May 22, 1984 
Dr. William J. Gartland, Jr. 
Director, Office of Recombinant 
DNA Activities 
Building 31, 3B10 
National Institutes of Health 
Bethesda, Maryland 20205 
RE: Federal Register Notice for June 1, 1984 RAC Meeting, 
49 _F._R. 17672 (April 24, 1984) 
Dear Dr. Gartland: 
On behalf of Genex Corporation I would like to express our support for the 
"Proposed Amendment of Procedures for Scale-Up of Organisms Listed in Appendix C" 
contained in Section I of the Federal Register notice. We urge its acceptance 
by the Recombinant DNA Advisory Committee (RAC) for the reasons outlined below. 
The proposed modification of Appendix K-II-D to require that exhaust gases be 
treated so as to "minimize" rather than "prevent" the release of viable organ- 
isms is necessary in order to make the requirement realistic. Even HEPA filters, 
which are specifically recommended in Appendix K-II-D, are rated as removing 
only 99.97% of the particles larger than 0.2 microns. Thus, the term "prevent" 
is too restrictive to be operationally useful. 
Part 3 of the Proposed Amendment, which explicitly grants to the Institutional 
Biosafety Committee (IBC) the right to exercise some latitude in the application 
of Pl-LS containment requirements to organisms covered by Appendix C, is appro- 
priate for several reasons. These organisms are exempt from the NIH Guidelines 
at the laboratory level because they have been shown to present no significant 
risk to health or the environment. Therefore, it would seem reasonable to allow 
the IBC to relax certain aspects of the Pl-LS requirements after careful review 
of the host-vector system, the large-scale process description, the equipment 
to be utilized, and the emergency spill procedures. For example, in order to 
accommodate process and equipment realities, it may in some instances be appro- 
priate for the IBC to allow certain large-scale transfer or processing operations 
involving viable organisms to be carried out without absolute containment. Pro- 
viding that worker exposure and environmental losses are minimized, this type of 
latitude should present no significant risk. 
Granting the IBC authority and responsibility to decide on a case-by-case basis 
the exact containment conditions for large-scale use of these exempt organisms 
is in keeping with the increasing shift of oversight responsibility to the local 
Genex Corporation • Science & Technology Center • 1 6020 Industrial Drive • Gaithersburg, Maryland 20877 
(301) 258-0552 • Telex 908775 
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