VIROGENETICS CORPORATION 
465 JORDAN ROAD 
RENSSELAER TECHNOLOGY PARK 
TROY, NY 12180 USA 
VIROGENETICS 
TROVAC 
TEL. (518) 283-8389 
FAX (518) 283-0936 
REQUEST FOR REDUCTION IN BIOSAFETY LEVEL REQUIREMENTS FOR 
THREE RECOMBINANT POXVIRUS VACCINE VECTORS-- 
NYVAC, ALVAC, AND TROVAC 
The Office of Recombinant DNA Activities (ORDA) recognizes that several different 
combinations of laboratory practices, containment equipment, and laboratory design may be 
appropriate for containment of specific research activities. The selection of alternative methods 
of primary containment is dependent on the level of biological containment provided by the host- 
vector system ( Guidelines for Research Involving Recombinant DNA Molecules, Appendix G-II ). 
We are asking for a reduction in containment level for three of our recombinant poxviruses, 
NYVAC, ALVAC and TROVAC from BL-2 to BL-1 because we believe they "do not present 
a significant risk to health or environment" (Ibid, Section IV-Q, due to the extent of biological 
containment provided by their construction. Such a change in classification would more 
accurately reflect the pathogenicity of the organisms and their potential hazard to man, as well 
as facilitate the development of safe and efficacious human and veterinary vaccines based on 
these vectors. 
According to the Guidelines, any combination of vector and host which is to provide biological 
containment must be chosen or constructed so that the following types of "escape" are 
minimized: 
i) survival of the vector in its host outside the laboratory 
ii) transmission of the vector from the host to other non-laboratory hosts 
We will demonstrate minimization of these types of "escape" for both vectors, via biological 
containment, to a degree which we believe justifies the reduction in biosafety level we are 
requesting. 
The format in which we are presenting our information is similar to that used by the USDA for 
their Veterinary Biologies Summary Information Format. Briefly, the format provides a 
synopsis of specific characteristics of the recombinant, with attached appendices for further 
detail. Each recombinant will be described and appendicized separately. For clarity, a glossary 
is enclosed on the following page. 
[158] 
Recombinant DNA Research, Volume 18 
