3 
Dr. McGarrity, Chair, called the October 5, 1984, meeting of the Working Group 
on Release into the Environment to order at 9:15 a.m. He welcomed a new member 
of the working group. Dr. David Pramer of the Waksman Institute of Microbiology, 
and the ad hoc consultants for this meeting, Dr. Robert Colwell of the University 
of California and Dr. Susan Hirano of the University of Wisconsin. Dr. McGarrity 
also noted that Dr. Morris Levin had replaced Dr. John Fcwle as the representative 
from the Environmental Protection Agency (EPA). 
Dr. McGarrity said the working group would consider three topics at its 
October 5 meeting: (1) a guidance document for investigators submitting proposals 
involving field testing of genetically modified microorganisms; (2) a report on 
the status of the proposed national conference on risk assessment of genetically 
modified organisms to be released to the environment; and (3) the format of the 
response to the report The Environmental Implications of Genetic Engineering 
(called the Gore Report) of the staff of the Subcommittee on Investigations and 
Oversight of the House of Representatives Ccrrmittee on Science and Technology. 
Development of a Points to Consider Document for Microorganisms 
Dr. McGarrity said with the growing recognition that genetic engineering systems 
were being developed to modify successfully plants, the Recombinant DNA Advisory 
Conmittee (RAC) and its working groups over a two-year period constructed guide- 
lines for field testing of certain modified plants. These guidelines have been 
incorporated into the NIH Guidelines for Research Involving Recombinant DNA 
Molecules as Appendix L, Release into the Environment of Certain Plants (Attach- 
ment II). In addition, the RAC, the RAC Plant Working Group, and the RAC 
Working Group on Release into the Environment have developed the document 
Points to Consider for Submissions Under Appendix L (Attachment III) as guidance 
to investigators wishing to submit proposals involving field testing of certain 
modified plants. The points to consider document is a "working" document and is 
not part of the NIH Guidelines for Research Involving Recombinant DNA Molecules. 
Dr. McGarrity said the Working Group on Release into the Environment at the 
October 5 meeting will new attempt to develop a points to consider document for 
submissions involving field testing of genetically modified microorganisms. 
Dr. McGarrity said a subgroup of volunteers (Drs. Lacy, Milewski, Pirone, Tolin, 
and Vidaver) had constructed a preliminary draft document (Attachment IV). 
[Executive Secretary's Note: The minutes of the telephone conference call meet- 
ings during vhich this preliminary draft document was developed are appended to 
these minutes as Attachments V and VI]. 
Dr. McGarrity said the document developed by the Working Group on Release into 
the Environment would be sent for acceptance to the RAC. RAC is advisory to 
the Director, National Institutes of Health (NIH), who has the authority to 
set policy. 
Dr. McGarrity pointed out that EPA feels its Toxics Substances Control Act 
(TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) statutes 
may apply to genetically modified microorganisms. The EPA has sent several 
documents to the Working Group on Release into the Environment (Attachments 
VII, VIII, IX, X) to elicit comment and to provide information. 
[ 13 ] 
