Fine-tuning biotech review, regulation.

Fine-tuning biotech review, regulation

At the recent meeting of the National Institutes of Health's Recombinant DNA Advisory Committee (RAC), the votes were: one yes, one no, one maybe.

The RAC agreed to exempt from special review experiments involving environmental release of organisms that have had genetic material deleted through engineering. The new rule extends a current exemption from the laboratory into the environment.

The releases may still come under review by other federal agencies; the change, according to Susan Gottesman of NIH, who proposed the amendment, will enable NIH to accept the authority of those other agencies in some cases.

The amendment's main purpose is as a reminder, Gottesman says, that "deletions happen all the time in nature. Because the NIG guidelines are directed toward biotechnology and its ability to make something unique, I felt this was an appropriate place to remind people that deletions are not unique." Under the revised guidelines, experiments like the controversial one involving release of "ice-minus" bacteria (SN: 6/7/86, p.366) probably would not come under RAC's review.

The RAC rejected a request by the Boston-based Committee for Responsible Genetics to permanently prohibit certain kinds of experiments in human gene therapy. The activist group wants to ban experiments in gene therapy that could alter germline cells, and therapies for disorders that are not "life-threatening or severely disabling." The RAC has already declared these categories to be unacceptable at present.

Also proposed at the meeting was a redefinition of the term "recombinant DNA." The term has been an accommodating one, flexing to describe an organism whose own DNA has been rearranged or changed as well as an organism that has had foreign DNA inserted into it. Under the proposed redefinition, "recombinant DNA" would refer only to the latter. According to Gottesman, committee members were hesistant about the change on theoretical grounds; there are some categories of experimentation (such as human gene therapy) in which the group would like to retain the authority to review proposals in the first category as well, she says. The committee, which did not make a decision, will continue to discuss the proposal at its next meeting, in February.

This week, the House Science and Technology Committee released a report detailing its view on the administration's guidelines for biotechnology regulation (SN: 6/28/86, p.407; 8/2/86, p.71). According to a spokesperson for the committee, the report will ask the administration to reconsider several points: definitions (for example, some committee members want the definition of "intergeneric organism" broadened to include transfer of noncoding material); questions of jurisdiction between regulatory agencies; and the resulting possibility that similar organisms will be treated differently in review by different agencies.