SEPTEMBER 6-7 - MINUTES OF MEETING 
3 
the document is very precise with respect to ORDA, but less precise with 
respect to responsibilities of RAC members. In response to a statement 
by Dr. Walters, Mr. Riseberg said that "personal supervision" means 
supervision by the RAC member and not by an assistant or secretary of 
the RAC member. Dr. Gottesman said that this would probably require use 
of a unique locked file cabinet. Mr. Thornton, who has had experience 
with handling confidential information in Congress and in the Navy, 
said that it is the responsibility of the authorized individual to main- 
tain confidentiality. He said that caution must be exercised, but that 
in most cases confidential material can be mingled with personal files. 
Mr. Riseberg said that the problem is control and not the mixing of 
confidential and non-conf idential materials. He noted that FDA considers 
a number of items, such as locked files, to be sufficient to ensure 
adequate control. Dr. Walters expressed concern that if the precedent 
is a requirement for locked files it will involve buying new equipment 
to protect confidential information. Dr. Set low said that the alternative 
would be to look at confidential material only during closed portions 
of the RAC meeting. In response to a question by Dr. Walters, Mr. Riseberg 
said that a safe deposit box at a bank would be a reasonable way of 
safekeeping documents. The RAC requested that a copy of Section 1905, 
Title 18 U.S.C. be attached to the document being discussed. Dr. Gartland 
said that RAC members vjould be asked to sign the "Commitment to Protect 
Privileged Recombinant DNA Information" (Attachment A to Document 696) 
before the meeting goes into closed session to review proprietary 
information. 
IV. PROPOSED AMENDMENT OF SECTIONS II-D-l-a-(l) and III-A-l-b-(l) 
Dr. Nickolas Panopoulos of the University of California, Berkeley proposed 
amendment of Sections II-D-l-a-(l) and III-A-l-b-(l) of the Guidelines 
concerning the presence of conjugative plasmids and generalized trans- 
ducing phages in EKl systems. The proposed amendments rewritten by Dr. Resnick 
of ORDA were published for comment in the Federal Register on July 31, 
1979. During the 30-day comment period, no comments were received. 
Dr. Campbell said that Dr. Panopoulos' proposed first amendment specifically 
authorizes the presence of conjugative plasmids and generalized transducing 
phages when the donor exchanges with E. coli but is not on the exchanger 
list. He said that this amendment simply clarifies the intent of 
existing language which authorizes use of conjugative plasmids as 
cloning vectors under these circumstances. Dr. Campbell said that he 
was confused by Dr. Panopoulos' proposed second amendment because it 
appears to require raising the required level of physical containment 
by one step when conjugative plasmids are present but not when they 
are used as vectors. Dr. Campbell, beginning with the text as published 
for comment in the Federal Register , recommended deletion of the second 
sentence proposed to be added to Section III-A-l-b-(l) . He recommended 
that the first sentence proposed to be added should be accepted, but 
that it should be moved to precede the last sentence in the paragraph 
above it. 
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