EDC Criteria: does the latest draft respond to criticisms?

December 16, 2016 at 6:24 pm | Posted in Feature Articles | Leave a comment

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Improvements in evidence
appraisal, but not in
burden of proof

As the debate about how to identify of endocrine disruptors for regulation in the EU comes to a head, the EU Commission has published another draft of its proposed criteria for identification of EDCs. These will be discussed and potentially voted on by Member States on 21 December.

The previous draft was criticised in an open letter by a group of scientists for proposing a confused set of processes for assessing evidence of endocrine disrupting potential, and for setting too high a bar for classifying problematic chemicals as EDCs.

While the new draft resolves (at least on a generous reading) most of the technical issues identified in the letter (see points 1, 3 and 4 in the letter), the more contentious and political issues remain untouched (points 2 and 5).

Improvements in the draft:

  • On a perhaps over-generous reading, the two-tier approach to evidence appears to have been eliminated: the criteria now seem to aim at ensuring that, in addition to data produced using standardised protocols, all relevant non-protocol data is systematically identified and assessed (see paras 2a and 2b). The suggestion that assessment of non-protocol data should happen in parallel or through a secondary process appears to no longer be present.
  • The wording around how to apply the weight of evidence assessment is less muddled: there is now a relatively simple list of six things which need to be accounted for which seems comprehensive and flexible enough to allow SR methods, without being overly prescriptive about what the methods should be.
  • The ambiguous language around “may cause adverse effects” appears to have been cleared up.

Remaining problems:

  • There still needs to be introduction of categories of endocrine disruptor that reflect the strength of the available evidence. (Note that the French authorities are insisting that EDCs should be identified according to three distinct categories: known; presumed; and suspected.)
  • There is still too high a burden of proof on identifying EDCs. Paragraph 1b of the new draft should simply read “alters the function of the endocrine system” (it being unclear what work the term “mode of action” is doing here), while paragraph 1c should read something like “the adverse effect is plausibly a consequence of altered function of the endocrine system”.
  • The new draft has retained the wording which changes the regulation from being a hazard-based approach to a risk-based approach, i.e. “negligible exposure” to “negligible risk”.

Other groups have raised additional criticisms, including registering surprise at some new criteria relating to identification of EDCs as they affect wildlife populations.

Overall, in spite of the resolution of some important technical issues, it would appear there is still a long way to go before the criteria address the major points of controversy in identifying chemicals for regulation as endocrine disruptors.

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