Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
34503 
is responsible for ensuring that the 
research is conducted in full conformity 
with the provisions of the NIH 
Guidelines. In order to fulfill this 
responsibility, the institution shall: 
Section IV-^l-a. Establish and 
implement policies that provide for the 
safe conduct of recombinant DN A 
research and that ensure compliance 
with the NIH Guidelines. As part of its 
general responsibilities for 
implementing the NIH Guidelines, the 
institution may establish additional 
procedures, as deemed necessary, to 
govern the institution and its 
components in the discharge of its 
responsibilities under the NIH 
Guidelines. Such procedures may 
include: (i) Statements formulated by 
the institution for the general 
implementation of the NIH Guidelines, 
and (ii) any additional precautionary 
steps the institution deems appropriate. 
Section IV-B-l-b. Establish an 
Institutional Biosafety Committee that 
meets the requirements set forth in 
Section IV-B-2-a and carries out the 
functions detailed in 
Section IV-B-2-b. 
Section IV-B-l-c. Appoint a 
Biological Safety Officer (who is also a 
member of the Institutional Biosafety 
Committee) if the institution: (i) 
Conducts recombinant DNA research at 
Biosafety Level (BL) 3 or BL4, or (ii) 
engages in large scale (greater than 10 
liters) research. The Biological Safety 
Officer carries out the duties specified 
in Section rV-B-3. 
Section IV-B-l-d. Assist and ensure 
compliance with the NIH Guidelines by 
Principal Investigators conducting 
research at the institution as specified in 
Section IV-B—4. 
Section IV-B-l-e. Ensure appropriate 
training for the Institutional Biosafety 
Committee Chair and members. 
Biological Safety Officer (when 
applicable). Principal Investigators, and 
laboratory staff regarding laboratory 
safety and implementation of the NIH 
Guidelines. The Institutional Biosafety 
Committee Chair Is responsible for 
ensuring that Institutional Biosafety 
Committee members are appropriately 
trained. The Principal Investigator is 
responsible for ensuring that laboratory 
staff are appropriately trained. The 
institution is responsible for ensuring 
that the Principal Investigator has 
sufficient training; however, this 
responsibility may be delegated to the 
Institutional Biosafety Committee. 
Section IV-B-l-f. Eietermine the 
necessity for health surveillance of 
pcrsormel involved in connection with 
individual recombinant DNA projects; 
and if appropriate, conduct a health 
surveillance program for such projects. 
The institution shall establish and 
maintain a health surveillance program 
for personnel engaged in large scale 
research or production activities 
involving viable organisms containing 
recombinant DNA molecules which 
require BL3 containment at the 
laboratory scale. The institution shall 
establish and maintain a health 
surveillance program for personnel 
engaged in animal resear^ involving 
viable recombinant DNA-containing 
microorganisms that require BL3 or 
greater containment in the laboratory. 
The Laboratory Safety Monograph 
discusses various components of such a 
program (e.g., records of agents handled, 
active investigation 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 increased risk in 
any endeavor where infectious agents 
are handled. Examples cited in the 
Laboratory Safety Monograph Include 
gastrointestinal disorders and treatment 
with steroids, immimosuppressive 
drugs, or antibiotics. Workers with such 
disorders or treatment should be 
evaluated to determine whether they 
should be engaged in research with 
potentially hazardous organisms during 
their treatment or illness. Copies of the 
Laboratory Safety Monograph are 
available from the Office of 
Recombinant DNA Activities, National 
Institutes of Health, Building 31, Room 
4B11, Bethesda, Maryland 20892, (3^1) 
4Q&-9838. 
Section IV-B-l-g. Report any 
significant problems, violations of the 
NIH Guidelines, or any significant 
research-related accidents and illnesses 
to NIH/ORDA within thirty da3rs, imless 
the institution determines that a report 
has already been filed by the Principal 
Investigator or Institutional Biosafety 
Committee. Reports shall be sent to the 
Office of Recombinant DNA Activities. 
National Institutes of Health, Building 
31, Room 4B11, Bethesda. Maryland 
20892, (301) 496-9838. 
Section IV-B-2. Institutional Biosafety 
Committee (IBC) 
The institution shall establish an 
Institutional Biosafety Committee whose 
responsibilities need not be restricted to 
recombinant DNA. The Institutional 
Biosafety Committee shall meet the 
following requirements: 
Section IV-B-2-a. Membership and 
Procedures 
Section IV-B-2-a-(l). The Institutional 
Biosafety Committee ftiust be comprised 
of 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 
recombinant DNA research and to 
identify 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 Institutional Biosafety 
Conunittee) and who represent the 
interest of the surrounding community 
with respect to health and protection of 
the environment (e.g., officials of state 
or local public health or environmental 
protection agencies, members of other 
local governmental bodies, or persons 
active in medical, occupational health, 
or environmental concerns in the 
community). The Institutional Biosafety 
Committee shall include at least one 
individual with expertise in plant, plant 
pathogen, or plant pest containment 
principles when experiments utilizing 
Appendix P require prior approval by 
the Institutional Biosafety Committee. 
The Institutional Biosafety Committee 
shall include at least one scientist with 
expertise in animal contaliunent 
principles when experiments utilizing 
Appendix Q require Institutional 
Biosafety Committee prior approval. 
When the institution conducts 
recombinant DNA research at BL3 or 
BL4, a Biological Safety Officer is 
mandatory and shall be a member of the 
Institutional Biosafety Committee (see 
Section IV-B-3). 
Section IV-B-2-a-(2). In order to 
ensure the competence necessary to 
review and approve recombinant DNA 
activities, it is recommended that the 
Institutional Biosafety Committee: (i) 
include persons with expertise in 
recombinant DNA technology, 
biological safety, and physical 
contaiiunent; (ii) include or have 
available as consultants persons 
knowledgeable in institutional 
commitments and policies, applicable 
law, standards of professioneJ conduct 
and practice, community attitudes, and 
the environment, and (iil) include at 
least one member representing the 
laboratory technical staff. 
Section IV-B-2-a-(3). The institution 
shall file a report with NIH/ORDA 
which inclucles the names and 
biographical sketches of all Institutional 
Biosafety Committee members, 
including community members, in such 
form and at such times as required by 
NIH/ORDA. 
Section IV-B-2-a-(4). No member of 
an Institutional Biosafety Committee 
may be involved (except to provide 
information requested oy the 
Institutional Biosafety Committee) in 
the review or approval of a project in 
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Recombinant DNA Research, Volume 19 
