60124 
NOTICES 
In the Administrative Practices Sup- 
plement. 
IV-C-4. “Institution” means any 
public or private entity (including Fed- 
eral, State, and local government 
agencies). 
IV-C-5. "Institutional Biosafety 
Committee” or "IBC” means a com- 
mittee that (i) meets the requirements 
for membership specified in Section 
IV-D-2, and (ii) reviews, approves, and 
oversees projects in accordance with 
the responsibilities defined in Section 
IV-D-2 and -3. 
IV-C-6. "NIH Office of Recombin- 
ant DNA Activities” or "ORDA” 
means the office within NIH with re- 
sponsibility for (i) reviewing and co- 
ordinating all activities of NIH related 
to the Guidelines, and (ii) performing 
other duties as defined in Section IV- 
E— 3. 
IV-C-7. "Recombinant DNA Adviso- 
ry Committee” or "RAC” means the 
public advisory committee that advises 
the Secretary, the Assistant Secretary 
for Health, and the Director of the 
National Institutes of Health concern- 
ing recombinant DNA research. The 
RAC shall be constituted as specified 
in Section IV-E-2. 
IV-C-8. "Director, NIH” or “Direc- 
tor” means the Director of the Nation- 
al Institutes of Health and any other 
officer or employee of NIH to whom 
authority has been delegated. 
IV-C-9 "Federal Interagency Adviso- 
ry Committee on Recombinant DNA 
Research” means the committee estab- 
lished in October 1976 to advise the 
Secretary, HEW, the Assistant Secre- 
tary for Health, and the Director, 
NIH, on the coordination of those as- 
pects of all Federal programs and ac- 
tivities which relate to recombinant 
DNA research. 
IV-C-10. “Administrative Practice 
Supplement" or “APS” means a publi- 
cation to accompany the NIH Guide- 
lines specifying administrative proce- 
dures for use at NTH and at Institu- 
tions. 
IV-C-11. “Laboratory Safety Mono- 
graph” or “LSM” means a publication 
to accompany the NIH Guidelines de- 
scribing practices, equipment, and 
facilities in detail. 
IV-D. Responsibilities of the Institu- 
tion 
IV-D-1. Each Institution conducting 
or sponsoring recombinant DNA re- 
search covered by these Guidelines is 
responsible for ensuring that the re- 
search is carried out in full conformity 
with the provisions of the Guidelines. 
In order to fulfill this responsibility, 
the Institution shall: 
IV-D-l-a. Establish and implement 
policies that provide for the safe con- 
duct of recombinant DNA research 
and that ensure compliance with the 
Guidelines. The Institution, as part of 
its general responsibilities for imple- 
menting the Guidelines, may establish 
additional procedures, as deemed nec- 
essary, to govern the Institution and 
its components in the discharge of its 
responsibilities under the Guidelines. 
This may include (i) statements for- 
mulated by the Institution for general 
implementation of the Guidelines and 
(ii) whatever additional precautionary 
steps the Institution may deem appro- 
priate. 
rV-D-l-b. Establish an Institutional 
Biosafety Committee (IBC) that meets 
the requirements set forth in Section 
IV-D-2 and carries out the functions 
detailed in Section IV-D-3. 
IV-D-l-c. Submit, for each recom- 
binant DNA project that meets with 
its approval, a Memorandum of Under- 
standing and Agreement (MUA) to the 
funding agency for approval and regis- 
tration. All projects, however, can pro- 
ceed upon IBC approval (before sub- 
mission of the MUA to the funding 
agency) except for the following, 
which require prior approval by NIH 
(or other funding agency designated 
by NIH for this purpose): 
IV-D-l-c-(l). Projects for which 
containment levels are not specified by 
the Guidelines or NIH, 
IV-D-l-c-(2). Projects requiring P4 
containment, 
IV-D-l-c-(3). Reductions of more 
than one step in containment levels 
(see Section III-A-3), 
IV-D-l-c-(4). Reductions of contain- 
ment level for projects involving pri- 
mate DNA (see Section III-A-3), 
IV-D-l-c-(5). Reductions of contain- 
ment to levels below PI + EK1 (see 
Section III-A-3), 
IV-D-l-c-(6). The first project con- 
ducted in a facility at P3 containment, 
or 
TV-D-l-c-(7). The first project con- 
ducted by an Institution. 
