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Sample records for risk assessment assays

  1. 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

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

    PubMed

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

    2016-01-01

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

  3. Risk assessment of an abandoned pyrite mine in Spain based on direct toxicity assays.

    PubMed

    García-Gómez, Concepción; Sánchez-Pardo, Beatriz; Esteban, Elvira; Peñalosa, Jesús Manuel; Fernández, María Dolores

    2014-02-01

    This research reports the risk assessment of an abandoned pyrite mine using direct toxicity assays of soil and groundwater samples taken at the site. The toxicity of As and heavy metals from mining soils to soil and aquatic organisms was studied using the Multispecies Soil System (MS-3) in soil columns. Ecotoxicological assessment was performed with soil samples diluted with a control soil at concentrations of 12.5, 25, 50 and 100% test soil/soil (w/w). In this way, changes in the mobility and bioavailability of soil contaminants due to changes in geochemical soil properties via soil dilution were studied. The toxicity of water samples was tested on algae and Daphnia magna. The assessment of the mining area indicated that the current presence of As and heavy metals at the site may cause injuries to soil and aquatic organisms in the entire research area. Moreover, this investigation demonstrated that changes in geochemical conditions can increase the availability of arsenic and, consequently, the environmental risk of these soils. A good correlation was not found between toxicity parameters and the concentrations of soil contaminants based on total and extracted element concentrations. This finding reinforces the usefulness of direct toxicity assays for evaluating environmental risk.

  4. Examination of the local lymph node assay for use in contact sensitization risk assessment.

    PubMed

    Gerberick, G F; House, R V; Fletcher, E R; Ryan, C A

    1992-10-01

    The purpose of this study was to evaluate the utility of the murine local lymph node assay (LLNA) for contact sensitization risk assessment. Cellular proliferative activity in draining lymph nodes was determined for individual animals on Day 5 following four daily epicutaneous applications of the test chemical to the ears. Seventeen chemicals were tested, covering a range of materials including preservatives, drug actives, and perfume raw materials. The assay was found to be useful for identifying strong, moderate, and some weak sensitizers as defined by other testing methods (guinea pig, human). For evaluating the antigen specificity of the LLNA proliferative response, an in vitro blastogenesis assay was used. Dendritic cells (DC) isolated from lymph nodes of mice treated 24 hr earlier with trinitrochlorobenzene (TNCB) were capable of in vitro stimulation of lymphocytes from TNCB-sensitized mice, but not lymphocytes from mice sensitized to the preservative mixture of 5-chloro-2-methylisothiazolinone plus 2-methylisothiazolinone (MCI/MI). Conversely, DC from mice treated 24 hr earlier with MCI/MI were capable of stimulating lymphocytes from MCI/MI-sensitized mice, but were unable to stimulate lymphocytes from TNCB-sensitized mice, demonstrating the specificity of the response. The results of these studies support the use of the murine LLNA for both investigative and predictive contact sensitization testing. The LLNA offers the advantages of requiring less time for completion, incorporating an objective endpoint, requiring approximately half the number of animals, and being less costly than most currently employed guinea pig test methods. In addition, we believe the murine LLNA is a useful test to incorporate into a scheme for contact sensitization risk assessment.(ABSTRACT TRUNCATED AT 250 WORDS)

  5. 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

  6. Sensitivity of isolated eggs of pond snails: a new method for toxicity assays and risk assessment.

    PubMed

    Liu, Tengteng; Koene, Joris M; Dong, Xiaoxiao; Fu, Rongshu

    2013-05-01

    The concentration of heavy metals in the environment is normally low. We here address whether using the development of isolated pond snail Radix auricularia eggs would provide a more sensitive endpoint and whether the gelatinous matrix of the egg mass surrounding the eggs indeed protects the snail embryos. In the present study, artificial removal of the gelatinous matrix of egg masses greatly increased the sensitivity of developing eggs to a heavy metal (cadmium). The sensitivity of isolated eggs to cadmium was determined using several convenient endpoints, including mortality, hatching rate, and heart rate, with an acute toxicity test and a subchronic test. In the acute toxicity test, a 96-h LC(50) value of 58.26 μg/L cadmium was determined. In the subchronic toxicity test, sublethal effects in terms of a significant reduction in hatching rate could be found in the 25-μg/L treatment, and a significant decrease of heart rate was observed in both treatments (5 and 25 μg/L). The high sensitivity of isolated eggs indicates that such tests can be efficient for toxicity assays and risk assessment, although one needs to keep in mind that the ecologically relevant measure of toxicity will be how eggs are affected when they are still inside the egg mass.

  7. Can physiological endpoints improve the sensitivity of assays with plants in the risk assessment of contaminated soils?

    PubMed

    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 results

  8. 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

  9. Can physiological endpoints improve the sensitivity of assays with plants in the risk assessment of contaminated soils?

    PubMed

    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 results

  10. 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

  11. 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.

  12. 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.; 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.

  13. A modified host-cell reactivation assay to measure repair of alkylating DNA damage for assessing risk of lung adenocarcinoma.

    PubMed

    Wang, Luo; Wei, Qingyi; Shi, Qiuling; Guo, Zhaosheng; Qiao, Yawei; Spitz, Margaret R

    2007-07-01

    The nicotine-derived nitrosamine 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) induces lung adenocarcinoma through formation of DNA adducts. Our previous research on susceptibility to tobacco-induced carcinogenesis focused on benzo[a]pyrene diol epoxide (BPDE) as the in vitro mutagen for phenotype measurements of DNA repair capacity (DRC) in mammalian cells. Here, we present a modified host-cell reactivation (HCR) assay to measure lymphocytic DRC for alkylating DNA damage as is induced by the tobacco-specific nitrosamine, NNK. We substituted dimethyl sulfate (DMS) to create alkylating damage in pCMVluc plasmid DNA and established the damage-repair dose-response curves in both normal and nucleotide excision repair-deficient lymphoblastoid cell lines and in phytohemagglutinin (PHA)-stimulated primary lymphocytes. We then successfully measured the DRC in PHA-stimulated lymphocytes from 48 patients with lung adenocarcinoma and 45 cancer-free controls and tested our hypothesis that lower DRC for alkylating damage is associated with an increased risk of lung adenocarcinoma. The cases exhibited a lower mean DRC than did the controls. A >3-fold increased risk (odds ratio = 3.21; 95% confidence interval = 1.25-8.21) was found for those with DRC levels below the control median. There was no correlation between the DRC measured with this DMS-HCR assay and that from the parallel BPDE-HCR assay. Interestingly, risk increased to >10-fold for those with sub-optimal DRC measured by both DMS- and BPDE-HCR assays. We conclude that variability in DRC is a risk factor for lung cancer and our results provide proof of principle for a new assay that can assess DRC for NNK-induced DNA damage. PMID:17341660

  14. 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.

  15. Assessment of genotoxicity risk in operation room personnel by the alkaline comet assay.

    PubMed

    El-Ebiary, A A; Abuelfadl, A A; Sarhan, N I; Othman, M M

    2013-06-01

    This study was conducted to evaluate the possible genotoxic effects of waste anesthetic gases. Comet assay was performed on peripheral blood lymphocytes of 60 volunteers: 20 healthy unexposed office workers and 40 operation room (OR) personnel at Tanta University Hospital (Egypt). The exposed personnel were anesthetists (6 females and 7 males), surgeons (10 males), nurses (9 females), and technicians (8 males). The study revealed significantly increased comet parameters (mean comet tail length and mean percentage of DNA in the tail) in peripheral blood lymphocytes of OR personnel in comparison with control individuals. The maximum DNA damage was observed in anesthesia technicians, whereas the nurses showed the least DNA damage. Furthermore, significant difference was observed between smoker and nonsmokerOR personnel in relation to mean comet tail length. However, no significant difference was seen due to age, gender, or duration of exposure. Also, significant increase in mean percentage of tail DNA was observed in smoker individuals of both exposed and control groups. As a conclusion, this study points to the risk of DNA damage in personnel who are exposed to waste anesthetic gases.

  16. 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

  17. 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...

  18. [Use of comet assay for the risk assessment of oil- and chemical-industry workers].

    PubMed

    Megyesi, János; Biró, Anna; Wigmond, László; Major, Jenő; Tompa, Anna

    2014-11-23

    Bevezetés: A comet assay a DNS száltöréseinek kimutatására alkalmas fluoreszcens mikroszkópos módszer. Jelentősége az alacsony sejtszámú mintáknál mutatkozik, képes számokban kifejezni a DNS-károsodást a nem proliferáltatható sejtekben. Célkitűzés: Genotoxikus, illetve oxidatív DNS-károsodásokat mértünk foglalkozásuk során benzollal, policiklusos aromás szénhidrogénekkel, illetve sztirollal exponált csoportokban. Célunk volt annak megvizsgálása, hogy a módszer használható-e genotoxikológiai monitorhatás markereként. Módszer: A comet assay alaplépései mellett az enzimkezelt mintát formamido-pirimidin-DNS glikoláz restrikciós enzimmel kezeljük, ami az oxidatív DNS-károsodás mértékére utal. Eredmények: A kezeletlen (genotoxikus DNS-károsodás) és a kezelt (oxidatív DNS-károsodás) minták esetében emelkedés volt tapasztalható a csóvahosszokat illetően minden csoporton belül a kontrollhoz képest. Következtetések: Megállapítható, hogy a környezeti (munkahelyi) expozíció valószínűsíthető a vizsgált csoportokban. A comet assay kitűnő hatásmarker, illetve kiegészítő módszer lehet egy monitorrendszerben, amelynek adatai tájékoztatást adhatnak a munkahelyeken emelkedett genotoxikus hatások jelenlétéről vagy hiányáról. Orv. Hetil., 2014, 155(47), 1872–1875.

  19. 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...

  20. The comet assay in Environmental Risk Assessment of marine pollutants: applications, assets and handicaps of surveying genotoxicity in non-model organisms.

    PubMed

    Martins, Marta; Costa, Pedro M

    2015-01-01

    Determining the genotoxic effects of pollutants has long been a priority in Environmental Risk Assessment (ERA) for coastal ecosystems, especially of complex areas such as estuaries and other confined waterbodies. The acknowledged link between DNA damage, mutagenicity and carcinogenicity to the exposure to certain toxicants has been responsible to the growing interest in determining the genotoxic effects of xenobiotics to wildlife as a measure of environmental risk. The comet assay, although widely employed in in vivo and in vitro toxicology, still holds many constraints in ERA, in large part owing to difficulties in obtaining conclusive cause-effect relationships from complex environments. Nevertheless, these challenges do not hinder the attempts to apply the alkaline comet assay on sentinel organisms, wild or subjected to bioassays in or ex situ (from fish to molluscs) as well to standardise protocols and establish general guidelines to the interpretation of findings. Fish have been regarded as an appealing subject due to the ease of performing the comet assay in whole blood. However, the application of the comet assay is becoming increasingly common in invertebrates (e.g. in molluscan haemocytes and solid tissues such as gills). Virtually all sorts of results have been obtained from the application of the comet assay in ERA (null, positive and inconclusive). However, it has become clear that interpreting DNA damage data from wild organisms is particularly challenging due to their ability to adapt to continuous environmental stressors, including toxicants. Also, the comet assay in non-model organisms for the purpose of ERA implies different constraints, assumptions and interpretation of findings, compared with the in vitro procedures from which most guidelines have been derived. This paper critically reviews the application of the comet assay in ERA, focusing on target organisms and tissues; protocol developments, case studies plus data handling and

  1. 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

    2009-09-01

    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.

  2. Intra-laboratory evaluation of Microbial Assay for Risk Assessment (MARA) for potential application in the implementation of the Water Framework Directive (WFD).

    PubMed

    Wadhia, Kirit; Dando, Terry; Thompson, K Clive

    2007-09-01

    The Microbial Assay for Risk Assessment (MARA) is an innovative system based on an array of 11 different microbial species freeze-dried in a 96-well micro-titre plate format. Developed for testing the toxicity of chemicals, mixtures and environmental samples, the assay employs species of a taxonomically diverse range. In addition to ten prokaryotic species, a eukaryote (yeast) is included in the range. The MARA's innate scope of a multi-dimensional test allows determination of toxicity based on a unique assay fingerprint or index, numerically expressed as the mean Microbial Toxic Concentration (MTC). The most significant potential of the test is in the additional inference that can be conveyed to the toxicity evaluation because of the presence of each of the constituent species. In view of the fact that conventional aquatic bioassays, like fish or cladoceran tests, are expensive and impractical, the MARA could provide a cost-effective solution for routine ecotoxicological testing. The performance of the MARA was evaluated to ascertain its capability and potential scope. Sensitivity to toxicants and different environmental samples was assessed. Evaluation included comparison with other tests: namely Microtox, invertebrate (Daphnia magna and Thamnocephalus platyurus) microbiotests, and respiration-inhibition and nitrification-inhibition tests. The most sensitive invertebrate test was found to be the T. platyurus microbiotest for three of the four metals tested. The LC(50) values for this test for Cd(ii), Cr(vi) and As(iii) were 0.2, 0.018 and 0.3 mg l(-1), respectively; and the corresponding most sensitive MARA species MTC values were 4.4, 2.8 and 17 mg l(-1), respectively.

  3. 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

  4. Environmental genotoxicity and cancer risk in humans: a combined evaluation correlating the results of the Tradescantia micronucleus assay in the field and human biomarker assessments in serum. I. The TRAD-MCN assay.

    PubMed

    Sadowska, A; Pluygers, E; Narkiewicz, M; Pawelczak, A; Lata, B

    1994-01-01

    It is well documented that environmental pollution from industrial activity, sewage farms, hazardous waste sites, incinerators, etc, contributes to the overall cancer risk and that this contribution can be considerable under certain circumstances. It is important, therefore, to identify the level of genotoxic activity in the environment and to relate it to biomarkers of cancer risk in humans. After reviewing a range of cytogenetic assays, we have selected the Tradescantia micronucleus assay (TRAD-MCN) developed by Ma et al to be used in indoor and field evaluations. The meiotic pollen mother cells of T clone 4430 are particularly sensitive to chemical pollutants; the buds are exposed for 6-8 h. We describe assays made down wind from a coal-fired power station and from the vicinity of two waste sites. Statistically significant results were obtained at 200 m and 600 m down wind from the power station; higher levels of micronucleus frequencies (MN) were found in foggy rather than dry conditions. Similarly, in the vicinity of two waste sites the MN frequencies were significantly increased in both dry and foggy conditions up to 1.5 km down wind; this was despite previous efforts to rehabilitate the sites. The TRAD-MCN assay is sensitive, reproducible, easy to perform, well standardized, inexpensive and undemanding in equipment. We propose that it be the primary test for genotoxicity evaluation and mapping followed, in suspicious areas, by human biomarker assays.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. Biosafety Risk Assessment Methodology

    SciTech Connect

    Caskey, Susan Adele; Gaudioso, Jennifer M.; Salerno, Reynolds Mathewson; Wagner, Stefan M.; Shigematsu, Mika; Risi, George; Kozlovac, Joe; Halkjaer-Knudsen, Vibeke; Prat, Esmeralda

    2010-10-01

    Laboratories that work with biological agents need to manage their safety risks to persons working the laboratories and the human and animal community in the surrounding areas. Biosafety guidance defines a wide variety of biosafety risk mitigation measures, which include measures which fall under the following categories: engineering controls, procedural and administrative controls, and the use of personal protective equipment; the determination of which mitigation measures should be used to address the specific laboratory risks are dependent upon a risk assessment. Ideally, a risk assessment should be conducted in a manner which is standardized and systematic which allows it to be repeatable and comparable. A risk assessment should clearly define the risk being assessed and avoid over complication.

  14. 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)

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. Ozone Risk Assessment Utilities

    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

  4. Bio Risk Assessment Tool

    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

  5. 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.

  6. 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.

  7. Biosafety Risk Assessment Model

    SciTech Connect

    Daniel Bowen, Susan Caskey

    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.

  8. 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

  9. Risk assessment of welders using analysis of eight metals by ICP-MS in blood and urine and DNA damage evaluation by the comet and micronucleus assays; influence of XRCC1 and XRCC3 polymorphisms.

    PubMed

    Iarmarcovai, G; Sari-Minodier, I; Chaspoul, F; Botta, C; De Méo, M; Orsière, T; Bergé-Lefranc, J L; Gallice, P; Botta, A

    2005-11-01

    The aims of the present study were to assess the occupational risk of welders using analysis of metals in biological fluids, DNA damage evaluation by complementary genotoxic endpoints and the incidence of polymorphisms in DNA repair genes. A biomonitoring study was conducted that included biometrology (blood and urinary concentrations of aluminium, cadmium, chromium, cobalt, lead, manganese, nickel, zinc by ICP-MS), comet and cytokinesis-block micronucleus assays in peripheral lymphocytes and genetic polymorphisms of XRCC1 (p.Arg399Gln) and XRCC3 (p.Thr241Met). This study included 60 male welders divided into two groups: group 1 working without any collective protection device and group 2 equipped with smoke extraction systems. A control group (n = 30) was also included in the study. Higher chromium, lead and nickel blood and urinary concentrations were detected in the two groups of welders compared to controls. Statistically differences between welders of group 1 and group 2 were found for blood concentration of cobalt and urinary concentrations of aluminium, chromium, lead and nickel. The alkaline comet assay revealed that welders had a significant increase of OTMchi2 distribution at the end of a work week compared to the beginning; a significant induction of DNA strand breaks at the end of the week was observed in 20 welders out of 30. The cytokinesis-block micronucleus assay showed that welders of group 1 had a higher frequency of chromosomal damage than controls. The XRCC1 variant allele coding Gln amino acid at position 399 was found to be associated with a higher number of DNA breaks as revealed by the comet assay. Increased metal concentrations in biological fluids, DNA breaks and chromosomal damage in lymphocytes emphasized the need to develop safety programmes for welders.

  10. Biomechanical Rupture Risk Assessment

    PubMed Central

    2016-01-01

    Abdominal aortic aneurysm (AAA) rupture is a local event in the aneurysm wall that naturally demands tools to assess the risk for local wall rupture. Consequently, global parameters like the maximum diameter and its expansion over time can only give very rough risk indications; therefore, they frequently fail to predict individual risk for AAA rupture. In contrast, the Biomechanical Rupture Risk Assessment (BRRA) method investigates the wall’s risk for local rupture by quantitatively integrating many known AAA rupture risk factors like female sex, large relative expansion, intraluminal thrombus-related wall weakening, and high blood pressure. The BRRA method is almost 20 years old and has progressed considerably in recent years, it can now potentially enrich the diameter indication for AAA repair. The present paper reviews the current state of the BRRA method by summarizing its key underlying concepts (i.e., geometry modeling, biomechanical simulation, and result interpretation). Specifically, the validity of the underlying model assumptions is critically disused in relation to the intended simulation objective (i.e., a clinical AAA rupture risk assessment). Next, reported clinical BRRA validation studies are summarized, and their clinical relevance is reviewed. The BRRA method is a generic, biomechanics-based approach that provides several interfaces to incorporate information from different research disciplines. As an example, the final section of this review suggests integrating growth aspects to (potentially) further improve BRRA sensitivity and specificity. Despite the fact that no prospective validation studies are reported, a significant and still growing body of validation evidence suggests integrating the BRRA method into the clinical decision-making process (i.e., enriching diameter-based decision-making in AAA patient treatment).

  11. 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.

  12. 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.

  13. Biosafety Risk Assessment Model

    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

  14. Risk Assessment Workgroup report.

    PubMed

    Donohue, Joyce; Orme-Zavaleta, Jennifer; Burch, Michael; Dietrich, Daniel; Hawkins, Belinda; Lloyd, Tony; Munns, Wayne; Steevens, Jeffery; Steffensen, Dennis; Stone, Dave; Tango, Peter

    2008-01-01

    The Risk Assessment Work Group focused on six charge questions related to CHABS, cyanobacteria and their toxins. The charge questions covered the following topics: Research needed to reduce uncertainty in establishing health based guidelines. Research that minimize the cost and maximize the benefits of various regulatory approaches. Exposure pathways for receptors of concern. Data available to support the derivation of health-based guideline values for harmful cyanobacterial algal blooms. Ecological services that guidelines or regulations should protect? A framework for making risk management determinations that incorporates consideration of the characteristics of CHABs, the risk for human health, ecosystem viability, and the costs and benefits of CHABs detection and management? The Work Group concluded that there is a considerable amount of human case-study data and information from animal studies to demonstrate that cyanobacterial toxins pose a hazard to humans, domestic animals, wildlife, and the ecosystem. However, the data on dose-response are limited and confounded by a lack of sufficient pure toxin to conduct most of the toxicological studies that will be needed in order to answer remaining questions on risk, and to provide the data for quantitative dose-response analysis. The Work Group recommended that research on purification or synthesis of pure toxin must be accomplished before the large scale studies to establish dose-response relationships will be possible. As the necessary-pure toxins become available, the Work Group recommended that studies be prioritized by the impact that they will have on reducing the uncertainty in the risk assessment in order to minimize the research costs and maximize the risk assessment benefits. Use of quantitative structure activity relationships (QSAR) and toxicity equivalency factor studies are also recommended as approaches for filling dose-response data gaps. The Work Group recognized that CHABs rarely introduce single

  15. 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.

  16. 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.

  17. Risk assessment and risk management of mycotoxins.

    PubMed

    2012-01-01

    Risk assessment is the process of quantifying the magnitude and exposure, or probability, of a harmful effect to individuals or populations from certain agents or activities. Here, we summarize the four steps of risk assessment: hazard identification, dose-response assessment, exposure assessment, and risk characterization. Risk assessments using these principles have been conducted on the major mycotoxins (aflatoxins, fumonisins, ochratoxin A, deoxynivalenol, and zearalenone) by various regulatory agencies for the purpose of setting food safety guidelines. We critically evaluate the impact of these risk assessment parameters on the estimated global burden of the associated diseases as well as the impact of regulatory measures on food supply and international trade. Apart from the well-established risk posed by aflatoxins, many uncertainties still exist about risk assessments for the other major mycotoxins, often reflecting a lack of epidemiological data. Differences exist in the risk management strategies and in the ways different governments impose regulations and technologies to reduce levels of mycotoxins in the food-chain. Regulatory measures have very little impact on remote rural and subsistence farming communities in developing countries, in contrast to developed countries, where regulations are strictly enforced to reduce and/or remove mycotoxin contamination. However, in the absence of the relevant technologies or the necessary infrastructure, we highlight simple intervention practices to reduce mycotoxin contamination in the field and/or prevent mycotoxin formation during storage. PMID:23477199

  18. Assessment of plaque assay methods for alphaviruses.

    PubMed

    Juarez, Diana; Long, Kanya C; Aguilar, Patricia; Kochel, Tadeusz J; Halsey, Eric S

    2013-01-01

    Viruses from the Alphavirus genus are responsible for numerous arboviral diseases impacting human health throughout the world. Confirmation of acute alphavirus infection is based on viral isolation, identification of viral RNA, or a fourfold or greater increase in antibody titers between acute and convalescent samples. In convalescence, the specificity of antibodies to an alphavirus may be confirmed by plaque reduction neutralization test. To identify the best method for alphavirus and neutralizing antibody recognition, the standard solid method using a cell monolayer overlay with 0.4% agarose and the semisolid method using a cell suspension overlay with 0.6% carboxymethyl cellulose (CMC) overlay were evaluated. Mayaro virus, Una virus, Venezuelan equine encephalitis virus (VEEV), and Western equine encephalitis virus (WEEV) were selected to be tested by both methods. The results indicate that the solid method showed consistently greater sensitivity than the semisolid method. Also, a "semisolid-variant method" using a 0.6% CMC overlay on a cell monolayer was assayed for virus titration. This method provided the same sensitivity as the solid method for VEEV and also had greater sensitivity for WEEV titration. Modifications in plaque assay conditions affect significantly results and therefore evaluation of the performance of each new assay is needed.

