Recombinant DNA Advisory Committee - 09/9-10/93 
(5) warnings applicable to BL2 guidelines, (6) a "Biosafety Clearance Agreement" to be 
signed by the user and his/her IBC, and (7) a listing of BL2 practices advisable for use 
with the cloning system. Dr. Miller commended the investigators for the Users' Manual 
and stated that the investigators have adequately responded to all of the RACs previous 
concerns. Dr. Miller recommended approval of the request to reduce the physical 
containment level from BL3 to BL2. 
Review— Dr. Krogstad 
Dr. Krogstad commented on the well prepared Users' Manual. This manual addresses 
most of the concerns raised during the previous RAC review. He suggested that the 
important areas of the manual should be highlighted in boldface type. The only issue 
still of concern is how laboratory personnel will be informed of the potential risks. 
Every individual in the laboratory, even if they do not use the SFV system, should sign 
the "Biosafety Clearance Agreement" as an acknowledgement that they have been 
informed of the potential risks associated with the SFV expression system. SFV is an 
infectious agent that can spread by aerosol. He recommended reducing only the 
containment level for the expression system from BL3 to BL2; however, for the parent 
virus, SFV, which is a Class 3 agent, the containment level should not be reduced. There 
is still substantial risk of serious disease among people who become infected as a result 
of laboratory accidents or as a result of natural transmission. 
Review-Dr. Post 
Dr. Post stated that the Users' Manual prepared by the investigators addresses all the 
previous concerns raised by the RAC, and he recommended use of this SFV/Helper 2 
Gene Expression System at BL2 containment. Dr. Post still expressed his concern about 
the discrepancy between the classification of Sindbis virus (Class 2) and SFV (Class 3). 
The scientific justification for this distinction is weak. 
Other Comments 
Dr. Miller said that requiring all laboratory personnel to sign the Biosafety Clearance 
Agreement will be unworkable. It should be the Pi's responsibility to ensure that all 
laboratory personnel have been adequately informed. Dr. Geiduschek and Dr. Straus 
considered that it is appropriate for all individuals who are likely to be exposed to this 
agent to acknowledge the risks in writing. 
Investigator Response— Dr. Temple 
Dr. Temple stated that in compliance with the NIH Guidelines , everyone entering a BL2 
facility must be informed of the activities within the laboratory. The PI is responsible for 
ensuring compliance with the NIH Guidelines. For practical reasons, it is difficult to 
keep track of all individuals who are entering and exiting the facility. Dr. Temple 
explained that according to the NIH Guidelines , when an infectious agent is in use in a 
laboratory, there sire special entry requirements, i.e., a hazard warning sign must be 
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