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Application A436 Draft Assessment Exec Summary

8 May 2002

Draft Assessment Report

DEADLINE FOR PUBLIC SUBMISSIONS to the Authority in relation to this matter:

19 June 2002

(See ' Invitation for Public Submissions ' for details

Full Report [ pdf 517kb ]


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 lines 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 thecry1Ac 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 otherBt proteins, is highly selective in controlling Lepidopteran insects. The use of two Btgenes results in increased protection against insect attack and may also delay the development of resistance to Bt pesticides. The uid A 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 ANZFA. 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.

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 the first round of public consultation in relation to this Application on 17 July 2001. In response, 57 submissions were received. The majority of these opposed the approval of oil and linters from insect-protected cotton containing event 15985 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. Many submissions raised environmental concerns regarding GM crops. The food safety concerns raised in submissions have been addressed by the draft safety assessment report.

Full Report [ pdf 517kb ]


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