Environmental risk assessment: a critical approach of the European TGD in an in situ application

The aim of this study was to test field relevance of the prospective methodology for the assessment of environmental risk described in the EU technical guidance document (TGD) [European Commission 2003. Technical guidance document in support of Commission Directive 93/67/EEC on Risk assessment for new notified substances and Commission Regulation (EC) No 1488/94 on Risk assessment for existing substances and Commission Directive (EC) 98/8 on biocides, second ed. European Commission, Luxembourg, Part 1, 2 and 3, 760 pp.]. To achieve this goal, an environmental risk assessment was performed according to the TGD for two major contaminants, atrazine and diuron, that are present in the Seine River estuary (France) and listed in the EU Water Framework Directive (Directive 2000/60/CE). Results showed that atrazine presented a source of risk in the upper- and mid-estuary throughout the 1993 and 1996 spring seasons. Diuron introduced a risk into the same areas throughout spring periods of 1993-2005. Results are discussed and some suggestions for a more realistic in situ risk assessment are given. For the computation of a more relevant PNEC for pesticides, their specific mode of action should be taken into consideration as well as ecotoxicological data on species endemic to the considered area.     

Environmental assessment of Norwegian priority pharmaceuticals based on the EMEA guideline

An environmental risk assessment of eleven pharmaceuticals according to the guideline recommended by the European Medicines Evaluation Agency (EMEA) was performed. Cefuroxime, ciprofloxacin, cyclophosphamide, diclofenac, ethinylestradiol, ibuprofen, metoprolol, paracetamol, sulfamethoxazole, tetracycline and trimethoprim were selected for assessment by the Norwegian Pollution Control Authority. Predicted environmental concentrations (PECs) were calculated according to both the EMEA guideline and a conventional model for comparison and ranged from 0.0002 to 45 microg/L. Available acute and chronic toxicity data were collected from the literature, although no data were available for cyclophosphamide. Toxicity tests showed cyclophosphamide to have relatively low acute toxicity with an EC50 for Pseudokirchneriella subcapitata >100 mg/L and a Daphnia magna reproduction NOEC of 56 mg/L. These and the literature data were used to derive predicted no effect concentrations (PNEC). Risk quotients (PEC/PNEC) were then calculated for all 11 pharmaceutical compounds. Risk quotients greater than 1 were obtained for ciprofloxacin, diclofenac, ethinylestradiol, sulfamethoxazole and tetracycline according to the EMEA guideline. Measured environmental concentrations (MECs) confirmed that the release of ciprofloxacin from wastewater treatment works may potentially be of environmental concern in Norway.     

A framework for prioritizing fragrance materials for aquatic risk assessment

More than 2,100 chemically defined organic chemicals are listed in the Research Institute of Fragrance Materials/Flavor and Extract Manufacturers' Association (RIFM/FEMA) Database that are used as ingredients of fragrances for consumer products. An approach was developed for prioritizing these fragrance materials for aquatic risk assessment by first estimating the predicted environmental concentration (PEC) of these fragrance materials in the aquatic environment based upon their physicochemical properties and annual volume of use. Subsequently, an effect level was predicted with a general quantitative structure-activity relationship (QSAR) for aquatic toxicity, and a predicted no-effect concentration (PNEC) was calculated from this effect level by using an assessment factor (AF) that accounts for uncertainty in the toxicity QSAR prediction. A conservative AF of 10(6) was applied to the endpoint predicted by the QSAR to provide an adequate margin of safety in the calculation of the PNEC. The PEC was compared to the PNEC to characterize the risk to freshwater aquatic organisms (e.g., Daphnia magna and Pimephales promelas). If the ratio of PEC to PNEC was below one, the material was considered to have negligible environmental risk and to be acceptable for the aquatic environment at current use levels. If this ratio exceeded one, the PNEC was refined by using more specific QSAR models (Ecological Structure-Activity Relationships [ECOSAR]). If the ratio continued to exceed one, the material became a candidate for further aquatic risk assessment procedures, which involve iterative steps to refine the PEC, the PNEC, or both by using measured ecotoxicological endpoints. Prioritization for this latter process can be based upon the magnitudes of the estimated PEC:PNEC ratios. When using the first tier of this approach, only 568 of 2,141 fragrance materials (26.5%) in the RIFM/FEMA Database had PEC:PNEC ratios greater than one. This percentage decreased to only 164 materials (7.7%) when PNECs were derived with ECOSAR. Comparison of predicted PECs and PNECs with those based upon measured data confirmed the conservatism and low risk for type I errors associated with the framework. These combined exercises demonstrated the ability of this highly precautionary risk-based screening approach to quickly prioritize a large number of materials without benefit of experimental ecotoxicological or fate data.     

