29 
"VII-B-3. Sample collection from a closed system, the addition 
of materials to a closed system and the transfer of culture 
fluids frcm one closed system to another shall be done in a 
manner which prevents the release of aerosols or contamination 
of exposed surfaces." 
Dr. Waitz suggested that the word "minimizes" be substituted for the word 
"prevents." He suggested that the word "prevents" implies an absolute 
condition which at the Pl-LS level is neither realistic nor necessary. 
Dr. Waitz said the Schering Corporation IBC interprets "prevents" in an 
absolute sense. Mr. r\jth said the Eli Lilly and Cfcmpany IBC also tends to 
be conservative in interpretation. Dr. Harvin pointed out that the word 
"minimize" is open to a great deal of interpretation. 
Dr. McKinney said the Large-Scale Review Working Group did not discuss this 
proposal at its meeting on October 26, 1982. Dr. McKinney said he was not 
prepared to discuss the difference between the word "prevents" and the word 
"minimizes." He thought the word "prevents" is permissive, and suggested 
the current wording is adequate . 
Dr. Gottesman asked if procedures would change if the word "minimizes" was 
substituted for "prevents." Dr. Waitz said he did not believe procedures 
would be markedly different. 
Dr. Martin moved that the word "minimize" be substituted for the word 
"prevents" in Section VII-B-3. Dr. Daloz seconded the motion. 
By a vote of ten in favor, four opposed, and four abstentions, the RAC 
recommended the motion. 
XIV. PROPOSED INCORPORATION INTO GUIDELINES OF PHYSICAL CONTAINMENT RECOMMENDATIONS 
FOR LARGE-SCALE USES OF ORGANISMS CONTAINING RECOMBINANT DNA MOLECULES. 
Dr. Nightingale introduced the proposal (tabs 1096, 1101/lV, 1110, 
1095/l/R) of Dr. Allan Waitz to incorporate the Physical Containment 
Recommendations for Targe-Scale Uses of Organisms Containing Recombinant 
DNA Molecules into the Guidelines as a new appendix. 
Dr. Niqhtingale said Dr. Waitz believes such an action would pro/ide a 
more efficient mechanism for further comment or change to the Recommenda- 
tions. Dr. Waitz also expressed concern that failure to take such action 
may leave a perceived gap in the overall regulatory scheme thereby encourag- 
ing the development of conflicting regulatory requirements. He thought 
this action would aid the IBCs by organizing all necessary specifications 
in one document . 
Dr. Nightingale said the Large-Scale Review Working Group, which met on 
October 26, 1982, forwarded this proposal to the Working Group on Revision 
of the Guidelines without comment. 
ni4] 
