Draft DG SANCO document: addressing the new challenges for risk assessment--an industry perspective

The draft European Commission's Directorate General for Health and Consumer Policy (DG SANCO) document represents the state of the art in environmental risk assessment (ERA) including new trends and combining high level environmental protection and realism. Using the ecosystem services concept, it offers a promising approach to determine which impact may be tolerable, where, and when. Established ERA uses a stepwise approach starting with standardized internationally accepted studies combined with appropriate assessment factors (AFs) and where needed followed by higher tier assessments and respective adjusted AFs. The draft SANCO document follows this approach and presents additional refinements to improve the realism of risk assessment, which is desirable; however, that such additional data becomes a standard requirement without a clear need must be avoided. The idea of additional AFs presented in parts of this article should accordingly first consider risks and benefits in line with this approach and only be requested if data indicates their necessity. In addition, the suggested focus on uncertainty analysis without any obvious according benefits in terms of reduced assessment factors where uncertainty is reduced, is still a challenge. The requirement for science- and/or data-based relevant concerns before requesting more data, and the list of requirements for new innovative approaches that should be met before such approaches can be used in regulatory ecological risk assessments, is well-founded and strongly supported. Modeling has been included in ERA to allow extrapolation of risk assessments without the need of excessive (animal) testing; it will also address uncertainties more quantitatively. However, this should be done in an overall realistic ecological assessment; simply adding up various individual uncertainties and worst-case assumptions must be avoided, as this is counterproductive for the use of this valuable tool. The need for expert judgment should be low at the lower tiers of ERA; however, more complex and less standard ERA will still require significant expertise.