Environmental risk assessment for the widely used iodinated X-ray contrast agent iopromide (Ultravist)

Iodinated X-ray contrast media are diagnostic pharmaceuticals that are applied to enhance the contrast between organs or vessels examined and surrounding tissues during radiography. These substances are applied in doses up to ca. 200 g per person (corresponding to approx 100 g iodine) and are rapidly excreted. In the sewage system they contribute to the burden of adsorbable organic halogens (AOX). To assess the potential environmental impact of this release, studies on environmental fate and effects were conducted for a risk assessment of the frequently used X-ray contrast medium iopromide (brand name: Ultravist). A screening test for biological degradation (OECD Screening Test 301 E) led to iopromide being classified as not readily biodegradable. Therefore, the predicted environmental concentration (PEC) in surface water was calculated in a first step. The resulting concentration of 2 microgram/liter was then compared in a second step with the predicted no-effect concentration as derived from a battery of ecotoxicity tests. In short-term toxicity tests with bacteria (Vibrio fisheri, Pseudomonas putida), algae (Scenedesmus subspicatus), crustaceans (Daphnia magna), and fish (Danio rerio, Leuciscus idus) no toxic effects were detected at the highest tested concentration of 10 g/liter. In a chronic toxicity test with D. magna no effect was observed at the highest tested concentration of 1 g/liter. Using an assessment factor of 100 the ratio between the predicted environmental concentration (PEC) and the predicted no-effect concentration (PNEC) was calculated to be 相似文献   

Environmental risk assessment of six human pharmaceuticals: are the current environmental risk assessment procedures sufficient for the protection of the aquatic environment?

In this study, exposure and ecotoxicity data of six human pharmaceuticals (carbamazepine, clofibric acid, diclofenac, ofloxacin, propranolol, and sulfamethoxazole) were collected, including our own experimental data and literature data. From this data collection, the two-tiered European draft guideline on the environmental risk assessment of human pharmaceuticals was tested. Measured environmental concentrations in effluents from France and in effluents and surface waters from Germany were compared to the predicted environmental concentrations (PECs) in both countries. In a similar manner, predicted no-effect concentrations (PNECs) derived from acute data and PNECs derived from chronic data were estimated for each pharmaceutical and corresponding PEC/PNEC ratios then were compared in both countries. Globally, results demonstrated that all environmental concentrations (predicted or measured) for each considered pharmaceutical exceeded the 10-ng/L cutoff value, which requires the implementation of the second-tier assessment based on ecotoxicity data. Moreover, the six pharmaceuticals showed a relatively limited acute toxicity, and carbamazepine and propranolol were inaccurately identified as having negligible risks under the current European draft procedure. Such results lead to discussion of the actual procedure on pharmaceuticals, especially on the need of appropriate ecotoxicity tests.     

Effects and risk assessment of linear alkylbenzene sulfonates in agricultural soil. 5. Probabilistic risk assessment of linear alkylbenzene sulfonates in sludge-amended soils

Linear alkylbenzene sulfonates (LAS) can be found in high concentrations in sewage sludge and, hence, may enter the soil compartment as a result of sludge application. Here, LAS may pose a risk for soil-dwelling organisms. In the present probabilistic risk assessment, statistical extrapolation has been used to assess the risk of LAS to soil ecosystems. By use of a log-normal distribution model, the predicted no-effect concentration (PNEC) was estimated for soil fauna, plants, and a combination of these. Due to the heterogeneous endpoints for microorganisms, including functional as well as structural parameters, the use of sensitivity distributions is not considered to be applicable to this group of organisms, and a direct, expert evaluation of toxicity data was used instead. The soil concentration after sludge application was predicted for a number of scenarios and used as the predicted environmental concentration (PEC) in the risk characterization and calculation of risk quotients (RQ = PEC/PNEC). A LAS concentration of 4.6 mg/kg was used as the current best estimate of PNEC in all RQ calculations. Three levels of LAS contamination (530, 2,600, and 16,100 mg/kg), three half-lives (10, 25, and 40 d), and five different sludge loads (2, 4, 6, 8, and 10 t/ha) were included in the risk scenarios. In Denmark, the initial risk ratio would reach 1.5 in a realistic worst-case consideration. For countries not having similar sludge regulations, the estimated risk ratio may initially be considerably higher. However, even in the most extreme scenarios, the level of LAS is expected to be well beyond the estimated PNEC one year after application. The present risk assessment, therefore, concludes that LAS does not pose a significant risk to fauna, plants, and essential functions of agricultural soils as a result of normal sewage sludge amendment. However, risks have been identified in worst-case scenarios.     

