Transcript A Cautionary Approach to the Precautionary Principle

A Cautionary Approach to the
Precautionary Principle
Bernard D. Goldstein, MD
Dean
University of Pittsburgh
Graduate School of Public Health
Range of Expert Judgment
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Range of Expert Judgment
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CATNIP PRINCIPLE
CATNIP PRINCIPLE
CHEAPEST AVAILABLE
TECHNOLOGY NOT
INVOLVING PROSECUTION
Precautionary Principle Described
in the Rio Declaration:
Nations shall use the precautionary approach
to protect the environment. Where there are
threats of serious or irreversible damage,
scientific uncertainty shall not be used to
postpone cost-effective measures to prevent
environmental degradation.
When an activity raises threat of harm
to human health or the environment,
precautionary measures should be
taken even if some cause and effect
relationships are not fully established
scientifically.
Wingspread Statement
Differences between the Rio and Wingspread
Definitions of Precautionary Principle
•
Thrust of Statement
– Rio: Negative: lack of certainty should not postpone measures
– Wingspread: Positive: measures should be taken
•
Extent of Harm
– Rio: Serious and irreversible damage
– Wingspread: Not specified
•
Extent of Costs
– Rio: Action should be cost effective
– Wingspread: Not specified
•
Areas of Relevance
– Rio: Environment
– Wingspread: Health and environment
Definition of the Precautionary
Principle
(Cynical American Version)
The Precautionary Principle is a
nebulous doctrine developed by
Europeans as a means to erect a trade
barrier against any item that can be
produced more efficiently in the United
States.
Risk Assessment
and/or/vs
the Precautionary Principle
Risk Assessment
Is risk assessment
antidemocratic?
“Those of us who support the Precautionary
Principle do so in part because we perceive our
democratic rights to a clean environment and
health have been violated”
“This technocratic process (risk assessment)
purports to put the decisions into an objective
framework but the process gives greater power to
corporate interests and tends to violate individual
and collective rights to health”
Tickner and Ketelson, 2001
“Risk assessment obscures and removes the
fundamental right to say ‘no’ to
unnecessary poisoning of one’s body and
environment”
Mary O’Brien, Making Better Environmental Decisions,
MIT Press, Cambridge, MA, 2000
RISK ASSESSMENT AND THE
PRECAUTIONARY PRINCIPLE
• The Precautionary Principle is already incorporated in
Risk Assessment
“Precautionary” aspects of risk
assessment
• Factors of ten (“safety” factors)
• 95% upper confidence limits
• Models with prudent default assumptions
(exposure; dose response; hazard identification)
• Inertia (regulatory prudence)
• Maximally exposed individual vs
population based approaches
RISK ASSESSMENT AND THE
PRECAUTIONARY PRINCIPLE
• The Precautionary Principle is already incorporated in
Risk Assessment
• The Precautionary Principle should be incorporated
into Risk Assessment
RISK ASSESSMENT AND THE
PRECAUTIONARY PRINCIPLE
• The Precautionary Principle is already incorporated in
Risk Assessment
• The Precautionary Principle should be incorporated
into Risk Assessment
• The Precautionary Principle and Risk Assessment are
completely antithetical
Control of Hazardous Air Pollutants in the United
States
BEFORE 1990
Burden of proof
Regulatory
Control For
Listed Pollutant
Role of Risk
Assessment
AFTER 1990
To list chemical,
EPA must
demonstrate that
ambient levels of
pollutant produce
risk
Risk based
application of
control technology
To remove
chemical from list,
industry must
demonstrate that
chemical does not
produce risk
Maximum
available control
technology
Primary
Secondary
Precautionary Principle
Should invoking the precautionary
principle automatically trigger
research to determine if the
precaution is needed?
Invoking the Precautionary Principle
Requires Three Conditions to be Met:
1. Sufficient scientific information to raise the
possibility of adverse impacts on humans or the
environment.
Invoking the Precautionary Principle
Requires Three Conditions to be Met:
1. Sufficient scientific information to raise the
possibility of adverse impacts on humans or the
environment.
