Scribd
Upload
48 views35 pages

Risk Assessment: Bruce Case

The document outlines the key components of risk assessment including definitions, hazard evaluation, risk perception, communication, and management. It discusses the process of risk analysis and defines risk assessment as the determination of human health effects from activities and chemicals. Key aspects of hazard evaluation like epidemiological and animal studies are examined. The levels of evidence for carcinogenicity from the IARC are explained. Steps of exposure assessment, dose-response assessment, and risk characterization are introduced.

Uploaded by

Lion Khushi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
48 views35 pages

Risk Assessment: Bruce Case

The document outlines the key components of risk assessment including definitions, hazard evaluation, risk perception, communication, and management. It discusses the process of risk analysis and defines risk assessment as the determination of human health effects from activities and chemicals. Key aspects of hazard evaluation like epidemiological and animal studies are examined. The levels of evidence for carcinogenicity from the IARC are explained. Steps of exposure assessment, dose-response assessment, and risk characterization are introduced.

Uploaded by

Lion Khushi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
You are on page 1/ 35

Risk Assessment

Bruce Case
Risk Assessment: Lecture Outline
1. Definitions: Risk Analysis, Risk Assessment
(Evaluation) and their components
2. A detailed look at HAZARD EVALUATION
3. Risk Perception, Risk Communication, Risk
Management
4. An example of risk assessment: Mesothelioma
among Quebec asbestos mining area women.
5. Risk and the precautionary principle
Buzzword Alert!
There are a number of technical
terms in this lecture
Yes, you have to know them!
These terms have precise
meaning, even though you will
often see them MIS-used.
Since risk assessment is (or aims
to be) a scientific activity we must
agree on terminology
Risk Analysis
This is the overall term for all of
Risk Science
It has four elements:
- Risk Assessment (Risk
Evaluation)
- Risk Communication
- Risk Perception
- Risk Management (Risk
Characterization (EPA))
Definition of Risk
Assessment
Risk Assessment, or risk evaluation,
is a scientific/ mathematical discipline
which is
a substantive, changing and

controversial field
Definition of Risk Assessment
at the margin of our understanding of
the health effects of chemicals and
other substances
best defined as the determination of

pathology caused by human


production and activity, with the
understanding that "pathology" is a
change in some aspect of human
anatomical structure or function
Risk Assessment: Two Roads
Qualitative Quantitative
- virtually the same thing as A formal process
hazard evaluation step of with four steps
Quantitative Risk Ends with a
Assessment mathematical
estimation of
- is the material harmful to actual risk,
humans under any usually quantified
circumstances as deaths per
- Codified by agencies, 1,000,000 per
especially for cancer year or less.
Risk Management:
Putting the
elements together
Hazard Evaluation is the equivalent of
Qualitative Risk Assessment.
(in many instances the three further steps are not taken)
Examples: EPA, IARC Cancer Monographs
Types of Study Available for Hazard
Evaluation
BEST: Human Evidence
(Epidemiology)

Next best: Whole animal studies


(toxicology; animals exposed to
known dose and allowed to live to
times of sacrifice or natural death)
Types of Study Available for Hazard
Evaluation
Other:
In-vitro studies (studies on cells in

culture)
Structure-function relationship

study and similar


Identification of active compounds

in metabolism
Study for Hazard Evaluation: Human

Case reports (example: angiosarcoma of


liver)
Case series (example: mesothelioma in
S. Africa)
Descriptive epidemiology (much like
geographic study; ecological fallacy is a
problem)
Study for Hazard Evaluation: Human

Analytical epidemiology:
best: cohort studies: following exposed
humans through time
second best: case-referent studies:
comparing cases of given disease to
MATCHED referents and noting
differences in exposure.
Study for Hazard Evaluation: Animal
Studies of cells (in vitro studies: example
O2-)
Acute toxicity studies (how much does it
take to kill half of all the animals?)
Chronic toxicity studies:
Best method but very expensive and

time-consuming
Proper design (doses, sacrifice times,

animal selection) a must.


