Generic Assessment Endpoints Are Needed for Ecological Risk Assessment

This article presents arguments for the development of generic assessment endpoints for ecological risk assessment. Generic assessment endpoints would be ecological entities and attributes that are assumed to be worthy of protection in most contexts. The existence of generic assessment endpoints would neither create a requirement that they be used in every assessment nor preclude the use of other assessment endpoints. They would simply be a starting point in the process of identifying the assessment endpoints for a particular assessment. They are needed to meet legal mandates, to provide a floor for environmental degradation, to provide some consistency in environmental regulation, as exemplars for site- or project-specific assessment endpoints, to allow development of methods and models, to give risk managers the courage to act, for screening and site-independent assessments, to support environmental monitoring, to facilitate communication, and to avoid paralysis by analysis. Generic assessment endpoints should include not only a list of entities and attributes, but also explanations of each endpoint, guidance on their use and interpretation, and measures and models that could be used to estimate them.     

Sensitivity Analysis,Dominant Factors,and Robustness of the ECETOC TRA v3, Stoffenmanager 4.5, and ART 1.5 Occupational Exposure Models

Occupational exposure modeling is widely used in the context of the E.U. regulation on the registration, evaluation, authorization, and restriction of chemicals (REACH). First tier tools, such as European Centre for Ecotoxicology and TOxicology of Chemicals (ECETOC) targeted risk assessment (TRA) or Stoffenmanager, are used to screen a wide range of substances. Those of concern are investigated further using second tier tools, e.g., Advanced REACH Tool (ART). Local sensitivity analysis (SA) methods are used here to determine dominant factors for three models commonly used within the REACH framework: ECETOC TRA v3, Stoffenmanager 4.5, and ART 1.5. Based on the results of the SA, the robustness of the models is assessed. For ECETOC, the process category (PROC) is the most important factor. A failure to identify the correct PROC has severe consequences for the exposure estimate. Stoffenmanager is the most balanced model and decision making uncertainties in one modifying factor are less severe in Stoffenmanager. ART requires a careful evaluation of the decisions in the source compartment since it constitutes ～75% of the total exposure range, which corresponds to an exposure estimate of 20–22 orders of magnitude. Our results indicate that there is a trade off between accuracy and precision of the models. Previous studies suggested that ART may lead to more accurate results in well‐documented exposure situations. However, the choice of the adequate model should ultimately be determined by the quality of the available exposure data: if the practitioner is uncertain concerning two or more decisions in the entry parameters, Stoffenmanager may be more robust than ART.     

Assessments of Direct Human Exposure—The Approach of EU Risk Assessments Compared to Scenario-Based Risk Assessment

The awareness of potential risks emerging from the use of chemicals in all parts of daily life has increased the need for risk assessments that are able to cover a high number of exposure situations and thereby ensure the safety of workers and consumers. In the European Union (EU), the practice of risk assessments for chemicals is laid down in a Technical Guidance Document; it is designed to consider environmental and human occupational and residential exposure. Almost 70 EU risk assessment reports (RARs) have been finalized for high-production-volume chemicals during the last decade. In the present study, we analyze the assessment of occupational and consumer exposure to trichloroethylene and phthalates presented in six EU RARs. Exposure scenarios in these six RARs were compared to scenarios used in applications of the scenario-based risk assessment approach to the same set of chemicals. We find that scenarios used in the selected EU RARs to represent typical exposure situations in occupational or private use of chemicals and products do not necessarily represent worst-case conditions. This can be due to the use of outdated information on technical equipment and conditions in workplaces or omission of pathways that can cause consumer exposure. Considering the need for exposure and risk assessments under the new chemicals legislation of the EU, we suggest that a transparent process of collecting data on exposure situations and of generating representative exposure scenarios is implemented to improve the accuracy of risk assessments. Also, the data sets used to assess human exposure should be harmonized, summarized in a transparent fashion, and made accessible for all risk assessors and the public.     

