Gene Technology Amendment Regulations 2025 (Vic)

Gene Technology Amendment Regulations 2025

S.R. No. 51/2025

TABLE OF PROVISIONS

Regulation  Page

1Objective

2Authorising provision

3Principal Regulations

4Functions of the Regulator

5Prescribed authorities

6Review of decisions

7Schedule 1A—Techniques that are not gene technology

8Schedule 1—Organisms that are not genetically modified organisms

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Endnotes

STATUTORY RULES 2025

S.R. No. 51/2025

Gene Technology Act 2001

Gene Technology Amendment Regulations 2025

The Governor in Council makes the following Regulations:

Dated: 17 June 2025

Responsible Minister:

MARY-ANNE THOMAS
Minister for Health

ANGELA SMITH

Clerk of the Executive Council

1Objective

The objective of these Regulations is to amend the Gene Technology Regulations 2021 to make minor and technical changes consistent with changes made to the Gene Technology Regulations 2001 of the Commonwealth.

2Authorising provision

These Regulations are made under section 193 of the Gene Technology Act 2001.

3Principal Regulations

In these Regulations, the Gene Technology Regulations 2021[1] are called the Principal Regulations.

4Functions of the Regulator

For the note at the foot of regulation 5A of the Principal Regulations substitute—

"Note

Regulation 5A of the Commonwealth Regulations sets out the Regulator's functions of—

(a)making inspectors available to be appointed as inspectors under the National Health Security Act 2007 of the Commonwealth; and

(b)making inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.".

5Prescribed authorities

In regulation 9 of the Principal Regulations—

(a)for paragraph (d) substitute—

"(d)  that part of the Department of Health and Aged Care of the Commonwealth known as the Australian Industrial Chemicals Introduction Scheme;";

(b)in paragraph (f), after "Health" insert "and Aged Care".

6Review of decisions

In the note at the foot of regulation 38 of the Principal Regulations, for "the Administrative Appeals Tribunal" substitute "the Administrative Review Tribunal".

7Schedule 1A—Techniques that are not gene technology

(1)For item 1 in the table in Schedule 1A to the Principal Regulations substitute—

"1

Either of the following transfers, if the transfer does not involve genetically modified material—

(a)   nuclear transfer;

(b)   transfer of plastids or mitochondria.".

(2)For item 11 in the table in Schedule 1A to the Principal Regulations substitute—

"11

Introduction of nucleic acid or nucleic acid analogue into an organism, if—

(a)   the introduction of the nucleic acid or nucleic acid analogue does not result in an alteration of the organism's genome sequence; and

(b)   the introduction of the nucleic acid or nucleic acid analogue cannot give rise to an infectious agent; and

(c)   in the case of nucleic acid or nucleic acid analogue that is DNA—the DNA cannot be transcribed.".

8Schedule 1—Organisms that are not genetically modified organisms

(1)In item 6 in the table in Schedule 1 to the Principal Regulations—

(a)for "An organism" substitute "A micro‑organism";

(b)in paragraph (b), for "vector" substitute "exchanged".

(2)In item 10 in the table in Schedule 1 to the Principal Regulations, for "no longer present" substitute "either no longer present or are epigenetic".

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ENDNOTES

[1] Reg. 3: S.R. No. 94/2021.