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May 2, 2000


Unwisdom from the Academy


Unwisdom from the Academy

By Henry I. Miller

The Scientist 14[9]:35, May. 1,

A long-awaited report from the National
Academy of Sciences (NAS) on proposed Environmental Protection Agency
(EPA) regulation of recombinant DNA-manipulated plants that was
released last month has been interpreted in contradictory ways. The
Washington Post reported that "crops that are genetically
engineered to produce their own pesticides appear to be safe,"
and CBS news observed that the NAS review was "the closest thing
to a seal of approval gene-altered foods have ever received."
Not surprisingly, therefore, many of those long opposed to
biotechnology promptly denounced it as "junk science."
However, the always-antibiotech Environmental Defense had a still
different take, interpreting the report as condemning too-lenient
regulation by the government. Its creative press release headline was
"Scientific Panel Calls For Stronger Controls on Biotechnology;
Short-Sighted Government Approach Fails to Protect Long-Term Public

Skepticism about the NAS report is justified, but for reasons
different from those the antitechnology activists offer. Analyzing
the product instead of responding to the spin and the buzz, one finds
that the report is flawed on procedural, scientific, and policy
grounds. It is internally inconsistent and scientifically obtuse and
conflicts directly with previous reports by the Academy and other
prominent, mainstream scientific groups. Worst of all, it paves the
way for EPA to introduce an illogical, burdensome regulatory scheme
that has been condemned repeatedly by the scientific community.

A fundamental problem is that the committee that produced the report
simply ignored the crucial aspects of its charge--namely, "to
examine the existing and proposed regulations to qualitatively assess
their consequences for research, development, and commercialization
of [recombinant plants modified to enhance pest resistance]";
and to "provide recommendations to address the identified
risk/benefits, and, if warranted, for the existing and proposed
regulation of [recombinant plants modified to enhance pest
resistance]." This point is essential because, as discussed
below, every other major analysis has found the EPA's regulatory
approach wholly unscientific and potentially damaging to agricultural

The pivotal question about biotech regulation by the EPA and others,
which has been addressed repeatedly by a variety of expert groups
over two decades, is whether the use of recombinant DNA techniques
should be a trigger for (process-based) regulation. The scientific
community, including two previous studies from the Academy itself,
has said no--that recombinant DNA techniques are merely an extension,
or refinement, of the kinds of genetic manipulation that have been
performed for decades or even centuries. A 1987 report from the
Academy ("Introduction of Recombinant DNA-Engineered Organisms
into the Environment: Key Issues") concluded that there is no
evidence of unique hazards, either in the use of recombinant DNA
techniques or in the movement of genes between unrelated organisms.
In 1989, another Academy study ("Field Testing Genetically
Modified Organisms: Framework for Decisions") went even further:
"With classical techniques of gene transfer, a variable number
of genes can be transferred, the number depending on the mechanism of
transfer; but predicting the precise number or the traits that have
been transferred is difficult, and we cannot always predict the
phenotypic expression that will result. With organisms modified by
molecular methods, we are in a better, if not perfect, position to
predict the phenotypic expression." That committee also
recommended that "the nature of the process [of genetic
modification] is not a useful criterion for determining whether the
product requires less or more oversight."

Nor was it only Academy committees that objected to the EPA approach,
which circumscribes only recombinant DNA-manipulated plants for case
by case review of field trials and subjects each variety to onerous
pesticide registration procedures. A large segment of the scientific
community has condemned the EPA proposal without equivocation. A 1996
report by 11 scientific societies that represent 80,000 biologists
and food professionals excoriated the EPA's approach and warned of
negative consequences for agriculture and consumers, if the EPA's
policy were to be implemented. They predicted that it

"Discourage the development of new pest-resistant crops, thereby
prolonging the use of synthetic chemical pesticides; Increase the
regulatory burden for those developing pest-resistant varieties of
crops, while also increasing federal and state bureaucracy; 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 ...; 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 limit the use of
valuable genetic resources and new technologies to improve crop
protection from pests and diseases."

In 1998 the Council on Agricultural Science and Technology (CAST), an
international consortium of 36 scientific and professional groups,
reiterated the 11 societies' criticisms, characterizing the EPA's
approach as "scientifically indefensible" and observing
that treating gene-spliced plants as pesticides would "undermine
public confidence in the food supply."

It was extraordinary, therefore, to find in the April report from the
Academy that "the committee has chosen to take EPA's proposed
rule and the overarching [federal governmental] coordinated framework
as given." This critical decision enabled the committee to
produce a report that accepts a policy that has been censured
repeatedly; a policy that calls into question the long, distinguished
history of breeding pest resistance into plants that has produced
enormous improvements in food production and safety, worldwide; a
policy that would have thwarted the Green Revolution that has been,
literally, life-giving to hundreds of millions of starving people in
developing countries.

That the April report contains language endorsing the scientific
consensus on what factors confer risk--"the committee agrees
that the properties of a genetically modified organism should be the
focus of risk assessments, not the process by which it was
produced"--only emphasizes the logical inconsistency of choosing
to ignore the central, fundamental tenet of the EPA's approach to
regulation. That tenet--that the use of recombinant DNA techniques
should serve as the trigger to regulation--violates a basic principle
of regulation: that the degree of scrutiny should be commensurate
with risk.

Another fundamental problem with the April report is that it ignores
the part of the federal framework that is supposed to guide
regulatory approaches such as that of the EPA. 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 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,
an unequivocal statement that merely the use of recombinant DNA
techniques is not an appropriate trigger for oversight.

How could the internationally esteemed National Academy of Sciences
have gone so far wrong in assessing the EPA policy? The committee was
"stacked." Committee members and invited reviewers were
included with disregard for obvious conflicts of interest and bias,
including well-known ideological opposition to biotechnology and
previous work on the regulatory approach in question while employed
at EPA. Three members of the 12-person committee (Stanley Abramson,
Fred Betz, and Morris Levin) are former EPA staff who had helped to
craft and defend a variety of process-based regulatory policies while
at the agency, and another (Rebecca Goldburg) has produced a
succession of antibiotechnology tracts over the past decade.
Moreover, during the formal review process, the document was reviewed
by another former senior EPA official (Lynn Goldman) who had been
instrumental in crafting and defending the policy in question, and by
an antibiotechnology activist (Jane Rissler).

Bruce Alberts, the president of the Academy, has written that the
composition of the committee attempted to achieve "an
appropriate balance of viewpoints." Instead of balance, he has
achieved bias.

This travesty need not have happened. When the committee was first
established, several eminent scientists expressed reservations to
Alberts 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 NAS. His problematical response was to
add Rebecca Goldburg, yet another antibiotech member who was not a
member of the Academy.

The most consequential result of this flawed report will be to
promote unwarranted regulatory barriers to the development of pest
control strategies that can reduce farmers' reliance on chemical
pesticides and enhance productivity. The warnings of the 11
societies' and CAST reports--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 the report and the
now-inevitable EPA announcement of its final rule will unnecessarily
inflate the costs of research on and the commercialization of new
plant varieties. It may spell the end of the new biotechnology
applied widely and cost effectively to agriculture and world food
production needs.S

Henry I. Miller is a senior research fellow at the Hoover Institution
and an adjunct scholar at the Competitive Enterprise Institute.
E-mail: miller@hoover.stanford.edu. He is the author of Policy
Controversy in Biotechnology: An Insider's View (R.G. Landes,