Extract from of Gene Technology Technical Advisory Committee (GTTAC) Communique 5 (22 August 2002)

2.3 Advice on Canola

GTTAC considered two applications for the proposed release of GM canola in Australia.

General Release of Roundup Ready® Canola (Brassica napus) in Australia (DIR 020)

The OGTR has received an application from Monsanto Australia Ltd (Monsanto) for a licence for the intentional release of GM Canola that has been modified to tolerate glyphosate, the active ingredient in the herbicide Roundup®.

Monsanto proposes the commercial cultivation of Roundup Ready® canola in all the current and future canola growing regions of Australia, which potentially includes New South Wales, Victoria, South Australia, Western Australia, Queensland, Tasmania and the Australian Capital Territory. The Tasmanian State Government currently has a moratorium on the planting of GM plants in that State through the Plant Quarantine Act 1997 (TAS). Accordingly, in addition to a licence issued under the Gene Technology Act 2000 (CWLTH) and corresponding State laws, any release of Roundup Ready® canola in Tasmania would also require approval from the Tasmanian State Government. The use of genetically modified crops in Tasmania is currently restricted to approved research trials and no approval would be considered for any commercial planting.

Monsanto proposes a phased introduction of Roundup Ready® canola which enables the use of glyphosate for weed control with a limited release of approximately 5000 hectares in the first year (2003) in the canola growing regions of south eastern Australia. Monsanto expects a steady increase in the area sown to Roundup Ready® canola over a number of years across the canola growing regions of Australia, with the rate of increase being determined by market acceptance and seed and variety availability. Monsanto proposes to continue to work closely with the grains industry to manage the introduction of Roundup Ready® canola. Glyphosate is not currently registered for use on canola by the NRA.

The canola plants and their by-products, would be used in the same manner as conventional canola, including for human food and animal feed. After harvest of the Roundup Ready® canola, the grain will enter the general commerce supply chain in Australia for domestic and export markets. Canola is grown commercially primarily for its seeds which yield about 40% oil and a high protein animal feed. Canola oil, which does not contain genetic material, is used in the manufacture of a variety of food products. Canola meal is primarily used as a feed for livestock, but it is also used in poultry and fish feed, pet foods and fertilisers.

Monsanto proposes a systematic and strategic approach to risk management and product stewardship through the implementation of its Roundup Ready Canola Technology Stewardship Strategy, which includes a Roundup Ready Canola Crop Management Plan. These will be consistent with the Guidelines for Industry Stewardship Programs and Crop Management Plans proposed by the Plant Industries Committee of the Primary Industries Standing Committee (under the Primary Industries Ministerial Council) and the Guidelines for Supply Chain Management of GM Canola being developed by the Gene Technology Grains Committee.

GTTAC advises the Regulator that:

(a)   The following risks or potential risks, especially given the commercial scale of the release, should be assessed in relation to the Roundup Ready canola application from Monsanto: -       toxicity or allergenicity of Roundup Ready canola; -       weediness or increased potential for weediness, including the persistence of canola in non-agricultural habitats and the factors determining such persistence; -       potential for the introduced genes to be transferred to into other organisms by cross pollination; and -       any other potential hazards, including whether commercial release is likely to result in changes to agricultural practices that may have an environmental impact.

(b)   The potential for glyphosate tolerant canola to occur along roadsides does not present a significant risk to the environment.

(c)   In addition, the applicant should be requested to provide further information on glucosinolate production and to provide a crop management plan.

(d)   The inclusion of data on the chromosomal location of the transgenes in the molecular characterisation of the GMO would be useful if available. However, it is not absolutely required for the assessment.

(e)   The applicant should be required to provide a detailed herbicide resistance management plan and any recommendations made regarding supply chain management.

Commercial Release of InVigor® Hybrid Canola (Brassica napus) for use in the Australian Cropping System (DIR 021)

The OGTR has received an application from Aventis CropScience Pty Ltd (Aventis) for a licence for the intentional release of a GMO into the environment. The aim of the proposed release is to allow the commercial use of InVigor® canola lines T45, Topas 19/2, MS1, MS8, RF1, RF2 and RF3 in Australian agriculture and continuing product research and development programs based on these lines.

