Executive Summary




НазваниеExecutive Summary
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Risk Assessment and

Risk Management Plan for

DIR 091


Commercial release of cotton genetically modified for insect resistance (WideStrikeTM Insect Protection Cotton)


Applicant: Dow AgroSciences Australia Ltd


November 2009


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Executive Summary

Introduction


The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of licence application (DIR 091) from Dow AgroSciences Australia Ltd (Dow) for a commercial release of genetically modified (GM) cotton.

The Gene Technology Act 2000 (the Act), the Gene Technology Regulations 2001 and corresponding state and territory law govern the comprehensive and highly consultative process undertaken by the Regulator before making a decision on whether or not to issue a licence to deal with a GMO. The decision is based upon a Risk Assessment and Risk Management Plan (RARMP) prepared by the Regulator in accordance with requirements of the legislation. RARMPs apply the Risk Analysis Framework and are finalised following consultation with a wide range of experts, agencies and authorities, and the public1.

The application


Dow has applied for a licence for dealings involving the intentional release of GM WideStrike™ Insect Protection (WideStrike™) cotton. The applicant proposed that the commercial release would allow WideStrike™ cotton to be grown in all cotton growing areas of Australia south of latitude 22º South, and that plant material from the GM cotton be used in the same manner as plant material from non-GM cotton and other commercially approved GM cotton(s), and enter general commerce.

WideStrike™ cotton has been genetically modified for resistance to insects. The GM cotton contains two genes derived from a common soil bacterium. These genes confer resistance to a range of major lepidopteran caterpillar pests of cotton.

In addition to the genes for insect resistance, the GM cotton contains a selectable marker gene from a common soil bacterium. This gene confers tolerance to the herbicide glufosinate ammonium. During development of the GM cotton, this marker gene enabled identification and selection of plant tissues in which this herbicide tolerance gene was also present. Short regulatory sequences that control expression of the genes are also present in the GM cotton.

WideStrike™ cotton has been previously approved for field trials in Australia under licences DIR 040/2003 and DIR 044/2003 issued to Dow. There have been no reports of adverse effects on human health and safety or the environment resulting from these releases.

The GM cotton proposed for release meets the definition of an agricultural chemical product under the Agricultural and Veterinary Chemicals Code Act 1994, due to its production of insecticidal substances. Therefore, WideStrike™ GM cotton is also subject to regulation by the Australian Pesticide and Veterinary Medicines Authority (APVMA). The APVMA is currently assessing an application from Dow for WideStrike™ cotton. The applicant does not intend glufosinate ammonium to be used as an herbicide in the field and therefore does not intend to seek approval from APVMA for the use of this herbicide on WideStrike™ cotton.

The oil and cotton linters derived from this GM cotton have been approved by Food Standards Australia New Zealand (FSANZ) for use in human food2.

Confidential Commercial Information


Some details, including the gene and protein sequences of the introduced synthetic genes and molecular characterisation of WideStrike™ cotton, have been declared Confidential Commercial Information (CCI) under section 185 of the Act. The confidential information was made available to the prescribed experts and agencies that were consulted on the RARMP for this application.
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