Exporting Seafood to the USA Steven Wilson Chief Quality Officer USDC Seafood Inspection Program

1. Exporting Seafood to the USASteven WilsonChief Quality OfficerUSDC Seafood Inspection Program

2. U.S. Food Safety Agencies EPA HHS USDA USDC NOAA Voluntary, Regulatory Compliance plus product quality inspection services FDA Mandatory Regulatory Compliance

3. Overview • Federal • Voluntary • Fee-for-Service • Domestic and Overseas

4. Services • In-plant Inspection & Certification • Continuous • System Evaluation • Lot Inspection & Certification • Consultative Services • HACCP Plan Development and Validation • Third Party Verifications • Training • Analytical testing

5. Participants & Beneficiaries • Harvesters • Processors • Distributors • Retailers • Food Service Operators • Importers and Exporters • Foreign Processors • Foreign Governments • Consumers

6. Seafood Imports • Over 85% of Seafood Products Consumed in U.S. are Imported • Numerous Species & Product Forms • Originate from Countries with Wide-Ranging Infrastructure, Capabilities, & Controls

7. Stakeholders • Public • Industry • Legislative Bodies • Government Agencies • Consumer Advocate Groups

8. Drivers • Buyer/Supplier Relationship • Liability Concerns • Media Coverage • Technically Savvy Public • Alternative Choices are Abundant

9. Recent Legislation • Public Health Security and Bioterrorism Response Act of 2002 (Bioterrorism Act) • Prior Notice • Registration of Firms Exporting to USA • Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) • Country of Origin Labeling (COOL) • 2008 Farm Bill

10. Emerging Program Requirements • ISO 9001 • Customer Quality Requirements • Food Defense • ISO 22000/PAS 220

11. Specific Concerns of Aquaculture • Pollutants • Drug Residues • Economic Integrity • Cost of Production • Vast Number of Raising Areas

12. Supplier/Buyer Relationship • Supply Chain Management • Use of Approved Suppliers • Buyers Specification and Verification • Importers Gaining Prominence

13. System Evaluation • Process Analysis and Control • Traceability • Documentation of Procedures • Recording Results

14. End Item Evaluation • High Comfort Level • Economic Fraud Concerns • Liability Concerns • Statistical Inference of Results • Sensitivity of Analyses

15. Agencies on Import to USA • USFDA • USDA-FSIS • USDA-AMS • USDA-APHIS • USDC-NMFS

16. Animal and Plant Health • Animal Plant Health Inspection Service • National Marine Fisheries Service

17. Food Safety Inspection Service • Meat • Beef • Pork • Rabbit • Horse • Etc. • Poultry • Eggs

18. Reinspection at Import • After product clears U.S. Customs product is reinspected • Assignment is computerized and dependent upon compliance history • Type of inspection is determined: net weight checks, condition of container, product defects, incubation of canned goods and laboratory analysis • Additional random sampling for drug and pesticide residues • Shipment is usually released before results are obtained

19. Agricultural Marketing Service • Fruits • Vegetables • Dairy • Tobacco • Cotton

20. Market Orders • Must meet the same or comparable grade, size, quality and maturity requirements • Avacados, dates, hazelnuts, grapefruit, table grapes, kiwifruit, olives, onions, oranges, Irish potatoes, plums, prunes raisins, tomatoes, walnuts • Products checked at border posts by U.S. Customs

21. U.S. Food and Drug Administration • Responsible for All Foods except meat and poultry • Also responsible for various other products (toys, blood, medical devices, pharmaceuticals, etc.)

22. Snapshot of Seafood Laws and Regulations (FD&C Act) • 402 a(1) Food Contains Poisonous or Deleterious Substance • 402 a(2) Food Contains Added Poisonous or Deleterious Substance • 402 a(3) Food Contains Filthy, Putrid, or Decomposed Substance • 402 a(4) Food Prepared, Packed or Held Under Insanitary Conditions Whereby it May be Contaminated with Filth or Whereby it May have been Rendered Injurious to Health

23. Snapshot of Seafood Laws and Regulations • GMP Regulation (21 CFR 110) • Seafood HACCP Regulation (21 CFR 123) • Low Acid Canned Food Regulation (21 CFR 113) • Guidance (e.g., Fish and Fishery Products Hazard Guide)

