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May 29, 2000




The following message was received at AgBioView-owner@listbot.com
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Published by the Washington Legal Foundation, May 26, 2000:


Henry I. Miller and Gregory Conko; Henry I. Miller is a Senior
Research Fellow at Stanford University's Hoover
Institution, and from 1989 to 1994 he served as director of the U.S. Food
and Drug Administration's Office of Biotechnology.
Gregory Conko is Director of Food Safety Policy at the Competitive
Enterprise Institute in Washington, D.C.

Agricultural biotechnology is under attack around the world by
activists and government officials who see regulation as a
growth industry. Opponents of the technology raise the specter of various
potential threats to the environment and human health
-- assertions that are supported by neither the weight of evidence nor the
judgements of the scientific community. Nevertheless,
anti-biotech campaigners represent a growing political force. They
advocate strict legal standards for the evaluation of new
technologies, which threaten technological progress and deny its benefits
to consumers.

A Gap Between Science and Regulation

The discovery of gene-splicing (recombinant DNA) techniques some thirty
years ago was heralded as a signal advance for the
future of medicine, agriculture, and other applications. Foods and
pharmaceuticals developed with this new biotechnology have
been available in the U.S. for nearly two decades. During that time, a
wide consensus has grown in the scientific community that
because gene-splicing is more precise and predictable than older
techniques of genetic modification -- such as selection and
cross-breeding -- it is at least as safe. In its highly regarded 1987
report, the National Academy of Sciences (NAS) concluded
that "the risks associated with the introduction of [gene-spliced]
organisms are the same in kind as those associated with
unmodified organisms and organisms modified by other methods." It also
found that judgements about safety should be based
upon the specific characteristics of each individual product, not upon the
methods used to develop it. In subsequent reports
released in 1989 and in April of this year, the NAS reiterated its support
for those earlier findings.

Nevertheless, the United States and many foreign nations have developed
regulatory systems that single out gene-spliced
products for heightened scrutiny and discriminatory treatment, regardless
of the level of risk individual products pose. In the
United States, Environmental Protection Agency regulations have
unnecessarily inflated the development costs of gene-spliced
plants and microorganisms and have stifled much commercial and,
especially, university-based research. They have all but
destroyed the once-promising development of "biorational" microbial
pesticides and of gene-spliced microbes for remediation of
toxic wastes by making it vastly more difficult and expensive to test new
products outside laboratories and greenhouses. U.S.
Department of Agriculture regulations, which admittedly have been less
stifling, are similarly biased against gene-spliced
products. Among domestic regulatory bodies, only the Food and Drug
Administration (FDA) once stood as a counter to this
general trend. Though forces within the FDA have at times been
antagonistic to biotechnology, the agency's official policy has
tended to treat gene-spliced foods cautiously but fairly. Unfortunately,
the FDA recently announced a change in policy that will
begin treating gene-spliced foods in discriminatory fashion.

Internationally, the regulatory situation is even worse. Regulations
developed by many foreign countries and various agencies of
the United Nations single out gene-splicing for at least heightened
scrutiny, and sometimes bans and moratoria. These rules are
frequently rationalized on the basis of the unscientific "precautionary
principle," which states that regulatory action ought to be
taken to avoid a risk even when there is incomplete scientific evidence as
to its magnitude or potential impacts. In practice, it has
been interpreted to mean that a technology should not be used unless and
until it has been shown to be absolutely safe. This
means that the usual burden of proof is reversed. New technologies are
thus assumed to be guilty until their innocence can be
proven to a standard demanded by their critics -- in most cases, a
practical impossibility. Dr. Elizabeth M. Whelan, president of
the American Council on Science and Health, aptly sums up the shortcomings
of the precautionary principle:

First, it always assumes worst-case scenarios. Second, it distracts
consumers and policy makers alike from the known and
proven threats to human health. And third, it assumes no health detriment
from the proposed regulations and restrictions. By
that I mean that the precautionary principle overlooks the possibility
that real public health risks can be associated with
[expending resources on] eliminating minuscule, hypothetical risks.

