7 
"If there is ciny (±ance that the original Class 3 agent 
can be regenerated frcam the cloned DNA, the containment 
level shall be no loMsr than that appropriate for the 
eigent itself." 
Dr. Gottesman seconded the amendment. By a vote of twenty in favor, none 
opposed, and one abstention the amendment was adopted. 
Suboption C-5-b, eliminating prior review requirements for experiments 
involving deliberate expressicxi of eukaryotic genes, was discussed by 
the RAC. No proposal was advanced to substitute sutoption C-5-a for 
subopt icxi C-5-b. 
Mr. Thornton said the next vote would occur on the perfected substitute 
motion, i.e., option C with suboptions C-l-b, C-2-a, C-3-a, C-4-b with 
the added Canpbell sentence, and C-5-b. Ey a vote of thirteen in favor, 
ei^t opposed, and no abstentions the RAC substituted this perfeoted 
motion. 
Mr. Thornton then called the vote on the motion. By a vote of thirteen in 
favor, eight opposed, and no abstentions, the RAC adopted the motion. 
V. FR0P06ED BIOSAFETY GUIDELINES FX3R MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES 
Mr. Thornton introduced Dr. Jc^ Richardson of the Centers for Disease Con- 
trol to brief the RAC on the status of the "Proposed Biosafety Guidelines 
for Miorobiological and Biomedical Laboratories." Dr. Richardson said that 
a notice soliciting public comment had been issued in the Federal Register 
in October 1980. Since that announcement, approximately 300 written 
comments were received by the NIH and the CDC. 
Most respcHises from industry and state health departments were si^jportive 
of the underlying philosophy, although some reservations were expressed 
concerning classifications of p>articular agents, or of recommended prac- 
tices at a particular containment level. Responses from academic institu- 
tions and many clinical laboratories did not support either the philosophy 
of a voluntary national guideline or the classifications of many of the 
etiological agents or some of the work practices and facility recommen- 
dations. Many of the academic institutions and some of the clinical labor- 
atories see the pjrcposed guidelines as the first step in the develcpment 
of federal regulations. Mary academic institutions are coicemed about 
possible premature iirplementations of the pxopjosed guidelines by IBCs. 
Also, ccocem has been expressed that the time provided for public comment 
is insufficient. 
In response to these concerns. Dr. Richardson said that public comments 
received after April 15 will also be considered. He said that there is no 
existing Public Health Service authority under vhich intrastate laboratory 
activities could be regulated, and that neither NIH or OX: is interested 
in assuming this task. 
[96] 