Aventis only proposes to commercialise InVigor® hybrid canola derived from MS8 and RF3 lines for use by Australian farmers. Canola derived from T45, Topas 19/2, MS1, RF1 and RF2 lines has been approved for food and environmental release in a number of other countries and Aventis is also seeking approval for these lines to achieve consistency with existing overseas regulatory approvals.

InVigor® canola plants have been genetically modified to introduce a hybrid breeding system based on male sterile (MS) and fertility restorer (RF) lines, and to be tolerant to the herbicide glufosinate ammonium, the active ingredient in the herbicides Liberty® and Basta®. Lines T45 and Topas 19/2 have been genetically modified to introduce glufosinate ammonium tolerance, but do not contain the hybrid breeding system. Aventis have indicated that the use of InVigor® canola will also provide the option of using herbicides which have glufosinate ammonium as their active ingredient, in conjunction with other measures, for the control of weeds in the crop. Liberty® is not currently registered by the NRA for use on canola. Basta® is registered by the NRA for use in horticulture.

The canola lines Topas 19/2, MS1, RF1 and RF2 also contain the nptII gene from the bacterium Escherichia coli which confers resistance to some aminoglycosides including the antibiotics neomycin, kanamycin and gentamicin. The antibiotic resistance trait was used as a selectable marker in the initial laboratory stages to select canola plants that were genetically modified.

Aventis proposes the commercial cultivation of InVigor® canola potentially over all the current and future canola growing regions of Australia, which includes New South Wales, Victoria, South Australia, Western Australia, Queensland, Tasmania and the Australian Capital Territory. However, as noted for DIR 020, release in Tasmania would also require the approval of the Tasmanian Government which has imposed a moratorium on the cultivation of GM food crops under its Plant Quarantine Act.

Aventis proposes a phased introduction of InVigor® canola with a limited release in the first year (2003), including seed increase and demonstration sites. Aventis expects that the scale of the release will expand slowly and that the scale of the expansion will be dependent on market acceptance, seed and variety availability. Aventis proposes to work closely with the canola industry to manage the introduction of InVigor® canola.

Aventis proposes to implement a stewardship program for the management of InVigor® canola. The stewardship program, including the Crop Management Plan for InVigor® canola, will be consistent with the Guidelines for Supply Chain Management of GM Canola being developed by the Gene Technology Grains Committee.

GTTAC advises the Regulator:

(a)   The following risks or potential risks, especially given the commercial scale of the release, should be assessed in relation to the InVigor® canola application from Aventis: -       toxicity or allergenicity of InVigor canola; -       weediness or increased potential for weediness, including the persistence of canola in non-agricultural habitats and the factors determining such persistence; -       potential for the introduced genes to be transferred to other organisms by cross pollination; -       any other potential hazards, including whether commercial release is likely to result in changes to agricultural practices that may have an environmental impact; and -       any hazards associated with the nptII gene.

(b)   The RARMP should include a provision that glufosinate-ammonium tolerant canola should not be grown in vineyards. Glufosinate-ammonium is used to control weeds in vineyards.

(c)   Inclusion of data on the chromosomal location of the transgenes in the molecular characterisation of the GMO, would be useful if available. However, this is not absolutely required for the assessment.

(d)   In addition, the applicant should be requested to provide a detailed crop management plan, including a resistance management plan and any provisions made regarding supply chain management.

Extract from Gene Technology Technical Advisory Committee (GTTAC) Communique 8(8-9 April 2003)

Advice on Canola

GTTAC considered the RARMP prepared in response to the following application concerning the release of transgenic canola in Australia.

Commercial release of InVigor® canola (Brassica napus) for use in the Australian cropping system (DIR 021/2002)

The OGTR has received an application from Bayer CropScience Pty Ltd (Bayer) for the commercial release of GM canola into the environment.

