April 7, 2010 by Mark Crane
I’ve recently completed work for European Competent Authorities to develop instructive examples when translating environmental risks into environmental impacts for informing socioeconomic analysis (SEA) and eventual decision making under REACH. There’s a slideshow below and the remainder of the post lists the main conclusions and recommendations.
The specific objectives of the project were:
- To identify two substances for use as examples in this project. These were:
- Nickel as an example of a substance with a large amount of environmental exposure and effects data when compared with most other substances subject to the Existing Substances Regulations, which pre-dated REACH.
- Medium Chain Chlorinated Paraffins (MCCPs) as an example of a substance with a typical environmental exposure and toxicity database
- To identify the risk assessment scenarios for these examples that are most relevant for restriction considerations
- To analyse for these scenarios the outcomes of hazard and exposure assessments.
- To develop and apply different approaches to translate these risk assessment outcomes into ecological impacts and analyse how far the outcome of the impact assessment is affected by each approach.
- To summarise strengths and weaknesses in both the risk assessment approach and the approaches used to translate risk assessment outputs into impact assessment inputs for each case study.
- To review and briefly summarise the ecological and ecotoxicological literature to identify what is realistically achievable for SEA, given the current theoretical and empirical knowledge base.
- To identify information and data which could be useful for SEA but are not currently provided by the risk assessment reports, assign such information needs to the categories “need-to-know” and “nice-to-know”, and provide a view on expected changes in the extent and quality of information in future CSRs under REACH.
- To summarise which approaches appear to be useful in general and which issues require individual, case-specific approaches.
Background to REACH Restriction procedure
A Member State or the European Chemicals Agency (ECHA) can identify a substance for potential Restriction under REACH. The Restrictions procedure is designed to address, on a European Community-wide basis, unacceptable risks to human health or the environment that arise from the manufacture, use, or placing on the market of a substance. A “Restriction” is any condition for, or prohibition of, manufacture, use or placing on the market, and can be applied to a substance on its own, in a preparation, or in an article. Examples of environmental “triggers” for preparation of a Restriction Dossier might be that total environmental exposure from aggregated sources of a substance is considered likely to cause an unacceptable risk at a regional level, or that combined exposure may occur through degradation of another substance to form a substance of concern, or that management of any risks is beyond the capability of individual Registrants.
The Restriction procedure is as follows:
- The Member State or ECHA submits a Restriction Dossier to ECHA according to Annex XV of REACH and associated guidance documents (Guidance for the preparation of an annex XV dossier for restrictions and Guidance on socio-economic analysis – restrictions).
- Two ECHA committees – those for risk assessment (RAC) and for socio-economic analysis (SEAC) – form an opinion on the proposal in parallel, but with communication over cross-cutting issues.
- The final decision on Restriction lies with the European Commission’s College of Commissioners, with any adopted Restrictions subsequently included in Annex XVII of the REACH regulation.
- SEAC must form an opinion about the proportionality of a proposed risk reduction measure, while RAC must form an opinion on the measure’s adequacy at reducing the risk. Unfortunately, the outputs from standard environmental (chemical) risk assessments are not the same as the impact assessment inputs required for socioeconomic analysis (SEA), so the two committees are using two different “currencies” when forming their opinions. This makes it difficult to develop co-ordinated and coherent opinions about Restrictions.
Outputs from environmental risk assessments are usually in the form of Risk Characterisation Ratios (RCRs), in which a Predicted Environmental Concentration (PEC) is divided by a Predicted No Effect Concentration (PNEC). If the RCR is >1 then a potential risk is assumed. However, socioeconomic impact assessment requires the translation of an RCR or its underpinning data into a “value”. For example, there may be an environmental risk that a substance causes long-term adverse effects on an aquatic ecosystem because of an RCR >1. Translating this rather vague risk assessment outcome into an assessment of impact requires further, ideally quantitative, information on how severe and extensive these effects are likely to be in the real world, and how different risk management measures might alter this risk.
