Agricultural Bioterrorism: Preparing, and Preventing it

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 20th 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

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 beingdone ? • To Detect • To Deter • To Prevent

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

16. Supply Chain

17. Detection • Syndromic Surveillance • Biowatch • Food Net • Laboratory Networks

18. 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

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

21. 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

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

23. Bioterrorism Preparedness and Response Act of 2002www.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

24. 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

25. 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.html

26. 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.html

27. 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

30. 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

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

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

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

34. Any questions?