9 
Mr. Pauker pointed out that GMAG still requires some central notification 
and registration. Dr. Wright said the Q1AG guidelines generally required 
higher containment levels them the NIH Guidelines. Others said that the 
latest OtAG revision seemed to lead to generedly lower containment levels 
in the U. K. as conpared to the U. S. 
VI . PROPOSED PROCEDURES FOR MINOR MODIFICATIONS OF PREVIOUSLY APPROVED lARGE- 
SCALE REOOMBINANr ENA EXPERIMENTS 
A. Application Procedures for Minor Modifications of Previously Approved 
Large-Scale Recombinant CNA Experiments . 
Dr. Gottesnan began discussion of the proposed application procedures 
for minor modifications of previously approved large-scale recombinant 
HA experiments (tabs 965, 976/3). Dr. Gottesnan said that currently 
all large-scale experiments are reviewed by the full RAC; the proposal 
is an attenpt to develop an expedited procedure for minor modifications 
of previously approved large-scale experiments. The proposal provides 
a procedure for determining whether a modification is minor. A 
request for evaluation of a minor modification would be sent to ORDA. 
If QRDA believes it is a minor modification, the request will be 
sent to a working group ccrposed of at least two RAC members. If 
possible, these members should have participated in the review of 
the original approved. If the working group unanimously agrees that 
the modification is minor and that the diemges do not significantly 
alter the organism in a way that is likely to affect containment of 
the organism or the vector, or the nature of the expressed product 
from that presented originally to RAC, recamendaticn for ap^Jroval 
will be transmitted to ORDA. If the working group does not so find, 
the proposal would be presented to the full RAC for consideration. 
Dr. Gottesman moved acceptance of the proposed language. Dr. Bems 
seconded the notion. 
Dr. Goldstein suggested that each proposed be circulated to all RAC 
members at the time that it is sent for review to the working group. 
This would provide an opportunity for all RAC members to comment. 
He further suggested that the decision of the working group be trans- 
mitted to all RAC members. Dr. Gottesman suggested instead that a 
summary of minor modifications epproved between meetings using the 
minor modification working group procedure be provided to RAC at 
each RAC meeting. Dr. Goldstein accepted this proposed, and it was 
agreed that CRDA would provide such a sumnary. 
Dr. Leibowitr of Schering-Plough Corporation suggested that certain 
minor modifications of previously approved large-sc£de experiments 
using ^ ooli K-12 host-vector systems might be approved by the 
local IBC. Dr. Gottesnan said she preferred the minor modification 
( 37 ) 
