Risk Assessment:

A Conceptual
Introduction
Tee L. Guidotti
Occupational Health Program
University of Alberta

Risk Assessment
Risk assessment is the systematic evaluation of
the likelihood of an adverse effect arising from
exposure in a defined population.
Risk assessment is a systematic process for
describing and qualifying the risks associated
with hazardous substances, action or events.
(Covello)

Other Important Terms

Hazard
the intrinsic potential for harm
toxicity, injury, damage, cost
specific to an exposure level

Risk
probability of (adverse) outcome

Opportunity
likelihood that significant exposure will occur

A Definition of Risk
Risk = (H, E, O, P)
Hazard Exposure Opportunity
Population (at Risk)

Risk Analysis, Risk Management

Risk Analysis
Hazard identification
Risk assessment
Risk evaluation

Risk Management

Option generation
Option evaluation
Option selection
Implementation and enforcement

Types of Risk Assessment

Qualitative
knowledge of hazard
knowledge of exposure
opportunity
estimates of exposure
magnitude
knowledge of exposureresponse
informed judgement

Quantitative
quantification of hazard
estimates of population
at risk
exposure assessment
known or extrapolated
exposure-response
estimate of risk

Steps in Risk Assessment - 1

1 Release assessment
potential of emission, effluent, contact
pathways of exposure
subject to change

2 Exposure assessment
intensity
frequency
duration

Steps in Risk Assessment - 2

3 Consequence assessment
human health-related outcomes
ecological impact
psychological impact
cost impact

4 Risk estimation
probability of adverse effect for individual
probability of adverse effect in population

Step by Step through Risk

Assessment

Step 1. Release Assessment - 1

Identification of the characteristics of risk
source or risk agent that may predict failure
or release:

monitoring (recording past experience)

performance (simulation or experiential)
testing (systematic trials)
incident evaluation (detailed investigation)
modeling (e.g. fault trees , failure analysis)

Step 1. Release Assessment - 2

Outcomes:
probability of failure or exposure event
understanding of how this may happen
identification of critical faults or failures

Problems:
analysis is counterintuitive, complicated
may miss multifactoral outcomes
assumes a perfect understanding of the system

Step 2. Exposure Assessment - 1

Essential elements:
pathway and route of exposure
fate and disposition, dilution, degradation
distribution, duration and magnitude of exposures at
point of contact
multiple exposures and multiple sources of exposure
susceptible populations

Step 2. Exposure Assessment - 2

Methods:
Direct measurement
environmental measurement
personal measurement
biological exposure monitoring

Indirect measurement
biological effect monitoring
biomarkers of exposure (narrowly defined)
surveys, consumption records

Step 2. Exposure Assessment - 3

Indirect Exposure Estimation

extrapolation, ecological association

categorization (exposure matrices)
simulation
surrogate measurements
modeling
surface water
groundwater
air dispersion

Step 3. Consequence Assessment

General framework:
Probability of
Outcome/
Magnitude of
Outcome

High

Low

High

Typically a
structural
problem

Unusual
catastrophic
events

Low

Common
minor
problem

Seldom a
concern

Step 3. Consequence Assessment

Identify plausible outcomes associated with
exposure levels implied by exposure assessment
Consider susceptible populations and atypical
responses
Consider health effects as: acute, chronic, lethal
Interest in subclinical effects growing

Step 3. Consequence Assessment

Key information in Consequence Assessment:
exposure-response relationships

extrapolation from animal studies

toxicological exposure-response relationship
epidemiologic exposure-response relationship
low-dose extrapolation problem

stochastic effects
modeling

Step 4. Risk Estimation - 1

Expressions of risk estimates:
most likely, nominal, best guess
worst case, conservative assumptions
range of probabilities

Analyses of sensitivity:
critical assumptions
behaviour of model (e.g. Monte Carlo)
multiple models, assess convergence of prediction

Step 4. Risk Estimation - 2

Assumptions:
Human (epidemiological) data preferable to
extrapolated data from animal studies
If animal data must be used, correct for BSA
Conservative assumptions; 95% UL
Humans considered as sensitive as most sensitive
known animal species
Linear, non-threshold model is the UL of response

Step 4. Risk Estimation - 3

A generic mathematical model:
Correcting for BSA, assume B = slope
B = p/d, p = 95% UL frequency, d = dose
Exposure assessment derives estimate for d,
based on 70 y lifetime
Risk = Bd, if set at 10-6, then derive
D (allowable) = 106B per lifetime

Some Problems of Risk Assessment

Quantification (conversion to lives, $, P)

Comparability
Exposure-response relationships at low levels
Chronic low-level v. rare catastrophes
Uncertainty bands

What Determines When a Risk is

Acceptable?

Acceptability of Risk - 1

Catastrophic potential
Familiarity +
Understanding of risk +
Scientific uncertainty
Controllability + (may be an illusion!)
Voluntariness +
Obvious benefit to community +

Acceptability of Risk - 2

Impact on children, future generations

Victim identity (put a face to the number)
Dread
Institutional trust + (few institutions trusted)
Media attention
History +
Equity + (inequity, maldistribution of risk )

Acceptability of Risk - 3
Reversibility +
Personal or family stake in outcome
Attributability (responsible party)
Also:
Cultural differences in acceptability
Outrage (Sandeman), distinct from equity
Profundity (threat to social stability)

Utility of Risk Assessment

Facilitates communication
Framework for critical review of data, assumptions
Allows problem to be disaggregated into
component parts
Gaps analysis
Comparison of policy options
Risk comparison

Standardization of Risk Assessment

U.S. federal approach
EPA
NAS/NRC/IOM
Interagency Regulatory Liaison Group: EPA, OSHA,
CPSC, FDA, FSQS (now defunct)

Health Canada, Health Protection Branch

European Community
World Health Organization