26 
designed their experiments to assess the ability of the altered organisms 
to compete with resident organisms. She said she would like to see these 
data when they become available. 
Dr. Holmes responded to the request to evaluate the antibiotic resistance 
genes proposed for use as markers. He said use of some of the proposed 
antibiotic markers raises minimal concern. However, he thought rifampicin 
resistance is not widely disseminated in nature and is useful in treating 
certain human diseases. For this reason he suggested rifampicin not be 
used. Dr. Friedman said rifampicin resistance is encoded by a chromosomal 
gene, so resistance probably would not be transferred to other organisms. 
Dr. Martin moved acceptance of the proposal with exclusion of the use of 
antibiotics for emergency procedures. By a vote of nineteen in favor, 
none opposed, ard no abstentions, the motion was recommended. 
X. PROPOSED MODIFICATIONS OF SECTION III-B-5 OF THE GUIDELINES 
Dr. McKinney said the RAC Large-Scale Review Working Group, which met on 
October 26, 1982, has forwarded to RAC without comment a proposal (tabs 
1095/I/A, 1101/11) by Dr. Allan Waitz of DN\X Corporation (a wholly owned 
subsidiary of Schering-Plough Corporation) to amend Section III-B-5 of the 
NIH Guidelines. Section III-B-5 specifies that for experiments involving 
more than 10 liters of culture appropriate containment will be determined 
by the IBC. C*r. Waitz argued that greater flexibility in scale-up procedures 
would be gained if the IBC could be notified simultaneously with initiation 
of large-scale procedures involving EL_ coli K-12, Saccharomyces cerevisiae 
and Bacillus subtil is host-vector systems. Dr. Waitz suggested that Section 
III-B-5 be modified to read as follows: 
"III-B-5. Experiments Involving More than 10 Liters of Culture . 
The appropriate containment will be decided by the IBC except 
where exempted under Section III-D-5. Where appropriate, the 
large-scale containment recommendations of the NIH should be 
used (45 FR 24968)." 
Language in Appendix C, Exeirptions Under III-D-5 , would also be modified 
to reflect this change. The relevant paragraphs of Appendix C-II, C-III, 
and C-IV, which' deal with exceptions to the exemption, would be modified to 
read as follows: 
"Large-scale experiments (i.e., more than 10 liters of culture) 
require IBC notice simultaneously with the initiation of experi- 
ments where IBC-approved practices and an IBC-approved Pl-LS 
containment facility will be used. Where these conditions are 
not satisfied, refer to Part III-B-5." 
[1111 
