FDA Food Safety Modernization Act Proposed Produce Safety Regulation
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The document summarizes the Food Safety Modernization Act and the FDA's proposed produce safety regulations. It discusses why the law was needed due to issues like globalization and the increasing complexity of the food supply. It then outlines key provisions of the law around prevention, inspections/compliance, imports, and partnerships. It focuses on new requirements for importers to verify the safety of foreign suppliers and facilities. Finally, it discusses the FDA's approach to implementing the new rules through education, outreach, and flexibility.
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FDA Food Safety Modernization Act Proposed Produce Safety Regulation
- 1. FDA Food Safety Modernization Act Michael Rogers, M.S. Director, Latin America Office Food and Drug Administration FDA – Latin America Regional Office US-FDA-LAO@fda.hhs.gov 06/06/12 #1 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 2. Agenda • Why is the law needed? • Provisions of the law; focus on imports • Implementation 06/06/12 #2 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 3. Food Safety Modernization Act “I thank the President and members of Congress for recognizing that the burden that foodborne illness places on the American people is too great, and for taking this action.” Margaret A. Hamburg, M.D., Commissioner of Food and Drugs 06/06/12 #3 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 4. New law updates authority and tools 2011 – Food Safety Modernization Act 1976 Medical Device Amendments 1938 – Food, Drug, and Cosmetic Act 1906 – Pure Food and Drug Act 06/06/12 #4 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 5. Why is the law needed? Globalization • 15 percent of U.S. food supply is imported Food supply more high-tech & complex • More foods in the marketplace • New hazards in foods not previously seen Shifting demographics • Growing population (about 30%) of individuals are especially “at risk” for foodborne illness 06/06/12 #5 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 6. The Public Health Imperative • Foodborne illness is a significant burden – About 48 million (1 in 6 Americans) get sick each year – 128,000 are hospitalized – 3,000 die • Immune-compromised individuals more susceptible – Infants and children, pregnant women, older individuals, those on chemotherapy • Foodborne illness is not just a stomach ache—it can cause life-long chronic disease – Arthritis, kidney failure 06/06/12 #6 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 7. Main Themes of the Legislation Prevention Inspections, Compliance, Enhanced Partnerships & Response Import Safety 06/06/12 #7 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 8. Prevention: The cornerstone of the legislation • Comprehensive preventive controls for food facilities – Prevention is not new, but Congress gave FDA explicit authority to use the tool more broadly – Strengthens accountability for prevention • Produce safety standards • Intentional adulteration standards 06/06/12 #8 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 9. Inspection, Compliance & • Response Mandated inspection frequency – Considering new ways to inspect • New tools – Mandatory recall – Expanded records access – Expanded administrative detention – Suspension of registration – Enhanced product tracing – Third party laboratory testing 06/06/12 #9 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 10. Enhanced Partnerships: Vital to Success • Reliance on inspections by other agencies that meet standards • State/local & international capacity building • Improve foodborne illness surveillance • National agriculture & food defense strategy • Consortium of laboratory networks • Easier to find recall information 06/06/12 #10 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 11. Import Safety: Most Groundbreaking • Shift Importers now responsible for ensuring their suppliers have adequate preventive controls in place • Can rely on third parties to certify that foreign food facilities meet U.S. requirements • Can require mandatory certification for high-risk foods • Voluntary qualified importer program--expedited review • Can deny entry if FDA access for inspection is denied • Requires food from abroad to be as safe as domestic 06/06/12 #11 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 12. Import Safety Mandates Sec. 301. Foreign supplier verification program • Requires importers to verify their suppliers use risk- based preventive controls that provide same level of protection as U.S. requirements and that product is not adulterated or misbranded. Sec. 302. Voluntary qualified importer program • Allows for expedited review and entry of products from qualified importers received from certified facilities Sec. 303. Certification for high-risk food imports • FDA has discretionary authority to require assurances of compliance for high-risk foods 06/06/12 #12 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 13. Import Safety Mandates Sec. 304. Prior notice of imported food shipments • Requires information on prior refusals to be added to prior notice submission Sec. 305. Capacity building • FDA mandate to work with foreign governments to build food safety capacity Sec. 306. Inspection of foreign food facilities • Can deny entry if FDA access for inspection is denied Sec. 201. Targeting of inspection resources • Increased inspection of foreign as well as domestic facilities 06/06/12 #13 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 14. Import Safety Mandates Sec. 307. Accreditation of third-party auditors • FDA can rely on accredited third parties to certify that foreign food facilities meet U.S. requirements Sec. 308. Foreign Offices of the Food and Drug Administration. • Establish offices in foreign countries to provide assistance on food safety measures for food exported to the U.S. Sec. 309. Smuggled Food • In coordination with DHS, better identify and prevent entry of smuggled food 06/06/12 #14 