May 21-23 - MINUTES OF MEETING 
9 
The vote on the motion to table was 9 in favor, 9 against, with 1 
abstention. Dr. Setlcw then cast a vote in favor of the motion to table. 
Later in the meeting, Dr. Setlow appointed a Working Group on Procedures 
consisting of Drs. Milton Zaitlin (Chairman), Karim Ahmed, and Michael 
Resnick (ORDA staff). 
VII. REGISTRATION OF PROJECTS AND PROTECTION OF PROPRIETARY INFORMATION 
Dr. Talbot summarized the current situation with regard to the voluntary 
registration of projects under the 1978 Guidelines. He noted that the 
Food and Drug Administration (FDA) published a Notice of Intent to Propose 
Regulations in the December 22, 1978 Federal Register . A number of 
ccmmentators have questioned FDA's authority to regulate basic research. 
FDA is currently considering the comments. Dr. Talbot said that NIH 
is considering procedures for the protection of proprietary information. 
Mr. Riseberg summarized the provisions of the Freed an of Information Act 
(FOIA) . He summarized procedures NIH would use to determine whether 
proprietary information is involved in a submission. If such is the 
case, it would be not subject to the disclosure provisions of FOIA. 
He noted that there are criminal penalties for the unauthorized release 
of priv Hedged information. 
Dr. Krimsky made a motion that the RAC recanmends supporting mandatory 
compliance by non-NIH funded institutions (with the NIH recombinant DNA 
Guidelines). Dr. Krimsky stated that he cannot see the justification 
for treating industry differently from academia. Dr. Parkinson said 
that he is reluctant to prepose additional regulations. He added that 
it is likely that FDA and OSHA have authority, and he requested a 
discussion of occupational health with representatives of OSHA and 
NIOSH at the next meeting of the RAC. Dr. Walters said that he prefers 
trying a voluntary scheme with incentives for industry to participate. 
Dr. Talbot said that the Secretary of HEW is on record as opposing the 
use of Section 361 of the PHS act to regulate reccmbinant CNA research. 
Dr. Walters stated that everyone agrees that private industry should be 
in compliance with the Guidelines and should register projects. There 
is a difference of opinion with regard to strategy, i.e., whether there 
should be a voluntary or mandatory system. 
Dr. Zaitlin moved to table Dr. Krimsky' s motion. The motion to table 
failed to carry by a vote of 6 in favor, 11 opposed, with 3 abstentions. 
Dr. Redford then proposed an amendment to Dr. Krimsky ' s motion bo the 
effect that the RAC is deeply concerned by the lack of assurance of 
industrial compliance with the Guidelines and it suggests that the 
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