Brussels, 15 September 2017 – According to media reports, large sections of the EU report evaluating the independent science on glyphosate’s potential risk to human health have been copied, word for word on many pages, from Monsanto’s application for the renewal of glyphosate’s licence, filed on behalf of the Glyphosate Task Force (a consortium of more than 20 companies). The sections concerned address the potential genotoxicity, carcinogenicity and reproductive toxicity as reported in the scientific literature.
Commenting on the discovery Franziska Achterberg, Greenpeace EU Food Policy Director said:
“Whether this is a question of negligence or intent, it is completely unacceptable for government bodies to pass off industry analysis as their own. It calls into question the entire EU pesticide approval process. If regulators rely on the industry’s evaluation of the science without doing their own assessment, the decision whether pesticides are deemed safe or not is effectively in the industry’s hands. Voting against glyphosate is the last opportunity our governments have to fulfil their duty to protect us from this dangerous chemical.”
Throughout the discussions about glyphosate, the European Food Safety Authority (EFSA) and the relevant German national authority (Bundesinstitut für Risikobewertung, BfR) have emphasised that they have done their own evaluations of the studies. However, an initial comparison of the Monsanto application and the EU report shows this is not the case.
It suggests that BfR and consequently EFSA have failed to conduct their own review of an important number of independent scientific studies on potential human health impacts of glyphosate, including genotoxicity, carcinogenicity and reproductive toxicity. Entrusted with delivering an independent scientific assessment, the authorities have effectively passed Monsanto’s interpretation off as their own.
EFSA evades responsibility for its role
EFSA is claiming that the Renewal Assessment Report (RAR) is not its own work; and that instead the health risk assessment in the RAR is the work of the BfR. It is correct that authorities from the Rapporteur Member State (RMS), Germany, drafted the RAR, but their work was subsequently reviewed by other national authorities, the European Commission and EFSA. None commented on the excessive copying from Monsanto’s submission. EFSA then drafted its conclusion based on the 4,300-page report. The RAR and the EFSA conclusion are therefore inherently related. EFSA’s own description of the process is online.
Has the BfR and EFSA been transparent about copying the descriptions of studies?
The RAR discloses that the BfR copied sections concerning unpublished industry studies from the Monsanto’s glyphosate application, and provided its own comments on them in italics (“RMS comments”). However, the report does not disclose that the BfR also copied Monsanto’s description and analysis of the independent studies published in peer-reviewed scientific journals.
In fact, the report explicitly states that the BfR evaluated and commented on these studies: “The publications on subject areas 1-4 are presented in the chapters on Genotoxicity, Long term toxicicity [sic] and carcinogenicity, Reproductive Toxicity and Neurotoxicity of the report. (…) Important publications are presented in summaries as quoted from the articles followed by Klimisch ratings and by RMS comments on the paper” (page 515 of the 4,300-page report).
EFSA has issued a statement saying: “Every scientific study is scrutinised for relevance and reliability by EU risk assessors based on the evidence contained within the study.”
Similarly, Peter Bleser, State Secretary at the German Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) which oversees the BfR, stated in response to a written question by a German member of parliament that all studies were evaluated by the BfR. He went on to say that only the descriptions of the “original studies submitted by the applicants”, not the published studies, were taken from the Glyphosate Task Force (GTF) and commented on in italic by the Rapporteur Member State (i.e. the BfR).
As reported in the media, a comparison of the documents has now called these statements into question. It appears that the regulatory authorities responsible for reviewing the evidence have instead taken Monsanto’s interpretation and presented them as their own – a flagrant and unacceptable failure on the part of the authorities.
Review of the published literature on genotoxicity:
Review of the published literature on reproductive toxicity:
Review of the published literature on carcinogenicity:
|In the GTF application for glyphosate renewal||In the GTF application for glyphosate renewal|
|In the EU report (copied text highlighted in orange)||In the EU report (copied text highlighted in orange)|
Franziska Achterberg – Greenpeace EU food policy director: +32 (0)498 36 24 03, email@example.com
Laura Ullmann: Greenpeace communications officer: +32 (0)2 274 1915, +32 (0)486 88 52 12 firstname.lastname@example.org
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 European Food Safety Authority, EFSA Statement regarding the EU assessment of glyphosate and the so-called “Monsanto papers”, June 2017, p. 3 https://storage.googleapis.com/planet4-eu-unit-stateless/2018/08/f74ef8ae-f74ef8ae-20170608_glyphosate_statement.pdf
Peter Bleser, State Secretary at the German Federal Ministry of Food, Agriculture and Consumer Protection (BMELV), in response to a written question (7 September 2015), page 40 http://dipbt.bundestag.de/dip21/btd/18/059/1805977.pdf
Peter Bleser, State Secretary at the German Federal Ministry of Food, Agriculture and Consumer Protection (BMELV), in response to a written question (29 June 2015), page 38 https://storage.googleapis.com/planet4-eu-unit-stateless/2018/08/66bd8e2f-66bd8e2f-1805455.pdf