Invitation to Comment on PROPOSAL to include dealings with CUT FLOWERS OF genetically modified carnations on the GMO Register
The Gene Technology Regulator (the Regulator) has received an application from International Flower Developments Pty Ltd (IFD) to include dealings with genetically modified (GM) blue carnations on the GMO Register. If approved, it will not be necessary for people undertaking dealings with the GM blue carnations to hold or be covered by a GMO licence.
In 2015, the Regulator issued licence DIR 134 to IFD for the commercial release of GM blue carnations, which authorised the import, transport and disposal of cut flowers Australia-wide. In the current application, IFD is seeking to have the same dealings included on the GMO Register. Inclusion on the GMO Register occurs by way of legislative instrument made by the Regulator under section 78 of the Gene Technology Act 2000.
For these dealings to be included on the GMO Register, the Regulator must be satisfied that any risks posed by the dealings are minimal and that that the dealings are sufficiently safe to be 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 licenced under DIR 134.
A consultation version of the risk assessment and risk management plan (RARMP) has been prepared for this application. The consultation RARMP provides a science-based evaluation and concludes that the dealings with the GM carnations pose negligible risk to people or the environment. The consultation RARMP is available on the OGTR website under ‘What’s New’ or by contacting the OGTR (see below). The RARMP and licence for DIR 134 and ‘The biology of Dianthus caryophyllus L. (carnation)’ are also available on the website.
The Regulator is seeking additional information and invites written submissions on matters relevant to risks to human health and safety and the environment that may be posed by the dealings with GM blue carnations proposed for inclusion on the GMO Register. Please quote the reference number Reg-002 in any correspondence. Submissions should be received by close of business on 25 March 2020.
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 to provide for the regulation of gene technology in Australia, addressing the need for a framework that balances the potential benefits of genetically modified organisms (GMOs) with the protection of human health and the environment. The Act was introduced by the Australian Parliament to establish a regulatory scheme that ensures the safe use, handling, and release of GMOs. One of the key policy objectives of the Act is to minimise risks to human health and the environment while facilitating the development and use of gene technology. The Office of the Gene Technology Regulator (OGTR), which operates under the auspices of the Act, is responsible for assessing applications and determining whether certain dealings with GMOs can be conducted without the need for a licence. This involves a rigorous evaluation process to ensure that any risks associated with the dealings are minimal. The Act empowers the Regulator to include dealings with certain GMOs on the GMO Register, thereby exempting them from the need for a licence, provided the Regulator is satisfied that the dealings pose negligible risk.
Scope and Application
The proposed amendment to the GMO Register under the Gene Technology Act 2000 applies to dealings with genetically modified cut flowers of blue carnations developed by International Flower Developments Pty Ltd (IFD). This Act is a Commonwealth legislation that regulates the use and handling of genetically modified organisms (GMOs) in Australia, aiming to ensure that any risks to human health and the environment are minimised. The Regulator's decision to potentially exempt these dealings from the need for a GMO licence hinges on the assessment that the risks associated with handling and dealing with these genetically modified carnations are minimal. This proposal extends to the entire Australian jurisdiction, and its implementation would affect anyone involved in the import, transport, and disposal of these GM carnations. The exclusion from requiring a GMO licence for these dealings, if approved, would streamline the regulatory process for IFD and potentially other entities involved in similar activities. The consultation process invites submissions from interested parties to provide additional insights on any potential risks, ensuring a thorough evaluation before any legislative amendments are made.
Key Provisions
The main provisions of the proposal outlined in the Gazette, C2020G00137, revolve around the inclusion of dealings with genetically modified (GM) blue carnations on the GMO Register. This proposal, submitted by International Flower Developments Pty Ltd (IFD) to the Gene Technology Regulator (Regulator), seeks to exempt these dealings from requiring a GMO licence (section 78 of the Gene Technology Act 2000). If approved, this would mean that any individual or entity dealing with these GM carnations could do so without needing a specific licence. This proposal stems from a previous licence, DIR 134, issued in 2015, which authorised the import, transport, and disposal of these flowers across Australia. This current application aims to expand that licence to include the same dealings on the GMO Register.
The obligations placed on the parties by this Act include a thorough risk assessment and management plan (RARMP), which must be scientifically evaluated and concluded to pose negligible risk to human health and safety and the environment. This plan, which is available for consultation on the Office of the Gene Technology Regulator (OGTR) website, plays a crucial role in determining whether the dealings with these GM carnations can be deemed safe and low-risk. The Regulator is mandated to ensure that these dealings are sufficiently safe and that any risks are minimal before including them on the GMO Register. Furthermore, the Regulator must consider any additional information and written submissions received from the public on this matter.
The legislation also outlines the consequences for non-compliance. While the specific civil or criminal penalties for breaches of the Gene Technology Act 2000 are not detailed in this particular proposal, it is understood that breaches of the Act can result in significant penalties. These may include fines and, in severe cases, imprisonment. The exact penalties would depend on the nature and severity of the breach. The Regulator has the authority to take enforcement actions against any entity or individual found to be in violation of the Act, ensuring compliance with the stipulated guidelines and safety measures.