The Worldwide Movement of Food and Animal Products: Second Guessing Response to Threats

1. The Worldwide Movement of Food and Animal Products: Second Guessing Response to Threats Barry N. Pittman, DVM, MPH, DACVPM Area Emergency Coordinator MO & KS USDA APHIS Veterinary Services

4. As of Friday, the harsh statistics of this epidemic had reached 39 dead and over 3,517 sick, 839 of them with life-threatening kidney disease. …shortcomings in the food safety system… fresh produce does not receive enough attention under the current food safety system.

5. Agenda • Identify the vast flow of food, animals, and animal products exported and imported into the country. • Discuss the protective mechanisms in place to ensure the safety of these products. • Identify the threats to the flow of products and response methods in place to match those threats.

6. The vast flow of food, animals, and animal products exported and imported into the country.

7. U.S. Food Supply “going global…” • Sourcing of foods and ingredients reaching out to world markets • 15% of U.S. food supply is currently imported • > 75% of our seafood originates outside of the U.S. • > 60% of our fresh produce • According to USDA ERS the volume of imported food has seen a dramatic increase over the last 10 years and will continue to rise Source: USDA Economic Research Service http://www.ers.usda.gov

8. Overview of Imported Food • According to the CDC, food imports to the United States have almost doubled in the past decade, from $36 billion in 1997 to more than $70 billion in 2007. • FDA inspectors now sample just 1.3 percent of all imported food shipments entering the country. • Imported foods now comprise 13 percent of the American diet, according to the U.S. Department of Agriculture.

9. Overview of Imported Food, Part 2. • Just 1.3% of imported fish, vegetables, fruit and other foods are inspected — yet those government inspections regularly reveal food unfit for human consumption. • Frozen catfish from China, beans from Belgium, jalapenos from Peru, blackberries from Guatemala, baked goods from Canada, India and the Philippines — the list of tainted food detained at the border by the Food and Drug Administration stretches on. • One month in 2007 FDA detained nearly 850 shipments of grains, fish, vegetables, nuts, spice, oils and other imported foods for issues ranging from filth to unsafe food coloring to contamination with pesticides to salmonella. • Each year, the average American eats about 260 pounds of imported foods, including processed, ready-to-eat products and single ingredients.

10. Overview of Imported Food, Part 3. • According to the FDA, there are currently 226,377 foreign food establishments in over 150 countries that are registered to export food products to the U.S. • The FDA opened the first of its three China offices in Beijing in late 2008, and then in the cities of Shanghai and Guangzhou, to provide greater oversight, additional inspections and collaboration regarding food, pharmaceuticals medical devices and cosmetics that are exported to the United States. China is the fourth largest exporter of food to the U.S.

11. Overview of exported food & animal products • Exporting Food Products from the United States • Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an "export certificate" for products regulated by the Food and Drug Administration (FDA). Please note that: • FDA does not require that you obtain an export certificate, • FDA is not required by law to issue export certificates (although the agency intends to continue to provide this service as resources permit), and • FDA does not issue certificates for food manufactured outside the U.S. • If you export food, it is your responsibility to: • follow U.S. laws and regulations, and • follow the requirements of the countries to which you export.

12. Overview of exported food & animal products, Part 2 • Export a Live Animal (includes semen, embryos...) or Animal Product • International health certificates for the export of animals from the United States are completed by an accredited veterinarian who certifies herd and animal health status, conducts tests, and records test results for the individual animals being exported. Complete and signed international health certificates for the export of animals from the United States must be endorsed by a Veterinary Services area office in order to be valid. • The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) has created the International Animal Product Export Regulations (IREGS) to provide exporters with our best understanding of importing countries requirements for certain animal-origin products.

