The document discusses risk perception and the precautionary principle. It notes that risk perception is critical in risk assessment but often ignored. The precautionary principle advocates taking precautionary measures even in the face of scientific uncertainty about risks. It originated in German environmental law and has been adopted in various international agreements. The principle argues that lack of full scientific certainty should not delay cost-effective actions to prevent harm. It discusses methods to apply precaution like bans, alternatives assessments, and testing requirements.

1. Ahmed-Refat AG Refat
4/11/2014

2. Risk perception
The task of decision-makers in
defining "acceptable" risk,
as part of the risk assessment process
is complicated because people may
not only hold different views about
the "acceptability" of a particular
risk, but also perceive "different risks
differently".
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3. Risk perception
Hence “Risk perception” is a
critical element of risk
assessment and treatment which
is ignored at the decision-maker's
threat!
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4. Attributes of Risk Perception and
Acceptance
• Voluntarily- involuntarily
• Natural – industrial
• Familiar – exotic
• Not dreaded-dread hazard
• Knowable – unknowable
• No alternatives - many alternatives
• Chronic – catastrophic
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5. Acceptable" risk
• Even if risk experts could agree on a ranking of
risks : "acceptable" from "unacceptable" risk
• Society does not generally necessarily view
"equal risks equally".
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6. Acceptable" risk
• The Perceptions of risks and associated benefits,
the "fairness" associated with risks and benefits
is an important element in risk acceptance.
• Who bears the risk? Who obtains most of the
benefit? How is this share of risk and benefit?
Another important influence on "acceptability" is
trust in the processes and institutional
arrangements for management of risk .
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7. Acceptable" risk
• Hence what is an acceptable risk to one
individual or group or to one society may be
quite unacceptable to another individual or
group or to another society.
• It follows that risk assessment requires
negotiation between the stakeholders to
define an "acceptable" level of risk
for each "risk situation".
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8. Case Studies : Misoprostol
Example (1)
Misoprostol
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9. Case Studies : Misoprostol
• Misoprostol, a drug that prevents gastric ulcers.
Misoprostol was developed in the early 1980s
and first approved in some nations in 1985.
• The FDA, however, did not approve Misoprostol
until 1988. Even though the drug was already
available in several dozen foreign countries, the
FDA subjected Misoprostol to a nine-and-one-
half-month review.
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10. Case Studies : Misoprostol
• At the time, between 10,000 and
20,000 people died of gastric ulcers
per year.
• Had Misoprostol been approved more
rapidly, it could have saved as many as
8,000 to 15,000 lives.
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11. Case Studies : Misoprostol
• Thus, in seeking to prevent one risk—the risk of
approving an unsafe drug—the FDA
contributed to the risk of gastric ulcers by
preventing the use of a potentially lifesaving
drug.
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12. Example (2) Asbestos
• It is now well accepted that asbestos causes
the potentially fatal diseases of
mesothelioma, lung cancer and asbestosis.
The time between exposure and effect is
delayed in some cases by up to 30 years or
more, making cause-effect links difficult to
prove conclusively.
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13. Example (2) Asbestos
• There were however, clear signs from the
1930s of the harmful effects of asbestos and a
North American insurance company back in
1917 had the commercial "wisdom" not to
insure asbestos workers.
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14. Example (2) Asbestos
• Nevertheless, it took until the early 1980s
before asbestos was banned for most uses in
Australia. Authorities waited for strong
epidemiological evidence before responding,
rather than taking precautionary action
following the much earlier, suspicious but not
conclusive, evidence available as early as the
1930s.
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15. Example (2) Asbestos
• A consequence of the lack of precautionary
action is that many people have died from
asbestos-related disease, there have been
large claims against corporations involved with
asbestos mining and manufacture, and
Australia has the highest rate of mesothelioma
in the world.
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16. Characteristic of environmental
problems
• 1- spatial dimension
• 2-Time-lag
• 3- Quantitative side of matters.
• 4- Cumulative effect.
• 5-Irreversibility
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17. Characteristic of environmental
problems
1- spatial dimension
Environmental problems tend
not to stop at national borders
and pollution created in one
country often
causes problems far away
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18. Characteristic of environmental
problems
2-There often exists a time-lag
between the
human behaviour and the
moment at which the
problem caused by this
behaviour becomes clear
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19. Characteristic of environmental
problems
3- the quantitative side of matters.
