The Commerce Department has ruled that companies may apply for accelerated patents on creation of new forms of life in the laboratory that some scientists say could seriously endanger humans.
The ruling bypasses a major safety guideline laid down by the National Institutes of Health, which is concerned about the unknown dangers in the new field of genetic research - the creation of new forms of life by combining existing ones.
The guideline, which requires advance disclosure of the biological material to be used and information on its use, now covers government and university laboratories, but has not yet been extended to private companies.
The effect of the department's ruling could be to encourage private industries to carry out genetic research without reporting in advance their plans so they can be screened for safety by review bodies.
The ruling affects several major technological, chemical and drug companies, such as General Electric, Dow Chemical, Merek and Upjohn, which have started or are considering such efforts.
The ruling was punlished without other public announcement in the Federal Register of Jan. 13, one week before the end of the Ford administration.
Some members of Congress, scientists and environmentalists have voiced concern about the department's ruling. The critics have called it a unilateral go-ahead to industry to enter the new genetic research field.
The rule was attacked on the Senate floor Friday by Dale Bumpers (D-Ark). Saying it raises "serious questions or public safety," he introduced a bill to require tight regulation of industrial as well as university laboratories doing genetic research.
A Senate Health Subcommittee aide said Sens. Edward M. Kennedy (D-Mass.) and Jacob K. Javits (R-N.Y.), the subcommittee's chairman and ranking minority member, respectively, will ask that the order be withdrawn pending public discussion, including Senate hearings.
The research involved joins genetic material from different organisms - the material called DNA or deoxyribonucleic acid - to study the innermost processes of life or to try to make new biological products.
The unknown hazards of such research - if, for example, some new hybrid bacteria proved dangerous and spread widely - led scientist themselves to call for a temporary and voluntary moratorium in June, 1974.
Last June the National Institutes of Health ended the moratorium by issuing strict guidelines to govern scientists in NIH and university laboratories supported by federal funds.
Last September President Ford asked NIH Director Donald Fredrickson to head an inter-agency committee to determine how to apply the NIH guidelines to industry so it also could enter the field safely. The committee expects to issue a report by mid-March.
The Commerce Department order was made without the inter-agency committee's approval.
Frederickson said last week he was surprised by the order and had hoped such an action would be taken only as part of actions that would permit and monitor industry participation.
The Commerce order was signed by C. Marshall Dann, commissioner of patents, and his superior, Betsy Ancker-Johnson, assistant secretary for science and technology.
It says a company may qualify for "accelerated" patent action only if it complies with the NIH safety guidelines "except" for "deviations considered essential to avoid disclosure of proprietary information or loss patent rights."
Officials of drug firms and others have argued that it makes no sense for them to do such research at all unless they can protect their commercial secrets until they are patented.
Once a patent is issued, all the information in it is made public.
But Sen. Bumpers maintained that the Commerce ruling "seems to subvert the NIH guidelines." He said "there are serious questions" as to whether proprietary rights should be put before public safety in this field.
Ancker-Johnson, a Boeing Co. executive before she was named assistant secretary in 1973, said in an interview that, "I made the order for two reasons, to encourage industry to complying with the NIH guidelines - since any company can do this research now without telling anyone or complying with any guidelines - and to get people into this research because I think it has tremendous potential."
Scientist have said that combining genetic material from different organisms might lead to new drugs and new food plants.
Ancker-Johnson pointed out that previous patent rules still in effect permit anyone to do any biological research, then seek a patent under normal procedure, which takes about 18 months.
Under the accelerated procedure, "the application goes to the top of the pile" and the patent may be issued within six months, she said. The same accelerated procedure has been made available in recent years in the environmental and energy fields, she added.
"There's no reason the public needs to know" the precise nature of the biological material a company is working with or "what it is they're trying to accomplish," Ancker-Johnson said.
It is precisely these things that the public and other scientists should know if they are to independently judge a process' potential danger or safety, said Burke Zimmerman, a bio-physicist with the Environmental Defense Fund.
That organization and the Natural Resources Defense Council have petitioned the Department of Health, Education, and Welfare to extend the NIH guidelines to everyone, and to issue any final regulations or policy only after public participation in the decision-making.