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Monsanto MON863 Corn

What is MON863 Corn?

MON 863 corn (or maize line MON 863) was produced to express a gene encoding a specific insecticidal protein to control infestation of corn with corn root-worm. The presence of this protein means that the corn is genetically engineered to be resistant to the corn root-worm which can normally cause significant damage to the corn crop.

What is the issue?

Questions had been raised as to the safety of MON863 corn by one of the European Union Member States represented by the French Commission for Genetic Engineering. The questions arose from the submission to the European Commission of an additional 90-day MON863 corn feeding study in rats, carried out by the manufacturers, Monsanto. This study had not been submitted to Food Standards Australia New Zealand (FSANZ) for the safety assessment conducted during 2003. A study of this type is not required by FSANZ for safety assessment.

Is this corn available in New Zealand?

FSANZ approved the corn for use in Australia and New Zealand in October 2003 after conducting a comprehensive pre-market safety assessment of food derived from MON863 corn as required by Standard 1.5.2 of the Australia New Zealand Food Standards Code. A copy of the final assessment report is available on the FSANZ website www.foodstandards.gov.au.

What other foods are derived from this corn?

Foods that can be derived from this corn include high fructose corn syrup, corn starch, and corn flour. Such products are processed into breakfast cereals, baking products, extruded confectionary and corn chips.

What information is required to be submitted to FZANZ for a food safety assessment for an application such as for MON863 corn?

Those seeking approval for a new GM food must supply FSANZ with relevant scientific information, which must have been generated according to international standards of good laboratory practice in independently audited laboratories. FSANZ gathers extra information from many sources, including peer-reviewed scientific literature, general technical information, independent scientists, regulatory agencies, international bodies and the community.

Before it will recommend approval of a GM food, FSANZ must be satisfied that the food does not have any potential for toxicity or allergenicity (note that no-one can test for any new toxins or allergens – if you don’t know what to look for how can you look?) and is not likely to pose any new health risks when compared with its conventional counterpart. Those GM foods that have been approved are considered to be as safe as their non-GM counterparts with no additional risks.

Does the rat corn feeding study, not included in the original application to FSANZ, mean that the corn and foods derived from the corn is unsafe?

No, it does not mean the food is unsafe.

It should be noted that the extra rat corn feeding study is not a ‘toxicity’ study as originally reported in media releases, but rather a study designed to give general information about the normal growth and well-being of animals fed with GM food or feed. As such it is narrow in design and scope, and the interpretation of such studies in relation to the safety of food is therefore limited. FSANZ does not require this type of animal feeding study s to be submitted as part of an application a GM food.

In the case of the MON 863 corn, the extent of the compositional data, molecular composition characterisation and toxicity / allergenicity data provided was considered sufficient to determine the safety and nutritional adequacy of the food. However, the applicant did submit in this case a feeding study in broiler chickens, which was evaluated as part of the assessment of MON863 corn as additional supporting information.

Has the information contained in the rat corn feeding study conducted by Monsanto been assessed by FSANZ?

FSANZ has assessed the summary data and the supplemental analyses performed by the applicant on the 90 day feeding study in rats.

Has this corn been accepted by other countries besides Australia and New Zealand?

The European Food Safety Authority, having examined all the available data, including the 90 day feeding study in rats together with supplemental analysis completed by Monsanto, approved MON863 corn for use in the European Union in April 2004, stating that the “placing on the market of MON 863 is unlikely to have an adverse affect on human and animal health or on the environment in the context of its proposed use”. MON 863 corn has also been approved for use in Japan, Canada and the United States.

Further information on GM foods sold in New Zealand and on labelling requirements for GM foods