Monsanto reiterated Monday that, contrary to published reports, it supplied all required information to the European Food Safety Authority (EFSA) prior to EFSA's 2004 favorable scientific opinion on the company's MON 863 YieldGard Rootworm corn.
"Published reports suggest that there is new information about MON 863 that has not been submitted to EU regulators. That is not the case," says Jerry Hjelle, vice president for Monsanto Worldwide Regulatory Affairs. "Monsanto has provided all required data and studies, including the subject rat study, to European regulatory authorities, and EFSA reviewed these studies before issuing its opinion."
Reuters reported Monday that a Monsanto study found that rats fed the biotech corn had smaller kidneys and blood composition different from rats not fed the corn.
MON 863 YieldGard(R) Rootworm contains a protein that specifically targets corn rootworm larvae, allowing the corn plant to naturally protect its roots against the damaging pest. This product has completed full regulatory review and has been grown commercially in the United States and Canada since 2003, and has also been approved for import and food use in many countries around the world, including Japan, Korea, Taiwan, the Philippines, Russia and Mexico.
Monsanto says as part of the European regulatory process, the company supplied all required information to EFSA and national regulatory bodies in the EU member states. EFSA evaluated the complete dossier and adopted a positive scientific opinion on April 2, 2004, concluding that "the placing on the market of MON 863 is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed use."
In addition, after questions of possible effects on rats were addressed, EFSA's Scientific Panel on Genetically Modified Organisms published a statement on October 29, 2004, reaffirming the original conclusions on the safety of MON 863 and concluding the alleged effects in rats are not the result of MON 863 consumption. A number of other national regulatory authorities, including Germany's RKI and France's AFSSA and CGB, concurred with EFSA's positive opinion on the safety of MON 863.
After a vote last week by the Regulatory Committee for Regulation (EC) No 258/97, comprising the representatives of Member States, the MON 863 dossier will now be referred to the Council of Ministers for a decision.