Several months after the oil tanker Prestige foundered and sank off Spain’s Galician coast, spilling 20,000 tons of fuel oil, it is clear the catastrophe is one of the worst in history.
Oil continues to leak, contaminating hundreds of miles of the Spanish coast, and sludge from the spill has been detected in Portugal and France. The region’s lucrative fishing industry, which had the largest fishing fleet in Europe and employed 120,000 people, has been decimated. One shudders to think about comparable damage to, say, the George’s Bank fishing grounds off New England, the Chesapeake Bay, or the Los Angeles-San Diego coast.
Those who are trying to manage the Spanish spill now face another challenge: advice from a team of “experts” from the U.S. Environmental Protection Agency, the same geniuses whose Draconian regulations ensure we have no effective high-tech tools available for responding to these disasters.
Mired in the Nineteenth Century
Current technology, worthy only of the nineteenth century, includes methods such as deploying booms to contain the oil, spreading mats to absorb it, and slopping bacterial growth media onto the beaches in order to stimulate the growth of bacteria already there.
There used to be great expectations for modern biotechnology applied to “bioremediation,” the biological cleanup of toxic wastes, including oil. Soon after the catastrophic 1989 Exxon Valdez spill, William Reilly, then head of EPA, recalled, “When I saw the full scale of the disaster in Prince William Sound in Alaska … my first thought was: Where are the exotic new technologies, the products of genetic engineering, that can help us clean this up?”
The answer was simple, and in Reilly’s own backyard: Biotechnology research and development were discouraged by a decade-old preliminary regulation from EPA under the Toxic Substances Control Act. That policy has proved a potent disincentive to the testing and use of the most sophisticated new genetic engineering techniques. In April 1997, EPA issued the regulation in final form, ensuring that for the foreseeable future biotech researchers in several industrial sectors, including bio-cleanup, would be intimidated and inhibited by regulatory barriers.
EPA regulation inhibits research with any “new” organism (defined as one that contains combinations of DNA from unrelated sources) that might, for example, literally eat up oil spills. For EPA, “newness” is synonymous with risk. Because gene-splicing techniques can be used easily to create new gene combinations with DNA from disparate sources, these techniques “have the greatest potential to pose risks to people or the environment,” according to the agency’s press release accompanying the rule.
That’s like arguing that newer, more comfortable, and better constructed automobiles are actually more dangerous, because people are likely to drive them longer distances.
Risk Assessment, not Rocket Science
Scientific principles and common sense dictate the questions that are central to risk analysis for any new organism. For example, how hazardous is the organism you started with? Is it a harmless, ubiquitous organism found in garden soil, or one that causes illness in humans or animals? Does the genetic change merely make the organism able to degrade oil more efficiently, or does it have other effects, such as making it more resistant to antibiotics and therefore difficult to control?
EPA’s decision to subject the new biotechnology to extraordinary regulatory requirements–a decision emulated around the world–is incompatible with long-standing, widely held scientific consensus, which holds that new biotechnology is merely an extension, or refinement, of earlier, cruder techniques of genetic modification.
The evidence against EPA’s approach to new biotech products is overwhelming. The U.S. National Academy of Sciences has stated there is no evidence that novel hazards are produced by gene-splicing or the movement of genes between unrelated organisms.
The U.S. National Research Council went even further, saying that because the new technology makes it possible to introduce pieces of DNA that contain one or a few well-characterized genes–unlike older genetic techniques, which transfer or modify a variable number of genes haphazardly–the use of the newest biotechnology techniques actually lowers the already minimal risk associated with field testing.
All of this means that users of the new techniques can be more certain about the traits they introduce into the organisms, and that surprises down the road are less likely.
EPA’s regulation requires costly case-by-case government review of virtually all field trials of gene-spliced microorganisms. “Naturally occurring” organisms are exempt from this process, however, even if they might foul waterways or pose other serious environmental or public health risks. Moreover, EPA continues to exempt from review all small-scale field trials of chemicals, including those similar to paraquat, DDT, and sarin.
Discriminating against New Technology
The bottom line is that organisms crafted with the newest, most sophisticated, and most precise genetic techniques are subject to discriminatory, extraordinary regulation. Research proposals for field trials must be reviewed case by case, and companies face uncertainty about ultimately obtaining commercial approvals, even if products should prove safe and effective.
Government policymakers seem oblivious to the power of regulatory roadblocks. The expense and uncertainty of R&D with gene-spliced organisms have virtually eliminated the new biotechnology from application to bioremediation. Companies know that experiments using the new biotechnology will meet a wall of red tape, politics, and vast expense.
Unscientific and regressive regulatory policies have already left a legacy of environmental damage and reliance on inferior methods for the cleanup of wastes. Too bad for the Spanish fishing industry … and for the victims of future spills.
Henry I. Miller is a fellow at the Hoover Institution and author of “Policy Controversy in Biotechnology: An Insider’s View.” His email address is [email protected].
