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Sample records for risk assessment assays

  1. Mind the gap: Concerns using endpoints from endocrine screening assays in risk assessment.

    PubMed

    Wheeler, James R; Weltje, Lennart; Green, Richard M

    2014-08-01

    Endocrine screening assays not only provide mechanistic information on the potential of a substance to interact with the endocrine system, but also data potentially relevant for risk assessment. However, these screening assays have a number of limitations that should be considered before the direct use of such data for risk assessment purposes. This paper discusses the limitations that should be considered for both human and environmental risk assessment. A proposal is made to provide an objective and transparent process in order to consider which endpoint(s) might be incorporated into a risk assessment, and when more definitive studies may be of value. The proposal is complemented with an easy-to-follow flowchart to aid industry scientists and regulators when evaluating the relevance of these data. Such an approach is necessary to ensure the appropriate use of screening data to further our understanding of the eco/toxicological profile of substances undergoing screening. PMID:24887212

  2. Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics.

    PubMed

    Joubert, Marisa K; Deshpande, Meghana; Yang, Jane; Reynolds, Helen; Bryson, Christine; Fogg, Mark; Baker, Matthew P; Herskovitz, Jonathan; Goletz, Theresa J; Zhou, Lei; Moxness, Michael; Flynn, Gregory C; Narhi, Linda O; Jawa, Vibha

    2016-01-01

    An In Vitro Comparative Immunogenicity Assessment (IVCIA) assay was evaluated as a tool for predicting the potential relative immunogenicity of biotherapeutic attributes. Peripheral blood mononuclear cells from up to 50 healthy naïve human donors were monitored up to 8 days for T-cell proliferation, the number of IL-2 or IFN-γ secreting cells, and the concentration of a panel of secreted cytokines. The response in the assay to 10 monoclonal antibodies was found to be in agreement with the clinical immunogenicity, suggesting that the assay might be applied to immunogenicity risk assessment of antibody biotherapeutic attributes. However, the response in the assay is a measure of T-cell functional activity and the alignment with clinical immunogenicity depends on several other factors. The assay was sensitive to sequence variants and could differentiate single point mutations of the same biotherapeutic. Nine mAbs that were highly aggregated by stirring induced a higher response in the assay than the original mAbs before stirring stress, in a manner that did not match the relative T-cell response of the original mAbs. In contrast, mAbs that were glycated by different sugars (galactose, glucose, and mannose) showed little to no increase in response in the assay above the response to the original mAbs before glycation treatment. The assay was also used successfully to assess similarity between multiple lots of the same mAb, both from the same manufacturer and from different manufacturers (biosimilars). A strategy for using the IVCIA assay for immunogenicity risk assessment during the entire lifespan development of biopharmaceuticals is proposed. PMID:27494246

  3. Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics

    PubMed Central

    Joubert, Marisa K.; Deshpande, Meghana; Yang, Jane; Reynolds, Helen; Bryson, Christine; Fogg, Mark; Baker, Matthew P.; Herskovitz, Jonathan; Goletz, Theresa J.; Zhou, Lei; Moxness, Michael; Flynn, Gregory C.; Narhi, Linda O.; Jawa, Vibha

    2016-01-01

    An In Vitro Comparative Immunogenicity Assessment (IVCIA) assay was evaluated as a tool for predicting the potential relative immunogenicity of biotherapeutic attributes. Peripheral blood mononuclear cells from up to 50 healthy naïve human donors were monitored up to 8 days for T-cell proliferation, the number of IL-2 or IFN-γ secreting cells, and the concentration of a panel of secreted cytokines. The response in the assay to 10 monoclonal antibodies was found to be in agreement with the clinical immunogenicity, suggesting that the assay might be applied to immunogenicity risk assessment of antibody biotherapeutic attributes. However, the response in the assay is a measure of T-cell functional activity and the alignment with clinical immunogenicity depends on several other factors. The assay was sensitive to sequence variants and could differentiate single point mutations of the same biotherapeutic. Nine mAbs that were highly aggregated by stirring induced a higher response in the assay than the original mAbs before stirring stress, in a manner that did not match the relative T-cell response of the original mAbs. In contrast, mAbs that were glycated by different sugars (galactose, glucose, and mannose) showed little to no increase in response in the assay above the response to the original mAbs before glycation treatment. The assay was also used successfully to assess similarity between multiple lots of the same mAb, both from the same manufacturer and from different manufacturers (biosimilars). A strategy for using the IVCIA assay for immunogenicity risk assessment during the entire lifespan development of biopharmaceuticals is proposed. PMID:27494246

  4. Immunological Assays as an Opportunity of Assessment of Health Risks of Airborne Particle Mixture Including Nanoparticles

    NASA Astrophysics Data System (ADS)

    Brzicová, Táňa; Lochman, Ivo; Danihelka, Pavel; Lochmanová, Alexandra; Lach, Karel; Mička, Vladimír

    2013-04-01

    The aim of this pilot study was to evaluate perspectives of the assessment of nonspecific biological effects of airborne particulate matter including nanoparticles using appropriate immunological assays. We have selected various in vitro immunological assays to establish an array allowing us to monitor activation of the cell-mediated and humoral response of both the innate and adaptive immunity. To assess comprehensive interactions and effects, the assays were performed in whole blood cultures from healthy volunteers and we used an original airborne particle mixture from high pollution period in Ostrava region representing areas with one of the most polluted air in Europe. Even if certain effects were observed, the results of the immunological assays did not prove significant effects of airborne particles on immune cells' functions of healthy persons. However, obtained data do not exclude health risks of long-term exposure to airborne particles, especially in case of individuals with genetic predisposition to certain diseases or already existing disease. This study emphasizes the in vitro assessment of complex effects of airborne particles in conditions similar to actual ones in an organism exposed to particle mixture present in the polluted air.

  5. Thrombotic risk assessment in antiphospholipid syndrome: the role of new antibody specificities and thrombin generation assay.

    PubMed

    Sciascia, Savino; Baldovino, Simone; Schreiber, Karen; Solfietti, Laura; Radin, Massimo; Cuadrado, Maria J; Menegatti, Elisa; Erkan, Doruk; Roccatello, Dario

    2016-01-01

    Antiphospholipid syndrome (APS) is an autoimmune condition characterized by the presence of antiphospholipid antibodies (aPL) in subjects presenting with thrombosis and/or pregnancy loss. The currently used classification criteria were updated in the international consensus held in Sidney in 2005. Vascular events seem to result of local procoagulative alterations upon triggers influence (the so called "second-hit theory"), while placental thrombosis and complement activation seem to lead to pregnancy morbidity. The laboratory tests suggested by the current classification criteria include lupus anticoagulant, a functional coagulation assay, and anticardiolipin and anti-β2-glycoprotein-I antibodies, generally detected by solid phase enzyme-linked immunosorbent assay. The real challenge for treating physicians is understanding what is the actual weight of aPL in provoking clinical manifestations in each case. As thrombosis has a multi-factorial cause, each patient needs a risk-stratified approach. In this review we discuss the role of thrombotic risk assessment in primary and secondary prevention of venous and arterial thromboembolic disease in patients with APS, focusing on new antibody specificities, available risk scoring models and new coagulation assays. PMID:27429595

  6. Evaluation of usefulness of Microbial Assay for Risk Assessment (MARA) in the cyanobacterial toxicity estimation.

    PubMed

    Sieroslawska, Anna

    2014-07-01

    The aim of the study was to elucidate the usefulness of the Microbial Assay for Risk Assessment (MARA) to evaluate toxicity in samples containing cyanobacterial products. Cyanobacterial extracts with different cyanotoxin contents and pure cyanotoxins-microcystin-LR, cylindrospermopsin and anatoxin-a-were tested. On the basis of the microbial reaction, MARA indicated only slight or no toxicity in the studied extracts. Similarly, no or low toxicity of pure toxins was detected at the concentrations used (up to 10 μg/ml). Weak relationships between the reactions of individual organisms exposed to cyanotoxin-containing extracts and to the same pure toxins were observed. On the other hand, inhibition of some organisms, such as Pichia anomalia, whose growth was not impacted by pure cyanotoxins, indicated the presence of other biologically active compounds in the studied extracts. In conclusion, MARA assay is not enough sensitive to be used as a good tool for cyanotoxin screening. It may, however, be applied in searching for antimicrobial/antifungal cyanobacteria-derived compounds. PMID:24682641

  7. Can Physiological Endpoints Improve the Sensitivity of Assays with Plants in the Risk Assessment of Contaminated Soils?

    PubMed Central

    Gavina, Ana; Antunes, Sara C.; Pinto, Glória; Claro, Maria Teresa; Santos, Conceição; Gonçalves, Fernando; Pereira, Ruth

    2013-01-01

    Site-specific risk assessment of contaminated areas indicates prior areas for intervention, and provides helpful information for risk managers. This study was conducted in the Ervedosa mine area (Bragança, Portugal), where both underground and open pit exploration of tin and arsenic minerals were performed for about one century (1857 – 1969). We aimed at obtaining ecotoxicological information with terrestrial and aquatic plant species to integrate in the risk assessment of this mine area. Further we also intended to evaluate if the assessment of other parameters, in standard assays with terrestrial plants, can improve the identification of phytotoxic soils. For this purpose, soil samples were collected on 16 sampling sites distributed along four transects, defined within the mine area, and in one reference site. General soil physical and chemical parameters, total and extractable metal contents were analyzed. Assays were performed for soil elutriates and for the whole soil matrix following standard guidelines for growth inhibition assay with Lemna minor and emergence and seedling growth assay with Zea mays. At the end of the Z. mays assay, relative water content, membrane permeability, leaf area, content of photosynthetic pigments (chlorophylls and carotenoids), malondialdehyde levels, proline content, and chlorophyll fluorescence (Fv/Fm and ΦPSII) parameters were evaluated. In general, the soils near the exploration area revealed high levels of Al, Mn, Fe and Cu. Almost all the soils from transepts C, D and F presented total concentrations of arsenic well above soils screening benchmark values available. Elutriates of several soils from sampling sites near the exploration and ore treatment areas were toxic to L. minor, suggesting that the retention function of these soils was seriously compromised. In Z. mays assay, plant performance parameters (other than those recommended by standard protocols), allowed the identification of more phytotoxic soils. The

  8. Integrated cryptosporidium assay to determine oocyst density, infectivity, and genotype for risk assessment of source and reuse water.

    PubMed

    King, Brendon; Fanok, Stella; Phillips, Renae; Swaffer, Brooke; Monis, Paul

    2015-05-15

    Cryptosporidium continues to be problematic for the water industry, with risk assessments often indicating that treatment barriers may fail under extreme conditions. However, risk analyses have historically used oocyst densities and not considered either oocyst infectivity or species/genotype, which can result in an overestimation of risk if the oocysts are not human infective. We describe an integrated assay for determining oocyst density, infectivity, and genotype from a single-sample concentrate, an important advance that overcomes the need for processing multiple-grab samples or splitting sample concentrates for separate analyses. The assay incorporates an oocyst recovery control and is compatible with standard primary concentration techniques. Oocysts were purified from primary concentrates using immunomagnetic separation prior to processing by an infectivity assay. Plate-based cell culture was used to detect infectious foci, with a monolayer washing protocol developed to allow recovery and enumeration of oocysts. A simple DNA extraction protocol was developed to allow typing of any wells containing infectious Cryptosporidium. Water samples from a variety of source water and wastewater matrices, including a semirural catchment, wastewater, an aquifer recharge site, and storm water, were analyzed using the assay. Results demonstrate that the assay can reliably determine oocyst densities, infectivity, and genotype from single-grab samples for a variety of water matrices and emphasize the varying nature of Cryptosporidium risk extant throughout source waters and wastewaters. This assay should therefore enable a more comprehensive understanding of Cryptosporidium risk for different water sources, assisting in the selection of appropriate risk mitigation measures. PMID:25769833

  9. Integrated Cryptosporidium Assay To Determine Oocyst Density, Infectivity, and Genotype for Risk Assessment of Source and Reuse Water

    PubMed Central

    King, Brendon; Fanok, Stella; Phillips, Renae; Swaffer, Brooke

    2015-01-01

    Cryptosporidium continues to be problematic for the water industry, with risk assessments often indicating that treatment barriers may fail under extreme conditions. However, risk analyses have historically used oocyst densities and not considered either oocyst infectivity or species/genotype, which can result in an overestimation of risk if the oocysts are not human infective. We describe an integrated assay for determining oocyst density, infectivity, and genotype from a single-sample concentrate, an important advance that overcomes the need for processing multiple-grab samples or splitting sample concentrates for separate analyses. The assay incorporates an oocyst recovery control and is compatible with standard primary concentration techniques. Oocysts were purified from primary concentrates using immunomagnetic separation prior to processing by an infectivity assay. Plate-based cell culture was used to detect infectious foci, with a monolayer washing protocol developed to allow recovery and enumeration of oocysts. A simple DNA extraction protocol was developed to allow typing of any wells containing infectious Cryptosporidium. Water samples from a variety of source water and wastewater matrices, including a semirural catchment, wastewater, an aquifer recharge site, and storm water, were analyzed using the assay. Results demonstrate that the assay can reliably determine oocyst densities, infectivity, and genotype from single-grab samples for a variety of water matrices and emphasize the varying nature of Cryptosporidium risk extant throughout source waters and wastewaters. This assay should therefore enable a more comprehensive understanding of Cryptosporidium risk for different water sources, assisting in the selection of appropriate risk mitigation measures. PMID:25769833

  10. Potential of the microbial assay for risk assessment (MARA) for assessing ecotoxicological effects of herbicides to non-target organisms.

    PubMed

    Fai, Patricia Bi Asanga; Mbida, Mpoame; Demefack, Jean Marc; Yamssi, Cedric

    2015-11-01

    Many microbiotests that have been proposed for use in the risk assessment of environmental pollutants have the drawback of lacking relevant published data on various aspects of their test application possibilities and therefore do not receive the regulatory recognition which they may deserve. The MARA bioassay lacks published data for many relevant environmental pollutants, particularly pesticides and this may limit its use in regulatory framework. The present study has assessed the sensitivity of the MARA bioassay relative to other established bioassays (Daphnia magna and Oreochromis niloticus) to two widely used herbicide formulations: Roundup (having glyphosate as active ingredient) and Herbextra (with the active ingredient being 2,4-dichlorophenoxyacetic acid-2,4-D). Roundup was found to be more toxic than Herbextra in all three bioassays. The D. magna EC50 s obtained for Roundup and Herbextra were respectively 5.55 and 356.61 mg/l while the LC50 s for O. niloticus were 11.30 and 222,28 mg/l respectively. In the case of the MARA bioassay microbial toxic concentrations (MTCs) for individual species ranged from 6.85 to 468 mg/l with an overall mean MTC of 101.82 mg/l for glyphosate and from 74.67 to 13,333 mg/l for 2,4-D giving an overall mean MTC of 2855.88 mg/l. Although the overall MTCs from the MARA bioassay were much higher than the LC50 s and EC50 s from the fish and daphnia bioassays respectively, the most sensitive MARA organism for each of the herbicides had MTCs that were comparable to or lower than the corresponding endpoints from the other bioassays implying that the MARA assay is a potentially useful bioassay for risk assessment of pesticides. PMID:26362569

  11. A combined approach to investigate the toxicity of an industrial landfill's leachate: Chemical analyses, risk assessment and in vitro assays

    SciTech Connect

    Baderna, D.; Maggioni, S.; Boriani, E.; Gemma, S.; Molteni, M.; Bluegreen Biotech Srl ; Lombardo, A.; Colombo, A.; Bordonali, S.; Rotella, G.; Lodi, M.; Benfenati, E.

    2011-05-15

    Solid wastes constitute an important and emerging problem. Landfills are still one of the most common ways to manage waste disposal. The risk assessment of pollutants from landfills is becoming a major environmental issue in Europe, due to the large number of sites and to the importance of groundwater protection. Furthermore, there is lack of knowledge for the environmental, ecotoxicological and toxicological characteristics of most contaminants contained into landfill leacheates. Understanding leachate composition and creating an integrated strategy for risk assessment are currently needed to correctly face the landfill issues and to make projections on the long-term impacts of a landfill, with particular attention to the estimation of possible adverse effects on human health and ecosystem. In the present study, we propose an integrated strategy to evaluate the toxicity of the leachate using chemical analyses, risk assessment guidelines and in vitro assays using the hepatoma HepG2 cells as a model. The approach was applied on a real case study: an industrial waste landfill in northern Italy for which data on the presence of leachate contaminants are available from the last 11 years. Results from our ecological risk models suggest important toxic effects on freshwater fish and small rodents, mainly due to ammonia and inorganic constituents. Our results from in vitro data show an inhibition of cell proliferation by leachate at low doses and cytotoxic effect at high doses after 48 h of exposure. - Research highlights: {yields} We study the toxicity of leachate from a non-hazardous industrial waste landfill. {yields} We perform chemical analyses, risk assessments and in vitro assays on HepG2 cells. {yields} Risk models suggest toxic effects due to ammonia and inorganic constituents. {yields} In vitro assays show that leachate inhibits cell proliferation at low doses. {yields} Leachate can induce cytotoxic effects on HepG2 cells at high doses.

  12. Developing an in vivo toxicity assay for RNAi risk assessment in honey bees, Apis mellifera L.

    PubMed

    Vélez, Ana María; Jurzenski, Jessica; Matz, Natalie; Zhou, Xuguo; Wang, Haichuan; Ellis, Marion; Siegfried, Blair D

    2016-02-01

    Maize plants expressing dsRNA for the management of Diabrotica virgifera virgifera are likely to be commercially available by the end of this decade. Honey bees, Apis mellifera, can potentially be exposed to pollen from transformed maize expressing dsRNA. Consequently, evaluation of the biological impacts of RNAi in honey bees is a fundamental component for ecological risk assessment. The insecticidal activity of a known lethal dsRNA target for D. v. virgifera, the vATPase subunit A, was evaluated in larval and adult honey bees. Activity of both D. v. virgifera (Dvv)- and A. mellifera (Am)-specific dsRNA was tested by dietary exposure to dsRNA. Larval development, survival, adult eclosion, adult life span and relative gene expression were evaluated. The results of these tests indicated that Dvv vATPase-A dsRNA has limited effects on larval and adult honey bee survival. Importantly, no effects were observed upon exposure of Am vATPase-A dsRNA suggesting that the lack of response involves factors other than sequence specificity. The results from this study provide guidance for future RNAi risk analyses and for the development of a risk assessment framework that incorporates similar hazard assessments. PMID:26454117

  13. A combined approach to investigate the toxicity of an industrial landfill's leachate: chemical analyses, risk assessment and in vitro assays.

    PubMed

    Baderna, D; Maggioni, S; Boriani, E; Gemma, S; Molteni, M; Lombardo, A; Colombo, A; Bordonali, S; Rotella, G; Lodi, M; Benfenati, E

    2011-05-01

    Solid wastes constitute an important and emerging problem. Landfills are still one of the most common ways to manage waste disposal. The risk assessment of pollutants from landfills is becoming a major environmental issue in Europe, due to the large number of sites and to the importance of groundwater protection. Furthermore, there is lack of knowledge for the environmental, ecotoxicological and toxicological characteristics of most contaminants contained into landfill leacheates. Understanding leachate composition and creating an integrated strategy for risk assessment are currently needed to correctly face the landfill issues and to make projections on the long-term impacts of a landfill, with particular attention to the estimation of possible adverse effects on human health and ecosystem. In the present study, we propose an integrated strategy to evaluate the toxicity of the leachate using chemical analyses, risk assessment guidelines and in vitro assays using the hepatoma HepG2 cells as a model. The approach was applied on a real case study: an industrial waste landfill in northern Italy for which data on the presence of leachate contaminants are available from the last 11 years. Results from our ecological risk models suggest important toxic effects on freshwater fish and small rodents, mainly due to ammonia and inorganic constituents. Our results from in vitro data show an inhibition of cell proliferation by leachate at low doses and cytotoxic effect at high doses after 48 h of exposure. PMID:21316652

  14. Bridging Functional and Structural Cardiotoxicity Assays Using Human Embryonic Stem Cell-Derived Cardiomyocytes for a More Comprehensive Risk Assessment.

    PubMed

    Clements, Mike; Millar, Val; Williams, Angela S; Kalinka, Sian

    2015-11-01

    More relevant and reliable preclinical cardiotoxicity tests are required to improve drug safety and reduce the cost of drug development. Current in vitro testing strategies predominantly take the form of functional assays to predict the potential for drug-induced ECG abnormalities in vivo. Cardiotoxicity can also be structural in nature, so a full and efficient assessment of cardiac liabilities for new chemical entities should account for both these phenomena. As well as providing a more appropriate nonclinical model for in vitro cardiotoxicity testing, human stem cell-derived cardiomyocytes offer an integrated system to study drug impact on cardiomyocyte structure as well as function. Employing human embryonic stem cell-derived cardiacmyocytes (hESC-CMs) on 3 assay platforms with complementary insights into cardiac biology (multielectrode array assay, electrophysiology; impedance assay, cell movement/beating; and high content analysis assay, subcellular structure) we profiled a panel of 13 drugs with well characterized cardiac liabilities (Amiodarone, Aspirin, Astemizole, Axitinib, AZT, Bepridil, Doxorubicin, E-4031, Mexiletine, Rosiglitazone, Sunitinib, Sibutramine, and Verapamil). Our data show good correlations with previous studies and reported clinical observations. Using multiparameter phenotypic profiling techniques we demonstrate the dynamic relationship that exists between functional and structural toxicity, and the benefits of this more holistic approach to risk assessment. We conclude by showing for the first time how the advent of transparent MEA plate technology enables functional and structural cardiotoxic responses to be recorded from the same cell population. This approach more directly links changes in morphology of the hESC-CMs with recorded electrophysiology signatures, offering even greater insight into the wide range of potential drug impacts on cardiac physiology, with a throughput that is more amenable to early drug discovery. PMID:26259608

  15. Gaining acceptance for the use of in vitro toxicity assays and QIVIVE in regulatory risk assessment.

    PubMed

    Meek, M E Bette; Lipscomb, John C

    2015-06-01

    Testing strategies are anticipated to increasingly rely on in vitro data as a basis to characterize early steps or key events in toxicity at relevant dose levels in human tissues. Such strategies require quantitative in vitro to in vivo extrapolation to characterize dose-response as a basis for comparison with exposure to estimate risk. Current experience in the incorporation of mechanistic and in vitro data in risk assessment is considered here in the context of identified principles to increase the potential for timely acceptance of more progressive and tailored testing strategies by the regulatory community. These principles are outlined as transitioning in a familiar context, tiering to acquire experience and increase confidence, contextual knowledge transfer to facilitate interpretation and communication, coordination and development of expertise and continuing challenge. A proposed pragmatic tiered data driven framework which includes increasing reliance on in vitro data and quantitative in vitro to in vivo extrapolation is considered in the context of these principles. Based on this analysis, possible additional steps that might facilitate timely evolution and potentially, uptake are identified. PMID:25598226

  16. UK approach to assessing assays and filters designed to reduce the risk of transfusion-transmitted vCJD.

    PubMed

    Thomas, S; Turner, M L; Williamson, L M

    2013-09-01

    Three cases of vCJD transmission by blood transfusion have been reported in the UK, and a fourth case discovered at post-mortem. Modelling has been conducted to predict the number of cases that may occur in the future through transfusion, based on estimates of prevalence, infectivity and susceptibility, and a number of steps have been taken to reduce the risk of transmission. These include deferral of previously transfused donors, leucocyte depletion of all components, importation of plasma for certain patient groups and for fractionation, and the collection of the majority of platelets from single donors (by apheresis). However, even with these interventions, some future cases are still predicted. The UK-wide Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) considers the evidence for clinical and cost-effectiveness of any proposed intervention, such as prion assays and filters, and makes recommendations to the governments of the UK. The development of prion assays is challenging as prions do not generate an immune response, do not have nucleic acid and are present in blood in very low concentrations against a high background of normal prion protein. It is critically important that prion assays show high levels of sensitivity and - especially -specificity for a healthy blood donor population. Assessment is impacted by the very short supply of positive human samples, necessitating the use of animal models. Filters that are capable of removing prions from blood components have been developed and CE marked, but it is again necessary to use animal models to study their efficacy. Guidelines have been produced for the assessment of the quality of red cells filtered through these devices, and a clinical safety study has recently been completed. In conclusion, the evaluation of screening assays and prion filters is challenging, time-consuming and costly, but these evaluations are critical to policy making. PMID:23928183

  17. Skin sensitization risk assessment model using artificial neural network analysis of data from multiple in vitro assays.

    PubMed

    Tsujita-Inoue, Kyoko; Hirota, Morihiko; Ashikaga, Takao; Atobe, Tomomi; Kouzuki, Hirokazu; Aiba, Setsuya

    2014-06-01

    The sensitizing potential of chemicals is usually identified and characterized using in vivo methods such as the murine local lymph node assay (LLNA). Due to regulatory constraints and ethical concerns, alternatives to animal testing are needed to predict skin sensitization potential of chemicals. For this purpose, combined evaluation using multiple in vitro and in silico parameters that reflect different aspects of the sensitization process seems promising. We previously reported that LLNA thresholds could be well predicted by using an artificial neural network (ANN) model, designated iSENS ver.1 (integrating in vitro sensitization tests version 1), to analyze data obtained from two in vitro tests: the human Cell Line Activation Test (h-CLAT) and the SH test. Here, we present a more advanced ANN model, iSENS ver.2, which additionally utilizes the results of antioxidant response element (ARE) assay and the octanol-water partition coefficient (LogP, reflecting lipid solubility and skin absorption). We found a good correlation between predicted LLNA thresholds calculated by iSENS ver.2 and reported values. The predictive performance of iSENS ver.2 was superior to that of iSENS ver.1. We conclude that ANN analysis of data from multiple in vitro assays is a useful approach for risk assessment of chemicals for skin sensitization. PMID:24444449

  18. APPLICATION OF FROG EMBRYO TERATOGENESIS ASSAY-XENOPUS TO ECOLOGICAL RISK ASSESSMENT

    EPA Science Inventory

    An expert workshop recently was convened to consider the FETAX (frog embryo teratogenesis assay-Xenopus) as a screening method for identifying the potential development toxicity of single chemicals and chemical mixtures. Comparison of FETAX data with acute toxicity data from tes...

  19. Validation of the cell cycle G2 delay assay in assessing ionizing radiation sensitivity and breast cancer risk

    PubMed Central

    Hill, Jeff W; Tansavatdi, Kristina; Lockett, Kristin L; Allen, Glenn O; Takita, Cristiane; Pollack, Alan; Hu, Jennifer J

    2009-01-01

    Genetic variations in cell cycle checkpoints and DNA repair genes are associated with prolonged cell cycle G2 delay following ionizing radiation (IR) treatment and breast cancer risk. However, different studies reported conflicting results examining the association between post-IR cell cycle delay and breast cancer risk utilizing four different parameters: cell cycle G2 delay index, %G2–M, G2/G0–G1, and (G2/G0–G1)/S. Therefore, we evaluated whether different parameters may influence study results using a data set from 118 breast cancer cases and 225 controls as well as lymphoblastoid and breast cancer cell lines with different genetic defects. Our results suggest that cell cycle G2 delay index may serve as the best parameter in assessing breast cancer risk, genetic regulation of IR-sensitivity, and mutations of ataxia telangiectasia mutated (ATM) and TP53. Cell cycle delay in 21 lymphoblastoid cell lines derived from BRCA1 mutation carriers was not different from that in controls. We also showed that IR-induced DNA-damage signaling, as measured by phosphorylation of H2AX on serine 139 (γ-H2AX) was inversely associated with cell cycle G2 delay index. In summary, the cellular responses to IR are extremely complex; mutations or genetic variations in DNA damage signaling, cell cycle checkpoints, and DNA repair contribute to cell cycle G2 delay and breast cancer risk. The cell cycle G2 delay assay characterized in this study may help identify subpopulations with elevated risk of breast cancer or susceptibility to adverse effects in normal tissue following radiotherapy. PMID:21188122

  20. ACTIVITIES TO DEVELOP AN INTERIM GUIDANCE FOR MICROARRAY-BASED ASSAYS FOR REGULATORY AND RISK ASSESSMENT APPLICATIONS AT EPA

    EPA Science Inventory

    Abstract for presentation. Advances in genomics will have significant implications for risk assessment policies and regulatory decision making. In 2002, EPA issued its lnterim Policy on Genomics which stated that such data may be considered in the decision making process, but tha...

  1. Assessment of relative bioavailability of heavy metals in soil using in vivo mouse model and its implication for risk assessment compared with bioaccessibility using in vitro assay.

    PubMed

    Kang, Yuan; Pan, Weijian; Liang, Siyun; Li, Ning; Zeng, Lixuan; Zhang, Qiuyun; Luo, Jiwen

    2016-10-01

    There is limited study to simultaneously determine the relative bioavailability of heavy metals such as Cd, Pb, Cu, Cr(VI), and Ni in soil samples. In the present study, the bioaccessibility of heavy metals using in vitro assay was compared with the relative bioavailability of heavy metals using in vivo mouse model. The bioaccessibility of heavy metals ranged from 9.05 ± 0.97 % (Cr) to 42.8 ± 3.52 % (Cd). The uptake profile of heavy metals in soil and solution samples in mouse revealed that the uptake kinetics could be fitted to a two-compartment model. The relative bioavailability of heavy meals ranged from 34.8 ± 7.0 % (Ni) to 131 ± 20.3 % (Cu). Poor correlation between bioaccessibility and relative bioavailability of heavy metals was observed (r (2) = 0.11, p > 0.05). The relative bioavailability of heavy metals was significantly higher than the bioaccessibility of heavy metals (p < 0.05). The present study indicated that the in vitro digestion method should be carefully employed in risk assessment. PMID:26603169

  2. Assessment of the potential genotoxic risk of medicinal Tamarindus indica fruit pulp extract using in vivo assays.

    PubMed

    Silva, F M V; Leite, M F; Spadaro, A C C; Uyemura, S A; Maistro, E L

    2009-01-01

    Tamarindus indica has been used in folk medicine as an antidiabetic, a digestive aid, and a carminative, among other uses. Currently, there is no information in the toxicology literature concerning the safety of T. indica extract. We evaluated the clastogenic and/or genotoxic potential of fruit pulp extract of this plant in vivo in peripheral blood and liver cells of Wistar rats, using the comet assay, and in bone marrow cells of Swiss mice, using the micronucleus test. The extract was administered by gavage at doses of 1000, 1500 and 2000 mg/kg body weight. Peripheral blood and liver cells from Wistar rats were collected 24 h after treatment, for the comet assay. The micronucleus test was carried out in bone marrow cells from Swiss mice collected 24 h after treatment. The extract made with T. indica was devoid of clastogenic and genotoxic activities in the cells of the rodents, when administered orally at these three acute doses. PMID:19768670

  3. Biosensor assay of neuropathy target esterase in whole blood as a new approach to OPIDN risk assessment: review of progress.

    PubMed

    Makhaeva, Galina F; Malygin, Vladimir V; Strakhova, Nadezhda N; Sigolaeva, Larisa V; Sokolovskaya, Lidia G; Eremenko, Arkady V; Kurochkin, Ilya N; Richardson, Rudy J

    2007-04-01

    Organophosphates (OPs) that inhibit neuropathy target esterase (NTE) with subsequent ageing can produce OP-induced delayed neuropathy (OPIDN). NTE inhibition in lymphocytes can be used as a biomarker of exposure to neuropathic OPs. An electrochemical method was developed to assay NTE in whole blood. The high sensitivity of the tyrosinase carbon-paste biosensors for the phenol produced by hydrolysis of the substrate, phenyl valerate, allowed NTE activity to be measured in diluted samples of whole blood, which cannot be done using the standard colorimetric assay. The biosensor was used to establish correlations of NTE inhibitions in blood with that in lymphocytes and brain after dosing hens with a neuropathic OP. The results of further studies demonstrated that whole blood NTE is a reliable biomarker of neuropathic OPs for up to 96 hours after exposure. These validation results suggest that the biosensor NTE assay for whole blood could be developed to measure human exposure to neuropathic OPs as a predictor of OPIDN. The small blood volume required (100 microL), simplicity of sample preparation and rapid analysis times indicate that the biosensor should be useful in biomonitoring and epidemiological studies. The present paper is an overview of our previous and ongoing work in this area. PMID:17615108

  4. Comparison of cytomegalovirus (CMV) enzyme-linked immunosorbent spot and CMV quantiferon gamma interferon-releasing assays in assessing risk of CMV infection in kidney transplant recipients.

    PubMed

    Abate, Davide; Saldan, Alda; Mengoli, Carlo; Fiscon, Marta; Silvestre, Cristina; Fallico, Loredana; Peracchi, Marta; Furian, Lucrezia; Cusinato, Riccardo; Bonfante, Luciana; Rossi, Barbara; Marchini, Francesco; Sgarabotto, Dino; Rigotti, Paolo; Palù, Giorgio

    2013-08-01

    Assessing cytomegalovirus (CMV)-specific cell-mediated immunity (CMI) represents an appealing strategy for identifying transplant recipients at risk of infection. In this study, we compared two gamma interferon-releasing assays (IGRAs), Quantiferon-CMV and CMV enzyme-linked immunosorbent spot (ELISPOT), to determine the ability of each test to predict protective CMV-specific T-cell responses. Two hundred twenty-one Quantiferon-CMV and ELISPOT tests were conducted on 120 adult kidney transplant recipients (KTRs), including 100 CMV-seropositive transplant recipients (R+) and 20 CMV-seronegative transplant recipients of a CMV-positive donor (D+/R-). As a control cohort, 39 healthy adult subjects (including 33 CMV-seropositive and 6 CMV-seronegative subjects) were enrolled. CMV IgG serology was used as a reference for both tests. In the CMV-seropositive individuals, the ELISPOT and Quantiferon-CMV assays provided 46% concordance with the serology, 12% discordance, 18% disagreement between ELISPOT or Quantiferon-CMV and the serology, and 24% gray areas when one or both tests resulted in weak positives. None of the CMV-seronegative subjects showed detectable responses in the ELISPOT or the Quantiferon-CMV test. In transplant recipients, both the ELISPOT and Quantiferon-CMV assays positively correlated with each other and negatively correlated with CMV DNAemia in a significant way (P<0.05). During the antiviral prophylaxis, all 20 D+/R- KTRs we examined displayed undetectable Quantiferon-CMV and ELISPOT results, and there was no evidence of CMV seroconversion. The receiving operator curve (ROC) statistical analysis revealed similar specificities and sensitivities in predicting detectable viremia (areas under the curve [AUC], 0.66 and 0.62 for Quantiferon-CMV and ELISPOT, respectively). ELISPOT and Quantiferon-CMV values of >150 spots/200,000 peripheral blood mononuclear cells (PBMCs) and >1 to 6 IU gamma interferon (IFN-γ) were associated with protection from CMV

  5. Risk assessment of PCDD/Fs levels in human tissues related to major food items based on chemical analyses and micro-EROD assay.

    PubMed

    Tsang, H L; Wu, S C; Wong, C K C; Leung, C K M; Tao, S; Wong, M H

    2009-10-01

    Nine groups of food items (freshwater fish, marine fish, pork, chicken, chicken eggs, leafy, non-leafy vegetables, rice and flour) and three types of human samples (human milk, maternal serum and cord serum) were collected for the analysis of PCDD/Fs. Results of chemical analysis revealed PCDD/Fs concentrations (pg g(-1) fat) in the following ascending order: pork (0.289 pg g(-1) fat), grass carp (Ctenopharyngodon idellus) (freshwater fish) (0.407), golden thread (Nemipterus virgatus) (marine fish) (0.511), chicken (0.529), mandarin fish (Siniperca kneri) (marine fish) (0.535), chicken egg (0.552), and snubnose pompano (Trachinotus blochii) (marine fish) (1.219). The results of micro-EROD assay showed relatively higher PCDD/Fs levels in fish (2.65 pg g(-1) fat) when compared with pork (0.47), eggs (0.33), chicken (0.13), flour (0.07), vegetables (0.05 pg g(-1) wet wt) and rice (0.05). The estimated average daily intake of PCDD/Fs of 3.51 pg EROD-TEQ/kg bw/day was within the range of WHO Tolerable Daily Intake (1-4 pg WHO-TEQ/kg bw/day) and was higher than the Provisional Tolerable Daily Intake (PMTL) (70 pg for dioxins and dioxin-like PCBs) recommended by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) [Joint FAO/WHO Expert Committee on Food Additives (JECFA), Summary and conclusions of the fifty-seventh meeting, JECFA, 2001.]. Nevertheless, the current findings were significantly lower than the TDI (14 pg WHO-TEQ/kg/bw/day) recommended by the Scientific Committee on Food of the Europe Commission [European Scientific Committee on Food (EU SCF), Opinions on the SCF on the risk assessment of dioxins and dioxin-like PCBs in food, 2000.]. However, it should be noted that micro-EROD assay overestimates the PCDD/Fs levels by 2 to 7 folds which may also amplify the PCDD/Fs levels accordingly. Although the levels of PCDD/Fs obtained from micro-EROD assay were much higher than those obtained by chemical analysis by 2 to 7 folds, it provides a cost-effective and

  6. RISK ASSESSMENT AND RISK MANAGEMENT

    EPA Science Inventory

    Risk assessment of mixtures of environmental pollutants has become a subject of increasing public and regulatory concern. ypically, assessment of mixtures has been based on aggregating the risks associated with the individual constituents of the mixture. his approach does not con...

  7. Nondestructive assay confirmatory assessment experiments: mixed oxide

    SciTech Connect

    Lemming, J.F.

    1980-04-30

    The confirmatory assessment experiments demonstrate traceable nondestructive assay (NDA) measurements of plutonium in mixed oxide powder using commercially available spontaneous-fission assay systems. The experiments illustrate two major concepts: the production of calibration materials using calorimetric assay, and the use of paired measurements for measurement assurance. Two batches of well-characterized mixed oxide powder were used to establish the random and systematic error components. The major components of an NDA measurement assurance technique to establish and maintain traceability are identified and their functions are demonstrated. 20 refs., 10 figs., 10 tabs.

  8. Heart Attack Risk Assessment

    MedlinePlus

    ... Pressure Tools & Resources Stroke More Heart Attack Risk Assessment Updated:May 31,2016 We're sorry, but ... Can You Recognize a Heart Attack? Quiz Risk Assessment Patient Information Sheets: Heart Attack Heart Attack Personal ...

  9. Teaching Risk Assessment.

    ERIC Educational Resources Information Center

    Oravec, Jo Ann

    2000-01-01

    Risk management training cannot prevent hazards, but can help students learn to deal with them more efficiently. A risk-assessment and risk-communication approach to dealing with computer problems can be applied in the business classroom. (JOW)

  10. Risk Assessment: Evidence Base

    NASA Technical Reports Server (NTRS)

    Johnson-Throop, Kathy A.

    2007-01-01

    Human systems PRA (Probabilistic Risk Assessment: a) Provides quantitative measures of probability, consequence, and uncertainty; and b) Communicates risk and informs decision-making. Human health risks rated highest in ISS PRA are based on 1997 assessment of clinical events in analog operational settings. Much work remains to analyze remaining human health risks identified in Bioastronautics Roadmap.

  11. Digestion Assays in Allergenicity Assessment of Transgenic Proteins

    PubMed Central

    Herman, Rod A.; Storer, Nicholas P.; Gao, Yong

    2006-01-01

    The food-allergy risk assessment for transgenic proteins expressed in crops is currently based on a weight-of-evidence approach that holistically considers multiple lines of evidence. This approach recognizes that no single test or property is known to distinguish allergens from nonallergens. The stability of a protein to digestion, as predicted by an in vitro simulated gastric fluid assay, currently is used as one element in the risk assessment process. A review of the literature on the use of the simulated gastric fluid assay to predict the allergenic status of proteins suggests that more extensive kinetic studies with well-characterized reference proteins are required before the predictive value of this assay can be adequately judged. PMID:16882518

  12. Combination of retinyl palmitate and UV-filters: phototoxic risk assessment based on photostability and in vitro and in vivo phototoxicity assays.

    PubMed

    Benevenuto, Carolina Gomes; Guerra, Lucas Offenbecker; Gaspar, Lorena Rigo

    2015-02-20

    This study aimed to assess the phototoxic potential of combined UV-filters and retinyl palmitate (RP) in the presence or not of bemotrizinol (BMTZ), employing photostability and in vitro and in vivo phototoxicity assays. The formulations tested contained octocrylene (OCT), octyl methoxycinnamate (OMC), benzophenone-3 (BZP-3) and RP (photostable) or octocrylene (OCT), octyl methoxycinnamate (OMC), avobenzone (AVO) and RP (less photostable). Both formulations were supplemented with bemotrizinol. Photostability was evaluated by exposing, or not, formulations spread on a glass plate to UVA/UVB irradiation. The resulting products were quantified by HPLC analysis. In vitro phototoxicity of UV-filters and combinations were evaluated using 3T3 viable monolayer fibroblast cultures submitted, or not, to irradiation according to OECD TG 432. In vivo photoallergy and photoxicity were assessed by clinical studies (photopatch test). Photostability assays showed that UV-filter bemotrizinol was a better photostabilizer for RP/benzophenone-3 than for RP/avobenzone. The in vitro phototoxicity of the combination RP/avobenzone was reduced by bemotrizinol. Clinical studies did not indicate phototoxic or photoallergenic potentials in all formulations tested. It is concluded that the 3T3 NRU phototoxicity test may be considered a supplementary assay in formulation developments, since it can detect chemically unstable and potentially phototoxic combinations. However, extrapolation of in vitro positive results to human photopatch tests may be performed only to a limited extent. PMID:25533240

  13. Schedule Risk Assessment

    NASA Technical Reports Server (NTRS)

    Smith, Greg

    2003-01-01

    Schedule risk assessments determine the likelihood of finishing on time. Each task in a schedule has a varying degree of probability of being finished on time. A schedule risk assessment quantifies these probabilities by assigning values to each task. This viewgraph presentation contains a flow chart for conducting a schedule risk assessment, and profiles applicable several methods of data analysis.

  14. GM Risk Assessment

    NASA Astrophysics Data System (ADS)

    Sparrow, Penny A. C.

    GM risk assessments play an important role in the decision-making process surrounding the regulation, notification and permission to handle Genetically Modified Organisms (GMOs). Ultimately the role of a GM risk assessment will be to ensure the safe handling and containment of the GMO; and to assess any potential impacts on the environment and human health. A risk assessment should answer all ‘what if’ scenarios, based on scientific evidence.

  15. GM Risk Assessment.

    PubMed

    Sparrow, Penny A C

    2009-01-01

    GM risk assessments play an important role in the decision-making process surrounding the regulation, notification and permission to handle Genetically Modified Organisms (GMOs). Ultimately the role of a GM risk assessment will be to ensure the safe handling and containment of the GMO; and to assess any potential impacts on the environment and human health. A risk assessment should answer all 'what if' scenarios, based on scientific evidence. This chapter sets out to provide researchers with helpful guidance notes on producing their own GM risk assessment. While reference will be made to UK and EU regulations, the underlying principles and points to consider are generic to most countries. PMID:19009454

  16. Strategic Risk Assessment

    NASA Technical Reports Server (NTRS)

    Derleth, Jason; Lobia, Marcus

    2009-01-01

    This slide presentation provides an overview of the attempt to develop and demonstrate a methodology for the comparative assessment of risks across the entire portfolio of NASA projects and assets. It includes information about strategic risk identification, normalizing strategic risks, calculation of relative risk score, and implementation options.

  17. Risk Assessment Overview

    NASA Technical Reports Server (NTRS)

    Prassinos, Peter G.; Lyver, John W., IV; Bui, Chinh T.

    2011-01-01

    Risk assessment is used in many industries to identify and manage risks. Initially developed for use on aeronautical and nuclear systems, risk assessment has been applied to transportation, chemical, computer, financial, and security systems among others. It is used to gain an understanding of the weaknesses or vulnerabilities in a system so modification can be made to increase operability, efficiency, and safety and to reduce failure and down-time. Risk assessment results are primary inputs to risk-informed decision making; where risk information including uncertainty is used along with other pertinent information to assist management in the decision-making process. Therefore, to be useful, a risk assessment must be directed at specific objectives. As the world embraces the globalization of trade and manufacturing, understanding the associated risk become important to decision making. Applying risk assessment techniques to a global system of development, manufacturing, and transportation can provide insight into how the system can fail, the likelihood of system failure and the consequences of system failure. The risk assessment can identify those elements that contribute most to risk and identify measures to prevent and mitigate failures, disruptions, and damaging outcomes. In addition, risk associated with public and environment impact can be identified. The risk insights gained can be applied to making decisions concerning suitable development and manufacturing locations, supply chains, and transportation strategies. While risk assessment has been mostly applied to mechanical and electrical systems, the concepts and techniques can be applied across other systems and activities. This paper provides a basic overview of the development of a risk assessment.

  18. ECOLOGICAL RISK ASSESSMENT WORKSHOP

    EPA Science Inventory

    As ecological risk assessment evolves, it is moving beyond focus on single species toward addressing multiple species and their interactions, and from assessing effects of simple chemical toxicity to the cumulative impacts of multiple interacting chemical, physical, and biologica...

  19. Diabetic foot risk assessment.

    PubMed

    Woodbury, M Gail

    2016-05-01

    Diabetes is a serious chronic disease that results in foot complications for many people world-wide. In 2014, the World Health Organization estimated the global prevalence of diabetes in adults to be 9%. To ascertain the risk that an individual patient might develop a diabetic foot ulcer that could lead to an amputation, clinicians are strongly encouraged to perform a risk assessment. Monteiro-Soares and Dinis-Ribeiro have presented a new DIAbetic FOot Risk Assessment with the acronym DIAFORA. It is different from other risk assessments in that it predicts the risk of developing both diabetic foot ulcers and amputation specifically. The risk variables were derived by regression analysis based on a data set of 293 patients from a high-risk setting, a Hospital Diabetic Foot Clinic, who had diabetes and a diabetic foot ulcers. Clear descriptions of the risk variables are provided as well as sensitivity, specificity, positive and negative predictive values for the risk categories. As an added benefit, likelihood ratios are provided that will help clinicians determine the risk of amputation for individual patients. Having a risk assessment form is important for clinician use and examples exist. A question is raised about the effectiveness of risk assessment and how effectiveness might be determined. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26825436

  20. Propidium monoazide RTqPCR assays for the assessment of hepatitis A inactivation and for a better estimation of the health risk of contaminated waters.

    PubMed

    Fuster, Noemí; Pintó, Rosa M; Fuentes, Cristina; Beguiristain, Nerea; Bosch, Albert; Guix, Susana

    2016-09-15

    The waterborne transmission of hepatitis A virus (HAV), the main cause of acute hepatitis, is well documented. Recently, two ISO proposals for sensitive determination of this pathogen by RTqPCR in water and food have been published (ISO/TS 15216-1 and ISO/TS 15216-2), and could enable the formulation of regulatory standards for viruses in the near future. However, since detected viral genomes do not always correlate with virus infectivity, molecular approaches need to be optimized to better predict infectivity of contaminated samples. Two methods involving the use of propidium monoazide (PMA), with or without Triton X-100, prior to RTqPCR amplification were optimized and adapted to infer the performance of infectious viral inactivation upon two different water treatments: free chlorine and high temperature. Significant correlations between the decrease of genome copies and infectivity were found for both inactivation procedures. The best procedure to infer chlorine inactivation was the PMA-RTqPCR assay, in which 1, 2 or 3-log genome copies reductions corresponded to reductions of infectious viruses of 2.61 ± 0.55, 3.76 ± 0.53 and 4.92 ± 0.76 logs, respectively. For heat-inactivated viruses, the best method was the PMA/Triton-RTqPCR assay, with a 1, 2 or 3-log genome reduction corresponding to reductions of infectious viruses of 2.15 ± 1.31, 2.99 ± 0.79 and 3.83 ± 0.70 logs, respectively. Finally, the level of damaged virions was evaluated in distinct types of water naturally contaminated with HAV. While most HAV genomes quantified in sewage corresponded to undamaged capsids, the analysis of a river water sample indicated that more than 98% of viruses were not infectious. Although the PMA/Triton-RTqPCR assay may still overestimate infectivity, it is more reliable than the RTqPCR alone and it seems to be a rapid and cost-effective method that can be applied on different types of water, and that it undeniably provides a more accurate measure of the

  1. Cancer Risk Assessment Primer.

    ERIC Educational Resources Information Center

    Aidala, Jim

    1985-01-01

    Describes the scientific basis of cancer risk assessment, outlining the dominant controversies surrounding the use of different methods for identifying carcinogens (short-term tests, animal bioassays, and epidemiological studies). Points out that risk assessment is as much an art as it is a science. (DH)

  2. Landslide risk assessment

    USGS Publications Warehouse

    Lessing, P.; Messina, C.P.; Fonner, R.F.

    1983-01-01

    Landslide risk can be assessed by evaluating geological conditions associated with past events. A sample of 2,4 16 slides from urban areas in West Virginia, each with 12 associated geological factors, has been analyzed using SAS computer methods. In addition, selected data have been normalized to account for areal distribution of rock formations, soil series, and slope percents. Final calculations yield landslide risk assessments of 1.50=high risk. The simplicity of the method provides for a rapid, initial assessment prior to financial investment. However, it does not replace on-site investigations, nor excuse poor construction. ?? 1983 Springer-Verlag New York Inc.

  3. Public Risk Assessment Program

    NASA Technical Reports Server (NTRS)

    Mendeck, Gavin

    2010-01-01

    The Public Entry Risk Assessment (PERA) program addresses risk to the public from shuttle or other spacecraft re-entry trajectories. Managing public risk to acceptable levels is a major component of safe spacecraft operation. PERA is given scenario inputs of vehicle trajectory, probability of failure along that trajectory, the resulting debris characteristics, and field size and distribution, and returns risk metrics that quantify the individual and collective risk posed by that scenario. Due to the large volume of data required to perform such a risk analysis, PERA was designed to streamline the analysis process by using innovative mathematical analysis of the risk assessment equations. Real-time analysis in the event of a shuttle contingency operation, such as damage to the Orbiter, is possible because PERA allows for a change to the probability of failure models, therefore providing a much quicker estimation of public risk. PERA also provides the ability to generate movie files showing how the entry risk changes as the entry develops. PERA was designed to streamline the computation of the enormous amounts of data needed for this type of risk assessment by using an average distribution of debris on the ground, rather than pinpointing the impact point of every piece of debris. This has reduced the amount of computational time significantly without reducing the accuracy of the results. PERA was written in MATLAB; a compiled version can run from a DOS or UNIX prompt.

  4. GAR Global Risk Assessment

    NASA Astrophysics Data System (ADS)

    Maskrey, Andrew; Safaie, Sahar

    2015-04-01

    Disaster risk management strategies, policies and actions need to be based on evidence of current disaster loss and risk patterns, past trends and future projections, and underlying risk factors. Faced with competing demands for resources, at any level it is only possible to priorities a range of disaster risk management strategies and investments with adequate understanding of realised losses, current and future risk levels and impacts on economic growth and social wellbeing as well as cost and impact of the strategy. The mapping and understanding of the global risk landscape has been greatly enhanced by the latest iteration of the GAR Global Risk Assessment and the objective of this submission is to present the GAR global risk assessment which contributed to Global Assessment Report (GAR) 2015. This initiative which has been led by UNISDR, was conducted by a consortium of technical institutions from around the world and has covered earthquake, cyclone, riverine flood, and tsunami probabilistic risk for all countries of the world. In addition, the risks associated with volcanic ash in the Asia-Pacific region, drought in various countries in sub-Saharan Africa and climate change in a number of countries have been calculated. The presentation will share thee results as well as the experience including the challenges faced in technical elements as well as the process and recommendations for the future of such endeavour.

  5. Schedule Risk Assessment

    NASA Technical Reports Server (NTRS)

    Smith, Grego

    2004-01-01

    Schedule Risk Assessment (SRA) determines the probability of finishing on or before a given point in time. This viewgraph presentation introduces the prerequisites, probability distribution curves, special conditions, calculations, and results analysis for SRA.

  6. Schedule Risk Assessment

    NASA Technical Reports Server (NTRS)

    Smith, Greg

    2003-01-01

    Schedule Risk Assessment needs to determine the probability of finishing on or before a given point in time. Task in a schedule should reflect the "most likely" duration for each task. IN reality, each task is different and has a varying degree of probability of finishing within or after the duration specified. Schedule risk assessment attempt to quantify these probabilities by assigning values to each task. Bridges the gap between CPM scheduling and the project's need to know the likelihood of "when".

  7. Added value of molecular assay Xpert MTB/RIF compared to sputum smear microscopy to assess the risk of tuberculosis transmission in a low-prevalence country.

    PubMed

    Opota, O; Senn, L; Prod'hom, G; Mazza-Stalder, J; Tissot, F; Greub, G; Jaton, K

    2016-07-01

    Airborne precautions are required at hospital admission for patients with suspected pulmonary tuberculosis. The isolation is maintained until 3 serially collected sputum smears are acid-fast bacilli negative, a time- and labor-intensive method with limited sensitivity and specificity, which has a great impact on patient flow management. We evaluated the possibility of replacing the result of microscopy by the semiquantitative result of the molecular point-of-care test Xpert MTB/RIF to assess patients' transmission risk to quickly guide airborne isolation decisions in low-endemic countries. The performance of the Xpert MTB/RIF, used as a first-line test, was compared to the results of microscopy for specimens (n=242) collected from May 2010 to December 2014 in Lausanne, Switzerland. The sensitivity and specificity of Xpert MTB/RIF were 91.5% (65/71) and 99.6% (170/171), respectively, vs. 64.8% (46/71) and 94.2% (161/171) for microscopy. Samples with negative Xpert MTB/RIF were all smear negative for Mycobacterium tuberculosis (negative predictive value, 100%). The semiquantitative results of Xpert MTB/RIF-high, medium, low or very low-were found to correlate with acid-fast bacilli detection: positive predictive value of 100% (6/6), 96.5% (27/28), 52.2% (12/23) and 11.1% (1/9) respectively. Finally, when including clinical criteria, we identified 11 smear-negative but Xpert MTB/RIF-positive patients with a significant transmission potential. In conclusion, our data support the introduction of an Xpert MTB/RIF-based strategy as a replacement of smear microscopy for a faster and more accurate management of tuberculosis patients' transmission risk in a low-prevalence country. PMID:27139592

  8. Environmental risk assessment

    SciTech Connect

    MacDonell, M.M.

    1997-10-01

    This paper presents a current overview of the basic elements of environmental risk assessment within the basic four-step process of hazard identification, exposure assessment, toxicity assessment, and risk characterization. These general steps have been applied to assess both human and ecological risks from environmental exposures. Approaches used to identify hazards and exposures are being refined, including the use of optimized field sampling and more representative, rather than conservative,upper-bound estimates. In addition, toxicity data are being reviewed more rigorously as US and European harmonization initiatives gain strength, and the classification of chemicals has become more qualitative to more flexibly accommodate new dose-response information as it is developed. Finally, more emphasis is being placed on noncancer end points, and human and ecological risks are being weighed against each other more explicitly at the risk characterization phase. Recent advances in risk-based decision making reflect the increased transparency of the overall process, with more explicit incorporation of multiple trade-offs. The end result is a more comprehensive life-cycle evaluation of the risks associated with environmental exposures at contaminated sites.

  9. Single concentration loss of activity assay provides an improved assessment of drug-drug interaction risk compared to IC50-shift.

    PubMed

    Wong, Simon G; Lee, Mey; Wong, Bradley K

    2016-11-01

    1. The utility of two abbreviated, higher-throughput assays [IC50-shift and the loss of activity (LOA) assay] to evaluate time-dependent inhibition (TDI) of 24 structurally related compounds was compared. 2. Good correlation (R(2)  = 0.90) between % inhibition and kinact/KI suggested that the LOA assay has utility as an indicator of TDI potential. Weaker correlation was observed for the shifted IC50 (IC50(T = 30)) (R(2) = 0.61) and the fold-shift in IC50 (R(2) = 0.17). 3. Primary mechanism for poor correlation was depletion of active enzyme at concentrations > 1 μM leading to greater than predicted inhibition in the IC50-shift assay. 4. Previously reported strong correlations between IC50(T = 30) and kinact/KI were found to be dependent on potent TDI compounds with kinact/KI > 30; correlation was reduced for moderate inhibitors (kinact/KI < 30). LOA assay maintained good correlation even when strong TDI compounds were excluded. 5. LOA assay (% Inhibition at 30 min, 10 μM) was a good predictor of in vivo DDI (AUCr), providing a graded response with low potential for false negatives or positives. IC50-shift assay had bias for over-predicting in vivo DDI and was more likely to identify false positives. PMID:26956546

  10. Bio Risk Assessment Tool

    SciTech Connect

    Pohl, Phillip

    2004-07-22

    The Biosecurity Risk Assessment Tool (BRAT) is a new type of computer application for the screening-level assessment of risk to dairy operations. BRAT for Dairies is designed to be intuitive and easy to use. Users enter basic data-property address, feed management, employee population, and so on - into the interface. Using these data and rules found in an expert system. BRAT for Dairies consults appropriate sections of its database. The expert system determines the risk implications of the basic data, e.g. diseases are closely tied to pen location with respect to the outside world, When the analysis is complete, BRAT for Dairies evaluates and allocates the risk for each hazard, ranks the risks, and displays the results graphically.

  11. Microbiological Quantitative Risk Assessment

    NASA Astrophysics Data System (ADS)

    Dominguez, Silvia; Schaffner, Donald W.

    The meat and poultry industry faces ongoing challenges due to the natural association of pathogens of concern (e.g., Salmonella, Campylobacter jejuni, Escherichia coli O157:H7) with a variety of domesticated food animals. In addition, pathogens such as Listeria monocytogenes pose a significant cross-contamination risk during further meat and poultry processing, distribution, and storage. Furthermore, the meat and poultry industries are constantly changing with the addition of new products, use of new raw materials, and targeting of new consumer populations, each of which may give rise to potential new risks. National and international regulations are increasingly using a “risk-based” approach to food safety (where the regulatory focus is driven by the magnitude of the risk), so risk assessment is becoming a valuable tool to systematically organize and evaluate the potential public health risk posed by food processing operations.

  12. Ozone Risk Assessment Utilities

    Energy Science and Technology Software Center (ESTSC)

    1999-08-10

    ORAMUS is a user-friendly, menu-driven software system that calculates and displays user-selected risk estimates for health effects attributable to short-term exposure to tropospheric ozone. Inputs to the risk assessment are estimates of exposure to ozone and exposure-response relationships to produce overall risk estimates in the form of probability distributions. Three fundamental models are included: headcount risk, benchmark risk, and hospital admissions. Exposure-response relationships are based on results of controlled human exposure studies. Exposure estimates aremore » based on the EPA''s probabilistic national ambient air quality standards (NAAQS) exposure model, pNEM/Osub3, which simulates air quality associated with attainment of alternative NAAQS. Using ORAMUS, risk results for 27 air quality scenarios, air quality in 9 urban areas, 33 health endpoints, and 4 chronic health endpoints can be calculated.« less

  13. Bio Risk Assessment Tool

    Energy Science and Technology Software Center (ESTSC)

    2004-07-22

    The Biosecurity Risk Assessment Tool (BRAT) is a new type of computer application for the screening-level assessment of risk to dairy operations. BRAT for Dairies is designed to be intuitive and easy to use. Users enter basic data-property address, feed management, employee population, and so on - into the interface. Using these data and rules found in an expert system. BRAT for Dairies consults appropriate sections of its database. The expert system determines the riskmore » implications of the basic data, e.g. diseases are closely tied to pen location with respect to the outside world, When the analysis is complete, BRAT for Dairies evaluates and allocates the risk for each hazard, ranks the risks, and displays the results graphically.« less

  14. Northwest Climate Risk Assessment

    NASA Astrophysics Data System (ADS)

    Mote, P.; Dalton, M. M.; Snover, A. K.