13. Overview of exported food & animal products, Part 3 • Partial list of animals and animal products exported to other countries daily • Cattle (dairy heifers, beef, rodeo stock, others), horses, poultry, swine, elk, deer, emu, ostrich, others • Pets (all varieties) • Hides/skins (fresh chilled untreated) • Semen • Embryos • Serum (bovine, equine, etc.) • Bone gel • Pet & zoo animal food & chews (Hill’s, Diamond, Purina, Iams, Zoopreem, others) • Cell cultures (female New Zealand white rabbit microsomes, etc) • Technical blood (equidae & non-equidae) • Colostrum for animal consumption • Inedible beef tallow

14. Just a few of the problems… • 2001- outbreak of salmonella in Mexican cantaloupes killed two people and sickened 25 others across 15 states. • 2003- Mexican green onions in salsa at Chi Chi’s Restaurant killed 6 people with > 600 sick from rare fulminant hepatitis A disease. • 2006- an outbreak of nonfatal scombroid fish poisoning linked to tuna steaks imported from Vietnam and Indonesia sickened 15 people in Louisiana and Tennessee. • 2007- wheat gluten from China that contained the toxic chemical melamine and was used as an additive in pet food sold under more than 100 brand names. Hundreds of dogs and cats died; 3 million broiler chickens had been fed the contaminated surplus pet food and then had been sold to restaurants and supermarkets across the country. • 2007- a salmonella outbreak caused Dole Fresh Fruit Co. to recall roughly 6,104 cartons of imported cantaloupes from Costa Rica that were distributed to wholesalers in the eastern United States…

15. Most recent problems… • June 18, Associated Press – (Wisconsin) Bacteria that sickened 16 matches Wis. farm's. • June 18, Food Safety News – (Illinois) Staph found in Illinois bakery tied to outbreak. Staphylococcus aureus (S. aureus) was found inside a Chicago-area cake bakery • June 17, Associated Press – (North Carolina; Ohio) Earth Fare burgers recalled in Akron, Ohio. Earth Fare of Fletcher, North Carolina, recalled its frozen Natural Spicy Bean Burgers because of possible salmonella contamination.

16. More most recent problems… • June 23, Food Safety News – (National) Two more seafood processors with violations. Vacuum-packed cold smoked mackerel from Auburn, Washington, and ready-to-eat lobster meat products, tuna and pasteurized crabmeat products from Middletown, Rhode Island, are among the latest seafoods to be found adulterated by the U.S. Food and Drug Administration (FDA). • June 23, Food Safety News – (Maryland) FDA shuts down Maryland kimchi maker. The U.S. Food and Drug Administration (FDA) announced June 22 that Sungwon Inc. of Columbia, Maryland, corporation, and the company's president have signed a consent decree of permanent injunction, which shuts down company operations.

17. FDA recent OIG Report • June 23, The Packer – (National) Report: FDA jeopardizes food safety. The U.S. Food and Drug Administration's (FDA) Office of Inspector General (IG) concluded, in a new report, that the FDA has generally failed to promptly initiate recalls, allowed some food companies to continue shipping despite failed inspections and often ignored its own procedures. The study was based on a year-long evaluation of 17 food recalls from 2007 to 2008. The study included a variety of recalls, including those involving cheese, mussel meat, fish, and four separate recalls of fresh cantaloupes from Honduras. The IG's office directed the FDA to review the report as it implements the Food Safety Modernization Act. Development and implementation of food recalls was not adequate to ensure the safety of the U.S. food supply, according to the report, and the FDA often didn't follow its own procedures.

22. Genetically modified organisms

24. The protective mechanisms in place to ensure the safety of these products.

25. Melamine: Multi-Agency Response • In April 2007, FDA determined a shipment of rice protein imported from China was contaminated with melamine • The rice protein was used in the production of pet food and animal feed • FSIS, FDA, and APHIS worked together to determine if a public health threat existed: • FSIS role: animal inspection prior to slaughter and assisting FDA in tracing adulterated feed • FDA role: monitoring safety of animal feed • APHIS role: determine if products from affected animals could enter the food supply

26. Polonium: Multi-Agency Response • In May 2007, U.S. Geological Survey (USGS) sampled ground water in Nevada for polonium 210 • Test results showed one aquifer, which supplied drinking water to livestock at two dairy operations, contained polonium 210 • FSIS, FDA, and APHIS worked together to determine if a public health threat existed: • FSIS role: ensure the safety and wholesomeness of meat and meat products • FDA role: ensure the safety of milk and milk products • APHIS role: determine if products from affected animals could enter the food supply

27. What is food defense?

28. What is food defense? • Food Safety – the protection of food products from unintentional contamination by agents reasonably likely to occur in the food supply (e.g., Salmonella) • Food Defense – the protection of food products from intentional contamination by biological, chemical, physical, or radiological agents • Food safety measures [like hazard analysis critical control points (HACCP)] are not designed to prevent or mitigate deliberate contamination • Food Security – the reliable availability of a sufficient quantity and quality of nutritious food

