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EFSA’s and ECHA’s Glyphosate Evaluations are Scientifically Flawed

By: Claire Robinson

EFSA’s and ECHA’s logos

New analysis by cancer expert shows that the EU’s food safety and chemicals agencies failed to spot eight instances of increased tumours in rodents following glyphosate exposure

In their assessments of glyphosate’s carcinogenicity, the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) failed to spot eight instances of increased tumours following glyphosate exposure in rodent tests sponsored by industry, a new analysis reveals.

The German Federal Institute for Risk Assessment, BfR, comes in for strong criticism. In its original report that fed into the EU’s glyphosate assessment, BfR only identified 20% of the 21 positive tumour findings found in the new analysis.

The analysis was performed by Dr Chris Portier,* a retired leading environmental health and carcinogenicity specialist who was an “invited specialist” to the Expert Group on glyphosate of IARC, the World Health Organisation’s cancer research arm. IARC concluded in 2015 that glyphosate is a probable human carcinogen.

EFSA and ECHA subsequently disagreed, concluding that the chemical is non-carcinogenic. But according to Dr Portier, both agencies “failed to identify all statistically significant cancer findings in the chronic rodent carcinogenicity studies with glyphosate.”

This, Dr Portier says, “suggests that the evaluations applied to the glyphosate data are scientifically flawed, and any decisions derived from these evaluations will fail to protect public health.”

Dr Portier writes, “I continue to have serious concerns about the scientific quality of the evaluations by both EFSA and ECHA on a number of issues”.

Dr Portier reports his findings in a letter to Jean-Claude Juncker, president of the European Commission (see link below). Dr Portier asks that the evaluations by EFSA and ECHA are repeated and that the data underlying these evaluations are publicly released. These data are currently held as commercially confidential but were partially released to a group of MEPs at their request. Dr Portier was then given  access to the material. For his review, he also examined some industry data that was made available in a scientific paper supported by Monsanto (Greim and colleagues, 2015).

Failure to examine original data

In his letter to President Juncker, Dr Portier refers to a recent article in which an EFSA spokesperson defended the agency’s glyphosate assessment. An NGO report had accused EFSA experts of being influenced by industry-sponsored reviews concluding that the chemical was safe, rather than carrying out an independent examination of the crucial raw data generated by industry carcinogenicity tests in animals.

The EFSA spokesperson had insisted that “EFSA and EU member states rely primarily on the original studies and the underlying raw data which they check themselves.”

But after examining the raw data that was released to the MEPs, Dr Portier concluded otherwise: “My review of the recently available data suggests this is not the case and that again, several important positive findings [of carcinogenicity from glyphosate] have been missed.”

These positive findings of carcinogenicity had also not been reported by the Glyphosate Task Force (GTF), the coalition of pesticide manufacturers that is attempting to get the chemical re-authorised in Europe, in its report to the EU authorities in support of glyphosate’s re-authorisation.

These common failings of the GTF report and the EU authorities’ assessments raise the question of whether the authorities were relying on the report of the GTF, rather than examining the industry raw data for themselves, as is required by rigorous scientific practice.

There appears to be no excuse for the EU authorities to turn a blind eye to these results. They had the benefit of the IARC review, which highlighted positive findings of carcinogenicity in those industry studies that were available to the IARC working group. In addition, EFSA and ECHA, as well as BfR in a post-IARC re-evaluation of its original report, had actually admitted the existence of additional industry studies with positive results.

Given these facts, Dr Portier adds that “it is difficult to understand why BfR, EFSA and ECHA failed to re-evaluate all of the available data”, using an appropriate statistical test.

Dr Portier lists several major concerns that have not been adequately addressed in the EU authorities’ assessments. These are:
* EFSA’s classification of the human evidence as “very limited” is not a valid characterization under the relevant EU law (the CLP guidelines) and fails to properly address the strength of the available evidence;
* Both EFSA and ECHA dismissed positive findings because they fell inside of the range of the historical controls (this is an improper use of historical control evidence);
* Both EFSA and ECHA compared findings across different animal strains and different study durations to conclude that studies were inconsistent (this is not scientifically justifiable); and
* Both EFSA and ECHA characterize the evidence for genotoxicity (DNA damage) as negative, yet a review of the evidence released by EFSA and the open scientific literature suggest there are many studies demonstrating genotoxicity.

Serious omissions

Dr Portier writes, “After numerous scientists from EFSA, from ECHA, from BfR and from the Glyphosate Task Force have reviewed and evaluated this massive amount of data, there are still serious omissions in the way in which these data have been assessed and reported.” He asks that “the agencies involved in the evaluation of glyphosate conduct their own analyses” of the tumours identified in his review and “amend the record of their decision as appropriate rather than simply ignoring these observations.”

Dr Portier criticises the lack of transparency of the EU’s glyphosate assessment. While some of the industry raw data were made available in response to the MEPs’ request, vital sections including the materials and methods, analysis and discussion sections from the study reports are not available. These omissions, says Dr Portier, make it impossible for outside scientists to judge the quality of the studies, the rigour of the methods used to analyze the data, or to determine if there are legitimate reasons in these discussions why the tumours identified in his review were excluded from the assessment.

Dr Portier concludes, “I firmly support the principle that scientific evidence should be used to help guide societal decisions about health risks to humans. However, the individual scientific studies must be carefully summarized and reviewed if their findings are to serve as a true guidance. The glyphosate hazard classification appears to have been a good example of how lack of transparency regarding the scientific evidence that underlies important public health decisions can erode public trust and raise concerns. I respectfully request that you instruct the appropriate agencies to review the evidence submitted herein and ask that you refrain from making any decisions on glyphosate until these positive findings are included.

“I also request that, in the interest of scientific transparency, EFSA should release all of the raw data in all areas of toxicology for all pesticides so scientists interested in repeating the evaluations by EFSA and ECHA can do so.”

We at GMWatch believe that it would be unacceptable for the EU to re-authorise glyphosate until the authorities have addressed all the points raised in Dr Portier’s analysis, using scientific arguments.

* Dr Portier is the former director of the National Center for Environmental Health and Agency for Toxic Substances and Disease Registry at the US Centers for Disease Control and Prevention (CDC). Prior to that role, he spent 32 years with the National Institute of Environmental Health Sciences (NIEHS), where he served as the NIEHS associate director, director of the Environmental Toxicology Program, and associate director of the National Toxicology Program. In retirement, Dr Portier, who was an “invited specialist” to the IARC review on glyphosate, has done some part-time work for the Environmental Defense Fund.

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