Recombinant DNA Advisory Committee - 12/1-2/94 
Dr. Par km an asked if the underlying philosophy of the risk group and inconsistencies in the listings are the 
major problems. Dr. Straus said these two are part of his concerns, and the other concern is "risk group* 
versus "biosafety level." The factors necessary to assign an organism to different levels of physical containment 
are not clearly stated. The advantage of the existing classification is that it sets firm standards as to how a 
particular organism is handled. The risk group classification leaves too much room for interpretation. Dr. 
Saha agreed that this issue requires further discussion. 
Dr. Miller said the concept for risk group is reasonable since it assigns certain risk to an organism rather than 
a containment level that could vary depending on the circumstances in which the experiment is performed. 
Minor inconsistencies of the classification can be amended during the public comment period. Dr. Miller said 
that CRAB can serve as a standing committee to update Appendix B in the future. Dr. Straus said although 
there is some merit to the new risk group concept, there are experts who differ in their opinion regarding this 
classification concept. Dr. Miller said that RAC members can vote on approval or disapproval of this 
document. 
As a point of clarification. Dr. Wivel said today’s discussion is to identify the problems with this proposal. The 
proposed Appendix B will be published in the Federal Register for public comment, and the RAC can make a 
decision at the March meeting. There were discussions among RAC members about whether to invite experts 
to comment on different parts of the proposed Appendix B. Dr. Miller stated that the proposal definitely has 
to be published for public comment. Dr. Saha agreed it should be published for comment and experts can be 
solicited to comment on specific areas, e.g., brucellosis. Dr. Saha stated that the concept of the risk group is 
reasonable; it conveys an assessment of the inherent risk of an organism that allows the local IBC to 
determine a physical containment level appropriate for a particular experiment. Dr. Wivel said a complication 
of this classification scheme can be illustrated by the example of handling the HTV. It is a Risk Group 2 
organism that can be handled either at BL2, or at BL2 with BL3 practices, or at BL3 for large-scale 
production. The question is whether Appendix B should include this kind of complicated directives. 
Dr. Straus stated his major reservation about this document is its vagueness and ambiguity as illustrated with 
the HTV example, but he agreed that the proposal should be published for comment. He asked Dr. Fleming 
to provide a statement about the rationale for several proposed changes in the classification of organisms. Dr. 
Straus asked if the changes of Appendix B would require amendments to other appendices of the NIH 
Guidelines. Dr. Wivel explained that there will be minor changes to the NIH Guidelines] ; however, no major 
changes will be required. Dr. Straus speculated that the IBC would welcome a more specific guidance from 
the NIH Guidelines. Dr. Miller said that changes involving other parts of the NIH Guidelines are very simple, 
e.g., substituting the words "Class 2" with "Risk Group 2" in Section m-C-l-a that reads as the following: 
"Experiments involving the introduction of recombinant DNA into Class 2 agents shall be conducted at 
Biosafety Level (BL)-2 containment." 
Dr. Walters asked if it is the RAC consensus to publish the proposed Appendix B in the Federal Register for 
comment in advance of the March RAC meeting. Mr. Capron favored the idea of publishing the proposal 
with accompanying explanation of the changes. Ms. Meyers stated that the amendment of Appendix B should 
be an ongoing process. Dr. Wivel explained that in the last few years, there have been several requests for 
reduction of containment level approved by the RAC. Dr. Parkman asked what percentage of org anisms in 
the list would have containment levels other that indicated in the risk group number. Dr. Straus stated 
approximately around 10% of the listed organisms would need assigning to different containment levels 
according to circumstances of the experiments, e.g., simian immunodeficiency virus. Dr. Walters said if there 
is no objection, the proposal will be published in the Federal Register prior to the next RAC meeting. He 
called on Dr. Fleming to make her comment. 
Dr. Fleming explained that the concept of risk group came from a recommendation by World Health 
Organization. The idea of putting together the revised Appendix B is to provide the IBCs with an updated 
guidance for handling etiologjc agents. Appendix B is to be used in conjunction with the BMBL book. The 
book contains agent summary statements that recommend containment levels according to several factors, such 
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Recombinant DNA Research, Volume 20 
