Risk, Risk Ranking and the AFSS:
Where are we going?

Barry Hooberman, MPH, Ph.D.
Center for Veterinary Medicine/FDA

AFSS Public Meeting
September 12, 2006  

Slide 2

Overview

• Why are we doing this?
• What is risk?
• Why are we ranking risks?
• How are we going to apply a risk ranking approach to the AFSS?
• Where are we at today? 

Slide 3

The Purpose of the AFSS

• To develop and implement a comprehensive, risk-based, preventive animal feed safety system that minimizes, reduces or eliminates the risks to animal and human health that can arise from animal feed 

Slide 4

Feed Contamination Episodes
 

Slide 5

Why a Risk-Based Approach?

• Risk assessment is a logical process for collecting, organizing and analyzing information to inform a risk decision (“science-based decision making”).
• Risk assessment approach is also a forecasting process for the prevention of illnesses/adverse health risks.
• Eases the interactions between decision makers, stakeholders, and the public 

Slide 6

What is Risk?

Risk is a function of hazard and exposure
Risk = Hazard x Exposure

Slide 7

Can I cross this street safely?

Hazards

Exposure

Consequences 

Slide 8

Risk Assessment Poses Four Simple Questions:

• What can go wrong?
  - Hazard Identification
• What are the consequences?
  - Consequence Assessment
• How can it happen?
  - Exposure Assessment
• What is the likelihood it would go wrong?
  - Risk Estimation

Slide 9

Risk Analysis Approach

Risk Communication

Define the Problem
Risk Assessment
Report Risk Assessment
Risk Management Options        Risk Management Decisions

Slide 10

Risk Management Asks: 

• What can be done?
• What options are available?
• What are risk trade-offs in terms of risks, benefits and costs?
• What are the impacts of current management decisions on future options?

Slide 11

Implementing Risk Management

I wonder if I can cross before
the light…

The Risk analysis cycle repeats! 

Slide 12

What is Risk Ranking?

• Risk assessments provide the “facts” for risk analysis.

Slide 13

Risk Ranking

• The risk management decisions about which risks to manage first are value-laden decisions.

Slide 14

How Will Ranked Risks  Be Used?

• Decide how risks from contaminants can best be prevented or controlled:
  - Do limits for higher-risk contaminants need to be identified?  If yes, which contaminants?
  - Do analytical methods for higher-risk contaminants need to be developed?
  - What process changes can feed manufacturers  make to reduce risks from contaminants?
  - What surveillance/sampling programs are needed to ensure compliance with contaminant limits?

Slide 15

Risk Ranking

!CAUTION!

• AFSS risk ranking system does not estimate individual risks!
• The ranked risks are relative risks

!CAUTION!
 

Slide 16

Framework of the AFSS Risk Model

Slide 17

Risk Assessment – Four Steps

• Step 1:  What can go wrong?
  - Hazard Identification
• What are the consequences?
  - Consequence Assessment
• How can it happen?
  - Exposure Assessment
• What is the likelihood it would go wrong?
  - Risk Estimation

Slide 18

Source Materials

Slide 19

Risk Assessment - Four Steps 

• What can go wrong?
  - Hazard Identification
• Step 2:  What are the consequences?
  - Health Consequence Assessment
• How can it happen?
  - Exposure Assessment
• What is the likelihood it would go wrong?
  - Risk Estimation
   

Slide 20

Risk Ranking Method Step 2

• Health Consequences
  - Two factors:

  • Likelihood of the illness
    - If you are exposed to the hazardous agent, how likely is it that you will become ill?
    - May be referred to as the potency of the hazardous agent (e.g., the amount of hazard required to cause the illness/adverse effect)
  • Severity of the illness
    - If you become ill, how severe is the illness? (e.g., death v. depressed weight gain v. skin irritation)
     

Slide 21

Risk Ranking Method Step 2 

• Health Consequences Score
  - Potency and Severity combined

Slide 22

Risk Ranking Method Step 2

• Health Consequences Score
  - What It May Look Like Numerically 

Slide 23

Risk Assessment - Four Steps

• What can go wrong?
  - Hazard Identification
• What are the consequences?
  - Consequence Assessment
• Step 3:  How can it happen?
  - Exposure Assessment
• What is the likelihood it would go wrong?
  - Risk Estimation 

Slide 24

Risk Ranking Method Step 3

• Exposure
  Stay tuned for next meeting! 

Slide 25

Risk Assessment - Four Steps 

• What can go wrong?
  - Hazard Identification
• What are the consequences?
  - Consequence Assessment
• How can it happen?
  - Exposure Assessment
• Step 4:  What is the likelihood it would go wrong?
  - Risk Estimation

Slide 26

Risk Ranking Method Step 4

• Relative Risk Score
       Stay tuned for future meeting! 

Slide 27

Limitations

• Risk-Ranking Method
  - A semi-quantitative method pushes most assignments into the middle of the range
   

  • Does not distinguish between intermediate risks
    - Acute vs. mild chronic (severed finger vs. long-term health effect)
    - High exposure/low consequence vs. low exposure/high consequence 

Slide 28

Limitations

• DATA!
  - A major challenge
   

  • A larger issue for exposure
  • Limited measured data for many hazards
  • Strong reliance on expert opinion (not that there is anything wrong with that!)