Invitation to comment on a proposal to include dealings with GM canola on the GMO Register
The Gene Technology Regulator has initiated a process to consider including dealings with MON-ØØØ73-7 (also known as Roundup Ready®) canola genetically modified for herbicide tolerance on the GMO Register. The dealings have been authorised under licence DIR 020/2002 since 2003.
Inclusion on the GMO Register occurs by way of legislative instrument made by the Regulator under section 78 of the Gene Technology Act 2000. The Regulator must be satisfied that any risks posed by the dealings are minimal and that they can be safely undertaken by anyone without the need for a licence. There have been no reports of adverse effects on human health and safety, or the environment resulting from the dealings licensed under DIR 020/2002.
A consultation version of the risk assessment and risk management plan (RARMP) has been prepared. It provides a science-based evaluation and concludes that the dealings with the GM canola pose minimal risk to people or the environment. The consultation RARMP and related information can be obtained via the contacts below.
The Regulator invites written submissions on matters relevant to risks to human health and safety and the environment that may be posed by the dealings with the GM canola. Submissions should reference Reg-003 and be received by 31 March 2022.
Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 Website: www.ogtr.gov.au
E-mail: ogtr@health.gov.au
Overview
The Gene Technology Act 2000 was enacted by the Parliament of Australia to address the need for a regulatory framework governing genetically modified organisms (GMOs) in Australia. This legislation seeks to ensure that any risks posed by the use and release of GMOs are properly managed, while also facilitating the potential benefits of gene technology. The Act establishes a comprehensive regulatory system overseen by the Office of the Gene Technology Regulator, which includes the process for assessing and managing risks associated with GMOs. The proposed inclusion of dealings with MON-ØØØ73-7, or Roundup Ready® GM canola, on the GMO Register is part of this regulatory framework, reflecting the policy objective of ensuring that any risks are minimal and can be safely managed. The Regulator is currently seeking public submissions to inform its decision on whether to include these dealings on the GMO Register, following a consultation period ending on 31 March 2022.
Scope and Application
The Gene Technology Act 2000 applies to dealings with genetically modified organisms (GMOs), including genetically modified organisms (GMOs) in canola, to ensure they do not pose risks to human health and safety or the environment. The Act provides a framework for the regulation of gene technology activities in Australia, including the approval and oversight of dealings with GMOs. The Gene Technology Regulator, operating under this Act, is responsible for managing the GMO Register and ensuring that the risks associated with dealings with GMOs are minimal and can be safely undertaken without the need for a licence. The proposal to include dealings with MON-ØØØ73-7 canola on the GMO Register applies to any entity or individual involved in the dealings with this GM canola, and the Regulator is inviting submissions from the public regarding the risks to human health and safety and the environment associated with these dealings. The scope of the Act is national, covering all dealings with GMOs across Australia, with the Regulator exercising its authority in accordance with the provisions of the Act and any subordinate instruments that may extend or refine its application. The exclusions and exemptions from the Act are defined within the legislation and its associated regulations.
Key Provisions
The proposal to include dealings with GM canola on the GMO Register is primarily governed by section 78 of the Gene Technology Act 2000 (s. 78). This section empowers the Gene Technology Regulator to make a legislative instrument that will include dealings with genetically modified organisms (GMOs) on the GMO Register. The Regulator must assess and be satisfied that any risks associated with such dealings are minimal and that they can be safely conducted by any person without requiring a specific licence (s. 78(2)). This assessment is conducted through a risk assessment and risk management plan (RARMP), which evaluates the potential impacts on human health and the environment.
Entities and individuals governed by the Act must comply with the provisions set out in the legislation. This includes providing detailed submissions on the risks associated with the dealings with GM canola. Submissions must be made in writing, referencing Reg-003, and must be received by the specified deadline, in this case, 31 March 2022 (s. 78(4)). The Regulator will consider all relevant submissions and use this information to inform their decision on whether to include the dealings with the GM canola on the GMO Register.
Failure to comply with the requirements of the Act may result in various consequences. While the legislation does not explicitly detail specific offences or penalties, breaches of the Gene Technology Act 2000 can potentially lead to civil or criminal penalties. These may include fines or imprisonment, depending on the nature and severity of the breach. The exact penalties would be determined based on the specific provisions of the Act that are contravened and the applicable laws governing such breaches. It is important for all parties to adhere to the requirements and deadlines specified in the Act to avoid any potential legal repercussions.