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FDA Interstate Travel Program Update

FDA Interstate Travel Program Update. IFSA Conference Long Beach, California September 20, 2012 Bruce E. Kummer. Overview FDA Food Safety Modernization Act. The Public Health Imperative. Foodborne illness is a significant burden About 48 million (1 in 6 Americans) get sick each year

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FDA Interstate Travel Program Update

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  1. FDA Interstate Travel Program Update IFSA Conference Long Beach, California September 20, 2012 Bruce E. Kummer

  2. OverviewFDA Food Safety Modernization Act

  3. 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

  4. Why was the law needed? Globalization 15 percent of U.S. food supply is imported Food supply more high-tech and 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

  5. Main Themes of the Legislation Prevention Inspections, Compliance, and Response Enhanced Partnerships Import Safety

  6. Inspection, Compliance, and Response Mandated inspection frequency More inspections, but with preventive controls in place, we can consider new ways to inspect New tools Mandatory recall Expanded records access Expanded administrative detention Suspension of registration Enhanced product tracing Third party laboratory testing

  7. Import Safety: Most groundbreaking shift Importers now responsible for ensuring that their foreign suppliers have adequate preventive controls in place FDA 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

  8. Enhanced Partnerships: Vital to Success Reliance on inspections by other agencies that meet standards State/local and international capacity building Improve foodborne illness surveillance National agriculture and food defense strategy Consortium of laboratory networks Easier to find recall information

  9. Updated list and more information can be found at http://www.fda.gov/fsma Fees (sec. 107) New dietary ingredients (sec. 113) Anti-smuggled food strategy (sec. 201) Registration of food Facilities (sec. 103) Prior Notice of imported food shipments (sec. 304) Administrative detention of food (sec. 207) Consumer-friendly web search for recalls (sec. 205) Guidance to Seafood Industry on food safety hazards (sec. 103) Implementation Progress (8/2001)

  10. Snapshots of sections of the FSMA homepage found at http://www.fda.gov/fsma

  11. Strategic Communications & Outreach Team – Sharon Natanblut Inspection & Compliance Barbara Cassens Imports Roberta Wagner Reports & Studies David Dorsey Federal/State Integration Joe Reardon Prevention Standards Don Kraemer Fees Roxanne Schweitzer Implementation Executive Committee Reports to Congress/ Studies Inspection & Auditor Fees Operational Partnership Mandatory Recall / Recall Communications Importer Verification & VQIP Produce Safety Regulation Import Certification Produce Safety Guidance Administrative Enforcement Tools Capacity Building Accredited Third- Party Certification Preventive Controls Regulation Registration Training Lab Accreditation & Integrated Consortium / FERN Preventive Controls Guidance Frequency of Inspection Safe Food Transport International Capacity Building Manner of Inspection / Food Safety Plan Review Food Defense Comparability Tracing Contaminants Task A: Prior Notice RFR Improvements

  12. General Approach to Preventive Controls 1. Identify Hazard 2. Understand Cause 5. Review & Adjust 3. Implement Preventive Controls 4. Monitor Effectiveness 4. Monitor Effectiveness

  13. Prevention: The Cornerstone Comprehensive preventive controls for human and animal food facilities Prevention is not new, but Congress has given FDA explicit authority to use the tool more broadly Strengthens for prevention Produce safety standards Intentional adulteration standards Transportation

  14. Prevention Standards Mandates Sec. 105. Standards for Produce Safety Establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables Applies to raw agricultural commodities for which FDA determines that such standards minimize the risk of serious adverse health consequences or death.

  15. Prevention Standards Mandates Sec. 111. Sanitary Transportation of Food Addresses implementation of the Sanitary Food Transportation Act of 2005, which requires persons engaged in food transportation to use sanitary transportation practices to ensure that food is not transported under conditions that may render it adulterated.

