The European Food Safety Authority (EFSA) today made public almost all supporting documents and data submitted by Monsanto for the authorisation in 2003 of its genetically modified maize NK603. The data was released alongside the announcement by EFSA that it intends to embark on a broad transparency initiative designed to make data from its risks assessments more available to the broad scientific community and other interested parties.
The move is consistent with the recommendations of an external evaluation of EFSA by Ernst & Young last September which called on EFSA to increase transparency over how it reached its decisions on applications. James Ramsay, a spokesman for EFSA, which is based in Parma Italy, says the plan to release more data in 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.
EFSA said that it chose to make the NK603 data publicly available first given 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 incidences of tumours — the 500MB download contains all data apart from small amounts of commercially-confidential data, says Ramsay. The French study has been roundly criticised by scientists and authorities as being methodologically flawed.