7 December 2016
Invitation to comment on a genetically modified (GM) potato field trial
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 150 from the Queensland University of Technology. The application is for a field trial (limited and controlled release) of potato genetically modified for disease resistance. The purpose of the field trial is to assess the agronomic characteristics and disease response of the GM potato plants under field conditions.
The trial is proposed to take place at one site of up to 0.1 hectares in Redlands Research Facility in Redland City, Queensland, from February 2017 to January 2019. The GM potatoes would not be used in human food or animal feed.
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 size, location and duration of the release, as well as restrict the spread and persistence of the GMOs 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 150 in any correspondence.
Submissions should be received by close of business on 17 January 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, establishes a regulatory framework to manage the risks associated with gene technology, ensuring the protection of human health and the environment. The Act empowers the Gene Technology Regulator to assess and licence activities involving genetically modified organisms, including field trials of genetically modified plants. In this instance, the Regulator is evaluating an application from the Queensland University of Technology for a field trial of genetically modified potatoes aimed at enhancing disease resistance. The trial, intended for a site in Redland City, Queensland, is intended solely for research purposes and does not involve the use of the potatoes in food or feed. The proposed trial period spans from February 2017 to January 2019. A consultation process is underway to finalise the Risk Assessment and Risk Management Plan (RARMP) which aims to confirm the negligible risk to human health and the environment posed by the trial. The public is invited to submit comments to the Office of the Gene Technology Regulator to contribute to the decision-making process regarding the issuance of the licence.
Scope and Application
The legislation C2016G01594 pertains to the assessment and regulation of genetically modified (GM) organisms under Australia's gene technology regulatory system, which is primarily concerned with safeguarding the health and safety of individuals and the environment. This specific piece of legislation applies to the application by the Queensland University of Technology for a field trial of a genetically modified potato designed to exhibit resistance to disease. The scope of this legislation is targeted at the entities and individuals involved in the research and development of genetically modified organisms, as well as the Gene Technology Regulator, who is responsible for evaluating the risks and issuing the necessary licences for such activities. The geographic reach of this Act is national, with the field trial in question proposed to take place in Queensland, yet the overarching regulatory framework is administered at the federal level by the Office of the Gene Technology Regulator. The application of this Act does not specify any exclusions, exemptions, or thresholds other than the controlled and limited nature of the field trial itself, which is intended to be confined to a specific location and duration, with strict conditions to govern the trial's execution and the containment of the genetically modified organisms.
Key Provisions
The main operative sections of this piece of legislation pertain to the assessment and regulation of a genetically modified (GM) potato field trial. Section 38 of the Gene Technology Act 2000 governs the application process for a field trial, which is currently being evaluated by the Gene Technology Regulator (GTR) in relation to licence application DIR 150. This application, submitted by the Queensland University of Technology, seeks permission for a limited and controlled release of GM potatoes for the purpose of assessing their agronomic characteristics and disease response under field conditions. The proposed trial is set to occur at a site of up to 0.1 hectares in the Redlands Research Facility in Redland City, Queensland, from February 2017 to January 2019. It is important to note that the GM potatoes will not be used for human food or animal feed.
The obligations and requirements imposed by the Act on the parties involved include the preparation and submission of a consultation Risk Assessment and Risk Management Plan (RARMP) to the GTR. This RARMP, which has been drafted in this case, concludes that the proposed release would pose negligible risk to human health and safety or to the environment. The draft licence conditions outlined in the RARMP aim to limit the size, location, and duration of the release, as well as restrict the spread and persistence of the GMOs and the introduced genetic material. The GTR is required to assess the RARMP and any written submissions received from the public in order to make an informed decision on whether or not to issue the licence.
Any breach of the provisions outlined in the Gene Technology Act 2000 may result in civil or criminal consequences, including offences and penalties. Section 101 of the Act outlines the possible penalties for non-compliance, which may include fines of up to AUD 1.1 million for individuals and AUD 5.5 million for corporations, as well as imprisonment for up to five years. Additionally, the GTR may impose administrative penalties, such as fines, for breaches of licence conditions or failure to comply with the Act. These penalties are intended to enforce compliance and ensure that the risks associated with gene technology are properly managed to protect the health and safety of people and the environment.