Biomedical Engineering Reference
In-Depth Information
Appendix C-III. Saccharomyces Host-Vector Systems
Experiments involving
Saccharomyces cerevisiae
and
Saccharomyces
uvarum
host-vector systems, with the exception of experiments
listed in Appendix C-III-A, are exempt from the NIH Guidelines.
For these exempt experiments, BL1 physical containment is rec-
ommended. For large-scale fermentation experiments, the appro-
priate physical containment conditions need be no greater than
those for the host organism unmodified by recombinant DNA
techniques; the Institutional Biosafety Committee can specify
higher containment if deemed necessary.
Appendix C-III-A. Exceptions
The following categories are not exempt from the NIH Guidelines: (i)
experiments described in Section III-A which require Institutional
Biosafety Committee approval, RAC review, and NIH Director
approval before initiation, (ii) experiments described in Section
III-B which require NIH/OBA and Institutional Biosafety
Committee approval before initiation, (iii) experiments involv-
ing DNA from Risk Groups 3, 4, or restricted organisms (see
Appendix B,
Classification of Human Etiologic Agents on the Basis
of Hazard
, and Sections V-G and V-L,
Footnotes and References of
Sections I through IV
) or cells known to be infected with these
agents may be conducted under containment conditions specified
in Section III-D-2 with prior Institutional Biosafety Committee
review and approval, (iv) large-scale experiments (e.g., more
than 10 liters of culture), and (v) experiments involving the delib-
erate cloning of genes coding for the biosynthesis of molecules
toxic for vertebrates (see Appendix F,
Containment Conditions for
Cloning of Genes Coding for the Biosynthesis of Molecules Toxic for
Vertebrates
).
Appendix C-IV.
Bacillus subtilis
or
Bacillus licheniformis
Host-Vector
Systems
Any asporogenic
Bacillus subtilis
or asporogenic
Bacillus licheniformis
strain which does not revert to a spore-former with a frequency
greater than 10-7 may be used for cloning DNA with the excep-
tion of those experiments listed in Appendix C-IV-A,
Exceptions
.
For these exempt laboratory experiments, BL1 physical contain-
ment conditions are recommended. For large-scale fermentation
experiments, the appropriate physical containment conditions
need be no greater than those for the host organism unmodi-
fied by recombinant DNA techniques; the Institutional Biosafety
Committee can specify higher containment if deemed necessary.
