Biosafety Guidelines For Research On Genetically Modified ...

SECTION 4: EXPERIMENTS COVERED BY THE GUIDELINES
4.1 CATEGORY A – EXPERIMENTS REQUIRING IBC APPROVAL AND GMAC
NOTIFICATION (REGULATED EXPERIMENTS WITH SIGNIFICANT RISKS)
This category includes experiments which may pose high risks to laboratory
workers, the community or the environment. This category also includes
experiments for which the type or level of hazard is unclear. The level of
containment required will vary depending on the kind of experiments and their
assessed hazard.
In general, experiments involving biological agents or toxins that are defined as
First, Second and Fifth Schedules of the BATA and/or classified as Risk Group
3 and 4 of the OSH Guidelines will fall within this Category A.
A facility of containment of, at least, level BSL2 (as determined by the IBC and
with reference to the Biosafety level detailed by the ATCC and CDC) is
required.
This category of work requires IBC assessment and approval, followed by
GMAC notification before work begins. Principal investigators should not
commence work on proposals assessed as Category A until advised by the
IBC, following IBC’s receipt of GMAC acknowledgement of notification. Please
refer to Section 3 for procedures for submitting proposal forms and obtaining
GMAC advice.
The following classes of experiments fall within Category A:
A(i)
Experiments with toxin producers:
• Experiments using DNA which encodes a vertebrate toxin having an
LD50 of less than 100 µg/kg. Appendix 4 lists some toxins falling
under this sub-category.
• Experiments in which toxin genes are expressed at a high-level,
even if the LD50 is greater than 100 µg/kg. Experiments using
uncharacterised DNA from toxin-producing organisms and, which
therefore, could contain toxin sequences also falls under this subcategory.
However, experiments using DNA which has been fully
characterised and shown not to code for a toxin, from a toxinproducing
organism as donor, is not included in this sub-category.
A(ii)
A(iii)
Experiments using viral vectors whose host range includes human cells,
and where the viral vectors contain one or more inserted DNA
sequences coding for a product known; to play a role in the regulation of
cell growth; or to be toxic to human cells. (Special conditions for working
with viral vectors encoding oncogenes are given in Appendices 5 and
6.)
Experiments involving introduction of DNA into microorganisms which
can cause plant or animal (including human) diseases when used as
host or vector, except:
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