Attachment V - Page 3 
3 
Dr. Lacy called the working croup's attention to the second paragraph of 
Dr. Vidaver's document; he questioned whether critical literature citations 
should be requested as part of a sumrmry of relevant background information. 
Dr. P Irene thought this was implied by the phrase "relevant background." 
Dr. Vidaver pointed out that in seme cases, this type of information may not be 
available. She cited the example of patent disclosures. .She said RAC could 
always request additional information frem submitters. Dr. Vidaver felt that 
to date industry has been very cooperative; she expected it 'would continue to 
be so. 
Dr. Lacy wondered whether describing more of the type of information RAC would 
like to review would speed the review process. 
Dr. Milewski asked if the second sentence of the second paragraph should request 
"A summary of relevant background information and preliminary results...." The 
working group agreed. Dr. Vidaver asked Dr. milewski to check on the language 
of the document "Points to Consider for Submission Under Appendix L, " as 
Dr. Vidaver had taken this language directly from that document. 
Dr. Milewski called the attention of the working group to the first item of 
Dr. Vidaver's document. Dr. Pirone suggested items one and two of Dr. Vidaver’s 
document might be combined and item three fran the SPA document might be inserted 
after these items. 
Dr. Vidaver asked if information requirements- should apply to both the source 
organisms and the modified organisms. Dr. Pirone agreed they should; he said 
RAC would like to knew what the modified organism would do, and should be 
aware of the properties of the source organisms. He suggested the properties 
of the source organisms could strongly affect the properties of the modified 
organisms . 
Dr. Pirone said another iirportant consideration was to determine that CNA 
coding for a noxious characteristic would not be introduced into the recipient 
modified organism. Dr. Tolin said that earlier guidelines had referred to 
"well-characterized DMA" to imply this consideration. She pointed out that 
vector DMA (e.g. , pBR322 DNA) could also be introduced into the organism and 
the effect of this DNA should also be known. Dr. Tolin felt item three of 
Dr. Vidaver's document adequately addressed questions on the properties of the 
vectors. She suggested the language should request more information on the 
function of the inserted sequence. 
Dr. Lacy suggested that item five of Dr. Vidaver's document should also contain 
language requiring information on the differences between source and modified 
organisms. He thought items four and nine also required some clarification of 
language so as to request this information. 
Dr. Lacy also felt some consideration should be given to the effect of the 
modified organism on target and non-target organisms. 
Dr. Pirone suggested that item five might request information on the insert el 
DMA. Dr. Tolin suggested the language of items three and five might be combined. 
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