Recombinant DNA Advisory Committee - 12/1-2/94 
patients with recurrent brain tumors. The primary objective of this initial study is to determine if the 
treatment is associated with any significant toxicity. The ultimate goal is to develop a more effective and a less 
toxic vector for brain tumor gene therapy. 
XIV. PROPOSED AMENDMENTS TO APPENDIX B, CLASSIFICATION OF ETIOLOGIC AGENTS AND 
ONCOGENIC VIRUSES ON THE BASIS OF HAZARD OF THE NIH GUIDELINES/ DR. FLEMING 
In a letter dated June 24, 1993, Dr. Fleming requested that Appendix B should be revised to conform with the 
most recent taxonomy and agent risk groups as described in Biosafety in Microbiological and Biomedical 
Laboratories (BMBL), 3rd edition. May 1993, U. S. Department of Health and Human Services. At its 
September 9-10, 1993, meeting, the RAC recommended that the revised Appendix B should not be adopted 
until letters of concurrence were submitted by the Centers for Disease Control and Prevention and the NIH 
Division of Safety. In a telephone conference on October 20, 1994, Dr. Fleming stated that Appendix B would 
be reviewed by experts from the Centers of Disease Control and Prevention and the American Society for 
Microbiology (ASM). The revised Appendix B was submitted for RAC review. 
Dr. Wivel said that Appendix B is an essential guideline for the local Institutional Biosafety Committees 
(IBCs) to set the appropriate physical containment levels for etiologic agents. It is an important task that Dr. 
Fleming has been undertaken to update this document. Appendix B is a classification based on human and 
animal pathogenicity of the organisms and the physical containment levels are assigned according to the known 
pathogenicities. Appendix B is intended to be used in conjunction with the BMBL book. The proposed 
Appendix B has been reviewed by a Committee to Revise Appendix B (CRAB) assembled by Dr. Fleming 
under the aegis of the ASM. CRAB members include the following: Ms. Mary Cipriano, Abbott 
Laboratories, Abbott, Illinois; Dr. Joseph H. Coggin, Jr., University of South Alabama, Mobile, Alabama; Dr. 
Diane O. Fleming, Bowie, Maryland; Dr. Mary Gilchrist, University of Cincinnati, Cincinnati, Ohio; Ms. Janet 
Hindler, University of California, Los Angeles, California; Dr. Jonathan Y. Richmond, Centers for Disease 
Control and Prevention, Atlanta, Georgia; Ms. Amy Melnick, American Society for Microbiology, Washington, 
D.C.; Dr. Moselio Schaechter, Tufts University, Boston, Massachusetts; and Dr. Joseph E. McDade, Centers 
for Disease Control and Prevention, Atlanta, Georgia. 
Review-Dr. Straus 
Dr. Straus agreed that the task to update the Appendix B is overdue. The intent of the updated Appendix B is 
to harmonize the classification between the existing Appendix B and the recent edition (3rd edition, 1993) of 
the BMBL book. Dr. Straus stated that there are one global and several minor issues. The global issue 
involves the new concept of "risk group." It has meanings different from the old classification system. 
Different levels of physical containment can be assigned to an organism in a particular risk group depending 
on factors such as large volume, aerosol, or how it is handled. There are revised groupings of the listing for 
oncogenic viruses and other organisms. Dr. Straus noticed several inconsistencies in the listings, for example, 
classification of Chlamydia psittaci, Bacillus an throe is, adenoviruses, prions and several retroviruses. He asked 
Dr. Fleming to explain the rationale behind the reclassification of organisms. He said it is premature for him 
to make any specific comment. 
Review-Dr. Saha 
Dr. Saha said a thorough review cannot be made since he received the revised Appendix B just a few days ago. 
The concept of the new Appendix B is to classify organisms into "risk groups," and a particular "risk group" 
could be assigned to different physical containment levels. This document needs a taxonomist and other 
experts to comment on this new lis ting. Proposed Appendix B should be published in the Federal Register for 
public comments before the next RAC meeting. 
Other Comments 
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