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NIH GUIDES WOULD REDEFINE rDNA TO EXEMPT RESEARCH INVOLVING

Executive Summary

NIH GUIDES WOULD REDEFINE rDNA TO EXEMPT RESEARCH INVOLVING deletions, single base changes and rearrangements of genetic material within a single genome, under a proposal drafted by the National Institutes of Health Recombinant DNA Advisory Committee (RAC) on Dec. 5. Rearrangements involving the introduction of DNA from different organisms, however, or from different strains of the same organism still would be classified as recombinant DNA. The proposal would globally redefine the meaning of "recombinant DNA" throughout the NIH guidelines. It was one of two "options" considered by the RAC working group on definitions intended to exempt certain types of research from review by the full RAC. Both options will be published in the Federal Register for public comment prior to RAC's next meeting Feb. 2. The second option is more limited in scope and modifies a proposed amendment to the guidelines approved by RAC at its last meeting. That earlier proposal, which is being evaluated by NIH Director Wyngaarden, would exempt from RAC review deliberate release experiments involving genetically engineered organisms created through deletions or rearrangements. The current modification would extend the environmental release exemption to research involving single base changes and amplifications within a single genome. While the NIH working group on definitions was nearly unanimous in its decision to send both options to the full RAC for consideration, separate votes indicated a majority of the panel favored the environmental release exemption. In other actions, the working group approved new guidelines language that would define "deliberate release" as the "planned introduction of recombinant DNA-containing microorganisms, plants or animals into the environment." The proposal will be considered by RAC. According to several working group members, the move to define the term has been motivated largely by concerns that "deliberate" has a pejorative connotation, at least among members of the public.
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