APPLICATION A484 - FOOD FROM INSECT-PROTECTED MON863 CORN
09/03
21 May 2003
DRAFT ASSESSMENT REPORT
DEADLINE FOR PUBLIC SUBMISSIONS to the Authority in relation to this matter: |
Full Report [ pdf 459kb ]
Executive Summary
An Application was received from Monsanto Australia Limited on 4 December 2002 seeking approval for food derived from insect-protected MON863 corn under Standard 1.5.2 – Food Produced Using Gene Technology of the Australia New Zealand Food Standards Code (the Code). Standard 1.5.2 requires that GM foods undergo a pre-market safety assessment before they may be sold in Australia and New Zealand.
The new genetic traits in MON863 corn confer protection against the corn rootworm, a significant pest of corn crops in certain regions of the United States and Canada. Protection is conferred by expression in the plant of a bacterially derived protein toxin (a Bt-toxin) that is specific for beetle larvae. MON863 corn also contains a new gene encoding resistance to the antibiotic neomycin and related aminoglycoside antibiotics.
MON863 corn has been developed for cultivation in the United States and Canada only, but food derived from this corn could enter the market in Australia and New Zealand via imported products, once it is grown on a commercial scale.
FSANZ has completed a comprehensive safety assessment of food from MON863 corn as required under the standard. The assessment included consideration of: (i) the genetic modification to the plant; (ii) the safety of any transferred antibiotic resistance genes; (iii) the potential toxicity and allergenicity of any new proteins; and (iv) the composition and nutritional adequacy of the food, including whether there had been any unintended changes.
No potential public health and safety concerns were identified in the assessment of food from MON863 corn. Therefore, on the basis of all the available evidence, including detailed studies provided by the applicant, it has been concluded that food derived from MON863 corn is as safe and wholesome as food derived from other corn varieties.
If approved, food from MON863 corn will require labelling if novel DNA and/or protein are present in the final food. Ingredients derived from corn likely to satisfy this criterion are starch, modified starch ingredients, meal/semolina and flour. Other ingredients, such as refined oil, glucose syrups and high fructose syrups are unlikely to contain either novel DNA or protein.
Two regulatory options were considered in the assessment: either (1) no approval; or (2) approval of food from MON863 corn based on the conclusions of the safety assessment. Following an assessment of the potential impact of each of the options on the affected parties (consumers, the food industry and government), Option 2 is the preferred option as it potentially offers significant benefits to all sectors with very little associated negative impact. The proposed amendment to the Code, giving approval to food from MON863 corn, is therefore considered necessary, cost effective and of net benefit to both food producers and consumers.
In response to the invitation to comment on the Initial Assessment Report, four submissions were received from the public. The majority expressed support for the application, contingent on a satisfactory safety assessment.
Full Report [ pdf 459kb ]