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Development of a Workable Framework for Consistent Regulatory Decision-

Background

Scientific data should form the foundation upon which regulatory and societal decisions
on the assessment and management of the health risks of chemicals can be established.
When developing such decisions, there is a need to evaluate all the available data and to
weight these accordingly. But hazard and risk assessors face a number of challenges in
progressing this task. In particular, no accepted European guidance is available on the
extent to which data (both effects and/or exposure) need to be available before healthbased
decisions on the assessment and management of chemical risks can be reliably
made, and how such data may necessarily differ (in terms of their spread, quality, etc.) in
the context of their intended use e.g. between occupational and non-occupational
situations, and related considerations e.g. differing endpoints.
There is therefore a benefit in developing a rationally based framework that assists hazard
and risk assessors to determine the acceptability of available data on chemicals in the
context in which it is likely to be used. For example, might further data be advisable
before a decision can reasonably be reached in the context of the uncertainties that are
presented? How complete must be the available effects and/or exposure data set before
soundly-based decisions can be reached on matters of public health concern? And to what
degree should issues of data quality or absence inform quasi-scientific judgements such
as the interpretation and application of the Precautionary Principle? It is envisaged that
such a framework would also present benefits for industry and society by both delivering
a basis for a consistent approach to health-based decision making, and through ensuring
that resources can be directed at those areas considered most in need, including
considerations arising from animal welfare.

Scope

  • Critically review the established decision-making processes in operation in different European health fora with the aim of evaluating the extent to which they can provide a framework against which rules might be developed to provide a consistent and
    defensible basis for making health-based regulatory decisions on chemicals. In particular, to examine the available bioethics processes in use in areas of medicine and health care e.g. Institutional Review Boards, in order to ascertain the utility of their underpinning principles for application in the field of public health decisionmaking on chemicals. This review should also include consideration of previous initiatives e.g. within national standard setting bodies, that may have addressed other aspects of the field relevant to the overall question.
  • Using case studies from existing European regulatory approaches for the assessment and management of chemical risks, seek to apply (and/or modify) the rules to establish a convention that might be usefully applied in such circumstances. In developing such rules, a distinction should be drawn between the nature of decisions that might be reached based upon sound evidence, and those which may be influenced
    by potential concerns.
  • Explore, within the context of different use/exposure scenarios, any "points of diminishing returns" where the "moral imperative" to acquire information is offset by an ability to take soundly-based decisions and to act on them.
  • Develop proposals based upon these comparisons for a workable framework that would be applicable across the range of circumstances likely to be encountered in the field of chemicals assessment and control (i.e. a definition of the applicability domain)
  • Organise a multi stakeholder, pan-European workshop (ideally as part of an appropriate professional conference or similar event), at which these issues would be discussed and steps set in place to begin to establish a workable European consensus in the area.

Timing: It is envisaged the project would last for 12 to 18 months.

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