(1) Subject to subsection (1), a dealing involving a
host/vector system mentioned in part 2.2 and producing not more than 25L of
GMO culture in each vessel containing the resultant culture. (2)
The donor nucleic acid— (a) must meet either of
the following requirements: (i) the acid must not be derived
from organisms implicated in, or with a history of causing, disease in
otherwise healthy— (A) human beings; or (B)
animals; or (C) plants; or (D) fungi;
(ii) the acid must be characterised and the information derived
from its characterisation show that it is unlikely to increase the capacity of
the host or vector to cause harm; and
Example Donor nucleic acid would not comply with par (ii) if its
characterisation shows that, in relation to the capacity of the host or vector
to cause harm, it— (a) provides an advantage; or (b)
adds a potential host species or mode of transmission; or (c)
increases its virulence, pathogenicity or transmissibility.
Note An example is part of the regulation, is not exhaustive and
may extend, but does not limit, the meaning of the provision in which it
appears (see Legislation Act, s 126 and s 132). (b) must
not code for a toxin with an LD50 of less than 100μg/kg; and (c)
must not code for a toxin with an LD50 of 100μg/kg or more, if the
intention is to express the toxin at high levels; and (d) must
not be uncharacterised nucleic acid from a toxin-producing organism; and (e)
must not include a viral sequence, unless the donor nucleic
acid— (i) is missing at least 1 gene essential for viral
multiplication that— (A) is not available in the cell
into which the nucleic acid is introduced; and (B) will not
become available during the dealing; and (ii) cannot restore
replication competence to the vector. |