  19. 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

  20. Optimal Temporal Risk Assessment

    PubMed Central

    Balci, Fuat; Freestone, David; Simen, Patrick; deSouza, Laura; Cohen, Jonathan D.; Holmes, Philip

    2011-01-01

    Time is an essential feature of most decisions, because the reward earned from decisions frequently depends on the temporal statistics of the environment (e.g., on whether decisions must be made under deadlines). Accordingly, evolution appears to have favored a mechanism that predicts intervals in the seconds to minutes range with high accuracy on average, but significant variability from trial to trial. Importantly, the subjective sense of time that results is sufficiently imprecise that maximizing rewards in decision-making can require substantial behavioral adjustments (e.g., accumulating less evidence for a decision in order to beat a deadline). Reward maximization in many daily decisions therefore requires optimal temporal risk assessment. Here, we review the temporal decision-making literature, conduct secondary analyses of relevant published datasets, and analyze the results of a new experiment. The paper is organized in three parts. In the first part, we review literature and analyze existing data suggesting that animals take account of their inherent behavioral variability (their “endogenous timing uncertainty”) in temporal decision-making. In the second part, we review literature that quantitatively demonstrates nearly optimal temporal risk assessment with sub-second and supra-second intervals using perceptual tasks (with humans and mice) and motor timing tasks (with humans). We supplement this section with original research that tested human and rat performance on a task that requires finding the optimal balance between two time-dependent quantities for reward maximization. This optimal balance in turn depends on the level of timing uncertainty. Corroborating the reviewed literature, humans and rats exhibited nearly optimal temporal risk assessment in this task. In the third section, we discuss the role of timing uncertainty in reward maximization in two-choice perceptual decision-making tasks and review literature that implicates timing uncertainty

  1. 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)

  2. Practical approaches to risk assessment.

    PubMed

    Brooke-Taylor, S

    2001-06-01

    The importance of using risk assessment in developing food regulations is growing with the globalization of our food supply. The World Trade Organization has entrenched the principles of science-based risk assessment in the Agreement on Sanitary and Phytosanitary Measures. The relevant international organization for food standards, the Codex Alimentarius Commission, recognises risk analysis, and its component parts risk assessment, risk management and risk communication, as the basis for scientific decision-making. Risk assessment comprises two activities: hazard evaluation; and exposure estimation. A hazard may be chemical, microbiological or nutritional in origin. The practical application of risk assessment in Australia is illustrated in this presentation by four examples involving: (1) food additives, (2) microbiological safety of imported raw milk cheeses, (3) genetically modified foods and (4) imported food inspection.

  3. 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.

  4. Computer Security Risk Assessment

    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

  5. 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.…

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. [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.

  11. [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

  12. 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

  13. Topographical Risk Assessment

    SciTech Connect

    Phil Daling, PNNL

    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 senior 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.

  14. Topographical Risk Assessment

    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

  15. Alkaline Comet Assay for Assessing DNA Damage in Individual Cells.

    PubMed

    Pu, Xinzhu; Wang, Zemin; Klaunig, James E

    2015-08-06

    Single-cell gel electrophoresis, commonly called a comet assay, is a simple and sensitive method for assessing DNA damage at the single-cell level. It is an important technique in genetic toxicological studies. The comet assay performed under alkaline conditions (pH >13) is considered the optimal version for identifying agents with genotoxic activity. The alkaline comet assay is capable of detecting DNA double-strand breaks, single-strand breaks, alkali-labile sites, DNA-DNA/DNA-protein cross-linking, and incomplete excision repair sites. The inclusion of digestion of lesion-specific DNA repair enzymes in the procedure allows the detection of various DNA base alterations, such as oxidative base damage. This unit describes alkaline comet assay procedures for assessing DNA strand breaks and oxidative base alterations. These methods can be applied in a variety of cells from in vitro and in vivo experiments, as well as human studies.

  16. The comet assay: assessment of in vitro and in vivo DNA damage.

    PubMed

    Bajpayee, Mahima; Kumar, Ashutosh; Dhawan, Alok

    2013-01-01

    Rapid industrialization and pursuance of a better life have led to an increase in the amount of chemicals in the environment, which are deleterious to human health. Pesticides, automobile exhausts, and new chemical entities all add to air pollution and have an adverse effect on all living organisms including humans. Sensitive test systems are thus required for accurate hazard identification and risk assessment. The Comet assay has been used widely as a simple, rapid, and sensitive tool for assessment of DNA damage in single cells from both in vitro and in vivo sources as well as in humans. Already, the in vivo comet assay has gained importance as the preferred test for assessing DNA damage in animals for some international regulatory guidelines. The advantages of the in vivo comet assay are its ability to detect DNA damage in any tissue, despite having non-proliferating cells, and its sensitivity to detect genotoxicity. The recommendations from the international workshops held for the comet assay have resulted in establishment of guidelines. The in vitro comet assay conducted in cultured cells and cell lines can be used for screening large number of compounds and at very low concentrations. The in vitro assay has also been automated to provide a high-throughput screening method for new chemical entities, as well as environmental samples. This chapter details the in vitro comet assay using the 96-well plate and in vivo comet assay in multiple organs of the mouse.

  17. 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.

  18. Guide for ecological risk assessment

    SciTech Connect

    1998-04-01

    Ecological risk assessment evaluates the likelihood that adverse ecological effects may occur or are occurring as a result of exposure to one or more stressors. Ecological risk assessment provides a critical element for environmental decision making by giving risk managers an approach for considering available scientific information along with the other factors they need to consider (e.g., social, legal, political, or economic) in selecting a course of action. The primary audience for this document is risk assessors and risk managers at EPA, although these Guidelines also may be useful to others outside the Agency.

  19. A phytoplankton growth assay for routine in situ environmental assessments.

    PubMed

    Moreira-Santos, Matilde; Soares, Amadeu M V M; Ribeiro, Rui

    2004-06-01

    This study proposes an ecologically relevant and cost-effective phytoplankton growth assay for routine in situ toxicity assessments. Assay procedures were developed applying, to the extent possible, the rationale behind the design of standard algal assays. Chlorella vulgaris was selected as test species because it grows well immobilized in alginate beads and has a wide geographic distribution. The performance of the assay in a freshwater system impacted by acid mine drainage demonstrated the suitability of assay chambers and procedures. The test system, made of inexpensive materials, allowed the rapid and easy deployment of the assay. The deployment of extra chambers at reference sites provided the ability to periodically check whether algal growth had already reached recommended growth criteria (time at which the assay should end). By deploying chambers filled with control medium at all sites, temperature was identified to explain 95% of the variation in growth. By using an artificial nutrient source shown capable of promoting algal growth according to recommended standards, toxicity from the mine effluent was distinguish from in situ nutrient limitation effects. The very good agreement (r2 = 90%) between mean in situ growth rates estimated by microscopy and by spectrophotometry and their similar coefficient of variation showed the latter to be a suitable straightforward methodology for assay endpoint estimation.

  20. Risk Assessment/Management Tool

    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

  1. 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

  2. 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.

  3. 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.

  4. Risk and Risk Assessment in Environmental Education.

    ERIC Educational Resources Information Center

    Chiras, Daniel D.

    1982-01-01

    Risk assessment (the identification of hazards, the determination of the probability of a hazardous event occurring, and an estimation of the severity of such an event's occurrence) is suggested as a technique to be used to analyze current issues in environmental education in an objective manner. (PEB)

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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

  11. 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.

  12. 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...

  13. 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.

  14. 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.

  15. 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...

  16. 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.

  17. 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

  18. Assessing equivalence of two assays using sensitivity and specificity.

    PubMed

    Quiroz, Jorge; Burdick, Richard K

    2007-01-01

    The equivalence of two assays is determined using the sensitivity and specificity relative to a gold standard. The equivalence-testing criterion is based on a misclassification rate proposed by Burdick et al. (2005) and the intersection-union test (IUT) method proposed by Berger (1982). Using a variance components model and IUT methods, we construct bounds for the sensitivity and specificity relative to the gold standard assay based on generalized confidence intervals. We conduct a simulation study to assess whether the bounds maintain the stated test size. We present a computational example to demonstrate the method described in the paper.

  19. 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

  20. 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 ...

  1. 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.

  2. Risk assessment of sensitizing agents.

    PubMed

    Gerberick, G F

    1994-01-01

    This review describes an approach that has been used to assess the skin sensitization risk of new product ingredients prior to and after marketing. The risk assessment process utilizes a comparative toxicological approach in which data on the inherent toxicity of a material and the exposure to it through manufacturing or consumer use or foreseeable misuse are integrated and compared with data generated by 'benchmark' materials of similar chemistry or product application, or both. This approach has been valuable in providing an accurate assessment of skin sensitization potential and the basis for eventual safe marketing of a wide range of consumer household and personal care products and topical pharmaceuticals.

  3. 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

  4. Collision risk assessment

    NASA Astrophysics Data System (ADS)

    Sánchez Ortiz, N.; Belló Mora, M.; Graziano, M.; Pina Caballero, F.; Sánchez Pérez, J. M.; Klinkrad, H.

    2001-10-01

    Avoidance of near misses or collisions is required for almost all satellites on orbit, but it is of particular interest for manned missions and spacecraft at densely populated regions. In order to avoid these possible collisions, it is needed to determine a possible conjunction and its associated uncertainty. Two main constraints must be taken into account when a tool to forecast the collision risk of an object is being developed: the high number of objects in space and the accuracy of the catalogued object data. The number of objects on Earth orbit makes impossible to propagate all the catalogued objects, thus filtering and parallel processing techniques are presented. The accuracy of the catalogued object data and the propagation of the error over the time identify a position ellipsoid of error, whose behaviour has an important influence on some parameters on the filtering techniques and the way the collision probability is computed. Some collision probability methods are presented.

  5. Risk assessment methodologies for biotechnology impact assessment

    NASA Astrophysics Data System (ADS)

    Gillett, James W.

    1986-07-01

    By combining hazard assessment of effects of a potential biotechnology product with exposure assessments based on study of the genetically engineered organism's fate, conclusions may be reached about the risk involved in release of the product to the environment. In order to make this risk assessment, criteria (including regulatory endpoints) must be established and then developed further against a data base from well-accepted tests. Other aspects requiring research and development include test evaluation, quality assurance, statistical procedures, and methods of identifying and monitoring not only the nominal organism(s) in the products, but also any contaminating material or organisms to which the genetically engineered components may be transferred in the environment. Application of microcosm technology to testing of genetically engineered organisms is expected to be important, since these systems may be used safely to understand fate and effects prior to (or in place of) testing the product in the environment. Limitations in the use of microcosms may be offset by the cost-effectiveness and incisiveness of results, as has been shown for other pollutants. Risk management for biotechnology products currently lacks an adequate background, but components of the process exist or can be developed. New resources, in terms of personnel, training, facilities, and funding, will be needed in order to apply the risk assessment paradigm used for toxic chemicals and pesticides. We will need to know:

  6. 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

  7. Earthquake Risk Assessment and Risk Transfer

    NASA Astrophysics Data System (ADS)

    Liechti, D.; Zbinden, A.; Rüttener, E.

    Research on risk assessment of natural catastrophes is very important for estimating its economical and social impact. The loss potentials of such disasters (e.g. earthquake and storms) for property owners, insurance and nationwide economies are driven by the hazard, the damageability (vulnerability) of buildings and infrastructures and depend on the ability to transfer these losses to different parties. In addition, the geographic distribution of the exposed values, the uncertainty of building vulnerability and the individual deductible are main factors determining the size of a loss. The deductible is the key element that steers the distribution of losses between insured and insurer. Therefore the risk analysis concentrates on deductible and vulnerability of insured buildings and maps their variations to allow efficient decisions. With consideration to stochastic event sets, the corresponding event losses can be modelled as expected loss grades of a Beta probability density function. Based on deductible and standard deviation of expected loss grades, the loss for the insured and for the insurer can be quantified. In addition, the varying deductible impact on different geographic regions can be described. This analysis has been carried out for earthquake insurance portfolios with various building types and different deductibles. Besides quantifying loss distributions between insured and insurer based on uncertainty assumptions and deductible consideration, mapping yields ideas to optimise the risk transfer process and can be used for developing risk mitigation strategies.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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)

  14. Toxicological risk assessment. Volume 2

    SciTech Connect

    Clayson, D.B.; Krewski, D.; Munro, I.

    1985-01-01

    This book contains the following chapters: Epidemiological Methods for Assessment of Human Cancer Risk. Assessment of Human Exposure to Environmental Contaminants with Special Reference to Cancer. Influence of Nutrition, Immunologic Status, and Other Factors on Development of Cancer. Significance of Benefits in Regulatory Decision Making. Measuring Health Benefits. Food Safety Regulations. Case Study-Asbestos. Vinyl Chloride - A Cancer Case Study. An Integrated Approach to the Study of Formaldehyde Carcinogenicity in Rats and Mice. Determination of Human Risk in Regulating Polychlorinated Biphenyls Saccharin - A Bitter-Sweet Case.

  15. 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).

  16. Decade of karst risk assessment

    NASA Astrophysics Data System (ADS)

    Yolkin, Vladimir

    2010-05-01

    Karst is one of the most hazardous processes on the Earth, at about 13% of the Russian area, including more than 300 towns and thousands of smaller settlements with 19% of the total population of Russia, are subject to karst deformations (Ragozin, 1994). During the time period 2000-2004, regional karst hazard and risk assessment was developed as an example of the Tatarstan Republic (Ragozin and Yolkin, 2003). The published paper was the first Russian research paper dedicated the technique and cartographic examples of probabilistic-deterministic risk assessment from karst processes. At present time, the technique of assessment of karst risk is improved, as well as investigations with reference to various areal or linear recipients are performed. In particular, for the pipeline systems the assessment of karst economic risk adapts, according to two scenarios: the pessimistic one (the most adverse in consequences) and the most probable (Yolkin and Anikeev, 2007, Yolkin, 2008,2009). By karst risk we mean the probabilistic index of hazard of karst and karst-suffosion sinkholes and surface settlements established for a certain object as it possible losses in various spheres for a given time period. Quantitative karst-hazard and risk assessment is carried out on the basis of the analysis of geological structure of territory, hydrogeological and engineering-geological conditions of territory, identification and prediction of karst hazards in time and space, assessment of vulnerability of objects to karst hazards, ranking and mapping of karst hazards as well as karst economic, social risks of losses. The obtained values of economic or social risk are the basis for choosing engineering protection measures, alternative design solutions and for estimating service conditions. It is necessary to mention that the procedure of vulnerability assessment is poorly developed with reference not only to karst sinkholes, but also to dangerous geological processes in general. For

  17. 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

  18. 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.

  19. 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…

  20. Integrated Disposal Facility Risk Assessment

    SciTech Connect

    MANN, F. M.

    2003-06-03

    An environmental risk assessment associated with the disposal of projected Immobilized Low-Activity Waste, solid wastes and failed or decommissioned melters in an Integrated Disposal Facility was performed. Based on the analyses all performance objectives associated with the groundwater, air, and intruder pathways were met.

  1. 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.

  2. 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.

  3. OVERCOMING OBSTACLES TO POPULATIONS RISK ASSESSMENT

    EPA Science Inventory

    Driven by management goals, statutory requirements and stakeholder interests, populations of wildlife and aquatic organisms often are the assessment endpoint entities (assessment populations) identified in site-specific ecological risk assessments. Yet, risks to populations are ...

  4. 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.

  5. 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.

  6. [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

  7. 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.

  8. 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...

  9. 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…

  10. 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…

  11. 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

  12. [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

  13. Risk Assessment Terminology: Risk Communication Part 2

    PubMed Central

    Bentley, Stefano; Giacometti, Federica; Piva, Silvia; Serraino, Andrea

    2016-01-01

    The paper describes the terminology of risk communication in the view of food safety: different aspects of risk perception (perceived risk, media triggers, the psychometric paradigm, fright factors and cultural determinants of risk perception) are described. The risk profile elements are illustrated in the manuscript: hazard-food commodity combination(s) of concern; description of the public health problem; food production, processing, distribution and consumption; needs and questions for the risk assessors; available information and major knowledge gaps and other risk profile elements. PMID:27800443

  14. Disability and work: risk assessment.

    PubMed

    Meusz, C

    Recent parliamentary debate has brought the rights of disabled people back into the spotlight of media attention. In the workplace, the occupational health nurse (OHN) is uniquely placed to make a positive contribution to the achievement of equal opportunities for people with disabilities. The author describes a risk assessment approach to the occupational health and safety of disabled persons and their employers. Such approaches can help to ensure that the work skills of all employees are used to maximum potential.

  15. 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

  16. 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

  17. Acellular comet assay: a tool for assessing variables influencing the alkaline comet assay.

    PubMed

    Kennedy, Erin K; McNamee, James P; Prud'homme Lalonde, Louise; Jones, Trevor; Wilkinson, Diana

    2012-01-01

    In this study, an acellular modification to the alkaline comet assay to further evaluate key variables within the assay that may influence the outcome of genotoxicity studies is described. This acellular comet assay can detect differences of 0.2 Gy of (60)Co gamma-ray radiation between 0 and 1 Gy and differences of 1 Gy between 0 and 8 Gy; thus, this assay is applicable for a wide range of DNA damage levels. It is also shown that DNA damage from different radiation energies was not significantly different from (60)Co gamma-ray. This assay displayed a statistical increase in DNA damage due to uncontrolled exposure to natural light; however, the slope of the dose-response curve for light-exposed samples was similar to that for samples protected from light. A comparison of the alkaline comet assay with the acellular comet assay allowed for the intrinsic repair capacity of the alkaline comet assay to be quantified.

  18. 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

  19. Can Public Health Risk Assessment Using Risk Matrices Be Misleading?

    PubMed Central

    Vatanpour, Shabnam; Hrudey, Steve E.; Dinu, Irina

    2015-01-01

    The risk assessment matrix is a widely accepted, semi-quantitative tool for assessing risks, and setting priorities in risk management. Although the method can be useful to promote discussion to distinguish high risks from low risks, a published critique described a problem when the frequency and severity of risks are negatively correlated. A theoretical analysis showed that risk predictions could be misleading. We evaluated a practical public health example because it provided experiential risk data that allowed us to assess the practical implications of the published concern that risk matrices would make predictions that are worse than random. We explored this predicted problem by constructing a risk assessment matrix using a public health risk scenario—Tainted blood transfusion infection risk—That provides negative correlation between harm frequency and severity. We estimated the risk from the experiential data and compared these estimates with those provided by the risk assessment matrix. Although we validated the theoretical concern, for these authentic experiential data, the practical scope of the problem was limited. The risk matrix has been widely used in risk assessment. This method should not be abandoned wholesale, but users must address the source of the problem, apply the risk matrix with a full understanding of this problem and use matrix predictions to inform, but not drive decision-making. PMID:26287224

  20. 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...

  1. 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

  2. Risk Assessment Terminology: Risk Communication Part 1

    PubMed Central

    Bentley, Stefano; Giacometti, Federica; Piva, Silvia; Serraino, Andrea

    2016-01-01

    The paper describes the terminology of risk communication in the view of food safety: the theory of stakeholders, the citizens’ involvement and the community interest and consultation are reported. Different aspects of risk communication (public communication, scientific uncertainty, trust, care, consensus and crisis communication) are discussed. PMID:27800435

  3. Supporting Risk Assessment: Accounting for Indirect Risk to Ecosystem Components.

    PubMed

    Murray, Cathryn Clarke; Mach, Megan E; Martone, Rebecca G; Singh, Gerald G; O, Miriam; Chan, Kai M A

    2016-01-01

    The multi-scalar complexity of social-ecological systems makes it challenging to quantify impacts from human activities on ecosystems, inspiring risk-based approaches to assessments of potential effects of human activities on valued ecosystem components. Risk assessments do not commonly include the risk from indirect effects as mediated via habitat and prey. In this case study from British Columbia, Canada, we illustrate how such "indirect risks" can be incorporated into risk assessments for seventeen ecosystem components. We ask whether (i) the addition of indirect risk changes the at-risk ranking of the seventeen ecosystem components and if (ii) risk scores correlate with trophic prey and habitat linkages in the food web. Even with conservative assumptions about the transfer of impacts or risks from prey species and habitats, the addition of indirect risks in the cumulative risk score changes the ranking of priorities for management. In particular, resident orca, Steller sea lion, and Pacific herring all increase in relative risk, more closely aligning these species with their "at-risk status" designations. Risk assessments are not a replacement for impact assessments, but-by considering the potential for indirect risks as we demonstrate here-they offer a crucial complementary perspective for the management of ecosystems and the organisms within. PMID:27632287

  4. Supporting Risk Assessment: Accounting for Indirect Risk to Ecosystem Components

    PubMed Central

    Mach, Megan E.; Martone, Rebecca G.; Singh, Gerald G.; O, Miriam; Chan, Kai M. A.

    2016-01-01

    The multi-scalar complexity of social-ecological systems makes it challenging to quantify impacts from human activities on ecosystems, inspiring risk-based approaches to assessments of potential effects of human activities on valued ecosystem components. Risk assessments do not commonly include the risk from indirect effects as mediated via habitat and prey. In this case study from British Columbia, Canada, we illustrate how such “indirect risks” can be incorporated into risk assessments for seventeen ecosystem components. We ask whether (i) the addition of indirect risk changes the at-risk ranking of the seventeen ecosystem components and if (ii) risk scores correlate with trophic prey and habitat linkages in the food web. Even with conservative assumptions about the transfer of impacts or risks from prey species and habitats, the addition of indirect risks in the cumulative risk score changes the ranking of priorities for management. In particular, resident orca, Steller sea lion, and Pacific herring all increase in relative risk, more closely aligning these species with their “at-risk status” designations. Risk assessments are not a replacement for impact assessments, but—by considering the potential for indirect risks as we demonstrate here—they offer a crucial complementary perspective for the management of ecosystems and the organisms within. PMID:27632287

  5. 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...

  6. Assessing research risks systematically: the net risks test.

    PubMed

    Wendler, D; Miller, F G

    2007-08-01

    Dual-track assessment directs research ethics committees (RECs) to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants. PMID:17664310

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. Risk modelling for vaccination: a risk assessment perspective.

    PubMed

    Wooldridge, M

    2007-01-01

    Any risk assessment involves a number of steps. First, the risk manager, in close liaison with the risk assessor, should identify the question of interest. Then, the hazards associated with each risk question should be identified. Only then can the risks themselves be assessed. Several questions may reasonably be asked about the risk associated with avian influenza vaccines and their use. Some apply to any vaccine, while others are specific to avian influenza. Risks may occur during manufacture and during use. Some concern the vaccines themselves, while others address the effect of failure on disease control. The hazards associated with each risk question are then identified. These may be technical errors in design, development or production, such as contamination or failure to inactivate appropriately. They may relate to the biological properties of the pathogens themselves displayed during manufacture or use, for example, reversion to virulence, shedding or not being the right strain for the subsequent challenge. Following a consideration of risks and hazards, the information needed and an outline of the steps necessary to assess the risk is summarized, for an illustrative risk question using, as an example, the risks associated with the use of vaccines in the field. A brief consideration of the differences between qualitative and quantitative risk assessments is also included, and the potential effects of uncertainty and variability on the results are discussed.

  15. 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...

  16. [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.

  17. 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.

  18. 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.

  19. 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.

  20. [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.

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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...

  6. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with... LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL STRUCTURES Project-Based...

  7. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with... LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL STRUCTURES Project-Based...

  8. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with... LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL STRUCTURES Project-Based...

  9. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with... LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL STRUCTURES Project-Based...

  10. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with... LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL STRUCTURES Project-Based...

  11. 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

  12. 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.

  13. 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.

  14. Biologically based, quantitative risk assessment of neurotoxicants.

    PubMed

    Slikker, W; Crump, K S; Andersen, M E; Bellinger, D

    1996-01-01

    The need for biologically based, quantitative risk assessment procedures for noncancer endpoints such as neurotoxicity has been discussed in reports by the United States Congress (Office of Technology Assessment, OTA), National Research Council (NRC), and a federal coordinating council. According to OTA, current attention and resources allocated to health risk assessment research are inadequate and not commensurate with its impact on public health and the economy. Methods to include continuous rather than dichotomous data for neurotoxicity endpoints, biomarkers of exposure and effects, and pharmacokinetic and mechanistic data have been proposed for neurotoxicity risk assessment but require further review and validation before acceptance. The purpose of this symposium was to examine procedures to enhance the risk assessment process for neurotoxicants and to discuss techniques to make the process more quantitative. Accordingly, a review of the currently used safety factor risk assessment approach for neurotoxicants is provided along with specific examples of how this process may be enhanced with the use of the benchmark dose approach. The importance of including physiologically based pharmacokinetic data in the risk assessment process and specific examples of this approach is presented for neurotoxicants. The role of biomarkers of exposure and effect and mechanistic information in the risk assessment process are also addressed. Finally, quantitative approaches with the use of continuous neurotoxicity data are demonstrated and the outcomes compared to those generated by currently used risk assessment procedures. PMID:8838636

  15. 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.

  16. 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,…

  17. 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...

  18. 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 ...

  19. 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...

  20. 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...

  1. Risk Assess: What's Safe? What's Not? Why?

    ERIC Educational Resources Information Center

    Duffy, Roslyn

    2010-01-01

    "Risk assess!" The words sound like a verbal stop sign. "Stop! Think! Consider!" In this article, the author presents an example of risk assessing that came from a nature education conference in Crieff, Scotland, that she attended as part of an international group of educators seeking ways to increase children's experiences with nature. The…

  2. 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.

  3. 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.

  4. Mitigation by vitamin C of the genotoxic effects of nicotine in mice, assessed by the comet assay and micronucleus induction.

