Implementing Probabilistic Risk Assessment in USEPA Superfund Program

Application of probabilistic risk analysis to human health and ecological risk assessment is a young science. Probabilistic risk assessment (PRA), as exemplified by Monte Carlo Analysis (MCA), is more suitable to quantify the confidence or level of uncertainty in risk estimates compared with the traditional point estimate approach. Within the United States Environmental protection Agency (USEPA) the Office of Emergency and Remedial Response (OERR) is implementing PRA as part of the Superfund administrative reform activities. The OERR is completing a guidance document accompanied by a workbook. OERR is continuing its outreach effort to present PRA to the public and USEPA staff, and is organizing a training course. This paper presents an overview of the OERR's PRA implementation effort to date.     

A toxicological basis to derive generic interspecies uncertainty factors for application in human and ecological risk assessment

A new method is proposed to derive the size of the interspecies uncertainty factor (UF) that is toxicologically and statistically based. The method is based on the biological/evolutionary assumption that similarity in susceptibility to toxic substances is a function of phylogenetic relatedness. This assumption is assessed via a large and highly structured aquatic database with over 500 agents tested in specific binary toxicity comparison (i.e., when two species have been tested with the same chemical under identical conditions) for dozens of species of wide phylogenetic relatedness. The methodology takes into account the generic need to estimate a response in any species (not just human) and the need to predict responses for new chemical agents. The method involves quantifying interspecies variation in susceptibility to numerous toxic substances via the use of binary interspecies comparisons that are converted to a 95% UF. This interspecies UF represents an estimate of the upper 95% of the population of 95% prediction intervals (PI) for binary interspecies comparisons within four categories of phylogenetic relatedness (species‐within‐genus, genera‐within‐family, families‐within‐order, orders‐within‐class). The 95% interspecies UFs range from a low of 10 for species‐within‐genus up to 65 for orders‐within‐class. Most mammalian toxicology studies involving mice, rats, cats, dogs, gerbils, and rabbits are orders‐within‐class categories for human risk assessment and would be provided a 65‐fold UF. Larger or smaller interspecies UF values could be selected based on the level of protection desired. The procedures described have application to both human and ecological risk assessment.     

Metals that Drive Health-Based Remedial Decisions for Soils at U.S. Department of Defense Sites

This study was undertaken to establish which metals are most likely to drive the risk-based remedial decision-making process at those U.S. Department of Defense (DoD) sites that are affected by metals in site soils. Our approach combined queries of various databases, interviews with U.S. Environmental Protection Agency (USEPA) experts in each Region, and communication with database administrators and DoD personnel. The databases that were used were comprehensive for DoD sites, yet sometimes contained inaccuracies. Metal concentration data for various DoD facilities were screened against established regulatory criteria for both human health and ecological endpoints. Results from this analysis were compared against the information gleaned from the interviews. This preliminary analysis indicates that the five metals that most frequently exceeded risk-based screening criteria for potential human health concerns at DoD sites, in descending order of frequency, are lead, arsenic, cadmium, chromium, and antimony. The metals that most frequently exceeded ecological screening criteria, in order, are lead, cadmium, mercury, zinc, arsenic, chromium, and selenium. Although the majority of USEPA personnel interviewed indicated that human health risk, rather than ecological endpoints, generally drives remedial decision-making, the data indicated that ecological screening thresholds were exceeded more often than human health standards.     

Genomics: Applications,Challenges, and Opportunities for the U.S. Environmental Protection Agency

Genomics information has great potential to enhance assessment of risks to human health and the environment. Although understanding genomic responses with respect to adverse ecological and human health outcomes is not, as yet, established, it is important to consider the likely future impacts of genomics technologies on risk assessment and decision-making. Four areas are identified as those likely to be influenced by the generation of genomics information within, and the submission of such information to, the U.S. Environmental Protection Agency (USEPA): risk assessment, prioritization of contaminants and contaminated sites, monitoring, and reporting provisions. For each of these risk assessment and regulatory applications, representative activities are presented to illustrate the application. Three major challenges for the USEPA associated with genomics are also identified in the areas of research, technical development, and capacity. The USEPA's initial activities to address these challenges are discussed. The Agency recognizes it must be prepared to use genomics information, and that many scientific, policy, ethical, and legal concerns will need to be addressed. The USEPA also recognizes it is essential to continue to collaborate with other federal agencies, academia, the regulated community, and other stakeholders in order to benefit from ongoing advances in genomics in the wider scientific and regulatory communities.     