The Uncertainty Factor in the setting of Occupational Exposure Standards

In recent years new programmes have appeared within the EC and OECD involving risk assessment of chemicals in relation to their potential health effects on various sections of the human population, including workers. As an element of such programmes judgements are required to be made about the acceptability of occupational exposure to chemicals at particular levels, taking into account the toxicological data available. Some of these programmes seek to establish ‘health-based’ occupational exposure limits. Uncertainty Factors have a significant influence in such considerations. There is a notable absence of published information in relation to the quantitative aspects of decision-making in this area.This paper discusses the current situation regarding Uncertainty Factors involved in deriving a ‘health-based’ occupational exposure limit, the Occupational Exposure Standard (OES) in the U.K. The Uncertainty Factors involved in the proposals of the WATCH (Working Group on the Assessment of Toxic Chemicals) panel of the Health and Safety Commission's Advisory Committee on Toxic Substances, for OES values for substances considered in the period 1990–1993 have been analysed.     

Glutaraldehyde in Hospital Wastewater

Glutaraldehyde (GA) solutions are widely used in hospitals to disinfect reusable fiber-optic endoscopes. These solutions are dumped after use in the aquatic environment without any particular safety precautions. Taking into account the quantity of GA consumed daily and the released water volume, the predicted hospital wastewater concentration was estimated at 0.50 mg/L. To measure the real GA concentration present in hospital wastewater, we developed an analytical technique that is simple, sensitive, and reliable. This method consists of a water sample concentration and purification by solid phase extraction and then a spectrophotometric determination. This analytical method was used for a 1-week surveillance program at Rouen University Hospital (2,600 beds). The wastewater tested showed the presence of a concentrated peak approximately eight times higher than the predicted wastewater concentration. The environmental impact of GA release into the aquatic environment was then studied. A predicted no-effect concentration (PNEC) < 1 μg/L was calculated. In most situations the predicted environmental concentration (PEC) was found to be <0.5 μg/L taking into account the hospital wastewater dilution in its way to the sewage treatment plant and GA biodegradation. The PEC/PNEC ratio is then < 1, showing that this release are not expected to present a significant risk to the aquatic environment. However in situations of insufficient dilution or of major release, the PEC/PNEC ratio become > 1, and an environmental risk should be expected. An internal prevention program of the various hospital departments to assure GA rational use, and a release spreading would give an additional safety margin to consider GA as safe in terms of environmental risk. Received: 19 January 2001/Accepted: 10 September 2001     

Determination and aquatic risk assessment of pesticide residues in riparian drainage canals in northeastern Greece

An approach combining monitoring and ecotoxicological data has been undertaken to assess pesticide loading in the drainage canals of two transboundary rivers of northeastern Greece near the Greek/Bulgarian/Turkish borders as well as the subsequent risk to non-target aquatic organisms. Aquatic risk assessment was based on the Risk Quotient (RQ=MEC/PNEC) regarding three trophic levels, algae, aquatic invertebrates and fish. Alachlor, atrazine, carbaryl, carbofuran, cypermethrin, DEA, DIA, diazinon, dimethoate, endosulfan, metolachlor, monilate, prometryn and trifluralin were the compounds detected at the highest concentrations on a regular basis. Extreme concentrations were observed just after high rainfall events during the month of pesticide application. Aquatic risk assessment revealed non-acceptable risk for 10 compounds when median concentrations were used as ΜEC values. However, should extreme concentrations be taken into account, 15 compounds were considered as likely to pose a threat to aquatic organisms. Conformity to EC environmental quality standards is also discussed.     

