13 
i 
The vector components would be the plaanid vectors already approved for 
HV1 Bacillus subtilis systems. The motion was adopted by a vote of 
fourteen in favor, none opposed, and two abstentions. 
XII. PROPOSED REVISION OF SUBSECTIONS OF SECTION III-C-1-e 
Dr. Bems presented the history of the proposal (tabs 920, 931/6) to revise 
Section III-C-l-e-(l )-(b) of the Guidelines. A notice appeared in the 
Federal Register of January 31, 1980, concerning proposed revision of 
Section III-C-1-e, and its subsections. It was recommended that Sections 
III-C-1-e, Ill-C-l-e-(l) , III-C-l-e-( 1 )-(a) , and III-C-l-e-(l)-(b) , of the 
Guidelines be changed and that a new Section III-C-l-e-(l)-(c) be added. 
Section III-C-l-e-( 2) would remain unchanged. The RAC, at its March 6-7, 
1980 meeting, recommended adoption of Sections III-C-1-e, Ill-C-l-e-(l) , 
and III-C-e-( 1 )-( a) as published in the Federal Register of January 31, 
1980 with certain modifications in Section III-C-l-e-(l)-(a) . The 
Director, NIH, accepted this recommendation and promulgated the following 
sections in the Federal Register of April 14, 1980: 
"III-C-1-e. All Viral Vectors. 
Ill-C-l-e-(l) . Other experiments involving eukaryotic virus 
vectors can be done as follows: 
"III-C-l-e-(l)-(a) . Recombinant ENA molecules containing no 
more than two-thirds of the genome of any eukaryotic virus [all 
viruses from a single Family (36) being considered identical 
(50)] may be propagated and maintained in cells in tissue 
culture using PI containment. For such experiments, it must 
be shown that the cells lack helper virus for the specific 
Families of defective viruses being used. The ENA may contain 
fragments of the genomes of viruses from more than one Family 
but each fragment must be less than two- thirds of a gencme." 
At the March 1980 meeting, the RAC deferred consideration of Sections III-C- 
l-e-(l)-(b) and III-C-l-e-(l)-(c) pending accumulation of additional data. 
A working group met on May 13, 1980 in Miami Beach, Florida, to discuss 
appropriate containment for experiments in which less than two-thirds of 
a eukaryotic viral genome is rescued with helper virus. The language devel- I 
oped by the working group appeared in the Federal Register of August 21, 
1980: 
"III-C-l-e-(l)-(b) . Recombinants with less than two-thirds 
of the genome of any eukaryotic virus may be rescued with 
a helper virus using P2 containment if wild type strains 
of the virus are CDC Class 1 or 2 agents, or using p 3 
containment if wild type strains of the virus are CDC 
Class 3 agents ( 1 ) . " 
[ 172 ] 
