7.1 Australian approvals of GM cotton

7.1.1 Previous releases approved by Genetic Manipulation Advisory Committee or the Regulator


58. All but one of the GM cotton lines containing single transformation events that are proposed for limited and controlled release in this application have been previously approved for limited and controlled release in Australia. One of the GM cotton lines, genetically modified for herbicide tolerance, had not been previously assessed by the Regulator.

59. Previous approvals for commercial release of other cotton varieties genetically modified for insect resistance and/or herbicide tolerance are:
    • insect resistant INGARD® G. hirsutum (DIR 022/2002; withdrawn from the market in 2004 in favour of Bollgard II® G. hirsutum)
    • glyphosate tolerant Roundup Ready® G. hirsutum (DIR 023/2002 and DIR 066/2006; withdrawn from the market in 2009 in favour of Roundup Ready Flex® G. hirsutum)
    • glyphosate tolerant / insect resistant Roundup Ready®/INGARD® G. hirsutum (DIR 023/2002; withdrawn from the market in favour of Bollgard II®/Roundup Ready® G. hirsutum)
    • insect resistant Bollgard II® G. hirsutum (DIR 012/2002 and DIR 066/2006)
    • insect resistant / glyphosate tolerant Bollgard II®/Roundup Ready® G. hirsutum (DIR 012/2002 and DIR 066/2006; withdrawn from the market in 2009 in favour of Bollgard II®/Roundup Ready Flex® G. hirsutum)
    • glyphosate tolerant Roundup Ready Flex® G. hirsutum (DIR 059/2005 and DIR 066/2006)
    • glyphosate tolerant / insect resistant Roundup Ready Flex®/Bollgard II® G. hirsutum (DIR 059/2005 and DIR 066/2006)
    • glufosinate ammonium tolerant LibertyLink® G. hirsutum (DIR 062/2005)
    • glufosinate ammonium tolerant / insect resistant LibertyLink®/Bollgard II® G. hirsutum (DIR 062/2005)
    • insect resistant / glufosinate ammonium tolerant WideStrike cotton (DIR 091).
60. In addition, a number of limited and controlled releases of similar GMOs have been approved. To date, the Regulator has not received any reports of adverse effects caused by these authorised releases.

61. Information on all DIR assessments and approvals by the Regulator can be found on the OGTR website. Information on which assessments and approvals are relevant to the GMOs proposed for release in this application is covered by CCI. The confidential information was made available to the prescribed experts and agencies that were consulted on the RARMP for this application.

7.1.2 Approvals by other government agencies


62. 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, National Industrial Chemicals Notification and Assessment Scheme and Australian Quarantine Inspection Service (AQIS)4.

63. FSANZ is responsible for human food safety assessment and food labelling, including GM food. FSANZ has previously assessed all of the GM cotton lines produced by single transformation events that are proposed for limited and controlled release and has given approval for their use in food. These approvals would also cover the stacked GM cotton varieties produced by conventional cross-breeding between approved lines. However, the applicant will not use materials generated from the GM cotton varieties in the release in human food or in animal feed.

64. APVMA has regulatory responsibility for agricultural chemicals, including herbicides and insecticidal products, in Australia. Some of the varieties of GM cotton proposed for release meet the definition of an agricultural chemical product under the Agricultural and Veterinary Chemicals Code Act 1994, due to their production of insecticidal substances, and therefore these plants are subject to regulation by the APVMA. The applicant intends to apply herbicide to the GM cotton fields during the trial, which is also subject to regulation by the APVMA.

65. A permit from AQIS will be required to enable import of GM cotton seed from the USA.

66. In addition, dealings authorised by the Regulator may be subject to the operation of State legislation declaring areas to be GM, GM free, or both, for marketing purposes.

67. Additional information relevant to approvals of GM cotton by other Australian government agencies is covered by CCI. The confidential information was made available to the prescribed experts and agencies that were consulted on the RARMP for this application.

7.2 International approvals of GM cotton


68.. All of the GM cotton lines containing single transformation events that are proposed for limited and controlled release in this application have been approved for release and have undergone field trials in other countries.

69. Additional information relevant to international approvals of GM cotton is covered by CCI. The confidential information was made available to the prescribed experts and agencies that were consulted on the RARMP for this application.


4 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.