A Novel Approach to Determining a Population-Level Threshold in Ecological Risk Assessment: A Case Study of Zinc

A novel approach to population-level assessment was applied in order to demonstrate its utility in estimating and managing the risk of zinc in a water environment. Much attention has been paid to population-level risk assessment, but there have been no attempts to determine a “safe” population-level concentration as an environmental criterion. Based on the published results of toxicity tests for various species, we first theoretically derived a threshold concentration at which a population size is unchanged due to the adverse effects of zinc exposure. To derive a zinc concentration that will protect populations in natural environments, we adopted the concept of species sensitivity distribution. Assuming the threshold concentrations of a set of species are log-normally distributed, we calculated the 95% protection level of zinc (PHC₅ :population-level hazardous concentration of 5% of species), which is 107 μg/L. Meanwhile, the 95% protection criterion (HC₅) based on conventional individual-level chronic toxicity, was calculated to be 14.6 μg/L. The environmentally “safe” concentration for a population-level endpoint is about 7 times greater than that for an individual-level endpoint. The proposed method provides guidance for a pragmatic approach to population-level ecological risk assessment and the management of chemicals.     

A Risk Assessment Framework for Waterborne Pathogens and Requirements for Producing a Complete Protocol

The U.S. Environmental Protection Agency (USEPA), Office of Water, is developing a risk assessment protocol for determining microbiological pathogen risks in water (drinking, recreational, waste waters, etc.). This effort has been conducted in collaboration with the International Life Sciences Institute. A microbiological risk assessment framework was prepared and has been peer reviewed in the open literature and vetted at the USEPA and other federal government risk assessment venues. Some goals in development of the Framework were to make it comprehensive, easy to understand and to use, since it is recognized that improvements to the framework structure and instructional material would facilitate its use. The USEPA's Office of Water wishes to develop improved tools, methods, and approaches for conducting the analysis phase for risk assessments and would like to evaluate its efficacy for a broad range of waterborne pathogens in water/wastewater media. Improved understanding of microbiological survival, infectivity, and virulence factors is needed, especially at the genomic and proteomic levels to accurately assess the occurrence and fate of pathogens in water and to predict what intrinsic factors allow pathogens to be invasive and virulent. Development of improved dose-response models (including animal models) for pathogen exposures focusing on the dynamic circumstances of immunity, secondary spread, and sensitive subpopulations, would be useful additions to the Framework. In the future, USEPA may consider establishing comprehensive pathogen risk assessment guidelines that all its program offices can use.     

Evaluating the role of ion composition on the toxicity of copper to Ceriodaphnia dubia in very hard waters

The mitigating effect of increasing hardness on metal toxicity is reflected in water quality criteria in the United States over the range of 25-400 mgl(-1) (as CaCO(3)). However, waters in the arid west of the US frequently exceed 400 mgl(-1) hardness, and the applicability of hardness-toxicity relationships in these waters is unknown. Acute toxicity tests with Ceriodaphnia dubia were conducted at hardness levels ranging from approximately 300 to 1,200 mgl(-1) using reconstituted waters that mimic two natural waters with elevated hardness: (1) alkaline desert southwest streams (Las Vegas Wash, NV), and (2) low alkalinity waters from a CaSO(4)-treated mining effluent in Colorado. The moderately-alkaline EPA synthetic hard water was also included for comparison. Copper toxicity did not consistently vary as a function of hardness, but likely as a function of other water quality characteristics (e.g., alkalinity or other correlated factors). The hardness equations used in regulatory criteria, therefore, may not provide an accurate level of protection against copper toxicity in all types of very hard waters. However, the mechanistic Biotic ligand model generally predicted copper toxicity within +/-2X of observed EC(50) values, and thus may be more useful than hardness for modifying water quality criteria.     