24. Requirements for Imported Seafood • Must appear to meet the requirements of the FD&C Act • Produced in compliance with the Seafood HACCP regulation or be from a country with an MOU or similar agreement • Importer must show affirmative steps • Importer of record must have product specifications ensuring compliance

25. Types of Detention • Detention of an Individual Entry (based on Sample Collection or Physical Examination) • Detention Without Physical Examination

26. Detention Criteria • Recommendation of FDA After a Regulatory Visit • Recommendation of a Foreign Competent Authority • Shipment Appears Violative

27. Violative Sample • Product may have adverse health consequences • Product contains actionable levels of pesticides, aflatoxin, or chemical contaminants

28. Violative Sample • Not in compliance with low acid canned food regulations • Contains unapproved or misused ingredients or additives • Not in compliance with nutritional labeling education act (Retail packages)

29. Procedures for Individual Detentions • Appears violative (damage packages, thawing, etc.) • FDA samples and analyzes lot • Lot released if no violation • Non-violation does not affect future shipment • Violative product not allowed entry

30. Detention without Physical Examination • A Shipment has the appearance of adulteration under the FD&C Act • Based on an Import Alert issued to address a perceived problem • Firms, Countries, and Regions may be subject to DWPE

31. How to Get Off DWPE • Firms must have 5 compliant shipments in a six month period • At least one shipment audited by FDA to ensure analytical validity • Shipment must represent usual products and different production runs • Countries and Regions must have 12 compliant shipments • Apply to the Division of Import Operation Policy

32. Removal From DWPE • FDA must be assured that firms are compliant over a reasonable period to remove from DWPE • FDA needs adequate product for sampling • FDA may request other documentation • Shipment must be compliant to all other provisions of US laws and regulations • FDA may require an establishment inspection

33. Bioterrorism Act Requirements • All Food Firms must be registered • Online at http://www.cfsan.fda.gov/~furls/ovffreg.html • By mail or fax with Form 3537 available at http://www.cfsan.fda.gov/~furls/papercd.html#forms • Address: U.S. Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857 • Fax: (301) 210-0247

34. Bioterrorism Act Requirements • Prior Notice Contact • http://www.cfsan.fda.gov/~pn/pnoview.html • Prior Notice of a Food Shipment must be submitted: • No more than 5 days before arrival, except for food arriving by international mail, and no less than • 2 hours before arrival—land by road • 4 hours before arrival—land by rail • 4 hours before arrival—air • 8 hours before arrival--water

35. Approved Aquaculture Drugs • Chorionic Gonadotropin • Oxytetracycline monoalkyl trimethyl ammonium • Sulfadimethoxine ormetoprim • Tricaine methanesulfonate • Formalin • Sulfamerazine

36. Regulatory Process for Serious Violations—Warning Letter • If a Warning Letter or Untitled Letter is issued, there will be a follow-up investigation • If the same or similar problem is found then the process is repeated • May result in a court injunction or product seizure • Foreign processor may be placed on Detention Without Physical Examination

37. Avoiding Regulatory Problems • Make corrections as soon as possible! Communicate to FDA in writing • Domestic firms need to submit corrective action before the inspection is classified • Foreign firms need to submit corrections to Investigator before they leave the country • If the firm cannot agree with the inspection results, the industry may petition the FDA regarding the scientific validity of HACCP controls • Enforcement may be held in abeyance until a review is made

38. Consequences of a Regulatory Action • Disruption of Production—Long Term • Inability to move product in commerce • More frequent inspections • Warning Letters are published. • DWPE for foreign firms may impose burden of illustrating product is safe resulting in costly analytical testing

39. Country of Origin Labeling • Mechanism of Traceability • Applies to Retail Establishments • Only certain size establishments must comply • Aquacultured Fish vs Wild Caught

40. Conclusions • Regulatory Actions Can Disrupt Business • FDA Desires Compliance through Cooperative Interchange • Positive steps can be taken by industry • FDA will accommodate good faith disagreements • Stronger Focus on Food Chain • Importers are Held Responsible • Quality is a Driver for Change • Government/Industry Partnerships • Quality Management Influence on Policy

41. Thank you!