US officials face major hurdles in regulating genetic engineering
Regulating genetic engineering to protect public safety has become substantially more difficult. Yesterday, the concern was to prevent the escape of novel organisms from laboratory test tubes and industrial vats.
Now, the concern is to ensure that the impact of such organisms remains benign when they are deliberately released into the environment.
Neither legislators wondering how to set up a regulatory system nor such would-be regulators as the US Environmental Protection Agency (EPA) are adequately prepared to face this challenge, says Anthony Robbins, an authority on public health and a member of the staff of the US House of Representatives. This is because the scientific basis for sound regulation doesn't yet exist, he says.
Dr. Robbins outlined this new challenge ealier this week at a symposium held during the annual meeting of the American Association for the Advancement of Science. He drew an analogy with regulation of toxic chemicals. In that case, the science of toxicology provides a solid base of knowledge and tests for regulating the chemicals. But the issues raised by introducing novel organisms - which literally have a life of their own - are ecological, not toxicological, Robbins explained. And, at present, he said, there is no science of predictive ecology. There is no adequate body of scientific knowledge - let alone test procedures - for judging the risk to public safety when a genetically engineered organism is deliberately released.
The fact that the United States - indeed, the world - already faces this challenge was highlighted May 16 when Federal Judge John J. Sirica enjoined Prof. Stephen Lindow and the University of California at Berkeley from field-testing a bacterium that has been ''engineered'' to reduce frost damage on potatoes.
Social activist Jeremy Rifkin and associates have sued the university and the National Institutes of Health (NIH), which funds the research, to force them to provide an environmental impact statement under the National Environmental Policy Act (NEPA). Judge Sirica halted field tests until that suit is settled.
Dr. Lindow was scheduled to take part in the symposium here but was unable to attend. But symposium chairman Joseph N. Onek, a lawyer with Onek, Klein, and Farr, in Washington, D.C., said he had talked at length with Lindow and could summarize Lindow's view of the situation.
Among other things, Mr. Onek said, Lindow points out that Sirica's injunction will have a chilling effect on university research while having little impact on industry. The NEPA requirement applies only to federally funded research. In practice, that means largely university research. This could mean less open research and less exchange of scientific knowledge because of the need for industrial secrecy.
Onek and other symposium speakers agreed with Robbins that the issues raised by genetic engineering have entered a new phase. The EPA will begin regulating release of novel organisms using its authority under the Toxic Substances Control Act (TOSCA). It would consider Lindow's use of bacteria a ''pesticide'' application, for example. Don Clay of the EPA, however, acknowledged that his agency would be feeling its way as it entered this new regulatory field.
The challenge has come more quickly than anyone had expected, Robbins said. Furthermore, he added, ''We have moved from a research phase, housed primarily in universities, to an industrial phase.'' Thus Congress has to consider regulating actions of major domestic and international companies.
Robbins said that, given the uncertainties, Congress is unlikely to act quickly to try to set up a regulatory system. He explained that the lack of an adequate science of predictive ecology means that issues of liability cannot yet be assessed, as well as questions of safety. Yet, he said, the liability that would arise from ecological damage caused by an organism considered ''safe'' could exceed the potential liability of a major accident with a nuclear power plant. Given the current ignorance, it is impossible for Congress to judge adequately how to split that liability between private companies and the taxpayers. Furthermore, Robbins added, there is the challenge of international cooperation. Organisms know no national borders. Even if an adequate regulatory system can be established in the US, there would be little real safety unless other nations also established adequate controls.
Biotechnology is cheap, Robbins noted. It is ''low tech.'' Many countries are likely to engage in it. One of its widest applications now is likely to be in agriculture. That means releasing living organisms, not just using chemical products produced by such organisms.
Thus, Robbins said, the new challenge of regulating genetic engineering is not one the US can meet for itself alone. Even to deal with it adequately within US borders requires global cooperation.