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Federal Register / Vol. 45, No. 147 / Tuesday, July 29, 1980 / Notices 
During the thirty-day comment period, 
no comments were received. The RAC 
discussed this issue at the June 5-6, 1980 
meeting. It was suggested that the 
wording "beyond that which occurs by 
natural genetic exchange” in Section I-E 
should be added to Section III and 
Section IV-E-l-b-2-e following the 
clause “* * * which increases the 
virulence and host range of a plant 
pathogen." In addition, it was suggested 
that the language of Section IV-E-l-b- 
2-e shoud be clarified by addition of the 
phrase “assigning containment levels,” 
A modified Section IV-E-l-b-2-e would 
read: 
IV-E-l-b-2-e. Assigning containment 
levels for experiments with recombinant 
DNA horn Class 3 'organisms [1] and 
assigning containment levels for experiments 
which increase the host range and virulence 
of plant pathogens beyond that which occurs 
by natural genetic exchange. 
With these modifications, the RAC 
accepted the proposals by a vote of 
fourteen in favor, none opposed, and 
three abstentions. 
I accept these recommendations. 
I-D. Proposal To Amend Section I-D-6 
fo the Guidelines 
In a letter of April 10, 1980, Dr. Irving 
Johnson of Lilly Research Laboratories 
proposed, among other changes, that 
Section I-D-6 of the Guidelines should 
be amended. The proposal would delete 
the second paragraph of Section I-D-6, 
which reads as follows: 
We differentiate between small- and large- 
scale experiments jvith organisms containing 
recombinant DN As because the probability 
of escape from containment barriers normally 
increases with increasing scale. 
The proposal was published for thirty 
days of comment in die Federal Register 
of April 30, 1980 [45 FR 28908]. 
No comments concerning this 
proposal were received during the 
thirty-day comment period. 
The RAC discussed this proposal at 
the June 5-6, 1980 meeting. It was 
pointed out that the probability of 
escape does not necessarily increase 
with increasing scale. The RAC noted 
that the paragraph constitutes prefatory 
language and that its deletion would not 
change the containment standards of the 
Guidelines. 
By a vote of fourteen in favor, one 
opposed, and one abstention, the RAC 
recommended that the second 
paragraph of Section I-D-6 of the 
Guidelines be deleted. 
I accept this recommendation. 
I-E. Proposal To Amend Portions of 
Section III-A-2-a, Viruses of 
Eukaryotes 
In the 1980 Guidelines a level of 
biological containment requiring the use 
of an "HVl host and a vector certified 
for use in an HV2 system” was 
substituted for “an EKl host and a 
vector certified for use in an EK2 
system.” This level of biological 
containment is abbreviated as “HVlCV” 
in Tabe III and Footnote 40 of the 1980 
Guidelines. At the December 6-7, 1979 
meeting of the RAC, a working group 
was appointed to review the 
appropriateness of this level of 
biological containment. The working 
group proposed that HV2 biological 
containment be required for these 
experiments. Accordingly, a proposal to 
amend portions of Sections III-A-2-a, 
Viruses of Eukaryotes, was published in 
the Federal Register of January 31, 1980 
[45 FR 7182], 
The RAC discussed this proposal at 
the March 6-7, 1980 meeting. During the 
discussion, the RAC agreed that the 
“CV" nomenclature, developed for EK 
host-vector systems, did not seem 
appropriate for HV systems in general. 
However, the RAC felt that requiring the 
use of HV2 systems instead of HVlCV 
imposed an unnecessarily stringent level 
of containment. The RAC voted to 
publish for comment in the Federal 
Register a proposal to sustitute HVl for 
HVlCV in all places in the Guidelines. 
The proposal as published in the 
Federal Register of April 30, 1980 reads 
as follows: 
Substitute the term “an HVl host-vector" 
for “an HVl host and a vector certified for 
use in an HV2 system" in Section III-A-2-a- 
(lHa)-(3)-{b) and substitute the term “an 
HVl host-vector" for “an HVl host and a 
vector certified for use in an HV2 system, or 
P3 + HVl,” in Sections III-A-2-a-(l)-(aH2)- 
(c), III-A-2-a-{l)-{bHlHb), III-A-2-a-(l)- 
(b) — ( 2 ) — (b), III-A-2-a-{2)-{aHl)-(b), HI-A-2- 
a-(2HaH2)-{b), and III-A-2-a-(2)-(c}-{2)- 
(b). In Table III, whenever any one of the 
following three terms appears, (“HVlCV 
[40],” “HVlCV[40] or P3 + HVl," or 
“HV1CV[40] or P3 + HVl[38]") it would be 
changed to “HVl”. 
No comments were received during 
the thirty-day comment period. The RAC 
at its June 5-6, 1980 meeting, once again 
examined this issue. A motion ,to table 
failed by a vote of two in favor, nine 
opposed, and three abstentions. By a 
vote of nine in favor, and five opposed, 
the RAC accepted these proposed 
changes as published in the Federal 
Register. 
I accept this recommendation. 
I-F. Proposal To Amend Section III-B-3 
of the Guidelines 
Dr. Allan Campbell of Stanford 
University proposed the the RAC 
consider amending Section III-B-3 of the 
Guidelines , which currently read as 
follows: 
III- B-3. Non-HVl systems. Containment 
levels for other classes of experiments 
involving non HVl systems may be approved 
by the Director, NIH. [See Sections IV-E-1- 
b-(l)-(b), IV-E-l-b-(2)-(c), and IV-E-l-b- 
(3)— (b)]. 
In those cases where genetic exchange has 
not been demonstrated between two 
bacterial species A and B, neither of which is 
known to be pathogenic for man, animals or 
plants, recombinant DNA experiments 
involving only A and B can be conducted 
under P3 Containment. (2A) 
Dr. Campbell stated that the P3 
containment level was assigned to this 
type of experiment because of 
apprehensions that the category might 
contain some experiments for which 
that level was appropriate, rather than 
that all experiments in this category 
were perceived as requiring P3 
containment. He proposed amending 
this section to "assert RAC’s intention to 
review individual proposals in an open- 
minded manner with respect to realistic 
evaluation of possible hazard, and to 
discourage the inference that the P3 
level, as it applies to a specific 
experiment, has been set on the basis of 
information about the organisms 
involved." 
Dr. Campbell’s proposed changes in 
the Guidelines were published in the 
Federal Register of April 30, 1980 [45 FR 
28906] for thirty days of public comment, 
as follows: 
A. Section III-B-3, paragraph 2, would be 
amended to read: 
In those cases where genetic exchange has 
not been demonstrated between two 
bacterial species A and B, neither of which is 
known to be pathogenic for man, animals or 
plants, recombinant DNA experiments 
involving only A and B can be conducted . 
under P3 containment [2A]. Lower levels of 
physical containment may be assigned by 
NIH for specific donor-receipient 
combinations (See Section IV-E-l-b-2-(f). 
B. A new Section IV-E-l-b-2-(f] would be 
added to the Guidelines as follows: 
IV- E-l-b-2-{f). Assigning containment 
levels for experiments in which both donor 
and recipient are non-pathogenic prokaryotes 
(See Section III-B-3). 
No comments were received during 
the thirty-day comment period. The RAC 
discussed this issue at the June 5-6, 1980 
meeting. During the discussion, Dr. 
Campbell said that the term “non- 
pathogenic" refers to CDC Class 1 
etiological agents. It was noted that the 
proposal simplifies procedures by 
removing the requirement that proposals 
to lower physical containment levels for 
[143] 