Study for Hazard Evaluation: Animal: Problems
Ethical Concerns (see: papers by Peter Singer and
Henry Spira):
e.g. Rack L, Spira H. Animal rights and modern
toxicology Toxicol Ind Health 1989 Jan;5(1):133-43.
Conversely: non-realistic models may be
useless;
e.g. animal intra-tracheal injection versus
inhalation
e.g. use of rats (who do not have the same
respiratory tract structure as humans: HOGS
are best!!!)
Study for Hazard Evaluation: Human: Problems
Ethical Concerns
Expense
LATENCY
Practical considerations: for example the
use of questionnaires or interviews in a
case-referent study and:
- sample size, response rate

- selection bias and other bias


Hazard Evaluation: Synthesis: IARC Group 1
GROUP 1: AGENT CARCINOGENIC TO HUMANS
Assignment to this category is based on a finding
of "sufficient" evidence of carcinogenicity in
humans. This implies a causal relationship
between exposure to a chemical and cancer in
epidemiological studies in which "...chance, bias
and confounding could be ruled out with
reasonable confidence"13.
Hazard Evaluation: Synthesis: IARC 2A
GROUP 2A: AGENT PROBABLY CARCINOGENIC TO
HUMANS
limited or inadequate evidence in
epidemiological studies for carcinogenicity:
the agent falls into this category if there is
"sufficient" evidence from experimental animal
work. Causal relationship has been shown in two
or more species of animals OR in two or more
independent studies in one species.
Hazard Evaluation: Synthesis: IARC 2B
GROUP 2B: AGENT POSSIBLY CARCINOGENIC TO
HUMANS
sufficient evidence for carcinogenicity neither in
humans nor in experimental animals.
a "credible" causal HUMAN relationship is
suggested but bias, chance and confounding
cannot be ruled out AND sufficient animal evidence
OR
"inadequate" evidence in humans but "sufficient"
animal evidence.
Hazard Evaluation: Synthesis: IARC 3:
GROUP 3: AGENT NOT CLASSIFIABLE FOR HUMAN
CARCINOGENICITY
category for agents which cannot otherwise be
classified.
Really a garbage category scientifically, but
corresponds to some extent to the Precautionary
Principle
GMOs could possibly fit this category
Hazard Evaluation: Synthesis: IARC 4

GROUP 4: AGENT "PROBABLY" NOT


CARCINOGENIC TO HUMANS
animal studies in at least two species
showing that the substance is not
carcinogenic.
If there is a large body of negative
animal evidence:
the agent will fall into this category
even if there is some, but
"inadequate", epidemiological evidence
Exposure Assessment 1
How much of a pollutant do people
inhale/ ingest ?
In what period of time?
How many people will be exposed?
To what? Or which (e.g. PCB)?
From what source(s)?
With what interaction(s) (e.g.
smoking)
Exposure Assessment 2

Example: Total suspended


particulates
Sample stacks; sample

environment; sample PEOPLE


Characterize the particles

(carbon? Asbestos?)
Exposure Assessment 3

Model the exposure (using for


example wind speed)
Determine the source(s)

Find out anything special about

the population
Exposure Assessment
Dose-response relationships
"how much is dangerous" ?
Animal data and (preferably) human
occupational data used: example:
BEIR IV
The problem of thresholds
Extrapolation: most common
convention is the use of some
multiple of the upper bound of the
95% confidence interval
SLOPE (b) of the lung cancer/ exposure curve:
SMR = 100 + [b times (cumulative exposure)]

Slope
(extent per Textile: 1.0
unit
exposure)
of risk Manufacture
(mixed): 0.2

Mining: .05

Degree of exposure ----


Different principles for
cancer and non-cancer
The threshold issue
D
I
S
E
Issue: Which
A line is correct?
S
E

Exposure ---
The threshold problem:
points are at high dose
Jones
1956
Tremblay
1998
Smith
1989
Risk Characterization/
Management 1

What Is the Extra Risk to Health?


Maximum Individual Lifetime Cancer Risks:
Risk Characterization/
Management 2
What Is the Distribution of Individual Risks?

Population
Cancer Risks can
be calculated
from the
Distributed
Individual Risks

This is where
we do the
math
Risk Perception; Risk
Communication
The balance between risk and
outrage
High risk/ low outrage: radon and lung
cancer?
Low risk/ high outrage: asbestos in
schools?
The media as an "amplifier"
Voluntary vs. Involuntary Risk
(smoking vs. hazardous waste siting)
Known vs. Unknown Risk (lead pipes;
lead in gas)
Risk assessment based
on the
linear exposure-effect
model
y
x
b = x
y
R.A.
1.0 background risk

+
Exposure
assessment
Cumulative exposure

You might also like