An evaluation of the role of risk-based decision-making in a former manufactured gas plant site remediation

Environmental remediation decisions are driven by the need to minimize human health and ecological risks posed by environmental releases. The Risk Assessment Guidance for Superfund Sites enunciates the principles of exposure and risk assessment that are to be used for reaching remediation decisions for sites under Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Experience with remediation management under CERCLA has led to recognition of some crucial infirmities in the processes for managing remediation: cleanup management policies are ad hoc in character, mandates and practices are strongly conservative, and contaminant risk management occurs in an artificially narrow context. The purpose of this case study is to show how a policy of risk-based decision-making was used to avoid customary pitfalls in site remediation. This case study describes the risk-based decision-making process in a remedial action program at a former manufactured gas plant site that successfully achieved timely and effective cleanup. The remediation process operated outside the confines of the CERCLA process under an administrative consent order between the utility and the New Jersey Department of Environmental Protection. A residential use end state was negotiated as part of this agreement. The attendant uncertainties, complications, and unexpected contingencies were overcome by using the likely exposures associated with the desired end state to structure all of the remediation management decisions and by collecting site-specific information from the very outset to obtain a detailed and realistic characterization of human health risks that needed to be mitigated. The lessons from this case study are generalizable to more complicated remediation cases, when supported by correspondingly sophisticated technical approaches.     

Reducing Risk in Hazardous Waste Management

Over the past several years, the Environmental Protection Agency has attempted to institutionalize an approach to its activities that is characterized by an active attempt to separate risk assessment from risk management activities. This approach, while not new in concept, has only been evolving at EPA for about four years. The Office of Research and Development, or ORD, has organized its research planning activities around this risk assessment-risk management concept. In order for the approach to succeed, it is necessary to develop the data and methodology necessary to undertake risk assessments both in the area of human health and ecology, and to develop methods to reduce those risks. Accordingly, we have organized our research planning into four major areas: Human Health Risk, Environmental or Ecological Risk, Exposure Assessment, and Risk Reduction. What I would like to do is outline briefly the breadth and diversity of EPA’s research program and the Agency’s research needs.     

Environmental risk assessment of phosphonates,used in domestic laundry and cleaning agents in The Netherlands

In the long-term cooperative project Voluntary Plan of Action (1990) between the Dutch Soap and Detergent Association (NVZ) and the Dutch Ministry of Housing, Spatial Planning and the Environment (VROM) environmental risk assessments of several main components of laundry cleaning formulations were completed. As a part of that project the environmental risk assessment of HEDP, ATMP, EDTMP and DTPMP phosphonates used in detergent applications has been carried out according to the EU Technical Guidance Document for Environmental Risk Assessment for New and Existing Chemicals. All PEC/PNEC ratios were well below 1. Results of this assessment based on the total industry volumes from 1995 and 1998 indicate that the environmental risk of these phosphonates is low in The Netherlands with properly functioning sewage treatment plants.     

Human health and environmental risk assessment: the need for a more harmonised and integrated approach

Historically the procedures for human risk assessment and for risk assessment have developed separately with different terminologies and separate data bases. The identification that there are many common features and that sharing of certain types of data for risk assessment purposes would be beneficial is a driver towards a better integration of their procedures. Risk assessors are facing increasing challenges from governments, stimulated by public pressure for (i) human and environmental risk assessments of an ever growing number of products and processes, (ii) further restrictions of the use of animal tests and human studies on ethical grounds, (iii) the requirement to demonstrate that the assessments are independent, transparent and of high quality, (iv) reducing resources in particular a diminishing number of individuals with the scientific depth, breadth and independence act as risk assessors, (v) the need to incorporate new sciences continually and new discoveries into the risk assessment process. It is important for society that these challenges are met successfully. This requires changes in both risk assessment procedures and in the infrastructure needed to support them. Risk assessment is a science based process for establishing the likelihood of adverse effects to human health and to the environment from specific chemical, biological and physical agents. In the last few years there has been a renewed effort, by international bodies such as WHO, OECD and the EU, to achieve a more integrated and harmonised approach to risk assessment. Before examining the potential for a more integrated approach to risk assessment it is timely to consider the key factors which have led to the current position.     

