1. Presented by The ASIS Agriculture and Food Security Council
ASIS International 53rd Annual Seminar and Exhibits 2007
Panel Discussion Agriculture and Food-borne Bioterrorism Facilitating Effective Prevention, Mitigation, Response, and Recovery
Presented by
The ASIS Agriculture and Food Security Council

2. Agenda Background Scenarios Observations Mitigation Strategies
Protecting the Brand

3. Background
Definitions
Food Safety – Ensuring that food is safe to eat based on proper processing techniques, shelf life, and other factors
Food Security – Ensuring that food supplies are abundant to sustain populations
Food Defense – Ensuring that food is protected from purposeful adulteration/terrorism
Operationally, there is significant overlap. However, there are legal implications regarding these definitions.

4. Background
Threats
Inadvertent/non-terrorism contamination – occurs somewhat frequently and always a possibility
Terrorism
The Times, January 25, Britain’s laboratories ordered to strengthen security on stocks of more than 100 deadly viruses and bacteria
MI5 warned that Islamic terrorists are training in germ warfare. Biological agents include polio, rabies, tuberculosis and avian flu. Food poisoning bacteria such as E. coli and the sources of a number of rare tropical and Middle Eastern illnesses are also included.
Global Security Newswire, November 10, 2006 – The threat (of use of biological weapons arsenals) has shifted to terrorists and other non-state actors (Deputy Assistant Secretary of State Donald Mahley)

5. Background
Recent FDA Recalls
August 13, 2007 – Toothpaste manufactured in China recalled after shown to contain diethylene glycol (DEG)
August 10, 2007 – 7,500 sandwiches recalled due to potential to be contaminated with Listeria monocytogenes
August 7, 2007 – Herring recalled because the product may be contaminated with Clostridium botulinum
August 3, 2007 – French Cut Green Beans in 14.5 ounce cans recalled because the product may not have been processed adequately to eliminate the potential for botulism toxin
July 27, 2007 – A 51-year-old San Diego County woman contracted botulism after eating canned chili with beans
July 21, 2007 – A large food company voluntarily expanded its recall of canned meat products originally announced on July 18 due to the risk of botulinum toxin
Listeria - an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

6. Scenarios
Spinach and E. Coli 0157:H7
First case reported by the State of Wisconsin in August 2006
Field sample test results were reported on October 12
26 states were affected and one case was confirmed in Canada
205 cases reported including 31 cases involving Hemolytic Uremic Syndrome
104 hospitalizations (over 50%)
3 deaths (ID, NE, WI) & 1 death likely (MD)
$100 Million Sales and Crop Losses (UC)

7. Scenarios

8. Fresh Spinach Industry
Scenarios
Fresh Spinach Industry
$157 million (2005 Farm Value)
75% of US supply comes from California
31,000 acres
70% of California supply comes from Monterey County
3 billion servings of fresh spinach consumed annually
Average American eats 2 pounds per year

9. National Spinach Unit Volume Sales (Source: AC Neilson)
Cello Spinach
Bulk Spinach
Joe- this is just a place holder slide.
Will update this and label.-Kori

10. Illnesses were first reported to the CDC August 22 – September 5
Scenarios
TIMELINE
August 19, 2006
Illnesses were first reported to the CDC
August 22 – September 5
82% of the total illnesses were reported
160 cases reported
CDC begins to confirm through genetic fingerprinting the E. coli 0157:H7 strain
September 13
CDC notifies the FDA of a multi-state food borne illness outbreak

11. FDA issues a consumer advisory not to eat bagged spinach
Scenarios
September 14
FDA issues a consumer advisory not to eat bagged spinach
Advisory is issued late in the evening, many news services don’t pick it up.
171 reported illnesses,
26 states,
50 confirmed
September 15
Advisory is nationwide, retail markets and restaurants removing spinach from their shelves and menus.

