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Federal Register / Vol. 51, No. 88 / Wednesday, May 7, 1986 / Notices 
(b) Meetings of the BSCC shall be held 
periodically. Some public meetings will 
'be held. 
(c) Confidential business information 
and proprietary information shall be 
protected under the confidentiality 
requirements of each member agency. 
(d) Subcommittees and working 
groups, with participation not restricted 
to BSCC members or full-time Federal 
employees, may be formed to assist the 
BSCC in its work. 
(e) All BSCC members will be full- 
time Federal employees whose 
compensation, reimbursement for travel 
expenses and other costs shall be borne 
by their respective agencies. 
(f) Each member of the BSCC shall 
provide such agency support and 
resources as may be available and 
necessary for the operation of the BSCC 
including undertaking special studies as 
come within the functions assigned 
herein. 
(g) An Office of Science and 
Technology Policy staff member will 
serve as BSCC Executive Secretary. 
Appendix K — Physical Containment for 
Large-Scale Uses of Organisms 
Containing Recombinant DNA 
Molecules 
This part of the Guidelines specifices 
physical containment guidelines for 
large-scale (greater than 10 liters of 
culture) research or production involving 
viable organisms containing 
recombinant DNA molecules. It shall 
apply to large-scale research or 
production activities as specified in 
Section III— B— 5 of the Guidelines. 
All provisions of the Guidelines shall 
apply to large-scale research or 
production activities with the following 
modifications: 
• Appendix K shall replace Appendix 
G when quantities in excess of 10 liters 
of culture are involved in research or 
production. 
• The institutions shall appoint a 
Biological Safety Officer (BSO) if it 
engages in large-scale research or 
production activities involving viable 
organisms containing recombinant DNA 
molecules. The duties of the BSO shall 
include those specified in Section IV-B- 
4 of the Guidelines. 
• 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 program shall 
include: preassignment and periodic 
physical and medical examinations; 
collection, maintenance and analysis of 
serum specimens for monitoring 
serologic changes that may result from 
the employee's work experience; and 
provisions for the investigation of any 
serious, unusual or extended illnesses of 
employees to determine possible 
occupational origin. 
Appendix K-l. — Selection of Physical 
Containment Levels. 
The selection of the physical 
containment level required for 
recombinant DNA research or 
production involving more than 10 liters 
of culture is based on the containment 
guidelines established in Part III of the 
Guidelines. For purposes of large-scale 
research or production, three physical 
containment levels are established. 
These are referred to as BLl-LS, BL2- 
LS, and BL3-LS. The BL-LS level of 
physical containment is required for 
large-scale research or production of 
viable organisms containing 
recombinant DNA molecules which 
require BLI containment at the 
laboratory scale. (The BLl-LS level of 
physical containment is recommended 
for large-scale research or production of 
viable organisms for which BLI is 
recommended at the laboratory scale 
such as those described in Appendix C.) 
The BL2-LS level of physical 
containment is required for large-scale 
research or production of viable 
organisms containing recombinant DNA 
molecules which require BL2 
containment at the laboratory scale. The 
BL3-LS level of physical containment is 
required for large-scale research or 
production of viable organisms 
containing recombinant DNA molecules 
which require BL3 contaiment at the 
laboratory scale. No provisions are 
made for large-scale research or 
production of viable organisms 
containing recombinant DNA molecules 
which require BL4 containment at the 
laboratory scale. If necessary, these 
requirements will be established by NEH 
on an individual basis. 
Appendix K-II — BLl-LS Level 
Appendix K-II-A. Cultures of viable 
organisms containing recombinant DNA 
molecules shall be handled in a closed 
system (e.g., closed vessel used for the 
propagation and growth of cultures) or 
other primary containment equipment 
(e.g., biological safety cabinet containing 
a centrifuge used to process culture 
fluids) which is designed to reduce the 
potential for escape of viable organisms. 
Volumes less than 10 liters may be 
handled outside of a closed system or 
other primary containment equipment 
provided all physical containment 
requirements specified in Appendix G- 
II-A of the Guidelines are met. 
Appendix K-II-B. Culture fluids 
(except as allowed in Appendix K-II-C) 
shall not be removed from a closed 
system or other primary containment 
equipment unless the viable organisms 
containing recombinant DNA molecules 
have been inactivated by a validated 
inactivation procedure. A validated 
inactivation procedure is one which has 
been demonstrated to be effective using 
the organism that will serve as the host 
for propagating the recombinant DNA* 
molecules. 
Appendix K-II-C. Sample collection 
from a closed system, the addition of 
materials to a closed system, and the 
transfer of culture fluids from one closed 
system to another shall be done in a 
manner which minimizes the release of 
aerosols or contamination of exposed 
surfaces. 
Appendix K-II-D. Exhaust gases 
removed from a closed system or other 
primary containment equipment shall be 
treated by filters which have efficiencies 
equivalent to HEPA filters or by other 
equivalent procedures (e.g., incineration) 
to minimize the release of viable 
organisms containing recombinant DNA 
molecules to the environment. 
Appendix K-II-E. A closed system or 
other primary containment equipment 
that has contained viable organisms 
containing recombinant DNA molecules 
shall not be opened for maintenance or 
other purposes unless it has been 
sterilized by a validated sterilization 
procedure. A validated sterilization 
procedure is one which has been 
demonstrated to be effective using the 
organism that will serve as the host for 
propagating the recombinant DNA 
molecules. 
Appendix K-II-F. Emergency plans 
required by Section IV-B-3-f shall 
include methods and procedures for 
handling large losses of culture on an 
emergency basis. 
Appendix K-II I — BL2-LS Level 
Appendix K-III-A. Cultures of viable 
organisms containing recombinant DNA 
molecules shall be handled in a closed 
system (e.g., closed vessel used for the 
propagation and growth of cultures) or 
other primary containment equipment 
(e.g., Class III biological safety cabinet 
containing a centrifuge used to process 
culture fluids) which is designed to 
prevent the escape of viable organisms. 
Volumes less than 10 liters may be 
handled outside of a closed system or 
other primary containment equipment 
provided all physical containment 
requirements specified in Appendix G- 
II— B of the Guidelines are met. 
Appendix K-III-B. Culture fluids 
(except as allowed in Appendix K— III— C) 
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