Proposed Commercial Release of GM Cotton

Council has received Notification from the Department of Health – Office of the Gene Technology Regulator for Licence Application DIR 145

Summary of the Risk Assessment and Risk Management Plan (Consultation Version) for Licence Application DIR 145


The Gene Technology Regulator (the Regulator) has received a licence application (DIR 145) for the intentional, commercial scale release of insect resistant and herbicide tolerant genetically modified (GM) cottons in Australia. The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application, which concludes that the proposed release poses negligible risks to human health and safety and to the environment and that no specific risk treatment measures are required. Licence conditions have been drafted for the proposed release. The Regulator invites submissions on the RARMP, including draft licence conditions, to inform the decision on whether or not to issue a licence.

Application number DIR 145
Applicant Monsanto Australia Limited (Monsanto)
Project title Commercial release of cotton genetically modified for insect resistance and herbicide tolerance (Bollgard® 3 XtendFlex™  and XtendFlex™ cotton)
Parent organism Cotton (Gossypium hirsutum L.)
Introduced genes and modified traits Three insect resistance genes:

·        vip3A synthetic gene from Bacillus thuringiensis (Bt)

·        cry1Ac gene from Bt

·        cry2Ab gene from Bt

Three herbicide tolerance genes:

·        cp4 epsps gene (two copies) from Agrobacterium sp. strain CP4 (glyphosate tolerance)

·        bar gene from Streptomyces hygroscopicus (glufosinate tolerance)

·        dmo gene from Stenotrophomonas maltophilia (dicamba tolerance)

Four selectable marker genes:

·        nptII gene from Escherichia coli (antibiotic resistance)

·        aph4 gene from E. coli (antibiotic resistance)

·        uidA gene from E. coli (reporter)

·        aad gene from E. coli (antibiotic resistance)

Proposed locations Australia-wide
Primary purpose Commercial release of the GM cotton

Risk assessment  The risk assessment concludes that risks to the health and safety of people or the environment from the proposed dealings, either in the short or long term, are negligible. No specific risk treatment measures are required to manage these negligible risks.

The risk assessment process considers how the genetic modification and activities conducted with the GMO might lead to harm to people or the environment. Risks are characterised in relation to both the seriousness and likelihood of harm, taking into account information in the application, relevant previous approvals, current scientific knowledge and advice received from a wide range of experts, agencies and authorities consulted on the preparation of the RARMP. Both the short and long term are considered.

Credible pathways to potential harm that were considered included: toxic and allergenic properties of the GM cotton; potential for increased weediness of the GM cotton relative to unmodified plants; and vertical transfer of material to other sexually compatible plants.

The principal reasons for the conclusion of negligible risks are: the GM cottons have been produced by conventional breeding from GM parental cotton lines. Two of the three GM parent cottons have been approved for commercial release and the third has been approved for field trial in Australia. The risks associated with these cottons and combinations thereof, have been assessed previously as negligible. One of the GM parental lines (individually and in combination with another GM line) currently makes up over 90% of Australian commercial cotton production, without reports of adverse effects on human health or the environment. The genes and their products have been assessed as posing no increased risk of toxicity or allergenicity to humans or animals, or toxicity to other beneficial organisms. GM cotton has limited capacity to spread and persist in undisturbed environments and can be controlled using integrated weed management in agricultural and high intensity use areas. In addition, food made from the GM parental cotton lines has been approved by Food Standards Australia New Zealand (FSANZ) as safe for human consumption and this approval covers food from lines produced by conventional breeding from these.

Risk management   As the risk assessment did not identify any risks that require treatment, no specific risk treatment measures are proposed. However, the draft licence contains a range of general conditions to provide ongoing oversight of the release.

