Federal Register / VoL 47, No. 102 / Wednesday, May 26, 1982 J Notices 
23113 
vectors under conditions which permit a 
productive infection. 
"In such cases, serious consideration 
should be given to raising the physical 
containment by at least one level.” 
k. Mention of the CDC would be 
deleted in Sections III-B-3-a, III-B-3-b, 
and III-B-3-C. 
l. Section III-B-3-c would be modified 
to delete any mention of Class 5 agents 
as follows: 
"in-B-3-c. Experiments involving the 
use of infectious Class 4 viruses [1], or 
defective Class 4 viruses in the presence 
of helper virus, may be carried out under 
P4 containment." 
m. A new Section IIl-B-3-d would be 
added as follows: 
"III-B-3-d. Experiments involving the 
use of infectious Class 5 [1] viruses, or 
defective Class 5 viruses in the presence 
of helper virus will be determined on a 
case-by-case basis following ORDA 
review. A USDA permit is required for 
work with Class 5 pathogens [18,20]." 
n. Section JII-B-4-a would be 
modified to read as follows; 
'‘III-B-4-a. DNA from any source 
except for greater than two-thirds of a 
eukaryotic viral genome may be 
transferred to any non-human 
vertebrate organism and propagated 
under conditions of physical 
containment comparable to PI and 
appropriate to the organism under study 
[2]. It is important that the investigator 
demonstrate that the fraction of the viral 
gename being utilized does not lead to 
productive infection.” 
4. Section IV. Roles and 
Responsibilities. 
a. In the second paragraph of Section 
rV-A, Policy, the responsibility of the 
Institution would be emphasized by 
italicizing pertinent language, i.e.: 
“The Guidelines are intended to help 
the Institution, the Institutional 
Biosafety Committee [IBC], the 
Biological Safety Officer, and the 
Principal Investigator determine the 
safeguards that should be inplemented. 
These Guidelines will never be complete 
or final, since all conceivable 
experiments involving recombinant 
DNA cannot be foreseen. Therefore, it is 
the responsibility of the Institution and 
those associated with it to adhere to the 
purpose of the Guidelines as well as to 
specifics. " 
b. Section IV-D, Responsibilities of 
the Institution, would be renumbered to 
become Section IV-B. 
c. The language of Section IV-D-2, 
Membership and Procedures of the IBC, 
would be remunbered and modified to 
read as follows: 
“IV-B-2. Membership and Procedures 
of the IBC. The institution shall 
establish an Institutional Biosafety 
Committee (IBCJ whose responsibilities 
need not be restricted to recombinant 
DNA. The committee shall meet the 
following requirements * * *" 
d. The requirement specifying that 
20% of the IBC membership be non- 
affiliated with the Institution would be 
eliminated. Section IV-D-2-a would be 
renumbered and modified to read as 
follows: 
"IV-B-2-a. The IBC shall comprise no 
fewer than five members so selected 
that they collectively have experience 
and expertise in recombinant DNA 
technology and the -capability to assess 
the safety of recombanant DNA research 
experiments and any potential risk to 
public health or the environment. At 
least two members shall not be 
affiliated with the Institution [apart from 
their membership on the IBC) and shall 
represent the interest of the surrounding 
community with respect to health and 
protection of the environment. Members 
meet this reqiurement if, for example, 
they are officials of State or local public 
health or environmental protection 
agencies, members of other local 
governmental bodies, or persons active 
m medical, occupational health, or 
environmental concerns in the 
community. The Biological Safety 
Officer (BSOJ, mandatory when 
research is being conducted at the P3 
and P4 levels, shall be a member (See 
Section IV-B-4.)" 
e. The language of Section IV-D-2-b 
on professional ccHnpetence and the 
specification on laboratory staff would 
be renumbered and modified to read as 
follows: 
‘TV-B-2-b. In order to ensure the 
competence necessary to review 
recombinant DNA activities, it is 
recommended that (i) the IBC include 
persons with expertise in recombinant 
DNA technology, biological safety, and 
physical containment; (n) the IBC 
include, or have available as 
consultants, persons knowledgeable in 
institutional commitments ans policies, 
applicable law, standards of 
professional conduct and practice, 
community attitudes, and the 
environment; and (iii) at least one 
member be from the laboratory 
technical staff." 
f. Section IV-D-2-e would be 
renumbered and modified to read as 
follows; 
‘TV-B-2-e. The Institution, who is 
ultimately responsible for the 
effectiveness of the IBC, may establish 
procedures that the IBC will follow in its 
initial and continuing review of 
applications, proposals, and activities. 
(IK review procedures are specified in 
Section IV-B-3-a.)" 
g. Section IV-D-2-f would be deleted. 
Section IV-D-2-f currently reads as 
follows: 
“IV-D-2-f. Central to implementation 
of the Guidehnes is the review of 
experiments by the fflC." 
h. Section IV-D-2-h would be 
renumbered and modified to read as 
follows: 
‘TV-B-2-g. Upon request, the 
Institution shall make available to the 
public all minutes of IBC meetings and 
any documents submitted to or received 
from funding agencies which the latter 
are required to make available to the 
public. If comments are made by 
members of the public on IBC actions, 
the Institution shall forward to MH both 
the comments and IBC's response.” 
i. Two new specifications would be 
added to Section IV-D-3 (renumbered 
IV-B-3), Functions of the IBC, as 
follows: 
"1V-B-3-C. Lowering containment 
levels for certain experiments as 
specified in Sections III-B-2. IV-B- 3-d. 
Setting containment levels as specified 
in III-B-4-b and III-B-5.” 
The Section would be renumbered to 
reflect these additionB. 
j. A new Section under IV-D-5-a 
(renumbered IV-B-5-a) would be added 
to reflect 4he F4’s responsibility unddner 
Section lU-C as follows: 
“IV-B-5-a-(2). Defeimine whether 
experiments sre covered by Section lU- 
C and follow the appropriate 
procedures;” 
The other Sections within IV-D-5 
(remunbered IV-B-5) would be 
renumbered to reflect this addition. 
k. Section IV-D-5-e-{5), Publications, 
would be deleted. Section IV-T3-5-e-(5) 
currently reads as follows: 
“IV-D-5-e-(5). Publications. Pis are 
urged to include, in all publications 
reporting on recombinant DNA researdv 
a description of the physical and 
biological containment procedures 
employed." 
l. Section IV-E, Responsibilities of 
NIH, would be renumbered to become 
Section IV-C. 
m. The first sentence of the second 
paragraph of Section IV-E-l 
(renumbered IV-C-1), Director, would 
be modified to read as follows: 
"The Director has responsibilities 
under the Guidelines that involve the 
NIH Office of Recombinant DNA 
Activities (ORDA) and the Recombinant 
DNA Advisory Committee (RAC). 
ORDA’s responsibilities imder the 
Guidelines are administrative. Advice 
from the RAC is primarily scientific and 
technical. In certain circumstances, 
there is specific opportunity for public 
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