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Federal Register / Vol. 45, No. 12 / Thursday, January 17, 1980 / Notices 
II— C. Exception to Prohibition To Permit 
Cloning of Foot-and-Mouth Desease 
Virus in E. coli K-12 
Permission is granted to clone foot- 
and-mouth disease virus in the EKlCV 
host-vector system consisting of an E. 
coli K-12 and the vector pBR322, all 
work to be done at the Plum Island 
Animal Disease Center. 
II-D. Amendment of Section I-D of the 
Guidelines 
The following text is added at the end 
of Section I-D of the Guidelines: 
“Experiments in Categories I-D-l, I-D- 
2, 1-D-3, 1-D-5, and experiments 
involving ‘wild type’ host-vector systems 
are excepted from the prohibitions, 
provided that these experiments are 
designed for risk assessment purposes 
and are conducted within the NIH high- 
containment facilities located in 
Building 41-T on the Bethesda campus 
and in Building 550 located at the 
Frederick Cancer Research Center. The 
selection of laboratory practices and 
containment equipment for such 
experiments shall be approved by 
ORDA following consultation with the 
RAC Risk-Assessment Subcommittee 
and the NIH Biosafety Committee. 
ORDA shall inform RAC members of the 
proposed risk-assessment projects at the 
same time it seeks consultation from the 
RAC Risk-Assessment Subcommittee 
and the NIH Biosafety Committee. If a 
major biohazard is determined, the 
clones will be destroyed after the 
completion of the experiment rather 
than retaining them in the high 
containment facility. Other clones that 
are non-hazardous or not of major 
hazard will be retained in the high 
containment.” 
Additional Announcement of the 
Director, NIH 
Section IV— E— 1— b— (3)— (d) of the 
Guidelines gives responsibility to the 
Director, NIH, for “authorizing, under 
procedures specified by the RAC, large- 
scale experiments (i.e., involving more 
than 10 liters of culture) for recombinant 
DNAs that are rigorously characterized 
and free of harmful sequences.” 
On December 3, 1979, the Director, 
NIH, on the recommendation of the 
Recombinant DNA Advisory Committee, 
approved a request from Genentech, 
Inc., for the large-scale culture of EKl 
host-vector systems carrying the 
chemically synthesized insulin A chain, 
insulin B chain, and the hormone 
somatostatin. The request was approved 
with the understanding that Genentech, 
Inc., has agreed to permit an observer, 
designated by NIH, to visit the facilities 
if NIH should choose to inspect the site. 
The principal investigator is Dr. Brian, 
T. Sheehan. The work is to be done, as 
stipulated in the submission by 
Genentech, Inc., in a “P2 laboratory 
housing fermentors modified and tested 
to totally contain the recombinant 
organisms until they are chemically or 
physically killed at the end of each 
fermentation * * * at the research and 
development facility at 460 Point San 
Bruno Boulevard, South San Francisco, 
California 94080.” 
Dated: January 10, 1980. 
Donald S. Fredrickson, 
Director, National Institutes of Health. 
[FR Doc. 80-1648 Filed 1-16-80; 8;45 am) 
BILLING CODE 4110-08-M 
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