1. Processed Food Industry Expanding Exports to the United States Carl C Reynolds

2. U.S. REGULATORY AUTHORITIES U.S. Department of Agriculture (USDA) –Domestic and Imported Meat Poultry Eggs Establish Ingredient Standards and Approve Recipes and Labels for Processed Meat and Poultry Products

3. U.S. REGULATORY AUTHORITIES Environmental Protection Agency –Water and Air Quality –Pesticide Approval and Registration –Establish Tolerances for Pesticides FDA and USDA Enforces Pesticide Tolerances Customs and Border Protection –Collects Duties and Tariffs

4. U.S. REGULATORY AUTHORITIES Food and Drug Administration –Foods –Drugs –Cosmetics –Medical Devices –Veterinary Drugs and Feeds –Biological Products –Radiation Devices

5. FOOD SAFETY CONTROL HACCP Hazard Analysis Critical Control Point Management Tool Used to Protect Food From Biological, Chemical and Physical Hazards

6. Traditional inspection methods versus The HACCP approach

7. HACCP HACCP is not a stand alone program HACCP requires prerequisite programs HACCP is not a zero-risk system Designed to minimize the risk of food-safety hazards Goal is to fix problems before they become hazards

8. Prerequisite Programs Good Manufacturing Practices SSOP: Sanitation Standard Operating Procedures Product specifications for ingredients and components Documented recall program for finished products

9. HACCP Principles 1.Conduct Hazard Analysis 2.Determine the Critical Control Points (CCP’s) in the Process 3.Establish Critical Limits 4.Monitor Each CCP 5.Establish Corrective Actions 6.Establish Verification Procedures 7.Establish Record Keeping Requirements and Documentation Procedures

10. HAZARD A biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

11. HAZARDS True Health Hazard, not just Undesirable Conditions or Contaminants: Hair Insects Filth Economic Fraud Decomposition or Spoilage Other Issues Not Directly Related to Food Safety

12. SPECIFIC COMMODITY REQUIREMENTS SEAFOOD HACCP –Applies to all processors of fish or fishery products in the U.S. and foreign countries exporting to the U.S. –Except harvesting, transporting or retail sales Processing – a broad definition –Handling, storing, preparing, freezing, changing into different market forms, heading, shucking, manufacturing, packing, labeling, dockside unloading and holding

13. IMPORTER REQUIREMENTS Fish or fishery product from country with MOU with FDA that documents equivalency of the foreign inspection system with the U.S. system. Written verification procedures for ensuring that fish or fishery product offered for import meet the requirements of Seafood HACCP

14. SPECIFIC COMMODITY REQUIREMENTS Juice Sold as Such or Used as an Ingredient in Beverages –Juice means the aqueous liquid, purees, or concentrates expressed or extracted from one or more fruits or vegetables Processing –Commercial, custom, or institutional processing of juice products Does not include – Harvesting, picking, or transporting raw agricultural products

15. IMPORTER REQUIREMENTS Obtain juice from country with MOU with FDA that documents equivalency of the foreign inspection system with the U.S. system. Written verification procedures for ensuring that juice offered for import meet the requirements of juice HACCP.

16. SPECIFIC COMMODITY REQUIREMENTS Thermally Processed Low Acid Canned Foods Packaged in Hermetically Sealed Containers –pH greater than 4.6 –Water activity (a w ) greater than 0.85 Acidified Foods –Low acid foods to which acids or acid foods have been added

17. IMPORTER REQUIREMENTS There are No Specific Importer Requirements for Low Acid or Acidified Foods –Each Manufacturing Facility (Domestic and Foreign) must Register with FDA. –Must File Scheduled Process with FDA for Each Product in Each Container Size. –Must Use Specific Forms

18. PACKAGING Any container or wrapping in which any food is enclosed for delivery or display to retail purchasers –Food Additives –Food Contact Surfaces

19. FOOD LABELING Food is misbranded if: –False or misleading in any particular Bears false or misleading statement Fails to bear material fact –Fails to bear required information –Bears standardized name but does not conform to compositional standard –Bears nutrient content claim or health claim that is not authorized

20. FOOD LABELING Label –Any written, printed or graphic matter on the immediate container or on the food Labeling –All written, printed, or graphic matter accompanying the food - includes website Advertising –Material that does not “accompany” the food

21. FOOD LABELING Required Label Information –Statement of identity –Net Contents –Ingredients –Name and place of business –Nutrition Labeling

22. Principal Display Panel

23. Allergen Labeling Establishes new definition of misbranding – failure to bear plain language name of major food allergen Effective date: January 1, 2006 Products labeled before date can be sold

24. MAJOR FOOD ALLERGENS Milk Eggs Fish (specific name) Crustacean shellfish (specific name) Tree nuts (specific name) Wheat Peanuts Soybeans

25. FOOD ALLERGENS Ingredients: semolina, rice flour, pine nuts, tomato juice, whey, sodium caseinate, and natural flavoring. Contains wheat, milk, pine nuts, and peanuts Ingredients: semolina (wheat), rice flour, pine nuts, tomato juice, whey (milk), sodium caseinate, and natural flavoring (peanuts).

26. COUNTRY OF ORIGIN LABELING Under Customs Law: –All foreign goods must be labeled with the country of origin when they are offered for entry into the United States: “Product of Turkey”

27. IMPORTED FOODS Meet Same Standards as Domestic Products –Not Adulterated –Labeled Correctly in English –Produced Under Sanitary Conditions –Food and Color Additives Must be Approved by FDA

28. IMPORTS: REGULATORY FDA does not have statutory authority to conduct inspections of food processing facilities in foreign countries. Determine compliance by sampling and examination of shipment at the point of entry. FDA refuses entry for those entries that appear to have been manufactured, processed, or packed under insanitary conditions.

29. BIOTERRORISM ACT REQUIREMENTS Requires the registration of all food facilities. Requires domestic firms to include the name of an Emergency Contact person and foreign firms to also include the name of a U.S. Agent who can also serve as the emergency contact. Defines facility as any factory, warehouse, or establishment of an importer that manufactures, processes, packs, or holds food. Failure to register a prohibited act.

30. BIOTERRORISM ACT REQUIREMENTS Prior Notice of Imported Food Shipments Time Frames 2 Hours Before Arrival by Land or Road 4 Hours Before Arrival by Air or by Land by Rail 8 Hours Before Arrival by Water Must be Received and Confirmed Electronically by FDA Before Food is Mailed by International Mail

31. Thank You