Development of risk-based air quality management strategies under impacts of climate change

Climate change is forecast to adversely affect air quality through perturbations in meteorological conditions, photochemical reactions, and precursor emissions. To protect the environment and human health from air pollution, there is an increasing recognition of the necessity of developing effective air quality management strategies under the impacts of climate change. This paper presents a framework for developing risk-based air quality management strategies that can help policy makers improve their decision-making processes in response to current and future climate change about 30-50 years from now. Development of air quality management strategies under the impacts of climate change is fundamentally a risk assessment and risk management process involving four steps: (1) assessment of the impacts of climate change and associated uncertainties; (2) determination of air quality targets; (3) selections of potential air quality management options; and (4) identification of preferred air quality management strategies that minimize control costs, maximize benefits, or limit the adverse effects of climate change on air quality when considering the scarcity of resources. The main challenge relates to the level of uncertainties associated with climate change forecasts and advancements in future control measures, since they will significantly affect the risk assessment results and development of effective air quality management plans. The concept presented in this paper can help decision makers make appropriate responses to climate change, since it provides an integrated approach for climate risk assessment and management when developing air quality management strategies. Implications: Development of climate-responsive air quality management strategies is fundamentally a risk assessment and risk management process. The risk assessment process includes quantification of climate change impacts on air quality and associated uncertainties. Risk management for air quality under the impacts of climate change includes determination of air quality targets, selections of potential management options, and identification of effective air quality management strategies through decision-making models. The risk-based decision-making framework can also be applied to develop climate-responsive management strategies for the other environmental dimensions and assess costs and benefits of future environmental management policies.     

Air toxics in Canada measured by the National Air Pollution Surveillance (NAPS) program and their relation to ambient air quality guidelines

This study reports ambient concentrations of 63 air toxics that were measured in Canada by the National Air Pollution Surveillance (NAPS) program over the period 2009–2013. Measured concentrations are compared with ambient air quality guidelines from Canadian jurisdictions, and compounds that exceeded guidelines are identified and discussed. Although this study does not assess risk or cumulative effects, air toxics that approached guidelines are also identified so that their potential contribution to ambient air toxics pollution can be considered. Eleven air toxics exceeded at least one guideline, and an additional 16 approached guidelines during the study period. Four compounds were measured using methods whose detection limits exceeded a guideline value, three of which could not be compared with guidelines, since they were not detected in any samples. The assessment of several metal(loid) concentrations is tentative, since they were measured only in fine particulate matter (PM) but compared with guidelines based on coarse or total PM. Improvements to sampling and analysis techniques for the latter compounds as well as for those whose methods are subject to known uncertainties would improve confidence in reported concentrations and their relation to applicable guidelines. Analysis of sampling strategies for all compounds found to exceed or approach guidelines would contribute to ensuring that their spatiotemporal coverage is adequate. Examination of the air toxics not measured by NAPS but having guidelines in Canadian jurisdictions or being included in other programs such as the U.S. National-Scale Air Toxics Assessment (NATA) would contribute to ensuring that the full suite of pollutants relevant to ambient air quality in Canada is subject to adequate study. The results of this study can be applied to evaluating the effectiveness of toxic substances management in Canada.

Implications: Recent measurements of 63 air toxics in Canada by the National Air Pollution Surveillance (NAPS) program showed that 11 compounds exceeded daily or annual ambient air quality guidelines and that an additional 16 compounds approached such guidelines within an order of magnitude. The results of this study can be applied to evaluating the effectiveness of toxic substances management in Canada and to identifying compounds that merit further investigation.     

Risk of polycyclic aromatic hydrocarbon (PAH) exposure from ingested food: the Azerbaijan case study

Risks due to polycyclic aromatic hydrocarbons (PAHs) exposure from food consumption for the population of Azerbaijan were determined using deterministic and probabilistic methods. The guidelines and methods described and presented in the United States Environmental Protection Agency (U.S. EPA) Risk Assessment Guidance for Superfund (RAGS) Part A was used in performing the risk assessments. The current study utilized concentration data from different sources representing international studies performed over the past decade to determine those food products that contribute the most exposure to PAHs through ingestion for the Azeri population. Due to lack of concentration data from middle-Eastern countries, only European countries were considered and used for this analysis. Using the benzo[a]pyrene (BaP) toxicity equivalency factors (TEFs) to adjust the concentrations of the individual PAH compounds to BaP equivalent concentrations, risk analyses were performed. Deterministic risk estimates fell within probabilistic risk estimates. Child risks were consistently four to seven times higher in magnitude than adult risks. Risk potentials determined for the food exposure pathway were also determined to be up to ten times higher in magnitude than risks determined from exposures due to other pathways such as soil contamination. It was observed that three major factors contributed to the variability in the assessment results, which were child and adult body weights, consumption rates of the different food groups, and the variances of the input data. The most prevalent pathways of PAH exposure from the dietary patterns of the Azerbaijani population were determined to be from bread and bakery products, milk and dairy products, and egg products.     

