BackgroundWhilst a number of genetically modified organisms (GMOs) are approved for commercial release in Australia (a carnation, a number of varieties of cotton and two varieties of canola), a far greater number and type of GMOs are approved for commercial use overseas.
Worldwide, there are approximately 80 different types of GM crops that have been approved for commercialisation in 16 countries. Most of these GMOs are different modifications to the four main crops: canola, soybean, maize and cotton. However, other commercially released crops include papaya, potato, squash, and tomato.
There is a potential for unapproved GMOs to gain entry into Australia by appearing as trace amounts in conventional imports leading to the ‘unintended presence’ (UP) of GMOs.
In 2002 an inter-departmental Working Group on Unintended Presence was formed to manage Unintended Presence of Unapproved GMOs. The Working Group had representation from the major Australian Government agencies responsible for this issue, including Biotechnology Australia, the Department of Environment and Heritage, the Department of Agriculture, Fisheries and Forestry, the Department of Foreign Affairs and Trade, FSANZ and the OGTR.
It was agreed that seeds imported for sowing should be addressed as a priority with other potential sources of unintended presence to follow according to the risks they present.
An Unintended Presence strategy was developed by the Working Group and approved by the Biotechnology Ministerial Council in May 2005.
The StrategyThree main overarching principles were used to guide development of this strategy:
- industry co-regulation;
- isolation of risks offshore, and;
- government monitoring to focus on highest risk imports.
This strategy is made up of six practical components:
|Risk profiling – identifying seed imports posing the highest likelihood of unintended presence||The OGTR has established a memorandum of understanding with AQIS to access data on imports. Data on imported seeds for sowing, together with information on overseas commercial production of GMOs and input from the Department of Environment, Water, Heritage and the Arts, and other relevant agencies was used to identify eight priority crops. Four additional crops that may pose a higher likelihood of unintended presence were subsequently identified.||Quality assurance/identity preservation||Industry uses quality assurance and identity preservation systems for seed quality purposes. The OGTR has developed a program for auditing and testing industry quality assurance systems that industry has agreed and adopted.|
|Laboratory testing||The OGTR’s voluntary code of conduct refers to industry testing programs. Industry needs to be able to assure itself that it is managing the risk of importing unapproved seeds. Discussions between the OGTR and the National Measurement Institute about appropriate testing methodologies are ongoing.|
|Approvals/advance risk assessments for Australia’s regulatory agencies||The OGTR has prepared GMO incident response documents for 12 crops identified through risk profiling as having the highest likelihood of unintended presence in imports of seeds for sowing (canola, cotton, maize, potato, tomato, papaya, soybean, squash, alfalfa, grasses, rice and wheat). These documents will provide a basis for rapid risk assessment and management actions should an unintended presence of an unapproved GMO be detected.|
|Post market detection||The OGTR recognises the legislative limitations of preventing unintended imports of unapproved GMOs and has worked cooperatively with industry to develop a voluntary code. The code aims to isolate risks as early as possible in the commercial seed supply chain. In 2007 the OGTR inspected a number of the larger seed breeding operations (Bayer CropSciences Pty Ltd, Pacific Seeds Pty Ltd, Pioneer Hi-Bred Australia Pty Ltd, HSR Group Pty Ltd and Syngenta Seeds Pty Ltd). This allowed the OGTR to build its knowledge base of the industry and the QA systems used by the major players. These inspections focused on canola as the ASF had already developed GM testing protocols for this crop. In 2008 the OGTR and the Australian Seed Federation assessed the effectiveness of the first stage of reviews completed in 2007, noting that no issues of concern were identified for the five companies participating in the quality assurance reviews. The OGTR is continuing work with the Australian Seed Federation to expand the quality assurance review program as needed. These activities are supported by the standard OGTR practice of investigating information about potential and possible incidents.|
|Enforcement action||In the event of detection of unapproved GMOs, appropriate responses would be determined on a case-by-case risk management basis. The OGTR continues consultation with Australian Government agencies, relevant industry organisations and states and territories to develop an incident response plan.|
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What should an organisation do if they find an unintended presence of an unapproved GMO in their breeding program?It is important that organisations contact the OGTR as soon as possible. The GT act was amended in 2007 to include a provision for the Regulator to issue an “Inadvertent Dealing” licence. If the Regulator is satisfied that a person has come into possession of a GMO inadvertently the Regulator may, with the agreement of the person, treat the person as having made an inadvertent dealings application under section 40A of the Gene Technology Act 2000 (the Act). A person may also apply for a licence under section 40 of the Act in respect of an inadvertent dealing. The Regulator may issue a temporary licence (no longer than 12 months) to the person for the purposes of disposing of the GMO in a manner which protects the health and safety of people and the environment. Consideration of Inadvertent Dealings applications follows simpler process than required for other application types.
Pro-active regulatory option
There is an option for organisations to become part of the gene technology regulatory scheme to provide them with a more flexible approach to the management of any unintended presence of unapproved GMOs should that occur. This option would in effect give them prior approval to deal with (ie grow) the GMO, as long as that dealing was undertaken in an appropriate standard plant house.
To be able to use this option organisations would need to meet some requirements under the GT Act prior to becoming aware of the presence of the unapproved GMO.
These requirements are:
- have an appropriate plant house certified as a PC2 Plant House;
- have access to an Institutional Biosafety Committee,
- have the IBC assess the NRLD to ensure that it meets the statutory requirements for the future conduct of Notifiable Low Risk Dealings
Frequently Asked Questions:What traits should I be testing for?
The OGTR keeps a list of GMOs that are approved for commercial production in Australia
Any trait that is not listed there is not approved for commercial release. Organisations may choose to initially conduct screening tests for general GM content, ie tests that identify the main promoters used in development of GMOs. If a GMO is identified then it may be necessary to identify the particular trait to determine if it is approved for production in Australia or not.
What do I do if I find that there is GMO content in my conventional seed?
Contact the OGTR as soon as possible. Knowingly dealing with a GMO is an offence unless the GMO is approved or otherwise authorised. We can help you work through the options available to you.
Can’t I just destroy the GM plant/s?
Once you know that the plant is a GM plant, it is an offence under the Gene Technology Act 2000, to conduct any dealing with the GMO which includes destruction of the GMO.
But the GMO is already growing, so isn’t that an offence as well?
Yes it is, however as you did not know it was a GMO when you started growing it, and if you have contacted the OGTR when you first identified that it was a GMO, you will have taken reasonable steps to meet your legal obligations in those circumstances. The OGTR can then issue an inadvertent dealing licence to legalise any dealings until the destruction of the GMO.
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