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.
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