Lancaster University
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ID: 018203919412-57
Lobbying Activity
Response to Criteria to identify endocrine disruptors for biocidal products
6 Jul 2016
I am one among a number of researchers looking at how to make best use of the best evidence to identify and classify endocrine disruptors. While we are encouraged that the proposal acknowledges the role which systematic review (SR) methods could play in identifying EDCs, and are satisfied with the use of the WHO/IPCS definition as a basis for the regulatory definition of EDC, we have two major concerns about the proposed criteria.
Firstly, the criteria place an under-defined, potentially unprecedentedly high, burden of proof on identifying problem compounds as having endocrine disrupting properties, with the result that the identification process will be either conducted inconsistently, or only a very small proportion of actual EDCs may be classified as such.
Secondly, the criteria present a confused set of processes for identifying, evaluating and integrating scientific evidence which unnecessarily privilege certain types of data, and cannot be adequately operationalised for regulatory identification of EDCs.
To resolve these issues, we have recommended the following:
1. A clear, unambiguous definition of “known to cause adverse effects relevant for human health”.
2. Allowance for regulatory identification of a chemical substance as an EDC in the absence of “sufficient” evidence of harm from epidemiological studies.
3. The introduction of a hierarchy of categories for EDCs, with clear, unambiguous criteria distinguishing “known” from e.g. “probable”, “possible” or “not classifiable”.
4. The articulation of a systematic and coherent process for integrating evidence across the three components of the WHO/IPCS definition of EDC.
5. The definition of clear and unambiguous standards for strength of evidence within each of the three individual components of the EDC definition.
6. Ensuring all evidence is assessed on merit without prior privileging of certain study types.
Overall, we are concerned that the proposed regulatory text creates an unprecedented and incoherent burden of proof for classifying a compound as an EDC. It unnecessarily privileges certain types of evidence (such as studies "performed according to internationally agreed study protocols", which need no a priori elevation if proper evidence synthesis methods for identifying EDCs are used); it implements an opaque and ill-defined standard with a potentially very high burden of proof for identifying a compound as a “known” EDC (by requiring robust evidence of harm in humans before a compound can be identified and regulated as an EDC); and as such it is difficult to see how the process for classifying compounds as an EDC will either be reliable (in that it can distinguish chemicals which require regulatory attention from those which do not) or credible (in that it will be trusted by stakeholders).
The regulatory proposal is complex and the issues it raises require much more space for a full response than the 4000 characters permitted here. Our open letter to Commissioner Andriukaitis, to which I am a signatory, covers the reasoning behind the above points in more detail and can be downloaded here:
http://policyfromscience.com/wp-content/uploads/2016/07/Open-Letter-to-Andriukaitis-about-EDC-Criteria.pdf
[Note: This feedback duplicates my response to the initiative "Criteria to identify endocrine disruptors for plant protection products".]
Read full responseResponse to Criteria to identify endocrine disruptors for plant protection products
6 Jul 2016
I am one among a number of researchers looking at how to make best use of the best evidence to identify and classify endocrine disruptors. While we are encouraged that the proposal acknowledges the role which systematic review (SR) methods could play in identifying EDCs, and are satisfied with the use of the WHO/IPCS definition as a basis for the regulatory definition of EDC, we have two major concerns about the proposed criteria.
Firstly, the criteria place an under-defined, potentially unprecedentedly high, burden of proof on identifying problem compounds as having endocrine disrupting properties, with the result that the identification process will be either conducted inconsistently, or only a very small proportion of actual EDCs may be classified as such.
Secondly, the criteria present a confused set of processes for identifying, evaluating and integrating scientific evidence which unnecessarily privilege certain types of data, and cannot be adequately operationalised for regulatory identification of EDCs.
To resolve these issues, we have recommended the following:
1. A clear, unambiguous definition of “known to cause adverse effects relevant for human health”.
2. Allowance for regulatory identification of a chemical substance as an EDC in the absence of “sufficient” evidence of harm from epidemiological studies.
3. The introduction of a hierarchy of categories for EDCs, with clear, unambiguous criteria distinguishing “known” from e.g. “probable”, “possible” or “not classifiable”.
4. The articulation of a systematic and coherent process for integrating evidence across the three components of the WHO/IPCS definition of EDC.
5. The definition of clear and unambiguous standards for strength of evidence within each of the three individual components of the EDC definition.
6. Ensuring all evidence is assessed on merit without prior privileging of certain study types.
Overall, we are concerned that the proposed regulatory text creates an unprecedented and incoherent burden of proof for classifying a compound as an EDC. It unnecessarily privileges certain types of evidence (such as studies "performed according to internationally agreed study protocols", which need no a priori elevation if proper evidence synthesis methods for identifying EDCs are used); it implements an opaque and ill-defined standard with a potentially very high burden of proof for identifying a compound as a “known” EDC (by requiring robust evidence of harm in humans before a compound can be identified and regulated as an EDC); and as such it is difficult to see how the process for classifying compounds as an EDC will either be reliable (in that it can distinguish chemicals which require regulatory attention from those which do not) or credible (in that it will be trusted by stakeholders).
The regulatory proposal is complex and the issues it raises require much more space for a full response than the 4000 characters permitted here. Our open letter to Commissioner Andriukaitis, to which I am a signatory, covers the reasoning behind the above points in more detail and can be downloaded here:
http://policyfromscience.com/wp-content/uploads/2016/07/Open-Letter-to-Andriukaitis-about-EDC-Criteria.pdf
I look forward to these issues being addressed in the revised proposal.
Read full response