Health, Education and Welfare Secretary Joseph A. Califano Jr. has urged Commerce Secretary Juanita Kreps to cancel a patent order exempting firms from some of HEW's safety guidelines on creation of new forms of life.
He asked her to await the recommendation of a five-month-old inter-agency committee on how to regulate firms entering this research area - one that holds both new promise and new danger, according to scientists. The committee's report is expected in March.
Two California legislative committees also have asked Kreps to cancel the order. One is headed by Charles Warren of Los Angeles, who White House sources have said probably will be named chairman of the federal Council on Environmental Quality.
A council official yesterday said, "We'll be asking the Commerce Department why it didn't make an environmental assessment fof the effect of its order or issue an environmental impact statement."
Several firms - including General Electric, merck and other drug makers - are beginning or considering experiments in joining the genes of different organisms to create new forms of life. Such research also has started at some universities.
Last year, HEW's National Institutes of Health issued strict safety guidelines to prevent escape of any new organism that proved dangerous to human beings.
The guidelines require researchers to reveal their plans, including the bacterial or other genetic materials they use, so their safety can be assessed by independent experts.
It is this part of the NIH guidelines that Betsy Ancker-Johnson, assistant commerce secretary for science and technology, said companies need not necessarily follow. She ruled on Jan. 10 that they could apply for accelerated patents if they followed the rest of the guidelines.
She maintained that this tightened, rather than relaxed, usual patent procedures under which firms can do any research they please with no guideline compliance.
But Califano said in a letter Monday that the interagency committee is seeking some way to apply the NIH guidelines to govern all industrial research.
The California state assembly committees - one on resources, land use and energy headed by Warren and on e on health headed by Barry Keene of Eureka - told Kreps Monday: "The effect of your department's ruling is to give a free hand to industry to carry on genetic research."
The committees asked her to rescind the Ancker-Johnson ruling and extend the NIH guidelines to cover industry completely "in view of the seriousness of risk involved."
A spokesman for Kreps said she was studying the issue before replying to Califano and others. The Senate health subcommittee expects to hold hearings on the subject in early April, following a National Academy of Sciences public forum March 7-9.