European union system for the evaluation of substances: the second version

This publication presents major changes in the assessment of the risks of chemicals to human health and the environment as implemented in the second version of the European Union System for the Evaluation of Substances, EUSES 2.0. EUSES is a harmonised quantitative risk assessment tool for chemicals. It is the PC-implementation of the technical guidelines developed within the framework of EU chemical legislation for industrial chemicals and biocides. As such, it is designed to support decision making by risk managers in government and industry and to assist scientific institutions in the risk assessment for these substances. The development of EUSES 2.0 is a co-ordinated project of the European Chemicals Bureau, EU Member States and the European chemical industry. Several model concepts, the technical background and the user interface of EUSES have been improved considerably. Major changes in the environmental assessment such as the implementation of emission scenario documents for industrial chemicals and biocides, the addition of the marine risk assessment, the enhancement of the regional model to include global scales, and improvements in the secondary poisoning and environmental effects modelling will be discussed. The update of the human risk assessment module in EUSES focuses on the risk characterisation for both threshold and non-threshold substances with, among others, the introduction of assessment factors. The performance of EUSES is illustrated in an example showing the human and environmental risk assessment of a sanitation disinfectant for private use.     

Environmental risk assessment of musk ketone and musk xylene in the Netherlands in accordance with the EU-TGD

An environmental risk assessment has been carried out for musk ketone and musk xylene according to the EU Technical Guidance Document for Environmental Risk Assessment for New and Existing Substances [1]. Musk ketone and musk xylene are used in fragrances for cosmetics and household products. For the fragrance industry these are important fragrance ingredients because of their excellent substantivity as well as for their unique smell, which determines largely the odor of a product.

The initial environmental risk assessment is based on information provided by the fragrance industry as represented in the Netherlands by its association NEA, by the Research Institute for Fragrance Materials (RIFM) and data reported in the international open literature. The risk assessment includes an evaluation of the risks for aquatic organisms in surface water and sediment and for soil organisms in soil after application of sewage sludge. Secondary poisoning of fish-eating birds and mammals is considered as well. For each compartment the Predicted Environmental Concentration (PEC) is compared to the Predicted No Effect Concentration (PNEC) to obtain PEC/PNEC ratios. Since monitoring data are available in water, sediment and fish, similar ratios are obtained with measured concentrations instead of the predicted ones.

For both substances, PEC/PNEC ratios are at or below 0.1 for organisms in the aquatic environment, including sediment organisms. PEC/PNEC ratios for fish-eating predators are 0.01. Ratios based on monitoring data are below 0.01 for all of these organisms. For soil organisms the PEC/PNEC ratio is 0.5 for musk ketone and 1.3 for musk xylene. Although in the Netherlands (as well as in some other European countries), sewage sludge presently finds no application as fertilizer on agricultural soil, the aim of environmental policy is to upgrade the sludge quality to enable future applications on agricultural and grassland. The reliability of the predicted soil concentrations can be greatly improved by obtaining experimental data on fate and behaviour of musk ketone and musk xylene in digested sludge and soil.

The risk assessment provides reassurance for the aquatic compartment while pointing the way for obtaining aditional data for the soil compartment.     

Assessment of the environmental fate and effects of the PPARgamma receptor agonist, pioglitazone

The environmental fate and effects of pioglitazone prescribed for the treatment of type 2 diabetes were evaluated in an environmental risk assessment following the European Medicines Agency (EMA) "Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use"; EMEA/CHMP/SWP/4447/00. A predicted environment concentration (PEC) for surface water was estimated at 0.023μgL(-1), (action limit of 0.01μgL(-1)) triggering a comprehensive battery of laboratory evaluations. Pioglitazone and its major metabolites were determined not to significantly adsorb to sewage solids, were not persistent in the aquatic environment, did not bioaccumulate and were non-toxic to aquatic organisms. Pioglitazone does not pose an unacceptable risk to groundwater supplies, with concentrations not anticipated to be a risk to aquatic organisms or human drinking water supplies. Pioglitazone does not pose a risk of secondary poisoning.     