2. Uncertainty as to the extent of the effects, with a
possible worst case scenario of highly
significant harm.
Invoking the Precautionary Principle
Requires Three Conditions to be Met:
1. Sufficient scientific information to raise the
possibility of adverse impacts on humans or the
environment.
2. Uncertainty as to the extent of the effects, with a
possible worst case scenario of highly
significant harm.
3. The action advocated under the precautionary
principle must have significant economic of
societal costs.
The extent that a society lives by the
precautionary principle can best be
measured by the extent to which
precautionary actions turn out
to have been unnecessary.
Role of Surveillance as a Basis for Actions
Under the Precautionary Principle
Is it getting worse or is it getting better?
–
Global climate change vs POPS
How would we know?
–
–
Indicators
Biological Markers: Exposure, Effect,
Susceptibility
Public Health and Prevention
Risk assessment is a more effective tool for secondary
as compared to primary prevention.
The precautionary principle is primary prevention
The relative value of primary prevention as compared to
treatment is 16:1
The Precautionary Principle
Protection of Public Health and the
Environment
or
Protection of Trade and National
Interests
Example of a Public Health Loss
Ascribable to the Precautionary
Principle: Zambia
• Widespread hunger due to food shortages in
Zambia in 2002
• Cornmeal is base of standard Zambian diet
• 75% of food supplied to Zambia by UN
World Food Program (WFP) donated by US
• Corn sent by US is routinely part of US diet
Example of a Public Health Loss
Ascribable to the Precautionary
Principle: Zambia
• Zambia has ruled that GMO corn is not safe and
will not distribute it. Zambia is also concerned
about losing any future export market to EU.
• In August 2002, 14,000 metric tons of US grain in
storehouses and much more on way, but only 7000
tons of food, approx. 2 weeks worth, available for
distribution to 2.5 million people in need
Example of a Public Health Loss
Ascribable to the Precautionary
Principle: Zambia
• Zambian President Levy Mwanawasa said “I’m not
prepared to accept that we should use our people as
guinea pigs”.
• Asked if he believes US grain is poisonous, Zambian
Agriculture Minister Sikatana stated: “What else
would you call an allergy caused by a substance? That
substance that the person reacts to is poisonous”
• “Many Zambians … wonder why friends who received
the American corn before the ban went into effect have
not died”
»
Henri Cauvin, NY Times, 8/30/02; 9/4/02
Implications of Problems in
European Agriculture
• Recent agriculture industry problems in EU
countries include:
– BSE (Mad Cow Disease)
– Hoof and mouth disease
– Dioxins in chicken feed
• These problems have led to public distrust and to
support for the Precautionary Principle.
• The Precautionary Principle justifies exclusion of
usual US food products, even though the US has
had none of these agricultural problems
Differential Implications of
French HIV Hemophilia Scandal
to EU and to US
• Many hemophiliacs died unnecessarily of AIDs
• Due to French government delaying approval of
an assay developed by US company to detect HIV
virus prior to transfusion of blood products.
• Goal of delay said to be to allow Pasteur Institute
to develop its own HIV detection test
• Resultant scandal led to jail for head of blood
bank in France and suggestions of cabinet
involvement
Differential Implications of
French HIV Hemophilia Scandal
to EU and to US
• Implications to Europeans: Distrust in scientific
institutions - and therefore the need for the
Precautionary Principle
• Implications to Americans: Europeans can not be
trusted to act fairly in trade matters even if it puts
their own citizens at high risk - and the
Precautionary Principle is just another European
trade tactic
Role of Perception in Public
Health Policy Decisions
The Precautionary Principle as a
Place to Hide Behind
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Refuge from the need to understand science
Simplistic shortcut to regulatory action
Policy high ground (feel good approach)
Avoidance of trade off decisions
Three Examples of Public Health Actions
that Could Have Benefited From
Application
of the Precautionary Principle
1. Oxygenated fuels
States)
(United
2. Arsenic in water supplies
(Bangladesh)
3. Hepatitis C
(Egypt)