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GENE TECHNOLOGY (MISCELLANEOUS) AMENDMENT ACT 2008 (NO 46 OF 2008) - SECT 24

24—Amendment of section 71—Variation of licence

        (1)         Section 71(1)—delete subsection (1) and substitute:

        (1)         The Regulator may vary a licence, by notice in writing given to the licence holder—

            (a)         at any time, on the Regulator's own initiative; or

            (b)         on application by the licence holder.

        (1A)         An application for a variation must be in writing and must contain—

            (a)         such information as is prescribed by the regulations (if any); and

            (b)         such information as is specified in writing by the Regulator.

        (2)         Section 71(2)—delete "However, the" and substitute:

The

        (3)         Section 71—after the note to subsection (2) insert:

        (2A)         The Regulator must not vary a licence if the original application for the licence was an application to which section 50A applied, unless—

            (a)         the Regulator is satisfied that the principal purpose of the licence as proposed to be varied is to enable the licence holder, and persons covered by the licence, to conduct experiments; and

            (b)         the application for variation proposes, in relation to any GMO in respect of which dealings are proposed to be authorised as a result of the variation—

                  (i)         controls to restrict the dissemination or persistence of the GMO and its genetic material in the environment; and

                  (ii)         limits on the proposed release of the GMO; and

            (c)         the Regulator is satisfied that the controls and limits are of such a kind that it is appropriate for the Regulator not to seek the advice referred to in section 50(3).

Note—

Section 50A applies to an application that proposes controls and limits on the dissemination, persistence and release of the GMO concerned and is for the purpose of conducting experiments.

        (2B)         The Regulator must not vary a licence if the Regulator is satisfied that the risk assessment and the risk management plan in respect of the original application for the licence did not cover the risks posed by the dealings proposed to be authorised by the licence as varied.

        (4)         Section 71(4)—delete "However, the Regulator must not vary the" and substitute:

The Regulator must not vary a

        (5)         Section 71—after subsection (4) insert:

        (5)         The Regulator must not vary a licence unless any local council that the Regulator considers appropriate has been consulted on the proposed variation.

        (6)         The Regulator must not vary a licence in the circumstances (if any) prescribed by the regulations.

        (7)         If an application has been made for variation of a licence, the Regulator must vary the licence, or refuse to vary the licence, within the period (if any) prescribed by the regulations.

        (8)         For the purposes of subsection (2A)—

"controls" has the same meaning as in section 50A(2);

"limits" has the same meaning as in section 50A(3).



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