Conceptual model for improving the link between exposure and effects in the aquatic risk assessment of pesticides

Assessment of risks to aquatic organisms is important in the registration procedures for pesticides in industrialised countries. This risk assessment consists of two parts: (i) assessment of effects to these organisms derived from ecotoxicological experiments (=effect assessment), and (ii) assessment of concentration levels in relevant environmental compartments resulting from pesticide application (=exposure assessment). Current procedures lack a clear conceptual basis for the interface between the effect and exposure assessments which may lead to a low overall scientific quality of the risk assessment. This interface is defined here as the type of concentration that gives the best correlation to ecotoxicological effects and is called the ecotoxicologically relevant concentration (ERC). Definition of this ERC allows the design of tiered effect and exposure assessments that can interact flexibly and efficiently. There are two distinctly different exposure estimates required for pesticide risk assessment: that related to exposure in ecotoxicological experiments and that related to exposure in the field. The same type of ERC should be used consistently for both types of exposure estimates. Decisions are made by comparing a regulatory acceptable concentration (=RAC) level or curve (i.e., endpoint of the effect assessment) with predicted environmental concentration (=PEC) levels or curves (endpoint of the exposure assessment). For decision making based on ecotoxicological experiments with time-variable concentrations a tiered approach is proposed that compares (i) in a first step single RAC and PEC levels based on conservative assumptions, (ii) in a second step graphically RAC and PEC curves (describing the time courses of the RAC and PEC), and (iii) in a third step time-weighted average RAC and PEC levels.     

Risk assessment and risk communication in chemical exposure

The Directorate-General V at the European Commission has published a report called "Guidance on risk assessment at work". Several industrial enterprises and associations also have issued corresponding guidelines. The field presents quite a diverse variety on how risks should be assessed and managed at work, who should do it and in which form reports should be presented and to whom. The understanding of different directives and guidelines is further aggravated by confusing subtleties in definitions and terminology. Traditionally Occupational Health Professionals have had their natural consultative role in Risk Assessment and Risk Management, but growing changes in attitudes tend more and more to ignore the importance of health expertise while dealing with risks threatening health. Terminology in terms of "Hazard", "Risk", "Risk Assessment", "Risk Management" will be addresses and explained. Examples of guiding will be presented.     

Quantitative structure-activity relationships for predicting potential ecological hazard of organic chemicals for use in regulatory risk assessments

The use of quantitative structure-activity relationships (QSARs) for deriving the predicted no-effect concentration of discrete organic chemicals for the purposes of conducting a regulatory risk assessment in Europe and the United States is described. In the United States, under the Toxic Substances Control Act (TSCA), the TSCA Interagency Testing Committee and the U.S. Environmental Protection Agency (U.S. EPA) use SARs to estimate the hazards of existing and new chemicals. Within the Existing Substances Regulation in Europe, QSARs may be used for data evaluation, test strategy indications, and the identification and filling of data gaps. To illustrate where and when QSARs may be useful and when their use is more problematic, an example, methyl tertiary-butyl ether (MTBE), is given and the predicted and experimental data are compared. Improvements needed for new QSARs and tools for developing and using QSARs are discussed.     

Ecotoxicological impact of pharmaceuticals found in treated wastewaters: study of carbamazepine,clofibric acid,and diclofenac

In four countries (France, Greece, Italy, and Sweden) occurrence in sewage treatment plant (STP) effluents and ecotoxicity of the pharmaceuticals carbamazepine, clofibric acid, and diclofenac were investigated. Bioassays were performed on bacteria, algae, microcrustaceans, and fishes in order to calculate their predicted no-effect concentrations (PNEC) and to perform a first approach of risk characterization. For this aim, risk has been estimated by the predicted environmental concentration/PNEC ratio and the measured environmental concentration/PNEC ratio. First, regarding the PNEC, carbamazepine appears to be the more hazardous compound. Second, even though it is demonstrated that carbamazepine, clofibric acid, and diclofenac have been detected in effluents, only carbamazepine have been detected in all sewage treatment plants with the greatest concentrations. Third, risk quotients greater than unity were calculated only for carbamazepine, suggesting that risk for the water compartment is expected.     

