Members of European Parliament (MEPs) wrote a letter last week to the U.S. District Judge overseeing the Monsanto Roundup litigation, seeking to learn more about the validity of the scientific conclusions EU regulators reached on the carcinogenicity of glyphosate, the active ingredient in Roundup.
The letter, signed by MEPs Bart Staes of Belgium, Heidi Hautala of Finland, Benedek Javor of Hungary and Michele Rivasi of France, asked U.S. District Court Judge Vince Chhabria for access to a number of key deposition transcripts and other relevant court documents from the ongoing Monsanto Roundup multidistrict litigation (MDL) in Northern California.
According to the letter, the MEPs want help untangling the diverging scientific arguments and conclusions surrounding the EU glyphosate assessment. Specifically, the European legislators want to know how the World Health Organization’s International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA) reached “contradictory conclusions on the carcinogenicity of glyphosate.”
In the spring of 2015, IARC issued a report on glyphosate, concluding the chemical is a probable human carcinogen. The authors of the report evaluated all of the publicly available scientific literature on glyphosate, then through a transparent and rigorous process, decided on the degree to which the evidence supported the chemical’s potential to cause cancer.
Months after the IARC report was published, EFSA issued a report of its own, concluding that glyphosate is unlikely to be carcinogenic for humans. One key difference between the IARC report and the EFSA report is that EFSA utilized unpublished studies as the “core basis” for its conclusion, including studies funded by industry.
In their letter the MEPs expressed “strong doubts on the validity of the EU agencies’ assessments and we have strong reasons to believe that EFSA, in particular, has been too dependent on industry-based data and sealed scientific reports, notably from Monsanto, for their assessment of glyphosate.”
Here is the full letter sent by the MEPs to Judge Chhabria:
Dear Judge Chhabria,
We, elected Members of the European Parliament, are writing to ask for your assistance in helping us untangle the scientific arguments surrounding glyphosate, and in particular to help us in our enquiry on the validity of the conclusions of the European Food Safety Authority (EFSA) on whether this herbicide causes cancer in humans or not. For reasons outlined below, this is linked with the ongoing court case concerning the Roundup/Monsanto Liability (Case MDL no. 2741 re Roundup Products Liability Litigation), under your jurisdiction.
The glyphosate issue debate has been, and remains, a huge public health and regulatory issue for European policy makers. A heated debate on the safety of the world’s most used herbicide active substance is ongoing, both at European Union and national level and across the political spectrum. The general public and civil society is also actively engaged and an EU- wide petition has been signed by 1.3 million citizens, who are calling on European decision makers to ban glyphosate.
A very practical reason for this attention is that the EU’s current authorization of glyphosate will expire by 31 December 2017 at the latest. The discussion on whether the EU should re- authorize glyphosate to be sold on the European market, as well as the scientific debate on whether this herbicide is carcinogenic for humans, is therefore currently very high on the agenda of the different EU institutions (in particular in European the Parliament, Council and European Commission). As legislators, not scientists, we rely on scientists and scientific bodies to help us understand the complex science and metabolic pathways of this and other active substances. Unfortunately, this understanding is not helped by the fact that different scientific bodies have reached contradictory conclusions on the carcinogenicity of glyphosate. EFSA concluded that glyphosate is unlikely to be carcinogenic for humans in November 2015 and the European Chemicals Agency (ECHA) concluded that no classification was warranted in March 2017 respectively. On the contrary, the WHO’s International Agency for Research on Cancer (IARC) classified glyphosate as a probable carcinogen for humans in spring of 2015.
As EU legislators responsible for legislating in the interest of public health, and in order to have the most reliable, solid and independent opinions, we need to be sure that public institutions base their assessments as much as possible on independent science and publicly available reports, free from any political or economic interference.
However, after preliminary investigations, strong doubts remain on the validity of the EU agencies’ assessments and we have strong reasons to believe that EFSA, in particular, has been too dependent on industry-based data and sealed scientific reports, notably from Monsanto, for their assessment of glyphosate. Recent reports indicate that the pesticide industry had advance access to the European Food Safety Authority’s safety assessment of glyphosate: “Shortly before the agency revealed its 2015 safety assessment for the world’s most widely-used herbicide, industry representatives were asked to file redaction requests and were even able to edit the documents at the very last minute”.
With all this in mind, we have been following Court Case MDL no. 2741 re Roundup Products Liability Litigation under your jurisdiction with great interest. Especially since one of the reasons for our concern has been the EU agencies’ use of studies of which some mentioned in the so called ‘Monsanto Papers’, unsealed this spring as part of the court case. As you know, the Monsanto paper revelations showed that Monsanto had authored some scientific studies on glyphosate, downplaying its risks, which were then attributed to scientists. Both EFSA and ECHA made reference to these studies in their assessment of whether glyphosate causes cancer or not. We need to know how much these kind of studies have been used in the ‘balancing of evidence’ and for that we need to have as much of the facts on the table.
Our concerns about EFSA’s assessment have been further increased by news, that former EPA-expert Jess Rowlands, the US expert exposed in the ‘Monsanto Papers’, in a possible collusion with Monsanto, actively intervened in EFSA’s glyphosate assessment. He provided information which reassured EFSA in its decision to discard the conclusions of a key study (Kumar) showing cancer in mice exposed to glyphosate. Following the revelation, EFSA told the press and civil society that it had double-checked Rowlands’ information before they decided to disregard the Kumar-study as non-reliable. But when requested to prove this with documents on how they had actually performed these double-checks, EFSA had no documents to show’.
The Monsanto Papers have implications of course that go well beyond glyphosate. There is a wider issue of the lack of transparency in the EU’s assessment of active chemical substances. According to EFSA, the main reason that certain parts of the studies it used, have not been disclosed, is because of the need ‘to protect the commercial interests of the study owners’ (represented by the Glyphosate Task Force). EFSA also claims that there is ‘no overriding public interest’ in the information that would merit its publication.
In our view, assessment of potentially harmful substances by EU agencies must be based on fully independent and publicly available studies so that they are open to proper scrutiny. Not only would this improve the robustness of the assessment, it would also help increase public trust in the important work these agencies do. This is why we recently filed a case before the European Court of Justice, in order to get full public access to all underlying scientific reports and documents used by EFSA.
On October 11th both the Agriculture Committee and the Committee for Public Health and Environment of the European Parliament will hold a joint hearing on the Monsanto Papers and the way EU-agencies reached their conclusions on glyphosate. In order to prepare for this important hearing to the best of our abilities, to regulate effectively and understand what credibility to assign to certain studies and to the conclusions of EFSA and ECHA, as well as on the possible interference of Monsanto in their decision making processes, we are seeking more information.
We would therefore be very grateful, after consideration of the facts above, if you could provide us access to the deposition transcripts from the mentioned court case of the following people: Donna Farmer, David Saltmiras, William Heydens, David Heering, Dan Jenkins, along with any accompanying and relevant documents or other evidence.
We would also like to formally and kindly ask you to place this letter in the court file.
We look forward to your reply and remain at your disposal regarding any clarification you seek or questions you may have concerning this request.
Bart Staes, Heidi Hautala, Benedek Javor and Michel Rivasi
Members of the European Parliament