12. Scenarios
September 15
Natural Selections Foods issues a voluntary recall of all labels (30) and products containing spinach
94 confirmed illnesses
September 17
River Ranch issues a voluntary recall of spinach products; raw product was purchased from NSF
-- Bellissima, Dole -- Cheney Brothers -- Coastline -- Cross Valley -- D'Arrigo Brothers -- Earthbound Farm -- Emeril, Sysco -- Fresh Point -- Green Harvest -- Jansal Valley -- Mann -- Mills Family Farm -- Natural Selection Foods -- Nature's Basket -- O Organic (Safeway)
-- Premium Fresh -- President's Choice -- Pride of San Juan -- Pro-Mark, Compliments -- ProAct -- Rave Spinach -- Ready Pac -- River Ranch, Superior -- Riverside Farms -- Snoboy -- Tanimura & Antle -- The Farmer's Market -- Trader Joe's

13. RLB Distributing (New Jersey) initiates a voluntary recall
Scenarios
September 18
Media frenzy begins
September 19
RLB Distributing (New Jersey) initiates a
voluntary recall
September 20
New Mexico Dept of Health confirms finding E .coli 0157:H7 in a bag of Dole baby spinach
Code date P227
September 21
FDA narrows investigation to 9 farms in Monterey,
Santa Clara, San Benito Counties of California
Town Hall meeting in Salinas with FDA, CDHS

14. Trace back code P227 (packed August 15)
Scenarios
September 22
Utah Dept of Health finds E .coli 0157:H7 in a bag of Dole baby spinach
Trace back code P227 (packed August 15)
FDA amends spinach advisory, restriction down to 3 county area (Monterey, Santa Clara, San Benito)
S.T. Produce (Seattle) initiates a voluntary recall
Pacific Coast Fruit Co (Portland) initiates a voluntary recall
Work begins on the Short Term Action Plan

15. 187 cases of illness in 26 states & Canada
Scenarios
September 29
FDA lifts the consumer advisory on spinach from the 3 county area of California
September 30
187 cases of illness in 26 states & Canada
5 firms issuing product recalls
10 confirmed product samples with E .coli 0157:H7 in 8 states
FDA declares the outbreak to be over

16. FBI issue search warrants at NSF, Growers Express and Primus Labs
Scenarios
October 2
Spinach harvest resumes following Guidelines of the Short Term Action Plan
October 4
FBI issue search warrants at NSF, Growers Express and Primus Labs

17. A two year old boy in Idaho 81 year old women in Nebraska
Scenarios
October 6
3 deaths are confirmed
A two year old boy in Idaho
81 year old women in Nebraska
77 year old women in Wisconsin
October 8
The Nunes Co voluntarily recalls green leaf lettuce following water test results of irrigation water used on the crop
October 10
Meeting with regulators in Sacramento to request the industry’s need for mandatory food safety standards

18. FDA investigation narrows to 4 farms
Scenarios
October 12
FDA investigation narrows to 4 farms
E. coli strain isolated in cow manure near one of the farms
Potential sources of contamination
Contaminated irrigation water
Wildlife intrusion, wild pigs
Use of animal based soil amendments/manures
Concern over the 4 Ws
Water
Wildlife
Workers
Waste (Manures)

19. - Flooding - Animal Activity - Adjacent Land Use October
Scenarios
October
Legislative Hearings by State Senator Florez:
PRODUCE CONTAMINATION HITS POLITICAL BATTLEFIELD: A California senator plans to call for a state-monitored system that tracks produce and holds growers more accountable for food safety, but a farming association is proposing a self-regulating system that puts the onus on handlers and shippers to protect against E. coli and other contaminants.  -The New York Times
Buyers group sets expectations of mandatory, uniform food safety standards with letter to industry (October 26)
Development of Best Management Practices (WGA)
Water Sources
Water Use
Soil Amendments
- Flooding
- Animal Activity
- Adjacent Land Use

20. Taco Bell illness outbreak (Northeast) 71 illnesses, 53 hospitalized
Scenarios
November/December
Taco Bell illness outbreak (Northeast)
71 illnesses, 53 hospitalized
8 HUS, no deaths
Taco John illness outbreak (Minnesota & Iowa)
81 illnesses, 26 hospitalized
2 HUS, no deaths
While unrelated, the likely cause of contamination was chopped lettuce grown in the Central Valley