    PubMed

    Kahl, Vivian F S; Reyes, Juliana M; Sarmento, Merielen S; da Silva, Juliana

    2012-05-15

    Nicotine has been reported to cause acute toxicity and to present long-term risks, such as chromosomal damage and genetic instability. The genotoxicity of nicotine may be mediated partly by an oxidative mechanism. We have evaluated the effects of the antioxidant vitamin C on nicotine-induced genotoxicity in mice. The comet assay and the micronucleus test were used to assess the effects of nicotine (15mg/kg) at different exposure times (2, 4, and 24h in the comet assay; 24h in the micronucleus test). Pretreatment with vitamin C 24h before nicotine exposure strongly protected mice against nicotine-induced DNA damage. PMID:22331007

  5. 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

  6. 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...

  7. 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...

  8. 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...

  9. 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

  10. 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.

  11. 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.

  12. Risk Assessment for Tooth Wear.

    PubMed

    Kontaxopoulou, Isavella; Alam, Sonia

    2015-08-01

    Tooth wear has an increasing prevalence in the UK population. The aetiology is commonly multifactorial, and the aetiopathology is through a combination of erosion, attrition, abrasion and abfraction. Erosion is associated with intrinsic or extrinsic acids, and therefore subjects with reflux disease and eating disorders are at increased risk. Fruit juice, fruits and carbonated drink consumption, frequency of consumption and specific habits are also risk factors. Attrition is more prevalent in bruxists. Other habits need to be considered when defining the risk of tooth wear. Abrasion is usually associated with toothbrushing and toothpastes, especially in an already acidic environment. Patients with extensive lesions that affect dentin may be at higher risk, as well as those presenting with unstained lesions. Monitoring of the progress of tooth wear is recommended to identify those with active tooth wear. Indices for tooth wear are a helpful aid. PMID:26556515

  13. Risk Assessment for Tooth Wear.

    PubMed

    Kontaxopoulou, Isavella; Alam, Sonia

    2015-08-01

    Tooth wear has an increasing prevalence in the UK population. The aetiology is commonly multifactorial, and the aetiopathology is through a combination of erosion, attrition, abrasion and abfraction. Erosion is associated with intrinsic or extrinsic acids, and therefore subjects with reflux disease and eating disorders are at increased risk. Fruit juice, fruits and carbonated drink consumption, frequency of consumption and specific habits are also risk factors. Attrition is more prevalent in bruxists. Other habits need to be considered when defining the risk of tooth wear. Abrasion is usually associated with toothbrushing and toothpastes, especially in an already acidic environment. Patients with extensive lesions that affect dentin may be at higher risk, as well as those presenting with unstained lesions. Monitoring of the progress of tooth wear is recommended to identify those with active tooth wear. Indices for tooth wear are a helpful aid.

  14. Genotoxicity of environmental agents assessed by the alkaline comet assay.

    PubMed

    Møller, Peter

    2005-01-01

    Generation of DNA damage is considered to be an important initial event in carcinogenesis. A considerable battery of assays exists for the detection of different genotoxic effects of compounds in experimental systems, or for investigations of exposure to genotoxic agents in environmental or occupational settings. Some of the tests may have limited use because of complicated technical setup or because they only are applicable to a few cell types. The single cell gel electrophoresis (comet) assay is technically simple, relatively fast, cheap, and DNA damage can be investigated in virtually all mammalian cell types without requirement for cell culture. The aim of this thesis was to evaluate the comet assay as a genotoxicity test in genetic toxicology of environmental agents, encompassing both experimental animal models and biomonitoring. The comet assay detects strand breaks (SB). The cells are embedded in agarose and lysed, generating nucleus-like structures in the gel (referred to as nucleoids). Following alkaline electrophoresis, the DNA strands migrate toward the anode, and the extent of migration depends on the number of SB in the nucleoid. The migration is visualized and scored in a fluorescence microscope after staining. Broad classes of oxidative DNA damage can be detected as additional SB if nucleoids are incubated with bacterial DNA glycosylase/endonuclease enzymes. Oxidized pyrimidines and purines can be detected by incubation with endonuclease III and formamidopyrimidine DNA glycosylase, respectively. The animal experimental studies indicated that the comet assay was able to detect genotoxic effects of diesel exhaust particles in lung tissue, 2-amino-3-methylimidazo[4,5-f]quinoline (IQ)-induced DNA damage in colon epithelial cells and liver tissue, and benzene-induced damage in bone marrow and liver cells. The strength of the comet assay was further outlined by application of repair enzymes, indicating no oxidative DNA base damage following IQ treatment

  15. 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.

  16. 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

  17. Enhancing the Ecological Risk Assessment Process

    SciTech Connect

    Dale, Virginia H

    2008-01-01

    The Ecological Processes and Effects Committee of the US Environmental Protection Agency Science Advisory Board conducted a self-initiated study and convened a public workshop to characterize the state of the ecological risk assessment (ERA), with a view toward advancing the science and application of the process. That survey and analysis of ERA in decision making shows that such assessments have been most effective when clear management goals were included in the problem formulation; translated into information needs; and developed in collaboration with decision makers, assessors, scientists, and stakeholders. This process is best facilitated when risk managers, risk assessors, and stakeholders are engaged in an ongoing dialogue about problem formulation. Identification and acknowledgment of uncertainties that have the potential to profoundly affect the results and outcome of risk assessments also improves assessment effectiveness. Thus we suggest (1) thorough peer review of ERAs be conducted at the problem formulation stage and (2) the predictive power of risk-based decision making be expanded to reduce uncertainties through analytical and methodological approaches like life cycle analysis. Risk assessment and monitoring programs need better integration to reduce uncertainty and to evaluate risk management decision outcomes. Postdecision audit programs should be initiated to evaluate the environmental outcomes of risk-based decisions. In addition, a process should be developed to demonstrate how monitoring data can be used to reduce uncertainties. Ecological risk assessments should include the effects of chemical and nonchemical stressors at multiple levels of biological organization and spatial scale, and the extent and resolution of the pertinent scales and levels of organization should be explicitly considered during problem formulation. An approach to interpreting lines of evidence and weight of evidence is critically needed for complex assessments, and it

  18. 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.

  19. 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

  20. 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

  1. Enzymatic MPG DNA repair assays for two different oxidative DNA lesions reveal associations with increased lung cancer risk.

    PubMed

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

    2014-12-01

    DNA repair is a major mechanism for minimizing mutations and reducing cancer risk. Here, we present the development of reproducible and specific enzymatic assays for methylpurine DNA glycosylase (MPG) repairing the oxidative lesions 1,N6-ethenoadenine (εA) and hypoxanthine (Hx) in peripheral blood mononuclear cells protein extracts. Association of these DNA repair activities 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 MPG-εA in case patients was 15.8 units/μg protein (95% CI 15.3-16.3), significantly higher than in control subjects-15.1 (14.6-15.5), *P = 0.011. The adjusted odds ratio for lung cancer associated with a one SD increase in MPG-εA activity (2.48 units) was significantly bigger than 1 (OR = 1.6, 95% CI = 1.1-2.4; *P = 0.013). When activity of OGG1, a different DNA repair enzyme for oxidative damage, was included in the model, the estimated odds ratio/SD for a combined MPG-εA-OGG1 score was 2.6 (95% CI 1.6-4.2) *P = 0.0001, higher than the odds ratio for each single assay. The MPG enzyme activity assays described provide robust functional risk biomarkers, with increased MPG-εA activity being associated with increased lung cancer risk, similar to the behavior of MPG-Hx. This underscores the notion that imbalances in DNA repair, including high DNA repair, usually perceived as beneficial, can cause cancer risk. Such DNA repair risk biomarkers may be useful for risk assessment of lung cancer and perhaps other cancer types, and for early detection techniques such as low-dose CT.

  2. 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

  3. A PCR-based microwell-plate hybrid capture assay for high-risk human papillomavirus.

    PubMed

    Wang, Yumei; Liu, Yan; Ding, Yaping; Sun, Nan; Gong, Yafang; Gao, Shangxian

    2014-12-01

    Human papillomavirus (HPV) is associated with cervical cancer. In this study, we developed a high-throughput microwell-plate hybrid capture (MPHC) method for epidemiological studies of high-risk HPV (HRHPV). The results with 1238 cervical specimens from female outpatients showed a concordance rate of 94.3 % between the MPHC and Hybrid Capture II assay. The MPHC assay showed an average HRHPV rate of 29.3 % for high-risk populations in populous cities of China. The established MPHC assay could sensitively and specifically detect 13 types of HRHPV and is suitable for large-scale screening, especially in areas where real-time PCR or fluorescence equipment is unavailable.

  4. Nuclear insurance risk assessment using risk-based methodology

    SciTech Connect

    Wendland, W.G. )

    1992-01-01

    This paper presents American Nuclear Insurers' (ANI's) and Mutual Atomic Energy Liability Underwriters' (MAELU's) process and experience for conducting nuclear insurance risk assessments using a risk-based methodology. The process is primarily qualitative and uses traditional insurance risk assessment methods and an approach developed under the auspices of the American Society of Mechanical Engineers (ASME) in which ANI/MAELU is an active sponsor. This process assists ANI's technical resources in identifying where to look for insurance risk in an industry in which insurance exposure tends to be dynamic and nonactuarial. The process is an evolving one that also seeks to minimize the impact on insureds while maintaining a mutually agreeable risk tolerance.

  5. 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.

  6. Dissecting the assays to assess microbial tolerance to toxic chemicals in bioprocessing.

    PubMed

    Zingaro, Kyle A; Nicolaou, Sergios A; Papoutsakis, Eleftherios T

    2013-11-01

    Microbial strains are increasingly used for the industrial production of chemicals and biofuels, but the toxicity of components in the feedstock and product streams limits process outputs. Selected or engineered microbes that thrive in the presence of toxic chemicals can be assessed using tolerance assays. Such assays must reasonably represent the conditions the cells will experience during the intended process and measure the appropriate physiological trait for the desired application. We review currently used tolerance assays, and examine the many parameters that affect assay outcomes. We identify and suggest the use of the best-suited assays for each industrial bioreactor operating condition, discuss next-generation assays, and propose a standardized approach for using assays to examine tolerance to toxic chemicals.

  7. Microfluidic platforms for advanced risk assessments of nanomaterials.

    PubMed

    Mahto, Sanjeev Kumar; Charwat, Verena; Ertl, Peter; Rothen-Rutishauser, Barbara; Rhee, Seog Woo; Sznitman, Josué

    2015-05-01

    In the past few years, promising efforts to utilize microfabrication-based technologies have laid the foundation for developing advanced, and importantly more physiologically-realistic, microfluidic methods for risk assessment of engineered nanomaterials (ENMs). In the present review, we discuss the wave of recent developments using microfluidic-based in vitro models and platforms for nanotoxicological assays, such as determination of cell viability, cellular dose, oxidative stress and nuclear damage. Here, we specifically highlight the tangible advantages of microfluidic devices in providing promising tools to tackle many of the current and ongoing challenges faced with traditional toxicology assays. Most importantly, microfluidic technology not only allows to recreate physiologically-relevant in vitro models for nanotoxicity examinations, but also provides platforms that deliver an attractive strategy towards improved control over applied ENM doses. In a final step, we present examples of state-of-the-art microfluidic platforms for in vitro assessment of potential adverse ENM effects.

  8. 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 ...

  9. 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.

  10. 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…

  11. 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.

  12. 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

  13. Perioperative risk assessment. Common misconceptions.

    PubMed

    Mishriki, Y Y

    1989-04-01

    Proper assessment of the preoperative patient is a blend of the art and science of medicine. The body of literature dealing with the various facets of this assessment has grown in the past few years. Unfortunately, this core of knowledge is neither well taught to residents-in-training nor well appreciated by many practicing physicians. Thus, evaluation of the surgical patient is often guided by personal anecdotes and unjustified assumptions. Seven common misconceptions are addressed in this article. PMID:2648378

  14. Framework for metals risk assessment [ Journal Article

    EPA Science Inventory

    This is a science-based document that describes basic principles that address the special attributes and behaviors of metals and metal compounds to be considered when assessing their human health and ecological risks.

  15. Assessing risk: Putting toxicity in perspective

    SciTech Connect

    Williams, C.

    1993-08-01

    Opinions on risk assessment vary from believing the process to be a purely pursuit at one extreme to professing that it is merely a {open_quotes}plug and chug{close_quotes} or {open_quotes}turn the crank{close_quotes} exercise at the other. Those familiar with the field recognize, however, that risk assessment is basically a process of exercising good scientific analysis and judgement. More specifically, risk assessment is the devise by which one arrives at decisions concerning accidental chemical exposures, chemical tolerances in food, allowable workplace chemical exposures and chemicals in the environment from uncontrolled industrial and waste sites. This paper discussess risk assessment and relations to the Superfund.

  16. 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,...

  17. Salivary Biomarkers for Caries Risk Assessment

    PubMed Central

    Guo, Lihong; Shi, Wenyuan

    2013-01-01

    Saliva contains various microbes and host biological components that could be used for caries risk assessment. This review focuses on the research topics that connect dental caries with saliva, including both the microbial and host components within saliva. PMID:23505756

  18. 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)

  19. 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<...

  20. 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

  1. 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

  2. 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.

  3. 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

  4. 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...

  5. 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

  6. 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…

  7. 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...

  8. 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.

  9. 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...

  10. A HESI consortium approach to assess the human predictive value of non-clinical repolarization assays.

    PubMed

    Trepakova, Elena S; Koerner, John; Pettit, Syril D; Valentin, Jean-Pierre

    2009-01-01

    Drug-induced ventricular arrhythmia and Torsades de Pointes remain a serious public health issues in bringing safe new pharmaceuticals to the market place. Under the auspices of the International Life Science Institute (ILSI)-Health and Environmental Sciences Institute (HESI), a consortium involving representatives from pharmaceutical companies, regulatory agencies and opinion leaders from the scientific and medical research communities has been initiated. The objectives are (1) to assess the concordance between signals in non-clinical repolarization assays and clinical QT interval prolongation; (2) to investigate the mechanisms for any discrepancy identified between non-clinical and clinical results and to determine viable and successful alternative approaches to identify these compounds; and (3) to assess the proarrhythmic potential of such compounds. At present, the consortium is conducting a retrospective analysis of non-clinical and clinical data from both FDA and contributing companies' databases and supplementing with a literature review. The overall objectives of these initial efforts are to establish a quantitative integrated risk assessment for each compound; to define criteria for concordance and apply them to the database in order to identify non-concordant compounds.

  11. Assessment of Synthetic Matrix Metalloproteinase Inhibitors by Fluorogenic Substrate Assay.

    PubMed

    Lively, Ty J; Bosco, Dale B; Khamis, Zahraa I; Sang, Qing-Xiang Amy

    2016-01-01

    Matrix metalloproteinases (MMPs) are a family of metzincin enzymes that act as the principal regulators and remodelers of the extracellular matrix (ECM). While MMPs are involved in many normal biological processes, unregulated MMP activity has been linked to many detrimental diseases, including cancer, neurodegenerative diseases, stroke, and cardiovascular disease. Developed as tools to investigate MMP function and as potential new therapeutics, matrix metalloproteinase inhibitors (MMPIs) have been designed, synthesized, and tested to regulate MMP activity. This chapter focuses on the use of enzyme kinetics to characterize inhibitors of MMPs. MMP activity is measured via fluorescence spectroscopy using a fluorogenic substrate that contains a 7-methoxycoumarin-4-acetic acid N-succinimidyl ester (Mca) fluorophore and a 2,4-dinitrophenyl (Dpa) quencher separated by a scissile bond. MMP inhibitor (MMPI) potency can be determined from the reduction in fluorescent intensity when compared to the absence of the inhibitor. This chapter describes a technique to characterize a variety of MMPs through enzyme inhibition assays.

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

    PubMed

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

    2016-09-15

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

  13. Risk assessment Barter Island radar installation, Alaska

    SciTech Connect

    1995-05-05

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

  14. 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.

  15. Assessing Your Board's Risk Tolerance

    ERIC Educational Resources Information Center

    Griswold, John S.; Jarvis, William F.

    2014-01-01

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

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

    PubMed

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

    2016-07-01

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

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

    PubMed

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

    2016-07-01

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

  18. NATIONAL-SCALE ASSESSMENT OF AIR TOXICS RISKS

    EPA Science Inventory

    The national-scale assessment of air toxics risks is a modeling assessment which combines emission inventory development, atmospheric fate and transport modeling, exposure modeling, and risk assessment to characterize the risk associated with inhaling air toxics from outdoor sour...

  19. Biological Based Risk Assessment for Space Exploration

    NASA Technical Reports Server (NTRS)

    Cucinotta, Francis A.

    2011-01-01

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

  20. Risk Assessment in the 21st Century

    EPA Science Inventory

    For the past ~50 years, risk assessment depended almost exclusively on animal testing for hazard identification and dose-response assessment. Originally sound and effective, with increasing dependence on chemical tools and the number of chemicals in commerce, this traditional app...

  1. Validating a multifactorial falls risk assessment.

    PubMed

    James, Michele B; Kimmons, Nancy J; Schasberger, Britta; Lefkowitz, Abigail

    2014-01-01

    Reducing risk of falls has been identified as a national safety goal by The Joint Commission (TJC). The purpose was to determine if the total score on the multifactorial Falls Risk Assessment accurately identifies the risk of falls in a homebound client. In addition, the study examined if any individual item had a higher predictive power with the incidence of falls. One hundred clients (> 65 years old) who sustained an avoidable fall during a home care episode of care, plus 25 home care clients in the same age range and time period, who did not fall. A retrospective chart review, including Falls Risk Assessment (FRA) performed at start of care, demographic information, specific physical therapy (PT) evaluation, and visit notes if necessary to determine if the fall met the inclusion criteria. Scores for each individual area of the assessment were collected for statistical analysis. Data were analyzed by a biostatistician using simple linear regression, t-tests, and regression of variable combinations. The total score on the multifactorial risk assessment tool was shown to have a strong relationship with incidence of falls. The average scores of individuals who fell after assessment were significantly higher than those of individuals who did not fall. No single factors were found to be highly predictive. A single approach to decreasing falls is likely to be less effective than a multipronged approach. Caregivers and providers are advised to consider the entirety of the falls risk and direct comprehensive interventions to address the multiple factors that lead to falls.

  2. Blue print for building a risk assessment

    SciTech Connect

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

    1997-05-01

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

  3. Incorporating Nonchemical Stressors Into Cumulative Risk Assessments

    PubMed Central

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

    2012-01-01

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

  4. Hanford waste vitrification systems risk assessment

    SciTech Connect

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

    1991-09-01

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

  5. Modeling food spoilage in microbial risk assessment.

    PubMed

    Koutsoumanis, Konstantinos

    2009-02-01

    In this study, I describe a systematic approach for modeling food spoilage in microbial risk assessment that is based on the incorporation of kinetic spoilage modeling in exposure assessment by combining data and models for the specific spoilage organisms (SSO: fraction of the total microflora responsible for spoilage) with those for pathogens. The structure of the approach is presented through an exposure assessment application for Escherichia coli O157:H7 in ground beef. The proposed approach allows for identifying spoiled products at the time of consumption by comparing the estimated level of SSO (pseudomonads) with the spoilage level (level of SSO at which spoilage is observed). The results of the application indicate that ignoring spoilage in risk assessment could lead to significant overestimations of risk.

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

    PubMed

    Wesselschmidt, Robin L

    2011-01-01

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

  7. Integrating public risk perception into formal natural hazard risk assessment

    NASA Astrophysics Data System (ADS)

    Plattner, Th.; Plapp, T.; Hebel, B.

    2006-06-01

    An urgent need to take perception into account for risk assessment has been pointed out by relevant literature, its impact in terms of risk-related behaviour by individuals is obvious. This study represents an effort to overcome the broadly discussed question of whether risk perception is quantifiable or not by proposing a still simple but applicable methodology. A novel approach is elaborated to obtain a more accurate and comprehensive quantification of risk in comparison to present formal risk evaluation practice. A consideration of relevant factors enables a explicit quantification of individual risk perception and evaluation. The model approach integrates the effective individual risk reff and a weighted mean of relevant perception affecting factors PAF. The relevant PAF cover voluntariness of risk-taking, individual reducibility of risk, knowledge and experience, endangerment, subjective damage rating and subjective recurrence frequency perception. The approach assigns an individual weight to each PAF to represent its impact magnitude. The quantification of these weights is target-group-dependent (e.g. experts, laypersons) and may be effected by psychometric methods. The novel approach is subject to a plausibility check using data from an expert-workshop. A first model application is conducted by means of data of an empirical risk perception study in Western Germany to deduce PAF and weight quantification as well as to confirm and evaluate model applicbility and flexibility. Main fields of application will be a quantification of risk perception by individual persons in a formal and technical way e.g. for the purpose of risk communication issues in illustrating differing perspectives of experts and non-experts. For decision making processes this model will have to be applied with caution, since it is by definition not designed to quantify risk acceptance or risk evaluation. The approach may well explain how risk perception differs, but not why it differs. The

  8. Personalized Cancer Risk Assessments for Space Radiation Exposures.

    PubMed

    Locke, Paul A; Weil, Michael M

    2016-01-01

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

  9. Personalized Cancer Risk Assessments for Space Radiation Exposures

    PubMed Central

    Locke, Paul A.; Weil, Michael M.

    2016-01-01

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

  10. Assessing patients' risk of febrile neutropenia: is there a correlation between physician-assessed risk and model-predicted risk?

    PubMed

    Lyman, Gary H; Dale, David C; Legg, Jason C; Abella, Esteban; Morrow, Phuong Khanh; Whittaker, Sadie; Crawford, Jeffrey

    2015-08-01

    This study evaluated the correlation between the risk of febrile neutropenia (FN) estimated by physicians and the risk of severe neutropenia or FN predicted by a validated multivariate model in patients with nonmyeloid malignancies receiving chemotherapy. Before patient enrollment, physician and site characteristics were recorded, and physicians self-reported the FN risk at which they would typically consider granulocyte colony-stimulating factor (G-CSF) primary prophylaxis (FN risk intervention threshold). For each patient, physicians electronically recorded their estimated FN risk, orders for G-CSF primary prophylaxis (yes/no), and patient characteristics for model predictions. Correlations between physician-assessed FN risk and model-predicted risk (primary endpoints) and between physician-assessed FN risk and G-CSF orders were calculated. Overall, 124 community-based oncologists registered; 944 patients initiating chemotherapy with intermediate FN risk enrolled. Median physician-assessed FN risk over all chemotherapy cycles was 20.0%, and median model-predicted risk was 17.9%; the correlation was 0.249 (95% CI, 0.179-0.316). The correlation between physician-assessed FN risk and subsequent orders for G-CSF primary prophylaxis (n = 634) was 0.313 (95% CI, 0.135-0.472). Among patients with a physician-assessed FN risk ≥ 20%, 14% did not receive G-CSF orders. G-CSF was not ordered for 16% of patients at or above their physician's self-reported FN risk intervention threshold (median, 20.0%) and was ordered for 21% below the threshold. Physician-assessed FN risk and model-predicted risk correlated weakly; however, there was moderate correlation between physician-assessed FN risk and orders for G-CSF primary prophylaxis. Further research and education on FN risk factors and appropriate G-CSF use are needed.

  11. Resource handbook on transportation risk assessment.

    SciTech Connect

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

    2003-01-01

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

  12. Risk assessment and risk management of noncriteria pollutants.

    PubMed

    Lee, S D

    1990-10-01

    Noncriteria air pollutants are synonymous with hazardous air pollutants (HAPs), air toxics or toxic air pollutants (TAPs). The term noncriteria pollutants refers to all air pollutants except for the criteria pollutants (SOx, PM, NOx, CO, O3, and Pb). Air toxics are pervasive in our environment worldwide in varying degrees. Uses of these chemicals are varied and numerous; their emissions are ubiquitous, and they include organic compounds such as chlorinated hydrocarbons, dioxins, aldehydes, polynuclear aromatic hydrocarbons, and heavy metals such as chromium, nickel, cadmium, and mercury. There are more than 70,000 chemicals that are in use commercially in the United States, and we know relatively little about their ambient concentrations, persistence, transport and transformation as well as their effects on health and the environment, many of which take decades to emerge. The United States Environmental Protection Agency, under the authority of Section 112 of the Clean Air Act, is mandated to regulate any air pollutant which, in the Administrator's judgment, "causes, or contributes to, air pollution which may reasonably be anticipated to result in an increase in serious irreversible or incapacitating reversible illness." For such regulatory decision-making, EPA's Office of Health and Environmental Assessment (OHEA) provides scientific assessment of health effects for potentially hazardous air pollutants. In accordance with risk assessment guidelines developed by OHEA over the years, Health Assessment Documents (HADs) containing risk assessment information were prepared and were subjected to critical review and careful revision to produce Final Draft HADs which serve as scientific databases for regulatory decision-making by the Office of Air Quality Planning and Standards (OAQPS) in its risk management process. EPA developed databases such as the Integrated Risk Information System (IRIS) and the National Air Toxics Information Clearinghouse (NATICH) and a technical

  13. Risk factors for and assessment of constipation.

    PubMed

    Chapman, Sherree; Hungerford, Catherine

    2015-04-01

    Constipation commonly occurs in older people, particularly in hospital or residential care settings, and leads to decreased quality of life and increased healthcare costs. Despite its frequency, however, nurses often overlook the condition. One possible reason for this may be the lack of appropriate tools or scales for nurses to assess risk factors for developing constipation. This article identifies, from the academic literature, 14 risk factors for developing constipation in older people. These factors are then considered in light of four common constipation assessment charts. The article concludes by arguing the need for more comprehensive assessment tools to, firstly, identify risk factors; and, secondly, support the implementation of appropriate preventative strategies that will enable better health outcomes for older people.

