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Date:

June 19, 2000

Subject:

JUDGE BIOTECH BY THE REAL RISKS

 

AgBioView - http://www.agbioworld.org, http://agbioview.listbot.com

JUDGE BIOTECH BY THE REAL RISKS:

FANATICAL OPPONENTS OF GENE-SPLICED
ORGANISMS ARE RAISING COSTS SO HIGH THAT MANY NEW CROPS AND ENVIRONMENTAL
TECHNIQUES WILL NEVER BE DEVELOPED
June 20, 2000 National Post

Henry I. Miller and Gregory Conko
Junk Science Week

Biotechnology opponents don't criticize cross-breeding, selection,
mutagenesis and other traditional forms of genetic modification. Their
opposition, sometimes verging on the hysterical, is directed at one
particular form of genetic modification-gene-splicing (also known as
recombinant DNA) -- a 30-year-old discovery that has been heralded as a
signal advance for the future of medicine, agriculture, environmental
protection and other applications.

Foods and pharmaceuticals developed with this new biotechnology have been
available in the United States for nearly two decades. During that time, the
scientific community has come to a wide consensus that gene-splicing,
because it is more precise and predictable than older techniques, is at
least as safe. In its highly regarded 1987 report, the U.S. National Academy
of Sciences 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 judgments about safety should be based upon each individual product's
specific characteristics, 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.

Other groups have concurred. An authoritative 1993 report of the British
House of Lords Select Committee on Science and Technology observed that, "as
a matter of principle, [gene-spliced] products should be regulated according
to the same criteria as any other product," and that for Britain to focus
regulation on gene-splicing was "excessively precautionary, obsolescent and
unscientific."

Nevertheless, the United States and many other 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 costs of developing
gene-spliced plants and micro-organisms 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 are similarly biased
against gene-spliced products.

Internationally, the regulatory situation is even worse. Regulations
developed by many countries and various UN agencies 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 promotes regulatory action 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, reversing the usual burden of proof. 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.
Elizabeth Whelan, president of the American Council on Science and Health,
aptly sums up the precautionary principle's shortcomings:
"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, unscientific new regulations. The UN's major regulatory
initiatives relating to biotechnology are contained within the Cartagena
Protocol on Biosafety, finalized 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 the protocol's
provisions show that the agreement has less to do with such legitimate
concerns and more to do with trade protectionism and 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, new biotechnology often offers 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 with
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 because 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.
The precautionary principle also enables 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, no clearly defined evidentiary
standard exists to satisfy demands for an assurance of "safety." Nor does
the biosafety protocol-or any other document incorporating the
precautionary principle-include any procedural safeguard that would
mitigate disguised protectionism. Under this new standard (really a
non-standard) of evidence, which European officials have warmly embraced and
implemented, regulatory bodies are free arbitrarily to withhold approvals
indefinitely.

These unsavory developments leave only the World Trade Organization-one of
the few international defenders of scientifically sound risk regulation
-- as a defence against protectionism and corrupt regulators. To make the
world safe for the deployment of the precautionary principle against free
trade, anti-technology activists are trying-with some success-to write
the precautionary principle into the 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. Because the
WTO tends to defer to Codex principles for guidance on what constitutes
acceptable regulatory decisions, Codex measures profoundly influence
international trade.

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 potato 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.
Wrong-headed public policy already has exacted a high price. In the United
States, huge industrial sectors have been affected. Department of
Agriculture regulations have made experiments with gene-spliced plants 10-
to 20-fold more expensive than the very same field trials with virtually
identical organisms crafted with older, less precise techniques. As a
result, research and development lags far behind its potential, depriving
consumers of, for example, sunflowers modified to yield a more healthful
cooking oil. The Environmental Protection Agency has attacked biotechnology
on several fronts. A regulation under the Toxic Substances Control Act has
halted most research into gene-spliced micro-organisms that might be used,
for example, to clean up toxic wastes. 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.
These trends plague other countries as well, with the actions of some
governments crossing the line from the merely excessive to the absurd. First
Britain and now Japan are moving toward making the import of unapproved
gene-spliced varieties a criminal act-legislative actions more
appropriate to plutonium than petunias.

By pushing research and development costs through the roof, these regulatory
and legislative barbarities have destroyed the technology's egalitarian
potential. Agricultural biotechnology, touted in the 1970s as promising to
reduce the use of agricultural chemicals and 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. In contrast
to the biopharmaceutical sector, there are actually fewer agricultural
biotech companies in the United States now than a decade ago, leading to
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.