Probability Density Functions Describing 24-Hour Inhalation Rates For Use in Human Health Risk Assessments

A Monte Carlo simulation was undertaken to estimate the amount of air inhaled over a typical 24-hour period by six age groups of Canadians. The objective of the simulation was to derive probability density functions that could be used to describe inhalation rates in probabilistic health risk assessments involving airborne contaminants. The six age groups considered were those typically employed in human health risk assessments in Canada: infants (aged 0 to 6 months), toddlers (aged 7 months to 4 years), children (aged 5 to 11 years), teenagers (aged 12 to 19 years), adults (aged 20 to 59 years), and seniors (aged 60 years and older). The resulting distributions are considered equally applicable to Americans as Canadians, however, since the study relied heavily on time-activity information gathered in the USA. Existing time-activity and breathing rate studies were reviewed in order to define random variables describing probable durations that North Americans spend at various levels of activity and their probable inhalation rates while at each level of activity. These random variables were combined in a Monte Carlo simulation to empirically generate probability density functions describing 24-hour inhalation rates for each age group. The simulation suggested that most age groups' 24 hour inhalation rates can be represented with log-normal probability density functions. Arithmetic mean values and standard deviations for these distributions are as follows: approximately 9.3 ± 2.4?m³/day for toddlers; 14.6 ± 3.0?m³/day for children; 15.8 ± 3.7?m³/day for teenagers; 16.2 ± 3.8?m³/day for adults; and 14.2 ± 3.3?m³/day for seniors. The distribution of infants' 24-hour inhalation rates was found to be better represented by a normal distribution than a log-normal distribution. The mean and standard deviation for the infants' normal distribution are 2.1 ± 0.58?m³/day. Inhalation rates were also estimated separately for male and female toddlers, children, teenagers, adults and seniors. These estimates suggested that males inhale on average 8% to 27% more air than females of the same age. Because infants' activity patterns and minute volumes did not appear to be strongly correlated with gender, a single probability density function was deemed satisfactory to describe male and female infants' 24-hour inhalation rates.     

Adequacy Conditions for Reporting Uncertainty in Chemical Risk Assessments

Uncertainty may influence decision-making. A prerequisite for a decision to be well founded is thus that scientific experts inform decision-makers about all decision relevant uncertainty. A set of conditions is provided for adequate characterization of scientific uncertainty for the purposes of regulatory decision-making. These conditions require specification of (1) the character and degree of uncertainty about the assessment variables, (2) the possibility of reducing the uncertainty, and (3) the degree of agreement among experts. Furthermore, it is required that (4) the information covered by the previous conditions is presented in a clear and comprehensible way. The point of departure is that characterizing scientific uncertainty conceptually means specifying all potentially important possibilities that are consistent with the state of scientific knowledge. The conditions are intended to be applied to human health risk assessment of chemicals. However, the basic approach, to consider potentially important possibilities, should be useful also to environmental, and site-specific risk assessment.     

Use of Indicators in Ecological Risk Assessments for Persistent,Bioaccumulative Toxicants

This paper synthesizes several presentations on the use of indicators in ecological risk assessments for persistent, bioaccumulative toxicants (PBTs). The presentations were organized around two chemical case studies: (1) mercury, and (2) compounds that exhibit an Ah-receptor based mode-of-action. Presenters summarized the current practice of ecological risk assessment for these compounds and described research on known or suspected impacts. In addition, this paper addresses three special topics that apply broadly to all PBTs: (1) the convergence of ecological assessment and ecological risk assessment, (2) integration of ecological and human health risk assessment, and (3) risk assessments for population-level effects.     

An Evaluation of Risk Drivers from a Sample of Risk Assessments Conducted for the U.S. Army

We evaluate risk drivers at selected U.S. Army installations by developing a database containing contaminant-pathway-receptor combinations that exceed regulatory thresholds for ecological (toxicity quotient greater than one), human health cancer risk (predicted incremental lifetime cancer risk greater than one in ten thousand), and noncancer human health (hazard index greater than one). We compare the risk drivers from the database to reported corrective action objectives from available decision documents. For noncancer hazards, explosives (particularly in ground water) dominate the reported exceedances of regulatory thresholds in the database. PAHs in home-grown produce show the highest number of exceedances of regulatory thresholds for cancer risk. For ecological risks, PAHs in both terrestrial and aquatic environments dominate the exceedances of regulatory thresholds. All available cleanup levels were derived based on human health exposures rather than ecological exposures, except for one site. In general, ecological risks were considered to be “more uncertain,” and that was used as a basis for not relying on backcalculated target levels on the basis of ecological risk. The reverse was true for human health risks: the “conservative” assumptions incorporated into the modeling provided the justification for backcalculating health-protective target levels.     

