TCS Daily

Cleaning House

By Henry I. Miller - July 18, 2003 12:00 AM

Agricultural biotechnology suddenly is headline news -- the focus of a vitriolic transatlantic trade squabble, and the subject of pointed public comments recently by President Bush. At a conference in Washington, he extolled biotechnology's achievements and its potential to feed the starving inhabitants of less developed countries.

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 techniques 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 Department of Agriculture and Environmental Protection Agency have adopted regulatory approaches to biotechnology that are fundamentally as unscientific and regressive as those in Europe; they're just applied in a slightly less aggressive fashion.

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."

These strictures for federal agencies are contained in a statement of policy published in 1992 which clarifies how the regulation of gene-splicing-modified organisms should be approached. It calls explicitly for "a risk-based" approach to the oversight of gene-spliced products, asserting that the "[e]xercise of oversight in the scope of discretion afforded by statute should be based on the risk posed by the introduction and should not turn on the fact that an organism has been modified by a particular process or technique."

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 may result in plant diseases or pests, or the dissemination of "noxious weeds." "Plant pests" are defined as any organism "which can directly or indirectly injure or cause disease or damage in or to any plants or parts thereof, or any processed, manufactured, or other products of plants." The APHIS regulations incorporate an inclusive list of organisms that are or that harbor plant pests. This approach is essentially binary: A plant that an investigator might wish to introduce into the field is either on the proscribed, 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," defined as "any organism or any product altered or produced through gene-splicing technology, which is a plant pest, or for which there is reason to believe is a plant pest." The phrase "for which there is reason to believe is a plant pest" has been broadly interpreted by USDA to include any organism that includes any amount of DNA from a plant pest -- even a snippet of DNA that is incapable of conferring pathogenicity. It was defined this way specifically: Because small sections of DNA from plant viruses or bacteria are often used in the gene-splicing process to aid in the transfer of DNA between organisms, the USDA definition captures virtually all gene-spliced plants for case by case review.

In order to field test or introduce a regulated article, a researcher must apply to USDA for a permit and submit comprehensive data that includes a description of the regulated article; identification of the donor organism (from which genetic material was obtained or transferred); the intended date and location of importation, movement, or release; how the regulated article differs from the "unmodified" parental plant; the experimental protocol for the release; description of facilities to be used; the measures to ensure confinement; and the plans for disposition of the regulated article upon termination of the field trial. After a plant has undergone sufficient testing and evaluation, the sponsor can petition USDA for a "determination of non-regulated status," which permits a gene-spliced plant -- at long last -- to be treated by regulators like any other plant, with no limitations on experimentation, cultivation or sale.

USDA's case-by-case permitting process and costly field test design and other requirements have made gene-spliced plants disproportionately expensive to develop and test. A field trial with a gene-spliced plant may be 10-20 times more expensive than the same experiment performed with a plant that has an identical phenotype, but which 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 wide-cross combination 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 allergenic. 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 molecular methods of the new biotechnology allow breeders to identify and characterize the exact changes that have been made in the progeny.

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 interest in or 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.

This discriminatory regulation by USDA is the most far-reaching and costly biotech-related abuse by the USDA. But it is not the only one. Another is the department's National Biotechnology Impact Assessment Program, an expensive boondoggle that holds conferences, publishes newsletters and makes grants for risk assessment, all focused on the meaningless pseudo-category of gene-spliced organisms. Similarly, there is large set-aside within USDA's competitive grants program, the Biotechnology Risk Assessment Research Grants Program, for "biotechnology risk assessment."

These wasteful, superfluous programs exert a corrupting influence on scientific research and public opinion. Scientific consensus holds that agricultural applications of gene-splicing technology do not themselves create any new, incremental risk compared to conventionally modified organisms. Thus, risk assessment experiments should focus on important scientific questions wherever they arise, without being constrained to gene-spliced organisms. Also, the existence of a special "pot" of money induces researchers to cast proposals of almost any sort (and often of little scientific merit) as "risk assessment," in order to be eligible for the set-aside.

Worse still, by focusing assessments solely on gene-spliced organisms, rather than on a comparison of organisms modified by various methods, the inevitable response to new research findings is for the press to ignore the broader context, while highlighting some newly discovered, supposed risk of gene-splicing.

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 unscientific and more incompetently implemented than anywhere else in government.

However, exploiting the old Washington DC political tradition that once something has been said three times it becomes a fact, federal regulators continually remonstrate that their policies are scientifically defensible and risk based. What is remarkable is not that they are disingenuous (another old Washington tradition), but how consistently they get away with claims that are clearly untrue.

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 malignant effects of their administration's regulatory policy.

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