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Executive Summary

NIH rDNA MICROBE ENVIRONMENTAL RELEASE "POINTS TO CONSIDER" draft document is being developed by the NIH Recombinant DNA Advisory Cmte. (RAC) Working Group on Release into the Environment. The draft, which was considered during an Oct. 5 working group meeting, is a "checklist" of points to consider for scientists planning to submit proposals to NIH that would involve environmental release of rDNA microorganisms, Institute for Medical Research (New Jersey) Dept. of Microbiology Chief and Working Group Chairman Gerard McGarrity said. The draft would require information including "but not limited to" a summary of the proposed experiment, including the objectives, significance, and justification for the request, the document says. Investigators would be required to provide NIH with identification, taxonomy, source and strain of the recombinant organism to be released as well as a detailed description of the molecular biology of the rDNA organism's "construction method," "introduced genes," "stability in the lab," and "uniqueness," the draft states. NIH is currently enjoined from approving any federally-funded experiments involving the deliberate release of rDNA molecules into the environment, under a May 16 ruling by U.S. District Court Judge John Sirica. In addition to purely descriptive information about the modified microorganism and the organism donating the inserted DNA, the draft would call on scientists to provide a description of the ecological role of the non-modified organism and the expected role of the recombinant microbe. "The intent of gathering ecological information is to assess the likelihood of establishment, persistence and dispersal of the recombinant organism and the probability of an adverse effect," the draft says. "Data related to any anticipated or non-anticipated effects of the modified microorganism from microcosm, greenhouse, and/or growth chamber experiments that simulate natural conditions" is also requested under the draft.

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