  14. Method and apparatus for assessing cardiovascular risk

    NASA Technical Reports Server (NTRS)

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

    1998-01-01

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

  15. Concepts of modern risk assessment and management.

    PubMed

    Corbin, S B

    1994-01-01

    An emerging and increasingly complex array of environmental health concerns face dental practitioners in both the private and public sectors. These concerns are challenging and possibly threatening the traditionally inviolable dentist-patient relationship. Regulatory bodies, health risk experts, attorneys, and enthusiastic media are inserting themselves into the process. Essential assets for "successful" dental practitioners include enhanced expertise in basic science and technology, including the area of risk assessment, and development of broadened perspectives and skills for communicating with patients and the public.

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

    SciTech Connect

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

    1995-12-31

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

  17. Recidivism Risk Assessment for Adult Sexual Offenders.

    PubMed

    Holoyda, Brian J; Newman, William J

    2016-02-01

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

  18. Assessment of health risks of policies

    SciTech Connect

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

    2014-09-15

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

  19. Recording pressure ulcer risk assessment and incidence.

    PubMed

    Plaskitt, Anne; Heywood, Nicola; Arrowsmith, Michaela

    2015-07-15

    This article reports on the introduction of an innovative computer-based system developed to record and report pressure ulcer risk and incidence at an acute NHS trust. The system was introduced to ensure that all patients have an early pressure ulcer risk assessment, which prompts staff to initiate appropriate management if a pressure ulcer is detected, thereby preventing further patient harm. Initial findings suggest that this electronic process has helped to improve the timeliness and accuracy of data on pressure ulcer risk and incidence. In addition, it has resulted in a reduced number of reported hospital-acquired pressure ulcers.

  20. New method for assessing risks of email

    NASA Astrophysics Data System (ADS)

    Raja, Seyyed H.; Afrooz, Farzad

    2013-03-01

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

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

    SciTech Connect

    Not Available

    1989-06-01

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

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

    PubMed

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

    2013-02-01

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

  3. Health effects of risk-assessment categories

    SciTech Connect

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

    1983-10-01

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

  4. TOXICOGENOMICS AND HUMAN DISEASE RISK ASSESSMENT

    EPA Science Inventory


    Toxicogenomics and Human Disease Risk Assessment.

    Complete sequencing of human and other genomes, availability of large-scale gene
    expression arrays with ever-increasing numbers of genes displayed, and steady
    improvements in protein expression technology can hav...

  5. Risk Assessment with Adolescent Sex Offenders

    ERIC Educational Resources Information Center

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

    2005-01-01

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

  6. Computational Toxicology in Cancer Risk Assessment

    EPA Science Inventory

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

  7. Chemical Mixtures: Cancer Risk Assessment Approaches

    EPA Science Inventory

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

  8. CUMULATIVE RISK ASSESSMENT FOR QUANTITATIVE RESPONSE DATA

    EPA Science Inventory

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

  9. Clinical Model for Suicide Risk Assessment.

    ERIC Educational Resources Information Center

    Kral, Michael J.; Sakinofsky, Isaac

    1994-01-01

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

  10. Assessing suicide risk in older adults.

    PubMed

    Diggle-Fox, Barbara Suzy

    2016-10-20

    Suicide in older adults is continuing to rise and, as the older population increases, so will the rate of suicide. By learning more about the risk factors, assessment areas to explore, and ways to improve treatment, primary care providers can help decrease the incidence of suicidal behaviors in this population. PMID:27623296

  11. AXES OF EXTRAPOLATION IN RISK ASSESSMENTS

    EPA Science Inventory

    Extrapolation in risk assessment involves the use of data and information to estimate or predict something that has not been measured or observed. Reasons for extrapolation include that the number of combinations of environmental stressors and possible receptors is too large to c...

  12. QUANTITATIVE RISK ASSESSMENT FOR MICROBIAL AGENTS

    EPA Science Inventory

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

  13. Cytokinesis-blocked micronucleus assay as a novel biomarker for lung cancer risk.

    PubMed

    El-Zein, Randa A; Schabath, Matthew B; Etzel, Carol J; Lopez, Mirtha S; Franklin, Jamey D; Spitz, Margaret R

    2006-06-15

    In this case-control study, we modified the cytokinesis-block micronucleus (CBMN) assay, an established biomarker for genomic instability, to evaluate susceptibility to the nicotine-derived nitrosamine 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) by measuring the frequency of NNK-induced chromosomal damage endpoints (micronuclei, nucleoplasmic bridges, and nuclear buds) per 1,000 binucleated lymphocytes. Spontaneous and NNK-induced chromosomal damage were significantly higher in lung cancer patients compared with controls. Forty-seven percent of cases (versus 12% of controls) had >or=4 spontaneous micronuclei, 66% of cases (and no controls) had >or=4 spontaneous nucleoplasmic bridges, and 25% of cases (versus 5% of controls) had >or=1 spontaneous nuclear bud (P < 0.001). Similarly, 40% of cases (versus 6% of the controls) had >or=5 NNK-induced micronuclei, 89% of cases (and no controls) had >or=6 induced nucleoplasmic bridges, and 23% of cases (versus 2% of controls) had >or=2 induced nuclear buds (P < 0.001). When analyzed on a continuous scale, spontaneous micronuclei, nucleoplasmic bridges, and nuclear buds were associated with 2-, 29-, and 6-fold increases in cancer risk, respectively. Similarly, NNK-induced risks were 2.3-, 45.5-, and 10-fold, respectively. We evaluated the use of CBMN assay to predict cancer risk based on the numbers of micronuclei, nucleoplasmic bridges, and nuclear buds defined by percentile cut points in controls. Probabilities of being a cancer patient were 96%, 98%, and 100% when using the 95th percentiles of spontaneous and NNK-induced micronuclei, nucleoplasmic bridges, and nuclear buds, respectively. Our study indicates that the CBMN assay is extremely sensitive to NNK-induced genetic damage and may serve as a strong predictor of lung cancer risk. PMID:16778224

  14. The NASA Space Radiobiology Risk Assessment Project

    NASA Astrophysics Data System (ADS)

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

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

  15. Resources for global risk assessment: the International Toxicity Estimates for Risk (ITER) and Risk Information Exchange (RiskIE) databases.

    PubMed

    Wullenweber, Andrea; Kroner, Oliver; Kohrman, Melissa; Maier, Andrew; Dourson, Michael; Rak, Andrew; Wexler, Philip; Tomljanovic, Chuck

    2008-11-15

    The rate of chemical synthesis and use has outpaced the development of risk values and the resolution of risk assessment methodology questions. In addition, available risk values derived by different organizations may vary due to scientific judgments, mission of the organization, or use of more recently published data. Further, each organization derives values for a unique chemical list so it can be challenging to locate data on a given chemical. Two Internet resources are available to address these issues. First, the International Toxicity Estimates for Risk (ITER) database (www.tera.org/iter) provides chronic human health risk assessment data from a variety of organizations worldwide in a side-by-side format, explains differences in risk values derived by different organizations, and links directly to each organization's website for more detailed information. It is also the only database that includes risk information from independent parties whose risk values have undergone independent peer review. Second, the Risk Information Exchange (RiskIE) is a database of in progress chemical risk assessment work, and includes non-chemical information related to human health risk assessment, such as training modules, white papers and risk documents. RiskIE is available at http://www.allianceforrisk.org/RiskIE.htm, and will join ITER on National Library of Medicine's TOXNET (http://toxnet.nlm.nih.gov/). Together, ITER and RiskIE provide risk assessors essential tools for easily identifying and comparing available risk data, for sharing in progress assessments, and for enhancing interaction among risk assessment groups to decrease duplication of effort and to harmonize risk assessment procedures across organizations.

  16. Resources for global risk assessment: The International Toxicity Estimates for Risk (ITER) and Risk Information Exchange (RiskIE) databases

    SciTech Connect

    Wullenweber, Andrea Kroner, Oliver; Kohrman, Melissa; Maier, Andrew; Dourson, Michael; Rak, Andrew; Wexler, Philip; Tomljanovic, Chuck

    2008-11-15

    The rate of chemical synthesis and use has outpaced the development of risk values and the resolution of risk assessment methodology questions. In addition, available risk values derived by different organizations may vary due to scientific judgments, mission of the organization, or use of more recently published data. Further, each organization derives values for a unique chemical list so it can be challenging to locate data on a given chemical. Two Internet resources are available to address these issues. First, the International Toxicity Estimates for Risk (ITER) database ( (www.tera.org/iter)) provides chronic human health risk assessment data from a variety of organizations worldwide in a side-by-side format, explains differences in risk values derived by different organizations, and links directly to each organization's website for more detailed information. It is also the only database that includes risk information from independent parties whose risk values have undergone independent peer review. Second, the Risk Information Exchange (RiskIE) is a database of in progress chemical risk assessment work, and includes non-chemical information related to human health risk assessment, such as training modules, white papers and risk documents. RiskIE is available at (http://www.allianceforrisk.org/RiskIE.htm), and will join ITER on National Library of Medicine's TOXNET ( (http://toxnet.nlm.nih.gov/)). Together, ITER and RiskIE provide risk assessors essential tools for easily identifying and comparing available risk data, for sharing in progress assessments, and for enhancing interaction among risk assessment groups to decrease duplication of effort and to harmonize risk assessment procedures across organizations.

  17. Transparent Global Seismic Hazard and Risk Assessment

    NASA Astrophysics Data System (ADS)

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

    2013-04-01

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

  18. Exploring the uncertainties in cancer risk assessment using the integrated probabilistic risk assessment (IPRA) approach.

    PubMed

    Slob, Wout; Bakker, Martine I; Biesebeek, Jan Dirk Te; Bokkers, Bas G H

    2014-08-01

    Current methods for cancer risk assessment result in single values, without any quantitative information on the uncertainties in these values. Therefore, single risk values could easily be overinterpreted. In this study, we discuss a full probabilistic cancer risk assessment approach in which all the generally recognized uncertainties in both exposure and hazard assessment are quantitatively characterized and probabilistically evaluated, resulting in a confidence interval for the final risk estimate. The methodology is applied to three example chemicals (aflatoxin, N-nitrosodimethylamine, and methyleugenol). These examples illustrate that the uncertainty in a cancer risk estimate may be huge, making single value estimates of cancer risk meaningless. Further, a risk based on linear extrapolation tends to be lower than the upper 95% confidence limit of a probabilistic risk estimate, and in that sense it is not conservative. Our conceptual analysis showed that there are two possible basic approaches for cancer risk assessment, depending on the interpretation of the dose-incidence data measured in animals. However, it remains unclear which of the two interpretations is the more adequate one, adding an additional uncertainty to the already huge confidence intervals for cancer risk estimates.

  19. Fragility fracture: recent developments in risk assessment.

    PubMed

    Aspray, Terry J

    2015-02-01

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

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

    PubMed Central

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

    2016-01-01

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

  1. Multilocus Genetic Risk Scores for Venous Thromboembolism Risk Assessment

    PubMed Central

    Soria, José Manuel; Morange, Pierre‐Emmanuel; Vila, Joan; Souto, Juan Carlos; Moyano, Manel; Trégouët, David‐Alexandre; Mateo, José; Saut, Noémi; Salas, Eduardo; Elosua, Roberto

    2014-01-01

    Background Genetics plays an important role in venous thromboembolism (VTE). Factor V Leiden (FVL or rs6025) and prothrombin gene G20210A (PT or rs1799963) are the genetic variants currently tested for VTE risk assessment. We hypothesized that primary VTE risk assessment can be improved by using genetic risk scores with more genetic markers than just FVL‐rs6025 and prothrombin gene PT‐rs1799963. To this end, we have designed a new genetic risk score called Thrombo inCode (TiC). Methods and Results TiC was evaluated in terms of discrimination (Δ of the area under the receiver operating characteristic curve) and reclassification (integrated discrimination improvement and net reclassification improvement). This evaluation was performed using 2 age‐ and sex‐matched case–control populations: SANTPAU (248 cases, 249 controls) and the Marseille Thrombosis Association study (MARTHA; 477 cases, 477 controls). TiC was compared with other literature‐based genetic risk scores. TiC including F5 rs6025/rs118203906/rs118203905, F2 rs1799963, F12 rs1801020, F13 rs5985, SERPINC1 rs121909548, and SERPINA10 rs2232698 plus the A1 blood group (rs8176719, rs7853989, rs8176743, rs8176750) improved the area under the curve compared with a model based only on F5‐rs6025 and F2‐rs1799963 in SANTPAU (0.677 versus 0.575, P<0.001) and MARTHA (0.605 versus 0.576, P=0.008). TiC showed good integrated discrimination improvement of 5.49 (P<0.001) for SANTPAU and 0.96 (P=0.045) for MARTHA. Among the genetic risk scores evaluated, the proportion of VTE risk variance explained by TiC was the highest. Conclusions We conclude that TiC greatly improves prediction of VTE risk compared with other genetic risk scores. TiC should improve prevention, diagnosis, and treatment of VTE. PMID:25341889

  2. Behavioral toxicology, risk assessment, and chlorinated hydrocarbons

    SciTech Connect

    Evangelista de Duffard, A.M.; Duffard, R.

    1996-04-01

    Behavioral end points are being used with greater frequency in neurotoxicology to detect and characterize the adverse effects of chemicals on the nervous system. Behavioral measures are particularly important for neurotoxicity risk assessment since many known neurotoxicants do not result in neuropathology. The chlorinated hydrocarbon class consists of a wide variety of chemicals including polychlorinated biphenyls, clioquinol, trichloroethylene, hexachlorophene, organochlorine insecticides (DDT, dicofol, chlordecone, dieldrin, and lindane), and phenoxyherbicides. Each of these chemicals has effects on motor, sensory, or cognitive function that are detectable using functional measures such as behavior. Furthermore, there is evidence that if exposure occurs during critical periods of development, many of the chlorinated hydrocarbons are developmental neurotoxicants. Developmental neurotoxicity is frequently expressed as alterations in motor function or cognitive abilities or charges in the ontogeny of sensorimotor reflexes. Neurotoxicity risk assessment should include assessments of the full range of possible neurotoxicological effects, including both structural and functional indicators of neurotoxicity. 121 refs., 1 tab.

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

    PubMed Central

    Evangelista de Duffard, A M; Duffard, R

    1996-01-01

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

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

    EPA Science Inventory

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

  5. Opioid risk assessment in palliative medicine.

    PubMed

    Dale, Rebecca; Edwards, Jeremy; Ballantyne, Jane

    2016-03-01

    Pain management with opioids is an integral part of palliative medicine. As the doses and durations of opioid therapy increase, the inherent risks of opioid therapy rise. Although opioids are effective analgesics, they bring with them complex medical and psychological side effects. Aberrant behavior is dangerous and can be difficult to identify as it results in a splitting in the goals of treatment between the patient and providers. One effective strategy in preventing that situation is through the early identification of at-risk patients. There are several tools that can help identify patients at higher risk of addiction and aberrant behaviors during opioid therapy. Structured use of these tools in conjunction with the clinic exam, regular follow-up visits, and lab testing can further reduce patient risk and improve success in opioid therapy. This article will review the background behind a structured strategy for opioid risk assessment using the Opioid Risk Tool, SOAPP-R, and DIRE tools. In addition, example aberrant behaviors and follow-up strategies will be reviewed. It will be demonstrated that careful screening and follow-up allow risk factors to be recognized and addressed early. PMID:27058865

  6. Silent Aircraft Initiative Concept Risk Assessment

    NASA Technical Reports Server (NTRS)

    Nickol, Craig L.

    2008-01-01

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

  7. A toolbox for rockfall Quantitative Risk Assessment

    NASA Astrophysics Data System (ADS)

    Agliardi, F.; Mavrouli, O.; Schubert, M.; Corominas, J.; Crosta, G. B.; Faber, M. H.; Frattini, P.; Narasimhan, H.

    2012-04-01

    Rockfall Quantitative Risk Analysis for mitigation design and implementation requires evaluating the probability of rockfall events, the probability and intensity of impacts on structures (elements at risk and countermeasures), their vulnerability, and the related expected costs for different scenarios. A sound theoretical framework has been developed during the last years both for spatially-distributed and local (i.e. single element at risk) analyses. Nevertheless, the practical application of existing methodologies remains challenging, due to difficulties in the collection of required data and to the lack of simple, dedicated analysis tools. In order to fill this gap, specific tools have been developed in the form of Excel spreadsheets, in the framework of Safeland EU project. These tools can be used by stakeholders, practitioners and other interested parties for the quantitative calculation of rock fall risk through its key components (probabilities, vulnerability, loss), using combinations of deterministic and probabilistic approaches. Three tools have been developed, namely: QuRAR (by UNIMIB), VulBlock (by UPC), and RiskNow-Falling Rocks (by ETH Zurich). QuRAR implements a spatially distributed, quantitative assessment methodology of rockfall risk for individual buildings or structures in a multi-building context (urban area). Risk is calculated in terms of expected annual cost, through the evaluation of rockfall event probability, propagation and impact probability (by 3D numerical modelling of rockfall trajectories), and empirical vulnerability for different risk protection scenarios. Vulblock allows a detailed, analytical calculation of the vulnerability of reinforced concrete frame buildings to rockfalls and related fragility curves, both as functions of block velocity and the size. The calculated vulnerability can be integrated in other methodologies/procedures based on the risk equation, by incorporating the uncertainty of the impact location of the rock

  8. Microbiological risk assessment in developing countries.

    PubMed

    Cahill, Sarah M; Jouve, Jean-Louis R

    2004-09-01

    Microbiological risk assessment (MRA) has been evolving at the national and international levels as a systematic and objective approach for evaluating information pertaining to microbiological hazards in foods and the risks they pose. This process has been catalyzed by international food trade requirements to base sanitary measures on sound scientific evidence and appropriate risk assessments. All countries, including developing countries, need to understand and use MRA. MRA is resource intensive, as has been demonstrated by some of the the assessments undertaken in industrialized countries. However, when used in the appropriate circumstances MRA offers many benefits. The process of undertaking MRA improves the understanding of key issues, enables an objective evaluation of risk management options, and provides a scientific justification for actions. Although the gap between developing countries and some industrialized countries is quite extensive with regard to MRA, many developing countries recognize the need to at least understand and move toward using MRA. This process requires development of infrastructure and enhancement of scientific and technical expertise while making optimal use of limited resources. International organizations, such as the Food and Agriculture Organization of the United Nations, are in a position to provide countries with guidance, training, information resources, and technical assistance to develop and/or strengthen food safety infrastructure. Enhanced cooperation and collaboration at all levels are needed for such efforts to be successful and to ensure that MRA, as a food safety tool, is available to all countries. PMID:15453597

  9. A skin sensitization risk assessment approach for evaluation of new ingredients and products.

    PubMed

    Gerberick, G F; Robinson, M K

    2000-06-01

    Skin sensitization risk assessment of new ingredients or products is critical before their introduction into the marketplace. The risk assessment process described in this article involves evaluation of skin sensitization hazard, consideration of all potential human exposures, comparative ingredient/product benchmarking, and, when appropriate, the management of the risk. In this article, a risk assessment process is reviewed along with a description of the risk assessment tools that are employed for evaluating a new ingredient or product. The basic process we use for evaluating the skin sensitization risk of a new product or ingredient is considered a no effect/safety factor approach. The tools used for conducting a risk assessment include structure activity relationship analysis, exposure assessment, preclinical testing (e.g., local lymph node assay [LNNA]) and clinical testing (e.g., human repeat insult patch testing [HRIPT]). The skin sensitization risk assessment process described in this paper has been used successfully for many years for the safe introduction of new products into the marketplace. This process is dynamic--it can be applied to a diversity of product categories (e.g., shampoo, transdermal drug). In summary, the skin sensitization risk assessment process described in this article allows one to carefully assess the skin sensitization potential of a new ingredient or product so that it can be safely introduced into the marketplace.

  10. Clinical Risk Assessment in Intensive Care Unit

    PubMed Central

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

    2013-01-01

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

  11. 2009 Space Shuttle Probabilistic Risk Assessment Overview

    NASA Technical Reports Server (NTRS)

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

    2010-01-01

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

  12. Assessment of genotoxic effects of flumorph by the comet assay in mice organs.

    PubMed

    Zhang, T; Zhao, Q; Zhang, Y; Ning, J

    2014-03-01

    The present study investigated the genotoxic effects of flumorph in various organs (brain, liver, spleen, kidney and sperm) of mice. The DNA damage, measured as comet tail length (µm), was determined using the alkaline comet assay. The comet assay is a sensitive assay for the detection of genotoxicity caused by flumorph using mice as a model. Statistically significant increases in comet assay for both dose-dependent and duration-dependent DNA damage were observed in all the organs assessed. The organs exhibited the maximum DNA damage in 96 h at 54 mg/kg body weight. Brain showed maximum DNA damage followed by spleen > kidney > liver > sperm. Our data demonstrated that flumorph had induced systemic genotoxicity in mammals as it caused DNA damage in all tested vital organs, especially in brain and spleen.

  13. Trends in quantitative cancer risk assessment.

    PubMed Central

    Morris, S C

    1991-01-01

    Quantitative cancer risk assessment is a dynamic field, more closely coupled to rapidly advancing biomedical research than ever before. Six areas of change and growth are identified: expansion from models of cancer initiation to a more complete picture of the total carcinogenic process; trend from curve-fitting to biologically based models; movement from upperbound estimates to best estimates, with a more complete treatment of uncertainty; increased consideration of the role of susceptibility; growing development of expert systems and decision support systems; and emerging importance of risk communication. PMID:2050076

  14. Code System for Seismic Probabilistic Risk Assessment.

    2001-03-27

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

  15. Towards a nanospecific approach for risk assessment.

    PubMed

    Dekkers, Susan; Oomen, Agnes G; Bleeker, Eric A J; Vandebriel, Rob J; Micheletti, Christian; Cabellos, Joan; Janer, Gemma; Fuentes, Natalia; Vázquez-Campos, Socorro; Borges, Teresa; Silva, Maria João; Prina-Mello, Adriele; Movia, Dania; Nesslany, Fabrice; Ribeiro, Ana R; Leite, Paulo Emílio; Groenewold, Monique; Cassee, Flemming R; Sips, Adrienne J A M; Dijkzeul, Aart; van Teunenbroek, Tom; Wijnhoven, Susan W P

    2016-10-01

    In the current paper, a new strategy for risk assessment of nanomaterials is described, which builds upon previous project outcomes and is developed within the FP7 NANoREG project. NANoREG has the aim to develop, for the long term, new testing strategies adapted to a high number of nanomaterials where many factors can affect their environmental and health impact. In the proposed risk assessment strategy, approaches for (Quantitative) Structure Activity Relationships ((Q)SARs), grouping and read-across are integrated and expanded to guide the user how to prioritise those nanomaterial applications that may lead to high risks for human health. Furthermore, those aspects of exposure, kinetics and hazard assessment that are most likely to be influenced by the nanospecific properties of the material under assessment are identified. These aspects are summarised in six elements, which play a key role in the strategy: exposure potential, dissolution, nanomaterial transformation, accumulation, genotoxicity and immunotoxicity. With the current approach it is possible to identify those situations where the use of nanospecific grouping, read-across and (Q)SAR tools is likely to become feasible in the future, and to point towards the generation of the type of data that is needed for scientific justification, which may lead to regulatory acceptance of nanospecific applications of these tools.