Risk management is used to protect the health and safety of people and to protect the environment by controlling or mitigating risk. The risk management plan evaluates and treats identified risks 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, the Regulator has drafted licence conditions regarding post-release review (PRR) to ensure that there is ongoing oversight of the release and to allow the collection of information to verify the findings of the RARMP. The draft licence, detailed in Chapter 4 of the consultation RARMP, also contains a number of general conditions relating to ongoing licence holder suitability, auditing and monitoring, and reporting requirements, which include an obligation to report any unintended effects.

Call for comment

The Regulator invites submissions on the RARMP, including the draft licence conditions, for application DIR 145 from Monsanto.

The closing date for written submissions is 26 October 2016.

The Regulator would particularly value comments on risks to the health and safety of people or the environment that may be posed by the proposed commercial release.

Please note that issues such as food safety and labelling, the use of agricultural chemicals and marketing and trade implications do NOT fall within the scope of the evaluations conducted by the Regulator. These are the responsibilities of other agencies and authorities.

The consultation RARMP and other supporting documentation can be accessed on the OGTR website via ‘What’s New’. You can also request a copy of the RARMP or the application from the OGTR – please quote application number DIR 143.

If you have any questions about the RARMP or the evaluation process, please contact:
The Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 Canberra ACT 2601
Tel: 1800 181 030
Fax: 02 6271 4202
OGTR website: 

Questions & Answers on licence application DIR 145 – Commercial release of genetically modified cotton 

What is this application for? 

Monsanto Australia Ltd is is seeking approval for the commercial cultivation of two types of genetically modified (GM) cotton:

  • Xtend Flex™ cotton, modified for herbicide tolerance
  • Bollgard® 3 Xtend Flex™ cotton, modified for both insect resistance and herbicide tolerance.
  • If approved, the GM cottons would be grown in all cotton growing areas of Australia and their products would enter general commerce, including use in human food and animal feed.

How has the GM cotton been modified? 

Xtend Flex™ cotton contains three introduced genes for herbicide tolerance: one gene confers tolerance to the herbicide glyphosate, a second gene confers tolerance to glufosinate herbicides and the third gene confers tolerance to dicamba. Thus, farmers can use one or all of these herbicides for weed control without damaging their cotton crop. All three genes were sourced from common bacterial species, found in the environment.

In addition to the three herbicide tolerance genes, Bollgard® 3 Xtend Flex™ cotton contains three bacterial genes that confer insect resistance. The genes encode proteins that are toxic to specific pest insects that cause major yield losses in cotton crops. Combining three different insecticidal genes is expected to reduce the chance of insect pests developing resistance.

The GM cottons also contain four introduced selectable marker genes derived from a common bacterium. Three of the genes confer antibiotic resistance and the fourth allows colour selection. They were used to select the plants during laboratory development of the GM cottons and do not have any function when plants are grown in the field.

Is this GM cotton safe? 

Food Standards Australia New Zealand has approved the use of food derived from the GM cottons proposed for release.

The draft risk assessment concluded that this proposed release of GM cottons poses negligible risks to the health and safety of people or the environment. Therefore, the draft licence does not propose any specific measures to manage risk. If the Regulator authorises the release, general licence conditions will be imposed to ensure that there is ongoing oversight of the release.

If approved, the GM cottons would also be subject to regulation by the Australian Pesticides and Veterinary Medicines Authority, which assesses all herbicides and insecticidal products used in Australia and sets their conditions of use.

How can I comment on this application? 

A consultation Risk Assessment and Risk Management Plan (RARMP) has been prepared for application DIR 145. The full RARMP and a summary are available on the OGTR website under ‘What’s New’ or via the Freecall number below. You are invited to comment on the RARMP, in particular on any risks to the health and safety of people or to the environment that may be posed by the proposed release.

Please note that the consultation period closes on 26 October 2016 and written submissions are required by this date.

What are the next steps in the evaluation process? 

Submissions regarding the health and safety of people or the environment will be taken into account in finalising the RARMP, which will then inform the Regulator’s decision on whether or not to issue a licence.


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