Recombinant DNA Advisory Committee - 09/9-10/93 
posted, and the access to the laboratory is limited to those individuals authorized by the 
PI. In cases of mixed-use facilities, the containment requirement for the highest level of 
activities should be observed by all individuals within the same facility. 
Dr. Straus expressed his concern about commercial distribution of the SFV/Helper 2 
Gene Expression System even if all the BL2 safety rules are observed. He said he is still 
concerned about the pathogenicity of SFV, noting that an incidence of fatality was 
previously reported. The rationale for safe use of this agent in the laboratory is based 
on experiences of a very limited number of individuals (approximately 50). This sample 
size of individuals is too small to predict risk for the wider use that would occur if this 
product becomes commercially available. An example of this risk is polio virus which 
causes paralysis in 1 out of 1,000 infected individuals. Although it has been handled 
safely by qualified investigators in the laboratory, its use as a cloning vector would not be 
justified in an unvaccinated population. Dr. Temple said that over 400 laboratory 
workers have successfully worked with SFV over the last decade, and there have been no 
instances of symptomatic disease. 
Dr. Miller agreed with Dr. Krogstad that a stipulation for approval should be added that 
would require that the PI obtain signatures from all laboratory personnel who are 
regularly present in the laboratory and agreed that this stipulation adequately addresses 
the safety concern. 
Committee Motion 
A motion was made by Dr. Miller and seconded by Dr. Krogstad to approve the request 
to reduce the level of physical containment for SFV/Helper 2 Gene Expression System 
to be distributed by Life Technologies, Inc., from BL3 to BL2. Approval of the request 
is contingent on the requirement that the PI must obtain signatures from all laboratory 
personnel certifying that they have been informed of the possible risks associated with 
this expression system and that they have read the Users Manual. The motion to 
approve the request passed by a vote of 13 in favor, 2 opposed, and 1 abstention. 
XIV. AMENDMENT TO APPENDIX B OF THE NIH GUIDELINES REGARDING 
UPDATING APPENDIX B: CLASSIFICATION OF MICROORGANISMS ON THE 
BASIS OF HAZARD/DR. FLEMING 
Presentation-Dr. Fleming 
Dr. Walters called on Dr. Fleming of the Mid-Atlantic Biological Safety Association, 
Bowie, Maryland, to present her updated listing of Appendix B: Classification of 
Microorganisms on the Basis of Hazard. Dr. Fleming explained that the current 
Appendix B is based on biohazard information about etiologic agents obtained in the 
1970s. Since that time, there have been several updated publications from the Centers 
for Disease Control (CDC) and the NIH. An updated classification was published in 
1980, and was incorporated into a book entitled: Biosafety in Microbiological and 
Biomedical Laboratories, published in 1984. The latest edition of the NIH/CDC 
Recombinant DNA Research, Volume 18 
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