{ "id": "R43724", "type": "CRS Report", "typeId": "REPORTS", "number": "R43724", "active": true, "source": "EveryCRSReport.com, University of North Texas Libraries Government Documents Department", "versions": [ { "source": "EveryCRSReport.com", "id": 457732, "date": "2016-12-16", "retrieved": "2016-12-22T16:29:32.198703", "title": "Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)", "summary": "Congress passed comprehensive food safety legislation in December 2010 (FDA Food Safety Modernization Act, or FSMA, P.L. 111-353), representing the largest expansion and overhaul of U.S. food safety authorities since the 1930s. FSMA greatly expanded food safety oversight authority at the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS). Among its many provisions, FSMA expanded FDA\u2019s authority to conduct a mandatory recall of contaminated food products; enhanced surveillance systems to investigate foodborne illness outbreaks; established new preventive controls and food safety plans at some food processing facilities and farms; enhanced FDA\u2019s traceability capacity within the nation\u2019s food distribution channels; increased inspection frequencies of high-risk food facilities (both domestic and foreign facilities); and expanded FDA\u2019s authority and oversight capabilities with regard to foreign companies that supply food imports to the United States. \nUnder FSMA, FDA is responsible for more than 50 regulations, guidelines, and studies. This included seven \u201cfoundational\u201d rules required to fully implement FSMA covering:\nPreventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. \nPreventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals. \nProduce Safety: Establishes science-based standards for growing, harvesting, packing, and holding produce on domestic and foreign farms. \nForeign Supplier Verification Program: Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers. \nThird Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. \nSanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food. \nIntentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm. \nThese regulations were to have been proposed or, in some cases, finalized within one to two years of enactment (roughly January 2012 and January 2013); other rules were to have been submitted within 18 months of enactment (roughly mid-2012). However, many of these regulations did not become final until 2016. Other FDA actions under FSMA were also delayed. Several factors contributed to these delays, including the Office of Management and Budget\u2019s (OMB's) review process, extensions in the public comment and response period for many of FDA\u2019s proposed rules and the agency\u2019s re-proposal of key provisions of some major regulations, and also, according to FDA, limited agency resources and the lack of availability of discretionary appropriations. Delays in FDA\u2019s rulemaking process resulted in many FSMA regulations being released according to a court-ordered schedule under a federal lawsuit brought by the Center for Food Safety. \nFull implementation of the most FSMA regulations will be phased in over the next several years, mostly to provide flexibility to farms and food businesses to comply with the new requirements, as provided for in the enacted law. In addition, in September 2016, FDA further extended the compliance dates for many regulated facilities, especially small and very small businesses.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R43724", "sha1": "73ab00b05b66a554b103c29ef57cd25ac653a284", "filename": "files/20161216_R43724_73ab00b05b66a554b103c29ef57cd25ac653a284.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R43724", "sha1": "0dbf28baf5500c2b9955e545ed4c42c774b49f79", "filename": "files/20161216_R43724_0dbf28baf5500c2b9955e545ed4c42c774b49f79.pdf", "images": null } ], "topics": [ { "source": "IBCList", "id": 4771, "name": "Food Safety" } ] }, { "source": "EveryCRSReport.com", "id": 450190, "date": "2016-02-25", "retrieved": "2016-04-06T17:01:04.076268", "title": "Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)", "summary": "Congress passed comprehensive food safety legislation in December 2010 (FDA Food Safety Modernization Act, or FSMA, P.L. 111-353), representing the largest expansion and overhaul of U.S. food safety authorities since the 1930s. FSMA greatly expanded food safety oversight authority at the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS). Among its many provisions, FSMA expanded FDA\u2019s authority to conduct a mandatory recall of contaminated food products; enhanced surveillance systems to investigate foodborne illness outbreaks; established new preventive controls and food safety plans at some food processing facilities and farms; enhanced FDA\u2019s traceability capacity within the nation\u2019s food distribution channels; increased inspection frequencies of high-risk food facilities (both domestic and foreign facilities); and expanded FDA\u2019s authority and oversight capabilities with regard to foreign companies that supply food imports to the United States. \nUnder FSMA, FDA is responsible for more than 50 regulations, guidelines, and studies. This included seven \u201cfoundational\u201d rules required to fully implement FSMA covering:\nPreventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. \nPreventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals. \nProduce Safety: Establishes science-based standards for growing, harvesting, packing, and holding produce on domestic and foreign farms. \nForeign Supplier Verification Program: Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers. \nThird Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. \nSanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food. \nIntentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm. \nThese regulations were to have been proposed or, in some cases, finalized within one to two years of enactment (roughly January 2012 and January 2013); other rules were to have been submitted within 18 months of enactment (roughly mid-2012). However, many of these regulations did not become final until 2015, and regulations for two rules have yet to be finalized. Other FDA actions under FSMA also have been delayed. Several factors have contributed to delays in FSMA implementing, including the Office of Management and Budget\u2019s (OMB's) review process, extensions in the public comment and response period for many of FDA\u2019s proposed rules and the agency\u2019s re-proposal of key provisions of some major regulations, and also, according to FDA, limited agency resources and the lack of availability of discretionary appropriations. Delays in FDA\u2019s rulemaking process resulted in many FSMA regulations being released according to a court-ordered schedule under a federal lawsuit brought by the Center for Food Safety. \nThis report documents the scheduled timeline for action on selected FSMA provisions, as specified in the enacted law, and FDA-reported actions taken to date, based on available FDA press releases and publicly available progress reports.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R43724", "sha1": "6fdffd6bf357eb52fd8f27b8b664f898ca6f8a04", "filename": "files/20160225_R43724_6fdffd6bf357eb52fd8f27b8b664f898ca6f8a04.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R43724", "sha1": "1bfa104a80df3ac66130765c390ddb200b629afa", "filename": "files/20160225_R43724_1bfa104a80df3ac66130765c390ddb200b629afa.pdf", "images": null } ], "topics": [ { "source": "IBCList", "id": 2621, "name": "Food Safety" } ] }, { "source": "University of North Texas Libraries Government Documents Department", "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc461914/", "id": "R43724_2014Sep22", "date": "2014-09-22", "retrieved": "2014-12-05T09:57:41", "title": "Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)", "summary": "This report documents the scheduled timeline for action on selected FDA Food Safety Modernization Act (FSMA) provisions, as specified in the enacted law, and FDA-reported actions taken to date, based on available FDA press releases and publicly available progress reports.", "type": "CRS Report", "typeId": "REPORT", "active": false, "formats": [ { "format": "PDF", "filename": "files/20140922_R43724_5bcfa8856c30f31c95bfa01c25cc9bcf85e31381.pdf" }, { "format": "HTML", "filename": "files/20140922_R43724_5bcfa8856c30f31c95bfa01c25cc9bcf85e31381.html", "source": "pymupdf" } ], "topics": [ { "source": "LIV", "id": "Food", "name": "Food" }, { "source": "LIV", "id": "Food safety", "name": "Food safety" }, { "source": "LIV", "id": "Government regulation", "name": "Government regulation" } ] } ], "topics": [ "Agricultural Policy", "Appropriations" ] }