3 
Dr. McGarrity called the meeting of the Working Group on Release into the 
Environment to order at 9:00 a.m. He asked the participants to identify 
themselves. 
Dr. McGarrity said four agenda items would be addressed during the meeting: 
(1) updates on agency activities related to field testing of genetically 
modified organisms frcm the National Institutes of Health (NIH) , Environmental 
Protection Agency (EPA), U.S. Department of Agriculture (USDA), National 
Science Foundation (NSF) , and the Food and Drug Administration (FDA); (2) the 
guidance document entitled "Points to Consider for Submissions Involving Testing 
in the Environment of Microorganisms Derived by Recombinant ENA Techniques" 
(Attachments II and III); (3) an update on the conference being organized by 
the American Society for Microbiology (ASM) on the effects of releases of 
modified organisms into the environment; and (4) BL1 testing conditions for 
modified microorganisms in greenhouses (Attachment IV). 
IPDATES ON AGENCY ACTIVITIES 
Dr. Gartlard said the Federal Register of December 31, 1984, contains a proposal 
for a coordinated framework for regulation of biotechnology. This Federal 
Register attempts to provide a concise index of U.S. laws related to biotech- 
nology, to clarify the policies of the major regulatory agencies involved in 
reviewing products and processes of biotechnology, to describe a scientific 
advisory mechanism for assessment of biotechnology issues, and to explain hew 
the activities of the Federal agencies will be coordinated. 
Dr. Gartland said the Recombinant DNA Advisory Committee (RAC) was instituted 
in 1974 to oversee the NIH Guidelines for Research Involving Recombinant ENA 
Molecules. Review of biomedical research applications has been and will 
probably continue to be RAC's major emphasis. 
Dr. Gartland said the NIH had given approval for field testing of three different 
proposals involving organisms modified using recombinant ENA. These proposed 
tests are currently enjoined under the lawsuit brought against the NIH and 
Department of Health and Human Services (DHHS) by the Foundation on Economic 
Trends. The NIH has recently completed an Environmental Assessment (EA) on 
one of these cases (the proposal by Drs. Stephen Lindcw and Nickolas Fbncpoulos 
of the University of California, Berkeley, to field test modified ice nucleating 
bacteria). This EA has been filed by the NIH with the U.S. Court of Appeals; 
the NIH is requesting the injunction be lifted and field testing be allowed to 
proceed while the court is considering the lawsuit filed by the Foundation on 
Economic Trends. 
Dr. Gartland said no NSF representative is attending the February 11, 1985, 
meeting of the Working Group on Release into the Environment; he could report, 
however, that NSF is attempting to institute a committee to deal with ecology 
issues in biotechnology. 
Dr . Morris Levin of the EPA said EPA is assenibling a risk assessment program 
on environmental impacts of introductions of modified organisms. The EPA is 
( 298 ] 
