Attachment VI - Page 1 
DEPARTMENT CF HEALTH AND HJMAN SERVICES 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES CF HEALTH 
RECOMBINANT DNA ADVISORY COMMITTEE 
SUBGROUP OF WORKING GROUP ON RELEASE INTO THE ENVIRONMENT 
MINUTES OF MEETING 
SEPTEMBER 21, 1984 
A subgroup of the Working Group on Release into the Environment met by telephone 
conference call from 3:45 p.m. to 4:15 p.m. on September 21, 1984, to attempt 
to develop a document dealing with points to consider in data submissions for 
experiments involving field testing of microorganisms . Drs. George Lacy, 
Thomas Pirone, Sue Tolin, Anne Vidaver , and Elizabeth Milewski participated. 
Dr. Lacy introduced the document (Attachment I) which he and Dr. Tolin had 
generated on the basis of the September 14, 1984, telephone conference call. 
Drs. Vidaver and Pirone felt the document was well done; they had several minor 
suggested modifications. 
Dr. Vidaver thought the general outline was good; she suggested that the word 
"characteristics" be substituted for the word "traits" wherever the word 
"traits" appears in the document. 
Dr. Tolin asked if item II-C should explicitly state that information on toxo- 
genicity be included in any proposal. She noted that this idea is implied in 
item II-C by the word "physiological." Drs. Vidaver and Pirone agreed that 
toxogenicity is implied in the term "physiological" and need not be stated 
explictly in the document. 
Dr. Pirone questioned the language of item III-A-4; he wondered if this 
language might be more logically included under item III-C-1. Dr. Lacy said 
item III-A-4 attempts to ask the following question: if the ENA construct 
consists of x + y, and x represents the gene, what is the function of the 
excess of ENA, y? Would the presence of y affect the characteristics of the 
organism? Dr. Lacy suggested the word "excess" might be added to the language 
of item III-A-4 to clarify this concept. 
Dr. Vidaver felt the language of item III-B-2 which contains a similar concept 
was not clear. Item II-B-2 reads as follows: 
"Describe the amount of any vector DNA remaining in the fined construction. 
Is any effect anticipated from this ENA? 
Dr. Lacy suggested that language might be modified to read as follows: 
"Describe the amount of any vector ENA remaining in the final construction. 
Predict whether any changes in pathological , ecological, physiological, or 
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