  16. Examples of Compliance with Prevention Standards Sanitation Training for supervisors and employees Environmental controls and monitoring Food allergen controls Recall contingency plan Good Manufacturing Practices (GMPs) Supplier verification activities

  17. FSMA’s Effects on FDA’s ITP Continued focus on risk-based approach for future work-planning • consolidated plan for all food programs- high risk vs. non-high risk • consolidated sample collection plan SCOPE

  18. 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. Sec. 302. Voluntary qualified importer program Allows for expedited review and entry; facility certification required Sec. 303. Certification for high-risk food imports FDA has discretionary authority to require assurances of compliance for high-risk foods

  19. 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

  20. 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

  21. Accreditation Body Accredits 3rd parties Sec. 307 3rd Party Certification Certify high-risk food imports Sec. 303 Foreign supplier verification program Foreign firms obtain 3rd party certification as needed Sec. 301 Voluntary Qualified Importer Program Importer inspection and product certification enable expedited product entry Sec. 302 Import Provisions Work as a Whole

  22. Changes to 2009 Food Code Recommended in 2011 Supplement • Food establishments must have a certified food protection manager (new 2-102.12) • Food establishments have a plan for responding to and properly cleaning up after an employee or other individual becomes physically ill in areas where food may be prepared, stored or served (new 2-501.11)

  23. Changes to 2009 Food Code Recommended in 2011 Supplement • Person In Charge (PIC) has duties of: • Assuring all operating procedures required by Food Code are developed & implemented • Verifying that all employees are informed RE: reporting certain health conditions that relate to transmitting food borne illness • Assuring that food the establishment receives after operating hours is delivered in a manner that does not create a food safety hazard (modified 2-501.11)

  24. Changes to 2009 Food Code Recommended in 2011 Supplement • Clarification of appropriate exceptions to the prohibition of bare hand contact with ready-to-eat foods prepared in the establishment • assembly of food that will be cooked to 165 degrees F. prior to service (new 3-301.11(D))

  25. Changes to 2009 Food Code Recommended in 2011 Supplement • New requirements for devices used to generate chemical sanitizers on-site in the food establishment (new 4-501.114(F))

  26. Changes to 2009 Food Code Recommended in 2011 Supplement • Supplement to 2009 Food Code available on the FDA web page at: • http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode2009/ucm272584.htm

  27. Proposed Food Code Change from 2012 Conference for Food Protection • Non-continuous cooking parameters

  28. Applicability of Seafood HACCP : • http://www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/SeafoodHACCP/ucm194434.htm • Question 16 in Q & A of the Definitions section (21 CFR 123.3) : Airline caterers are retail operations, under FDA's Interstate Travel Program (I.T.P.) program, and therefore are exempt from the regulation. • Question 4  in Q & A of the Definitions section ( 21 CFR 1233.3): Seafood sandwiches (i.e. tuna) that are made for a third party vendor e.g. Starbucks are not exempt from Seafood HACCP  Reasoning: The vendors themselves sell the product retail, and are, therefore, exempt. However, the manufacturer sells the product wholesale and is, therefore, covered. The manufacturer must also be engaged in interstate commerce in order to be covered by the regulation, but, with canned tuna, that is highly likely. 

  29. FDA Water Regulations related to EPA’s Aircraft Drinking Water Rule • 21 CFR 1240.80 • only “potable water” to be provided for drinking & culinary purposes by aircraft operators for aircraft operating in interstate commerce • potable water from FDA approved watering points

  30. FDA/EPA connection on “potable water” (“finished water”) • 21 CFR 1240.83 Potable water • from water supply that meets EPA’s Primary Drinking Water Regulations in 40 CFR 141 • the methods of and facilities for delivery of such water to aircraft and surrounding conditions are sanitary & not disease-producing

  31. FDA Authorities and regulations • Part 1240 – Control of Communicable Diseases 21CFR1240.83 – Approval of Watering Points“The Commissioner of Food and Drugs shall approve any watering point ….” • Subpart D – Servicing Areas for Land and Air Conveyances 21CFR1250.60 – “…air conveyances …shall use only such servicing areas … as have been approved by the Commissioner of Food and Drugs….”

  32. Potable Water Servicing

  33. FDA’s Aircraft Watering Points and Servicing Areas Inventory Search • http://www.accessdata.fda.gov/scripts/AircraftWateringPoints/index.cfm • Accessible to airline customers and public • Based on national Official Establishment Inventory of aircraft watering point watering points and servicing areas

  34. Bruce E. Kummer Interstate Travel Program Mgr. bruce.kummer@fda.hhs.gov Tel. No. 240-402-2142 QUESTIONS ???

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