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A436 - FAR Exec Summary (21 August 2002)

FINAL ASSESSMENT REPORT

21 August 2002

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EXECUTIVE SUMMARY

ANZFA began assessment on a new genetically modified cotton line on 27 April 2001 after receiving an Application from Monsanto Australia Limited. The Application seeks approval under Standard A18/1.5.2 - Food Produced Using Gene Technology, for foods derived from cotton containing event 15985. The presence of this event in cotton confers protection against insect attack and such lines are known commercially as Bollgard II® cotton. Cotton containing this event is not currently commercially grown but an Application to grow it commercially in Australia has been lodged with the Office of the Gene Technology Regulator.

This cotton variety was developed from an already genetically modified cotton line (cotton line 531), the oil and linters from which were approved in July 2000, as part of Application A341 - Insect-Protected Cotton, also known as Ingard® cotton. Cotton line 531 contains three transferred genes, the primary gene of interest being the cry1Ac gene conferring insect protection to the cotton plant. Oil and linters from this line were found to be as safe as those from conventional cotton varieties.

Insect-protected cotton containing event 15985 was developed from cotton line 531 by the introduction of two additional genes - cry2Ab (another Bt gene) and uidA. The cry2Ab gene encodes an insecticidal protein that, like other Bt proteins, is highly selective in controlling Lepidopteran insects. The use of two Bt genes results in additional protection against insect attack and may also delay the development of resistance to Bt pesticides. The uidA gene is a marker gene that allows selection of transformed tissue based on the presence of a colour marker.

Oil and linters derived from insect-protected cotton containing event 15985 have been evaluated according to the safety assessment guidelines prepared by FSANZ. The assessment considered the following aspects of the food: (1) the nature of the genetic modification; (2) general safety issues such as history of use and the potential for transfer of antibiotic resistance genes to microorganisms in the human digestive tract; (3) characterisation of novel proteins including toxicological and allergenicity issues; and (4) comparative analyses and nutritional impact of the food. On the basis of the available information, it is concluded that oil and linters derived from cotton event 15985 are as safe and wholesome as those produced from other commercial cotton varieties. A detailed food safety report on cotton containing event 15985 has been prepared. This report has been submitted to three external examiners for review. The comments from each reviewer are favourable and support the findings and conclusions of FSANZ's safety assessment.

Changes to the labelling requirements of Standard A18/1.5.2 came into effect on 7 December 2001. Under the revised standard, oil and linters manufactured from cotton lines containing event 15985 will likely be exempt from labelling given that such highly processed foods do not contain protein or DNA. No additional labelling subject to clause 7 is required.

ANZFA undertook two rounds of public consultation in relation to this Application. In response, 57 submissions were received during the first round, and 215 were received in the second round. The majority of the second round submissions were supportive of the approval of oil and linters from this GM cotton primarily on the basis of benefits arising from potential reductions in pesticide usage.

The majority of the first round submissions opposed the approval of the cotton primarily on the basis that all foods produced from GM crops are perceived to be unsafe, that not all foods will be labelled and that the process for assessment is flawed. Food safety concerns raised in submissions have been addressed by the Final Assessment Report and to date it has not been notified of any Ministerial Council policy guidelines relevant to this proposal.

The ANZFA to FSANZ transitional requirements for an Application at final assessment stage have been followed and no additional submissions have been received. The draft (i.e. full) assessment that was carried out by ANZFA has been reviewed.

In certain circumstances Australia and New Zealand have an obligation to notify the World Trade Organisation (WTO) of changes to food standards to enable other member countries of the WTO to make comment. Notification is required in the case of any new or changed standards which may have a significant trade effect and which depart from the relevant international standard (or where no international standard exists). This matter was notified to the WTO because there is significant international interest in the safety of GM foods and the proposed amendments may have a liberalising effect on trade.

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