FDA Interstate Travel Program Update

1. FDA Interstate Travel Program Update IFSA GAEC Meeting Washington, DC January 29, 2013

2. UpdateFDA Food Safety Modernization Act

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

4. Proposed Rules under the FDA Food Safety Modernization Act Version 1/8/2013

5. Five Proposed Rules EstablishFood Safety Framework • Produce Safety Standards - Published Jan. 2013 • Preventive Controls for Human Food - Published Jan. 2013 • Foreign Supplier Verification Program • Preventive Controls for Animal Food • Accredited Third Party Certification

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

7. Preventive Controls for Human Food

8. Key Principles • Confirms industry’s primary role on food safety • Prevention of hazards • Risk-based

9. Summary of Requirements • Hazard Analysis and Risk-Based Preventive Controls • Each facility would be required to implement a written food safety plan that focuses on preventing hazards in foods • Updated Good Manufacturing Practices- 21 CFR 117 (proposed)

10. Who is Covered? • Facilities that manufacture, process, pack or hold human food • In general, facilities required to register with FDA under sec. 415 of the FD&C Act • Applies to domestic and imported food • Some exemptions and modified requirements are being proposed

11. Hazard Analysis and Risk-Based Preventive Controls

12. Preventive Controls Required • Process controls • Food allergen controls • Sanitation controls • Recall plan • In addition, seeking comment on supplier approval and verification program

13. Verification Required • Validation • Calibration • Review of records • In addition, seeking comment on review of complaints, finished product and environmental testing

14. Updated Good Manufacturing Practices • Protection against allergen cross-contact • Updated language; certain provisions containing recommendations would be deleted • Comments requested on mandating training and whether rule should require, rather than recommend, certain provisions

15. Exemptions and Modified Requirements • “Qualified” facilities: • Very small businesses (3 definitions being proposed—less than $250,000, less than $500,000 and less than $1 million in total annual sales) OR • Food sales averaging less than $500,000 per year during the last three years AND • Sales to qualified end users must exceed sales to others

16. Exemptions and Modified Requirements • Foods subject to low-acid canned food regulations (microbiological hazards only) • Foods subject to HACCP (seafood and juice) • Dietary supplements • Alcoholic beverages

17. Exemptions and Modified Requirements • Facilities, such as warehouses, that only store packaged foods that are not exposed to the environment • Certain storage facilities such as grain elevators that store only raw agricultural commodities intended for further distribution or processing

18. Effective and Compliance Dates Effective date: 60 days after the final rule is published Compliance Dates Small Businesses—a business employing fewer than 500 persons would have two years after publication.

19. 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.

20. How to Comment onthe Proposed Rules • http://www.regulations.gov • Link to rules on http://www.fda.gov/fsma • Comment period is 120 days; exact due date will be in the Federal Register • Comment periods on major FSMA proposals will be coordinated to enable comment on how the rules can best work together.

21. Public meetings Presentations Listening sessions Alliances Produce Safety Preventive Controls Sprouts Safety Guidance documents Outreach and Technical Assistance Will Continue Partnerships will be essential

22. More Information Available • Web site: http://www.fda.gov/fsma • Subscription feature available • Send questions to FSMA@fda.hhs.gov

23. Food Labeling • “package” means any container or wrapping in which any food, drug, device or cosmetic is enclosed for use in the delivery or display of such commodities to retail purchasers 21 CFR 1.20

24. Food Labeling • 21 CFR 101.9 (j)(2) (ii) exemption from nutritional labeling (if no nutritional claims)- food products which are served in other establishments in which food is served for immediate consumption (e.g. institutional food service establishments, such as… transportation carriers such as trains and airplanes…)

25. Food Labeling • Allergen labeling for “Big 8” allergens: • Peanuts • Soybeans • Milk • Eggs • Fish • Crustacea • Tree nuts • Wheat

26. Food Labeling Discussion • Individual meals • Trays • Meal carriers/carts • Buy-On- Board

27. 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. 

28. 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

29. 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

30. 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….”

31. Potable Water Servicing

32. 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

33. Bruce E. Kummer bruce.kummer@fda.hhs.gov Tel. No. 240-402-2142 Timothy M. Albright timothy.albright@fda.hhs.gov Tel. No. 240-402-1413 QUESTIONS ???