D. Graham, Ph.D., Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget
Executive Office of the President
Delivered at the Brookings-AEI Conference on
"Risk, Science, and Public Policy: Setting Social and Environmental
Priorities," St. Regis Hotel, Mount Vernon Room
very much for the opportunity to participate in this Conference. From
my days as a public health scholar, I have had a strong interest in the
question of how to expend lifesaving resources wisely. I believe conferences
like this one, as well as more intensive analytic efforts, such as the
Copenhagen Consensus, play an important role in advancing the national
and international dialogue on lifesaving investments.
my topic is risk and precaution, as these concepts have arisen in the
translantic policy debates about regulatory policy. For the past two years,
my colleagues and I have been participating in an informal dialogue with
EU officials on how to better understand regulatory policies in the USA
and the EU. Sponsored by the German Marshall Fund and Duke University,
these useful sessions -- conducted under the Chatham House rules that
encourage an unusual degree of candor -- have been successful in causing
some mutual education on both sides of the Atlantic. Obviously, these
discussions occurred in the context of heated policy disagreements about
issues such as the Kyoto approach to global climate change, the safety
of hormone-treated beef, and the future of genetically-modified foods.
system in the United States, particularly as it applies to public health,
safety and environmental issues, is evolving. According to Professor Cass
Sunstein of the University of Chicago, the US system is becoming the "Cost-Benefit"
regulatory state. I believe President Bush's first term, when studied
by historians, will be considered a period of refinement and reinforcement
of the cost-benefit perspective. At OMB, for example, we (1) have reaffirmed
the important cost-benefit principles stated by President Clinton in Executive
Order 12866, which amplified those originally advanced by President Reagan;
(2) have used authority in the Information Quality Act to enhance the
quality of data and analysis used by federal regulators, (3) have modernized
OMB's analytic guidance to agencies through OMB Circular A-4, and (4)
have proposed minimum standards of independent peer review of regulatory
science by qualified specialists. Taken together, these modest steps by
OMB are intended to strengthen the roles of science, engineering and economics
in federal regulatory policy.
USA moves in this science-based direction, we fear that the European Union
is moving in a different direction. Professor David Vogel of the University
of California at Berkeley recently completed a comparative study of USA
and EU regulatory policy. In his article published in the European Journal
of Environmental Law, he noted that "The precautionary principle
has emerged as a critical component of the new European approach to risk
regulation as well as an important focus of disagreement between the US
and Europe. . . Europeans are seeking to widen the basis upon which a
country may exclude products on the grounds that they pose either unknown
or unacceptable risks, while the US is seeking to strengthen the role
of risk assessment in order to limit the ability of its trading partners
to use regulations as non-tariff barriers."
As US policy
makers, we realize that advocacy of the precautionary principle is here
to stay and we must learn to understand the origins and ramifications
of this advocacy. It appears that "the precautionary principle",
stated as such , has its origins in Swedish and German environmental policy.
The intent is to promote longrun foresight in response to emerging yet
persistent environmental problems. Policy makers are urged to anticipate
and respond to potential problems, rather than waiting for perfect science
to take protective steps. The principle was explicitly mentioned in the
Amsterdam Treaty governing the creation of the European Union, though
it was originally applied only to environmental policy. More recently,
the European Commission clarified, in its 2000 "Communication",
that the principle applies to consumer protection (including plant and
animal health) as well as to environmental protection. At international
meetings, representatives of the EU have repeatedly sought to have this
principle recognized as an internationally important legal construct.
In the United
States we recognize that precaution is a sensible idea. Public health
historians have taught us that tragedies can occur from insufficient consideration
of precaution in risk management. Prominent illustrations in this literature
include tobacco, asbestos and lead. Concerning the health risks of each
of these substances, historians have argued that harm could have been
mitigated or prevented altogether if policy makers had acted upon preliminary
indications of danger to public health.
not overlook the scientific complexities that underpin each of these examples.
