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FRAME and the Royal Commission on Environmental Pollution: common recommendations for assessing risks posed by chemicals under the EU REACH system.

This document discusses recommendations made by FRAME and the Royal Commission on Environmental Pollution (RCEP) with regard to the current European Commission proposals on the Registration, Evaluation and Authorisation of Chemicals (REACH) system for assessing the risks of chemicals to humans, wildlife and the environment. Of several common aims and recommendations, the two most important are: a) the greater use of non-animal testing methods, especially computational prediction methods (for example, [quantitative] structure-activity relationships, expert systems and biokinetic modelling) for prioritising chemicals for hazard assessment; and b) the greater use of intelligent exposure-based targeted risk assessment, with less emphasis being placed on tonnage-triggers. FRAME has produced a decision-tree testing scheme to illustrate the way in which these approaches could be used, together with in vitro test methods. This scheme has been slightly modified to take account of proposals subsequently made by the RCEP. In addition, FRAME points out that new and improved computational methods are needed through more coordinated research, and that these and existing methods need to be validated. The similarities between the independent publications of FRAME and the RCEP add weight to the recommendations that each have made concerning the implementation of the REACH system.

Animal Testing Alternatives↗

FRAME and the Royal Commission on Environmental Pollution: common recommendations for assessing risks posed by chemicals under the EU REACH system.

This document discusses recommendations made by FRAME and the Royal Commission on Environmental Pollution (RCEP) with regard to the current European Commission proposals on the Registration, Evaluation and Authorisation of Chemicals (REACH) system for assessing the risks of chemicals to humans, wildlife and the environment. Of several common aims and recommendations, the two most important are: a) the greater use of non-animal testing methods, especially computational prediction methods (for example, [quantitative] structure-activity relationships, expert systems and biokinetic modelling) for prioritising chemicals for hazard assessment; and b) the greater use of intelligent exposure-based targeted risk assessment, with less emphasis being placed on tonnage-triggers. FRAME has produced a decision-tree testing scheme to illustrate the way in which these approaches could be used, together with in vitro test methods. This scheme has been slightly modified to take account of proposals subsequently made by the RCEP. In addition, FRAME points out that new and improved computational methods are needed through more coordinated research, and that these and existing methods need to be validated. The similarities between the independent publications of FRAME and the RCEP add weight to the recommendations that each have made concerning the implementation of the REACH system.

Journal Article↗

Lead in alcoholic beverages.

Following the finding that blood lead concentrations in middle-aged men were positively associated with alcohol consumption, the Royal Commission on Environmental Pollution recommended that information on lead in alcoholic beverages be obtained. The results reported here were obtained in response to the Royal Commission's request. About 90% of canned and bottled beers contained less than or equal to 10 micrograms/l of lead, whereas nearly half the draught beers sampled contained greater than 10 micrograms/l and 4% contained greater than 100 micrograms/l. Opening the cans and bottles and pouring the contents into a glass had no significant effect on the lead concentration in the beer. All wines sampled directly from the bottle, that is without pouring, contained less than 250 micrograms/l of lead. However the lead concentration in some wines contained in lead-capped bottles increased significantly when the wine was poured from the bottle, in one instance the increment was 1890 micrograms/l. It is concluded that consumption of beer containing 50 micrograms/l of lead could make a substantial contribution to blood lead concentrations in man. Consumption of 1 l/day of wine containing 150 micrograms/l of lead could also make a major contribution to blood lead concentrations. Lead contamination of wine when it is poured from a bottle, which had been lead-capped, can sometimes greatly increase lead concentrations in the wine.

Beer↗

A preliminary statistical examination of the effects of uncertainty and variability on environmental regulatory criteria for ozone.

Basing the quantitative expression of environmental regulatory standards and associated compliance criteria on statistical principles has recently received attention in Europe, most visibly in a study by the UK Royal Commission on Environmental Pollution. These issues are timely for consideration in the USA, where a recent periodic review of National Ambient Air Quality Standards (NAAQS) has led to revision of the regulatory standards for ambient ozone and particulate matter. Salient statistical issues include accounting for errors of the first and second kind due to sampling and measurement error. These issues appear routine statistically and also may seem absent from regulations, but neither is necessarily the case. This paper is directed towards developing a methodology for examining the problem of dealing with uncertainty and variation in environmental regulations and compliance criteria. Our approach is illustrated through statistical analysis of the (old) 1 hour and the (new) 8 hour standards for ambient ozone, based on intensive monitoring in California's San Joaquin Valley during summer 1990 performed under the SARMAP Project. This paper presents preliminary findings based on quantifying measurement error or precision in terms of small-scale spatial and temporal variability, laying the groundwork for future work.

Air Pollutants↗

Lead intake and blood lead in two-year-old U.K. urban children.

A comprehensive study of a group of 2-year-old urban children (n = 97), designed to provide quantitative information simultaneously for lead intakes via all identified pathways, has been carried out in Birmingham (U.K.). Results showed that for children whose blood levels and exposure to environmental lead were within the normal range for the U.K., blood lead concentration was significantly related to a combination of house dust lead loading and an overall rate of touching objects, to water lead concentration and to the parents' smoking habits. On the basis of assumptions used by the Royal Commission on Environmental Pollution (RCEP), the estimated average total uptake of lead was 36 micrograms day-1; of this, 97% was from ingestion from dust, food and water and only 3% from inhalation.

Air Pollutants↗

Conceptual frameworks for setting environmental standards.

Following the Second European Conference on Environment and Health, held from 20 to 22 June 1994 in Helsinki, the World Health Organization (WHO) established a National Environmental Health Action Plan pilot project. During 1995, and as part of its work for this project with the WHO European Environmental Health Committee, the UK Royal Commission on Environmental Pollution began to seek evidence for the basis of setting environmental standards and to ask if a more consistent and robust basis can be found for establishing them. This paper explores the conceptual frameworks needed to help establish policy and address practical questions associated with different pollutants, exposures and environmental settings. It addresses sustainable development, inter-generational equity and environmental quality, the European Charter on Environment and Health, the Treaty of Maastricht, economic, educational and training issues, risk assessment, the role of environmental epidemiology, and definitions of environmental quality objectives, environmental health indicators, environmental epidemiology and environmental impact assessment.

Environmental Health↗

Assessing the power and quality of epidemiologic studies of asbestos-exposed populations.

This paper briefly discusses criteria for evaluating epidemiologic studies for risk assessment purposes, using asbestos as an example. Asbestos is one of the few carcinogens for which substantial data exist on exposures to humans. However, there are major difficulties in using these data for conducting risk assessments. In particular, exposure data are often incomplete, and risk assessments usually involve extrapolating from the higher exposures of the occupational environments to the lower levels typically encountered in the nonoccupational environment. The term "asbestos" refers to the fibrous form of several minerals, and levels of exposures to these fibers are not easily assessed. Criteria for evaluating epidemiologic studies used in an Ontario Royal Commission report on asbestos are discussed. The importance of considering the statistical power of studies to detect an excess risk is examined using as examples major cohort studies of asbestos-exposed workers, as summarized in a report by the U.S. National Research Council.

Asbestos↗