22 
XVIII. PROTOCOL REQUIRING ASSIGNMENT OF CONTAINMENT LEVELS 
Dr. Brill introduced a request (tab 941) from Dr. Dean Taylor of Shiith 
Kline and French Laboratories. Dr. Taylor proposed to transform proto- 
plasts of Streptosporangium with a plasmid vector constructed to contain 
(1) the E\ coli plasmid pBR322, (2) a Streptosporangium plasmid, pSgB-1, 
(3) an antibiotic resistance determinant from Streptomyces species or 
HV1 approved Bacillus subtil is cloning vectors, and (4) flanking sequences 
from the Streptomyces plasmid vector from which the determinant is isolated. 
A letter from the CDC stating that the species may reasonably be treated 
as a Class 1 agent had been appended to Dr. Taylor's request. 
Or. Brill moved approval at P2 physical containment. Dr. Scandal ios 
seconded the motion. By a vote of seventeen in favor, none opposed, and 
one abstention, the RAC adopted the proposal. 
XIX. PROPOSED AMENDMENT OF SECTION IV-E-2 
Mr. Thornton then called the attention of the RAC to part two of a proposal 
(tabs 918, 931/11/B) from Dr. Irving Johnson, Eli Lilly and Company, to 
add a new Section IV-E-2-b to the Guidelines as follows: 
"A permanent subcommittee of the RAC shall be responsible for 
advising the Director, NIH, on the actions, listed in Sec- 
tion IV-E-l-b-(3)-(d) pertaining to large-scale applications. 
Submissions that are in compliance with the Guidelines may be 
recommended by the subcommittee to the Director of NIH for 
approval. The subcommittee shall also be authorized to consider 
preliminary plans for large-scale operations and to recommend 
approval contingent upon completion of the large-scale facility 
according to those plans. The subcommittee will be responsible 
for expeditiously processing applications." 
Ms. Cason noted that earlier in the meeting (Section XVI) the RAC had 
voted to establish a large-scale review subcommittee. She moved to 
table discussion of this proposal. By a vote of fourteen in favor, 
three opposed , the RAC agreed to table further discussion of the proposal. 
XX. MINOR MODIFICATIONS OF LARGE-SCALE PROTOCOLS 
Dr. Gottesman said that at the last meeting the Working Group on Large- 
Scale Procedures had presented a proposal for dealing with minor modifi- 
cations of previously approved large-scale protocols. She said objections 
to aspects of the proposal had been raised, and the RAC had voted" to 
defer further discussion until this meeting. She felt any proposal 
should address the following issues: 
[ 181 ] 