Genotoxicity risk assessment: a proposed classification strategy

Recent advances in genetic toxicity (mutagenicity) testing methods and in approaches to performing risk assessment are prompting a renewed effort to harmonize genotoxicity risk assessment across the world. The US Environmental Protection Agency (EPA) first published Guidelines for Mutagenicity Risk Assessment in 1986 that focused mainly on transmissible germ cell genetic risk. Somatic cell genetic risk has also been a risk consideration, usually in support of carcinogenicity assessments. EPA and other international regulatory bodies have published mutagenicity testing requirements for agents (pesticides, pharmaceuticals, etc.) to generate data for use in genotoxicity risk assessments. The scheme that follows provides a proposed harmonization approach in which genotoxicity assessments are fully developed within the risk assessment paradigm used by EPA, and sets out a process that integrates newer thinking in testing battery design with the risk assessment process. A classification strategy for agents based on inherent genotoxicity, dose-responses observed in the data, and an exposure analysis is proposed. The classification leads to an initial level of concern for genotoxic risk to humans. A total risk characterization is performed using all relevant toxicity data and a comprehensive exposure evaluation in association with the genotoxicity data. The result of this characterization is ultimately used to generate a final level of concern for genotoxic risk to humans. The final level of concern and characterized genotoxicity risk assessment are communicated to decision makers for possible regulatory action(s) and to the public.     

Assessment of the contamination level of bottom sediments of Amursky Bay (Sea of Japan) and their potential toxicity

The contamination of surface bottom sediments of the Amursky Bay (the Sea of Japan) and their potential toxicity were assessed by the computation of contamination indexes and the ecological risk index, as well as by comparison of the concentrations of toxicants in the sediments with the sediment quality guidelines (SQD) values adopted by the US Environmental Protection Agency (EPA). It was shown that sediments from the coastal zone of Amursky Bay adjacent to the Vladivostok City were the most contaminated. The organochlorine pesticide DDT and such heavy metals as zinc, copper, and nickel were major inputs to the potential toxicity of the sediments. Linear regression analysis revealed positive, although not always significant, correlations between the ecological risk index and quotients characterizing the level of pathological changes in the gonads and the number of anomalies in the development of progeny of the sea urchin Strongylocentrotus intermedius. The obtained data array enables us to conclude that contamination of bottom sediments by heavy metals and DDT causes great risk for the reproduction of S. intermedius and other benthic invertebrates in the coastal part of Amursky Bay adjoining the city.     

Distribution characteristics,sources, and ecological risk assessment of polycyclic aromatic hydrocarbons in sediments from Haizhou Bay,China

Sixteen USEPA priority polycyclic aromatic hydrocarbons (PAHs) were analyzed by gas chromatography–mass spectrometry. Twenty samples were collected from the surface sediments of Haizhou Bay in this survey. This research aimed to identify the PAHs' contamination level, composition pattern, pollution sources, and assess the ecological risk of PAHs. The results showed that the sum of PAH concentrations ranged from 116.6 ng g^?1 to 2414.9 ng g^?1 (mean: 662.42 ng g^?1), which is higher than the reported values for different wetlands worldwide. Three- and four-ring PAHs (accounts for more than 70% of the total PAH content) were predominant in the wetland sediment. The PAHs source distribution in the surface sediments were determined using diagnostic ratio and PCA/MLR. Consequently, multiple PAHs sources were found. Of the total PAH, 79.25% was derived from vehicular emission, 20.75% from coal combustion. The effect range low/effect range median (ERL/ERM) values indicated a low toxicity risk level. However, the fluoranthene concentrations exceeded the ERL level, and even the ERM level, in some stations. The mean effects range–median quotient (M-ERM-Q) suggests a low ecological risk for the PAHs in the sediments.     

