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6-Regulation: The Precautionary Principle: Legal doctrine or Rorschach inkblot test?



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TITLE:  The Precautionary Principle: Legal doctrine or Rorschach
        inkblot test?
SOURCE: ISB News Report, by Phillip B. C. Jones
        Information Systems for Biotechnology
        isb@nbiap.biochem.vt.edu
DATE:   September 2000

-------------------- archive: http://www.gene.ch/ --------------------


The Precautionary Principle: Legal doctrine or Rorschach inkblot test?

The precautionary principle may have first appeared in 1976 in the 
national law of former West Germany as "Vorsorgeprinzip," a view that 
the government should avoid environmental damage by cautious 
planning. Some have suggested that the precautionary principle first 
entered international law in the World Charter for Nature, adopted by 
the United Nations General Assembly in 1982, while others point to 
the Ministerial Declaration of the Second Conference on the 
Protection of the North Sea (1987). The principle was clearly 
recognized during the U.N. Conference on Environment and Development 
in Rio de Janeiro in 1992. The principle also resides in the Treaty 
Establishing the European Community and can be found in the preamble 
of the Cartagena Protocol on Biosafety to the Convention on 
Biological Diversity (2000). But, what is the precautionary principle?


What It Is, Is . . .

According to the Commission of the European Communities, the 
precautionary principle is a full-fledged, general principle of 
international law. This is a significant position for the European 
Commission to take. Three primary sources of international law are 
treaties and conventions, customary practices, and general 
principles. The latter are principles that are intrinsic to legal 
systems of the world, or are principles derived from the nature of 
international community, such as territorial integrity. An example of 
a general principle common to many national legal systems is res 
judicata, which asserts that a matter is settled once a final 
judgment has been made.

If the precautionary principle is a general principle of 
international law, then it can be used as a subsidiary source of law 
to complete a treaty. However, not all nations recognize the 
precautionary principle as such. US officials, for example, have 
recently referred to it as the "so-called" precautionary principle, 
an outlook that probably reflects the principle's lack of a precise 
definition.


A Principle That Is Polysemous And Abstruse, And Yet Not Totally 
Cryptic

To some, the precautionary principle implies that precautions should 
be taken even if a cause and effect relationship between an activity 
and its potential harm to the environment, or to human health, has 
yet to be scientifically established. According to one commentator, 
the first documented use of the precautionary principle occurred in 
1854 when Dr. John Snow found an association, but not a causal 
connection, between drinking water from a London pump and a cholera 
epidemic. That is, Dr. Snow apparently decided that the potential 
cost of being wrong in removing the water pump handle was likely to 
be much smaller than the potential cost of not removing the handle.

The conceptual core of the precautionary principle seems to be that 
if a regulatory inaction permits environmental risks that are in some 
way uncertain, but non-negligible, then regulatory inaction is 
unjustified. Elements woven into the principle include a willingness 
to take precautions in advance of formal scientific proof, and to 
consider of the cost-effectiveness of action, the intrinsic value of 
non-human life forms, and concerns for future generations. An 
underlying mandate of the precautionary principle is that, in the 
face of scientific uncertainty, a party should refrain from actions 
that might harm the environment, and that those who oppose this 
prohibition have the burden of proof for assuring the safety of the 
proposed action.

A significant problem in implementing the precautionary principle as 
a policy tool arises from the extreme variability in its 
interpretation, with approaches ranging from eco-centric and risk 
averse to utilitarian and risk-taking. For example, certain 
formulations of the precautionary principle require that actions must 
be taken in advance of scientific certainty, while others contend 
that deliberate inaction is not justified by a lack of scientific 
certainty. Some interpretations allow cost-benefit analysis and 
discretionary judgment, and yet others call for clear proof of safety 
before new technologies can be adopted.

A basic unresolved question about the precautionary principle 
concerns the amount of evidence (or lack thereof) needed to invoke 
it. Should evidence of "likely harm" or "serious or irreversible 
harm" trigger the principle? As one observer notes, the precautionary 
principle has deviated from a strong mandate for precautionary action 
toward a universal sentiment, with little guidance on practical 
implementation.

Despite the variability in its interpretation, the precautionary 
principle gets a workout. For instance, France banned imports of 
British beef based on the precautionary principle. Earlier this year, 
the German government used the precautionary principle as the 
rationale for banning the commercial scale cultivation of Bt corn by 
Novartis. Additional examples include decisions by the EU to ban 
American and Canadian beef produced with growth-promoting hormones, 
and to delay approval of genetically engineered crops for sale in 
European markets.

