19 
Ihis modification would delegate authority to the IBC to review proposals 
and set containment for large-scale procedures vAien certain ^ coli K-12, 
B, subtil is and cerevisiae host-vector systems are used . Large-scale pro- 
cedures employing other host-vector systems would continue to be reviewed by 
RAC and approved ty the NIH. 
Dr. McKinney said that the majority of requests for exceptions to the 10 liter 
limit have been submitted by industry. Dr. McKinney felt that industry's 
response to Part VI, Voluntary Conpliance, of the Guidelines has been respon- 
sible. He suggested that Dr. Johnson's proposal would serve to improve operat- 
ing conditions, both at the research and industrial level, and facilitate 
large-scale production utilizing ^ coli K-12, ^ subtilis or ^ cerevisiae 
host-vector systems. He moved adcption of the proposal. 
Dr. McGarrity said he had reviewed the September 2 letter sutanitted to the RAC 
by Dr. Susan Wright as well as the attached report entitled "Hazards Involved 
in the Industrial Use of Microorganisms." Hie latter report was contracted 
for by the Commission of the European Ccmmunities (CEC) to evaluate the hazards 
involved in the industrial development, production and use of microbial cells 
and their products. 
Dr. McGarrity addressed the criticisms Dr. Wright raised against Dr. Johnson's 
proposal. Dr. McGarrity agreed with Dr. Wright that the statement "the 
principle of the absence of increased risk with increased volume has been 
accepted by the RAC," as advanced by Dr. Johnson is inaccurate. He said 
Dr. Johnson draws a broader conclusion than is warranted frcm the decision 
at the June 1980 RAC Meeting to delete a sentence fron Section I-D-6. 
However, he said that since June 1980 there have been many develcpments 
which indicate a modification in RAC's view. For example, in September 
1980, RAC delegated the responsibility of reviewing physical facilities 
for large-scale experiments to the local IBCs. 
In another criticism. Dr. Wright stated "that the British Genetic Manipulation 
Advisory Group (®1AG) is to consider in late September a proposal from the 
Confederation of British Industry (CBI) to weaken the British controls for 
large-scale work should not be used to justify the Lilly proposal." She 
further stated that ". . . it is not at all clear that GMAG will take the 
'positive action' v^ich Dr. Johnson anticipates." Dr. McGarrity said he agreed 
with Dr. Wright that the RAC should not be influenced in its decisions by 
possible decisions GMAG may take. 
In other criticisms. Dr. Wright asserts "the fact that 'no unforeseen 
difficulties have been encountered' vrtien the industry has operated under con- 
trols involving prior review cannot be used to justify the claim that no 
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