Federal Register / Vol. 47. No. 167 / Friday, August 27, 1982 / Notices 
38043 
“responsibilities need not be restricted 
to recombinant DNA," 
(2) in Section lV-B-2-a, the 
requirement was deleted that 20 percent 
of the IBC membership not be affiliated 
with the institution (although the 
requirement was retained that at least 2 
IBC members not be affiliated with the 
institution] and 
(3) in Section IV-B-2-b, language 
recommending that “at least one 
member be a nondoctoral person from a 
laboratory technical staff was modified 
to read “at least one member be from 
the laboratory technical staff.” 
Dr. Berns commented on the proposal 
to delete the word “nondoctoral". He 
said some members of the working 
group felt a “nondoctoral" technician 
with actual “hand-on" experience was 
most appropriate for this "slot" on the 
IBC. Others members felt that anyone 
who had “hand on” experience and who 
was not a principal investigator 
(including technician, research associate 
or post-doctoral fellow) was an 
appropriate representative of the 
laboratory technical staff. Following 
much discussion, the term “nondoctoral” 
had been deleted from the proposed 
revised Guidelines by the working 
group. 
Dr. Ahmed questioned why the 
requirement was deleted that 20 percent 
of the IBC membership by non-affiliated 
with the Institution. Dr. Bems offered 
the example of an IBC just fulfilling the 
20 percent specification, but wishing to 
add an additional specialist affiliated 
with the university. 
When this specialist was appointed, 
non-affiliated representation would fall 
below 20 percent, and the university 
would have to appoint another non- 
affiliated member. Dr. Bems said the 
working group felt the percentage of 
non-affiliated members was not critical 
as long as two non-affiliated members 
were present on the IBC. Dr. Ahmed 
pointed out that on an IBC composed of 
20 members, with 2 non-affiliated 
members, non-affiliated representation 
would 6e 10 percent, or half of the non- 
affiliated composition mandated under 
the current Guidelines. He said the 
failure to maintain this requirement 
troubled him. Dr. Mason point out that a 
five-membered IBC would have at least 
40 percent of its membership non- 
affiliated. Dr. McKinney said he 
believed that the institution, which 
appoints members to the IBC, will 
respond to the intent of the Guidelines 
and appoint IBCs of an appropriate 
composition. 
Moving to the next section. Dr. 
Nightingale called the attention of the 
RAC to Section IV-B-2-f. Section IV-B- 
2-f reads: 
Institutions are encouraged to open IBC 
meetings to the public whenever possible, 
consistent with protection of privacy and 
proprietary interests. 
Dr. Nightingale said no modifications 
were suggested for this section, but 
noted that one member of the working 
group, Ms. King, felt the issue of open 
meetings should be evaluated at some 
point in the future, and that open 
meetings probably should eventually be 
required. 
Dr. Nightingale finally noted the 
addition of proposed language to 
Section IV-D-4. The proposed language 
reads: 
Note. — Other Federal agencies which have 
adopted the NIH Guidelines may have the 
authority to terminate funding to their 
grantees should these grantees not comply 
with the NIH Guidelines. 
She felt this statement is not sufficient 
and that the section should be expanded 
to include a description of the Federal 
Interagency Advisory Committee on 
Recombinant DNA Research and of its 
membership. Dr. Goldstein felt that 
some description of the Interagency 
Committee, particularly a statement that 
its members have agreed to abide by the 
NIH Guidelines, would be desirable. Dr. 
Gottesman suggested that an Appendix, 
describing the Interagency Committee, 
its agency members, and a statement 
that these agencies have agreed to abide 
by the Gui^lines, be added to the 
Guidelines. References would be made 
to this new Appendix at (1) Section IV- 
C-l-a-(4) which describes the Director’s 
responsibility for maintaining this 
committee, and (2) under Section IV-D-4 
in place of the “Note.” Dr. Ahmed 
suggested the proposed Appendix 
should also describe how the 
Interagency Committee was formed, 
who it reports to, and what 
responsibilities member agencies have 
assumed with respect to the NIH 
Guidelines. Dr. Ahmed agreed to accept 
this amendment, as did Dr. Bems. 
Dr. Goldstein said he still had 
concerns on the potential use of 
recombinant DNA technology for 
biological warfare. He-noted that the 
Department of Defense (DoD) is a 
member of the Interagency Committee. 
He said that earlier in the meeting RAC 
heard of classified research conducted 
by DoD. However, several questions on 
this research had not been answered to 
Dr. Goldstein's satisfaction by the DoD 
representative. Dr. McCullough said that 
many DoD biomedical research projects 
are unclassified, but there are projects 
in defensive biological warfare 
techniques and processes that are 
classified. These projects might include 
aerosol detection devices, antibody 
identification devices, or air sampling 
processes. These are not weapons. Dr. 
Goldstein asked if the motion made 
earlier in the meeting concerning the use 
of recombinant DNA technology for 
biological warfare might be 
reconsidered. Dr. Ahmed seconded. By a 
vote of flve in favor, thirteen opposed, 
and no abstentions the RAC, however, 
refused to reconsider the earlier motion. 
Mr. Thorton called the attention of the 
RAC to Part D of tab 1072 which 
includes certain sections of the current 
Guidelines which the working group 
suggested deleting but which NIH staff 
felt should be retained. He said the 
version which Dr. Ahmed had moved 
includes these sections. If any member 
does not approve of the retention of any 
section, a specific motion to delete 
should be made. The sections to be 
retained are: (1) Section I-D-5 of Section 
I-D, General Definitions, which defines 
“Director, NIH,” (2) Section IV-B-5-b 
and its subsections of IV-B-5, Principal 
Investigator, which deals with 
submissions by the principal 
investigator to the NIH, (3) Section IV- 
C-l-b-(l)-(®) Section IV-C-l-b- 
(IHb) of Section IV-C-l-b, Specific 
Responsibilities of the Director, and (4) 
Section rV-C-l-b^2) and its 
subsections which detail certain lesser 
actions which are the responsibility of 
the Director. No motion to delete any of 
these sections was made. 
Dr. Brill returned to the issue of the 
classification of Klebsiella as a Class 2 
agent in Appendix B. He suggested that 
the language in Appendix B which reads 
“Klebsiella — all species and all 
serotypes” be modiHed to read 
"Klebsiella — all strains known to 
originate from human and animal 
sources.” Dr. Gottesman asked vvhat an 
investigator would assume if he did not 
know the source of a strain. Dr. Brill 
replied that an investigator would 
assume that particular Klebsiella strain 
was a Class 1 agent. Dr. Gottesman 
pointed out that no new restrictions 
were being imposed on investigators 
working with Klebsiella by the proposed 
revised Guidelines. She questioned the 
appropriateness of modifying this 
language at this RAC meeting without 
data sufficient to formulate a reasonable 
motion. She felt a working group could 
examine the issue in greater detail. Dr. 
Ahmed agreed the issue should be 
referred to a working group; he felt 
insufficient information was available at 
the moment. Dr. McKiimey said the 
Classification of Etiologic Agents states 
that “human etiologic agents” have been 
classified. Presumably, those strains of 
Klebsiella classified in proposed 
Appendix B are only the human 
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