Safety claims on genotoxicity and carcinogenicity are unreliable

The report by the German Federal Institute for Risk Assessment, BfR, that will be used to decide whether glyphosate is re-approved by the EU authorities has serious deficiencies, according to an analysis by the toxicologist Dr Peter Clausing.

BfR concluded from its examination of studies on glyphosate that “the available data do not show carcinogenic or mutagenic properties of glyphosate nor that glyphosate is toxic to fertility, reproduction or embryonal/fetal development in laboratory animals.”

But Clausing’s analysis shows that in order to reach this conclusion, BfR ignored important scientific studies, failed to apply up-to-date statistical analyses to industry data, and made false statements about historical control data that were used to dismiss findings that glyphosate caused cancer in mice.

Another serious deficiency of BfR’s analysis is in the area of glyphosate’s genotoxicity (ability to damage DNA), where BfR appears to have ignored a third of the relevant literature.

Clausing wrote his analysis after obtaining a leaked copy of the RAR, which remains hidden from the public. However, it seems that industry had privileged access to an earlier revision of the RAR. This is revealed by the fact that in March this year a group of industry-linked authors published a review claiming that glyphosate is not carcinogenic, in which they reference a version of the RAR dated 29 January 2015.

This is an example of the unhealthy closeness of regulators to the industry.

BfR’s actions on glyphosate will come under renewed scrutiny after the European Food Safety Authority (EFSA) publishes its findings on glyphosate’s safety later in the year.
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The Glyphosate Renewal Assessment Report: An analysis of gaps and deficiencies

Dr Peter Clausing
PAN Germany and Bewegt Politik Campakt!
http://www.pan-germany.org/download/Glyphosat-Studie_Campact_PAN_korrigiert.pdf

Executive summary

The Renewal Assessment Report (RAR) is the basis for the legal decision whether approval should be granted for future use of glyphosate within the European Community. The RAR is supposed to provide the results of the assessment made by the authorities of a dossier that the applicant, i.e. the industry (in our case the Glyphosate Task Force, GTF), is obliged to submit. The analysis at hand provides evidence for serious deficiencies of the RAR in crucial areas of risk assessment. The most important examples are provided in the areas of genotoxicity and carcinogenicity. The deficiencies include neglect and wrong description of important scientific publications, lack of applying up-to-date statistical analyses to the data provided by industry and false statements about historical control data used to dismiss important results from carcinogenicity studies in mice.

Specifically consideration of mechanistic evidence for glyphosate’s carcinogenic effects, i.e. oxidative stress and genotoxicity is missing or insufficient. The report remains mute about oxidative stress as related to genotoxicity and almost one third of the scientific literature on genotoxicity is missing. In addition at least one important study on genotoxicity received a false and distorted description by the BfR. Furthermore, the handling of an important mouse carcinogenicity study by industry (i.e. not applying state-of-the-art statistical methods and wrong claims about historical control data) give the impression that this was done deliberately.
 
The current analysis demonstrated omissions and distortion of facts in the “Toxicology and Metabolism” part of the draft RAR that was submitted to the EFSA. The Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment, BfR) which was in charge of this part of the RAR has full responsibility for these gaps and deficiencies. The German Government claims that the BfR performed a “detailed, quality-assured examination of all... original studies and the studies published in the scientific literature”. The present analysis contradicts this statement by providing evidence that the agency overlooked or ignored important findings and that numerous publications from the scientific literature have not even been taken into consideration. The weakening of evidence by three different processes, i.e. neglect of studies, failure of analysis and distortion of facts, nourishes the suspicion that this was done on purpose.

It should be noted that this assessment is based on a review of the 31 March 2015 version of the RAR which is not publicly available.