TCS Daily

Biotech's Crazed Critics

By Henry I. Miller - July 28, 2004 12:00 AM

It's hard to top some of the loony things that have been said about the new biotechnology. Technophobe Jeremy Rifkin claimed, for example, that genetically engineered bacteria might disrupt weather patterns, and that biotechnology threatens "a form of annihilation every bit as deadly as nuclear holocaust." And at one of the six public meetings convened by the British government to discuss biotechnology, there was conjecture about whether the SARS virus originated in gene-spliced cotton in China.

But in a recent article, anti-biotechnology activist Steven Druker came up with a real doozy. The gist of his argument is that by filing a complaint at the World Trade Organization against the EU's regulatory practices toward biotech-derived crops and foods, the United States "has been bullying the EU to abandon a principle that is the cornerstone of its own food safety law." As evidence, Druker cites U.S. food safety regulation that "places the burden of proof on the manufacturer and requires that foods containing new additives be presumed unsafe until proven safe."

The principle that Druker alludes to is the extreme "precautionary principle," much beloved in Europe, which holds that while a product, technology or activity has not yet been proven to be absolutely safe, it should be prohibited.

Not only is the basic premise of Druker's argument absurd, but the example he invokes to prove his case -- the requirement in U.S. law for the review of food additives before they are sold -- in fact proves exactly the opposite. He appears not to understand what a food additive is.

Under American law, a new food or food ingredient is either "generally recognized as safe" (GRAS) or it is a food additive and requires government review and approval. The maker of the product gets to determine whether or not the product is GRAS.

Conceptually, the objective of pre-marketing regulation (as opposed to post-marketing policing of the marketplace for products that cause problems) generally is to circumscribe for review potentially high-risk categories of products, such as food additives (which are, by definition, not generally recognized as safe), pesticides, prescription drugs and nuclear power plants.

In contrast, all of the gene-spliced, or "genetically modified" (GM), plants now on the market are widely recognized to be a negligible- or very-low risk category, as are the vast majority of the varieties being tested or contemplated. No one should find this surprising. The U.S. National Research Council observed fifteen years ago, "With classical techniques of gene transfer, a variable number of genes can be transferred, the number depending on the mechanism of transfer; but predicting the precise number or the traits that have been transferred is difficult, and we cannot always predict the [traits] that will result. With organisms modified by molecular methods, we are in a better, if not perfect, position to predict the [traits]."

More recently, even EU Commissioner for Health and Consumer Protection David Byrne acknowledged that Europe's precautionary labeling and traceability rules have nothing to do with protecting consumer health or the natural environment. And an analysis by the EU that summarizes the conclusions of 81 different EU-funded research projects spanning 15 years concluded that because gene-spliced plants and foods are made with highly precise and predictable scientific techniques, they are at least as safe, and often safer, than their conventional counterparts.

The relevant U.S. government policies that govern gene-spliced foods lie primarily not in the food additive regulations but in two others. The first, a 1992 announcement from the White House Office of Science and Technology Policy, articulates "a risk-based, scientifically sound approach" to the oversight of biotech products generally, according to which neither oversight nor the degree of regulatory scrutiny should "turn on the fact that an organism has been modified by a particular process or technique."

The second, also published in 1992, describes specifically the FDA's official policy toward foods derived from "new plant varieties." This announcement, intended to clarify the FDA's position on the regulation of gene-splicing and gene-spliced plants, explained that the "regulatory status of a food, irrespective of the method by which it is developed, is dependent upon objective characteristics of the food and the intended use." This genuinely risk-based approach treats gene-spliced and other foods no differently and requires case-by-case review by regulators only when the products raise specific safety concerns.

In short, official U.S. policy dictates unequivocally that merely the use of gene-splicing techniques is not an appropriate trigger for case-by-case review, or "precautionary" regulation, of foods. The FDA's approach is, thus, consistent with the consensus of the scientific community.

Therein lie the fundamental differences between the U.S. and European approaches to the precautionary principle. Many, if not most, countries impose extra scrutiny on higher risk categories of activities, technologies, or products. But out of ignorance, caprice or protectionism, Europe has chosen to vastly over-regulate gene-splicing, a negligible-risk, proven, beneficial technology.

What are the effects of this disparity? Since 1998, 61 percent of the private-sector institutions surveyed by the European Commission's Joint Research Center have canceled research projects that involve gene-splicing technology, and there has been a near-meltdown of field trials of gene-spliced organisms. From an unimpressive peak level of 264 field trials in Europe in 1997, there were only 35 in 2002. By contrast, U.S. plant biologists and plant breeders perform thousands of field trials annually, and last year more than 45 million hectares of commercial gene-spliced crops were planted.

But there is more to this story. Druker's op-ed goes on to grind one of his favorite axes -- one that's so old it's showing rust: He bashes the FDA's twelve-year-old risk-based policy of treating gene-spliced foods no differently from conventional foods except as scientific factors may dictate, and he accuses the FDA of "cover[ing] up the warnings of their own scientific experts about the unique risks of" gene-spliced foods. He bases that accusation on documents that supposedly show that several of the hundreds of FDA staffers who were involved in the formation and promulgation of agency biotech policy were more conservatively inclined, because they pointed out that even small genetic alterations in an organism can cause many changes.

Cover-up? Unique risks? Neither claim stands up to scrutiny. I headed the FDA's Office of Biotechnology at the time, and I was astonished at the virtual unanimity, both inside and outside the agency, of opinion toward the FDA's risk-based approach to regulation, which was consistent with the widespread scientific consensus about the high degree of precision and predictability of gene-splicing techniques.

But the proof of the pudding is in the eating, and over the past twelve years, the FDA's policy has worked flawlessly for tens of thousands of food products containing gene-spliced ingredients -- of which to date Americans have consumed more than a trillion servings.

Druker's risible accusations about FDA cover-ups and U.S. government actions "cloaked in hypocrisy and driven by deception" shed a great deal more light on his own paranoia than on public policy.

Henry I. Miller, a fellow at the Hoover Institution and the Competitive Enterprise Institute, headed the FDA's Office of Biotechnology from 1989-1993. His latest book," The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution," will be published next month by Praeger Publishers.


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