A call for thoughtful regulation of the genetic-engineering industry
The US Environmental Protection Agency has its eye on genetic engineering. This budding industry is beginning to move its experiments out of the laboratory and into the field for testing. Products of this research will soon be entering the market in substantial amounts.
Thus, although the potential hazards are uncertain and the agency's legal authority in this field is unclear, some of its officials believe it is time to set regulatory guidelines. Donald R. Clay, acting assistant administrator of the EPA's pesticides and toxic substances office, hopes to publish these for public comment early next year. But already it is clear that the issue of releasing man-tailored organisms and their biochemical products into the channels of commerce is approaching what Rep. George Brown (D) of California calls a ''major decision point.''
Last month, he told a meeting of the Industrial Biotechnology Association that EPA's action is likely to set the tone for regulation in this field. There are important unsettled questions, such as how to classify genetically engineered organisms as items of commerce - or whether a well-known biochemical, such as an enzyme, should be considered a ''new'' chemical for purposes of regulation, if it is produced by these organisms. EPA's resolution of such questions is likely to be incorporated into - or at least to strongly influence - any permanent legislation Congress may enact to regulate the new industry.
Since that mid-October meeting, Clay and other EPA officials have been explaining that they are taking as broad an approach as possible to these issues. Although biologists may see little difference between bacteria found in the wild and similar bacteria that are altered to produce - or not to produce - a specific biochemical, much of the public doesn't share that perception. Clay reflects wide concern when he likens such doctored organisms to the gypsy moth in terms of their possible impact on the environment.
Fears of exactly this sort lie behind the lawsuit that was brought to halt release of a genetically altered bacterium for field tests in California. Wild bacteria of this type (Pseudomona syringe) secrete a protein that provides a nucleus for frost formation. In the doctored bacteria, the gene for this protein has been neutralized. A University of California research team wants to release such bacteria to test whether or not they can displace their wild cousins and thus retard frost on crop plants.
Such a test would have been allowed under the research guidelines of the National Institutes of Health. But Jeremy Rifkin, president of the Foundation for Economic Trends and an opponent of genetic engineering, and Michael Fox, scientific director of the Humane Society of the United States, have brought suit to cancel permission for the tests. They argue, among other things, that the possibility for subtle environmental damage has not been sufficiently studied.
This is precisely the concern that the EPA is trying to address, even though Congress has never given it specific authority in this new field. At this point, Clay is taking the position that genetically altered bacteria that are intended to reduce the effects of wild bacteria are a ''pesticide'' whether or not they produce any biochemical poisons. Thus he is prepared to use the EPA's standing authority to regulate pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Clay takes encouragement from advice of the agency's Office of General Council. This office recently said the EPA has ample authority to regulate the genetic engineering industry under both FIFRA and the Toxic Substances Control Act.
The industry, however, is unlikely to see it that way. Defining a slightly engineered bacterium as a ''pesticide'' or calling a well-known chemical ''new'' just because genetic engineering is involved is likely to be considered an attempt at overregulation. Clay says he expects the whole issue to wind up in the courts. If EPA can sustain its position there, he says, well and good. If not, then Congress will likely be stimulated to clarify EPA's authority in this new field.
What is important at this point, however, is that Clay's office has recognized that the regulation of the new biotechnology is an extraordinary issue. It is very much like the issue of regulation of nuclear power - having uncertain, but potentially wide, environmental implications and being charged with substantial public concern.
Thus it is good that the EPA is bringing matters to a ''major decision point.''
It is important that, unlike the case of nuclear power, the regulation of this nascent industry be thoroughly thought through and established in a way both to protect the public interest and to command public confidence.
Officials of companies in this new industry would do well to heed Congressman Brown's advice and cooperate with the EPA in formulating sensible regulation rather than trying to fight the tide of public policy in wasteful court battles.
