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Office of Biotechnology Activities
National Institutes of Health
6705 Rockledge Drive, Suite 750, MSC 7985
Bethesda, Maryland 20892-7985

Re: Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)

The American Society for Microbiology’s Public and Scientific Affairs Board is writing to comment on the pending action before the NIH Recombinant DNA Advisory Committee (RAC) concerning the proposed experimental protocol to create a strain of Chlamydia trachomatis with tetracycline resistance as a genetically selectable marker. The NIH RDNA Guidelines require approval of this experiment by the Institutional Biosafety Committee, the RAC, and the NIH Director before initiation.

Since tetracycline is used therapeutically for the treatment of Chlamydia infections and we are not aware that resistance to tetracycline has been detected to occur naturally, we believe it is appropriate for the RAC to carefully consider the conduct of this experiment. The ASM notes that other drugs are available for the treatment of Chlamydia infections but given the increase in antibiotic resistance, the ASM believes that appropriate precautions should be considered to protect against the loss of a therapeutically valuable drug. The ASM recommends that the RAC carefully consider the necessity of using tetracycline resistance for the proposed experiments and the containment level that should be employed for the experiment if tetracycline resistance is inserted into a Chlamydia strain. The ASM is not recommending a higher level of containment, but rather that the matter be carefully evaluated by experts experienced with highly infectious agents and infectious diseases. We believe that such deliberation will require expertise beyond that currently embodied within the RAC membership. We, therefore, recommend that RAC use a consultative process to ensure appropriate expertise is brought into the deliberations about the proposed experimental protocol, its safety, and the appropriate requirements for biocontainment when experiments are approved involving resistance to therapeutically valuable antibiotics when such resistance is not known to occur naturally. The ASM is ready to assist the RAC and the NIH in identifying individuals who can assist in this deliberative process.

Thank you for the opportunity to submit comments.

Sincerely,

Diane E. Griffin, M.D., Ph.D., ASM President
Ruth L. Berkelman, M.D., Chair, Public and Scientific Affairs Board

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