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U. CALIF. rDNA DELIBERATE RELEASE EXPERIMENT: FEDERAL COURT HALT

Executive Summary

U. CALIF. rDNA DELIBERATE RELEASE EXPERIMENT: FEDERAL COURT HALT to the test will drive applied rDNA research out of universities and into the private sector, the University of California, Berkeley, contends in a brief filed in D.C. Circuit Court. In May, D.C. Federal Judge John Sirica issued a preliminary injunction halting a planned university field test of a genetically-altered bacteria designed to make potatoes more frost resistant until NIH prepared an environmental impact statement. "The district court's injunction, if it is left standing, deals a potentially fatal blow to the future of rDNA research in this country," the university argued. "It will drive applied rDNA research from academic institutions into commercial and industrial enterprises that receive no NIH funding." The federal court ruling applies only to research regulated by NIH's rDNA guidelines. Private sector research is not technically affected by the ruling since industry compliance with the NIH guides is voluntary. A separate deliberate release experiment, proposed by Cetus Madison Corp and Advanced Genetic Scienes received proliminary approval by NIH's rDNA Advisory Cmte. NIH Director Wyngaarden is expected to issue a final decision in the near future on the Cetus/Advanced Genetic Sciences proposal. The university, NIH, and the American Council on Education are seeking to overturn the preliminary injunction Sirica granted in response to a lawsuit filed by the Foundation of Economic Trends. The brief contends that the court is demanding the "impossible" of NIH -- that it prepare an environmental impact statement "in order to rensom the scientific work it has taken hostage." No impact statement is possible, the brief contended, "when there is no program." The court's ruling, the school said, has also "crippled NIH's ability to gather pertinent scientific data while demanding that NIH develop criteria for which those data are essential." In a July 28 filing with Sirica, the Foundation on Economic Trends asserted that the ruling should be extended to all licensees of Stanford University's basic rDNA process patent. The group based its contention on the license agreement negotiated between Stanford University and the University of California, San Francisco. When the institutions negotiated a license to the process, both schools sought the govt.'s opinion on rDNA inventions developed under NIH funding. NIH ruled that the licensees of the patent agreement had to provide "assurance of compliance with the physical and biological containment standards set forth in the (BRACKET)NIH rDNA(BRACKET) guidelines," the foundation explained. The group's filing declared: "Advanced Genetic Sciences and Cetus Madison Corp. and the country's other biotechnology companies that found it necessary to become licensees are thus bound under the (BRACKET)patent(BRACKET) agreement to comply with the guidelines." Therefore, the filing arues, "licensee-biotechnology firms are under as strong a compulsion as are NIH-funded entities such as the University of California, Berkeley, to obtain NIH approval. Indeed, the compulsion is stronger; the latter institutions would only lose funding; (BRACKET)Advanced Genetic Sciences(BRACKET) and other licensees face losing their right to conduct such experiments if they should proceed without NIH approval."

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