Potential Airborne Asbestos Exposure and Risk Associated with the Historical Use of Cosmetic Talcum Powder Products

Over time, concerns have been raised regarding the potential for human exposure and risk from asbestos in cosmetic‐talc–containing consumer products. In 1985, the U.S. Food and Drug Administration (FDA) conducted a risk assessment evaluating the potential inhalation asbestos exposure associated with the cosmetic talc consumer use scenario of powdering an infant during diapering, and found that risks were below levels associated with background asbestos exposures and risk. However, given the scope and age of the FDA's assessment, it was unknown whether the agency's conclusions remained relevant to current risk assessment practices, talc application scenarios, and exposure data. This analysis updates the previous FDA assessment by incorporating the current published exposure literature associated with consumer use of talcum powder and using the current U.S. Environmental Protection Agency's (EPA) nonoccupational asbestos risk assessment approach to estimate potential cumulative asbestos exposure and risk for four use scenarios: (1) infant exposure during diapering; (2) adult exposure from infant diapering; (3) adult exposure from face powdering; and (4) adult exposure from body powdering. The estimated range of cumulative asbestos exposure potential for all scenarios (assuming an asbestos content of 0.1%) ranged from 0.0000021 to 0.0096 f/cc‐yr and resulted in risk estimates that were within or below EPA's acceptable target risk levels. Consistent with the original FDA findings, exposure and corresponding health risk in this range were orders of magnitude below upper‐bound estimates of cumulative asbestos exposure and risk at ambient levels, which have not been associated with increased incidence of asbestos‐related disease.     

Probabilistic Modeling of the Fate of Listeria Monocytogenes in Diced Bacon During the Manufacturing Process

To assess the impact of the manufacturing process on the fate of Listeria monocytogenes, we built a generic probabilistic model intended to simulate the successive steps in the process. Contamination evolution was modeled in the appropriate units (breasts, dice, and then packaging units through the successive steps in the process). To calibrate the model, parameter values were estimated from industrial data, from the literature, and based on expert opinion. By means of simulations, the model was explored using a baseline calibration and alternative scenarios, in order to assess the impact of changes in the process and of accidental events. The results are reported as contamination distributions and as the probability that the product will be acceptable with regards to the European regulatory safety criterion. Our results are consistent with data provided by industrial partners and highlight that tumbling is a key step for the distribution of the contamination at the end of the process. Process chain models could provide an important added value for risk assessment models that basically consider only the outputs of the process in their risk mitigation strategies. Moreover, a model calibrated to correspond to a specific plant could be used to optimize surveillance.     

Ecological Risk Assessment Framework for Low-Altitude Aircraft Overflights: I. Planning the Analysis and Estimating Exposure

An ecological risk assessment framework for low-altitude aircraft overflights was developed, with special emphasis on military applications. The problem formulation and exposure analysis phases are presented in this article; an analysis of effects and risk characterization is presented in a companion article. The intent of this article is threefold: (1) to illustrate the development of a generic framework for the ecological risk assessment of an activity, (2) to show how the U.S. Environmental Protection Agency's ecological risk assessment paradigm can be applied to an activity other than the release of a chemical, and (3) to provide guidance for the assessment of ecological risks from low-altitude aircraft overflights. The key stressor for low-altitude aircraft overflights is usually sound, although visual and physical (collision) stressors may also be significant. Susceptible and regulated wildlife populations are the major assessment endpoint entities, although plant communities may be impacted by takeoffs and landings. The exposure analysis utilizes measurements of wildlife locations, measurements of sound levels at the wildlife locations, measurements of slant distances from aircraft to wildlife, models that extrapolate sound from the source aircraft to the ground, and bird-strike probability models. Some of the challenges to conducting a risk assessment for aircraft overflights include prioritizing potential stressors and endpoints, choosing exposure metrics that relate to wildlife responses, obtaining good estimates of sound or distance, and estimating wildlife locations.     

Projections of Cancer Risks Attributable to Future Exposure to Asbestos

To assess the maximum possible impact of further government regulation of asbestos exposure, projections were made of the use of asbestos in nine product categories for the years 1985-2000. A life table risk assessment model was then developed to estimate the excess cases of cancer and lost person-years of life likely to occur among those occupationally and nonoccupationally exposed to the nine asbestos product categories manufactured in 1985-2000. These estimates were made under the assumption that government regulation remains at its 1985 level. Use of asbestos in the nine product categories was predicted to decline in all cases except for friction products. The risk assessment results show that, although the cancer risks from future exposure to asbestos are significantly less than those from past exposures, in the absence of more stringent regulations, a health risk remains.     

