The Heritage Foundation  [Printer-friendly version]
January 15, 2004


[Rachel's introduction: "A subjective concept such as 'the
precautionary principle' is itself dangerous because it permits what
conservative scholars have called 'precaution without principle.""]

By John D. Graham, Ph.D.

The concept of a universal precautionary principle apparently has its
origins in early German and Swedish thinking about environmental
policy, particularly the need for policymakers to practice foresight
in order to prevent long-range environmental problems. The concept was
included in the Amsterdam Treaty--an important step toward
establishment of the European Union--but the concept was left
undefined and was applied only to environmental policy. In the past 20
years, there have been numerous references to precaution in various
international treaties, statements of advocacy groups, and academic
writings, but the significance of the principle in international law
remains uncertain.

In recent years there has been growing international interest in the
subject of precaution. Reacting to criticism that the principle was
too ambiguous, the European Commission in 2000 issued a formal
"Communication" about the precautionary principle. This Communication
extended the applicability of the principle to public health and
consumer protection as well as environmental policy. For several
years, the German Marshall Fund has been working with Duke University
to sponsor several informal dialogue sessions involving governmental
officials and academics from Europe and the USA. Several months ago,
the Canadian government released a "Framework" document for the
application of precaution in science-based decisions about risk.

The United States government believes it is important to understand
that, notwithstanding the rhetoric of our European colleagues, there
is no such thing as the precautionary principle. Indeed, the Swedish
philosopher Sandin has documented 19 versions of the precautionary
principle in various treaties, laws, and academic writings. Although
these versions are similar in some respects, they have major
differences in terms of how uncertain science is evaluated, how the
severity of consequences is considered, and how the costs and risks of
precautionary measures are considered. The United States government
believes that precaution is a sensible idea, but there are multiple
approaches to implementing precaution in risk management.
Defining the Principle

Given the ambiguity about the precautionary principle, it may be
useful to start with a dictionary definition. Webster's 2nd Edition of
the New World Dictionary defines precaution as "care taken beforehand"
or "a measure taken beforehand against possible danger." Understood in
this way, precaution is a well-respected notion that is practiced
daily in the stock market, in medicine, on the highway, and in the
workplace. In both business and politics, decision makers seek the
right balance between taking risks and behaving in a precautionary

Before joining the Office of Management and Budget, I served for 17
years on the faculty of the Harvard School of Public Health. In that
capacity I learned that public health historians have documented the
preventable pain and suffering that can occur from insufficient
consideration of the need for precaution. In the United States we felt
that pain as a result of how we handled emerging science about
tobacco, lead, and asbestos. Historians teach us that the major health
problems from these substances could have been reduced or prevented
altogether if decision makers had reacted to early scientific
indications of harm in a precautionary manner.

We should not belittle the scientific complexities in each of these
examples. Take the link between smoking and lung cancer. Although this
link now seems obvious, in the middle of the previous century the link
was not obvious to many competent and thoughtful physicians. They knew
that many lifetime smokers never developed lung cancer; they also knew
that some lung cancer patients had never been smokers. Compounding the
problem was the inability of laboratory scientists to produce lung
tumors in laboratory animals exposed by inhalation. In the final
analysis, it took large-scale statistical studies of smokers to
resolve the issue. In fact, there was a large scale study of the
health of British physicians that played an important role in building
the medical consensus against smoking.

In each of these examples (tobacco, lead, and asbestos), it was
epidemiology rather than the experimental sciences that played the
most pivotal role in identifying health risks. Ironically, it is
epidemiology that is now one of the more controversial contributors to
public health science.
Exaggerated Claims of Hazard

There is no question that postulated hazards sometimes prove more
serious and/or widespread than originally anticipated. Ralph Nader has
previously argued that this is the norm in regulatory science, while
the European Commission recently issued a report of case studies where
hazards appear to have been underestimated. However, the dynamics of
science are not so easily predicted. Sometimes claims of hazard prove
to be exaggerated, and in fact there are cases of predictions of doom
that have simply not materialized.

Consider the "dismal theorem" of the Reverend Thomas Malthus (1798).
He hypothesized that population would grow exponentially while sources
of sustenance would only grow arithmetically. The result, he
predicted, would be that living standards would fail to rise beyond
subsistence levels. However, history has shown this theorem to be
incorrect. Malthus did not foresee the technological advances that
have allowed both population and standard of living to rise steadily
and substantially.

A more recent example in the USA concerns the popular artificial
sweetener saccharine. The Food and Drug Administration declared the
regulatory equivalent of war against this product on the basis of
experimental laboratory test results. The finding was that huge doses
of saccharine cause bladder cancer in rodents. While the FDA attempted
to ban saccharine based on this evidence, the U.S. Congress overturned
the FDA's action. With the benefit of hindsight, it now appears that
the FDA's attempted ban may have been poorly grounded in science. Just
recently, the federal government in the USA removed saccharine from
the official list of "carcinogens" for two reasons: experimental
biologists have found that saccharin causes bladder tumors in rodents
through a mechanism (cell proliferation) that is unlikely to be
relevant to low-dose human exposures; and large-scale epidemiological
studies of saccharine users have found no evidence that the product is
linked to excess rates of bladder cancer in people.

