Technical Review of the Gene Technology Regulations 2001 – call for submissions

Overview

The Gene Technology Regulations 2001, enacted to regulate genetically modified organisms (GMOs) in Australia, have been the subject of a technical review by the Gene Technology Regulator (OGTR). This review aims to provide clarity on the regulatory status of organisms developed using new technologies and ensure that such technologies are regulated proportionately to their risk profile. It was enacted by the Parliament of Australia and its policy objective is to maintain the current policy settings of the gene technology regulatory scheme while adapting to new scientific understandings. The review is not permitted to alter the definition of ‘GMO’ in the Gene Technology Act 2000, but it can exclude or alter exclusions for specific techniques or organisms based on updated scientific evidence. Submissions on proposed amendments, supported by rationales and science-based arguments, are invited and will be published on the OGTR website, with confidential information appropriately redacted. Personal details will be removed for privacy reasons before publication.

Scope and Application

The Office of the Gene Technology Regulator (OGTR) is undertaking a technical review of the Gene Technology Regulations 2001, which applies to all entities and persons involved in the development, use, or release of genetically modified organisms (GMOs) in Australia. This includes researchers, developers, and industries involved in biotechnology and genetic engineering. The review aims to clarify whether organisms created using new technologies are subject to regulation as GMOs and to ensure that new technologies are regulated proportionately to the risks they present. The review is intended to maintain the current policy settings of the gene technology regulatory scheme, and thus cannot modify the definition of 'GMO' in the Gene Technology Act 2000. However, it may exclude specific techniques or organisms from regulation if they were not clearly addressed at the inception of the scheme, or alter exclusions if scientific understanding of the risks has evolved. The review is national in scope, affecting all jurisdictions within Australia. Submissions to the review can be made by email or mail and should address the consultation questions presented in the Discussion Paper available on the OGTR website, with all submissions to be supported by a rationale and, where possible, a science-based argument. Submissions will be published on the OGTR website after the consultation period, with confidential information treated accordingly and personal details removed for privacy reasons.

Key Provisions

The primary sections of the Gazette C2016G01367 pertain to the technical review of the Gene Technology Regulations 2001, which aim to clarify the regulation of genetically modified organisms (GMOs) in light of new technologies (section 1). This review, conducted by the Office of the Gene Technology Regulator (OGTR), seeks to determine whether organisms developed using new techniques are subject to the existing regulatory framework (section 2). The review cannot amend the definition of 'GMO' as stipulated in the Gene Technology Act 2000, but it can exclude certain techniques or organisms from regulation if they were not clearly addressed at the inception of the scheme, or alter existing exclusions based on updated scientific understanding (section 3). The Act imposes several obligations on the parties involved. Firstly, it requires the OGTR to maintain the current policy settings of the gene technology regulatory scheme, ensuring that any changes made are consistent with these policies (section 4). Submissions made to the OGTR must address the consultation questions presented in the Discussion Paper, and any proposals for amendments must be supported by a rationale and, ideally, a science-based argument (section 5). Additionally, all proposals must be submitted by 2 December 2016, and while submissions will be published on the OGTR website, confidential information can be treated as such if clearly marked and kept separate from non-confidential material (section 6). Failure to comply with the requirements of the Act may result in several consequences. While the Gazette does not explicitly state any specific offences or penalties for breaches, it is reasonable to infer that non-compliance with the submission requirements or the provision of confidential information could lead to administrative or legal repercussions. Such breaches might include the withholding of publication of the submission or potential legal action for mishandling confidential information. The precise nature of these consequences would likely be determined by the OGTR in accordance with relevant laws and regulations.