A Robust Approach to Risk Assessment Based on Species Sensitivity Distributions

The guidelines for setting environmental quality standards are increasingly based on probabilistic risk assessment due to a growing general awareness of the need for probabilistic procedures. One of the commonly used tools in probabilistic risk assessment is the species sensitivity distribution (SSD), which represents the proportion of species affected belonging to a biological assemblage as a function of exposure to a specific toxicant. Our focus is on the inverse use of the SSD curve with the aim of estimating the concentration, HCp, of a toxic compound that is hazardous to p% of the biological community under study. Toward this end, we propose the use of robust statistical methods in order to take into account the presence of outliers or apparent skew in the data, which may occur without any ecological basis. A robust approach exploits the full neighborhood of a parametric model, enabling the analyst to account for the typical real‐world deviations from ideal models. We examine two classic HCp estimation approaches and consider robust versions of these estimators. In addition, we also use data transformations in conjunction with robust estimation methods in case of heteroscedasticity. Different scenarios using real data sets as well as simulated data are presented in order to illustrate and compare the proposed approaches. These scenarios illustrate that the use of robust estimation methods enhances HCp estimation.     

Scenario-Based Risk Assessment of Multi-Use Chemicals: Application to Solvents

The risk through chemical exposure is commonly characterized by ratios of exposure concentrations and effect levels (risk quotients). For chemicals with many different applications such as solvents, however, in addition to the risk quotients of different exposure situations it is useful to determine the corresponding numbers of exposed individuals, that is, not only the magnitude but also the extent of the risk. To this end, the Scenario-Based Risk Assessment (SceBRA) method has been developed that makes use of a large set of scenarios, each of which describes a typical situation regarding handling a solvent or solvent-containing product. The scenarios cover the life-cycle steps of production, distribution, and use of solvents. For each scenario, SceBRA provides the risk quotient, r, and the number of exposed individuals, N. This study investigated seven solvents that are used in large amounts in Switzerland. For each solvent, characteristic distributions of r and N values were calculated, making it possible to compare different solvents with respect to their risk profile. Graphical representations of the r, N data provide an informative way for analyzing and communicating the results of SceBRA.     

Characterizing the Risk of Infection from Mycobacterium tuberculosis in Commercial Passenger Aircraft Using Quantitative Microbial Risk Assessment

Quantitative microbial risk assessment was used to predict the likelihood and spatial organization of Mycobacterium tuberculosis ( Mtb ) transmission in a commercial aircraft. Passenger exposure was predicted via a multizone Markov model in four scenarios: seated or moving infectious passengers and with or without filtration of recirculated cabin air. The traditional exponential ( k  = 1) and a new exponential ( k  = 0.0218) dose-response function were used to compute infection risk. Emission variability was included by Monte Carlo simulation. Infection risks were higher nearer and aft of the source; steady state airborne concentration levels were not attained. Expected incidence was low to moderate, with the central 95% ranging from 10⁻⁶ to 10⁻¹ per 169 passengers in the four scenarios. Emission rates used were low compared to measurements from active TB patients in wards, thus a "superspreader" emitting 44 quanta/h could produce 6.2 cases or more under these scenarios. Use of respiratory protection by the infectious source and/or susceptible passengers reduced infection incidence up to one order of magnitude.     

The Spokane Tribe''s Multipathway Subsistence Exposure Scenario and Screening Level RME

Exposure scenarios are a critical part of risk assessment; however, representative scenarios are not generally available for tribal communities where a traditional subsistence lifestyle and diet are relevant and actively encouraged. This article presents portions of a multipathway exposure scenario developed by AESE, Inc. in conjunction with the Spokane Tribal Cultural Resources Program. The scenario serves as the basis for a screening-level reasonable maximum exposure (RME) developed for the Midnite Uranium Mine Superfund site. The process used in developing this scenario balances the need to characterize exposures without revealing proprietary information. The scenario and resulting RME reflect the subsistence use of original and existing natural resources by a hypothetical but representative family living on the reservation at or near the mine site. The representative family lives in a house in a sparsely populated conifer forest, tends a home garden, partakes in a high rate of subsistence activities (hunting, gathering, fishing), uses a sweat lodge daily, has a regular schedule of other cultural activities, and has members employed in outdoor monitoring of natural and cultural resources. The scenario includes two largely subsistence diets based on fish or game, both of which include native plants and home-grown produce. Data gaps and sources of uncertainty are identified. Additional information that risk assessors and agencies need to understand before doing any kind of risk assessment or public health assessment in tribal situations is presented.     

