ALBERT

Notes: When the transportation risk posed by shipments of hazardous chemical and radioactive materials is being assessed, it is necessary to evaluate therisks associated with both vehicle emissions and cargo-related risks. Diesel exhaust and fugitive dust emissions from vehicles transporting hazardous shipments lead to increased air pollution, which increases the risk of latent fatalities in the affected population along the transport route. The estimated risk from these vehicle-related sources can often be as large or larger than the estimated risk associated with the material being transported. In this paper, data from the U.S. Environmental Protection Agency's Motor Vehicle-Related Air Toxics Study are first used to develop latent cancer fatality estimates per kilometer of travel in rural and urban areas forall diesel truck classes. These unit risk factors are based on studies investigating the carcinogenic nature of diesel exhaust. With the same methodology, the current per-kilometer latent fatality risk factor used in transportation risk assessments for heavy diesel trucks in urban areas is revised and the analysis expanded to provide risk factors for rural areas and all diesel truck classes. These latter fatality estimates may include, but are not limited to, cancer fatalities and are based primarily on the most recent epidemiological data available on mortality rates associated with ambient air PM-10 concentrations.

Notes: Risk assessors often use different probability plots as a way to assessthe fit of a particular distribution or model by comparing the plotted points to a straight line and to obtain estimates of the parameters in parametric distributions or models. When empirical data do not fall in a sufficiently straight line on a probability plot, and when no other single parametricdistribution provides an acceptable (graphical) fit to the data, the risk assessor may consider a mixture model with two component distributions. Animated probability plots are a way to visualize the possible behaviors of mixture models with two component distributions. When no single parametric distribution provides an adequate fit to an empirical dataset, animated probability plots can help an analyst pick some plausible mixture models for the data based on their qualitative fit. After using animations during exploratory data analysis, the analyst must then use other statistical tools, including but not limited to: Maximum Likelihood Estimation (MLE) to find the optimal parameters, Goodness of Fit (GoF) tests, and a variety of diagnostic plots to check the adequacy of the fit. Using a specific example with two LogNormal components, we illustrate the use of animated probability plots asa tool for exploring the suitability of a mixture model with two component distributions. Animations work well with other types of probability plots, and they may be extended to analyze mixture models with three or more component distributions.

Notes: For carcinogens, this paper provides a quantitative examination of the roles of potency and weight-of-evidence (WOE) in setting permissible exposure limits (PELs) at the U.S. Occupational Safety and Health Administration (OSHA) and threshold limit values (TLVs) at the private American Conference of Governmental Industrial Hygienists (ACGIH). On normative grounds, both of these factors should influence choices about the acceptable level of exposures. Our major objective is to examine whether and in what ways these factors have been considered by these organizations. A lesser objective is to identify outliers, which might be candidates for further regulatory scrutiny. Our sample (N=48) includes chemicals for which EPA has estimated a unit risk as a measure of carcinogenic potency and for which OSHA or the ACGIH has a PEL or TLV. Different assessments of the strength of the evidence of carcinogenicity were obtained from EPA, ACGIH, and the International Agency for Research on Cancer. We found that potency alone explains 49% of the variation in PELs and 62% of the variation in TLVs. For the ACGIH, WOE plays a much smaller role than potency. TLVs set by the ACGIH since 1989 appear to be stricter than earlier TLVs. We suggest that this change represents evidence that the ACGIH had responded to criticisms leveled at it in the late 1980s for failing to adopt sufficiently protective standards. The models developed here identify 2-nitropropane, ethylene dibromide, and chromium as having OSHA PELs significantly higher than predicted on the basis of potency and WOE.

Notes: Much has been written about the development and application of quantitative methods for estimating under uncertainty the long-term radiological performance of underground disposal of radioactive wastes. Until recently, interest has been focused almost entirely on the technical challenges regardless of the role of the organization responsible for these analyses. Now the dialogue between regulators, the repository developer or operator, and other interested parties in the decision-making process receives increasing attention, especially in view of some current difficulties in obtaining approvals to construct or operate deep facilities for intermediate or high-level wastes. Consequently, it is timely to consider the options for regulators’review and evaluation of safety submissions, at the various stages in the site selection to repository closure process, and to consider, especially, the role for performance assessment (PA) within the programs of a regulator both before and after delivery of such a submission. The origins and broad character of present regulations in the European Union (EU) and in the OECD countries are outlined and some regulatory PA reviewed. The issues raised are discussed, especially in regard to the interpretation of regulations, the dangers from the desire for simplicity in argument, the use of regulatory PA to review and challenge the PA in the safety case, and the effects of the relationship between proponent and regulator. Finally, a very limited analysis of the role of PA in public hearings is outlined and recommendations are made, together with proposals for improving the mechanisms for international collaboration on technical issues of regulatory concern.

