Abstracts (PDF file, 1.8MB) - Society for Risk Analysis

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SRA 2013 Annual Meeting Abstracts T2-F.2 Renn, O.; Jovanovic, A.; Schroeter, R.*; University of Stuttgart; regina.schroeter@sowi.uni-stuttgart.de Social Unrests as systemic Risks In this paper we develop a framework of social unrest within a complex understanding of systemic risk. The term ‘systemic’ describes the extent to which any risk is embedded in the larger contexts of social and cultural aspects that shape our understanding of risk, influence our attention to causal relationships and trigger our activities for handling these risks. Social unrest can be grouped into this framework of systemic risks. It can be a cause of risk to others, it can be a consequence of experiencing risk or the manifestation of such a risk or it can be a promoter of a risk chain that is located in other functional systems of society . Since social unrest is more a process of escalation than a finite state of the world we have conceptualized the term in from of a step-by-step escalation scheme. Each step makes social unrest more severe. We assume that that people who will engage themselves publicly on any subject have to be dissatisfied with their situation or perceive a problem that they would like to address. Even if people are dissatisfied nothing will happen unless that dissatisfaction is displayed in some kind of public arenaUnsatisfied people have to become active . If public expression of dissatisfaction and the organization of protest does not help to improve the situation the probability for further social mobilization increases. Social mobilization goes beyond expressing dissatisfaction. It comprises all activities that require an organizational effort to concentrate forces, to develop and enact a strategy for gaining public attention and for putting pressure on those who are targeted to make changes. In the course of this process, activities may get more and more radical, in particular if these collective protest actions are ignored or even oppressed . Then the continuum enters the next step: violent outbreak. This can ultimately lead to civil war. T4-B.4 Rhomberg, LR; Gradient; lrhomberg@gradientcorp.com Using existing study data or methodologies from epidemiology and toxicology to evaluate diverse stressors Much discussion of cumulative risk assessment (CRA) has focused on exploring in principle whether multiple chemical exposures and variation in levels of non-chemical stressors can lead to risks different than those estimated on an agent-by-agent basis. This perspective talk examines practical issues in conducting and applying CRA in real cases, in which one seeks to support risk management actions with empirical evidence on combinations and interactions, where the tangle of conceivable causes and interactions needs to be resolved into a set that are important and can be characterized. Experimental data limit the scope of varying influences and are hard to apply to complex real populations, while with epidemiological data it is often hard to sort out identifiable roles for individual influences. Examining patterns of correlation of exposures, stressors, and outcomes in real populations offers some insights. Distinguishing confounding from joint action, and correlation of independent influences from their modification of one anothers' actions are key questions. Rigorous problem formulation can help focus efforts on finding ways to support the needed distinctions for decisionmaking. M4-B.3 Rhomberg, LR; Gradient; lrhomberg@gradientcorp.com Challenges and approaches for evidence integration regarding endocrine disruption, exemplified by the case of bisphenol A As least in part, the often rancorous debates about scientific support regarding endocrine disruption in general – and more particularly about nonmonotonic dose-response curves and the application of hormonal mode-of-action data not tied to clear adverse effects – may be ascribed to lack of clearly agreed upon approaches for integration of diverse and unfamiliar lines of evidence. The debate on the possible low-dose effects of bisphenol A exemplifies many of these issues. This perspective talk examines the issues and suggests approaches to weight of evidence and integration among lines of evidence. Endocrine disruption is a mode of action, not an endpoint, and so traditional endpoint-oriented toxicity testing may need different kinds of examination. Endocrine activity is inherently about modulation of physiological states through small changes in low concentrations of causative agents, so low-dose issues, shapes of dose-response curves, and effects of natural background processes need special consideration. This puts a premium on consistency of effects and their dose dependence across studies and on a plausible hormonally mediated mechanism in assessing effects that also applies with a consistent