17 
Dr. Sharpies questioned whether the working group could develop specific data 
requir orients vhen it cannot decide how much information will be required to 
review each proposal. 
Dr. McGarrity suggested the working group attempt to evaluate the requirements 
detailed in the body of the document. The working group agreed to work on 
Sections I, II, III, and IV of the draft document. 
Dr. McGarrity drew the attention of the working group to Section I, Summary , of 
the document. He questioned whether this portion of the document should ask for 
a description of alternative methods of accomplishing the goal. Dr. Gottesman 
felt alternative methods should be discussed in the context of risk assessment 
issues. Dr. Pirone agreed alternative approaches should be discussed when the 
risk/benefit ratio is evaluated in the section of the document dealing with 
risk assessment. Dr. Arntzen said a discussion of alternate approaches should 
not be required by the working group document if the development of this 
technology is to be promoted. 
Dr. Sharpies asked whether alternative approaches need to be described in 
environmental assessments (EAs). She felt the investigator should describe 
alternatives if the NIH will file EAs for these types of experiments. 
Dr. Vidaver suggested the language of Section I, Summary , should read as follows: 
"Present a summary of the proposed trial including objectives, significance, 
and justification for the request." 
Dr. Lacy moved acceptance of this language. By a vote of ten in favor, none 
opposed, and no abstentions, the working group accepted this language. 
Dr. Lacy suggested the title of Section II, Derivation of Modified Organism to be 
Released, should be changed to Genetic Considerations^ He also suggested 
the title of Section II-A, Characteristics of the Nonmodified Parental Organism 
to be Modified and Released~~into the Environment , should read, Characteristics - 
of the Nonmodified Parental Organism . The title of Section II-B, Molecular Biology I 
of Modifications, should read. Molecular Biology of the Modified Organism. 
I 
In discussing potential modifications of Section II of the document, the working 
group voiced several considerations. Dr. Vidaver suggested the points in Section 
II should be stated in the form of sentences. Dr. Sharpies asked how the term 
"relevant genetics" was defined in Section II-B-l-b of the document. 
i 
Dr. Gottesman said "relevant genetics" referred to the genetics of the modified 
and parental organisms. 
Dr. Sharpies pointed out that Section II-B-1 of the document did not require the 
introduced gene be identified. Drs. Vidaver and Gottesnan suggested Section 
H-B-l-a be modified to request both the source and the function of the 
introduced gene. 
[194] 
