5 
IV. MEETING OF INSTITUTIONAL BIOSAFETY COMMITTEE (IBC) CHAIRPERSONS AND IBC 
SURVEY 
Dr. Krause, the Director of the National Institute of Allergy and Infectious 
Diseases (NIAID) , said that the NIH sponsored an IBC chairperson meeting 
approximately two years ago. He said NIAID now vrould sponsor a second IBC 
chairperson meeting on November 24-25, 1980. Dr. Krimsky and several 
IBC Chairmen are on the Planning Committee. Dr. Nutter said the November 
1980 meeting would serve two purposes: (1) it will permit IBC chairpersons 
to meet and attempt to resolve common problems, and (2) it is viewed as 
the first stage in a formal evaluation process. He invited RAC members to 
attend. He then reviewed the format of the meeting; a plenary introductory 
session the first morning, will be followed by three separate workshops 
that afternoon. The workshops deal with (1) the IBC as a means of imple- 
menting institutional oversight, (2) health surveillance, monitoring and 
certification, and (3) procedures and operations. A second plenary session 
dealing with workshop reports is planned for the second morning. Ibis 
session will be followed by a plenary session dealing with other federal 
regulations and guidelines impacting on biomedical science. 
Dr. Nutter noted that a Request for Proposals (RFP) is being developed to 
evaluate all IBCs. Based on the results of the November 24-25 meeting, 
the RFP may be reviewed. Dr. Gottesman noted that Dr. Dutton's survey 
evaluated public participation in an IBC operation. She said a second 
important question is the effectiveness of the IBC in assuring compliance 
with the containment levels of the Guidelines. 
V. PROPOSED PROCEDURES FOR REVIEW OF LARGE-SCALE APPLICATIONS 
Dr. Logan of OS HA distributed copies of a September 24, 1980 letter from 
Dr. Bingham to Dr. Fredrickson (Attachment III). Dr. Gottesman reviewed 
the background of the proposal for revised procedures for review of large- 
scale applications. She noted that at the past few RAC meetings, there 
has been extensive discussion of the role of RAC and of the NIH in the 
review of large-scale proposals particularly submitted by industrial 
concerns. She moved approval of the following proposal which had been 
published in the Federal Register (tab 931/7) of August 21, 1980 for 
ccmment: 
"The following procedures should be adopted for approval of requests 
to grow greater than 10 liters of organisms containing recombinant 
ENA. The RAC will determine if a given recombinant ENA-containing 
strain is rigorously characterized and the absence of harmful 
sequences established. Such a determination shall include specifi- 
cation of a containment level (P-LS). These determinations should 
not in any way be construed as RAC certification of safe laboratory 
procedures for industrial scale-up. Adherence to the specified 
containment conditions is the responsibility of the local IBC." 
[164] 
