MINUTES OF MEETING - June 5-6 
35 
XXV. PROCEDURES FOR REVIEW OF REQUESTS TO GO OVER 10 LITERS (Continued) 
Dr. Gottesman presented proposed language based on committee motions on 
the procedures for review of requests to go over 10 liters in volume 
(Section II of these Minutes). She said she had sought and incorporated 
comments from Drs. Young, Goldstein and Krimsky. She read the following 
proposed language: 
"Motion to be published in the Federal Register for final consideration 
at the September 1980 RAC meeting: 
Hie following procedures should be adopted for approval of requests 
to grow greater than 10 liters of organisms containing recombinant 
DNA: 
1. RAC will determine if a given recombinant DNA-containing 
strain is in fact 'fully characterized and free of harmful 
sequences.' Such a determination shall include specifica- 
tion of a containment level (P-LS). 
2. Ihese determinations should not in any way be construed as 
RAC certification of safe laboratory procedures for indus- 
trial scale-up. Adherence to the specified containment 
conditions is the responsibility of the local IBC and 
appropriate regulatory agencies. 
While the RAC will focus its deliberation on scientific analysis and 
specification of containment (P-LS) procedures at the industrial level, 
we urge: 
1. that enforcement of these containment guidelines be included 
in any regulatory process; 
2. that inclusion of appropriate medical surveillance programs be 
seriously considered." 
Dr. Gottesman expressed hope that the RAC would agree on language for 
publication in the Federal Register. She said she had already received 
a suggestion that the words "rigorously characterized and the absence of 
harmful sequences established," be substituted for the phrase "...fully 
characterized and free of harmful sequences." 
Dr. Ahmed suggested that the language of the clause "that enforcement of 
these containment guidelines be included in any regulatory process" 
be clarified. He said "regulation" implies "enforcement." Et. Goldstein 
said the proposed language attempted to ensure that the issue would be 
dealt with properly by another agency. Dr. Baltimore objected to the 
proposal as the thinking of the RAC. He said that other Federal agencies 
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