EFSA continues "to withhold sections of the studies that, in our view, are crucial for an independent assessment”, say MEPs
The four Green MEPs who requested access to unpublished industry studies on glyphosate have put in a second request to the European Food Safety Authority (EFSA) asking for more information.
In their letter to Dirk Detken, the head of legal and regulatory affairs at EFSA, MEPs Heidi Hautala, Benedek Jávor, Michèle Rivasi and Bart Staes say that they welcome the fact that EFSA sent them the unpublished raw data on the genotoxicity and carcinogenicity of glyphosate, and EFSA’s recognition that their motivation was to allow independent scrutiny of the data.
But the MEPs say that EFSA is continuing "to withhold sections of the studies that, in our view, are crucial for an independent assessment". They are asking EFSA to send them the sections on "material, conditions and methods" as well as "results and discussion".
This documentation, they point out, is necessary in order to:
1. Know the chemical purity of the substance
2. Assess whether the statistical method most appropriate for the analysis of the results was established before commencing the study (thus, presumably, ensuring that industry cannot cherry-pick the statistical analytical methods that give the desired result)
3. Ascertain the origin of the animals used, as this relates to the controversial issue of historical control data (which is often used by industry and regulators to dismiss findings of harm within individual experiments)
4. To verify "potentially speculative claims with regard to viral infections" in the pathology reports, and
5. To check whether the evaluation of observed tumour incidences was done correctly.
The MEPs also say that those parts of the studies bearing regulatory certification by dedicated laboratories and including the statement on Good Laboratory Practice must be made available. Industry studies are supposed to conform to Good Laboratory Practice rules.
The EU access-to-documents legislation permits some exceptions to disclosure but the MEPs cite examples of case law to argue that EFSA cannot refuse their request.
The letter says that EFSA would have to prove that an interest would be undermined by disclosure. In other words EFSA has to examine each document and prove that a serious risk is "reasonably foreseeable and not purely hypothetical".
The MEPs also demand that EFSA disclose the names and declarations of interest of all the member state representatives involved in the glyphosate assessment – something the Authority has not done, though a few experts have made voluntarily declarations.
The MEPs’ letter cites the legal case, ClientEarth v EFSA (615/13P), in which the European Court of Justice concluded that identifying the experts who comment on EFSA draft guidance is necessary "so that the impartiality of each of those experts in carrying out their tasks as scientists in the service of EFSA could be specifically ascertained".
The MEPs also argue that there is “a clear overriding public interest in disclosure of the information on material, experimental conditions and methods, as well as results and discussion“, something which EFSA has denied.
The case will set an important precedent for other regulatory evaluations of pesticides and other chemicals, which are similarly based on unpublished industry studies.