Bayer are seeking regulatory approval for seven similar GM ‘lines’ of canola which have all been trialled previously in Australia under limited and controlled conditions. Although Bayer only intends to commercialise two lines in Australia, the applicant is seeking approval for all seven GM canola lines to achieve consistency with existing overseas regulatory approvals.

Oil derived from all seven canola lines has been approved for use in human food in Australia by Food Standards Australia New Zealand. The GM canola from the proposed release would be used as oil in human food, or in animal feed, in the same way as conventional (non-GM) canola.

The hybrid canola seed, which Bayer seeks to commercialise in Australia as InVigor® canola, is produced with a novel hybrid generation system based on two genetically modified ‘parent’ lines of canola: a male sterile (MS) line that contains a male sterility gene (barnase), and a fertility restorer (RF) line containing a fertility restorer gene (barstar). The progeny are expected to have enhanced agronomic performance, otherwise known as ‘hybrid vigour’.

All seven GM canola lines include a gene that confers tolerance to the herbicide glufosinate ammonium. The herbicide tolerance serves as a dominant marker for the introduced traits during breeding and hybrid seed production. It may also be used for the control of weeds in the canola crop, although glufosinate ammonium is not currently registered for use in broad-acre cropping in Australia. Bayer is seeking registration of glufosinate ammonium for use on InVigor® canola under the trade name Liberty® through the APVMA.

Four of the GM canola lines contain a gene that provides a ‘marker’ for antibiotic resistance in plants. This gene is used to identify and select modified plants during the development stage.

In accordance with section 184 of the Act, Bayer has sought approval to enable detailed technical information on precise gene constructs and molecular characterisation data to be declared ‘Confidential Commercial Information’. However, this information was made available to GTTAC and other prescribed expert authorities that were consulted on the preparation of the RARMP.

GTTAC discussed the RARMP for this application and advised the Regulator as follows:

The Committee agrees with the assessment made by the OGTR on risk of toxicity, allergenicity, weediness and gene transfer. There is no risk to human health and safety above those presented by conventional canola, and that while the probability of gene transfer to other canola plants was high, the overall rate of outcrossing would be very low and the impact of this would be negligible; and

The Committee agrees with the proposed licence conditions, however advised that consideration should be given to:

   -       clarifying licence condition Part 2, Section 2.2.2 which requires the applicant to report adverse impacts to human health and safety and the environment.; and

   -       the means of collecting data on the area planted to each GMO, as required by licence condition Part 2, Section 2.2.3 as it would be preferable to collect this information independently rather than via the applicant.

Extract from Gene Technology Technical Advisory Committee (GTTAC) Communique 11(19-20 November and 18 December 2003)

Advice on Canola

GTTAC considered the RARMPs prepared in response to the following applications concerning the release of GM canola in Australia:

General release of Roundup Ready (Brassica napus) in Australia (DIR 020/2002)

The OGTR received an application from Monsanto Australia Ltd (Monsanto) for a licence for the intentional release of GM Canola that has been modified to tolerate glyphosate, the active ingredient in the herbicide Roundup®. The use of Roundup Ready® canola will allow the application of glyphosate for the control of weeds which emerge following crop planting. A parallel application for registration for the use of Roundup® on Roundup Ready® canola was made to the Australian Pest and Veterinary Medicines Authority (APVMA). The APVMA is responsible for the registration of agricultural chemicals for use in Australia.

Monsanto proposes the commercial cultivation of Roundup Ready® canola in all current and future canola growing regions of Australia, which potentially includes NSW, Vic, Qld, South Australia (SA), Western Australia, Tasmania and the Australian Capital Territory. Release of Roundup Ready® canola requires State or Territory government approval where various moratoria regarding GM crops have been imposed.

The canola plants and their by-products, would be used in the same manner as conventional canola, including for human food and animal feed. The use of oil derived from Roundup Ready® canola was approved by Food Standards Australia New Zealand in November 2000.

