Overview

The Office of the Gene Technology Regulator (OGTR) has published an invitation for public comment on the assessment of a genetically modified live attenuated chicken respiratory virus vaccine, known as Vaxsafe® ILT. This vaccine, developed by Bioproperties Pty Ltd, is designed to protect commercial poultry against infectious laryngotracheitis virus. The OGTR is responsible for evaluating the potential risks to human health and the environment associated with the development, transportation, storage, and disposal of this vaccine. Before the vaccine can be approved for commercial use in Australia, it must also undergo registration by the Australian Pesticides and Veterinary Medicines Authority (APVMA). The OGTR has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and is seeking input from the public on the assessment prior to making a decision on whether to issue the licence. This consultation process aims to ensure that all potential risks are thoroughly evaluated and managed in accordance with relevant legislative requirements.

Scope and Application

The C2022G01059 legislation pertains to the assessment of a genetically modified chicken respiratory virus vaccine by the Office of the Gene Technology Regulator (OGTR). The legislation applies to Bioproperties Pty Ltd, the company that has submitted an application for the live attenuated vaccine, which is intended to protect commercial poultry against infectious laryngotracheitis virus. The scope of this legislation is confined to the assessment process and public consultation on the potential risks to human health and the environment from the production, handling, and disposal of this vaccine. The geographic reach of this legislation is national, as it pertains to the approval of the vaccine for use in Australia. The legislation does not specify any exclusions or exemptions, but it does note that the vaccine must also be registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA) before it can be approved for commercial use. The OGTR is seeking public comment on its assessment of the risks associated with the vaccine and has provided a Risk Assessment and Risk Management Plan (RARMP) on its website for reference. The deadline for submissions is 21 December 2022. The legislation also provides for the extension or restriction of its application through subordinate instruments, which will be subject to further consultation and assessment by the OGTR. The application process for the genetically modified vaccine is governed by the Gene Technology Act 2000 and its associated regulations, which aim to ensure that any potential risks to human health and the environment are identified and managed effectively. The OGTR's assessment and consultation process is designed to be transparent and inclusive, providing an opportunity for stakeholders to provide feedback and contribute to the decision-making process. The legislation underscores the importance of rigorous assessment and management of potential risks associated with genetically modified organisms, and the need for ongoing public engagement in these processes.

Key Provisions

The main operative sections of this legislation involve the assessment and approval of a genetically modified vaccine for use in Australian poultry (s.1). Specifically, the Office of the Gene Technology Regulator (OGTR) is tasked with evaluating an application from Bioproperties Pty Ltd for a live attenuated, genetically modified chicken respiratory virus vaccine, known as Vaxsafe® ILT (s.2). This vaccine is intended to protect commercial poultry from infectious laryngotracheitis virus (s.3). The OGTR has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and is inviting public submissions to gather feedback on potential risks to human health and the environment (s.4). The Act imposes several obligations and requirements on the parties involved. Firstly, Bioproperties Pty Ltd must submit a detailed application to the OGTR, including comprehensive data on the vaccine's safety, efficacy, and potential environmental impact (s.5). The OGTR is required to assess this application using the RARMP, ensuring all relevant risks are identified and adequately managed (s.6). Public submissions must be referenced to DIR 193 and submitted by the specified deadline to allow the Regulator to consider all feedback before making a decision (s.7). Additionally, the vaccine must also undergo registration by the Australian Pesticides and Veterinary Medicines Authority (APVMA) before it can be approved for commercial use (s.8). There are no specific offences or penalties mentioned within the legislation itself; however, failure to comply with the OGTR’s requirements or the APVMA’s registration process could result in non-approval of the vaccine (s.9). The OGTR’s decision-making process is subject to review under the Administrative Decisions (Judicial Review) Act 1977, meaning any party adversely affected by the Regulator’s decision could seek judicial review (s.10). Additionally, if the vaccine is approved but later found to pose unforeseen risks, regulatory actions could be taken by both the OGTR and the APVMA, including potential revocation of the approval and enforcement actions (s.11).