When applied to agricultural and food biotechnology, the precautionary
principle focuses solely on the possibility that new
products may pose theoretical risks. But this standard ignores the very
real, existing risks that could be mitigated or eliminated
by those products. Applying the precautionary principle in this way often
results in increasing -- not decreasing -- overall risk.
For example, if the precautionary principle had been applied decades ago
to innovations like polio vaccines and antibiotics,
regulators might have prevented occasionally serious, and sometimes fatal,
side effects by delaying or denying approval of those
products, but that precaution would have come at the expense of millions
of lives lost to infectious diseases.

Using the precautionary principle as justification, half a dozen UN
programs and agencies have targeted biotechnology with a
sweeping array of burdensome new regulations. The UN's major regulatory
initiatives relating to biotechnology are contained
within the Cartagena Protocol on Biosafety, finalized at a meeting in
Montreal in January 2000. The goal of these regulations is
ostensibly to ensure that the development and use of gene-spliced
organisms are undertaken in a manner that prevents or reduces
the risks to biological diversity and human health. But even a cursory
examination of the protocol shows that the agreement has
less to do with legitimate concerns about public health and the
environment, and more to do with trade protectionism and
pandering to anti-technology ideology. In the name of enhancing
biodiversity and habitat conservation, the biosafety protocol
establishes the framework for a precautionary regulatory regime over
nearly all international shipments of gene-spliced
agricultural products.

In Europe, the precautionary principle is becoming an ever more popular
excuse to limit the introduction of new technologies. In
February 2000, just days after the biosafety protocol was finalized, the
German government decided capriciously to block the
commercial-scale cultivation of a gene-spliced corn variety by the
biotechnology company Novartis. This action came one day
before the new variety was expected to be approved for commercial use by
the Ministry of Agriculture, which specifically cited
the need to respect the precautionary principle and called for more
research into the crop plant's potential hazards.

Ironically, many of the new biotechnology's products would offer
environmental benefits, such as crop plants that have greater
yields and require less agricultural chemicals, biological alternatives to
chemical pesticides, and various biological methods of
cleaning up toxic wastes and purifying water. But as a result of the
excessive new rules, researchers around the world will see
their regulatory expenses skyrocket and their potential markets shrink.
What will expand are opportunities for corruption among
regulatory officials because application of the precautionary principle
essentially gives regulators carte blanche to require as
much or as little testing as they see fit. The precautionary principle's
great appeal to regulators stems precisely from its ambiguity
and arbitrariness.

Furthermore, the precautionary principle provides ample opportunity for
protectionism-minded politicians to thwart competition
and extract concessions from biotech researchers. While its proponents
publicly argue that the precautionary principle should
not be used as a disguised form of protectionism, there is no clearly
defined evidentiary standard that could be used to satisfy
demands for an assurance of "safety." Nor is there any procedural
safeguard in the biosafety protocol -- or any other document
that incorporates the precautionary principle -- that would serve to
mitigate such disguised protectionism. Under this new
standard of evidence, which European officials have warmly embraced and
implemented, regulatory bodies are free arbitrarily to
withhold approvals indefinitely.

Growing Threat to Science-Based Regulation

These unsavory developments leave only the World Trade Organization (WTO)
as a defense against protectionism and corrupt
regulators restricting trade. Historically, the WTO has been one of the
few international defenders of scientifically-sound risk
regulation. It should come as no surprise, therefore, that the mechanisms
under which the WTO evaluates human health and
environmental safety regulations are also under assault. In order to make
the world safe for the deployment of the precautionary
principle against free trade, anti-technology activists are trying to
undermine the WTO by writing the precautionary principle into
another set of international food safety standards drafted by the Codex
Alimentarius Commission, a joint program of the UN's
World Health Organization and Food and Agriculture Organization. Parties
to the Codex are not directly bound by its
regulatory guidelines, but the WTO tends to defer to Codex principles for
guidance on acceptable regulatory decisions.
Therefore, Codex measures have a great influence on international trade.