城市生态风险评价研究进展

随着城市化发展和城市人居环境的恶化,城市生态风险越来越受到关注,但尚缺乏有关城市生态风险评价的深入系统研究.本文依据城市生态学原理及生态风险评价框架从驱动力、风险源、风险受体与评价终点,以及生态风险综合评价方法等方面对城市生态风险评价研究进行综述.指出城市经济社会活动类型与程度是城市生态风险产生的主要驱动力;城市生态系统不同等级功能实体和城市整体是城市生态风险评价中的风险受体;城市生态风险评价终点包括城市生态系统结构、过程、功能要素,以及城市整体水平的性质和功能变化;耦合了社会经济需求的生态系统模型是城市生态风险评价方法的发展方向.未来城市生态风险评价研究应明确生态风险管理具体目标,确定综合性评价终点,建立多指标评价体系和综合评价方法.     

Probabilistic Risk Assessment and Risk Mapping of Sediment Metals in Sydney Harbour Embayments

Sediment metal concentrations in embayments of Sydney Harbour, acquired from the literature and from samples collected for this study, were used to generate contaminant probability density distributions using AQUARISK. The sediment metal concentrations often exceeded Australia's interim sediment quality guidelines. Similarly, estuarine spiked sediment toxicity test literature provided adverse biotic effects concentration data to generate species sensitivity distributions using AQUARISK. Although the harbor is subject to other inorganic and organic contamination, we have used sediment metals to demonstrate an approach for ecological risk mapping and environmental management prioritization. Sufficient spiked sediment toxicity test data were found for only three metals—Cd, Cu, and Zn—and some tests were likely to overestimate toxicity. The estimates of the hazardous concentration to 5% of species (the 50th percentile of the 95% species protection level) were 5, 12, and 40 mg/kg DW of total sediment metal for Cd, Cu, and Zn, respectively. These values were generally low when compared with the interim sediment quality guidelines due to the overestimation of toxic effects in the literature data. The parameters for the species sensitivity distributions have been combined with the measured sediment metal concentrations in Homebush Bay to generate risk maps of the estimated species impact for each metal as well as for all three metals collectively assuming proportional additivity. This has demonstrated the utility of comparing contaminants on a consistent scale—ecological risk.     

Self screening for risk of melanoma: validity of self mole counting by patients in a single general practice.

OBJECTIVE--To validate self screening by patients of high mole counts, assess the within family association of sun protection behaviour and mole counts, and estimate prevalence of risk factors for melanoma. SETTING AND SUBJECTS--Systematic sample of families from a single affluent general practice population in Wessex. DESIGN--Subjects completed a questionnaire about risk factors for melanoma and counted their moles. Subsequently a mole count was done by a general practitioner trained at dermatology clinics. MAIN OUTCOME MEASURES--Validation of self counts by observer''s count. Within family association of sun protection behaviour and mole counts; self reported risk factors. RESULTS--199/237 subjects (84%) returned the questionnaire; 212/237 (89%) were examined. High counts by patients on the front of the trunk (> 7 moles of > or = 2 mm) were reasonably sensitive (79%), predictive (75%), and specific (97%) of the observer''s mole counts (kappa = 0.74), unlike arm or total body counts. Sun protection behaviour correlated between individuals and other family members (Spearman''s coefficient r = 0.50, P < 0.01). In the past three months 15/114 adults (13.2%, 95% confidence interval 7.0% to 19.4%) reported any change in a mole and 6/114 (5.3%, 2.0% to 11.1%) "major" changes; 6/109 adults (5.5%, 2.1% to 11.6%) had both high mole counts and freckling. CONCLUSIONS--Asking patients to count trunk moles could be a feasible way of identifying patients at high risk of melanoma. Concentrating on reported major changes in moles should avoid considerable workload in general practice. The generalisability of these findings and the adverse effects, net benefit in earlier diagnosis and prevention, and workload implications of such self screening need further research.     