  16. Towards a nanospecific approach for risk assessment.

    PubMed

    Dekkers, Susan; Oomen, Agnes G; Bleeker, Eric A J; Vandebriel, Rob J; Micheletti, Christian; Cabellos, Joan; Janer, Gemma; Fuentes, Natalia; Vázquez-Campos, Socorro; Borges, Teresa; Silva, Maria João; Prina-Mello, Adriele; Movia, Dania; Nesslany, Fabrice; Ribeiro, Ana R; Leite, Paulo Emílio; Groenewold, Monique; Cassee, Flemming R; Sips, Adrienne J A M; Dijkzeul, Aart; van Teunenbroek, Tom; Wijnhoven, Susan W P

    2016-10-01

    In the current paper, a new strategy for risk assessment of nanomaterials is described, which builds upon previous project outcomes and is developed within the FP7 NANoREG project. NANoREG has the aim to develop, for the long term, new testing strategies adapted to a high number of nanomaterials where many factors can affect their environmental and health impact. In the proposed risk assessment strategy, approaches for (Quantitative) Structure Activity Relationships ((Q)SARs), grouping and read-across are integrated and expanded to guide the user how to prioritise those nanomaterial applications that may lead to high risks for human health. Furthermore, those aspects of exposure, kinetics and hazard assessment that are most likely to be influenced by the nanospecific properties of the material under assessment are identified. These aspects are summarised in six elements, which play a key role in the strategy: exposure potential, dissolution, nanomaterial transformation, accumulation, genotoxicity and immunotoxicity. With the current approach it is possible to identify those situations where the use of nanospecific grouping, read-across and (Q)SAR tools is likely to become feasible in the future, and to point towards the generation of the type of data that is needed for scientific justification, which may lead to regulatory acceptance of nanospecific applications of these tools. PMID:27255696

  17. Improving environmental risk assessment of human pharmaceuticals.

    PubMed

    Ågerstrand, Marlene; Berg, Cecilia; Björlenius, Berndt; Breitholtz, Magnus; Brunström, Björn; Fick, Jerker; Gunnarsson, Lina; Larsson, D G Joakim; Sumpter, John P; Tysklind, Mats; Rudén, Christina

    2015-05-01

    This paper presents 10 recommendations for improving the European Medicines Agency's guidance for environmental risk assessment of human pharmaceutical products. The recommendations are based on up-to-date, available science in combination with experiences from other chemical frameworks such as the REACH-legislation for industrial chemicals. The recommendations concern: expanding the scope of the current guideline; requirements to assess the risk for development of antibiotic resistance; jointly performed assessments; refinement of the test proposal; mixture toxicity assessments on active pharmaceutical ingredients with similar modes of action; use of all available ecotoxicity studies; mandatory reviews; increased transparency; inclusion of emission data from production; and a risk management option. We believe that implementation of our recommendations would strengthen the protection of the environment and be beneficial to society. Legislation and guidance documents need to be updated at regular intervals in order to incorporate new knowledge from the scientific community. This is particularly important for regulatory documents concerning pharmaceuticals in the environment since this is a research field that has been growing substantially in the last decades.

  18. Asteroid Risk Assessment: A Probabilistic Approach.

    PubMed

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

    2016-02-01

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

  19. Asteroid Risk Assessment: A Probabilistic Approach.

    PubMed

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

    2016-02-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

  3. Risk and revisionism in arsenic cancer risk assessment.

    PubMed Central

    Mushak, P; Crocetti, A F

    1995-01-01

    Oral exposures of nonoccupational populations to environmental inorganic arsenic are associated with skin and internal cancers as well as various noncarcinogenic effects. Cancer risk assessments have been based largely on epidemiological studies of a large population exposed to inorganic arsenic in well water in Taiwan. Criticisms and skepticism of the use of the Taiwanese data for estimating arsenic cancer risks outside of Taiwan, including potential use by the U.S. Environmental Protection Agency for regulatory purposes, have been expressed on various grounds. The nature and extent of such criticisms have sharpened with recent findings in the exposed Taiwanese of increased incidence of internal cancers (bladder, kidney, liver, and lung), in addition to already-observed skin cancer, coupled with a good likelihood that these findings will produce more stringent arsenic regulation in the United States and elsewhere. These criticisms collectively posit a revisionist view that: 1) cancer incidence among the Taiwanese was amplified by a number of host and environmental factors not applicable elsewhere, 2) the cancer dose-response curve may not be linear at the lower exposures elsewhere, and 3) there is a toxicokinetic and metabolic threshold to cancer risk that was exceeded by the Taiwanese. However, a number of the arguments against wide use of the Taiwanese data are flawed and subject to challenge. We explore some of these arguments and their critical evaluation, particularly as they concern certain exposure, metabolic, and nutritional determinants of the cancer risk of inorganic arsenic in the Taiwanese. PMID:7588479

  4. [Risk assessment of genetically modified organisms].

    PubMed

    Costa, Thadeu Estevam Moreira Maramaldo; Dias, Aline Peçanha Muzy; Scheidegger, Erica Miranda Damasio; Marin, Victor Augustus

    2011-01-01

    Since the commercial approve in 1996, the global area of transgenic crops has raised more than 50 times. In the last two decades, governments have been planning strategies and protocols for safety assessment of food and feed genetically modified (GM). Evaluation of food safety should be taken on a case-by-case analysis depending on the specific traits of the modified crops and the changes introduced by the genetic modification, using for this the concept of substantial equivalence. This work presents approaches for the risk assessment of GM food, as well as some problems related with the genetic construction or even with the expression of the inserted gene.

  5. Supplemental Hazard Analysis and Risk Assessment - Hydrotreater

    SciTech Connect

    Lowry, Peter P.; Wagner, Katie A.

    2015-04-01

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

  6. Risk assessment meta tool LDRD final report.

    SciTech Connect

    Bouchard, Ann Marie; Osbourn, Gordon Cecil

    2006-12-01

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

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

    PubMed

    Baracco, Alessandro

    2014-01-01

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

  8. Probabilistic risk assessment of disassembly procedures

    SciTech Connect

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

    1993-11-01

    The purpose of this report is to describe the use of Probabilistic Risk (Safety) Assessment (PRA or PSA) at a Department of Energy (DOE) facility. PRA is a methodology for (i) identifying combinations of events that, if they occur, lead to accidents (ii) estimating the frequency of occurrence of each combination of events and (iii) estimating the consequences of each accident. Specifically the study focused on evaluating the risks associated with dissembling a hazardous assembly. The PRA for the operation included a detailed evaluation only for those potential accident sequences which could lead to significant off-site consequences and affect public health. The overall purpose of this study was to investigate the feasibility of establishing a risk-consequence goal for DOE operations.

  9. Degraded Environments Alter Prey Risk Assessment

    PubMed Central

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

    2013-01-01

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

  10. Chernobyl accident: A comprehensive risk assessment

    SciTech Connect

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

    1999-11-01

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

  11. Chernobyl accident: A comprehensive risk assessment

    SciTech Connect

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

    1999-01-01

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

  12. Obsolescence Risk Assessment Process Best Practice

    NASA Astrophysics Data System (ADS)

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

    2012-05-01

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

  13. Risk assessment of GM plants: avoiding gridlock?

    PubMed

    Wilkinson, Mike J; Sweet, Jeremy; Poppy, Guy M

    2003-05-01

    Cultivation of genetically modified crops is presently based largely on four crops containing few transgenes and grown in four countries. This will soon change and pose new challenges for risk assessment. A more structured approach that is as generic as possible is advocated to study consequences of gene flow. Hazards should be precisely defined and prioritized, with emphasis on quantifying elements of exposure. This requires coordinated effort between large, multidisciplinary research teams.

  14. Implementing caries risk assessment and clinical interventions.

    PubMed

    Young, Douglas A; Featherstone, John D B

    2010-07-01

    This article suggests a practical methodology to implement the scientific information presented in the earlier articles into clinical practice. The Caries Balance/Imbalance Model and a practical caries risk assessment procedure for patients aged 6 years through adult illustrate evidence-based treatment options. Neither the forms nor the clinical protocols are meant to imply that there is currently only one correct way that this can be achieved; they are used in this article only as examples.

  15. Natural-technological risk assessment and management

    NASA Astrophysics Data System (ADS)

    Burova, Valentina; Frolova, Nina

    2016-04-01

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

  16. Ecological risk assessment benefits environmental management

    SciTech Connect

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

    1994-12-31

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

  17. Korean Risk Assessment Model for Breast Cancer Risk Prediction

    PubMed Central

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

    2013-01-01

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

  18. Optimization and Performance Assessment of the Chorion-Off [Dechorinated] Zebrafish Developmental Toxicity Assay.

    PubMed

    Panzica-Kelly, Julieta M; Zhang, Cindy X; Augustine-Rauch, Karen A

    2015-07-01

    The Dechorinated Zebrafish Embryo Developmental toxicity assay was originally developed from a training set of 31 compounds and reported to be 87% concordant with in vivo teratogenicity data (Brannen, K. C., Panzica-Kelly, J. M., Danberry, T. L., and Augustine-Rauch, K. A. (2010). Development of a zebrafish embryo teratogenicity assay and quantitative prediction model. Birth Defects Res. 89, 66-77.). The assay includes scoring larva treated in a concentration range for malformations of specific morphological structures/organ systems. The model includes identifying a no-adverse-effect-level (NOAEL) and the concentration resulting in 25% lethality (LC25) at 5 days postfertilization. An LC25/NOAEL ratio ≥10 classifies a compound positive for teratogenic potential. A consortium effort evaluated a modified version of this assay which involved enzymatic chorion treatment instead of manual dissection and used experimental replicates for final classification. The modified assay achieved an 85% overall predictivity (Gustafson, A. L., Stedman, D. B., Ball, J., Hillegass, J. M., Flood, A., Zhang, C. X., Panzica-Kelly, J., Cao, J., Coburn, A., Enright, B. P., et al. (2012). Inter-laboratory assessment of a harmonized zebrafish developmental toxicology assay - progress report on phase I. Reprod. Toxicol. 33, 155-164.). The objective of this study was to perform a thorough performance evaluation of the dechorinated assay by repeating the original training set and testing additional compounds in experimental replicates. When the initial training set was repeated with inclusion of experimental replicates, the overall predictivity was 83%. Model performance was tested with an additional 34 compounds and achieved overall predictivity of 74%. When the training and test sets were combined (63 compounds) the assay's final sensitivity was 83% and the specificity was 71%. Total predictivity was 78% with relatively balanced predictivity for nonteratogens (77%) and teratogens (78%). The

  19. Benzothiazole toxicity assessment in support of synthetic turf field human health risk assessment.

    PubMed

    Ginsberg, Gary; Toal, Brian; Kurland, Tara

    2011-01-01

    Synthetic turf fields cushioned with crumb rubber may be a source of chemical exposure to those playing on the fields. Benzothiazole (BZT) may volatilize from crumb rubber and result in inhalation exposure. Benzothiazole has been the primary rubber-related chemical found in synthetic turf studies. However, risks associated with BZT have not been thoroughly assessed, primarily because of gaps in the database. This assessment provides toxicity information for a human health risk assessment involving BZT detected at five fields in Connecticut. BZT exerts acute toxicity and is a respiratory irritant and dermal sensitizer. In a genetic toxicity assay BZT was positive in Salmonella in the presence of metabolic activation. BZT metabolism involves ring-opening and formation of aromatic hydroxylamines, metabolites with mutagenic and carcinogenic potential. A structural analogue 2-mercaptobenzothiazole (2-MBZT) was more widely tested and so is used as a surrogate for some endpoints. 2-MBZT is a rodent carcinogen with rubber industry data supporting an association with human bladder cancer. The following BZT toxicity values were derived: (1) acute air target of 110 μg/m(3) based upon a BZT RD(50) study in mice relative to results for formaldehyde; (2) a chronic noncancer target of 18 μg/m(3) based upon the no-observed-adverse-effect level (NOAEL) in a subchronic dietary study in rats, dose route extrapolation, and uncertainty factors that combine to 1000; (3) a cancer unit risk of 1.8E-07/μg-m(3) based upon a published oral slope factor for 2-MBZT and dose-route extrapolation. While there are numerous uncertainties in the BZT toxicology database, this assessment enables BZT to be quantitatively assessed in risk assessments involving synthetic turf fields. However, this is only a screening-level assessment, and research that better defines BZT potency is needed.

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

    PubMed Central

    Roychowdhury, Ashimesh; Adshead, Gwen

    2014-01-01

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

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

    PubMed

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

    2016-05-01

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

  2. Use of coefficient of variation in assessing variability of quantitative assays.

    PubMed

    Reed, George F; Lynn, Freyja; Meade, Bruce D

    2002-11-01

    We have derived the mathematical relationship between the coefficient of variation associated with repeated measurements from quantitative assays and the expected fraction of pairs of those measurements that differ by at least some given factor, i.e., the expected frequency of disparate results that are due to assay variability rather than true differences. Knowledge of this frequency helps determine what magnitudes of differences can be expected by chance alone when the particular coefficient of variation is in effect. This frequency is an operational index of variability in the sense that it indicates the probability of observing a particular disparity between two measurements under the assumption that they measure the same quantity. Thus the frequency or probability becomes the basis for assessing if an assay is sufficiently precise. This assessment also provides a standard for determining if two assay results for the same subject, separated by an intervention such as vaccination or infection, differ by more than expected from the variation of the assay, thus indicating an intervention effect. Data from an international collaborative study are used to illustrate the application of this proposed interpretation of the coefficient of variation, and they also provide support for the assumptions used in the mathematical derivation.

  3. Use of Coefficient of Variation in Assessing Variability of Quantitative Assays

    PubMed Central

    Reed, George F.; Lynn, Freyja; Meade, Bruce D.

    2002-01-01

    We have derived the mathematical relationship between the coefficient of variation associated with repeated measurements from quantitative assays and the expected fraction of pairs of those measurements that differ by at least some given factor, i.e., the expected frequency of disparate results that are due to assay variability rather than true differences. Knowledge of this frequency helps determine what magnitudes of differences can be expected by chance alone when the particular coefficient of variation is in effect. This frequency is an operational index of variability in the sense that it indicates the probability of observing a particular disparity between two measurements under the assumption that they measure the same quantity. Thus the frequency or probability becomes the basis for assessing if an assay is sufficiently precise. This assessment also provides a standard for determining if two assay results for the same subject, separated by an intervention such as vaccination or infection, differ by more than expected from the variation of the assay, thus indicating an intervention effect. Data from an international collaborative study are used to illustrate the application of this proposed interpretation of the coefficient of variation, and they also provide support for the assumptions used in the mathematical derivation. PMID:12414755

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

    PubMed

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

    2016-05-01

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

  5. Offshore blowouts, data for risk assessment

    SciTech Connect

    Holand, P.

    1995-12-31

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

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

    PubMed

    Silverman, Morton M

    2014-09-01

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

  7. Project Fox: Assessing Risks Posed By Asteroids

    NASA Astrophysics Data System (ADS)

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

    2013-12-01

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

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

    EPA Science Inventory

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

  9. Ecological risk assessment of a decommissioned military base

    SciTech Connect

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

    1995-12-31

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

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

    NASA Astrophysics Data System (ADS)

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

    2014-09-01

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

  11. Clinical validation of the HPV-risk assay, a novel real-time PCR assay for detection of high-risk human papillomavirus DNA by targeting the E7 region.

    PubMed

    Hesselink, A T; Berkhof, J; van der Salm, M L; van Splunter, A P; Geelen, T H; van Kemenade, F J; Bleeker, M G B; Heideman, D A M

    2014-03-01

    The HPV-Risk assay is a novel real-time PCR assay targeting the E7 region of 15 high-risk human papillomavirus (HPV) types (i.e., HPV16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68), and provides additional genotype information for HPV16 and HPV18. This study evaluated the clinical performance and reproducibility of the HPV-Risk assay with cervical scraping specimens and its utility with self-collected (cervico)vaginal specimens. The clinical performance of the HPV-Risk assay for cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) with cervical scraping specimens was evaluated by a noninferiority analysis, relative to high-risk HPV GP5+/6+ PCR, following international guidelines for HPV test requirements for cervical cancer screening. The HPV-Risk assay showed clinical sensitivity for CIN2+ of 97.1% (95% confidence interval [CI], 89.1 to 99.3%; 67/69 samples) and a clinical specificity for CIN2+ of 94.3% (95% CI, 92.5 to 95.7%; 777/824 samples). The clinical sensitivity and specificity were noninferior to those of GP5+/6+ PCR (noninferiority score test, P=0.006 and 0.0003, respectively). Intralaboratory reproducibility over time (99.5% [95% CI, 98.6 to 99.8%]; 544/547 samples, kappa=0.99) and interlaboratory agreement (99.2% [95% CI, 98.6 to 99.8%]; 527/531 samples, kappa=0.98) for the HPV-Risk assay with cervical scraping specimens were high. The agreement of the HPV-Risk assay results for self-collected (cervico)vaginal specimens and clinician-obtained cervical scraping specimens was also high, i.e., 95.9% (95% CI, 85.1 to 99.0%; 47/49 samples, kappa=0.90) for self-collected lavage samples and 91.6% (95% CI, 84.6 to 95.6%; 98/107 samples, kappa=0.82) for self-collected brush samples. In conclusion, the HPV-Risk assay meets the cross-sectional clinical and reproducibility criteria of the international guidelines for HPV test requirements and can be considered clinically validated for cervical screening purposes. The

  12. Visual Impairment/Intracranial Pressure Risk Assessment

    NASA Technical Reports Server (NTRS)

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

    2010-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

    Goodwin, Anne M.

    2009-01-01

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

  16. Assessment of assay sensitivity and precision in a malaria antibody ELISA.

    PubMed

    Rajasekariah, G Halli R; Kay, Graeme E; Russell, Natrice V; Smithyman, Anthony M

    2003-01-01

    Many types of ELISA-based immunodiagnostic test kits are commercially available in the market for specific indications. These kits provide necessary assay components, reagents, and guidelines to perform the assay under designated optimal conditions. By using these kits, any unknown or test sample can be assessed as negative or positive based on the results of referral calibrator (Ref+ve and Ref-ve) samples. It is essential to provide reliable test kits to end-users with adequate quality control analysis. Therefore, it is necessary to check the kit for any variations in its performance. While developing a malaria antibody ELISA test-kit, we optimized assay conditions with chequer-board analyses and developed an assay protocol. We have taken out kits randomly from the assembly line and had them evaluated by operators who are new to the test-kits. Assays are performed as per the test guidelines provided. Sera, diluted serially, have shown a clear discriminatory signal between a negative vs. positive sample. A COV is determined by evaluating the Ref-ve calibrator in replicate antigen-coated wells from 6 different plates. This COV is used as a tool to determine S/N ratio of test samples. Besides Ref-ve and Ref+ve calibrators, additional field serum samples are tested with the test kit. Several performance indices, such as mean, standard deviation, %CV are calculated, and the inter- and intra-assay variations determined. The assay precision is determined with large and small replicate samples. In addition, assays are performed concurrently in triplicate-, duplicate-, and single-wells, and the results are analyzed for any assay variations. Different plate areas are identified in antigen-coated 96-well plates and tested blind to detect any variations. The S/N ratio is found to be a very effective tool in determining the assay sensitivity. The %CV was within 10-15%. Variations seen in the assays are found to be due to operator errors and not due to kit reagents. These

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

    PubMed Central

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

    2013-01-01

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

  18. Asteroid Airbursts: Risk Assessment and Reduction

    NASA Astrophysics Data System (ADS)

    Boslough, M.

    2015-12-01

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

  19. A classification scheme for risk assessment methods.

    SciTech Connect

    Stamp, Jason Edwin; Campbell, Philip LaRoche

    2004-08-01

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

  20. Environmental risk assessment in GMO analysis.

    PubMed

    Pirondini, Andrea; Marmiroli, Nelson

    2008-01-01

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

  1. Workshop overview: Arsenic research and risk assessment

    SciTech Connect

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

    2007-08-01

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

  2. Environmental risk assessment in GMO analysis.

    PubMed

    Pirondini, Andrea; Marmiroli, Nelson

    2010-01-01

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

  3. Environmental risk assessment in GMO analysis.

    PubMed

    Pirondini, Andrea; Marmiroli, Nelson

    2008-01-01

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

  4. Environmental risk assessment in GMO analysis.

    PubMed

    Pirondini, Andrea; Marmiroli, Nelson

    2010-01-01

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

  5. Spent Nuclear Fuel Alternative Technology Risk Assessment

    SciTech Connect

    Perella, V.F.

    1999-11-29

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

  6. Use of a Standardized MxA Protein Measurement-Based Assay for Validation of Assays for the Assessment of Neutralizing Antibodies Against Interferon-β

    PubMed Central

    Subramanyam, Meena; Goelz, Susan; Goyal, Jaya; Jethwa, Vijay; Jones, Wendy; Files, James G.; Kramer, Daniel; Bird, Chris; Dilger, Paula; Tovey, Michael; Lallemand, Christophe; Thorpe, Robin

    2013-01-01

    Effective monitoring of the development of neutralizing antibodies (NAbs) against IFN-β in multiple sclerosis (MS) patients on IFN-β therapy is important for clinical decision making and disease management. To date, antiviral assays have been the favored approach for NAb determination, but variations in assay conditions between laboratories and the increasing use of novel assays have contributed to the reporting of inconsistent antibody data between laboratories and between products. This study, undertaken at the request of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), is a joint effort by manufacturers of IFN-β products (approved in Europe) towards harmonization of a NAb assay that facilitates generation of comparable NAb data, which, in conjunction with clinical outcomes, should prove useful for clinicians treating MS patients with IFN-β products. This article describes the standardized cellular myxovirus resistance protein A (MxA) protein measurement-based assay for detection of IFN-β NAbs and its use for the validation of assays used for the quantitative determination of such antibodies. Although titers varied between laboratories and the products used, utilization of IFN-β1a rather than IFN-β1b as the challenge antigen produced more consistent results in the NAb assay. Adoption of the standardized assay improves comparability between laboratories circumventing problems that arise when different, nonstandardized assays are employed for immunogenicity assessment. Based on the data, the EMA recommended for standardization purposes, the use of IFN-β1a in NAb assays, independent of the therapeutic product used for therapy and validation of new NAb procedures against the standardized assay described. PMID:23848523

  7. Considering Environmental and Occupational Stressors in Cumulative Risk Assessments

    EPA Science Inventory

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

  8. THE ROLE OF RISK ASSESSMENT IN ADDRESSING HAZARDOUS WASTE ISSUES

    EPA Science Inventory

    Risk assessment plays many important roles in addressing hazardous waste issues. In addition to providing a scientific framework and common health metric to evaluate risks. Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or "Superfund") risk assessm...

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

    EPA Science Inventory

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

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

    SciTech Connect

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

    1987-09-01

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

  11. Skin sensitization testing in potency and risk assessment.

    PubMed

    Kimber, I; Basketter, D A; Berthold, K; Butler, M; Garrigue, J L; Lea, L; Newsome, C; Roggeband, R; Steiling, W; Stropp, G; Waterman, S; Wiemann, C

    2001-02-01

    The purpose of this article is to review, and make recommendations for, the use of relevant skin sensitization test methods, for the purposes of determination of relative potency and the threshold dose necessary for the induction of skin sensitization, and for risk assessment. In addressing the first area, the utility of three guinea pig tests (the guinea pig maximization test, the occluded patch test, and the open epicutaneous test) of the local lymph node assay (LLNA) and of human volunteer testing for the assessment of relative potency and identification of thresholds for sensitization were considered. The following conclusions were drawn. (1) Although attempts have been made to modify the guinea pig maximization test for the purposes of deriving dose-response relationships, this method is usually unsuitable for determination of relative sensitizing potency. (2) Guinea pig methods that do not require the use of adjuvant and which employ a relevant route of exposure (the occluded patch test and the open epicutaneous test) are more appropriate for the assessment of relative skin-sensitizing potency. (3) The LLNA is suitable for the determination of relative skin sensitizing potency, and the adaptation of this method for derivation of comparative criteria such as EC3 values (the estimated concentration of test chemical required to induce a stimulation index of 3 in the LLNA) provides an effective and quantitative basis for such measurements. (4) For all the methods identified above, potency is assessed relative to other chemical allergens of known skin sensitizing potential. The estimation of likely threshold concentrations is dependent upon the availability of suitable benchmark chemicals of known potency for human sensitization. (5) Human testing (and specifically, the Human Repeat Insult Patch Test) can provide information of value in confirming the absence of skin sensitizing activity of formulations and products under specific conditions of use and exposure

  12. Ecological risk assessment of contaminated soil.

    PubMed

    Jensen, John; Pedersen, Marianne Bruus

    2006-01-01

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

  13. Twenty Years of Progress in Violence Risk Assessment

    ERIC Educational Resources Information Center

    Hanson, R. Karl

    2005-01-01

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

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

    USGS Publications Warehouse

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

    2015-01-01

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

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

    PubMed

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

    2015-03-10

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

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

    PubMed

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

    2015-05-01

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

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

    PubMed

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

    2015-01-01

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

  18. Session: Pre-development project risk assessment

    SciTech Connect

    Curry, Richard; Linehan, Andy

    2004-09-01

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

  19. Assessing risk of solid waste compost

    SciTech Connect

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

    1987-03-01

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

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

    SciTech Connect

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

    1990-09-19

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

  1. Methodological challenges in health risk assessment. Final report

    SciTech Connect

    Not Available

    1987-10-12

    Risk assessment, a major activity of both health and regulatory agencies, is subject to large and unavoidable uncertainties. Thus, different teams of knowledgeable experts can come to different conclusions about risks to human health from various sorts of hazards. This report examines and compares analyses by two or more agencies of ten health hazards or potential hazards: ethylene dibromide, formaldehyde, Tris, dioxin (limited to cancer risks of contaminated soil), lead (reproductive effects), cotton dust, noise (long-term hearing impairment), passive smoking, dietary fat (cancer risks), and the radiation hazards of mammography. Each set of risk assessments is analyzed in depth. The report then turns to cross-cutting analyses of such matters as setting priorities for risk assessment, approaches and methods used to evaluate different kinds of risks, and the relationships between risk assessment and risk management. Overall, the report found large differences among risk assessments of the same hazard, but these differences are often quite appropriate.

