The European Food Safety Authority (EFSA) today made public almost all supporting documents and data submitted by Monsanto for the authorization in 2003 of its genetically modified maize (corn) NK603. The data were released alongside the announcement by the EFSA that it intends to embark on a broad transparency initiative designed to make data from its risk assessments more available to the broad scientific community and other interested parties.
The move is consistent with the recommendations of an external evaluation of the EFSA by Ernst & Young last September, which called on the EFSA to increase transparency over how it reached its decisions on applications. James Ramsay, a spokesman for the EFSA, which is based in Parma, Italy, says that the plan to release more data in the future is still in the “very early stages” and that a final scheme will be announced after further discussion with stakeholders. The EFSA announcement follows a similar move by the European Medicines Agency, which this year will make public all clinical-trial data it gets from industry as part of product registration.
The EFSA said that it chose to make the NK603 data publicly available first because of the level of public interest in response to a French-led study published in September, which claimed that rats fed the maize or glyphosate herbicide suffered adverse health effects including increased incidence of tumours. The 500-MB download contains all data apart from a small amount of commercially confidential information, says Ramsay. The French study has been roundly criticized by scientists and authorities as being methodologically flawed.
“While the Authority has already made available these data upon specific request on several occasions, any member of the public or scientific community will now be able to examine and utilise the full data sets used in this risk assessment,” the EFSA said in a statement.
Gilles-Eric Séralini, a molecular biologist at the University of Caen, France, who led the study, has refused to make his raw data available until the EFSA made its NK603 data available. Séralini had already scheduled a press conference for tomorrow afternoon at the European Parliament to hand his data over to a bailiff. Séralini says that he welcomes the EFSA move but also wants raw data on glyphosate-safety studies. The researcher also intends to announce tomorrow that he will pursue several of his critics for libel.