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

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SRA 2013 Annual Meeting Abstracts T1-E.4 Furukawa, K; Radiation Effects Research Foundation; furukawa@rerf.or.jp A Bayesian semi-parametric dose response estimation in radiation risk assessment Characterizing the dose effect relationship and estimating acceptable exposure levels are the primary goal of quantitative risk assessments. In analysis of health risks associated with exposure to ionizing radiation, while there is a clear agreement that moderate to high radiation doses cause harmful effects in humans, we have insufficient information to understand the possible biological effects at low doses, e.g., doses below 0.1 Gy. A conventional approach to dose response analyses tends to base inference on an idealized model that is chosen primarily due to the lack of statistical power, which may be misleading in characterizing the low dose effects and, especially, estimating their uncertainties. As an alternative approach, this study proposes a Bayesian semi-parametric model that has a piecewise linear dose response function with auto-regressive priors as a smoother, applied to data grouped in closely spaced dose categories. A simulation study shows that the proposed approach can yield relatively robust and efficient estimations under various situations assuming dose response relationships that are often considered as possible models of radiation oncogenesis at low doses. The new approach is applied to the cancer incidence data of the Life Span Study cohort of Japanese atomic bomb survivors, which has long been an important data source for developing quantitative estimates of risk from exposure to radiation. W3-F.5 Fusco, MP; Global Catastrophe Research Institute; markpfusco@gmail.com Christian Apocalyptic Literature in Theological Scholarship & The 'Prepper' Movement There has been an increase in the number and variety of movements in the United States that are preparing for a global catastrophic event. The motivation inspiring these ‘preppers’ is as varied as their understanding of how future scenarios (political, social, environmental, extraterrestrial, technological, biological, etc.), will necessarily lead to devastation on the global level. Each of these approaches provides data points given its unique methods and interpretative frameworks. Preppers often take their interpretation and projection of hard scientific data as being commensurate with their religious presuppositions. In the presentation we will outline how theological scholarship understands the scriptural account of the last days as recorded in the book of Revelation, as one means to frame a conversation with preppers. T3-E.1 Gaborek, BJ; Bellin, CA; Dellarco, M; Egeghy, P; Heard, N; Jensen, E; Lander, DR; Tanir, JY*; Zaleski, RT; Sunger, N; DuPont ; jtanir@hesiglobal.org Optimizing a Tiered Exposure Framework to Aid Risk Assessment Decision-Making The science of risk assessment is utilized on a world-wide basis by regulatory authorities and industry to protect the health and welfare of humans and the environment from a broad range of chemicals, biological materials, and consumer products. Risk assessment is based on evaluating both the hazard (toxicological impact) and the exposure (likelihood and frequency of contact) components of risk, most often in a quantitative manner. During the last several years, exposure has been incorporated earlier and more prominently into the risk assessment process. In addition, numerous organizations across the globe have initiated a “tiered” approach to utilizing exposure data. Generally in a tiered exposure assessment, the first quantified estimates are deterministic and tending toward overestimation. These lower tier exposure estimates are often useful in screening or prioritizing additional efforts. With advancement to higher tiers, the estimates become progressively less conservative and more certain. Consequently, these exposure predictions often facilitate decision-making at a more chemical or product-specific level. As part of the ILSI Health and Environmental Sciences Institute’s RISK21 initiative, the Exposure Science Sub-team focused on developing a novel, streamlined, and tiered approach for estimating exposure that maximizes use of readily available information (existing approaches, tools, and data) and that aligns with available hazard data. The goal of this effort was to identify efficiencies that, if implemented in risk assessment, would facilitate quicker decision-making and focus resources in areas with greatest information value. As an introduction to subsequent presentations in this symposium, this discussion introduces the proposed framework, briefly compares it to other tiered frameworks, and then describes the Tier 0 level of the framework with some degree of detail. This abstract does not necessarily reflect U.S. EPA policy. P.24 Gadagbui, B; Maier, A; Nance, P*; JayJock, M; Franklin, C; Toxicology Excellence for Risk Assessment; nance@tera.org A Decision Tool for Assessing Polymers and Polymeric Substances with Potential Hazards to Human Health Polymers display a wide variety of characteristics - e.g., presence of non-bound residual monomers, polymerization chemicals, degradation products, and additives - that may pose a potential health hazard. There is a paucity of direct testing data on many polymers to adequately evaluate their toxicity, but several regulatory agencies have provided guidance for assessing polymer safety. We evaluated each of these approaches and identified the strengths and weaknesses of each. No single published model appears to cover all characteristics of interest. This suggests the need to develop a comprehensive decision tool to identify polymeric substances that may pose potential toxicological hazards to human health. We developed a decision tool that incorporates a weight of evidence approach integrating information for many individual hazard flags. Hazard flags were placed into four broad categories: (1) empirical hazard information on the polymer or residual monomer; (2) evidence of toxicity based on structural properties (i.e., based on polymer class, monomer components, or reactive functional groups); (3) potential for significant tissue dose (i.e., based on molecular weight distribution or systemic bioavailability); and (4) hazard based on foreseeable special use considerations. Some of these hazard flags have not been considered previously by the regulatory agencies. We tested this approach for a number of polymers to demonstrate how the new tool (integrates) incorporates all available regulatory approaches as well as the new features and provides a comprehensive decision framework for evaluating polymer safety. December 8-11, 2013 - Baltimore, MD
