1. Agricultural Bioterrorism: Preparing, and Preventing it Dr. John Sanders DVM, DACVPM February 22, 2007 Jonesboro, Arkansas

2. Please put all electronic communication devices on silent or vibrate

3. Outline Is Agricultural Bioterrorism new? What is stake? What is being done? What regulations did FDA develop as a result of the Bioterrorism Preparedness act of 2002

4. What is Agricultural Bioterrorism? The use, or threatened use, of biological (to include toxins), chemical, or radiological agents against some component of agriculture in such a way as to adversely impact the agriculture industry or any component thereof, the economy, or the consuming public.

5. Is Agricultural Bioterrorism new? No Military weapons (troops / Civilians –Use of ergot to poison wells in the 6th century BC –Athenian poisoning of Kirrha (590 B.C.) –Use of Harlequin bug against confederate crops in the 1860’s –World War II Japan uses B. anthracis, Shigella spp, V. Cholera, S. paratyphi, and Y. Pestis against the China and Manchuria

6. Agricultural Bioterrorism - examples Terrorist / Criminal acts –Estranged roommate infects roommates with visceral larva migrans -1970 –Use of Salmonella sp on a salad bar by the Rajneesh cult-1984 –Discovery of cyanide in grapes from Chile in 1989 –Wife poisons husband with Ricin 1995 –Lab Technician infects 12 co-workers with S. dysenteria laced pastries 1996

7. Review done by Carus of 20 th century events 222 cases were documented 24 confirmed use 28 probable or possible use 11 threatened use (probable or confirmed possession 121 threatened use ( no confirmed poison) 5 confirmed possession 6 probable or possible possession 13 possible interest in acquisition 14 false case or hoaxes

8. What is stake? Food and fiber accounts for ~16.4% of the Gross Domestic Product (GDP) 24 million Americans are employed in some aspect of agriculture Heavily tied to other industries and sectors

10. What is stake? (continued) Food sector a huge economic engine: $1.24 trillion/year Food system complexity makes contamination a real risk –2,128,000 farms –30,000 food manufacturing sites (94,000 foreign) –19,000 re-packers/packers (87,000 foreign) –224,000 retail food stores –565,000 food service outlets

11. U.S. Exports, 2001 Soybeans$5 billionBeef/veal$2.6 billion Corn for grain$4.5 billionPoultry (meat) $1.6 billion Wheat$3.2 billionDairy products $1.1 billion Tobacco$1.2 billionPork$1 billion Non-animal exports $40.5 billionEggs$189 mil Cattle (live)$271 mil Animal exports = $12.2 billion Total agriculture exports = $52.7 billion

12. Public Health Issues Several zoonotic diseases –Many diseases have human health consequences ( Salmonella, E. coli O157:H7, SARS?, NIPAH) Human only pathogens –Shigella –Hepatitis A –Norovirus

13. NIPAH and E. coli O157:H7

14. What is being done ? To Detect To Deter To Prevent

15. Food Safety and Defense ` Sound Science Food Safety Programs Food Defense Enhancements -Industry and Consumer Guidance -Industry and Consumer Guidance

16. Supply Chain

17. FOOD SAFETY AND DEFENSE FOOD PRODUCTION FLOW DIAGRAM Government and Industry must work together at all steps FARM Transport Food Processor/ Feed lot/Feed mill Retail Transport Food can be contaminated with microbes, toxins, chemicals, heavy metals

18. Detection Syndromic Surveillance Biowatch Food Net Laboratory Networks

19. Public Health System Primarily a state/local system with reporting to federal agencies. Federal Agencies provide support when requested Foodborne illness outbreak responses highly variable across jurisdictions Primarily treatment/response and investigation to prevent repeat outbreaks Outbreak intervention capabilities limited

20. Detection and Deterrence Food Emergency Response Network –Food Emergency response Laboratories Working with DHS, USDA, CDC

22. Deter/Prevent Guidance to Industry –Drafts Published 1/9/02; Final 3/19/03 Processors Importers –Drafts Published 3/19/03 Retail Cosmetics –Milk Security Guidance; Final 7/11/03 –www.fda.gov

23. Preventation ALERT ( see graphic below) www.cfsan.fda.gov/~dms/alert.html

24. Bioterrorism Preparedness and Response Act of 2002 www.fda.gov/oc/bioterrorism/bioact.htm Sec. 303 - Administrative Detention Sec. 305 – Registration Sec. 306 (b) – Establishment and Maintenance of Records (Traceback) Sec. 307 - Prior Notice Sec. 313 – Zoonotic Surveillance

25. Sec. 303 - Administrative Detention Administrative detention: provides the FDA expanded authority for detaining food products if there is “credible evidence or information indicating the article presents a threat of serious adverse health consequences or death to humans or animals.” Fact sheet can be found at http://www.cfsan.fda.gov/~dms/fsbtac21.html

26. Sec. 305 – Registration Registration of firms that manufactures, processes, packs, or holds food. Information required includes the name and location of facilities, product trade names, and general food categories. Fact sheet- http://www.cfsan.fda.gov/~dms/fsbtac12.ht ml

27. Section 306 - Records Currently a Proposed Rule Who is covered :Domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food intended for human or animal consumption in the U. S. and foreign facilities that manufacture, process, pack or hold food intended for human or animal consumption in the U.S. Fact Sheet- http://www.cfsan.fda.gov/~dms/fsbtac23.ht ml

28. Section 306- cont. What records must be established and maintained –Identify the immediate non-transporter previous sources of all foods received –Identify the immediate non-transporter subsequent recipients of all foods released How long must the records be retained? –Perishable foods – 1 year –Non Perishable foods- 2 years Fact Sheet - http://www.fda.gov/oc/bioterrorism/records_fs.html

31. Sec. 307 - Prior Notice Prior notification of all imported food shipments into the United States. Requires that notification be provided prior to entry into the United States Failure to notify will result in a refusal of shipments to enter the United States, and failure to disclose relevant information could also result in a refusal of permission to advance to a port of entry. Fact sheet - http://www.cfsan.fda.gov/~dms/fsbtac13.html

32. Examples Of Outreach Materials Available On FDA’s Website

33. Next steps – Food Security, Safety, and defense Interagency cooperation Industry awareness, coordination, and cooperation Consumer awareness

34. Additional information at http://www.cfsan.fda.gov/~dms/defterr.html

35. Any questions?