Identification and evaluation of computer models for predicting environmental concentrations of pharmaceuticals and veterinary products in the Nordic environment

According to European Union Council directive 2001/83, an application for the marketing authorization of a medicinal product shall be accompanied by an environmental risk assessment, including an exposure assessment. Computerized exposure models constitute an important tool in predicting environmental exposure to substances yet to be introduced on the market. This paper reports the process of identifying appropriate exposure models for estimating PECs (Predicted Environmental Concentrations) for pharmaceuticals and veterinary products, focusing on emissions to Swedish aquatic and terrestrial environments via water and sludge from sewage treatment plants. From a large number of information sources, a set of 181 potentially relevant exposure models was identified. A process of scrutinizing and testing these models resulted in a final selection of two models, namely SimpleTreat 3.1 that is used to estimate distribution and elimination of chemicals in sewage treatment plants (resulting in a PEC), and VetPec, suited for veterinary products, that estimates PEC in soil (including pore water), groundwater, and surface water. It is concluded that there is still potential for further development of exposure model(s) specifically designed for pharmaceutical emissions to the Nordic environment and climate. Furthermore, increased regulatory data requirements would facilitate the use of existing models, and improve the quality of the output data from these models.     

Deterministic and probabilistic acute-based environmental risk assessment for naproxen for western Europe

An environmental risk assessment (ERA) was made for the common nonsteroidal anti-inflammatory drug naproxen. The ERA was performed according to deterministic and probabilistic methods, based on different predicted environmental concentrations (PECs) and measured environmental concentrations (MECs) on the exposure side as well as on published and newly elaborated acute ecotoxicity data on the effects side. Compilation of a large set of MECs allowed a qualification of the various PEC derivations. The European Medicines Evaluation Authority (EMEA) phase I PEC was shown to be far above realistic values, while the refined EMEA phase II (A and B) PECs were not too far from the 95th percentile MEC, in agreement with their nature as local PECs. The western European continental and regional PECs extrapolated based on actual use data, using the European Union system for the evaluation of substances, with the region reconfigured for Germany where most of the available European MECs are from, were in good to very close agreement with the median MECs. No risk to surface waters is apparent by any of the methodologies applied from the current use of naproxen; however, because only insufficient chronic ecotoxicity data are available, this is a preliminary conclusion.     

Role of exposure databases in risk assessment.

Risk assessments have assumed an increasingly important role in the management of risks in this country. The determination of which pollutants or public health issues are to be regulated, the degree and extent of regulation, and the priority assigned to particular problems are all areas of risk assessment that influence the country's $100 billion annual investment in environmental protection. Recent trends in public policy have brought the practice of risk assessment under greater scrutiny. As policy makers increasingly insist that specific numerical risk levels (so-called bright lines) be incorporated into regulatory decisions, the stakes for good risk assessment practice, already high, are raised even further. Enhancing the scientific basis of risk assessments was a major goal of the Workshop on Exposure Databases. In this article, we present the Risk Assessment Work Group's evaluation of the use of exposurerelated databases in risk assessment and the group's recommendations for improvement. The work group's discussion focused on the availability, suitability, and quality of data that underly exposure assessments, a critical component of risk assessment. The work group established a framework for evaluation, based on exposure scenarios typically used in regulatory decisions. The scenarios included examples from Superfund, the Clean Air Act, the Toxic Substances Control Act, and other regulatory programs. These scenarios were used to illustrate current use of exposure data, to highlight gaps in existing data sources, and to discuss how improved exposure information can improve risk assessments. The work group concluded that many of the databases available are designed for purposes that do not meet exposure and risk assessment needs. Substantial gaps exist in measurements of actual human exposure and in the data necessary to model exposures, to characterize distributions of exposure, to identify high-risk groups, and to identify possible environmental inequities in exposure. The work group, on the basis of its findings, made both short-term and longer-term recommendations for improving the collection of exposure data in the future.     

Accurate prediction of the response of freshwater fish to a mixture of estrogenic chemicals

Existing environmental risk assessment procedures are limited in their ability to evaluate the combined effects of chemical mixtures. We investigated the implications of this by analyzing the combined effects of a multicomponent mixture of five estrogenic chemicals using vitellogenin induction in male fathead minnows as an end point. The mixture consisted of estradiol, ethynylestradiol, nonylphenol, octylphenol, and bisphenol A. We determined concentration-response curves for each of the chemicals individually. The chemicals were then combined at equipotent concentrations and the mixture tested using fixed-ratio design. The effects of the mixture were compared with those predicted by the model of concentration addition using biomathematical methods, which revealed that there was no deviation between the observed and predicted effects of the mixture. These findings demonstrate that estrogenic chemicals have the capacity to act together in an additive manner and that their combined effects can be accurately predicted by concentration addition. We also explored the potential for mixture effects at low concentrations by exposing the fish to each chemical at one-fifth of its median effective concentration (EC50). Individually, the chemicals did not induce a significant response, although their combined effects were consistent with the predictions of concentration addition. This demonstrates the potential for estrogenic chemicals to act additively at environmentally relevant concentrations. These findings highlight the potential for existing environmental risk assessment procedures to underestimate the hazard posed by mixtures of chemicals that act via a similar mode of action, thereby leading to erroneous conclusions of absence of risk.     