GTTAC discussed the RARMP and supporting information at length and agreed that this GMO is as safe to human health and safety and the environment as conventional canola. However, during the comprehensive discussion members raised concerns relating to the practical use of Roundup Ready® canola and Roundup® herbicide. These concerns included the potential impact the introduction and management of Roundup Ready® canola may have on herbicide usage and the development of herbicide resistance. The Committee discussed the use of non-glyphosate herbicides on GM volunteers in non GM canola crops, and management of roadside volunteers resulting from seed spillage. The Committee recognised that these concerns were being considered by the APVMA as the responsible regulatory authority.

The Committee resolved to write to the APVMA outlining their concerns regarding the potential for development of herbicide resistance as a result of inappropriate herbicide use following the introduction of Roundup Ready® canola.

GTTAC advised the Regulator that:

• The Committee agrees with the risk assessment made by the OGTR, including the conclusions of the RARMP;
• The section on Toxicity and Allergenicity should clearly indicate that there is no difference between the GM and non-GM plants, except for the expressed genes;
• The RARMP should adequately explain why the main areas of concern identified by GTTAC (potential development of herbicide resistance) do not fall under the Gene Technology Act; and
• The Committee agrees with the proposed licence conditions;
• The RARMP should include information on current industry standards for the proximity of seed crops to commercial crops.

Extract from Community Consultative Com-mittee (GTCCC) Communique 4 (20 February 2003)

The GTCCC meeting agenda on 20 February 2003 was a full agenda incorporating a report tabled by the Regulator on the activities of the OGTR since the Committee last met in November 2002 and a detailed report on the status of two applications received by the OGTR for the commercial release of GM canola. The Committee received progress reports from the current working groups established in July 2002 to provide specific advice to the Regulator. These working groups will continue out-of-session and are due to report again at the next meeting in 2003.

The Committee determined that it wished to provide advice to the Regulator on a number of topics arising from both the meeting and the discussions of the previous day:

Commercial GM Canola Applications

Following considerable discussion of this item, it was moved by Dr Rosemary Robins and seconded by Professor Frank Vanclay that the Regulator be advised, in relation to these applications, that:

‘The GTCCC expresses concern that a state of community unreadiness exists concerning the risks to the environment of the commercial release of GM canola, so significant that the applications should be declined at this time.’

Seven members voted in favour of this resolution and two against.

The GTCCC having previously resolved that the extent and nature of any dissent from the majority opinion in a meeting be included in the meeting communique, Mr Donald Coles and Mr Bruce Lloyd requested that their dissenting votes be formally recorded. Mr Coles, in dissenting, outlined the following reasons for his dissent:

• the perception that there is a state of community unreadiness is not borne out by the response to date from the GTGC in releasing their consultation draft on canola industry stewardship protocols;
• the Plant Industries Committee of the Primary Industries Standing Committee also released consultation guidelines in 2002 for industry stewardship programs and crop management plans;
• the GTCCC was not technically qualified to review the risks to the environment posed by or as a result of the commercial release of GM canola;
• it is not the role of the GTCCC to deny a potentially valuable tool for reducing herbicide resistant weeds to the Australian farming community; and
• it is not the role of the OGTR, as specified in the Act, to dictate supply chain matters.

Mr Lloyd, in dissenting, outlined the following reasons for his dissent:

• the GTCCC was not technically qualified to review the risks to the environment posed by or as a result of the commercial release of GM canola; and
• the matter should be referred by the Regulator to the Gene Technology Technical Advisory Committee for consideration of any risks.

The Regulator will take into account the Committee’s advice as part of the applications assessment process. The assessment process includes extensive public consultation, which is yet to commence, on the risk assessment and risk management plans that are prepared in respect of each application.

Canola Industry Stewardship Protocols

Following consideration on the GTGC presentation on the draft Canola Industry Stewardship Protocols the Committee resolved to thank the GTGC representatives for their time in coming to Mount Gambier and for their preparedness to answer wide-ranging questions on the day.

The GTCCC will also write to the GTGC requesting that they further develop the coexistence protocol framework to enable the GTCCC to make a more informed judgement about the state of readiness for the commercial release of GM canola in Australia.