NIH Proposes to Exempt Certain Low-Risk Transgenic Rodent Breeding Experiments from the NIH Guidelines for Research Involving Recombinant DNA Molecules

Based on suggestions from the scientific community, as well as input from the Recombinant DNA Advisory Committee, the NIH Office of Biotechnology Activities (OBA) has published a proposal to revise the NIH Guidelines to exempt the breeding of well-characterized transgenic rodents that can be maintained under Biosafety Level (BL) 1 conditions. This exemption would not apply, however, to the breeding of rodents that have a gene encoding more than fifty percent of an exogenous eukaryotic virus or those transgenic rodents in which the transgene is under the control of a gammaretroviral promoter. The full version of the proposal may be found in the July 20, 2010 Volume 75, number 138 Federal Register. Comments on the proposal may be submitted to OBA by email at, by fax to 301-496-9839, or by the postal service at: 6705 Rockledge Drive, Suite 750, Bethesda , Maryland 20892-7985. All comments on the proposed revisions must be submitted by September 1, 2010. All written comments received will be available for public inspection weekdays between the hours of 8:30 a.m. and 5:00 p.m. in the NIH OBA office at the address above. If you have questions, or require additional information about these proposed revisions, please feel free to contact OBA at 301-496-9838 or

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