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

    PubMed

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

    2015-01-01

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

  3. NEUROBEHAVIORAL TESTING IN HUMAN RISK ASSESSMENT

    PubMed Central

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

    2008-01-01

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

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

    PubMed

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

    2014-12-01

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

  5. The Validation and Clinical Implementation of BRCAplus: A Comprehensive High-Risk Breast Cancer Diagnostic Assay

    PubMed Central

    Chong, Hansook Kim; Wang, Tao; Lu, Hsiao-Mei; Seidler, Sara; Lu, Hong; Keiles, Steven; Chao, Elizabeth C.; Stuenkel, A. J.; Li, Xiang; Elliott, Aaron M.

    2014-01-01

    Breast cancer is the most commonly diagnosed cancer in women, with 10% of disease attributed to hereditary factors. Although BRCA1 and BRCA2 account for a high percentage of hereditary cases, there are more than 25 susceptibility genes that differentially impact the risk for breast cancer. Traditionally, germline testing for breast cancer was performed by Sanger dideoxy terminator sequencing in a reflexive manner, beginning with BRCA1 and BRCA2. The introduction of next-generation sequencing (NGS) has enabled the simultaneous testing of all genes implicated in breast cancer resulting in diagnostic labs offering large, comprehensive gene panels. However, some physicians prefer to only test for those genes in which established surveillance and treatment protocol exists. The NGS based BRCAplus test utilizes a custom tiled PCR based target enrichment design and bioinformatics pipeline coupled with array comparative genomic hybridization (aCGH) to identify mutations in the six high-risk genes: BRCA1, BRCA2, PTEN, TP53, CDH1, and STK11. Validation of the assay with 250 previously characterized samples resulted in 100% detection of 3,025 known variants and analytical specificity of 99.99%. Analysis of the clinical performance of the first 3,000 BRCAplus samples referred for testing revealed an average coverage greater than 9,000X per target base pair resulting in excellent specificity and the sensitivity to detect low level mosaicism and allele-drop out. The unique design of the assay enabled the detection of pathogenic mutations missed by previous testing. With the abundance of NGS diagnostic tests being released, it is essential that clinicians understand the advantages and limitations of different test designs. PMID:24830819

  6. Cytogenetic status of healthy children assessed with the alkaline comet assay and the cytokinesis-block micronucleus cytome assay.

    PubMed

    Gajski, Goran; Gerić, Marko; Oreščanin, Višnja; Garaj-Vrhovac, Vera

    2013-01-20

    In the present study the alkaline comet assay and the cytokinesis-block micronucleus cytome (CBMN Cyt) assay were used to evaluate the baseline frequency of cytogenetic damage in peripheral blood lymphocytes (PBLs) of 50 healthy children from the general population in Croatia (age, 11.62±1.81 years). Mean values of tail length, tail intensity and tail moment, as comet assay parameters, were 12.92±0.10, 0.73±0.06 and 0.08±0.01, respectively. The mean frequency of micronuclei (MN) for all subjects was 2.32±0.28 per 1000 bi-nucleated cells, while the mean frequency of nucleoplasmic bridges (NPBs) was 1.72±0.24 and of nuclear buds (NBUDs) 1.44±0.19. The mean nuclear division index (NDI) was 1.70±0.05. When comet-assay parameters were considered, higher mean values for all three were found for the female population. According to the Mann-Whitney U test applied on the results of the comet assay, the only statistically significant difference between the male and female populations was found for tail length. Similar to the results obtained by the comet assay, girls showed higher mean values of all three measured parameters of the CBMN Cyt assay. This difference was statistically significant for total number of NPBs only. In the case of the NDI, a higher mean value was also obtained in girls, but this difference was not statistically significant. The results obtained present background data that could be considered as normal values for healthy children living in urban areas, and can later on serve as baseline values for further toxicological monitoring. Additionally, the usefulness of both techniques in measuring cytogenetic damage during bio-monitoring of children is confirmed.

  7. Simplified probabilistic risk assessment in fuel reprocessing

    SciTech Connect

    Solbrig, C.W.

    1993-03-01

    An evaluation was made to determine if a backup mass tracking computer would significantly reduce the probability of criticality in the fuel reprocessing of the Integral Fast Reactor. Often tradeoff studies, such as this, must be made that would greatly benefit from a Probably Risk Assessment (PRA). The major benefits of a complete PRA can often be accrued with a Simplified Probabilistic Risk Assessment (SPRA). An SPRA was performed by selecting a representative fuel reprocessing operation (moving a piece of fuel) for analysis. It showed that the benefit of adding parallel computers was small compared to the benefit which could be obtained by adding parallelism to two computer input steps and two of the weighing operations. The probability of an incorrect material moves with the basic process is estimated to be 4 out of 100 moves. The actual values of the probability numbers are considered accurate to within an order of magnitude. The most useful result of developing the fault trees accrue from the ability to determine where significant improvements in the process can be made. By including the above mentioned parallelism, the error move rate can be reduced to 1 out of 1000.

  8. Simplified probabilistic risk assessment in fuel reprocessing

    SciTech Connect

    Solbrig, C.W.

    1993-01-01

    An evaluation was made to determine if a backup mass tracking computer would significantly reduce the probability of criticality in the fuel reprocessing of the Integral Fast Reactor. Often tradeoff studies, such as this, must be made that would greatly benefit from a Probably Risk Assessment (PRA). The major benefits of a complete PRA can often be accrued with a Simplified Probabilistic Risk Assessment (SPRA). An SPRA was performed by selecting a representative fuel reprocessing operation (moving a piece of fuel) for analysis. It showed that the benefit of adding parallel computers was small compared to the benefit which could be obtained by adding parallelism to two computer input steps and two of the weighing operations. The probability of an incorrect material moves with the basic process is estimated to be 4 out of 100 moves. The actual values of the probability numbers are considered accurate to within an order of magnitude. The most useful result of developing the fault trees accrue from the ability to determine where significant improvements in the process can be made. By including the above mentioned parallelism, the error move rate can be reduced to 1 out of 1000.

  9. The new tapestry of risk assessment

    PubMed Central

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

    2008-01-01

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

  10. Assessing risk factors for periodontitis using regression

    NASA Astrophysics Data System (ADS)

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

    2013-10-01

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

  11. A statistical model for collective risk assessment

    NASA Astrophysics Data System (ADS)

    Keef, Caroline; Tawn, Jonathan A.; Lamb, Rob

    2010-05-01

    In this paper we present the theoretical basis of a statistical method that can be used as the basis of a collective risk assessment for country (or continent)-wide events. Our method is based on the conditional dependence model of Heffernan and Tawn (2004), which has been extended to handle missing data and temporal dependence by Keef et al (2009). This model describes the full joint distribution function of a set of variables and incorporates separate models for the marginal and dependence characteristics of the set using a copula approach. The advantages of this model include; the flexibility in terms of types of dependence modelled; the ability to handle situations where the dependence in the tails of the data is not the same as that in the main body of the data; the ability to handle both temporal and spatial dependence; and the ability to model a large number of variables. In this paper we present further extensions to the statistical model which allow us to simulate country-wide extreme events with the correct spatial and temporal structure and show an application to river flood events. Heffernan J. E. and Tawn J. A. (2004) A conditional approach for multivariate extreme values (with discussion) J. R. Statist. Soc. B, 66 497-546 Keef, C., J. Tawn, and C. Svensson. (2009). Spatial risk assessment for extreme river flows. Applied Statistics 58,(5) pp 601-618

  12. Hydrogen quantitative risk assessment workshop proceedings.

    SciTech Connect

    Groth, Katrina M.; Harris, Aaron P.

    2013-09-01

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

  13. Cyanide analyses for risk and treatability assessments

    SciTech Connect

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

    1994-12-31

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

  14. Physiologically based pharmacokinetics and cancer risk assessment.

    PubMed Central

    Andersen, M E; Krishnan, K

    1994-01-01

    Physiologically based pharmacokinetic (PBPK) modeling involves mathematically describing the complex interplay of the critical physicochemical and biological determinants involved in the disposition of chemicals. In this approach, the body is divided into a number of biologically relevant tissue compartments, arranged in an anatomically accurate manner, and defined with appropriate physiological characteristics. The extrapolation of pharmacokinetic behavior of chemicals from high dose to low dose for various exposure routes and species is possible with this approach because these models are developed by integrating quantitative information on the critical determinants of chemical disposition under a biological modeling framework. The principal application of PBPK models is in the prediction of tissue dosimetry of toxic moiety (e.g., parent chemical, reactive metabolite, macromolecular adduct) of a chemical. Such an application has been demonstrated with dichloromethane, a liver and lung carcinogen in the B6C3F1 mouse. The PBPK model-based risk assessment approach estimated a cancer risk to people of 3.7 x 10(-8) for a lifetime inhalation exposure of 1 micrograms/m3, which is lower by more than two orders of magnitude than that calculated by the U.S. Environmental Protection Agency using the linearized multistage model (for low-dose extrapolation) and body surface correction factor (for interspecies scaling). The capability of predicting the target tissue exposure to toxic moiety in people with PBPK models should help reduce the uncertainty associated with the extrapolation procedures adopted in conventional dose-response assessment. PMID:8187697

  15. VOLCANIC RISK ASSESSMENT - PROBABILITY AND CONSEQUENCES

    SciTech Connect

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

    2005-08-26

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

  16. Simulation Assisted Risk Assessment: Blast Overpressure Modeling

    NASA Technical Reports Server (NTRS)

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

    2006-01-01

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

  17. Earthquake Hazard and Risk Assessment for Turkey

    NASA Astrophysics Data System (ADS)

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

    2010-05-01

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

  18. Quality assurance checks on ecological risk assessments

    SciTech Connect

    Ferson, S.; Ginzburg, L.

    1995-12-31

    Three major criticisms are routinely made against probabilistic ecological risk assessments: (1) input distributions are often not available, (2) correlations and dependencies are often ignored, and (3) mathematical structure of the ecological model is often questionable. These criticisms are well understood by risk analysts, but it is generally assumed that their only solution is additional empirical effort to develop input distributions, measure correlations and validate the model. As a practical matter, since such empirical information is typically incomplete (and indeed often quite sparse), analysts are forced to make assumptions without empirical justifications. There are, however, computational methods that may allow analysts to sidestep a lack of information to partially or completely answer the three criticisms. When empirical information about the input distributions is limited, comprehensive representations of uncertainty can be estimated using traditional confidence interval or bounding procedures. Using recently developed methods, the probability distribution bounds can be used directly in calculations. When the correlation and dependency structure among variables is unknown, bounds on solutions can be computed without having to make unjustified and possibly false assumptions about independence. Finally, automated checks on the ecological model or mathematical expression used in the risk analysis can be employed to ensure the absence of several classes of structural and mathematical errors. Several kinds of profound errors which are routinely committed in practice, including dimensional or unit discordance, infeasible configurations for correlation, and multiple instantiations of a repeated variable, can all be detected using currently available methods and software.

  19. Probabilistic Risk Assessment of disassembly procedures

    SciTech Connect

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

    1993-10-01

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

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

    ERIC Educational Resources Information Center

    Campbell, Martin; McCue, Michael

    2013-01-01

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

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

    SciTech Connect

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

    2010-03-15

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

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

    PubMed

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

    2010-04-01

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

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

    PubMed

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

    2015-06-01

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

  4. 78 FR 36787 - Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND 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...

  5. [Regional atmospheric environment risk source identification and assessment].

    PubMed

    Zhang, Xiao-Chun; Chen, Wei-Ping; Ma, Chun; Zhan, Shui-Fen; Jiao, Wen-Tao

    2012-12-01

    Identification and assessment for atmospheric environment risk source plays an important role in regional atmospheric risk assessment and regional atmospheric pollution prevention and control. The likelihood exposure and consequence assessment method (LEC method) and the Delphi method were employed to build a fast and effective method for identification and assessment of regional atmospheric environment risk sources. This method was applied to the case study of a large coal transportation port in North China. The assessment results showed that the risk characteristics and the harm degree of regional atmospheric environment risk source were in line with the actual situation. Fast and effective identification and assessment of risk source has laid an important foundation for the regional atmospheric environmental risk assessment and regional atmospheric pollution prevention and control.

  6. Quantitative Risk Assessment for Enhanced Geothermal Systems

    NASA Astrophysics Data System (ADS)

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

    2011-12-01

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

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

    NASA Technical Reports Server (NTRS)

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

    2008-01-01

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

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

    PubMed

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

    2016-10-01

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

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

    PubMed

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

    2016-10-01

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

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

    PubMed Central

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

    2008-01-01

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

  11. Ecological risk assessment of contaminated soil.

    PubMed

    Jensen, John; Pedersen, Marianne Bruus

    2006-01-01

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

  12. Melanoma susceptibility genes and risk assessment.

    PubMed

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

    2014-01-01

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

  13. Poor prognosis of hypocoagulability assessed by thrombin generation assay in disseminated intravascular coagulation.

    PubMed

    Lee, Kyunghoon; Kim, Ji-Eun; Kwon, Jihyun; Kim, Inho; Yoon, Sung-Soo; Park, Seonyang; Han, Kyou-Sup; Kim, Hyun Kyung

    2014-04-01

    Overall assessment of the hemostatic system including procoagulant and anticoagulant changes may help assess the clinical status and prognosis of disseminated intravascular coagulation (DIC). The thrombin generation assay provides useful information about the global hemostatic status. Therefore, we measured several parameters of global hemostatic potential by the thrombin generation assay in patients suspected of having DIC. A total of 114 patients with suspected DIC were included. The thrombin generation assay was performed on the calibrated automated thrombogram using tissue factor with or without the addition of thrombomodulin, showing three parameters: lag time, endogenous thrombin potential (ETP), and peak thrombin. Both 1 and 5 pmol/l tissue factor-stimulated ETP and peak thrombin were well correlated with DIC severity. Interestingly, antithrombin level greatly affected ETP, whereas protein C influenced lag time. Prognostic analysis revealed that the area under the curve of peak thrombin stimulated by 1 pmol/l tissue factor was superior to that of D-dimer. Moreover, multivariate Cox analysis showed that the lag time and time to peak with both 1 and 5 pmol/l tissue factor were independent prognostic markers. ETP and peak thrombin well reflect DIC severity. Hypocoagulability manifesting as prolonged lag time and time to peak is expected to be an independent prognostic marker in DIC.

  14. Radiological risk assessment of environmental radon

    NASA Astrophysics Data System (ADS)

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

    2013-11-01

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

  15. Radiological risk assessment of environmental radon

    SciTech Connect

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

    2013-11-27

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

  16. Risk assessment of malicious biocontamination of food.

    PubMed

    Elad, Daniel

    2005-06-01

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

  17. Performing Probabilistic Risk Assessment Through RAVEN

    SciTech Connect

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

    2013-06-01

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

  18. Mechanical system reliability and risk assessment

    NASA Astrophysics Data System (ADS)

    Cruse, T. A.; Mahadevan, S.; Huang, Q.; Mehta, S.

    1994-11-01

    A new methodology is reported for the prediction of the reliability of mechanical structures subject to multiple failure modes, including noncritical damage. The reduction of system reliability due to accumulated damage is quantitatively estimated by updating the critical system failure states at each level of damage. Correlated design variables are automatically accounted for in the system reliability calculations. Second-order reliability bounds are reported which are unbiased to the ordering of the events. A system risk assessment methodology is also reported that accounts for the cost of multiple types of failure modes and includes the effect of inspection success on reducing the consequences of system failure. Application of the new technology is illustrated for a simplified system model of an aeropropulsion rotor system. However, the methodology is general and is applicable to any engineering system.

  19. System Analysis and Risk Assessment System.

    2000-11-20

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

  20. Probabilistic integrated risk assessment of human exposure risk to environmental bisphenol A pollution sources.

    PubMed

    Fu, Keng-Yen; Cheng, Yi-Hsien; Chio, Chia-Pin; Liao, Chung-Min

    2016-10-01

    Environmental bisphenol A (BPA) exposure has been linked to a variety of adverse health effects such as developmental and reproductive issues. However, establishing a clear association between BPA and the likelihood of human health is complex yet fundamentally uncertain. The purpose of this study was to assess the potential exposure risks from environmental BPA among Chinese population based on five human health outcomes, namely immune response, uterotrophic assay, cardiovascular disease (CVD), diabetes, and behavior change. We addressed these health concerns by using a stochastic integrated risk assessment approach. The BPA dose-dependent likelihood of effects was reconstructed by a series of Hill models based on animal models or epidemiological data. We developed a physiologically based pharmacokinetic (PBPK) model that allows estimation of urinary BPA concentration from external exposures. Here we showed that the daily average exposure concentrations of BPA and urinary BPA estimates were consistent with the published data. We found that BPA exposures were less likely to pose significant risks for infants (0-1 year) and adults (male and female >20 years) with <10(-6)-fold increase in uterus weight and immune response outcomes, respectively. Moreover, our results indicated that there was 50 % risk probability that the response outcomes of CVD, diabetes, and behavior change with or without skin absorption would increase 10(-4)-10(-2)-fold. We conclude that our approach provides a powerful tool for tracking and managing human long-term BPA susceptibility in relation to multiple exposure pathways, and for informing the public of the negligible magnitude of environmental BPA pollution impacts on human health.

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

    SciTech Connect

    Lamuro, R.J.

    1992-09-30

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

  2. Limitations of the clonal agar assay for the assessment of primary human ovarian tumour biopsies.

    PubMed Central

    Bertoncello, I.; Bradley, T. R.; Campbell, J. J.; Day, A. J.; McDonald, I. A.; McLeish, G. R.; Quinn, M. A.; Rome, R.; Hodgson, G. S.

    1982-01-01

    114 biopsy specimens from 70 patients with ovarian carcinoma at all stages of disease were submitted for assessment of clonogenic capacity in agar. A highly significant correlation was found between agar clonogenicity and patient survival after biopsy. However, problems related to inherent tumour heterogeneity, quality of sample and tissue disaggregation indicate that this technique may have limited applicability in the routine assessment of patients. Only 41 biopsy specimens (36%) from 31 patients (44.3%) complied with the prerequisite criteria for agar clonogenic assessment, namely: (a) the confirmed presence of malignant cells in the biopsy, (b) the ability to prepare a single-cell suspension, and (c) adequate viable cell numbers for assay. Furthermore, although the dominant patterns of agar clonogenic growth could be identified and correlated with stage of disease, the heterogeneity in both initial clonogenic capacity and "self-renewal" capacity assessed by the ability of primary clones to propagate in liquid culture and reclone in agar was too inconsistent for the assay to be used as a prognostic index for the individual patient. Images Figure PMID:7093117

  3. Some issues in risk assessment for agricultural chemicals.

    PubMed

    Rodricks, J V; Rachman, N J

    1990-01-01

    Risk assessment is now a significant feature of most environmental risk management programs, in both industry and government. The purpose of this paper is to describe the elements of risk assessment, their strengths and limitations, and their relationship to other activities, including research and risk management. Risk assessment issues to be examined are those especially important to the agricultural community, including problems of high-risk subpopulations, exposure through unauthorized pathways (e.g., those resulting from groundwater contamination or pesticide misuse), and inadequacies in toxicity and residue data bases.

  4. Assessing calibration of multinomial risk prediction models.

    PubMed

    Van Hoorde, Kirsten; Vergouwe, Yvonne; Timmerman, Dirk; Van Huffel, Sabine; Steyerberg, Ewout W; Van Calster, Ben

    2014-07-10

    Calibration, that is, whether observed outcomes agree with predicted risks, is important when evaluating risk prediction models. For dichotomous outcomes, several tools exist to assess different aspects of model calibration, such as calibration-in-the-large, logistic recalibration, and (non-)parametric calibration plots. We aim to extend these tools to prediction models for polytomous outcomes. We focus on models developed using multinomial logistic regression (MLR): outcome Y with k categories is predicted using k - 1 equations comparing each category i (i = 2, … ,k) with reference category 1 using a set of predictors, resulting in k - 1 linear predictors. We propose a multinomial logistic recalibration framework that involves an MLR fit where Y is predicted using the k - 1 linear predictors from the prediction model. A non-parametric alternative may use vector splines for the effects of the linear predictors. The parametric and non-parametric frameworks can be used to generate multinomial calibration plots. Further, the parametric framework can be used for the estimation and statistical testing of calibration intercepts and slopes. Two illustrative case studies are presented, one on the diagnosis of malignancy of ovarian tumors and one on residual mass diagnosis in testicular cancer patients treated with cisplatin-based chemotherapy. The risk prediction models were developed on data from 2037 and 544 patients and externally validated on 1107 and 550 patients, respectively. We conclude that calibration tools can be extended to polytomous outcomes. The polytomous calibration plots are particularly informative through the visual summary of the calibration performance.

  5. Evolutionary Consequences for Ecological Risk Assessment and Management.

    ERIC Educational Resources Information Center

    Gochfeld, Michael; Burger, Joanna

    1993-01-01

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

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

    SciTech Connect

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

    1999-07-01

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

  7. The risk assessment of environmental and human hazards

    SciTech Connect

    Paustenbach, D.J.

    1988-01-01

    A complete handbook for conducting risk assessments for environmental and occupational health hazards. This casebook, the first of its kind, presents 22 case studies, including many of the most important and thorough risk assessments ever conducted. Describes state-of-the-art approaches to assessing the low-dose response, estimating exposure, and evaluating the risks to birds and fish. Serves as a how-to-text, as well as a reference for developing high-quality environmental and human health risk assessments. Covers diverse hazards, such as waste sites; contaminated air, soil, and water; consumer products; and indoor air. All assessments are fully documented and referenced.

  8. Gasbuggy Site Assessment and Risk Evaluation

    SciTech Connect

    2011-03-01

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

  9. Health Risk Assessment of Irradiated Topaz

    NASA Astrophysics Data System (ADS)

    Nelson, Kevin Lyle

    1991-06-01

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

  10. Prenatal Child Abuse Risk Assessment: A Preliminary Validation Study.

    ERIC Educational Resources Information Center

    Weberling, Lara Cady; Forgays, Deborah Kirby; Crain-Thoreson, Catherine; Hyman, Ira

    2003-01-01

    Tested the validity of the Brigid Collins Risk Screener (BCRS) to assess child abuse risk in a sample of 49 expectant mothers. Found that at 3 months postpartum, high-risk mothers scored significantly lower on the quality of infants' physical, social, and emotional environments than moderate or low-risk mothers. Concluded that the BCRS appears to…

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

    ERIC Educational Resources Information Center

    Granello, Darcy Haag

    2010-01-01

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

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

    ERIC Educational Resources Information Center

    Kroner, Daryl G.

    2005-01-01

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

  13. Transuranic and Low-Level Boxed Waste Form Nondestructive Assay Technology Overview and Assessment

    SciTech Connect

    G. Becker; M. Connolly; M. McIlwain

    1999-02-01

    The Mixed Waste Focus Area (MWFA) identified the need to perform an assessment of the functionality and performance of existing nondestructive assay (NDA) techniques relative to the low-level and transuranic waste inventory packaged in large-volume box-type containers. The primary objectives of this assessment were to: (1) determine the capability of existing boxed waste form NDA technology to comply with applicable waste radiological characterization requirements, (2) determine deficiencies associated with existing boxed waste assay technology implementation strategies, and (3) recommend a path forward for future technology development activities, if required. Based on this assessment, it is recommended that a boxed waste NDA development and demonstration project that expands the existing boxed waste NDA capability to accommodate the indicated deficiency set be implemented. To ensure that technology will be commercially available in a timely fashion, it is recommended this development and demonstration project be directed to the private sector. It is further recommended that the box NDA technology be of an innovative design incorporating sufficient NDA modalities, e.g., passive neutron, gamma, etc., to address the majority of the boxed waste inventory. The overall design should be modular such that subsets of the overall NDA system can be combined in optimal configurations tailored to differing waste types.

