Biomedical Engineering Reference
In-Depth Information
Appendix K-IV-L. Emergency plans required by Sections IV-B-2-b-(6),
Institutional Biosafety Committee
, and IV-B-3-c-(3),
Biological Safety Officer,
, shall
include methods and procedures for handling large losses of culture on an
emergency basis.
Appendix K-V: Biosafety Level 3 (BL3)—Large Scale
Appendix K-V-A. Spills and accidents that result in overt exposures to organ-
isms containing recombinant DNA molecules are immediately reported to
the Biological Safety Officer, Institutional Biosafety Committee, NIH/OBA,
and other appropriate authorities (if applicable). Reports to NIH/OBA shall
be sent to the Office of Biotechnology Activities, National Institutes of Health,
6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985 (20817
for non-USPS mail), 301-496-9838, 301-496-9839 (fax). Medical evaluation, sur-
veillance, and treatment are provided as appropriate and written records are
maintained.
Appendix K-V-B. Cultures of viable organisms containing recombinant
DNA molecules shall be handled in a closed system (e.g., closed vessels
used for the propagation and growth of cultures) or other primary con-
tainment 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 provided all physical containment requirements
specified in Appendix G-II-C,
Physical Containment Levels—Biosafety Level
3
, are met.
Appendix K-V-C. Culture fluids (except as allowed in Appendix K-V-D)
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 that has been demonstrated to be
effective using the organisms that will serve as the host for propagating the
recombinant DNA molecules. Culture fluids that contain viable organisms
or viral vectors intended as the final product may be removed from the pri-
mary containment equipment by way of closed systems for sample analysis,
further processing, or final fill.
Appendix K-V-D. 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 conducted in a manner that prevents the
release of aerosols or contamination of exposed surfaces.
Appendix K-V-E. Exhaust gases removed from a closed system or other
primary containment equipment shall be treated by filters that have efficien-
cies equivalent to high efficiency particulate air/HEPA filters or by other