Identifying Uncertainty in Environmental Risk Assessments: The Development of a Novel Typology and Its Implications for Risk Characterization

Environmental risk analysts need to draw from a clear typology of uncertainties when qualifying risk estimates and/or significance statements about risk. However, categorizations of uncertainty within existing typologies are largely overlapping, contradictory, and subjective, and many typologies are not designed with environmental risk assessments (ERAs) in mind. In an attempt to rectify these issues, this research provides a new categorization of uncertainties based, for the first time, on the appraisal of a large subset of ERAs, namely 171 peer-reviewed environmental weight-of-evidence assessments. Using this dataset, a defensible typology consisting of seven types of uncertainty (data, language, system, extrapolation, variability, model, and decision) and 20 related sub-types is developed. Relationships between uncertainties and the techniques used to manage them are also identified and statistically evaluated. A highly preferred uncertainty management option is to take no action when faced with uncertainty, although where techniques are applied they are commensurate with the uncertainty in question. Key observations are applied in the form of guidance for dealing with uncertainty, demonstrated through ERAs of genetically modified higher plants in the European Union. The presented typology and accompanying guidance will have positive implications for the identification, prioritization, and management of uncertainty during risk characterization.     

Practical Issues in the Use of Probabilistic Risk Assessment

Probabilistic risk assessment (PRA) represents an important step in the evolution of risk assessment methodology to assist decision-making at hazardous waste sites. Despite considerable progress in the development of PRA techniques, regulatory acceptance of PRA has been limited, in part because a number of practical issues in its use must yet be resolved. A recent workshop on PRA identified several areas to be addressed, including the need for: (1) better demonstration of the value of PRA in risk management; (2) PRA training and education opportunities; (3) the development of technical criteria for acceptability of a PRA; (4) policy decisions on acceptable risk distributions; (5) ways to deal with risk communication issues; and (6) a variety of technical issues, including ways to include estimates of variability and uncertainty associated with toxicity values. Solutions to many of these issues will require better dialog between risk assessors and risk managers than has existed in the past.     

Extrapolation in Human Health and Ecological Risk Assessments: Proceedings of a Symposium

A symposium was conducted in April 1998 by the U.S. Environmental Protection Agency's National Health and Environmental Effects Research Laboratory (NHEERL) to explore issues of extrapolation in human health and ecological risk assessments. Over the course of three and one half days, leading health and ecology experts presented and discussed research methods and approaches for extrapolating data among taxa and across levels of biological organization, through time, and across spatial scales. The intended result of this symposium was enhanced interaction among a diverse array of scientists, policymakers, and risk assessors to promote identification of approaches for reducing the uncertainties of extrapolation in risk assessment.     

Risk Assessment and Safety Evaluation Using Probabilistic Fault Tree Analysis

Risk assessment is an essential prelude to the development of accident prevention strategies in any chemical or petrochemical industry. Many techniques and methodologies such as HAZOP, failure mode effect analysis, fault tree analysis, preliminary hazard analysis, quantitative risk assessment and probabilistic safety analysis are available to conduct qualitative, quantitative, and probabilistic risk assessment. However, these methodologies are limited by: extensive data requirements, the length of study, results are not directly interpretable for decision making, simulation is often difficult, and they are applicable only at the operation or late design stage. Khan et al. (2001a) recently proposed a detailed methodology for risk assessment and safety evaluation. This methodology is simple, yet it is effective in safety and design-related decision making, and it has been applied successfully to many case studies. It is named SCAP, where S stands for safety, C and A stand for credible accident respectively, and P stands for probabilistic fault tree analysis. This paper recapitulates the SCAP methodology and demonstrates its application to a petrochemical plant.     

Axes of Extrapolation in Risk Assessment

Extrapolation in risk assessment involves the use of data and information to estimate or predict something that has not been measured or observed. Reasons for extrapolation include that the number of combinations of environmental stressors and possible receptors is too large to characterize risks comprehensively, that direct characterization is sometimes impossible, and that the power to characterize risk in a particular situation can be enhanced by using information obtained in other similar situations. Three types of extrapolation are common in risk assessments: biological (including between taxa and across levels of biological organization), temporal, and spatial. They can be thought of conceptually as the axes of a 3-dimensional graph defining the state space of biological, temporal, and spatial scales within which extrapolations are made. Each of these types of extrapolation can introduce uncertainties into risk assessments. Such uncertainties may be reduced through synergistic research facilitated by the sharing of methods, models, and data used by human health and ecological scientists     

Potential for the Adoption of Probabilistic Risk Assessments by End-Users and Decision-Makers

