2 
a points to consider document for submissions involving field testing of genetically 
modified microorganisms; and (2) to provide RAC and the public an opportunity 
to comment on the draft document. He said the preamble written by Dr. Gottesman 
had not been seen by all members of the Working Group on Release into the 
Environment prior to presentation of the draft document to the RAC on October 
29, 1984. 
Dr. McGarrity said he had mixed feelings about sending the preliminary draft 
document to RAC since same people tend to disregard the draft designation and 
treat the document as if it were final. On the whole, however, he felt the 
effort to inform RAC in this manner had been productive; and he had received 
several general ccmmsnts on the document. He said he would introduce these 
comments at the appropriate point in the working group discussion. 
Dr. McGarrity reported that Mr. Jeremy Rifkin of the Foundation on Economic 
Trends and his attorney, Mr. Lee Rogers, had criticized the preliminary draft 
document (Attachment II); they contended the document did not meet the require- 
ments of the National Environmental Policy Act (NEPA). Dr. McGarrity said he 
had informed Mr. Rifkin that the working group draft was not an attempt to 
address the NEPA requirements but rather an attempt to provide submission 
guidance for investigators. A second criticism by Messrs. Rifkin and Rogers 
was that the working group draft did not contain standard protocols and criteria 
for evaluation. Dr. McGarrity said he had replied that the consensus of the 
working group and of other experts is that case-by-case review is the only 
valid way to proceed as preposed applications will vary widely, and there is 
not sufficient scientific information available to formulate standard criteria. 
Dr. Gottesman suggested the working group might consider aligning the draft 
document with seme NEPA requirements to simplify the task of organizing data 
and information into the NEPA format should the NIH be required to prepare 
environmental assessments. 
Dr. McGarrity asked the working group to evaluate the draft document (Attach- 
ment II) first as a whole and then to consider the document point by point. 
He called the attention of the working group to the preamble of the document. 
Dr. McGarrity suggested the working group might wish to add language to the 
preamble indicating that the document would be updated regularly; he said the 
! document currently being developed by the RAC Working Group on Hunan Gene 
j Therapy includes such a prevision. 
j Dr. McGarrity said one canrrent he had received on the preamble was that the 
I language did not inform the investigator of the review procedure; the commenta- 
tor suggested this information be included in the preamble. 
I 
1 Dr. Clowes said the draft document (Attachment II) developed by the Working 
i Group on Release into the Environment should not contain language which would 
rigorously prescribe the manner in which protocol review would proceed. He 
felt specifying that the Institutional Biosafety Committees (IBCs) must review 
the proposal before it is submitted to RAC may place the IBC in a difficult 
situation. Broad expertise is required bo adequately review proposals involving 
^ field testing of modified organisms. He pointed out that most IBCs are set up 
| 
I 
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