reg 1Citation

These regulations are the Gene Technology Regulations 2007 ¹.

reg 2Commencement

These regulations come into operation on the day on which the Gene Technology Act 2006 comes into operation ¹.

reg 3Definitions

In these regulations —

advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool;

animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings;

characterised, in relation to nucleic acid, means nucleic acid that has been sequenced and in respect of which there is an understanding of potential gene products or potential functions;

code for, for Schedule 2, has the meaning given in Schedule 2 Part 3;

Commonwealth regulations means the Gene Technology Regulations 2001 of the Commonwealth;

expert adviser means —

(a)

in Part 4 — an expert adviser appointed under section 102(1) of the Commonwealth Act; and

(b)

in Part 6 — an expert adviser appointed under section 113(1) of the Commonwealth Act;

genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology;

genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology;

infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host;

known means known within the scientific community;

non‑conjunctive plasmid, for Schedule 2, has the meaning given in Schedule 2 Part 3;

non‑vector system, for Schedule 2, has the meaning given in Schedule 2 Part 3;

nucleic acid means either, or both, deoxyribonucleic acid (DNA), or ribonucleic acid (RNA), of any length;

oncogenic modification means a genetic modification that is capable of inducing unregulated cell proliferation in a vertebrate cell;

packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions;

pathogenic, in relation to an organism, means having the capacity to cause disease or abnormality;

pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality;

physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities;

plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell;

shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected;

toxin means a substance that is toxic to any vertebrate;

toxin‑producing organism means an organism producing toxin with a LD₅₀ of less than 100μg/kg;

transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the vital particle with the cell membrane.

Note for this regulation:

Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example —

accredited organisation

Commonwealth Act

deal with

environment

facility

Gene Technology Technical Advisory Committee

GMO

GM product

Institutional Biosafety Committee

intentional release of the GMO into the environment (see section 11)

notifiable low risk dealing

Regulator

reg 3ANumbering

(1)

In order to maintain consistent numbering between these regulations and the Commonwealth regulations —

(a)

if the Commonwealth regulations contain a regulation that is not required in these regulations, the provision number and heading to the Commonwealth regulation are included in these regulations despite the omission of the body of the regulation; and

(b)

if these regulations contains a regulation that is not included in the Commonwealth regulations, the regulation is numbered so as to maintain consistency in numbering between provisions common to both regulations.

(2)

A provision number and heading mentioned in subregulation (1)(a) form part of these regulations.

Notes for this regulation:

1. A note appears under each heading of a kind mentioned in subregulation (1)(a) describing the omitted Commonwealth regulation.

2. A note appears under each regulation of a kind mentioned in subregulation (1)(b) highlighting the non‑appearance of an equivalent provision in the Commonwealth regulations.

3. This regulation does not appear in the Commonwealth regulations.

reg 3BNotes

Notes do not form part of these regulations.

Note for this regulation:

This regulation does not appear in the Commonwealth regulations.

reg 4Techniques not constituting gene technology

For the purposes of paragraph (c) of the definition of “gene technology” in section 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.

reg 5Organisms that are not genetically modified organisms

For the purposes of paragraph (e) of the definition of “genetically modified organism” in section 10(1) of the Act, an organism mentioned in Schedule 1 is not a genetically modified organism.

reg 6Dealings exempt from licensing

(1)

For the purposes of section 32(3) of the Act, a dealing, in relation to a GMO, is an exempt dealing if —

(a)

it is a dealing of a kind mentioned in Schedule 2 Part 1; and

(b)

it does not involve a genetic modification other than a modification described in Schedule 2 Part 1; and

(c)

it is conducted in accordance with applicable technical and procedural guidelines, as in force from time to time under section 27(d) of the Act, relating to —

(i)

containment of the GMO; and

(ii)

if the dealing involves transporting the GMO — transport;

and

(d)

it does not involve an intentional release of the GMO into the environment; and

(e)

it does not involve a retroviral vector that is able to transduce human cells.

(2)

For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.

Notes for this regulation:

1. A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of “deal with” in section 10(1) of the Act.

2. Exemption from provisions of the Act does not preclude the application of another law of the State or a law of the Commonwealth or another State.

reg 6AParticular dealings relating to COVID‑19 vaccine exempt dealings

(1)

In this regulation —

Health Minister means the Minister responsible for the administration of the Health Services Act 2016;

relevant dealing means a dealing with a GMO that —

(a)

is —

(i)

authorised under a GMO licence issued under the Commonwealth Act; and

(ii)

undertaken by a person, or a person in a class of persons, approved under subregulation (3)(a);

(b)

is specified in an emergency dealing determination in force under section 72B of the Commonwealth Act; or

(c)

is declared by the Commonwealth regulations to be a notifiable low risk dealing; or

(d)

is specified by the Commonwealth regulations to be an exempt dealing; or

(e)

is included in the GMO Register.

(2)

For the purposes of section 32(3) of the Act, a dealing with a GMO is an exempt dealing if the dealing —

(a)

relates to a vaccine for COVID‑19; and

(b)

is a relevant dealing; and

(c)

is conducted in accordance with any applicable technical and procedural guidelines approved by the Minister under subregulation (3)(b).

(3)

The Minister may, after consulting the Health Minister, by written notice published in the Gazette —

(a)

approve a person or class of persons to deal with a GMO for the purposes of paragraph (a)(ii) of the definition of relevant dealing in subregulation (1); and

(b)

approve technical and procedural guidelines to deal with a GMO for the purposes of subregulation (2)(c).

(4)

Without limiting subregulation (3)(b), the Minister may approve technical and procedural guidelines as in force from time to time under section 27(d) of the Commonwealth Act.

(5)

If the Minister approves technical and procedural guidelines, the Minister must publish the technical and procedural guidelines on the website of the department of the Public Service principally assisting in the administration of the Act.

[Regulation 6A inserted: SL 2020/145 r. 4.]

reg 7Application for license — prescribed fee

Note for this regulation:

At the commencement of the regulations, no application fee is prescribed under section 40(6) of the Act.

reg 8Time limit for deciding an application

(1)

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 —

(a)

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

(b)

in relation to an application to which Part 5 Division 4 of the Act applies — 170 days after the day the application is received by the Regulator.

(2)

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

(a)

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

(b)

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;

(c)

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 —

(i)

begins on the day of publication; and

(ii)

ends on the day when the public hearing ends;

(d)

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

(i)

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

(ii)

the Regulator is —

(A)

considering the application; or

(B)

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

(e)

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

(i)

begins on the day the request is made; and

(ii)

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.

(3)

The Regulator, when seeking advice under section 50(3) or 52(3) of the Act, or from the Gene Technology Ethics 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.

reg 9Prescribed authorities

For the purposes of sections 50(3)(c) and 52(3)(c) of the Act, the following Commonwealth authorities and agencies are prescribed —

(a)

Food Standards Australia New Zealand;

(b)

Australian Quarantine and Inspection Service;

(c)

National Health and Medical Research Council;

(d)

the Director, National Industrial Chemical Notification and Assessment Scheme under the Industrial Chemical (Notification and Assessment) Act 1989 of the Commonwealth;

(e)

Australian Pesticides and Veterinary Medicines Authority;

(f)

Therapeutic Goods Administration, Department of Health and Aged Care.

Gene Technology Regulations 2007

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