    2012-12-01

    As part of the US National Climate Assessment, the Northwest region undertook a process of climate risk assessment. This process included an expert evaluation of previously identified impacts, their likelihoods, and consequences, and engaged experts from both academia and natural resource management practice (federal, tribal, state, local, private, and non-profit) in a workshop setting. An important input was a list of 11 risks compiled by state agencies in Oregon and similar adaptation efforts in Washington. By considering jointly the likelihoods, consequences, and adaptive capacity, participants arrived at an approximately ranked list of risks which was further assessed and prioritized through a series of risk scoring exercises to arrive at the top three climate risks facing the Northwest: 1) changes in amount and timing of streamflow related to snowmelt, causing far-reaching ecological and socioeconomic consequences; 2) coastal erosion and inundation, and changing ocean acidity, combined with low adaptive capacity in the coastal zone to create large risks; and 3) the combined effects of wildfire, insect outbreaks, and diseases will cause large areas of forest mortality and long-term transformation of forest landscapes.

  15. GM risk assessment.

    PubMed

    Sparrow, P A C

    2010-03-01

    GM risk assessments (GMRAs) play an important role in the decision-making process surrounding the regulation, notification and permission to handle Genetically Modified Organisms (GMOs). Ultimately the role of each GMRA will be able to ensure the safe handling and containment of the GMO; and to asses any potential impacts on the environment and human health. A risk assessment should answer all "what if" scenarios, based on scientific evidence. This article sets out to provide researchers with helpful guidance notes on producing their own GMRA. While reference is made to UK and EU regulations, the underlying principles and points to consider are generic to most countries. PMID:20087690

  16. Biosafety Risk Assessment Model

    SciTech Connect

    2011-05-27

    Software tool based on a structured methodology for conducting laboratory biosafety risk assessments by biosafety experts. Software is based upon an MCDA scheme and uses peer reviewed criteria and weights. The software was developed upon Microsoft’s .net framework. The methodology defines likelihood and consequence of a laboratory exposure for thirteen unique scenarios and provides numerical relative risks for each of the relevant thirteen. The software produces 2-d graphs reflecting the relative risk and a sensitivity analysis which highlights the overall importance of each factor. The software works as a set of questions with absolute scales and uses a weighted additive model to calculate the likelihood and consequence.

  17. Microbial Risk Assessment

    NASA Technical Reports Server (NTRS)

    Ott, C. M.; Mena, K. D.; Nickerson, C.A.; Pierson, D. L.

    2009-01-01

    Historically, microbiological spaceflight requirements have been established in a subjective manner based upon expert opinion of both environmental and clinical monitoring results and the incidence of disease. The limited amount of data, especially from long-duration missions, has created very conservative requirements based primarily on the concentration of microorganisms. Periodic reevaluations of new data from later missions have allowed some relaxation of these stringent requirements. However, the requirements remain very conservative and subjective in nature, and the risk of crew illness due to infectious microorganisms is not well defined. The use of modeling techniques for microbial risk has been applied in the food and potable water industries and has exceptional potential for spaceflight applications. From a productivity standpoint, this type of modeling can (1) decrease unnecessary costs and resource usage and (2) prevent inadequate or inappropriate data for health assessment. In addition, a quantitative model has several advantages for risk management and communication. By identifying the variable components of the model and the knowledge associated with each component, this type of modeling can: (1) Systematically identify and close knowledge gaps, (2) Systematically identify acceptable and unacceptable risks, (3) Improve communication with stakeholders as to the reasons for resource use, and (4) Facilitate external scientific approval of the NASA requirements. The modeling of microbial risk involves the evaluation of several key factors including hazard identification, crew exposure assessment, dose-response assessment, and risk characterization. Many of these factors are similar to conditions found on Earth; however, the spaceflight environment is very specialized as the inhabitants live in a small, semi-closed environment that is often dependent on regenerative life support systems. To further complicate modeling efforts, microbial dose

  18. Formaldehyde risk assessment

    EPA Science Inventory

    We would like to comment on the paper by Crump et al. (2008), ‘Sensitivity analysis of biologically motivated model for formaldehyde-induced respiratory cancer in humans’. We are authors of the formaldehyde cancer risk assessment described in Conolly et al. (2003, 2004) that is t...

  19. Risk Assessment in Criminal Sentencing.

    PubMed

    Monahan, John; Skeem, Jennifer L

    2016-03-28

    The past several years have seen a surge of interest in using risk assessment in criminal sentencing, both to reduce recidivism by incapacitating or treating high-risk offenders and to reduce prison populations by diverting low-risk offenders from prison. We begin by sketching jurisprudential theories of sentencing, distinguishing those that rely on risk assessment from those that preclude it. We then characterize and illustrate the varying roles that risk assessment may play in the sentencing process. We clarify questions regarding the various meanings of "risk" in sentencing and the appropriate time to assess the risk of convicted offenders. We conclude by addressing four principal problems confronting risk assessment in sentencing: conflating risk and blame, barring individual inferences based on group data, failing adequately to distinguish risk assessment from risk reduction, and ignoring whether, and if so, how, the use of risk assessment in sentencing affects racial and economic disparities in imprisonment. PMID:26666966

  20. Risk Assessment System

    NASA Technical Reports Server (NTRS)

    1993-01-01

    FEAT, a software system for evaluating risks, was developed by Lockheed and later enhanced under NASA funding. FEAT uses directed graph - or digraph - models to provide information on cause and effect if a set of failure events occurs. James Miller, the program designer at Lockheed, formed DiGraphics, Inc. to market the software that has evolved from FEAT. The Diquest Analyzer, the company's flagship product, assists product designers in identifying the redundancies and weaknesses of a system. The software has applications in the chemical industry for risk assessment, design evaluation, and change management. Additional markets have been found in operations monitoring diagnostics and training of new personnel.

  1. Methylmercury risk assessment issues

    SciTech Connect

    Lipfert, F.W.; Saroff, L.

    1996-07-01

    This paper reviews the general background of health risks associated with mercury (Hg), primarily methylmercury (MeHg), with a view towards application to advanced technologies that could reduce any contributions from coal combustion. The need for accurate assessment of such risks is discussed, since Hg is now widely dispersed in the environment and cannot easily be eliminated. The primary pathway of MeHg intake is through eating contaminated fish. The issues of concern include identification of critical health outcomes (various neurological indices) and their confounding factors, accurate assessment of MeHg intake rates, and appropriate use of dose-response functions. Ultimately, such information will be used to evaluate alternative coal combustion systems.

  2. Biosafety Risk Assessment Model

    Energy Science and Technology Software Center (ESTSC)

    2011-05-27

    Software tool based on a structured methodology for conducting laboratory biosafety risk assessments by biosafety experts. Software is based upon an MCDA scheme and uses peer reviewed criteria and weights. The software was developed upon Microsoft’s .net framework. The methodology defines likelihood and consequence of a laboratory exposure for thirteen unique scenarios and provides numerical relative risks for each of the relevant thirteen. The software produces 2-d graphs reflecting the relative risk and a sensitivitymore » analysis which highlights the overall importance of each factor. The software works as a set of questions with absolute scales and uses a weighted additive model to calculate the likelihood and consequence.« less

  3. Risk assessment handbook

    SciTech Connect

    Farmer, F.G.; Jones, J.L.; Hunt, R.N.; Roush, M.L.; Wierman, T.E.

    1990-09-01

    The Probabilistic Risk Assessment Unit at EG G Idaho has developed this handbook to provide guidance to a facility manager exploring the potential benefit to be gained by performance of a risk assessment properly scoped to meet local needs. This document is designed to help the manager control the resources expended commensurate with the risks being managed and to assure that the products can be used programmatically to support future needs in order to derive maximum beneflt from the resources expended. We present a logical and functional mapping scheme between several discrete phases of project definition to ensure that a potential customer, working with an analyst, is able to define the areas of interest and that appropriate methods are employed in the analysis. In addition the handbook is written to provide a high-level perspective for the analyst. Previously, the needed information was either scattered or existed only in the minds of experienced analysts. By compiling this information and exploring the breadth of knowledge which exists within the members of the PRA Unit, the functional relationships between the customers' needs and the product have been established.

  4. Risk assessment handbook

    SciTech Connect

    Farmer, F.G.; Jones, J.L.; Hunt, R.N.; Roush, M.L.; Wierman, T.E.

    1990-09-01

    The Probabilistic Risk Assessment Unit at EG&G Idaho has developed this handbook to provide guidance to a facility manager exploring the potential benefit to be gained by performance of a risk assessment properly scoped to meet local needs. This document is designed to help the manager control the resources expended commensurate with the risks being managed and to assure that the products can be used programmatically to support future needs in order to derive maximum beneflt from the resources expended. We present a logical and functional mapping scheme between several discrete phases of project definition to ensure that a potential customer, working with an analyst, is able to define the areas of interest and that appropriate methods are employed in the analysis. In addition the handbook is written to provide a high-level perspective for the analyst. Previously, the needed information was either scattered or existed only in the minds of experienced analysts. By compiling this information and exploring the breadth of knowledge which exists within the members of the PRA Unit, the functional relationships between the customers` needs and the product have been established.

  5. Ecological risk assessment of endocrine disruptors.

    PubMed

    Hutchinson, T H; Brown, R; Brugger, K E; Campbell, P M; Holt, M; Länge, R; McCahon, P; Tattersfield, L J; van Egmond, R

    2000-11-01

    The European Centre for Ecotoxicology and Toxicology of Chemicals proposes a tiered approach for the ecological risk assessment of endocrine disruptors, integrating exposure and hazard (effects) characterization. Exposure assessment for endocrine disruptors should direct specific tests for wildlife species, placing hazard data into a risk assessment context. Supplementing the suite of mammalian screens now under Organization for Economic Cooperation and Development (OECD) validation, high priority should be given to developing a fish screening assay for detecting endocrine activity in oviparous species. Taking into account both exposure characterization and alerts from endocrine screening, higher tier tests are also a priority for defining adverse effects. We propose that in vivo mammalian and fish assays provide a comprehensive screening battery for diverse hormonal functions (including androgen, estrogen, and thyroid hormone), whereas Amphibia should be considered at higher tiers if there are exposure concerns. Higher tier endocrine-disruptor testing should include fish development and fish reproduction tests, whereas a full life-cycle test could be subsequently used to refine aquatic risk assessments when necessary. For avian risk assessment, the new OECD Japanese quail reproduction test guideline provides a valuable basis for developing a test to detecting endocrine-mediated reproductive effects; this species could be used, where necessary, for an avian life-cycle test. For aquatic and terrestrial invertebrates, data from existing developmental and reproductive tests remain of high value for ecological risk assessment. High priority should be given to research into comparative endocrine physiology of invertebrates to support data extrapolation to this diverse fauna. PMID:11102288

  6. Ecological risk assessment of endocrine disruptors.

    PubMed Central

    Hutchinson, T H; Brown, R; Brugger, K E; Campbell, P M; Holt, M; Länge, R; McCahon, P; Tattersfield, L J; van Egmond, R

    2000-01-01

    The European Centre for Ecotoxicology and Toxicology of Chemicals proposes a tiered approach for the ecological risk assessment of endocrine disruptors, integrating exposure and hazard (effects) characterization. Exposure assessment for endocrine disruptors should direct specific tests for wildlife species, placing hazard data into a risk assessment context. Supplementing the suite of mammalian screens now under Organization for Economic Cooperation and Development (OECD) validation, high priority should be given to developing a fish screening assay for detecting endocrine activity in oviparous species. Taking into account both exposure characterization and alerts from endocrine screening, higher tier tests are also a priority for defining adverse effects. We propose that in vivo mammalian and fish assays provide a comprehensive screening battery for diverse hormonal functions (including androgen, estrogen, and thyroid hormone), whereas Amphibia should be considered at higher tiers if there are exposure concerns. Higher tier endocrine-disruptor testing should include fish development and fish reproduction tests, whereas a full life-cycle test could be subsequently used to refine aquatic risk assessments when necessary. For avian risk assessment, the new OECD Japanese quail reproduction test guideline provides a valuable basis for developing a test to detecting endocrine-mediated reproductive effects; this species could be used, where necessary, for an avian life-cycle test. For aquatic and terrestrial invertebrates, data from existing developmental and reproductive tests remain of high value for ecological risk assessment. High priority should be given to research into comparative endocrine physiology of invertebrates to support data extrapolation to this diverse fauna. PMID:11102288

  7. Risk Assessment: Implications for Biologic Education.

    ERIC Educational Resources Information Center

    Ost, David H.

    1995-01-01

    Discusses risk assessment, including risk assessment as a modeling process, models and social values, political decision making, the public, and risk assessment techniques in the biology classroom. (MKR)

  8. Defense Programs Transportation Risk Assessment

    SciTech Connect

    Clauss, D.B.

    1994-08-01

    This paper provides an overview of the methodology used in a probabilistic transportation risk assessment conducted to assess the probabilities and consequences of inadvertent dispersal of radioactive materials arising from severe transportation accidents. The model was developed for the Defense Program Transportation Risk Assessment (DPTRA) study. The analysis incorporates several enhancements relative to previous risk assessments of hazardous materials transportation including newly-developed statistics on the frequencies and severities of tractor semitrailer accidents and detailed route characterization using the 1990 Census data.

  9. Risk Factor Assessment Branch (RFAB)

    Cancer.gov

    The Risk Factor Assessment Branch (RFAB) focuses on the development, evaluation, and dissemination of high-quality risk factor metrics, methods, tools, technologies, and resources for use across the cancer research continuum, and the assessment of cancer-related risk factors in the population.

  10. Integrating Risk Context into Risk Assessments: The Risk Context Scale

    ERIC Educational Resources Information Center

    Kroner, Daryl G.; Gray, Andrew L.; Goodrich, Ben

    2013-01-01

    The context in which offenders are released is an important component of conducting risk assessments. A sample of 257 supervised male parolees were followed in the community ("M" = 870 days) after an initial risk assessment. Drawing on community-based information, the purpose of this study was to evaluate the recently developed Risk Context Scale.…

  11. Computer Security Risk Assessment

    Energy Science and Technology Software Center (ESTSC)

    1992-02-11

    LAVA/CS (LAVA for Computer Security) is an application of the Los Alamos Vulnerability Assessment (LAVA) methodology specific to computer and information security. The software serves as a generic tool for identifying vulnerabilities in computer and information security safeguards systems. Although it does not perform a full risk assessment, the results from its analysis may provide valuable insights into security problems. LAVA/CS assumes that the system is exposed to both natural and environmental hazards and tomore » deliberate malevolent actions by either insiders or outsiders. The user in the process of answering the LAVA/CS questionnaire identifies missing safeguards in 34 areas ranging from password management to personnel security and internal audit practices. Specific safeguards protecting a generic set of assets (or targets) from a generic set of threats (or adversaries) are considered. There are four generic assets: the facility, the organization''s environment; the hardware, all computer-related hardware; the software, the information in machine-readable form stored both on-line or on transportable media; and the documents and displays, the information in human-readable form stored as hard-copy materials (manuals, reports, listings in full-size or microform), film, and screen displays. Two generic threats are considered: natural and environmental hazards, storms, fires, power abnormalities, water and accidental maintenance damage; and on-site human threats, both intentional and accidental acts attributable to a perpetrator on the facility''s premises.« less

  12. EXPOSURE ASSESSMENT: INPUT INTO RISK ASSESSMENT

    EPA Science Inventory

    The validity of a risk assessment can be no better than that of the exposure assessment upon which it is based. he general paucity of relevant exposure data, combined with the limited appreciation by most risk assessors of the critical dimensions and metrics of exposure, often le...

  13. Metabolism, variability and risk assessment.

    PubMed

    Dorne, J L C M

    2010-02-01

    improve the risk assessment of chemical mixtures were explored (1) harmonization of the use of uncertainty factors for human and ecological risk assessment using mechanistic descriptors (2) use of toxicokinetics interaction data to derive UFs for chemical mixtures. The use of toxicokinetics data in risk assessment are discussed together with future approaches including sound statistical approaches to optimise predictability of models and recombinant technology/toxicokinetics assays to identify metabolic routes for chemicals and screen mixtures of environmental health importance. PMID:19932147

  14. Information needs for risk assessment

    SciTech Connect

    DeRosa, C.T.; Choudhury, H.; Schoeny, R.S.

    1990-12-31

    Risk assessment can be thought of as a conceptual approach to bridge the gap between the available data and the ultimate goal of characterizing the risk or hazard associated with a particular environmental problem. To lend consistency to and to promote quality in the process, the US Environmental Protection Agency (EPA) published Guidelines for Risk Assessment of Carcinogenicity, Developmental Toxicity, Germ Cell Mutagenicity and Exposure Assessment, and Risk Assessment of Chemical Mixtures. The guidelines provide a framework for organizing the information, evaluating data, and for carrying out the risk assessment in a scientifically plausible manner. In the absence of sufficient scientific information or when abundant data are available, the guidelines provide alternative methodologies that can be employed in the risk assessment. 4 refs., 3 figs., 2 tabs.

  15. Probabilistic Risk Assessment: A Bibliography

    NASA Technical Reports Server (NTRS)

    2000-01-01

    Probabilistic risk analysis is an integration of failure modes and effects analysis (FMEA), fault tree analysis and other techniques to assess the potential for failure and to find ways to reduce risk. This bibliography references 160 documents in the NASA STI Database that contain the major concepts, probabilistic risk assessment, risk and probability theory, in the basic index or major subject terms, An abstract is included with most citations, followed by the applicable subject terms.

  16. Exploration Health Risks: Probabilistic Risk Assessment

    NASA Technical Reports Server (NTRS)

    Rhatigan, Jennifer; Charles, John; Hayes, Judith; Wren, Kiley

    2006-01-01

    Maintenance of human health on long-duration exploration missions is a primary challenge to mission designers. Indeed, human health risks are currently the largest risk contributors to the risks of evacuation or loss of the crew on long-duration International Space Station missions. We describe a quantitative assessment of the relative probabilities of occurrence of the individual risks to human safety and efficiency during space flight to augment qualitative assessments used in this field to date. Quantitative probabilistic risk assessments will allow program managers to focus resources on those human health risks most likely to occur with undesirable consequences. Truly quantitative assessments are common, even expected, in the engineering and actuarial spheres, but that capability is just emerging in some arenas of life sciences research, such as identifying and minimize the hazards to astronauts during future space exploration missions. Our expectation is that these results can be used to inform NASA mission design trade studies in the near future with the objective of preventing the higher among the human health risks. We identify and discuss statistical techniques to provide this risk quantification based on relevant sets of astronaut biomedical data from short and long duration space flights as well as relevant analog populations. We outline critical assumptions made in the calculations and discuss the rationale for these. Our efforts to date have focussed on quantifying the probabilities of medical risks that are qualitatively perceived as relatively high risks of radiation sickness, cardiac dysrhythmias, medically significant renal stone formation due to increased calcium mobilization, decompression sickness as a result of EVA (extravehicular activity), and bone fracture due to loss of bone mineral density. We present these quantitative probabilities in order-of-magnitude comparison format so that relative risk can be gauged. We address the effects of

  17. [Forensic assessment of violence risk].

    PubMed

    Pujol Robinat, Amadeo; Mohíno Justes, Susana; Gómez-Durán, Esperanza L

    2014-03-01

    Over the last 20 years there have been steps forward in the field of scientific research on prediction and handling different violent behaviors. In this work we go over the classic concept of "criminal dangerousness" and the more current of "violence risk assessment". We analyze the evolution of such assessment from the practice of non-structured clinical expert opinion to current actuarial methods and structured clinical expert opinion. Next we approach the problem of assessing physical violence risk analyzing the HCR-20 (Assessing Risk for Violence) and we also review the classic and complex subject of the relation between mental disease and violence. One of the most problematic types of violence, difficult to assess and predict, is sexual violence. We study the different actuarial and sexual violence risk prediction instruments and in the end we advise an integral approach to the problem. We also go through partner violence risk assessment, describing the most frequently used scales, especially SARA (Spouse Assault Risk Assessment) and EPV-R. Finally we give practical advice on risk assessment, emphasizing the importance of having maximum information about the case, carrying out a clinical examination, psychopathologic exploration and the application of one of the described risk assessment scales. We'll have to express an opinion about the dangerousness/risk of future violence from the subject and some recommendations on the conduct to follow and the most advisable treatment. PMID:24913749

  18. Validation of an LDH Assay for Assessing Nanoparticle Toxicity

    PubMed Central

    Han, Xianglu; Gelein, Robert; Corson, Nancy; Wade-Mercer, Pamela; Jiang, Jingkun; Biswas, Pratim; Finkelstein, Jacob N.; Elder, Alison; Oberdörster, Günter

    2014-01-01

    Studies showed that certain cytotoxicity assays were not suitable for assessing nanoparticle (NP) toxicity. We evaluated a lactate dehydrogenase (LDH) assay for assessing copper (Cu-40, 40 nm), silver (Ag-35, 35 nm; Ag-40, 40 nm), and titanium dioxide (TiO2-25, 25 nm) NPs by examining their potential to inactivate LDH and interference with β-nicotinamide adenine dinucleotide (NADH), a substrate for the assay. We also performed a dissolution assay for some of the NPs. We found that the copper NPs, because of their high dissolution rate, could interfere with the LDH assay by inactivating LDH. Ag-35 could also inactivate LDH probably because of the carbon matrix used to cage the particles during synthesis. TiO2-25 NPs were found to adsorb LDH molecules. In conclusion, NP interference with the LDH assay depends on the type of NPs and the suitability of the assay for assessing NP toxicity should be examined case by case. PMID:21722700

  19. Which high-risk HPV assays fulfil criteria for use in primary cervical cancer screening?

    PubMed

    Arbyn, M; Snijders, P J F; Meijer, C J L M; Berkhof, J; Cuschieri, K; Kocjan, B J; Poljak, M

    2015-09-01

    Several countries are in the process of switching to high-risk human papillomavirus (hrHPV) testing for cervical cancer screening. Given the multitude of available tests, validated assays which assure high-quality screening need to be identified. A systematic review was conducted to answer the question which hrHPV tests fulfil the criteria defined by an international expert team in 2009, based on reproducibility and relative sensitivity and specificity compared to Hybrid Capture-2 or GP5+/6+ PCR-enzyme immunoassay. These latter two hrHPV DNA assays were validated in large randomized trials and cohorts with a follow-up duration of 8 years or more. Eligible studies citing the 2009 guideline were retrieved from Scopus (http://www.scopus.com) and from a meta-analysis assessing the relative accuracy of new hrHPV assays versus the standard comparator tests to detect high-grade cervical intraepithelial neoplasia or cancer in primary screening. The cobas 4800 HPV test and Abbott RealTime High Risk HPV test were consistently validated in two and three studies, respectively, whereas the PapilloCheck HPV-screening test, BD Onclarity HPV assay and the HPV-Risk assay were validated each in one study. Other tests which partially fulfil the 2009 guidelines are the following: Cervista HPV HR Test, GP5+/6+ PCR-LMNX, an in-house E6/E7 RT quantitative PCR and MALDI-TOF (matrix-assisted laser desorption-ionization time-of-flight). The APTIMA HPV assay targeting E6/E7 mRNA of hrHPV was also fully validated. However, the cross-sectional equivalency criteria of the 2009 guidelines were set up for HPV DNA assays. Demonstration of a low risk of CIN3+ after a negative APTIMA test over a longer period is awaited to inform us about its utility in cervical cancer screening at 5-year or longer intervals. PMID:25936581

  20. Topographical Risk Assessment

    Energy Science and Technology Software Center (ESTSC)

    2002-09-24

    TRA was developed as a computer tool for the DOE Office of River Protection (ORP) that will provides the capability to visualize and rapidly understand information about the risks associated with the River protection Project (RPP). Previously, technical and programmatic risk management within ORP had relied heavily on risk lists and other techniques that presented risk information but did not place it in perspective of the overall project. This made it difficult for ORP seniormore » management to understand the risk information presented, prioritize their activities, and provide direction to ORP staff and contractors about how to manage specific risk events. The TRA visualization tool, provides the appropriate context and perspective that allows senior management to effectively manage risks. Basically, the TRA overlays information about risks associated with specific activities and their magnitudes on top of the project baseline schedule. this provides senior management with information about the magnitudes of specific risk events as well as their timing, and allows them to focus their attention and resources on the risks that merit attention and possible further action. The TRA tool can also be used to display other types of information associated with scheduled activities, such as cost to date, technical performance, schedule performance, etc. Additionally, the base of the 3-dimensional representation can be changed to other types of graphics, such as maps, process flow diagrams, etc., which allows the display of other types of informatio, such as hazards, health and safety risks, and system availability.« less

  1. CAROLINA CENTER FOR COMPUTATIONAL TOXICOLOGY: ASSAYS, MODELS AND TOOLS FOR NEXTGEN SAFETY ASSESSMENTS

    EPA Science Inventory

    The Center will develop new methods and tools, and will continue to collaborate closely with EPA, Tox21 and other environmental scientists. New in vitro populationbased assays and computer-based models that fill critical gaps in risk assessment will be developed and deliver...

  2. RISK ASSESSMENT FOR BENEFITS ANALYSIS

    EPA Science Inventory

    Among the important types of information considered in decision making at the U.S. Environmental Protection Agency (EPA) are the outputs of risk assessments and benefit-cost analyses. Risk assessments present estimates of the adverse consequences of exposure to environmental poll...

  3. Cancer Risk Prediction and Assessment

    Cancer.gov

    Cancer prediction models provide an important approach to assessing risk and prognosis by identifying individuals at high risk, facilitating the design and planning of clinical cancer trials, fostering the development of benefit-risk indices, and enabling estimates of the population burden and cost of cancer.

  4. Risk-Assessment Computer Program

    NASA Technical Reports Server (NTRS)

    Dias, William C.; Mittman, David S.

    1993-01-01

    RISK D/C is prototype computer program assisting in attempts to do program risk modeling for Space Exploration Initiative (SEI) architectures proposed in Synthesis Group Report. Risk assessment performed with respect to risk events, probabilities, and severities of potential results. Enables ranking, with respect to effectiveness, of risk-mitigation strategies proposed for exploration program architecture. Allows for fact that risk assessment in early phases of planning subjective. Although specific to SEI in present form, also used as software framework for development of risk-assessment programs for other specific uses. Developed for Macintosh(TM) series computer. Requires HyperCard(TM) 2.0 or later, as well as 2 Mb of random-access memory and System 6.0.8 or later.

  5. Risk Assessment/Management Tool

    Energy Science and Technology Software Center (ESTSC)

    2010-12-31

    RAMTool performs the following: • A tool to perform facility and programmatic risk assessments, produce risk registers, develop risk management plans (RMPs), link risks to improvement/risk-reduction projects, and actively manage risks • Ability to conduct risk assessments. Ease of determination of probability and consequence based on industry standard risk matrices. Complies with site risk management performance document. Provides multiple outputs/report for required risk forms. Conduct quick risk data analysis. • Performs/calculates a facility risk factormore » (RF) and a programmatic RF. Supports project and initiative prioritization and funding in order to make solid decisions on risk reduction. Assigns responsibility and accountability at a risk owner (RO) level. Monitors and tracks progress toward completing mitigation strategies. Ability to import massive amounts of data at the push of a button. Integrates development of a Risk Management Plan (RMP) Built for ease-of-use – design, built, and used by technical/management personnel. Can be customized (functions and/or reports) for further analysis« less

  6. Risk Assessment/Management Tool

    SciTech Connect

    Carlos Castillo, Jerel Nelson

    2010-12-31

    RAMTool performs the following: • A tool to perform facility and programmatic risk assessments, produce risk registers, develop risk management plans (RMPs), link risks to improvement/risk-reduction projects, and actively manage risks • Ability to conduct risk assessments. Ease of determination of probability and consequence based on industry standard risk matrices. Complies with site risk management performance document. Provides multiple outputs/report for required risk forms. Conduct quick risk data analysis. • Performs/calculates a facility risk factor (RF) and a programmatic RF. Supports project and initiative prioritization and funding in order to make solid decisions on risk reduction. Assigns responsibility and accountability at a risk owner (RO) level. Monitors and tracks progress toward completing mitigation strategies. Ability to import massive amounts of data at the push of a button. Integrates development of a Risk Management Plan (RMP) Built for ease-of-use – design, built, and used by technical/management personnel. Can be customized (functions and/or reports) for further analysis

  7. 78 FR 36787 - Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... HUMAN SERVICES Food and Drug Administration Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia... the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the... the current guidelines, and the importance of a uniform assay schema. Date and Time: The...

  8. Risk Assessment and Integration Team (RAIT) Portfolio Risk Analysis Strategy

    NASA Technical Reports Server (NTRS)

    Edwards, Michelle

    2010-01-01

    Impact at management level: Qualitative assessment of risk criticality in conjunction with risk consequence, likelihood, and severity enable development of an "investment policy" towards managing a portfolio of risks. Impact at research level: Quantitative risk assessments enable researchers to develop risk mitigation strategies with meaningful risk reduction results. Quantitative assessment approach provides useful risk mitigation information.

  9. Balancing risk: Ethical issues in risk assessment

    SciTech Connect

    Longstreth, J.D.

    1992-06-01

    The last five decades have seen an explosive growth of information, accompanied by the development of a strong environmental movement. These two factors have been critical contributors to the development of the scientific discipline that has come to be called risk analysis or risk assessment. In this context, risk assessment can be described as an analytic approach used to organize large amounts of information from diverse disciplines so as to evaluate the possible impacts of pollution on human health and the environment. Early efforts in this field focused on the protection of human health. More recently, however, it has been realized that humans and their environment are intimately linked and that environmental impacts must also be evaluated. At some point, it seems likely that the joint goals of protecting human health and the environment may come into conflict. This essay reviews current developments in the assessment of risks both to humans and the environment in order to expose similarities and differences with the ultimate aim of opening a dialogue between scientists in the different disciplines so that evaluation strategies can be designed which will enable decision makers to make trade-offs between human health and environmental risk is an informed and egalitarian way.

  10. REGIONAL SCALE COMPARATIVE RISK ASSESSMENT

    EPA Science Inventory

    Regional Vulnerability Assessment (ReVA) is an approach to regional-scale ecological risk assessment that is currently under development by EPA's Office of Research and Development. The pilot assessment will be done for the mid-Atlantic region and builds on data collected for th...

  11. Quantitative risk assessment system (QRAS)

    NASA Technical Reports Server (NTRS)

    Weinstock, Robert M (Inventor); Smidts, Carol S (Inventor); Mosleh, Ali (Inventor); Chang, Yung-Hsien (Inventor); Swaminathan, Sankaran (Inventor); Groen, Francisco J (Inventor); Tan, Zhibin (Inventor)

    2001-01-01

    A quantitative risk assessment system (QRAS) builds a risk model of a system for which risk of failure is being assessed, then analyzes the risk of the system corresponding to the risk model. The QRAS performs sensitivity analysis of the risk model by altering fundamental components and quantifications built into the risk model, then re-analyzes the risk of the system using the modifications. More particularly, the risk model is built by building a hierarchy, creating a mission timeline, quantifying failure modes, and building/editing event sequence diagrams. Multiplicities, dependencies, and redundancies of the system are included in the risk model. For analysis runs, a fixed baseline is first constructed and stored. This baseline contains the lowest level scenarios, preserved in event tree structure. The analysis runs, at any level of the hierarchy and below, access this baseline for risk quantitative computation as well as ranking of particular risks. A standalone Tool Box capability exists, allowing the user to store application programs within QRAS.

  12. Building Better Environmental Risk Assessments.

    PubMed

    Layton, Raymond; Smith, Joe; Macdonald, Phil; Letchumanan, Ramatha; Keese, Paul; Lema, Martin

    2015-01-01

    Risk assessment is a reasoned, structured approach to address uncertainty based on scientific and technical evidence. It forms the foundation for regulatory decision-making, which is bound by legislative and policy requirements, as well as the need for making timely decisions using available resources. In order to be most useful, environmental risk assessments (ERAs) for genetically modified (GM) crops should provide consistent, reliable, and transparent results across all types of GM crops, traits, and environments. The assessments must also separate essential information from scientific or agronomic data of marginal relevance or value for evaluating risk and complete the assessment in a timely fashion. Challenges in conducting ERAs differ across regulatory systems - examples are presented from Canada, Malaysia, and Argentina. One challenge faced across the globe is the conduct of risk assessments with limited resources. This challenge can be overcome by clarifying risk concepts, placing greater emphasis on data critical to assess environmental risk (for example, phenotypic and plant performance data rather than molecular data), and adapting advances in risk analysis from other relevant disciplines. PMID:26301217

  13. Risk assessment in international operations

    SciTech Connect

    Stricklin, Daniela L.

    2008-11-15

    During international peace-keeping missions, a diverse number of non-battle hazards may be encountered, which range from heavily polluted areas, endemic disease, toxic industrial materials, local violence, traffic, and even psychological factors. Hence, elevated risk levels from a variety of sources are encountered during deployments. With the emphasis within the Swedish military moving from national defense towards prioritization of international missions in atypical environments, the risk of health consequences, including long term health effects, has received greater consideration. The Swedish military is interested in designing an optimal approach for assessment of health threats during deployments. The Medical Intelligence group at FOI CBRN Security and Defence in Umea has, on request from and in collaboration with the Swedish Armed Forces, reviewed a variety of international health threat and risk assessment models for military operations. Application of risk assessment methods used in different phases of military operations will be reviewed. An overview of different international approaches used in operational risk management (ORM) will be presented as well as a discussion of the specific needs and constraints for health risk assessment in military operations. This work highlights the specific challenges of risk assessment that are unique to the deployment setting such as the assessment of exposures to a variety of diverse hazards concurrently.

  14. Building Better Environmental Risk Assessments

    PubMed Central

    Layton, Raymond; Smith, Joe; Macdonald, Phil; Letchumanan, Ramatha; Keese, Paul; Lema, Martin

    2015-01-01

    Risk assessment is a reasoned, structured approach to address uncertainty based on scientific and technical evidence. It forms the foundation for regulatory decision-making, which is bound by legislative and policy requirements, as well as the need for making timely decisions using available resources. In order to be most useful, environmental risk assessments (ERAs) for genetically modified (GM) crops should provide consistent, reliable, and transparent results across all types of GM crops, traits, and environments. The assessments must also separate essential information from scientific or agronomic data of marginal relevance or value for evaluating risk and complete the assessment in a timely fashion. Challenges in conducting ERAs differ across regulatory systems – examples are presented from Canada, Malaysia, and Argentina. One challenge faced across the globe is the conduct of risk assessments with limited resources. This challenge can be overcome by clarifying risk concepts, placing greater emphasis on data critical to assess environmental risk (for example, phenotypic and plant performance data rather than molecular data), and adapting advances in risk analysis from other relevant disciplines. PMID:26301217

  15. Risk assessment in international operations.

    PubMed

    Stricklin, Daniela L

    2008-11-15

    During international peace-keeping missions, a diverse number of non-battle hazards may be encountered, which range from heavily polluted areas, endemic disease, toxic industrial materials, local violence, traffic, and even psychological factors. Hence, elevated risk levels from a variety of sources are encountered during deployments. With the emphasis within the Swedish military moving from national defense towards prioritization of international missions in atypical environments, the risk of health consequences, including long term health effects, has received greater consideration. The Swedish military is interested in designing an optimal approach for assessment of health threats during deployments. The Medical Intelligence group at FOI CBRN Security and Defence in Umeå has, on request from and in collaboration with the Swedish Armed Forces, reviewed a variety of international health threat and risk assessment models for military operations. Application of risk assessment methods used in different phases of military operations will be reviewed. An overview of different international approaches used in operational risk management (ORM) will be presented as well as a discussion of the specific needs and constraints for health risk assessment in military operations. This work highlights the specific challenges of risk assessment that are unique to the deployment setting such as the assessment of exposures to a variety of diverse hazards concurrently. PMID:18325560

  16. Qualitative methods for assessing risk

    SciTech Connect

    Mahn, J.A.; Hannaman, G.W.; Kryska, P.

    1995-03-01

    The purpose of this document is to describe a qualitative risk assessment process that supplements the requirements of DOE/AL 5481.1B. Although facility managers have a choice of assessing risk either quantitatively or qualitatively, trade offs are involved in making the most appropriate choice for a given application. The results that can be obtained from a quantitative risk assessment are significantly more robust than those results derived from a qualitative approach. However, the advantages derived from quantitative risk assessment are achieved at a greater expenditure of money, time and convenience. This document provides the elements of a framework for performing a much less costly qualitative risk assessment, while retaining the best attributes of quantitative methods. The approach discussed herein will; (1) provide facility managers with the tools to prepare consistent, site wide assessments, and (2) aid the reviewers who may be tasked to evaluate the assessments. Added cost/benefit measures of the qualitative methodology include the identification of mechanisms for optimally allocating resources for minimizing risk in an expeditious, and fiscally responsible manner.

  17. Caries management by risk assessment.

    PubMed

    Young, Douglas A; Featherstone, John D B

    2013-02-01

    Caries disease is multifactorial. Whether caries disease will be expressed and damage dental hard tissue is dependent on the patient's own unique make-up of pathogenic risk factors and protective factors. Objectives This manuscript will review the science of managing caries disease based on assessing caries risk. Methods The caries balance/imbalance model and a practical caries risk assessment procedure for patients aged 6 years through adult will illustrate how treatment options can be based on caries risk. Results Neither the forms nor the clinical protocols are meant to imply there is currently only one correct way this can be achieved, rather are used in this manuscript as examples only. Conclusions It is important to have the forms and protocols simple and easy to understand when implementing caries management by risk assessment into clinical practice. The science of CAMBRA based on the caries balance/imbalance model was reviewed and an example protocol was presented. PMID:24916678

  18. RESIDUAL RISK ASSESSMENTS

    EPA Science Inventory

    Each source category previously subjected to a technology-based standard will be examined to determine if health or ecological risks are significant enough to warrant further regulation. These assesments utilize existing models and data bases to examine the multi-media and multi-...

  19. ECOLOGICAL RISK ASSESSMENT

    EPA Science Inventory

    The Ecological Soil Screening Level (Eco-SSL) Work Group, composed of scientists and risk assessors from EPA, Environment Canada, DOE, Army, Navy, Air Force, states, industry, academia, and consulting companies, has been working on the development of scientifically sound, ecologi...

  20. ADVANCED PESTICIDE RISK ASSESSMENT TECHNOLOGY

    EPA Science Inventory

    The use of herbicides, insecticides, fungicides, and growth regulating chemicals is necessary in modern agriculture, silviculture, and public health vector control operations. The task for environmental risk assessment is to delineate the food chain contamination and ecological v...

  1. RISK ASSESSMENT OF WASTEWATER DISINFECTION

    EPA Science Inventory

    A risk assessment data base is presented for several waste-water disinfection alternatives, including chlorination, ozonation, chlorination/dechlorination, and ultraviolet radiation. The data base covers hazards and consequences related to onsite use and transportation of the dis...

  2. APPROACHES FOR INTEGRATED RISK ASSESSMENT

    EPA Science Inventory

    Recognizing the need to enhance the effectiveness and efficiency of risk assessments globally, the WHO International Programme on Chemical Safety, the U.S. Environmental Protection Agency, the European Commission, and the Organization for Economic Cooperation and Development form...

  3. Improving pandemic influenza risk assessment

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Assessing the pandemic risk posed by specific non-human influenza A viruses remains a complex challenge. As influenza virus genome sequencing becomes cheaper, faster and more readily available, the ability to predict pandemic potential from sequence data could transform pandemic influenza risk asses...

  4. The risk assessment information system

    SciTech Connect

    Kerr, S.B.; Bonczek, R.R.; McGinn, C.W.; Land, M.L.; Bloom, L.D.; Sample, B.E.; Dolislager, F.G.

    1998-06-01

    In an effort to provide service-oriented environmental risk assessment expertise, the Department of Energy (DOE) Center for Risk Excellence (CRE) and DOE Oak Ridge Operations Office (ORO) are sponsoring Oak Ridge National Laboratory (ORNL) to develop a web-based system for disseminating risk tools and information to its users. This system, the Risk Assessment Information System (RAIS), was initially developed to support the site-specific needs of the DOE-ORO Environmental Restoration Risk Assessment Program. With support from the CRE, the system is currently being expanded to benefit all DOE risk information users and can be tailored to meet site-specific needs. Taking advantage of searchable and executable databases, menu-driven queries, and data downloads, using the latest World Wide Web technologies, the RAIS offers essential tools that are used in the risk assessment process or anywhere from project scoping to implementation. The RAIS tools can be located directly at http://risk.lsd.ornl.gov/homepage/rap{_}tool.htm or through the CRE`s homepage at http://www.doe.gov/riskcenter/home.html.

  5. Risk: assessment, acceptability and management

    SciTech Connect

    Not Available

    1981-01-01

    Risk assessment, particularly of risks to the public health resulting from government and industry decisions, is discussed. Cost/benefit analysis as applied to such situations as human deaths and the contracting of cancer by humans is discussed. The role of government regulations and standards is discussed.

  6. Anthropic Risk Assessment on Biodiversity

    NASA Astrophysics Data System (ADS)

    Piragnolo, M.; Pirotti, F.; Vettore, A.; Salogni, G.

    2013-01-01

    This paper presents a methodology for risk assessment of anthropic activities on habitats and species. The method has been developed for Veneto Region, in order to simplify and improve the quality of EIA procedure (VINCA). Habitats and species, animals and plants, are protected by European Directive 92/43/EEC and 2009/147/EC but they are subject at hazard due to pollution produced by human activities. Biodiversity risks may conduct to deterioration and disturbance in ecological niches, with consequence of loss of biodiversity. Ecological risk assessment applied on Natura 2000 network, is needed to best practice of management and monitoring of environment and natural resources. Threats, pressure and activities, stress and indicators may be managed by geodatabase and analysed using GIS technology. The method used is the classic risk assessment in ecological context, and it defines the natural hazard as influence, element of risk as interference and vulnerability. Also it defines a new parameter called pressure. It uses risk matrix for the risk analysis on spatial and temporal scale. The methodology is qualitative and applies the precautionary principle in environmental assessment. The final product is a matrix which excludes the risk and could find application in the development of a territorial information system.

  7. Carcinogen risk assessment

    SciTech Connect

    Hazelwoold, R.N.

    1987-01-01

    This article describes the methods by which risk factors for carcinogenic hazards are determined and the limitations inherent in the process. From statistical and epidemiological studies, the major identifiable factors related to cancer in the United States were determined to be cigarette smoking, diet, reproductive and sexual behavior, infections, ultraviolet and ionizing radiation, and alcohol consumption. The incidence of lung cancer due to air pollutants was estimated to be less than 2%. Research needs were discussed.

  8. Space Radiation Risk Assessment

    NASA Astrophysics Data System (ADS)

    Blakely, E.

    Evaluation of potential health effects from radiation exposure during and after deep space travel is important for the future of manned missions To date manned missions have been limited to near-Earth orbits with the moon our farthest distance from earth Historical space radiation career exposures for astronauts from all NASA Missions show that early missions involved total exposures of less than about 20 mSv With the advent of Skylab and Mir total career exposure levels increased to a maximum of nearly 200 mSv Missions in deep space with the requisite longer duration of the missions planned may pose greater risks due to the increased potential for exposure to complex radiation fields comprised of a broad range of radiation types and energies from cosmic and unpredictable solar sources The first steps in the evaluation of risks are underway with bio- and physical-dosimetric measurements on both commercial flight personnel and international space crews who have experience on near-earth orbits and the necessary theoretical modeling of particle-track traversal per cell including the contributing effects of delta-rays in particle exposures An assumption for biologic effects due to exposure of radiation in deep space is that they differ quantitatively and qualitatively from that on earth The dose deposition and density pattern of heavy charged particles are very different from those of sparsely ionizing radiation The potential risks resulting from exposure to radiation in deep space are cancer non-cancer and genetic effects Radiation from

  9. Taking the Risk Out of Risk Assessment

    NASA Technical Reports Server (NTRS)

    2005-01-01

    The ability to understand risks and have the right strategies in place when risky events occur is essential in the workplace. More and more organizations are being confronted with concerns over how to measure their risks or what kind of risks they can take when certain events transpire that could have a negative impact. NASA is one organization that faces these challenges on a daily basis, as effective risk management is critical to the success of its missions especially the Space Shuttle missions. On July 29, 1996, former NASA Administrator Daniel Goldin charged NASA s Office of Safety and Mission Assurance with developing a probabilistic risk assessment (PRA) tool to support decisions on the funding of Space Shuttle upgrades. When issuing the directive, Goldin said, "Since I came to NASA [in 1992], we've spent billions of dollars on Shuttle upgrades without knowing how much they improve safety. I want a tool to help base upgrade decisions on risk." Work on the PRA tool began immediately. The resulting prototype, the Quantitative Risk Assessment System (QRAS) Version 1.0, was jointly developed by NASA s Marshall Space Flight Center, its Office of Safety and Mission Assurance, and researchers at the University of Maryland. QRAS software automatically expands the reliability logic models of systems to evaluate the probability of highly detrimental outcomes occurring in complex systems that are subject to potential accident scenarios. Even in its earliest forms, QRAS was used to begin PRA modeling of the Space Shuttle. In parallel, the development of QRAS continued, with the goal of making it a world-class tool, one that was especially suited to NASA s unique needs. From the beginning, an important conceptual goal in the development of QRAS was for it to help bridge the gap between the professional risk analyst and the design engineer. In the past, only the professional risk analyst could perform, modify, use, and perhaps even adequately understand PRA. NASA wanted

  10. Sudden Cardiac Arrest (SCA) Risk Assessment

    MedlinePlus

    ... Find a Specialist Share Twitter Facebook SCA Risk Assessment Sudden Cardiac Arrest (SCA) occurs abruptly and without ... of all ages and health conditions. Start Risk Assessment The Sudden Cardiac Arrest (SCA) Risk Assessment Tool ...

  11. Qualitative methods for assessing risk

    SciTech Connect

    Mahn, J.A.; Hannaman, G.W.; Kryska, P.

    1995-04-01

    The Department of Energy`s (DOE) non-nuclear facilities generally require only a qualitative accident analysis to assess facility risks in accordance with DOE Order 5481.1B, Safety Analysis and Review System. Achieving a meaningful qualitative assessment of risk necessarily requires the use of suitable non-numerical assessment criteria. Typically, the methods and criteria for assigning facility-specific accident scenarios to the qualitative severity and likelihood classification system in the DOE order requires significant judgment in many applications. Systematic methods for more consistently assigning the total accident scenario frequency and associated consequences are required to substantiate and enhance future risk ranking between various activities at Sandia National Laboratories (SNL). SNL`s Risk Management and National Environmental Policy Act (NEPA) Department has developed an improved methodology for performing qualitative risk assessments in accordance wi the DOE order requirements. Products of this effort are an improved set of qualitative description that permit (1) definition of the severity for both technical and programmatic consequences that may result from a variety of accident scenarios, and (2) qualitative representation of the likelihood of occurrence. These sets of descriptions are intended to facilitate proper application of DOE criteria for assessing facility risks.

  12. EPA's neurotoxicity risk assessment guidelines.

    PubMed

    Boyes, W K; Dourson, M L; Patterson, J; Tilson, H A; Sette, W F; MacPhail, R C; Li, A A; O'Donoghue, J L

    1997-12-01

    The proposed Neurotoxicity Risk Assessment Guidelines (U.S. EPA, 1995c Fed. Reg. 60(192), 52032-52056) of the U.S. Environmental Protection Agency (EPA) were the subject of a workshop at the 1997 Meeting of the Society of Toxicology. The workshop considered the role of guidelines in the risk assessment process, the primary features, scientific basis, and implications of the guidelines for EPA program offices, as well as for industrial neurotoxicologists from the perspectives of both pesticides and toxic substances regulation. The U.S. National Academy of Sciences (NAS, 1983, Risk Assessment in the Federal Government: Managing the Process) established a framework for distinguishing risk management from risk assessment, the latter being the result of integrating hazard identification, hazard characterization, and exposure assessment data. The guidelines are intended to establish operating principles that will be used when examining data in a risk assessment context. The proposed neurotoxicity risk assessment guidelines provide a conceptual framework for deciding whether or not a chemically induced effect can be considered to be evidence of neurotoxicity. Topics in the proposed guidelines include structural and functional effects, dose-response and -duration considerations, and relationships between effects. Among the issues that must be considered are the multiplicity of chemical effects, the levels of biological organization in the nervous system, and the tests, measurements, and protocols used. Judgment of the adversity of an effect depends heavily on the amount and types of data available. The attribution of a chemically induced effect to an action on the nervous system depends on several factors such as the quality of the study, the nature of the outcome, dose-response and time-response relationships, and the possible involvement of nonneural factors. The guidelines will also serve as a reference for those conducting neurotoxicity testing, as well as establish a

  13. Neurotoxicity in risk assessment

    SciTech Connect

    Weiss, B.

    1988-01-01

    Neurotoxicity is a property of many metals, even those deemed biologically essential. Manganese, one of the essential elements, can induce a syndrome displaying aspects of both Parkinsonism and dystonia, but accompanied, as well, by psychological abnormalities. At low exposure levels, however, neurotoxicity may be detectable with psychological tests. Mercury vapor exposure also induces neurological signs, psychological aberrations, and subtle evidence of dysfunction on psychological tests. Methylmercury and lead are particularly toxic to the developing brain. The most recent research indicates that psychological testing may uncover deficits even in children showing no evidence of impairment. Because of their special features, neurotoxic endpoints may have to be evaluated for risks by a process that diverges significantly from the standard program based on carcinogenicity.

  14. A functional assay-based strategy for nanomaterial risk forecasting.

    PubMed

    Hendren, Christine Ogilvie; Lowry, Gregory V; Unrine, Jason M; Wiesner, Mark R

    2015-12-01

    The study of nanomaterial impacts on environment, health and safety (nanoEHS) has been largely predicated on the assumption that exposure and hazard can be predicted from physical-chemical properties of nanomaterials. This approach is rooted in the view that nanoöbjects essentially resemble chemicals with additional particle-based attributes that must be included among their intrinsic physical-chemical descriptors. With the exception of the trivial case of nanomaterials made from toxic or highly reactive materials, this approach has yielded few actionable guidelines for predicting nanomaterial risk. This article addresses inherent problems in structuring a nanoEHS research strategy based on the goal of predicting outcomes directly from nanomaterial properties, and proposes a framework for organizing data and designing integrated experiments based on functional assays (FAs). FAs are intermediary, semi-empirical measures of processes or functions within a specified system that bridge the gap between nanomaterial properties and potential outcomes in complex systems. The three components of a functional assay are standardized protocols for parameter determination and reporting, a theoretical context for parameter application and reference systems. We propose the identification and adoption of reference systems where FAs may be applied to provide parameter estimates for environmental fate and effects models, as well as benchmarks for comparing the results of FAs and experiments conducted in more complex and varied systems. Surface affinity and dissolution rate are identified as two critical FAs for characterizing nanomaterial behavior in a variety of important systems. The use of these FAs to predict bioaccumulation and toxicity for initial and aged nanomaterials is illustrated for the case of silver nanoparticles and Caenorhabditis elegans. PMID:26188653

  15. Topics in cancer risk assessment.

    PubMed Central

    Olin, S S; Neumann, D A; Foran, J A; Scarano, G J

    1997-01-01

    The estimation of carcinogenic risks from exposure to chemicals has become an integral part of the regulatory process in the United States within the past decade. With it have come considerable controversy and debate over the scientific merits and shortcomings of the methods and their impact on risk management decisions. In this paper we highlight selected topics of current interest in the debate. As an indication of the level of public concern, we note the major recent reports on risk assessment from the National Academy of Sciences and the U.S Environmental Protection Agency's proposed substantial revisions to its Guidelines for Carcinogen Risk Assessment. We identify and briefly frame several key scientific issues in cancer risk assessment, including the growing recognition of the importance of understanding the mode of action of carcinogenesis in experimental animals and in humans, the methodologies and challenges in quantitative extrapolation of cancer risks, and the question of how to assess and account for human variability in susceptibility to carcinogens. In addition, we discuss initiatives in progress that may fundamentally alter the carcinogenesis testing paradigm. PMID:9114281

  16. Genotoxicity assessment of melamine in the in vivo Pig-a mutation assay and in a standard battery of assays.

    PubMed

    Tu, Honggang; Zhang, Ming; Zhou, Changhui; Wang, Zheng; Huang, Pengcheng; Ou, Hongmei; Chang, Yan

    2015-01-01

    The genotoxicity of melamine was evaluated with the combined Pig-a mutation/micronucleus assay, the bacterial reverse mutation assay, and the in vitro cytokinesis-block micronucleus assay (CBMN). Five groups of six- to eight-week-old male Sprague-Dawley (SD) rats were given three daily doses of vehicle control (100% pure sesame oil), melamine (500, 1000, and 2000 mg/kg) or positive control (N-ethyl-N-nitrosourea, ENU, 20 mg/kg) by oral gavage. Peripheral blood was sampled pre-dose (day -1) and at time points up to day 60. Pig-a mutant frequencies were determined in total red blood cells (RBCs) and reticulocytes (RETs) as RBC(CD59-) and RET(CD59-) frequencies, on days -1, 15, 29 and 60, and micronucleus frequencies were measured in RETs on day 4. No significant increases in RBC(CD59-) or RET(CD59-) frequencies were observed for the melamine-treated group at any of the time points studied, but the positive control, ENU, induced statistically significant increases compared with the vehicle control. Similar results were obtained in the micronucleus assay. Melamine did not induce statistically significant increases in %MN-RET. In the bacterial reverse mutation assay, melamine was tested from 62.5 to 1000 μg/plate in tester strains TA97a, TA98, TA100, TA102, and TA1535, with and without metabolic activation, and no evidence of toxicity or mutagenicity was observed at any dose tested. In the in vitro CBMN assay, in Chinese hamster ovary (CHO) cells, melamine was tested (75, 150, and 300 μg/mL) in the presence and absence of S9 mix, and no positive increases in the number of cells containing micronuclei were seen. These results suggest that melamine does not exhibit significant genotoxic potential. These data could be valuable for risk assessment purposes and also for further characterizing the new in vivoPig-a gene mutation assay. PMID:25726176

  17. Space shuttle operational risk assessment

    NASA Astrophysics Data System (ADS)

    Fragola, Joseph R.; Maggio, Gaspare

    1996-03-01

    A Probabilistic Risk Assessment (PRA) of the Space Shuttle system has recently been completed. This year-long effort represents a development resulting from seven years of application of risk technology to the Space Shuttle. These applications were initiated by NASA shortly after the Challenger accident as recommended by the Rogers and Slay Commission reports. The current effort is the first integrated quantitative assessment of the risk of the loss of the shuttle vehicle from 3 seconds prior to liftoff to wheel-stop at mission end. The study which was conducted under the direction of NASA's Shuttle Safety and Mission Assurance office at Johnson Spaceflight Center focused on shuttle operational risk but included consideration of all the shuttle flight and test history since the beginning of the program through Mission 67 in July of 1994.

  18. Assessing Risk of Innovation

    SciTech Connect

    Allgood, GO

    2001-08-15

    Today's manufacturing systems and equipment must perform at levels thought impossible a decade ago. Companies must push operations, quality, and efficiencies to unprecedented levels while holding down costs. In this new economy, companies must be concerned with market shares, equity growth, market saturation, and profit. U.S. manufacturing is no exception and is a prime example of businesses forced to adapt to constant and rapid changes in customer needs and product mixes, giving rise to the term ''Agile Manufacturing''. The survival and ultimate success of the American Manufacturing economy may depend upon its ability to create, innovate, and quickly assess the impact that new innovations will have on its business practices. Given the need for flexibility, companies need proven methods to predict and measure the impact that new technologies and strategies will have on overall plant performance from an enterprise perspective. The Value-Derivative Model provides a methodology and approach to assess such impacts in terms of energy savings, production increases, quality impacts, emission reduction, and maintenance and operating costs as they relate to enabling and emerging technologies. This is realized by calculating a set of first order sensitivity parameters obtained from expanding a Taylor Series about the system's operating point. These sensitivity parameters are invariant economic and operational indicators that quantify the impact of any proposed technology in terms of material throughput, efficiency, energy usage, environmental effects, and costs. These parameters also provide a mechanism to define metrics and performance measures that can be qualified in terms of real economic impact. Value-Derivative Analysis can be applied across all manufacturing and production segments of our economy and has found specific use in steel and textiles. Where economic models give the cost of conducting a business, Value-Derivative Analysis provides the cost to conduct

  19. Improving pandemic influenza risk assessment

    PubMed Central

    Russell, Colin A; Kasson, Peter M; Donis, Ruben O; Riley, Steven; Dunbar, John; Rambaut, Andrew; Asher, Jason; Burke, Stephen; Davis, C Todd; Garten, Rebecca J; Gnanakaran, Sandrasegaram; Hay, Simon I; Herfst, Sander; Lewis, Nicola S; Lloyd-Smith, James O; Macken, Catherine A; Maurer-Stroh, Sebastian; Neuhaus, Elizabeth; Parrish, Colin R; Pepin, Kim M; Shepard, Samuel S; Smith, David L; Suarez, David L; Trock, Susan C; Widdowson, Marc-Alain; George, Dylan B; Lipsitch, Marc; Bloom, Jesse D

    2014-01-01

    Assessing the pandemic risk posed by specific non-human influenza A viruses is an important goal in public health research. As influenza virus genome sequencing becomes cheaper, faster, and more readily available, the ability to predict pandemic potential from sequence data could transform pandemic influenza risk assessment capabilities. However, the complexities of the relationships between virus genotype and phenotype make such predictions extremely difficult. The integration of experimental work, computational tool development, and analysis of evolutionary pathways, together with refinements to influenza surveillance, has the potential to transform our ability to assess the risks posed to humans by non-human influenza viruses and lead to improved pandemic preparedness and response. DOI: http://dx.doi.org/10.7554/eLife.03883.001 PMID:25321142

  20. Improving pandemic influenza risk assessment.

    PubMed

    Russell, Colin A; Kasson, Peter M; Donis, Ruben O; Riley, Steven; Dunbar, John; Rambaut, Andrew; Asher, Jason; Burke, Stephen; Davis, C Todd; Garten, Rebecca J; Gnanakaran, Sandrasegaram; Hay, Simon I; Herfst, Sander; Lewis, Nicola S; Lloyd-Smith, James O; Macken, Catherine A; Maurer-Stroh, Sebastian; Neuhaus, Elizabeth; Parrish, Colin R; Pepin, Kim M; Shepard, Samuel S; Smith, David L; Suarez, David L; Trock, Susan C; Widdowson, Marc-Alain; George, Dylan B; Lipsitch, Marc; Bloom, Jesse D

    2014-01-01

    Assessing the pandemic risk posed by specific non-human influenza A viruses is an important goal in public health research. As influenza virus genome sequencing becomes cheaper, faster, and more readily available, the ability to predict pandemic potential from sequence data could transform pandemic influenza risk assessment capabilities. However, the complexities of the relationships between virus genotype and phenotype make such predictions extremely difficult. The integration of experimental work, computational tool development, and analysis of evolutionary pathways, together with refinements to influenza surveillance, has the potential to transform our ability to assess the risks posed to humans by non-human influenza viruses and lead to improved pandemic preparedness and response. PMID:25321142

  1. Assessing the Relative Risk of Aerocapture Using Probabalistic Risk Assessment

    NASA Technical Reports Server (NTRS)

    Percy, Thomas K.; Bright, Ellanee; Torres, Abel O.

