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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 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

  3. 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

  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. 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.

  10. 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

  11. 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

  12. 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.

  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. 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

  13. 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

  14. 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.

  15. 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

  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. 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...

  1. 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...

  2. 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...

  3. 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.

  4. 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...

  5. 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.

  6. 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.

  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. 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 ...

  10. 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

  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

    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

  20. 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

  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, 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  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 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.

  2. 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.

  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. 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...

  10. 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.

  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. 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

  2. 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.

  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. 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 ...

  7. 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...

  8. 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...

  9. 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; 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...

  10. 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'...

  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. 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...

  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

    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

  1. 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

  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. 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.

  11. 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

  12. 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

  13. 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

  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. 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

  8. 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<...

  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. 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,...

  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. 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 ...

  16. 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

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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…

  3. 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...

  4. 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

  5. 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...

  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...