Assessment of bioconcentration and secondary poisoning of surfactants

The relevance of the bioconcentration behaviour of surfactants for the secondary poisoning assessment and for the risk characterisation in the bird and mammalian food chain has been investigated. The approach used is described in the recently revised EU Technical Guidance Document for the Risk Assessment of Substances. The results demonstrate that, based on experimentally derived bioconcentration factors, environmental concentrations and effects in animals, there is a clear level of safety for both linear alkylbenzene sulphonate (LAS) and alcohol ethoxylates (AE), the most important surfactants by volume. To assess other surfactants used in detergents, a bioconcentration factor that would need to be attained for secondary poisoning to be of concern has been estimated from predicted environmental concentrations and known long-term effects data in animals. Based on the known structural similarity of these surfactants to LAS and AE and the ubiquitous nature of the enzymatic systems that are present in biotransformation processes in organisms, it is concluded that bioconcentration of these surfactants to these levels is highly unlikely. Therefore the potential for secondary poisoning effects of these surfactants is extremely low.     

Biological water quality assessment of running waters based on macroinvertebrate communities: history and present status in Europe

This paper reviews the history and development of biological water quality assessment using macroinvertebrates in Europe, and critically evaluates each of the principal approaches used. As the biotic approach incorporates the most highly regarded features of the saprobic and diversity approaches, it has received the most attention in recent years. Most modern biotic index and score systems have evolved from the Trent Biotic Index, through a series of refinements and adaptations (i.e. the Extended Biotic Index, Chandler's Score, Indice Biotique) into the two modern systems. These methods are the Biological Monitoring Working Party System, used mainly in Great Britain, and the Belgian Biotic Index Method. The results of these techniques are now influencing policy decisions concerning surface water management in Europe, where macroinvertebrate community assessment are being used as a planning tool for managing water uses, for ambient monitoring, and for evaluating the effectiveness of pollution control measures. New research directions aimed at improving the performance of bioassessment techniques are being explored. These include defining reference communities based on stream typology which can then be used to set water quality objectives, and applying these methods to the assessment of toxic pollution.     

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.     

A framework for risk characterization of environmental pollutants.

Risk characterization is defined by both the U.S. National Academy of Sciences and the U.S. EPA as the estimation of human health risk due to harmful (i.e., toxic or carcinogenic) substances or organisms. Risk characterization studies are accomplished by integrating quantitative exposure estimates and dose-response relationships with the qualitative results of hazard identification. A Risk Characterization Framework has been developed to encourage a systematic approach for analysis and presentation of risk estimates. This methodology subdivides the four common components of the risk assessment process into ten elements. Each of these elements is based on a term in a predictive risk equation. The equation allows independent computations of exposure, dose, lifetime individual risk, and risk to affected populations. All key assumptions in the predictive risk equation can be explicitly shown. This is important to understand the basis and inherent uncertainties of the risk estimation process. The systematic treatment of each of the ten elements in this framework aids in the difficult job of comparing risk estimates by different researchers using different methodologies. The Risk Characterization Framework has been applied to various indoor and outdoor air pollutants of a carcinogenic nature. With further development, it also promises to be applicable to noncarcinogenic effects.     

Substance-related environmental monitoring strategies regarding soil, groundwater and surface water — an overview

Substance-related monitoring is an essential tool within environmental risk assessment processes. The soundness of policy decisions including risk management measures is often directly related to the reliability of the environmental monitoring programs. In addition, monitoring programs are required for identifying new and less-investigated pollutants of concern in different environmental media. Scientifically sound and feasible monitoring concepts strongly depend on the aim of the study. The proper definition of questions to be answered is thus of pivotal importance. Decisions on sample handling, storage and the analysis of the samples are important steps for the elaboration of problem-oriented monitoring strategies. The same applies to the selection of the sampling sites as being representative for scenarios to be investigated. These steps may become critical to handle for larger international monitoring programs and thus trigger the quality of their results. This study based on the work of an IUPAC (International Union of Pure and Applied Chemistry) task group addresses different kinds and approaches of substance-related monitoring of different compartments of soil, groundwater and surface water, and discusses their advantages and limitations. Further important aspects are the monitoring across policies and the monitoring data management using information systems.     