  14. Dynamic Attack Tree Tool for Risk Assessments

    SciTech Connect

    Black, Karl

    2012-03-13

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

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

    PubMed

    Landis, Wayne G

    2006-01-01

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

  16. Falls risk assessment in older patients in hospital.

    PubMed

    Matarese, Maria; Ivziku, Dhurata

    2016-07-27

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

  17. Statistical problems in the assessment of nuclear risks

    SciTech Connect

    Easterling, R. G.

    1980-01-01

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

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

    Cancer.gov

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

  19. GT1-7 cell-based cytoxicity screening assay on 96-well microplates as a platform for the safety assessment of genetically modified Gerbera hybrida extracts.

    PubMed

    Fallarero, Adyary; Ainasoja, Miia; Sandberg, Malena; Teeri, Teemu H; Vuorela, Pia M

    2009-01-01

    In this investigation, a GT1-7 cell-based cytotoxicity screening assay in 96-well microplates was set up. The assay, using propidium iodide fluorescence, was proven to be reliable, with good quality (Z' = 0.51) and low plate-to-plate and day-to-day variations. Further on, a library containing extracts from 227 genetic modification (GM) Gerbera hybrida and 42 Gerbera varieties was screened; however, no differences between them were found. Based on these findings, we propose the use of the current assay within the first-tier screening studies of large collections. Also, these results provide valuable information for GM Gerbera risk-assessment purposes and offer a model for the toxicity cell-based screening of GM crops.

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

    SciTech Connect

    1995-03-01

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

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

    PubMed

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

    2016-06-01

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

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

    PubMed

    Young, Anna M; Hallford, Dennis M

    2013-01-01

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

  3. A novel renal epithelial cell in vitro assay to assess Candida albicans virulence

    PubMed Central

    Szabo, Edina K; MacCallum, Donna M

    2014-01-01

    Candida albicans, an opportunistic fungal pathogen, can cause severe systemic infections in susceptible patient groups. Systemic candidiasis is mainly studied in the mouse intravenous challenge model, where progressive infection correlates with increased early renal chemokine levels. To develop a new in vitro assay to assess C. albicans virulence, which reflects the events occurring in the murine infection model, renal M-1 cortical collecting duct epithelial cells were evaluated as the early producers of cytokines in response to C. albicans. We show that renal epithelial cells respond only to live C. albicans cells capable of forming hyphae, producing chemokines KC and MIP-2, with levels correlating with epithelial cell damage. By assaying epithelial cell responses to strains of known virulence in the murine intravenous challenge model we demonstrate that renal epithelial cells can discriminate between virulent and attenuated strains. This simple, novel assay is a useful initial screen for altered virulence of C. albicans mutants or clinical isolates in vitro and provides an alternative to the mouse systemic infection model. PMID:24225657

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

    PubMed Central

    Zacharewski, T

    1998-01-01

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

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

    PubMed

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

    2015-03-01

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

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

    PubMed

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

    2016-04-01

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

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

    PubMed Central

    Young, Anna M.; Hallford, Dennis M.

    2012-01-01

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

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

    PubMed

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

    2016-06-01

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

  9. Risk assessment and toxicology databases for health effects assessment

    SciTech Connect

    Lu, P.Y.; Wassom, J.S.

    1990-12-31

    Scientific and technological developments bring unprecedented stress to our environment. Society has to predict the results of potential health risks from technologically based actions that may have serious, far-reaching consequences. The potential for error in making such predictions or assessment is great and multiplies with the increasing size and complexity of the problem being studied. Because of this, the availability and use of reliable data is the key to any successful forecasting effort. Scientific research and development generate new data and information. Much of the scientific data being produced daily is stored in computers for subsequent analysis. This situation provides both an invaluable resource and an enormous challenge. With large amounts of government funds being devoted to health and environmental research programs and with maintenance of our living environment at stake, we must make maximum use of the resulting data to forecast and avert catastrophic effects. Along with the readily available. The most efficient means of obtaining the data necessary for assessing the health effects of chemicals is to utilize applications include the toxicology databases and information files developed at ORNL. To make most efficient use of the data/information that has already been prepared, attention and resources should be directed toward projects that meticulously evaluate the available data/information and create specialized peer-reviewed value-added databases. Such projects include the National Library of Medicine`s Hazardous Substances Data Bank, and the U.S. Air Force Installation Restoration Toxicology Guide. These and similar value-added toxicology databases were developed at ORNL and are being maintained and updated. These databases and supporting information files, as well as some data evaluation techniques are discussed in this paper with special focus on how they are used to assess potential health effects of environmental agents. 19 refs., 5 tabs.

  10. Development of a collision risk assessment tool

    NASA Astrophysics Data System (ADS)

    Alarcon Rodriguez, J.; Martinez Fadrique, F.; Klinkrad, H.

    The avoidance of near misses and catastrophic collisions is of particular interest to manned missions and to valuable assets at densely populated altitude regions. GMV has developed a software tool for ESOC, ESA's European Space Operations Centre, which forecasts close conjunctions of selected spacecraft with over 8,000 objects included in the USSPACECOM catalog. The Collision Risk Assessment Tool (CRASS) generates collision risk estimates and collision warnings based on collision probability for a time span on the order of one week. In the framework of this activity, several collision probability algorithms have been implemented and tested. Considerable effort has also been placed in the characterisation of orbit determination errors and covariance propagation. The direct comparison of orbits of several spacecraft against a large catalog is an extremely computation intensive task. As a consequence, pre-filtering and parallel computing techniques have been proposed and used in the past as a means to reduce the computing time. However, the "smart sieve" algorithm devised and implemented by GMV retains the reliability of a "direct" method while drastically reducing the computing time. Therefore, the "smart sieve" is far more reliable than traditional pre-filtering techniques with no need for parallel computing. Besides, the method presents no constraints or singularities for any terrestrial orbit, as it is not based on simplifying assumptions. In summary, the method's main characteristics are general applicability, high reliability, and high computing efficiency. As a result of the increased efficiency, the field of application of the tool can be extended to other challenging problems. For instance, all to all comparisons of objects within a large catalog, or comparisons of a single spacecraft against a complete catalog over long periods of time can be completed in a reasonable time.

  11. Assessing human health risk in the USDA forest service

    SciTech Connect

    Hamel, D.R.

    1990-12-31

    This paper identifies the kinds of risk assessments being done by or for the US Department of Agriculture (USDA) Forest Service. Summaries of data sources currently in use and the pesticide risk assessments completed by the agency or its contractors are discussed. An overview is provided of the agency`s standard operating procedures for the conduct of toxicological, ecological, environmental fate, and human health risk assessments.

  12. [Research progress on index system of regional ecological risk assessment].

    PubMed

    Meng, Ji-Jun; Zhao, Chun-Hong

    2009-04-01

    Regional ecological risk assessment (RERA) covers the assessments of multiple risk sources, receptors, and endpoints, while the selection of assessment indices is quite complicated, being a hotspot in regional environment management research. Domestic and international researches on RERA revealed that three processes in RERA are of vital, i.e., risk probability assessment measured by risk probability index, status and value assessment of ecosystem at regional scale indicated by ecological index, and vulnerability assessment of each ecosystem in a region under risk measured by vulnerability index. The main problems in the establishment of RERA index system are the strong subjectivity and poor comparability, and thus, the index system should be set up in the three key processes under the principles of objectivity, integration, hierarchy, and comparability. Due to the fact that the status and value assessment of ecosystem is most complicated, the index system should be formulated by compulsory and optional components to increase the comparability of RERA results between regions.

  13. Cancer Risk Assessment for Space Radiation

    NASA Technical Reports Server (NTRS)

    Richmond, Robert C.; Curreri, Peter A. (Technical Monitor)

    2002-01-01

    is predominantly used for assessing cancer risk caused by space radiation, and that is the Japanese atomic bomb survivors. Fact #2: The atomic-bomb-survivor database, itself a remarkable achievement, contains uncertainties. These include the actual exposure to each individual, the radiation quality of that exposure, and the fact that the exposure was to acute doses of predominantly low-LET radiation, not to chronic exposures of high-LET radiation expected on long-duration interplanetary manned missions.

  14. Risk assessment of Pseudomonas aeruginosa in water.

    PubMed

    Mena, Kristina D; Gerba, Charles P

    2009-01-01

    enhances its growth. The organism is usually found in whirlpools when the chlorine concentrations are low, but it has been isolated even in the presence of 3.00 ppm residual free chlorine (Price and Ahearn 1988). Many outbreaks of folliculitis and ear infections have been reportedly associated with the use of whirlpools and hot tubs that contain P. aeruginosa (Ratnam et al. 1986). Outbreaks have also been reported from exposure to P. aeruginosa in swimming pools and water slides. Although P. aeruginosa has a reputation for being resistant to disinfection, most studies show that it does not exhibit any marked resistance to the disinfectants used to treat drinking water such as chlorine, chloramines, ozone, or iodine. One author, however, did find it to be slightly more resistant to UV disinfection than most other bacteria (Wolfe 1990). Although much has been written about biofilms in the drinking water industry, very little has been reported regarding the role of P. aeruginosa in biofilms. Tap water appears to be a significant route of transmission in hospitals, from colonization of plumbing fixtures. It is still not clear if the colonization results from the water in the distribution system, or personnel use within the hospital. Infections and colonization can be significantly reduced by placement of filters on the water taps. The oral dose of P. aeruginosa required to establish colonization in a healthy subject is high (George et al. 1989a). During dose-response studies, even when subjects (mice or humans) were colonized via ingestion, there was no evidence of disease. P. aeruginosa administered by the aerosol route at levels of 10(7) cells did cause disease symptoms in mice, and was lethal in aerosolized doses of 10(9) cells. Aerosol dose-response studies have not been undertaken with human subjects. Human health risks associated with exposure to P. aeruginosa via drinking water ingestion were estimated using a four-step risk assessment approach. The risk of colonization

  15. Seismic risk assessment of Navarre (Northern Spain)

    NASA Astrophysics Data System (ADS)

    Gaspar-Escribano, J. M.; Rivas-Medina, A.; García Rodríguez, M. J.; Benito, B.; Tsige, M.; Martínez-Díaz, J. J.; Murphy, P.

    2009-04-01

    The RISNA project, financed by the Emergency Agency of Navarre (Northern Spain), aims at assessing the seismic risk of the entire region. The final goal of the project is the definition of emergency plans for future earthquakes. With this purpose, four main topics are covered: seismic hazard characterization, geotechnical classification, vulnerability assessment and damage estimation to structures and exposed population. A geographic information system is used to integrate, analyze and represent all information colleted in the different phases of the study. Expected ground motions on rock conditions with a 90% probability of non-exceedance in an exposure time of 50 years are determined following a Probabilistic Seismic Hazard Assessment (PSHA) methodology that includes a logic tree with different ground motion and source zoning models. As the region under study is located in the boundary between Spain and France, an effort is required to collect and homogenise seismological data from different national and regional agencies. A new homogenised seismic catalogue, merging data from Spanish, French, Catalonian and international agencies and establishing correlations between different magnitude scales, is developed. In addition, a new seismic zoning model focused on the study area is proposed. Results show that the highest ground motions on rock conditions are expected in the northeastern part of the region, decreasing southwards. Seismic hazard can be expressed as low-to-moderate. A geotechnical classification of the entire region is developed based on surface geology, available borehole data and morphotectonic constraints. Frequency-dependent amplification factors, consistent with code values, are proposed. The northern and southern parts of the region are characterized by stiff and soft soils respectively, being the softest soils located along river valleys. Seismic hazard maps including soil effects are obtained by applying these factors to the seismic hazard maps

  16. Validity of thermal ramping assays used to assess thermal tolerance in arthropods.

    PubMed

    Overgaard, Johannes; Kristensen, Torsten Nygaard; Sørensen, Jesper Givskov

    2012-01-01

    Proper assessment of environmental resistance of animals is critical for the ability of researchers to understand how variation in environmental conditions influence population and species abundance. This is also the case for studies of upper thermal limits in insects, where researchers studying animals under laboratory conditions must select appropriate methodology on which conclusions can be drawn. Ideally these methods should precisely estimate the trait of interest and also be biological meaningful. In an attempt to develop such tests it has been proposed that thermal ramping assays are useful assays for small insects because they incorporate an ecologically relevant gradual temperature change. However, recent model-based papers have suggested that estimates of thermal resistance may be strongly confounded by simultaneous starvation and dehydration stress. In the present study we empirically test these model predictions using two sets of independent experiments. We clearly demonstrate that results from ramping assays of small insects (Drosophila melanogaster) are not compromised by starvation- or dehydration-stress. Firstly we show that the mild disturbance of water and energy balance of D. melanogaster experienced during the ramping tests does not confound heat tolerance estimates. Secondly we show that flies pre-exposed to starvation and dehydration have "normal" heat tolerance and that resistance to heat stress is independent of the energetic and water status of the flies. On the basis of our results we discuss the assumptions used in recent model papers and present arguments as to why the ramping assay is both a valid and ecologically relevant way to measure thermal resistance in insects.

  17. Assessment of Dextran Antigenicity of Intravenous Iron Preparations with Enzyme-Linked Immunosorbent Assay (ELISA)

    PubMed Central

    Neiser, Susann; Koskenkorva, Taija S.; Schwarz, Katrin; Wilhelm, Maria; Burckhardt, Susanna

    2016-01-01

    Intravenous iron preparations are typically classified as non-dextran-based or dextran/dextran-based complexes. The carbohydrate shell for each of these preparations is unique and is key in determining the various physicochemical properties, the metabolic pathway, and the immunogenicity of the iron-carbohydrate complex. As intravenous dextran can cause severe, antibody-mediated dextran-induced anaphylactic reactions (DIAR), the purpose of this study was to explore the potential of various intravenous iron preparations, non-dextran-based or dextran/dextran-based, to induce these reactions. An IgG-isotype mouse monoclonal anti-dextran antibody (5E7H3) and an enzyme-linked immunosorbent assay (ELISA) were developed to investigate the dextran antigenicity of low molecular weight iron dextran, ferumoxytol, iron isomaltoside 1000, ferric gluconate, iron sucrose and ferric carboxymaltose, as well as isomaltoside 1000, the isolated carbohydrate component of iron isomaltoside 1000. Low molecular weight iron dextran, as well as dextran-based ferumoxytol and iron isomaltoside 1000, reacted with 5E7H3, whereas ferric carboxymaltose, iron sucrose, sodium ferric gluconate, and isolated isomaltoside 1000 did not. Consistent results were obtained with reverse single radial immunodiffusion assay. The results strongly support the hypothesis that, while the carbohydrate alone (isomaltoside 1000) does not form immune complexes with anti-dextran antibodies, iron isomaltoside 1000 complex reacts with anti-dextran antibodies by forming multivalent immune complexes. Moreover, non-dextran based preparations, such as iron sucrose and ferric carboxymaltose, do not react with anti-dextran antibodies. This assay allows to assess the theoretical possibility of a substance to induce antibody-mediated DIARs. Nevertheless, as this is only one possible mechanism that may cause a hypersensitivity reaction, a broader set of assays will be required to get an understanding of the mechanisms that may

  18. 75 FR 82387 - Next Generation Risk Assessment Public Dialogue Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-30

    ... robust system for chemical risk assessment by incorporating new knowledge about molecular system biology... molecular systems biology, the advent of several recent reports from the National Research Council,...

  19. A new approach to risk assessment integrating scientific evaluation and economic assessment of costs and benefits.

    PubMed

    Barnard, R C

    1996-10-01

    Traditional quantitative risk assessment based on conservative generic assumptions led to an upper-bound risk value with minimum or no consideration of costs and benefits. There is a growing consensus for a new approach to risk assessment based on a combination of scientific risk assessment and economic cost-benefit analysis. Scientific evaluation would be improved to support the economic cost-benefit analysis. The objective is to demonstrate whether the benefits justify the costs. The move in the new direction is shown by Executive Order 12866 and the Office of Management and Budget implementing document, the proposed regulatory reform legislation in Congress, the draft report of the Risk Assessment and Risk Management Commission, and the Safe Drinking Water Act Amendments of 1996 that enacted the new approach combining scientific and economic assessment of risk. This Commentary discusses these developments with particular reference to contemplated changes in scientific risk assessment to support a parallel economic risk-benefit analysis. PMID:8933625

  20. An Integrated Approach to Risk Assessment for Concurrent Design

    NASA Technical Reports Server (NTRS)

    Meshkat, Leila; Voss, Luke; Feather, Martin; Cornford, Steve

    2005-01-01

    This paper describes an approach to risk assessment and analysis suited to the early phase, concurrent design of a space mission. The approach integrates an agile, multi-user risk collection tool, a more in-depth risk analysis tool, and repositories of risk information. A JPL developed tool, named RAP, is used for collecting expert opinions about risk from designers involved in the concurrent design of a space mission. Another in-house developed risk assessment tool, named DDP, is used for the analysis.

  1. A comparison of risk assessment techniques from qualitative to quantitative

    SciTech Connect

    Altenbach, T.J.

    1995-02-13

    Risk assessment techniques vary from purely qualitative approaches, through a regime of semi-qualitative to the more traditional quantitative. Constraints such as time, money, manpower, skills, management perceptions, risk result communication to the public, and political pressures all affect the manner in which risk assessments are carried out. This paper surveys some risk matrix techniques, examining the uses and applicability for each. Limitations and problems for each technique are presented and compared to the others. Risk matrix approaches vary from purely qualitative axis descriptions of accident frequency vs consequences, to fully quantitative axis definitions using multi-attribute utility theory to equate different types of risk from the same operation.

  2. Risk assessment of thyroid follicular cell tumors.

    PubMed Central

    Hill, R N; Crisp, T M; Hurley, P M; Rosenthal, S L; Singh, D V

    1998-01-01

    Thyroid follicular cell tumors arise in rodents from mutations, perturbations of thyroid and pituitary hormone status with increased stimulation of thyroid cell growth by thyroid-stimulating hormone (TSH), or a combination of the two. The only known human thyroid carcinogen is ionizing radiation. It is not known for certain whether chemicals that affect thyroid cell growth lead to human thyroid cancer. The U.S. Environmental Protection Agency applies the following science policy positions: 1) chemically induced rodent thyroid tumors are presumed to be relevant to humans; 2) when interspecies information is lacking, the default is to assume comparable carcinogenic sensitivity in rodents and humans; 3) adverse rodent noncancer thyroid effects due to chemically induced thyroid-pituitary disruption are presumed to be relevant to humans; 4) linear dose-response considerations are applied to thyroid cancer induced by chemical substances that either do not disrupt thyroid functioning or lack mode of action information; 5) nonlinear thyroid cancer dose-response considerations are applied to chemicals that reduce thyroid hormone levels, increase TSH and thyroid cell division, and are judged to lack mutagenic activity; and 6) nonlinear considerations may be applied in thyroid cancer dose-response assessments on a case-by-case basis for chemicals that disrupt thyroid-pituitary functioning and demonstrate some mutagenic activity. Required data for risk assessment purposes is mode of action information on mutagenicity, increases in follicular cell growth (cell size and number) and thyroid gland weight, thyroid-pituitary hormones, site of action, correlations between doses producing thyroid effects and cancer, and reversibility of effects when dosing ceases. Images Figure 1 Figure 2 Figure 3 PMID:9681971

  3. Risk Assessment During the 2002 Etnean Eruption

    NASA Astrophysics Data System (ADS)

    Rongo, R.; Crisci, G. M.

    2003-04-01

    A two-dimensional cellular automata model for the simulation of lava flows, has been in the past validated on real cases of Etnean eruptions. Its latest release, SCIARA-hex1 was applied on the 1991--93 Etnean eruption in the validation phase. Lava flows can be viewed as a dynamic system based on local interactions with discrete time and space, where space is represented by hexagonal cells, whose specification (state) describes the characteristics (substates) of the corresponding piece of space. The substates are: altitude, lava thickness, temperature, lava flows. SCIARA-hex1 was applied during the Etnean crisis in the summer of 2001, when a new eruption threatened the town of Nicolosi. The real-case study was performed in collaboration with the Italian National Institute of Geophysics and Vulcanology of Catania, Sicily. A new real-time application of SCIARA has been the risk assessment for the new event which occurred in the autumn of 2002. Two major eruptions have charactersied this event. The first, started on the NE flank of the volcano, with lava generated by a fracture between 2500 ma.s.l and 2350 ma.s.l., near the 1809 fracture and point towards the town of Linguaglossa. The second one has interested the SW flank, with an emission point near 2700 ma.s.l., between the SE main crater and La Montagnola and flowing over the 2001 lava field. The simulation results have been consistent with the real lava flow paths, despite poor morphology data due to the presence of solidified magma from the 2001 event. SCIARA has proved to be a reliable and flexible tool for forecasting lava flow paths and for assessing hazard for this event, besides the development of real-time scenarios.

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

    PubMed Central

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

    2014-01-01

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

  5. Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.

    PubMed

    Vaithianathan, Soundarya; Raman, Siddarth; Jiang, Wenlei; Ting, Tricia Y; Kane, Maureen A; Polli, James E

    2015-07-01

    The therapeutic equivalence of generic and brand name antiepileptic drugs has been questioned by neurologists and the epilepsy community. A potential contributor to such concerns is pharmaceutical quality. The objective was to assess the biopharmaceutic risk of brand name Lamictal 100 mg tablets and generic lamotrigine 100 mg tablets from several manufacturers. Lamotrigine was characterized in terms of the Biopharmaceutics Classification System (BCS), including aqueous solubility and Caco-2 permeability. A panel of pharmaceutical quality tests was also performed on three batches of Lamictal, three batches of Teva generic, and one batch of each of four other generics: appearance, identity, assay, impurity, uniformity of dosage units, disintegration, dissolution, friability, and loss on drying. These market surveillance results indicate that all brand name and generic lamotrigine 100 mg tablets passed all tests and showed acceptable pharmaceutical quality and low biopharmaceutic risk. Lamotrigine was classified as a BCS class IIb drug, exhibiting pH-dependent aqueous solubility and dissolution. At pH 1.2 and 4.5, lamotrigine exhibited high solubility, whereas lamotrigine exhibited low solubility at pH 6.8, including non-sink dissolution. Lamotrigine showed high Caco-2 permeability. The apparent permeability (Papp) of lamotrigine was (73.7 ± 8.7) × 10(-6) cm/s in the apical-to-basolateral (AP-BL) direction and (41.4 ± 1.6) × 10(-6) cm/s in the BL-AP direction, which were higher than metoprolol's AP-BL Papp of (21.2 ± 0.9) × 10(-6) cm/s and BL-AP Papp of (34.6 ± 4.6) × 10(-6) cm/s. Overall, lamotrigine's favorable biopharmaceutics from a drug substance perspective and favorable quality characteristics from a tablet formulation perspective suggest that multisource lamotrigine tablets exhibit a low biopharmaceutic risk.

  6. Risk Assessment and Risk Management in Offenders with Intellectual Disabilities: Are We There Yet?

    ERIC Educational Resources Information Center

    Pouls, Claudia; Jeandarme, Inge

    2015-01-01

    Research on risk assessment and risk management in offenders with intellectual disabilities (OIDs), although far behind compared to the mainstream offender literature, is now expanding. The current review provides an overview of the predictive value of risk assessment and treatment outcome monitoring tools developed for both mainstream forensic…

  7. Benzene and leukemia. An epidemiologic risk assessment

    SciTech Connect

    Rinsky, R.A.; Smith, A.B.; Hornung, R.; Filloon, T.G.; Young, R.J.; Okun, A.H.; Landrigan, P.J.

    1987-04-23

    To assess quantitatively the association between benzene exposure and leukemia, we examined the mortality rate of a cohort with occupational exposure to benzene. Cumulative exposure for each cohort member was estimated from historical air-sampling data and, when no sampling data existed, from interpolation on the basis of existing data. The overall standardized mortality ratio (a measure of relative risk multiplied by 100) for leukemia was 337 (95 percent confidence interval, 154 to 641), and that for multiple myeloma was 409 (95 percent confidence interval, 110 to 1047). With stratification according to levels of cumulative exposure, the standardized mortality ratios for leukemia increased from 109 to 322, 1186, and 6637 with increases in cumulative benzene exposure from less than 40 parts per million-years (ppm-years), to 40 to 199, 200 to 399, and 400 or more, respectively. A cumulative benzene exposure of 400 ppm-years is equivalent to a mean annual exposure of 10 ppm over a 40-year working lifetime; 10 ppm is the currently enforceable standard in the United States for occupational exposure to benzene. To examine the shape of the exposure-response relation, we performed a conditional logistic-regression analysis, in which 10 controls were matched to each cohort member with leukemia. From this model, it can be calculated that protection from benzene-induced leukemia would increase exponentially with any reduction in the permissible exposure limit.

