3 
" (?) Predictina the specific type, magnitude or probability of environmental 
effects associated with deliberate release will be extrenely difficult 
at the present time. 
"( 3 ' The current regulatory framework does not guarantee that adequate consid- 
eration will be given to potential environmental effects of a deliberate 
release 
Dr. McGarrity said he had concluded in light of vhiat he had read that currently 
no agency has both expertise and regulatory authority in this area. He asked 
each of the aoency representatives present at the meeting to describe their 
aaency's activity in the area of genetic engineering. 
Dr. Gartland said the questions posed by Dr. Talbot were one approach undertaken 
by the NIH. He said the NIH has approved to date three proposals involving field 
testing of organisms modified by recombinant ENA techniques. He gave an update 
on the status of the three proposals: Dr. Ronald Davis of Stanford University 
has suggested that he might in June 1984 field test com which has been trans- 
formed by com DNA or modified com sequences; Dr. John Sanford of Cornell 
University will not be field testing tcmato and totacco plants transformed with 
bacterial and yeast DNA as growth chamber and greenhouse experiments have not 
been successful; and Drs. Nickolas foncpoulos and Steven Lindcw of the University 
of California, Berkeley, have been threatened with litigation should they 
proceed with plans to field test bacteria lacking the genes coding for protein- 
aceous ice nucleation foci. 
Dr. Miller of the Food and Drug Administration (FDA) said FDA for the past 3 
or 4 years has been regulating drugs and biologies produced using genetic 
enaineering techniques. He said FDA has a recombinant DNA coordinating committee 
\hich functions administratively within FDA. 
Dr. Tolin of the U.S. Department of Agriculture (USDA) said that USDA has been 
active for seme time in the recombinant DNA area. She pointed out that USEft 
has sponsored and participated in several workshops addressing recombinant ENA 
issues. She said USDA has an internal administrative advisory carrmittee, the 
Agriculture Recombinant Advisory Committee. 
Dr. Fowle of the Environmental Protection Agency (EPA) said that EPA is 
attempting to increase its research activity in this area. At the moment, EPA 
depends on I3AC for guidance, and EPA will undoubtedly work closely with NIH 
when jurisdictional issues have been ironed out. Dr. Hollander of EPA said 
EPA has not yet published it "intention to regulate," thus, EPA has not yet 
received any formal inquiries in the genetic engineering area. 
E>r . Gartland asked how a "pest" is defined under the Federal Insecticide, 
Fungicide, and Radenticide Act (FIFRA) statutes. Dr. Hollander replied that 
FIFRA grants authority to EPA to regulate the sale, distribution, and use of 
pesticides and defines a pesticide as any substance or mixture of substances 
intended for preventing, destroying, repelling, or mitigating any pest. A pest 
is defined as any virus, bacteria, or other micro-organism (except viruses. 
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