21. California Leafy Greens Marketing Agreement is certified
Scenarios
January 2007
CDFA holds public hearings on the formation of a marketing agreement binding handlers to mandatory food safety practices for lettuce and leafy greens
February
California Leafy Greens Marketing Agreement is certified
Advisory Board met for the first time Feb 23
Legislation is introduced to make CDHS the governing food safety body in California

22. California Leafy Green Products Handler Marketing Agreement (LGMA)
Scenarios
California Leafy Green Products Handler Marketing Agreement (LGMA)
Industry sponsored standards enforced by CDFA
Voluntary signatories – contractually bound
Funded by per carton assessment - 2 cents
Inspections by state auditors for compliance
Use of a seal or mark to indicate compliance

23. FDA & CDHS issue their Final Report Paicines Ranch – Mission Organics
Scenarios
March
FDA & CDHS issue their Final Report
Paicines Ranch – Mission Organics
Inconclusive on exact source of contamination
Areas of concern
Contaminated irrigation water
Animal intrusion – feral pigs
Field proximity and adjacent land use – cattle grazing
Issues of sanitary practices at the processing plant

24. Leafy Greens Marketing Agreement Begins Best Management Practices
Scenarios
April
Leafy Greens Marketing Agreement Begins
Best Management Practices
Audit Program by CDFA Inspectors
Mandatory Seal attached to Bills of Lading
Web site: caleafygreens.ca.gov
Model Program for National Initiative
California - 99% of members in the program

25. Pet Food Recall - Melamine
Scenarios
Pet Food Recall - Melamine
Found in wheat gluten imported from China – caused recall of 60 million cans and pouches of dog and cat food in mid-March of 2007
Rice protein concentrate also found to contain melamine
April 19 – California Department of Food and Agriculture (CDFA) labs detected melamine in urine from hogs at the American Hog Farm in Ceres, CA
FDA is working with CDFA to study the issue
FDA and USDA believe the likelihood of illness after eating pork from swine fed the contaminated product would be very low
April 26 – Swine known to have been fed adulterated product will not be approved to enter the food supply (USDA cannot rule out the possibility that food produced from animals fed this product could also be adulterated)

26. Pet Food Recall - Melamine
Scenarios
Pet Food Recall - Melamine
Rice protein concentrate imported by Wilbur-Ellis beginning in August 2006 – company did not become aware of the contamination until April 2007
FDA has determined the rice protein was used in the production of pet food and a portion of the pet food was used to produce animal feed
Ongoing investigation is tracing products distributed since August 2006 by Wilbur-Ellis throughout the distribution chain
No evidence of harm to humans associated with the processed pork product – no recall of meat products processed from these animals is being issued

27. Pet Food Recall - Melamine
Scenarios
Pet Food Recall - Melamine
Testing and joint investigation continue – evidence indicating harm to humans will necessitate appropriate actions
Neither FDA nor USDA has uncovered any evidence of harm to the swine from the contaminated feed.
Dilutional factor and lack of evidence of illnesses in swine fed the waste pet food – low probability of human illness
Centers for Disease Control and Prevention systems have limited ability to detect subtle problems due to melamine and melamine-related compounds
FDA is developing and implementing further tests and risk assessments based on toxicity of the compounds and how much consumers could be expected to actually consume
States believed to have received and used contaminated product: California, Kansas, New York, North Carolina, South Carolina and Utah

28. Potential Causal Factors
Observations
Potential Causal Factors
Spinach
Human sources
Migrant workers
Inappropriate facilities
Accidental/purposeful?
Natural sources
Animals – domesticated and wild

29. Potential Causal Factors
Observations
Potential Causal Factors
Spinach
Natural conditions
Depth to ground water (water table)
Surface water sources
Soil type
Process issues
Poor drainage
Poor washing techniques
Irrigation, etc.

