Integrated testing and intelligent assessment—new challenges under REACH

BACKGROUND, AIM AND SCOPE: Due to a number of drawbacks associated with the previous regime for the assessment of new and existing chemicals, the European Union established a new regulation concerning the registration, evaluation, authorisation and restriction of chemicals (REACH). All relevant industrial chemicals must now be assessed. Instead of the authorities, industry itself is responsible for the risk assessment. To achieve better and more efficient assessments while reducing animal testing, all information-standard, non-standard and non-testing-has to be used in an integrated manner. To meet these challenges, the current technical guidance documents for risk assessment of new and existing chemicals had to be updated and extended considerably. This was done by experts in a number of REACH Implementation Projects. This paper presents the most relevant results of the expert Endpoint Working Group on Aquatic Toxicity in order to illustrate the change of paradigm in the future assessment of hazards to the aquatic environment by chemical substances. MAIN FEATURES AND CHALLENGES: REACH sets certain minimum data requirements in order to achieve a high level of protection for human health and the environment. It encourages the assessor to use alternative information instead of or in addition to standard one. This information has to be equivalent to the standard information requirement and adequate to draw overall conclusions with respect to the regulatory endpoints classification and labelling, persistent, bioaccumulative and toxic (PBT) assessment and predicted no-effect concentrations (PNEC) derivation. The main task of the expert working group was to develop guidance on how to evaluate the toxicity of a substance based on integration of information from different sources and of various degrees of uncertainty in a weight of evidence approach. INTEGRATED TESTING AND INTELLIGENT ASSESSMENT: In order to verify the equivalence and adequacy of different types of information, a flexible sequence of steps was proposed, covering characterisation of the substance, analysis of modes of action, identification of possible analogues, evaluation of existing in vivo and in vitro testing data as well as of QSAR results. Finally, all available data from the different steps have to be integrated to come to an overall conclusion on the toxicity of the substance. This weight of evidence approach is the basis for the development of integrated testing strategies (ITS), in that the available evidence can help to determine subsequent testing steps and is essential for an optimal assessment. Its flexibility helps to meet the different requirements for drawing conclusions on the endpoints classification and labelling, PNEC derivation as well as PBT assessment. The integration of all kinds of additional information in a multi-criteria assessment reduces the uncertainties involved with extrapolation to the ecosystem level. The weight of evidence approach is illustrated by practical examples. CONCLUSIONS AND PERSPECTIVES: REACH leads to higher challenges in order to make sound decisions with fewer resources, i.e. to move away from extensive standard testing to an intelligent substance-tailored approach. Expert judgement and integrated thinking are key elements of the weight of evidence concept and ITS, potentially leading to better risk assessments. Important sub-lethal effects such as endocrine disruption, which are not covered by the current procedure, can be considered. Conclusions have to be fully substantiated: Risk communication will be an important aspect of future assessments.     

Anthropogenic metal cycles in China

The flows and stocks of seven important industrial metals were characterized for mainland China for several years in the dynamically changing decade of 1994–2004. One-year snapshot cycles are provided for chromium, nickel, and silver. For copper, zinc, lead, and iron, multiple-year cycles have been completed; they demonstrate that the flows of these metals into use in China doubled between 2000 and 2004. Although the Chinese per capita flows from production to disposal are mostly shown to be below the global average rate, they are increasing or are expected to increase dramatically. The metal resource efficiency is evaluated for several indicators of material flow analysis; these metrics for China are also below the global average values. The research quantitatively illustrates that China’s metal cycles may pose significant resource and environmental challenges in terms of their magnitudes and potential for growth.     

The effect of an ergonomic intervention on musculoskeletal, psychosocial, and visual strain of VDT data entry work: the United States part of the international study.