Incorporation of Pharmacokinetics in Noncancer Risk Assessment: Example with Chloropentafluorobenzene

Noncancer risk assessment traditionally relies on applied dose measures, such as concentration in inhaled air or in drinking water, to characterize no-effect levels or low-effect levels in animal experiments. Safety factors are then incorporated to address the uncertainties associated with extrapolating across species, dose levels, and routes of exposure, as well as to account for the potential impact of variability of human response. A risk assessment for chloropentafluorobenzene (CPFB) was performed in which a physiologically based pharmacokinetic model was employed to calculate an internal measure of effective tissue dose appropriate to each toxic endpoint. The model accurately describes the kinetics of CPFB in both rodents and primates. The model calculations of internal dose at the no-effect and low-effect levels in animals were compared with those calculated for potential human exposure scenarios. These calculations were then used in place of default interspecies and route-to-route safety factors to determine safe human exposure conditions. Estimates of the impact of model parameter uncertainty, as estimated by a Monte Carlo technique, also were incorporated into the assessment. The approach used for CPFB is recommended as a general methodology for noncancer risk assessment whenever the necessary pharmacokinetic data can be obtained.     

Risk Assessment and Alternatives Assessment: Comparing Two Methodologies

The selection and use of chemicals and materials with less hazardous profiles reflects a paradigm shift from reliance on risk minimization through exposure controls to hazard avoidance. This article introduces risk assessment and alternatives assessment frameworks in order to clarify a misconception that alternatives assessment is a less effective tool to guide decision making, discusses factors promoting the use of each framework, and also identifies how and when application of each framework is most effective. As part of an assessor's decision process to select one framework over the other, it is critical to recognize that each framework is intended to perform different functions. Although the two frameworks share a number of similarities (such as identifying hazards and assessing exposure), an alternatives assessment provides a more realistic framework with which to select environmentally preferable chemicals because of its primary reliance on assessing hazards and secondary reliance on exposure assessment. Relevant to other life cycle impacts, the hazard of a chemical is inherent, and although it may be possible to minimize exposure (and subsequently reduce risk), it is challenging to assess such exposures through a chemical's life cycle. Through increased use of alternatives assessments at the initial stage of material or product design, there will be less reliance on post facto risk‐based assessment techniques because the potential for harm is significantly reduced, if not avoided, negating the need for assessing risk in the first place.     

Decisions,Science, and Values: Crafting Regulatory Alternatives Analysis

Emerging “prevention‐based” approaches to chemical regulation seek to minimize the use of toxic chemicals by mandating or directly incentivizing the adoption of viable safer alternative chemicals or processes. California and Maine are beginning to implement such programs, requiring manufacturers of consumer products containing certain chemicals of concern to identify and evaluate potential safer alternatives. In the European Union, the REACH program imposes similar obligations on manufacturers of certain substances of very high concern. Effective prevention‐based regulation requires regulatory alternatives analysis (RAA), a methodology for comparing and evaluating the regulated chemical or process and its alternatives across a range of relevant criteria. RAA has both public and private dimensions. To a significant degree, alternatives analysis is an aspect of product design; that is, the process by which private industry designs the goods it sells. Accordingly, an RAA method should reflect the attributes of well‐crafted product design tools used by businesses. But RAA adds health and environmental objectives to the mix of concerns taken into account by the product designer. Moreover, as part of a prevention‐based regulatory regime, it implicates important public values such as legitimacy, equity, public engagement, and accountability. Thus, an RAA should reflect both private standards and public values, and be evaluated against them. This article adopts that perspective, identifying an integrated set of design principles for RAA, and illustrating the application of those principles.     

Influence of Safety Measures on the Risks of Transporting Dangerous Goods Through Road Tunnels

Quantitative risk assessment (QRA) models are used to estimate the risks of transporting dangerous goods and to assess the merits of introducing alternative risk reduction measures for different transportation scenarios and assumptions. A comprehensive QRA model recently was developed in Europe for application to road tunnels. This model can assess the merits of a limited number of "native safety measures." In this article, we introduce a procedure for extending its scope to include the treatment of a number of important "nonnative safety measures" of interest to tunnel operators and decisionmakers. Nonnative safety measures were not included in the original model specification. The suggested procedure makes use of expert judgment and Monte Carlo simulation methods to model uncertainty in the revised risk estimates. The results of a case study application are presented that involve the risks of transporting a given volume of flammable liquid through a 10-km road tunnel.     

