8.1 Australian approvals of InVigor® x Roundup Ready® canola and related GMOs

8.1.1 Previous releases approved by the Gene Technology Regulator or authorised by the Genetic Manipulation Advisory Committee

246. InVigor® x Roundup Ready® canola has been approved by the Regulator for limited and controlled release (field trials) under licences DIR 069/2006 and DIR 104.

247. Field trials of InVigor® canola began in Australia in 1996. The first field trials were overseen by the Genetic Manipulation Advisory Committee (GMAC) as Planned Releases (PR) PR-62, PR-63 and their respective extensions. Under the current regulatory system, trials were subsequently approved by the Regulator under licence DIR 010/2001. Commercial release of InVigor® Hybrid canola was approved by the Regulator in 2003 under licence DIR 021/2002. As yet, InVigor® Hybrid canola has not been commercially grown in Australia.

248. Field trials of Roundup Ready® canola began in Australia in 1997. The trials were overseen by GMAC as PR-77 and associated extensions and were approved by the Regulator under licence DIR 011/2001. Commercial release of Roundup Ready® canola was approved by the Regulator in 2003 under licence DIR 020/2002. Commercial production began in New South Wales and Victoria in 2008 and in Western Australia in 2010.

249. In total, the Regulator has issued seven licences for the limited and controlled release of various GM canola lines (see www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ir-1). In addition, there have been field trials of GM canola lines with various traits under the former voluntary system overseen by the Genetic Manipulation Advisory Committee (GMAC) (see RARMP for DIR 103 for further detail).

250. There have been no credible reports of adverse effects on human health or the environment resulting from any of these releases.

8.1.2 Approvals by other Australian government agencies

251. Australia’s gene technology regulatory system operates as part of an integrated legislative framework that avoids duplication and enhances coordinated decision making. The Regulator is responsible for assessing risks to the health and safety of people and the environment associated with the use of gene technology. However, dealings conducted under a licence issued by the Regulator may also be subject to regulation by other Australian government agencies that regulate GMOs or GM products, including Food Standards Australia New Zealand (FSANZ), Australian Pesticides and Veterinary Medicines Authority (APVMA), Therapeutic Goods Administration (TGA), National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and Australian Quarantine Inspection Service (AQIS)1

252. FSANZ is responsible for human food safety assessment and food labelling, including GM food. FSANZ has approved the use of food derived from Roundup Ready® canola and the GM canola lines approved under licence DIR 021/2002 . These approvals are listed in the Schedule to Standard 1.5.2 of the Australia New Zealand Food Standards Code under Items 1.1 (RoundupReady®) and 1.2 (InVigor®). These approvals were gazetted in December 2000 and May 2002, respectively. FSANZ has determined that food derived from these GM lines of canola is as safe for human consumption as food derived from conventional canola (non-GM) varieties (ANZFA 2000; ANZFA 2001b). These approvals also cover InVigor® x Roundup Ready® canola.

253. APVMA has regulatory responsibility for the supply of agricultural chemicals, including herbicides and insecticidal products, in Australia. Bayer has been granted registration of glufosinate ammonium containing products for use on InVigor® canola (Liberty®) and Liberty Link® cotton (Liberty® 150 and Liberty® 200). Glufosinate ammonium containing products are not registered for use in any other broad-acre cropping in Australia. Glufosinate ammonium is also the active ingredient in the products Basta® and Finale® registered for weed control in horticultural and viticultural crops and in non-crop agricultural areas, commercial and industrial areas and rights-of-way.

254. Glyphosate is a broad-spectrum herbicide and is the active constituent of a range of proprietary herbicides registered by the APVMA, including Roundup Ready® herbicides for use on Roundup Ready® canola and Roundup Ready® cotton. Glyphosate has been registered for use in non-selective (general) weed control in broad-acre agriculture, horticulture and non-cropped areas including industrial areas and roadsides and is a widely used chemical in all these situations.

255. The APVMA have advised that amendments to the labels of glufosinate ammonium and glyphosate herbicide would be required for their use on commercial scale plantings of InVigor® x Roundup Ready® canola.

256. In addition, dealings authorised by the Regulator may be subject to the operation of State and Territory legislation declaring areas to be GM, GM free, or both, for marketing purposes. The Act allows for areas to be designated under State and Territory law for the purpose of preserving the identity of non-GM or GM crops for marketing purposes. Following the Regulator’s approval in 2003 of GM InVigor® canola and GM Roundup Ready® canola on human health and environmental safety grounds, all jurisdictions except Queensland and the Northern Territory enacted legislation to delay the commercial release of GM crops, including GM canola, until marketability, agricultural trade and segregation issues were better understood. Subsequently, GM canola approved by the Regulator has been allowed to be commercially cultivated in New South Wales, Victoria and Western Australia.

8.2 International approvals

257. InVigor® x Roundup Ready® canola proposed for release is approved for commercial release in the USA and Canada, but has not yet been grown commercially.

258. The parental GM canola lines MS8, RF3, MS8 x RF3 and GT73 have been approved for commercial release in Canada, the USA and Japan. GM InVigor® canola and GM Roundup Ready® canola have been grown commercially in North America since 1995 and 1996, respectively.

1 More information on Australia’s integrated regulatory framework for gene technology is contained in the Risk Analysis Framework available from the Office of the Gene Technology Regulator (OGTR). Free call 1800 181 030.