29. Food Defense: A Multi-Agency Task USDA | APHIS APHIS provides leadership in ensuring the health and care of animals and plants. • VS prevents, controls and/or eliminates animal diseases and monitors and promotes animal health and productivity • Plant Protection and Quarantine division prevents the entry, establishment, and spread of plant pests and diseases

30. Food Defense: A Multi-Agency Task USDA | FSIS • Regulates meat, poultry, and egg processors • Inspects food animals for diseases before and after slaughter • Responds to meat, poultry, and egg safety (human) emergencies

31. Food Defense: A Multi-Agency Task DHS (Border Inspection) • Detects and prevents the illegal entry of persons, animals, and food items into the country • Monitors commercial cargo, live animals, and persons entering the country

32. Food Defense: A Multi-Agency Task HHS | FDA • Oversees all domestic and imported food, including shell eggs (except meat and poultry) • Inspects food production establishments and warehouses • Monitors safety of animal feed HHS | CDC (Centers for Disease Control and Prevention) • Investigates food-borne disease outbreaks • Maintains a nationwide system of food-borne disease surveillance • Trains local and State food safety personnel

33. Food Defense: A Multi-Agency Task U.S. Environmental Protection Agency • Oversees drinking water (except bottled) • Regulates toxic substances and wastes to prevent adverse environmental impact DOI | USGS • Monitor wildlife diseases • Conducts water resources programs Department of Defense • Chemical, biological, radiological and nuclear (CBRN) activities

37. The threats to the flow of products and response methods in place to match those threats.

38. The obvious threats… • Overt terrorists • Pirates • Oppressive governments • Thieves • Boycotts • Trade barriers • Political ramifications

39. The response to the obvious…

40. June 7, 2011 - German E. coli outbreak prompts agroterrorist concerns in U.K. Animal Health SmartBrief to: barry.n.pittman 06/07/2011 11:49 AM Terrorism in the UK Food chain at risk of being poisoned by terrorist groups Food and drink sold in Britain is under a growing threat from terrorist groups which might try to poison supplies, the Government’s security advisers have warned.

41. Agricultural Intelligence Working Group • Began in 2000 • Informal network of Federal agencies • Participants are analysts responsible for analyzing threat information and coordinating/ responding to Food and Agriculture incidents • Facilitates information sharing

42. INTERPOL NCTC FDA DHS NSA DoD USDA AGINT Working Group DOE FSIS ARS CIA FBI NORTHCOM

43. Foreign Animal Disease Threat (FADT) Subcommittee • In July 2005, the National Science and Technology Council invited several Federal agencies to establish the FADT Subcommittee • Foreign animal disease threats of high economic consequence (> $10B) • Diseases capable of temporally and geographically impacting existing mitigation systems

44. FADT Subcommittee (cont.) • Three working groups: • Foreign Animal Disease Modeling • Countermeasure Development (vaccines and diagnostics) • Decontamination and Disposal • Interagency Cooperation: • Agriculture • Homeland Security • Environmental Protection Agency • Interior • Health and Human Services • National Science Foundation • Defense • State • Executive Office of the President

46. Food Defense in the 21st Century Requires effective communication & collaboration • to identify threats • to plan for and respond to incidents • to recover quickly

47. The insidious threats… • Corporate espionage • Profit drive • Costs • Intentional contamination

48. Food Safety Modernization Act (FSMA) • The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. • Most sweeping overhaul of the food safety system since 1938. • Law reflects risk-based integrated global systems approach • Provisions covering: • Prevention • Inspection and Compliance • Response • Imports • Enhanced Partnerships

49. Prevention For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply.  This mandate includes:  • Mandatory preventive controls for food facilities (Final rule due 18 months following enactment) • Mandatory produce safety standards (Final regulation due about 2 years following enactment) • Authority to prevent intentional contamination (Final rule due 18 months following enactment)

50. Inspection and Compliance The FSMA recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. Therefore, it will be necessary for FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge. FSMA provides FDA with important new tools for inspection and compliance, including:   • Mandated inspection frequency Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years. • Records access • Testing by accredited laboratories (Establishment of accreditation program due 2 years after enactment)