In the area of risk assessment associated with ecotoxicological and plant protection products, probabilistic risk assessment (PRA) methodologies have been developed that enable quantification of variability and uncertainty. Despite the potential advantages of these new methodologies, end-user and regulatory uptake has not been, to date, extensive. A case study, utilizing the Theory of Planned Behavior, was conducted in order to identify potential determinants of end-user adoption of probabilistic risk assessments associated with the ecotoxicological impact of pesticides. Seventy potential end-users, drawn from academia, government, industry, and consultancy organizations, were included in the study. The results indicated that end-user intention to adopt PRA varied across the different end-user groups. The regulatory acceptance of PRA was contingent on social acceptance across the regulatory community regarding the reliability and utility of the outputs. Training in interpretation of outputs is therefore highly relevant to regulatory acceptance. In other end-user sectors, a positive attitude toward PRA, “hands on” experience, and perceived capability of actually performing PRA is an important determinant of end-user intention to adopt PRA. It is concluded that training programs targeted to the specific needs of different end-user sectors should be developed if end-user adoption of PRA is to be increased.     

Recommended Avian Toxicity Reference Value for Cadmium: Justification and Rationale for Use in Ecological Risk Assessments

The understanding of Cd impacts to avian species has been improved by recent studies and the extensive literature review completed as part of the development of the U.S. Environmental Protection Agency's Ecological Soil Screening Levels (Eco-SSLs). Therefore, we sought to update the Cd toxicity reference value (TRV) for birds used by regulatory agencies and resource trustees in California for predictive ecological risk assessments. We surveyed the available literature sources, particularly TRVs between the currently used TRV (0.08 mg/kg/d) and the Eco-SSL TRV (1.47 mg/kg/d) to identify the lowest, ecologically relevant no observed adverse effect levels (NOAELs) for oral exposure of birds to Cd. As a result, we identified an ecologically protective NOAEL TRV of 0.7 mg/kg/d, based primarily on renal effects in wood ducks, but supported by another study with both renal and reproductive endpoints. In addition, a lowest observed adverse effect level (LOAEL) of 1.0 mg/kg/d was selected based on kidney nephrosis in mallards. Overall, these updated TRVs incorporate more recent studies on Cd toxicity in birds while establishing thresholds based on ecologically relevant endpoints.     

Distribution Characteristics and Risk Assessments of PAHs in Fish from Lake Taihu,China

The concentrations of PAHs in four species of fish (Common carp, Crucian carp, Bighead carp, and Topmouth culter) from Lake Taihu were tested, and the human health risks of PAHs by fish consumption were evaluated. Results showed that concentrations of PAHs in fish from Lake Taihu were 52.5–247.6 ng/g wet weight (ww), and the BaP equivalent concentrations of total PAHs (B[a]P_eq) were 0.2–0.6 ng/g ww, which were less than the screening value of 2.6 ng/g wet for human consumption. The concentration sequences of PAHs in fish from Lake Taihu from high to low were Bighead carp > Crucian carp > Common carp > Topmouth culter. The human health risk level of PAHs by fish consumption was 5.8 ± 2.5 × 10^?6, which was less than the maximum acceptable risk level of 1 × 10^?5 for human health set by the U.S. Environmental Protection Agency. The tissue residue guideline (TRG) of PAHs for protecting aquatic wildlife was 1.3 mg/kg diet ww, which was higher than the concentrations of PAHs in fish from Lake Taihu. The results indicated that fish consumption from Lake Taihu would not cause health risk or harmful effects on wildlife that consume aquatic biota.     

An Ecological Risk Assessment of Inorganic Chloramines in Surface Water

Inorganic chloramines are formed when chlorine and ammonia are combined in water. These substances are frequently used as a secondary disinfectant for drinking water and are by-products of processes involving the disinfection of wastewaters and the control of biological fouling in cooling water systems. For chloraminate drinking water, the total residual chlorine (TRC) concentration may be almost completely due to monochloramine. Based on 1995 and 1996 survey data, the most significant and prevalent TRC loading to the Canadian environment is from municipal wastewater releases. Drinking water releases are the next most important source of chloramine entry into the Canadian environment, while TRC releases from other sources, such as cooling water, zebra mussel control practices and industrial wastewater, are much less important. A probabilistic water quality model was used to model two wastewater discharges and a cooling water discharge to different freshwater systems. The resulting exposure distributions were then compared with three incipient lethality endpoints, i.e., 50% mortality to the invertebrate Ceriodaphnia dubia and 50% and 20% mortality to juvenile chinook salmon (Oncorhynchus tshawytscha). For each discharge scenario studied, there were moderate to high probabilities of significant adverse effects on aquatic life up to 1.9?km from the effluent sources.     

