Biomedical Engineering Reference
In-Depth Information
Other exemptions may also apply to bacteria and yeast but with the fol-
lowing limitations:
Appendix C-II.
Escherichia coli
K-12 Host-Vector Systems
Experiments which use
Escherichia coli
K-12 host-vector systems,
with the exception of those experiments listed in Appendix
C-II-A, are exempt from the NIH Guidelines provided that: (i)
the
Escherichia coli
host does not contain conjugation proficient
plasmids or generalized transducing phages; or (ii) lambda or
lambdoid or Ff bacteriophages or nonconjugative plasmids (see
Appendix C-VIII.
Footnotes and References of Appendix C
) shall be
used as vectors. However, experiments involving the insertion
into
Escherichia coli
K-12 of DNA from prokaryotes that exchange
genetic information (see Appendix C-VIII.
Footnotes and References
of Appendix C
) with
Escherichia coli
may be performed with any
Escherichia coli
K-12 vector (e.g., conjugative plasmid). When a
nonconjugative vector is used, the
Escherichia coli
K-12 host may
contain conjugation-proficient plasmids either autonomous or
integrated, or generalized transducing phages. For these exempt
laboratory experiments, Biosafety Level (BL) 1 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.
Appendix C-II-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) experi-
ments described in Section III-B which require NIH/OBA and
Institutional Biosafety Committee approval before initiation,
(iii) experiments involving 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 cloning of toxin molecule 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
).
