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U.S. Department of Health and Human Services

Animal & Veterinary

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Safety & Health

Risk-Ranking Model -- Next Steps

May 14, 2008

Risk-Ranking Model – Next Steps

Risk-Ranking Model – Next Steps - Slide 1

Slide 2

Goals for Today

  • Concepts in Building the AFSS Risk Model

    • Types of data available to CVM

      • Chemical contaminants
      • Microbial contaminants
    • How data on exposure and health consequences can be
      integrated and … the difficulties in doing so 
Risk-Ranking Model – Next Steps - Slide 2

Slide 3

DATA

  • Continue to gather and incorporate additional data

    • Primarily an issue in exposure

      • Limited measured data for many hazards
      • Strong reliance on expert opinion (not that there is anything wrong with that!)
    • Also an issue in health consequences
      Mycotoxins 
Risk-Ranking Model – Next Steps - Slide 3

Slide 4

Data?!?

  • Why build a risk model when we know there are data constraints?

    • To organize existing data and maximize its use
    • To identify the types of data that are needed
    • To facilitate the acquisition of that data by demonstrating how it will be used 
Risk-Ranking Model – Next Steps - Slide 4

Slide 5

DATA?!?

  • Should relevant data not be available to allow the drawing of conclusions with sufficient certainty, what is usefulness of the model?

    • Inform decision-makers about what can be said and what cannot be said with reasonable certainty
    • Identify data gaps
    • Inform the Center about the state of regulation for animal feeds
    • Demonstrate ways in which the Center may implement a risk-based approach
    • Inform stakeholders that FDA is willing to adopt new tools and techniques to ensure that the food supply is safe 
Risk-Ranking Model – Next Steps - Slide 5

Slide 6

Next Steps

  • Data Review
  • Assumptions Review
  • Model Refinement – Mathematics
  • Validation
  • Expansion of model to other animals species 
Risk-Ranking Model – Next Steps - Slide 6

Slide 7

Issues

  • Microbial vs. Chemical rankings
     
  • Modifying Factors – Processing
  • Modifying Factors – Transport and Storage
     
  • Capturing Uncertainty
  • Capturing Data Quality
     
  • Characterizing Health Consequences for Animals (life stages, acute vs. chronic) 
Risk-Ranking Model – Next Steps - Slide 7

Slide 8

Issues 

  • Qualitative vs. Quantitative

    • Does a relative risks model present a true picture of the risks? 
Risk-Ranking Model – Next Steps - Slide 8