8 May 2002
Final Assessment Report
Full Report [ pdf 425kb ]
An application was received from Monsanto Australia Ltd on 29 May 2000 seeking approval under Standard A18/1.5.2 - Food Produced Using Gene Technology for food derived from corn line NK603 that has been genetically modified to provide tolerance to glyphosate, a broad-spectrum herbicide. The corn is not grown in either Australia or New Zealand but, if approved, could be found in imported processed foods.
In corn line NK603, the glyphosate-tolerance trait is generated in the plants through the addition of a bacterial EPSPS gene derived from a common soil bacterium,Agrobacteriumsp. strain CP4 (CP4 EPSPS). The enzyme produced from the CP4 EPSPS gene has a reduced affinity for the herbicide compared with the corn enzyme, and thus confers glyphosate tolerance to the whole plant.
The bacterial gene used to confer tolerance to glyphosate in this Application is the same gene used in certain genetically modified varieties of soybean, canola, sugar beet and cotton. Foods derived from these modified crop lines have already undergone a safety assessment and have been approved [1] in Australia and New Zealand under Standard A18/1.5.2.
The safety of food derived from glyphosate-tolerant corn line NK603 has been evaluated according to the safety assessment guidelines prepared by ANZFA. The assessment considered the following issues: (1) the nature of the genetic modification; (2) general safety issues such as novel protein expression and the potential for transfer of antibiotic resistance genes to microorganisms in the human digestive tract; (3) toxicological issues; and (4) nutritional issues. On the basis of the available information, it is concluded that food derived from corn line NK603 is as safe and wholesome as food produced from other commercial corn varieties. A detailed food safety report on NK603 corn has been prepared.
The labelling of food derived from corn line NK603 has been considered according to the new labelling requirements of Standard A18/1.5.2 that came into effect on 7 December 2001. Under these requirements, food products manufactured from corn line NK603 will require labelling if novel DNA and/or protein is present in the final food.
ANZFA undertook two rounds of public consultation in relation to this Application. In response, 6 submissions were received during the first round, and 29 were received in the second round. The majority of the submissions were not supportive of the Application, primarily on the basis of perceived health and environmental concerns. However, the food safety concerns raised in submissions have been addressed by the safety assessment report. The Applicant submitted further, recently completed, technical information during the second period of consultation that, on evaluation, does not alter the conclusions of the safety assessment.
In certain circumstances Australia and New Zealand have an obligation to notify the 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 liberalizing effect on trade.
[1] The Food Standards Code, refer to the Table to clause 2 of Standard A18-Food Produced Using Gene Technology (Volume1), or Standard 1.5.2 (Volume 2).