rationale across endpoints and studies. The application of these principles to evaluation of bisphenol A low-dose toxicity is discussed. M2-A.1 Rhomberg, LR; Bailey, EA*; Gradient; lrhomberg@gradientcorp.com Hypothesis-based weight of evidence: an approach to assessing causation and its application to regulatory toxicology Regulators are charged with examining existing scientific information and coming to judgments about the state of knowledge regarding toxicological properties of agents. The process needs to be seen as sound and objective. The challenge is that information is often far from definitive, containing gaps and outright contradictions. The particular results of studies must be generalized and extrapolated to apply to the target populations of the risk assessment. Existing weight-of-evidence approaches have been criticized as either too formulaic, ignoring the complexity and case-specificity of scientific interpretation, or too vague, simply calling for professional judgment that is hard to trace to its scientific basis. To meet these challenges, I discuss an approach – termed Hypothesis-Based Weight of Evidence (HBWoE) – that emphasizes articulation of the hypothesized generalizations, their basis and span of applicability, that make data constitute evidence for a toxicologic concern in the target population. The common processes should be expected to act elsewhere as well – in different species or different tissues – and so outcomes that ought to be affected become part of the basis for evaluating success and defining the limits applicability. A compelling hypothesis is one that not only provides a common unified explanation for various results, but also has its apparent exceptions and failures to account for some data plausibly explained. Ad hoc additions to the explanations introduced to "save" hypotheses from apparent contradictions need to be recognized. In the end we need an "account" of all the results at hand, specifying what is ascribed to hypothesized common causal processes and what to special exceptions, chance, or other factors. Evidence is weighed by considering whether an account including a proposed causal hypothesis is more plausible than an alternative that explains all of the results at hand in different ways. December 8-11, 2013 - Baltimore, MD
SRA 2013 Annual Meeting Abstracts W4-G.2 Rhomberg, LR*; Bailey, LA; Nascarella, MA; Gradient; lrhomberg@gradientcorp.com Hypothesis-based weight-of-evidence and dose-response evaluation for naphthalene carcinogenicity Human health risk assessment consists of bringing to bear a large body of in vitro, animal, and epidemiologic studies on the question of whether environmental exposures to a substance are a potential risk to humans. The body of scientific information, however, is typically less than definitive and often contains apparent contradictions. We applied our Hypothesis-Based Weight-of-Evidence (HBWoE) method to systematically and comparatively evaluate the large body of data and hypothesized modes of action for inhaled naphthalene carcinogenesis, expressing the relative degrees of credence that should be placed in alternative possible interpretations of the data, considering consistencies, inconsistencies, and contradictions within the data set. Guided by the outcome of our WoE evaluation, we conducted a dose-response evaluation of naphthalene exposure and neoplastic and non-neoplastic lesions, with the ultimate goal of deriving naphthalene toxicity values applicable to human health risk assessment. Our approach was to consider the applicability of the rat nasal tumors to serve as a basis for estimation of potential human respiratory-tract cancer risk. We did this by considering the mode of action (MoA) underlying the animal tumors seen in bioassays, including the metabolic activation and detoxification of inhaled naphthalene as they depend on air concentration, as well as the nature, tissue locations, and dependence on tissue-dose of key precursor responses. Species differences in tissue dosimetry were used to evaluate whether parallel tissues in humans, or other tissues in the respiratory tract, could be subject to tissue doses that could prompt the key events of the apparent MoA. The points of departure derived from rodent dose-response evaluations were extrapolated to human equivalent concentrations through application of a rat/human PBPK model that describes cross-species dosimetry of the upper respiratory tract, lung, and liver. T4-B.2 Rice, GE*; Teuschler, LK; National Center for Environmental Assessment/ORD/US EPA; rice.glenn@epa.gov Grouping of diverse stressors for cumulative risk analysis (CRA) by media, time and toxicity CRAs may address multiple chemical, physical, biological or psychosocial stressors. Approaches for grouping diverse stressors prior to risk analysis can simplify some complexities associated with CRAs. For CRAs involving chemical mixtures, this entails