    2005-01-01

    A recent study performed for the Aerocapture Technology Area in the In-Space Propulsion Technology Projects Office at the Marshall Space Flight Center investigated the relative risk of various capture techniques for Mars missions. Aerocapture has been proposed as a possible capture technique for future Mars missions but has been perceived by many in the community as a higher risk option as compared to aerobraking and propulsive capture. By performing a probabilistic risk assessment on aerocapture, aerobraking and propulsive capture, a comparison was made to uncover the projected relative risks of these three maneuvers. For mission planners, this knowledge will allow them to decide if the mass savings provided by aerocapture warrant any incremental risk exposure. The study focuses on a Mars Sample Return mission currently under investigation at the Jet Propulsion Laboratory (JPL). In each case (propulsive, aerobraking and aerocapture), the Earth return vehicle is inserted into Martian orbit by one of the three techniques being investigated. A baseline spacecraft was established through initial sizing exercises performed by JPL's Team X. While Team X design results provided the baseline and common thread between the spacecraft, in each case the Team X results were supplemented by historical data as needed. Propulsion, thermal protection, guidance, navigation and control, software, solar arrays, navigation and targeting and atmospheric prediction were investigated. A qualitative assessment of human reliability was also included. Results show that different risk drivers contribute significantly to each capture technique. For aerocapture, the significant drivers include propulsion system failures and atmospheric prediction errors. Software and guidance hardware contribute the most to aerobraking risk. Propulsive capture risk is mainly driven by anomalous solar array degradation and propulsion system failures. While each subsystem contributes differently to the risk of

  2. Tsunami risk assessment in Indonesia

    NASA Astrophysics Data System (ADS)

    Strunz, G.; Post, J.; Zosseder, K.; Wegscheider, S.; Mück, M.; Riedlinger, T.; Mehl, H.; Dech, S.; Birkmann, J.; Gebert, N.; Harjono, H.; Anwar, H. Z.; Sumaryono; Khomarudin, R. M.; Muhari, A.

    2011-01-01

    In the framework of the German Indonesian Tsunami Early Warning System (GITEWS) the assessment of tsunami risk is an essential part of the overall activities. The scientific and technical approach for the tsunami risk assessment has been developed and the results are implemented in the national Indonesian Tsunami Warning Centre and are provided to the national and regional disaster management and spatial planning institutions in Indonesia. The paper explains the underlying concepts and applied methods and shows some of the results achieved in the GITEWS project (Rudloff et al., 2009). The tsunami risk assessment has been performed at an overview scale at sub-national level covering the coastal areas of southern Sumatra, Java and Bali and also on a detailed scale in three pilot areas. The results are provided as thematic maps and GIS information layers for the national and regional planning institutions. From the analyses key parameters of tsunami risk are derived, which are integrated and stored in the decision support system of the national Indonesian Early Warning Centre. Moreover, technical descriptions and guidelines were elaborated to explain the developed approach, to allow future updates of the results and the further development of the methodologies, and to enable the local authorities to conduct tsunami risk assessment by using their own resources.

  3. Benzidine dihydrochloride: risk assessment.

    PubMed

    Littlefield, N A; Nelson, C J; Gaylor, D W

    1984-02-01

    Benzidine, recognized as a bladder carcinogen in man and as a liver carcinogen in experimental animals, is the chemical basis of as many as 200 commercial dyes. Physiological processes can metabolize these dyes to release benzidine, thereby creating a potential exposure hazard. To assess this hazard, both sexes of F1 hybrid (genetically homogeneous) and monohybrid (genetically heterogeneous) mice from a BALB/c male and C57BL/6 female cross were exposed for their respective lifespans to benzidine dihydrochloride in their drinking water at concentrations of 0, 30, 40, 60, 80, 120, and 160 ppm for males, and 0, 20, 30, 40, 60, 80, and 120 ppm for females. Animals were removed from the study when they were dead or moribund. This study was terminated after 33 months of exposure. Using the endpoint of hepatocellular adenomas and carcinomas, the Armitage Doll multistage model was used to describe the tumor rates in the experimental dose range and to obtain the upper confidence level on tumor rates. Linear interpolation was used between zero dose and the upper confidence level of the lowest experimental dosage for predicting potential low dose tumor rates. Dose-response effects on body weight, survival, and liver neoplasms were noted in both stocks. For each of the endpoints, the females were more susceptible than males and the F1 (homogeneous) stock was more susceptible than the monohybrid cross (heterogeneous). The calculated virtually "safe" dose predicted to produce less than one per million F1 female mice with a liver tumor is 0.045 ppb. One part per billion of benzidine dihydrochloride in the drinking water of these mice is estimated to produce liver tumors in less than 2.23 mice per 100,000 population. PMID:6363187

  4. Environmental Risk Assessment of Nanomaterials

    NASA Astrophysics Data System (ADS)

    Bayramov, A. A.

    In this paper, various aspects of modern nanotechnologies and, as a result, risks of nanomaterials impact on an environment are considered. This very brief review of the First International Conference on Material and Information Sciences in High Technologies (2007, Baku, Azerbaijan) is given. The conference presented many reports that were devoted to nanotechnology in biology and business for the developing World, formation of charged nanoparticles for creation of functional nanostructures, nanoprocessing of carbon nanotubes, magnetic and optical properties of manganese-phosphorus nanowires, ultra-nanocrystalline diamond films, and nanophotonics communications in Azerbaijan. The mathematical methods of simulation of the group, individual and social risks are considered for the purpose of nanomaterials risk reduction and remediation. Lastly, we have conducted studies at a plant of polymeric materials (and nanomaterials), located near Baku. Assessments have been conducted on the individual risk of person affection and constructed the map of equal isolines and zones of individual risk for a plant of polymeric materials (and nanomaterials).

  5. Probabilistic risk assessment: Number 219

    SciTech Connect

    Bari, R.A.

    1985-11-13

    This report describes a methodology for analyzing the safety of nuclear power plants. A historical overview of plants in the US is provided, and past, present, and future nuclear safety and risk assessment are discussed. A primer on nuclear power plants is provided with a discussion of pressurized water reactors (PWR) and boiling water reactors (BWR) and their operation and containment. Probabilistic Risk Assessment (PRA), utilizing both event-tree and fault-tree analysis, is discussed as a tool in reactor safety, decision making, and communications. (FI)

  6. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Risk assessment. 35.315 Section...

  7. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with... 24 Housing and Urban Development 1 2011-04-01 2011-04-01 false Risk assessment. 35.315 Section...

  8. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with... 24 Housing and Urban Development 1 2012-04-01 2012-04-01 false Risk assessment. 35.315 Section...

  9. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with... 24 Housing and Urban Development 1 2014-04-01 2014-04-01 false Risk assessment. 35.315 Section...

  10. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with... 24 Housing and Urban Development 1 2013-04-01 2013-04-01 false Risk assessment. 35.315 Section...

  11. The GARD assay for assessment of chemical skin sensitizers.

    PubMed

    Johansson, Henrik; Albrekt, Ann-Sofie; Borrebaeck, Carl A K; Lindstedt, Malin

    2013-04-01

    Allergic contact dermatitis is a skin disease caused by an immunologic reaction to low molecular weight compounds, so called haptens. These substances are commonly present in products used by humans in daily life, such as in cosmetics and fragrances, as well as within chemical industry and in pharmaceuticals. The frequent usage of these compounds in different applications has led to increasing incidences of allergic contact dermatitis, which has become a substantial economic burden for society. As a consequence, chemicals are routinely tested for their ability to induce skin sensitization, using animal models such as the murine Local Lymph Node Assay. However, recent legislations regulate the use of animal models within chemical testing. Thus, there is an urgent need for in vitro alternatives to replace these assays for safety assessment of chemicals. Recently, we identified a signature of predictive genes, which are differentially regulated in the human myeloid cell-line MUTZ-3 when stimulated with sensitizing compounds compared to non-sensitizing compounds. Based on these findings, we have formulated a test strategy for assessment of sensitizing compounds, called Genomic Allergen Rapid Detection, GARD. In this paper, we present a detailed method description of how the assay should be performed. PMID:23032079

  12. Dynamical systems probabilistic risk assessment.

    SciTech Connect

    Denman, Matthew R.; Ames, Arlo Leroy

    2014-03-01

    Probabilistic Risk Assessment (PRA) is the primary tool used to risk-inform nuclear power regulatory and licensing activities. Risk-informed regulations are intended to reduce inherent conservatism in regulatory metrics (e.g., allowable operating conditions and technical specifications) which are built into the regulatory framework by quantifying both the total risk profile as well as the change in the risk profile caused by an event or action (e.g., in-service inspection procedures or power uprates). Dynamical Systems (DS) analysis has been used to understand unintended time-dependent feedbacks in both industrial and organizational settings. In dynamical systems analysis, feedback loops can be characterized and studied as a function of time to describe the changes to the reliability of plant Structures, Systems and Components (SSCs). While DS has been used in many subject areas, some even within the PRA community, it has not been applied toward creating long-time horizon, dynamic PRAs (with time scales ranging between days and decades depending upon the analysis). Understanding slowly developing dynamic effects, such as wear-out, on SSC reliabilities may be instrumental in ensuring a safely and reliably operating nuclear fleet. Improving the estimation of a plant's continuously changing risk profile will allow for more meaningful risk insights, greater stakeholder confidence in risk insights, and increased operational flexibility.

  13. Health risk assessment of irradiated topaz

    SciTech Connect

    Nelson, J.W.; Baum, J.W. )

    1993-01-01

    Irradiated topaz gemstones are currently processed for color improvement by subjecting clear stones to neutron or high-energy electron irradiations, which leads to activation of trace elements in the stones. Assessment of the risk to consumers required the identification and quantification of the resultant radionuclides and the attendant exposure. Representative stones from Brazil, India, Nigeria, Sri Lanka were irradiated and analyzed for gamma ray and beta particle emissions, using sodium iodide and germanium spectrometers; and Geiger-Muller, plastic and liquid scintillation, autoradiography, and thermoluminescent-dosimetry measurement techniques. Based on these studies and other information derived from published literature, dose and related risk estimates were made for typical user conditions. New criteria and methods for routine assays for acceptable release, based on gross beta and gross photon emissions from the stones, were also developed.

  14. Moving Forward in Human Cancer Risk Assessment

    PubMed Central

    Paules, Richard S.; Aubrecht, Jiri; Corvi, Raffaella; Garthoff, Bernward; Kleinjans, Jos C.

    2011-01-01

    Background The current safety paradigm for assessing carcinogenic properties of drugs, cosmetics, industrial chemicals, and environmental exposures relies mainly on in vitro genotoxicity testing followed by 2-year rodent bioassays. This testing battery is extremely sensitive but has low specificity. Furthermore, rodent bioassays are associated with high costs, high animal burden, and limited predictive value for human risks. Objectives We provide a response to a growing appeal for a paradigm change in human cancer risk assessment. Methods To facilitate development of a road map for this needed paradigm change in carcinogenicity testing, a workshop titled “Genomics in Cancer Risk Assessment” brought together toxicologists from academia and industry and government regulators and risk assessors from the United States and the European Union. Participants discussed the state-of-the-art in developing alternative testing strategies for carcinogenicity, with emphasis on potential contributions from omics technologies. Results and Conclusions The goal of human risk assessment is to decide whether a given exposure to an agent is acceptable to human health and to provide risk management measures based on evaluating and predicting the effects of exposures on human health. Although exciting progress is being made using genomics approaches, a new paradigm that uses these methods and human material when possible would provide mechanistic insights that may inform new predictive approaches (e.g., in vitro assays) and facilitate the development of genomics-derived biomarkers. Regulators appear to be willing to accept such approaches where use is clearly defined, evidence is strong, and approaches are qualified for regulatory use. PMID:21147607

  15. Collegiate Alcohol Risk Assessment Guide.

    ERIC Educational Resources Information Center

    Anderson, David S.; Janosik, Steven M.

    An instrument to help administrators assess the liability resulting from alcohol-related activities on the college campus is presented. The hazards and associated liability of these events can be reduced by developing an aggressive risk management strategy designed to inform, educate, and coordinate the actions of individuals and groups associated…

  16. Picillo Farm ecological risk assessment

    SciTech Connect

    Rury, P.M.; Turton, D.J.

    1995-12-31

    Under the direction of US Environmental Protection Agency, Region 1, a baseline ecological risk assessment (ERA) was conducted for terrestrial, wetland, and aquatic ecosystems located on-site and off-site/downstream of a Superfund site in Coventry, Rhode Island. Surveys of biota and ecosystems were focused in the vicinity of 26 soil, sediment, and surface water sampling locations used for the RI/FS site contamination assessment, to cross-link data on biological receptors to site-specific habitat maps. Classes of contaminants of concern (COCs), selected independently for each medium based on exceedances of ecotoxicity criteria, for which risks to one or more indicator communities and species were calculated, included VOCs, SVOCs, metals, PCBs and pesticides. Simple hazard quotients were used to estimate risks for benthic and pelagic communities of the aquatic and wetland exposure zones, using AWQC and NOAA sediment guidelines. These aquatic criteria also were applied to a site-specific exposure models for all life stages of the Green Frog (Rana clamitans). To complement the benthic invertebrate risk estimates, site-derived sediments also were used for toxicity tests of Chironomus tentans and Hyalella azteca. Published, species-specific and/or extrapolated toxicity effects endpoints were used in site-specific, mathematical food chain exposure assessment models for the Amedcan Woodcock (Scolopax minor), Short-tailed Shrew (Blarina brevicauda) and Mink (Mustela vison), to estimate organismal risks for a variety of foraging scenarios within one or more exposure zone. Incremental site contributions to risks from metals were inferred using local background data, whereas all risks from organic compounds were assumed to be site-derived.

  17. Uncertainties in risk assessment at USDOE facilities

    SciTech Connect

    Hamilton, L.D.; Holtzman, S.; Meinhold, A.F.; Morris, S.C.; Rowe, M.D.

    1994-01-01

    The United States Department of Energy (USDOE) has embarked on an ambitious program to remediate environmental contamination at its facilities. Decisions concerning cleanup goals, choices among cleanup technologies, and funding prioritization should be largely risk-based. Risk assessments will be used more extensively by the USDOE in the future. USDOE needs to develop and refine risk assessment methods and fund research to reduce major sources of uncertainty in risk assessments at USDOE facilities. The terms{open_quote} risk assessment{close_quote} and{open_quote} risk management{close_quote} are frequently confused. The National Research Council (1983) and the United States Environmental Protection Agency (USEPA, 1991a) described risk assessment as a scientific process that contributes to risk management. Risk assessment is the process of collecting, analyzing and integrating data and information to identify hazards, assess exposures and dose responses, and characterize risks. Risk characterization must include a clear presentation of {open_quotes}... the most significant data and uncertainties...{close_quotes} in an assessment. Significant data and uncertainties are {open_quotes}...those that define and explain the main risk conclusions{close_quotes}. Risk management integrates risk assessment information with other considerations, such as risk perceptions, socioeconomic and political factors, and statutes, to make and justify decisions. Risk assessments, as scientific processes, should be made independently of the other aspects of risk management (USEPA, 1991a), but current methods for assessing health risks are based on conservative regulatory principles, causing unnecessary public concern and misallocation of funds for remediation.

  18. Probabilistic risk assessment familiarization training

    SciTech Connect

    Phillabaum, J.L.

    1989-01-01

    Philadelphia Electric Company (PECo) created a Nuclear Group Risk and Reliability Assessment Program Plan in order to focus the utilization of probabilistic risk assessment (PRA) in support of Limerick Generating Station and Peach Bottom Atomic Power Station. The continuation of a PRA program was committed by PECo to the U.S. Nuclear Regulatory Commission (NRC) prior to be the issuance of an operating license for Limerick Unit 1. It is believed that increased use of PRA techniques to support activities at Limerick and Peach Bottom will enhance PECo's overall nuclear excellence. Training for familiarization with PRA is designed for attendance once by all nuclear group personnel to understand PRA and its potential effect on their jobs. The training content describes the history of PRA and how it applies to PECo's nuclear activities. Key PRA concepts serve as the foundation for the familiarization training. These key concepts are covered in all classes to facilitate an appreciation of the remaining material, which is tailored to the audience. Some of the concepts covered are comparison of regulatory philosophy to PRA techniques, fundamentals of risk/success, risk equation/risk summation, and fault trees and event trees. Building on the concepts, PRA insights and applications are then described that are tailored to the audience.

  19. Behavioral assay for assessing effects of pollutants on fish chemoreception

    SciTech Connect

    Lemly, A.D.; Smith, R.J.

    1986-04-01

    Behavioral assays are sensitive to sublethal levels of pollution but they usually require highly trained personnel and long observation periods. We describe a system that combines the sensitivity of a behavioral assay with commercially available automated monitoring equipment. The observation system consists of a special aquarium coupled to a recirculating water system, and an Opto-Varimex-Aqua activity tracking meter (Columbus Instruments, Columbus, Ohio) interfaced to a microcomputer. The tracking meter forms an intersecting, planar grid of light beams which, when interrupted by fish movements, is translated into a digitized signal and fed to the computer. The assay is based on the response of fish to natural chemical stimuli such as food odors or pheromones. When these stimulus solutions are injected into the water circulation the response of the fish is monitored by the computer system, which is capable of discriminating and quantifying changes in eight parameters. Normal responses to stimuli are compared with the response of fish that have been exposed to pollutants. We have successfully used this technique to examine effects of reduced pH on the response of fathead minnows, Pimephales promelas, to chemical feeding stimuli. The system should be easily adapted to any laboratory concerned with testing for effects of toxic substances, and will identify effects of pollution that have thus far been difficult or impossible to assess.

  20. [Predictive microbiology and risk assessment].

    PubMed

    Hildebrandt, G; Kleer, J

    2004-05-01

    Predictive microbiology (predictive modelling PM), in spite of its limits and short-comings, may often contribute to a reduction of the problems arising when HACCP systems are established or microbiological risk assessment is done. Having identified the agents which constitute a risk and the contamination rate and density in the raw material, the influences of production steps and storage on these microorganisms have to be examined. Finally, there should be an exposure assessment, i.e. an estimate of the contamination density in the final product at the time of consumption. Should the exposure assessment together with data from dose response assessments reveal a potential for intake of inacceptable numbers of organisms, the risk identified has to be characterized. As a consequence, risk management should result in a modification of the composition of the product and/or of the production process so that the risk does not surpass an acceptable limit. For this approach it is indispensable to have product- and process-specific information on the multiplication of pathogens prior to heat treatment, on reduction of their density by thermal treatment and on growth or dying of organisms having survived heat treatment or penetrated into the product after heat treatment as post-process contaminant. Commonly, challenge tests are conducted to provide such information. But they are time consuming and, as their results are only valid for the specific product tested and the conditions prevailing during the experiment, the have to be repeated if there is any modification of intrinsic or extrinsic factors. At least partially, the PM may replace the challenge tests. The efficiency of the models is rated particularly high if they are used already at the stage of product development when the question has to be answered whether a planned recipe or process of production are already save or have to be modified to become save. PMID:15233338

  1. Ecosystem Services as Assessment Endpoints in Ecological Risk Assessment

    EPA Science Inventory

    The focus of ecological risk assessment (ERA) is on assessment endpoints, explicit expressions of environmental values to be protected. Traditionally, the ecological entities identified in assessment endpoints have been components of ecosystems deemed by risk assessors to be impo...

  2. Nuclear weapon system risk assessment

    SciTech Connect

    Carlson, D.D.

    1993-11-01

    Probabilistic risk assessment (PRA) is a process for evaluating hazardous operations by considering what can go wrong, the likelihood of these undesired events, and the resultant consequences. Techniques used in PRA originated in the 1960s. Although there were early exploratory applications to nuclear weapons and other technologies, the first major application of these techniques was in the Reactor Safety Study, WASH-1400, {sup 1} in which the risks of nuclear power accidents were thoroughly investigated for the first time. Recently, these techniques have begun to be adapted to nuclear weapon system applications. This report discusses this application to nuclear weapon systems.

  3. Ecological risk assessment: Lessons learned

    SciTech Connect

    DeShields, B.R.; Stelljes, M.E.; Hawkins, E.T.; Alsop, W.R.

    1995-12-31

    On the basis of experience with ecological risk assessments and regulatory involvement in the process, a number of lessons can be learned relating to design, implementation, and reporting of ecological risk assessments. A number of case studies will be presented in order to evaluate the advantages and disadvantages of different approaches. Issues surrounding the selection of assessment and measurement endpoints, receptors, accuracy of models when compared with field data, bioavailability of chemicals, selection of appropriate reference sites, availability of relevant toxicological data, utility of bioassays, and accounting for temporal and seasonal variability, species adaptation, and ecological relevance will be examined. In addition, effective ways of dealing with limitations such as duration and cost of the assessments will be evaluated. Case studies ranging from large, complex Superfund sites to small, relatively simplistic sites will be included. By scrutinizing the approaches used and the outcomes of these case studies, insight can be gained that will allow risk assessors to deal with limitations and to focus future efforts to provide useful and relevant information and sound scientifically-based results.

  4. Evaluation of In Vitro Assays For Assessing the Toxicity of Cigarette Smoke and Smokeless Tobacco

    PubMed Central

    Wan, J.; Johnson, M.; Schilz, J.; Djordjevic, M.V.; Rice, J.R.; Shields, P.G.

    2009-01-01

    Introduction In vitro toxicology studies of tobacco and tobacco smoke have been used to understand why tobacco use causes cancer and to assess the toxicological impact of tobacco product design changes. The need for toxicology studies has been heightened given that the FDA’s newly granted authority over tobacco products requires mandating performance standards for tobacco products and evaluate manufacturers’ health claims. The goal of this review is to critically evaluate in vitro toxicology methods related to cancer for assessing tobacco products and to identify related research gaps. Methods PubMed database searches were used to identify tobacco-related in vitro toxicology studies published since 1980. Articles published prior to 1980 with high relevance also were identified. The data was compiled to examine: 1) goals of the study; 2) methods for collecting test substances; 3) experimental designs; 4) toxicological endpoints, and; 5) relevance to cancer risk. Results A variety of in vitro assays are available to assess tobacco and tobacco smoke that address different modes of action, mostly using non-human cell models. Smokeless tobacco products perform poorly in these assays. While reliable as a screening tool for qualitative assessments, the available in vitro assays have been poorly validated for quantitative comparisons of different products. Assay batteries have not been developed, although they exist for non-tobacco assessments. Extrapolating data from in vitro studies to human risks remains hypothetical. Conclusions In vitro toxicology methods are useful for screening toxicity, but better methods are needed for today’s context of regulation and evaluation of health claims. PMID:19959677

  5. Reevaluating Interrater Reliability in Offender Risk Assessment

    ERIC Educational Resources Information Center

    van der Knaap, Leontien M.; Leenarts, Laura E. W.; Born, Marise Ph.; Oosterveld, Paul

    2012-01-01

    Offender risk and needs assessment, one of the pillars of the risk-need-responsivity model of offender rehabilitation, usually depends on raters assessing offender risk and needs. The few available studies of interrater reliability in offender risk assessment are, however, limited in the generalizability of their results. The present study…

  6. Assessing and Managing Risk with Suicidal Individuals

    ERIC Educational Resources Information Center

    Linehan, Marsh M.; Comtois, Katherine A.; Ward-Ciesielski, Erin F.

    2012-01-01

    The University of Washington Risk Assessment Protocol (UWRAP) and Risk Assessment and Management Protocol (UWRAMP) have been used in numerous clinical trials treating high-risk suicidal individuals over several years. These protocols structure assessors and treatment providers to provide a thorough suicide risk assessment, review standards of care…

  7. [Risk Assessment and Risk Management of Chemicals in China].

    PubMed

    Wang, Tie-yu; Zhou, Yun-qiao; Li, Qi-feng; Lü, Yong-long

    2016-02-15

    Risk assessment and risk management have been increasingly approved as an effective approach for appropriate disposal and scientific management of chemicals. This study systematically analyzed the risk assessment methods of chemicals from three aspects including health risk, ecological risk and regional risk. Based on the current situation of classification and management towards chemicals in China, a specific framework of risk management on chemicals was proposed by selecting target chemicals, predominant industries and related stakeholders as the objects. The results of the present study will provide scientific support for improving risk assessment and reasonable management of chemicals in China. PMID:27363124

  8. La Conchita Landslide Risk Assessment

    NASA Astrophysics Data System (ADS)

    Kropp, A.; Johnson, L.; Magnusen, W.; Hitchcock, C. S.

    2009-12-01

    Following the disastrous landslide in La Conchita in 2005 that resulted in ten deaths, the State of California selected our team to prepare a risk assessment for a committee of key stakeholders. The stakeholders represented the State of California, Ventura County, members of the La Conchita community, the railroad, and the upslope ranch owner (where the slide originated); a group with widely varying views and interests. Our team was charged with characterizing the major hazards, developing a series of mitigation concepts, evaluating the benefits and costs of mitigation, and gathering stakeholder input throughout the process. Two unique elements of the study were the methodologies utilized for the consequence assessment and for the decision-making framework. La Conchita is exposed to multiple slope hazards, each with differing geographical distributions, as well as depth and velocity characteristics. Three consequence matrices were developed so that the potential financial losses, structural vulnerabilities, and human safety exposure could be evaluated. The matrices utilized semi-quantitative loss evaluations (both financial and life safety) based on a generalized understanding of likely vulnerability and hazard characteristics. The model provided a quantitative estimate of cumulative losses over a 50-year period, including losses of life based on FEMA evaluation criteria. Conceptual mitigation options and loss estimates were developed to provide a range of risk management solutions that were feasible from a cost-benefit standpoint. A decision tree approach was adopted to focus on fundamental risk management questions rather than on specific outcomes since the committee did not have a consensus view on the preferred solution. These questions included: 1. Over what time period can risks be tolerated before implementation of decisions? 2. Whose responsibility is it to identify a workable risk management solution? 3. Who will own the project? The decision tree

  9. Risk assessment of shellfish toxins.

    PubMed

    Munday, Rex; Reeve, John

    2013-11-01

    Complex secondary metabolites, some of which are highly toxic to mammals, are produced by many marine organisms. Some of these organisms are important food sources for marine animals and, when ingested, the toxins that they produce may be absorbed and stored in the tissues of the predators, which then become toxic to animals higher up the food chain. This is a particular problem with shellfish, and many cases of poisoning are reported in shellfish consumers each year. At present, there is no practicable means of preventing uptake of the toxins by shellfish or of removing them after harvesting. Assessment of the risk posed by such toxins is therefore required in order to determine levels that are unlikely to cause adverse effects in humans and to permit the establishment of regulatory limits in shellfish for human consumption. In the present review, the basic principles of risk assessment are described, and the progress made toward robust risk assessment of seafood toxins is discussed. While good progress has been made, it is clear that further toxicological studies are required before this goal is fully achieved. PMID:24226039

  10. Risk Assessment of Shellfish Toxins

    PubMed Central

    Munday, Rex; Reeve, John

    2013-01-01

    Complex secondary metabolites, some of which are highly toxic to mammals, are produced by many marine organisms. Some of these organisms are important food sources for marine animals and, when ingested, the toxins that they produce may be absorbed and stored in the tissues of the predators, which then become toxic to animals higher up the food chain. This is a particular problem with shellfish, and many cases of poisoning are reported in shellfish consumers each year. At present, there is no practicable means of preventing uptake of the toxins by shellfish or of removing them after harvesting. Assessment of the risk posed by such toxins is therefore required in order to determine levels that are unlikely to cause adverse effects in humans and to permit the establishment of regulatory limits in shellfish for human consumption. In the present review, the basic principles of risk assessment are described, and the progress made toward robust risk assessment of seafood toxins is discussed. While good progress has been made, it is clear that further toxicological studies are required before this goal is fully achieved. PMID:24226039

  11. A High Content Assay to Assess Cellular Fitness

    PubMed Central

    Antczak, Christophe; Mahida, Jeni P.; Singh, Chanpreet; Calder, Paul A.; Djaballah, Hakim

    2013-01-01

    A universal process in experimental biology is the use of engineered cells; more often, stably or transiently transfected cells are generated for the purpose. Therefore, it is important that cell health assessment is conducted to check for stress mediated by induction of heat shock proteins (Hsps). For this purpose, we have developed an integrated platform that would enable a direct assessment of transfection efficiency (TE) combined with cellular toxicity and stress response. We make use of automated microscopy and high content analysis to extract from the same well a multiplexed readout to assess and determine optimal chemical transfection conditions. As a proof of concept, we investigated seven commercial reagents, in a matrix of dose and time, to study transfection of an EGFP DNA plasmid into HeLa cells and their consequences on health and fitness; where we scored for cellular proliferation, EGFP positive cells, and induction of Hsp10 and Hsp70 as makers of stress responses. FuGENE HD emerged as the most optimal reagent with no apparent side effects suitable for performing microtiter based miniaturized transfection for both chemical and RNAi screening. In summary, we report on a high content assay method to assess cellular overall fitness upon chemical transfection. PMID:23957721

  12. Risk Assessment-- A Science in Controversy.

    ERIC Educational Resources Information Center

    Ravetz, J. R.

    1982-01-01

    Discusses principle themes/issues of risk assessment, using examples from the "nuclear debate." Indicates that while an objective scientific core to decisions on risks exists, this is conditioned in its interpretation by inexactness, uncertainty, and value-commitments. Considers risk assessment elements, risk quantification in real problems, and…

  13. ECO 201: Overview of Ecological Risk Assessment

    EPA Science Inventory

    The objectives of this course is to provide participants with knowledge about the fundamentals of ecological risk assessment. A brief history of how ecological risk assessment has evolved over time and how it is both similar to and different from human health risk assessment wil...

  14. Human factors and risk assessment

    SciTech Connect

    Al-Minhali, A.

    1996-11-01

    A case study was presented in the 1994 Abu Dhabi International Exhibition and Conference (ADIPEC, 94) which discussed the importance of investigating human factors in the design of a high integrity protection system (HIPS) to be installed on an offshore high pressure gas platform, (SPE reference ADSPE 80). This paper will follow up on the design changes, installation and operation of the HIPS with emphasis on practical implications as a result of improper integration of human factors in the system reliability and risk assessment studies.

  15. Risks, risk assessment and risk competence in toxicology

    PubMed Central

    Stahlmann, Ralf; Horvath, Aniko

    2015-01-01

    Understanding the toxic effects of xenobiotics requires sound knowledge of physiology and biochemistry. The often described lack of understanding pharmacology/toxicology is therefore primarily caused by the general absence of the necessary fundamental knowledge. Since toxic effects depend on exposure (or dosage) assessing the risks arising from toxic substances also requires quantitative reasoning. Typically public discussions nearly always neglect quantitative aspects and laypersons tend to disregard dose-effect-relationships. One of the main reasons for such disregard is the fact that exposures often occur at extremely low concentrations that can only be perceived intellectually but not by the human senses. However, thresholds in the low exposure range are often scientifically disputed. At the same time, ignorance towards known dangers is wide-spread. Thus, enhancing the risk competence of laypersons will have to be initially restricted to increasing the awareness of existing problems. PMID:26195922

  16. HPV16 Seropositivity and Subsequent HPV16 Infection Risk in a Naturally Infected Population: Comparison of Serological Assays

    PubMed Central

    Lin, Shih-Wen; Ghosh, Arpita; Porras, Carolina; Markt, Sarah C.; Rodriguez, Ana Cecilia; Schiffman, Mark; Wacholder, Sholom; Kemp, Troy J.; Pinto, Ligia A.; Gonzalez, Paula; Wentzensen, Nicolas; Esser, Mark T.; Matys, Katie; Meuree, Ariane; Quint, Wim; van Doorn, Leen-Jan; Herrero, Rolando; Hildesheim, Allan; Safaeian, Mahboobeh

    2013-01-01

    Background Several serological assays have been developed to detect antibodies elicited against infections with oncogenic human papillomavirus (HPV) type 16. The association between antibody levels measured by various assays and subsequent HPV infection risk may differ. We compared HPV16-specific antibody levels previously measured by a virus-like particle (VLP)-based direct enzyme-linked immunoassay (ELISA) with levels measured by additional assays and evaluated the protection against HPV16 infection conferred at different levels of the assays. Methodology/Principal Findings Replicate enrollment serum aliquots from 388 unvaccinated women in the control arm of the Costa Rica HPV vaccine trial were measured for HPV16 seropositivity using three serological assays: a VLP-based direct ELISA; a VLP-based competitive Luminex immunoassay (cLIA); and a secreted alkaline phosphatase protein neutralization assay (SEAP-NA). We assessed the association of assay seropositivity and risk of subsequent HPV16 infection over four years of follow-up by calculating sampling-adjusted odds ratios (OR) and HPV16 seropositivity based on standard cutoff from the cLIA was significantly associated with protection from subsequent HPV16 infection (OR = 0.48, CI = 0.27–0.86, compared with seronegatives). Compared with seronegatives, the highest seropositive tertile antibody levels from the direct ELISA (OR = 0.53, CI = 0.28–0.90) as well as the SEAP-NA (OR = 0.20, CI = 0.06, 0.64) were also significantly associated with protection from HPV16 infection. Conclusions/Significance Enrollment HPV16 seropositivity by any of the three serological assays evaluated was associated with protection from subsequent infection, although cutoffs for immune protection were different. We defined the assays and seropositivity levels after natural infection that better measure and translate to protective immunity. PMID:23301022

  17. Operant assays for assessing pain in preclinical rodent models: highlights from an orofacial assay.

    PubMed

    Murphy, Niall P; Mills, Richard H; Caudle, Robert M; Neubert, John K

    2014-01-01

    Despite an immense investment of resources, pain remains at epidemic proportions. Given this, there has been an increased effort toward appraising the process by which new painkillers are developed, focusing specifically on why so few analgesics make it from the benchside to the bedside. The use of behavioral assays and animal modeling for the preclinical stages of analgesic development is being reexamined to determine whether they are truly relevant, meaningful, and predictive. Consequently, there is a strengthening consensus that the traditional reflex-based assays upon which several decades of preclinical pain research has been based are inadequate. Thus, investigators have recently turned to the development of new preclinical assays with improved face, content, and predictive validity. In this regard, operant pain assays show considerable promise, as they are more sensitive, present better validity, and, importantly, better encompass the psychological and affective dimensions of pain that trouble human pain sufferers. Here, we briefly compare and contrast reflex assays with operant assays, and we introduce a particular operant orofacial pain assay used in a variety of experiments to emphasize how operant pain assays can be applied to preclinical studies of pain. PMID:25103871

  18. RISK AND RISK ASSESSMENT IN WATER-BASED RECREATION

    EPA Science Inventory

    The great number of individuals using recreational water resources presents a challenge with regard to protecting the health of these recreationists. Risk assessment provides a framework for characterizing the risk associated with exposure to microbial hazards and for managing r...

  19. Biotoxicity assessment of pyrene in soil using a battery of biological assays.

    PubMed

    Khan, Muhammad Imran; Cheema, Sardar Alam; Tang, Xianjin; Shen, Chaofeng; Sahi, Shahbaz Talib; Jabbar, Abdul; Park, Joonhong; Chen, Yingxu

    2012-11-01

    A test battery, composed of a range of biological assays, was applied to evaluate the ecological health of soil aged for 69 days and spiked with a range of pyrene levels (1.04, 8.99, 41.5, 72.6, 136, and 399 μg g(-1) dry soil; Soxhlet-extracted concentrations after 69 days of aging). Chinese cabbage (Brassica rapa), earthworm (Eisenia fetida), and bacteria (Vibrio fischeri) were used as test organisms to represent different trophic levels. Among the acute ecotoxicity bioassays used, the V. fischeri luminescence inhibition assay was the most sensitive indicator of pyrene toxicity. We observed >8 % light inhibition at the lowest concentration (1.04 μg g(-1)) pyrene, and this inhibition increased to 60 % at 72.6 μg g(-1). The sensitivity ranking for toxicity of the pyrene-contaminated soil in the present study was in the following decreasing order: root elongation of Chinese cabbage < earthworm mortality (14 days) < earthworm mortality (28 days) < luminescence inhibition (15 min) < luminescence inhibition (5 min). In addition, genotoxic effects of pyrene were also evaluated by using comet assay in E. fetida. The strong relationship between DNA damage and soil pyrene levels showed that comet assay is suitable for testing the genotoxicity of pyrene-polluted soil. In addition, tail moment was well correlated with soil pyrene levels (r (2) = 0.99). Thus, tail moment may be the most informative DNA-damage parameter representing the results of comet assay. Based on these results, the earthworm DNA damage assay and Microtox test are rapid and sensitive bioassays and can be used to assess the risk of soil with low to high levels of hydrocarbon pollution. Furthermore, an analysis of the toxic effects at several trophic levels is essential for a more comprehensive understanding of the damage caused by highly contaminated soil. PMID:22941450

  20. A Quantitative Toxicogenomics Assay for High-throughput and Mechanistic Genotoxicity Assessment and Screening of Environmental Pollutants.

    PubMed

    Lan, Jiaqi; Gou, Na; Rahman, Sheikh Mokhles; Gao, Ce; He, Miao; Gu, April Z

    2016-03-15

    The ecological and health concern of mutagenicity and carcinogenicity potentially associated with an overwhelmingly large and ever-increasing number of chemicals demands for cost-effective and feasible method for genotoxicity screening and risk assessment. This study proposed a genotoxicity assay using GFP-tagged yeast reporter strains, covering 38 selected protein biomarkers indicative of all the seven known DNA damage repair pathways. The assay was applied to assess four model genotoxic chemicals, eight environmental pollutants and four negative controls across six concentrations. Quantitative molecular genotoxicity end points were derived based on dose response modeling of a newly developed integrated molecular effect quantifier, Protein Effect Level Index (PELI). The molecular genotoxicity end points were consistent with multiple conventional in vitro genotoxicity assays, as well as with in vivo carcinogenicity assay results. Further more, the proposed genotoxicity end point PELI values quantitatively correlated with both comet assay in human cell and carcinogenicity potency assay in mice, providing promising evidence for linking the molecular disturbance measurements to adverse outcomes at a biological relevant level. In addition, the high-resolution DNA damaging repair pathway alternated protein expression profiles allowed for chemical clustering and classification. This toxicogenomics-based assay presents a promising alternative for fast, efficient and mechanistic genotoxicity screening and assessment of drugs, foods, and environmental contaminants. PMID:26855253

  1. Risk assessment of silver nanoparticles

    NASA Astrophysics Data System (ADS)

    Shipelin, V. A.; Gmoshinski, I. V.; Khotimchenko, S. A.

    2015-11-01

    Nanoparticles of metallic silver (Ag) are among the most widely used products of nanotechnology. Nanosized colloidal silver (NCS) is presented in many kinds of production as solutions of particles with diameter less than 100 nm. NCS is used in a variety of fields, including food supplements, medicines, cosmetics, packaging materials, disinfectants, water filters, and many others. Problems of toxicity and related safety of NCS for humans and environmental systems are recently overestimated basing on data of numerous toxicological studies in vitro and in vivo. The article discusses the results of current studies in recent years and the data of author's own experiments on studying the safety of NCS, that allows to move on to risk assessment of this nanomaterial presented in consumer products and environmental samples.

  2. Risk assessment of metal vapor arcing

    NASA Technical Reports Server (NTRS)

    Hill, Monika C. (Inventor); Leidecker, Henning W. (Inventor)

    2009-01-01

    A method for assessing metal vapor arcing risk for a component is provided. The method comprises acquiring a current variable value associated with an operation of the component; comparing the current variable value with a threshold value for the variable; evaluating compared variable data to determine the metal vapor arcing risk in the component; and generating a risk assessment status for the component.

  3. Assessing risks to ecosystem quality

    SciTech Connect

    Barnthouse, L.W.

    1995-12-31

    Ecosystems are not organisms. Because ecosystems do not reproduce, grow old or sick, and die, the term ecosystem health is somewhat misleading and perhaps should not be used. A more useful concept is ``ecosystem quality,`` which denotes a set of desirable ecosystem characteristics defined in terms of species composition, productivity, size/condition of specific populations, or other measurable properties. The desired quality of an ecosystem may be pristine, as in a nature preserve, or highly altered by man, as in a managed forest or navigational waterway. ``Sustainable development`` implies that human activities that influence ecosystem quality should be managed so that high-quality ecosystems are maintained for future generations. In sustainability-based environmental management, the focus is on maintaining or improving ecosystem quality, not on restricting discharges or requiring particular waste treatment technologies. This approach requires management of chemical impacts to be integrated with management of other sources of stress such as erosion, eutrophication, and direct human exploitation. Environmental scientists must (1) work with decision makers and the public to define ecosystem quality goals, (2) develop corresponding measures of ecosystem quality, (3) diagnose causes for departures from desired states, and (4) recommend appropriate restoration actions, if necessary. Environmental toxicology and chemical risk assessment are necessary for implementing the above framework, but they are clearly not sufficient. This paper reviews the state-of-the science relevant to sustaining the quality of aquatic ecosystems. Using the specific example of a reservoir in eastern Tennessee, the paper attempts to define roles for ecotoxicology and risk assessment in each step of the management process.

  4. Limitations and relative utility of screening assays to assess engineered nanoparticle toxicity in a human cell line

    SciTech Connect

    Monteiro-Riviere, N.A.; Inman, A.O.; Zhang, L.W.

    2009-01-15

    Single-walled carbon nanotubes (SWCNT), fullerenes (C{sub 60}), carbon black (CB), nC{sub 60}, and quantum dots (QD) have been studied in vitro to determine their toxicity in a number of cell types. Here, we report that classical dye-based assays such as MTT and neutral red (NR) that determine cell viability produce invalid results with some NM (nanomaterials) due to NM/dye interactions and/or NM adsorption of the dye/dye products. In this study, human epidermal keratinocytes (HEK) were exposed in vitro to CB, SWCNT, C{sub 60}, nC{sub 60}, and QD to assess viability with calcein AM (CAM), Live/Dead (LD), NR, MTT, Celltiter 96 AQueous One (96 AQ), alamar Blue (aB), Celltiter-Blue (CTB), CytoTox One{sup TM} (CTO), and flow cytometry. In addition, trypan blue (TB) was quantitated by light microscopy. Assay linearity (R{sup 2} value) was determined with HEK plated at concentrations from 0 to 25,000 cells per well in 96-well plates. HEK were treated with serial dilutions of each NM for 24 h and assessed with each of the viability assays. TB, CAM and LD assays, which depend on direct staining of living and/or dead cells, were difficult to interpret due to physical interference of the NM with cells. Results of the dye-based assays varied a great deal, depending on the interactions of the dye/dye product with the carbon nanomaterials (CNM). Results show the optimal high throughput assay for use with carbon and noncarbon NM was 96 AQ. This study shows that, unlike small molecules, CNM interact with assay markers to cause variable results with classical toxicology assays and may not be suitable for assessing nanoparticle cytotoxicity. Therefore, more than one assay may be required when determining nanoparticle toxicity for risk assessment.

  5. Assessment of the integrity of compounds stored in assay-ready plates using a kinase sentinel assay.

    PubMed

    Chen, Ada; Zhao, Xiaoning; Mercer, Laina; Su, Cheng; Zalameda, Leeanne; Liu, Yichin; Lembke, Amanda; Eastwood, Heather; Dang, Son; Oung, Thim; Xia, Xiaoyang; Young, Stephen W; Xiao, Shouhua; McCarter, John D

    2013-09-01

    Sentinel assays are a convenient adjunct to LC-MS purity assessment to monitor the integrity of compounds in pharmaceutical screening collections over time. To assess the stability of compounds stored both at room temperature and at -20°C in assay-ready plates that were either vacuum pack-sealed using a convenient industrial vacuum sealing method or individually sealed using conventional foil seals, a diverse collection of ~ 5,000 compounds was assayed using a robust biochemical kinase assay at intervals over a one year period. Assay results at each time point were compared to those of initial assay using a series of correlations of compound Percent of Control (POC) values as well as IC50 values of a subset of compounds in 200 nL or 500 nL plates. The fraction of hits in common between initial assays and assays at later time points ranged from 82% to 95% over one year and remained relatively constant over time with all storage temperatures or sealing methods tested. A majority of the hits that exhibited a consistent gradual trend to lower potency over one year storage were shifted to lower potency upon the rapid removal of DMSO solvent. Compound precipitation rather than compound decomposition is the likely reason for trends to lower potency for most such compounds over the storage period. Plates stored at room temperature featured a significantly higher fraction of hits that exhibited a trend to lower apparent potency than those stored at -20°C suggesting that this lower temperature is preferable for longer-term storage. PMID:23651141

  6. Environmental risk assessment of paroxetine.

    PubMed

    Cunningham, Virginia L; Constable, David J C; Hannah, Robert E

    2004-06-15

    watershed-based environmental risk assessment model, PhATE, to predict environmental concentrations (PECs). Comparison of the calculated PECs with the PNEC allows an assessment of potential environmental risk. Within the 1-99% of stream segments in the PhATE model, PEC values ranged from 0.003 to 100 ng/L. The risk assessment PEC/PNEC ratios ranged from approximately 3 x 10(-8) to approximately 3 x 10(-3), indicating a wide margin of safety, since a PEC/PNEC ratio <1 is generally considered to represent a low risk to the environment. In addition, Microtox studies carried out on PM biodegradation byproducts indicated no detectable residual toxicity. Any compounds in the environment as a result of the biodegradation of PM should be innocuous polar byproducts that should not exert any toxic effects. PMID:15260335

  7. INCORPORATING NONCHEMICAL STRESSORS INTO CUMMULATIVE RISK ASSESSMENTS

    EPA Science Inventory

    The risk assessment paradigm has begun to shift from assessing single chemicals using "reasonable worst case" assumptions for individuals to considering multiple chemicals and community-based models. Inherent in community-based risk assessment is examination of all stressors a...

  8. [Urban ecological risk assessment: a review].

    PubMed

    Wang, Mei-E; Chen, Wei-Ping; Peng, Chi

    2014-03-01

    With the development of urbanization and the degradation of urban living environment, urban ecological risks caused by urbanization have attracted more and more attentions. Based on urban ecology principles and ecological risk assessment frameworks, contents of urban ecological risk assessment were reviewed in terms of driven forces, risk resources, risk receptors, endpoints and integrated approaches for risk assessment. It was suggested that types and degrees of urban economical and social activities were the driven forces for urban ecological risks. Ecological functional components at different levels in urban ecosystems as well as the urban system as a whole were the risk receptors. Assessment endpoints involved in changes of urban ecological structures, processes, functional components and the integrity of characteristic and function. Social-ecological models should be the major approaches for urban ecological risk assessment. Trends for urban ecological risk assessment study should focus on setting a definite protection target and criteria corresponding to assessment endpoints, establishing a multiple-parameter assessment system and integrative assessment approaches. PMID:24984514

  9. A Quantitative Software Risk Assessment Model

    NASA Technical Reports Server (NTRS)

    Lee, Alice

    2002-01-01

    This slide presentation reviews a risk assessment model as applied to software development. the presentation uses graphs to demonstrate basic concepts of software reliability. It also discusses the application to the risk model to the software development life cycle.

  10. DEVELOPMENT OF APPROACHES FOR CUMULATIVE RISK ASSESSMENT

    EPA Science Inventory

    A population focused cumulative health risk assessment of a contaminated site or situation can include the evaluation of toxic risk from multiple chemicals, by multiple pathways, over different time frames of exposure, with multiple sensitive population subgroups, and possibly ot...

  11. Colon Cancer Risk Assessment - Gauss Program

    Cancer.gov

    An executable file (in GAUSS) that projects absolute colon cancer risk (with confidence intervals) according to NCI’s Colorectal Cancer Risk Assessment Tool (CCRAT) algorithm. GAUSS is not needed to run the program.

  12. Bioassay-based risk assessment of complex mixtures

    SciTech Connect

    Donnelly, K.C.; Safe, S.H.; Randerath, K.; Randerath, E.

    1994-12-31

    To compare the standard chemical-based risk assessment with in vitro genotoxicity assays, two complex environmental mixtures from a wood preserving site were analyzed in the Salmonella/microsome and E. coli prophage induction assays. Using GC/MS, sample 003 was found to contain relatively low levels of polycyclic aromatic hydrocarbons (PNAs) and elevated levels of polychlorinated dibenzo-p-dioxins (PCDDs), while sample 005 had higher levels of PNAs and relatively low levels of PCDDs. The complex mixtures were sequentially extracted with methylene chloride and methanol for analysis in Salmonella, or extracted with 1:1 hexane: acetone mixture for analysis in the prophage induction assay. At a dose of 1.0 mg/plate in Salmonella strain TA98 with metabolic activation, the methanol extract of sample 003 induced 197 net revertants, while sample 005 induced 436 net revertants. In the prophage induction assay, with activation, the hexane:acetone extract of sample 003 induced a fold increase that was slightly lower than that observed with sample 005. The estimated incremental carcinogenic risk for dermal adsorption and ingestion was 1.5E-3 for sample 003, while for sample 005 the estimated risk was 1.5E-2. Thus, the sample which induced the maximum response in both bioassays also had the highest estimated cancer risk. However, the frequency of PNA-DNA adducts in both skin and liver tissues was appreciably higher with sample 005 than with sample 003.

  13. Issues in risk assessment. Final report

    SciTech Connect

    Not Available

    1993-01-01

    The volume is the first in a series to be prepared by the Committee on Risk Assessment Methodology (CRAM) in the National Research Council's Board on Enviromental Studies and Toxicology. Three issues related to risk assessment are addressed here: use of the maximum tolerated dose (MTD) in animal bioassays for carcinogenicity, the two-state model of carcinogenesis, and a paradigm for ecologic risk assessment.

  14. [Forest health ecological risk assessment in China].

    PubMed

    Xiao, Fengjin; Ouyang, Hua; Cheng, Shulan; Zhang, Qiang

    2004-02-01

    Forest health ecological risk assessment is an important factor in forest resources management. In this paper, we selected forest fire, forest disease-pest disasters and acid rain as main risk sources, described the risk resources by probability, intensity and distributing, and mapped each risk source. The endpoints were the damages that the risk acceptor might and these damages might cause ecosystems' organization and function changing under the uncertainty risk sources. Endpoints of forest might compose of productivity descent, reducing biodiversity, forest degrading, forest ecological function declining, furthermore, forest disappearing. We described exposure in terms of intensity, space, and time. In the exposure and hazard analysis, we used fragile index to show frangibility or resistibility (resistibility is reverse to frangibility), and analyzed the damages by different risk sources. Risk assessment and management was the integrated phase of the research. Because of the spatial heterogeneity of risk sources, all risk index were overlaid in the China map by GIS, which divided the region into 30 ecological risk sub-zones (provinces), according to risk index of each risk sub-zone, and the forest in China was divided into six levels of risk zones. In every level of risk zones, we also put forward the countermeasures for forest health ecological risk management. The result of assessment could provide scientific basis for forest management. PMID:15146655

  15. Recombinant virus assay: a rapid, phenotypic assay for assessment of drug susceptibility of human immunodeficiency virus type 1 isolates.

    PubMed Central

    Kellam, P; Larder, B A

    1994-01-01

    Antiviral drug susceptibility assays for clinical human immunodeficiency virus type 1 (HIV-1) isolates are required to monitor the development of drug resistance during clinical trials and antiretroviral drug therapy. First-generation phenotypic assays possess a number of drawbacks, not least the selection of unrepresentative virus populations during cocultivation. Here we describe a rapid phenotypic assay for the assessment of the susceptibility of clinical isolates to reverse transcriptase (RT) inhibitors. This procedure, called the recombinant virus assay, allows the generation of viable virus by homologous recombination of a PCR-derived pool of RT coding sequences into an RT-deleted, noninfectious proviral clone, pHIV delta BstEII. A nested PCR procedure has been optimized to allow the amplification of an RT pool from both uncultured and cocultured infected patient peripheral blood lymphocyte (PBL) DNA for subsequent use in the creation of recombinant viruses. Analysis of two patients during the course of zidovudine therapy showed that this approach produced viruses which accurately exhibited the same genotype and phenotype as that of the original infected PBL DNA. The recombinant virus assay can be performed in approximately 3 weeks without the use of donor PBLs and therefore represents a rapid, nonselective procedure for the assay of clinical isolates. Images PMID:8141575

  16. Metal Vapor Arcing Risk Assessment Tool

    NASA Technical Reports Server (NTRS)

    Hill, Monika C.; Leidecker, Henning W.

    2010-01-01

    The Tin Whisker Metal Vapor Arcing Risk Assessment Tool has been designed to evaluate the risk of metal vapor arcing and to help facilitate a decision toward a researched risk disposition. Users can evaluate a system without having to open up the hardware. This process allows for investigating components at risk rather than spending time and money analyzing every component. The tool points to a risk level and provides direction for appropriate action and documentation.

  17. Integrated Environmental Modeling: Quantitative Microbial Risk Assessment

    EPA Science Inventory

    The presentation discusses the need for microbial assessments and presents a road map associated with quantitative microbial risk assessments, through an integrated environmental modeling approach. A brief introduction and the strengths of the current knowledge are illustrated. W...

  18. Practical Education through Risk Assessment Case Studies

    NASA Astrophysics Data System (ADS)

    Tokai, Akihiro

    Although, the staff for assessing environmental risk of chemicals is required in individual units of industrial sectors, there are very few systemic academic curriculums on risk assessment of chemicals in Japanese institutions of higher education. In order to meet such a social needs, Osaka University opened a limited-period program of environmental risk management for both students and working people in 2005. The author describes the contribution of his experience in offering a course on environmental risk assessment of chemicals as a part of the program. The course afforded students a kind of practical training for risk assessment. This paper also involves what to do for strengthening the education activity of risk assessment.

  19. Quantitative assessment of hemadsorption by myxoviruses: virus hemadsorption assay.

    PubMed

    Hahon, N; Booth, J A; Eckert, H L

    1973-04-01

    The standardization and quantitative evaluation of an assay for myxoviruses, based on the enumeration of individual infected clone 1-5C-4 cells manifesting hemadsorption within 24 h of infection, are described. Hemadsorption was detectable earlier than immunofluorescence in infected cells or hemagglutinins in culture medium. The relationship between virus concentration and cells exhibiting hemadsorption was linear. The assay was highly precise, sensitive, and reproducible. PMID:4349248

  20. Risk Assessment Update: Russian Segment

    NASA Technical Reports Server (NTRS)

    Christiansen, Eric; Lear, Dana; Hyde, James; Bjorkman, Michael; Hoffman, Kevin

    2012-01-01

    BUMPER-II version 1.95j source code was provided to RSC-E- and Khrunichev at January 2012 MMOD TIM in Moscow. MEMCxP and ORDEM 3.0 environments implemented as external data files. NASA provided a sample ORDEM 3.0 g."key" & "daf" environment file set for demonstration and benchmarking BUMPER -II v1.95j installation at the Jan-12 TIM. ORDEM 3.0 has been completed and is currently in beta testing. NASA will provide a preliminary set of ORDEM 3.0 ".key" & ".daf" environment files for the years 2012 through 2028. Bumper output files produced using the new ORDEM 3.0 data files are intended for internal use only, not for requirements verification. Output files will contain these words ORDEM FILE DESCRIPTION = PRELIMINARY VERSION: not for production. The projectile density term in many BUMPER-II ballistic limit equations will need to be updated. Cube demo scripts and output files delivered at the Jan-12 TIM have been updated for the new ORDEM 3.0 data files. Risk assessment results based on ORDEM 3.0 and MEM will be presented for the Russian Segment (RS) of ISS.

  1. Risk communication in environmental assessment

    SciTech Connect

    Rahm-Crites, L.

    1996-08-26

    Since the enactment of NEPA and other environmental legislation, the concept of `risk communication` has expanded from simply providing citizens with scientific information about risk to exploring ways of making risk information genuinely meaningful to the public and facilitating public involvement in the very processes whereby risk is analyzed and managed. Contemporary risk communication efforts attempt to find more effective ways of conveying increasingly complex risk information and to develop more democratic and proactive approaches to community involvement, in particular to ensuring the participation of diverse populations in risk decisions. Although considerable progress has been made in a relatively short time, risk communication researchers and practitioners currently face a number of challenges in a time of high expectations, low trust, and low budgets.

  2. Development of APE1 enzymatic DNA repair assays: low APE1 activity is associated with increase lung cancer risk.

    PubMed

    Sevilya, Ziv; Leitner-Dagan, Yael; Pinchev, Mila; Kremer, Ran; Elinger, Dalia; Lejbkowicz, Flavio; Rennert, Hedy S; Freedman, Laurence S; Rennert, Gad; Paz-Elizur, Tamar; Livneh, Zvi

    2015-09-01

    The key role of DNA repair in removing DNA damage and minimizing mutations makes it an attractive target for cancer risk assessment and prevention. Here we describe the development of a robust assay for apurinic/apyrimidinic (AP) endonuclease 1 (APE1; APEX1), an essential enzyme involved in the repair of oxidative DNA damage. APE1 DNA repair enzymatic activity was measured in peripheral blood mononuclear cell protein extracts using a radioactivity-based assay, and its association with lung cancer was determined using conditional logistic regression with specimens from a population-based case-control study with 96 lung cancer cases and 96 matched control subjects. The mean APE1 enzyme activity in case patients was 691 [95% confidence interval (CI) = 655-727] units/ng protein, significantly lower than in control subjects (mean = 793, 95% CI = 751-834 units/ng protein, P = 0.0006). The adjusted odds ratio for lung cancer associated with 1 SD (211 units) decrease in APE1 activity was 2.0 (95% CI = 1.3-3.1; P = 0.002). Comparison of radioactivity- and fluorescence-based assays showed that the two are equivalent, indicating no interference by the fluorescent tag. The APE1Asp148Glu SNP was associated neither with APE1 enzyme activity nor with lung cancer risk. Taken together, our results indicate that low APE1 activity is associated with lung cancer risk, consistent with the hypothesis that 'bad DNA repair', rather than 'bad luck', is involved in cancer etiology. Such assays may be useful, along with additional DNA repair biomarkers, for risk assessment of lung cancer and perhaps other cancers, and for selecting individuals to undergo early detection techniques such as low-dose CT. PMID:26045303

  3. Assessing reservoir operations risk under climate change

    USGS Publications Warehouse

    Brekke, L.D.; Maurer, E.P.; Anderson, J.D.; Dettinger, M.D.; Townsley, E.S.; Harrison, A.; Pruitt, T.

    2009-01-01

    Risk-based planning offers a robust way to identify strategies that permit adaptive water resources management under climate change. This paper presents a flexible methodology for conducting climate change risk assessments involving reservoir operations. Decision makers can apply this methodology to their systems by selecting future periods and risk metrics relevant to their planning questions and by collectively evaluating system impacts relative to an ensemble of climate projection scenarios (weighted or not). This paper shows multiple applications of this methodology in a case study involving California's Central Valley Project and State Water Project systems. Multiple applications were conducted to show how choices made in conducting the risk assessment, choices known as analytical design decisions, can affect assessed risk. Specifically, risk was reanalyzed for every choice combination of two design decisions: (1) whether to assume climate change will influence flood-control constraints on water supply operations (and how), and (2) whether to weight climate change scenarios (and how). Results show that assessed risk would motivate different planning pathways depending on decision-maker attitudes toward risk (e.g., risk neutral versus risk averse). Results also show that assessed risk at a given risk attitude is sensitive to the analytical design choices listed above, with the choice of whether to adjust flood-control rules under climate change having considerably more influence than the choice on whether to weight climate scenarios. Copyright 2009 by the American Geophysical Union.

  4. Ecological risk assessment framework -- the NAS perspective

    SciTech Connect

    Barnthouse, L.W.

    1993-06-01

    A Workshop on Ecological Risk Assessment was held on February 26--March 1, 1991, at Airlie House, Warrenton, Virginia. In addition to presentation and discussion of the case study papers, the workshop included breakout sessions to discuss conceptual and technical aspects of ecological risk assessment. A general consensus emerged that an ecological version of the 1983 framework is desirable and feasible. The committee concluded that the 1983 human health framework could be expanded to accomodate both human health and ecological risk assessment. For general applicability to ecological assessments, the 1983 scheme requires augmentation to address some of the interfaces between science and management, primarily because of the need to focus on appropriate questions relevant to applicable environmental law and policy under different circumstances. Specifically, the scheme needs modification to address (1) the influence of legal and regulatory considerations on the initial stages of ecological risk assessment and (2) the importance of characterizing ecological risks in terms that are intelligible to risk managers. The committee`s opinion is that these augmentations are as important for human health risk assessment as they are for ecological risk assessment. This paper briefly describes the framework recommended by the Committee and compares it to EPA`s recently-published Framework for Ecological Risk Assessment.