The behaviour of one single person
or factory
might be harmless, but combined
with behaviour of others the
effects might be disastrous
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20. Characteristic of environmental
problems
4- the cumulative effect.
In themselves, the introduction
might be harmless, but
together with other
substances a toxic mix might
be formed.
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21. Characteristic of environmental
problems
5- The irreversibility of some
effects of human behaviour
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22. Ethical Tool To Take A Risk
Advocates need a
decision-making
and action tool
with ethical power
and scientific rigor.
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23. Ethical Tool To Take A Risk
The
precautionary
principle,
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24. Ethical Tool To Take A Risk
• The precautionary principle, has become a
critical aspect of environmental agreements
and environmental activism throughout the
world.
P.P offers the public and decision-makers
a forceful, common-sense approach to
environmental and public health
problems.
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25. Precautionary Principle Application
Level 1:
Impacts are potentially serious
(unacceptable) or irreversible and
uncertainty is high: a strict application of
the principle is required, insisting on
complete reversibility and putting a
strong burden of proof6 on development
proponents.
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26. Precautionary Principle Application
Level 2:
• Impacts may be serious but potentially
reversible and a reasonable amount of
data is available to appreciate risk: large
safety margins should be ensured in
assessments and decisions and use of the
best available technology should be
strictly required, i.e., regardless of costs.
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27. Precautionary Principle Application
Level 3:
• Impacts are considered largely
acceptable (and/or potentially reversible)
and reasonably good scientific and other
information is available: lower safety
margins are accepted. The best available
technology is required only if
economical.
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28. Precautionary Principle Application
Level 4:
Potential losses are considered
neither serious nor irreversible:
decisions could be based on
traditional cost-benefit analysis.
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29. Sources of Uncertainty
• Lack of understanding of important cause-
effect relationships, lack of scientific theory to
explain these (eg effects of chemicals on
humans and other organisms, concentration
of chemicals in food chains).
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30. Sources of Uncertainty
• - Models that do not correspond to reality
because they are simplifications and/or
because we lack understanding of processes
(eg models of the flow of chemicals through
an ecosystem and the impacts of those
chemicals on ecosystem components).
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31. Sources of Uncertainty
• - Lack of evidence on where the boundaries
should be set for assessment of hazards (eg
How many factors may influence the hazard?
What type of consequences may occur? Over
what area and time span?).
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32. Sources of Uncertainty
• - Poor quality of available data because of
sampling or measurement inadequacies, lack
of replication, lack of time series data .
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33. Sources of Uncertainty
• - Data gaps, such as no measurements on
baseline environmental conditions at a project
site.
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34. Sources of Uncertainty
• - Toxicological data that have been
extrapolated from animals to humans and
from high dose short-term experiments to low
dose longer term situations.
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35. Sources of Uncertainty
• - Natural variation in environmental
parameters due to weather, climate change.
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36. Sources of Uncertainty
• - Necessary assumptions on which estimates
are based and the sensitivity of the resulting
estimates to changes in assumptions.
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37. Sources of Uncertainty
• - Novelty of the project in terms of technology,
chemicals, or siting- lack of experience or
historical data.
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38. The precautionary principle
• Where possible risks to the
environment and public health
have been identified, action
should be taken instead of
waiting for conclusive evidence of
a causal relationship
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39. The precautionary principle
Precaution: “An action taken in
advance to protect against
possible danger or failure; a
safeguard. Caution practised in
advance.
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40. Sir Austin Bradford Hill, 1965:
• "All scientific work is incomplete - whether it
be observational or experimental.
• All scientific work is liable to be upset or
modified by advancing knowledge. That does
not confer upon us a freedom to ignore the
knowledge we already have or postpone the
action that it appears to demand at a given
time.
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41. Key Elements of the P Principle
• 1. Taking anticipatory action to prevent harm
in the face of scientific uncertainty.
2. Exploring alternatives, including the
alternative of "no action."
3. Considering the full cost of environmental
and health impacts over time.
4. Increasing public participation in decision
making.
5. Shifting the responsibility for providing
evidence to the proponents of an activity.
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42. The precautionary principle
• A set of agreed cost-effective measures and
actions, including future courses of action,
which ensures prudent foresight, reduces or
avoids risk to the resources, the environment,
and the people, to the extent possible, taking
explicitly into account existing uncertainties
and the potential consequences of being
wrong3
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43. The precautionary principle
• clear evidence of threats cannot always be
obtained before damage occurs. It is often
necessary to make decisions in the face of
persistent uncertainty and ignorance
•
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44. The precautionary principle
• The origin of the precautionary principle is
generally traced to the concept of “principle
of advance caring” - in German environmental
law in the early 1970s.This principle states
that environmental policy requires a
cautionary approach and was introduced to
provide a decision-making tool for
environmental risk managers.
