Posts Tagged data
A short post on manufactured nanomaterials and data. (Readers will be aware that although the blog focuses mostly on litigation, I dabble in regulatory research and practice, too. And that nanotechnology regulation has been a consistent interest of mine).
Thank you Lynn Bergeson and Carla Hutton for flagging the study by EUON on data collection and reporting methodology for manufactured nanomaterials. EUON, the European Union’s Observatory for Nanomaterials, is hosted by ECHA – the EU’s Chemicals Agency. The study’s purpose is made clear on p.15 (only) of the report: the overall context is for the regulators to have an overview of the heterogeneous market for nanomaterials. In order to do so, the study measures the reliability etc of existing reports and studies on the nanomaterials market. It concludes that a Delphi study of the existing research would be required.
For those of you with an interest in information flows and the transparency of data, the implications are clear: part of the exercise of regulating new technologies is to know what is out there; and manufacturers’ data clearly are not making it into the public domain in a transparent and coherent manner. Consider alongside this report, for instance the proposed US EPA rule on transparency in regulator science.
Update 9 November 2018 the General Court has now annulled the Commission’s Regulation.
I reported at the time on the General Court‘s decision in Dyson. The CJEU yesterday in Case -44/16P agreed, albeit in less prosaic terms than my earlier post, that the Court’s reasoning was wanting. The case now goes back to the General Court to reconsider those pleas made by Dyson which the Court considers to have been insufficiently answered.
Of most interest to readers of this blog is the argument re proof, science and procedure (at 72 ff): According to the Commission, Dyson does not explain in what way the development of a test with a loaded receptacle would have been more proportionate. The Commission submits that it was not obliged to show that no better test method could be developed, and that it was on the contrary for Dyson to prove that a more appropriate test method existed, which in the view of the General Court it failed to do.
The Court of Justice agrees that the General Court’s entertainment of this question is wanting – the particular parameter was required under the delegating Directive, alleged absence of a reliable test is not enough to ignore it. That is not to say, that upon reconsideration the eventual General Court’s answer may not be the same.