17 May 2017
Invitation to comment on field trials of a
genetically modified (GM) vaccine for chickens
Australia’s gene technology regulatory system is designed to protect the health and safety of people and the environment by identifying risks posed by, or as a result of, gene technology and managing those risks.
The Gene Technology Regulator is currently assessing licence application DIR 154 from Bioproperties Pty Ltd. The application is for field trials, under limited and controlled conditions, of a live attenuated GM vaccine, Vaxsafe® ILT, for the protection of chickens against infectious laryngotracheitis virus. The purpose of the trials is to assess the efficacy and safety of the vaccine under farm conditions.
The trials are proposed to take place on selected chicken farms in New South Wales and Victoria, over a 5 year period. As is common in veterinary vaccine trials, the vaccinated chickens could enter general commerce, including use in human food or animal feed.
Use of veterinary products also requires approval by the Australian Pesticides and Veterinary Medicines Authority (APVMA). The APVMA has issued a permit to Bioproperties Pty Ltd to allow the supply and limited use of the GM vaccine for the purposes of conducting research.
A consultation Risk Assessment and Risk Management Plan (RARMP) has been prepared, which concludes that the proposed release would pose negligible risk to human health and safety or to the environment. A range of draft licence conditions would limit the scale, location and duration of the release, as well as restrict the spread and persistence of the GMO and the introduced genetic material.
The Regulator welcomes written submissions in order to finalise the RARMP, which will then inform the decision on whether or not to issue the licence. The consultation RARMP and related documents can be obtained from the OGTR website under What’s New or by contacting the Office. Please quote application DIR 154 in any correspondence.
Submissions should be received by close of business on 27 June 2017.
Office of the Gene Technology Regulator, MDP 54, GPO BOX 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 Facsimile: 02 6271 4202 E-mail: ogtr@health.gov.au
OGTR website www.ogtr.gov.au
Overview
The Gene Technology Act 2000, enacted by the Australian Parliament, aims to regulate the use of gene technology to safeguard human health and the environment. This Act was introduced to address the need for a robust framework governing the use and potential risks associated with genetically modified organisms (GMOs). The Office of the Gene Technology Regulator (OGTR) is responsible for overseeing the application process and ensuring compliance with the regulatory requirements. The policy objective of the Act is to facilitate the safe development and use of gene technology while mitigating any potential risks to public health and the environment. This Act provides a comprehensive legislative structure to manage the introduction and use of GMOs in Australia, ensuring that all activities involving gene technology are conducted under strict oversight and regulation.
Scope and Application
The scope of this legislation pertains to the proposed field trials of a genetically modified (GM) vaccine for chickens, specifically the live attenuated GM vaccine Vaxsafe® ILT, developed by Bioproperties Pty Ltd. This legislation applies to the entities involved in the research and trial process, including the applicant, Bioproperties Pty Ltd, as well as the regulatory authorities, the Gene Technology Regulator and the Australian Pesticides and Veterinary Medicines Authority (APVMA). The application and subsequent trials are geographically focused on selected chicken farms in New South Wales and Victoria, spanning a period of five years. The legislation is part of Australia's gene technology regulatory system, which aims to protect health, safety, and the environment by managing risks associated with gene technology. The Act does not specify exclusions or thresholds but does provide for the assessment and management of risks through a Risk Assessment and Risk Management Plan (RARMP). The RARMP outlines draft licence conditions to limit the release, spread, and persistence of the GMO and introduced genetic material. The legislation also allows for the consideration of public submissions to finalise the RARMP, which will inform the decision on whether to issue the licence.
Key Provisions
The primary provisions of this legislation are outlined in section 17 May 2017, where it is noted that the Gene Technology Regulator is assessing a licence application (DIR 154) from Bioproperties Pty Ltd for field trials of a genetically modified (GM) vaccine, Vaxsafe® ILT, intended to protect chickens against infectious laryngotracheitis virus (section 1). The trials, proposed to take place in New South Wales and Victoria over a five-year period, aim to evaluate the vaccine's efficacy and safety under farm conditions (section 1). Additionally, the Australian Pesticides and Veterinary Medicines Authority (APVMA) has issued a permit for the limited use of the GM vaccine for research purposes (section 1).
The legislation imposes certain obligations and requirements on Bioproperties Pty Ltd and other parties involved in the trials. These include the preparation of a consultation Risk Assessment and Risk Management Plan (RARMP) that assesses the risks to human health and the environment, and the implementation of draft licence conditions to limit the release scale, location, and duration, as well as restrict the spread and persistence of the GMO and introduced genetic material (section 1). Furthermore, Bioproperties Pty Ltd must comply with the APVMA permit conditions for the use of the GM vaccine (section 1).
In terms of penalties and consequences for breach, the legislation does not explicitly state penalties for non-compliance with the trial conditions or APVMA permit. However, failure to adhere to the established regulatory framework and permit conditions could lead to legal consequences, including revocation of the permit, suspension or cancellation of the licence, and potential civil or criminal liability for any harm caused to human health or the environment (section 1). The exact penalties would depend on the nature and severity of the breach, as well as applicable laws and regulations.