Proposed Amendments to the Gene Technology Regulations 2001
Feedback updated 18 Jun 2026
We asked
Between 5 January and 1 May 2026, the Department of Health, Disability and Ageing sought your feedback on proposed approach to making changes to the Gene Technology Regulations 2001. A consultation paper outlining the policy intent for making changes to the regulations was published alongside supporting factsheets to help stakeholders respond to the consultation questions.
To support stakeholder engagement and understanding, an online information session was held on 6 February 2026 to explain the proposed approach to making changes and answer questions. Stakeholders could also ask questions by email or request a meeting, and we published a summary of questions and answers on the consultation hub.
The proposed changes to the regulations are part of the broader legislative reform arising from the Third Review of the National Gene Technology Scheme.
You said
Over 700 subscribers to the National Gene Technology Scheme were directly invited to participate in this consultation, in addition to announcements shared by state and territory governments and the Office of the Gene Technology Regulator.
The 8-week consultation period generated strong engagement, with 50 submissions across regulated organisations, research entities, peak bodies, government agencies, institutional biosafety committees, universities, and members of the public.
A majority of the submissions supported key elements of the proposed changes, including the structural amendments to the regulations, updated definitions, changes to the risk assessment and risk management plan process (RARMPs) and the new risk tiering system (including GMO permits).
The feedback received also identified several areas for further consideration. Some submissions raised concerns about the proposed 12‑month commencement period and the acronyms for some authorised dealing classes. Stakeholders also sought greater clarity on transitional arrangements, the proposed inclusion of certain gene edited plants on the GMO Register, and the application of the reforms in clinical, therapeutic and veterinary contexts. Most submissions suggested that additional guidance materials would help regulated stakeholders adapt to the proposed reforms.
A small number of submissions raised issues that were outside the scope of this phase of consultation, were general in nature, or had already been considered in earlier consultation phases for these reforms.
We did
We have analysed the feedback received through the consultation and are working with the Office of the Gene Technology Regulator, the Gene Technology Standing Committee and relevant government agencies to finalise the policy and drafting of the Gene Technology Amendment Regulations.
The feedback will also inform the development of future communications and educational materials to help stakeholders understand and transition to the proposed approach.
We thank all individuals and organisations who provided a submission to this consultation. Your input has played an important role in shaping the reform process and will help ensure that gene technology is regulated and managed in a way that is fit-for-purpose and proportionate to risk.
Published responses
View submitted responses where consent has been given to publish the response.
Overview
We would like to thank all the stakeholders that took part in public consultation on the proposed amendments to the Gene Technology Act 2000 (GT Act) that occurred in late 2024.
Amendments to the Gene Technology Regulations 2001 (GT Regulations) are the next step in implementing the legislative reforms to underpin implementation of the remaining recommendations of the Third Review. The proposed amendments will ensure the National Gene Technology Scheme (the Scheme) maintains flexibility to deal with future developments and challenges.
Consultation with stakeholders is important in the development of legislation. It provides an opportunity for affected industries, regulated entities, academic institutions, researchers, and interested members of the public to review the proposed amendments to the legislation and consider how they may be impacted.
Consultation responses should be provided via the survey in the consultation hub. Where possible, reasoning and supporting information should be included. Providing responses via the survey in the consultation hub will ensure that input can be effectively considered against the relevant proposed amendments.
It is recommended that the questions in this consultation are considered in conjunction with the provided consultation paper, which describes the key amendments in detail, and provides context to the proposed changes.
An information sheet on the proposed authorisation pathways has been included to support understanding of how certain dealings with GMOs may be treated under the new regulations. This is described in Part 3 of the consultation paper and can be downloaded below.
Please note that the proposed approach to amending the GT Regulations will be further refined following this consultation where appropriate or necessary in response to feedback on the consultation paper.
You do not have to provide a response to all questions - only those that you wish to provide relevant feedback on.
Why your views matter
Participation in this consultation provides stakeholders with an opportunity to contribute to the development of regulations that may affect them. Engaging in the consultation process allows individuals, organisations, and institutions to:
- Provide informed feedback on the proposed amendments;
- Identify potential implications for their sector, operations, or community;
- Support the creation of balanced and effective regulation through evidence-based input.
Stakeholder contributions are a important component of transparent and inclusive policy development. All submissions will be carefully considered to ensure the final regulations are well-informed and appropriately targeted.
What happens next
Thank you to all stakeholders who provided their views on the proposed policy approach for making changes to the Gene Technology Regulations 2001 (GT Regulations). This consultation is now closed.
Consultation on the proposed policy approach to amending the GT Regulations was open between 5 January and 1 May 2026. The submission feedback will help inform drafting of the Gene Technology Amendment Regulations before being considered by gene technology ministers.
Stay up to date with developments on these important legislative reforms by subscribing to the National Gene Technology Scheme mailing list.
Audiences
- Academics
- Biogicals
- Businesses
- Commonwealth agencies
- Community groups
- General public
- Local governments
- Non-government organisations
- State government agencies
Interests
- Food standards
- Health and Medical Research
- Health technology
- Legislation
- Regulatory policy
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