A Framework for Risk Characterization of Environmental Pollutants

Risk characterization is defined by both the U.S. National Academy of Sciences and the U.S. EPA as the estimation of human health risk due to harmful (i.e., toxic or carcinogenic) substances or organisms. Risk characterization studies are accomplished by integrating quantitative exposure estimates and dose-response relationships with the qualitative results of hazard identification.

A Risk Characterization Framework has been developed to encourage a systematic approach for analysis and presentation of risk estimates. This methodology subdivides the four common components of the risk assessment process into ten elements. Each of these elements is based on a term in a predictive risk equation. The equation allows independent computations of exposure, dose, lifetime individual risk, and risk to affected populations. All key assumptions in the predictive risk equation can be explicitly shown. This is important to understand the basis and inherent uncertainties of the risk estimation process.

The systematic treatment of each of the ten elements in this framework aids in the difficult job of comparing risk estimates by different researchers using different methodologies. The Risk Characterization Framework has been applied to various indoor and outdoor air pollutants of a carcinogenic nature. With further development, it also promises to be applicable to noncarcinogenic effects.     

Risk assessment approaches for ecosystem responses to transient pollution events in urban receiving waters

Alternative risk assessment approaches are reviewed for the evaluation of the ecological status and health of urban receiving waters subject to intermittent pollution events. Performance-based criteria founded on exceedance probabilities and related to the end-of-pipe discharge of chemical-specific substances comprise the conventional basis for setting regulatory standards in both North America and Europe. The difficulties and limitations of this approach, particularly in identifying realistic chronic, sub-lethal toxic risks arising from complex effluents are discussed. The potential role of Toxicity Based Criteria (TBC) for setting ecological consent limits for stormwater effluents is considered and the capabilities and limitations of Direct Toxicity Assessment (DTA) are identified. The inability of DTA procedures to satisfactorily evaluate chronic, sub-lethal risks has led to increasing interest in the potential use of in-situ biomarker techniques for the fingerprinting of stress-response properties as a means of diagnosing risk assessment for integrated urban runoff management.     

An exploratory look at hydrocarbon data from the Photochemical Assessment Monitoring Stations network

This paper describes some characteristics of speciated nonmethane organic compound (NMOC) data collected in 1994 at five Photochemical Assessment Monitoring Stations (PAMS) and archived in the U.S. Environmental Protection Agency's Aerometric Information Retrieval System (AIRS). Topics include data completeness, distribution of individual NMOCs in concentration categories relative to minimum detectable levels, percentage of total NMOC associated with the sum of the 55 PAMS target compounds, and use of scatterplots to diagnose chromatographic misidentification of compounds. This is an early examination of a database that is expanding rapidly, and the insights presented here may be useful to both the producers and future users of the data for establishing consistency and quality control.     

基于BP网络的水质综合评价模型及其应用

讨论了BP网络模型存在的不足及建模条件,提出了建立合理的BP网络模型的基本原则和步骤.针对水质评价问题,通过在各类水质污染指标浓度区间内生成随机分布样本的方法,组成足够多用于BP网络训练、检验和测试用的样本,建立了辽河水质综合评价的BP网络模型;给出了区分不同类别水质的模型分界值样本和模型输出分界值.     

Model selection and evaluation for risk assessment of dioxin-contaminated sites

The general European population has a total intake of dioxins and dioxin-like chemicals near the limit recommended by the European Union, making additional exposure above background levels undesirable. For populations living near dioxin-contaminated sites, additional exposure may occur by intake of locally produced food, inhalation of particles, dermal contact with soils, or other exposure pathways. Risk assessment tools are required to estimate risks associated with contaminated sites and to set priorities for site remediation. Here, we review several multimedia models that can be applied as tools to support risk assessment. We then present a strategy to select, apply, evaluate, and adapt a model to address a specific situation. The case study we consider is a risk assessment of generic background dioxin exposure in Sweden, and we compare the predictions with environmental observations and exposure data from Sweden. Arguments are presented for selecting the CalTOX model for this case study. We demonstrate the application, evaluation, and adaptation of the model and discuss the requirements for extending the analysis to conduct risk assessment for subpopulations living near dioxin-contaminated sites.