Students of risk science are aware that the number of alleged hazards
far exceeds the number that are ever proven based on sound science.
Consider the following scares: electric power lines and childhood
leukemia, silicone breast implants and auto-immune disorders, cell
phones and brain cancer, and disruption of the endocrine system of the
body from multiple, low-dose exposures to industrial chemicals. In
each of these cases, early studies that suggested danger were not
replicated in subsequent studies performed by qualified scientists.
Efforts at replication or verification were simply not successful. At
the same time, when early studies are replicated by independent work,
such as occurred with the acute mortality events following exposure to
fine particles in the air, it is important for public health
regulators to take this information seriously in their regulatory

Given that the dynamics of science are not predictable, it is
important to consider the dangers of excessive precaution. One of
those is the threat to technological innovation. Imagine it is 1850
and the following version of the precautionary principle is adopted:
No innovation shall be approved for use until it is proven safe, with
the burden of proving safety placed on the technologist. Under this
system, what would have happened to electricity, the internal
combustion engine, plastics, pharmaceuticals, the Internet, the cell
phone and so forth? By its very nature, technological innovation
occurs through a process of trial-and-error and refinement, and this
process could be disrupted by an inflexible version of the
precautionary principle.

Many risk specialists in the USA regret some of the prior policy steps
we have taken on the basis of precaution. In U.S. energy policy, for
example, the Three Mile Island incident had a large policy impact,
though even today there is no evidence of significant public health
harm caused by the accident at Three Mile Island. In fact, there has
been a de facto moratorium on the construction of new nuclear power
plants in the USA. We have become more deeply dependent on fossil
fuels for energy, and now precaution is being invoked as a reason to
enact stricter rules on use of fossil fuels. Part of the answer may
rest with clean coal technologies and renewable energy, but we should
not foreclose the advanced nuclear option. Recent Progress in Europe

In comparing the actions of different countries and regions, it is
important to avoid the fallacy that Europe is precautionary while the
USA is not. The late Aaron Wildavsky, in his studies of risk
regulation, observed that cultures engage in risk selection. Some have
argued that the USA is more tolerant than Europe of the possible risks
of bioengineered foods, global climate change, and industrial chemical
exposures. However, a fair analysis would also show that Europe has
been less precautionary than the USA on diesel engine exhaust,
environmental tobacco smoke, and lead in gasoline. In fact, the recent
comparative research by Professor Jonathan Wiener of Duke University
has found no evidence to support the popular myth that Europe is
generally more precautionary than the USA.

A subjective concept such as "the precautionary principle" is itself
dangerous because it permits what conservative scholars have called
"precaution without principle." In particular, the principle may be
easily manipulated by commercial interests for rent-seeking purposes.
According to Conko and Miller, students of biotech policy, the EU
policy on genetically modified organisms "creates a bizarre
bureaucratic distinction that favors certain classes of products
widely made in Europe." This practice is hardly new. That is precisely
what the World Trade Organization found in its earlier decision
against the EU ban on hormone-treated beef, a ban that had no
grounding in public health science.

Although there are many reasons to be skeptical about Europe's stance
on precaution, there are recent signs of progress from Europe. Take
the response of Brussels to "mad cow's disease." Once the British
government and industry had taken all reasonable steps to address this
problem, Brussels instructed member states of the EU to lift their
bans on beef imports from the UK. All member states complied except
France, which argued that French beef might still be safer than
British beef and that France has the right to invoke the precautionary
principle. Brussels took France to the European Court of Justice,
where the Court ruled against France, indicating that speculative
appeals to the precautionary principle must have some grounding in

Much more recently, the European Commission has rejected an
unauthorized use of the precautionary principle by the provincial
government of Upper Austria. In March of this year Austria notified
Brussels of its proposed ban of genetically modified seeds that the EC
had approved for cultivation under the EC Directive 90/220. Upper
Austria appealed to the precautionary principle but Brussels overruled
them: "Recourse to the precautionary principle presupposes that
potentially dangerous effects... have been identified, and that
scientific evaluation does not allow the risk to be determined with
sufficient certainty." The EC noted that Upper Austria had not made
this case and there was certainly nothing unique about the safety of
genetically modified seeds in Upper Austria.

While it is fashionable to criticize Europe on the subject of
precaution, and much of that criticism is deserved, it should also be
noted that the EC's official views on precaution are becoming more
nuanced. In the February 2000 Communication, for example, we found the
following views that are similar to the perspective of the U.S.

1. Precaution is a necessary and useful concept but it is subjective
and susceptible to abuse by policymakers for trade purposes.
2. Scientific and procedural safeguards need to be applied to risk
management decisions based on precaution.
3. Adoption of precautionary measures should be preceded by objective
scientific evaluations, including risk assessment and benefit-cost
analysis of alternative measures.
4. There are a broad range of precautionary measures, including bans,
product restrictions, education, warning labels, and market-based
approaches. Even targeted research programs to better understand a
hazard are a precautionary measure.
5. Opportunities for public participation--to discuss efficiency,
fairness and other public values--are critical to sound risk

In OMB's 2003 Report to Congress on the Costs and Benefits of
Regulation, we also emphasize the important role that analytic tools
have in informing regulatory judgments about precaution. There are
offshoots of cost-benefit analysis called value-of-information
analysis and decision analysis that were designed precisely for the
purpose of analyzing problems with large degrees of scientific
uncertainty. These tools are already widely used in engineering and
business and are increasingly applied to environmental issues. We urge
readers to consult OMB's report for references to this growing
analytic literature on precautionary regulation.

In summary, there are two major perils associated with an extreme
approach to precaution. One is that technological innovation will be
stifled, and we all recognize that innovation has played a major role
in economic progress throughout the world. A second peril, more
subtle, is that public health and the environment would be harmed as
the energies of regulators and the regulated community would be
diverted from known or plausible hazards to speculative and ill-
founded ones. For these reasons, please do not be surprised if the
U.S. government continues to take a precautionary approach to calls
for adoption of a universal precautionary principle in regulatory

John D. Graham, Ph.D., is Administrator of the Office of Information
and Regulatory Affairs at the U.S. Office of Management and Budget.

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