  5. Toward a Molecular Equivalent Dose: Use of the Medaka Model in Comparative Risk Assessment.

    EPA Science Inventory

    Recent challenges in risk assessment underscore the need to compare the results of toxicity and dose-response testing among a growing list of animal models and, possibly, an array of in vitro screening assays. Assays that quantify types of DNA damage that are directly relevant to...

  6. Current Challenges in Neurotoxicity Risk Assessment

    EPA Science Inventory

    Neurotoxicity risk assessment must continue to evolve in parallel with advances in basic research. Along with this evolution is an expansion in the scope of neurotoxicity assessments of environmental health risks. Examples of this expansion include an increasing emphasis on compl...

  7. Assessment Tools for the Evaluation of Risk

    EPA Science Inventory

    ASTER (Assessment Tools for the Evaluation of Risk) was developed by the U.S. EPA Mid-Continent Ecology Division, Duluth, MN to assist regulators in performing ecological risk assessments. ASTER is an integration of the ECOTOXicology Database (ECOTOX; Assessing nanoparticle risk poses prodigious challenges

    EPA Science Inventory

    Risk assessment is used both formally and informally to estimate the likelihood of an adverse event occurring, for example, as a consequence of exposure to a hazardous chemical, drug or other agent. Formal risk assessments in government regulatory agencies have a long history of ...

  8. LINES OF EVIDENCE IN WILDLIFE RISK ASSESSMENTS

    EPA Science Inventory

    Ecological risk assessment has evolved rapidly from a qualitative set of observations to a quantitative science during the past decade. Methods for assessing risk to wildlife, however, remain largely theoretical as the empirical data required for accurate estimates of exposure o...

  9. Risk Assessment and Stewardship of Bt Crops

    EPA Science Inventory

    Registration of Bt crops as part of the FIFRA requirements involves the assessment of environmental risk associated with the new crop variety. The assessment analysis stipulates that the seed producer provide clear and unambiguous information relating to certain risk categories a...

  10. NEUROTOXICOLOGY IN REGULATION AND RISK ASSESSMENT

    EPA Science Inventory

    The paper is to be published in the proceedings of a conference on learning disabilities. It summarizes the need for neurotoxicology data in risk assessment, the regulatory agencies which have authority to require toxicity testing, the overall process of risk assessment and the p...

  11. Risk Assessment: An Examination of Assumptions.

    ERIC Educational Resources Information Center

    Prince-Embury, Sandra

    A meta-analysis of theoretical debates concerned with the assessment of risk associated with the use of nuclear power as an energy source is presented in this paper. Based on a central premise that risk assessment has a direct impact on national policy decisions and is associated with different perspectives reflective of different social sectors,…

  12. DRAFT PROPOSED GUIDELINES FOR ECOLOGICAL RISK ASSESSMENT

    EPA Science Inventory

    This document is part of a continuing, long-term effort to develop Agency-wide ecological risk assessment guidelines for EPA. The goal of the guidelines is to improve the quality and consistency of the Agency's ecological risk assessments. These guidelines move beyond the Agency'...

  13. Fuzzy sets applications for cancer risk assessment.

    PubMed

    Molchanov, P A; Dudatiev, A V; Podobna, Y Y; Molchanova, O P

    2002-09-01

    The method of cancer risk assessment on the basis of the Fuzzy Set Theory is presented. The method is based on a multifactor risk assessment of cancer diseases. The individual risk of cancer disease is evaluated as the probability of disease multiplied by the value of an individual dose. An acupuncture method of cancer risk assessments was developed. The method is based on the analysis of changes of an electromagnetic field (biofield) of a person. The method allows to determine both cancer probability and probable location of the process. PMID:12298344

  14. Approximate risk assessment prioritizes remedial decisions

    SciTech Connect

    Bergmann, E.P. )

    1993-08-01

    Approximate risk assessment (ARA) is a management tool that prioritizes cost/benefit options for risk reduction decisions. Management needs a method that quantifies how much control is satisfactory for each level of risk reduction. Two risk matrices develop a scheme that estimates the necessary control a unit should implement with its present probability and severity of consequences/disaster. A second risk assessment matrix attaches a dollar value to each failure possibility at various severities. Now HPI operators can see the cost and benefit for each control step contemplated and justify returns based on removing the likelihood of the disaster.

  15. Dynamic risk simulation to assess risk along roads

    NASA Astrophysics Data System (ADS)

    Voumard, Jérémie; Caspar, Olivier; Derron, Marc-Henri; Jaboyedoff, Michel

    2013-04-01

    Risk generated through natural hazards on roads is usually calculated with an equation which integrates various parameters of hazard and traffic. These are static variables as hazard frequency and number of vehicles crossing the dangerous section. This traditional methodology cannot take into account the dynamic variations of traffic and interactions between vehicles such as speeds modifications due to the section sinuosity, slowdowns resulting saturated traffic or creation of vehicles columns in front of traffic lights. The influence of traffic dynamics on the risk estimation is not addressed with the standard methodologies. Here we show, with the help of a dynamic traffic simulator specially developed for this project, that the variations of traffic greatly influence the risk results. Several sections of an alpine road in Switzerland were analyzed with the method of dynamic risk and compared with the results of the conventional method of risk calculation. It was possible to demonstrate that risk significantly increases on sinuous sections with the decreasing of vehicles speed. It has been highlighted that well positioned traffic lights, outside the risk area, can prevent a risk increase during a construction site, while a column of vehicles located within the danger zone greatly increases the risk. These results demonstrate the importance to consider the traffic in a dynamic way to assess risk to the closest field reality. Thus, recommendations to reduce risk on the roads can be given using a dynamic traffic simulator, modeling interactions between vehicles. Eventually, dynamic risk assessment can also be integrated into existing methodologies that consider only static parameters.

  16. Russian risk assessment methods and approaches

    SciTech Connect

    Dvorack, M.A.; Carlson, D.D.; Smith, R.E.

    1996-07-01

    One of the benefits resulting from the collapse of the Soviet Union is the increased dialogue currently taking place between American and Russian nuclear weapons scientists in various technical arenas. One of these arenas currently being investigated involves collaborative studies which illustrate how risk assessment is perceived and utilized in the Former Soviet Union (FSU). The collaborative studies indicate that, while similarities exist with respect to some methodologies, the assumptions and approaches in performing risk assessments were, and still are, somewhat different in the FSU as opposed to that in the US. The purpose of this paper is to highlight the present knowledge of risk assessment methodologies and philosophies within the two largest nuclear weapons laboratories of the Former Soviet Union, Arzamas-16 and Chelyabinsk-70. Furthermore, This paper will address the relative progress of new risk assessment methodologies, such as Fuzzy Logic, within the framework of current risk assessment methods at these two institutes.

  17. Environmental radiation: risk benchmarks or benchmarking risk assessment.

    PubMed

    Bates, Matthew E; Valverde, L James; Vogel, John T; Linkov, Igor

    2011-07-01

    In the wake of the compound March 2011 nuclear disaster at the Fukushima I nuclear power plant in Japan, international public dialogue has repeatedly turned to questions of the accuracy of current risk assessment processes to assess nuclear risks and the adequacy of existing regulatory risk thresholds to protect us from nuclear harm. We confront these issues with an emphasis on learning from the incident in Japan for future US policy discussions. Without delving into a broader philosophical discussion of the general social acceptance of the risk, the relative adequacy of existing US Nuclear Regulatory Commission (NRC) risk thresholds is assessed in comparison with the risk thresholds of federal agencies not currently under heightened public scrutiny. Existing NRC thresholds are found to be among the most conservative in the comparison, suggesting that the agency's current regulatory framework is consistent with larger societal ideals. In turning to risk assessment methodologies, the disaster in Japan does indicate room for growth. Emerging lessons seem to indicate an opportunity to enhance resilience through systemic levels of risk aggregation. Specifically, we believe bringing systemic reasoning to the risk management process requires a framework that (i) is able to represent risk-based knowledge and information about a panoply of threats; (ii) provides a systemic understanding (and representation) of the natural and built environments of interest and their dependencies; and (iii) allows for the rational and coherent valuation of a range of outcome variables of interest, both tangible and intangible. Rather than revisiting the thresholds themselves, we see the goal of future nuclear risk management in adopting and implementing risk assessment techniques that systemically evaluate large-scale socio-technical systems with a view toward enhancing resilience and minimizing the potential for surprise. PMID:21608107

  18. Evaluation of Chair-Side Assays in High Microbiological Caries-Risk Subjects.

    PubMed

    Saravia, Marta Estela; Silva, Lea Assed Bezerra; Silva, Raquel Assed Bezerra; Lucisano, Marília Pacífico; Echevarría, Andrea Uribe; Echevarría, Jorge Uribe; Nelson-Filho, Paulo

    2015-01-01

    The aim of this study was to evaluate the commercial chair-side assays Saliva-Check Mutans and ClinproTM Cario L-PopTM in high microbiological caries-risk dental students compared with conventional semi-quantitative colony counting culture-based technique as the reference method. Saliva samples from 93 subjects of both sexes aged 18-26 years were seeded (Köhler and Bratthall method) on plates containing SB-20M culture medium method and 12 subjects with high caries risk were selected. These 12 individuals were subjected to determination of caries risk using two commercial rapid detection chair-side assays (Saliva-Check Mutans and ClinproTM Cario L-PopTM) according to the manufacturers' instructions. The results were analyzed by the Kappa correlation test using SAS statistical software. There was a perfect agreement (Kappa=1) among the three caries risk evaluation methods - chair-side assays and semi-quantitative CFU count (control) - in all subjects. The results suggest that the commercial chair-side assays evaluated in this study may be practical and useful to identify high microbiological caries-risk subjects. PMID:26963201

  19. Cheese Microbial Risk Assessments — A Review

    PubMed Central

    Choi, Kyoung-Hee; Lee, Heeyoung; Lee, Soomin; Kim, Sejeong; Yoon, Yohan

    2016-01-01

    Cheese is generally considered a safe and nutritious food, but foodborne illnesses linked to cheese consumption have occurred in many countries. Several microbial risk assessments related to Listeria monocytogenes, Staphylococcus aureus, and Escherichia coli infections, causing cheese-related foodborne illnesses, have been conducted. Although the assessments of microbial risk in soft and low moisture cheeses such as semi-hard and hard cheeses have been accomplished, it has been more focused on the correlations between pathogenic bacteria and soft cheese, because cheese-associated foodborne illnesses have been attributed to the consumption of soft cheeses. As a part of this microbial risk assessment, predictive models have been developed to describe the relationship between several factors (pH, Aw, starter culture, and time) and the fates of foodborne pathogens in cheese. Predictions from these studies have been used for microbial risk assessment as a part of exposure assessment. These microbial risk assessments have identified that risk increased in cheese with high moisture content, especially for raw milk cheese, but the risk can be reduced by preharvest and postharvest preventions. For accurate quantitative microbial risk assessment, more data including interventions such as curd cooking conditions (temperature and time) and ripening period should be available for predictive models developed with cheese, cheese consumption amounts and cheese intake frequency data as well as more dose-response models. PMID:26950859

  1. Cheese Microbial Risk Assessments - A Review.

    PubMed

    Choi, Kyoung-Hee; Lee, Heeyoung; Lee, Soomin; Kim, Sejeong; Yoon, Yohan

    2016-03-01

    Cheese is generally considered a safe and nutritious food, but foodborne illnesses linked to cheese consumption have occurred in many countries. Several microbial risk assessments related to Listeria monocytogenes, Staphylococcus aureus, and Escherichia coli infections, causing cheese-related foodborne illnesses, have been conducted. Although the assessments of microbial risk in soft and low moisture cheeses such as semi-hard and hard cheeses have been accomplished, it has been more focused on the correlations between pathogenic bacteria and soft cheese, because cheese-associated foodborne illnesses have been attributed to the consumption of soft cheeses. As a part of this microbial risk assessment, predictive models have been developed to describe the relationship between several factors (pH, Aw, starter culture, and time) and the fates of foodborne pathogens in cheese. Predictions from these studies have been used for microbial risk assessment as a part of exposure assessment. These microbial risk assessments have identified that risk increased in cheese with high moisture content, especially for raw milk cheese, but the risk can be reduced by preharvest and postharvest preventions. For accurate quantitative microbial risk assessment, more data including interventions such as curd cooking conditions (temperature and time) and ripening period should be available for predictive models developed with cheese, cheese consumption amounts and cheese intake frequency data as well as more dose-response models. PMID:26950859

  2. AN ASSESSMENT OF INTEGRATED RISK ASSESSMENT (Journal Article)

    EPA Science Inventory

    In order to promote international understanding and acceptance of the integrated risk assessment process, the WHO/IPCS, in collaboration with the U.S. EPA and the OECD, initiated a number of activities related to integrated risk assessment. In this project, WHO/IPCS defines inte...

  3. Suicide risk assessment in high-risk adolescents.

    PubMed

    Gray, Barbara P; Dihigo, Sharolyn K

    2015-09-13

    A significant number of adolescents experience depression and other mental health disorders that may put them at risk for suicide. Mental health assessment is an important component of primary healthcare. Depression and suicide risk screening can assist healthcare providers in preventing suicides. PMID:26262455

  4. Health Risk Assessments for Alumina Refineries

    PubMed Central

    Coffey, Patrick S.

    2014-01-01

    Objective: To describe contemporary air dispersion modeling and health risk assessment methodologies applied to alumina refineries and to summarize recent results. Methods: Air dispersion models using emission source and meteorological data have been used to assess ground-level concentrations (GLCs) of refinery emissions. Short-term (1-hour and 24-hour average) GLCs and annual average GLCs have been used to assess acute health, chronic health, and incremental carcinogenic risks. Results: The acute hazard index can exceed 1 close to refineries, but it is typically less than 1 at neighboring residential locations. The chronic hazard index is typically substantially less than 1. The incremental carcinogenic risk is typically less than 10−6. Conclusions: The risks of acute health effects are adequately controlled, and the risks of chronic health effects and incremental carcinogenic risks are negligible around referenced alumina refineries. PMID:24806721

  5. Risk assessment of carcinogens in food

    SciTech Connect

    Barlow, Susan

    2010-03-01

    Approaches for the risk assessment of carcinogens in food have evolved as scientific knowledge has advanced. Early methods allowed little more than hazard identification and an indication of carcinogenic potency. Evaluation of the modes of action of carcinogens and their broad division into genotoxic and epigenetic (non-genotoxic, non-DNA reactive) carcinogens have played an increasing role in determining the approach followed and provide possibilities for more detailed risk characterisation, including provision of quantitative estimates of risk. Reliance on experimental animal data for the majority of risk assessments and the fact that human exposures to dietary carcinogens are often orders of magnitude below doses used in experimental studies has provided a fertile ground for discussion and diverging views on the most appropriate way to offer risk assessment advice. Approaches used by national and international bodies differ, with some offering numerical estimates of potential risks to human health, while others express considerable reservations about the validity of quantitative approaches requiring extrapolation of dose-response data below the observed range and instead offer qualitative advice. Recognising that qualitative advice alone does not provide risk managers with information on which to prioritise the need for risk management actions, a 'margin of exposure' approach for substances that are both genotoxic and carcinogenic has been developed, which is now being used by the World Health Organization and the European Food Safety Authority. This review describes the evolution of risk assessment advice on carcinogens and discusses examples of ways in which carcinogens in food have been assessed in Europe.

  6. Systems Toxicology: The Future of Risk Assessment

    PubMed Central

    Sauer, John Michael; Hartung, Thomas; Leist, Marcel; Knudsen, Thomas B.; Hoeng, Julia; Hayes, A. Wallace

    2016-01-01

    Risk assessment, in the context of public health, is the process of quantifying the probability of a harmful effect to individuals or populations from human activities. With increasing public health concern regarding the potential risks associated with chemical exposure, there is a need for more predictive and accurate approaches to risk assessment. Developing such an approach requires a mechanistic understanding of the process by which xenobiotic substances perturb biological systems and lead to toxicity. Supplementing the shortfalls of traditional risk assessment with mechanistic biological data has been widely discussed but not routinely implemented in the evaluation of chemical exposure. These mechanistic approaches to risk assessment have been generally referred to as systems toxicology. This Symposium Overview article summarizes 4 talks presented at the 35th Annual Meeting of the American College of Toxicology. PMID:25804424

  7. PRA (Probabilistic Risk Assessments) Participation versus Validation

    NASA Technical Reports Server (NTRS)

    DeMott, Diana; Banke, Richard

    2013-01-01

    Probabilistic Risk Assessments (PRAs) are performed for projects or programs where the consequences of failure are highly undesirable. PRAs primarily address the level of risk those projects or programs posed during operations. PRAs are often developed after the design has been completed. Design and operational details used to develop models include approved and accepted design information regarding equipment, components, systems and failure data. This methodology basically validates the risk parameters of the project or system design. For high risk or high dollar projects, using PRA methodologies during the design process provides new opportunities to influence the design early in the project life cycle to identify, eliminate or mitigate potential risks. Identifying risk drivers before the design has been set allows the design engineers to understand the inherent risk of their current design and consider potential risk mitigation changes. This can become an iterative process where the PRA model can be used to determine if the mitigation technique is effective in reducing risk. This can result in more efficient and cost effective design changes. PRA methodology can be used to assess the risk of design alternatives and can demonstrate how major design changes or program modifications impact the overall program or project risk. PRA has been used for the last two decades to validate risk predictions and acceptability. Providing risk information which can positively influence final system and equipment design the PRA tool can also participate in design development, providing a safe and cost effective product.

  8. NASA Human System Risk Assessment Process

    NASA Technical Reports Server (NTRS)

    Francisco, D.; Romero, E.

    2016-01-01

    NASA utilizes an evidence based system to perform risk assessments for the human system for spaceflight missions. The center of this process is the multi-disciplinary Human System Risk Board (HSRB). The HSRB is chartered from the Chief Health and Medical Officer (OCHMO) at NASA Headquarters. The HSRB reviews all human system risks via an established comprehensive risk and configuration management plan based on a project management approach. The HSRB facilitates the integration of human research (terrestrial and spaceflight), medical operations, occupational surveillance, systems engineering and many other disciplines in a comprehensive review of human system risks. The HSRB considers all factors that influence human risk. These factors include pre-mission considerations such as screening criteria, training, age, sex, and physiological condition. In mission factors such as available countermeasures, mission duration and location and post mission factors such as time to return to baseline (reconditioning), post mission health screening, and available treatments. All of the factors influence the total risk assessment for each human risk. The HSRB performed a comprehensive review of all potential inflight medical conditions and events and over the course of several reviews consolidated the number of human system risks to 30, where the greatest emphasis is placed for investing program dollars for risk mitigation. The HSRB considers all available evidence from human research and, medical operations and occupational surveillance in assessing the risks for appropriate mitigation and future work. All applicable DRMs (low earth orbit for 6 and 12 months, deep space for 30 days and 1 year, a lunar mission for 1 year, and a planetary mission for 3 years) are considered as human system risks are modified by the hazards associated with space flight such as microgravity, exposure to radiation, distance from the earth, isolation and a closed environment. Each risk has a summary

  9. RESIDUAL RISK ASSESSMENTS - RESIDUAL RISK ASSESSMENT FOR COKE OVENS

    EPA Science Inventory

    This source category previously subjected to a technology-based standard will be examined to determine if health or ecological risks are significant enough to warrant further regulation for Coke Ovens. These assesments utilize existing models and data bases to examine the multi-m...

  10. DNA Damage among Wood Workers Assessed with the Comet Assay.

    PubMed

    Bruschweiler, Evin Danisman; Wild, Pascal; Huynh, Cong Khanh; Savova-Bianchi, Dessislava; Danuser, Brigitta; Hopf, Nancy B

    2016-01-01

    Exposure to wood dust, a human carcinogen, is common in wood-related industries, and millions of workers are occupationally exposed to wood dust worldwide. The comet assay is a rapid, simple, and sensitive method for determining DNA damage. The objective of this study was to investigate the DNA damage associated with occupational exposure to wood dust using the comet assay (peripheral blood samples) among nonsmoking wood workers (n = 31, furniture and construction workers) and controls (n = 19). DNA damage was greater in the group exposed to composite wood products compared to the group exposed to natural woods and controls (P < 0.001). No difference in DNA damage was observed between workers exposed to natural woods and controls (P = 0.13). Duration of exposure and current dust concentrations had no effect on DNA damage. In future studies, workers' exposures should include cumulative dust concentrations and exposures originating from the binders used in composite wood products. PMID:27398027

  11. DNA Damage among Wood Workers Assessed with the Comet Assay

    PubMed Central

    Bruschweiler, Evin Danisman; Wild, Pascal; Huynh, Cong Khanh; Savova-Bianchi, Dessislava; Danuser, Brigitta; Hopf, Nancy B.

    2016-01-01

    Exposure to wood dust, a human carcinogen, is common in wood-related industries, and millions of workers are occupationally exposed to wood dust worldwide. The comet assay is a rapid, simple, and sensitive method for determining DNA damage. The objective of this study was to investigate the DNA damage associated with occupational exposure to wood dust using the comet assay (peripheral blood samples) among nonsmoking wood workers (n = 31, furniture and construction workers) and controls (n = 19). DNA damage was greater in the group exposed to composite wood products compared to the group exposed to natural woods and controls (P < 0.001). No difference in DNA damage was observed between workers exposed to natural woods and controls (P = 0.13). Duration of exposure and current dust concentrations had no effect on DNA damage. In future studies, workers’ exposures should include cumulative dust concentrations and exposures originating from the binders used in composite wood products. PMID:27398027

  12. Vehicle emission unit risk factors for transportation risk assessments

    SciTech Connect

    Biwer, B.M.; Butler, J.P.

    1999-12-01

    When the transportation risk posed by shipments of hazardous chemical and radioactive materials is being assessed, it is necessary to evaluate the risks 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 by as large or larger than the estimated risk associated with the material being transported. In this paper, data from the US 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 for all 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 assessment 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.

  13. Vehicle emission unit risk factors for transportation risk assessments.

    PubMed

    Biwer, B M; Butler, J P

    1999-12-01

    When the transportation risk posed by shipments of hazardous chemical and radioactive materials is being assessed, it is necessary to evaluate the risks 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 for all 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. PMID:10765454

  14. ASSESSING RISKS TO THE DEVELOPING IMMUNE SYSTEM

    EPA Science Inventory

    There is no standardized laboratory animal testing approach to assess the potential toxicity of chemicals to the developing immune system. The goal of this research is to apply a panel of in vivo, ex vivo and in vitro assays to determine whether the developing (i.e., prenatal, n...

  15. Genotoxicity Assessment of Erythritol by Using Short-term Assay

    PubMed Central

    Chung, Young-Shin

    2013-01-01

    Erythritol is a sugar alcohol that is widely used as a natural sugar substitute. Thus, the safety of its usage is very important. In the present study, short-term genotoxicity assays were conducted to evaluate the potential genotoxic effects of erythritol. According to the OECD test guidelines, the maximum test dose was 5,000 μg/plate in bacterial reverse mutation tests, 5,000 μg/ml in cell-based assays, and 5,000 mg/kg for in vivo testing. An Ames test did not reveal any positive results. No clastogenicity was observed in a chromosomal aberration test with CHL cells or an in vitro micronucleus test with L5178Y tk+/− cells. Erythritol induced a marginal increase of DNA damage at two high doses by 24 hr of exposure in a comet assay using L5178Y tk+/− cells. Additionally, in vivo micronucleus tests clearly demonstrated that oral administration of erythritol did not induce micronuclei formation of the bone marrow cells of male ICR mice. Taken together, our results indicate that erythritol is not mutagenic to bacterial cells and does not cause chromosomal damage in mammalian cells either in vitro or in vivo. PMID:24578795

  16. Improving antenatal risk assessment in women exposed to high risks.

    PubMed

    Perry, Natasha; Newman, Louise K; Hunter, Mick; Dunlop, Adrian

    2015-01-01

    Antenatal substance use and related psychosocial risk factors are known to increase the likelihood of child protection involvement; less is known about the predictive nature of maternal reflective functioning (RF) in this population. This preliminary study assessed psychosocial and psychological risk factors for a group of substance dependent women exposed to high risks in pregnancy, and their impact on child protection involvement. Pregnant women on opiate substitution treatment (n = 11) and a comparison group (n = 15) were recruited during their third trimester to complete measures of RF (Pregnancy Interview), childhood trauma, mental health and psychosocial assessments. At postnatal follow-up, RF was reassessed (Parent Development Interview - Revised Short Version) and mother-infant dyads were videotaped to assess emotional availability (EA). Child protection services were contacted to determine if any concerns had been raised for infant safety. Significant between-group differences were observed for demographics, psychosocial factors, trauma and mental health symptoms. Unexpectedly, no significant differences were found for RF or EA between groups. Eight women in the 'exposed to high risks' group became involved with child protection services. Reflective functioning was not significantly associated with psychosocial risk factors, and therefore did not mediate the outcome of child protection involvement. Women 'exposed to high risks' were equally able to generate a model of their own and their infants' mental states and should not be seen within a deficit perspective. Further research is required to better understand the range of risk factors that predict child protection involvement in high risk groups. PMID:23982989

  17. How probabilistic risk assessment can mislead terrorism risk analysts.

    PubMed

    Brown, Gerald G; Cox, Louis Anthony Tony

    2011-02-01

    Traditional probabilistic risk assessment (PRA), of the type originally developed for engineered systems, is still proposed for terrorism risk analysis. We show that such PRA applications are unjustified in general. The capacity of terrorists to seek and use information and to actively research different attack options before deciding what to do raises unique features of terrorism risk assessment that are not adequately addressed by conventional PRA for natural and engineered systems-in part because decisions based on such PRA estimates do not adequately hedge against the different probabilities that attackers may eventually act upon. These probabilities may differ from the defender's (even if the defender's experts are thoroughly trained, well calibrated, unbiased probability assessors) because they may be conditioned on different information. We illustrate the fundamental differences between PRA and terrorism risk analysis, and suggest use of robust decision analysis for risk management when attackers may know more about some attack options than we do. PMID:20846169

  18. Subjective risk assessment for planning conservation projects

    NASA Astrophysics Data System (ADS)

    Game, Edward T.; Fitzsimons, James A.; Lipsett-Moore, Geoff; McDonald-Madden, Eve

    2013-12-01

    Conservation projects occur under many types of uncertainty. Where this uncertainty can affect achievement of a project’s objectives, there is risk. Understanding risks to project success should influence a range of strategic and tactical decisions in conservation, and yet, formal risk assessment rarely features in the guidance or practice of conservation planning. We describe how subjective risk analysis tools can be framed to facilitate the rapid identification and assessment of risks to conservation projects, and how this information should influence conservation planning. Our approach is illustrated with an assessment of risks to conservation success as part of a conservation plan for the work of The Nature Conservancy in northern Australia. Risks can be both internal and external to a project, and occur across environmental, social, economic and political systems. Based on the relative importance of a risk and the level of certainty in its assessment we propose a series of appropriate, project level responses including research, monitoring, and active amelioration. Explicit identification, prioritization, and where possible, management of risks are important elements of using conservation resources in an informed and accountable manner.

  19. A Tutorial on Probablilistic Risk Assessement and its Role in Risk-Informed Decision Making

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon

    2010-01-01

    This slide presentation reviews risk assessment and its role in risk-informed decision making. It includes information on probabilistic risk assessment, typical risk management process, origins of risk matrix, performance measures, performance objectives and Bayes theorem.

  20. An Approach for Assessing the Signature Quality of Various Chemical Assays when Predicting the Culture Media Used to Grow Microorganisms

    SciTech Connect

    Holmes, Aimee E.; Sego, Landon H.; Webb-Robertson, Bobbie-Jo M.; Kreuzer, Helen W.; Anderson, Richard M.; Unwin, Stephen D.; Weimar, Mark R.; Tardiff, Mark F.; Corley, Courtney D.

    2013-02-01

    We demonstrate an approach for assessing the quality of a signature system designed to predict the culture medium used to grow a microorganism. The system was comprised of four chemical assays designed to identify various ingredients that could be used to produce the culture medium. The analytical measurements resulting from any combination of these four assays can be used in a Bayesian network to predict the probabilities that the microorganism was grown using one of eleven culture media. We evaluated combinations of the signature system by removing one or more of the assays from the Bayes network. We measured and compared the quality of the various Bayes nets in terms of fidelity, cost, risk, and utility, a method we refer to as Signature Quality Metrics

  1. Risk Assessment Stability: A Revalidation Study of the Arizona Risk/Needs Assessment Instrument

    ERIC Educational Resources Information Center

    Schwalbe, Craig S.

    2009-01-01

    The actuarial method is the gold standard for risk assessment in child welfare, juvenile justice, and criminal justice. It produces risk classifications that are highly predictive and that may be robust to sampling error. This article reports a revalidation study of the Arizona Risk/Needs Assessment instrument, an actuarial instrument for juvenile…

  2. Operationalization Of The Professional Risks Assessment Activity

    NASA Astrophysics Data System (ADS)

    Ivascu, Victoria Larisa; Cirjaliu, Bianca; Draghici, Anca

    2015-07-01

    Professional risks assessment approach (integration of analysis and evaluation processes) is linked with the general concerns of nowadays companies for their employees' health and safety assurances, in the context of organizations sustainable development. The paper presents an approach for the operationalization of the professional risk assessment activity in companies through the implementation and use of the OnRisk platform (this have been tested in some industrial companies). The short presentation of the relevant technical reports and statistics on OSH management at the European Union level underlines the need for the development of a professional risks assessment. Finally, there have been described the designed and developed OnRisk platform as a web platform together with some case studies that have validate the created tool.

  3. Establishment of a Predictive In Vitro Assay for Assessment of the Hepatotoxic Potential of Oligonucleotide Drugs

    PubMed Central

    Sewing, Sabine; Boess, Franziska; Moisan, Annie; Bertinetti-Lapatki, Cristina; Minz, Tanja; Hedtjaern, Maj; Tessier, Yann; Schuler, Franz; Singer, Thomas; Roth, Adrian B.

    2016-01-01

    Single stranded oligonucleotides (SSO) represent a novel therapeutic modality that opens new space to address previously undruggable targets. In spite of their proven efficacy, the development of promising SSO drug candidates has been limited by reported cases of SSO-associated hepatotoxicity. The mechanisms of SSO induced liver toxicity are poorly understood, and up to now no preclinical in vitro model has been established that allows prediction of the hepatotoxicity risk of a given SSO. Therefore, preclinical assessment of hepatic liability currently relies on rodent studies that require large cohorts of animals and lengthy protocols. Here, we describe the establishment and validation of an in vitro assay using primary hepatocytes that recapitulates the hepatotoxic profile of SSOs previously observed in rodents. In vitro cytotoxicity upon unassisted delivery was measured as an increase in extracellular lactate dehydrogenase (LDH) levels and concomitant reduction in intracellular glutathione and ATP levels after 3 days of treatment. Furthermore, toxic, but not safe, SSOs led to an increase in miR-122 in cell culture supernatants after 2 days of exposure, revealing the potential use of miR122 as a selective translational biomarker for detection of SSO-induced hepatotoxicity. Overall, we have developed and validated for the first time a robust in vitro screening assay for SSO liver safety profiling which allows rapid prioritization of candidate molecules early on in development. PMID:27442522

  4. Establishment of a Predictive In Vitro Assay for Assessment of the Hepatotoxic Potential of Oligonucleotide Drugs.

    PubMed

    Sewing, Sabine; Boess, Franziska; Moisan, Annie; Bertinetti-Lapatki, Cristina; Minz, Tanja; Hedtjaern, Maj; Tessier, Yann; Schuler, Franz; Singer, Thomas; Roth, Adrian B

    2016-01-01

    Single stranded oligonucleotides (SSO) represent a novel therapeutic modality that opens new space to address previously undruggable targets. In spite of their proven efficacy, the development of promising SSO drug candidates has been limited by reported cases of SSO-associated hepatotoxicity. The mechanisms of SSO induced liver toxicity are poorly understood, and up to now no preclinical in vitro model has been established that allows prediction of the hepatotoxicity risk of a given SSO. Therefore, preclinical assessment of hepatic liability currently relies on rodent studies that require large cohorts of animals and lengthy protocols. Here, we describe the establishment and validation of an in vitro assay using primary hepatocytes that recapitulates the hepatotoxic profile of SSOs previously observed in rodents. In vitro cytotoxicity upon unassisted delivery was measured as an increase in extracellular lactate dehydrogenase (LDH) levels and concomitant reduction in intracellular glutathione and ATP levels after 3 days of treatment. Furthermore, toxic, but not safe, SSOs led to an increase in miR-122 in cell culture supernatants after 2 days of exposure, revealing the potential use of miR122 as a selective translational biomarker for detection of SSO-induced hepatotoxicity. Overall, we have developed and validated for the first time a robust in vitro screening assay for SSO liver safety profiling which allows rapid prioritization of candidate molecules early on in development. PMID:27442522

  5. STRESS PATHWAY-BASED REPORTER ASSAYS TO ASSESS TOXICITY OF ENVIRONMENTAL CHEMICALS.

    EPA Science Inventory

    There is an increasing need for assays for the rapid and efficient assessment of toxicities of large numbers of environmental chemicals. To meet this need, we are developing cell-based reporter assays that measure the activation of key molecular stress pathways. We are using pro...

  6. CANCER RISK ASSESSMENT FOR CHLOROFORM

    EPA Science Inventory

    Chloroform is a common chlorination by-product in drinking water. EPA has regulated chloroform as a probable human carcinogen under the Safe Drinking Water Act. The cancer risk estimate via ingestion was based on the 1985 Jorgenson study identifying kidney tumors in male Osborne ...

  7. USE OF GENOMIC DATA IN RISK ASSESSMENT

    EPA Science Inventory

    Use of Genomic Data in Risk Assessment
    John C. Rockett
    Reproductive Toxicology Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development, United States Environmental Protection Agency, Research Triangle Park, NC 27711, USA<...

  8. Uncertainty in Mixtures and Cumulative Risk Assessment

    EPA Science Inventory

    Humans and environmental species are rarely exposed to single chemicals. These chemicals typically affect multiple tissues through multiple modes of action, which may depend on the dose. Mixtures risk assessment may employ dose response information from the mixture of interest,...

  9. Assessing Risk with GASB Statement No. 3.

    ERIC Educational Resources Information Center

    Wood, Venita M.; Scott, Bob

    1987-01-01

    Discusses a Government Accounting Standards Board (GASB) publication designed to provide financial statement users with information to assess a government's actual and future deposit and investment market and credit risk. (MLF)

  10. GUIDELINES FOR CARCINOGEN RISK ASSESSMENT (1986)

    EPA Science Inventory

    In 1983, the National Academy of Sciences (NAS)/National Research Council (NRC) published its report entitled Risk Assessment in the Federal Government: Managing the Process. In that report, the NRC recommended that Federal regulatory agencies establish "inference guidelines" to ...

  11. TOXICOLOGICAL BASIS FOR DRINKING WATER RISK ASSESSMENT

    EPA Science Inventory

    The U.S. Environmental Protection Agency (EPA) is charged with protecting human health and the environment. Environmental protection decisions are often guided by risk assessments that are used to develop regulatory policy and other related guidance. Historically, in environmen...

  12. Electrochemical chip-based genomagnetic assay for detection of high-risk human papillomavirus DNA.

    PubMed

    Bartosik, Martin; Durikova, Helena; Vojtesek, Borivoj; Anton, Milan; Jandakova, Eva; Hrstka, Roman

    2016-09-15

    Cervical cancer, being the fourth leading cause of cancer death in women worldwide, predominantly originates from a persistent infection with a high-risk human papillomavirus (HPV). Detection of DNA sequences from these high-risk strains, mostly HPV-16 and HPV-18, represents promising strategy for early screening, which would help to identify women with higher risk of cervical cancer. In developing countries, inadequate screening options lead to disproportionately high mortality rates, making a fast and inexpensive detection schemes highly important. Electrochemical sensors and assays offer an alternative to current methods of detection. We developed an electrochemical-chip based assay, in which target HPV DNA is captured via magnetic bead-modified DNA probes, followed by an antidigoxigenin-peroxidase detection system at screen-printed carbon electrode chips, enabling parallel measurements of eight samples simultaneously. We show sensitive detection in attomoles of HPV DNA, selective discrimination between HPV-16 and HPV-18 and good reproducibility. Most importantly, we show application of the assay into both cancer cell lines and cervical smears from patients. The electrochemical results correlated well with standard methods, making this assay potentially applicable in clinical practice. PMID:27132004

  13. Risk Assessment and Alternatives Assessment: Comparing Two Methodologies

    PubMed Central

    2015-01-01

    The selection and use of chemicals and materials with less hazardous profiles reflects a paradigm shift from reliance on risk minimization through exposure controls to hazard avoidance. This article introduces risk assessment and alternatives assessment frameworks in order to clarify a misconception that alternatives assessment is a less effective tool to guide decision making, discusses factors promoting the use of each framework, and also identifies how and when application of each framework is most effective. As part of an assessor's decision process to select one framework over the other, it is critical to recognize that each framework is intended to perform different functions. Although the two frameworks share a number of similarities (such as identifying hazards and assessing exposure), an alternatives assessment provides a more realistic framework with which to select environmentally preferable chemicals because of its primary reliance on assessing hazards and secondary reliance on exposure assessment. Relevant to other life cycle impacts, the hazard of a chemical is inherent, and although it may be possible to minimize exposure (and subsequently reduce risk), it is challenging to assess such exposures through a chemical's life cycle. Through increased use of alternatives assessments at the initial stage of material or product design, there will be less reliance on post facto risk‐based assessment techniques because the potential for harm is significantly reduced, if not avoided, negating the need for assessing risk in the first place. PMID:26694655

  14. Lead poisoning in precious metals refinery assayers: a failure to notify workers at high risk.

    PubMed

    Kern, D G

    1994-05-01

    Lead poisoning in a precious metals refinery fire assayer and a routine OSHA inspection prompted an investigation of the index facility, a survey of the industry, and efforts to notify assayers of this previously unrecognized hazard. Air and blood samples were obtained at the index facility. Management personnel from all fire assay laboratories in Rhode Island and southern Massachusetts were interviewed. The industry's trade association, OSHA, NIOSH, trade unions, and the media were asked to assist in a nationwide notification effort. Assayers at the index facility had excessive exposures to lead due to an age-old, lead-based assaying method that remains the industry gold standard. Blood lead levels of the three assayers (mean 61.3 micrograms/dl, range 48-86 micrograms/dl) were considerably higher than those of 16 other refinery workers (mean 27.4 micrograms/dl, range 13-49 micrograms/dl). The industry survey revealed inadequate knowledge of both the lead hazard and the applicability of the OSHA lead standard. Notification efforts failed in large part due to economic obstacles. The notification of workers at high risk of lead exposure and the eradication of occupational lead poisoning will require greater attention to economic forces. PMID:8030646

  15. MULTIMEDIA HUMAN EXPOSURE AND RISK ASSESSMENT MODELING

    EPA Science Inventory

    Exposures and health risk comparisons from different sites may be used for allocating limited resources available for remedial action. It is important that comparisons between different sites use similar levels of site-specific data and/or screening level data. Risk assessment c...

  16. Risk Assessment in Child Sexual Abuse Cases

    ERIC Educational Resources Information Center

    Levenson, Jill S.; Morin, John W.

    2006-01-01

    Despite continuing improvements in risk assessment for child protective services (CPS) and movement toward actuarial prediction of child maltreatment, current models have not adequately addressed child sexual abuse. Sexual abuse cases present unique and ambiguous indicators to the investigating professional, and risk factors differ from those…

  17. 2007 TOXICOLOGY AND RISK ASSESSMENT CONFERENCE

    EPA Science Inventory

    EPA has announced

    The 2007 Toxicology and Risk Assessment Conference
    Cincinnati Marriott North, West Chester (Cincinnati), OH
    April 23- 26, 2007 - Click to register!

    The Annual Toxicology and Risk Ass...

  18. Risk Assessment in Finland: Theory and Practice

    PubMed Central

    Pääkkönen, Rauno

    2010-01-01

    The Finnish risk assessment practice is based on the Occupational Safety and Health (OSH) Act aiming to improve working conditions in order maintain the employees' work ability, and to prevent occupational accidents and diseases. In practice there are hundreds of risk assessment methods in use. A simple method is used in small and medium sized enterprises and more complex risk evaluation methods in larger work places. Does the risk management function in the work places in Finland? According to our experience something more is needed. That is, understanding of common and company related benefits of risk management. The wider conclusion is that commitment for risk assessment in Finland is high enough. However, in those enterprises where OSH management was at an acceptable level or above it, there were also more varied and more successfully accomplished actions to remove or reduce the risks than in enterprises, where OSH management was in lower level. In risk assessment it is important to process active technical prevention and exact communication, increase work place attraction and increase job satisfaction and motivation. Investments in OSH are also good business. Low absenteeism due to illness or accidents increases directly the production results by improved quality and quantity of the product. In general Finnish studies have consistently shown that the return of an invested euro is three to seven-old. In national level, according to our calculations the savings could be even 20% of our gross national product. PMID:22953157

  19. PROPOSED GUIDELINES FOR CARCINOGEN RISK ASSESSMENT

    EPA Science Inventory

    The Proposed Guidelines for Carcinogen Risk Assessment were published in the Federal Register on April 23, 1996 (Federal Register: 17960-18011) for a 120-day public review and comment period. The Proposed Guidelines are a revision of EPA's 1986 Guidelines for Carcinogen Risk Ass...

  20. 2009 TOXICOLOGY AND RISK ASSESSMENT CONFERENCE

    EPA Science Inventory

    EPA has announced

    The 2009 Toxicology and Risk Assessment Conference
    Cincinnati Marriott North, West Chester (Cincinnati), OH
    April 27-30, 2009 - Click to register!

    The Annual Toxicology and Risk Ass...

  1. NANOTECHNOLOGY RISK ASSESSMENT CASE STUDY WORKSHOPS

    EPA Science Inventory

    Nanotechnology is expected to present both benefits and risks to human health and the environment. The assessment of risks related to nanotechnology requires information on the potential for exposure to, and adverse effects of, nanomaterials and their by-products. To help ensure...

  2. FRAMEWORK FOR INORGANIC METALS RISK ASSESSMENT

    EPA Science Inventory

    The EPA has prepared a framework to guide risk assessors in assessing human and ecological risks of inorganic metals. Metals and metal compounds have properties not generally encountered with organic chemicals. For example, metals are neither created nor destroyed by biological a...

  3. FRAMEWORK FOR CUMULATIVE RISK ASSESSMENT (REVIEW DRAFT)

    EPA Science Inventory

    Several reports have highlighted the importance of understanding the accumulation of risks from multiple environmental stressors. These include the National Research Council's 1994 report Science and Judgment in Risk Assessment and the 1997 report by the Presidential/Cong...

  4. 2008 TOXICOLOGY AND RISK ASSESSMENT CONFERENCE

    EPA Science Inventory

    EPA has announced

    The 2008 Toxicology and Risk Assessment Conference
    Cincinnati Marriott North, West Chester (Cincinnati), OH
    April 14 - 17, 2008 - Click to register!

    The Annual Toxicology and Risk ...

  5. Risk assessment in Finland: theory and practice.

    PubMed

    Anttonen, Hannu; Pääkkönen, Rauno

    2010-09-01

    The Finnish risk assessment practice is based on the Occupational Safety and Health (OSH) Act aiming to improve working conditions in order maintain the employees' work ability, and to prevent occupational accidents and diseases. In practice there are hundreds of risk assessment methods in use. A simple method is used in small and medium sized enterprises and more complex risk evaluation methods in larger work places. Does the risk management function in the work places in Finland? According to our experience something more is needed. That is, understanding of common and company related benefits of risk management. The wider conclusion is that commitment for risk assessment in Finland is high enough. However, in those enterprises where OSH management was at an acceptable level or above it, there were also more varied and more successfully accomplished actions to remove or reduce the risks than in enterprises, where OSH management was in lower level. In risk assessment it is important to process active technical prevention and exact communication, increase work place attraction and increase job satisfaction and motivation. Investments in OSH are also good business. Low absenteeism due to illness or accidents increases directly the production results by improved quality and quantity of the product. In general Finnish studies have consistently shown that the return of an invested euro is three to seven-old. In national level, according to our calculations the savings could be even 20% of our gross national product. PMID:22953157

  6. Training for suicide risk assessment and suicide risk formulation.

    PubMed

    Silverman, Morton M; Berman, Alan L

    2014-10-01

    Suicide and suicidal behaviors are highly associated with psychiatric disorders. Psychiatrists have significant opportunities to identify at-risk individuals and offer treatment to reduce that risk. Although a suicide risk assessment (SRA) is a core competency requirement, many lack the requisite training and skills to appropriately assess for suicide risk. Moreover, the standard of care requires psychiatrists to foresee the possibility that a patient might engage in suicidal behavior, hence to conduct a suicide risk formulation (SRF) sufficient to guide triage and treatment planning. An SRA gathers data about observable and reported symptoms, behaviors, and historical factors that are associated with suicide risk and protection, ascertained by way of psychiatric interview; collateral information from family, friends, and medical records; and psychometric scales and/or screening tools. Based on data collected via an SRA, an SRF is a process whereby the psychiatrist forms a judgment about a patient's foreseeable risk of suicidal behavior in order to inform triage decisions, safety and treatment plans, and interventions to reduce risk. This paper addresses the need for a revised training model in SRA and SRF, and proposes a model of training that incorporates the acquisition of skills, relying heavily on case application exercises. PMID:25059537

  7. Performance Assessment of Human and Cattle Associated Quantitative Real-time PCR Assays - slides

    EPA Science Inventory

    The presentation overview is (1) Single laboratory performance assessment of human- and cattle associated PCR assays and (2) A Field Study: Evaluation of two human fecal waste management practices in Ohio watershed.

  8. [Individual risk assessment of caries].

    PubMed

    Schaeken, M J; Mikx, F H

    1992-06-01

    The estimation of individual caries risk factors and the related preventive treatment in the dental practice are discussed. Salivary counts of mutans streptococci and lactobacilli reflect the bacteriological attack (mutans streptococci) and sugar intake (lactobacilli). Caries resistance can be estimated by measurement of the salivary secretion rate and buffer capacity. Treatment of high caries risk patients should be directed against etiological factors. Salivary flow rates and buffer capacity can be stimulated by daily (sugar-free) gum-chewing. For the use of fluoridated toothpaste and sugar intake the dentist is dependent upon the cooperation of the patient. The bacteriological factor in the caries process can be suppressed by application of chlorhexidine varnish. PMID:11820133

  9. A framework for combining social impact assessment and risk assessment

    SciTech Connect

    Mahmoudi, Hossein; Renn, Ortwin; Vanclay, Frank; Hoffmann, Volker; Karami, Ezatollah

    2013-11-15

    An increasing focus on integrative approaches is one of the current trends in impact assessment. There is potential to combine impact assessment with various other forms of assessment, such as risk assessment, to make impact assessment and the management of social risks more effective. We identify the common features of social impact assessment (SIA) and social risk assessment (SRA), and discuss the merits of a combined approach. A hybrid model combining SIA and SRA to form a new approach called, ‘risk and social impact assessment’ (RSIA) is introduced. RSIA expands the capacity of SIA to evaluate and manage the social impacts of risky projects such as nuclear energy as well as natural hazards and disasters such as droughts and floods. We outline the three stages of RSIA, namely: impact identification, impact assessment, and impact management. -- Highlights: • A hybrid model to combine SIA and SRA namely RSIA is proposed. • RSIA can provide the proper mechanism to assess social impacts of natural hazards. • RSIA can play the role of ex-post as well as ex-ante assessment. • For some complicated and sensitive cases like nuclear energy, conducting a RSIA is necessary.

  10. APPLICATION OF FETAX IN ECOLOGICAL RISK ASSESSMENTS: A CRITICAL ASSESSMENT

    EPA Science Inventory

    A workshop sponsored by NIEHS in 2000 evaluated the use of FETAX as a screening method for identifying the developmental toxicity potenial of chemical and environmental samples. Workshop recommendations pertinent to environmental risk assessment suggested that additional comparat...

  11. Risk assessment Barter Island radar installation, Alaska

    SciTech Connect

    1995-05-05

    This document contains the baseline human health risk assessment and the ecological risk assessment (ERA) for the Barter Island Distant Early Warning (DEW) Line radar installation. Fourteen sites at the Barter Island radar installation underwent remedial investigations (RIS) during the summer of 1993. The presence of chemical contamination in the soil, sediments, and surface water at the installation was evaluated and reported in the Barter Island Remedial Investigation/Feasibility Study (RI/FS) United States Air Force 1994a. The analytical data reported in the RI/FS form the basis for the human health and ecological risk assessment. The primary contaminants of concern at the 14 sites are diesel and gasoline from past spills and/or leaks. The general location of the Barter Island radar installation is shown in Figure 1-1. The 14 sites investigated and the types of samples collected at each site are presented in Table 1-1. The purpose of the risk assessment is to evaluate the human and ecological health risks that may be associated with chemicals released to the environment at the 14 sites investigated during the RIs. The risk assessment characterizes the probability that measured concentrations of hazardous chemical substances will cause adverse effects in humans or the environment in the absence of remediation. The risk assessment will be used to determine if remediation (site cleanup) is necessary and also to rank sites for remedial action. Additionally, it will be used as a model for the risk assessment to be performed at the other DEW Line installations (Bullen Point, Oliktok Point, Point Lonely, Barrow Point, Wainwright, and Point Lay) and the Cape Lisburne radar installation. pg18. JMD.

  12. Assessing Your Board's Risk Tolerance

    ERIC Educational Resources Information Center

    Griswold, John S.; Jarvis, William F.

    2014-01-01

    In the wake of the financial crisis, trustees of many endowed nonprofit institutions realized that their portfolio was riskier than they thought and their own ability to tolerate loss wasn't as strong as they imagined. What can board and investment committee members do to improve their ability to assess their--and their institution's--capacity for…

  13. Biological Based Risk Assessment for Space Exploration

    NASA Technical Reports Server (NTRS)

    Cucinotta, Francis A.

    2011-01-01

    Exposures from galactic cosmic rays (GCR) - made up of high-energy protons and high-energy and charge (HZE) nuclei, and solar particle events (SPEs) - comprised largely of low- to medium-energy protons are the primary health concern for astronauts for long-term space missions. Experimental studies have shown that HZE nuclei produce both qualitative and quantitative differences in biological effects compared to terrestrial radiation, making risk assessments for cancer and degenerative risks, such as central nervous system effects and heart disease, highly uncertain. The goal for space radiation protection at NASA is to be able to reduce the uncertainties in risk assessments for Mars exploration to be small enough to ensure acceptable levels of risks are not exceeded and to adequately assess the efficacy of mitigation measures such as shielding or biological countermeasures. We review the recent BEIR VII and UNSCEAR-2006 models of cancer risks and their uncertainties. These models are shown to have an inherent 2-fold uncertainty as defined by ratio of the 95% percent confidence level to the mean projection, even before radiation quality is considered. In order to overcome the uncertainties in these models, new approaches to risk assessment are warranted. We consider new computational biology approaches to modeling cancer risks. A basic program of research that includes stochastic descriptions of the physics and chemistry of radiation tracks and biochemistry of metabolic pathways, to emerging biological understanding of cellular and tissue modifications leading to cancer is described.

  14. Ecosystem services as assessment endpoints for ecological risk assessment.

    PubMed

    Munns, Wayne R; Rea, Anne W; Suter, Glenn W; Martin, Lawrence; Blake-Hedges, Lynne; Crk, Tanja; Davis, Christine; Ferreira, Gina; Jordan, Steve; Mahoney, Michele; Barron, Mace G

    2016-07-01

    Ecosystem services are defined as the outputs of ecological processes that contribute to human welfare or have the potential to do so in the future. Those outputs include food and drinking water, clean air and water, and pollinated crops. The need to protect the services provided by natural systems has been recognized previously, but ecosystem services have not been formally incorporated into ecological risk assessment practice in a general way in the United States. Endpoints used conventionally in ecological risk assessment, derived directly from the state of the ecosystem (e.g., biophysical structure and processes), and endpoints based on ecosystem services serve different purposes. Conventional endpoints are ecologically important and susceptible entities and attributes that are protected under US laws and regulations. Ecosystem service endpoints are a conceptual and analytical step beyond conventional endpoints and are intended to complement conventional endpoints by linking and extending endpoints to goods and services with more obvious benefit to humans. Conventional endpoints can be related to ecosystem services even when the latter are not considered explicitly during problem formulation. To advance the use of ecosystem service endpoints in ecological risk assessment, the US Environmental Protection Agency's Risk Assessment Forum has added generic endpoints based on ecosystem services (ES-GEAE) to the original 2003 set of generic ecological assessment endpoints (GEAEs). Like conventional GEAEs, ES-GEAEs are defined by an entity and an attribute. Also like conventional GEAEs, ES-GEAEs are broadly described and will need to be made specific when applied to individual assessments. Adoption of ecosystem services as a type of assessment endpoint is intended to improve the value of risk assessment to environmental decision making, linking ecological risk to human well-being, and providing an improved means of communicating those risks. Integr Environ Assess Manag

  15. Seismic risk assessment for Yerevan city

    NASA Astrophysics Data System (ADS)

    Durgaryan, Raffi

    2014-05-01

    The purpose of the study was to conduct a seismic risk assessment for the territory of Yerevan city with the aim to evaluate potential earthquake hazard and associated risk and losses. This study enables the assessment of seismic risk in the city and evaluates the geographical distribution of potential human and building losses due to proposed earthquake scenarios. The results of this study are presented in form of various mapped seismic hazard parameters such as peak ground acceleration, spectral acceleration, as well as assessed parameters for expected life, building and lifeline losses. The study has been the first of its kind for Yerevan city that will serve as the first step in building a risk analysis tools to be used by governmental entities and other organizations for planning future disaster response efforts.

  16. Risk assessment as a framework for decisions.

    SciTech Connect

    Rechard, Robert Paul; McKenna, Sean Andrew; Borns, David James

    2010-12-01

    The risk assessment approach has been applied to support numerous radioactive waste management activities over the last 30 years. A risk assessment methodology provides a solid and readily adaptable framework for evaluating the risks of CO2 sequestration in geologic formations to prioritize research, data collection, and monitoring schemes. This paper reviews the tasks of a risk assessment, and provides a few examples related to each task. This paper then describes an application of sensitivity analysis to identify important parameters to reduce the uncertainty in the performance of a geologic repository for radioactive waste repository, which because of importance of the geologic barrier, is similar to CO2 sequestration. The paper ends with a simple stochastic analysis of idealized CO2 sequestration site with a leaking abandoned well and a set of monitoring wells in an aquifer above the CO2 sequestration unit in order to evaluate the efficacy of monitoring wells to detect adverse leakage.

  17. Blue print for building a risk assessment

    SciTech Connect

    Otsuki, H.K.; Eagan-McNeill, E.

    1997-05-01

    Federal and stet regulations require the operator of a miscellaneous waste treatment unit to demonstrate compliance with environmental performance standard. A sample risk assessment is demonstrated as a means of showing compliance for such a treatment unit. A new Open Burning and Open Detonation (OB/OD) facility for explosive wastes at LLNL experimental site is used. Simplified, the process of performing a risk assessment consists of characterization of the treatment operation and estimation of emission rates; evaluation of the emission dispersion to estimate acute exposure; and evaluation of human and environmental risks. Each step may require the environmental analysts to perform detained date gathering, modeling and calculations, and to negotiate with facility operations personnel and regulatory representatives. The Risk Assessment Protocol, which explains the assumptions, model selection and inputs, and data selection, must ultimately withstand the rigors of regulatory review and public scrutiny.s

  18. Hanford waste vitrification systems risk assessment

    SciTech Connect

    Miller, W.C.; Hamilton, D.W.; Holton, L.K.; Bailey, J.W.

    1991-09-01

    A systematic Risk Assessment was performed to identify the technical, regulatory, and programmatic uncertainties and to quantify the risks to the Hanford Site double-shell tank waste vitrification program baseline (as defined in December 1990). Mitigating strategies to reduce the overall program risk were proposed. All major program elements were evaluated, including double-shell tank waste characterization, Tank Farms, retrieval, pretreatment, vitrification, and grouting. Computer-based techniques were used to quantify risks to proceeding with construction of the Hanford Waste Vitrification Plant on the present baseline schedule. Risks to the potential vitrification of single-shell tank wastes and cesium and strontium capsules were also assessed. 62 refs., 38 figs., 26 tabs.

  19. Incorporating Nonchemical Stressors Into Cumulative Risk Assessments

    PubMed Central

    Rider, Cynthia V.; Dourson, Michael L.; Hertzberg, Richard C.; Mumtaz, Moiz M.; Price, Paul S.; Simmons, Jane Ellen

    2012-01-01

    The role of nonchemical stressors in modulating the human health risk associated with chemical exposures is an area of increasing attention. On 9 March 2011, a workshop titled “Approaches for Incorporating Nonchemical Stressors into Cumulative Risk Assessment” took place during the 50th Anniversary Annual Society of Toxicology Meeting in Washington D.C. Objectives of the workshop included describing the current state of the science from various perspectives (i.e., regulatory, exposure, modeling, and risk assessment) and presenting expert opinions on currently available methods for incorporating nonchemical stressors into cumulative risk assessments. Herein, distinct frameworks for characterizing exposure to, joint effects of, and risk associated with chemical and nonchemical stressors are discussed. PMID:22345310

  20. Cardiac risk assessment: decreasing postoperative complications.

    PubMed

    Thanavaro, Joanne L

    2015-02-01

    Preoperative cardiac assessment helps identify patients undergoing noncardiac surgery who are at risk for significant postoperative cardiac complications and those who may benefit from additional preoperative evaluation and perioperative care. Advanced practice nurses can identify surgery- and patient-related risks by conducting a thorough health history and physical examination. Multiple risk indices and evidence-based guidelines are available to inform health care providers regarding patient evaluation and strategies to reduce postoperative cardiac risk. In general, preoperative tests are recommended only if the findings will influence medical therapy or perioperative monitoring or will require postponement of surgery until a cardiac condition can be corrected or stabilized. Medication management is a crucial component of the preoperative assessment; providers may need to initiate the use of beta-blockers and make decisions regarding continuing or withholding antiplatelet and anticoagulant therapy. Preoperative cardiac risk stratification, medication reconciliation, and device management are essential for providing safe care for patients. PMID:25645037

  1. The teratoma assay: an in vivo assessment of pluripotency.

    PubMed

    Wesselschmidt, Robin L

    2011-01-01

    A teratoma is a nonmalignant tumor comprised of a disorganized mixture of cells and small foci of tissue comprised of cells from all three of the embryonic germ-layers. By definition, a cell is pluripotent if it can differentiate into cells derived from all three of the embryonic germ-layers: ectoderm, mesoderm, and endoderm. In the teratoma assay, putative pluripotent stem cells (PSCs) are implanted into an immune-compromised mouse where they may proliferate and differentiate to form a teratoma. The PSCs grow at the implantation site supported by a complex mixture of factors from the local milieu, as well as circulating factors that are vital components of normal mammalian physiology. After a predetermined time of 6-12 weeks or when the tumor has reached sufficient size, it is removed and subjected to histopathological analysis. The teratoma may be further processed by immunocytochemistry and gene expression profiling. This chapter describes methods to generate teratomas through the implantation of putative PSC lines in the SCID mouse. Implantation at the following sites is described: (1) intramuscular, (2) subcutaneous, (3) under the testis capsule, and (4) under the kidney capsule. PMID:21822879

  2. Safety analysis, risk assessment, and risk acceptance criteria

    SciTech Connect

    Jamali, K.; Stack, D.W.; Sullivan, L.H.; Sanzo, D.L.

