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 use of human experience data in the EU risk assessment process.

The incorporation of human experience data (HD) into the risk assessment process is encouraged by various authorities with the aim of improving the robustness of the subsequent findings. HD, however, can present in many forms, ranging from epidemiological studies to the accumulated experiences from poison centers. This diversity of the human experience, combined with the manner in which it may (or may not) present, creates several challenges for risk assessors if they are to give available HD due weight in the RA process. An evaluation was made of how HD has been cited and used within the 64 human health RAs published by the EU to the end of 2005. In all RAs, HD had been cited to some degree. But there was no consistency between how cited data had subsequently been taken forward and used in the evaluation of different endpoints, either between the RAs authored by the same or different EU Member States. The lack of any accepted guidance for addressing the role that HD can play within the RA process appears to lead to this situation. Recommendations are provided on the scope and focus such guidance could usefully be expected to take.

Scientific governance and the process for exposure scenario development in REACH.

The primary process established by the European Commission to address the science needed to define key REACH concepts and to help rationally implement REACH's ambitions is enshrined in a series of activities known as the REACH Implementation Projects (RIPs). These are projects that aim to define the methodology that could be used, and present the basis for guidance on the actual principles and procedures that may be (are proposed to be) followed in the development of the required documentation that ensures the safe use of chemicals. In order to develop soundly based and equitable regulation, it is necessary that science governance using established and accepted scientific principles must take a leading role. The extent to which such governance is embraced will be determined by many factors, but notably the process adopted to enable scientific discussion to take place. This article addresses the issues of science as they have impacted on the exemplification of the Exposure Scenario concept under REACH. The current RIP activities have created a non-adversarial process in which the key stakeholders are able to discuss the key REACH challenges. But the RIP activities will be finalised before REACH comes into force. A suitable mechanism should perhaps now be identified to ensure that this positive spirit of scientific discussion and collaboration can continue to benefit REACH and those that it serves well into the future.

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 Commission's 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.

Making sense of human biomonitoring data: findings and recommendations of a workshop.

The ability to measure chemicals in humans (often termed biomonitoring) is far outpacing the ability to interpret reliably these data for public health purposes, creating a major knowledge gap. Until this gap is filled, the great promise of routinely using biomonitoring data to support decisions to protect public health cannot be realized. Research is needed to link biomonitoring data quantitatively to the potential for adverse health risks, either through association with health outcomes or using information on the concentration and duration of exposure, which can then be linked to health guidelines. Developing such linkages in the risk assessment paradigm is one of the primary goals of the International Council of Chemical Associations' (ICCA) Long-Range Research Initiative (LRI) program in the area of biomonitoring. Therefore, ICCA sponsored a workshop to facilitate development of a coordinated agenda for research to enable an improved interpretation of human biomonitoring data. Discussions addressed three main topics: (1) exploration of the link between exposure, dose, and human biomonitoring data, (2) the use of computational tools to interpret biomonitoring data, and (3) the relevance of human biomonitoring data to the design of toxicological studies. Several overarching themes emerged from the workshop: (a) Interpretation and use of biomonitoring data should involve collaboration across all sectors (i.e., industry, government, and academia) and countries. (b) Biomonitoring is not a stand-alone tool, and it should be linked to exposure and toxicological dose information. (c) Effective communication is critical, because when uncertainty about the actual risks is high, the perceived risks grow in the absence of communication. (d) The scope of future biomonitoring activities encompasses a variety of research approaches - from advancing the science to fill data gaps to advancing the accessibility of the current knowledge to enable better information sharing.