Recently, the Codex Alimentarius Commission established a working group
specifically to consider the need for special rules
related to biotechnology and food. The first meeting, held in March 2000,
began auspiciously, with Codex Chairman (and U.S.
Department of Agriculture official) Thomas J. Billy defending
biotechnology and arguing that the risk-based characteristics of a
new product are the most important determinant of the necessary level of
scrutiny, not the production techniques used.
Unfortunately, this scientific approach was not heard from again. Instead,
the group moved deliberately toward circumscribing
only food products made with gene-splicing for various Draconian and even
bizarre regulatory procedures and requirements
without objection from the U.S. delegation. The creation of obstacles was,
of course, exactly the agenda of many of those
assembled. Motivations vary: The Europeans want to stop gene-spliced
products because they are mostly made by American
companies, and the radical environmental activists (who are permitted to
participate in Codex meetings) are ideologically opposed
to new technology. Their opposition to biotechnology was nothing new.

The reason for the lack of objection or direction from the U.S. delegation
was apparently domestic politics -- namely, an
imminent change in the United States' own policy. The FDA announced in May
a new policy that reverses both its scientific
approach to food regulation, and a twenty-year old commitment not to
discriminate against biotechnology-derived foods and
pharmaceuticals. Thousands of biotech foods in U.S. supermarkets have been
regulated under the FDA's 1992 policy on
products from "new plant varieties," which defined certain potentially
hazardous characteristics of new foods that, if present,
required greater scrutiny by the agency, and which could have resulted in
additional testing and labeling, or banishment from
commerce. But this policy applied irrespective of whether the plant arose
by gene-splicing or conventional methods of genetic
modification. Thus, the agency's approach conformed with the scientific
consensus on gene-spliced foods and with the
fundamental principle that the degree of investigation should be
commensurate with risk. The FDA's recent reversal in policy,
however, singles out gene-spliced foods for the sort of discriminatory
oversight that the agency once opposed. The impending
change in domestic regulatory policy tied the U.S. delegation's hands at
the Codex meeting and will continue to do so in other
important international forums.

High Cost of the New Regulatory Burdens

Excessive international regulation imposes significant burdens on trade in
gene-spliced foods. Its greatest effect, however, will be
to slow dramatically the pace of technological progress in the
impoverished regions around the world most in need of
lower-input, more robust and nutritious crop plants. Agricultural
biotechnology is particularly vulnerable, because the required
case-by-case regulatory review removes an important tool of crop breeders:
the ability to test large numbers of new varieties in
field trials readily and rapidly. In traditional plant breeding, an
individual breeder of corn, soybean, wheat, or potatoes commonly
tests tens of thousands of distinct new genetic variants each year. But
the protocol's stultifying regulation will prevent this level
of research activity for genetic variants developed with the newest and
most precise techniques.

Ill-conceived public policy has already exacted a high price. The inflated
costs of research and development make it harder for
academic and charitable institutions to sponsor research targeted at poor
subsistence farmers and consumers. Agricultural
biotechnology, touted in the 1970s as promising to increase food
productivity in the developing world, has increasingly become a
boutique technology applied primarily to large commodity crops and focused
on making high-value-added products useful
mainly to farmers in industrialized countries. Furthermore, many small
agricultural biotechnology companies have failed under
the weight of burdensome regulation. Many more have had to merge with
large firms to remain competitive. In contrast to the
biopharmaceutical sector, there are actually fewer agricultural biotech
companies in the United States now than a decade ago. The
result of such consolidation is reduced competition and innovation.
Ultimately, consumers will pay inflated prices for
overregulated products and higher taxes to support bloated bureaucracies,
and they will have fewer options in the marketplace.

Myopic regulatory decisions have real costs for citizens of the U.S. and
other nations. It is these citizens who continue to
underwrite both the direct and indirect expenses of ultimate compliance
with the new regulations. And in the longer term, the
added expense of unnecessary regulations will serve as a potent
disincentive to research and development, especially on the kinds
of low-value-added products used in agriculture in general and subsistence
farming in particular. Consequently, many countries
will become no more than hungry spectators to the revolution in
agricultural biotechnology.

More than one billion people in the world now live on less than a dollar a
day, and hundreds of millions are severely
malnourished. By increasing the efficiency of agriculture and food
production in myriad ways, gene-spliced products can
significantly increase the availability and nutritional value of foods and
reduce their cost. But the application of the precautionary
principle will stall progress and exact a substantial human toll. The huge
stakes -- both in human and commercial terms --
demand that regulators instead create scientifically sound, risk-based
frameworks for the regulation of biotechnology.