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SRA 2013 Annual Meeting Abstracts P.113 Liu, LH*; Chan, CC; Wu, KY; National Taiwan University; smorezed@gmail.com Probabilistic Risk Assessment for 2-Amino-1-Methyl-6-Phenylimidazo[4,5-b]- Pyridine (PhIP) through Daily Consumption of High-Temperature Processed Meats and Fishes in Taiwan 2-amino-1-methyl-6-phenylimidazo[4,5-b]pyridine (PhIP) has been reported present in many panfried, oven-broiled, and grilled meats and fishes which are important sources of nutrients. It caused colon, prostate and mammary cancer in animal bioassay and is classified as a possible human carcinogen. PhIP can cause the formation of DNA adducts and a mutagen, and a genotoxicity mode of action is relevant to human. Daily dietary intakes of PhIP through consumption of the high-temperature processed meats and fishes have been of great concerns. Therefore, this study was aimed to perform a probabilistic cancer risk assessment on PhIP due to daily consumption of these meats and fishes for the Taiwanese population. Dose-response modeling was performed with the Benchmark dose software for PhIP, a BMDL10 at 0.248 (mg/kg-day) was adopted for species extrapolation to assess a cancer-slope factor 0.4029(kg-day/mg). PhIP concentrations in meats and fishes cooked at different methods were cited from literatures. Questionnaires were used to collect the frequency consuming these meats and fishes from 123 study subjects to adjust the intake rates of these meats and fishes from National survey data. Probabilistic assessment of cancer risk and margin of exposure (MOE) was conducted by using the Monte Carlo simulation with the Crystal Ball software. The results reveal that a mean cancer risk is 4.64 x10(-6), and the bound of its upper 95th confidence interval is 1.58x10(-5), and the mean MOE is 270,000, and its lower bound 95th confidence interval is 10,000. M3-I.2 Liu, X; Saat, MR*; Barkan, CPL; University of Illinois at Urbana-Champaign; mohdsaat@illinois.edu Alternative Strategies to Positive Train Control (PTC) for Reducing Hazardous Materials Transportation Risk The Rail Safety Improvement Act of 2008 requires railroads to implement Positive Train Control (PTC) on most lines transporting Toxic Inhalation Hazard (TIH) materials before 31 December 2015. The motivation for this requirement is the belief that by so doing, the likelihood of accidents in which TIH materials would be released would be reduced. However, the particular types of accidents that PTC can prevent comprise only a small percentage of the total accidents with the potential to result in a TIH release. Association of American Railroads (AAR) estimates that these PTC-preventable accidents (PPA) are less than 4% of total mainline accidents. Meanwhile, implementation of PTC is extremely costly. Cost benefit analysis of the PTC rule by Federal Railroad Administration (FRA) indicates that the railroads will incur approximately $20 in PTC costs for each $1 in PTC safety benefit. Consequently, the industry believes that there are other, more cost-effective means of reducing the risk of TIH accidents. This study identified a set of the most promising potential alternative strategies to PTC, and quantitatively assess their potential to reduce TIH transportation risk. P.54 Liu, SY*; Chang, CS; Chung, YC; Chen, CC; Wu, KY; National Taiwan University; r01841027@ntu.edu.tw Probabilistic Cancer Risk Assessment for Aflatoxin B 1 with Bayesian Statistics Markov Chain Monte Carlo Simulation Aflatoxins are found present in nuts, peanuts, corns, spices, traditional Chinese medicine, maize and rice. Particularly, aflatoxin B1 has been shown to induce liver cancer (hepatocellular carcinomaor ,HCC) in many species of animals and is classified as a human carcinogen by IARC. Exposure to aflatoxin B1 through food consumption is considered as a risk factor for hepatocellular carcinoma (HCC) and could cause synergetic effects to the infection of hepatitis B virus. However, the available residues in foods are very limited, and the intake rates of foods containing aflatoxin B1 are very uncertain. Therefore, the aim of this study was to perform probabilistic cancer risk assessment for aflatoxin B1 with Bayesain statistics coupled with Marko chain Monte Carlo simulation (BS-MCMC) to reduce uncertainty in the distributions of aflatoxin B1 residues and the intakes. The aflatoxin B1 residue data was cited from official reports of routine monitoring data published by Taiwan Food and Drug Administration. Questionnaires were used to collect the frequency of consuming these foods containing aflatoxin B1 from 124 study subjects. A cancer slope factor, 0.128 (g/kg/day)-1, was assessed with the Benchmark dose software and linear extrapolation. These data were used as prior information for BS-MCMC modeling. Our results reveal that the cancer risk was 2.642.07 x10-7 for the HBsAg (-) population and 6.755.29 x10-6 for the HBsAg (+) population. These results suggest that reduction of aflatoxin B1 exposure is necessary for the HBsAg (+) population. W3-E.1 Liu, CL*; Luke, NL; CDM Smith; liush@cdmsmith.com Application of Lead and Arsenic Bioavailability in Human Health Risk Assessment for a Sediment Site Lead smelting slag was used to construct seawalls and jetties in a waterfront park approximately 40 years ago and battery casing wastes were disposed at the site. As a result, soil, groundwater, surface water and sediment have been contaminated with lead and arsenic. To evaluate the physical and chemical characteristics of lead and arsenic detected at the site and to determine the degree to which lead and arsenic are available for uptake into the human body, a site-specific in-vitro bioavailability and speciation study was performed. The in-vitro bioavailability test involved a laboratory procedure that is designed to mimic some of the conditions of the human digestive tract. Quantitative electron microprobe analysis (EMPA) was used to determine chemical speciation, particle size distribution, association of the metal-bearing forms, frequency of occurrence, and relative mass. Results of the in-vitro study indicated that bioavailability of lead and arsenic varied widely among different samples, both within and across each area. The relative bioavailability for lead ranged from 12% to 84% and averaged about 56%. Similar to lead, in-vitro bioaccessibility for arsenic was also highly variable, ranging from 0.3% to 63%, with an average of 14%. The EMPA study revealed that lead and arsenic were mainly associated with iron oxyhydroxide, which is expected to be moderately bioavailable. Site-specific bioavailability factors were developed that resulted in more realistic human health risk characterization results and remediation goals. December 8-11, 2013 - Baltimore, MD
