13 November 2013

Decision


The Gene Technology Regulator (the Regulator) has decided to issue a licence for this application for a limited and controlled release of a genetically modified organism (GMO) into the environment. A Risk Assessment and Risk Management Plan (RARMP) for this application was prepared by the Regulator in accordance with requirements of the Gene Technology Act 2000 (the Act) and corresponding state and territory legislation, and finalised following consultation with a wide range of experts, agencies and authorities, and the public. The RARMP concludes that this field trial poses negligible risks to human health and safety and the environment and that any risks posed by the dealings can be managed by imposing conditions on the release.

The application



Application numberDIR 123
ApplicantNuseed Pty Ltd
Project titleLimited and controlled release of canola genetically modified for altered oil content
Parent organismCanola (Brassica napus L.)
Introduced genes and modified traits
  • Seven genes involved in the biosynthesis of omega-3 fatty acids (altered oil content for human nutrition, animal nutrition and food processing)1
  • one gene from a bacterium (selectable marker)
Proposed locationsSites are to be selected from 153 possible local government areas in NSW, Victoria and Western Australia
Proposed release sizeUp to four sites in 2014 (maximum of 2 hectares per site), six sites in 2015 (maximum of 10 ha per site) and up to ten sites in each subsequent year (maximum of 20 ha per site)
Proposed release datesMarch 2014 – March 2019
Primary purposeTo evaluate the agronomic characteristics, oil content and genetic stability of the GM canola under field conditions.

Omega-3 fatty acids are oil constituents that are considered to have health benefits for humans, especially the long chain omega-3 fatty acids. The main sources of long chain omega-3 fatty acids in the human diet are oily fish, other fish and seafood. The genetic modification is expected to allow the GM canola to produce these oils. Nuseed proposes to undertake some small-scale animal feeding experiments with GM material produced during this trial. If this project is successful, in the long term Nuseed may investigate the use of material from GM canola lines as supplements for use in animal feed and human food.

Risk assessment


The risk assessment concludes that risks to the health and safety of people, or the environment, from the proposed release are negligible.

The risk assessment process considered how the genetic modification and proposed activities conducted with the GMOs might lead to harm to people or the environment. Risks were characterised in relation to both the seriousness and likelihood of harm, taking into account information in the application (including proposed limits and controls), relevant previous approvals and current scientific/technical knowledge. Both the short and long term were considered.

Credible pathways to potential harm that were considered included: unintended exposure to the GM plant material; unintended effects of the genetic modification; increased spread and persistence of the GM canola relative to unmodified plants; and transfer of the introduced genetic material to non-GM canola or other sexually compatible plants. Potential harms associated with these pathways included toxicity to people and other animals, allergic reactions in people and environmental harms associated with weediness. No new risks to people or the environment were identified from the advice received on the consultation RARMP.

The principal reasons for the conclusion of negligible risks are that the proposed limits and controls effectively contain the GMOs and their genetic material and minimise exposure; the introduced genetic modifications are unlikely to cause harm to people or the environment; and genes similar to the introduced genes are common in the environment.

Risk management plan

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The risk management plan concludes that risks posed by the proposed dealings can be managed so as to protect people and the environment by imposing conditions on the release.

Risk management is used to control or mitigate risk. The risk management plan evaluates and treats identified risks, evaluates controls and limits proposed by the applicant, and considers general risk management measures. The risk management plan is given effect through licence conditions.

As the level of risk is assessed as negligible, specific risk treatment is not required. However, as this is a limited and controlled release, the licence includes limits on the size, locations and duration of the release, as well as controls including containment provisions at the trial sites; prohibiting the use of GM plant materials in human food; allowing use for animal feed only under experimental conditions; destroying GM plant materials not required for further studies; transporting GM plant materials in accordance with the Regulator’s guidelines; and conducting post-harvest monitoring at the trial sites to ensure all GMOs are destroyed.


1The identities of the genes have been declared Confidential Commercial Information (CCI) under section 185 of the Act.