ECHA has identified the following additional problems in translating environmental risk assessment outputs into socio-economic impacts:
- a chemical’s persistence is a key reason for concern about its presence in the environment, but this persistence makes it difficult to quantify any changes in impacts over time;
- the persistence of chemicals gives rise to trans-boundary issues, with this further complicating both the quantification of effects and any attempts to value such effects (as it gives rise to problems concerning ‘whose values’ should be assumed);
- an absence of environmental monitoring data (together with transport, fate and behaviour data in some cases) that would enable one to establish the geographic extent of environmental concentrations above the no effects level;
difficulties in linking data on toxicity for most sensitive species to other species or to ecosystem effects;
- combinations of sources contributing to environmental concentrations, including natural sources, point source emissions to air and water, widely dispersed downstream uses and consumer uses, which have led to difficulties in determining how restrictions on some of the uses would affect concentrations in the environment; and
- significant variations across the EU in the processes used, the continuous or sporadic nature of use and emissions, and of existing levels of treatment.
This type of problem is not confined to the European Union. In the United States, Natural Resource Damage Assessment (NRDA) requires explicit consideration of socioeconomic impacts so that costs and liabilities can be determined, but the outputs of Environmental Risk Assessments (ERAs) at Superfund sites are insufficient to achieve this. A Superfund ERA is site-specific, in contrast to the more generic environmental risk assessment of chemicals under REACH, so outputs should be more amenable to translation into NRDA inputs. The difficulty in achieving this translation between ERAs and NRDAs in the United States illustrates the formidable technical obstacles to achieving it for chemical risk assessments and SEAs in Europe. However, in contrast, the requirement under REACH for the RAC and SEAC to work effectively together means that the sociological barriers to cooperation between ERA and NRDA practitioners in the United States should not exist.
The conclusions from my review were:
- Ecology and ecotoxicology are currently unable to deliver theoretical or empirical answers to questions such as “what and where will be the population reduction in the most sensitive species and consequent changes at the ecosystem level over the next 20 years?“ Even when very large amounts of time and money have been spent in developing an environmental risk assessment, such as for nickel, the extent and quality of the available data are insufficient to answer such “nice to know” questions.
- Companies usually supply information on discharges to the environment under strict confidentiality conditions. This is the case currently and will not change under REACH. It is not therefore possible to map the precise geographical extent of emissions (and possible impacts) without breaking confidentiality, unless those substances are reported in public domain databases such as the European Pollutant Release and Transfer Register.
- Screening of environmental compartments and steps through EUSES is a cost-effective way of focussing resources on only those steps and compartments with RCRs greater than 1. However, care must be taken to ensure that fair comparisons are made between Risk Management Options, and that substances with a greater amount of empirical data are not penalised solely for that reason. There is some evidence that this is the case for MCCPs and their potential substitute in leather fat liquors, Long Chain Chlorinated Paraffins (LCCPs). Plotting and comparing species sensitivity distributions for all available data for all alternative substances, even when the number and extent of these data falls short of ECHA requirements, is a very useful way of ensuring that comparisons are fair. Similarly, plotting and comparing dose-response curves for critical ecotoxicity data used to determine PNECs is an important way of ensuring that application of different assessment factors to different alternatives does not obscure similarities or differences in toxicity.
- It is unlikely that Chemical Safety Reports and Restriction dossiers performed as required under REACH will contain information that can be used to make reliable predictions of the impacts of specific Risk Management Options on particular groups of organisms in particular locations. This is because:
- Exposure data are usually sparse, so Predicted Exposure Concentrations will include a large number of default assumptions in EUSES. Only site-specific monitoring data would change this, and such data are expensive to gather reliably, especially if there are many potential discharges. This will not be cost-effective in those cases where the costs of Restriction are apparently low. An exception to this is those facilities that report their emissions for inclusion on the European Pollutant Release and Transfer Register.
- Effects data are usually based on the results of laboratory toxicity tests, which have only limited use when projecting to demographic impacts on organism populations in the real environment. This remains the case even when sophisticated bioavailability corrections are availability for substances such as data-rich metals (e.g. nickel and copper). Mesocosm or field data on organism communities are required for this, and these are rarely collected for most substances, except for pesticides and metals.
