29581 - Environmental Risk Assessment and Management Services for Chemicals (ERAS2)

a) To provide specialist advice on chemical fate, behaviour and (eco)toxicity for evaluations of environmental hazard. This will include the critical analysis and summary of scientific data included in test reports or retrieved from academic literature searches for specific substances; advice on test strategies to investigate a concern for specific chemicals or properties; and/or the critical review of comments received as a part of a consultation on a regulatory dossier. Chemicals of interest include both organic and inorganic substances (including polymers and nanomaterials), with a particular focus on persistent, bioaccumulative/mobile and toxic (PB/MT) substances and endocrine disruption. Under some circumstances, advice on mammalian toxicology may be needed to support the development of environmental quality standards, the identification of substances of very high concern (e.g. as part of a PBT or POPs assessment) or a secondary poisoning assessment).

b) To provide specialist advice on chemical emissions and environmental exposure and, risk. This will include the critical analysis and summary of scientific data retrieved from academic literature searches for specific substances or included in REACH Chemical Safety Assessments; advice on the refinement of exposure assessments; and/or the critical review of comments received as a part of a consultation on a regulatory dossier. This could involve modelling (including human exposure via the environment), analysis of monitoring data and mapping, as well as an expert understanding of usage patterns.

c) To review assessments undertaken by third parties, including where necessary identification of issues of particular interest to the UK. The main focus will be on industry assessments carried out under the REACH Regulation. However, documents produced under other legislation (e.g. the Stockholm Convention) or by other national or international regulatory bodies may also be relevant. The work is expected to involve:

i) checking — data (e.g. in terms of adequacy),

— hazard and risk assessment approaches (including assumptions),

— testing proposals or derogations, and/or

— hazard classification proposals.

ii) where necessary, the provision of UK data regarding use patterns, supply volumes, releases, monitoring data (including, but not exclusive to, surface water, groundwater, apex predators), etc.; this may require consultation with industry.

For a review of a formal EU Substance Evaluation, for example, a check should be made for technical errors or omissions and consistency, with reference to the available REACH Technical Guidance and OECD Test Guideline documents. Key studies on which the assessment is based should be identified and checked for reliability and relevance, together with all assumptions, justifications and discussions, especially if a different approach to that in the Technical Guidance has been used.

The need for this type of work (c) is likely to be infrequent.

d) To develop and improve existing hazard/risk assessment methods. This includes evaluating and providing advice on chemical test methods and models (e.g. data estimation methods such as quantitative structure activity relationships (QSAR), in vitro screening assays, Adverse Outcome Pathways (AOPs), international test guidelines, probabilistic risk assessment, etc.), as required. The contractor may be required to review reports in this area, consider the suitability of a proposed method to investigate a concern or provide comments on draft proposals for a particular method.

e) Other technical advice as necessary, for example on particular concerns for biologically active molecules (such as pesticides), methods of chemical analysis, ecological impacts, etc.

a) To provide specialist advice on chemical emissions and environmental exposure, risk and risk management options. This will include the critical analysis and summary of scientific data retrieved from academic literature searches for specific substances or included in Applications for Authorisation (AfA); advice on the refinement of exposure assessments; and/or the critical review of comments received as a part of a consultation on a regulatory dossier. This could involve modelling (including human exposure via the environment), analysis of monitoring data and mapping, as well as an expert understanding of usage patterns, socio-economic factors and emission control techniques.

b) To develop and improve existing risk management methods. This includes evaluating and providing advice on measuring the effectiveness of regulatory intervention and models (e.g. probabilistic risk assessment, etc.), as required. The contractor may be required to review reports in this area, consider the suitability of a proposed method to investigate a concern or provide comments on draft proposals for a particular method.

c) To review assessments undertaken by third parties, including where necessary identification of issues of particular interest to the UK. The main focus will be on industry assessments and submissions made under the UK REACH Regulation. However, documents produced under other legislation (e.g. the Stockholm Convention) or by other national or international regulatory bodies may also be relevant. The work is expected to involve:

i) checking — data (e.g. in terms of adequacy),

— risk assessment approaches (including assumptions), and

— risk management proposals.

ii) where necessary, the provision of UK data regarding use patterns, supply volumes, releases, etc.; this may require consultation with industry.