Aside from its possible use as an excuse for trade protectionism, one 
reason for the popularity of the precautionary principle is that it 
reflects the current mood of distrust of technologies that are 
perceived to be risky and forced on a naive public by commercial 
interests aligned with governments. The precautionary principle also 
reflects misgivings over perceived manipulations of cost-benefit 
analysis by powerful commercial interests.


A More Certain Way To Deal With Uncertainty?

The Commission of the European Communities issued a report outlining 
a definite approach for implementing the precautionary principle. At 
the outset, the Commission explained that the precautionary principle 
presupposes that the potential dangers of a product or process are 
known; but that current scientific evaluation does not allow the 
risks to be precisely determined. In the European Commission's view, 
action based on the precautionary principle should be proportional to 
the chosen level of protection, nondiscriminatory in application, and 
consistent with measures taken under similar circumstances. 
Furthermore, precautionary measures should be subject to cost-benefit 
analyses and reviewed in light of new scientific evidence. The 
Commission also stated that, if action is deemed necessary, the 
measures based on the precautionary principle should contain the 
capacity to assign responsibility for producing new scientific 
evidence when required for a more comprehensive risk assessment.

Certain manifestations of the precautionary principle present a 
challenge to the scientifically based process of risk assessment. The 
European Commission's approach, which explicitly blends precautionary 
measures with scientific analysis, may well lay a foundation for the 
future development of the precautionary principle. It is unclear, 
however, whether any particular formulation of the precautionary 
principle, no matter how balanced and well reasoned, could become 
accepted on an international level.


Can One Size Fit All?

One of the prerequisites for effective implementation of a treaty 
that includes a precautionary principle directive is the definitive 
interpretation of the principle in terms of practical measures. 
Without such interpretation, the principle would remain as a token 
statement of belief. However, the perception of risk, the very 
trigger for invoking the precautionary principle, varies between 
populations of various countries, and between groups within a 
particular country. To take one example, several studies indicate 
that it is the qualitative factors of risk, rather than the magnitude 
of the probability of an adverse outcome, that influence consumer 
acceptance of foods produced using biotechnology.

The upshot is that an implementation of the precautionary principle 
may only be feasible when stakeholders collaborate at the national 
level to make a decision in a particular context, trading costs 
against benefits, and identifying those levels of damage deemed 
tolerable to that society. In other words, the precautionary 
principle will be put into practice according to the predominant 
national values. Since the presumption of the precautionary approach 
is that a precautionary action must be taken despite a lack of full 
scientific information, policy decisions must be based upon ethical, 
moral, or political grounds, as well as the science. As the European 
Commission notes, establishing an acceptable level of risk for 
society is a political responsibility.

Both the European Commission and US officials contend that decision-
making procedures should be transparent and should involve all 
interested parties. A process that treats uncertainty in an open 
manner, rather than dismissing or downplaying it, may begin to 
address the concerns that are fueling the popularity of the 
precautionary principle. In the long run, dealing with the underlying 
apprehensions that have fostered the precautionary principle may be 
more practical than attempting to devise a formulation intended to 
fit all nations.

Sources

1. Commission of the European Communities. 2000. Communication from 
the Commission on the Precautionary Principle. Available: http://
europa.eu.int/comm/dgs/health_consumer/library/pub/pub07_en.pdf

2. Knoppers BM and Mathios A, eds. 1998. Biotechnology and the 
Consumer. Kluwer Academic Publishers.

3. Lynch OJ and Maggio G. 1997. Human rights, environment, and 
economic development: Existing and emerging standards in 
international law and global society. Available: http://
204.127.239.82/olp3i.html

4. Kellerhals MD, Jr. 2000. U.S. Codex Delegation Seeks Science-Based 
Food Safety Guidelines. Available: http://usinfo.state.gov/topical/
global/biotech/00040603.htm

5. Raffensperger C and Tickner J, eds. 1999. Protecting Public Health 
and the Environment: Implementing the Precautionary Principle. Island 
Press, Inc.

6. VanderZwaag, D. 1997. CEPA and the precautionary principle/
approach. Available: http://www.ec.gc.ca/cepa/ip18/e18_01.html

Phillip B. C. Jones
PhD., J.D.
Seattle, Washington
mailto:pbcj@wolfenet.com 





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