Misfires in Biotech Trenches

Agricultural biotechnology suddenly is headline news—the focus of a vitriolic trans-Atlantic trade squabble, and even the subject of pointed public comments by President Bush. At a conference in <?xml:namespace prefix = st1 ns = “urn:schemas-microsoft-com:office:smarttags” />Washington last month, he extolled biotechnology's achievements and its potential to feed the starving inhabitants of less developed countries.<?xml:namespace prefix = o ns = “urn:schemas-microsoft-com:office:office” />

The president also took the opportunity to blast the EU, saying that European anti-biotechnology hysteria based on “unfounded and unscientific fears” had caused many European governments to ban the testing and use of new crop varieties crafted with gene-splicing, the most precise technique of biotechnology. “We should encourage the spread of safe, effective biotechnology to win the fight against global hunger,” the president said.

However, sound public policy, like charity, begins at home, and Mr. Bush's own Agriculture Department and Environmental Protection Agency have adopted regulatory approaches to biotechnology as unscientific and regressive as those in Europe; they're just applied in a slightly less aggressive fashion. American farmers and consumers are paying the price.     

The dirty little secret of U.S. biotech policy is that regulation at the USDA and EPA is internally inconsistent and contradicts the official overarching federal policy—developed during the previous Bush administration with the formal agreement of the agencies—which stipulates that regulation of biotechnology products should be “risk-based,” “scientifically sound” and focused on “the characteristics of the biotechnology product and the environment into which it is being introduced, not the process by which the product is created.”     

What we have is exactly the opposite: regulation that arguably has an inverse relationship to risk, and that is triggered by the use of gene-splicing techniques.     

Consider USDA's approach to regulation. The USDA regulates the importation and interstate movement of plants and plant products that are pests, which are defined by means of an inclusive list. This approach is essentially “thumbs up or down”: A plant that an investigator might wish to introduce into the field is either on the prohibited, inclusive list of plants pests, and, therefore, requires a permit—or it's exempt.     

This straightforward approach is risk-based, in that the organisms that are required to undergo case-by-case governmental review are an enhanced-risk group—organisms that can injure or damage plants—compared to plants not considered to be plant pests.     

So far, so good, but this risk-based regulation has an evil twin.     

For the past 15 years, USDA also has maintained a parallel regime focused exclusively on plants altered or produced through gene-splicing techniques. In order to establish this mechanism, in which the scope of what is regulated is essentially independent of risk, USDA tortured the original concept of a plant pest as something known to be harmful, and crafted a new category—a “regulated article,” which was defined in a way to capture essentially every gene-spliced plants for case-by-case review, regardless of its potential risk.    

In order to field test or introduce a regulated article, a researcher must apply to USDA for a permit and submit a huge amount of data, which makes gene-spliced plants extraordinarily expensive to develop and test. A field trial with a gene-spliced plant may be 10 times to 20 times more expensive than the same experiment performed with a plant that has identical properties, but was modified with less precise genetic techniques.     

Consider an actual example of this incongruity in USDA's approach. There are several varieties of a new pre-gene-splicing manmade “species” of wheat called Triticum agropyrotriticum, which resulted from the hybridization of the genomes of bread wheat and a grass sometimes called quackgrass or couchgrass. Possessing all the chromosomes of wheat and one extra whole genome from the quackgrass, T. agropyrotriticum has been independently produced for both animal feed and human food in the former Soviet Union, Canada, the United States, France, Germany and China.     

At least in theory, several kinds of problems could arise from a genetic construction that introduces tens of thousands of “alien” genes into an established plant variety. These concerns include the potential for increased invasiveness of the plant in the field, and the possibility that quackgrass-derived proteins could be toxic or cause an allergic reaction. Yet dozens of new varieties are produced each year through these imprecise traditional methods of genetic improvement and enter the marketplace and food supply without any governmental review or special labeling. Only the precise gene-splicing methods allow breeders to identify and characterize the exact changes that have been made in the offspring.     

This increased precision and predictability make biotech-derived foods safer than conventional ones—but paradoxically they are far more intensively regulated. Government regulators have not shown the slightest concern about the greater risks of plant breeding that would occur with less precise, less predictable techniques. However, if a single gene from quackgrass were introduced into wheat via gene-splicing techniques, the draconian regulatory regime applies.     

This sort of inconsistency is irreconcilable. It is like subjecting cars with disk brakes, four-wheel drive and radial tires to a special, enhanced regulatory regime—and then limiting only those vehicles to 30 miles an hour.     

The portions of the agricultural biotechnology landscape that have not been ravaged by the USDA have been laid waste by the EPA, whose policies are equally illogical and discriminatory.     

The harsh reality is that unscientific federal regulatory policies, combined with unwise decisions on individual products, have created a seemingly irreversible morass. And even well-intentioned public comments by the president and secretary of agriculture, extolling the virtues of the new biotechnology, do nothing to reverse the malign effects of their administration's regulatory policy.