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April 5, 2000





Henry I. Miller, MD

The long-awaited report from the US National Academy of Sciences on
proposed EPA regulation of biotech plants as "plant pesticides" was
released this week [5 April]. On procedural, scientific and policy
grounds the report corrupts the reputation and credibility of the
Academy. It is not only internally inconsistent and scientifically
obtuse, but conflicts directly with previous reports by the Academy and
other prominent scientific groups.

The EPA now has a clear path to introduce a regulatory scheme that has
been condemned repeatedly by the scientific community.

The committee members and the invited reviewers were included with
apparent disregard for obvious conflicts of interest, including
ideological opposition to biotechnology and having worked on the policy
under review while employed at EPA. Three members of the twelve-person
committee (Stanley Abramson, Fred Betz and Morris Levin) are former EPA
staffers who had helped to craft and defend the policy while in the
government; and another (Rebecca Goldburg) has produced a litany of
anti-biotechnology tracts over the past decade. And during the formal
review process, the document was reviewed by another former EPA
official (Lynn Goldman) who was instrumental in crafting and defending
the policy in question, and by another anti-biotechnology crusader
(Jane Rissler).

Given the makeup of the committee and reviewers, it is not surprising
that the chairman concluded that the federal agencies responsible for
regulating biotech plants, including the EPA, "have generally done a
good job," but the scientific community strongly disagrees. A 1996
report on the same EPA "plants as pesticides" policy by eleven
scientific societies (coordinated by the Chicago-based Institute of
Food Technologists), which represent 80,000 biologists and food
professionals, excoriated the EPA's unscientific approach and warned of
a number of negative consequences for agriculture and consumers, were
the EPA's policy to be implemented. They predicted that it would:

"O Discourage the development of new pest-resistant crops, thereby
prolonging the use of synthetic chemical pesticides;

O Increase the regulatory burden for those developing pest-resistant
varieties of crops, while also increasing federal and state

O Limit the use of biotechnology for the development of pest-resistant
plants to those developers that can pay the increased costs associated
with additional regulation . . .;

O Handicap the United States in competition for international markets
because of U.S. government policy that new pest-resistant varieties, or
products from these varieties, be identified as containing their own
‘pesticides'; and

O Limit the use of valuable genetic resources and new technologies to
improve crop protection from pests and diseases."

Or compare the just-released NAS report to the findings published in
October 1998 by the Council on Agricultural Science and Technology, an
international consortium of 36 scientific and professional groups,
which echoed the eleven societies' criticisms of the EPA policy. Its
issue paper, "The Proposed EPA Plant Pesticide Rule," characterized the
EPA's policy approach as "scientifically indefensible" and observed
that treating gene-spliced plants as pesticides would "undermine public
confidence in the food supply."

How could the NAS have gone so far wrong in its assessment of the EPA
policy? A partial explanation is buried on page 12 of the Executive
Summary of the just-released report: "the committee has chosen to take
EPA's proposed rule and the overarching [federal governmental]
coordinated framework as given."

In other words, the committee, composed largely of individuals who were
known to favor the EPA approach, decided not to review the scientific
basis for the EPA's policy: The committee simply rejected its original
charge. They produced a report that accepts and even endorses a policy
that calls into question a long history of breeding pest resistance
into plants that has produced enormous improvements in food production
and safety, worldwide; a policy that would have prevented the Green
Revolution, that has been of inestimable benefit to millions of
starving people in developing countries. The EPA policy imposes
regulations regardless of the actual levels of risk, thereby violating
a fundamental principle of regulation -- that the degree of scrutiny
should be commensurate with risk. It also contradicts the seminal
finding of an earlier Academy committee that in 1989 concluded that
"the nature of the process [of genetic modification] is not a useful
criterion for determining whether the product requires less or more
oversight." The just-released report's agreement with the 1989 study
on this point ("the committee agrees that the
properties of a genetically modified organisms should
be the focus of risk assessments, not the process by
which it was produced [emphasis in original]") emphasizes the logical
inconsistency of simply ignoring the central, fundamental tenet of the
EPA's approach to regulation -- namely, that the use of gene-splicing
techniques should serve as the trigger to regulation.

The committee that produced the just-released Academy report
specifically (and conveniently) ignored the part of the federal
framework that governs regulatory approaches such as EPA's "plants as
pesticides" policy. That guidance is contained in a 1992 statement of
policy from the White House Office of Science and Technology Policy,
"Exercise of Federal Oversight Within Scope of Statutory Authority:
Planned Introductions of Biotechnology Products into the Environment,"
which sets forth the appropriate basis for agencies' oversight. It
describes "a risk-based, scientifically sound approach to the oversight
of planned introductions of biotechnology products into the environment
that focuses on the characteristics of the . . . product and the
environment into which it is being introduced, not the process by which
the product is created. Exercise of oversight in the scope of
discretion afforded by statute should be based on the risk posed by the
introduction and should not turn on the fact that an organism has been
modified by a particular process or technique."

In short, merely the use of gene-splicing is not an appropriate trigger
for oversight -- yet the current report simply ignores that fundamental
tenet of the federal framework and chooses to accept EPA's contrary
approach as a given.

Perhaps the most troubling aspect of the report is that it and the
process behind it are products of the internationally esteemed National
Academy of Sciences. How could this have happened? When the
committee was first established, several eminent scientists expressed
reservations to the President of the Academy about its composition, the
potential conflicts of interest, and the fact that none of the members
of the committee, except the chairman, was a member of the National

The most significant result of this ill-conceived report will be to
advance unwarranted and debilitating regulatory barriers to the
development of much needed pest control strategies that can reduce
farmers' reliance on chemical pesticides. The warnings of the eleven
societies' report — decreased choices available to farmers for
defending against disease and pests, increased reliance on chemical
pesticides, and all the rest -- apply as well to this Academy report.
The prestige of the Academy attached to this report and the
now-inevitable EPA announcement of its "plants as pesticides"
regulation may spell the end of the new biotechnology applied widely to
agriculture and world food production needs.

Henry I. Miller is a Senior Research Fellow at Stanford University's
Hoover Institution, an Adjunct Scholar at the Competitive Enterprise
Institute, and the author of Policy Controversy in Biotechnology: An
Insider's View (R.G. Landes Co., 1997).