Update: MON863 corn safety assessment
June 2005
Food Standards Australia New Zealand (FSANZ) assessed food from insect protected MON863 corn as Application A484 and the Final Assessment Report, which recommended its approval for Australia and New Zealand, was released on 8 October 2003. The amendment to Standard 1.5.2 - Food Produced Using Gene Technology - of the Australia New Zealand Food Standards Code (the Code) permitting MON863 corn came into effect in December 2003 in Australia and in April 2004 in New Zealand. A copy of our Final Assessment report is available from the FSANZ website http://www.foodstandards.gov.au/_srcfiles/A484_Final_Assessment_Report.pdf .
FSANZ completed a comprehensive safety assessment of food derived from MON863 corn as required by Standard 1.5.2. FSANZ evaluated all the available safety data including an acute oral toxicity study using mice and a feeding study in chickens. No potential public health and safety concerns were identified during the assessment and no further data was deemed necessary or requested. No studies on rats were made available to FSANZ.
FSANZ is now aware of the additional 90-day feeding study in rats that was provided by Monsanto to the German Competent Authority and subsequently assessed. This new study is not an animal toxicity study as originally reported in media releases. Animal feeding studies are designed to give general information about the normal growth and well-being of animals fed with GM food or feed and are therefore narrow in design, scope and interpretation. Animal toxicity studies are designed to assess the potential for any adverse effects of a substance by assessing a wide range of concentrations and toxicological endpoints.
FSANZ is also aware that the French Commission for Genetic Engineering raised some questions in relation to the rat feeding study. In response a supplemental analysis of selected findings was provided by Monsanto. The European Food Safety Authority (EFSA) examined the 90-day feeding study in rats, together with the supplemental analysis completed by Monsanto, and subsequently adopted a positive scientific opinion on 2 April 2004, concluding that the “the placing on the market of MON863 is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed use.”
FSANZ does not require feeding studies in animals, such as this 90-day feeding study in rats, to be submitted as part of an application to FSANZ for a GM food. Where GM varieties have been shown to be compositionally equivalent to conventional varieties, feeding studies using target livestock species will add little to a safety assessment and are generally not warranted. In the case of MON863 corn, the extent of the compositional data, molecular characterisation and toxicity / allergenicity data was considered sufficient to establish the nutritional adequacy of the food. However, Monsanto submitted a feeding study in broiler chickens, which was evaluated as part of the assessment of MON863 corn as additional supporting information. The rapidly growing broiler is considered to be sensitive to changes in nutrient quality in diets, and therefore is often used as a model to assess normal growth and well-being and the wholesomeness of corn. The data demonstrate that MON863 corn is equivalent to its conventional counterpart and other commercial varieties of corn in terms of its ability to support the rapid growth of broiler chicks.
Despite the optional status of feeding studies, FSANZ made contact with Monsanto who subsequently provided a summary of the feeding study in rats and supplemental analyses. FSANZ requested Monsanto to also supply the full raw data for the rat feeding study on MON863. This data arrived at FSANZ accompanied by a full claim for commercial-in-confidence (CCI) under section 39 of the FSANZ Act. FSANZ did not agree to the CCI claim, and so the raw data was immediately returned to Monsanto in line with the conditions upon which it was supplied to FSANZ.
FSANZ has assessed the summary of the feeding study, including the supplemental analyses, and this assessment can be accessed via the following link.
Review of 13-Week Rat Feeding Study with MON863 Corn - October 2004 [ pdf 186 kb ]