28 
Dr. McKinney moved that the RAC accept the language proposed by the RAC 
Large-Scale Review Working Group. Hr. Martin seconded the motion. 
By a vote of nineteen in favor, none opposed, and no abstentions, the RAC 
recommended the motion. 
XII. PROPOSED MODIFICATION OF SECTIONS VII-B-1, VII-C-1, and VII-D-1 OF THE 
PHYSICAL CONTAINMENT RECOMMENDATIONS 
Dr. McKinney introduced the proposal (tabs 1095/II/B, 1101/III/B, 1104) 
of Dr. Allan Waitz to revise Sections VII-B-1, VII-C-1 and VII-D-1 of the 
Physical Containment Recommendations for Large-Scale Uses of Organisms 
Containing Recombinant DNA Molecules. The current language specifies that 
cultures of viable organisms containing recombinant CNA molecules shall be 
handled in closed systems which are designed to reduce the potential for 
escape (Section VII-B-1) or prevent (Sections VII-C-1 and Section VII-D-1) 
escape of viable organisms. 
Dr. Waitz suggested the first sentence in Sections VII-B-1, VII-C-1, and 
VII-D-1 should be modified to read as follows: 
"Cultures of viable organisms containing recombinant CNA 
molecules shall be handled in a closed system used for 
the propagation, growth and processing of cultures, other 
primary containment equipment, or other appropriate method 
of containment approved by the IBC, which is designed to 
reduce the potential for escape of viable organisms...." 
The Large-Scale Review Working Group, at its meeting on October 26, 1982, 
pointed out that a closed primary system is one frem which there is no 
release of organisms into the environment or work place; a primary system 
could be defined as a fermentor attached to several pieces of processing 
equipment. The working group agreed that the language as currently written 
is purposely flexible while at the same time conveying the intent; they, 
therefore, recommended against accepting this proposal. 
Dr. McKinney said he felt the current language is adequate. No motion was 
offered and the discussion ended. 
XIII. PROPOSED MODIFICATION OF SECTION VII-B-3 OF THE PHYSICAL COOTAINMENT GUIDELINES 
The proposal (tabs 1095/II/C, 1101/III/C) of Or. Allan Waitz to modify 
Section VII-B-3 of the Physical Containment Guidelines for Large-Scale Uses 
of Organisms Containing Recombinant DNA Molecules was introduced by 
Dr. McKinney. Section VII-B-3 reads as follows: 
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