21 
'If experiments in this category are submitted for review to another 
Federal agency, the submitter shall notify ORDA; ORDA may then 
determine that such review serves the same purpose, and based on 
that determination, notify the submitter that no RAC review will 
take place, no NIH approval is necessary, and the experiment may 
proceed upon approval fran the other Federal Agency. ' " 
Dr. Johnson said this proposal had originally been discussed by RAC at the 
May 3, 1985, meeting, and tabled. Dr. Talbot said Dr. Miller of the FDA 
had informed RAC at the May 3, 1985, meeting that he would submit for the 
September 23, 1985, RAC meeting a proposal requiring, rather than only 
permitting, NIH to defer to other agencies in such cases. Dr. Miller has 
not submitted such a proposal. Dr. Lardy said the only reason RAC tabled 
Dr. Talbot's proposal at the last meeting was because it anticipated 
receiving an EDA proposal and preferred to evaluate both proposals at the 
same time. 
Dr. Pramer said it was very inport ant to act on Dr. Talbot's proposal in 
light of the earlier presentation by Dr. Healy. 
Dr. Davis asked if a codicil could be added to Dr. Talbot's proposal 
suggesting that other agencies could defer to RAC. Dr. Talbot said it 
would not be appropriate to put such a statement in the NIH Guidelines, 
but it could be suggested informally to other agencies. 
Dr. Clarence Styron of Monsanto Company asked whether Dr. Talbot's proposal 
would affect IBCs. Dr. Talbot said Institutional Biosafety Committees 
would retain their functions; they would not defer to other agencies. 
Dr. Walters moved RAC accept the proposal offered by Dr. Talbot. Dr. Rapp 
seconded the motion. 
By a vote of seventeen in favor, none opposed, and no abstentions, the RAC 
accepted Dr. Talbot's proposal. 
VII. REQUEST TO CLONE SHIGA-LIKE TOXIN FROM ENTEROBACTERIACEAE AND VIBRIONACEAE 
Dr. Gottesman recounted the history of the proposal (tabs 1229, 1235/1, 
1236, 1238) to clone the Shiga-like toxin from Enterobacteriaceae and 
Vibrionaceae . Dr. Alison O'Brien of the Uniformed Services University of 
the Health Sciences had previously (49 FR 36052) received permission from 
NIH to clone the structural gene of the Shiga-like toxin (SLT) of Escherichia 
ooli in EL_ ooli K-12. The conditions under which the gene may be cloned 
are described in Appendix F-IV-H of the NIH Guidelines as follows: 
"The intact structural gene(s) of the Shiga-like toxin from EL coli may 
be cloned in E. coli K-12 under BL3 + EX1 containment conditions. 
[403] 
