8 
with certain expertise. He said he objected to the language of 
Dr. Johnson's proposal. 
By a vote of thirteen in favor, two opposed, and two abstentions the RAC 
reconmended the language proposed by Ms. Cason, i.e.: 
"Members should be chosen to provide expertise in fermentation 
technology engineering and other aspects of large-scale pro- 
duction." 
VII. PROPOSED BIOSAFETY GUIDELINES FOR BIOMEDICAL LABORATORIES 
Dr. John Richardson, CDC, said the proposed guidelines (tab 915) are a 
more comprehensive listing of microorganisms than the 1974 CDC Classifi- 
cation of Etiologic Agents on the Basis of Hazard. He said the proposed 
biosafety guidelines designate four biosafety levels which correspond 
closely to the P-levels of the NIH Guidelines for Research Involving 
Recombinant ENA Molecules. The CDC guidelines propose three categories of 
laboratory activities (1) manipulation of small quantities or low 
concentrations of the agent, (2) manipulation of large quantities or 
high concentrations of the agent, and (3) manipulation of vertebrate 
animals infected with the agent. Ten thousand copies of the proposed 
biosafety guidelines will be distributed for comment. 
Dr. Bems asked Dr. Richardson to comment on the status of the CDC guide- 
lines. Et. Richardson replied that the CDC guidelines are voluntary. He 
said that the Department of Health and Human Services (HHS) does not have 
the authority to impose such guidelines as on an intrastate basis. 
VIII. PROPOSED PROCEDURES FOR REVIEW OF LARGE-SCALE APPLICATIONS (Continued) 
Dr. Krimsky returned to the concept which had been discussed previously 
(Section V) of a new RAC Subcommittee to deal with large-scale proposals. 
He would have the Subcommittee membership include RAC members as well as 
members from NIH and other agencies who have expertise in large-scale 
fermentation technology. He suggested it be indicated that approval 
for facilities does not in any way suggest that there is an enforcement 
operation. 
The question was posed whether the proposed subcommittee would review the 
physical containment aspects of individual large-scale applications after 
RAC has evaluated biological containment. Dr. Krimsky said it would; the 
RAC would review the biology of the systems, the subcommittee wstild sub- 
sequently review the physical containment, surveillance, monitoring, etc. 
It was suggested that a straw vote be taken on the concept. By a straw 
vote of eight in favor to three opposed, the RAC supported the concept. 
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