Pesticide risk assessment in a lagoon ecosystem. Part II: effect assessment and risk characterization

Ecotoxicological risk assessment for pesticides was performed on a coastal lagoon ecosystem (Orbetello lagoon, central Italy) according to the procedure described in the European technical guidance document (TGD) on risk assessment for new and existing substances. The procedure was applied to individual chemicals and to a mixture of chemicals with the same toxicological mode of action. Biomarker studies, measuring acetylcholinesterase (AchE) activity inhibition, were conducted on Zosterisessor ophiocephalus to compare the results of theoretical risk assessment with experimental measurements of ecotoxicological stress. Value and limitations of the risk assessment procedure and its application to site-specific environmental conditions are discussed. A tool crop risk index (CRI) for assessing the overall impact of pesticide use on a crop is proposed.     

Development of methods for evaluating toxicity to freshwater ecosystems

This article presents a summary of a collaborative research program involving five European research groups, that was partly funded by the European Commission under its Environmental Research Program. The objective of the program was to develop aquatic toxicity tests that could be used to obtain data for inclusion at Level 2 of the Risk Evaluation Scheme for the Notification of Substances as required by the 7th Amendment to EC Directive 79/831/EEC. Currently only a very limited number of test methods have been described that can be used for this purpose and these are based on an even smaller number of test species. Tests based upon algae (Chlamydomonas reinhardi, Scenedesmus subspicatus, and Euglena gracilis), protozoa (Tetrahymena pyriformis), rotifera (Brachionus calyciflorus), crustacea (Gammarus pulex), and diptera (Chironomus riparius) were developed. The tests encompassed a range of end points and were evaluated against four reference chemicals: lindane, 3, 4-dichloroaniline (DCA), atrazine, and copper. The capacity of the tests to identify concentrations that are chronically toxic in the field was addressed by comparing the effects threshold concentrations determined in the laboratory tests with those determined for similar and/or related species and end points in stream and pond mesocosm studies. The lowest no-observed-effect concentrations (NOEC), EC(x), or LC(x) values obtained for lindane, atrazine, and copper were comparable with the lowest values obtained in the mesocosms. The lowest chronic NOEC determined for DCA using the laboratory tests was approximately 200 times higher than the lowest NOEC in the mesocosms.     

Ambient copper concentrations in agricultural and natural European soils: an overview

Copper concentrations in soil are affected by a large number of processes related to the natural spatial variability (geochemistry), the amount released, the spatial and temporal distributions of these releases, and the large number of transportation, complexation, and dissolution processes. The present study reports the generated country-specific and land use-specific environmental concentration distributions of ambient copper exposure levels in European soils that were used for the derivation of "reasonable worst-case" predicted environmental copper concentrations (RWC-ambient copper PEC) for three types of soil uses: Agricultural soils, forest soils, and undefined grassland soils. Only recent and high-quality monitoring data (Q1) that comply with a number of criteria (i.e., sampling strategy, land use, digestion method, and absence of point sources) were selected for this purpose. Data treatment procedures used in the present study were based on the methods and concepts laid down in the European Union Technical Guidance Document on Risk Assessment and in the "combined monitoring-based and modeling-based priority setting" procedure. The derived median RWC-ambient copper PEC for European agricultural soils is 31.1 mg/kg dry weight, with the lowest and highest RWC-ambient copper PEC found in Belgium (16.1 mg/kg dry wt) and northern Italy (57.5 mg/kg dry wt), respectively. The high value for Italian soils probably is related to the (recent) volcanic origin of these soils. Similarly, RWC-ambient copper PECs were derived for forest soils and undefined grassland soils (24.4 and 35.3 mg/kg, respectively). Observed differences between the diifferent soil uses could be related to various parameters and processes that determine the copper levels in soil (e.g., soil type associated with specitic soil uses, addition of fertilizers and pesticides, and presence of cattle).