{"abstract":"The Food and Drug Administration (FDA or we) is adding regulations for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. These regulations will, for the first time, establish requirements for the current good manufacturing practice (CGMP) for food for animals. In addition, we are adding requirements for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. We are taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to humans and animals and to implement new statutory provisions in the FDA Food Safety Modernization Act (FSMA). The rule is intended to build an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system.","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/2015/09/17/2015-21921.html","cfr_references":[{"chapter":null,"citation_url":null,"part":11,"title":21},{"chapter":null,"citation_url":null,"part":16,"title":21},{"chapter":null,"citation_url":null,"part":117,"title":21},{"chapter":null,"citation_url":null,"part":500,"title":21},{"chapter":null,"citation_url":null,"part":507,"title":21},{"chapter":null,"citation_url":null,"part":579,"title":21}],"citation":"80 FR 56170","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective November 16, 2015, except for paragraph (2) of the definition of \"qualified auditor\" in Sec. 507.3, and Sec. Sec. 507.12(a)(1)(ii), 507.105(a)(2), 507.105(c), 507.110(d)(2)(ii), 507.130(d), 507.135(d), 507.175(c)(2), and 507.175(c)(13). FDA will publish a document in the Federal Register announcing the effective dates of paragraph (2) of the definition of \"qualified auditor\" in Sec. 507.3, Sec. Sec. 507.12(a)(1)(ii), 507.105(a)(2), 507.105(c), 507.110(d)(2)(ii), 507.130(d), 507.135(d), 507.175(c)(2), and 507.175(c)(13). Certain provisions have later compliance dates as discussed in section LIII \"Effective and Compliance Dates.\"","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0922"],"dockets":[],"document_number":"2015-21921","effective_on":"2015-11-16","end_page":56356,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/09/17/2015-21921.xml","html_url":"https://www.federalregister.gov/documents/2015/09/17/2015-21921/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-food-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-21921?publication_date=2015-09-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-09-17/2015-21921/mods.xml","not_received_for_publication":null,"page_length":187,"page_views":{"count":18360,"last_updated":"2026-07-27 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-09-17/pdf/2015-21921.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-21921.pdf?1441889119","publication_date":"2015-09-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/09/17/2015-21921.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"}},"regulation_id_numbers":["0910-AG10"],"regulations_dot_gov_info":{"supporting_documents":[{"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-0922-0562"},{"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-0922-0561"},{"title":"Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based\nPreventive Controls for Food for Animals; Technical Amendment","document_id":"FDA-2011-N-0922-0553"},{"title":"Reference 7. FRIA - Estimate of Foodborne proportion from Australia re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0545"},{"title":"Reference 2. FRIA - ERG final - Animal Feed Safety System April 2011 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0542"},{"title":"Reference 54 Codex Alimentarius Procedural Manual, 23rd Edition re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0530"},{"title":"Reference 50 FSIS Compliance Guideline HACCP Systems Validation re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0529"},{"title":"Reference 44 FDA E-mail Sign-up Page for Recalls re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0524"},{"title":"Reference 37 Recall Natura Pet Vitamin Insufficiency re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0518"},{"title":"Reference 24 Solely at Dictionary.com re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0510"}],"regulatory_plan":{"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"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0922","supporting_documents_count":177,"docket_id":"FDA-2011-N-0922","regulation_id_number":"0910-AG10","title":"Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food For Animals","checked_regulationsdotgov_at":"2015-10-07T06:00:11Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":56170,"subtype":null,"title":"Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","toc_doc":"Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","toc_subject":null,"topics":["Administrative practice and procedure","Animal drugs","Cancer","Computer technology","Food packaging","Foods","Labeling","Packaging and containers","Polychlorinated biphenyls (PCB's)","Radiation protection","Reporting and recordkeeping requirements"],"type":"Rule","volume":80}