Risk-Ranking Model – Next Steps

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 

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 

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 

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 

Slide 6

Next Steps

• Data Review
• Assumptions Review
• Model Refinement – Mathematics
• Validation
• Expansion of model to other animals species 

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) 

Slide 8

Issues 

• Qualitative vs. Quantitative

  • Does a relative risks model present a true picture of the risks?