Take the link between smoking and lung cancer. In the middle of the previous
century, many thoughtful clinicians were skeptical of this link. They
treated lung cancer patients who never smoked. They also treated heavy
smokers who never developed a lung ailment. It ultimately took large-scale
statistical studies, including a prominent one of British physicians,
to buttress the medical case against smoking.
have argued that postulated risks usually or always turn out to be worse
than originally anticipated. This was a view expressed by consumer advocate
Ralph Nader to ABC's John Stoussel in the prime-time TV special "Are
We Scaring Ourselves to Death?" (April 1996). The European Commission
appears to agree with this perspective, at least as indicated in a recent
report issued by the EC's environmental division. The report documents
17 case studies where hazards proved worse than originally anticipated;
they claim to have been unable to find any cases of reassuring science.
venture to say that the dynamics of science are not as predictable as
Nader and the EC suggest. Consider first the well-known "dismal theorem"
advanced by the late Rev. Thomas Malthus (1798). Malthus hypothesized
that population would grow exponentially while sources of sustenance would
grow arithmetically. He therefore predicted that global living standards
would eventually fall to subsistence levels. While his thesis is prominent,
contemporary textbooks cite an important flaw in his prediction. Malthus
did not account for the technological advances that would permit both
population and living standards to rise together.
more contemporary examples of postulated dangers that did not materialize.
In American regulatory history, the most prominent illustration would
be FDA's regulatory equivalent of war against the artificial sweetener
saccharin. FDA was alarmed when it was shown that rodents developed bladder
cancer after consuming large, sustained doses of saccharin. However, the
US Congress overturned FDA's attempted ban on saccharin -- in this case
an incriminated product was protected by popular opinion. After 25 years
of additional science, it now appears that Congress may have been on to
something. Experimental biologists have demonstrated that the rodent tumors
occurred because of cell proliferation, and this response does not occur
at the lower doses of saccharin that are typical of human consumption.
Epidemiologists have also learned, based on long-term studies of saccharin
users, that no elevation in bladder risk can be detected. Recently, the
US Department of Health and Human Services quietly recognized the scientific
realities by removing saccharin from the agency's official list of carcinogens.
recently there was an allegation that low-dose mixtures of industrial
chemicals are a threat to the endocrine system of the human body. Prior
to this allegation, the conventional view was that sufficiently low doses
of individual chemicals were safe, assuming such doses were determined
through standard toxicity tests. However, an explosive contrary experiment
was published in one of the best scientific journals in the USA. This
experiment found that low-dose exposures to a mixture ("soup")
of industrial chemicals can disrupt the endocrine system, even though
single chemical exposures may be safe. This provocative finding helped
provoke the US Congress to add new "endocrine testing" provisions
to the Safe Drinking Water Act Amendments of 1996. However, few people
realize that the veracity of this finding was later questioned, quite
seriously. To make a complex story short, the investigative arm of the
NIH examined this finding and determined that it arose from errors in
the scientific process. The findings have been retracted and, to the best
of my knowledge, this particular allegation of danger has never been verified.
examples are not sufficient, consider the hypothesis that magnetic fields
from electric powerlines are associated with the development of human
cancers. Early published studies found that living near a powerline was
associated with childhood leukemia and brain cancer in adults. The US
Congress launched a multi-year $50 million research effort to verify this
hypothesis. When the entire program was concluded several years ago, the
US government concluded that there was no consistent support for this
hypothesis in biology or epidemiology. I find it interesting that the
World Health Organization continues to examine the hypothesis, and is
holding international meetings about appropriate precautionary approaches
to this concern. While concern about magnetic fields from powerlines has
diminished in the USA, lawsuits have been filed against cell-phone companies
on the grounds that brain cancer may be related to use of cellular phones.
It will be instructive to follow this hypothesis in the years ahead.
scientific case studies as background, I would like to share with you
some of the reasons why officials of the US government are reluctant to
embrace what the EU refers to as "the" precautionary principle.
is no such thing as "the" precautionary principle. The Swedish
philosopher Sandin has documented 19 different versions of the principle.
