4 
An in-house group, together with investigators at Tufts University and 
the University of Rhode Island, will soon begin evaluating the biological 
containment of EK1 host cells and vectors during sewage treatment. Two contracts 
are about to be let on Assessment of Future Environmental Problems: Applied 
Genetics. One deals with agricultural concerns, the other with industrial 
concerns . 
Grants will be awarded for A Probability Analysis of Escape and Establish- 
ment of Laboratory Organisms (this will involve modeling and fault-tree analysis); 
and to study The Fate of Novel Genomes in Established Ecosystems (tracing the 
survival of labelled organisms). Dr. Harsanyi suggested that it might be useful 
to ascertain the survival of organisms currently used for pollution control. 
Dr. Still suggested the same for legume innocula microorganisms used to encourage 
biological nitrogen fixation. 
Report from FDA 
Dr. Goldberg noted that FDA has regulatory authority concerning only the 
products of recombinant DNA techniques, as distinct from other agencies whose 
concerns are primarily with the process. Five of the six FDA Bureaus will 
probably be dealing with products made by recombinant DNA techniques. The 
Bureau of Drugs will deal with pharmaceuticals, such as insulin and growth 
hormone. Single-cell protein would be evaluated by the Bureau of Foods. Human 
vaccines or interferon would be considered by the Bureau of Biologies. Animal 
drugs would be reviewed by the Bureau of Veterinary Medicine. Enzymes that are 
part of an in vitro diagnostic system would be considered by the Bureau of Medical 
Devices. Since the different FDA Bureaus have different statutory bases, each 
product of recombinant DMA techniques will be dealt with individually by the 
relevant FDA Bureau. 
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