Gene Technology Regulations 2021

For the purposes of section 43(3) of the Act, the period within which the Regulator must issue, or refuse to issue, a licence is—

in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or

in relation to an application to which Division 4 of Part 5 of the Act applies—

for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and

for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and

in any other case—255 days after the day the application is received by the Regulator.

For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted—

a Saturday, a Sunday or a public holiday in the Australian Capital Territory;

a day on which the Regulator cannot proceed with the decision-making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;

if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that—

begins on the day of publication; and

ends on the day when the public hearing ends;

a day on which the Regulator cannot proceed with the decision-making process, or a related function, because—

the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and

the Regulator is—

considering the application; or

waiting until any review rights under section 181 or 183 of the Act, in relation to the application, are exhausted;

if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that—

begins on the day the request is made; and

subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.

The Regulator, when seeking advice under section 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.

In subregulation (1)—