Risk Assessment of Polycyclic Aromatic Hydrocarbons in the Shenfu Irrigation Area in China and their Application for Determining the Optimum Land Use Model

In order to use contaminated soil safely, risk and use planning of contaminated soils by 16 priority polycyclic aromatic hydrocarbons (PAHs) of the United States Environmental Protection Agency (USEPA) in Shenfu Irrigation Area (SIA) were investigated. The toxic equivalency factor (TEF) approach and the risk quotient (RQ) approach were used to assess the carcinogenic risk and ecological risk of PAHs in the current agricultural use, respectively, and the ecological risk of PAHs in SIA under residential, commercial, and industrial land uses which could be used in the future were also evaluated. The results were as follows: 95.9% of soils in SIA were heavily contaminated by PAHs; Benzo[a]pyrene (BaP), Benzo[a]anthrancene (BaA), Benzo[b]fluoranthene (BbF), Benzo[k]fluoranthen (BkF), Benzo[g,h,i]perylene, Chrysene, Dibenz[a,h]anthracene (Dba), and Indeno[1,2,3-c,d]pyrene (Ipy) were the dominated carcinogenic PAHs, and there were no carcinogenic concerns for 81.6% of SIA; Anthracene, BaP, Fluoranthene, Naphthalene, Phenanthrene, BaA, BbF, BkF, Dba, Ipyr and Pyrene were considered the major ecological risk drivers, and there were medium to high ecological risks in 56.3% of SIA under agricultural use. However, the ecological risk can be reduced markedly by changing the land use mode; under residential/parkland land use 65.1% of SIA faced low risk and the rest faced negligible risk, while all areas faced negligible risk under industrial/commercial usage. Based on the risk assessment results, an optimum land use model (both human health-based and eco-based in the SIA) was achieved and will be helpful for the local government to plan how to use the land under low risk in the SIA.     

基于物种敏感性分布的微囊藻毒素与氮污染水体生态风险评估

应用物种敏感性分布(SSD)方法,可正向和反向评估物种的生态风险及确定保护物种的污染物浓度阈值,为水体生态风险管理提供依据.本文通过采集淡水生物毒性数据,构建SSD方程,在95%物种保护基础上评估微囊藻毒素、氨氮和亚硝态氮对淡水生物的生态风险浓度阈值(HC₅)和复合生态风险,以及不同暴露浓度下的潜在影响比例(PAF).结果表明: 微囊藻毒素对淡水生物的HC₅值为19.22 μg·L^-1,其水生态风险高于氨氮(HC₅ 6583.94 μg·L^-1)和亚硝态氮(HC₅ 334.33 μg·L^-1).不同类别生物对微囊藻毒素和氨氮、亚硝态氮的敏感性随暴露浓度不同存在差异.当微囊藻毒素与亚硝态氮的浓度低于临界浓度125.04、2989.40 μg·L^-1时,甲壳类对微囊藻毒素敏感性高于鱼类,对亚硝态氮敏感性则低于鱼类,而高于临界值其物种敏感性呈相反效应,但氨氮所引起的物种敏感性差异不显著.在代表性水体中,复合生态风险高于单一污染风险,微囊藻毒素、氨氮、亚硝态氮对全部物种的复合潜在影响比例msPAF为2.6%～5.6%,且太湖和红枫湖已超过HC₅生态风险阈值.     

Distribution,speciation, and ecological risk assessment of heavy metals in surface sediments of Jiaozhou Bay,China

This paper analyzed the distribution and speciation of seven heavy metals in sediments in Jiaozhou Bay. The ecological risk was assessed using three index approaches (i.e., risk assessment code (RAC), contamination factor (CF), and potential ecological risk index (PERI)) and by a comparison with sediment quality guidelines (Chinese Marine Sediment Quality Standards (CMSQS), and threshold effect level (TEL) and probable effect level (PEL) from the USEPA). Pb, Cr, As, Cu, Zn, and Hg contents at most sites were above the corresponding TEL and Class I criteria (CMSQS) value. Particularly, high contents of Cu, detected at sites S₇ (124.5 mg kg^?1) and S₈ (118.3 mg kg^?1), exceeded the respective PEL value, indicating that harmful biological effects might occur. Speciation analysis, individual CF, and RAC calculations suggested that Cd had the highest bioavailable fraction and thus posed a very high risk to aquatic ecosystem; Cu and Zn showed a medium–high risk. Both global CF and PERI analysis indicated a high pollution risk at sites S₇, S₁, S₃, and S₂, but the assessments of specific sites were different. The incomplete consistency suggested that it is necessary to consider both total contents and chemical speciation for providing a more realistic appraisal for the risk of heavy metals in sediments.     

