March 22, 2000 / Financial Times / HENRY MILLER
Excessive regulation of GM foods is misplaced and irrational and will make
it impossible for these products to compete in the market
Just weeks after
the completion of a disastrous "biosafety protocol" under the 1992 United
Nations Biodiversity Treaty, biotechnology applied to food and agriculture
has just received a blow from another UN agency, this one concerned with
international food standards.
What's new about anti-biotech sentiment at the UN? US government regulators
as essential and willing collaborators, that's what.
The result will be genetically modified (GM) food and food ingredients held
to standards that are irrational, far beyond those that any other products
can or should meet, and that prevent their competing successfully.
Last week, a task force of the 165-member Codex Alimentarius Commission,
the joint food standards programme of the UN's World Health Organisation
and Food and Agriculture Organisation, met in Chiba, Japan, to begin
discussions on issues related to biotechnology and food.
It began auspiciously, with Thomas J. Billy, the temporary chairman of the
Codex (and senior US Department of Agriculture official), noting that
biotechnology is merely "a new name or label for a process people have used
as long as we have been baking bread, fermenting wine or making cheese, or
cultivating crops and breeding animals". He alluded to the scientific
consensus that biotech is a continuum of new and old technologies, and that
modern GM techniques are "essentially a refinement of the kinds of genetic
modification long used to enhance micro-organisms, plants and animals for
food".
Then he posed the central question about biotech regulation: "Is the method
by which a product was created the important issue, or is it the
(product's) characteristics" that should be a trigger to regulatory
oversight? He concluded rightly that scientific consensus and the long
history of food regulation argue that the risk-based characteristics of a
new product - for example, changes in allergenicity or levels of endogenous
toxins - are most important, regardless of the production techniques used.
Neither Mr Billy's scientific approach nor his conclusions were heard from
again. Instead, the group moved deliberately towards circumscribing GM food
products with various draconian and even bizarre regulatory procedures and
requirements that will impair their competitiveness in the marketplace.
This was precisely the agenda of many of those assembled. Their motivations
vary. The Europeans - especially the European Commission and France - want
to stop GM products because they are mostly made by US companies, and the
radical environmental non-governmental organisations (NGOs), which are
permitted to participate in Codex meetings, are ideologically opposed to new
technology.
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 sets 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
delegation, headed by Robert Lake, food regulator at the US Food and Drug
Administration, never cited the important principle that the degree of
regulatory scrutiny should be commensurate with risk. Nor did it invoke the
scientific consensus about the essential equivalence between old and new
biotech. Instead, US delegates went with the flow - which seems destined to
carry food biotech down the drain.
This first session of the task force, which is scheduled to complete its
work in 2003, was dominated by the relentlessly anti-biotech European
Commission, which advocates both the creation of overt obstacles to the use
of GM techniques in food and agriculture, and also vagueness in regulatory
definitions and concepts. This ensures that regulators can be as arbitrary
and capricious as they wish.
(Thus, if the International Trade Commission favours the US on a judgment
about, say, hormones in beef, the European countries can retaliate by
invoking the precautionary principle - which says that a technology must be
proved absolutely safe before it can be used.)
The Commission's opposition to biotech was not new. But the US singing the
Europeans' tune - that was new.
Why the change? Politics.
Under pressure from anti-technology extremists and the Clinton
administration, the FDA plans soon to repudiate both its well-tested,
much-praised policy on new plant varieties - which is applied irrespective
of whether the plant arose from GM or "conventional" genetic engineering
methods - and its 20-year-old commitment not to discriminate against GM
products generally.
Within a few months, according to senior FDA officials, the agency expects
to announce a new requirement that all GM foods come to the agency for
pre-market evaluation. FDA officials orchestrated the phoney "pressure" for
such a change by holding public meetings at the end of last year that
offered activists an opportunity to stuff the ballot box, and at which the
discussion panels were packed with radical opponents of biotech.
This impending deterioration in domestic regulatory policy tied the US
delegation's hands at the Codex task force - and will continue to do so in
other international forums. Knowing that their own policy will soon
contravene the scientific consensus about biotech regulation constrains FDA
officials from pushing the scientific line.
The Codex task force is en route to codifying various procedures and
requirements more appropriate to potentially dangerous prescription drugs
or pesticides than to GM tomatoes, potatoes and strawberries. They include
long-term monitoring for adverse health effects and batteries of tests for
genetic stability, toxins, allergenicity, and so on.
Among the most egregious is something called "traceability", an array of
technical, labelling and record-keeping mechanisms to keep track of a plant
"from dirt to dinner plate", so that consumers will know whom to sue if
they get diarrhoea from GM prunes, and providing, in the words of the
Commission delegate, "a tool governments can use to remove products from
the market".
The prospect of unscientific, overly burdensome Codex standards for GM
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.
Food production has low profit margins and cannot easily absorb the costs
of gratuitous regulation. The overregulation of GM foods prevents its wide
application to food production, deprives farmers of important tools for
raising productivity, and denies to food manufacturers and consumers
greater choice among improved, innovative products.
Henry Miller is a fellow at the Hoover Institution. 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 biotech foods.
(posted without permission)