developing CRA exposure groups based on the media and timing of specific exposure combinations, including duration and intermittency of exposures/effects. CRA toxicity groups are developed using toxicological and epidemiological information to ascertain whether the chemicals in question share a common toxic mode of action or cause the same primary or secondary health outcome(s). Integrated CRA groups are then developed by merging the CRA exposure and toxicity groups. The chemicals in an integrated CRA group can plausibly exhibit exposures that overlap sufficiently in terms of pharmacokinetics or pharmacodynamics (e.g., persistent tissue damage); and exhibit interactions or cause the same health outcome(s). We extend this simple grouping concept to include buffers, factors that decrease the risk associated with a stressor. Finally, we extend this approach to non-chemical stressors, proposing a set of preliminary considerations for identifying non-chemical stressors that could be grouped with chemicals. Key considerations include: 1) ongoing or previous health conditions and disease states causing effects similar to those associated with a chemical’s effect; and 2) lifestages, lifestyle/occupational factors, and physical/biological stressors that may contribute to or buffer against a chemical’s effect. (The views expressed in this abstract are those of the authors and do not necessarily reflect the views or policies of the U.S. EPA.) T4-E.2 Rico, CM*; Barrios, AC; Hong, J; Morales, MI; McCreary, R; Lee, WY; Peralta-Videa, JR; Gardea-Torresdey, JL; The University of Texas at El Paso, University of California Center for Environmental Implications of Nanotechnology; cmrico@miners.utep.edu The interaction of CeO2 nanoparticles with rice: Impacts on productivity and nutritional value Cerium oxide nanoparticles (nCeO2) have significant interactions in plants; however, there are no reports yet on their impacts in rice (Oryza sativa). Rice is an important crop that support the economic activity, and nutritional and health status of more than four billion people around the globe. This study was performed to determine the influence of nCeO2 on rice at seedling and grain production stages by employing biochemical assays, in vivo imaging, and ICP, FTIR and synchrotron spectroscopy techniques. For the seedling stage study, rice seeds were grown for 10 days in nCeO2 suspensions (0, 62.5, 125, 250 and 500 mg l-1). In case of the grains study, rice was grown in soil at 0 and 500 mg nCeO2 kg-1. The data showed that Ce in root seedlings increased as the external nCeO2 increased without visible signs of toxicity. The H2O2 generation increased at 500 mg nCeO2 l-1, while the membrane damage was enhanced at 125 mg nCeO2 l-1. Fatty acid and lignin contents were markedly reduced at 500 mg nCeO2 l-1. The FTIR spectromicroscopy showed modifications in the biomolecular components of root xylem while synchrotron -XRF analysis revealed the presence of Ce in the vascular tissues of the roots. Results from the grains study showed that the starch, sugar, and antioxidant contents were not affected by the treatment. However, nCeO2 caused a dramatic reduction in globulin, prolamin, and glutelin protein contents, and in lauric, valeric, palmitic and oleic acids. In addition, the concentration of K, Na and Fe increased while S was markedly reduced. Rice grain also showed significantly higher amount of Ce in the nCeO2 treatment. Although no phenotypical changes were observed, the results illustrate that nCeO2 cause toxicity to rice. This study sheds light on the impacts of nCeO2 on the production and nutritive value of rice. T2-H.4 Risz, Y; Reich-Weiser, C; Cammarata, C*; Enviance Inc. ; ccammarata@enviance.com Identification of Hidden Risks and Associated Costs using Integrated Life Cycle Impact and Cost Assessment (ILCICA) Organizations are exposed to risks and associated hidden costs that are embedded in their supply chain and operations (e.g., health care, resource scarcity, remediation, reporting, fines, training, and safety equipment). Before developing risk mitigation strategies, organizations first must identify, quantify and prioritize these risks and resulting costs. This presentation will introduce an innovative methodology that blends life cycle assessment (LCA) with financial valuation techniques to more quickly and accurately assess environmental and health impacts and associated costs. Known as Integrated Life Cycle Impact and Cost Assessment (LCICA), this best-in-class method can assess cradle-to-grave impacts at any level of the organization and then monetize those impacts to clearly quantify risk to the bottom line. The discussion will be informed by lessons learned from two pilot studies conducted for the Department of Defense and in collaboration with leading Aerospace & Defense companies. December 8-11, 2013 - Baltimore, MD
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