A Quick Look At

Risk Assessment

Dr. Joe Blair

Senior Vice President
HACCP Consulting Group L.L.C.
----
Bucharest Romania
July 2007
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 Codex Alimentarius Commission
FAO/WHO (1995)

 Microbial risk assessment is a scientifically-

based process consisting of four steps:

1. Hazard Identification – identification of known or

potential health affects associated with a particular
agent (including microorganisms);

2. Exposure Assessment – the qualitative and/or

quantitative evaluation of the degree of intake likely to
occur

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 Codex - continued

3. Hazard Characterization – the quantitative and/or

qualitative evaluation of the nature of the adverse
effects associated with biological, chemical, and physical
agents that may be present in the food … for biological
agents .. A dose-response assessment should be
performed if the data is not available

4. Risk Characterization – Integration of Hazard

Identification, Hazard Characterization and Exposure
Assessment into as estimation of the adverse effects
likely to occur in a given population, including attendant
uncertainties.
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Scientific Risk Assessment

Very Complex – multidisciplinary, involves many

people

Difficult to Perform Well – must be able to

defend scientifically

Time Consuming – months/years

Very Costly – more than most individual

companies can afford
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Scientific Risk Assessment

Very important in effectively managing

public health agencies – examples:
Setting residue limits for various chemicals
Establishing regulatory control programs for
specific pathogens i.e. Listeria
monocytogenes; E. coli O157H7; Salmonella
enteriditis (in eggs)
 Establishing drug safety, effectiveness and
setting of withdrawal times

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 Example (USDA/FSIS)

A Risk Assessment for

Clostridium perfringens
In
Ready-to-Eat and Partially Cooked Meat
And Poultry Products
2005

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 C. perfringens
Risk Assesament

304 page document – open for public comment

Team of highly qualified ‘experts’

Table of Contents:
1. Scope – Public Health & Regulatory Context -
Mandate
Public health background
Policy context

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 Table of Contents I

2. Hazard Identification of C. perfrengens

 Effects and incidence
 Epidemiology of outbreaks
 Clonal characteristics of C. perfrengens from
outbreaks (DNA and other genetic
characteristics)
 Outbreaks of foodborne illness (CDC and
other data on outbreaks)
 Clinical presentation

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 Table of Contents II

3. Exposure assessment

 Outline of approach
 Principle steps
 General approach in deriving variability and
uncertainty distributions
 Selection and identification of servings
 Vegetative cell concentration in the meat
 Spore concentration in the meat

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 Table of Contents III

3. Exposure assessment -- continued

 Concentrations of C. perfringens in spices
 The fraction of spores that germinate
 The fraction of cells that are type A, CPE
positive
 The growth of C. perfringens and C.
botulinum

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 Table of Contents IV

3. Exposure assessment -- continued

 Growth during chilling, stabilization and
secondary cooking steps
 Storage and transportation of the foods
 Reheating and hot holding of RTE products
 The number of servings

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 Table of Contents V

4. Limitations of the exposure model

 Representation assumptions
 Other assumptions
 Limitations introducted by the methods used
in modeling
 Other limitations

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 Table of Contents VI

5. Hazard Characterization

 Data for Dose-response relationship
 Data Summary
 Dose-response modeling
 Uncertainties in dose-response modeling

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 Table of Contents VII

6. Risk Characterization

 Variations of the risk of diarrhea
 Uncertainty estimates
 Sources of illness-causing C. perfringens
 Response to Risk Management Questions
 Analysis of “what-if” scenarios
 Sensitivity Analysis (14 sub-topics, including
preparation before serving)

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 Table of Contents IX

 7. Research Needs

 8. References

 Appendices – 5

 Table of Figures -- 38
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 Risk Assessment
Definition (Wikipidia)

Is a step in the risk management process

that measures two quantities of a risk:
-- the magnitude of the potential loss
-- the probability that the loss will occur

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 Wikipidia Definition
Is Useful

 Hazard Analysis is One of the Steps or

Principles in HACCP.
 Scientific Risk Assessment not practical at
the plant level
 However, the seriousness of the risks and
the likelihood of occurrence are Essential
Considerations – AND they must be
scientifically sound

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