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Safety & Health

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

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  

Risk, Risk Ranking and the AFSS: Where are we going? - Slide 1

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? 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 2

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 
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 3

Slide 4

Feed Contamination Episodes
 

Year 

Location 

Hazard 

Feed 

1980s – 2006    

 

UK and others 

BSE 

Ruminant feed 

1997 

USA

Dioxins 

Ball clay flow agent 

1999, 2002, 2005 

Canada, USA 

Salmonella 

Pet treats

2001 

USA 

Dioxins 

Chelated trace minerals 

2002 

USA 

Dioxins 

Zinc oxide baghouse dust in trace minerals 

2004 

Germany 

Dioxins 

Clay used to separate potatoes 

2006 

USA 

Aflatoxin 

Dog food 

 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 4

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 
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 5

Slide 6

What is Risk?

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

 

Health Consequences

Severity
(skin irritation/off-feed to death)
+
Potency
(amount to cause illness)
 

Routes
(how are we exposed)
+
Likelihood
(improbable to common)
 

 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 6

Slide 7

Can I cross this street safely?

Hazards

Exposure

Consequences 

 

Risk, Risk Ranking and the AFSS: Where are we going? - Slide 7

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
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 8

Slide 9

Risk Analysis Approach

Risk Communication

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

 

Risk, Risk Ranking and the AFSS: Where are we going? - Slide 9

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?
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 10

Slide 11

Implementing Risk Management

I wonder if I can cross before
the light…

The Risk analysis cycle repeats! 

Risk, Risk Ranking and the AFSS: Where are we going? - Slide 11

Slide 12

What is Risk Ranking?

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

 

Risk        Risk  Risk 
Risk        Risk Risk 
Risk        Risk Risk AssessmentRisk 
Risk        Risk Risk 
Risk Risk 
  Risk 
  Risk 
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 12

Slide 13

Risk Ranking

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

 

Risk 

Values 

Risk 

Risk 

 

Risk 

Risk 

Risk Management 

Risk 

Risk 

 

Risk

Risk 

Costs 

Risk 

 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 13

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?
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 14

Slide 15

Risk Ranking

!CAUTION!

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

!CAUTION!
 

Risk, Risk Ranking and the AFSS: Where are we going? - Slide 15

Slide 16

Framework of the AFSS Risk Model

 
                  Hazard A
  
     Hazard B        Hazard C
Hazards
Ingredient 1Ingredient 2Ingredient 3 
Mill: Mix
 Feed Ingredients
and Sources (AAFCO,
CFR, other)
Mill: Heat
  
Distribution
 Manufacturing
Processes (10 process
categories)
Animals
  
 Humans Population(s)
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 16

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
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 17

Slide 18

Source Materials

Plant Origin

Animal Origin

Mineral Origin

Microbial Origin

Misc. Origin

Grains A, B, D

Mammalian protein meals

P, Ca, Na
D
 

Yeast & single cell protein
C, D

Human food waste
A, C

Oilseeds
A, B, D
 

Poultry meals
B, C, D, E
 

Trace element premixes
D

 

Animal manure
B, C, D
 

Molasses
B, D
 

Aquatic animal meals B, C, D

Non-nutritive adsorbents
D
 

 

 

Roots & tubers
A, B, D

Fats & oils B
 

 A = Mycotoxins
B = Agricultural chemicals
C = Microbial pathogens
D = Metals
E = Drug residues
F = TSEs
 
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 18

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
     
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 19

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)
       
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 20

Slide 21

Risk Ranking Method Step 2 

  • Health Consequences Score
    - Potency and Severity combined
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 21

Slide 22

Risk Ranking Method Step 2

  • Health Consequences Score
    - What It May Look Like Numerically 

 

High

3

6

9

Medium

2

4

6

Low

1

2

3

 

Low

Medium

High

 
Severity
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 22

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 
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 23

Slide 24

Risk Ranking Method Step 3

  • Exposure
    Stay tuned for next meeting! 
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 24

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
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 25

Slide 26

Risk Ranking Method Step 4

  • Relative Risk Score
         Stay tuned for future meeting! 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 26

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 
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 27

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!)
 
Risk, Risk Ranking and the AFSS: Where are we going? - Slide 28