6 
of risk would be obtained by multiplying together each separate evaluation of 
risk for each risk foe tor. 
Or. Sharpies thounht Section II-C of the subgroup document lumped together several 
separate ideas. She guestioned vbether the format used to structure the subgroup 
document was optimal for conveying the informational r eg uir orients. 
Dr. Cblwell felt the document should more explicitly state the types of data 
required for an ecological assessment. Dr. Pramer agreed; he cautioned, however, 
that too detailed a requirement checklist would create problems for an investi- 
gator as the investigator would have to decide which data requirements were 
pertinent. Dr. Pirone explained that the subgroup felt not all requirements 
would be relevant to all cases so it opted to write a simpler document. 
Dr. Miller asked if the subgroup preliminary draft document would apply to 
live vaccines developed with the recombinant ENA technique. Dr. Tolin said 
it would. Dr. Miller asked if an investigator would be required to receive 
NIH approval before seeking FDA approval for a vaccine. Dr. Tolin said FDA 
and NIH review are two independent processes. 
Dr. Miller suggested a working group document should contain a disclaimer 
stating that while certain information might be desirable, responses to all 
draft requirements are not necessarily required in every case. The disclaimer 
miqht also state that abbreviated responses might be preferrable in seme cases. 
Dr. Pramer said a working group document should state that evaluating the 
potential risk of field testing of modified microorganisms is difficult; the 
document might also state that submission guidance would be given by the Office 
of Peccmbinant DNA Activities (ORDA) . Dr. Gartland said ORDA currently offers 
such quidance, but this procedure does not always operate smoothly. Dr. MoGarrity 
explained that to date either RAC or its working group have ccmunicated to the 
investigators additional informational requirements for submitted proposals; the 
investigators have subsequently submitted modified proposals. Dr. Gottesman 
suggested a working group document might urge investigators to submit proposals 
for preliminary review by a working group to ascertain vhether additional 
information is necessary. 
Dr. Colwell felt the process of sending proposals back to investigators for 
additional data would be very time consuming and preferred that a working group 
document detail the types of information RAC might require for review. 
Dr. Gottesman said the working group might proceed by constructing a simple 
document with footnotes or appendices detailing the specific types of informa- 
tion to be submitted. 
Dr. Pirone felt a working (group document should clearly distinguish between 
requests to describe the characteristics of the parental organisms (donor and 
recipient) and the characteristics of the modified organism. 
Dr. Levin suqgested words such as "parental, source, donor" should be clearly 
defined in a working group document. Dr. Tolin explained that in the subgroup 
document (Attachment IV) the term "parental" designates the organism to be 
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