4 
bacteria, or other microorganisms on or in living man or other living animals) 
which the EPA Administrator declares to be a pest under Section 25(c)(1) of 
the Act. In regulations promulgated pursuant to FIFRA, microorganisms (includ- 
ing bacteria) and viruses which exist under circumstances that make them dele- 
terious to man or the environment are designated as pests. Dr. Hollander said 
the general counsel for the EPA Office of Pesticides and Toxic Substances 
(OPTS) believes that EPA can regulate the release of ice nucleation bacteria 
under these statutes. 
Dr. Hollander said EPA will attempt to regulate the release of recombinant CNA 
containing microorganisms which are not exempt as pesticides under Section 5 of 
the Toxic Substances Control Act (TSCA). Exempt organisms include organisms 
used for food, food additives, drugs, and pesticides. 
Dr. Clowes said he was unhappy with the attempt to regulate living organisms 
under TSCA. He felt it naive to believe that the whole is no more than the sum 
of the parts. He did not think TSCA could address the appropriate questions 
posed by use of living organisms. When the applicability of TSCA is debated in 
court, scientific arguments will be considered; and use of this statute to regu- 
late deliberate environmental releases does not make scientific sense. 
Dr. Gartland added that TSCA prescribes a notification process applied to 
commercial releases. Dr. Hollander noted, however, that EPA's counsel believes 
the TSCA statutes could be interpreted to regulate research in certain cases 
such as field testing of microorganisms which would normally be subject to TSCA 
once used commercially. 
Dr. Pimentel said enforcement of regulations for deliberate releases will be 
difficult. Dr. Tolin said USDA has considered the cost and the difficulty of 
enforcement versus the potential risk involved in the processes, and at the 
present time does not believe enforcement of regulations would benefit society. 
The cost of enforcement would be high, and genetic technologies have not yet 
shewn hazard. 
Dr. Miller said proposals involving recombinant DMA technology are only the 
tip of the iceberg; there are many other genetic techniques which will be 
employed to modify organisms. Dr. Pirone agreed. Dr. Gottesman said the 
potential hazard of several different types of genetic procedures might be 
evaluated; however, at the moment, the working group under the RAC charter 
can only evaluate recombinant DNA applications. She suggested that if USEA 
and EPA have developed testing procedures for environmental releases these 
procedures should be part of RAC review. 
Dr. Gottesman said RAC should not "over require" when the types of procedures 
to be evaluated are specified. She thought a distinction should be made between 
trivial and major modifications in organisms; it may be that proposals involving 
trivial modifications need not be reviewed. 
Dr. Pimentel felt that the working group could categorize "hazard." He suggested 
for example that experiments involving U.S. crop plants which are tropical in 
origin, annual, do not easily survive without man's intervention and are large 
enough to control present minimal hazard. He felt deliberate releases involving 
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