of John D. Graham, Ph.D., Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget
U.S. Executive Office of the President
Topic: Risk Management in a Complex World: The Fourth Transatlantic Dialogue
R. David Thomas Executive Conference Center, Duke University
Sunday, September 19, 2004
very much for the opportunity to participate in this last of four informal
dialogue sessions on the subject of precaution. On behalf of President
Bush, I want to thank the sponsors and organizers of these sessions for
bringing Europeans and Americans together to better understand how we
should think about precaution. I also want to welcome all of the participants
today -- and especially our European colleagues – and thank everyone
for your hard work and your willingness to travel in the face of the uncertain
risk of hurricanes Ivan and Jeanne.
We all realize
that these sessions have been conducted within a context of some strong
disagreements between European and American policy makers. That disagreement
exists at a fundamental level, concerning whether the so-called "precautionary
principle" is a well-defined construct. The disagreement extends
to real-world application of the construct on diverse issues such as genetically
modified foods and global climate change.
the persistence of policy disagreements, I believe these sessions have
been successful. They have fostered greater understanding about the dilemmas
faced by policymakers who confront incomplete scientific evidence about
a potential hazard. As an American official, I have also learned that
the European Commission sees the precautionary principle as a more subtle,
nuanced construct than I originally realized.
In my remarks
today, I will use the Commission's Communication on the precautionary
principle (2000) to demonstrate some key points of agreement, or at least
points that the US government finds reassuring. I will also conclude with
some residual areas of concern that are triggered by the Communication
and the evolving governance structure within the European Union.
with the Commission that decision-makers are "constantly struggling"
with the dilemma of how to make wise decisions in the face of scientific
uncertainty about potential hazards. The following six points of guidance
in the Commission's Communication are constructive and reassuring.
scope for precaution includes environmental protection, but is also broader,
and includes concern for potentially dangerous effects on human, animal
or plant health. We would argue for an even broader scope for precaution,
including concern for the economic well being and the quality of life
of people throughout the world, both today and in future generations.
Just as it is legitimate to invoke precaution with respect to a concern
for public health, it is legitimate to invoke precaution with respect
to concern for economic well being. In fact, to summarize a complex literature,
we should not forget that prosperity is healthier and greener than poverty.
We are encouraged that the Communication acknowledges an important role
for economics in the application of the precautionary principle, including
an examination of potential costs and benefits of alternative measures.
"the precautionary principle should be considered within a structured
approach to the analysis of risk . . . including risk assessment, risk
management and risk communication." (p. 3) This statement of the
Commission is reassuring. It highlights that precaution is not a substitute
for the risk-based approaches to decision making that the USA has developed
over the past thirty years. In this respect, the Commission's view of
precaution may differ somewhat from the views of precaution espoused by
some environmental advocates and academics in the United States.
implementation of an approach based on the precautionary principle should
start with a scientific evaluation, as complete as possible, and where
possible, identifying at each stage the degree of scientific uncertainty"
(p.3) This statement is reassuring. It says the precautionary approach
begins with science, rather than with popular opinion, media stories,
perceptions, or politics. There is already ample room for politics in
policy making on both sides of the Atlantic, and thus it is refreshing
to learn that the Commission believes that implementation of the precautionary
principle begins with an objective assessment of whatever science is available.
"a wide range of initiatives is available in the case of (precautionary)
action, going from a legally binding measure to a research project or
recommendation." This statement is reassuring. Many of my American
colleagues fear that the precautionary principle refers only to prohibitions
or burdensome legal restrictions. While we understand that bans and binding
rules are sometimes appropriate responses, it is reassuring that the Commission
recognizes additional scientific research to better understand a potential
hazard as a legitimate precautionary measure. For many potential hazards
in the early stage of scientific understanding, additional research may
be the most promising precautionary action. In some cases, an interim
legal restriction on a product or technology, combined with further research,
may be appropriate. We also fully concur that "precautionary measures
should be reviewed in light of scientific progress and amended as necessary."
we are encouraged that the European Commission recognizes a need to "avoid
unwarranted recourse to the precautionary principle" such as measures
that are a "disguised form of protectionism." This statement
is very reassuring. A subjective construct such as the precautionary principle
is susceptible to misuse and we are pleased that the Commission forsees
that potential problem. We also realize that the Commission has, on occasion,
taken aggressive actions to block unwarranted use of the principle by
Member States. For example, when France refused to lift the ban on British
beef (after the UK had implemented effective countermeasures against BSE),
the Commission persuaded the European Court of Justice that France's recourse
to the precautionary principle was unwarranted. More recently, the Commission
blocked an unwarranted recourse to the precautionary principle by Upper
Austria, in the context of permission to use a particular genetically
consider the Communication as a whole, it is apparent that the European
Commission's official view of the precautionary principle is thoughtful
rather than simplistic. Having said that, we continue to have some serious
concerns about the Communication, which I have discussed previously. We
also believe that the letter and spirit of the Communication are not always
followed in particular decisions, but that is a subject for a different
forum. At the present time, the US government is most interested in how
changes in European governance may influence the implementation of the
precautionary principle. Please let me elaborate briefly.
Communication commits the European Union to responsible use of the precautionary
principle, it is not entirely clear -- as an organizational matter --
what the checks and balances will be to ensure that the principle is used
properly. We should expect that regulators will often use their authority
responsibility. Nevertheless, in the United States, there are three principal
external checks against misuse of regulatory power: My office at OMB,
within the Executive Office of the President, has the expertise and authority
to compel regulators to reconsider the quality of their analysis and their
precautionary decisions; the federal judiciary has the power to review
final rules; and the United States Congress has authority to overturn
specific rules through the Congressional Review Act and other means. I
would like to learn more about how the EU will be organized to provide
external checks against the inevitable misuse of regulatory power.
On the subject
of scientific and economic analysis, there are often concerns about whether
a particular report is objective, comprehensive and transparent. In the
USA, each regulator must establish information-quality guidelines, and
prepare technical reports that adhere to these guidelines. My office at
OMB -- in collaboration with the President's Science Advisor -- is developing
government-wide standards for expert peer review of technical reports
before they are released by regulators. My office has also developed mechanisms
that permit members of the public, including industry and NGOs, to seek
correction of erroneous information distributed by regulators. Thus, even
if the regulator's peer review process does not detect an error, there
is a timely mechanism for the public to use to seek a correction.
I would like to learn
more about how the EU will be organized to ensure that the scientific
and economic information marshalled to support precautionary regulation
is dependable. I have no doubt that there is plenty of technical expertise
in Europe; the issue I am raising is one of governmental process for tapping
the best scientific talent and achieving quality control in official reports.
Finally, the Communication
uses the term "transparent" about good regulatory process and
endorses a role for "interested parties" to participate in the
study of precautionary measures. In the United States, we have established
means, under the Administrative Procedure Act, to ensure that the public
has an opportunity to participate in regulatory decision making. These
means include notice-and-comment procedures and public hearings prior
to final actions. I would like to learn more about how the EU as a whole
-- and the Commission in particular -- achieves transparency in precautionary
decision making, and whether the regulators provide ample opportunity
for meaningful public participation in the application of the precautionary
Thank you very much
for the opportunity to participate. I look forward to comments and questions.