Proposed minor and technical amendments to the Gene Technology Regulations 2001

Closed 8 Dec 2024

Opened 11 Nov 2024

Contact

Office of the Gene Technology Regulator

ogtr@health.gov.au

Feedback updated 2 Apr 2025

We asked

Australia’s National Gene Technology Scheme for the regulation of genetically modified organisms is comprised of the Commonwealth Gene Technology Act 2000 and Gene Technology Regulations 2001 (the Regulations), and corresponding State and Territory laws.

The Gene Technology Regulator sought the views of anyone likely to be affected by proposed minor and technical amendments to the Regulations.

A consultation paper was published online to assist interested stakeholders in addressing the consultation questions.

You said

During the 4-week consultation period, a total of 15 submissions were received from the research sector (universities, research institutes and researchers), agriculture-related peak bodies, government agencies, one company and one non-government organisation.

Submitters generally indicated they would benefit from improved clarity in the legislation.

Submitters that are regulated under the Act indicated that their regulatory burden would be either unchanged or reduced as a result of the amendments, for example, through improved clarity of regulatory requirements.

Although the amendment proposals received varying degrees of support from submitters, the issues raised by submitters did not warrant changes to the proposals.

We did

We analysed the feedback provided during the public consultation process and took into account submitter suggestions to improve clarity in finalising the Gene Technology Amendment (Minor Measures) Regulations 2025.

Following approval by the Gene Technology Ministers’ Meeting, the amendments to the Regulations were made by the Governor-General and commenced on 26 February 2025.

Overview

The Gene Technology Regulator (the Regulator) is consulting to seek the views of anyone likely to be affected by the proposed minor and technical amendments to the Gene Technology Regulations 2001 (the Regulations) described in the following pages. Feedback is specifically sought on whether the proposed minor and technical amendments described below would sufficiently improve clarity in the legislation, and on the impact the proposed amendments would have on regulated stakeholders.

This consultation is not seeking to identify additional aspects of the Regulations to amend. Concurrently, the Department of Health and Aged Care (the Department) is continuing to progress legislative changes to complete implementation of the Third Review of the Scheme[1]. A draft Gene Technology Amendment Bill was the subject of a recent consultation[2], and the Department will be consulting separately in due course on amending regulations. Policy changes should be pursued through the Department’s process, and the Regulator only proposes technical amendments to improve clarity and certainty in the legislation in the meantime.

The full text of the consultation can be found in the paper below. You can use this document to inform your consideration of the proposals before providing your submission through this platform.

 

What happens next

Submissions received through this consultation process will be taken into account by the Regulator in drafting and finalising the proposed amendments. A summary of submissions and general response to the issues raised will be published by the Office of the Gene Technology Regulator (OGTR).

The Regulator will provide advice to the Gene Technology Ministers’ Meeting regarding the finalised amendment proposals, as required by clause 40 of the Intergovernmental Gene Technology Agreement. If there is agreement, the OGTR would commence the Commonwealth regulation-making process. Throughout this process OGTR would keep regulated stakeholders up to date with any developments that might affect them, and post updates on the OGTR website.

Audiences

  • Academics
  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Local governments
  • General public
  • Community groups
  • Businesses
  • Biogicals

Interests

  • Legislation
  • Regulatory policy
  • Food standards
  • Environmental health
  • Health and Medical Research