    1997-08-01

    This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities and that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, `ensuring` plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is `safe.` Use of RACs requires quantitative estimates of consequence frequency and magnitude.

  3. GAD65 Autoantibodies Detected by Electrochemiluminescence Assay Identify High Risk for Type 1 Diabetes

    PubMed Central

    Miao, Dongmei; Guyer, K. Michelle; Dong, Fran; Jiang, Ling; Steck, Andrea K.; Rewers, Marian; Eisenbarth, George S.; Yu, Liping

    2013-01-01

    The identification of diabetes-relevant islet autoantibodies is essential for predicting and preventing type 1 diabetes (T1D). The aim of the current study was to evaluate a newly developed electrochemiluminescence (ECL)-GAD antibody (GADA) assay and compare its sensitivity and disease relevance with standard radioassay. The assay was validated with serum samples from 227 newly diagnosed diabetic children; 68 prediabetic children who were prospectively followed to T1D; 130 nondiabetic children with confirmed islet autoantibodies to insulin, GAD65, IA-2, and/or ZnT8 longitudinally followed for 12 ± 3.7 years; and 181 age-matched, healthy, antibody-negative children. The ECL-GADA assay had a sensitivity similar to that of the standard GADA radioassay in children newly diagnosed with T1D, prediabetic children, and high-risk children with multiple positive islet autoantibodies. On the other hand, only 9 of 39 nondiabetic children with only a single islet autoantibody (GADA only) by radioassay were positive for ECL-GADA. GADA not detectable by ECL assay is shown to be of low affinity and likely not predictive of future diabetes. In conclusion, the new ECL assay identifies disease-relevant GADA by radioassay. It may help to improve the prediction and correct diagnosis of T1D among subjects positive only for GADA and no other islet autoantibodies. PMID:23974918

  4. Personalized Cancer Risk Assessments for Space Radiation Exposures.

    PubMed

    Locke, Paul A; Weil, Michael M

    2016-01-01

    Individuals differ in their susceptibility to radiogenic cancers, and there is evidence that this inter-individual susceptibility extends to HZE ion-induced carcinogenesis. Three components of individual risk: sex, age at exposure, and prior tobacco use, are already incorporated into the NASA cancer risk model used to determine safe days in space for US astronauts. Here, we examine other risk factors that could potentially be included in risk calculations. These include personal and family medical history, the presence of pre-malignant cells that could undergo malignant transformation as a consequence of radiation exposure, the results from phenotypic assays of radiosensitivity, heritable genetic polymorphisms associated with radiosensitivity, and postflight monitoring. Inclusion of these additional risk or risk reduction factors has the potential to personalize risk estimates for individual astronauts and could influence the determination of safe days in space. We consider how this type of assessment could be used and explore how the provisions of the federal Genetic Information Non-discrimination Act could impact the collection, dissemination and use of this information by NASA. PMID:26942127

  5. Personalized Cancer Risk Assessments for Space Radiation Exposures

    PubMed Central

    Locke, Paul A.; Weil, Michael M.

    2016-01-01

    Individuals differ in their susceptibility to radiogenic cancers, and there is evidence that this inter-individual susceptibility extends to HZE ion-induced carcinogenesis. Three components of individual risk: sex, age at exposure, and prior tobacco use, are already incorporated into the NASA cancer risk model used to determine safe days in space for US astronauts. Here, we examine other risk factors that could potentially be included in risk calculations. These include personal and family medical history, the presence of pre-malignant cells that could undergo malignant transformation as a consequence of radiation exposure, the results from phenotypic assays of radiosensitivity, heritable genetic polymorphisms associated with radiosensitivity, and postflight monitoring. Inclusion of these additional risk or risk reduction factors has the potential to personalize risk estimates for individual astronauts and could influence the determination of safe days in space. We consider how this type of assessment could be used and explore how the provisions of the federal Genetic Information Non-discrimination Act could impact the collection, dissemination and use of this information by NASA. PMID:26942127

  6. Comparing rapid-screening and standard toxicity assays to assess known chemical contamination at a hazardous waste site

    SciTech Connect

    Martino, L.; Swigert, J.; Roberts, C.

    1995-12-31

    The thrust to streamline the Superfund site investigation/remediation program makes it critical for site investigators to utilize rapid screening methodologies to facilitate decision-making. However, screening methodologies providing information upon which decision-making is based must not only be rapid but also scientifically valid. This presentation compares and contrasts two rapid screening toxicity assessments, the Daphnia magna IQ Toxicity Test {trademark} and Microtox{trademark}, to a battery of standard aquatic toxicity tests using Lemna, Rana, Pimephales, Selenastruni and Ceriodaphnia. Chemical analysis of test water samples provided evidence of potential toxicological risk associated with the test samples. The study site was J-Field, Aberdeen Proving Ground, Maryland, a federal facility listed on the National Priority List that used to test and/or dispose of high explosives and chemical warfare agents in open pits or fields. Surface water samples from 20 sites were collected and used in the toxicity assessments. Water samples also were analyzed for explosives, chemical surety degradation compounds, Target Analyte List (inorganics), Target Compound List (organics) and selected pesticides and PCBs. The Microtox{trademark} assay did not reveal any toxicity present in the samples analyzed. Correlation analyses showed only slight correlation between the Daphnia magna IQ{trademark} assay and the standard 48-hour toxicity test. No correlation existed between the Microtox{trademark} assay and the aquatic toxicity tests. Results are discussed in light of the expected risk of the chemicals known to be present and the outcome of the toxicity tests.

  7. Resource handbook on transportation risk assessment.

    SciTech Connect

    Chen, S. Y.; Biwer, B. M.; Monette, F. A.; Environmental Assessment; SNL; BAPL; USOE; Battelle Memorial Inst.

    2003-01-01

    This resource handbook contains useful information to streamline radioactive material transportation risk assessments for National Environmental Policy Act (NEPA) documents prepared for U.S. Department of Energy (DOE) programs. Streamlining refers to instituting steps that can increase the efficiency of future assessments, reduce costs, and promote increased quality and consistency across the DOE complex. This handbook takes advantage of the wealth of information developed through decades of DOE's NEPA experience. It contains a review of historical assessments; a description of comprehensive and generally acceptable transportation risk assessment methodology (i.e., models); and a compilation of supporting data, parameters, and generally accepted assumptions. This handbook also includes a discussion paper that addresses cumulative impacts (Appendix A). The discussion paper illustrates the evolving and sometimes unresolved issues encountered in transportation risk assessment. Other topics, such as sabotage, environmental justice, and human factors, may be addressed in the future. This resource document was developed as the first primary reference book providing useful information for conducting transportation risk assessments for radioactive material in the NEPA context.

  8. In vitro method for medical risk assessment of laser fumes

    NASA Astrophysics Data System (ADS)

    Malkusch, W.; Rehn, B.; Bruch, J.

    1995-02-01

    Laser processing of different materials may produce toxic fumes. In preventive occupational medicine it is necessary to evaluate valid hygienic standards for work places. The basis for such hygienic standards is the classification of laser fumes by their fibrogenic, emphysematous, immunological or other harmful potencies in biological assay systems. This paper is part of a European project on laser safety. Our part in this project is the development of a method for the investigation of lung responses using in vitro cell assays. The appropriate laser fume samples will be supplied by other groups in this European project. In contrast to the cell assays usually used in risk assessment, our method is based on isolated target cells in the lung, such as alveolar macrophages. The test criteria are mediator release, surfactant reactions, release of reactive oxygen species and cell proliferation. As demonstrated in the lung response to other dusts (minerals, fibres etc) these parameters are medically relevant factors in the pathogenic alveolar dust response. The paper gives basic information about the method using lung cell assays and the results of known substances, in comparison with a dust generated by laser processing.

  9. Method and apparatus for assessing cardiovascular risk

    NASA Technical Reports Server (NTRS)

    Albrecht, Paul (Inventor); Bigger, J. Thomas (Inventor); Cohen, Richard J. (Inventor)

    1998-01-01

    The method for assessing risk of an adverse clinical event includes detecting a physiologic signal in the subject and determining from the physiologic signal a sequence of intervals corresponding to time intervals between heart beats. The long-time structure of fluctuations in the intervals over a time period of more than fifteen minutes is analyzed to assess risk of an adverse clinical event. In a preferred embodiment, the physiologic signal is an electrocardiogram and the time period is at least fifteen minutes. A preferred method for analyzing the long-time structure variability in the intervals includes computing the power spectrum and fitting the power spectrum to a power law dependence on frequency over a selected frequency range such as 10.sup.-4 to 10.sup.-2 Hz. Characteristics of the long-time structure fluctuations in the intervals is used to assess risk of an adverse clinical event.

  10. Reliability and risk assessment of structures

    NASA Technical Reports Server (NTRS)

    Chamis, C. C.

    1991-01-01

    Development of reliability and risk assessment of structural components and structures is a major activity at Lewis Research Center. It consists of five program elements: (1) probabilistic loads; (2) probabilistic finite element analysis; (3) probabilistic material behavior; (4) assessment of reliability and risk; and (5) probabilistic structural performance evaluation. Recent progress includes: (1) the evaluation of the various uncertainties in terms of cumulative distribution functions for various structural response variables based on known or assumed uncertainties in primitive structural variables; (2) evaluation of the failure probability; (3) reliability and risk-cost assessment; and (4) an outline of an emerging approach for eventual certification of man-rated structures by computational methods. Collectively, the results demonstrate that the structural durability/reliability of man-rated structural components and structures can be effectively evaluated by using formal probabilistic methods.

  11. Assessment of Risk for Recurrent Diverticulitis

    PubMed Central

    Sallinen, Ville; Mali, Juha; Leppäniemi, Ari; Mentula, Panu

    2015-01-01

    Abstract Recurrence of acute diverticulitis is common, and—especially complicated recurrence—causes significant morbidity. To prevent recurrence, selected patients have been offered prophylactic sigmoid resection. However, as there is no tool to predict whose diverticulitis will recur and, in particular, who will have complicated recurrence, the indications for sigmoid resections have been variable. The objective of this study was to identify risk factors predicting recurrence of acute diverticulitis. This is a retrospective cohort study of patients presenting with computed tomography–confirmed acute diverticulitis and treated nonresectionally during 2006 to 2010. Risk factors for recurrence were identified using uni- and multivariate Cox regression. A total of 512 patients were included. History of diverticulitis was an independent risk factor predicting uncomplicated recurrence of diverticulitis (1–2 earlier diverticulitis HR 1.6, 3 or more—HR 3.2). History of diverticulitis (HR 3.3), abscess (HR 6.2), and corticosteroid medication (HR 16.1) were independent risk factors for complicated recurrence. Based on regression coefficients, risk scoring was created: 1 point for history of diverticulitis, 2 points for abscess, and 3 points for corticosteroid medication. The risk score was unable to predict uncomplicated recurrence (AUC 0.48), but was able to predict complicated recurrence (AUC 0.80). Patients were further divided into low-risk (0–2 points) and high-risk (>2 points) groups. Low-risk and high-risk groups had 3% and 43% 5-year complicated recurrence rates, respectively. Risk for complicated recurrence of acute diverticulitis can be assessed using risk scoring. The risk for uncomplicated recurrence increases along with increasing number of previous diverticulitis. PMID:25715253

  12. Dynamic risk simulation to assess risk along roads

    NASA Astrophysics Data System (ADS)

    Voumard, J.; Caspar, O.; Derron, M.-H.; Jaboyedoff, M.

    2013-04-01

    Risk generated by natural hazards on roads is usually calculated with equations integrating various parameters related to hazard and traffic. These are static variables, like a rockfall hazard estimation for a road section or the average number of vehicles crossing this section every day. This methodology cannot take into account dynamic variations of traffic and interactions between vehicles such as speed modifications due to the sinuosity, slowdowns resulting of saturated traffic or vehicles columns forming in front of traffic lights. The influence of traffic dynamics on the risk estimation is not assessed with standard methodologies. Here we show, by mean of a dynamic traffic simulator, that the traffic variations may greatly influence the risk estimation over time. The risk is analysed on several alpine road sections in Switzerland using a dynamic vehicles approach and compared with the results of the static methodology. It demonstrates that risk significantly increases on sinuous sections because of the decreasing of vehicles speed. A more realistic risk can be obtained from a dynamic approach especially on mountain roads. A dynamic traffic simulator, modelling interactions between vehicles is a helpful tool to support decision making to reduce risk on roads.

  13. Disk Diffusion Assay to Assess the Antimicrobial Activity of Marine Algal Extracts.

    PubMed

    Desbois, Andrew P; Smith, Valerie J

    2015-01-01

    Marine algae are a relatively untapped source of bioactive natural products, including those with antimicrobial activities. The ability to assess the antimicrobial activity of cell extracts derived from algal cultures is vital to identifying species that may produce useful novel antibiotics. One assay that is used widely for this purpose is the disk diffusion assay due to its simplicity, rapidity, and low cost. Moreover, this assay gives output data that are easy to interpret and can be used to screen many samples at once irrespective of the solvent used during preparation. In this chapter, a step-by-step protocol for performing a disk diffusion assay is described. The assay is particularly well suited to testing algal cell extracts and fractions resulting from separation through bioassay-guided approaches. PMID:26108520

  14. Recidivism Risk Assessment for Adult Sexual Offenders.

    PubMed

    Holoyda, Brian J; Newman, William J

    2016-02-01

    Sexual offending is a significant public health problem in the USA due to its prevalence and the substantial impact it has on victims, victims' families, and the legal and mental health systems. The assessment of sexual offender recidivism risk is an important aspect of developing effective management strategies for sexual offenders in terms of placement, treatment, and other interventions. Researchers have developed numerous tools to aid in the assessment of sexual violence recidivism risk, including actuarial measures, structured professional judgment methods, and psychophysiologic assessment of sexual interests. The Static-99R and Sexual Violence Risk-20 are two instruments that have received substantial research attention for their ability to accurately compare offenders' risk of recidivism to normative group data. Penile plethysmography and visual reaction time are used to evaluate subjects' responses to sexual stimuli in an effort to characterize offenders' sexual arousal and interest, respectively. Though current research has focused on risk assessment tools' predictive utility, future research will need to examine the impact that actuarial and structured professional judgment tools have on reducing recidivism if they are to have relevance in the management of sexual offenders. PMID:26781555

  15. Assessment of health risks of policies

    SciTech Connect

    Ádám, Balázs; Molnár, Ágnes; Ádány, Róza; Bianchi, Fabrizio; Bitenc, Katarina; Chereches, Razvan; Cori, Liliana; Fehr, Rainer; Kobza, Joanna; Kollarova, Jana; and others

    2014-09-15

    The assessment of health risks of policies is an inevitable, although challenging prerequisite for the inclusion of health considerations in political decision making. The aim of our project was to develop a so far missing methodological guide for the assessment of the complex impact structure of policies. The guide was developed in a consensual way based on experiences gathered during the assessment of specific national policies selected by the partners of an EU project. Methodological considerations were discussed and summarized in workshops and pilot tested on the EU Health Strategy for finalization. The combined tool, which includes a textual guidance and a checklist, follows the top-down approach, that is, it guides the analysis of causal chains from the policy through related health determinants and risk factors to health outcomes. The tool discusses the most important practical issues of assessment by impact level. It emphasises the transparent identification and prioritisation of factors, the consideration of the feasibility of exposure and outcome assessment with special focus on quantification. The developed guide provides useful methodological instructions for the comprehensive assessment of health risks of policies that can be effectively used in the health impact assessment of policy proposals. - Highlights: • Methodological guide for the assessment of health risks of policies is introduced. • The tool is developed based on the experiences from several case studies. • The combined tool consists of a textual guidance and a checklist. • The top-down approach is followed through the levels of the full impact chain. • The guide provides assistance for the health impact assessment of policy proposals.

  16. Supplemental risk-assessment guidance for the Superfund program. Part 1. Guidance for Public-Health Risk Assessments. Part 2. Guidance for ecological Risk Assessments. Draft report (Final)

    SciTech Connect

    Not Available

    1989-06-01

    This guidance manual was developed to address the practical aspects and issues pertaining to the Superfund risk-assessment process for both public health and environment concerns. Part 1, Guidance for Public Health Risk Assessments, supplements the Superfund Public Health Evaluation Manual and Superfund Exposure Assessment Manual and the Endangerment Assessment Handbook. Explicit guidance on technical matters which should be followed in developing public health risk assessments for EPA Region 1. The guidance addresses hazard identification, dose-response assessment, exposure assessment, risk characterization, and uncertainty/limitations. Part 2 of the manual, Guidance for Ecological Risk Assessments, addresses the collection of site-specific data needed to support an ecological risk assessment, describes a framework for conducting the assessments, and provides several specific approaches for assessing risks to systems exposed to chemical contamination in different media.

  17. New method for assessing risks of email

    NASA Astrophysics Data System (ADS)

    Raja, Seyyed H.; Afrooz, Farzad

    2013-03-01

    E-mail technology, has become one of the requirements of human lives for correspondence between individuals. Given this, the important point is that the messages, server and client of e-mail and correspondences that exchanged between different people have acceptable security, to make people sure to use of this technology. In the information age, many of financial and non financial transactions are done electronically, data exchange takes place via the internet and theft and manipulation of data can make exorbitant cost in terms of integrity, financial, political, economic and culture. E-mail correspondence in there is same and it is very important. With review took place, a method that will focus on email system for risks assessment is not provided. We are examining ways of assessing for other systems and their strengths and weaknesses, then we use Mr Convery method for assessing email risks which it is for assessing network risks. At the end of paper we have offered special table for email risk assessment.

  18. Assessment of developmental delay in the zebrafish embryo teratogenicity assay.

    PubMed

    Teixidó, E; Piqué, E; Gómez-Catalán, J; Llobet, J M

    2013-02-01

    In this study we analyzed some aspects of the assessment of developmental delay in the zebrafish embryotoxicity/teratogenicity test and explored the suitability of acetylcholinesterase (AChE) activity as a biochemical marker and as a higher throughput alternative to morphological endpoints such as head-trunk angle, tail length and morphological score. Embryos were exposed from 4 to 52 h post-fertilization (hpf) to a selection of known embryotoxic/teratogen compounds (valproic acid, retinoic acid, caffeine, sodium salicylate, glucose, hydroxyurea, methoxyacetic acid, boric acid and paraoxon-methyl) over a concentration range. They were evaluated for AChE activity, head-trunk angle, tail length and several qualitative parameters integrated in a morphological score. In general, the different patterns of the concentration-response curves allowed distinguishing between chemicals that produced growth retardation (valproic and methoxyacetic acid) and chemicals that produced non-growth-delay related malformations. An acceptable correlation between the morphological score, AChE activity and head-trunk angle as markers of developmental delay was observed, being AChE activity particularly sensitive to detect delay in the absence of malformations. PMID:22898132

  19. Health effects of risk-assessment categories

    SciTech Connect

    Kramer, C.F.; Rybicka, K.; Knutson, A.; Morris, S.C.

    1983-10-01

    Environmental and occupational health effects associated with exposures to various chemicals are a subject of increasing concern. One recently developed methodology for assessing the health impacts of various chemical compounds involves the classification of similar chemicals into risk-assessment categories (RACs). This report reviews documented human health effects for a broad range of pollutants, classified by RACs. It complements other studies that have estimated human health effects by RAC based on analysis and extrapolation of data from animal research.

  20. Can we (actually) assess global risk?

    NASA Astrophysics Data System (ADS)

    Di Baldassarre, Giuliano

    2013-04-01

    The evaluation of the dynamic interactions of the different components of global risk (e.g. hazard, exposure, vulnerability or resilience) is one of the main challenges in risk assessment and management. In state-of-the-art approaches for the analysis of risk, natural and socio-economic systems are typically treated separately by using different methods. In flood risk studies, for instance, physical scientists typically focus on the study of the probability of flooding (i.e. hazard), while social scientists mainly examine the exposure, vulnerability or resilience to flooding. However, these different components are deeply interconnected. Changes in flood hazard might trigger changes in vulnerability, and vice versa. A typical example of these interactions is the so-called "levee effect", whereby heightening levees to reduce the probability of flooding often leads to increase the potential adverse consequences of flooding as people often perceive that flood risk was completely eliminated once the levee was raised. These interconnections between the different components of risk remain largely unexplored and poorly understood. This lack of knowledge is of serious concern as it limits our ability to plan appropriate risk prevention measures. To design flood control structures, for example, state-of-the-art models can indeed provide quantitative assessments of the corresponding risk reduction associated to the lower probability of flooding. Nevertheless, current methods cannot estimate how, and to what extent, such a reduction might trigger a future increase of the potential adverse consequences of flooding (the aforementioned "levee effect"). Neither can they evaluate how the latter might (in turn) lead to the requirement of additional flood control structures. Thus, while many progresses have been made in the static assessment of flood risk, more inter-disciplinary research is required for the development of methods for dynamic risk assessment, which is very much

  1. Risk Assessment with Adolescent Sex Offenders

    ERIC Educational Resources Information Center

    Christodoulides, T. E.; Richardson, G.; Graham, F.; Kennedy, P. J.; Kelly, T. P.

    2005-01-01

    The paper describes an evaluation of a risk assessment tool's effectiveness in distinguishing adolescent sexual offenders who had committed further sexual offences from those who had not. The sample consisted of 50 male adolescent sexual offenders referred to a forensic outpatient service within a healthcare setting. The adolescents within the…

  2. CUMULATIVE RISK ASSESSMENT FOR QUANTITATIVE RESPONSE DATA

    EPA Science Inventory

    The Relative Potency Factor approach (RPF) is used to normalize and combine different toxic potencies among a group of chemicals selected for cumulative risk assessment. The RPF method assumes that the slopes of the dose-response functions are all equal; but this method depends o...

  3. ECOTOXICOLOGY AND RISK ASSESSMENT FOR WETLANDS

    EPA Science Inventory

    This volume represents the proceedings of a workshop held from 30 July-3 August 1995 at Fairmont Hot Springs, Montana. The workshop was designed to meet the scientific and regulatory need for current information describing ecotoxicology and risk assessment for wetlands. Professio...

  4. Chemical Mixtures: Cancer Risk Assessment Approaches

    EPA Science Inventory

    Presentation will describe how EPA uses linear and nonlinear methods to derive cancer slope factors and reference doses,respectively, for single carcinogens, as described in EPA's 2005 Guidelines for Carcinogen Risk Assessment. Then, the presentation will show how these toxicity ...

  5. GUIDELINES FOR CARCINOGEN RISK ASSESSMENT (1996)

    EPA Science Inventory

    EPA's cancer guidelines set forth recommended principles and procedures to guide EPA scientists in assessing the cancer risks from chemicals or other agents in the environment. They also inform EPA decision makers and the public about these procedures. EPA published final cancer...

  6. QUANTITATIVE RISK ASSESSMENT FOR MICROBIAL AGENTS

    EPA Science Inventory

    Compared to chemical risk assessment, the process for microbial agents and infectious disease is more complex because of host factors and the variety of settings in which disease transmission can occur. While the National Academy of Science has established a paradigm for performi...

  7. ECOLOGICAL RISK ASSESSMENT IN THE FEDERAL GOVERNMENT

    EPA Science Inventory

    This report was prepared by an interagency work group under the auspices of the Committee on Environment and Natural Resources (CENR). The objective of the work group was to write a document on the major uses of ecological risk assessment by Federal agencies. Eight task groups we...

  8. EPIDEMIOLOGY IN RISK ASSESSMENT FOR REGULATORY POLICY

    EPA Science Inventory

    Epidemiology and risk assessment have several of the features needed to make the difficult decisions required in setting standards for levels of toxic agents in the workplace and environment. hey differ in their aims, orientation, and time scale. While the distribution of disease...

  9. PROPOSED GUIDELINES FOR ECOLOGICAL RISK ASSESSMENT

    EPA Science Inventory

    The Proposed Guidelines for Ecological Risk Assessment were published in the Federal Register on September 9, 1996 (61 FR 47552) for a 90 day public review and comment period. The Proposed Guidelines are being developed to improve the quality of and consistency among EPA's ecolog...

  10. Computational Toxicology in Cancer Risk Assessment

    EPA Science Inventory

    Risk assessment over the last half century has, for many individual cases served us well, but has proceeded on an extremely slow pace and has left us with considerable uncertainty. There are certainly thousands of compounds and thousands of exposure scenarios that remain unteste...

  11. AXES OF EXTRAPOLATION IN RISK ASSESSMENTS

    EPA Science Inventory

    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 c...

  12. PREGNANCY RISK ASSESSMENT MONITORING SYSTEM (PRAMS)

    EPA Science Inventory

    PRAMS, the Pregnancy Risk Assessment Monitoring System, is an ongoing state-specific population based surveillance system of the Centers for Disease Control and Prevention (CDC) and state health departments designed to improve the health of mothers and infants by reducing adverse...

  13. Clinical Model for Suicide Risk Assessment.

    ERIC Educational Resources Information Center

    Kral, Michael J.; Sakinofsky, Isaac

    1994-01-01

    Presents suicide risk assessment in a two-tiered model comprising background/contextual factors and subjectivity. The subjectivity portion is formulated around Shneidman's concepts of perturbation and lethality. Discusses decision of hospital admission versus ambulatory care. Suggests that theoretically informed approach should serve both…

  14. Public Workshops on Issues in Risk Assessment

    EPA Science Inventory

    Workshop Schedule

    • September 2-3, 2015 – Epigenetics and Cumulative Risk Assessment
      This workshop will examine the role that data on epigenetic changes may play...

    • The NASA Space Radiobiology Risk Assessment Project

      NASA Astrophysics Data System (ADS)

      Cucinotta, Francis A.; Huff, Janice; Ponomarev, Artem; Patel, Zarana; Kim, Myung-Hee

      The current first phase (2006-2011) has the three major goals of: 1) optimizing the conventional cancer risk models currently used based on the double-detriment life-table and radiation quality functions; 2) the integration of biophysical models of acute radiation syndromes; and 3) the development of new systems radiation biology models of cancer processes. The first-phase also includes continued uncertainty assessment of space radiation environmental models and transport codes, and relative biological effectiveness factors (RBE) based on flight data and NSRL results, respectively. The second phase of the (2012-2016) will: 1) develop biophysical models of central nervous system risks (CNS); 2) achieve comphrensive systems biology models of cancer processes using data from proton and heavy ion studies performed at NSRL; and 3) begin to identify computational models of biological countermeasures. Goals for the third phase (2017-2021) include: 1) the development of a systems biology model of cancer risks for operational use at NASA; 2) development of models of degenerative risks, 2) quantitative models of counter-measure impacts on cancer risks; and 3) indiviudal based risk assessments. Finally, we will support a decision point to continue NSRL research in support of NASA's exploration goals beyond 2021, and create an archival of NSRL research results for continued analysis. Details on near term goals, plans for a WEB based data resource of NSRL results, and a space radiation Wikepedia are described.

    • Bayesian Networks for enterprise risk assessment

      NASA Astrophysics Data System (ADS)

      Bonafede, C. E.; Giudici, P.

      2007-08-01

      According to different typologies of activity and priority, risks can assume diverse meanings and it can be assessed in different ways. Risk, in general, is measured in terms of a probability combination of an event (frequency) and its consequence (impact). To estimate the frequency and the impact (severity) historical data or expert opinions (either qualitative or quantitative data) are used. Moreover, qualitative data must be converted in numerical values or bounds to be used in the model. In the case of enterprise risk assessment the considered risks are, for instance, strategic, operational, legal and of image, which many times are difficult to be quantified. So in most cases only expert data, gathered by scorecard approaches, are available for risk analysis. The Bayesian Networks (BNs) are a useful tool to integrate different information and in particular to study the risk's joint distribution by using data collected from experts. In this paper we want to show a possible approach for building a BN in the particular case in which only prior probabilities of node states and marginal correlations between nodes are available, and when the variables have only two states.

    • New horizons in fracture risk assessment.

      PubMed

      Aspray, Terry J

      2013-09-01

      Fracture is the clinical outcome of concern in osteoporosis, a disease variably defined over the last 30 years, mostly in terms of bone mineral density (BMD). However, an 'osseocentric' view of the condition may have hampered our understanding of how best to identify patients at the greatest risk of fragility fracture. More recently, the identification of a number of clinical risk factors for fragility fracture and the creation of fracture risk assessment tools, such as FRAX®, QFracture and Garvan have helped in a move towards clinically useful definitions, using the common currency of 10-year major osteoporotic and 10-year hip fracture risks. However, there are a large number of available fracture risk assessment tools and there remain few validation studies comparing their performance. The National Institute for Health and Clinical Excellence has recently advocated the use of these methods in case finding and studies are underway in their clinical application. It seems likely that the operational definition of osteoporosis must now include fracture risk, which will never replace fracture incidence as a measure of clinical efficacy but may be used in future studies to define patient groups likely to benefit from intervention. We still need to understand more about the performance of these tools, particularly in the context of specific patient groups, such as those with vertebral osteoporosis, the frail, those who fall and patients with secondary osteoporosis. PMID:23892830

    • Temporal Assessment of the Impact of Exposure to Cow Feces in Two Watersheds by Multiple Host-Specific PCR Assays

      EPA Science Inventory

      Exposure to feces in two watersheds with different management histories was assessed by tracking cattle feces bacterial populations using multiple host-specific PCR assays. In addition, environmental factors affecting the occurrence of these markers were identified. Each assay wa...

    • Incinerator thermal release valve risk assessment

      SciTech Connect

      Stevens, J.B.

      1998-12-31

      Human health risk assessments were conducted on emissions from several types of incinerators--a hazardous waste combustor, a medical waste/tire combustor, and a refuse derived fuel combustor in three different states. As part of these studies, the short-term emissions from thermal release valves operating during upset conditions were additionally evaluated. The latter assessments addressed two specific risk-related questions: (1) what are the incremental long-term risks/hazards associated with these short-term emissions; (2) what are the acute health hazards associated with these emissions? For each study, emission estimates for both the incinerator stack and the thermal release valve were obtained from the facility. Stack testing was utilized to obtain stack gas concentrations of emissions at one facility; engineering estimates were used to ascertain emissions from the thermal release valve. The two facilities were proposed incinerators, so literature-derived emissions were used throughout.

    • The Comparison of MTT and CVS Assays for the Assessment of Anticancer Agent Interactions.

      PubMed

      Śliwka, Lidia; Wiktorska, Katarzyna; Suchocki, Piotr; Milczarek, Małgorzata; Mielczarek, Szymon; Lubelska, Katarzyna; Cierpiał, Tomasz; Łyżwa, Piotr; Kiełbasiński, Piotr; Jaromin, Anna; Flis, Anna; Chilmonczyk, Zdzisław

      2016-01-01

      Multiple in vitro tests are widely applied to assess the anticancer activity of new compounds, including their combinations and interactions with other drugs. The MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide) assay is one of the most commonly used assays to assess the efficacy and interactions of anticancer agents. However, it can be significantly influenced by compounds that modify cell metabolism and reaction conditions. Therefore, several assays are sometimes used to screen for potential anticancer drugs. However, the majority of drug interactions are evaluated only with this single method. The aim of our studies was to verify whether the choice of an assay has an impact on determining the type of interaction and to identify the source of discrepancies. We compared the accuracy of MTT and CVS (crystal violet staining) assays in the interaction of two compounds characterized by similar anticancer activity: isothiocyanates (ITCs) and Selol. Confocal microscopy studies were carried out to assess the influence of these compounds on the reactive oxygen species (ROS) level, mitochondrial membrane potential, dead-to-live cell ratio and MTT-tetrazolium salt reduction rate. The MTT assay was less reliable than CVS. The MTT test of Selol and 2-oxoheptyl ITC, which affected the ROS level and MTT reduction rate, gave false negative (2-oxoheptyl ITC) or false positive (Selol) results. As a consequence, the MTT assay identified an antagonistic interaction between Selol and ITC, while the metabolism-independent CVS test identified an additive or synergistic interaction. In this paper, we show for the first time that the test assay may change the interpretation of the compound interaction. Therefore, the test method should be chosen with caution, considering the mechanism of action of the compound. PMID:27196402

  1. The Comparison of MTT and CVS Assays for the Assessment of Anticancer Agent Interactions

    PubMed Central

    Śliwka, Lidia; Wiktorska, Katarzyna; Suchocki, Piotr; Milczarek, Małgorzata; Mielczarek, Szymon; Lubelska, Katarzyna; Cierpiał, Tomasz; Łyżwa, Piotr; Kiełbasiński, Piotr; Jaromin, Anna; Flis, Anna; Chilmonczyk, Zdzisław

    2016-01-01

    Multiple in vitro tests are widely applied to assess the anticancer activity of new compounds, including their combinations and interactions with other drugs. The MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide) assay is one of the most commonly used assays to assess the efficacy and interactions of anticancer agents. However, it can be significantly influenced by compounds that modify cell metabolism and reaction conditions. Therefore, several assays are sometimes used to screen for potential anticancer drugs. However, the majority of drug interactions are evaluated only with this single method. The aim of our studies was to verify whether the choice of an assay has an impact on determining the type of interaction and to identify the source of discrepancies. We compared the accuracy of MTT and CVS (crystal violet staining) assays in the interaction of two compounds characterized by similar anticancer activity: isothiocyanates (ITCs) and Selol. Confocal microscopy studies were carried out to assess the influence of these compounds on the reactive oxygen species (ROS) level, mitochondrial membrane potential, dead-to-live cell ratio and MTT-tetrazolium salt reduction rate. The MTT assay was less reliable than CVS. The MTT test of Selol and 2-oxoheptyl ITC, which affected the ROS level and MTT reduction rate, gave false negative (2-oxoheptyl ITC) or false positive (Selol) results. As a consequence, the MTT assay identified an antagonistic interaction between Selol and ITC, while the metabolism-independent CVS test identified an additive or synergistic interaction. In this paper, we show for the first time that the test assay may change the interpretation of the compound interaction. Therefore, the test method should be chosen with caution, considering the mechanism of action of the compound. PMID:27196402

  2. Transparent Global Seismic Hazard and Risk Assessment

    NASA Astrophysics Data System (ADS)

    Smolka, Anselm; Schneider, John; Pinho, Rui; Crowley, Helen

    2013-04-01

    Vulnerability to earthquakes is increasing, yet advanced reliable risk assessment tools and data are inaccessible to most, despite being a critical basis for managing risk. Also, there are few, if any, global standards that allow us to compare risk between various locations. The Global Earthquake Model (GEM) is a unique collaborative effort that aims to provide organizations and individuals with tools and resources for transparent assessment of earthquake risk anywhere in the world. By pooling data, knowledge and people, GEM acts as an international forum for collaboration and exchange, and leverages the knowledge of leading experts for the benefit of society. Sharing of data and risk information, best practices, and approaches across the globe is key to assessing risk more effectively. Through global projects, open-source IT development and collaborations with more than 10 regions, leading experts are collaboratively developing unique global datasets, best practice, open tools and models for seismic hazard and risk assessment. Guided by the needs and experiences of governments, companies and citizens at large, they work in continuous interaction with the wider community. A continuously expanding public-private partnership constitutes the GEM Foundation, which drives the collaborative GEM effort. An integrated and holistic approach to risk is key to GEM's risk assessment platform, OpenQuake, that integrates all above-mentioned contributions and will become available towards the end of 2014. Stakeholders worldwide will be able to calculate, visualise and investigate earthquake risk, capture new data and to share their findings for joint learning. Homogenized information on hazard can be combined with data on exposure (buildings, population) and data on their vulnerability, for loss assessment around the globe. Furthermore, for a true integrated view of seismic risk, users can add social vulnerability and resilience indices to maps and estimate the costs and benefits

  3. Fragility fracture: recent developments in risk assessment

    PubMed Central

    2015-01-01

    More than half of older women who sustain a fragility fracture do not have osteoporosis by World Health Organization (WHO) bone mineral density (BMD) criteria; and, while BMD has been used to assess fracture risk for over 30 years, a range of other skeletal and nonskeletal clinical risk factors (CRFs) for fracture have been recognized. More than 30 assessment tools using CRFs have been developed, some predicting fracture risk and others low BMD alone. Recent systematic reviews have reported that many tools have not been validated against fracture incidence, and that the complexity of tools and the number of CRFs included do not ensure best performance with poor assessment of (internal or comparative) validity. Internationally, FRAX® is the most commonly recommended tool, in addition to QFracture in the UK, The Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool in Canada and Garvan in Australia. All tools estimate standard 10-year risk of major osteoporotic and 10-year risk of hip fracture: FRAX® is able to estimate fracture risk either with or without BMD, but CAROC and Garvan both require BMD and QFracture does not. The best evidence for the utility of these tools is in case finding but there may be future prospects for the use of 10-year fracture risk as a common currency with reference to the benefits of treatment, whether pharmacological or lifestyle. The use of this metric is important in supporting health economic analyses. However, further calibration studies will be needed to prove that the tools are robust and that their estimates can be used in supporting treatment decisions, independent of BMD. PMID:25650086

  4. Behavioral toxicology, risk assessment, and chlorinated hydrocarbons.

    PubMed Central

    Evangelista de Duffard, A M; Duffard, R

    1996-01-01

    Behavioral end points are being used with greater frequency in neurotoxicology to detect and characterize the adverse effects of chemicals on the nervous system. Behavioral measures are particularly important for neurotoxicity risk assessment since many known neurotoxicants do not result in neuropathology. The chlorinated hydrocarbon class consists of a wide variety of chemicals including polychlorinated biphenyls, clioquinol, trichloroethylene, hexachlorophene, organochlorine insecticides (DDT, dicofol, chlordecone,dieldrin, and lindane), and phenoxyherbicides. Each of these chemicals has effects on motor, sensory, or cognitive function that are detectable using functional measures such as behavior. Furthermore, there is evidence that if exposure occurs during critical periods of development, many of the chlorinated hydrocarbons are developmental neurotoxicants. Developmental neurotoxicity is frequently expressed as alterations in motor function or cognitive abilities or changes in the ontogeny of sensorimotor reflexes. Neurotoxicity risk assessment should include assessments of the full range of possible neurotoxicological effects, including both structural and functional indicators of neurotoxicity. PMID:9182042

  5. Silent Aircraft Initiative Concept Risk Assessment

    NASA Technical Reports Server (NTRS)

    Nickol, Craig L.

    2008-01-01

    A risk assessment of the Silent Aircraft Initiative's SAX-40 concept design for extremely low noise has been performed. A NASA team developed a list of 27 risk items, and evaluated the level of risk for each item in terms of the likelihood that the risk would occur and the consequences of the occurrence. The following risk items were identified as high risk, meaning that the combination of likelihood and consequence put them into the top one-fourth of the risk matrix: structures and weight prediction; boundary-layer ingestion (BLI) and inlet design; variable-area exhaust and thrust vectoring; displaced-threshold and continuous descent approach (CDA) operational concepts; cost; human factors; and overall noise performance. Several advanced-technology baseline concepts were created to serve as a basis for comparison to the SAX-40 concept. These comparisons indicate that the SAX-40 would have significantly greater research, development, test, and engineering (RDT&E) and production costs than a conventional aircraft with similar technology levels. Therefore, the cost of obtaining the extremely low noise capability that has been estimated for the SAX-40 is significant. The SAX-40 concept design proved successful in focusing attention toward low noise technologies and in raising public awareness of the issue.

  6. Assessing calibration of prognostic risk scores.

    PubMed

    Crowson, Cynthia S; Atkinson, Elizabeth J; Therneau, Terry M

    2016-08-01

    Current methods used to assess calibration are limited, particularly in the assessment of prognostic models. Methods for testing and visualizing calibration (e.g. the Hosmer-Lemeshow test and calibration slope) have been well thought out in the binary regression setting. However, extension of these methods to Cox models is less well known and could be improved. We describe a model-based framework for the assessment of calibration in the binary setting that provides natural extensions to the survival data setting. We show that Poisson regression models can be used to easily assess calibration in prognostic models. In addition, we show that a calibration test suggested for use in survival data has poor performance. Finally, we apply these methods to the problem of external validation of a risk score developed for the general population when assessed in a special patient population (i.e. patients with particular comorbidities, such as rheumatoid arthritis). PMID:23907781

  7. A rapid assay for assessment of sphingosine kinase inhibitors and substrates

    PubMed Central

    Kharel, Yugesh; Mathews, Thomas P.; Kennedy, Andrew J.; Houck, Joseph D.; Macdonald, Timohy L.; Lynch, Kevin R.

    2011-01-01

    Sphingosine kinases catalyze the transfer of phosphate from ATP to sphingosine to generate sphingosine 1-phosphate, an important bioactive lipid molecule that mediates a diverse range of cell signaling processes. The conventional assay of sphingosine kinase enzymatic activity uses [γ-32P]ATP and sphingosine as substrates with the radiolabeled S1P product recovered by organic extraction, displayed by thin-layer chromatography and quantified by liquid scintillation counting. While this assay is sensitive and accurate, it is slow and labor intensive and thus precludes the simultaneous screening of more than a few inhibitor compounds. Herein we describe a 96 well assay for sphingosine kinases that is rapid and reproducible. Our method, which takes advantage of the limited solubility of S1P, detects radioactive S1P adhering to the plate by scintillation proximity counting. Our procedure obviates extraction into organic solvents, post-reaction transfers and chromatography. Further, our assay enables assessment of both inhibitors and substrates, and can detect endogenous sphingosine kinase activity in cell and tissue extracts. The sphingosine kinase kinetic parameter, Km, and the Ki values of inhibitors determined with our assay and the conventional assay were indistinguishable. These results document that our assay is well suited for the screening of chemical libraries of sphingosine kinase inhibitors. PMID:21216217

  8. Assessing the toxicity of sediments using the medaka embryo-larval assay and 2 other bioassays.

    PubMed

    Barhoumi, Badreddine; Clérandeau, Christelle; Landi, Laure; Pichon, Anaïk; Le Bihanic, Florane; Poirier, Dominique; Anschutz, Pierre; Budzinski, Hélène; Driss, Mohamed Ridha; Cachot, Jérôme

    2016-09-01

    Sediments are sinks for aquatic pollutants, and analyzing toxicity in such complex matrices is still challenging. To evaluate the toxicity of bioavailable pollutants accumulated in sediments from the Bizerte lagoon (Tunisia), a novel assay, the medaka embryo-larval assay by sediment contact, was applied. Japanese medaka (Oryzias latipes) embryos were incubated in direct contact with sediment samples up to hatching. Lethal and sublethal adverse effects were recorded in embryos and larvae up to 20 d postfertilization. Results from medaka embryo-larval assay were compared with cytotoxicity (Microtox®), genotoxicity (SOS chromotest), and pollutant content of sediments. The results highlight differences in the contamination profile and toxicity pattern between the different studied sediments. A significant correlation was shown between medaka embryo-larval assay by sediment contact and SOS chromotest responses and concentrations of most organic pollutants studied. No correlation was shown between pollutant levels and Microtox. According to the number of sediment samples detected as toxic, medaka embryo-larval assay by sediment contact was more sensitive than Microtox, which in turn was more sensitive than the SOS chromotest; and medaka embryo-larval assay by sediment contact allowed sediment toxicity assessment of moderately polluted sediments without pollutant extraction and using an ecologically realistic exposure scenario. Although medaka embryo-larval assay by sediment contact should be tested on a larger sample set, the results show that it is sensitive and convenient enough to monitor the toxicity of natural sediments. Environ Toxicol Chem 2016;35:2270-2280. © 2016 SETAC. PMID:26823140

  9. Use of cross-reactive serological assays for detecting novel pathogens in wildlife: assessing an appropriate cutoff for henipavirus assays in African bats.

    PubMed

    Peel, Alison J; McKinley, Trevelyan J; Baker, Kate S; Barr, Jennifer A; Crameri, Gary; Hayman, David T S; Feng, Yan-Ru; Broder, Christopher C; Wang, Lin-Fa; Cunningham, Andrew A; Wood, James L N

    2013-11-01

    Reservoir hosts of novel pathogens are often identified or suspected as such on the basis of serological assay results, prior to the isolation of the pathogen itself. Serological assays might therefore be used outside of their original, validated scope in order to infer seroprevalences in reservoir host populations, until such time that specific diagnostic assays can be developed. This is particularly the case in wildlife disease research. The absence of positive and negative control samples and gold standard diagnostic assays presents challenges in determining an appropriate threshold, or 'cutoff', for the assay that enables differentiation between seronegative and seropositive individuals. Here, multiple methods were explored to determine an appropriate cutoff for a multiplexed microsphere assay that is used to detect henipavirus antibody binding in fruit bat plasma. These methods included calculating multiples of 'negative' control assay values, receiver operating characteristic curve analyses, and Bayesian mixture models to assess the distribution of assay outputs for classifying seropositive and seronegative individuals within different age classes. As for any diagnostic assay, the most appropriate cutoff determination method and value selected must be made according to the aims of the study. This study is presented as an example for others where reference samples, and assays that have been characterised previously, are absent. PMID:23835034

  10. 2009 Space Shuttle Probabilistic Risk Assessment Overview

    NASA Technical Reports Server (NTRS)

    Hamlin, Teri L.; Canga, Michael A.; Boyer, Roger L.; Thigpen, Eric B.

    2010-01-01

    Loss of a Space Shuttle during flight has severe consequences, including loss of a significant national asset; loss of national confidence and pride; and, most importantly, loss of human life. The Shuttle Probabilistic Risk Assessment (SPRA) is used to identify risk contributors and their significance; thus, assisting management in determining how to reduce risk. In 2006, an overview of the SPRA Iteration 2.1 was presented at PSAM 8 [1]. Like all successful PRAs, the SPRA is a living PRA and has undergone revisions since PSAM 8. The latest revision to the SPRA is Iteration 3. 1, and it will not be the last as the Shuttle program progresses and more is learned. This paper discusses the SPRA scope, overall methodology, and results, as well as provides risk insights. The scope, assumptions, uncertainties, and limitations of this assessment provide risk-informed perspective to aid management s decision-making process. In addition, this paper compares the Iteration 3.1 analysis and results to the Iteration 2.1 analysis and results presented at PSAM 8.

  11. Clinical Risk Assessment in Intensive Care Unit

    PubMed Central

    Asefzadeh, Saeed; Yarmohammadian, Mohammad H.; Nikpey, Ahmad; Atighechian, Golrokh

    2013-01-01

    Background: Clinical risk management focuses on improving the quality and safety of health care services by identifying the circumstances and opportunities that put patients at risk of harm and acting to prevent or control those risks. The goal of this study is to identify and assess the failure modes in the ICU of Qazvin's Social Security Hospital (Razi Hospital) through Failure Mode and Effect Analysis (FMEA). Methods: This was a qualitative-quantitative research by Focus Discussion Group (FDG) performed in Qazvin Province, Iran during 2011. The study population included all individuals and owners who are familiar with the process in ICU. Sampling method was purposeful and the FDG group members were selected by the researcher. The research instrument was standard worksheet that has been used by several researchers. Data was analyzed by FMEA technique. Results: Forty eight clinical errors and failure modes identified, results showed that the highest risk probability number (RPN) was in respiratory care “Ventilator's alarm malfunction (no alarm)” with the score 288, and the lowest was in gastrointestinal “not washing the NG-Tube” with the score 8. Conclusions: Many of the identified errors can be prevented by group members. Clinical risk assessment and management is the key to delivery of effective health care. PMID:23930171

  12. Code System for Seismic Probabilistic Risk Assessment.

    Energy Science and Technology Software Center (ESTSC)

    2001-03-27

    Version 00 SEISIM1 calculates the probabilities of seismically induced failures for components and systems and propagates these calculations to determine the probability of accident sequences and the resulting total risk, which is quantified as an expected value of radiation release and exposure from a given nuclear power plant. SEISIM1 was developed as a fundamental tool for the systems analysis portion of the NRC's Seismic Safety Margins Research Program (SSMRP). The SSMRP provides a complete, self-containedmore » methodology to assess and quantify the risk to nuclear power plants from seismic events and seismically induced failures.« less

  13. OVERVIEW OF RISK ASSESSMENT FOR TOXIC AND PATHOGENIC AGENTS

    EPA Science Inventory

    Risk assessment is a process that defines the adverse health consequences of exposure to toxic or pathogenic agents. hen used in regulatory decision making, risk assessment is an important component of risk management, which "combines the risk assessment with the directives of re...

  14. Can Systematic Reviews Inform GMO Risk Assessment and Risk Management?

    PubMed

    Kohl, Christian; Frampton, Geoff; Sweet, Jeremy; Spök, Armin; Haddaway, Neal Robert; Wilhelm, Ralf; Unger, Stefan; Schiemann, Joachim

    2015-01-01

    Systematic reviews represent powerful tools to identify, collect, synthesize, and evaluate primary research data on specific research questions in a highly standardized and reproducible manner. They enable the defensible synthesis of outcomes by increasing precision and minimizing bias whilst ensuring transparency of the methods used. This makes them especially valuable to inform evidence-based risk analysis and decision making in various topics and research disciplines. Although seen as a "gold standard" for synthesizing primary research data, systematic reviews are not without limitations as they are often cost, labor and time intensive and the utility of synthesis outcomes depends upon the availability of sufficient and robust primary research data. In this paper, we (1) consider the added value systematic reviews could provide when synthesizing primary research data on genetically modified organisms (GMO) and (2) critically assess the adequacy and feasibility of systematic review for collating and analyzing data on potential impacts of GMOs in order to better inform specific steps within GMO risk assessment and risk management. The regulatory framework of the EU is used as an example, although the issues we discuss are likely to be more widely applicable. PMID:26322307

  15. Can Systematic Reviews Inform GMO Risk Assessment and Risk Management?

    PubMed Central

    Kohl, Christian; Frampton, Geoff; Sweet, Jeremy; Spök, Armin; Haddaway, Neal Robert; Wilhelm, Ralf; Unger, Stefan; Schiemann, Joachim

    2015-01-01

    Systematic reviews represent powerful tools to identify, collect, synthesize, and evaluate primary research data on specific research questions in a highly standardized and reproducible manner. They enable the defensible synthesis of outcomes by increasing precision and minimizing bias whilst ensuring transparency of the methods used. This makes them especially valuable to inform evidence-based risk analysis and decision making in various topics and research disciplines. Although seen as a “gold standard” for synthesizing primary research data, systematic reviews are not without limitations as they are often cost, labor and time intensive and the utility of synthesis outcomes depends upon the availability of sufficient and robust primary research data. In this paper, we (1) consider the added value systematic reviews could provide when synthesizing primary research data on genetically modified organisms (GMO) and (2) critically assess the adequacy and feasibility of systematic review for collating and analyzing data on potential impacts of GMOs in order to better inform specific steps within GMO risk assessment and risk management. The regulatory framework of the EU is used as an example, although the issues we discuss are likely to be more widely applicable. PMID:26322307

  16. Asteroid Risk Assessment: A Probabilistic Approach.

    PubMed

    Reinhardt, Jason C; Chen, Xi; Liu, Wenhao; Manchev, Petar; Paté-Cornell, M Elisabeth

    2016-02-01

    Following the 2013 Chelyabinsk event, the risks posed by asteroids attracted renewed interest, from both the scientific and policy-making communities. It reminded the world that impacts from near-Earth objects (NEOs), while rare, have the potential to cause great damage to cities and populations. Point estimates of the risk (such as mean numbers of casualties) have been proposed, but because of the low-probability, high-consequence nature of asteroid impacts, these averages provide limited actionable information. While more work is needed to further refine its input distributions (e.g., NEO diameters), the probabilistic model presented in this article allows a more complete evaluation of the risk of NEO impacts because the results are distributions that cover the range of potential casualties. This model is based on a modularized simulation that uses probabilistic inputs to estimate probabilistic risk metrics, including those of rare asteroid impacts. Illustrative results of this analysis are presented for a period of 100 years. As part of this demonstration, we assess the effectiveness of civil defense measures in mitigating the risk of human casualties. We find that they are likely to be beneficial but not a panacea. We also compute the probability-but not the consequences-of an impact with global effects ("cataclysm"). We conclude that there is a continued need for NEO observation, and for analyses of the feasibility and risk-reduction effectiveness of space missions designed to deflect or destroy asteroids that threaten the Earth. PMID:26215051

  17. Ligand-binding assays: risk of using a platform supported by a single vendor.

    PubMed

    Yohrling, Jennifer

    2009-06-01

    The use of biological reagents in ligand-binding assays (LBAs) presents inherent challenges when measuring the concentration of large molecules in complex matrices. As a result, there are relatively few platforms that provide the accuracy, precision and robustness needed to determine the concentration of macromolecular therapies and biomarkers, and demonstrate the presence or absence of an immune response. Some bioanalytical laboratories use only one LBA platform to reduce costs, increase efficiency and maintain optimal assay performance. However, the business and regulatory risks of using a single platform supported by only one vendor should be considered. This article summarizes the immunological methods used to support bioanalysis for large molecules that are supported by a single vendor, the benefits of being dedicated to a single platform for bioanalysis used for regulatory filings, the costs associated with restructuring if an immunoassay platform is discontinued and recommendations to mitigate risk when using LBAs in drug development. The experience with the recent discontinuation of the BioVeris™ electrochemiluminescent-based platform is discussed. PMID:21083158

  18. Practice management based on risk assessment.

    PubMed

    Sandberg, Hans

    2004-01-01

    The management of a dental practice is most often focused on what clinicians do (production of items), and not so much on what is achieved in terms of oral health. The main reason for this is probably that it is easier to measure production and more difficult to measure health outcome. This paper presents a model based on individual risk assessment that aims to achieve a financially sound economy and good oral health. The close-to-the-clinic management tool, the HIDEP Model (Health Improvement in a DEntal Practice) was pioneered initially in Sweden at the end of 1980s. The experience over a 15-year period with different elements of the model is presented, including: the basis of examination and risk assessment; motivation; task delegation and leadership issues; health-finance evaluations; and quality development within a dental clinic. DentiGroupXL, a software program designed to support the work based on the model, is also described. PMID:15646588

  19. The perinatal assessment of psychosocial risk.

    PubMed

    Haglund, L J; Britton, J R

    1998-06-01

    Although evaluation of psychosocial risk factors prior to perinatal hospital discharge has been advocated, the means for accomplishing such an evaluation are not well established. This article reviews several major psychosocial risk factors together with instruments that have been utilized to assess them during the perinatal period. Formal constructs reviewed include anxiety, depression, self-concept, general attitudes, life events, stress, adaptation, social support, marital and family functioning, and the home environment. Ongoing assessment of psychosocial status using formal instruments during routine perinatal care may provide a more complete picture of the psychosocial needs of the individual mother and her family, allowing for more appropriate, timely intervention and utilization of social and health care resources. PMID:9647002

  20. Assessing the cancer risk from environmental PCBs.

    PubMed Central

    Cogliano, V J

    1998-01-01

    A new approach to assessing the cancer risk from environmental polychlorinated biphenyls (PCBs) considers both toxicity and environmental processes to make distinctions among environmental mixtures. New toxicity information from a 1996 cancer study of four commercial mixtures strengthens the case that all PCB mixtures can cause cancer, although different mixtures have different potencies. Environmental processes alter PCB mixtures through partitioning, chemical transformation, and preferential bioaccumulation; these processes can increase or decrease toxicity considerably. Bioaccumulated PCBs are of greatest concern because they appear to be more toxic than commercial PCBs and more persistent in the body. The new approach uses toxicity studies of commercial mixtures to develop a range of cancer potency estimates and then considers the effect of environmental processes to choose appropriate values for representative classes of environmental mixtures. Guidance is given for assessing risks from different exposure pathways, less-than-lifetime and early-life exposures, and mixtures containing dioxinlike compounds. PMID:9618347

  1. Supplemental Hazard Analysis and Risk Assessment - Hydrotreater

    SciTech Connect

    Lowry, Peter P.; Wagner, Katie A.

    2015-04-01

    A supplemental hazard analysis was conducted and quantitative risk assessment performed in response to an independent review comment received by the Pacific Northwest National Laboratory (PNNL) from the U.S. Department of Energy Pacific Northwest Field Office (PNSO) against the Hydrotreater/Distillation Column Hazard Analysis Report issued in April 2013. The supplemental analysis used the hazardous conditions documented by the previous April 2013 report as a basis. The conditions were screened and grouped for the purpose of identifying whether additional prudent, practical hazard controls could be identified, using a quantitative risk evaluation to assess the adequacy of the controls and establish a lower level of concern for the likelihood of potential serious accidents. Calculations were performed to support conclusions where necessary.

  2. Degraded environments alter prey risk assessment.

    PubMed

    Lönnstedt, Oona M; McCormick, Mark I; Chivers, Douglas P

    2012-01-01

    Elevated water temperatures, a decrease in ocean pH, and an increasing prevalence of severe storms have lead to bleaching and death of the hard corals that underpin coral reef ecosystems. As coral cover declines, fish diversity and abundance declines. How degradation of coral reefs affects behavior of reef inhabitants is unknown. Here, we demonstrate that risk assessment behaviors of prey are severely affected by coral degradation. Juvenile damselfish were exposed to visual and olfactory indicators of predation risk in healthy live, thermally bleached, and dead coral in a series of laboratory and field experiments. While fish still responded to visual cues in all habitats, they did not respond to olfactory indicators of risk in dead coral habitats, likely as a result of alteration or degradation of chemical cues. These cues are critical for learning and avoiding predators, and a failure to respond can have dramatic repercussions for survival and recruitment. PMID:23403754

  3. Cardiovascular risk assessment in women - an update.

    PubMed

    Collins, P; Webb, C M; de Villiers, T J; Stevenson, J C; Panay, N; Baber, R J

    2016-08-01

    Cardiovascular disease is the leading cause of morbidity and mortality in postmenopausal women. Although it is a disease of aging, vascular disease initiates much earlier in life. Thus, there is a need to be aware of the potential to prevent the development of the disease from an early age and continue this surveillance throughout life. The menopausal period and early menopause present an ideal opportunity to assess cardiovascular risk and plan accordingly. Generally in this period, women will be seen by primary health-care professionals and non-cardiovascular specialists. This review addresses female-specific risk factors that may contribute to the potential development of cardiovascular disease. It is important for all health-care professionals dealing with women in midlife and beyond to be cognisant of these risk factors and to initiate female-specific preventative measures or to refer to a cardiovascular specialist. PMID:27327421

  4. [Methods of risk assessment and their validation].

    PubMed

    Baracco, Alessandro

    2014-01-01

    The review of the literature data shows several methods for the the risks assessment of biomnechanical overload of the musculoskeletal system in activities with repetitive strain of the upper limbs and manual material handling. The application of these methods should allow the quantification ofriskfor the working population, the identification of the preventive measures to reduce the risk and their effectiveness and thle design of a specific health surveillance scheme. In this paper we analyze the factors which must be taken into account in Occupational Medicine to implement a process of validation of these methods. In conclusion we believe it will necessary in the future the availability of new methods able to analyze and reduce the risk already in the design phase of the production process. PMID:25558718

  5. Risk assessment meta tool LDRD final report.

    SciTech Connect

    Bouchard, Ann Marie; Osbourn, Gordon Cecil

    2006-12-01

    The goal of this project was to develop a risk analysis meta tool--a tool that enables security analysts both to combine and analyze data from multiple other risk assessment tools on demand. Our approach was based on the innovative self-assembling software technology under development by the project team. This technology provides a mechanism for the user to specify his intentions at a very high level (e.g., equations or English-like text), and then the code self-assembles itself, taking care of the implementation details. The first version of the meta tool focused specifically in importing and analyzing data from Joint Conflict and Tactical Simulation (JCATS) force-on-force simulation. We discuss the problem, our approach, technical risk, and accomplishments on this project, and outline next steps to be addressed with follow-on funding.

  6. Chernobyl accident: A comprehensive risk assessment

    SciTech Connect

    Vargo, G.J.; Poyarkov, V.; Baryakhtar, V.; Kukhar, V.; Los, I.

