A Cautionary Approach to the Precautionary Principle

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A Cautionary Approach to the Precautionary
Principle

• Bernard D. Goldstein, MD
• Dean
• University of Pittsburgh
• Graduate School of Public Health

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Range of Expert Judgment
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Range of Expert Judgment
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CATNIP PRINCIPLE
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CATNIP PRINCIPLE

• CHEAPEST AVAILABLE TECHNOLOGY NOT INVOLVING
  PROSECUTION

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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.

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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
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Differences between the Rio and
WingspreadDefinitions 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

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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.

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Risk Assessmentand/or/vsthe Precautionary
Principle
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Risk Assessment

• Is risk assessment antidemocratic?

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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 violatedThis 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 healthTickner and
Ketelson, 2001
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Risk assessment obscures and removes the
fundamental right to say no to unnecessary
poisoning of ones body and environmentMary
OBrien, Making Better Environmental Decisions,
MIT Press, Cambridge, MA, 2000
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RISK ASSESSMENT AND THE PRECAUTIONARY PRINCIPLE

• The Precautionary Principle is already
  incorporated in Risk Assessment
  

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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
  

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RISK ASSESSMENT AND THE PRECAUTIONARY PRINCIPLE

• The Precautionary Principle is already
  incorporated in Risk Assessment
  
• The Precautionary Principle should be
  incorporated into Risk Assessment
  

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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
  

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Control of Hazardous Air Pollutants in the United
States
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Precautionary Principle

• Should invoking the precautionary principle
  automatically trigger research to determine if
  the precaution is needed?

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Invoking the Precautionary Principle Requires
Three Conditions to be Met

• Sufficient scientific information to raise the
  possibility of adverse impacts on humans or the
  environment.
  

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Invoking the Precautionary Principle Requires
Three Conditions to be Met

• Sufficient scientific information to raise the
  possibility of adverse impacts on humans or the
  environment.
  
• Uncertainty as to the extent of the effects, with
  a possible worst case scenario of highly
  significant harm.
  

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Invoking the Precautionary Principle Requires
Three Conditions to be Met

• Sufficient scientific information to raise the
  possibility of adverse impacts on humans or the
  environment.
  
• Uncertainty as to the extent of the effects, with
  a possible worst case scenario of highly
  significant harm.
  
• The action advocated under the precautionary
  principle must have significant economic of
  societal costs.
  

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• 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.

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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

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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 161

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The Precautionary Principle

• Protection of Public Health and the Environment
• or
• Protection of Trade and National Interests

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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

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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

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Example of a Public Health Loss Ascribable to the
Precautionary Principle Zambia

• Zambian President Levy Mwanawasa said Im 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

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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
  

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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
  

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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

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Role of Perception in Public Health Policy
Decisions
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The Precautionary Principle as a Place to Hide
Behind

• Refuge from the need to understand science
• Simplistic shortcut to regulatory action
• Policy high ground (feel good approach)
• Avoidance of trade off decisions

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Three Examples of Public Health Actionsthat
Could Have Benefited From Application of the
Precautionary Principle

• Oxygenated fuels (United States)
• Arsenic in water supplies (Bangladesh)
• Hepatitis C (Egypt)