February 3, 1996 - Classification of Human Etiologic Agents on the Basis of Hazard

Dr. Tom Shih
Biotechnology Program Advisor
The Office of Recombinant DNA Activity
National Institutes of Health
MSC 7010
6000 Executive Boulevard, Suite 302
Bethesda, MD 20982-7010

Dear Dr. Shih:

In a letter dated December 2, 1996 from the American Society for Microbiology, revisions were recommended for Appendix B of the NIH Guidelines for Research with Recombinant DNA Molecules to allow for the addition of certain select agents not previously listed. In response, your letter of December 20th requested more specific information on the taxonomic a nd risk classification of the agents.

Select agents were identified by the Centers for Disease Control and Prevention as being subject to special site registration and handling requirements under 42 CFR Part 72. Only three of the special agents are not currently listed in Appendix B, but should be added as follows:

Appendix B-III-D: Risk Group 3 viruses, Add;
Arenaviruses: Flexal

Justification: Flexal is already covered by "other viruses listed in the reference source" but now that it is on the list of select agents, it should be listed here also.

Appendix B-IV-D: Risk Group 4 viruses, Add;
Arenaviruses: Sabia
Paramyxoviruses: Equine morbillivirus

Justification: Dr. Richard P. Kiley, Chairman of the Subcommittee on Arboviral Laboratory Safety (SALS) has stated that both Sabia and equine morbillivirus are to be handled under Biosafety Level 4 containment.

Thank you for providing a mechanism for updating the list in Appendix B.

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