Australian Capital Territory Numbered Regulations

GENE TECHNOLOGY REGULATIONS 2004 (NO 17 OF 2004) - REG 13

    (1)     A person must not undertake a notifiable low risk dealing unless—

        (a)     the proposed dealing has been assessed, by an institutional biosafety committee, to be a dealing of a kind mentioned in schedule 3, part 3.1; and

        (b)     within 14 days after the day of completion of the assessment, the committee has notified the regulator, by giving the regulator, in relation to the proposed notifiable low risk dealing, the information stated in schedule 3, part 3.3; and

        (c)     the person, and the project supervisor for the proposed dealing, have received written notice from the committee that paragraph (b) has been complied with.

    (2)     A notifiable low risk dealing, when undertaken, must comply with the following requirements:

        (a)     the dealing must be conducted in a facility that—

              (i)     is certified by the regulator to—

    (A)     at least physical containment level 2; or

    (B)     any other containment level that the regulator considers suitable for conducting the dealing; and

              (ii)     is of appropriate design for the kind of dealing being undertaken;

        (b)     the conduct of the dealing must be properly supervised, and a record of details of the dealing kept;

        (c)     if the dealing involves human pathogens—it must be conducted only in accordance with the recommendations for vaccination given in Australian/New Zealand Standard AS/NZS 2243.3:1995 (Safety in laboratories: microbiology);

        (d)     to the extent that the dealing involves transporting a GMO, the transporting must be conducted in accordance with any relevant guidelines, as in force from time to time, issued by the regulator.

    (3)     For subregulation (1) (a), a proposed dealing is taken to be assessed if the assessment applies to—

        (a)     for the dealing—the particular GMO concerned, or a class of GMOs that includes that GMO; or

        (b)     for the particular GMO, or class of GMOs—a class of dealings that includes that dealing.

    (4)     The Legislation Act, section 47 (6) does not apply to the Australian/New Zealand Standard mentioned in subregulation (2) (c).

    (5)     From the commencement of these regulations until 2 years after the commencement, a person who complies with subregulation (2) may undertake a notifiable low risk dealing although any, or all, of the provisions of subregulation (1) have not been complied with if there is in force a notice issued by, or on behalf of, the genetic manipulation advisory committee declaring that the dealing is a notifiable low risk dealing.

    (6)     Subregulation (5) is a law to which the Legislation Act, section 88 (Repeal does not end effect of transitional laws etc) applies.

    (7)     Subregulations (5) and (6) and this subregulation expire 2 years after the day they commence.

Division 3.3     Certification and accreditation