Chris Money

Framework for integrating human and animal data in chemical risk assessment

Although regulatory agencies formally encourage the integration of all available data in chemical risk assessment, consistent implementation of this practice has been constrained by the lack of a clear, systematic method for doing so. In this paper, we describe a methodology for evaluating, classifying and integrating human and animal data into the risk assessment process that incorporates: (1) a balanced appraisal of human and animal data, (2) relevance to different stages of the risk assessment process, and (3) accommodation for different data quality requirements. The proposed framework offers a flexible, step-wise approach for determining which set of available data best support the chemical risk assessment that involves the rating and relative ranking of human and animal data quality. The evaluation of human data incorporates seven data quality elements, nature and specificity of the lead effect; evaluation of animal data incorporates data quality and relevance to humans. Results of simulations with selected chemicals previously evaluated in a formal risk assessment generally agreed with existing regulatory guidance. Application of the proposed framework across a wider range of chemical agents will improve transparency of the risk assessment process and validity of results, while informing continuous refinements to this evolving methodology.

Exposure scenarios for workers.

The new European chemicals legislation REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) requires the development of Exposure Scenarios describing the conditions and risk management measures needed for the safe use of chemicals. Such Exposure Scenarios should integrate considerations of both human health and the environment. Specific aspects are relevant for worker exposure. Gathering information on the uses of the chemical is an important step in developing an Exposure Scenario. In-house information at manufacturers is an important source. Downstream users can contribute information through direct contact or through their associations. Relatively simple approaches (Tier 1 tools, such as the ECETOC Targeted Risk Assessment and the model EASE) can be used to develop broad Exposure Scenarios that cover many use situations. These approaches rely on the categorisation of just a few determinants, including only a small number of risk management measures. Such approaches have a limited discriminatory power and are rather conservative. When the hazard of the substance or the complexity of the exposure situation require a more in-depth approach, further development of the Exposure Scenarios with Tier 2 approaches is needed. Measured data sets of worker exposure are very valuable in a Tier 2 approach. Some downstream user associations have attempted to build Exposure Scenarios based on measured data sets. Generic Tier 2 tools for developing Exposure Scenarios do not exist yet. To enable efficient development of the worker exposure part of Exposure Scenarios a further development of Tier 1 and Tier 2 tools is needed. Special attention should be given to user friendliness and to the validity (boundaries) of the approaches. The development of standard worker exposure descriptions or full Exposure Scenarios by downstream user branches in cooperation with manufacturers and importers is recommended.

A systematic approach for evaluating and scoring human data

An approach is described for how the quality of human data can be systematically assessed and categorised. The approach mirrors the animal data quality considerations set out by Klimisch et al., in order that human data quality can be addressed in a complementary manner and to help facilitate transparent (and repeatable) weight of evidence comparisons. Definitions are proposed for the quality and adequacy of data. Quality is differentiated into four categories. A description of how the scheme can be used for evaluating data reliability, especially for use when contributing entries to the IUCLID database, is shown. A discussion of how the criteria might also be used when determining overall data relevance is included. The approach is intended to help harmonise human data evaluation processes worldwide.

A proposed framework for the interpretation of biomonitoring data

Biomonitoring, the determination of chemical substances in human body fluids or tissues, is more and more frequently applied. At the same time detection limits are decreasing steadily. As a consequence, many data with potential relevance for public health are generated although they need not necessarily allow interpretation in term of health relevance. The European Centre of Ecotoxicology and Toxicology of Chemicals (ECETOC) formed a dedicated task force to build a framework for the interpretation of biomonitoring data. The framework that was developed evaluates biomonitoring data based on their analytical integrity, their ability to describe dose (toxicokinetics), their ability to relate to effects, and an overall evaluation and weight of evidence analysis. This framework was subsequently evaluated with a number of case studies and was shown to provide a rational basis to advance discussions on human biomonitoring allowing better use and application of this type of data in human health risk assessment.

The ECETOC approach to targeted risk assessment; lessons and experiences relevant to REACH

ECETOC has been developed an approach by which the health and environmental risks arising from the supply and use of chemicals can be quickly and reliably evaluated by chemical suppliers. The approach has been available as a web-based tool since 2004. During the development and implementation of the approach, ECETOC has consulted widely so that the approach is seen to meet the required levels of science while also meeting the differing needs of affected stakeholders. The consultation process has yielded a number of findings in terms of the considerations necessary for implementing successful risk-informed decision-making in a multi-stakeholder environment. Concurrently, as the European Commissions REACH legislative package has begun to take shape, it has also become apparent that the approach has a number of potential applications for aiding the process of risk assessment under REACH. This paper reviews these experiences within the broader context of the expectations that REACH places on chemical manufacturers and suppliers. In particular, it highlights the key role that REACH Exposure Scenarios have for evaluating, managing and communicating chemical risks.

European solvent industry group generic exposure scenario risk and exposure tool

The European Solvents Industry Group (ESIG) Generic Exposure Scenario (GES) Risk and Exposure Tool (EGRET) was developed to facilitate the safety evaluation of consumer uses of solvents, as required by the European Union Registration, Evaluation and Authorization of Chemicals (REACH) Regulation. This exposure-based risk assessment tool provides estimates of both exposure and risk characterization ratios for consumer uses. It builds upon the consumer portion of the European Center for Ecotoxicology and Toxicology of Chemicals (ECETOC) Targeted Risk Assessment (TRA) tool by implementing refinements described in ECETOC TR107. Technical enhancements included the use of additional data to refine scenario defaults and the ability to include additional parameters in exposure calculations. Scenarios were also added to cover all frequently encountered consumer uses of solvents. The TRA tool structure was modified to automatically determine conditions necessary for safe use. EGRET reports results using specific standard phrases in a format consistent with REACH exposure scenario guidance, in order that the outputs can be readily assimilated within safety data sheets and similar information technology systems. Evaluation of tool predictions for a range of commonly encountered consumer uses of solvents found it provides reasonable yet still conservative exposure estimates.

A structured approach to the evaluation of workplace chemical health risks

Abstract In order to respond to the increasing need for chemical suppliers to evaluate effectively and consistently the likely risks to health that the use of chemicals at work might present, the European Centre for Ecotoxicology and Toxicology of Chemicals has developed a tiered approach to this challenge. It builds on concepts that are already in use in some areas of workplace health and safety but, uniquely, applies them in the context of the chemicals supply chain. The approach applies these concepts in a series of tiers, in order to target, with increasing certainty, those situations that present a potential risk to human health. Adopting such an approach provides an ability to align the responsibilities and expectations of employers more closely with those of chemicals suppliers. This paper provides an overview of the approach and, specifically, a detailed commentary on the process used to evaluate workplace risks arising from the use of chemicals. It provides evidence, based on a limited validation exercise, that the approach not only serves as a useful tool in the product stewardship aspirations of the chemical industry, but potentially has a wider role within the context of the ongoing discussions in Europe on a new framework for the control of chemicals.