Consequence Management System: A Tool for Enhancing Food Safety and Defense

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Consequence Management SystemA Tool for
Enhancing Food Safety and Defense

• September 26, 2007
• AIChE Symposium
• Richard Fischer, PhD

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BTSafety LLC

• Mission Develop tools for government and
  industry that
• Help understand the consequences of food
  contamination events
• Enhance ability to respond rapidly and
  effectively to food safety and food defense
  incidents (assessment, preparation, and reaction)
• Allow rapid and effective recovery (Crisis
  Management and Response System CRS)

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Accomplished by

• Developing and populating critical databases
• Building and maintaining software systems that
  depict food contamination events
• Building scenarios that are data-based,
  decision-imperative and apolitical
• Providing training for system users

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Purpose of the CMS

• To model the evolution and potential outcomes of
  food safety and food defense events
• Quantifies and visually demonstrates the
  consequences of events
• Evaluates the impact of interventions on event
  mitigation using decision matrixes
• Can be used in advance of an event for planning,
  during an event for response, and as a training
  tool

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CMS Outbreak Pathway Modeling

• Portrays the evolution of food contaminations for
  specific products and agents geographically and
  temporally
• Analyses and depicts the entire pathway of an
  outbreak

Illness Medical Attn
Public Health
Intervention
Endpoints
Consumption
Distribution Processing
Contamination Production
TimingChanges in VolumeEffects of Processing
Changes in AgentEffects of People and Actions

• Quantifies the timing and consequences of events
  and interventions on consumers, hospitals,
  businesses, public, etc.

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Demonstration
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CMS Uses

• Policy Decisions
• NBACC / Battelle (2008 Biological and Radiologic
  Risk Assessments for Food)
• Bioterrorism Event Planning
• National Guard (planned table-top exercises)
• Food Industry
• Internal risk assessment and staff training
• Food and Ag Sector Coordinating Council
• Training
• FDA/Institute of Food Technologists (18 Food
  Defense Awareness Training Courses in last 2
  years)
• USDA/FSIS table-top exercise for the meat
  industry
• NCFPD Modified system for use in courses on
  supply chain logistics, food defense, public
  health
• DOD training for food safety inspectors

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The CMS is only as good as the data
Food Distribution
Disease Progression
Public Health Response
Event Impact
Consumption
Consumer demographics In-home handling
practices Consumption patterns
Agent characteristics Food-agent
interaction Dose response Secondary
transmission Disease states Symptoms Patient
response
Morbidity/ mortality Clinical
outcomes Economic impact QALYs Intervention
impact
Sourcing Processing Distribution
Organizational structure Detection Reporting
systems Recognition Type and speed of
response
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FDAs food list

• Lettuce
• Fluid milk
• Bottled water
• Dry milk-based infant formula
• Shrimp
• Chocolate bars
• Fresh squeezed orange juice

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Additional foods identified by DHS, USDA and CDC

• Spinach
• Ice cream
• Peanut butter
• Liquid eggs
• Precooked eggs
• Tomatoes
• Ground beef
• Fresh chicken
• RTE meats
• Enhanced pork loins

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Industry participation has been critical to CMS
development
Partial list of participating companies includes

• Two of the largest foodservice distributors in
  the U.S.
• Four national produce suppliers
• Several dairy processors in Minnesota and
  California (includes both independents and
  cooperatives, large and small processors)
• Two national dairy processors
• Largest manufacturer of RTE meat and enhanced
  pork products
• One of the nations largest suppliers of fresh
  chicken and ground beef
• Trade associations including UFPA, Western
  Growers, NPB, IDFA, IBWA, IFC, FMI

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Managing confidential data

• The data we collect is considered highly
  confidential
• Identity of companies not disclosed without
  permission
• Data sanitized of all company references
• Aggregate data used in the model
• Original data destroyed or returned
• Secure data storage
• Secure password protected server at BTSafety used
  exclusively for data storage
• Information is not available through FOI
• Confidentiality agreements available

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Consumption and in-home handling

• Consumption frequency and demographics come from
  the National Eating Trends (NET) panel
• Sample is 2000 households/5000 individuals
• Demographically and geographically matched to
  U.S. Census Bureau statistics
• Consumer purchase and handling data were
  collected in a custom-designed study of 650 - 750
  households representative of the total U.S.
• Interviews were conducted among households who
  purchased the category within the past 2 weeks

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Custom Questionnaire

• Where the product is purchased
• How soon is it consumed
• Who in the household consumes the first day and
  subsequent days
• How much is consumed the first day and subsequent
  days
• Product usage forms
• How long is it kept in the home

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Agents
Toxins
Microorganisms

• Bacillus anthracis
• Burkholderia mallei
• Burkholderia pseudomallei
• Cryptosporidium parvum
• Escherichia coli O157H7
• Francisella tularensis
• Salmonella typhi
• Salmonella enteritidis
• Shigella dysenteriae type 1
• Vibrio cholera
• Yersinia pestis
• BSE
• Norovirus

• Clostridium botulinum neurotoxin (A)
• Staphylococcal enterotoxin B
• Abrin
• Alpha-amanitin
• Ricin
• Saxitoxin
• Cyanide
• Arsenic trioxide
• Fluoroacetic acid
• Aldicarb

Chemicals
Other
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CDC collaboration on symptoms and disease
progression

• CDCs infectious disease experts assisted in the
  development of disease progression profiles for
  E. coli 0157H7, anthrax and C. botulinum toxin
• CDCs National Center for Environmental Health
  provides assistance on chemical agents
• We hope to work with CDCs Radiation Studies
  Branch on radiologic agents

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BTSafety has initiated personal interviews with
physicians and clinical laboratories on agent
recognition and response

• Triggering events that would lead to a personal
  or institutional report to public health
  authorities (i.e., unusual symptoms, number of
  patients with same symptoms, patient type, etc.)
• How likely gatekeepers would recognize symptoms
  associated with unusual agents
• Diagnostic tests ordered
• If, when and what medical treatment is prescribed

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Interview targets

• Clinical laboratory personnel
• Board certified toxicologists
• Emergency room physicians
• Attending physicians
• Hospitalists
• Clinicians
• Urgent Care physicians or nurse practitioners
• Large metro and small rural areas

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Differential recognition and response
capabilities of public health departments

• EDITS has shown a difference in timing of
  response by centralized and decentralized public
  health departments
• Other factors may influence outbreak recognition
  and response timeliness
• Is it worthwhile to explore these differences?
• Differential recognition and response timing
  could be built into the CMS

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Intervention strategies

• Expert elicitation with representatives of
  Fortune 50 food companies and public health
  officials on hold, recall and public health
  department triggering events
• NCFPD Risk Communication Team discussions on
  messages, media and effectiveness
• Quantifying the effectiveness of past holds and
  recalls by industry and government agencies
  (e.g., USDA and ground beef)

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Event Impact

• Morbidity and mortality estimates
• QALYs
• Medical expenses and lost wages
• Direct costs to industry (recalls,
  decontamination, disposal, etc.)
• Indirect costs to industry (consumer avoidance,
  erosion of brand equity, etc.)
• Collateral costs to the nation

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Economic data collection

• A prominent law firm that represents victims of
  foodborne illness is providing data (negotiating
  with a second firm)
• To date, we have gathered economic data for over
  300 people infected with E. coli 0157H7,
  Salmonella spp. or Shigella
• Data include medical bills incurred during a
  foodborne illness and self-reported lost wages

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Development of the CMS is funded by BTSafety, FDA
and DHS through the NCFPD and NBACC
National Biodefense Analysis and
Countermeasures Center
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Discussion