效率视角下的省域生态文明建设评价研究

在界定生态文明概念的基础上,从省域层面入手,选取25个具有可操作性的评价指标,构建以国土空间优化、资源节约集约利用和生态环境保护为一级指标的生态文明建设评价指标体系,综合运用网络层次分析和集对分析等研究方法,定量研究我国省域生态文明建设绩效;在此基础上,将国土空间优化绩效、资源节约集约利用绩效和生态环境保护绩效作为产出指标,将就业人数、科学技术财政支出、节能环保财政支出作为投入指标,运用数据包络分析法测度各省(市)生态文明建设效率,分析指标投入冗余和产出不足情况,并修正评价绩效。研究表明:(1)规模效率低于0.6的省份共24个,占80%,规模效率不高是制约生态文明建设水平提升的重要障碍;(2)在生态文明建设投入冗余和产出不足方面,数值较高的省(市)在地理分布上具有明显的区域聚集性;(3)领先地区资源节约集约利用绩效平均分高达3.92,落后地区平均分仅为0.84,生态文明建设绩效的差异性在资源节约集约利用方面表现的尤为明显;(4)人口规模偏大、绿色生态空间建设滞后于经济发展、水资源利用效率不高是多数生态强省(市)的薄弱环节。     

Selenium Thresholds for Fish from Cold Freshwaters

A review of reproductive effects studies with cold-water fish species including trout (cutthroat, brook, rainbow), white sucker, and northern pike indicates that they have higher tolerances to selenium taken up via dietary sources than warm-water fish species. The USEPA (2004) USEPA (U.S. Environmental Protection Agency). 2004. Draft Aquatic Life Water Quality Criteria for Selenium—2004, Washington, DC, , USA: Office of Water. EPA-822-D-04-001 [Google Scholar] draft Se tissue criterion of 7.9 mg/kg dw will provide a conservative level of protection for these cold-water fish species. However, site- and species-specific studies are required to set realistically protective upper guideline values.     

基于不同利益相关者认知分析的生态移民安置区生态风险识别

生态移民安置区内,不同群体在生态环境保护方面存在复杂的利益冲突.基于安置区内利益群体对风险类别、干扰强度的识别,构建相应的决策模型,是生态移民安置区生态风险管理亟待解决的重要课题.本文依据利益相关者理论划分出生态移民安置区4类不同利益群体,并采用参与式半结构访谈法和定性聚合法,构建了3类一级变量和13个二级变量的生态风险因子体系,进一步运用模糊认知图模型(FCM)和人工神经网络(ANN)开展生态移民安置区生态风险识别.结果表明: 从利益相关者群体生态风险变量认知来看,其共同点是不同利益群体对垃圾污染风险变量提及数量最多,但整体上又存在显著差异,即管理者注重环境保护政策的制定和实施;居民则关注生活水平的提高,且直接关系到其环保意识和行为;经济活动者多追求经济利益;环境保护者专注于生态环境问题.不同利益相关者群体认知图论指数结果显示,管理者和环境保护者对安置区生态风险认知较为全面且清晰.从安置区4方利益相关者的整体风险认知结果来看,生态环境风险因子显著影响居民的人身安全及满意度;公共政策对安置区风险管理起关键作用;风险变量的中心度结果进一步表明,提高居民生活水平是防范生态风险的关键.从利益相关者群体生态风险感知与管理情景模拟结果来看,解决垃圾污染有助于生态环境整体改善,且关键是要完善和落实相关公共政策;建立健全社会保障制度,直接关系居民生活水平和环保行为;加强基础设施建设,影响景观生态格局、生物生境和多样性,同时可提高居民满意度和公众参与度.