SRA 2013 Annual Meeting Abstracts M3-I.1 Locke, MS; Pipeline and Hazardous Materials Safety Administration; michael.locke@dot.gov A case study in estimating mitigated risk for safety regulators: Hazardous materials transportation Government oversight of industrial hazards is focused on the prevention and diminution of negative consequences (chiefly harm to humans, as well as environmental and property damage or loss), at times evaluating systemic performance only up to the point of judging whether the total magnitude of said consequences was greater or less than the previous year. In fields such as commercial transportation of dangerous goods, it can be difficult to assess how much of this annual variation would be preventable with further investment versus what is simply attributable to the inherent, residual risk of a multimodal, human-designed and human–run system. Presenting this data relative to trends in economic activity provides more context but is complicated by the often-fragmentary nature of exposure data, with volumes of material shipped being broadly surveyed only once every five years. Altogether, however, this information only gives part of the picture: failures of risk management. The U.S. Pipeline and Hazardous Materials Safety Administration, in the continual process of self-assessment, is developing methods for capturing estimates of successfully mitigated risk—that is, the potential consequences averted through purposeful intervention. This initiative intends to explore questions including: How or from when do we determine baseline risk? Can we decompose or partition the effects of government interventions such as regulations, outreach, and enforcement? What is the return on investment of a dollar spent on safety oversight? and How do we avoid double-counting benefits, i.e., saving the same life over again with every new regulation? T2-K.1 Lofstedt, R; Kings College London; ragnar.lofstedt@kcl.ac.uk The substitution principle in chemical regulation: A constructive critique The substitution principle is one of the building blocks of modern day chemical regulation as highlighted in the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. But what is the substitution principle, what is the history of its use and how do relevant authorities and regulatory actors view it? This article addresses these questions and is based on a grey literature review and 90 in-depth face-to-face formal and informal interviews with leading policy makers in Europe, with a specific focus on Scandinavia. The paper shows that the substitution principle is a surprisingly under researched topic and that there is no clear consensus on how to best apply the principle. The penultimate section puts forward a series of recommendations with regard to the use of the substitution principle which European policy makers and regulators may wish to adop W4-C.4 Long, KL; Nielsen, JM; Ramacciotti, FC*; Sandvig, RM; Song, S; ENVIRON International Corporation; framacciotti@environcorp.com A Risk Assessment Approach that Facilitates Site Redevelopment and Remediation When Future Site Uses are Uncertain Traditional approaches to site risk assessments are often not capable of supporting cleanup decisions for sites where future uses are still being decided because these approaches are based on defined exposure scenarios and exposure units that correspond to the future uses. At the same time, site owners or developers are often reluctant to make decisions about future uses without knowing the potential health risks and remediation costs associated with different future use options. This presentation describes a risk assessment approach that we have developed and applied at a number of sites to overcome these barriers to site redevelopment and remediation decisions. Our approach facilitates site decisions by conceptualizing every sample location as a potential exposure unit and evaluating the health risks and remediation costs for all future site uses under consideration at every potential exposure unit. The massive amounts of risk and remediation estimates generated from this approach are mapped in GIS to help stakeholders visualize the spatial distribution of health risks and the areas that would need remediation under all possible future use scenarios under consideration. By making the key consequences of future use options accessible to stakeholders, this approach not only overcomes barriers to decisions but also helps stakeholder optimize between site redevelopment benefits and remediation costs. W4-A.2 Loomis, D*; Straif, K; International Agency for Research on Cancer; loomisd@iarc.fr Evaluation of Causality in the IARC Monographs The IARC Monographs identify causes of cancer in the human environment. Since 1971 over 900 agents have been evaluated, with more than 100 classified as carcinogenic to humans and over 300 as probably or possibly carcinogenic. Initially the Monographs focused on environmental and occupational exposures to chemicals, but have expanded to other types of agents, such as personal habits, drugs and infections. The process of causal inference used for IARC’s evaluations is laid out in the Preamble to the Monographs. Working groups of invited experts evaluate human, animal and mechanistic evidence and reach a consensus evaluation of carcinogenicity. Human and animal cancer data are first assessed separately according to criteria established in the Preamble. The strength of the evidence for causation is categorised as Sufficient, Limited, Inadequate, or Suggesting lack of carcinogenicity. To arrive at an overall evaluation, the Working Group considers the totality of the evidence and assigns agents to one of 4 causal groups: 1 Carcinogenic to Humans; 2A Probably carcinogenic to humans; 2B Possibly carcinogenic to humans; 3 Not classifiable as to carcinogenicity to humans, or 4 Probably not carcinogenic to humans. The evaluation criteria reflect the Precautionary Principle in that sufficient evidence of carcinogenicity in animals can be used to classify an agent as possibly carcinogenic to humans when human data are inadequate. Mechanistic evidence can be also invoked to upgrade an evaluation in the absence of adequate human cancer data. Alternatively, strong evidence that a relevant mechanism is absent in humans can downgrade an evaluation based on animal cancer data. Comprehensive assessment of the evidence according to established causal criteria has made the Monographs an authoritative source for agencies and researchers worldwide. While the process described here is one of hazard identification, the Preamble also has scope for characterising risk quantitatively. December 8-11, 2013 - Baltimore, MD
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