SRA 2013 Annual Meeting Abstracts T1-K.4 Galloway, L*; Dolislager, F; Stewart, D; Tucker, K; University of Tennessee, Knoxville; galloway@utk.edu RELEASE OF OSRTI’S ONLINE RISK CALCULATOR L. Galloway, F. Dolislager, D. Stewart (The University of Tennessee, Knoxville) K. Tucker (Ingenium Professional Services, Inc.) The U.S. Environmental Protection Agency Office of Remediation and Technology Innovation (OSRTI) through an interagency agreement with Oak Ridge National Laboratory (ORNL) developed an online risk calculator for assessment of environmental media. This new tool allows users to enter concentrations in environmental media (soil, sediment, groundwater, surface water, fish, produce, beef and milk) for the calculation of cancer and noncancer risks. This tool is analogous, yet more comprehensive than the existing regional screening Level (RSL) calculator. Chronic daily intakes (CDIs) are calculated and combined with toxicity data to produce risk results. Users have the ability to not only select chemicals from a pick list and hand enter concentrations but also upload a simple data file containing media designation, exposure point concentrations, chemical name, CAS number and detection status. Baseline exposure assumptions are provided as defaults, however, the user is allowed to change and save their site-specific exposure parameters, chemical parameters and toxicity values in a user file for future use. Once risk results are obtained, they can be saved along with their site-specific data for later modification. Output will be formatted into a RAGS part D template, including toxicity metadata. This new tool will be useful for concerned citizens, risk assessors and risk managers. M4-C.5 Gelyani, A.M.*; Abrahamsen, E.B.; Asche, F; Heide, B; University of Stavanger, Stavanger, Norway; Safetec Nordic, Norway; alireza.m.gelyani@uis.no A note on what the effects are of a safety measure It is well known that investments in new safety measures do not always give the intended effect, as new safety measures are sometimes offset by behavioural changes. In this article we show that another cause for a reduced effect is that competition for resources can lead new safety measures to crowd out existing measures. As the resources spent on safety measures are usually scarce, a new safety measure can lead to reduced resources allocated to other measures. If this aspect is not taken into consideration, the effects of a single measure might be considered too high. An overinvestment in new safety measures might then occur. W3-K.4 Gelyani, A.M.*; Abrahamsen, E.B.; Selvik, J.T.; Authors 1 and 2: University of Stavanger, Norway; Author 3: International Research Institute of Stavanger (IRIS), Norway; alireza.m.gelyani@uis.no DECISION CRITERIA FOR UPDATING TEST INTERVALS FOR WELL BARRIERS In this paper we discuss whether or not decision upon test intervals for well barriers should adopt the same decision criteria as those recently suggested for Safety Instrumented Systems (SIS). We conclude that the criterion suggested for halving the test intervals for SIS is appropriate to use also for well barriers. The criterion for doubling the test interval for SIS is however not considered appropriate, as this criterion does not give a sufficient weight to the cautionary principle. A new type of criterion for doubling the test interval for well barriers that better reflects the uncertainties is suggested. W4-D.4 Geraci, CL; National Institute for Occupational Safety and Health; cgeraci@cdc.gov Closing research gaps for safer design principles for multiwalled carbon nanotubes; molecule, process, and products The multiwall carbon nanotube (MCNT) is one of the most widely studied materials to come out of nanotechnology. As a class of materials, the MWCNT has shown great promise in a wide range of applications; however, the research on applications has outpaced research on the potential implications for human health and the environment. Recent toxicological findings and dose-response based risk assessments support the need for an active risk-based approach to manage the development of MWCNT-based product applications. Unfortunately, there is little information available regarding actual human or environmental exposures to structure an informed risk characterization and develop a risk management approach. Research is needed to close key knowledge gaps that will, in turn, allow a more complete analysis of the risk associated with commercializing MWCNT-enabled products. More research is needed to at the molecular level to identify changes in the physical and chemical characteristics of MWCNTs that can alter the biologic behavior and result in a ‘safer’ MWCNT. Actual release and exposure assessments are needed during the manufacture and use of MWCNT so that more accurate risk characterizations can be performed. Research that develops and refines more specific and quantitative release and exposure data will allow for the development of more effective risk management approaches. Once MWCNTs are incorporated into an intermediate or product, the risk profile changes based on the potential for release of the MWCNT. Methods to identify and characterize release scenarios are needed to complete the life cycle risk analysis for MWCTs. Until results from the research needs identified here are available, risk managers will have to rely on minimizing or eliminating potential human exposures. More progressive approaches would include designing safer MWCNT, designing processes that have minimal releases, and designing products with a low potential for releasing MWCNT. December 8-11, 2013 - Baltimore, MD
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