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Recent applications to the Regulators

Over the past 13 years Monsanto’s global biotech trait pipeline has delivered 18 commercial products including first and second generation GM technologies. This pipeline will continue to flow with a number of exciting product concepts, including drought and healthier oil technologies, reaching commercialization in overseas markets as well as localized products moving closer to becoming reality in Australia. Our commitment to sustainable agriculture and to Australia has never been greater.

Some of the main highlights are:

  • Our third-generation insect resistant cotton is one step closer to commercialization here in Australia, with an application for a licence to conduct regulatory field trials submitted to the Office of the Gene Technology Regulator. A public comment period on the licence application is expected this month, with field trials planned to start next cotton season.

    Visit this link - http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir101 to see a copy of the OGTR Risk Assessment and Risk Management Plan (RARMP) which has just been released for public comment. Submissions close 15th June 2010.

  • The Australian Pesticides and Veterinary Medicine Authority (APVMA) have approved the registration of a new 470 g/L glyphosate product called “Roundup Dual Salt Technology Herbicide”, to replace our current product “Roundup CT Broadacre Herbicide”. The new product shows improved performance on tough weeds and in difficult conditions, enhanced compatibility for tank mixing, improved ease of handling and faster brownout for quicker results.

  • Our drought-resistant corn – leading the way to be the first of its kind to be commercialized anywhere in the world – received a positive draft safety assessment report from Food Standards Australia New Zealand, recommending that food containing this product can be imported into Australia. This is a vital link in delivering market acceptance of the new product, which is expected to be commercialised in the US in 2012. A second round of public comment is currently being undertaken on FSANZ’s draft safety assessment.

  • An application has been submitted to FSANZ to allow the import of food derived from SDA soy – a soy plant genetically modified to produce stearidonic acid (SDA), and therefore act as a land-based source of omega-3 fatty acids. This could supplement fish as a source of these nutrients. This is the first GM product with direct health benefits for consumers and represents the future of GM food. The application will now undergo a safety assessment by FSANZ and 2 rounds of public comment.

With Europe also recently handing down a GM cultivation approval, for a potato modified for increased starch levels, things are certainly progressing well for ag-biotechnology in the global regulatory environment.