    1999-01-01

    The authors, all of whom are Ukrainian and Russian scientists involved with Chernobyl nuclear power plant since the April 1986 accident, present a comprehensive review of the accident. In addition, they present a risk assessment of the remains of the destroyed reactor and its surrounding shelter, Chernobyl radioactive waste storage and disposal sites, and environmental contamination in the region. The authors explore such questions as the risks posed by a collapse of the shelter, radionuclide migration from storage and disposal facilities in the exclusion zone, and transfer from soil to vegetation and its potential regional impact. The answers to these questions provide a scientific basis for the development of countermeasures against the Chernobyl accident in particular and the mitigation of environmental radioactive contamination in general. They also provide an important basis for understanding the human health and ecological risks posed by the accident.

  7. Chernobyl accident: A comprehensive risk assessment

    SciTech Connect

    Vargo, G.J.; Poyarkov, V.; Baryakhtar, V.; Kukhar, V.; Los, I.

    1999-11-01

    The authors, all of whom are Ukrainian and Russian scientists involved with Chernobyl nuclear power plant since the April 1986 accident, present a comprehensive review of the accident. In addition, they present a risk assessment of the remains of the destroyed reactor and its surrounding shelter, Chernobyl radioactive waste storage and disposal sites, and environmental contamination in the region. The authors explore such questions as the risks posed by a collapse of the shelter, radionuclide migration from storage and disposal facilities in the exclusion zone, and transfer from soil to vegetation and its potential regional impact. The answers to these questions provide a scientific basis for the development of countermeasures against the Chernobyl accident in particular and the mitigation of environmental radioactive contamination in general. They also provide an important basis for understanding the human health and ecological risks posed by the accident.

  8. Risk Assessment for Destructive Re-Entry

    NASA Astrophysics Data System (ADS)

    Lips, T.; Koppenwallner, G.; Bianchi, L.; Klinkrad, H.

    2009-03-01

    From 2007 to 2008, Hypersonic Technology Göttingen (HTG) worked on a study called Risk Assessment for Destructive Re-entry (RADR). The main purposes of this study were to identify and to quantify the inherent uncertainties of re-entry analysis tools, and to provide possible risk mitigation measures. For these purposes, three basic risk scenarios were specified: a 1-ton-class satellite without propulsion for uncontrolled re-entry, a 6-ton-class satellite with propulsion and the capability to perform a controlled re-entry, and a 1-ton-class launcher upper stage re-entering uncontrolled. Based on the identified uncertainty parameters, variation analyses were conducted for these scenarios with the two ESA tools for re-entry analysis SCARAB (Spacecraft Atmospheric Reentry and Aerothermal Breakup) and SESAM (Spacecraft Entry Survival Analysis Module). This paper describes the major results of the RADR study.

  9. Obsolescence Risk Assessment Process Best Practice

    NASA Astrophysics Data System (ADS)

    Romero Rojo, F. J.; Roy, R.; Kelly, S.

    2012-05-01

    A component becomes obsolete when it is no longer available from the original manufacturer to the original specification. In long-lifecycle projects, obsolescence has become a major problem as it prevents the maintenance of the system. This is the reason why obsolescence management is now an essential part of the product support activities in sectors such as defence, aerospace, nuclear and railway; where systems need to be supported for several decades. The obsolescence risk assessment for the bill of materials (BoM) is a paramount activity in order to manage obsolescence proactively and cost-effectively. This is the reason why it was necessary to undertake a benchmarking study to develop best practice in this process. A total of 22 obsolescence experts from 13 different organisations/projects from across UK and USA have participated in this study. Their current processes and experience have been taken into account in the development of the best practice process for obsolescence risk assessment. The key factors that have to be analysed in the risk assessment process for each component in the BoM are: number of manufacturers, years to end of life, stock available, consumption rate and operational impact criticality. For the very high risk components, a more detailed analysis is required to inform the decisions regarding the most suitable mitigation strategies. On the contrary, for the low risk components, a fully proactive approach is neither appropriate nor cost effective. Therefore, it is advised for these components that obsolescence issues are dealt with reactively. This process has been validated using case studies with several experts from industry and is currently being implemented by the UK Ministry of Defence as technical guidance within the JSP 886 Volume 7 Part 8.13 standards.

  10. 49 CFR Appendix B to Part 236 - Risk Assessment Criteria

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 4 2011-10-01 2011-10-01 false Risk Assessment Criteria B Appendix B to Part 236... B to Part 236—Risk Assessment Criteria The safety-critical performance of each product for which risk assessment is required under this part must be assessed in accordance with the following...

  11. Estimating Toxicity Pathway Activating Doses for High Throughput Chemical Risk Assessments

    EPA Science Inventory

    Estimating a Toxicity Pathway Activating Dose (TPAD) from in vitro assays as an analog to a reference dose (RfD) derived from in vivo toxicity tests would facilitate high throughput risk assessments of thousands of data-poor environmental chemicals. Estimating a TPAD requires def...

  12. Korean Risk Assessment Model for Breast Cancer Risk Prediction

    PubMed Central

    Park, Boyoung; Ma, Seung Hyun; Shin, Aesun; Chang, Myung-Chul; Choi, Ji-Yeob; Kim, Sungwan; Han, Wonshik; Noh, Dong-Young; Ahn, Sei-Hyun; Kang, Daehee; Yoo, Keun-Young; Park, Sue K.

    2013-01-01

    Purpose We evaluated the performance of the Gail model for a Korean population and developed a Korean breast cancer risk assessment tool (KoBCRAT) based upon equations developed for the Gail model for predicting breast cancer risk. Methods Using 3,789 sets of cases and controls, risk factors for breast cancer among Koreans were identified. Individual probabilities were projected using Gail's equations and Korean hazard data. We compared the 5-year and lifetime risk produced using the modified Gail model which applied Korean incidence and mortality data and the parameter estimators from the original Gail model with those produced using the KoBCRAT. We validated the KoBCRAT based on the expected/observed breast cancer incidence and area under the curve (AUC) using two Korean cohorts: the Korean Multicenter Cancer Cohort (KMCC) and National Cancer Center (NCC) cohort. Results The major risk factors under the age of 50 were family history, age at menarche, age at first full-term pregnancy, menopausal status, breastfeeding duration, oral contraceptive usage, and exercise, while those at and over the age of 50 were family history, age at menarche, age at menopause, pregnancy experience, body mass index, oral contraceptive usage, and exercise. The modified Gail model produced lower 5-year risk for the cases than for the controls (p = 0.017), while the KoBCRAT produced higher 5-year and lifetime risk for the cases than for the controls (p<0.001 and <0.001, respectively). The observed incidence of breast cancer in the two cohorts was similar to the expected incidence from the KoBCRAT (KMCC, p = 0.880; NCC, p = 0.878). The AUC using the KoBCRAT was 0.61 for the KMCC and 0.89 for the NCC cohort. Conclusions Our findings suggest that the KoBCRAT is a better tool for predicting the risk of breast cancer in Korean women, especially urban women. PMID:24204664

  13. Natural-technological risk assessment and management

    NASA Astrophysics Data System (ADS)

    Burova, Valentina; Frolova, Nina

    2016-04-01

    EM-DAT statistical data on human impact and economic damages in the 1st semester 2015 are the highest since 2011: 41% of disasters were floods, responsible for 39% of economic damage and 7% of events were earthquakes responsible for 59% of total death toll. This suggests that disaster risk assessment and management still need to be improved and stay the principle issue in national and international related programs. The paper investigates the risk assessment and management practice in the Russian Federation at different levels. The method is proposed to identify the territories characterized by integrated natural-technological hazard. The maps of the Russian Federation zoning according to the integrated natural-technological hazard level are presented, as well as the procedure of updating the integrated hazard level taking into account the activity of separate processes. Special attention is paid to data bases on past natural and technological processes consequences, which are used for verification of current hazard estimation. The examples of natural-technological risk zoning for the country and some regions territory are presented. Different output risk indexes: both social and economic, are estimated taking into account requirements of end-users. In order to increase the safety of population of the Russian Federation the trans-boundaries hazards are also taken into account.

  14. Ecological risk assessment benefits environmental management

    SciTech Connect

    Fairbrother, A.; Kapustka, L.A.; Williams, B.A.; Glicken, J.

    1994-12-31

    The ecological risk assessment process in its ideal form is an unbiased approach for assessing the probability of harm to the environment as a consequence of a given action. This information can then be combined with other societal values and biases in the management of such risks. However, as the process currently is understood, decision makers often are accused of manipulating information in order to generate decisions or achieve buy in from the public in support of a particular political agenda. A clear understanding of the nature of the risk management process can help define areas where information should be free from social or personal bias, and areas where values and judgments are critical. The authors do not propose to discuss the individual`s decision-making process, but rather to address the social process of risk communication and environmentally-related decision-making, identifying which parts of that process require bias-free, scientifically generated information about the consequences of various actions and which parts need an understanding of the social values which underlie the informed choices among those possible actions.

  15. Risk assessment of urban air pollution.

    PubMed

    Törnqvist, M; Ehrenberg, L

    1992-12-01

    Urban air pollution, originating in western countries mainly from automotive engine exhausts, contains thousands of components, many of which are genotoxic, i.e. are putative cancer initiators. Other pollution components, such as NO2 and certain particles, may have cocarcinogenic/promotive effects, at least at higher exposure levels. Cancer risk assessment of this complex mixture has to combine data from the exposure history, from epidemiological studies as well as from animal carcinogenicity tests, and from in vitro studies of fractions and individual components. Data for metabolism and pharmaco-kinetics have also to be considered. A multiplicative linear model is assumed to be valid for cancer initiation at low levels. Attempts are being made to determine the target dose from ultimate carcinogens (reactive metabolites) via macromolecule adduct levels, and to base the risk assessment on the radiation-dose equivalent to the chemical dose. So far this has been possible only for simple alkenes, which are metabolized to epoxides, and indirectly, via benzo(a)pyrene (BaP), for particle-bound polycyclic aromatic hydrocarbons (PAH). The lifetime risk of cancer (all sites) from ethene is estimated accordingly to 1.4 x 10(-4) per microgram m-3, and from PAH to 12 x 10(-4) per ng m-3 BaP. For other components indicated to give risk contribution (NOx, volatile PAH, benzene, aldehydes, butadiene) essential data are lacking and only very rough estimates can be given at this time. PMID:1306130

  16. Violence risk assessment as a medical intervention: ethical tensions

    PubMed Central

    Roychowdhury, Ashimesh; Adshead, Gwen

    2014-01-01

    Risk assessment differs from other medical interventions in that the welfare of the patient is not the immediate object of the intervention. However, improving the risk assessment process may reduce the chance of risk assessment itself being unjust. We explore the ethical arguments in relation to risk assessment as a medical intervention, drawing analogies, where applicable, with ethical arguments raised by general medical investigations. The article concludes by supporting the structured professional judgement approach as a method of risk assessment that is most consistent with the respect for principles of medical ethics. Recommendations are made for the future direction of risk assessment indicated by ethical theory. PMID:25237503

  17. Assessing estuarine quality: A cost-effective in situ assay with amphipods.

    PubMed

    Martinez-Haro, Monica; Acevedo, Pelayo; Pais-Costa, Antónia Juliana; Taggart, Mark A; Martins, Irene; Ribeiro, Rui; Marques, João Carlos

    2016-05-01

    In situ assays based on feeding depression can be powerful ecotoxicological tools that can link physiological organism-level responses to population and/or community-level effects. Amphipods are traditional target species for toxicity tests due to their high sensitivity to contaminants, availability in the field and ease of handling. However, cost-effective in situ assays based on feeding depression are not yet available for amphipods that inhabit estuarine ecosystems. The aim of this work was to assess a short-term in situ assay based on postexposure feeding rates on easily quantifiable food items with an estuarine amphipod. Experiments were carried out under laboratory conditions using juvenile Echinogammarus marinus as the target individual. When 60 Artemia franciscana nauplii (as prey) were provided per individual for a period of 30 min in dark conditions, feeding rates could be easily quantified. As an endpoint, postexposure feeding inhibition in E. marinus was more sensitive to cadmium contamination than mortality. Assay calibration under field conditions demonstrated the relevance of sediment particle size in explaining individual feeding rates in uncontaminated water bodies. An evaluation of the 48-h in situ bioassay based on postexposure feeding rates indicated that it is able to discriminate between unpolluted and polluted estuarine sites. Using the harmonized protocol described here, the in situ postexposure feeding assay with E. marinus was found to be a potentially useful, cost-effective tool for assessing estuarine sediment and water quality. PMID:26874320

  18. Suicide risk assessment and suicide risk formulation: essential components of the therapeutic risk management model.

    PubMed

    Silverman, Morton M

    2014-09-01

    Suicide and other suicidal behaviors are often associated with psychiatric disorders and dysfunctions. Therefore, psychiatrists have significant opportunities to identify at-risk individuals and offer treatment to reduce that risk. Although a suicide risk assessment is a core competency requirement, many clinical psychiatrists lack the requisite training and skills to appropriately assess for suicide risk. Moreover, the standard of care requires psychiatrists to foresee the possibility that a patient might engage in suicidal behavior, hence to conduct a suicide risk formulation sufficient to guide triage and treatment planning. Based on data collected via a suicide risk assessment, a suicide risk formulation is a process whereby the psychiatrist forms a judgment about a patient's foreseeable risk of suicidal behavior in order to inform triage decisions, safety and treatment planning, and interventions to reduce risk. This paper addresses the components of this process in the context of the model for therapeutic risk management of the suicidal patient developed at the Veterans Integrated Service Network (VISN) 19 Mental Illness Research, Education and Clinical Center by Wortzel et al. PMID:25226200

  19. Ecological risk assessment of a decommissioned military base

    SciTech Connect

    Starodub, M.E.; Feniak, N.A.; Willes, R.F.; Moore, C.E.; Mucklow, L.; Marshall, L.

    1995-12-31

    The ecological health risks to selected terrestrial animals at a decommissioned military base in Atlantic Canada have been assessed. Areas of the base varied in terms of terrain, ground cover, as well as types and extent of contamination, dependent on former uses of the sites. Analysis of surficial soils, sediments, water and fish tissue at the base indicated contamination by metals, PCBs, and various petroleum products and their constituents. Identification of chemicals of concern was based on these analyses, in conjunction with detailed chemical selection procedures. Exposures to chemicals of concern for ecological receptors were assessed in one of two ways. The exposures of moose, snowshoe hare and meadow vole were estimated in areas with surficial contamination, based on expected exposures to environmental media via oral inhalation, and dermal routes of exposure. For two top predators (mink and bald-headed eagle), exposures to bioaccumulative chemicals (cadmium, lead, mercury and PCBs) via transport through the aquatic and/or terrestrial foodchain were estimated. A toxicological assessment was conducted for the chemicals of concern, to yield exposure limits derived from governmental regulations or developed based on no-observed-effect-levels (NOELs) reported in scientifically sound toxicological assays in relevant species. The risk evaluation of each chemical of concern was conducted as a comparison of the estimated total exposures to the exposure limits derived for the selected ecological receptors.

  20. Effect of assay specificity on the association of urine 11-dehydro thromboxane B2 determination with cardiovascular risk

    PubMed Central

    OLSON, M. T.; KICKLER, T. S.; LAWSON, J. A.; MCLEAN, R. C.; JANI, J.; FITZGERALD, G. A.; RADE, J. J.

    2013-01-01

    Summary Background Elevated urine 11-dehydro TXB2, an indicator of persistent thromboxane generation in aspirin-treated patients, correlates with adverse cardiovascular outcome and has recently been identified as an independent risk factor for vein graft thrombosis after cardiac bypass surgery in the Reduction in Graft Occlusion Rates (RIGOR) study. The polyclonal antibody-based ELISA used to measure 11-dehydro TXB2 in these previous studies is no longer clinically available and has been supplanted by a Food and Drug Administration (FDA)-cleared second-generation monoclonal antibody-based ELISA. Objectives To compare the laboratory and clinical performance of the first- and second-generation assays in a well-defined study population. Methods 11-dehydro TXB2 was quantified in 451 urine samples from 229 Reduction in Graft Occlusion Rates (RIGOR) subjects using both ELISA. Ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and spiking studies were used to investigate discordant assay results. The association of 11-dehydro TXB2 to clinical outcome was assessed for each assay using multivariate modeling. Results Median 11-dehydro TXB2 levels were higher by monoclonal antibody- compared with polyclonal antibody-based ELISA (856 vs. 399 pg mg−1 creatinine, P < 0.000001), with the latter providing values similar to UPLC-MS/MS. This discrepancy was predominantly as a result of cross-reactivity of the monoclonal antibody with 11-dehydro-2,3-dinor TXB2, a thromboxane metabolite present in a similar concentration but with a poor direct correlation with 11-dehydro TXB2. In contrast to the first-generation ELISA, 11-dehydro TXB2 measured by the monoclonal antibody-based ELISA failed to associate with the risk of vein graft occlusion. Conclusion Quantification of urine 11-dehydro TXB2 by monoclonal antibody-based ELISA was confounded by interference from 11-dehydro-2,3-dinor TXB2 which reduced the accuracy and clinical utility of this second

  1. Offshore blowouts, data for risk assessment

    SciTech Connect

    Holand, P.

    1995-12-31

    Blowouts are, besides gas leakages, the major contributor to the total risk for offshore installations. Therefore, the blowout risk is always included in Quantitative Risk Analyses (QRAs) of offshore installations in the Norwegian Sector of the North Sea. SINTEF Offshore Blowout Database has existed since 1984 (until 1990 it was called Marintek`s blowout database). In 1990 the responsibility of the database was transferred to SINTEF Safety and Reliability. Throughout these years the database has been used for assessing blowout risk associated to development and operation of fields offshore Norway. Six oil companies and two consultants are presently sponsoring the database. These companies are using the database when performing risk analyses. During the past three years the database has been subjected to a thorough quality improvement, both with respect to the user interface, and most important, regarding the blowout data included in the database. What is unique with this database, besides the high quality of blowout descriptions, is first that the blowout causes are categorized related to loss of primary and secondary barriers. Secondly that the user interface makes it possible to establish searches to withdraw information regarding any blowout type subjected for specific searches.

  2. Project Fox: Assessing Risks Posed By Asteroids

    NASA Astrophysics Data System (ADS)

    Reinhardt, J.; Chen, X.; Liu, W.; Manchev, P.; Paté-Cornell, M.

    2013-12-01

    In order to make decisions on how to invest limited research dollars on asteroid surveillance and mitigation options, an analytic understanding of the risks posed by impacts is necessary. Qualitative and quantitative studies have been performed to assess such risks, and some reasonable point estimates have been proposed. However, since consequential asteroid impacts tend to be rare events, point estimates and expected annual death rates do not adequately convey the heavy tail of the distribution, potentially leading to misguided resource allocations. We propose and develop a framework for new risk measures, including a distribution over the number of fatalities from asteroid impacts and the probability of a globally consequential impact. We implement a simulation of asteroid impacts using probabilistic inputs for impactor characteristics, and a Poisson process for asteroid arrivals over the next 100 years. Simulation results indicate that a significant portion of the risk to humans comes from asteroids in the 300-1000 meter diameter range; this is because asteroid impacts in this range can produce global effects, and are more frequent than those from asteroids greater than 1km in diameter. The relative importance of this size regime in overall asteroid impact risk is robust in simulation results, and we find the magnitude of risks is still sensitive to factors that contribute global effects from an asteroid impact. Initial results are provided on the sensitivity of impact risks to various mitigation measures, including 'civil defense' methods. These results underscore the need for next-generation survey missions, and can help provide the basis for setting future space telescope observation requirements.

  3. In vitro assays of angiogenesis for assessment of angiogenic and anti-angiogenic agents

    PubMed Central

    Goodwin, Anne M.

    2009-01-01

    Blood vessels, either in insufficient numbers or in excess, contribute to the pathogenesis of many diseases. Agents that stimulate angiogenesis can improve blood flow in patients with ischemic diseases, whereas anti-angiogenic agents are used to treat disorders ranging from macular degeneration to cancer. In this review I describe in vitro assays that can be used to assess the activity of agents that affect angiogenesis. Means of quantifying endothelial cell matrix degradation, migration, proliferation, apoptosis and morphogenesis are discussed, as are embryoid body, aortic ring and metatarsal assays of vessel outgrowth. Strengths and limitations of these techniques are also addressed. PMID:17631914

  4. Serum free light chain assays not total light chain assays are the standard of care to assess Monoclonal Gammopathies.

    PubMed

    Tietsche de Moraes Hungria, Vania; Allen, Syreeta; Kampanis, Petros; Soares, Elyara Maria

    2016-01-01

    The diagnosis of Multiple Myeloma is a challenge to the physician due to the non-specific symptoms (anemia, bone pain and recurrent infections) that are commonplace in the elderly population. However, early diagnosis is associated with less severe disease, including fewer patients presenting with acute renal injury, pathological fractures and severe anemia. Since 2006, the serum free light chain test Freelite(®) has been included alongside standard laboratory tests (serum and urine protein electrophoresis, and serum and urine immunofixation) as an aid in the identification of monoclonal proteins, which are a cornerstone for the diagnosis of Multiple Myeloma. The serum free light chain assay recognizes the light chain component of the immunoglobulin in its free form with high sensitivity. Other assays that measure light chains in the free and intact immunoglobulin forms are sensitive, but unfortunately, due to the nomenclature used, these assays (total light chains) are sometimes used in place of the free light chain assay. This paper reviews the available literature comparing the two assays and tries to clarify hypothetical limitations of the total assay to detect Multiple Myeloma. Furthermore, we elaborate on our study comparing the two assays used in 11 Light Chain Multiple Myeloma patients at presentation and 103 patients taken through the course of their disease. The aim of this article is to provide a clear discrimination between the two assays and to provide information to physicians and laboratory technicians so that they can utilize the International Myeloma Working Group guidelines. PMID:26969773

  5. Serum free light chain assays not total light chain assays are the standard of care to assess Monoclonal Gammopathies

    PubMed Central

    Tietsche de Moraes Hungria, Vania; Allen, Syreeta; Kampanis, Petros; Soares, Elyara Maria

    2016-01-01

    The diagnosis of Multiple Myeloma is a challenge to the physician due to the non-specific symptoms (anemia, bone pain and recurrent infections) that are commonplace in the elderly population. However, early diagnosis is associated with less severe disease, including fewer patients presenting with acute renal injury, pathological fractures and severe anemia. Since 2006, the serum free light chain test Freelite® has been included alongside standard laboratory tests (serum and urine protein electrophoresis, and serum and urine immunofixation) as an aid in the identification of monoclonal proteins, which are a cornerstone for the diagnosis of Multiple Myeloma. The serum free light chain assay recognizes the light chain component of the immunoglobulin in its free form with high sensitivity. Other assays that measure light chains in the free and intact immunoglobulin forms are sensitive, but unfortunately, due to the nomenclature used, these assays (total light chains) are sometimes used in place of the free light chain assay. This paper reviews the available literature comparing the two assays and tries to clarify hypothetical limitations of the total assay to detect Multiple Myeloma. Furthermore, we elaborate on our study comparing the two assays used in 11 Light Chain Multiple Myeloma patients at presentation and 103 patients taken through the course of their disease. The aim of this article is to provide a clear discrimination between the two assays and to provide information to physicians and laboratory technicians so that they can utilize the International Myeloma Working Group guidelines. PMID:26969773

  6. Water risk assessment for river basins in China based on WWF water risk assessment tools

    NASA Astrophysics Data System (ADS)

    Wei, N.; Qiu, Y.; Gan, H.; Niu, C.; Liu, J.; Gan, Y.; Zhou, N.

    2014-09-01

    Water resource problems, one of the most important environmental and socio-economic issues, have been a common concern worldwide in recent years. Water resource risks are attracting more and more attention from the international community and national governments. Given the current situations of water resources and the water environment, and the characteristics of water resources management and information statistics of China, this paper establishes an index system for water risk assessment in river basins of China based on the index system of water risk assessment proposed by the World Wide Fund For Nature (WWF) and German Investment and Development Co., Ltd (DEG). The new system is more suitable for Chinese national conditions and endorses the international assessment index. A variety of factors are considered to determine the critical values of classification for each index, and the indexes are graded by means of 5-grade and 5-score scales; the weights and calculation methods of some indexes are adjusted, with the remaining indexes adopting the method of WWF. The Weighted Comprehensive Index Summation Process is adopted to calculate the integrated assessment score of the river basin. The method is applied to the Haihe River basin in China. The assessment shows that the method can accurately reflect the water risk level of different river basins. Finally, the paper discusses the continuing problems in water risk assessment and points out the research required to provide a reference for further study in this field.

  7. Visual Impairment/Intracranial Pressure Risk Assessment

    NASA Technical Reports Server (NTRS)

    Fogarty, Jennifer A.; Durham, T.; Otto, C.; Grounds, D.; Davis, J. R.

    2010-01-01

    Since 2006 there have been 6 reported cases of altered visual acuity and intracranial pressure (ICP) in long duration astronauts. In order to document this risk and develop an integrated approach to its mitigation, the NASA Space Life Sciences Directorate (SLSD) and Human Research Program (HRP) have chosen to use the Human System Risk Board (HSRB) and the risk management analysis tool (RMAT). The HSRB is the venue in which the stakeholders and customers discuss and vet the evidence and the RMAT is the tool that facilitates documentation and comparison of the evidence across mission profiles as well as identification of risk factors, and documentation of mitigation strategies. This process allows for information to be brought forward and dispositioned so that it may be properly incorporated into the RMAT and contribute to the design of the research and mitigation plans. The evidence thus far has resulted in the identification of a visual impairment/intracranial pressure (VIIP) project team, updating of both short and long duration medical requirements designed to assess visual acuity, and a research plan to characterize this issue further. In order to understand this issue more completely, a plan to develop an Accelerated Research Collaboration (ARC) has been approved by the HSRB. The ARC is a novel research model pioneered by the Myelin Repair Foundation. It is a patient centered research model that brings together researchers and clinicians, under the guidance of a scientific advisory panel, to collaborate and produce results much quickly than accomplished through traditional research models. The data and evidence from the updated medical requirements and the VIIP ARC will be reviewed at the HSRB on a regular basis. Each review package presented to the HSRB will include an assessment and recommendation with respect to continuation of research, countermeasure development, occupational surveillance modalities, selection criteria, etc. This process will determine the

  8. Quantitative risk assessment of durable glass fibers.

    PubMed

    Fayerweather, William E; Eastes, Walter; Cereghini, Francesco; Hadley, John G

    2002-06-01

    This article presents a quantitative risk assessment for the theoretical lifetime cancer risk from the manufacture and use of relatively durable synthetic glass fibers. More specifically, we estimate levels of exposure to respirable fibers or fiberlike structures of E-glass and C-glass that, assuming a working lifetime exposure, pose a theoretical lifetime cancer risk of not more than 1 per 100,000. For comparability with other risk assessments we define these levels as nonsignificant exposures. Nonsignificant exposure levels are estimated from (a) the Institute of Occupational Medicine (IOM) chronic rat inhalation bioassay of durable E-glass microfibers, and (b) the Research Consulting Company (RCC) chronic inhalation bioassay of durable refractory ceramic fibers (RCF). Best estimates of nonsignificant E-glass exposure exceed 0.05-0.13 fibers (or shards) per cubic centimeter (cm3) when calculated from the multistage nonthreshold model. Best estimates of nonsignificant C-glass exposure exceed 0.27-0.6 fibers/cm3. Estimates of nonsignificant exposure increase markedly for E- and C-glass when non-linear models are applied and rapidly exceed 1 fiber/cm3. Controlling durable fiber exposures to an 8-h time-weighted average of 0.05 fibers/cm3 will assure that the additional theoretical lifetime risk from working lifetime exposures to these durable fibers or shards is kept below the 1 per 100,000 level. Measured airborne exposures to respirable, durable glass fibers (or shards) in glass fiber manufacturing and fabrication operations were compared with the nonsignificant exposure estimates described. Sampling results for B-sized respirable E-glass fibers at facilities that manufacture or fabricate small-diameter continuous-filament products, from those that manufacture respirable E-glass shards from PERG (process to efficiently recycle glass), from milled fiber operations, and from respirable C-glass shards from Flakeglass operations indicate very low median exposures of 0

  9. Assessment of the TLC/Salmonella assay for screening hazardous wastes

    SciTech Connect

    Houk, V.S.; Claxton, L.D.

    1987-09-01

    Using a modified version of the TLC/Salmonella assay developed by Bjorseth et al. (1982), 10 complex hazardous wastes were tested for mutagenic activity. The method couples thin-layer chromatography (TLC) with the Salmonella/mammalian-microsome (Ames) assay for the detection of mutagenic constituents in complex mixtures. Crude hazardous wastes and selected hazardous-waste extracts were fractionated on commercially available cellulose TLC plates. Mutagenicity testing was performed by applying a single overlay of minimal growth agar containing a tester strain of Salmonella and the optional metabolic activation system directly onto the developed chromatogram. Seven of 10 hazardous wastes demonstrated mutagenic activity when tested by the method. To assess the sensitivity of the modified TLC/Salmonella assay, 14 Salmonella mutagens from a wide range of chemical classes and polarities were tested. Eleven of the 14 mutagens were positive in the test system.

  10. A classification scheme for risk assessment methods.

    SciTech Connect

    Stamp, Jason Edwin; Campbell, Philip LaRoche

    2004-08-01

    This report presents a classification scheme for risk assessment methods. This scheme, like all classification schemes, provides meaning by imposing a structure that identifies relationships. Our scheme is based on two orthogonal aspects--level of detail, and approach. The resulting structure is shown in Table 1 and is explained in the body of the report. Each cell in the Table represent a different arrangement of strengths and weaknesses. Those arrangements shift gradually as one moves through the table, each cell optimal for a particular situation. The intention of this report is to enable informed use of the methods so that a method chosen is optimal for a situation given. This report imposes structure on the set of risk assessment methods in order to reveal their relationships and thus optimize their usage.We present a two-dimensional structure in the form of a matrix, using three abstraction levels for the rows and three approaches for the columns. For each of the nine cells in the matrix we identify the method type by name and example. The matrix helps the user understand: (1) what to expect from a given method, (2) how it relates to other methods, and (3) how best to use it. Each cell in the matrix represent a different arrangement of strengths and weaknesses. Those arrangements shift gradually as one moves through the table, each cell optimal for a particular situation. The intention of this report is to enable informed use of the methods so that a method chosen is optimal for a situation given. The matrix, with type names in the cells, is introduced in Table 2 on page 13 below. Unless otherwise stated we use the word 'method' in this report to refer to a 'risk assessment method', though often times we use the full phrase. The use of the terms 'risk assessment' and 'risk management' are close enough that we do not attempt to distinguish them in this report. The remainder of this report is organized as follows. In Section 2 we provide context for this report

  11. Asteroid Airbursts: Risk Assessment and Reduction

    NASA Astrophysics Data System (ADS)

    Boslough, M.

    2015-12-01

    Airbursts are events in which small (meters to tens-of-meters in diameter) asteroids deposit most of their energy in the atmosphere with a total energy greater than small nuclear explosions (>0.1 kilotons of TNT). The airburst risk is higher than previous assessments for two reasons. First, they are more frequent than previously thought. The Tunguska-class (~40 meters) population estimate has doubled, and Chelyabinsk-class (~20 meters) has increased by a factor of 2.6. Second, asteroid airbursts are significantly more damaging than previously assumed. In most cases, they more efficiently couple energy to the surface than nuclear explosions of the same yield. Past Near-Earth Object (NEO) risk assessments concluded that the largest asteroids (> 1 km) dominated the hazard. Large NEOs represent only a tiny fraction of the population but the potential for global catastrophe means that the contribution from low-probability, high-consequence events is large. Nearly 90% of these objects, none of which is on a collision course, have been catalogued. This has reduced their assessed near-term statistical risk by more than an order of magnitude because completion is highest for the largest and most dangerous. The relative risk from small objects would therefore be increasing even if their absolute assessed risk were not. Uncertainty in the number of small NEOs remains large and can only be reduced by expanded surveys. One strategy would be to count small NEOs making close passes in statistically significant numbers. For example, there are about 25 times as many objects of a given size that pass within the distance of geosynchronous orbit than collide with the earth, and 2000 times as many pass within a lunar distance (accounting for gravitational focusing). An asteroid the size of the Chelyabinsk impactor (~20 m) could potentially be observed within geosynchronous orbit every two years and within lunar orbit nearly once a week. A Tunguska-sized asteroid (~40 m) passes within a

  12. MECHANISM OF DIOXIN TOXICITY: RELATIONSHIP TO RISK ASSESSMENT

    EPA Science Inventory

    Risk characterization involves hazard identification, determination of dose/response relationships, and exposure assessment. mprovement of the risk assessment process requires inclusion of the best available science. ecent findings in the area of dioxin toxicity have led to a maj...

  13. Toxicologic Pathology: The Basic Building Block of Risk Assessment

    EPA Science Inventory

    Human health risk assessment is a critical factor in many risk management decisions. Evaluation of human health risk requires research the provides information that appropriately characterizes potential hazards from exposure. Pathology endpoints are the central response around ...

  14. Considering Environmental and Occupational Stressors in Cumulative Risk Assessments

    EPA Science Inventory

    While definitions vary across the global scientific community, cumulative risk assessments (CRAs) typically are described as exhibiting a population focus and analyzing the combined risks posed by multiple stressors. CRAs also may consider risk management alternatives as an anal...

  15. Workshop overview: Arsenic research and risk assessment

    SciTech Connect

    Sams, Reeder Wolf, Douglas C.; Ramasamy, Santhini; Ohanian, Ed; Chen, Jonathan; Lowit, Anna

    2007-08-01

    The chronic exposure of humans through consumption of high levels of inorganic arsenic (iAs)-contaminated drinking water is associated with skin lesions, peripheral vascular disease, hypertension, and cancers. Additionally, humans are exposed to organic arsenicals when used as pesticides and herbicides (e.g., monomethylarsonic acid, dimethylarsinic acid (DMA{sup V}) also known as cacodylic acid). Extensive research has been conducted to characterize the adverse health effects that result from exposure to iAs and its metabolites to describe the biological pathway(s) that lead to adverse health effects. To further this effort, on May 31, 2006, the United States Environmental Protection Agency (USEPA) sponsored a meeting entitled 'Workshop on Arsenic Research and Risk Assessment'. The invited participants from government agencies, academia, independent research organizations and consultants were asked to present their current research. The overall focus of these research efforts has been to determine the potential human health risks due to environmental exposures to arsenicals. Pursuant in these efforts is the elucidation of a mode of action for arsenicals. This paper provides a brief overview of the workshop goals, regulatory context for arsenical research, mode of action (MOA) analysis in human health risk assessment, and the application of MOA analysis for iAs and DMA{sup V}. Subsequent papers within this issue will present the research discussed at the workshop, ensuing discussions, and conclusions of the workshop.

  16. Environmental risk assessment in GMO analysis.

    PubMed

    Pirondini, Andrea; Marmiroli, Nelson

    2008-01-01

    Genetically modified or engineered organisms (GMOs, GEOs) are utilised in agriculture, expressing traits of interest, such as insect or herbicide resistance. Soybean, maize, cotton and oilseed rape are the GM crops with the largest acreage in the world. The distribution of GM acreage in the different countries is related with the different positions concerning labelling of GMO products: based on the principle of substantial equivalence, or rather based on the precautionary principle. The paper provides an overview on how the risks associated with release of GMO in the environments can be analysed and predicted, in view of a possible coexistence of GM and non-GM organisms in agriculture.Risk assessment procedures, both qualitative and quantitative, are compared in the context of application to GMOs considering also legislation requirements (Directive 2001/18/EC). Criteria and measurable properties to assess harm for human health and environmental safety are listed, and the possible consequences are evaluated in terms of significance.Finally, a mapping of the possible risks deriving from GMO release is reported, focusing on gene transfer to related species, horizontal gene transfer, direct and indirect effects on non target organisms, development of resistance in target organisms, and effects on biodiversity. PMID:19048472

  17. Environmental risk assessment in GMO analysis.

    PubMed

    Pirondini, Andrea; Marmiroli, Nelson

    2010-01-01

    Genetically modified or engineered organisms (GMOs, GEOs) are utilised in agriculture, expressing traits of interest, such as insect or herbicide resistance. Soybean, maize, cotton and oilseed rape are the GM crops with the largest acreage in the world. The distribution of GM acreage in the different countries is related with the different positions concerning labelling of GMO products: based on the principle of substantial equivalence, or rather based on the precautionary principle. The paper provides an overview on how the risks associated with release of GMO in the environments can be analysed and predicted, in view of a possible coexistence of GM and non-GM organisms in agriculture.Risk assessment procedures, both qualitative and quantitative, are compared in the context of application to GMOs considering also legislation requirements (Directive 2001/18/EC). Criteria and measurable properties to assess harm for human health and environmental safety are listed, and the possible consequences are evaluated in terms of significance.Finally, a mapping of the possible risks deriving from GMO release is reported, focusing on gene transfer to related species, horizontal gene transfer, direct and indirect effects on non target organisms, development of resistance in target organisms, and effects on biodiversity. PMID:21384330

  18. Spent Nuclear Fuel Alternative Technology Risk Assessment

    SciTech Connect

    Perella, V.F.

    1999-11-29

    A Research Reactor Spent Nuclear Fuel Task Team (RRTT) was chartered by the Department of Energy (DOE) Office of Spent Fuel Management with the responsibility to recommend a course of action leading to a final technology selection for the interim management and ultimate disposition of the foreign and domestic aluminum-based research reactor spent nuclear fuel (SNF) under DOE''s jurisdiction. The RRTT evaluated eleven potential SNF management technologies and recommended that two technologies, direct co-disposal and an isotopic dilution alternative, either press and dilute or melt and dilute, be developed in parallel. Based upon that recommendation, the Westinghouse Savannah River Company (WSRC) organized the SNF Alternative Technology Program to further develop the direct co-disposal and melt and dilute technologies and provide a WSRC recommendation to DOE for a preferred SNF alternative management technology. A technology risk assessment was conducted as a first step in this recommendation process to determine if either, or both, of the technologies posed significant risks that would make them unsuitable for further development. This report provides the results of that technology risk assessment.

  19. Tsunami risk assessments in Messina, Sicily - Italy

    NASA Astrophysics Data System (ADS)

    Grezio, A.; Gasparini, P.; Marzocchi, W.; Patera, A.; Tinti, S.

    2012-01-01

    We present a first detailed tsunami risk assessment for the city of Messina where one of the most destructive tsunami inundations of the last centuries occurred in 1908. In the tsunami hazard evaluation, probabilities are calculated through a new general modular Bayesian tool for Probability Tsunami Hazard Assessment. The estimation of losses of persons and buildings takes into account data collected directly or supplied by: (i) the Italian National Institute of Statistics that provides information on the population, on buildings and on many relevant social aspects; (ii) the Italian National Territory Agency that provides updated economic values of the buildings on the basis of their typology (residential, commercial, industrial) and location (streets); and (iii) the Train and Port Authorities. For human beings, a factor of time exposition is introduced and calculated in terms of hours per day in different places (private and public) and in terms of seasons, considering that some factors like the number of tourists can vary by one order of magnitude from January to August. Since the tsunami risk is a function of the run-up levels along the coast, a variable tsunami risk zone is defined as the area along the Messina coast where tsunami inundations may occur.

  20. Detection of at-risk pregnancy by means of highly sensitive assays for thyroid autoantibodies

    SciTech Connect

    Stagnaro-Green, A.; Roman, S.H.; Cobin, R.H.; El-Harazy, E.; Alvarez-Marfany, M.; Davies, T.F. )

    1990-09-19

    The authors screened 552 women who presented to their obstetrician in the first trimester of pregnancy using highly sensitive enzyme-linked immunosorbent assays for the presence of thyroglobulin and thyroidperoxidase autoantibodies and found an incidence of positivity of 19.6%. The tendency to secrete detectable levels of thyroid autoantibodies was significantly correlated with an increased rate of miscarriage. Thyroid autoantibody-positive women miscarried at a rate of 17%, compared with 8.4% for the autoantibody-negative women. Individual levels of thyroglobulin and thyroidperoxidase autoantibodies were similarly related to this increased miscarriage rate, with no evidence of autoantibody specificity in the relationship. Furthermore, the increase in miscarriages could not be explained by differences in thyroid hormone levels, the presence of cardiolipin autoantibodies, maternal age, gestational age at the time of maternal entry into the study, or previous obstetric history. They conclude that thyroid autoantibodies are an independent marker of at-risk pregnancy.

  1. Assessing transmissible spongiform encephalopathy species barriers with an in vitro prion protein conversion assay.

    PubMed

    Johnson, Christopher J; Carlson, Christina M; Morawski, Aaron R; Manthei, Alyson; Cashman, Neil R

    2015-01-01

    Studies to understanding interspecies transmission of transmissible spongiform encephalopathies (TSEs, prion diseases) are challenging in that they typically rely upon lengthy and costly in vivo animal challenge studies. A number of in vitro assays have been developed to aid in measuring prion species barriers, thereby reducing animal use and providing quicker results than animal bioassays. Here, we present the protocol for a rapid in vitro prion conversion assay called the conversion efficiency ratio (CER) assay. In this assay cellular prion protein (PrPC) from an uninfected host brain is denatured at both pH 7.4 and 3.5 to produce two substrates. When the pH 7.4 substrate is incubated with TSE agent, the amount of PrPC that converts to a proteinase K (PK)-resistant state is modulated by the original host's species barrier to the TSE agent. In contrast, PrPC in the pH 3.5 substrate is misfolded by any TSE agent. By comparing the amount of PK-resistant prion protein in the two substrates, an assessment of the host's species barrier can be made. We show that the CER assay correctly predicts known prion species barriers of laboratory mice and, as an example, show some preliminary results suggesting that bobcats (Lynx rufus) may be susceptible to white-tailed deer (Odocoileus virginianus) chronic wasting disease agent. PMID:25867521

  2. Assessing transmissible spongiform encephalopathy species barriers with an in vitro prion protein conversion assay

    USGS Publications Warehouse

    Johnson, Christopher J.; Carlson, Christina M.; Morawski, Aaron R.; Manthei, Alyson; Cashman, Neil R.

    2015-01-01

    Studies to understanding interspecies transmission of transmissible spongiform encephalopathies (TSEs, prion diseases) are challenging in that they typically rely upon lengthy and costly in vivo animal challenge studies. A number of in vitro assays have been developed to aid in measuring prion species barriers, thereby reducing animal use and providing quicker results than animal bioassays. Here, we present the protocol for a rapid in vitroprion conversion assay called the conversion efficiency ratio (CER) assay. In this assay cellular prion protein (PrPC) from an uninfected host brain is denatured at both pH 7.4 and 3.5 to produce two substrates. When the pH 7.4 substrate is incubated with TSE agent, the amount of PrPC that converts to a proteinase K (PK)-resistant state is modulated by the original host’s species barrier to the TSE agent. In contrast, PrPC in the pH 3.5 substrate is misfolded by any TSE agent. By comparing the amount of PK-resistant prion protein in the two substrates, an assessment of the host’s species barrier can be made. We show that the CER assay correctly predicts known prion species barriers of laboratory mice and, as an example, show some preliminary results suggesting that bobcats (Lynx rufus) may be susceptible to white-tailed deer (Odocoileus virginianus) chronic wasting disease agent.

  3. Cytotoxicity assays as tools to assess water quality in the Sinos River basin.

    PubMed

    Trintinaglia, L; Bianchi, E; Silva, L B; Nascimento, C A; Spilki, F R; Ziulkoski, A L

    2015-05-01

    Cytotoxicity assays using cell cultures may be an alternative to assess biological toxicity of surface waters and may help to improve the control of water quality. This study compared two methods to prepare culture media for the exposure of Hep-2 cells to water samples collected from the Rolante River, an important affluent of the Sinos River. The toxicity was evaluated using the MTT and neutral red assays. Two methods were used to prepare culture media. In method 1, the sample was diluted at 1:1, 1:10, 1:100, 1:1000, 1:10.000 (v/v, sample/medium) in a standard culture medium; in method 2, water samples were used as the solvent for the culture medium, which was prepared at concentrations of 100, 80, 60, 40 and 20%. Semi-confluent cultures were then exposed to the media test for 24 hours, and cytotoxicity was determined immediately using the MTT and NR assays. Mitochondrial activity (MTT) was significantly lower at all concentrations in both methods, except at 1:1000 in method 1. However, the lysosome viability (NR) results revealed cytotoxicity only in the 1:1 sample of method 1. Both culture preparation methods were efficient and sensitive to the MTT assay, but method 2 seemed to be more adequate for the NR assay. The Rolante River has cytotoxic contaminants to Hep-2 cells, which may be one of the explanations for the poor water quality of the Sinos River basin. PMID:26270217

  4. Twenty Years of Progress in Violence Risk Assessment

    ERIC Educational Resources Information Center

    Hanson, R. Karl

    2005-01-01

    Violence risk assessment has advanced considerably in the last 20 years. In the 1980s, leading professionals questioned the very possibility of valid violence risk assessments; now, many of the major risk factors have been identified, and professional debate focuses on how best to combine these risk factors into meaningful evaluations. An…

  5. Assessing suicidal risk with antiepileptic drugs

    PubMed Central

    Mula, Marco; Bell, Gail S; Sander, Josemir W

    2010-01-01

    Recently, the US Food and Drug Administration issued an alert about an increased risk for suicidality during treatment with antiepileptic drugs (AEDs) for different indications, including epilepsy. We discuss the issue of suicide in epilepsy with special attention to AEDs and the assessment of suicide in people with epilepsy. It has been suggested that early medical treatment with AEDs might potentially reduce suicide risk of people with epilepsy, but it is of great importance that the choice of drug is tailored to the mental state of the patient. The issue of suicidality in epilepsy is likely to represent an example of how the underdiagnosis of psychiatric symptoms, the lack of input from professionals (eg, psychologists, social workers, and psychiatrists), and the delay in an optimized AED therapy may worsen the prognosis of the condition with the occurrence of severe complications such as suicide. PMID:20957120

  6. Ecological risk assessment of contaminated soil.

    PubMed

    Jensen, John; Pedersen, Marianne Bruus

    2006-01-01

    This review has described three cases of ecological risk assessment. The cases include two heavy metals (Cu and Zn) and an anthropogenic organic chemical (DDT). It concludes that there are at least two major constraints hampering the use of laboratory tests to predict effects under natural field conditions. One key issue is bioavailability, and another is suboptimal conditions or multiple stresses in the field such as climatic stress (drought, frost), predators, competition, or food shortage. On the basis of the presented case studies, it was possible to answer three essential questions often raised in connection to ecological risk assessment of contaminated sites. 1. To what extend does soil screening level (SSL) estimate the risk? The SSL are generally derived at levels corresponding to the lowest observed effect levels in laboratory studies, which often is close to the background levels found in many soils. In the cases of zinc and especially DDT, the SSL seemed quite conservative, whereas for copper they resemble the level at which changes in the community structure of soil microarthropods and the plant community have been observed at contaminated sites. The SSL correspond as a whole relatively well with concentrations where no effects or only minor effects were observed in controlled field studies. However, large variation in field surveys can often make it difficult to conclude to what extent the SSL corresponded to no-effect levels in the field. 2. Do bioassays represent a more realistic risk estimate? Here, there is no firm conclusion. The zinc study in UK showed a better relationship between the outcome of ex situ bioassays and field observations than the SSL. The latter overestimated the risk compared to field observations. However, this would be species dependent, as the sensitivity to metals may vary considerably between recognized test species, even within the same group of organisms, such as Folsomia candida and Folsomia fimetaria or Eisenia fetida

  7. Conceptual models for cumulative risk assessment.

    PubMed

    Linder, Stephen H; Sexton, Ken

    2011-12-01

    In the absence of scientific consensus on an appropriate theoretical framework, cumulative risk assessment and related research have relied on speculative conceptual models. We argue for the importance of theoretical backing for such models and discuss 3 relevant theoretical frameworks, each supporting a distinctive "family" of models. Social determinant models postulate that unequal health outcomes are caused by structural inequalities; health disparity models envision social and contextual factors acting through individual behaviors and biological mechanisms; and multiple stressor models incorporate environmental agents, emphasizing the intermediary role of these and other stressors. The conclusion is that more careful reliance on established frameworks will lead directly to improvements in characterizing cumulative risk burdens and accounting for disproportionate adverse health effects. PMID:22021317

  8. Suicide risk assessment and risk formulation part II: Suicide risk formulation and the determination of levels of risk.

    PubMed

    Berman, Alan L; Silverman, Morton M

    2014-08-01

    The suicide risk formulation (SRF) is dependent on the data gathered in the suicide risk assessment. The SRF assigns a level of suicide risk that is intended to inform decisions about triage, treatment, management, and preventive interventions. However, there is little published about how to stratify and formulate suicide risk, what are the criteria for assigning levels of risk, and how triage and treatment decisions are correlated with levels of risk. The salient clinical issues that define an SRF are reviewed and modeling is suggested for an SRF that might guide clinical researchers toward the refinement of an SRF process. PMID:24286521

  9. An ECVAG† trial on assessment of oxidative damage to DNA measured by the comet assay

    PubMed Central

    Johansson, Clara; Møller, Peter; Forchhammer, Lykke; Loft, Steffen; Godschalk, Roger W. L.; Langie, Sabine A. S.; Lumeij, Stijn; Jones, George D. D.; Kwok, Rachel W. L.; Azqueta, Amaya; Phillips, David H.; Sozeri, Osman; Routledge, Michael N.; Charlton, Alexander J.; Riso, Patrizia; Porrini, Marisa; Allione, Alessandra; Matullo, Giuseppe; Palus, Jadwiga; Stepnik, Maciej; Collins, Andrew R.; Möller, Lennart

    2010-01-01

    The increasing use of single cell gel electrophoresis (the comet assay) highlights its popularity as a method for detecting DNA damage, including the use of enzymes for assessment of oxidatively damaged DNA. However, comparison of DNA damage levels between laboratories can be difficult due to differences in assay protocols (e.g. lysis conditions, enzyme treatment, the duration of the alkaline treatment and electrophoresis) and in the end points used for reporting results (e.g. %DNA in tail, arbitrary units, tail moment and tail length). One way to facilitate comparisons is to convert primary comet assay end points to number of lesions/106 bp by calibration with ionizing radiation. The aim of this study was to investigate the inter-laboratory variation in assessment of oxidatively damaged DNA by the comet assay in terms of oxidized purines converted to strand breaks with formamidopyrimidine DNA glycosylase (FPG). Coded samples with DNA oxidation damage induced by treatment with different concentrations of photosensitizer (Ro 19-8022) plus light and calibration samples irradiated with ionizing radiation were distributed to the 10 participating laboratories to measure DNA damage using their own comet assay protocols. Nine of 10 laboratories reported the same ranking of the level of damage in the coded samples. The variation in assessment of oxidatively damaged DNA was largely due to differences in protocols. After conversion of the data to lesions/106 bp using laboratory-specific calibration curves, the variation between the laboratories was reduced. The contribution of the concentration of photosensitizer to the variation in net FPG-sensitive sites increased from 49 to 73%, whereas the inter-laboratory variation decreased. The participating laboratories were successful in finding a dose–response of oxidatively damaged DNA in coded samples, but there remains a need to standardize the protocols to enable direct comparisons between laboratories. PMID:19948595

  10. Soil genotoxicity assessment--results of an interlaboratory study on the Vicia micronucleus assay in the context of ISO standardization.

    PubMed

    Cotelle, Sylvie; Dhyèvre, Adrien; Muller, Serge; Chenon, Pascale; Manier, Nicolas; Pandard, Pascal; Echairi, Abdelwahad; Silvestre, Jérôme; Guiresse, Maritxu; Pinelli, Eric; Giorgetti, Lucia; Barbafieri, Meri; Silva, Valéria C; Engel, Fernanda; Radetski, Claudemir M

    2015-01-01

    The Vicia micronucleus assay was standardized in an international protocol, ISO 29200, "Assessment of genotoxic effects on higher plants-Vicia faba micronucleus test," for soil or soil materials (e.g., compost, sludge, sediment, waste, and fertilizing materials). The aim of this interlaboratory study on the Vicia micronucleus assay was to investigate the robustness of this in vivo assay in terms of its applicability in different countries where each participant were asked to use their own seeds and reference soil, in agreement with the ISO 29200 standard. The ISO 29200 standard protocol was adopted for this study, and seven laboratories from three countries (France, Italy, and Brazil) participated in the study. Negative and positive controls were correctly evaluated by 100 % of the participants. In the solid-phase test, the micronucleus frequency (number of micronuclei/1,000 cells) varied from 0.0 to 1.8 for the negative control (i.e., Hoagland's solution) and from 5.8 to 85.7 for the positive control (i.e., maleic hydrazide), while these values varied from 0.0 to 1.7 for the negative control and from 14.3 to 97.7 for the positive control in the case of liquid-phase test. The variability in the data obtained does not adversely affect the robustness of the protocol assessed, on the condition that the methodology described in the standard ISO 29200 is strictly respected. Thus, the Vicia micronucleus test (ISO 29200) is appropriate for complementing prokaryotic or in vitro tests cited in legislation related to risk assessment of genotoxicity potential. PMID:25167825

  11. Risk assessment of acrylamide in foods.

    PubMed

    Dybing, E; Sanner, T

    2003-09-01

    Daily mean intakes of acrylamide present in foods and coffee in a limited Norwegian exposure assessment study have been estimated to be 0.49 and 0.46 microg per kg body weight in males and females, respectively. Testicular mesotheliomas and mammary gland adenomas have consistently been found in 2-year drinking water rat cancer studies with acrylamide. Acrylamide also shows initiating activity in mouse skin after systemic administration. Since acrylamide is converted to the mutagenic metabolite glycidamide and forms adducts to hemoglobin in rodents and humans, the tumorigenic endpoints in rats were assumed to be an expression of acrylamide genotoxicity. Using the default linear extrapolation methods LED10 and T25, the lifetime cancer hazard after lifelong exposure to 1 microg acrylamide per kg body weight per day, scaled to humans, was calculated to be, on average, 1.3 x 10-3. Using this hazard level and correlating it with the exposure estimates, a lifetime cancer risk related to daily intake of acrylamide in foods for 70 years in males was calculated to be 0.6 x 10-3, implying that 6 out of 10,000 individuals may develop cancer due to acrylamide. For females, the risk values were slightly lower. It must be emphasized that this risk assessment is conservative. A number of processes may result in nonlinearity of the dose-response relationships for acrylamide carcinogenicity in the low-dose region, including detoxication reactions, cell cycle arrest, DNA repair, apoptosis, and immune surveillance. Thus, the true risk levels related to acrylamide intake may be considerably lower. PMID:12805639

  12. 75 FR 82387 - Next Generation Risk Assessment Public Dialogue Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-30

    ... AGENCY Next Generation Risk Assessment Public Dialogue Conference AGENCY: Environmental Protection Agency... Generation of Risk Assessment'' (NexGen) program, EPA is announcing a 2-day public dialogue conference to... Information About the Conference The landscape of risk assessment is changing rapidly with new advances...

  13. Occupational exposure to formaldehyde: genotoxic risk evaluation by comet assay and micronucleus test using human peripheral lymphocytes.

    PubMed

    Costa, Solange; Pina, Carolina; Coelho, Patrícia; Costa, Carla; Silva, Susana; Porto, Beatriz; Laffon, Blanca; Teixeira, João Paulo

    2011-01-01

    Formaldehyde (FA) is a world high-production compound with numerous applications ranging from production of resins to medicines. Due to its sensitizing properties, irritating effects and potential cancer hazard FA is of great environmental health concern. Numerous studies in humans and experimental animals demonstrated that inhaled FA produced toxicity, genotoxicity, and cancer at distal sites. IARC, based on sufficient data, reclassified FA as a human carcinogen. The highest level of human exposure to this aldehyde occurs in occupational settings, namely, in pathology and anatomy laboratories, where FA is commonly used as a fixative and tissue preservative. Several studies consistently showed that the levels of airborne FA in anatomy laboratories exceeded recommended exposure criteria. In order to assess the genotoxic effects of chronic occupational exposure to FA, a group of pathology/anatomy workers was assessed using a micronucleus (MN) test and comet assay. The level of exposure to FA was also determined and the time-weighted average (TWA) of exposure was calculated for each subject. The TWA mean value for FA exposed workers was 0.43 ± 0.06 ppm, exceeding national and international recommended limit levels of 0.3 ppm. Both MN frequency and comet assay parameters were significantly higher in exposed subjects. Data obtained confirm a correlation between genetic damage and occupational exposure to FA. These data, along with recent implications of human carcinogenicity, point out the need for close monitoring of occupational exposure to FA. Implementation of security and hygiene measures as well as good practices campaigns may be crucial to decrease risk. PMID:21707428

  14. 76 FR 44891 - Monsanto Co.; Availability of Petition, Plant Pest Risk Assessment, and Environmental Assessment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ... time to prepare and submit comments on the Monsanto petition, our plant pest risk assessment, and our... assessment, and plant pest risk assessment are also available on the APHIS Web site at http://www.aphis.usda... petition, draft environmental assessment, or plant pest risk assessment, contact Ms. Cindy Eck at (301)...

  15. Session: Pre-development project risk assessment

    SciTech Connect

    Curry, Richard; Linehan, Andy

    2004-09-01

    This second session at the Wind Energy and Birds/Bats workshop consisted of two presentations followed by a discussion/question and answer period. The focus of the presentations was on the practices and methodologies used in the wind energy industry for assessing risk to birds and bats at candidate project sites. Presenters offered examples of pre-development siting evaluation requirements set by certain states. Presentation one was titled ''Practices and Methodologies and Initial Screening Tools'' by Richard Curry of Curry and Kerlinger, LLC. Presentation two was titled ''State of the Industry in the Pacific Northwest'' by Andy Linehan, CH2MHILL.

  16. Whither risk assessment? An overall perspective.

    PubMed

    Gori, G B

    1993-04-01

    Major regulatory initiatives in health and safety are increasingly viewed as too costly, not objectively justified, and thus failing in their mandate to ensure a fair social distribution of rights and burdens. Official but arbitrary assumptions in cancer risk assessment and open-ended statutory language encourage regulatory agencies to overregulate. Also, institutional self-serving motivations of regulatory agencies add incentives to expand regulation. Mitigation of the current regulatory crisis may come from curbing these selfish incentives, and from requiring that regulation be justified on the basis of strict scientific standards of evidence, rather than on arbitrary assumptions and conjectures. PMID:8484030

  17. Assessing risk of solid waste compost

    SciTech Connect

    Dyer, J.M.; Razvi, A.S. )

    1987-03-01

    This paper addresses the movement of metals in soils and their accumulation in plants. Research with sewage sludge compost indicates that these risks can be minimized with proper handling and management. The objectives of this study were: (I) to evaluate potential groundwater contamination due to plant nutrients and heavy metals in the compost; and (II) to assess the accumulation of metals in plants grown on compost-amended soil. Data are presented for analyses of nickel, lead, cadmium, copper and zinc in snap beans.

