Flawed. Gilles-Eric Séralini's study was inconclusive, two French agencies say.
Credit: G.-E. Séralini
Two French regulatory bodies agree that a highly controversial study about the potential harms of genetically modified (GM) food is inconclusive. The
study, which caused a public storm in France, had methodological flaws, the High Council of Biotechnology (HCB) and the Agency for Food, Environmental and
Occupational Health & Safety (ANSES) said on Monday. But HCB recommends that the study be repeated to reassure the public, while ANSES emphasizes the
need for more research into the long-term toxicity of GM crops.
At issue is a French study published on 19 September in Food and Chemical Toxicology by molecular biologist
Gilles-Eric Séralini of the University of Caen and his colleagues. The study reported that in rats, consumption of Monsanto's GM
corn variety NK603 was associated with earlier death and an increased risk of tumors.
The same day, the French government asked HCB and ANSES to assess whether the
study was valid; if so, the French government said it would ask the European Commission to ban the import of NK603 until appropriate evaluations were
carried out. (The European Food Safety Authority [EFSA] in Parma, Italy, gave NK603 a green light for import and processing in 2003.)
In its report, issued on Monday morning, HCB's
Scientific Committee says that "the experimental design, the statistical tools used by the study's authors, and their interpretation of the results suffer
from missing data and information and unacceptable methodological flaws." A few hours later, ANSES made public a separate report, which agreed that Séralini's data don't support the authors' claims.
Based on the two reports, "there is no reason to put into question the approval in France and in Europe of NK603 for animal feed and for human food," a
spokesperson for the Ministry of Agriculture tells ScienceInsider.
The two verdicts are in line with a tide of criticism that has been coming from all corners of the scientific world, including EFSA and Germany's Federal
Institute for Risk Assessment. The controversy around the study was fueled by accusations that Séralini and his team orchestrated media hype by giving
selected reporters advance access to the results but banning them from seeking outside comment. On Friday, six French science academies, in a rare joint statement, questioned the ethics of the way the team handled its
publicity, calling it "unacceptable" and "motivated more by ideological considerations than by the quality or pertinence of the obtained data." (They also
dismissed the results of the study.)
The two new reports, however, may set the stage for new types of studies of the risk of GM food. ANSES welcomed the "originality" of Séralini's study,
which it said was the first to test exposure, over a long period of time and at several
doses, to untreated GM plants, GM plants treated with the pesticides to which they were made resistant, and the pesticide itself. The agency, which has
been pushing for the toughening of European regulations on GM food approval, calls for more public money to be poured into studying what it sees as an
insufficiently documented health hazard.
The French government welcomed that proposal and announced a plan to ask for a revision of the European procedures surrounding
the evaluation, approval, and control of GM organisms. The ministry spokesperson insists the move was not triggered by Séralini's study. The government
also said it would maintain the French moratorium on growing GM crops.
While he affirms that he is "confident" about his scientific results, Séralini says he accepts that the two regulatory bodies find it inconclusive. He says
he welcomes the
recommendation by HCB's Economic, Ethical and Social Committee that the study be repeated following a protocol to be designed together with HCB and ANSES experts. But meanwhile, he says, "transparency is needed" on the
studies underlying NK603's approval, "so they can be scrutinized in the same persnickety way as … my study."