6 
Dr. McGarrity said the working group's objectives were: (1) to develop 
submission guidance for investigators wishing to test microorganisms 
modified through reccmbinarrt CNA in the field; and (2) to facilitate RAC 
review. 
Dr. McGarrity said the points to consider document begins with a general 
introduction to the tcpic of environmental testing. The first section of 
the document requests investigators to provide a general sumrary, to 
describe the objective (s) and the significance of the proposal, and to 
justify the proposal. The second section of the document requests infor- 
mation on the non-modified parental organism as well as information on 
the construction and molecular biology of the modified organism. The 
third section of the document requests information on environmental and 
ecological considerations. The fourth section of the document requests 
information on the conditions of the proposed field trial. The fifth 
section asks the investigator to provide a risk analysis. 
Dr. McGarrity emphasized that the points to consider are general guideposts. 
Some of the points may not need to be addressed in a particular application; 
on the other hand, more information than requested by the points to consider 
may be required for some applications. Review of applications would be 
performed on a case-by-case basis. 
Dr. McGarrity said these points to consider are not submitted for inclusion 
in the National Institutes of Health (NIH) Guidelines for Research Involving 
Recombinant DNA Molecules. The points to consider are intended to serve as 
guidance for investigators; these points should be flexible and modified as 
data accumulate frcm the testing continuum vhich extends frcm laboratory 
bench, to growth chamber or greenhouse, and to small-scale field testing. 
Dr. Talbot, Deputy Director of the National Institute of Allergy and 
Infectious Diseases, said neither a vote by the RAC nor acceptance by the 
NIH Director is required for points to consider documents; RAC might, 
therefore, sirrply note this document as the current thinking of the RAC. 
The document could then be sent to individuals requesting it. 
Dr. McGarrity said he would prefer to have RAC's administrative approval of 
the document. 
Mr. Mitchell asked hew a flexible cversight system could be develcped with 
the great diversity of organisms, test sites, and techniques vhich could 
be used in field testing. Dr. Gottesrren replied review must be performed 
on a case-by-case basis because of this great diversity. 
Dr. Gottesrmn said canment letters (tabs 1216, 1227) had been received on 
the points to consider document in response to the March 28, 1985, Federal 
Register announcement. She suggested these comments be considered by the 
workinq group at its next meeting. Dr. Pirone said the issues raised in 
these canment letters could be handled rather simply by the working group 
[ 126 ] 