Consideration of Background Radiation in Ecological Risk Assessments

Background or ambient concentrations are often considered in the evaluation of potential risks to ecological receptors from exposure to hazardous chemicals in the environment. Such an evaluation may be a component of the screening or final risk management process and sets the baseline from which risks contributed by site-related activities can be addressed. Although the process for the evaluation of potential radiological risks to ecological receptors is less formalized than the chemical hazard assessment process, background remains an issue that should be addressed when considering potential site-related impacts. This paper briefly presents the ecological risk assessment approaches used to address background radionuclide concentrations at three United States Department of Defense Facilities. The concepts of total radiation dose, and tolerance and adaptation of populations to radiation are also discussed within the context of background radiation.     

The Anna Karenina Principle Applied to Ecological Risk Assessments of Multiple Stressors

Successful ecological risk assessments are all alike; every unsuccessful ecological risk assessment fails in its own way. Tolstoy posited a similar analogy in his novel Anna Karenina: “Happy families are all alike; every unhappy family is unhappy in its own way.” By that, Tolstoy meant that for a marriage to be happy, it had to succeed in several key aspects. Failure on even one of these aspects, and the marriage is doomed. In this paper, I argue that the Anna Karenina principle also applies to ecological risk assessments involving multiple stressors. In particular, I argue that multiple stressors assessments and environmental decision making will not have a happy marriage unless the following can be achieved: (1) there must be societal and political buy-in to the assessment and decision-making process; (2) the assessment must have the latitude to consider a wide range of stressors and potential risk management options; (3) there must be a commitment to following a rigorous focusing of the assessment and to expending resources for model development and data collection; and (4) an adaptive management strategy must be adopted wherein risk management actions are undertaken, system response intensively observed and assessed, and revised management actions taken as appropriate. Failure to meet any of the above criteria for success will doom a multiple stressors assessment and prevent its use in effective decision-making.     

Considerations Regarding the Use of Reference Area and Baseline Information in Ecological Risk Assessments

There has been debate in the recent literature as to whether a reference assessment should be included in ecological risk assessments (ERAs) of contaminated sites, and if so, how such an evaluation can be incorporated in a way that aids in decision making. It is our view that an assessment of reference conditions can be useful in the ERA process, for both prospective and retrospective ERAs, given adequate resources and acknowledgement and understanding of the limitations and uncertainties associated with this information. Suggestions and considerations for incorporating reference area information into an ecological risk assessment are discussed.     

Incorporating Information on Bioavailability of Soil-Borne Chemicals into Human Health Risk Assessments

Definition of the term bioavailability varies in the environmental sciences. In human health risk assessment, bioavailability is defined as the fraction of the dose of chemical delivered that is absorbed into the systemic circulation. Bioavailability can be expressed as either absolute or relative bioavailability, and both are important in calculating risks from contaminants in soils. Bioavailability of chemicals is addressed in all risk assessments, although not always in a transparent manner. Because data on bioavailability are limited, approximations and assumptions regarding chemical uptake are extensively used. The risk assessment process could benefit from new information on the bioavailability of chemicals, but there are important questions about the best means to develop this information and how it should be used. To foster discussion on these issues, three articles are presented in this issue of the journal offering different perspectives on bioavailability method development, validation, and use.     

Conducting Ecological Risk Assessments of Inorganic Metals and Metalloids: Current Status

Ecological risk assessment (ERA) of inorganic metals and metalloids (metals) must be specific to these substances and cannot be generic because most metals are naturally occurring, some are essential, speciation affects bioavailability, and bioavailability is determined by both external environmental conditions and organism physiological/biological characteristics. Key information required for ERA of metals includes: emissions, pathways, and movements in the environment (Do metals accumulate in biota above background concentrations?); the relationship between internal dose and/or external concentration (Are these metals bioreactive?); and the incidence and severity of any effects (Are bioreactive metals likely to result in adverse or, in the case of essential metals, beneficial effects?) — ground-truthed in contaminated areas by field observations. Specific requirements for metals ERA are delineated for each ERA component (Hazard Identification, Exposure Analysis, Effects Analysis, Risk Characterization), updating Chapman and Wang (2000). In addition, key specific information required for ERA is delineated by major information category (conceptual diagrams, bioavailability, predicted environmental concentration [PEC], predicted no effect concentration [PNEC], tolerance, application [uncertainty] factors, risk characterization) relative to three different tiered, iterative levels of ERA: Problem Formulation, Screening Level ERA (SLERA), and Detailed Level ERA (DLERA). Although data gaps remain, a great deal of progress has been made in the last three years, forming the basis for substantial improvements to ERA for metals.