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Executive Summary

SACCHAROMYCES CEREVISIAE HOST-VECTOR SYSTEMS EXEMPTION FROM NIH DNA guidelines would be extended to experiments on cell lines of the yeast other than "laboratory strains" under a proposal to be considered by the agency's rDNA Advisory Committee (RAC) Sept. 23. The proposal by BioTechnica Internatl. of Cambridge, Massachusetts is explained in an Aug. 19 Federal Register notice. The proposal seeks to amend current NIH guidelines, which now exempt rDNA experiments using S. cerevisiae host-vector systems from the guidelines, "provided that laboratory strains are used." Currently, for exempt laboratory experiments, BL1 (biosafety level) physical containment conditions are recommended. For large-scale fermentation experiments, BLl-LS physical containment is recommended. The guidelines stipulate exceptions to the exemption, which the proposal does not seek to change. BioTechnica is also proposing a new exemption from the NIH guidelines for DNA experiments which use S. uvarum host-vector systems. RAC will also consider scientific requests for permission to clone Shiga-like toxin from the bacterial families Enterobacteriacease and Vibrionacease into E. coli K-12, and to clone a hybrid interleukin-2/diphtheria toxin gene in E. coli K-12. A RAC working group on toxins endorsed both proposals Aug. 16. The NIH advisors will review a revised document submitted by its working group on human gene therapy and public comments received on the draft. The document --"Points to Consider in the Design and Submission of Human Somatic-Cell Gene Therapy Protocols" -- would provide guidance in preparing proposals for NIH consideration. The revised draft contains a new section on "applicability" which was not a part of the document when RAC last considered the proposal.

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