Federal Register / Vol. 45, No. 147 / Tuesday. July 29, 1980 / Notices 
50527 
specific donor-recipient combinations 
falling under Section 111— B— 3 be 
published in the Federal Register for 
public comment, prior to review by the 
RAC. ' 
The RAC recommended acceptance of 
this proposal by a vote of thirteen in 
favor, none opposed, and four 
abstentions. 
I accept this recommendation. 
I-G. Proposal To Amend Section II1-C-4 
of the Guidelines 
Dr. Milton Zaitlin proposed at the 
March 6-7, 1980 RAC meeting that 
Section III— C— 4 of the Guidelines be 
amended to redefine a Pi greenhouse or 
growth chamber when certain infectious 
agents other than viruses are used as 
vectors. 
Dr. Zaitlin noted that the description 
of a Pi greenhouse or growth chamber in 
Section III-C-3, Plant Viral Host-Vector 
Systems, recommends positive air 
pressure be maintained in order to 
exclude insects which might transmit 
viruses. However, in the conditions 
considered in Section III— C— 4, i.e.. Plant 
Host-Vector Systems other than Viruses, 
the propagules themselves (spores, 
mycelia, etc.) should be contained, and 
negative air pressure would be more 
appropriate. 
He proposed that the following 
language be added at the end of Section 
III— C — 4: 
and (iii) negative air pressure should be 
employed in the greenhouse or growth 
chamber when infectious agents are used 
which generate airborne propagules. 
This proposal was published in the 
Federal Register of April 30, 1980 [45 FR 
28906]. No comments were received 
during the thirty-day comment period. 
The RAC considered this proposal at 
the June 5-6, 1980 meeting. The proposal 
was approved by a vote of fourteen in 
favor, and none opposed. 
I accept this recommendation. 
1-H. Request To Delete Language 
Requiring the Use of Cauliflower 
■Mosaic Virus (CaMV) Mutants Lacking 
the Aphid Transmission Factor From 
Section III-C-3. Request for Permission 
To Transfer DNA Fragments From 
Aphid Transmissible to Aphid 
Nontransmissible CaMV 
In a letter of January 17, 1980, Dr. 
Robert J. Shepherd of the University of 
California at Davis requested that 
paragraph four of Section III-C-3 of the 
Guidelines be deleted. This paragraph 
reads as follows: 
The CaMV strain used as a cloning vector 
shall be a mutant that lacks the aphid 
transmission factor. 
Dr. Shepherd suggested that it is 
inconsistent to restrict studies with 
cauliflower mosaic virus to non-insect 
transmissible strains when no such 
restriction is imposed on studies with 
bean golden mosaic virus and related 
viruses, the only other known group of 
DNA plant viruses. Dr. Shepherd noted 
that, under the PI containment 
conditions specified in the Guidelines, 
cauliflower mosaic virus is easily 
confined to a growth chamber or 
greenhouse. He added that CaMV has a 
very restricted host range and is neither 
seed nor pollen transmitted. 
Dr. Shepherd also requested 
permission to introduce DNA segments 
from aphid transmissible strains to non- 
aphid transmissible strains of CaMV in 
order to study the factors determining 
aphid transmissibility. 
A notice outlining Dr. Shepherd’s 
request appeared in the Federal Register 
of April 30, 1980 [45 FR 28906] for thirty 
days of public comment. 
No comments were received during 
the thirty-day comment period. 
The RAC discussed Dr. Shepherd’s 
proposal at the June 5-6, 1980 meeting. 
By a vote of ten in favor, none opposed, 
and four abstentions, the RAC 
recommended that paragraph four of 
Section III-C-3 be deleted from the 
Guidelines. By a vote of eleven in favor, 
none opposed, and three abstentions, 
the RAC recommended approval of Dr. 
Shepherd’s request for permission to 
introduce DNA segments from aphid 
transmissible strains to the genome of 
non-aphid transmissible strains of 
CaMV. 
I accept these recommendations. 
1-1. Status of Variola and Whitepox 
Viruses 
At the March 6-7, 1980 meeting of the 
RAC, the suggestion was made that any 
mention in the Guidelines of the variola 
viruses be marked with a symbol so that 
reference could be made to World 
Health Organization policy regarding 
worldwide efforts at eradicating these 
viruses. 
Accordingly, it was proposed that 
Appendix B, Classification of 
Microorganisms on the Basis of Hazard, 
be amended so that each mention of 
Alastrim, Smallpox and Whitepox will 
be marked with a symbol. With the 
concurrence of the Center for Disease 
Control, the following footnote, to be 
added to Appendix B, appeared in the 
Federal Register of April 30, 1980 [45 FR 
28908] for thirty days of comment: 
All activities, including storage of variola 
and whitepox are restricted to the single 
national facility (World Health Organization 
(WHO) Collaborating Center for Smallpox 
Research, Center for Disease Control, in 
Atlanta). 
During the thirty-day comment period, 
no comments were received. The RAC 
at its June 5-6, 1980 meeting 
recommended that the marking of any 
mention of Alastrim, Smallpox and 
Whitepox in Appendix B was 
appropriate, and approved the proposed 
language of the footnote by a vote of 
seventeen in favor, and none opposed. 
I accept this recommendation. 
/-/. Transfer of DNA Segments Cloned 
in Saccharomyces Cerevisiae Host- 
Vector Systems to Higher Plants 
Dr. Jane Setlow of Brookhaven 
National Laboratory suggested that the 
Guidelines include a general provision 
for cloning plant DNA in 
Saccharomyces cerevisiae and 
subsequently returning the cloned DNA 
to the plant. The following proposed 
amended language of the first sentence 
of Section III-C-7-b appeared in the 
Federal Register of April 30, 1980 [45 FR 
28908]: 
IlI-C-7-b. Transfer to Higher Plants. DNA 
from any nonprohibited source [Section 1-DJ 
which has been cloned and propagated in E. 
coli or S. cerevisiae under appropriate 
containment conditions, may be transferred 
with the E. coli or S. cerevisiae vector used 
for cloning to any higher plant organisms 
(Angiosperms and Gymnosperms) and 
propagated under conditions of physical 
containment comparable to PI and 
appropriate to the organism under study J2AJ. 
During the thirty-day comment period, 
no comments were received. 
The RAC discussed this proposal at 
the June 5-6, 1980 meeting. The proposal 
was accepted by a vote of twelve in 
favor, none opposed, and six 
abstentions. 
I accept this recommendation. 
The language of the Federal Register 
announcement of April 30, 1980 [45 FR 
28908] differed from the language of the 
revised Guidelines promulgated on 
January 29, 1980 [45 FR 6738]: the latter 
specify “PI conditions,” while the 
former said “appropriate containment 
conditions.” The phrase “appropriate 
containment" had been published in the 
April 30, 1980 Federal Register 
announcement as the proposal to 
include laboratory strain S. cerevisiae 
host-vector systems under Section III-O 
had not yet been considered by the RAC 
and the NIH. The latter proposal is now 
being accepted, and new language for 
Section III-O is being promulgated in 
this document. As laboratory strain S. 
cerevisiae host-vector systems will 
henceforth be included under Section 
III-O, the language stipulating Pi 
containment conditions, being more 
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