NOTE: The MUA shall be submitted 
to the funding agency within 30 days 
of the IBC approval. If the funding 
agency does not routinely register re- 
combinant DNA projects with NIH, 
the MUA must be submitted to NIH as 
well as to the funding agency. Author- 
ity to submit MUAs (or addenda) for 
which prior approval is not required 
may be delegated to the IBC chairper- 
son. All MUAs that require NIH ap- 
proval before the work can proceed 
shall be submitted to the NIH by the 
institutional official to whom the IBC 
is responsible. 
IV-D-l-d. Take appropriate action 
to bring protocols into compliance 
when advised by NIH or other funding 
agency that IBC-approved projects do 
not conform to standards set forth in 
the Guidelines. This responsibility 
may be delegated to the IBC. (See Ad- 
ministrative Practices Supplement for 
further details). 
IV-D-l-e. If the Institution is en- 
gaged in recombinant DNA research at 
the P3 or P4 containment level, ap- 
point a Biological Safety Officer 
(BSO), who shall be a member of the 
IBC and carry out the duties specified 
in Section IV-D-4. 
IV-D-l-f. Require that investigators 
responsible for research covered by 
these Guidelines comply with the pro- 
visions of Sectipn IV-D-5, and assist 
investigators to do so. 
IV-D-l-g. Ensure appropriate train- 
ing for the IBC chairperson and mem- 
bers, the BSO, Principal Investigators 
(Pis), and laboratory staff regarding 
the Guidelines, their implementation, 
and laboratory safety. Responsibility 
for training IBC members may be car- 
ried out through the IBC chairperson. 
Responsibility for training laboratory 
staff may be carried out through the 
PI. The Institution is responsible for 
seeing that the PI has sufficient train- 
ing, but may delegate this responsibili- 1 
ty to the IBC. 
rV-D-l-h. Determine the necessity, 
in connection with each project, for 
health surveillance of recombinant 
DNA research personnel, and conduct, 
if found appropriate, a health surveil- 
lance program for the project. [The 
Laboratory Safety Monograph (LSM) 
discusses various possible components 
of such a program— for example, rec- 
ords of agents handled, active invest!- . 
gation of relevant illnesses, and the 
maintenance of serial serum samples 
for monitoring serologic changes that 
may result from the employees’ work 
experience. Certain medical conditions 
may place a laboratory worker at in- 
creased risk in any endeavor where in- 
fectious agents are handled. Examples 
given in the LSM include gastrointesti- ' 
nal disorders and treatment with ster- 
oids, immunosuppressive drugs, or 
antibiotics. Workers with such disor- 
ders or treatment should be evaluated 
to determine whether they should be 
engaged in research with potentially 
hazardous organisms during their ' 
treatment or illness.] 
IV-D-l-i. Report within 30 days to 
ORDA any significant problems with J 
and violations of the Guidelines and 
significant .research-related accidents ,| 
and illnesses, unless the institution de- . 
termines that the PI or IBC has done ~| 
so. 
IV-D-2. Membership and Procedure 
of the IBC. The Institution shall estab- , 
lish an Institutional Biosafety Com- 
mittee (IBC) meeting the following re- 
quirements: 
IV-D-2-a. The IBC shall comprise 
no fewer than five members so select- 
ed that they collectively have expert- ' 
ence and expertise in recombinant l. 
DNA technology and the capability to 
assess the safety of recombinant DNA j 
research experiments and any poten- g 
tial risk to public health or the envi- 
ronment. At least two members (but 
not less than 20 percent of the mem- 
FEDERAL REGISTER, VOL. 43, NO. 247— FRIDAY, DECEMBER 22, 1978 