Risk assessment based on a STPA–FMEA method: A case study of a sweeping robot

Despite rapid developments in the quality and safety of consumer products, the rise of intelligent household appliances, such as sweeping robots, has introduced new safety concerns. Considering “person–product–environment” elements and the complex systems of emerging consumer products, this study presents a new method of risk assessment for consumer products: systems theoretic process analysis (STPA)–failure mode and effects analysis (FMEA). As a case study, this method is applied to the safety control of a sweeping robot. The results suggest that this method can identify all the possible failure modes and injury scenarios among the product components, and the safety constraints in the hierarchical control structure of the interactive system. Moreover, the STPA–FMEA method combines user and environmental factors with the value of product risk events, based on the risk priority number (RPN). This provides an accurate and orderly system to reduce or eliminate the root causes of accidents and injuries. Finally, analysis of unsafe control behavior and its causes can be used to suggest improved safety constraints, which can effectively reduce the risk of some injury scenarios. This paper presents a new method of risk assessment for consumer products and a general five-level complex index system.     

A Risk Assessment Framework for Assessing Metallic Nanomaterials of Environmental Concern: Aquatic Exposure and Behavior

Nanomaterials are finding application in many different environmentally relevant products and processes due to enhanced catalytic, antimicrobial, and oxidative properties of materials at this scale. As the market share of nano‐functionalized products increases, so too does the potential for environmental exposure and contamination. This study presents some exposure ranking methods that consider potential metallic nanomaterial surface water exposure and fate, due to nano‐functionalized products, through a number of exposure pathways. These methods take into account the limited and disparate data currently available for metallic nanomaterials and apply variability and uncertainty principles, together with qualitative risk assessment principles, to develop a scientific ranking. Three exposure scenarios with three different nanomaterials were considered to demonstrate these assessment methods: photo‐catalytic exterior paint (nano‐scale TiO₂), antimicrobial food packaging (nano‐scale Ag), and particulate‐reducing diesel fuel additives (nano‐scale CeO₂). Data and hypotheses from literature relating to metallic nanomaterial aquatic behavior (including the behavior of materials that may relate to nanomaterials in aquatic environments, e.g., metals, pesticides, surfactants) were used together with commercial nanomaterial characteristics and Irish natural aquatic environment characteristics to rank the potential concentrations, transport, and persistence behaviors within subjective categories. These methods, and the applied scenarios, reveal where data critical to estimating exposure and risk are lacking. As research into the behavior of metallic nanomaterials in different environments emerges, the influence of material and environmental characteristics on nanomaterial behavior within these exposure‐ and risk‐ranking methods may be redefined on a quantitative basis.     

Impact of Acquired Immunity and Dose‐Dependent Probability of Illness on Quantitative Microbial Risk Assessment

Dose‐response models in microbial risk assessment consider two steps in the process ultimately leading to illness: from exposure to (asymptomatic) infection, and from infection to (symptomatic) illness. Most data and theoretical approaches are available for the exposure‐infection step; the infection‐illness step has received less attention. Furthermore, current microbial risk assessment models do not account for acquired immunity. These limitations may lead to biased risk estimates. We consider effects of both dose dependency of the conditional probability of illness given infection, and acquired immunity to risk estimates, and demonstrate their effects in a case study on exposure to Campylobacter jejuni. To account for acquired immunity in risk estimates, an inflation factor is proposed. The inflation factor depends on the relative rates of loss of protection over exposure. The conditional probability of illness given infection is based on a previously published model, accounting for the within‐host dynamics of illness. We find that at low (average) doses, the infection‐illness model has the greatest impact on risk estimates, whereas at higher (average) doses and/or increased exposure frequencies, the acquired immunity model has the greatest impact. The proposed models are strongly nonlinear, and reducing exposure is not expected to lead to a proportional decrease in risk and, under certain conditions, may even lead to an increase in risk. The impact of different dose‐response models on risk estimates is particularly pronounced when introducing heterogeneity in the population exposure distribution.