The United States MEPS (musculoskeletal--eyestrain--psychosocial--stress) study consisted of 1 group of 28 female data entry operators. The intervention was in 3 parts: workstation redesign (including advanced ergonomic chairs, motorized adjustable workstations, advanced adjustable keyboards, adjustable copyholders, adjustable footrests, monitor support surfaces) and ergonomic training/coaching and corrective lenses. After the intervention, statistically significant reductions in physical signs (trigger points, neck and shoulder mobility), subjective reports of intensity and frequency of musculoskeletal pain, and subjective reports of visual problems were observed. Static load during the work sample, as assessed by experts, improved after the intervention as did measured postural angles of head and trunk and subjective assessment of users of ergonomic characteristics of the workplaces. For all of these measures, improvements observed 1 month after intervention were also observed in the 1-year follow-up. Trapezius load, as assessed by electromyography (EMG), decreased after intervention, but then increased in the follow-up. The increase was interpreted as a calibration problem.     

Wroc?aw's motorway ring-road--noise protection.

The 35.4-km stretch of the A8 motorway, i.e., Wroc?aw's motorway ring-road (WMRR), passes through the north-west part of the city of Wroc?aw and 4 neighbouring districts. Analyses have shown that WMRR will be a source of noise in the environment, which may adversely affect large areas. Normative environmental protection acts mandate taking all the necessary technical and organizational measures to reduce noise generated by the operation of WMRR in order to comply with the acoustic environment quality standards. The paper presents the research methodology adopted for assessing noise impact and designing acoustic barriers, and proposed designs of acoustic barriers which take into account the acoustic requirements, technical limitations, urban development, and architectural conditions.     

Variations in the Fluoride Level in Precipitation in a Region of Human Impact

The research concerns the Wielkopolski National Park (West Poland), which suffered a huge human impact in the 1970s and 1980s owing to the nearby location of an industrial plant. Since then, fundamental technological changes that it introduced into its production of phosphate fertilizers have radically reduced the amount of pollution emitted. A three-year study (2002–2004) of fluorides in precipitation in open terrain and under tree crowns showed their concentrations to range from levels below the detection limit (0.003 mg/l) to 0.560 mg/l. Those registered under tree crowns were several times higher and indicated substantial dry deposition of fluorides on the trees. The highest values were recorded in 2003, with 43% of samples ranging from 0.01 to 0.05 mg/l, and with 51% of throughfall ranging from 0.10 to 0.50 mg/l. A strong connection was shown to exist between fluoride and sulphate concentrations in the precipitation. An analysis was made of the available data on F concentrations in the air and the dust levels around the factory, but these figures did not show an unequivocal effect on F concentrations in precipitation. A great similarity was found to occur between the fluoride content in rainwater in the Wielkopolski National Park and in the centre of the nearby Poznań metropolitan area, which indicates that there are also other F sources besides the local factory.     

A Risk-Based Predictive Tool to Prevent Accidental Introductions of Nonindigenous Marine Species

Preventing the introduction of nonindigenous species (NIS) is the most efficient way to avoid the costs and impacts of biological invasions. The transport of fouling species on ship hulls is an important vector for the introduction of marine NIS. We use quantitative risk screening techniques to develop a predictive tool of the abundance and variety of organisms being transported by ocean-going yachts. We developed and calibrated an ordinal rank scale of the abundance of fouling assemblages on the hulls of international yacht hulls arriving in New Zealand. Fouling ranks were allocated to 783 international yachts that arrived in New Zealand between 2002 and 2004. Classification tree analysis was used to identify relationships between the fouling ranks and predictor variables that described the maintenance and travel history of the yachts. The fouling ranks provided reliable indications of the actual abundance and variety of fouling assemblages on the yachts and identified most (60%) yachts that had fouling on their hulls. However, classification tree models explained comparatively little of the variation in the distribution of fouling ranks (22.1%), had high misclassification rates (∼43%), and low predictive power. In agreement with other studies, the best model selected the age of the toxic antifouling paint on yacht hulls as the principal risk factor for hull fouling. Our study shows that the transport probability of fouling organisms is the result of a complex suite of interacting factors and that large sample sizes will be needed for calibration of robust risk models.