  18. Applying a weed risk assessment approach to GM crops.

    PubMed

    Keese, Paul K; Robold, Andrea V; Myers, Ruth C; Weisman, Sarah; Smith, Joe

    2014-12-01

    Current approaches to environmental risk assessment of genetically modified (GM) plants are modelled on chemical risk assessment methods, which have a strong focus on toxicity. There are additional types of harms posed by plants that have been extensively studied by weed scientists and incorporated into weed risk assessment methods. Weed risk assessment uses robust, validated methods that are widely applied to regulatory decision-making about potentially problematic plants. They are designed to encompass a broad variety of plant forms and traits in different environments, and can provide reliable conclusions even with limited data. The knowledge and experience that underpin weed risk assessment can be harnessed for environmental risk assessment of GM plants. A case study illustrates the application of the Australian post-border weed risk assessment approach to a representative GM plant. This approach is a valuable tool to identify potential risks from GM plants. PMID:24046097

  19. Evaluation of an in vitro cell culture assay for the potency assessment of recombinant human erythropoietin.

    PubMed

    Machado, Francine T; Maldaner, Fernanda P S; Perobelli, Rafaela F; Xavier, Bruna; da Silva, Francielle S; de Freitas, Guilherme W; Bartolini, Paolo; Ribela, M Tereza C P; Dalmora, Sérgio L

    2016-05-01

    Recombinant human erythropoietin is a sialoglycoprotein that stimulates erythropoiesis. To assess potency of human erythropoietin produced by recombinant technology, we investigated an in vitro TF-1 cell proliferation assay, which was applied in conjunction with a reversed-phase liquid chromatography method for the determination of the content of sialic acids. The results obtained, which were higher than 126.8ng/μg, were compared with those obtained with the in vivo normocythaemic mouse bioassay. The in vitro assay resulted in a non-significant lower mean difference of the estimated potencies (0.61% ± 0.026, p > 0.05). The use of this combination of methods represents an advance toward the establishment of alternative in vitro approaches, in the context of the Three Rs, for the potency assessment of biotechnology-derived medicines. PMID:27256453

  20. IonWorks Barracuda Assay for Assessment of State-Dependent Sodium Channel Modulators.

    PubMed

    Cerne, Rok; Wakulchik, Mark; Krambis, Michael J; Burris, Kevin D; Priest, Birgit T

    2016-03-01

    Voltage-gated sodium channels represent important drug targets. The implementation of higher throughput electrophysiology assays is necessary to characterize the interaction of test compounds with several conformational states of the channel, but has presented significant challenges. We describe a novel high throughput approach to assess the effects of test agents on voltage-gated sodium currents. The multiple protocol mode of the automated electrophysiology instrument IonWorks Barracuda was used to control the level of inactivation and monitor current stability. Good temporal stability of currents and spatial uniformity of inactivation were obtained by optimizing the experimental conditions. The resulting assay allowed for robust assessment of state-dependent effects of test agents and enabled direct comparison of compound potency across several sodium channel subtypes at equivalent levels of inactivation. PMID:26844665

  1. Assessment of cardiovascular risks and overall risks for noncardiac surgery.

    PubMed

    Chung, O Y; Beattie, C; Friesinger, G C

    1999-02-01

    Appropriate care of the elderly patient requires a concerted multi-disciplinary approach before, during, and after surgery to optimize functional outcomes, with the principal focus placed on improving quality of life and strategies for risk reduction. Perioperative physicians must be able to assess the biologic, not the chronologic, age of geriatric patients and their capacity for independent function. Physicians need to understand alterations in the physiology of elderly patients attributable to the normal aging process as well as the prevalence of concurrent pathologic conditions that necessitate special precautions. Maintaining autonomy and function as a result of an acute surgical intervention may be the most important outcome to the elderly patient. Most of the data available and guidelines promulgated do not specifically address the elderly population. It is important to collect data prospectively and use sophisticated methods for analyses to develop better management algorithms for these (often complicated) clinical issues in the elderly. PMID:10093774

  2. NEUROBEHAVIORAL TESTING IN HUMAN RISK ASSESSMENT

    PubMed Central

    Rohlman, Diane S.; Lucchini, Roberto; Anger, W. Kent; Bellinger, David C.; van Thriel, Christoph

    2008-01-01

    Neurobehavioral tests are being increasingly used in human risk assessment and there is a strong need for guidance. The field of neurobehavioral toxicology has evolved from research which initially focused on using traditional neuropsychological tests to identify “abnormal cases” to include methods used to detect sub-clinical deficits, to further incorporate the use of neurosensory assessment, and to expand testing from occupational populations to vulnerable populations including older adults and children. Even as exposures in the workplace are reduced, they have been increasing in the environment and research on exposure has now expanded to cross the entire lifetime. These neurobehavioral methods are applied in research and the findings used for regulatory purposes to develop preventative action for exposed populations. This paper reflects a summary of the talks presented at the symposium presented at the 11th meeting of the International Neurotoxicology Association. PMID:18539229

  3. An integrated framework for health and ecological risk assessment

    SciTech Connect

    Suter, Glenn W. . E-mail: suter.glenn@epa.gov; Vermeire, Theo; Munns, Wayne R.; Sekizawa, Jun

    2005-09-01

    The worldHealth Organization's (WHO's) International Program for Chemical Safety has developed a framework for performing risk assessments that integrate the assessment of risks to human health and risks to nonhuman organisms and ecosystems. The WHO's framework recognizes that stakeholders and risk managers have their own processes that are parallel to the scientific process of risk assessment and may interact with the risk assessment at various points, depending on the context. Integration of health and ecology provides consistent expressions of assessment results, incorporates the interdependence of humans and the environment, uses sentinel organisms, and improves the efficiency and quality of assessments relative to independent human health and ecological risk assessments. The advantage of the framework to toxicologists lies in the opportunity to use understanding of toxicokinetics and toxicodynamics to inform the integrated assessment of all exposed species.

  4. Increased Chromosomal Radiosensitivity in Women Carrying BRCA1/BRCA2 Mutations Assessed With the G2 Assay

    SciTech Connect

    Ernestos, Beroukas; Nikolaos, Pandis; Koulis, Giannoukakos; Eleni, Rizou; Konstantinos, Beroukas; Alexandra, Giatromanolaki; Michael, Koukourakis

    2010-03-15

    Purpose: Several in vitro studies suggest that BRCA1 and BRCA2 mutation carriers present increased sensitivity to ionizing radiation. Different assays for the assessment of deoxyribonucleic acid double-strand break repair capacity have been used, but results are rather inconsistent. Given the concerns about the possible risks of breast screening with mammography in mutation carrier women and the potentially damaging effects of radiotherapy, the purpose of this study was to further investigate the radiosensitivity of this population. Methods and Materials: The G2 chromosomal radiosensitivity assay was used to assess chromosomal breaks in lymphocyte cultures after exposure to 1 Gy. A group of familiar breast cancer patients carrying a mutation in the BRCA1 or BRCA2 gene (n = 15) and a group of healthy mutation carriers (n = 5) were investigated and compared with a reference group of healthy women carrying no mutation (n = 21). Results: BRCA1 and BRCA2 mutation carriers had a significantly higher number of mean chromatid breaks per cell (p = 0.006) and a higher maximum number of breaks (p = 0.0001) as compared with their matched controls. Both healthy carriers and carriers with a cancer history were more radiosensitive than controls (p = 0.002 and p = 0.025, respectively). Age was not associated with increased radiosensitivity (p = 0.868). Conclusions: Our results indicate that BRCA1 and BRCA2 mutation carriers show enhanced radiosensitivity, presumably because of the involvement of the BRCA genes in deoxyribonucleic acid repair and cell cycle control mechanisms.

  5. Assessment of Interpersonal Risk (AIR) in Adults with Learning Disabilities and Challenging Behaviour--Piloting a New Risk Assessment Tool

    ERIC Educational Resources Information Center

    Campbell, Martin; McCue, Michael

    2013-01-01

    A new risk assessment tool, "Assessment of Interpersonal Risk" (AIR), was piloted and evaluated to measure risk factors and compatibility between individuals living in an assessment and treatment unit in one NHS area. The adults with learning disabilities in this unit had severe and enduring mental health problems and/or behaviour that is severely…

  6. Bacterial assay for the rapid assessment of antifouling and fouling release properties of coatings and materials.

    PubMed

    D'Souza, Fraddry; Bruin, Anouk; Biersteker, Rens; Donnelly, Glen; Klijnstra, Job; Rentrop, Corne; Willemsen, Peter

    2010-04-01

    An assay has been developed to accurately quantify the growth and release behaviour of bacterial biofilms on several test reference materials and coatings, using the marine bacterium Cobetia marina as a model organism. The assay can be used to investigate the inhibition of bacterial growth and release properties of many surfaces when compared to a reference. The method is based upon the staining of attached bacterial cells with the nucleic acid-binding, green fluorescent SYTO 13 stain. A strong linear correlation exists between the fluorescence of the bacterial suspension measured (RFU) using a plate reader and the total bacterial count measured with epifluorescence microscopy. This relationship allows the fluorescent technique to be used for the quantification of bacterial cells attached to surfaces. As the bacteria proliferate on the surface over a period of time, the relative fluorescence unit (RFU) measured using the plate reader also shows an increase with time. This was observed on all three test surfaces (glass, Epikote and Silastic T2) over a period of 4 h of bacterial growth, followed by a release assay, which was carried out by the application of hydrodynamic shear forces using a custom-made rotary device. Different fixed rotor speeds were tested, and based on the release analysis, 12 knots was used to provide standard shear force. The assay developed was then applied for assessing three different antifouling coatings of different surface roughness. The novel assay allows the rapid and sensitive enumeration of attached bacteria directly on the coated surface. This is the first plate reader assay technique that allows estimation of irreversibly attached bacterial cells directly on the coated surface without their removal from the surface or extraction of a stain into solution. PMID:20039190

  7. A novel, micro, rapid and direct assay to assess total antioxidant capacity of solid foods.

    PubMed

    Condezo-Hoyos, Luis; Abderrahim, Fatima; Arriba, Silvia M; Carmen González, M

    2015-06-01

    A novel, micro, rapid and direct procedure to measure the total antioxidant capacity of solid foods using 2, 2-diphenyl-1-picrylhydrazyl (DPPH) (mR-QUENCHER-DPPH) was developed and validated. The mR-QUENCHER-DPPH assay was performed in semi-aqueous medium (methanol-Tris buffer) using very small sample amounts (below 3.6 µg), as estimated by a Bradford reagent-based chemical predictor, and it was completed in 10 min at room temperature. The total antioxidant capacity (TAC) of solid foods was expressed as scavenging capacity index (SCI, mmol DPPH scavenged per kg sample), a theoretical and stoichiometric parameter deduced in this study. SCI values measured by mR-QUENCHER-DPPH assay for cereals cous-cous (7.20±0.35), amaranth (7.99±0.35) and buckwheat (194.2±6.72); Goji fruit (91.27±3.98); lotus root (2402±168); and spices turmeric (3767±355), ginger (2493±283), and cinnamon (10461±2133) were further validated using Folin-Ciocalteau assay. Bland-Altman analysis showed that there were not statistically significant differences in TAC values as measured by both assays. In the same way, TAC values measured by mR-QUENCHER-DPPH were correlated with free (r=0.8088, P=0.0151), bound (r=0.9668, P<0.0001) and total (r=0.9067, P=0.0019) reducing capacity of extracts from solid foods as assessed by Folin-Ciocalteau assay. The mR-QUENCHER-DPPH assay allows to measure TAC values using micro-gram amounts in solid food samples with a wide content range of antioxidants (low, high and very high), and omitting the time-consuming dilution cellulose-step commonly employed in the traditional QUENCHER procedures. PMID:25863378

  8. Assessing risk factors for periodontitis using regression

    NASA Astrophysics Data System (ADS)

    Lobo Pereira, J. A.; Ferreira, Maria Cristina; Oliveira, Teresa

    2013-10-01

    Multivariate statistical analysis is indispensable to assess the associations and interactions between different factors and the risk of periodontitis. Among others, regression analysis is a statistical technique widely used in healthcare to investigate and model the relationship between variables. In our work we study the impact of socio-demographic, medical and behavioral factors on periodontal health. Using regression, linear and logistic models, we can assess the relevance, as risk factors for periodontitis disease, of the following independent variables (IVs): Age, Gender, Diabetic Status, Education, Smoking status and Plaque Index. The multiple linear regression analysis model was built to evaluate the influence of IVs on mean Attachment Loss (AL). Thus, the regression coefficients along with respective p-values will be obtained as well as the respective p-values from the significance tests. The classification of a case (individual) adopted in the logistic model was the extent of the destruction of periodontal tissues defined by an Attachment Loss greater than or equal to 4 mm in 25% (AL≥4mm/≥25%) of sites surveyed. The association measures include the Odds Ratios together with the correspondent 95% confidence intervals.

  9. The new tapestry of risk assessment

    PubMed Central

    Weiss, Bernard; Cory-Slechta, Deborah; Gilbert, Steven G.; Mergler, Donna; Miller, Elise; Miller, Claudia; Newland, M. Christopher; Rice, Deborah; Schettler, Ted

    2008-01-01

    Neurotoxicology is entering a new phase in how it views and practices risk assessment. Perhaps more than any of the other disciplines that comprise the science of toxicology, it has been compelled to consider a daunting array of factors other than those directly coupled to chemical and dose, and the age and sex of the subject population. In epidemiological investigations, researchers are increasingly cognizant of the problems introduced by allegedly controlling for variables classified as confounders or covariates. In essence, they reason, the consequence is blurring or even concealing interactions of exposure with modifiers such as the individual’s social ecology. Other researchers question the traditional practice of relying on values such as NOAELs when they are abstracted from a biological entity that in reality represents a multiplicity of intertwined systems. Although neurotoxicologists have come to recognize the complexities of assessing risk in all its dimensions, they still face the challenge of communicating this view to the health professions at large. PMID:18501430

  10. Cyanide analyses for risk and treatability assessments

    SciTech Connect

    MacFarlane, I.D.; Elseroad, H.J.; Pergrin, D.E.; Logan, C.M.

    1994-12-31

    Cyanide, an EPA priority pollutant and target analyte, is typically measured as total. However, cyanide complexation, information which is not acquired through total cyanide analysis, is often a driver of cyanide toxicity and treatability. A case study of a former manufacture gas plant (MGP) is used to demonstrate the usability of various cyanide analytical methods for risk and treatability assessments. Several analytical methods, including cyanide amenable to chlorination and weak acid dissociable cyanide help test the degree of cyanide complexation. Generally, free or uncomplexed cyanide is more biologically available, toxic, and reactive than complexed cyanide. Extensive site testing has shown that free and weakly dissociable cyanide composes only a small fraction of total cyanide as would be expected from the literature, and that risk assessment will be more realistic considering cyanide form. Likewise, aqueous treatment for cyanide can be properly tested if cyanide form is accounted for. Weak acid dissociable cyanide analyses proved to be the most reliable (and potentially acceptable) cyanide method, as well as represent the most toxic and reactive cyanide forms.

  11. Hydrogen quantitative risk assessment workshop proceedings.

    SciTech Connect

    Groth, Katrina M.; Harris, Aaron P.

    2013-09-01

    The Quantitative Risk Assessment (QRA) Toolkit Introduction Workshop was held at Energetics on June 11-12. The workshop was co-hosted by Sandia National Laboratories (Sandia) and HySafe, the International Association for Hydrogen Safety. The objective of the workshop was twofold: (1) Present a hydrogen-specific methodology and toolkit (currently under development) for conducting QRA to support the development of codes and standards and safety assessments of hydrogen-fueled vehicles and fueling stations, and (2) Obtain feedback on the needs of early-stage users (hydrogen as well as potential leveraging for Compressed Natural Gas [CNG], and Liquefied Natural Gas [LNG]) and set priorities for %E2%80%9CVersion 1%E2%80%9D of the toolkit in the context of the commercial evolution of hydrogen fuel cell electric vehicles (FCEV). The workshop consisted of an introduction and three technical sessions: Risk Informed Development and Approach; CNG/LNG Applications; and Introduction of a Hydrogen Specific QRA Toolkit.

  12. Simulation Assisted Risk Assessment: Blast Overpressure Modeling

    NASA Technical Reports Server (NTRS)

    Lawrence, Scott L.; Gee, Ken; Mathias, Donovan; Olsen, Michael

    2006-01-01

    A probabilistic risk assessment (PRA) approach has been developed and applied to the risk analysis of capsule abort during ascent. The PRA is used to assist in the identification of modeling and simulation applications that can significantly impact the understanding of crew risk during this potentially dangerous maneuver. The PRA approach is also being used to identify the appropriate level of fidelity for the modeling of those critical failure modes. The Apollo launch escape system (LES) was chosen as a test problem for application of this approach. Failure modes that have been modeled and/or simulated to date include explosive overpressure-based failure, explosive fragment-based failure, land landing failures (range limits exceeded either near launch or Mode III trajectories ending on the African continent), capsule-booster re-contact during separation, and failure due to plume-induced instability. These failure modes have been investigated using analysis tools in a variety of technical disciplines at various levels of fidelity. The current paper focuses on the development and application of a blast overpressure model for the prediction of structural failure due to overpressure, including the application of high-fidelity analysis to predict near-field and headwinds effects.

  13. Earthquake Hazard and Risk Assessment for Turkey

    NASA Astrophysics Data System (ADS)

    Betul Demircioglu, Mine; Sesetyan, Karin; Erdik, Mustafa

    2010-05-01

    Using a GIS-environment to present the results, seismic risk analysis is considered as a helpful tool to support the decision making for planning and prioritizing seismic retrofit intervention programs at large scale. The main ingredients of seismic risk analysis consist of seismic hazard, regional inventory of buildings and vulnerability analysis. In this study, the assessment of the national earthquake hazard based on the NGA ground motion prediction models and the comparisons of the results with the previous models have been considered, respectively. An evaluation of seismic risk based on the probabilistic intensity ground motion prediction for Turkey has been investigated. According to the Macroseismic approach of Giovinazzi and Lagomarsino (2005), two alternative vulnerability models have been used to estimate building damage. The vulnerability and ductility indices for Turkey have been taken from the study of Giovinazzi (2005). These two vulnerability models have been compared with the observed earthquake damage database. A good agreement between curves has been clearly observed. In additional to the building damage, casualty estimations based on three different methods for each return period and for each vulnerability model have been presented to evaluate the earthquake loss. Using three different models of building replacement costs, the average annual loss (AAL) and probable maximum loss ratio (PMLR) due to regional earthquake hazard have been provided to form a basis for the improvement of the parametric insurance model and the determination of premium rates for the compulsory earthquake insurance in Turkey.

  14. Probabilistic Risk Assessment of disassembly procedures

    SciTech Connect

    O`Brien, D.A.; Bement, T.R.; Letellier, B.C.

    1993-10-01

    Probabilistic Risk (Safety) Assessment (PRA or PSA) is an analytic methodology for identifying the combination of events that, if they occur, lead to accidents. Accidents are defined as those events causing loss or injury to people, property, or the environment. PRA also provides a method for estimating the frequency of occurrence of each combination of events and the consequences of each accident. The Los Alamos effort for this study is summarized as follows: The focus of the Los Alamos study was on evaluating the risks specifically associated with disassembling a Los Alamos-designed device. The PRA for the disassembly operation included a detailed evaluation only for those potential accident sequences which could lead to significant off-site consequences and affect public health. The overall purpose of this study was to investigate the feasibility of a risk consequence goal for DOE operations. Often called a Level 3 PRA (or PSA), the methods are general and can with a little modification be applied to other procedures or processes.

  15. VOLCANIC RISK ASSESSMENT - PROBABILITY AND CONSEQUENCES

    SciTech Connect

    G.A. Valentine; F.V. Perry; S. Dartevelle

    2005-08-26

    Risk is the product of the probability and consequences of an event. Both of these must be based upon sound science that integrates field data, experiments, and modeling, but must also be useful to decision makers who likely do not understand all aspects of the underlying science. We review a decision framework used in many fields such as performance assessment for hazardous and/or radioactive waste disposal sites that can serve to guide the volcanological community towards integrated risk assessment. In this framework the underlying scientific understanding of processes that affect probability and consequences drive the decision-level results, but in turn these results can drive focused research in areas that cause the greatest level of uncertainty at the decision level. We review two examples of the determination of volcanic event probability: (1) probability of a new volcano forming at the proposed Yucca Mountain radioactive waste repository, and (2) probability that a subsurface repository in Japan would be affected by the nearby formation of a new stratovolcano. We also provide examples of work on consequences of explosive eruptions, within the framework mentioned above. These include field-based studies aimed at providing data for ''closure'' of wall rock erosion terms in a conduit flow model, predictions of dynamic pressure and other variables related to damage by pyroclastic flow into underground structures, and vulnerability criteria for structures subjected to conditions of explosive eruption. Process models (e.g., multiphase flow) are important for testing the validity or relative importance of possible scenarios in a volcanic risk assessment. We show how time-dependent multiphase modeling of explosive ''eruption'' of basaltic magma into an open tunnel (drift) at the Yucca Mountain repository provides insight into proposed scenarios that include the development of secondary pathways to the Earth's surface. Addressing volcanic risk within a decision

  16. Risk and Ethical Concerns of Hunting Male Elephant: Behavioural and Physiological Assays of the Remaining Elephants

    PubMed Central

    Burke, Tarryne; Page, Bruce; Van Dyk, Gus; Millspaugh, Josh; Slotow, Rob

    2008-01-01

    Background Hunting of male African elephants may pose ethical and risk concerns, particularly given their status as a charismatic species of high touristic value, yet which are capable of both killing people and damaging infrastructure. Methodology/Principal Findings We quantified the effect of hunts of male elephants on (1) risk of attack or damage (11 hunts), and (2) behavioural (movement dynamics) and physiological (stress hormone metabolite concentrations) responses (4 hunts) in Pilanesberg National Park. For eleven hunts, there were no subsequent attacks on people or infrastructure, and elephants did not break out of the fenced reserve. For three focal hunts, there was an initial flight response by bulls present at the hunting site, but their movements stabilised the day after the hunt event. Animals not present at the hunt (both bulls and herds) did not show movement responses. Physiologically, hunting elephant bulls increased faecal stress hormone levels (corticosterone metabolites) in both those bulls that were present at the hunts (for up to four days post-hunt) and in the broader bull and breeding herd population (for up to one month post-hunt). Conclusions/Significance As all responses were relatively minor, hunting male elephants is ethically acceptable when considering effects on the remaining elephant population; however bulls should be hunted when alone. Hunting is feasible in relatively small enclosed reserves without major risk of attack, damage, or breakout. Physiological stress assays were more effective than behavioural responses in detecting effects of human intervention. Similar studies should evaluate intervention consequences, inform and improve best practice, and should be widely applied by management agencies. PMID:18560517

  17. Risk Assessment Tool for Estimating Your 10-Year Risk of Having a Heart Attack

    MedlinePlus

    ... Cardiovascular Risk: Systematic Evidence Review from the Risk Assessment Work Group The Evidence Report Full Report Accessible ... MB) Printer-friendly version (2 MB) Study Quality Assessment Tools Clinical Practice Guideline: Developed Under NHLBI Partnership ...

  18. CONFOUNDERS IN INTERPRETING PATHOLOGY FOR SAFETY AND RISK ASSESSMENT

    EPA Science Inventory

    The contribution of pathology assessment to toxicity assessment is invaluable but often not clearly understood. Pathology endpoints are the central response around which human health risk assessment is frequently determined; therefore, it is important that the general toxicology ...

  19. Environmental risk assessment of Polish wastewater treatment plant activity.

    PubMed

    Kudłak, Błażej; Wieczerzak, Monika; Yotova, Galina; Tsakovski, Stefan; Simeonov, Vasil; Namieśnik, Jacek

    2016-10-01

    Wastewater treatment plants (WWTPs) play an extremely important role in shaping modern society's environmental well-being and awareness, however only well operated and supervised systems can be considered as environmentally sustainable. For this reason, an attempt was undertaken to assess the environmental burden posed by WWTPs in major Polish cities by collecting water samples prior to and just after wastewater release points. Both classical and biological methods (Microtox(®), Ostracodtoxkit F™ and comet assay) were utilized to assess environmental impact of given WWTP. Interestingly, in some cases, water quality improvement indicated as a toxicity decrement toward one of the bio-indicating organisms makes water worse for others in the systems. This fact is particularly noticeable in case of Silesian cities where heavy industry and high population density is present. It proves that WWTP should undergo individual evaluation of pollutant removal efficiency and tuned to selectively remove pollutants of highest risk to surrounding regional ecosystems. Biotests again proved to be an extremely important tool to fully assess the impact of environmental stressors on water bodies receiving effluents from WWTPs. PMID:27376857

  20. Risk-Assessment for Equipment Operating on the Lunar Surface

    NASA Technical Reports Server (NTRS)

    Richmond, R. C.; Kusiak, A.; Ramachandran, N.

    2008-01-01

    Particle-size distribution of lunar dust simulant is evaluated using scanning electron spectroscopy in order to consider approaches to evaluating risk to individual mechanical components operating on the lunar surface. Assessing component risk and risk-mitigation during actual operations will require noninvasive continuous data gathering on numerous parameters. Those data sets would best be evaluated using data-mining algorithms to assess risk, and recovery from risk, of individual mechanical components in real-time.

  1. Quantitative Risk Assessment for Enhanced Geothermal Systems

    NASA Astrophysics Data System (ADS)

    Lowry, T. S.; McKenna, S. A.; Hadgu, T.; Kalinina, E.

    2011-12-01

    This study uses a quantitative risk-assessment approach to place the uncertainty associated with enhanced geothermal systems (EGS) development into meaningful context and to identify points of attack that can reduce risk the most. Using the integrated geothermal assessment tool, GT-Mod, we calculate the complimentary cumulative distribution function of the levelized cost of electricity (LCOE) that results from uncertainty in a variety of geologic and economic input parameter values. EGS is a developing technology that taps deep (2-10km) geologic heat sources for energy production by "enhancing" non-permeable hot rock through hydraulic stimulation. Despite the promise of EGS, uncertainties in predicting the physical end economic performance of a site has hindered its development. To address this, we apply a quantitative risk-assessment approach that calculates risk as the sum of the consequence, C, multiplied by the range of the probability, ΔP, over all estimations of a given exceedance probability, n, over time, t. The consequence here is defined as the deviation from the best estimate LCOE, which is calculated using the 'best-guess' input parameter values. The analysis assumes a realistic but fictitious EGS site with uncertainties in the exploration success rate, the sub-surface thermal gradient, the reservoir fracture pattern, and the power plant performance. Uncertainty in the exploration, construction, O&M, and drilling costs are also included. The depth to the resource is calculated from the thermal gradient and a target resource temperature of 225 °C. Thermal performance is simulated using the Gringarten analytical solution. The mass flow rate is set to produce 30 MWe of power for the given conditions and is adjusted over time to maintain that rate over the plant lifetime of 30 years. Simulations are conducted using GT-Mod, which dynamically links the physical systems of a geothermal site to simulate, as an integrated, multi-system component, the

  2. Ecological risk assessments for watersheds: Lessons learned from case studies

    SciTech Connect

    Marcy, S.K.M.

    1994-12-31

    The USEPA Office of Water and Risk Assessment Forum are co-sponsoring the development of watershed level ecological risk assessments in Big Darby Creek, OH, Clinch River, VA, Middle Platte River Wetlands, NE, Snake River, ID, and Waquoit Bay Estuary, MA. The case studies are testing the Agency`s Framework for Ecological Risk Assessment at a watershed scale for multiple stressors. During case study development much has been learned about how to apply and modify the principles in the Framework to landscape scale risk assessments. Insights include how to select appropriate assessment endpoints to drive the risk assessment, how to effectively increase involvement by risk management teams, and provide decision opportunities for managers throughout development. The case studies demonstrate diverse ways to conduct watershed risk assessments, and illustrate the importance of multiple risk hypotheses in conceptual models addressing the combined and relative risk of chemical, physical and biological stressors. Issues the case studies highlight include the need for a process to determine when watershed risk assessments are appropriate and at what level of complexity they should be performed, how to increase the use of the ecological risk assessments in management decision-making and how to determine the best risk reduction strategy. An update on the watershed case studies will be provided and the insights and issues stated above, discussed.

  3. United States Environmental Protection Agency: Use of risk assessment and risk management methodologies. Master's thesis

    SciTech Connect

    Lamuro, R.J.

    1992-09-30

    Make a full investigation of the policy implications and appropriate uses of risk assessment and risk management in regulatory programs under various Federal laws to prevent cancer and other chronic health effects which may result from exposure to hazardous substances. This is the primary mission of the Risk Assessment and Management Commission (Risk Commission). The Clean Air Act Amendments of 1990 (CAAA), created the Risk Commission reflecting Congress' concern over agency use of risk assessment and risk management techniques and methodologies to implement federal laws protective of human health. The Risk Commission is to consider: methods for measuring and describing risks of chronic health effects from hazardous substances; methods to reflect uncertainties associated with estimation techniques, and whether it is possible or desirable to develop a consistent risk assessment methodology or a consistent standard of acceptable risk for various federal programs.

  4. Melanoma susceptibility genes and risk assessment.

    PubMed

    Marzuka-Alcalá, Alexander; Gabree, Michele Jacobs; Tsao, Hensin

    2014-01-01

    Familial melanoma accounts for approximately a tenth of all melanoma cases. The most commonly known melanoma susceptibility gene is the highly penetrant CDKN2A (p16INK4a) locus, which is transmitted in an autosomal dominant fashion and accounts for approximately 20-50 % of familial melanoma cases. Mutated p16INK4a shows impaired capacity to inhibit the cyclin D1-CDK4 complex, allowing for unchecked cell cycle progression. Mutations in the second protein coded by CDKN2A, p14ARF, are much less common and result in proteasomal degradation of p53 with subsequent accumulation of DNA damage as the cell progresses through the cell cycle without a functional p53-mediated DNA damage response. Mutations in CDK4 that impair the inhibitory interaction with p16INK4a also increase melanoma risk but these mutations are extremely rare. Genes of the melanin biosynthetic pathway, including MC1R and MITF, have also been implicated in melanomagenesis. MC1R variants were traditionally thought to increase risk for melanoma secondary to intensified UV-mediated DNA damage in the setting of absent photoprotective eumelanin. Accumulation of pheomelanin, which appears to have a carcinogenic effect regardless of UV exposure, may be a more likely mechanism. Impaired SUMOylation of the E318K variant of MITF results in increased transcription of genes that confer melanocytes with a pro-malignant phenotype. Mutations in the tumor suppressor BAP1 enhance the metastatic potential of uveal melanoma and predispose to cutaneous/ocular melanoma, atypical melanocytic tumors, and other internal malignancies (COMMON syndrome). Genome-wide association studies have identified numerous low-risk alleles. Although several melanoma susceptibility genes have been identified, risk assessment tools have been developed only for the most common gene implicated with hereditary melanoma, CDKN2A. MelaPRO, a validated model that relies on Mendelian inheritance and Bayesian probability theories, estimates carrier

  5. Use of interferon-gamma release assays to calculate the annual risk of tuberculosis infection.

    PubMed

    Díez, Nuria; Giner, Empar; Latorre, Irene; Lacoma, Alícia; Roig, Francisco-Javier; Mialdea, Irene; Díaz, Jessica; Serra-Vidal, Mar; Escribano, Amparo; Domínguez, Jose

    2015-02-01

    The objective was to assess the annual risk of tuberculosis infection by means of tuberculin skin testing (TST) in children, evaluating whether QuantiFERON-TB Gold In-Tube (QFN-G-IT) could improve the accuracy. On the basis of the positive TST results, the global annual incidence was estimated at 0.78%, with an increase in the prevalence from 0.64% to 1.68% in 2 years. However, QFN-G-IT was only positive in 6 of the 25 children with positive TST. The confirmation of the positive TST results by QFN-G-IT provided more accurate annual incidence estimation. PMID:25144799

  6. Assessing health risks of synthetic vitreous fibers: an integrative approach.

    PubMed

    McClellan, R O

    1994-12-01

    This paper reviews a tiered approach to acquiring information from multiple experimental systems to understand and assess the potential human health risks of exposure to airborne synthetic fibers. The approach is grounded in the now widely accepted research-risk assessment-risk management paradigm. It involves the acquisition of information that will provide mechanistic linkages within the exposure-dose-response paradigm. It advocates the use of the inhalation route of exposure for developing relevant information for assessing human health risks and calls attention to serious problems encountered using nonphysiologic routes of administration to assess human health risks. PMID:7724844

  7. Radiological risk assessment of environmental radon

    NASA Astrophysics Data System (ADS)

    Khalid, Norafatin; Majid, Amran Ab; Yahaya, Redzuwan; Yasir, Muhammad Samudi

    2013-11-01

    Measurements of radon gas (222Rn) in the environmental are important to assess indoor air quality and to study the potential risk to human health. Generally known that exposure to radon is considered the second leading cause of lung cancer after smoking. The environmental radon concentration depends on the 226Ra concentration, indoor atmosphere, cracking on rocks and building materials. This study was carried out to determine the indoor radon concentration from selected samples of tin tailings (amang) and building materials in an airtight sealed homemade radon chamber. The radiological risk assessment for radon gas was also calculated based on the annual exposure dose, effective dose equivalent, radon exhalation rates and fatal cancer risk. The continuous radon monitor Sun Nuclear model 1029 was used to measure the radon concentration emanates from selected samples for 96 hours. Five types of tin tailings collected from Kampar, Perak and four samples of building materials commonly used in Malaysia dwellings or building constructions were analysed for radon concentration. The indoor radon concentration determined in ilmenite, monazite, struverite, xenotime and zircon samples varies from 219.6 ± 76.8 Bq m-3 to 571.1 ± 251.4 Bq m-3, 101.0 ± 41.0 Bq m-3 to 245.3 ± 100.2 Bq m-3, 53.1 ± 7.5 Bq m-3 to 181.8 ± 9.7 Bq m-3, 256.1 ± 59.3 Bq m-3 to 652.2 ± 222.2 Bq m-3 and 164.5 ± 75.9 Bq m-3 to 653.3 ± 240.0 Bq m-3, respectively. Whereas, in the building materials, the radon concentration from cement brick, red-clay brick, gravel aggregate and cement showed 396.3 ± 194.3 Bq m-3, 192.1 ± 75.4 Bq m-3, 176.1 ± 85.9 Bq m-3 and 28.4 ± 5.7 Bq m-3, respectively. The radon concentration in tin tailings and building materials were found to be much higher in xenotime and cement brick samples than others. All samples in tin tailings were exceeded the action level for radon gas of 148 Bq m-3 proposed by EPA except monazite 0.15 kg, struverite 0.15 kg and 0.25 kg. Whereas

  8. Radiological risk assessment of environmental radon

    SciTech Connect

    Khalid, Norafatin; Majid, Amran Ab; Yahaya, Redzuwan; Yasir, Muhammad Samudi

    2013-11-27

    Measurements of radon gas ({sup 222}Rn) in the environmental are important to assess indoor air quality and to study the potential risk to human health. Generally known that exposure to radon is considered the second leading cause of lung cancer after smoking. The environmental radon concentration depends on the {sup 226}Ra concentration, indoor atmosphere, cracking on rocks and building materials. This study was carried out to determine the indoor radon concentration from selected samples of tin tailings (amang) and building materials in an airtight sealed homemade radon chamber. The radiological risk assessment for radon gas was also calculated based on the annual exposure dose, effective dose equivalent, radon exhalation rates and fatal cancer risk. The continuous radon monitor Sun Nuclear model 1029 was used to measure the radon concentration emanates from selected samples for 96 hours. Five types of tin tailings collected from Kampar, Perak and four samples of building materials commonly used in Malaysia dwellings or building constructions were analysed for radon concentration. The indoor radon concentration determined in ilmenite, monazite, struverite, xenotime and zircon samples varies from 219.6 ± 76.8 Bq m{sup −3} to 571.1 ± 251.4 Bq m{sup −3}, 101.0 ± 41.0 Bq m{sup −3} to 245.3 ± 100.2 Bq m{sup −3}, 53.1 ± 7.5 Bq m{sup −3} to 181.8 ± 9.7 Bq m{sup −3}, 256.1 ± 59.3 Bq m{sup −3} to 652.2 ± 222.2 Bq m{sup −3} and 164.5 ± 75.9 Bq m{sup −3} to 653.3 ± 240.0 Bq m{sup −3}, respectively. Whereas, in the building materials, the radon concentration from cement brick, red-clay brick, gravel aggregate and cement showed 396.3 ± 194.3 Bq m{sup −3}, 192.1 ± 75.4 Bq m{sup −3}, 176.1 ± 85.9 Bq m{sup −3} and 28.4 ± 5.7 Bq m{sup −3}, respectively. The radon concentration in tin tailings and building materials were found to be much higher in xenotime and cement brick samples than others. All samples in tin tailings were exceeded the

  9. Risk assessment of malicious biocontamination of food.

    PubMed

    Elad, Daniel

    2005-06-01

    Throughout the last decades of the 20th century, the biological threat evolved from primarily a government-controlled weapon to a tool of terrorism. One of the consequences of this trend is the near impossibility of foreseeing when and how an act of bioterrorism will occur. The suitability of food products for such an act stems from the multitude of microorganisms that may be used for contamination and the vulnerability of the products during and after processing. Tests that would enable the detection of a large variety of microorganisms quickly, reliably, and economically should also provide satisfactory means to prevent acts of malicious biocontamination of food products. Until such means become available, a priority-based approach to the problem is probably the most practical. Priorities should be determined based on a systematic risk assessment to define the relative likelihood of a certain microorganism being used in an act of malicious food contamination. Criteria to be evaluated are availability, weaponization processes, delivery of an effective dose, probability of early detection, and the microorganism's resistance to the conditions to which it will be exposed. Because the results of such an assessment may vary according to prevailing conditions, the assessment must be based on the existing circumstances. The results of the assessment should then be applied to the various procedures of food processing, which should further reduce the number of potential microbial threats. Existing methods of screening food for contaminating microorganisms and existing food safety and security procedures such as hazard analysis and critical control point programs may have to be modified to become suitable for the detection of acts of bioterrorism. PMID:15954724

  10. Assessing environmental chemicals for estrogenicity using a combination of in vitro and in vivo assays.

    PubMed Central

    Shelby, M D; Newbold, R R; Tully, D B; Chae, K; Davis, V L

    1996-01-01

    Because of rampant concern that estrogenic chemicals in the environment may be adversely affecting the health of humans and wildlife, reliable methods for detecting and characterizing estrogenic chemicals are needed. It is important that general agreement be reached on which tests to use and that these tests then be applied to the testing of both man-made and naturally occurring chemicals. As a step toward developing a comprehensive approach to screening chemicals for estrogenic activity, three assays for detecting estrogenicity were conducted on 10 chemicals with known or suspected estrogenic activity. The assays were 1) competitive binding with the mouse uterine estrogen receptor, 2) transcriptional activation in HeLa cells transfected with plasmids containing an estrogen receptor and a response element, and 3) the uterotropic assay in mice. The chemicals studied were 17 beta-estradiol, diethylstilbestrol, tamoxifen, 4-hydroxytamoxifen, methoxychlor, the methoxychlor metabolite 2,2-bis(p-hydroxyphenyl)-1,1,1-trichloroethane (HPTE), endosulfan, nonylphenol, o,p'-DDT, and kepone. These studies were conducted to assess the utility of this three-assay combination in the routine screening of chemicals, or combinations of chemicals, for estrogenic activity. Results were consistent among the three assays with respect to what is known about the estrogenic activities of the chemicals tested and their requirements for metabolic activation. By providing information on three levels of hormonal activity (receptor binding, transcriptional activation, and an in vivo effect in an estrogen-responsive tissue), an informative profile of estrogenic activity is obtained with a reasonable investment of resources. Images p1296-a Figure 1. Figure 2. Figure 3. Figure 4. Figure 5. PMID:9118870

  11. Performing Probabilistic Risk Assessment Through RAVEN

    SciTech Connect

    A. Alfonsi; C. Rabiti; D. Mandelli; J. Cogliati; R. Kinoshita

    2013-06-01

    The Reactor Analysis and Virtual control ENviroment (RAVEN) code is a software tool that acts as the control logic driver and post-processing engine for the newly developed Thermal-Hydraulic code RELAP-7. RAVEN is now a multi-purpose Probabilistic Risk Assessment (PRA) software framework that allows dispatching different functionalities: Derive and actuate the control logic required to simulate the plant control system and operator actions (guided procedures), allowing on-line monitoring/controlling in the Phase Space Perform both Monte-Carlo sampling of random distributed events and Dynamic Event Tree based analysis Facilitate the input/output handling through a Graphical User Interface (GUI) and a post-processing data mining module

  12. System Analysis and Risk Assessment System.

    Energy Science and Technology Software Center (ESTSC)

    2000-11-20

    Version 00 SARA4.16 is a program that allows the user to review the results of a Probabilistic Risk Assessment (PRA) and to perform limited sensitivity analysis on these results. This tool is intended to be used by a less technical oriented user and does not require the level of understanding of PRA concepts required by a full PRA analysis tool. With this program a user can review the information generated by a PRA analyst andmore » compare the results to those generated by making limited modifications to the data in the PRA. Also included in this program is the ability to graphically display the information stored in the database. This information includes event trees, fault trees, P&IDs and uncertainty distributions. SARA 4.16 is incorporated in the SAPHIRE 5.0 code package.« less

  13. 7 CFR 1730.27 - Vulnerability and Risk Assessment (VRA).

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 11 2011-01-01 2011-01-01 false Vulnerability and Risk Assessment (VRA). 1730.27... Requirements § 1730.27 Vulnerability and Risk Assessment (VRA). (a) Each borrower with an approved RUS electric... destroyed would cause significant risk to the safety and health of the public; (3) Critical assets...

  14. 7 CFR 1730.27 - Vulnerability and Risk Assessment (VRA).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Vulnerability and Risk Assessment (VRA). 1730.27... Requirements § 1730.27 Vulnerability and Risk Assessment (VRA). (a) Each borrower with an approved RUS electric... destroyed would cause significant risk to the safety and health of the public; (3) Critical assets...

  15. Evolutionary Consequences for Ecological Risk Assessment and Management.

    ERIC Educational Resources Information Center

    Gochfeld, Michael; Burger, Joanna

    1993-01-01

    Discusses the use of the human health risk assessment model as a basis for developing ecological risk assessment (ERA). For ERA, risk to individuals is less important than the survival of the population, with the exception of endangered species. Suggests that ERA take into account the relative reproductive value of the potentially impacted…

  16. RISK ASSESSMENT AND MANAGEMENT: FRAMEWORK FOR DECISION MAKING

    EPA Science Inventory

    The risk assessment and risk management initiatives described in this report are tools which will help make possible more efficient protection of the environment and human health. e expect to gain the following specific management advantages: isk assessment and risk management he...

  17. FRAMEWORK FOR INORGANIC METALS RISK ASSESSMENT - 1/2007

    EPA Science Inventory

    The EPA¿s Risk Assessment Forum has prepared a framework to guide risk assessors in assessing human and ecological risks of inorganic metals. Metals and metal compounds have properties not generally encountered with organic chemicals. For example, metals are neither created nor d...

  18. Risk Assessment of the Carbon Nanotube Group

    PubMed Central

    Morimoto, Yasuo; Ogura, Isamu; Kobayashi, Norihiro; Naya, Masato; Ema, Makoto; Endoh, Shigehisa; Shimada, Manabu; Ogami, Akira; Myojyo, Toshihiko; Oyabu, Takako; Gamo, Masashi; Kishimoto, Atsuo; Igarashi, Takuya; Hanai, Sosuke

    2015-01-01

    This study assessed the health risks via inhalation and derived the occupational exposure limit (OEL) for the carbon nanotube (CNT) group rather than individual CNT material. We devised two methods: the integration of the intratracheal instillation (IT) data with the inhalation (IH) data, and the “biaxial approach.” A four‐week IH test and IT test were performed in rats exposed to representative materials to obtain the no observed adverse effect level, based on which the OEL was derived. We used the biaxial approach to conduct a relative toxicity assessment of six types of CNTs. An OEL of 0.03 mg/m3 was selected as the criterion for the CNT group. We proposed that the OEL be limited to 15 years. We adopted adaptive management, in which the values are reviewed whenever new data are obtained. The toxicity level was found to be correlated with the Brunauer‐Emmett‐Teller (BET)‐specific surface area (BET‐SSA) of CNT, suggesting the BET‐SSA to have potential for use in toxicity estimation. We used the published exposure data and measurement results of dustiness tests to compute the risk in relation to particle size at the workplace and showed that controlling micron‐sized respirable particles was of utmost importance. Our genotoxicity studies indicated that CNT did not directly interact with genetic materials. They supported the concept that, even if CNT is genotoxic, it is secondary genotoxicity mediated via a pathway of genotoxic damage resulting from oxidative DNA attack by free radicals generated during CNT‐elicited inflammation. Secondary genotoxicity appears to involve a threshold. PMID:25943334

  19. Inhalation cancer risk assessment of cobalt metal.

    PubMed

    Suh, Mina; Thompson, Chad M; Brorby, Gregory P; Mittal, Liz; Proctor, Deborah M

    2016-08-01

    Cobalt compounds (metal, salts, hard metals, oxides, and alloys) are used widely in various industrial, medical and military applications. Chronic inhalation exposure to cobalt metal and cobalt sulfate has caused lung cancer in rats and mice, as well as systemic tumors in rats. Cobalt compounds are listed as probable or possible human carcinogens by some agencies, and there is a need for quantitative cancer toxicity criteria. The U.S. Environmental Protection Agency has derived a provisional inhalation unit risk (IUR) of 0.009 per μg/m(3) based on a chronic inhalation study of soluble cobalt sulfate heptahydrate; however, a recent 2-year cancer bioassay affords the opportunity to derive IURs specifically for cobalt metal. The mechanistic data support that the carcinogenic mode of action (MOA) is likely to involve oxidative stress, and thus, non-linear/threshold mechanisms. However, the lack of a detailed MOA and use of high, toxic exposure concentrations in the bioassay (≥1.25 mg/m(3)) preclude derivation of a reference concentration (RfC) protective of cancer. Several analyses resulted in an IUR of 0.003 per μg/m(3) for cobalt metal, which is ∼3-fold less potent than the provisional IUR. Future research should focus on establishing the exposure-response for key precursor events to improve cobalt metal risk assessment. PMID:27177823

  20. Ecotoxicological and analytical assessment of hydrocarbon-contaminated soils and application to ecological risk assessment

    SciTech Connect

    Saterbak, A.; Toy, R.J.; Wong, D.C.L.; McMain, B.J.; Williams, M.P.; Dorn, P.B.; Brzuzy, L.P.; Chai, E.Y.; Salanitro, J.P.

    1999-07-01

    Ecotoxicological assessments of contaminated soil aim to understand the effect of introduced chemicals on the soil flora and fauna. Ecotoxicity test methods were developed and conducted on hydrocarbon-contaminated soils and on adjacent uncontaminated control soils from eight field locations. Tests included 7-d, 14-d, and chronic survival tests and reproduction assays for the earthworm (Eisenia fetida) and seed germination, root length, and plant growth assays for corn, lettuce, mustard, and wheat. Species-specific responses were observed with no-observed effect concentrations (NOECs) ranging from <1 to 100% contaminated soil. The 14-d earthworm survival NOEC was equal to or greater than the reproduction NOEC values for numbers of cocoons and juveniles, which were similar to one another. Cocoon and juvenile production varied among the control soils. Germination and root length NOECs for mustard and lettuce were less than NOECs for corn and wheat. Root length NOECs were similar to or less than seed germination NOECs. Statistically significant correlations for earthworm survival and seed germination as a function of hydrocarbon measurements were found. The 14-d earthworm survival and the seed germination tests are recommended for use in the context of a risk-based framework for the ecological assessment of contaminated sites.

  1. Steroid hormone measurements from different types of assays in relation to body mass index and breast cancer risk in postmenopausal women: Reanalysis of eighteen prospective studies.

    PubMed

    Key, T J; Appleby, P N; Reeves, G K; Travis, R C; Brinton, L A; Helzlsouer, K J; Dorgan, J F; Gapstur, S M; Gaudet, M M; Kaaks, R; Riboli, E; Rinaldi, S; Manjer, J; Hallmans, G; Giles, G G; Le Marchand, L; Kolonel, L N; Henderson, B E; Tworoger, S S; Hankinson, S E; Zeleniuch-Jacquotte, A; Koenig, K; Krogh, V; Sieri, S; Muti, P; Ziegler, R G; Schairer, C; Fuhrman, B J; Barrett-Connor, E; Laughlin, G A; Grant, E J; Cologne, J; Ohishi, W; Hida, A; Cauley, J A; Fourkala, E O; Menon, U; Rohan, T E; Strickler, H D; Gunter, M J

    2015-07-01

    Epidemiological studies have examined breast cancer risk in relation to sex hormone concentrations measured by different methods: "extraction" immunoassays (with prior purification by organic solvent extraction, with or without column chromatography), "direct" immunoassays (no prior extraction or column chromatography), and more recently with mass spectrometry-based assays. We describe the associations of estradiol, estrone and testosterone with both body mass index and breast cancer risk in postmenopausal women according to assay method, using data from a collaborative pooled analysis of 18 prospective studies. In general, hormone concentrations were highest in studies that used direct assays and lowest in studies that used mass spectrometry-based assays. Estradiol and estrone were strongly positively associated with body mass index, regardless of the assay method; testosterone was positively associated with body mass index for direct assays, but less clearly for extraction assays, and there were few data for mass spectrometry assays. The correlations of estradiol with body mass index, estrone and testosterone were lower for direct assays than for extraction and mass spectrometry assays, suggesting that the estimates from the direct assays were less precise. For breast cancer risk, all three hormones were strongly positively associated with risk regardless of assay method (except for testosterone by mass spectrometry where there were few data), with no statistically significant differences in the trends, but differences may emerge as new data accumulate. Future epidemiological and clinical research studies should continue to use the most accurate assays that are feasible within the design characteristics of each study. PMID:25304359

  2. Dietary risk assessment of spinosad in China.

    PubMed

    Gao, Renjun; Dong, Jing; Zhang, Wenji; Chen, William L

    2007-10-01

    Spinosad is an insect control agent that is derived from a naturally occurring soil bacterium, and is effective on several classes of insects, especially Lepidoptera larvae. Spinosad consists mainly of a mixture of spinosyns A and D and is registered for uses on a variety of crops in many countries including China. In order to understand the residue behavior of spinosad and to evaluate the dietary risk of spinosad residue in food in China, a number of residue studies were conducted on cotton, Chinese cabbage and eggplant. Residue detection methods using high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection have been validated for the detection of spinosad and its metabolites in cotton, Chinese cabbage and eggplant. The proposed definition of the residue for the estimation of spinosad dietary intake is the sum of spinosyns A and D. According to existing Chinese residue studies, the Supervised Trials Median Residues (STMRs) for cotton seed, Chinese cabbage and eggplant were less than 0.010, 0.103 and 0.045 mg/kg, respectively. Daily intake of spinosad residue in food was calculated by multiplying the pertinent Chinese food consumption data with the STMRs. Establishment of spinosad acceptable daily intake (ADI) of 0-0.02 mg/kg bw was based on a No Observed Adverse Effect Level (NOAEL) of 2.4 mg/kg bw per day and a 100-fold safety factor. Therefore, only 2% of the spinosad ADI is occupied by spinosad dietary daily intake in the Chinese population. The proposed maximum residue limits (MRLs) for spinosad on cotton seed, Chinese cabbage and eggplant are 0.01, 2 and 0.5 mg/kg, respectively. Although the STMRs for cotton and Chinese cabbage are lower or equal to STMRs used by Codex, no STMR for eggplant was used by Joint Meeting on Pesticide Residues (JMPR) when dietary risk assessment was carried out for spinosad. If these Chinese residue studies were considered during the Codex risk assessment process, the International Estimate Daily Intakes

  3. EUROarray human papillomavirus (HPV) assay is highly concordant with other commercial assays for detection of high-risk HPV genotypes in women with high grade cervical abnormalities.

    PubMed

    Cornall, A M; Poljak, M; Garland, S M; Phillips, S; Machalek, D A; Tan, J H; Quinn, M A; Tabrizi, S N

    2016-06-01

    The purpose of this study was to evaluate the performance of the EUROIMMUN EUROArray HPV genotyping assay against the Roche Cobas 4800, Roche HPV Amplicor, Roche Linear Array and Qiagen Hybrid Capture 2 assays in the detection of high-risk HPV (HR-HPV) from liquid based cervical cytology samples collected from women undergoing follow-up for abnormal cervical cytology results. Cervical specimens from 404 women undergoing management of high-grade cytological abnormality were evaluated by EUROarray HPV for detection of HR-HPV genotypes and prediction of histologically-confirmed cervical intraepithelial neoplasia grade 2 or higher (≥CIN2). The results were compared to Hybrid Capture 2, Cobas 4800 HPV, Amplicor and Linear Array HPV. Positivity for 14 HR-HPV types was 80.0 % for EUROarray (95 % CI; 75.7-83.8 %). Agreement (κ, 95 % CI) between the EUROarray and other HPV tests for detection of HR-HPV was good to very good [Hybrid Capture κ = 0.62 (0.54-0.71); Cobas κ = 0.81 (0.74-0.88); Amplicor κ = 0.68 (0.60-0.77); Linear Array κ = 0.77 (0.70-0.85)]. For detection of HR-HPV, agreement with EUROarray was 87.90 % (Hybrid Capture), 93.58 % (Cobas), 92.84 % (Amplicor) and 92.59 % (Linear Array). Detection of HR-HPV was not significantly different between EUROarray and any other test (p < 0.001). EUROarray was concordant with other assays evaluated for detection of high-risk HPV and showed sensitivity and specificity for detection of ≥ CIN2 of 86 % and 71 %, respectively. PMID:27048314

  4. Gasbuggy Site Assessment and Risk Evaluation

    SciTech Connect

    2011-03-01

    contaminant exposure scenario, drilling of natural gas wells near the site. The results of this risk evaluation will guide DOE's future surveillance and monitoring activities in the area to ensure that site conditions are adequately protective of human health. This evaluation is not a comprehensive risk assessment for the site; it is intended to provide assurance that DOE's monitoring approach can detect the presence of site-related contamination at levels well below those that would pose an unacceptable risk to human health.

  5. Health Risk Assessment of Irradiated Topaz

    NASA Astrophysics Data System (ADS)

    Nelson, Kevin Lyle

    1991-06-01

    Radiation-produced blue topaz, indistinguishable from natural blue topaz, is produced by several different techniques. Published information on radionuclides present, activity levels, equipment necessary to detect activated nuclides and dosimetric assessment is lacking. Using a 60 megawatt nuclear reactor, fifty-one samples of colorless topaz from Nigeria, Sri Lanka, India and Brazil were irradiated with thermal and fast neutron fluences ranging from 1.8 times 10 13 to 9.2 times 1018 neutrons cm^{-2}. Seventeen MeV electrons produced by a linear accelerator were also used to irradiate 36 colorless topaz from the same countries. Gamma ray or positron-emitting nuclides were identified using calibrated well-type NaI or germanium detectors. For germanium detectors having relative efficiencies of approximately 20 percent, an analysis time of one hour or more was needed. Geiger Mueller (G-M) detectors, scintillators (plastic and liquid), gas flow proportional counters, a ZnS detector and autoradiography techniques were used to measure charged particle activity. Isotopes produced from neutron activation included 182Ta, ^ {59}Fe, 46Sc, 51Cr, 54Mn, 124Sb, ^{32 }P, 77As, ^ {183}Ta, 77Ge, 72Ga, and ^{24 }Na. Possible nuclides produced from 17 MeV electron treatment include ^{68 }Ga, 64Cu, ^ {49}Cr, and 18F. Positive identification of the electron activated nuclides was not possible because of the short half-lives involved (<1 day). Of the possible pure beta emitters activated during neutron bombardment, 32P and 35S are the most likely to be produced. The identification of 32P was made using a three point beta absorption analysis with a G-M detector. Skin and breast cancer risk estimates were calculated for various sized topaz containing NRC exempt concentration levels. When compared to a negligible individual risk level (NIRL) of 10^{-7}, the risk of an irradiated topaz in contact with the skin or three inches from breast tissue was a small fraction of the NIRL. At a risk

  6. Issues in Violent Risk Assessment: Lessons Learned and Future Directions

    ERIC Educational Resources Information Center

    Kroner, Daryl G.

    2005-01-01

    Realizing that the assessment of dangerousness with a yes/no format as a poor form of violent risk assessment has been the most important lesson learned about violence in the last 20 years. Further examining (a) what outcome and (b) how the indicators of the outcome should be measured has resulted in better violent risk assessment. The most…

  7. The Process of Suicide Risk Assessment: Twelve Core Principles

    ERIC Educational Resources Information Center

    Granello, Darcy Haag

    2010-01-01

    Suicide risk assessment requires counselors to determine client risk factors, warning signs, and protective factors. The content of suicide assessment has received attention in the literature. The guiding principles of the process of suicide assessment, however, have not yet been articulated. This article contains 12 core process principles that…

  8. Falls risk assessment in older patients in hospital.

    PubMed

    Matarese, Maria; Ivziku, Dhurata

    2016-07-27

    Falls are the most frequent adverse event reported in hospitals, usually affecting older patients. All hospitals in NHS organisations develop risk prevention policies that include falls risk assessment. Falls risk assessment involves the use of risk screening tools, aimed at identifying patients at increased risk of falls, and risk assessment tools, which identify a patient's risk factors for falls. Various risk screening tools have been used in clinical practice, but no single tool is able to identify all patients at risk of falls or to accurately exclude all those who are not at risk of falls. Guidelines recommend that patients aged 65 years and over who are admitted to hospital should be considered at high risk of falls and that a multifactorial falls risk assessment should be performed. Therefore, falls risk assessment tools should be used to identify the risk factors for each inpatient aged 65 years or over, in order to determine the most appropriate care plan for falls prevention and to maximise patient mobility and independence. PMID:27461329

  9. 49 CFR Appendix B to Part 236 - Risk Assessment Criteria

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... to have a high degree of confidence. (b) How does the risk assessment handle interaction risks for... availability calculations for subsystems and components, Fault Tree Analysis (FTA) of the subsystems,...

  10. 49 CFR Appendix B to Part 236 - Risk Assessment Criteria

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... to have a high degree of confidence. (b) How does the risk assessment handle interaction risks for... availability calculations for subsystems and components, Fault Tree Analysis (FTA) of the subsystems,...

  11. 49 CFR Appendix B to Part 236 - Risk Assessment Criteria

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... to have a high degree of confidence. (b) How does the risk assessment handle interaction risks for... availability calculations for subsystems and components, Fault Tree Analysis (FTA) of the subsystems,...

  12. Breast Cancer Risk Assessment SAS Macro (Gail Model)

    Cancer.gov

    A SAS macro (commonly referred to as the Gail Model) that projects absolute risk of invasive breast cancer according to NCI’s Breast Cancer Risk Assessment Tool (BCRAT) algorithm for specified race/ethnic groups and age intervals.

  13. FRAMEWORK FOR CUMULATIVE RISK ASSESSMENT (EXTERNAL REVIEW DRAFT)

    EPA Science Inventory

    Several reports have highlighted the importance of understanding the accumulation of risks from multiple environmental stressors. These include the National Research Councils 1994 report Science and Judgment in Risk Assessment and the 1997 report by the Presidential/Congressional...

  14. Statistical problems in the assessment of nuclear risks

    SciTech Connect

    Easterling, R. G.

    1980-01-01

    Information on nuclear power plant risk assessment is presented concerning attitudinal problems; and methodological problems involving expert opinions, human error probabilities, nonindependent events, uncertainty analysis, and acceptable risk criteria.

  15. The kSORT Assay to Detect Renal Transplant Patients at High Risk for Acute Rejection: Results of the Multicenter AART Study

    PubMed Central

    Hsieh, Sue; Dai, Hong; Bestard, Oriol; Metes, Diana; Zeevi, Andrea; Gritsch, Albin; Cheeseman, Jennifer; Macedo, Camila; Peddy, Ram; Medeiros, Mara; Vincenti, Flavio; Asher, Nancy; Salvatierra, Oscar; Shapiro, Ron; Kirk, Allan; Reed, Elaine; Sarwal, Minnie M.