30. Potential Causal Factors
Observations
Potential Causal Factors
Melamine
Accidental introduction
Industrial crime
Upping the protein concentration
Sabotage
Terrorism/purposeful introduction

31. Observations
What if?
Had the spinach scenario been a purposeful, wide-spread adulteration scenario:
Lag between case reporting and field investigation (34 days) would have yielded increased morbidity and mortality
Probability of apprehending perpetrators would be near zero
State-to-state consistency in reporting is sporadic
Normal food safety protocols ineffective – contaminated water is “entrained” in the spinach

32. Observations
Contributing Factors
Import inspection/testing – private and government
Fewer FDA field inspectors today than pre-September 11, 2001
Approximately three percent of all products entering American ports are inspected
Lack of supply chain management protocol
Enormous lag in importation and identification of a problem

33. Domestic Issues Border inspectors
Mitigation Strategies
Domestic Issues
Border inspectors
Need better guidance on potential foreign animal diseases and other product inspection guidelines
Inspection resources must be bolstered to handle the magnitude of international passengers and cargo
New technology used to scan shipments must be used more consistently
Best management practices are needed to provide management objectives and tactics to ensure security
Lab capacity must be bolstered to allow more rapid identification of diseases

34. Domestic Issues Epidemiological standards should be established:
Mitigation Strategies
Domestic Issues
Epidemiological standards should be established:
PulseNet - A national network of public health and food regulatory agency laboratories coordinated by the CDC. Impeded by lack of consistent data.
Law enforcement must be participatory in food defense
Require more training for investigation and personal safety
Should work in tandem with food and public health agencies
Private/Public Sector Partnerships – To augment regulatory oversight, the private sector must step up food defense strategies in consultation with the government

35. International Issues Challenges Benefits of International Cooperation
Mitigation Strategies
International Issues
Challenges
Food imports are increasing rapidly-few are inspected
Countries are more interdependent to meet demand
Differing standards = greater opportunity for contamination, whether accidental or purposeful
Ever present threat of inadvertent or purposeful contamination
Benefits of International Cooperation
Food-related events and scientific advances in one country often have a direct effect on other regions
Example: Better information regarding Highly Pathogenic Avia Influenza is available in SE Asia
Coordinated strategies yield better prospects for success
Better, faster intelligence regarding terrorism

36. Food Processing, Wholesale and Retail
Mitigation Strategies
Food Processing, Wholesale and Retail
Personnel Security
Background checks – even cursory checks are better than nothing
Visitor policies – no one should be unattended
Supply Chain Validation
Know your suppliers (recent pet food adulteration)
Allows more confidence in prevention efforts
Allows better tracking capability in response posture
Coordinate with public health and agriculture departments
Understand their needs
Understand potential timelines – facilitate faster response
Know your role
Develop/review/revise all applicable response plans to address food defense
Emergency Response Plans
Continuity of Operations Plans
Communications Plans
Contingency Plans

37. Farm Level Mitigation Strategies Security Supply Chain Validation
Report suspicious behavior
Supply Chain Validation
Know your animal/feed/veterinary suppliers
Understand Agriculture Department procedures
Foreign Animal Disease Plans
Reporting requirements
Know your role
Develop/review/revise plan(s)
Animal Isolation Plan
Contingency Plans
Understand the signs and symptoms of disease
Be aware of potential sources of contamination
Human
Natural

38. The Importance of Brand
Protecting the Brand
The Importance of Brand
Kleenex
Tylenol
Farmland
Exxon
Consumer polls indicate that food safety and nutrition is the number one concern in making food buying decisions

39. Brand Strategies Prevention Internal External Government interaction
Protecting the Brand
Brand Strategies
Prevention
Internal
External
Government interaction
Responsive
Fast and Professional
Effective and Efficient
Honest and Forthcoming
Recovery
After Action Review/Root Cause Analysis
Improved Systems/Best Management Practices
Continued Honesty and Commitment to Quality

40. Questions? William Ramsey McCormick & Company, Inc. 18 Loveton Circle
Sparks, Maryland 21152
Phone:
Michael Steinle
Beck Disaster Recovery
2210 Inverness Drive
Lawrence, Kansas 66047
Phone:
Craig Watz
Federal Bureau of Investigation
Kansas City Field Office
1300 Summit
Kansas City, Missouri 64105
Phone:
Dr. Mike Fagel, CEM
Domestic Preparedness Operations 837 Hoyden Court, Suite 201
Aurora, Illinois 60506
Phone: