FEBRUARY 15-16 - MINUTES OF MEETING 
3 
II. REMARKS OF DIRECTOR f NIB 
Dr. Fredrickson welcomed the new members of the Committee. He stated that 
he perceives three phases in the history of the NIH Recombinant DNA Guide- 
lines. Phase I extended from the 1973 Gordon Conference to the issuance 
of the original Guidelines in June 1976. Phase II extended from June 1976 
until the revision process was completed in December 1978. Phase III began 
with the issuance of the revised Guidelines containing procedures for their 
continuing revision at a pace to be recommended by the RAC. He noted that 
the NIH usually has a two-tiered advisory structure consisting of a panel 
of scientific experts, such as a Study Section, and a more broadly based 
committee for setting overall policy, such as a National Advisory Council. 
Dr. Fredrickson stared that for reccmbinant ENA issues these two functions 
would be served by one committee, the newly expanded RAC. Dr. Campbell 
raised questions about the requirement for health surveillance under the 
revised Guidelines and about the risk assessment program. Dr. Fredrickson 
stated that the issue of health surveillance had been raised at the public 
hearing in September 1978 as an expression of concern for people working 
in the laboratory. The responsibility and procedures for health sur- 
veillance are at the local level. Drs. Campbell and Young said that more 
specific guidance on the intent of the health surveillance requirement 
would be appreciated by institutions. With regard to risk assessment, 
Dr. Fredrickson noted that CHEW has directed NIH to publish by March 30 
a preposed plan for a program to assess the risks of reccmbinant DNA 
research. The program will be administered by NIAID. The RAC will have 
opportunity to review the proposed plan at its next meeting. 
Dr. Bedford stated: 
"You used the words 'eventual elimination of these 
requirements' in your introductory remarks. Those 
words could have a tremendous significance in work 
with this ccmmittee. I wondered if you cared to 
elaborate on that, or on what kind of conditions 
you would think 'eventual elimination' would be 
justified." 
Dr. Fredrickson responded: 
"I believe that we will ccme to an understanding of 
the use of these techniques and their potential for 
creating both good and harm to a degree where it will 
not be necessary for us to have guidelines for their 
use. I am convinced of that. But I don't know when 
that will occur. That will occur when we understand 
enough to all agree that it should take place." 
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