Recombinant DMA Advisory Committee - 06/7-8/93 
that it is his belief that there is a low level of replication competent SFV that could 
emerge from large volumes of cells and cloning vectors in the laboratory setting. 
Dr. Temple stressed that the cloning vector is derived from an attenuated strain of SFV. 
Symptoms of SFV infection are very similar to infection by Sindbis virus. SFV is spread 
from animal to animal by mosquitos; human infection is incidental. The proposal 
specifically states that the vector is not going to be used in animal experiments. Dr. 
Temple said that passages of SFV through animals generally increase its virulence, as 
occurred in the one reported fatality. 
Dr. Miller emphasized that the investigators failed to include an information sheet 
describing safe usage and potential risk as was requested. 
Committee Motion 
A motion was made by Dr. Miller and seconded by Dr. Motulsky to defer approval of 
the proposal. The proposal was deferred until the investigators return to the RAC with 
the following: (1) a product information sheet informing customers of the potential 
health risk of the expression system, standard methods to be used for virus inactivation, a 
helper virus assay to detect SFV, and a description of symptoms and procedures to be 
followed in the event that SFV infection occurs in a laboratory worker (including 
methods to prevent transfer to insect vectors and environmental spread); and (2) SFV 
inactivation data. The motion to defer the request passed by a vote of 16 in favor, 2 
opposed, and 1 abstention. 
XXV. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING THE 
POXVIRUS VECTORS NYVAC, ALVAC, AND TROVAC- REDUCTION OF PHYSICAL 
CONTAINMENT FROM BL2 TO BL1/ DR. PAOLETTI 
Review-Dr. Gay 
Dr. Walters called on Dr. Gay, Chief Staff Veterinarian of the Office of Veterinary 
Biologies, U.S. Department of Agriculture (USDA), to present his ad hoc review of the 
proposal submitted by Ms. Arvilla L. Trag (on behalf of Dr. Enzo Paoletti) of 
Virogenetics Corporation, Troy, New York. Dr. Gay explained that this proposal 
requests a reduction in physical containment for 3 recombinant pox vectors NYVAC, 
ALVAC, and TROVAC from BL2 to BL1. Dr. Gay said that the Office of Veterinary 
Biologies is responsible for licensing all veterinary biologies in the United States. 
License applications have previously been reviewed for Rhone Merieux, Inc., for 2 
recombinant vector vaccines that were constructed with poxvirus-based vectors, 
TROVAC and ALVAC. TROVAC-NDV, a Newcastle Disease-Fowlpox Vaccine is 
based on TROVAC. ALVAC-RG, a Rabies Vaccine is based on ALVAC. The USDA 
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