Australia
October 19, 2012
DIR 118 - Notification of licence application - Commercial release of cotton genetically modified for herbicide tolerance - posted 19 October 2012
Receipt of licence application from Monsanto for dealings involving intentional release of genetically modified cotton (DIR 118)
Application
The Office of the Gene Technology Regulator (OGTR) has received a licence application from Monsanto Australia Ltd (Monsanto) for the commercial release of genetically modified (GM) cotton into the environment (DIR 118). The cotton species Gossypium barbadense, also known as pima cotton, has been modified to be tolerant to the herbicide glyphosate. The genetic modification in the GM pima cotton proposed for release is the same as that already approved for commercial release in another species of cotton, G. hirsutum, this latter GM cotton being known as Roundup Ready Flex® cotton. To distinguish these two GM cottons, the new GM cotton is referred to as Roundup Ready Flex® pima cotton.
Roundup Ready Flex® pima cotton has been produced by the conventional breeding of Roundup Ready Flex® G. hirsutum with unmodified G. barbadense.
Monsanto is seeking approval to release the GM cotton in all cotton growing areas of Australia. GM cotton and GM cotton-derived products from Roundup Ready Flex® pima cotton would enter general commerce, including use in human food and animal feed. Food Standards Australia New Zealand (FSANZ) has assessed and approved food from the GM parent (Roundup Ready Flex® G. hirsutum). This approval includes any food derived from offspring produced through conventional breeding, and therefore covers Roundup Ready Flex® pima cotton. The Australian Pesticides and Veterinary Medicines Authority (APVMA) has registered Roundup Ready® Herbicide by Monsanto for use on Roundup Ready Flex® cotton. This registration also applies to Roundup Ready Flex® pima cotton.
Purpose of this notification
At this stage, comment is not sought from members of the public. Later, the public will be asked to comment on a comprehensive Risk Assessment and Risk Management Plan (RARMP) for the application. The RARMP will be prepared taking into account advice received from prescribed experts, agencies and authorities, and relevant local councils, as specified in section 50 of the Gene Technology Act 2000. I expect this to be released for public comment and further advice from experts, agencies and authorities at the end of April 2013.
In the interim, you can obtain a copy of the application by contacting my Office (see contact details below, please quote the reference number DIR 118). As the application is quite lengthy, you may prefer to view a summary of the application, which is posted on our website along with this document at DIR 118 page.
If you have any questions or would like to receive a hard copy of the application summary, please contact the OGTR using the details below.
The Office of the Gene Technology Regulator, MDP 54, GPO Box 9848, Canberra, ACT, 2601
Telephone: 1800 181 030 Facsimile: 02 6271 4202 E-mail: ogtr@health.gov.au
Website http://www.ogtr.gov.au
Dr Joe Smith
Gene Technology Regulator
19 October 2012
DIR 118 - Questions and Answers
DIR 118 - Licence Application Summary
Reference material
Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator (2nd Edition) 2007
Topics
Species
