Recombinant DNA Advisory Committee - 09/9-10/93 
publication was published in May 1993 and is available from the Government Printing 
Office. The NIH/CDC publication contains quantitative risk-assessment information; 
however, this information has not been developed into a simplified list, i.e., updated 
Appendix B. The proposed Appendix B has been compiled from information derived 
from the NIH/CDC publication. Dr. Fleming stated that a copy of proposed Appendix 
B has been forwarded to the CDC for review. 
Discussion 
Dr. Miller noted that SFV is listed as both a Class II and a Class III agent, and it is 
unclear which containment level should be used. Dr. Post expressed concern about the 
interpretation of the information in the CDC/NIH publication and how this information 
has been transformed into the proposed Appendix B. Dr. Post stated that the RAC does 
not have the expertise or time to assess the accuracy of this interpretation. Many RAC 
members expressed similar lack of expertise to properly assess the accuracy of this list, 
and deferred voting on this proposal until expert opinions have been obtained from the 
CDC and NIH Division of Safety. 
Committee Motion 
The RAC recommended by consensus that the current classification of etiologic agents 
described in Biosafety in Microbiological and Biomedical Laboratories, 3rd edition. May 
1993, U. S. Department of Health and Human Services, should be endorsed by the RAC; 
however, the RAC retains the option to adopt any modifications to the CDC listing. The 
RAC recommended that the summary list (proposed Appendix B) should not be adopted 
by the RAC until the subcommittee receives letters of concurrence from both the CDC 
and NIH Division of Safety. 
XV. AMENDMENTS TO SECTIONS III, IV, V AND APPENDIX C AND F OF THE NIH 
GUIDELINES REGARDING THE CLONING OF TOXIN MOLECULES/DR WIVEL 
Dr. Walters called on Dr. Wivel to present his request for amendments to Sections IB, 
IV, and V, and Appendices C and F regarding the review process for experiments 
involving the cloning of toxin molecules. Dr. Wivel stated that these amendments will 
establish a new category of review entitled: Experiments that Require NIH (ORDA) 
and IBC Approval Before Initiation. Under this new category of review, experiments 
involving the cloning of toxin molecules that are lethal for vertebrates at an LD^ of < 
100 nanograms per kilogram of body weight will be reviewed by NIH (ORDA) in 
consultation with ad hoc toxin experts. Sections III, IV, V and Appendix C and F are 
proposed to read: 
"Section III. Guidelines for Covered Experiments. 
"Part III discusses experiments involving recombinant DNA. These experiments 
have been divided into five classes: 
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