Agracetus, a joint biotechnology venture by W. R. Grace & Co. and Cetus Corp., wants to conduct an outdoor field test of its genetically engineered tobacco plants, but is waiting for the regulatory clouds to clear.
No law prevents the company from proceeding with the test, yet it has lost two growing seasons by voluntarily seeking approval for the experiment from the National Institutes of Health in Bethesda.
An NIH advisory panel on gene-splicing has unanimously approved the experiment. A federal court judge, however, has ordered NIH to withhold final approval of all experiments involving the release of genetically altered organisms outside contained laboratories, pending the outcome of a lawsuit challenging the first such experiment.
Wisconsin-based Agracetus and other firms express concern and frustration over the regulatory uncertainty affecting some products of biotechnology. "It is unacceptable to leave biotechnology in regulatory limbo," said Edward G. Jefferson, chairman of E. I du Pont de Nemours & Co.
NIH is not a regulatory agency. But for almost a decade, it has been the only federal source of guidance to researchers and firms exploring the scientific and commercial possibilities of altering the genetic code carried by DNA, deoxyribonucleic acid.
Now other federal authorities are moving to take responsibility for the growing number of products making their way from microscope to market, well aware that their decisions could determine the competitive success of a new and promising industry. So far, the results are encouraging to some firms, frustrating to others and confusing to still others.
A White House interagency task force has decided that, for now, existing laws and agencies can handle the expected outpouring of bio-products. Agencies represented on the committee include NIH, the Food and Drug Administration, the Environmental Protection Agency and the Department of Agriculture.
The FDA already has approved the first recombinant DNA product, human insulin, and expects to review others, including human growth hormone, blood-clotting agents and vaccines against malaria, herpes and rabies.
Within the next two weeks, the White House task force plans to publish a Federal Register notice clarifying the regulatory path the new bio-products would follow to meet federal health and safety requirements.
The White House group, however, also concluded that the agencies need a new source of scientific expertise to help them evaluate the new products and processes. Existing resources are "not adequate to accommodate the needs of all the federal agencies involved," said Dr. Bernadine Bulkley, chairman of the White House Cabinet Council Working Group on Biotechnology, at a congressional subcommittee hearing last week.
The working group has endorsed a proposal to create an advisory panel of distinguished scientists to provide technical assistance as the agencies develop new policies and review new creations.
Bulkley said the advisory panel would include and be modeled on the NIH recombinant DNA advisory committee, called the RAC, which oversees NIH's guidelines for research involving gene-splicing.
The NIH guidelines serve as the safety standards for all lab work with recombinant DNA. Scientists and research institutions receiving NIH funds are required to follow the guidelines and seek NIH approval for certain classes of experiments, including those that would release genetically altered organisms outdoors.
Private companies need not follow the guidelines, but have always agreed to do so voluntarily.
"We are a young and small company," said Winston J. Brill, director of research at Agracetus, explaining why the firm will not proceed without NIH permission. "It is important for us to behave responsibly and to be perceived by our public as responsible."
Advanced Genetic Sciences Inc., however, does not have to wait any loner for NIH to approve its outdoor field test of genetically altered bacteria designed to inhibit the growth of frost on potatoes.
It has filed a package of data with the EPA, which recently outlined its plans to review genetically engineered pesticides on a case-by-case basis.
"The regulatory picture is starting to clear up," said Thomas Dyott, president of AGS, which has delayed its test for more than nine months while seeking government permission to proceed.
Although AGS may receive EPA permission to go ahead, a scientist sponsored by the Berkeley, Calif., firm to perform the identical experiment is still on hold. The scientist works for a university that receives NIH funding and therefore must get NIH approval for the field test. NIH gave its permission, but a federal court has blocked the test while determining if NIH properly considered the possible environmental effects of the experiment and others like it.
"We're still on hold," Dyott said. "But now it's a different kind of hold."