8 
MINUTES OF MEETING - June 5-6 
in recombinant DNA technology. The RAC, at its March 1980 meeting, 
recommended that the large-scale physical containment recomme rotations be 
published in the Federal Register . 
Dr. Gartland said that to date, thirteen institutions not otherwise 
covered by the NIH Guidelines have registered their biosafety committees 
with the NIH. Seven proposals to exceed the ten-liter limit have been 
reconmended for approval by the RAC and have been approved by the NIH. 
These proposals have been voluntarily submitted by two companies, Eli 
Lilly and Company, and Genentech, Inc. 
Dr. Gottesman proposed that for large-scale experiments, the RAC continue 
to determine whether a clone is fully characterized and free of harmful 
sequences and that it set a P-LS level. However, the RAC would not 
evaluate the physical containment facilities. Dr. Gottesman said that 
this responsibility would be shifted to the companies themselves. 
Dr. Nightingale supported Dr. Gottesman' s position but said she would 
prefer receiving some feedback of information to the RAC on implementa- 
tion of RAC decisions, at least on an interim basis. Dr. Baltimore 
stated that Dr. Gottesman' s proposal would allow companies to continue 
on in larger and larger volumes without rechecking with the RAC, once 
they had received initial RAC approval to exceed 10 liters, based on a 
RAC determination that a clone is fully characterized and free of harmful 
sequences. Dr. Baltimore suggested that in adopting Dr. Gottesman 's 
proposal, the RAC would be abrogating an area of self-imposed responsi- 
bility, leaving no oversight in any agency or group. 
Dr. Irving Johnson noted that Eli Lilly and Company had already been 
visited by representatives of the RAC, National Institute for Occupa- 
tional Safety and Health (NIOSH), and the Food and Drug Administration 
(FDA). Dr. Walters said he was sympathetic to the concept of dir i- 
guishing between evaluating biological aspects and evaluating physical 
containment. He suggested that perhaps a RAC subcommittee, modeled 
after the British Genetic Manipulation Advisory Group (GMAG) subcommittee, 
might be constituted, and might make site visits to industry to verify 
that the equipment is as described. Dr. Young said that there should be 
increased dialogue between ORDA and companies on containment facilities 
if RAC is not going to evaluate facilities on a case-by-case basis. 
Dr. Goldstein asked whether facilities where large volumes of etiological 
agents were grown in non-recombinant DNA cases, e.g., for vaccine produc- 
tion, were inspected and monitored. Dr. Dowdle, of the Center for Disease 
Control (CDC) , said that the Public Health Service has issued guidelines 
regarding the safe handling of infectious agents. Dr. Baltimore asked 
if these guidelines have statutory authority. Dr. Dowdle responded that 
the guidelines have no statutory authority and compliance is voluntary, 
but experience has shown that guidelines become an effective accepted 
standard . 
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