Professional Documents
Culture Documents
The Presidential /
Congressional
comission on Risk
Assessment and
Risk Management:
Final Report Volume
1, 1997.
EHRM framework
• Risk management is the process of identifying,
evaluating, selecting, and implementing actions
to reduce risk to human health and to
ecosystems.
• The goal of risk management is scientifically
sound, cost-effective, integrated actions that
reduce or prevent risks while taking into
account social, cultural, ethical, political, and
legal considerations.
EHRM framework
• Risk is defined as the probability that a substance or
situation will produce harm under specified
conditions. Risk is a combination of two factors:
– The probability that an adverse event will occur (such
as a specific disease or type of injury).
– The consequences of the adverse event.
• Risk encompasses impacts on public health and on
the environment, and arises from exposure and
hazard. Risk does not exist if exposure to a harmful
substance or situation does not or will not occur.
Hazard is determined by whether a particular
substance or situation has the potential to cause
harmful effects.
NRC: Red book
Risk assessment Risk management
Extrapolation Dose-response
assessment
Risk Evaluation of
characterization options
Measurements Exposure
and population assessment
characteristics Decisions and
actions
NRC 1983. Risk Assessment in the Federal Government: Managing the Progress.
The National Research Council. National Academy Press, Washington D.C.
NRC: Red book
• Regulatory actions are based on two distinct
elements, risk assessment and risk management.
• Risk assessment is the use of the factual base to
define the health effects of exposure of individuals
or populations to hazardous materials and
situations.
• Risk management is the process of weighing policy
alternatives and selecting the most appropriate
regulatory action, integrating the results of risk
assessment with engineering data and with social,
economic, and political concerns to reach a
decision.
NRC: Red book
• …the risk of cancer and other adverse health effects
associated with exposure of humans to toxic
substances.
• Many decisions of federal agencies in regulating
chronic health hazards… …improvements in
scientific and technologic capability to detect
potentially hazardous chemicals, in changes in
public expectations and concerns about health
protection, and in the fact that the costs and benefits
of regulatory policies fall unequally on different
groups...
NRC: Understanding Risk (Orange
book)
• Role and importance of deliberation
• Risk characterization as the link between assessment and
management
Public
officials
Problem Process Selecting Information Synthesis Decision
Natural and formulation design options & gathering Implementation
social scientists outcomes Evaluation
Interested and
affected parties Analysis and deliberation
Iteratio
▪ PBT/vPvB assessment
n
no yes
Dangerous or Risk characterisation
PBT/vPvB
yes no
Chemical safety report Risk controlled
Participation
and economy
about the
report
Participation
of the art in benefit-
Statements of risk analysis:
the ministry of Environmental
employment health. Manuscript.
and economy Evaluation
about the report
Assessment
evaluation
YVA
Ecological risk
assessment. Book. ???
Risk analysis
Risk analysis
Lessons from the KTL Centre of excellence in environmental health risk analysis
Hazard Options
identification generation
Q
R
A
Risk management
• Also, we could use the term ”impact management”
instead of ”risk management”.
• This is just a matter of tradition.
• (But if we had called this course Open assessment
and impact management, the professors hadn’t
been interested in including the course in ToxEn
MSc studies.)
Open risk management: context
• All risks emerge in a society (or group).
• The society observes the risks, valuates them, is
afraid of them, suffers from them, manages them,
and adapts to them.
Definition of open risk management
• How can scientific information and value
judgements be organised for improving societal
situations by identifying potential decisions and
relevant outcomes in a situation where open
participation is allowed?
– Emphasis: The decision situation should be clarified.
Machine for risk management within a
society
1. Identify a problem.
2. Formulate it as a (decision) question.
3. Perform argumentation about it.
1. Create hypotheses.
2. Attack and remove poor hypotheses.
4. Make conclusions.
5. Act based on the conclusions.
Definition of open assessment
• How can scientific information and value
judgements be organised for improving societal
decision-making in a situation where open
participation is allowed?
– Emphasis: The decision situation is clear, focus on
choosing good options.
Difference between OA and ORM
• There is no clear separation between open
assessment and open risk management.
• If your decision options are clear (for the moment),
you are more on OA side.
• However, be prepared for surprises and revisiting
your original questions (RM).
Theory of open risk management
• Incremental improvements
• Everyone involved
• The idea of justice as one basis
• Decision analysis as one basis after we know what
the decision is
• Open assessment/trialogue as one basis as the
method to reach shared understanding.
Assessment, management, and
communication
• A traditional view separates
– Risk assessment (by scientists)
– Risk management (by decision-makers)
– Risk communication (by all, but especially to
stakeholders)
• However, in trialogue there is no need for
separation.
There is no science-policy interface
• The most important tools for making science and
making policy are the same.
• Making artificial separations only confuse and slow
down efficient actions.
• This is not obvious, though. Why?
What are science and policy?
• ”Science is what a scientist does.”
• ”Policy is what a politician does.”
We know how is a scientist and who is a
politician. We can answer the question by
observation.
• This is a reasonable assumption, if the current way
is the best way to make science and policy. Is it?
What is the best way to make science and
policy?
• You cannot answer by observing.
– However, you can find problems by observing and
then try to understand why they exist.
• You can start from the ultimate objective and then
try to find efficient methods to reach it.
Different roles in decision-making
• Authority (has the decision-making power)
• Policy-maker (develops policies to be decided)
• NGO
• Industry and other commercially interested parties
• Other stakeholders
• Citizens
• Anyone
Independence of assessors?
• How to ensure that science is objective?
• What if assessments are only made to justify
existing decisions?
• Can political pressures be overcome if scientists
step out of the ivory tower?
• (Should this topic be discussed in more detail eg. In
a decision analysis lecture?)
Concepts in the theory
• Problem(s) identified (something wrong with the
world)
• Decisions (as responses to problems)
• Partners/actors:
– Decision maker of a particular decision (may be
several decisions)
– Those influenced in any way
– Everyone else
Performance
• Context about what we actually aim to achieve. How
do we know if we succeeded?
RM in the swine flu story
• Independent exploration
– Beginning of the Pandemic
– Prepredness in Finland and elsewhere
• Mini-presentations and discussions
• Summary