Notes: In this paper the problem of high-level nuclear waste disposal is viewed as a five-stage, cascaded decision problem. The first four of these decisions having essentially been made, the work of recent years has been focused on the fifth stage, which concerns specifics of the repository design. The probabilistic performance assessment (PPA) work is viewed as the outcome prediction for this stage, and the site characterization work as the information gathering option. This brief examination of the proposed Yucca Mountain repository through a decision analysis framework resulted in three conclusions: (1) A decision theory approach to the process of selecting and characterizing Yucca Mountain would enhance public understanding of the issues and solutions to high-level waste management; (2) engineered systems are an attractive alternative to offset uncertainties in the containment capability of the natural setting and should receive greater emphasis in the design of the repository; and (3) a strategy of “waste management” should be adopted, as opposed to “waste disposal,” as it allows for incremental confirmation and confidence building of a permanent solution to the high-level waste problem.

Notes: Physiologically-based toxicokinetic (PBTK) models are widely used to quantify whole-body kinetics of various substances. However, since they attempt to reproduce anatomical structures and physiological events, they have ahigh number of parameters. Their identification from kinetic data alone is often impossible, and other information about the parameters is needed to render the model identifiable. The most commonly used approach consists of independently measuring, or taking fom literature sources, some of the parameters, fixing them in the kinetic model, and then performing model identification on a reduced number of less certain parameters. This results in a substantial reduction of the degrees of freedom of the model. In this study, we show that this method results in final estimates of the free parameters whose precision is overestimated. We then compared this approach with an empirical Bayes approach, which takes into account not only the mean value, but also the error associated with the independently determined parameters. Blood and breath 2H8- toluene washout curves, obtained in17 subjects, were analyzed with a previously presented PBTK model suitable for person-specific dosimetry. Model parameters with the greatest effect onpredicted levels were alveolar ventilation rate QPC, fat tissue fraction VFC, blood air partition coefficient Kb, fraction of cardiac output to fat Qa/co and rate of extrahepatic metabolismVmax.p. Differences in the measured and Bayesian-fitted values of QPC, VFc and Kb were significant (p 〈 0.05), andthe precision of the fitted values Vmax.p and Qa/co went from 11 ± 5% to 75 ± 170% (NS) and from 8 ± 2% to 9 ± 2% (p 〈 0.05) respectively. The empirical Bayes approach did not result in less reliable parameter estimates: rather, it pointed out that the precision of parameter estimates can be overly optimistic when other parameters in the model, eitherdirectly measured or taken from literature sources, are treated as known without error. In conclusion, an empirical Bayes approach to parameter estimation resulted in a better model fit, different final parameter estimates, and more realistic parameter precisions.

Notes: The US Department of Transportation was interested in the risks associated with transporting Hydrazine in tanks with and without relief devices. Hydrazine is both highly toxic and flammable, as well as corrosive. Consequently, there was a conflict as to whether a relief device should be used or not. Data were not available on the impact of relief devices on release probabilities or the impact of Hydrazine on the likelihood of fires and explosions. In this paper, a Monte Carlo sensitivity analysis of the unknown parameters was used to assess the risks associated with highway transport of Hydrazine. To help determine whether or not relief devices should be used, fault trees and event trees were used to model the sequences of events that could lead to adverse consequences during transport of Hydrazine. The event probabilities in the event trees were derived as functions of the parameters whose effects were not known. The impacts of these parameters on the riskof toxic exposures, fires, and explosions were analyzed through a Monte Carlo sensitivity analysis and analyzed statistically through an analysis of variance. The analysis allowed the determination of which of the unknown parameters had a significant impact on the risks. It also provided the necessary support to a critical transportation decision even though the values of several key parameters were not known.