Commonwealth Numbered Regulations

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Requirements in relation to notifiable low risk dealings
A person must not undertake a notifiable low risk dealing unless:

the proposed dealing has been assessed, by an Institutional Biosafety Committee, to be a dealing of a kind mentioned in Part 1 of Schedule 3; and

within 14 days after 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 specified in Part 3 of Schedule 3; and

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:

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

is of appropriate design for the kind of dealing being undertaken;
the conduct of the dealing must be properly supervised, and a record of details of the dealing kept;

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

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 paragraph (1) (a), a proposed dealing is taken to be assessed if the assessment applies to:

in relation to the dealing — the particular GMO concerned, or a class of GMOs that includes that GMO; or

in relation to the particular GMO, or class of GMOs — a class of dealings that includes that dealing.

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.

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