    2014-01-01

    Background Development of noninvasive molecular assays to improve disease diagnosis and patient monitoring is a critical need. In renal transplantation, acute rejection (AR) increases the risk for chronic graft injury and failure. Noninvasive diagnostic assays to improve current late and nonspecific diagnosis of rejection are needed. We sought to develop a test using a simple blood gene expression assay to detect patients at high risk for AR. Methods and Findings We developed a novel correlation-based algorithm by step-wise analysis of gene expression data in 558 blood samples from 436 renal transplant patients collected across eight transplant centers in the US, Mexico, and Spain between 5 February 2005 and 15 December 2012 in the Assessment of Acute Rejection in Renal Transplantation (AART) study. Gene expression was assessed by quantitative real-time PCR (QPCR) in one center. A 17-gene set—the Kidney Solid Organ Response Test (kSORT)—was selected in 143 samples for AR classification using discriminant analysis (area under the receiver operating characteristic curve [AUC] = 0.94; 95% CI 0.91–0.98), validated in 124 independent samples (AUC = 0.95; 95% CI 0.88–1.0) and evaluated for AR prediction in 191 serial samples, where it predicted AR up to 3 mo prior to detection by the current gold standard (biopsy). A novel reference-based algorithm (using 13 12-gene models) was developed in 100 independent samples to provide a numerical AR risk score, to classify patients as high risk versus low risk for AR. kSORT was able to detect AR in blood independent of age, time post-transplantation, and sample source without additional data normalization; AUC = 0.93 (95% CI 0.86–0.99). Further validation of kSORT is planned in prospective clinical observational and interventional trials. Conclusions The kSORT blood QPCR assay is a noninvasive tool to detect high risk of AR of renal transplants. Please see later in the article for the Editors' Summary PMID

  16. Population-scale assessment endpoints in ecological risk assessment. Part 1: Reflections of stakeholder values.

    PubMed

    Landis, Wayne G

    2006-01-01

    The selection of appropriate assessment endpoints is a basic element of an ecological risk assessment, especially at regional or watershed scales. Because ecological services often are tied to specific species, the risk to populations is a critical endpoint and feature of ecological risk assessments. The first item is a discussion of the replacement of population-level risk assessment with the construct of a population-scale assessment endpoint. Next, the criteria that are currently used for assessment endpoints are reviewed and evaluated for utility in an ecological risk assessment. Following this examination, assessment endpoints from a number of regional-scale ecological risk assessments are compared. The outcome of this evaluation is that population-scale assessment endpoints are important expressions of the valued components of ecological structures. Finally, a few recommendations for the selection of assessment endpoints at a population scale are listed. PMID:16640323

  17. Dynamic Attack Tree Tool for Risk Assessments

    Energy Science and Technology Software Center (ESTSC)

    2012-03-13

    DATT enables interactive visualization, qualitative analysis and recording of cyber and other forms of risk. It facilitates dynamic risk-based approaches (as opposed to static compliance-based) to security and risk management in general. DATT allows decision makers to consistently prioritize risk mitigation strategies and quickly see where attention is most needed across the enterprise.

  18. Improving uncertainty analysis in European Union risk assessment of chemicals.

    PubMed

    Verdonck, Frederik A M; Souren, Astrid; van Asselt, Marjolein B A; Van Sprang, Patrick A; Vanrolleghem, Peter A

    2007-07-01

    Handling uncertainty in curren European Union (EU) risk assessment of new and existing substances is problematic for several reasons. The known or quantifiable sources of uncertainty are mainly considered. Uncertainty is insufficiently, explicitly communicated to risk managers and decision makers but hidden and concealed in risk quotient numbers that appear to be certain and, therefore, create a false sense of certainty and protectiveness. The new EU chemical policy legislation, REACH, is an opportunity to learn from interdisciplinary thinking in order to evolve to smart risk assessment: an assessment in which awareness and openness to uncertainty is used to produce better characterizations and evaluations of risks. In a smart risk assessment context, quantifying uncertainty is not an aim but just a productive means to refine the assessment or to find alternative solutions for the problem at stake. Guidance and examples are given on how to differentiate, assess, and use uncertainty. PMID:17695106

  19. Reference manual for toxicity and exposure assessment and risk characterization. CERCLA Baseline Risk Assessment

    SciTech Connect

    1995-03-01

    The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, 1980) (CERCLA or Superfund) was enacted to provide a program for identifying and responding to releases of hazardous substances into the environment. The Superfund Amendments and Reauthorization Act (SARA, 1986) was enacted to strengthen CERCLA by requiring that site clean-ups be permanent, and that they use treatments that significantly reduce the volume, toxicity, or mobility of hazardous pollutants. The National Oil and Hazardous Substances Pollution Contingency Plan (NCP) (USEPA, 1985; USEPA, 1990) implements the CERCLA statute, presenting a process for (1) identifying and prioritizing sites requiring remediation and (2) assessing the extent of remedial action required at each site. The process includes performing two studies: a Remedial Investigation (RI) to evaluate the nature, extent, and expected consequences of site contamination, and a Feasibility Study (FS) to select an appropriate remedial alternative adequate to reduce such risks to acceptable levels. An integral part of the RI is the evaluation of human health risks posed by hazardous substance releases. This risk evaluation serves a number of purposes within the overall context of the RI/FS process, the most essential of which is to provide an understanding of ``baseline`` risks posed by a given site. Baseline risks are those risks that would exist if no remediation or institutional controls are applied at a site. This document was written to (1) guide risk assessors through the process of interpreting EPA BRA policy and (2) help risk assessors to discuss EPA policy with regulators, decision makers, and stakeholders as it relates to conditions at a particular DOE site.

  20. Quantification of cerivastatin toxicity supports organismal performance assays as an effective tool during pharmaceutical safety assessment.

    PubMed

    Gaukler, Shannon M; Ruff, James S; Galland, Tessa; Underwood, Tristan K; Kandaris, Kirstie A; Liu, Nicole M; Morrison, Linda C; Veranth, John M; Potts, Wayne K

    2016-06-01

    A major problem in pharmaceutical development is that adverse effects remain undetected during preclinical and clinical trials, but are later revealed after market release when prescribed to many patients. We have developed a fitness assay known as the organismal performance assay (OPA), which evaluates individual performance by utilizing outbred wild mice (Mus musculus) that are assigned to an exposed or control group, which compete against each other for resources within semi-natural enclosures. Performance measurements included reproductive success, survival, and male competitive ability. Our aim was to utilize cerivastatin (Baycol(®), Bayer), a pharmaceutical with known adverse effects, as a positive control to assess OPAs as a potential tool for evaluating the safety of compounds during preclinical trials. Mice were exposed to cerivastatin (~4.5 mg/kg/day) into early adulthood. Exposure ceased and animals were released into semi-natural enclosures. Within enclosures, cerivastatin-exposed females had 25% fewer offspring and cerivastatin-exposed males had 10% less body mass, occupied 63% fewer territories, sired 41% fewer offspring, and experienced a threefold increase in mortality when compared to controls. OPAs detected several cerivastatin-induced adverse effects indicating that fitness assays, commonly used in ecology and evolutionary biology, could be useful as an additional tool in safety testing during pharmaceutical development. PMID:27247619

  1. The acute extracellular flux (XF) assay to assess compound effects on mitochondrial function.

    PubMed

    Wang, Ruolan; Novick, Steven J; Mangum, James B; Queen, Kennedy; Ferrick, David A; Rogers, George W; Stimmel, Julie B

    2015-03-01

    Numerous investigations have linked mitochondrial dysfunction to adverse health outcomes and drug-induced toxicity. The pharmaceutical industry is challenged with identifying mitochondrial liabilities earlier in drug development and thereby reducing late-stage attrition. Consequently, there is a demand for reliable, higher-throughput screening methods for assessing the impact of drug candidates on mitochondrial function. The extracellular flux (XF) assay described here is a plate-based method in which galactose-conditioned HepG2 cells were acutely exposed to test compounds, then real-time changes in the oxygen consumption rate and extracellular acidification rate were simultaneously measured using a Seahorse Bioscience XF-96 analyzer. The acute XF assay was validated using marketed drugs known to modulate mitochondrial function, and data analysis was automated using a spline curve fitting model developed at GlaxoSmithKline. We demonstrate that the acute XF assay is a robust, sensitive screening platform for evaluating drug-induced effects on mitochondrial activity in whole cells. PMID:25381255

  2. Assessment of phenolic herbicide toxicity and mode of action by different assays.

    PubMed

    Bettiol, Cinzia; De Vettori, Stefania; Minervini, Giovanni; Zuccon, Elisa; Marchetto, Davide; Ghirardini, Annamaria Volpi; Argese, Emanuele

    2016-04-01

    A phytotoxicity assay based on seed germination/root elongation has been optimized and used to evaluate the toxic effects of some phenolic herbicides. The method has been improved by investigating the influence of experimental conditions. Lepidium sativum was chosen as the most suitable species, showing high germinability, good repeatability of root length measurements, and low sensitivity to seed pretreatment. DMSO was the most appropriate solvent carrier for less water-soluble compounds. Three dinitrophenols and three hydroxybenzonitriles were tested: dinoterb, DNOC, 2,4-dinitrophenol, chloroxynil, bromoxynil, and ioxynil. Toxicity was also determined using the Vibrio fischeri Microtox® test, and a highly significant correlation was found between EC50 values obtained by the two assays. Dinoterb was the most toxic compound. The toxicity of hydroxybenzonitriles followed the order: ioxynil >bromoxynil >chloroxynil; L. sativum exhibited a slightly higher sensitivity than V. fischeri to these compounds. A QSAR analysis highlighted the importance of hydrophobic, electronic, and hydrogen-bonding interactions, in accordance with a mechanism of toxic action based on protonophoric uncoupling of oxidative phosphorylation. The results suggest that the seed germination/root elongation assay with L. sativum is a valid tool for the assessment of xenobiotic toxicity and can be recommended as part of a test battery. PMID:26695414

  3. Identification and assessment of endocrine disruptors: limitations of in vivo and in vitro assays.

    PubMed Central

    Zacharewski, T

    1998-01-01

    It has been suggested that chemicals and complex mixtures capable of modulating the endocrine system may contribute to adverse health, reproduction, and developmental effects in humans and wildlife. These effects include increased incidence of hormone-dependent cancers, compromised reproductive fitness, and abnormal reproductive system development. In response to public concern, regulatory agencies in North America and Europe are formulating potential strategies to systematically test chemicals and complex mixtures for their endocrine-disrupting activities. Because of the complexity of the endocrine system and the number of potential endocrine disruptor targets, a tiered approach involving a complementary battery of short- and long-term in vivo and in vitro assays that assesses both receptor and nonreceptor-mediated mechanisms of action is being considered. However, the available established assays use a limited number of end points, and significant information gaps exist for other potential targets in the endocrine system. In addition to discussing the merits and limitations of the assays that may be adopted, this paper also highlights potential problems associated with the use of a tiered testing strategy. PMID:9599705

  4. Validation of a fecal glucocorticoid metabolite assay to assess stress in the budgerigar (Melopsittacus undulatus).

    PubMed

    Young, Anna M; Hallford, Dennis M

    2013-01-01

    The budgerigar (Melopsittacus undulatus) is a small parrot native to Australia that is commonly held in zoos, laboratories, and private homes. Assessment of budgerigar stress levels would aid welfare monitoring and improve our understanding of their biology. Analyzing fecal glucocorticoid metabolites provides a noninvasive method to measure stress levels in birds. For this method to be reliable, the antibody to be used in an immunoassay must be carefully selected for each species, and validation must be performed. A common limitation in many existing assays is the inability to accurately detect variable fecal glucocorticoid metabolites in minute quantities of feces, requiring small samples to be combined. We have developed a double antibody radioimmunoassay protocol based on a commercially available (125) I-corticosterone radioimmunoassay kit for use in detecting fecal glucocorticoid metabolites in small quantities (<20 mg) of budgerigar droppings. The assay was validated pharmacologically with an adrenocorticotropic hormone challenge and with oral administration of corticosterone. Our validation has demonstrated our assay is both sensitive and a reliable approach to noninvasive monitoring of stress in budgerigars. PMID:22907869

  5. Validation of a fecal glucocorticoid metabolite assay to assess stress in the budgerigar (Melopsittacus undulatus)

    PubMed Central

    Young, Anna M.; Hallford, Dennis M.

    2012-01-01

    The budgerigar (Melopsittacus undulatus) is a small parrot native to Australia that is commonly held in zoos, laboratories, and private homes. Assessment of budgerigar stress levels would aid welfare monitoring and improve our understanding of their biology. Analyzing fecal glucocorticoid metabolites provides a non-invasive method to measure stress levels in birds. For this method to be reliable, the antibody to be used in an immunoassay must be carefully selected for each species, and validation must be performed. A common limitation in many existing assays is the inability to accurately detect variable fecal glucocorticoid metabolites levels in minute quantities of feces, requiring small samples to be combined. We have developed a double antibody radioimmunoassay protocol based on a commercially available 125I-corticosterone radioimmunoassay kit for use in detecting fecal glucocorticoid metabolites in small quantities (< 20 mg) of budgerigar droppings. The assay was validated pharmacologically with an adrenocorticotropic hormone challenge and with oral administration of corticosterone. Our validation has demonstrated our assay is both sensitive and a reliable approach to non-invasive monitoring of stress in budgerigars. PMID:22907869

  6. Assessing human health risk in the USDA forest service

    SciTech Connect

    Hamel, D.R.

    1990-12-31

    This paper identifies the kinds of risk assessments being done by or for the US Department of Agriculture (USDA) Forest Service. Summaries of data sources currently in use and the pesticide risk assessments completed by the agency or its contractors are discussed. An overview is provided of the agency`s standard operating procedures for the conduct of toxicological, ecological, environmental fate, and human health risk assessments.

  7. [Research progress on index system of regional ecological risk assessment].

    PubMed

    Meng, Ji-Jun; Zhao, Chun-Hong

    2009-04-01

    Regional ecological risk assessment (RERA) covers the assessments of multiple risk sources, receptors, and endpoints, while the selection of assessment indices is quite complicated, being a hotspot in regional environment management research. Domestic and international researches on RERA revealed that three processes in RERA are of vital, i.e., risk probability assessment measured by risk probability index, status and value assessment of ecosystem at regional scale indicated by ecological index, and vulnerability assessment of each ecosystem in a region under risk measured by vulnerability index. The main problems in the establishment of RERA index system are the strong subjectivity and poor comparability, and thus, the index system should be set up in the three key processes under the principles of objectivity, integration, hierarchy, and comparability. Due to the fact that the status and value assessment of ecosystem is most complicated, the index system should be formulated by compulsory and optional components to increase the comparability of RERA results between regions. PMID:19565785

  8. Validity of Thermal Ramping Assays Used to Assess Thermal Tolerance in Arthropods

    PubMed Central

    Overgaard, Johannes; Kristensen, Torsten Nygaard; Sørensen, Jesper Givskov

    2012-01-01

    Proper assessment of environmental resistance of animals is critical for the ability of researchers to understand how variation in environmental conditions influence population and species abundance. This is also the case for studies of upper thermal limits in insects, where researchers studying animals under laboratory conditions must select appropriate methodology on which conclusions can be drawn. Ideally these methods should precisely estimate the trait of interest and also be biological meaningful. In an attempt to develop such tests it has been proposed that thermal ramping assays are useful assays for small insects because they incorporate an ecologically relevant gradual temperature change. However, recent model-based papers have suggested that estimates of thermal resistance may be strongly confounded by simultaneous starvation and dehydration stress. In the present study we empirically test these model predictions using two sets of independent experiments. We clearly demonstrate that results from ramping assays of small insects (Drosophila melanogaster) are not compromised by starvation- or dehydration-stress. Firstly we show that the mild disturbance of water and energy balance of D. melanogaster experienced during the ramping tests does not confound heat tolerance estimates. Secondly we show that flies pre-exposed to starvation and dehydration have “normal” heat tolerance and that resistance to heat stress is independent of the energetic and water status of the flies. On the basis of our results we discuss the assumptions used in recent model papers and present arguments as to why the ramping assay is both a valid and ecologically relevant way to measure thermal resistance in insects. PMID:22427876

  9. Assessment of Dextran Antigenicity of Intravenous Iron Preparations with Enzyme-Linked Immunosorbent Assay (ELISA)

    PubMed Central

    Neiser, Susann; Koskenkorva, Taija S.; Schwarz, Katrin; Wilhelm, Maria; Burckhardt, Susanna

    2016-01-01

    Intravenous iron preparations are typically classified as non-dextran-based or dextran/dextran-based complexes. The carbohydrate shell for each of these preparations is unique and is key in determining the various physicochemical properties, the metabolic pathway, and the immunogenicity of the iron-carbohydrate complex. As intravenous dextran can cause severe, antibody-mediated dextran-induced anaphylactic reactions (DIAR), the purpose of this study was to explore the potential of various intravenous iron preparations, non-dextran-based or dextran/dextran-based, to induce these reactions. An IgG-isotype mouse monoclonal anti-dextran antibody (5E7H3) and an enzyme-linked immunosorbent assay (ELISA) were developed to investigate the dextran antigenicity of low molecular weight iron dextran, ferumoxytol, iron isomaltoside 1000, ferric gluconate, iron sucrose and ferric carboxymaltose, as well as isomaltoside 1000, the isolated carbohydrate component of iron isomaltoside 1000. Low molecular weight iron dextran, as well as dextran-based ferumoxytol and iron isomaltoside 1000, reacted with 5E7H3, whereas ferric carboxymaltose, iron sucrose, sodium ferric gluconate, and isolated isomaltoside 1000 did not. Consistent results were obtained with reverse single radial immunodiffusion assay. The results strongly support the hypothesis that, while the carbohydrate alone (isomaltoside 1000) does not form immune complexes with anti-dextran antibodies, iron isomaltoside 1000 complex reacts with anti-dextran antibodies by forming multivalent immune complexes. Moreover, non-dextran based preparations, such as iron sucrose and ferric carboxymaltose, do not react with anti-dextran antibodies. This assay allows to assess the theoretical possibility of a substance to induce antibody-mediated DIARs. Nevertheless, as this is only one possible mechanism that may cause a hypersensitivity reaction, a broader set of assays will be required to get an understanding of the mechanisms that may

  10. Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.

    PubMed

    Vaithianathan, Soundarya; Raman, Siddarth; Jiang, Wenlei; Ting, Tricia Y; Kane, Maureen A; Polli, James E

    2015-07-01

    The therapeutic equivalence of generic and brand name antiepileptic drugs has been questioned by neurologists and the epilepsy community. A potential contributor to such concerns is pharmaceutical quality. The objective was to assess the biopharmaceutic risk of brand name Lamictal 100 mg tablets and generic lamotrigine 100 mg tablets from several manufacturers. Lamotrigine was characterized in terms of the Biopharmaceutics Classification System (BCS), including aqueous solubility and Caco-2 permeability. A panel of pharmaceutical quality tests was also performed on three batches of Lamictal, three batches of Teva generic, and one batch of each of four other generics: appearance, identity, assay, impurity, uniformity of dosage units, disintegration, dissolution, friability, and loss on drying. These market surveillance results indicate that all brand name and generic lamotrigine 100 mg tablets passed all tests and showed acceptable pharmaceutical quality and low biopharmaceutic risk. Lamotrigine was classified as a BCS class IIb drug, exhibiting pH-dependent aqueous solubility and dissolution. At pH 1.2 and 4.5, lamotrigine exhibited high solubility, whereas lamotrigine exhibited low solubility at pH 6.8, including non-sink dissolution. Lamotrigine showed high Caco-2 permeability. The apparent permeability (Papp) of lamotrigine was (73.7 ± 8.7) × 10(-6) cm/s in the apical-to-basolateral (AP-BL) direction and (41.4 ± 1.6) × 10(-6) cm/s in the BL-AP direction, which were higher than metoprolol's AP-BL Papp of (21.2 ± 0.9) × 10(-6) cm/s and BL-AP Papp of (34.6 ± 4.6) × 10(-6) cm/s. Overall, lamotrigine's favorable biopharmaceutics from a drug substance perspective and favorable quality characteristics from a tablet formulation perspective suggest that multisource lamotrigine tablets exhibit a low biopharmaceutic risk. PMID:26001027

  11. Risk assessment and toxicology databases for health effects assessment

    SciTech Connect

    Lu, P.Y.; Wassom, J.S.

    1990-12-31

    Scientific and technological developments bring unprecedented stress to our environment. Society has to predict the results of potential health risks from technologically based actions that may have serious, far-reaching consequences. The potential for error in making such predictions or assessment is great and multiplies with the increasing size and complexity of the problem being studied. Because of this, the availability and use of reliable data is the key to any successful forecasting effort. Scientific research and development generate new data and information. Much of the scientific data being produced daily is stored in computers for subsequent analysis. This situation provides both an invaluable resource and an enormous challenge. With large amounts of government funds being devoted to health and environmental research programs and with maintenance of our living environment at stake, we must make maximum use of the resulting data to forecast and avert catastrophic effects. Along with the readily available. The most efficient means of obtaining the data necessary for assessing the health effects of chemicals is to utilize applications include the toxicology databases and information files developed at ORNL. To make most efficient use of the data/information that has already been prepared, attention and resources should be directed toward projects that meticulously evaluate the available data/information and create specialized peer-reviewed value-added databases. Such projects include the National Library of Medicine`s Hazardous Substances Data Bank, and the U.S. Air Force Installation Restoration Toxicology Guide. These and similar value-added toxicology databases were developed at ORNL and are being maintained and updated. These databases and supporting information files, as well as some data evaluation techniques are discussed in this paper with special focus on how they are used to assess potential health effects of environmental agents. 19 refs., 5 tabs.

  12. Cancer Risk Assessment for Space Radiation

    NASA Technical Reports Server (NTRS)

    Richmond, Robert C.; Curreri, Peter A. (Technical Monitor)

    2002-01-01

    is predominantly used for assessing cancer risk caused by space radiation, and that is the Japanese atomic bomb survivors. Fact #2: The atomic-bomb-survivor database, itself a remarkable achievement, contains uncertainties. These include the actual exposure to each individual, the radiation quality of that exposure, and the fact that the exposure was to acute doses of predominantly low-LET radiation, not to chronic exposures of high-LET radiation expected on long-duration interplanetary manned missions.

  13. An Integrated Approach to Risk Assessment for Concurrent Design

    NASA Technical Reports Server (NTRS)

    Meshkat, Leila; Voss, Luke; Feather, Martin; Cornford, Steve

    2005-01-01

    This paper describes an approach to risk assessment and analysis suited to the early phase, concurrent design of a space mission. The approach integrates an agile, multi-user risk collection tool, a more in-depth risk analysis tool, and repositories of risk information. A JPL developed tool, named RAP, is used for collecting expert opinions about risk from designers involved in the concurrent design of a space mission. Another in-house developed risk assessment tool, named DDP, is used for the analysis.

  14. A comparison of risk assessment techniques from qualitative to quantitative

    SciTech Connect

    Altenbach, T.J.

    1995-02-13

    Risk assessment techniques vary from purely qualitative approaches, through a regime of semi-qualitative to the more traditional quantitative. Constraints such as time, money, manpower, skills, management perceptions, risk result communication to the public, and political pressures all affect the manner in which risk assessments are carried out. This paper surveys some risk matrix techniques, examining the uses and applicability for each. Limitations and problems for each technique are presented and compared to the others. Risk matrix approaches vary from purely qualitative axis descriptions of accident frequency vs consequences, to fully quantitative axis definitions using multi-attribute utility theory to equate different types of risk from the same operation.

  15. Seismic risk assessment of Navarre (Northern Spain)

    NASA Astrophysics Data System (ADS)

    Gaspar-Escribano, J. M.; Rivas-Medina, A.; García Rodríguez, M. J.; Benito, B.; Tsige, M.; Martínez-Díaz, J. J.; Murphy, P.

    2009-04-01

    The RISNA project, financed by the Emergency Agency of Navarre (Northern Spain), aims at assessing the seismic risk of the entire region. The final goal of the project is the definition of emergency plans for future earthquakes. With this purpose, four main topics are covered: seismic hazard characterization, geotechnical classification, vulnerability assessment and damage estimation to structures and exposed population. A geographic information system is used to integrate, analyze and represent all information colleted in the different phases of the study. Expected ground motions on rock conditions with a 90% probability of non-exceedance in an exposure time of 50 years are determined following a Probabilistic Seismic Hazard Assessment (PSHA) methodology that includes a logic tree with different ground motion and source zoning models. As the region under study is located in the boundary between Spain and France, an effort is required to collect and homogenise seismological data from different national and regional agencies. A new homogenised seismic catalogue, merging data from Spanish, French, Catalonian and international agencies and establishing correlations between different magnitude scales, is developed. In addition, a new seismic zoning model focused on the study area is proposed. Results show that the highest ground motions on rock conditions are expected in the northeastern part of the region, decreasing southwards. Seismic hazard can be expressed as low-to-moderate. A geotechnical classification of the entire region is developed based on surface geology, available borehole data and morphotectonic constraints. Frequency-dependent amplification factors, consistent with code values, are proposed. The northern and southern parts of the region are characterized by stiff and soft soils respectively, being the softest soils located along river valleys. Seismic hazard maps including soil effects are obtained by applying these factors to the seismic hazard maps

  16. 77 FR 58590 - Determining Technical Adequacy of Probabilistic Risk Assessment for Risk-Informed License...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

    ... COMMISSION Determining Technical Adequacy of Probabilistic Risk Assessment for Risk-Informed License...: LWR Edition,'' Section 19.1, ``Determining the Technical Adequacy of Probabilistic Risk Assessment for...; email: Amy.Cubbage@nrc.gov . SUPPLEMENTARY INFORMATION: On May 22, 2012 (77 FR 30335), the NRC...

  17. Risk Assessment and Risk Management in Offenders with Intellectual Disabilities: Are We There Yet?

    ERIC Educational Resources Information Center

    Pouls, Claudia; Jeandarme, Inge

    2015-01-01

    Research on risk assessment and risk management in offenders with intellectual disabilities (OIDs), although far behind compared to the mainstream offender literature, is now expanding. The current review provides an overview of the predictive value of risk assessment and treatment outcome monitoring tools developed for both mainstream forensic…

  18. Immunotoxicology and its application in risk assessment.

    PubMed

    Rooney, Andrew A; Luebke, Robert W; Selgrade, Maryjane K; Germolec, Dori R

    2012-01-01

    Immunotoxicology is the study of undesired modulation of the immune system by extrinsic factors. Toxicological assessments have demonstrated that the immune system is a target following exposure to a diverse group of xenobiotics including ultraviolet radiation, chemical pollutants, therapeutics, and recreational drugs. There is a well-established cause and effect relationship between suppression of the immune response and reduced resistance to infections and certain types of neoplasia. In humans, mild-to-moderate suppression of the immune response is linked to reduced resistance to common community-acquired infections, whereas opportunistic infections, which are very rare in the general population, are common in individuals with severe suppression. Xenobiotic exposure may also result in unintended stimulation of immune function. Although a cause and effect relationship between unintended stimulation of the immune response and adverse consequences has yet to be established, evidence does suggest that hypersensitivity, autoimmunity, and pathological inflammation may be exacerbated in susceptible populations exposed to certain xenobiotics. Xenobiotics can act as allergens and elicit hypersensitivity responses, or they can modulate hypersensitivity responses to other allergens such as pollen or dust mite by acting as adjuvants, enhancing the development or expression of hypersensitivity. Allergic contact dermatitis, allergic rhinitis, and asthma are the most commonly encountered types of hypersensitivity reactions resulting from chemical exposure. The immunologic effectors and mechanisms involved in autoimmune reactions are the same as those associated with responses to foreign antigens; however, the reactions are directed against the host's own cells. Thus, chemicals that induce immune suppression, nonspecific immunostimulation, or hypersensitivity may also impact autoimmunity. Risk assessment for immunotoxicity should be performed using the same approaches and

  19. Risk assessment of thyroid follicular cell tumors.

    PubMed Central

    Hill, R N; Crisp, T M; Hurley, P M; Rosenthal, S L; Singh, D V

    1998-01-01

    Thyroid follicular cell tumors arise in rodents from mutations, perturbations of thyroid and pituitary hormone status with increased stimulation of thyroid cell growth by thyroid-stimulating hormone (TSH), or a combination of the two. The only known human thyroid carcinogen is ionizing radiation. It is not known for certain whether chemicals that affect thyroid cell growth lead to human thyroid cancer. The U.S. Environmental Protection Agency applies the following science policy positions: 1) chemically induced rodent thyroid tumors are presumed to be relevant to humans; 2) when interspecies information is lacking, the default is to assume comparable carcinogenic sensitivity in rodents and humans; 3) adverse rodent noncancer thyroid effects due to chemically induced thyroid-pituitary disruption are presumed to be relevant to humans; 4) linear dose-response considerations are applied to thyroid cancer induced by chemical substances that either do not disrupt thyroid functioning or lack mode of action information; 5) nonlinear thyroid cancer dose-response considerations are applied to chemicals that reduce thyroid hormone levels, increase TSH and thyroid cell division, and are judged to lack mutagenic activity; and 6) nonlinear considerations may be applied in thyroid cancer dose-response assessments on a case-by-case basis for chemicals that disrupt thyroid-pituitary functioning and demonstrate some mutagenic activity. Required data for risk assessment purposes is mode of action information on mutagenicity, increases in follicular cell growth (cell size and number) and thyroid gland weight, thyroid-pituitary hormones, site of action, correlations between doses producing thyroid effects and cancer, and reversibility of effects when dosing ceases. Images Figure 1 Figure 2 Figure 3 PMID:9681971

  20. THE ROLE OF EXPOSURE ANALYSIS IN HUMAN HEALTH RISK ASSESSMENT

    EPA Science Inventory

    This presentation will cover the basic methodologies used for assessing human exposures to environmental pollutants, and some of the scientific challenges involved in conducting exposure and risk assessments in support of regulatory evaluations.

  1. Advancing environmental risk assessment for transgenic biofeedstock crops

    PubMed Central

    Wolt, Jeffrey D

    2009-01-01

    Transgenic modification of plants is a key enabling technology for developing sustainable biofeedstocks for biofuels production. Regulatory decisions and the wider acceptance and development of transgenic biofeedstock crops are considered from the context of science-based risk assessment. The risk assessment paradigm for transgenic biofeedstock crops is fundamentally no different from that of current generation transgenic crops, except that the focus of the assessment must consider the unique attributes of a given biofeedstock crop and its environmental release. For currently envisioned biofeedstock crops, particular emphasis in risk assessment will be given to characterization of altered metabolic profiles and their implications relative to non-target environmental effects and food safety; weediness and invasiveness when plants are modified for abiotic stress tolerance or are domesticated; and aggregate risk when plants are platforms for multi-product production. Robust risk assessments for transgenic biofeedstock crops are case-specific, initiated through problem formulation, and use tiered approaches for risk characterization. PMID:19883509

  2. Landscape ecological risk assessment study in arid land

    NASA Astrophysics Data System (ADS)

    Gong, Lu; Amut, Aniwaer; Shi, Qingdong; Wang, Gary Z.

    2007-09-01

    The ecosystem risk assessment is an essential decision making system for predicting the reconstruction and recovery of a damaged ecosystem after intensive mankind activities. The sustainability of environment and resources of the lake ecosystem in arid districts have been paid close attention to by international communities as well as numerous experts and scholars. The ecological risk assessment offered a scientific foundation for making the decision and execution of ecological risk management. Bosten Lake, the largest inland freshwater lake in China, is the main water source of the industrial and agricultural production as well as the local residence in Yanqi basin, Kuara city and Yuri County in the southern Xinjiang. Bosten Lake also provides a direct water source for emergency transportation in the Lower Reaches of Tarim River. However, with the intensive utilizations of water and soil resources, the environmental condition in the Bosten Lake has become more and more serious. In this study, the theory and method of landscape ecological risk assessment has been practiced using 3S technologies combined with the frontier theory of landscape ecology. Defining the mainly risk resource including flood, drought, water pollution and rich nutrition of water has been evaluated based on the ecosystem risk assessment system. The main process includes five stages: regional natural resources analysis, risk receptor selection, risk sources evaluation, exposure and hazard analysis, and integrated risk assessment. Based on the risk assessment results, the environmental risk management countermeasure has been determined.

  3. Risk assessment compatible fire models (RACFMs)

    SciTech Connect

    Lopez, A.R.; Gritzo, L.A.; Sherman, M.P.

    1998-07-01

    A suite of Probabilistic Risk Assessment Compatible Fire Models (RACFMs) has been developed to represent the hazard posed by a pool fire to weapon systems transported on the B52-H aircraft. These models represent both stand-off (i.e., the weapon system is outside of the flame zone but exposed to the radiant heat load from fire) and fully-engulfing scenarios (i.e., the object is fully covered by flames). The approach taken in developing the RACFMs for both scenarios was to consolidate, reconcile, and apply data and knowledge from all available resources including: data and correlations from the literature, data from an extensive full-scale fire test program at the Naval Air Warfare Center (NAWC) at China Lake, and results from a fire field model (VULCAN). In the past, a single, effective temperature, T{sub f}, was used to represent the fire. The heat flux to an object exposed to a fire was estimated using the relationship for black body radiation, {sigma}T{sub f}{sup 4}. Significant improvements have been made by employing the present approach which accounts for the presence of temperature distributions in fully-engulfing fires, and uses best available correlations to estimate heat fluxes in stand-off scenarios.

  4. Benzene and leukemia. An epidemiologic risk assessment

    SciTech Connect

    Rinsky, R.A.; Smith, A.B.; Hornung, R.; Filloon, T.G.; Young, R.J.; Okun, A.H.; Landrigan, P.J.

    1987-04-23

    To assess quantitatively the association between benzene exposure and leukemia, we examined the mortality rate of a cohort with occupational exposure to benzene. Cumulative exposure for each cohort member was estimated from historical air-sampling data and, when no sampling data existed, from interpolation on the basis of existing data. The overall standardized mortality ratio (a measure of relative risk multiplied by 100) for leukemia was 337 (95 percent confidence interval, 154 to 641), and that for multiple myeloma was 409 (95 percent confidence interval, 110 to 1047). With stratification according to levels of cumulative exposure, the standardized mortality ratios for leukemia increased from 109 to 322, 1186, and 6637 with increases in cumulative benzene exposure from less than 40 parts per million-years (ppm-years), to 40 to 199, 200 to 399, and 400 or more, respectively. A cumulative benzene exposure of 400 ppm-years is equivalent to a mean annual exposure of 10 ppm over a 40-year working lifetime; 10 ppm is the currently enforceable standard in the United States for occupational exposure to benzene. To examine the shape of the exposure-response relation, we performed a conditional logistic-regression analysis, in which 10 controls were matched to each cohort member with leukemia. From this model, it can be calculated that protection from benzene-induced leukemia would increase exponentially with any reduction in the permissible exposure limit.

  5. Managing Risk Assessment in Science Departments.

    ERIC Educational Resources Information Center

    Forlin, Peter; Forlin, Chris

    1997-01-01

    Describes a health-and-safety risk-management audit in four Queensland, Australia high schools. One major outcome of this research project is the development of a comprehensive risk-management policy in compliance with the law. Other outcomes include the preparation of a professional-development package in risk-management policy for use as a…

  6. Significance of Semiquantitative Assessment of Preformed Donor-Specific Antibody Using Luminex Single Bead Assay in Living Related Liver Transplantation

    PubMed Central

    Yoshizawa, Atsushi; Egawa, Hiroto; Yurugi, Kimiko; Hishida, Rie; Tsuji, Hiroaki; Ashihara, Eiji; Miyagawa-Hayashino, Aya; Teramukai, Satoshi; Maekawa, Taira; Haga, Hironori; Uemoto, Sinji

    2013-01-01

    Aim. To analyze the risks of preoperatively produced donor-specific antibody (DSA) in liver transplantation. Methods. DSA was assessed using direct complement-dependent cytotoxicity (CDC) and anti-human globulin- (AHG-) CDC tests, as well as the Luminex Single Antigen assay. Among 616 patients undergoing blood type identical or compatible living donor liver transplantation (LDLT), 21 patients were positive for CDC or AHG-CDC tests, and the preserved serum from 18 patients was examined to determine targeted Class I and II antigens. The relationships between the mean fluorescence intensity (MFI) of DSA and the clinical outcomes were analyzed. Results. Patients were divided into 3 groups according to the MFI of anti-Class I DSA: high (11 patients with MFI > 10,000), low (2 patients with MFI < 10,000), and negative (5 patients) MFI groups. Six of 11 patients with high Class-I DSA showed positive Class-II DSA. Hospital death occurred in 7 patients of the high MFI group. High MFI was a significant risk factor for mortality (P = 0.0155). Univariate analysis showed a significant correlation between MFI strength and C4d deposition (P = 0.0498). Conclusions. HLA Class I DSA with MFI > 10,000 had a significant negative effect on the clinical outcome of patients with preformed DSA in LDLT. PMID:23818917

  7. A Randomized Clinical Trial of Anticaries Therapies Targeted according to Risk Assessment (Caries Management by Risk Assessment)

    PubMed Central

    Featherstone, J.D.B.; White, J.M; Hoover, C.I.; Rapozo-Hilo, M.; Weintraub, J.A.; Wilson, R.S.; Zhan, L.; Gansky, S.A.

    2012-01-01

    This randomized parallel group clinical trial assessed whether combined antibacterial and fluoride therapy benefits the balance between caries pathological and protective factors. Eligible, enrolled adults (n = 231), with 1–7 baseline cavitated teeth, attending a dental school clinic were randomly assigned to a control or intervention group. Salivary mutans streptococci (MS), lactobacilli (LB), fluoride (F) level, and resulting caries risk status (low or high) assays were determined at baseline and every 6 months. After baseline, all cavitated teeth were restored. An examiner masked to group conducted caries exams at baseline and 2 years after completing restorations. The intervention group used fluoride dentifrice (1,100 ppm F as NaF), 0.12% chlorhexidine gluconate rinse based upon bacterial challenge (MS and LB), and 0.05% NaF rinse based upon salivary F. For the primary outcome, mean caries increment, no statistically significant difference was observed (24% difference between control and intervention groups, p = 0.101). However, the supplemental adjusted zero-inflated Poisson caries increment (change in DMFS) model showed the intervention group had a statistically significantly 24% lower mean than the control group (p = 0.020). Overall, caries risk reduced significantly in intervention versus control over 2 years (baseline adjusted generalized linear mixed models odds ratio, aOR = 3.45; 95% CI: 1.67, 7.13). Change in MS bacterial challenge differed significantly between groups (aOR = 6.70; 95% CI: 2.96, 15.13) but not for LB or F. Targeted antibacterial and fluoride therapy based on salivary microbial and fluoride levels favorably altered the balance between pathological and protective caries risk factors. PMID:22472515

  8. A randomized clinical trial of anticaries therapies targeted according to risk assessment (caries management by risk assessment).

    PubMed

    Featherstone, J D B; White, J M; Hoover, C I; Rapozo-Hilo, M; Weintraub, J A; Wilson, R S; Zhan, L; Gansky, S A

    2012-01-01

    This randomized parallel group clinical trial assessed whether combined antibacterial and fluoride therapy benefits the balance between caries pathological and protective factors. Eligible, enrolled adults (n = 231), with 1-7 baseline cavitated teeth, attending a dental school clinic were randomly assigned to a control or intervention group. Salivary mutans streptococci (MS), lactobacilli (LB), fluoride (F) level, and resulting caries risk status (low or high) assays were determined at baseline and every 6 months. After baseline, all cavitated teeth were restored. An examiner masked to group conducted caries exams at baseline and 2 years after completing restorations. The intervention group used fluoride dentifrice (1,100 ppm F as NaF), 0.12% chlorhexidine gluconate rinse based upon bacterial challenge (MS and LB), and 0.05% NaF rinse based upon salivary F. For the primary outcome, mean caries increment, no statistically significant difference was observed (24% difference between control and intervention groups, p = 0.101). However, the supplemental adjusted zero-inflated Poisson caries increment (change in DMFS) model showed the intervention group had a statistically significantly 24% lower mean than the control group (p = 0.020). Overall, caries risk reduced significantly in intervention versus control over 2 years (baseline adjusted generalized linear mixed models odds ratio, aOR = 3.45; 95% CI: 1.67, 7.13). Change in MS bacterial challenge differed significantly between groups (aOR = 6.70; 95% CI: 2.96, 15.13) but not for LB or F. Targeted antibacterial and fluoride therapy based on salivary microbial and fluoride levels favorably altered the balance between pathological and protective caries risk factors. PMID:22472515

  9. Embedding climate change risk assessment within a governance context

    SciTech Connect

    Preston, Benjamin L

    2011-01-01

    Climate change adaptation is increasingly being framed in the context of climate risk management. This has contributed to the proliferation of climate change vulnerability and/or risk assessments as means of supporting institutional decision-making regarding adaptation policies and measures. To date, however, little consideration has been given to how such assessment projects and programs interact with governance systems to facilitate or hinder the implementation of adaptive responses. An examination of recent case studies involving Australian local governments reveals two key linkages between risk assessment and the governance of adaptation. First, governance systems influence how risk assessment processes are conducted, by whom they are conducted, and whom they are meant to inform. Australia s governance system emphasizes evidence-based decision-making that reinforces a knowledge deficit model of decision support. Assessments are often carried out by external experts on behalf of local government, with limited participation by relevant stakeholders and/or civil society. Second, governance systems influence the extent to which the outputs from risk assessment activities are translated into adaptive responses and outcomes. Technical information regarding risk is often stranded by institutional barriers to adaptation including poor uptake of information, competition on the policy agenda, and lack of sufficient entitlements. Yet, risk assessments can assist in bringing such barriers to the surface, where they can be debated and resolved. In fact, well-designed risk assessments can contribute to multi-loop learning by institutions, and that reflexive problem orientation may be one of the more valuable benefits of assessment.

  10. Evaluating the Risk of Child Abuse: The Child Abuse Risk Assessment Scale (CARAS)

    ERIC Educational Resources Information Center

    Chan, Ko Ling

    2012-01-01

    The present study developed the Child Abuse Risk Assessment Scale (CARAS), an actuarial instrument for the assessment of the risk of physical child abuse. Data of 2,363 Chinese parents (47.7% male) living in Hong Kong were used in the analyses. Participants were individually interviewed with a questionnaire assessing their perpetration of child…

  11. The Maricopa Integrated Risk Assessment Project: A New Way of Looking at Risk

    ERIC Educational Resources Information Center

    Unks, Ruth A.; Thor, Linda

    2008-01-01

    This article reviews the Maricopa Integrated Risk Assessment (MIRA) project and discusses its challenges and successes. Strategies and resources are offered for assisting community college administrators, faculty, and staff to successfully implement enterprise risk management at their institutions.

  12. Use of risk quotient and probabilistic approaches to assess risks of pesticides to birds

    EPA Science Inventory

    When conducting ecological risk assessments for pesticides, the United States Environmental Protection Agency typically relies upon the risk quotient (RQ). This approach is intended to be conservative in nature, making assumptions related to exposure and effects that are intended...

  13. Immunological risk assessment: The key to individualized immunosuppression after kidney transplantation.

    PubMed

    Pratschke, Johann; Dragun, Duska; Hauser, Ingeborg A; Horn, Sabine; Mueller, Thomas F; Schemmer, Peter; Thaiss, Friedrich

    2016-04-01

    The wide range of immunosuppressive therapies and protocols permits tailored planning of the initial regimen according to the immunological risk status of individual patients. Pre-transplant risk assessment can include many factors, but there is no clear consensus on which parameters to take into account, and their relative importance. In general younger patients are known to be at higher risk for acute rejection, compounded by higher rates of non-adherence in adolescents. Donor age and recipient gender do not appear to exert a meaningful effect on risk of rejection per se, but black recipient ethnicity remains a well-established risk factor even under modern immunosuppression regimens. Little difference in risk is now observed between deceased- and living-donor recipients. Immunological risk assessment has developed substantially in recent years. Cross-match testing with cytotoxic analysis has long been supplemented by flow cytometry, but development of solid-phase single-bead antigen testing of solubilized human leukocyte antigens (HLA) to detect donor-specific antibodies (DSA) permits a far more nuanced stratification of immunological risk status, including the different classes and intensities of HLA antibodies Class I and/or II, including HLA-DSA. Immunologic risk evaluation is now often based on a combination of these tests, but other assessments are becoming more widely introduced, such as measurement of non-HLA antibodies against angiotensin type 1 (AT1) receptors or T-cell ELISPOT assay of alloantigen-specific donor. Targeted densensitization protocols can improve immunological risk, notably for DSA-positive patients with negative cytotoxicity and flow cross-match. HLA mismatch remains an important and undisputed risk factor for rejection. Delayed graft function also increases the risk of subsequent acute rejection, and the early regimen can be modified in such cases. Overall, there is a shift towards planning the immunosuppressive regimen based on pre

  14. Performance of the Elecsys Rubella IgG Assay in the Diagnostic Laboratory Setting for Assessment of Immune Status

    PubMed Central

    Bartelt, Uwe; Knotek, Frank; Bunn, Kristina; Strobel, Sirpa; Dietz, Klaus; Enders, Gisela

    2013-01-01

    Rubella in early pregnancy bears a high risk for congenital defects (e.g., cataracts, hearing loss, and heart disease) and for long-term sequelae in the newborn. Despite implementation of vaccination programs in many regions, the threat of devastating consequences from congenital rubella virus infection remains and careful screening of maternal immune status before and during pregnancy helps to reduce the risk. This study compared the performance of the Elecsys Rubella IgG assay with that of other assays routinely used for screening. Samples from 1,090 women undergoing routine antenatal care were tested using the Elecsys and Enzygnost Rubella IgG assays and the hemagglutination inhibition test. Samples with hemagglutination inhibition titers of <32 (n = 148) were additionally tested using the Vidas, AxSYM, Liaison, and Architect Rubella IgG assays. Agreement of qualitative results from the Elecsys, Enzygnost, and hemagglutination inhibition assays was good in all samples. All assays showed 100.0% specificity. In samples with hemagglutination inhibition titers of <32, the Elecsys, AxSYM, and Enzygnost assays showed higher sensitivity (>90.0%) than the other immunoassays (78.6 to 82.4%). The Elecsys assay reported significantly higher rubella virus IgG levels than the other immunoassays across the whole set of 1,090 samples, with the largest bias and deviation from limits of agreement in Bland-Altman analysis. In conclusion, the Elecsys assay is highly sensitive and specific with regard to qualitative results and suitable for routine automated screening. However, given the considerable variation between quantitative results from different immunoassays, testing methods should be documented and the same assay used throughout an individual's antenatal follow-up wherever possible. PMID:23345585

  15. Seismic vulnerability assessments in risk analysis

    NASA Astrophysics Data System (ADS)

    Frolova, Nina; Larionov, Valery; Bonnin, Jean; Ugarov, Alexander

    2013-04-01

    The assessment of seismic vulnerability is a critical issue within natural and technological risk analysis. In general, there are three common types of methods used for development of vulnerability functions of different elements at risk: empirical, analytical and expert estimations. The paper addresses the empirical methods for seismic vulnerability estimation for residential buildings and industrial facilities. The results of engineering analysis of past earthquake consequences, as well as the statistical data on buildings behavior during strong earthquakes presented in the different seismic intensity scales, are used to verify the regional parameters of mathematical models in order to simulate physical and economic vulnerability for different building types classified according to seismic scale MMSK-86. Verified procedure has been used to estimate the physical and economic vulnerability of buildings and constructions against earthquakes for the Northern Caucasus Federal region of the Russian Federation and Krasnodar area, which are characterized by rather high level of seismic activity and high population density. In order to estimate expected damage states to buildings and constructions in the case of the earthquakes according to the OSR-97B (return period T=1,000 years) within big cities and towns, they were divided into unit sites and their coordinates were presented as dots located in the centers of unit sites. Then the indexes obtained for each unit site were summed up. The maps of physical vulnerability zoning for Northern Caucasus Federal region of the Russian Federation and Krasnodar area includes two elements: percent of different damage states for settlements with number of inhabitants less than 1,000 and vulnerability for cities and towns with number of inhabitants more than 1,000. The hypsometric scale is used to represent both elements on the maps. Taking into account the size of oil pipe line systems located in the highly active seismic zones in

  16. Dynamic risk simulation to assess natural hazards risk along roads

    NASA Astrophysics Data System (ADS)

    Voumard, J.; Caspar, O.; Derron, M.-H.; Jaboyedoff, M.

    2013-11-01

    Risk generated by natural hazards on roads is usually calculated with equations integrating various parameters related to hazard and traffic. These are static variables, like an average number of vehicles crossing this section every day and an average vehicle speed. This methodology cannot take into account dynamic variations of traffic and interactions between vehicles such as speed modifications due to windy roads, slowdowns resulting from saturated traffic or vehicle tailbacks forming in front of traffic lights. Here we show, by means of a dynamic traffic simulator, that traffic variations may greatly influence the risk estimation over time. The risk is analysed on several sections of an Alpine road in Switzerland using a dynamic vehicles approach, and compared with the results of the static methodology. It demonstrates that risk can significantly increase on sinuous sections because of decreasing vehicle speed. For example, along an 800 m-long section of road containing two hairpin bends, the dynamic risk is about 50% higher than the static one. Badly placed signalization, slowing down, or stopping the vehicles in a hazardous area may increase the risk by about 150% (i.e. 2.5 times higher) along a straight road section where vehicles speed is high. A more realistic risk can thus be obtained from a dynamic approach, especially on mountain roads. The dynamic traffic simulator developed for this work appears to be a helpful tool to support decision-making in reducing risk on mountain roads and it shows the importance of keeping the traffic moving as freely as possible.

  17. Assessment of the risk of transporting liquid chlorine by rail

    SciTech Connect

    Andrews, W.B.

    1980-03-01

    This report presents the risk of shipping liquid chlorine by rail. While chlorine is not an energy material, there are several benefits to studying chlorine transportation risks. First, chlorine, like energy materials, is widely used as a feedstock to industry. Second, it is the major purification agent in municipal water treatment systems and therefore, provides direct benefits to the public. Finally, other risk assessments have been completed for liquid chlorine shipments in the US and Europe, which provide a basis for comparison with this study. None of the previous PNL energy material risk assessments have had other studies for comparison. For these reasons, it was felt that a risk assessment of chlorine transportation by rail could provide information on chlorine risk levels, identify ways to reduce these risks and use previous studies on chlorine risks to assess the strengths and weaknesses of the PNL risk assessment methodology. The risk assessment methodology used in this study is summarized. The methodology is presented in the form of a risk assessment model which is constructed for ease of periodic updating of the data base so that the risk may be reevaluated as additional data become available. The report is sectioned to correspond to specific analysis steps identified in the model. The transport system and accident environment are described. The response of the transport system to accident environments is described. Release sequences are postulated and evaluated to determine both the likelihood and possible consequences of a release. Supportive data and analyses are given in the appendices. The risk assessment results are related to the year 1985 to allow a direct comparison with other reports in this series.

  18. Risk adjusting community rated health plan premiums: a survey of risk assessment literature and policy applications.

    PubMed

    Giacomini, M; Luft, H S; Robinson, J C

    1995-01-01

    This paper surveys recent health care reform debates and empirical evidence regarding the potential role for risk adjusters in addressing the problem of competitive risk segmentation under capitated financing. We discuss features of health plan markets affecting risk selection, methodological considerations in measuring it, and alternative approaches to financial correction for risk differentials. The appropriate approach to assessing risk differences between health plans depends upon the nature of market risk selection allowed under a given reform scenario. Because per capita costs depend on a health plan's population risk, efficiency, and quality of service, risk adjustment will most strongly promote efficiency in environments with commensurately strong incentives for quality care. PMID:7639879

  19. Assessing Fieldwork Risk for Undergraduate Projects. Directions: JGHE Study Guide.

    ERIC Educational Resources Information Center

    Higgitt, David; Bullard, Jo

    1999-01-01

    Discusses the five steps involved in conducting risk assessment for fieldwork using two examples of typical student projects: (1) identity the hazards; (2) identify who might be harmed; (3) evaluate the risks; (4) record the findings; and (5) review the assessment periodically. Addresses expeditions and work overseas. (CMK)

  20. Are Risk Assessments of a Terrorist Attack Coherent?

    ERIC Educational Resources Information Center

    Mandel, David R.

    2005-01-01

    Four experiments examined 3 types of violations of coherence criteria in risk assessments of a terrorist attack. First, the requirement that extensionally equivalent descriptions be assigned the same probability (i.e., additivity) was violated. Unpacking descriptions of an attack into subtypes led to an increase in assessed risk. Second,…

  1. Behavioral Risk Assessment of the Guarded Suicidal Patient

    ERIC Educational Resources Information Center

    Simon, Robert I.

    2008-01-01

    Psychiatrists and other mental health professionals are trained to assess patients by direct observation and examination. Short inpatient length of stay, brief outpatient visits, emergency room evaluations, and other time-limited clinical settings require rapid assessment of suicide risk. Recognition of behavioral suicide risk factors can assist…

  2. The Current Status of Graduate Training in Suicide Risk Assessment

    ERIC Educational Resources Information Center

    Liebling-Boccio, Dana E.; Jennings, Heather R.

    2013-01-01

    Directors and coordinators (n = 75) of graduate programs in school psychology approved by the National Association of School Psychologists (NASP) were surveyed regarding their training practices in suicide risk assessment. Respondents viewed the assessment of suicide risk as an important part of graduate instruction, and most believed that…

  3. ECOLOGICAL RISK ASSESSMENT FOR THE MIDDLE SNAKE RIVER, IDAHO

    EPA Science Inventory

    An ecological risk assessment was completed for the Middle Snake River, Idaho. In this assessment, mathematical simulations and field observations were used to analyze exposure and ecological effects and to estimate risk.

    The Middle Snake River which refers to a 100 km stret...

  4. Regulating by the Numbers: Probabilistic Risk Assessment and Nuclear Power.

    ERIC Educational Resources Information Center

    Nichols, Elizabeth; Wildavsky, Aaron

    1988-01-01

    Probabilistic risk assessment has been promoted within the Nuclear Regulatory Commission as a means of judging risk to the public and of determining regulatory measures. Interviews with engineers and other technically trained personnel reveal the difficulties created by expectations that this form of assessment should be applied. (TJH)

  5. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Risk assessment for candidates. 105.14 Section 105.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIMINAL HISTORY BACKGROUND CHECKS Aviation Training for Aliens and Other Designated Individuals § 105.14 Risk assessment...

  6. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Risk assessment for candidates. 105.14 Section 105.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIMINAL HISTORY BACKGROUND CHECKS Aviation Training for Aliens and Other Designated Individuals § 105.14 Risk assessment...

  7. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Risk assessment for candidates. 105.14 Section 105.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIMINAL HISTORY BACKGROUND CHECKS Aviation Training for Aliens and Other Designated Individuals § 105.14 Risk assessment...

  8. CHILDREN AS A SENSITIVE SUBPOPULATION FOR THE RISK ASSESSMENT PROCESS

    EPA Science Inventory

    Children as a sensitive subpopulation for the risk assessment process
    Abstract
    For cancer risk assessment purposes, it is necessary to consider how to incorporate sensitive subpopulations into the process to ensure that they are appropriately protected. Children represent o...

  9. NATO PILOT STUDY ON ADVANCED CANCER RISK ASSESSMENT METHODS

    EPA Science Inventory

    NCEA scientists are participating in a study of advanced cancer risk assessment methods, conducted under the auspices of NATO's Committee on the Challenges of Modern Society. The product will be a book of case studies that illustrate advanced cancer risk assessment methods, avail...

  10. Systems Biology & Mode of Action Based Risk Assessment

    EPA Science Inventory

    The application of systems biology for risk assessment of environmental chemicals is a national extension of its use in pharmaceutical research. The basis for this is the concept of a key event network that builds on existing mode of action frameworks for risk assessment. The a...

  11. 78 FR 27939 - Draft Interagency Risk Assessment-Listeria monocytogenes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-13

    ...The United States Department of Agriculture (USDA)/Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA)/Center for Food Safety and Applied Nutrition (CFSAN) are announcing the availability of the draft ``Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens.'' This draft quantitative risk assessment (QRA) includes an Interpretive Summary......

  12. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Risk assessment for candidates. 105.14 Section 105.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIMINAL HISTORY BACKGROUND CHECKS Aviation Training for Aliens and Other Designated Individuals § 105.14 Risk assessment...

  13. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Risk assessment for candidates. 105.14 Section 105.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIMINAL HISTORY BACKGROUND CHECKS Aviation Training for Aliens and Other Designated Individuals § 105.14 Risk assessment...

  14. 7 CFR 1730.27 - Vulnerability and Risk Assessment (VRA).

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 11 2013-01-01 2013-01-01 false Vulnerability and Risk Assessment (VRA). 1730.27 Section 1730.27 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES... Requirements § 1730.27 Vulnerability and Risk Assessment (VRA). (a) Each borrower with an approved RUS...

  15. 7 CFR 1730.27 - Vulnerability and Risk Assessment (VRA).

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 11 2012-01-01 2012-01-01 false Vulnerability and Risk Assessment (VRA). 1730.27 Section 1730.27 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES... Requirements § 1730.27 Vulnerability and Risk Assessment (VRA). (a) Each borrower with an approved RUS...

  16. 7 CFR 1730.27 - Vulnerability and Risk Assessment (VRA).

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 11 2014-01-01 2014-01-01 false Vulnerability and Risk Assessment (VRA). 1730.27 Section 1730.27 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES... Requirements § 1730.27 Vulnerability and Risk Assessment (VRA). (a) Each borrower with an approved RUS...

  17. Selection of Developmental Assessment Techniques for Infants at Risk.

    ERIC Educational Resources Information Center

    Parmelee, Arthur H.; And Others

    This report presents a cumulative risk score system designed to identify high-risk infants through multiple assessments over an extended period of time. The system scores prenatal, natal, and neonatal biological events and neonatal behavioral performance in an additive fashion. Infants are assessed in the first month of life to distinguish those…

  18. Current Challenges in Neurotoxicity Risk Assessment [Poster 2015

    EPA Science Inventory

    Neurotoxicity risk assessment must continue to evolve in parallel with advances in basic research. Along with this evolution is an expansion in the scope of neurotoxicity assessments of environmental health risks. Examples of this expansion include an increasing emphasis on compl...

  19. MINI REVIEW - EPIGENETIC PROCESSES AND CANCER RISK ASSESSMENT

    EPA Science Inventory

    Abstract: The U.S. Environmental Protection Agency's Guidelines for Carcinogen Risk Assessment encourages the use of mechanistic data in the assessment of human cancer risk at low (environmental) exposure levels. The key events that define a particular mode of action for tumor fo...

  20. Pharmacokinetics in risk assessment: drinking water and health. Volume 8

    SciTech Connect

    Not Available

    1987-01-01

    Contents include: risk assessment: historical perspectives; tissue dosimetry in risk assessment; modeling: an introduction; physiologically based pharmacokinetic modeling; allometry: body-size constraints in animal design; prediction of in vivo parameters of drug metabolism and distribution from in-vitro studies; dose, species, and route extrapolation; uncertainty in pharmacokinetic models using SIMUSOLV; interspecies and dose-route extrapolations; carcinogen DNA adducts as a measure of biological dose for risk analysis of carcinogenic data; resources available for simulation in toxicology; route-to-route extrapolation of dichloromethane exposure using a physiological pharmacokinetic model; sensitivity analysis in pharmacokinetic modeling; mutation accumulation: chronic cytotoxicant exposure; model for ethylene chloride and its application in risk assessment; mathematical modeling of ozone absorption in the lower respiratory tract; development of a physiologically based pharmacokinetic model for multiday inhalation of carbon tetrachloride; the delivered/administered dose relationship and its impact on formaldehyde risk estimates; pharmacokinetic simulation in risk assessment; hazard assessment: ozone; role of pharmacokinetic modeling in risk assessment; development of multispecies, multiroute pharmacokinetic models for methylene chloride and 1,1,1-trichloroethane (methyl chloroform); methotrexate: pharmacokinetics and assessment of toxicity; prospective predictions and validations in anticancer therapy; the application of pharmacokinetic data in carcinogenic risk assessment.