The data is not to be published on EFSA’s website but released to CEO and Green MEPs, who both filed an access to documents request to obtain it (CEO filed its access to documents in December 2015, the Green MEPs in March 2016). The purpose of such a decision is to enable scientific scrutiny into the EU’s assessment of glyphosate, which, controversially, found that it was “unlikely to cause cancer in humans”.
There are limitations to this decision: the files will not be released in machine-readable format, as only companies themselves have the studies in this format; the original conclusions of the authors of the studies will not be released, as well as several elements that can be considered commercially sensitive, so as to respect legal copyright obligations; and the whole extent of the disclosure will need to wait for the actual release of the data, that EFSA says will take another two months; but overall this is unprecedented for the agency and a very welcome and important step forward.
Until today, the data used by EU risk assessment bodies (the situation is comparable in most countries worldwide) to assess the toxicity of synthetic pesticides (and, actually, most regulated products put on the EU market) could not be published. This prevented the scientific scrutiny of crucial public health decisions by public authorities, an indefensible situation. This has been a scandal for too long, and in that sense today’s decision by EFSA is a very important first precedent in principle. It is also a very welcome demonstration of EFSA’s determination to improve its reputation, tarnished for too long by its lack of independence from companies it contributes to regulate.
That said, this decision and the way it was achieved also indicates how long there is still to go to reach a situation where such disclosure of essential regulatory data will become the norm and not the exception:
- It took an exceptional conflict between two public health agencies, EFSA and the International Agency for Research against Cancer (IARC), triggered by, precisely, the fact that EFSA had access to these studies and IARC not, to bring high-profile political attention to this problem.
- It took massive political pressure on EFSA and the European Commission for them to actually move (EFSA had been discussing its own transparency initiative since 2012, with little advances so far; Health Commissioner Andriukaitis even publicly asked industry to disclose these studies, which they didn’t – they only provided a “reading room”, a format preventing any serious analysis).
- It took 10 months of painful legal screening (to redact commercially sensitive elements from the studies) and tight negotiations between EFSA and Monsanto (and other companies). These thousands of hours of working time were a serious burden for an agency that is severely resource-constrained (it doesn’t even have the means to pay the external experts on its scientific panels).
- EFSA will not publish the data, but only share it with those who asked for it (CEO and Green MEPs).
- The fact that the data still isn’t in a machine-readable format makes it a significant burden for whoever will want to analyse it.
Our demands on regulatory data transparency, therefore, are worth repeating: complete, unrestricted and proactive online publication of full applicants’ files when these reach EFSA (as opposed to the current reactive regime which is time and resource-consuming for the authority) and, crucially, in an editable format enabling this data’s proper analysis.
Ultimately, these demands can only be fulfilled by an evolution of the regulatory framework, a decision only the European Commission, the European Parliament and Member States can take. Will they support EFSA in this important move, or will they surrender to industry’s pressures to maintain the status quo?
[UPDATE: the piece was corrected on 24 10 2016, “two public risk assessment agencies” was incorrect (IARC isn’t, see comment by conscientiam below) and was replaced by “two public health agencies”]
Image: “Open the Door”, by Mark Dries (Some rights reserved - CC BY-NC-ND 2.0)