A Cautionary Approach to the Precautionary Principle

Bernard D. Goldstein, MDDean

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 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

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 Assessmentand/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 AFTER 1990

Burden of proof To list chemical, EPA must demonstrate that ambient levels of pollutant produce risk

To remove chemical from list, industry must demonstrate that chemical does not produce risk

Regulatory Control For Listed Pollutant

Risk based application of control technology

Maximum available control technology

Role of Risk Assessment

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

• 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 (United States)

2. Arsenic in water supplies (Bangladesh)

3. Hepatitis C (Egypt)