The United States stands at a crossroad in deciding whether to set tighter bounds on genetic engineering. The issue has been smoldering for some time, largely revolving around open-air testing of microbes, such as last Friday's open-air test of a bacteria genetically tailored to retard frost formation on plants.
But the US Patent Office's recent decision to allow researchers to patent genetically engineered animals has increased the urgency of dealing with the issue, ethics specialists say.
``The time to draw the legal lines is now or never,'' says Mark Pastin, director of the Lincoln Center for Ethics at Arizona State University. ``Scientific advances are stepwise; no single step provokes thinking. But after enough steps, the trends are irreversible.''
The steps leading to the Patent Office decision began in 1980, when the US Supreme Court ruled by a 5-to-4 vote that genetically altered microbes could be patented. The case involved a bacterium that digests crude oil. The Patent Office originally refused the patent request, claiming that Congress never intended that patents be extended to living organisms.
Since then, patent protection has been extended to genetically engineered plants, although strong doubts still persist among some legal experts about the validity of taking the Supreme Court decision that far. Supporters and critics of the recent Patent Office decision say that as a result of the 1980 ruling, it was only a matter of time until someone tried to patent genetically engineered animals.
Kevin O'Connor, a legal analyst with the Congressional Office of Technology Assessment (OTA), says the Patent Office decision is a classic example of the clash between new technologies and laws written before such technologies were apparent. ``It's analogous to what happened with copyright laws and computers.''
The key difference, others add, is that the decision does not deal with computers but involves tinkering with highly evolved forms of life - and does so with little or no notion of the risks involved and insufficient mechanisms to monitor research.
The patent decision was a logical step, proponents say. ``It was the right decision, supplying the missing piece of the puzzle,'' says Richard Godown, president of the Industrial Biotechnology Association. ``If you could use recombinant DNA technology to produce a beef cow that could grow faster, bigger, and leaner'' than cows developed through traditional breeding techniques, ``you have a product with commercial value. You need to be able to defend your product.''
That defense is necessary, supporters say, because without it, someone could buy an animal with a specifically engineered trait and merely breed it with his own herd to pick up the desired characteristic.
Overall, the patent decision ``gives an air of seriousness to the economical and social impact of animal biotechnology,'' says Thomas Wagner, director of the Edison Center for the Study of Animal Biotechnology at Ohio University.
The patent decision raises some thorny ethical questions. These range from the prospects for suffering among animals undergoing the experiments to concerns about the implication for genetic engineering on humans. Critics question whether genetic engineering will solve basic problems relating to hunger and human health. And they ask questions regarding the accessibility of such technologies to those who really need it.
But at its most fundamental level, the issue highlighted by the patent decision is one of human intervention in nature, says Philip Bereano, an associate professor at the University of Washington who teaches courses on technology and public policy. ``Where do we draw the line? Do humans exist in and with nature, or is nature for man's exclusive use?''
Such questions are complex, Dr. Wagner says. ``I put animal life forms into three categories philosophically and morally. The first is wild animals who live in a natural ecosystem; the second is agricultural animals living in a synthetic ecosystem; and the third is human beings. I think the patent decision talks to the second category. Since we have created an artificial ecosystem, we almost have a moral requirement to alter farm animals to fit that ecosystem.'' He adds that there is ``no way that man can make a deer better able to survive in the wild than nature.'' Nor does he see as acceptable the introduction of genetic alteration to humans that could be passed from generation to generation.
The problem with such distinctions, others say, is that even if one accepts them, there is no adequate mechanism to ensure that they are respected.
It's an issue that will wind up in Congress's lap. Jeremy Rifkin, head of the Foundation on Economic Trends in Washington, and a longtime critic of biotechnology, has joined forces with the Humane Society and other animal rights groups to lobby Congress for a law banning patents on vertibrate and invertibrate animals. The coalition is also trying to drum up support from various farm groups.
The OTA is undertaking a six-part study that is examining biotechnology from a variety of angles.