Biosafety Guidelines For Research On Genetically Modified ...

4.2 CATEGORY B – EXPERIMENTS REQUIRING IBC APPROVAL (NOTIFIABLE
EXPERIMENTS WITH LOW RISKS)
This category includes experiments which may pose low-level risks to
laboratory workers, the community or the environment. These experiments
require at least Biosafety Level 2 physical containment (laboratory, plant house,
animal house, insectary, bird house or aquarium), as determined by the IBC
and with reference to the Biosafety level detailed by the ATCC and CDC. Some
experiments may require additional precautions or higher containment because
the donor DNA or its components are hazardous or infectious, for example
special containment features are needed for the housing of transgenic animals.
Recommendations for procedures for GM-BSL2 and other containment levels
are in the appendices (Appendix 7 et seq).
IBC assessment is required before work begins on this category of
experiments. Principal investigators should not commence work on proposals
assessed as Category B until specifically advised by the IBC. Procedures for
submitting proposal forms and obtaining IBC advice are in Section 2.
Category A takes precedence and Category A conditions apply if the
proposed experiments fall into both Categories A and B.
The following classes of experiments fall within Category B:
B(i)
B(ii)
B(iii)
Experiments with whole animals (including non-vertebrates) which
involve genetic manipulation of oocytes, zygotes or early embryos to
produce a novel organism. For transgenic animal work, prior approval
from the institution's bioethics committee is needed. (See Appendix 1 for
other relevant documents, Appendix 12 on the relevant administrative
procedures required by these Guidelines, and Appendix 13 et seq for
transgenic animal facility requirements.)
Genetic manipulation experiments involving the production of modified
whole plants.
Work with non-approved host/vector systems (i.e. other than those listed
in Appendix 2) where the host or vector either:
(a) does not cause disease in plants, humans or animals; or
(b) is able to cause disease in plants, humans or animals but the
introduced DNA is completely characterised and will not cause an
increase in the virulence of the host or vector.
B(iv) Experiments with approved host/vector systems, in which the gene
inserted is: (a) a pathogenic determinant; or (b) DNA that is not fully
characterised from microorganisms which are able to cause disease in
humans, animals or plants; or (c) an oncogene. (See Appendices 5 and
6 for work with oncogenes.)
Shot-gun cloning of mammalian DNA in approved host/vector systems does not
fall into this category. Approved host/vector systems are listed in Appendix 2.
Investigators may request to have new host/vector systems added to the list by
making a detailed submission to GMAC through their IBC.
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