- Most Environmental Risk Assessments are currently designed to produce generic risk assessments and so do not normally provide useful site-specific information. Even when site-specific data are requested during a risk assessment these are usually anonymised to maintain company confidentiality and the response rate can be very poor.
- The data provided in environmental exposure and hazard assessments can be used more fully in the following ways:
- Known uncertainties in the assumptions underlying EUSES modelling of PECs can be incorporated into a probabilistic exposure assessment.
- Species sensitivity distributions for groups of species toxicity data, or dose-response curves for single species data can be analysed to provide more detailed and directly comparable assessments of toxicity.
- Socioeconomic impact analyses performed recently for the rapporteurs of some important substances, such as nickel, have not attempted to quantify the costs and benefits of different risk management options. However, this does not appear to have hampered decision-making or productive relations with industry.
- Use of the benefits transfer approach recommended by ECHA is currently hampered by a lack of suitable studies in the EVRI database. This leads to over-reliance on a very few studies that may not be truly representative. It is therefore unlikely that the economic information available in the EVRI database is sufficiently robust to provide reliable inputs to a cost-benefit analysis.
- Multi-criteria analysis can be used in the absence of fully quantitative cost data. However, weighting of criteria requires care and would benefit from more detailed input from relevant stakeholders.
My specific recommendations were:
- Environmental risk assessors responsible for producing Chemical Safety Reports and Restriction dossiers should explicitly state all uncertainties in their assessments and how they have been dealt with in the assessment (e.g. by use of particular assessment factors). Ideally these should be summarised in a single section of the report, for ease of access, and they should be quantified wherever possible. Quantification should include an assessment of the most likely distribution of data on either empirical or theoretical grounds. We consider that this information is “need to know” because it allows consistent and fair comparison of alternative substances.
- The spreadsheet version of EUSES should be updated so that it is compatible with the most recent official version of EUSES. It should then be used to explore the range of likely PECs that result from uncertainty about input parameters using Monte Carlo analysis. Care should be taken to ensure that co-variances between data are considered. We also consider that this information is “need to know” because it allows consistent and fair comparison of alternative substances.
- Critical toxicity results (i.e. those used to estimate a PNEC) should be fully reported in CSRs and Restriction dossiers in tabular form so that they can be reanalysed if necessary. Species sensitivity distributions and dose-response curves should be plotted, even if in the case of SSDs there are insufficient data to fulfil a “standard” SSD requirement according to ECHA guidance. Again, we consider that this information is “need to know” because it allows consistent and fair comparison of alternative substances.
- If a benefits transfer approach is to be used under REACH, further directly relevant studies should be reviewed or commissioned and included in a database. However, there is some evidence to suggest that benefits transfer may not be a robust approach when costing the benefits of a Restriction under REACH. A full critical review of this approach is recommended before collecting any further studies or data. This “need to know” information may be readily available to economists.
- Multi-criteria analysis should be used to assess the costs and benefits of different Risk Management Options, as it seems that data for reliable costing of benefits will not be available sufficiently soon for the purposes of REACH. Three main approaches to weighting criteria could be adopted:
- Assume that all weights are equal. This is simple, but unrealistic, and does not take advantage of one of the major benefits of MCA.
- Develop a “one size fits all” weighting scheme. For example, it could always be assumed that differences between RMOs in costs are the most important, and that differences in risks are each 50% of this. However, this again does not take advantage of one of the major benefits of MCA, and is likely to lead to perverse outcomes, e.g. if cost differences are very small for a substance but differences in risks are very high.
- Weight criteria for each substance that is subject to a possible Restriction, on a case-by-case basis. This could either be undertaken by the RAC and SEAC alone or, preferably, be built into stakeholder engagement undertaken during preparation of a Restriction dossier.
- Members of SEAC should consider reformulation of the problem that they need to address and the inputs that they require from environmental risk assessments. This reformulation needs to recognise that, realistically, environmental risk assessment inputs will most likely only consist of information on:
- The range of RCRs across environmental compartments and RMOs at a generic EU or local level.
- Whether these risks are likely to occur across the EU or only in specific locations or Member States.
- The environmental compartments (water, sediment, soil, or prey items) in which there are potential risks.
- The persistence of a substance in the environment after its release has ceased.