David Acheson's Webinar Slides on Food Safety Legislation

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David Acheson's Webinar Slides on Food Safety Legislation

  1. 1. January 2011 1 Food Safety Modernization Act: Overview and Impact
  2. 2. 2 Food Safety Modernization Act Signed into law on January 4, 2011 Most sweeping overhaul of the food safety system since 1938 Several provisions are already in effect Increased inspection frequency Expanded records access Import certification authority Mandatory recall authority Fees Port shopping Whistleblower protection
  3. 3. 3 Mandatory Inspection Frequencies What is new? FDA must target inspection resources based on risk Known safety risk of the food Compliance history of a firm Rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls Mandatory inspection frequencies for: Domestic high-risk facilities Domestic low-risk facilities Foreign facilities Who is impacted? All registered facilities (any factory, warehouse, or establishment that manufactures, processes, packs or holds food)
  4. 4. 4 Mandatory Inspection Frequencies What will be different? FDA will not be able to meet requirements with current resources Utilize Federal, State, and Local regulatory partners (domestic facilities) Utilize third party certification (foreign facilities) Agreements with foreign governments Deny import of food from firms refusing inspection What does this mean Greater regulatory presence Increased oversight of and focus on imported food
  5. 5. 5 Expanded Records Access What is new? If FDA has a reasonable belief an article of food will cause severe adverse health consequences, a facility must provide FDA access to all records -- Relating to that article of food Relating to any other article of food that may have been impacted in a similar manner Who is impacted? Anyone who manufactures, processes, packs, distributes, receives, holds or imports food Farms and restaurants are excluded
  6. 6. 6 Expanded Records Access What will be different? Previously, FDA only had access to records relating to the specific article of food reasonably believed to present a threat of serious health consequences What does this mean? “Lower bar” for FDA to access records
  7. 7. 7 Mandatory Recall Authority What is new? Gives FDA authority to require a mandatory recall of product if responsible party refuses to voluntarily recall If FDA orders mandatory recall, informal hearing with the responsible party due within 2 days Failure to comply subject to civil penalties and criminal prosecution Incident Command Operation for each recall to coordinate government activities Who is impacted? Registered facilities that manufacture, process, pack, or hold food Farms, restaurants, and retail food establishments that are exempt from registering under Section 415 of the Food, Drug, and Cosmetic Act will not be directly impacted, but may be involved in recalls
  8. 8. 8 Mandatory Recall Authority What is new? Gives FDA authority to require a mandatory recall of product if responsible party refuses to voluntarily recall If FDA orders mandatory recall, informal hearing with the responsible party due within 2 days Failure to comply subject to civil penalties and criminal prosecution Incident Command Operation for each recall to coordinate government activities Who is impacted? Registered facilities that manufacture, process, pack, or hold food Farms, restaurants, and retail food establishments that are exempt from registering under Section 415 of the Food, Drug, and Cosmetic Act will not be directly impacted, but may be involved in recalls
  9. 9. 9 Mandatory Recall Authority What will be different Previously, if a firm refused to recall, FDA could issue press and pursue a court order, in each applicable jurisdiction, to seize the product Gives FDA authority to take action without prior court approval What does this mean? Majority of recalls occur voluntary and quickly because firms to not want to risk making consumers sick Fills a gap in FDA authority Probably will not be used on a routine basis
  10. 10. 10 Certification of Imported Food What is new? FDA may require imported food to be certified by accredited third-party auditor (which may be a foreign government) to ensure compliance with U.S. laws Certificates can apply to a specific shipment of food or to a facility Requirement for certification is based on: Known safety risks associated with the food Know safety risk of the country, territory, or region of origin Strength of the food safety system in the country, territory, or region of origin Who is impacted? Foreign manufacturers, processors, packers, holders, and importers Food safety auditors
  11. 11. 11 Certification of Imported Food What will be different? Entry of product into the U.S. may be delayed until certification is obtained What does this mean? Gives FDA additional leverage How FDA defines risk will be important Will likely take time to gain full effect, but may impact selected foods immediately
  12. 12. 12 Immediate Impact Other provisions: Fees Re-inspection of a facility (including importers) Cover all FDA recall related costs Participate in Voluntary Qualified Importer Program Port Shopping Requires notification by FDA to the Secretary of Homeland Security when food is refused admission to prevent importers from port shopping Whistleblower protections No entity engaged in manufacturing, processing, packing, transporting, distributing, receiving, holding or importing food may discharge or discriminate against a whistleblower
  13. 13. 13 Other Key Requirements Facility registration Preventive controls Protection against intentional adulteration Performance standards Standards for fresh produce Accreditation of third party auditors Accreditation of laboratories Traceability Foreign supplier verification program Prior notice of imported food
  14. 14. 14 Impact on Registered Facilities Biennial Facility Registration Sooner of 180 days or FDA issuing regulation FDA can suspend registration if food presents a reasonable probability of causing serious adverse health consequences Preventive Controls Requirement Identify hazards Implement preventive controls Monitor, correct, and verify Document Foreign supplier verification Food was produced in compliance with preventive controls and produce standards Food is not adulterated or misbranded
  15. 15. 15 Impact on Registered Facilities Tracking and tracing FDA to pilot product tracing in processed food and produce sectors Implement a product tracing system Additional record-keeping requirements for high-risk foods Protection against intentional contamination FDA to issue guidance on mitigation strategies FDA to issue regulations on who is required to implement mitigation strategies New dietary ingredients FDA guidance on definition of new dietary ingredient Evidence needed to document the safety of new dietary ingredients Appropriate methods for establishing the identify of a new dietary ingredient
  16. 16. 16 Impact on Importers Foreign supplier verification program Importers must verify that imported food is produced in compliance with U.S. laws and regulations Voluntary qualified importer program Expedited review of food offered by importers participating in the program Authority to require certification for imported food Allows FDA to require certificates of compliance with U.S. laws and regulations based on known risks associated with the food or country, region or territory of origin
  17. 17. 17 Impact on Importers Changes to prior notice requirements Must notify FDA of any country that refused the product Accreditation of third party auditors Conduct audits of foreign facilities and issue certifications to ensure product is in compliance with U.S. laws and regulations Determine if a facility is eligible to offer food for import under the voluntary qualified importer program
  18. 18. 18 Impact on Laboratories Accreditation of Laboratories FDA to develop program within 2 years Accreditation will be required for regulatory testing within 30 months Testing methods, use of new methods, method validation Model standards for accreditation Required plan for building capacity with foreign governments should include provisions for the multilateral acceptance of laboratory methods and testing and detection techniques Performance Standards FDA will review foodborne contaminants and issue regulations or guidance and action levelsas necessary to reduce risks
  19. 19. 19 Next Steps Monitor implementation of legislation Impact of much of the legislation is dependent on how regulations are drafted Implementation is dependent of FDA resources Provide input on rule-making process Stay in front of changes Understand and respond to dynamics Review current business and identify vulnerabilities and opportunities
  20. 20. Thank You 20

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