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May 6, 2000


FDA's Volte-Face on Food Biotech


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

Frances Greene observed in her communication regarding the FDA's policy
reversal on biotech foods that "The FDA should be
applauded for sticking to sound science . . . " If only her assumption
were accurate. See the manuscript below, which has been submitted for

Henry Miller
Hoover Institution
Stanford University

May 5, 2000

Henry I. Miller, MD
Phone (650) 725-0185; Fax (650) 723-0576; Home Phone (650) 368-1221

One of the FDA's few regulatory successes during the past decade has been
its oversight of biotechnology-derived, or gene-spliced, foods. For the
past eight years, the agency's official policy has treated gene-spliced and
other foods the same, and required scrutiny by regulators only when there
are specific safety concerns. This approach was widely applauded as
regulation that makes sense, protects consumers, and permits innovation.

However, under pressure from anti-technology extremists and the Clinton
administration, the agency this week announced a change in policy that
reverses both its scientific approach to food regulation and a twenty-year
old commitment not to discriminate against biotechnology-derived foods and

The new approach is tantamount to singling out only cars with advanced
engineering for a punitive tax. The result will be, in the long-term,
international bureaucracies meddling where they don't belong, disuse of a
stunning new technology, diminished choices for farmers and consumers, and
higher food prices.

Thousands of biotech foods in US supermarkets have been regulated under the
FDA's 1992 policy on products from "new plant varieties," which applied
irrespective of whether the plant arose by gene-splicing or conventional
genetic engineering methods. It 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. Thus, the agency's approach
conformed to the fundamental principle that the degree of scrutiny should
be commensurate with risk. Likewise, it was consistent with a widely held
scientific consensus that "conventional" and new biotechnology are
essentially equivalent, and that the highly precise gene-splicing
techniques, in fact, yield a better characterized and more predictable

At the same time that the official FDA policy treated biotech foods no
differently from others, the agency maintained a "voluntary consultation
procedure," in which producers of biotech foods were expected to consult
with the agency before marketing their products, and without exception they
did so. The major change announced on Wednesday would require the
producers to notify the FDA four months before marketing a gene-spliced
food and provide the agency with data that affirm the new food's safety.

What's so wrong with codifying essentially what was previously voluntary,
but standard, practice? Plenty.

First, the data requirements of the new policy are excessive. The FDA
lists nine categories of obligatory information whose level of detail is
far greater than would be required (or possible) for food products made
with less precise, less sophisticated techniques.

Second, the new policy reverses the FDA's twenty-year-old guiding
principles for oversight of biotechnology -- that regulation should focus
on real risks and should not turn on the use of one technique or another.
These tenets have provided effective oversight for thousands of new
biotechnology products, including foods, drugs, vaccines and diagnostic tests.

Finally, the FDA's abandonment of a scientific approach to biotech
regulation has greater implications, both geopolitical and temporal, as I
saw first-hand in March during a meeting in Japan of a task force of the
UN's food standards organization, the Codex Alimentarius Commission. The
change of policy at the FDA (which was then impending) strikingly altered
the dynamics of the negotiation.

The FDA has for decades been considered a world leader in biotech
regulation and could be relied upon in international forums to defend
scientific principles and vigorously advocate its own risk-based approach.
Faced with initial antagonism to the US position from other countries and
NGOs, which is not unusual at international negotiations on regulatory
issues, the US delegation commonly would set the tone by insisting on
adherence to scientific principles and explaining the scientific basis for
its own regulatory policy.

What was anomalous at the Codex task force meeting was that the US delegate
(and senior FDA food regulator), Robert Lake, never mentioned the FDA's own
risk-based approach. He never cited the important principle that the
degree of regulatory scrutiny should be commensurate with risk. Nor did he
invoke the scientific consensus about the essential equivalence between old
and new biotech.

Instead, the US followed the lead of the European Commission and France,
both vehemently anti-biotech, and agreed to work toward Draconian and
unscientific standards for gene-spliced foods. This first session of the
Codex task force, which is scheduled to complete its work in 2003, was
dominated by the relentlessly Luddite European Commission, which advocates
both the creation of overt obstacles to the use of gene-splicing techniques
in food production and agriculture, and also vagueness in regulatory
definitions and concepts. This ensures that regulators can be as arbitrary
and capricious toward biotech products as they wish. The prospect of
unscientific, overly burdensome Codex standards for gene-spliced foods is
ominous, because members of the WTO will, in principle, be required to
follow them, and they will provide cover for unfair trade practices.

The impending deterioration in domestic regulatory policy — that is, the
changes just announced — tied the hands of the US delegation in Japan, and
will continue to do so in other international forums that are addressing
biotech food regulation. These include two other Codex panels and the
Paris-based Organization for Economic Cooperation and Development.
International regulation is destined to become biotech food's bęte noire.

The long-standing FDA policy toward gene-spliced and other novel foods
worked admirably. It involved the government only in those extraordinarily
rare instances when products raised safety issues. For others, market
forces were permitted to work their magic, the result of which was eight
years of unprecedented choice for farmers, food producers and consumers.
The policy also encouraged strong FDA advocacy for scientific regulation
internationally, which has now ended with dire consequences.

Food production has low profit margins and cannot easily absorb the costs
of gratuitous regulation, domestic or international. The overregulation of
gene-spliced foods will prevent its wide application to food production,
deprive farmers of important tools for raising productivity, and deny to
food manufacturers and consumers greater choice among improved, innovative

Henry Miller is a fellow at the Hoover Institution and an adjunct scholar
at the Competitive Enterprise Institute. He was an FDA official from 1979
to 1994 and is an adviser to the US delegation to the Codex Alimentarius
Commission task force on foods produced with the new biotechnology.