Paul Whitehouse Environment Agency, UK Ag. Item 6a: Revisions to Technical Guidance for Deriving EQSs Responses to SCHER opinion Paul Whitehouse Environment Agency, UK SCG 3 March 2011 1

SCHER opinion – key points Thorough review of Technical Guidance Largely supportive, especially over some potentially contentious aspects e.g. biovailability-based approach for dealing with metals “Significantly improved” guidance for practitioners Point by point responses to SCHER opinion made available November 2010 Changes to text made January 2011 SCG 3 March 2011

Distinction between EQS and PNEC (from RA) Some concern that “guidance implies that concept of EQS and PNEC are similar” - EQS is binding - PNEC refined as part of tiered RA. Not usually possible with EQS Conceptual differences between EQS and PNEC now highlighted Some practical differences between PNECS and EQSs e.g. use of field/mesocosm data, bioavailability assumptions for metals Keen to avoid ‘reinventing’ guidance where useful precedents exist (e.g. REACH) Guidance explains that existing PNECs provide valuable starting point for EQS development EQSs - no formal route for generating new data. This can give rise to uncertainties in EQS which should be drawn to attention of policymakers SCG 3 March 2011

Reflecting regional differences in EQSs SCHER make the case for reflecting local or regional differences in waterbodies in the EQSs “refining the EQS for a specific waterbody” Aim is to generate EQSs that protect most vulnerable sites across EU - single EQS/substance favoured Communication problems with multiple standards The science and available data rarely allow separate EQSs for different ecoregions Metals are an exception – ‘generic’ EQS but local conditions explicitly accounted for (account for factors affecting (bio)availability, local backgrounds in tiered assessment) SCG 3 March 2011

Dealing with metals Scientific understanding and BLMs now at a level where they can be used Detailed guidance on accounting for biovailability where the evidence supports such an approach Generic EQS for high bioavailability conditions Tiered assessment for assessing compliance with EQS Commission workshop on metals planned for June 2011 SCG 3 March 2011

De minimus for data? SCHER suggests there is a de minimus for data availability, below which an EQS should not be derived TG allows an EQS to be proposed, even when data are sparse But … need to highlight uncertainties (e.g. missing data) and implications of that uncertainty (e.g. robustness of EQS Wider science/policy issue – scientist evaluates the data; policymaker decides whether or not to adopt EQS SCG 3 March 2011

Mixtures SCHER advise that concentration addition is reasonable model Final approach on mixtures should be postponed … EC initiative on mixtures and future SCHER opinion No changes to guidance made Awaiting Commission advice on dealing with mixtures (possible future revision) SCG 3 March 2011

EQSs for saltwaters and transitional waters Different approaches for dealing with EQSs for freshwater and marine ecosystems should be on a case-by-case basis SCHER does not accept additional AF for saltwaters Specific assessments for transitional waters should be conducted Consistency with REACH guidance favoured (additional AFs for estimating marine EQSs when data for marine taxa not available) ToR for EG-EQS encouraged consistency with REACH EQSs for transitional waters not usually possible because: data for species from transitional waters rarely available Understanding of salinity effects on most species inadequate to predict EQSs for intermediate (and fluctuating) salinities SCG 3 March 2011