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December 2, 1996 - Classification of Human Etiologic Agents on the Basis of Hazard

Tom Shih
Biotechnology Program Advisor
Office of Recombinant DNA Activities
Office of Science Policy and Technology Transfer
National Institutes of Health
6000 Executive Blvd. Suite 302
Bethesda, Maryland 20892

Dear Dr. Shih:

The American Society for Microbiology (ASM) is the largest, single, life science society in the world with over 42,000 members engaged in the field of microbiology and its sub-specialties. Our members work in research, clinical, industrial and government laboratories.

The ASM supports the concept of providing the latest information needed for safe work with microorganisms and has agreed to submit recommendations annually to the Recombinant DNA Advisory Committee (RAC) for the periodic revision of Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard, of the NIH Guidelines for Research Involving Recombinant DNA Molecules. The ASM's Public and Scientific Affairs Board Subcommittee on Laboratory Safety has proposed the following recommendations for corrections and revisions to Appendix B as published in the Federal Register on January 19, 1996. As an addendum, technical corrections, which should not require RAC approval are also attached.

The Centers for Disease Control and Prevention (CDC) developed and refined a list of select agents identified as potential weapons of bioterrorism in 42 CFR Part 72, as published in the Federal Register 61 (207) 55190-55200 on October 24, 1996. Based on that regulation, the ASM recommends that several viruses should now be added to those listed in Appendix B; Equine morbillivirus, Sabia, and Flexal, in addition to the Ebola viruses. Equine morbillivirus, a paramyxovirus, caused a fatal illness in a veterinarian. Sabia virus, an arenavirus, was the cause of a laboratory acquired illness at Yale University. The CDC defers to the Subcommittee on Arbovirus Laboratory Safety (SALS) of the American Society for Tropical Medicine and Hygiene for the hazard classification of these viruses. The RAC should accept the list of select agents as published and request that, in the future, the SALS provide the risk group classification to the RAC directly.

Although suggestions to include additional bacteria and viruses in Risk Group 2 were proposed, the organisms mentioned caused nosocomial or iatrogenic disease in patients with underlying diseases or conditions and thus did not fit the current criteria.

The ASM Subcommittee on Laboratory Safety will continue to review Appendix B during the coming year and will provide recommendations to the National Institutes of Health, Office of Recombinant DNA Activities in November of 1997. If we can be of any further assistance, please do not hesitate to contact us. Thank you for the opportunity to make recommendations in this matter.

ADDENDUM: ASM Technical corrections to Appendix B:

Section IV B-2B(3)

"Class" needs to be revised and updated to "Risk Group."

Appendix B-II-A, page 1487:

Acinetobacter baumannii formerly Acinetobacter calcoaceticus var anitratus is known as the Acinetobacter calcoaceticus-bagman complex. We can either add the var.anitratus or change to the complex name for the list.

Neisseria gonorrhoea is missing the final "e" on the species name: Neisseria gonorrhoeae

Appendix B-II-B, page 1487

Blastomyces dematitidis is missing an "r" in the species name: Blastomyces dermatitides