Biomedical Engineering Reference
In-Depth Information
viable, nonpathogenic, and non-toxigenic recombinant strains derived from
host organisms that have an extended history of safe large-scale use. Good
Large-Scale Practice is recommended for organisms such as those included
in Appendix C,
Exemptions under Section III-F-6
, which have built-in envi-
ronmental limitations that permit optimum growth in the large-scale set-
ting but limited survival without adverse consequences in the environment.
BL1-Large Scale is recommended for large-scale research or production of
viable organisms containing recombinant DNA molecules that require BL1
containment at the laboratory scale and that do not qualify for Good Large-
Scale Practice. BL2-Large Scale is recommended for large-scale research or
production of viable organisms containing recombinant DNA molecules
that require BL2 containment at the laboratory scale. BL3-Large Scale is rec-
ommended for large-scale research or production of viable organisms con-
taining recombinant DNA molecules that require BL3 containment at the
laboratory scale. No provisions are made for large-scale research or pro-
duction of viable organisms containing recombinant DNA molecules that
require BL4 containment at the laboratory scale. If necessary, these require-
ments will be established by NIH on an individual basis.
Appendix K-II: Good Large-Scale Practice (GLSP)
Appendix K-II-A. Institutional codes of practice shall be formulated and
implemented to assure adequate control of health and safety matters.
Appendix K-II-B. Written instructions and training of personnel shall be
provided to assure that cultures of viable organisms containing recombinant
DNA molecules are handled prudently and that the workplace is kept clean
and orderly.
Appendix K-II-C. In the interest of good personal hygiene, facilities (e.g.,
hand washing sink, shower, changing room) and protective clothing (e.g.,
uniforms, laboratory coats) shall be provided that are appropriate for the risk
of exposure to viable organisms containing recombinant DNA molecules.
Eating, drinking, smoking, applying cosmetics, and mouth pipetting shall
be prohibited in the work area.
Appendix K-II-D. Cultures of viable organisms containing recombinant
DNA molecules shall be handled in facilities intended to safeguard health
during work with microorganisms that do not require containment.
Appendix K-II-E. Discharges containing viable recombinant organisms
shall be handled in accordance with applicable governmental environmen-
tal regulations.
Appendix K-II-F. Addition of materials to a system, sample collection,
transfer of culture fluids within/between systems, and processing of culture
fluids shall be conducted in a manner that maintains employees' exposure
