Monsanto Responds to French Rat Study (Seralini, et al. 2012)

9/21/2012

In late September, a study conducted by a French university team (Seralini, et al.) was published by Food and Chemical Toxicology, and claimed to have found negative health effects in laboratory rats fed a diet of genetically modified corn. Numerous scientists and regulatory agencies have now had the opportunity to examine the study and have posted or published comments about it.

Updated as of 12/21/2012

Regulatory Authorities Respond:
Following release of the Seralini et al. publication, scientific authorities and regulatory bodies around the globe strongly criticized both the publication and the surrounding publicity efforts (links below). On November 28, the European Food Safety Authority (EFSA) issued its final assessment, including an extensive review of commentaries by EU Member States and other scientific and technical commentary.  The abstract of this assessment states (emphasis added):

… The assessments of Member States and EFSA revealed an overall agreement. The study as reported by Séralini et al. was found to be inadequately designed, analysed and reported. The authors of Séralini et al. provided a limited amount of relevant additional information in their answer to critics published in the journal Food and Chemical Toxicology. Taking into consideration Member States’ assessments and the authors’ answer to critics, EFSA reaches similar conclusions as in its first Statement (EFSA 2012). The study as described by Séralini et al. does not allow giving weight to their results and conclusions as published. Conclusions cannot be drawn on the difference in tumour incidence between treatment groups on the basis of the design, the analysis and the results as reported. Taking into consideration Member States’ assessments and the authors’ answer to critics, EFSA finds that the study as reported by Séralini et al. is of insufficient scientific quality for safety assessments. EFSA concludes that the currently available evidence does not impact on the ongoing re-evaluation of glyphosate and does not call for the reopening of the safety evaluations of maize NK603 and its related stacks. EFSA’s evaluation of the Séralini et al. article is in keeping with its role to review relevant scientific literature for risk assessment on an ongoing basis to ensure that the advice it provides is up-to-date.

Link to the full EFSA report:
Final review of the Séralini et al. (2012a) publication on a 2-year rodent feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and Chemical Toxicology

Monsanto's Response

Monsanto has also evaluated the study, and here is the company’s summary response (read Monsanto's original detailed response here): 

This study does not meet minimum acceptable standards for this type of scientific research, the findings are not supported by the data presented, and the conclusions are not relevant for the purpose of safety assessment. 

Toxicologists and public health experts find fundamental problems with the study design. Critical information about how the research was conducted is absent, and the data presented do not support the author’s interpretations. Among the key shortcomings are: 

• Research protocol does not meet OECD standards

• Source and quality of corn used is unclear.

• Critical details on diet preparation and dietary intake are absent.

• Complete lack of data pertaining to assertions of liver or kidney histopathology, liver function tests, and cytochrome activity.

• Lack of any statistical analysis for mortality or tumor incidence endpoints.

• Mortality rates and tumor incidence in all groups fall within historical norms for this strain of laboratory rats, which is known for a high incidence of tumors.

• Data presented are highly sporadic, using different methods for male and female animals, and are not sufficient to support conclusions drawn.

• There is a lack of dose-response relationship throughout the study. 

There is no plausible mechanism for the results reported with genetically modified corn, and the results are inconsistent with an extensive body of experience and scientific study. Extensive animal and in-vitro (test-tube) data has demonstrated that glyphosate does not cause cancer or tumors, nor is an endocrine disrupter. This study does not provide information which calls into question the extensive safety evaluations of glyphosate or Roundup brand agricultural herbicides.

 

Regulatory and Scientific Authorities’ Comments:

EFSA (European Food Safety Authority) Initial Assessment

EFSA Final opinion-delay notice

Germany- BfR (Institute for Risk Assessment)

Germany- BVL (Federal Office of Consumer Protection and Food Safety)

FSANZ (Australia New Zealand Food Standards)

France- ANSES (Agency for Food, Environmental, and Occupational Health and Safety)

France- HCB (High Counsel for Biotechnology)

Denmark- DTU National Food Institute

Belgium- BAC (Biotechnology Advisory Council)

Six French Academies of Science

Belgium- VIB (Life Sciences Institute)

European Federation of Biotechnology

ABNE (African Biosafety Network of Expertise)