1. Threat/Vulnerability Assessments for Foods FDA Science Board Advisory Committee Meeting November 6, 2003 Robert E. Brackett, Ph.D. Director, Food Safety and Security Center for Food Safety and Applied Nutrition Food and Drug Administration

2. Food Safety Mission To reduce foodborne hazards to greatest extent possible

3. Food Safety vs. Food Security Sound Science - Microbiology - Microbiology - Chemistry - Chemistry - Toxicology - Toxicology - Risk Assessments - Risk Assessments

4. Food Safety vs. Food Security Sound Science Food Safety Programs - GMPs - GMPs - HACCP - HACCP - Surveillance - Surveillance

5. Food Safety vs. Food Security ` Sound Science Food Safety Programs Food Security Enhancements - Physical security - Physical security - Personnel - Personnel

6. Strategies for Critical Infrastructures Awareness Prevention Preparedness Response Recovery

7. Awareness - 2001 Little Awareness of Vulnerability of U.S. Food Industry to Terrorism Little Awareness of Agents of Greatest Concern Little Awareness of Methods to Detect Agents in Foods Little Awareness of Characteristics and Behavior of Agents in Foods

8. Awareness - 2001 Highest Priority: Develop Situational Awareness –Importance of Foods –Most Important Foods and Agents –Protecting the Food Supply

9. Awareness of National Importance of Foods The DOD January 2001 Proliferation: Threat and Response report for the first time identified that attacks against the U.S. food supply could affect the economic stability of the country and erode military readiness. The White House February 2003 “National Strategy for the Physical Protection of Critical Infrastructures and Key Assess”: Designation of foods as Critical Infrastructure

10. Why Vulnerability Assessments? Identify Vulnerabilities to the Food Supply Prioritize Agency efforts –Guidance and Outreach –Inspections –Research Methods Development and Validation Characteristics and Behavior of Agents in Foods Pathogenicity/toxicity in Foods Countermeasures

11. Agency Vulnerability Assessments Evaluate public health consequences of product/threat agent/activity combinations associated with tampering/terrorist activity. Facilitate decision-making about resource allocation for prevention, protection and response steps to minimize risk. Morbidity and mortality were primary outcomes consideration. Did not consider other consequences (economic, public alarm, loss of confidence in the food supply, etc.), but they could overshadow morbidity and mortality.

12. Vulnerability Assessments Battelle Memorial Institute –Prior to 9/11/01 –Decision-making tool based

13. Vulnerability Assessments Battelle Memorial Institute Internal (FDA/CFSAN) – Operational Risk Management (ORM)

14. What is ORM? It is a 6-step sequence to increase operational effectiveness by anticipating hazards and reducing the potential for loss. Purpose of ORM The purpose of ORM is to minimize risks to acceptable levels, proportional to mission accomplishment Benefits of ORM Provides more effective use of resources reduce mishaps and can be used to improve food safety and security. Origin of ORM The concept grew out of idea developed to improve safety and reduced losses in aircraft, space vehicles and nuclear power. ORM FOR FOOD SAFETY AND SECURITY

15. FOOD SAFETY AND SECURITY - ORM 1. Identify the Hazards 2. Assess the Risks 3. Analyze Risk Control Measures 4. Make Control Decisions 5. Implement Risk Controls 6. Supervise and Review

16. ASSESS THE RISK - Severity  CATASTROPHIC—Complete business failure, death.  CRITICAL—Major business degradation, severe injury and illness.  MODERATE—Minor business degradation, minor injury or illness.  NEGLIGIBLE—Less than minor business degradation, less than minor injury or illness

17. ASSESSING THE RISK - Probability  Frequent-Occurs often in career to individual and population is continuously exposed  Likely-Occurs several times in a career and population are exposed regularly  Occasional-Will occur in a career and occurs sporadically in a population  Seldom-May occur in a career and occurs seldom in a population  Unlikely- So unlikely you can assume it will not occur in a career and occurs very rarely in a population

18. Criteria for Food/Agent Risk Operational Risk Management process –Calculates risk by combining assessments of severity and probability –Separate calculation for each agent and each activity –Enabled separation of food/agent/activity scenarios into high, medium, and low

19. Agent Considerations Accessibility to agent Public health impact (morbidity and mortality) Toxicity/Pathogenicity –Dose required to cause intended outcome Agent/food compatibility –Ability to withstand processing –Changes to sensory attributes of food

20. Step 2. Assess the Risk

21. Vulnerability Assessments Battelle Memorial Institute Internal (FDA/CFSAN) Institute of Food Technologist –Operational Risk Management

22. Assumptions of Early Assessments Morbidity and mortality only were considered - did not consider: –Economic consequences –Public alarm –Loss of confidence in the food supply –Interruption of the food stream These other consequences could overshadow morbidity and mortality

23. Vulnerability Assessments Battelle Memorial Institute Internal (FDA/CFSAN) Institute of Food Technologists CARVER + Shock –Commissioned by Homeland Security Council –Collaborative effort of USDA/FSIS and HHS/FDA

24. CARVER + Shock Offensive target prioritization tool Goal is to identify “critical nodes” that are the most likely targets for terrorist attack and to design “shields” to reduce the risk CARVER + Shock results in targeting conclusions that are consistent with the high risk vulnerabilities identified by ORM Agency assessments augmented because process allows identification of economic and psychological impact through entire food system

25. CARVER + Shock The process rates seven factors that affect the desirability of a target: –Criticality –public health or economic impact –Accessibility – physical access to target –Recuperability – ability of the system to recover from the attack –Vulnerability – ease of accomplishing the attack –Effect – amount of actual direct loss from an attack –Recognizability – ease of identifying target –Shock – combined measure of the physical, health, psychological and economic effects of an attack

26. Implementation of Food Security Efforts FoodsAgents MethodsTrainingSuppliesSecurityMitigationSampling Threat Assessment LaboratoryCapacity ProtectiveShields 200120022003

27. Summary Vulnerability and Threat Assessments allow FDA to Prioritize Efforts FDA has Acquired Important and Valuable Vulnerability Information Food Safety and Security Programs are Directly Influenced by Assessments FDA Will Continue to Conduct and Adapt Vulnerability Assessments for all FDA- regulated Products of Concern.