•
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45. The precautionary principle
• PP adopted by other European countries such
as Denmark, Sweden, and France, and was
extended from environmental matters to also
cover issues of public health..
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46. The precautionary principle
• PP also began to be in international treaties
and policy documents. The first of these was
the 1982 UN World Charter for Nature, which
stated that “Activities which are likely to pose
a significant risk to nature shall be preceded
by an exhaustive examination . . . and where
potential adverse effects are not fully
understood, the activities should not
proceed.
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47. The precautionary principle
• One of the most important
expressions of the precautionary
principle internationally is the Rio
Declaration from the 1992
UNcED- Agenda 21.
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48. The precautionary principle
• Rio 1992 declaration stated :
• In order to protect the environment, the
precautionary approach shall be widely
applied by States according to their
capabilities. Where there are threats of
serious or irreversible damage, lack of full
scientific certainty shall not be used as a
reason for postponing cost-effective measures
to prevent environmental degradation.
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49. Precautionary Principle Or
Precautionary Approach !!!???
• Approach: “A way and means of reaching
something. The method used in dealing with
or accomplishing something”
• Principle: “A basic truth, an assumption. A rule
or standard, especially of good behaviour. A
fixed or predetermined policy or mode of
action”
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50. Precautionary Principle Or Precautionary
Approach !!!???
• The term “approach” more accepted because
it implies more flexibility, admitting the
possibility of adapting technology and
measures to socio-economic conditions,
consistent with the requirement for
sustainability. On the contrary, the term
“principle” has developed a negative
undertone because it is usually given a radical
interpretation and has led to the outright ban
of technologies.
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51. The precautionary principle
•
‫االحترازية‬ ‫المقاربة‬
•
•
‫مبدأ‬
‫الحيطة‬
–
‫االحتراز‬ ‫مقاربة‬
•
‫مبدأ‬
‫االحتراز‬
–
‫الحيطة‬ ‫مقاربة‬
•
•
‫االحتراز‬
•
‫ادعي‬ ‫من‬ ‫على‬ ‫البينة‬
•
‫براءتك‬ ‫اثبت‬
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52. Principle 15: Rio Declaration, 1992
• "In order to protect the environment, the
precautionary approach shall be widely
applied by States according to their
capabilities. Where there are threats of
serious or irreversible damage, lack of full
scientific certainty shall not be used as a
reason for postponing cost-effective measures
to prevent environmental degradation."
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53. COMPONENTS OF PRECAUTION
1. Taking precautionary action before
scientific certainty of cause and effect
2. Setting goals
3. Seeking out and evaluating alternatives
4. Shifting burdens of proof
5. Developing more democratic and
thorough decision-making criteria and
methods
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54. METHODS OF PRECAUTION
1. Bans and phase-outs
2. Alternatives assessment
3. Health-based occupational exposure
4. Reverse onus chemical
5. Organic agriculture
6. Premarket or pre-activity testing
requirements.
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55. METHODS OF PRECAUTION
• Bans and phase-outs. A ban or phase-out
could be considered the strongest
precautionary action.
• Clean production and pollution prevention.
Clean production involves changes to
production systems or products that reduce
pollution at the source .
•
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56. METHODS OF PRECAUTION
• Alternatives assessment.
including a no-action alternative
• Health-based occupational exposure
limits list of occupational exposure limits
based on the lowest exposure level at
which health effects have been seen.
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57. METHODS OF PRECAUTION
• Reverse onus chemical listing put forward to
drive the development of information on
chemicals and their effects
‫عبئ‬
‫االثبات‬
-
‫لوم‬
In Denmark, one proposal would require a
chemical to be considered the most toxic in its
class if full information on its toxicity was not
available
•
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58. METHODS OF PRECAUTION
Organic agriculture.
It is risk averse, based on the principle of avoiding
substances / practices that might cause harm rather
than waiting for proof of harm.
Premarket or pre-activity testing requirements.
The FDA requires that all new
pharmaceuticals be tested for safety and efficacy before
entering the market. This model could be applied to
industrial chemicals and other activities.
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