FSANZ reaffirms its risk assessment of genetically modified corn MON 863
In an article published in the International Journal of Biological Sciences in June 2009, Séralini and colleagues have repeated their claims made in an earlier article (Séraliniet al., 2007) that a statistical re-analysis of the toxicity data originally reported by Hammondet al., 2006 provided evidence of hepatorenal effects in rats fed genetically modified maize for three months. No new data were presented in the current article. Instead, the authors commented on a published report by an expert panel (Doullet al., 2007) that discussed the risk assessment conducted by Séraliniet al. 2007. For reasons not stated, the authors did not address the numerous deficiencies of their statistical re-analysis that had been reported by several international regulatory agencies (FSANZ 2007; EFSA 2007a; EFSA 2007b; Monod 2007). Instead, they chose to focus on the issues raised in a later published report by Doullet al., 2007. In the absence of new data and the failure of the authors to acknowledge that the interpretation of toxicity studies does not only involve statistics but requires the need for biological context, FSANZ is of the opinion that the recent article from Séraliniet al. provide no grounds to revise its previous conclusions on the safety of MON 863 corn as a food. Food derived from MON 863 corn is as safe and wholesome as food derived from other commercial corn varieties.
References
Doull J, Gaylor D, Greim HA, Lovell DP, Lynch B, Munro IC. Report of an expert panel on the reanalysis by Séralini et al. (2007) of a 90-day study conducted by Monsanto in support of the safety of a genetically modified corn variety (MON 863).Food Chem Toxicol 2007;45:2073-2085.
European Food Safety Authority (EFSA) (2007a). Statement of the Scientific Panel on Genetically Modified Organisms on the analysis of data from a 90-day rat feeding study with MON 863 maize. Adopted 25 June 2007. http://www.efsa.europa.eu/cs/BlobServer/Statement/GMO_statement_MON863.pdf?ssbinary=true
European Food Safety Authority (EFSA) (2007b). EFSA review of statistical analyses conducted for the assessment of the MON 863 90-day rat feeding study. 28 June 2007. http://www.efsa.europa.eu/cs/BlobServer/Scientific_Document/sc_rep_efsa_stat_review,0.pdf?ssbinary=true
FSANZ. Review of the report by Séraliniet al., (2007): “New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity”. Food Standards Australia New Zealand July 2007. http://www.foodstandards.gov.au/_srcfiles/Review_of_Report_by_Seralini_et_al_July_2007.doc
Hammond B, Lemen J, Dudek R, Ward D, Jiang C, Nemeth M, Burns J. Results of a 90-day safety assurance study with rats fed grain from corn rootworm-protected corn.Food Chem Toxicol 2006;44:147-160.
Monod H., 2007. Expérience sur rats menée par Monsanto en 2001-2002 avec certains régimes comportant du maïs génétiquement modifié: analyse statistique des courbes d’évolution du poids. Study conducted upon request of the CGB (Commission du Génie Moléculaire, France).
http://www.ogm.gouv.fr/experimentations/evaluation_scientifique/cgb/autres_avis/Avis_CGB_MON 863_15juin2007.pdf
Séralini G-E, Cellier D, de Vendomois JS. New analysis of a rat feeding study with genetically modified maize reveals signs of hepatorenal toxicity.Arch Environ Contam Toxicol 2007;52:596-602.
Séralini G-E, de Vendomois JS, Cellier D, Sultan C, Buiatti M, Gallagher L, Antoniou M, Dronamraju KR. How subchronic and chronic health effects can be neglected for GMOs, pesticides or chemicals.Int J Biol Sci2009;5:438-443.
On the 13th March 2007 Greenpeace announced the publication of a new study on the safety of a genetically modified corn, MON 863 corn. The study, published in the journal Archives of Environmental Contamination and Toxicology, reported a new statistical analysis of a 90-day rat feeding study, performed with MON 863 corn. This feeding study was evaluated by FSANZ in 2005, at which time it was concluded that the study did not indicate any adverse effects from the consumption of MON 863 corn. The same conclusion was reached by other food regulatory agencies around the world.
FSANZ has now completed a detailed evaluation and report on the recent research article entitled “New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity” by Séralini et al [ word document 120kb ] Following an independent peer review of the report, FSANZ concludes that the use of alternative statistical tests did not identify any new safety concerns.
Background
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 ]