Federal Register / Vol. 50, No. 226 / Friday, November 22, 1985 / Notices 
48349 
none opposed, and no abstentions. Dr. 
Talbot’s proposal was again considered 
by the RAC at the September 23, 1985, 
meeting. By a vote of seventeen in favor, 
none opposed, and no abstentions, the 
RAC recommended the NIH accept this 
proposal. I accept this recommendation 
and Section III— A has been modified. 
II. Summary of Actions 
A. Amendment of Section F-IV-H of the 
N1H Guidelines 
Appendix F-IV-H has been modified 
to read as follows: 
"Appendix F-IV-H. The intact 
structural gcne(s) of the Shiga-like toxin 
from bacterial species classified in the 
families Enlerobacteriaceae or 
Vibronaceoe including Campylobacter 
species may be cloned in E. coli K-12 
under BL3 + EK1 containment 
conditions. 
"£■. coli host-vector systems 
expressing the Shiga-like toxin gene 
product may be moved from BL3 + EK1 
to BL2 + EKl containment conditions 
provided that: (1) the amount of toxin 
produced by the modified host-vector 
systems be no greater than that 
produced by the positive control strain 
Shigella dysenteriae 60R, grown, and 
measured under optimal conditions: and 
(2) the cloning vehicle is to be an EKl 
vector preferably belonging to the class 
of poorly mobilizable plasmids such as 
pBR322. pBR328, and pBR325. 
"Nontoxinogenic fragments of the 
Shiga-like toxin structural gene(s) may 
be moved from BI.3 -t- EKl to BL2'+ EKl 
containment conditions or such nontoxic 
fragments may be directly cloned in E. 
coli K-12 under BL2 + EK1 conditions 
provided that the E. coli host-vector 
systems containing the fragments do not 
contain overlapping fragments which 
together would encompass the Shiga- 
like toxin structural gene(s)." 
B. Addition of a New Appendix F-IV-K 
to the NIH Guidelines 
A new Appendix F-IV-K is added to 
the NIH Guidelines as follows: 
"A hybrid gene in which the gene 
coding for interleukin 2 fIL— 2) is joined 
to a specified segment of the gene 
encoding diphtheria toxin may be 
propagated in E. coli K-12 host-vector 
systems under BL2 containment plus 
BL3 practices, with the use of poorly 
mobilizable plasmid vectors such as EK2 
certified plasmids." 
C. Amendment of Appendix C-III of the 
NIH Guidelines 
The first paragraph of Appendix C— III 
is amended to read as follows: 
"Experiments which use 
Saccharomyces cerevisiae host-vector 
systems, with the exception of 
experiments listed below, are exempt 
from these Guidelines." 
A new second paragraph is added to 
Appendix C-III to read as follows: 
"Experiments which use 
Saccharomyces u varum host-vector 
systems, with the exception of 
experiments listed below, are exempt 
from these Guidelines." 
D. Modification of Section Ill-A of the 
NIH Guidelines 
A new sentence is added to the end of 
Section III— A of the NIH Guidelines 
("Experiments that Require RAC Review 
and NIH and IBC Approval Before 
Initiation") just before Section III— A— 1 of 
the NIH Guidelines as follows: 
“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 from the other 
Federal Agency." 
Dated: November 12, 1985. 
)ames B. VVyngaarden, M.D., 
Director, National Institutes of Health. 
| FR Doc. 85-27880 Filed 11-21-85; 8:45 am) 
BILLING COOE 4K0-01-M 
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