ThreatVulnerability Assessments for Foods

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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

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Food Safety MissionTo reduce foodborne hazards
to greatest extent possible
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Food Safety vs. Food Security
Sound Science - Microbiology -
Chemistry - Toxicology - Risk
Assessments
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Food Safety vs. Food Security
Sound Science
Food Safety Programs - GMPs - HACCP -
Surveillance
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Food Safety vs. Food Security

Sound Science
Food Safety Programs
Food Security Enhancements - Physical
security - Personnel
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Strategies for Critical Infrastructures

• Awareness
• Prevention
• Preparedness
• Response
• Recovery

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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

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Awareness - 2001

• Highest Priority Develop Situational Awareness
• Importance of Foods
• Most Important Foods and Agents
• Protecting the Food Supply

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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

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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

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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.

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Vulnerability Assessments

• Battelle Memorial Institute
• Prior to 9/11/01
• Decision-making tool based

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Vulnerability Assessments

• Battelle Memorial Institute
• Internal (FDA/CFSAN)
• Operational Risk Management (ORM)

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

• CATASTROPHICComplete business failure, death.
• CRITICALMajor business degradation, severe
  injury and illness.
• MODERATEMinor business degradation, minor injury
  or illness.
• NEGLIGIBLELess than minor business degradation,
  less than minor injury or illness

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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

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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

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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

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Step 2. Assess the Risk
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Vulnerability Assessments

• Battelle Memorial Institute
• Internal (FDA/CFSAN)
• Institute of Food Technologist
• Operational Risk Management

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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

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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

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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

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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

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Implementation of Food Security Efforts
2001
2002
2003
Threat Assessment
Laboratory Capacity
Protective Shields
Methods Training Supplies
Security Mitigation Sampling
Foods Agents
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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.