While certain themes are similar, crucial details vary (e.g., the degree
of scientific evidence necessary to justify precaution and the role of
economics in decisions made on grounds of precaution). Even the EC's 2000
"Communication" on precaution, though it provides constructive
guidance to policy makers, does not provide an explicit definition of
Americans recognize that sensible precautions are an important feature
of wise decision making. In fact, there are established approaches to
precaution defined in both decision theory and economics. We do not see
why a universal new principle is needed to cover what is already embedded
in the existing theories of "option value" and "value-of-information"
an extreme version of precaution were adopted, it could thwart the technological
innovation that has supported rising living standards throughout the world.
Consider the following thought experiment: It is 1850 and the following
strict version of the precautionary principle is being applied: No innovator
may market a new technology unless it meets an evidentiary standard of
absolute safety, including consideration of longterm effects. What would
have happened to electricity, the internal combustion engine, plastics,
pharmaceuticals, the Internet, cell phones and so forth? Innovation is
a process of trial, error, and refinement -- a critical process that could
be disrupted by overly simplistic views of precaution.
the proponents of the precautionary principle need to explain more clearly
how the principle addresses the risks of precautionary action. For example,
the USA has learned that when FDA regulation of new drugs became too stringent,
it caused harmful delays in the introduction of effective therapies into
medicine. Should the precautionary principle apply only to the potential
hazard of immediate concern, or should it also apply to the potential
risks of precautionary measures?
we see the precautionary principle as potential camouflage for protectionism,
even though the principle is often advocated to advance such lofty objectives
as protection, democracy and ethics. As the EC Communication recognizes,
it is important to make sure that the principle is not abused for illegitimate
trade proposes. Yet one of the early decisions of the World Trade Organization,
concerning the EC's ban on hormone-treated beef, illustrated how the EC
had attempted to justify a permanent ban on certain hormone-treated products
when the issue should have been handled under provisional authority that
is receptive to scientific advances. For years the USA has also been making
the case in Europe -- with limited success -- that genetically-modified
foods should be regulated based on science and risk assessment. Our backs
are now against the wall, and we are doing what this Administration does
not like to do: we are litigating the GMO issue in the World Trade Organization
in order to uphold the future viability of this promising technology.
we have intense policy disagreements with our European colleagues, we
have seen indications that the EU does recognize the need to subject the
precautionary principle to reasoned checks and balances. For example,
the EC's 2000 Communication on precaution describes the principle within
science-informed decision making that includes risk assessment, risk management
and risk communication. The Communication also describes a role for cost-benefit
analysis as well as other principles of risk managment such as proportionality.
More recently, the European Commission has issued papers outlining a more
rigorous process of "Better Regulation" where the tools of regulatory
impact analysis recommended by the OECD will be used more consistently
the domain of specific regulatory decisions, there are some signs of light
from a US government perspective. The Commission's handling of the aftermath
of the BSE fiasco is a case in point. When the UK had implemented a broad
range of effective countermeasures to address BSE, the Commission recommended
that all Member States lift their precautionary bans on importation of
British beef. In the final analysis, only one Member-State -- France --
refused to do so. Citing the precautionary principle, the French argued
that French beef may in fact be safer than British beef. Brussels found
little evidence to support the French position and contested the French
decision in the European Court of Justice. The Court sided with Brussels,
indicating that even a position based on the precautionary principle must
have some basis in science.
the European Commission has taken modest steps to authorize some genetically-modified
seeds. Officials in Upper Austria took a different view, invoking the
precautionary principle to preclude use of an authorized GM seed in Upper
Austria. Brussels rejected Upper Austria's position on the grounds that
the authorized GM seed should not have any greater risks in Upper Austria
than elsewhere in Europe. Again, Brussels stressed that appeal to the
precautionary principle must have some basis in science.
I have suggested that advocacy of the precautionary principle is here
to stay. Precaution is a sensible concept and is built into modern tools
of economic and decision analysis. The notion that a universal precautionary
principle is necessary should not be endorsed until (a) it is defined,
(b) it is shown to offer distinct advantages to the science-based approaches
to risk management currently employed in the USA. In other words, the
US Government will continue to take a precautionary approach to universal
adoption of "the" precautionary principle.