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 15. Role of Third-Party Certification Programs • Tool for importers to obtain needed assurances to meet their obligations for the foreign supplier verification program (sec. 301) • A way for importers to participate in the voluntary qualified importer program to expedite movement of food through the import process (sec. 302) • Can be required by FDA to accompany high-risk foods (sec. 303) 06/06/12 #15 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 16. FDA Accreditation Body (or FDA) Recognizes Accredits 3rd parties Accreditation Bodies Sec. 307 3rd Party Auditor Certify high-risk food imports Voluntary Qualified Foreign supplier Importer Program verification program Importer inspection and High-risk Food Foreign firms may use product certification enable Certification Certification as a tool expedited product entry When required by FDA Sec. 301 Sec. 302 Sec. 303 06/06/12 #16 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 17. Implementation Approach • Implementation already underway • Coalition needed • Transparency a priority • Focus on public health protection • Engage with stakeholders to help determine reasonable and practical ways to implement provisions 06/06/12 #17 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 18. Triggers Regulatory Process (Rulemaking) • Legislation • Petition • Court Decision • Accident/Incident • Technology Proposed Final Effective Triggering Event Rule Rule Date FSMA (Step 1) (Step 2) (Step 3) Initial Research • Identify problem Additional • Substantiate problem WE ARE HERE Tools • Determine solution 06/06/12 #18 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 19. Rulemaking Process: It Doesn’t Happen Overnight 1. FDA proposes rule and We are nearly here requests comments 2. FDA considers comments and issues final rule 3. FDA sets dates for companies to comply 06/06/12 #19 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 20. Strategic Communications Implementation Executive & Outreach Team – Committee Implementation Sharon Natanblut Executive Committee Prevention Inspection/ Federal/State Fees Reports/ Imports Standards Compliance David Elder Integration Studies Don Kraemer Barbara Cassens Joe Reardon David Wardrop David Dorsey Importer Mandatory Produce Safety Verification & Inspection & Reports to Recall and Recall Operational Regulation VQIP Auditor Fees Congress/ Communications Partnership Studies Produce Safety Administrative Import Guidance Enforcement Certification Tools Capacity Accredited Building Preventive Third- Party Controls Registration Certification Regulation Lab Accreditation & Preventive Frequency of Integrated Training Controls Inspection Consortium/ Guidance FERN International Safe Food Tracing Capacity Transport Building Manner of Food Defense Inspection/Food Comparability Safety Plan Review Contaminants Task A: RFR Prior Notice Improvements 06/06/12 #20 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 21. Implementation & Compliance Educate before we regulate • Partner with stakeholders to provide education & outreach Non-traditional strategy: • Educate & outreach to enhance compliance • Small entity compliance guide on how to comply with the regulations • Updated GAPs guidance • Utilize existing & develop new partnerships with governments • Consider how existing efforts & information may be used • Develop appropriate review & oversight mechanism • Interface with trade associations, commodity groups, individuals with diverse farming practices and operations Flexibility built into regulation via Alternative approaches, Variances and Compliance dates 06/06/12 #21 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 22. Additional Resources • FDA FSMA page: http://www.fda.gov/Food/FoodSafety/FSMA/default.htm • Produce Safety Alliance: http://producesafetyalliance.cornell.edu/psa.html • FDA Produce Safety Activities: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsV 06/06/12 #22 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 23. For more information • Web site at: www.fda.gov/fsma • Subscription feature available To Submit Comments: • www.regulations.g ov 06/06/12 #23 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 24. 06/06/12 #24 FDA’s Current Thinking: Proposed Produce Safety Regulation
- 25. Thank you! Questions? us-fda-lao@fda.hhs.gov • San José, CR: (506) 2519-2224 • México DF : (52) (55) 1997-1506 • Santiago, Chile: (562) 330 3035 06/06/12 #25 FDA’s Current Thinking: Proposed Produce Safety Regulation
Notas del editor
- Congress passed the FSMA with overwhelming bi-partisan majorities in December 2010 and President Obama signed the legislation into law on January 4, 2011.
- Sec. 301. Foreign supplier verification program Requires importers to verify their suppliers use risk-based preventive controls that provide same level of protection as U.S. requirements and that product is not adulterated or misbranded. Sec. 302. Voluntary qualified importer program Allows for expedited review and entry of products from qualified importers received from certified facilities Sec. 303. Certification for high-risk food imports FDA has discretionary authority to require assurances of compliance for high-risk foods
- The regulatory process, also known as “rulemaking,” is triggered by an event such as a petition, court decision, accident or incident, technology or legislation. The enactment of the Food Safety Modernization Act directed FDA to issue several regulations. After the triggering event, there are 3 primary steps in the process---Proposed Rule Making, Final Rule and Effective Date. We could have other interim steps like issuing a modified proposed rule or an interim final rule. However, we’ll present the basic process that we typically follow. Details of these 3 steps are on the NEXT SLIDE.
- The proposed rule & final rule & supporting documents are filed in FDA’s official docket on: http://www.regulations.gov & also can be accessed at www.fda.gov/fsma.
- These additional resources are available for information and updates so check back frequently.
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