18 
There being no motion on the subject, Mr. Mitchell ruled the matter closed. 
He then asked Drs. Walters and Martin to assist him in considering whether a 
statement setting forth RAC's concerns about this issue should be developed. 
Mr. Rifkin asked whether DOD would be required to submit classified experi- 
ments to the NIH for review. He asked if there are security clearance 
provisions for RAC members for review of classified materials. 
Dr. Gartland replied that the vast majority of experiments conducted by 
DOD, as with any university or commercial concern, would be generically 
covered by the NIH Guidelines and would not be individually submitted to 
NIH for RAC review. He said the NIH Guidelines did not have any provisions 
for security clearance. 
VI. REPORT OF RISK ASSESSMENT SUBCOMMITTEE 
Dr. Gottesrran said a series of questions (tab 1223) involving recombinant 
DNA risk assessment had originated in the Office of the Assistant Secretary 
for Planning and Evaluation (ASPE) of the Department of Health and Hunan 
Services (DHHS). This: memorandum had been forwarded by the Assistant 
Secretary for Health, HHS, to several HHS agencies (Food ana Drug Admini- 
stration, Centers for Disease Control, and -National Institutes of Health) 
for comment. The Director, NIH, suggested . the- Rxsk Assessment Subcommittee 
address these questions, and the Assistant Secretary ror Healtn concurred 
with this proposal. 
Dr. Gottesrran, Chair of the Risk Assessment Subcommittee, said she had 
polled subccrrmittee members on the issues and had collated the responses 
in order to develop a preliminary draft response to the ASPE memorandum. 
The subcommittee met by telephone conference call (tab 1223 ) on October 15, 
1984, to evaluate this preliminary draft response. Specific responses to 
the ASPE questions were also previously, discussed at the October 29, 1984, 
RAC meeting (tab 1222). 
Dr. Clowes said the Risk Assessment Subcommittee had addressed the question 
of whether the NIH Guidelines continue to be valid in light of new informa- 
tion generated in the past few years. The subcommittee agreed this informa- 
tion had been taken into consideration when the NIH Guidelines were designed 
or revised, and that certain sections of the NIH Guidelines were based on 
"worst case scenarios." The new information, thus, did not affect the 
validity of the NIH Guidelines. 
Dr. Gottesrran said the field of retrcvi rology is developing very rapidly 
and the subccrrmittee felt additional expertise should be sought to adequately 
address issues involving retroviruses. She proposed a discussion group 
with appropriate expertise be formed. The discussion group could attempt 
to "thrash out some of the issues" on retroviruses. 
[138] 
