Balancing Risk Assessment with the Realities of Uncertainty Risk Assessment andorvs the Precautionar

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Balancing Risk Assessment with the Realities of
UncertaintyRisk Assessment and/or/vs the
Precautionary Principle

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

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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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Risk Assessmentand/or/vsthe Precautionary
Principle
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What Are the Components of Risk Assessment?

• Hazard identification
• Dose-response evaluation
• Human exposure evaluation
• Risk characterization

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RISK ASSESSMENT AND THE PRECAUTIONARY
PRINCIPLEThree different views

• 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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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

• 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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Enshrinedbut not defined
The Precautionary Principle in Europe
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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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We do not spend our days in Brussels as some
might think in Machiavellian plotting to apply
precaution to the detriment of US businesses

• Margot Wallstrom Head of European Union
  Environmental Commission. European Institute,
  Washington, DC, 4/25/02. www.eurunion.org/index.h
  tm

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Example of EU Use of Precautionary Principle as a
Trade Barrier - AFLATOXIN

• Based upon Prec.Prin., EU has developed most
  stringent aflatoxin standard in world
• Excludes 700 million yearly of Subsaharan
  African produce to the advantage of European
  growers
• Difference in risk is less than 1 cancer/year in
  Europe

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Example of EU Use of Precautionary Principle as
a Trade Barrier - BEEF

• EU bans all beef from hormone-treated cattle
• EU lost WTO case brought by US and Canada
  primarily due to lack of risk assessment
• EUs assertion of role for precautionary
  principle rejected by WTO as not yet generally
  accepted as a regulatory approach.
• EUs own scientific commission found no risk
• WTO Panel also noted EU inconsistency

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European/US Differences

• Coupling of environmental and trade policies
• Citizen suits/Toxic torts
• Who makes the rules
• When the rules are made
• Citizen distrust of government/science
• Stakeholder involvement/postmodern democracy

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Control of Hazardous Air Pollutants in the United
States
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Potential Problems with the Precautionary
Principle as Exemplified by the 1990 CAAA HAP
Provisions

• What are the incentives for new technology?
• Once a compound is listed, why would there be
  interest in developing new toxicological or
  epidemiological data?
• For compounds on the list, what is the incentive
  to use the least toxic?
• Non-listed compounds are likely those for which
  there is no or negligible testing information and
  are more likely to cause unwanted surprises.
  Does the CAAA make these preferable?

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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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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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CATNIP PRINCIPLE
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CATNIP PRINCIPLE

• CHEAPEST AVAILABLE TECHNOLOGY NOT INVOLVING
  PROSECUTION

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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