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions" target title="Registration of Food Facilities and Other Submissions">Registration of Food Facilities</a> &nbsp;</li> </ul> <p><strong>Establishment and Maintenance of Records</strong></p> <p>In February 2012, FDA published an Interim Final Rule amending FDA’s regulation on the record availability requires in section 1.361 (21 CFR 1.361) as part of its implementation of the amendments to the Federal Food, Drug, and Cosmetic Act made by the FDA Food Safety Modernization Act.</p> <p>FDA Actions on the Food Safety Modernization Act of 2011:</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="432e3ea6-1355-48b9-ac46-ec6f50e92c9e" href="/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-what-you-need-know-about-administrative-detention-foods" target title="Small Entity Compliance Guide: What You Need To Know About Administrative Detention of Foods">What You Need to Know About Establishment and Maintenance of Records</a>&nbsp; (December 2004; April 2014)</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8cf91adc-72a1-498d-b339-2bcb66539686" href="/regulatory-information/search-fda-guidance-documents/guidance-industry-fda-records-access-authority-under-sections-414-and-704-federal-food-drug-cosmetic" target title="Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, &amp; Cosmetic Act">FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, &amp; Cosmetic Act</a> (April 2014)</li> <li><a href="https://www.federalregister.gov/documents/2014/04/04/2014-07550/establishment-maintenance-and-availability-of-records-amendment-to-record-availability-requirements" target="_blank">Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records</a> (April 2014)</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ff5cc7f1-4f24-4cba-96b0-7a6fae4f7ed5" href="/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-establishment-and-maintenance-records-persons-who" target title="Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)">Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)</a>&nbsp;(February 2012)</li> </ul> <p>FDA Actions on the Bioterrorism Act of 2002:</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1228081f-1d42-400c-9450-cca630480c32" href="/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fda-staff-guidance-records-access-authority-provided-title-iii-subtitle-public" title="Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002">Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 </a>(November 2005)</li> </ul> <p><strong>Administrative Detention</strong></p> <p>FDA Actions on the Food Safety Modernization Act of 2011:</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="432e3ea6-1355-48b9-ac46-ec6f50e92c9e" href="/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-what-you-need-know-about-administrative-detention-foods" target title="Small Entity Compliance Guide: What You Need To Know About Administrative Detention of Foods">What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide</a> (November 2004; October 2011; March 2013)</li> <li><a href="https://www.federalregister.gov/articles/2013/02/05/2013-02497/criteria-used-to-order-administrative-detention-of-food-for-human-or-animal-consumption" target="blank">Final Rule: Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption</a>&nbsp;(February 2013)</li> </ul> <p>FDA Actions on the Bioterrorism Act of 2002:</p> <ul> <li><a href="http://www.gpo.gov/fdsys/pkg/FR-2004-06-04/html/04-12366.htm" target="_blank">Final Rule: Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002</a> (June 2004)</li> </ul> <p><strong>Recalls</strong></p> <p>FDA Actions on the Food Safety Modernization Act of 2011:</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="bb7425e8-c110-49a6-b829-914349cb051a" href="/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fda-staff-questions-and-answers-regarding-mandatory-food-recalls" target title="Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls">Questions and Answers Regarding Mandatory Food Recalls</a> (May 2015)&nbsp;</li> </ul> <p><strong>Fees</strong></p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f65e0a1b-90d2-4954-9d9f-5f1b4bd84a76" href="/regulatory-information/search-fda-guidance-documents/guidance-industry-implementation-fee-provisions-section-107-fda-food-safety-modernization-act" target title="Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act">Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act</a> (September 2011)</li> </ul> <p><strong>Other Food Defense Historical/Archived Information</strong></p> <ul> <li>Importers and Filers: Food Security Preventive Measures Guidance (October 2007); See&nbsp;current&nbsp;<a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1cbd3c5f-8a35-4eed-9928-f84d0deb497c" href="/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-mitigation-strategies-protect-food-against-intentional-adulteration" target title="Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration">Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration</a> (March 2019)</li> <li>Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (October 2007); See current&nbsp;<a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1cbd3c5f-8a35-4eed-9928-f84d0deb497c" href="/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-mitigation-strategies-protect-food-against-intentional-adulteration" target title="Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration">Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration</a> (March 2019)</li> <li>Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT Training&nbsp;(February 22, 2007) – See updated <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="48666c82-55ee-42cb-9218-6035df68b333" href="/food/food-defense/food-defense-training-education" title="Food Defense Training &amp; Education">updated trainings</a> aligned with the provisions of the <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="82ece981-b686-4184-ae35-8fa0ae88222f" href="/food/food-safety-modernization-act-fsma/fsma-final-rule-mitigation-strategies-protect-food-against-intentional-adulteration" title="FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration">Final Rule: Mitigation Strategies to Protect Food Against Intentional Adulteration</a>&nbsp;(May 2016)</li> <li><a href="http://wayback.archive-it.org/7993/20171114172202/https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm061476.htm" target>Fact Sheet on Establishment and Maintenance of Records Under the Bioterrorism Preparedness and Response Act of 2002 (November 2005)</a>&nbsp;</li> <li><a href="http://wayback.archive-it.org/7993/20171114013231/https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm062177.htm" target>Fact Sheet: FDA's New Food Bioterrorism Regulation Final Rule: Administrative Detention</a> (May 2004)&nbsp;</li> </ul> <hr> <p style="margin-bottom:13px"></p><div class="callout"> <p class="text-align-center"><strong><a href="/food/food-defense">Food Defense Main Page</a></strong></p> <p class="text-align-center"><strong><a href="/food-safety-modernization-act-fsma">Food Safety Modernization Act (FSMA)</a></strong></p> <p class="text-align-center"><strong><a href="/industry-notices-and-guidance-documents">All FDA Guidance Documents</a></strong></p> <p class="text-align-center">For general food defense&nbsp;information, please email&nbsp;<a href="mailto:FoodDefense@fda.hhs.gov">fooddefense@fda.hhs.gov</a>.</p> </div> <br> <br> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section 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