Federal Regiater / Vol. 47, No. 167 / Friday. August 27, 1982 / NoHcee 
38051 
considered in Section m-C. All such 
experimenU can be carried out at Pi 
containment. For experiments in this 
category, a registration document as 
deschb^ In Section Ul-B must be dated 
and signed by the investigator and filed 
tvith the local IBC The IK shall review 
all such proposals, but IBC review prior 
to initiation of tha experiment is not 
reoulred. (The reader should refer to the 
policy statement in the first two 
paragraphs of Section fV-A.) 
For example, experiments in which all 
components derive from non-pa thogenic 
prokaryotes and non-pa thogenic lower 
eukaryotes fall under Section fll-C and 
can be carried out at Pi containment. 
Caution; Experiments InvoJving 
Formation of Recombinant DNA 
Molecules Containing no more Than 
TVo- Thirds of the Genome of any 
Eukaryotic Virus. Recombinant DNA 
molecules containing no more than two- 
thirds of the genome of any eukaryotic 
virus (all viruses from a single Family 
117] being considered Identical |19|) may 
be propagated and maintained in ^Is iia 
tisaue culture using Pi containmenL For 
such experiments, it must be shown that 
the cells lack helper virus for tha 
specific Families of defective viruses 
being used. If helper virus is present, 
procedures specified under Section IH- 
B-3 should be used. The NDA may 
contain fragments of the genome of 
viruses from more than one Family but 
each fragment must be less than two- 
thirds of a genome. 
ID-D. Exempt Experiments. The 
following recombinant DNA molecules 
are exempt from these Guidelines and 
no registration with the IBC is 
necessary. 
ID-D-1. Those that are not in 
organisms or viruses. 
Ul-O-2- Those that consist entirely of 
ONA segments from a single non- 
chromosomal or viral DNA source, 
though one or more of the segments may 
be a synthetic equivalent 
01-0-3. Those that consist entirely of 
DNA from a prokaryotic host including 
its indigenous plasmids or viruses, when 
propagated only in that host (or a 
closely related strain of the same 
species) or when transferred to another 
host by well established physiological 
means; also, those that consist entirely 
of DNA from an eukaryotic host 
including its chloroplasts. mitochondria, 
or plasmids (but excluding viruses), 
when propagated only in that host (or a 
closely related strain of same species). 
IIl-D-4. Certain specified 
recombinant DNA molecules that 
consist entirely of DNA segments from 
different species that exchange DNA by 
known physiological processes, though 
one or more of the segments may be a 
synthetic equivalent. A list of such 
exchangers will be prepared and 
periodically revised by the Director, 
NIH. with advice of the RAC. after 
appropriate notice and opportunity for 
public comment. (See Section FV-^l-b- 
(iHc).) Certain classes are exempt as of 
publication of these Revised Guidelines. 
The list Is in Appendix A. An updated 
list may be obtained from the (Office of 
Recombinant DNA Activities. National 
Institutes of Health. Bethesda. Maryland 
20205. 
UI-O-5. Other classes of recombinant 
DNA molecules, if the Director, NIH 
with advice of the RAC after 
appropriate notice and opportunity for 
public comment, finds that they do not 
present a significant risk to health or the 
environment. (See Section fV-C-l-b- 
(l)-<c).) Certain classes are exempt as of 
publication of these Revised Guidelines. 
The list is in Appendix C An updated 
list may be obtained from the Office of 
Recombinant ONA Activities. National 
Institutes of Health. Bethesda. Maryland 
20206. 
IV. Roles and Raspoosibllitias 
IV-A. Policy. Safely in activities 
involving recombinant DNA depends on 
the individual conducting them. The 
Guidelines cannot anticipate every 
possible situation. Motivation and good 
judgement are the key essentials to 
protection of health and the 
snvironmenL 
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 implemented. 
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 
intent of the Guidelines os well as to 
their specifics. 
Each Institution (and the IBC acting 
on its behalf) is responsible for ensuring 
that recombinant DNA activities comply 
with the Guidelines. General recognition 
of institutional authority and 
responsibility properly establishes 
accountability for safe conduct of the 
research at the local level. 
The following roles and 
responsibilities constitute an 
administrative framework in which 
safety is an essential and integral part of 
research involving recombinant DNA 
molecules. Further clarifications and 
interpretations of roles and 
responsibilities will be issued by NIH as 
necessary. 
rV-B. Responsibilities of the 
Institution. 
rV-B-1. General Information. Each 
Institution conducting or sponsoring 
recombinant DNA research covered by 
these Guidelines is responsible for 
ensuring that the research is carried out 
in full comformity with the provisions of 
the Guidelines. In order to hilflll this 
responsibility, the Institution shall: 
IV-B-l-a. Establish and implement 
policies that provide for the safe 
conduct of recombinant DNA research 
and that ensure compliance with the 
Guidelines. The Institution, as part of its 
general responsibilities for implementing 
the Guidelines, may establish additional 
procedures, as deemed necessary, to 
govern the institution and its 
components in the discharge of it 
responsibilities under the Guidelines. 
This may include (i) statements 
formulated by the Institution for general 
Implementation of the Guidelines and 
(ii) whatever additional precautionary 
steps the Institution may deem 
appropriate. 
IV-B-l-b. Establish an Institutional 
Biosafety Committee (IBC) that meets 
the requirements set forth in Section IV- 
B-2 and carries out the functions 
detailed in Section IV-B-3. 
IV-B-l-c. If the Institution is engaged 
in recombinant ONA research at the P3 
or P4 containment level appoint a 
Biological Safety OfGcer (^O), who 
shall be a memiMr of the IBC and carry 
out the duties specified in Section IV-B- 
4. 
rV-B-l-d. Require that investigators 
responsible for research covered by 
these Guidelines comply with the 
provisions of Section IV-B-5, and assist 
investigators to do so. 
fV-B-l-e. Ensure appropriate training 
for the IBC chairperson and members, 
the BSO, Principal Investigators (Pis), 
and laboratory staff regarding the 
Guidelines, their implementation, and 
laboratory safety. Responsibility for 
training IK members may be carried 
out through the IK chairperson. 
ResponsibiUty for training laboratory 
staff may be carried out through the Pi. 
The Institution is responsible for seeing 
that the PI has sufficient training, but 
may delegate this responsibility to the 
IK. 
IV-B-l-f. Determine the necessity, in 
connection with each project, for health 
surveillance of recombinant DNA 
research personnel and conduct, if 
found appropriate, a health surveillance 
program for the project. (The Laboratory 
Safety Monograph (LSM) discusses 
various possible components of such a 
program — for example, records of agents 
handled, active investigation of relevant 
( 5 ) 