  8. Risk assessment compatible fire models (RACFMs)

    SciTech Connect

    Lopez, A.R.; Gritzo, L.A.; Sherman, M.P.

    1998-07-01

    A suite of Probabilistic Risk Assessment Compatible Fire Models (RACFMs) has been developed to represent the hazard posed by a pool fire to weapon systems transported on the B52-H aircraft. These models represent both stand-off (i.e., the weapon system is outside of the flame zone but exposed to the radiant heat load from fire) and fully-engulfing scenarios (i.e., the object is fully covered by flames). The approach taken in developing the RACFMs for both scenarios was to consolidate, reconcile, and apply data and knowledge from all available resources including: data and correlations from the literature, data from an extensive full-scale fire test program at the Naval Air Warfare Center (NAWC) at China Lake, and results from a fire field model (VULCAN). In the past, a single, effective temperature, T{sub f}, was used to represent the fire. The heat flux to an object exposed to a fire was estimated using the relationship for black body radiation, {sigma}T{sub f}{sup 4}. Significant improvements have been made by employing the present approach which accounts for the presence of temperature distributions in fully-engulfing fires, and uses best available correlations to estimate heat fluxes in stand-off scenarios.

  9. Assessing the health risks of aluminum.

    PubMed

    Orme, J; Ohanian, E V

    1990-03-01

    Aluminum is a ubiquitous substance with over 4,000 uses. Aluminum, as aluminum sulfate, is commonly used in the United States as a coagulant in the treatment of drinking water. For many years aluminum was not considered to be toxic to humans. However, reports associating aluminum with several skeletal and neurological disorders in humans suggest that exposure to aluminum may pose a health hazard. In 1983 the US Environmental Protection Agency (EPA) announced plans to regulate a number of substances, including aluminum, in drinking water. Aluminum was considered because of its occurrence and apparent toxicity. Upon further evaluation of the health effects data the EPA proposed not to regulate aluminum as a result of the uncertainty of the toxicity of ingested aluminum. Putative causal associations between aluminum exposure and neurological disorders such as Alzheimer's disease have yet to be substantiated. Although several issues regarding the toxicity of ingested aluminum are unresolved, aluminum has been specified in the 1986 Amendments to the Safe Drinking Water Act, as one of 83 substances in drinking water to be regulated by 1989. Additional data are needed before the potential risk of aluminum can be assessed; therefore the EPA has deferred possible regulation until 1991. PMID:24202565

  10. Photogrammetry in Experiments for Hydrogeological Risk Assessment

    NASA Astrophysics Data System (ADS)

    Barazzetti, L.; Scaioni, M.; Feng, T.; Qiao, G.; Lu, P.; Tong, X.; Li, R.

    2013-01-01

    The construction of scaled-down simulation platforms is largely used to support investigations for the assessment of hydrological risk. Achieved outcomes can be integrated and assimilated to numerical analyses for the study of unstable slope collapse, debris transport, and hydrological modeling in general. During design of such simulation platforms, a relevant role has to be given to the spatial sensor network (SSN) to deploy, which is in charge of collecting geo-referenced, quantitative information during experiments. Photogrammetry (including 3D imaging sensors) can play an important role in SSN owing to its capability of collecting 2D images and 3D point clouds data covering wide surfaces without any contact. Different kinds of metric measurements can be then extracted from datasets. The aim of this paper is to give an overview and some examples on the potential of photogrammetry in hydrogeological experiments. After a general introduction on a few preliminary issues (sensors, calibration, ground reference, usage of imaging or ranging sensors), potential applications are classified into 2D and 3D categories. Examples are focused on a scaled-down landslide simulation platform developed at Tongji University (Shanghai, P. R. China).

  11. An Engulfment Assay: A Protocol to Assess Interactions Between CNS Phagocytes and Neurons

    PubMed Central

    Schafer, Dorothy P.; Lehrman, Emily K.; Heller, Christopher T.; Stevens, Beth

    2014-01-01

    Phagocytosis is a process in which a cell engulfs material (entire cell, parts of a cell, debris, etc.) in its surrounding extracellular environment and subsequently digests this material, commonly through lysosomal degradation. Microglia are the resident immune cells of the central nervous system (CNS) whose phagocytic function has been described in a broad range of conditions from neurodegenerative disease (e.g., beta-amyloid clearance in Alzheimer’s disease) to development of the healthy brain (e.g., synaptic pruning)1-6. The following protocol is an engulfment assay developed to visualize and quantify microglia-mediated engulfment of presynaptic inputs in the developing mouse retinogeniculate system7. While this assay was used to assess microglia function in this particular context, a similar approach may be used to assess other phagocytes throughout the brain (e.g., astrocytes) and the rest of the body (e.g., peripheral macrophages) as well as other contexts in which synaptic remodeling occurs (e.g. ,brain injury/disease). PMID:24962472

  12. Advancing environmental risk assessment for transgenic biofeedstock crops.

    PubMed

    Wolt, Jeffrey D

    2009-01-01

    Transgenic modification of plants is a key enabling technology for developing sustainable biofeedstocks for biofuels production. Regulatory decisions and the wider acceptance and development of transgenic biofeedstock crops are considered from the context of science-based risk assessment. The risk assessment paradigm for transgenic biofeedstock crops is fundamentally no different from that of current generation transgenic crops, except that the focus of the assessment must consider the unique attributes of a given biofeedstock crop and its environmental release. For currently envisioned biofeedstock crops, particular emphasis in risk assessment will be given to characterization of altered metabolic profiles and their implications relative to non-target environmental effects and food safety; weediness and invasiveness when plants are modified for abiotic stress tolerance or are domesticated; and aggregate risk when plants are platforms for multi-product production. Robust risk assessments for transgenic biofeedstock crops are case-specific, initiated through problem formulation, and use tiered approaches for risk characterization. PMID:19883509

  13. Advancing environmental risk assessment for transgenic biofeedstock crops

    PubMed Central

    Wolt, Jeffrey D

    2009-01-01

    Transgenic modification of plants is a key enabling technology for developing sustainable biofeedstocks for biofuels production. Regulatory decisions and the wider acceptance and development of transgenic biofeedstock crops are considered from the context of science-based risk assessment. The risk assessment paradigm for transgenic biofeedstock crops is fundamentally no different from that of current generation transgenic crops, except that the focus of the assessment must consider the unique attributes of a given biofeedstock crop and its environmental release. For currently envisioned biofeedstock crops, particular emphasis in risk assessment will be given to characterization of altered metabolic profiles and their implications relative to non-target environmental effects and food safety; weediness and invasiveness when plants are modified for abiotic stress tolerance or are domesticated; and aggregate risk when plants are platforms for multi-product production. Robust risk assessments for transgenic biofeedstock crops are case-specific, initiated through problem formulation, and use tiered approaches for risk characterization. PMID:19883509

  14. Analysis of Alternatives for Risk Assessment Methodologies and Tools

    SciTech Connect

    Nachtigal, Noel M.; Fruetel, Julia A.; Gleason, Nathaniel J.; Helms, Jovana; Imbro, Dennis Raymond; Sumner, Matthew C.

    2013-10-01

    The purpose of this document is to provide a basic overview and understanding of risk assessment methodologies and tools from the literature and to assess the suitability of these methodologies and tools for cyber risk assessment. Sandia National Laboratories (SNL) performed this review in support of risk modeling activities performed for the Stakeholder Engagement and Cyber Infrastructure Resilience (SECIR) division of the Department of Homeland Security (DHS) Office of Cybersecurity and Communications (CS&C). The set of methodologies and tools covered in this document is not intended to be exhaustive; instead, it focuses on those that are commonly used in the risk assessment community. The classification of methodologies and tools was performed by a group of analysts with experience in risk analysis and cybersecurity, and the resulting analysis of alternatives has been tailored to address the needs of a cyber risk assessment.

  15. Dangerousness and risk assessment: the state of the art.

    PubMed

    Bauer, Arie; Rosca, Paula; Khawalled, Razak; Gruzniewski, Adrian; Grinshpoon, Alex

    2003-01-01

    Risk or dangerousness is an issue which burdens the minds of all mental health and law enforcement professionals. Researchers have attempted to define its extent and constituent elements and to predict and assess it. Risk assessment is a complex task, influenced by the interaction of many variables, such as previous pattern of violence, biological, sociological and psychological factors, divided into facilitating and inhibiting factors. In our paper we discuss the theoretical concepts linked with dangerousness prediction and assessment, and then review the "first" and "second" generations of literature on dangerousness and risk assessment, including the actuarial instruments. We then present the current trends in the field, concentrating on the correlation between dangerousness and mental disorders, dangerousness analysis and risk management, a wider concept including prevention, treatment and communication of risk. Although great progress has been made in this field, there are still many unresolved issues, among them the development of valid instruments for the assessment of risk.

  16. Advancing environmental risk assessment for transgenic biofeedstock crops.

    PubMed

    Wolt, Jeffrey D

    2009-01-01

    Transgenic modification of plants is a key enabling technology for developing sustainable biofeedstocks for biofuels production. Regulatory decisions and the wider acceptance and development of transgenic biofeedstock crops are considered from the context of science-based risk assessment. The risk assessment paradigm for transgenic biofeedstock crops is fundamentally no different from that of current generation transgenic crops, except that the focus of the assessment must consider the unique attributes of a given biofeedstock crop and its environmental release. For currently envisioned biofeedstock crops, particular emphasis in risk assessment will be given to characterization of altered metabolic profiles and their implications relative to non-target environmental effects and food safety; weediness and invasiveness when plants are modified for abiotic stress tolerance or are domesticated; and aggregate risk when plants are platforms for multi-product production. Robust risk assessments for transgenic biofeedstock crops are case-specific, initiated through problem formulation, and use tiered approaches for risk characterization.

  17. Landscape ecological risk assessment study in arid land

    NASA Astrophysics Data System (ADS)

    Gong, Lu; Amut, Aniwaer; Shi, Qingdong; Wang, Gary Z.

    2007-09-01

    The ecosystem risk assessment is an essential decision making system for predicting the reconstruction and recovery of a damaged ecosystem after intensive mankind activities. The sustainability of environment and resources of the lake ecosystem in arid districts have been paid close attention to by international communities as well as numerous experts and scholars. The ecological risk assessment offered a scientific foundation for making the decision and execution of ecological risk management. Bosten Lake, the largest inland freshwater lake in China, is the main water source of the industrial and agricultural production as well as the local residence in Yanqi basin, Kuara city and Yuri County in the southern Xinjiang. Bosten Lake also provides a direct water source for emergency transportation in the Lower Reaches of Tarim River. However, with the intensive utilizations of water and soil resources, the environmental condition in the Bosten Lake has become more and more serious. In this study, the theory and method of landscape ecological risk assessment has been practiced using 3S technologies combined with the frontier theory of landscape ecology. Defining the mainly risk resource including flood, drought, water pollution and rich nutrition of water has been evaluated based on the ecosystem risk assessment system. The main process includes five stages: regional natural resources analysis, risk receptor selection, risk sources evaluation, exposure and hazard analysis, and integrated risk assessment. Based on the risk assessment results, the environmental risk management countermeasure has been determined.

  18. Managing Risk Assessment in Science Departments.

    ERIC Educational Resources Information Center

    Forlin, Peter; Forlin, Chris

    1997-01-01

    Describes a health-and-safety risk-management audit in four Queensland, Australia high schools. One major outcome of this research project is the development of a comprehensive risk-management policy in compliance with the law. Other outcomes include the preparation of a professional-development package in risk-management policy for use as a…

  19. Embedding climate change risk assessment within a governance context

    SciTech Connect

    Preston, Benjamin L

    2011-01-01

    Climate change adaptation is increasingly being framed in the context of climate risk management. This has contributed to the proliferation of climate change vulnerability and/or risk assessments as means of supporting institutional decision-making regarding adaptation policies and measures. To date, however, little consideration has been given to how such assessment projects and programs interact with governance systems to facilitate or hinder the implementation of adaptive responses. An examination of recent case studies involving Australian local governments reveals two key linkages between risk assessment and the governance of adaptation. First, governance systems influence how risk assessment processes are conducted, by whom they are conducted, and whom they are meant to inform. Australia s governance system emphasizes evidence-based decision-making that reinforces a knowledge deficit model of decision support. Assessments are often carried out by external experts on behalf of local government, with limited participation by relevant stakeholders and/or civil society. Second, governance systems influence the extent to which the outputs from risk assessment activities are translated into adaptive responses and outcomes. Technical information regarding risk is often stranded by institutional barriers to adaptation including poor uptake of information, competition on the policy agenda, and lack of sufficient entitlements. Yet, risk assessments can assist in bringing such barriers to the surface, where they can be debated and resolved. In fact, well-designed risk assessments can contribute to multi-loop learning by institutions, and that reflexive problem orientation may be one of the more valuable benefits of assessment.

  20. Significance of Semiquantitative Assessment of Preformed Donor-Specific Antibody Using Luminex Single Bead Assay in Living Related Liver Transplantation

    PubMed Central

    Yoshizawa, Atsushi; Egawa, Hiroto; Yurugi, Kimiko; Hishida, Rie; Tsuji, Hiroaki; Ashihara, Eiji; Miyagawa-Hayashino, Aya; Teramukai, Satoshi; Maekawa, Taira; Haga, Hironori; Uemoto, Sinji

    2013-01-01

    Aim. To analyze the risks of preoperatively produced donor-specific antibody (DSA) in liver transplantation. Methods. DSA was assessed using direct complement-dependent cytotoxicity (CDC) and anti-human globulin- (AHG-) CDC tests, as well as the Luminex Single Antigen assay. Among 616 patients undergoing blood type identical or compatible living donor liver transplantation (LDLT), 21 patients were positive for CDC or AHG-CDC tests, and the preserved serum from 18 patients was examined to determine targeted Class I and II antigens. The relationships between the mean fluorescence intensity (MFI) of DSA and the clinical outcomes were analyzed. Results. Patients were divided into 3 groups according to the MFI of anti-Class I DSA: high (11 patients with MFI > 10,000), low (2 patients with MFI < 10,000), and negative (5 patients) MFI groups. Six of 11 patients with high Class-I DSA showed positive Class-II DSA. Hospital death occurred in 7 patients of the high MFI group. High MFI was a significant risk factor for mortality (P = 0.0155). Univariate analysis showed a significant correlation between MFI strength and C4d deposition (P = 0.0498). Conclusions. HLA Class I DSA with MFI > 10,000 had a significant negative effect on the clinical outcome of patients with preformed DSA in LDLT. PMID:23818917

  1. Evaluating the Risk of Child Abuse: The Child Abuse Risk Assessment Scale (CARAS)

    ERIC Educational Resources Information Center

    Chan, Ko Ling

    2012-01-01

    The present study developed the Child Abuse Risk Assessment Scale (CARAS), an actuarial instrument for the assessment of the risk of physical child abuse. Data of 2,363 Chinese parents (47.7% male) living in Hong Kong were used in the analyses. Participants were individually interviewed with a questionnaire assessing their perpetration of child…

  2. Seismic vulnerability assessments in risk analysis

    NASA Astrophysics Data System (ADS)

    Frolova, Nina; Larionov, Valery; Bonnin, Jean; Ugarov, Alexander

    2013-04-01

    The assessment of seismic vulnerability is a critical issue within natural and technological risk analysis. In general, there are three common types of methods used for development of vulnerability functions of different elements at risk: empirical, analytical and expert estimations. The paper addresses the empirical methods for seismic vulnerability estimation for residential buildings and industrial facilities. The results of engineering analysis of past earthquake consequences, as well as the statistical data on buildings behavior during strong earthquakes presented in the different seismic intensity scales, are used to verify the regional parameters of mathematical models in order to simulate physical and economic vulnerability for different building types classified according to seismic scale MMSK-86. Verified procedure has been used to estimate the physical and economic vulnerability of buildings and constructions against earthquakes for the Northern Caucasus Federal region of the Russian Federation and Krasnodar area, which are characterized by rather high level of seismic activity and high population density. In order to estimate expected damage states to buildings and constructions in the case of the earthquakes according to the OSR-97B (return period T=1,000 years) within big cities and towns, they were divided into unit sites and their coordinates were presented as dots located in the centers of unit sites. Then the indexes obtained for each unit site were summed up. The maps of physical vulnerability zoning for Northern Caucasus Federal region of the Russian Federation and Krasnodar area includes two elements: percent of different damage states for settlements with number of inhabitants less than 1,000 and vulnerability for cities and towns with number of inhabitants more than 1,000. The hypsometric scale is used to represent both elements on the maps. Taking into account the size of oil pipe line systems located in the highly active seismic zones in

  3. The Maricopa Integrated Risk Assessment Project: A New Way of Looking at Risk

    ERIC Educational Resources Information Center

    Unks, Ruth A.; Thor, Linda

    2008-01-01

    This article reviews the Maricopa Integrated Risk Assessment (MIRA) project and discusses its challenges and successes. Strategies and resources are offered for assisting community college administrators, faculty, and staff to successfully implement enterprise risk management at their institutions.

  4. Use of risk quotient and probabilistic approaches to assess risks of pesticides to birds

    EPA Science Inventory

    When conducting ecological risk assessments for pesticides, the United States Environmental Protection Agency typically relies upon the risk quotient (RQ). This approach is intended to be conservative in nature, making assumptions related to exposure and effects that are intended...

  5. Assessment of the risk of transporting liquid chlorine by rail

    SciTech Connect

    Andrews, W.B.

    1980-03-01

    This report presents the risk of shipping liquid chlorine by rail. While chlorine is not an energy material, there are several benefits to studying chlorine transportation risks. First, chlorine, like energy materials, is widely used as a feedstock to industry. Second, it is the major purification agent in municipal water treatment systems and therefore, provides direct benefits to the public. Finally, other risk assessments have been completed for liquid chlorine shipments in the US and Europe, which provide a basis for comparison with this study. None of the previous PNL energy material risk assessments have had other studies for comparison. For these reasons, it was felt that a risk assessment of chlorine transportation by rail could provide information on chlorine risk levels, identify ways to reduce these risks and use previous studies on chlorine risks to assess the strengths and weaknesses of the PNL risk assessment methodology. The risk assessment methodology used in this study is summarized. The methodology is presented in the form of a risk assessment model which is constructed for ease of periodic updating of the data base so that the risk may be reevaluated as additional data become available. The report is sectioned to correspond to specific analysis steps identified in the model. The transport system and accident environment are described. The response of the transport system to accident environments is described. Release sequences are postulated and evaluated to determine both the likelihood and possible consequences of a release. Supportive data and analyses are given in the appendices. The risk assessment results are related to the year 1985 to allow a direct comparison with other reports in this series.

  6. Flood Risk Assessments of Architectural Heritage - Case of Changgyeonggung Palace

    NASA Astrophysics Data System (ADS)

    Lee, Hyosang; Kim, Ji-sung; Lee, Ho-jin

    2014-05-01

    The risk of natural disasters such as flood and earthquake has increased due to recent extreme weather events. Therefore, the necessity of the risk management system to protect architectural properties, a cultural heritage of humanity, from natural disasters has been consistently felt. The solutions for managing flood risk focusing on architectural heritage are suggested and applied to protect Changgyeonggung Palace, a major palace heritage in Seoul. After the probable rainfall scenario for risk assessment (frequency: 100 years, 200 years, and 500 years) and the scenario of a probable maximum precipitation (PMP) are made and a previous rainfall event (from July 26th to 28th in 2011) is identified, they are used for the model (HEC-HMS, SWMM) to assess flood risk of certain areas covering Changgyeonggung Palace to do flood amount. Such flood amount makes it possible to identify inundation risks based on GIS models to assess flood risk of individual architectural heritage. The results of assessing such risk are used to establish the disaster risk management system that managers of architectural properties can utilize. According to the results of assessing flood risk of Changgyeonggung Palace, inundation occurs near outlets of Changgyeonggung Palace and sections of river channel for all scenarios of flood risk but the inundation risk of major architectural properties was estimated low. The methods for assessing flood risk of architectural heritage proposed in this study and the risk management system for Changgyeonggung Palace using the methods show thorough solutions for flood risk management and the possibility of using the solutions seems high. A comprehensive management system for architectural heritage will be established in the future through the review on diverse factors for disasters.

  7. Immunological risk assessment: The key to individualized immunosuppression after kidney transplantation.

    PubMed

    Pratschke, Johann; Dragun, Duska; Hauser, Ingeborg A; Horn, Sabine; Mueller, Thomas F; Schemmer, Peter; Thaiss, Friedrich

    2016-04-01

    The wide range of immunosuppressive therapies and protocols permits tailored planning of the initial regimen according to the immunological risk status of individual patients. Pre-transplant risk assessment can include many factors, but there is no clear consensus on which parameters to take into account, and their relative importance. In general younger patients are known to be at higher risk for acute rejection, compounded by higher rates of non-adherence in adolescents. Donor age and recipient gender do not appear to exert a meaningful effect on risk of rejection per se, but black recipient ethnicity remains a well-established risk factor even under modern immunosuppression regimens. Little difference in risk is now observed between deceased- and living-donor recipients. Immunological risk assessment has developed substantially in recent years. Cross-match testing with cytotoxic analysis has long been supplemented by flow cytometry, but development of solid-phase single-bead antigen testing of solubilized human leukocyte antigens (HLA) to detect donor-specific antibodies (DSA) permits a far more nuanced stratification of immunological risk status, including the different classes and intensities of HLA antibodies Class I and/or II, including HLA-DSA. Immunologic risk evaluation is now often based on a combination of these tests, but other assessments are becoming more widely introduced, such as measurement of non-HLA antibodies against angiotensin type 1 (AT1) receptors or T-cell ELISPOT assay of alloantigen-specific donor. Targeted densensitization protocols can improve immunological risk, notably for DSA-positive patients with negative cytotoxicity and flow cross-match. HLA mismatch remains an important and undisputed risk factor for rejection. Delayed graft function also increases the risk of subsequent acute rejection, and the early regimen can be modified in such cases. Overall, there is a shift towards planning the immunosuppressive regimen based on pre

  8. HANFORD SAFETY ANALYSIS & RISK ASSESSMENT HANDBOOK (SARAH)

    SciTech Connect

    EVANS, C B

    2004-12-21

    The purpose of the Hanford Safety Analysis and Risk Assessment Handbook (SARAH) is to support the development of safety basis documentation for Hazard Category 2 and 3 (HC-2 and 3) U.S. Department of Energy (DOE) nuclear facilities to meet the requirements of 10 CFR 830, ''Nuclear Safety Management''. Subpart B, ''Safety Basis Requirements.'' Consistent with DOE-STD-3009-94, Change Notice 2, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses'' (STD-3009), and DOE-STD-3011-2002, ''Guidance for Preparation of Basis for Interim Operation (BIO) Documents'' (STD-3011), the Hanford SARAH describes methodology for performing a safety analysis leading to development of a Documented Safety Analysis (DSA) and derivation of Technical Safety Requirements (TSR), and provides the information necessary to ensure a consistently rigorous approach that meets DOE expectations. The DSA and TSR documents, together with the DOE-issued Safety Evaluation Report (SER), are the basic components of facility safety basis documentation. For HC-2 or 3 nuclear facilities in long-term surveillance and maintenance (S&M), for decommissioning activities, where source term has been eliminated to the point that only low-level, residual fixed contamination is present, or for environmental remediation activities outside of a facility structure, DOE-STD-1120-98, ''Integration of Environment, Safety, and Health into Facility Disposition Activities'' (STD-1120), may serve as the basis for the DSA. HC-2 and 3 environmental remediation sites also are subject to the hazard analysis methodologies of this standard.

  9. Structural equation modeling in environmental risk assessment.

    PubMed

    Buncher, C R; Succop, P A; Dietrich, K N

    1991-01-01

    Environmental epidemiology requires effective models that take individual observations of environmental factors and connect them into meaningful patterns. Single-factor relationships have given way to multivariable analyses; simple additive models have been augmented by multiplicative (logistic) models. Each of these steps has produced greater enlightenment and understanding. Models that allow for factors causing outputs that can affect later outputs with putative causation working at several different time points (e.g., linkage) are not commonly used in the environmental literature. Structural equation models are a class of covariance structure models that have been used extensively in economics/business and social science but are still little used in the realm of biostatistics. Path analysis in genetic studies is one simplified form of this class of models. We have been using these models in a study of the health and development of infants who have been exposed to lead in utero and in the postnatal home environment. These models require as input the directionality of the relationship and then produce fitted models for multiple inputs causing each factor and the opportunity to have outputs serve as input variables into the next phase of the simultaneously fitted model. Some examples of these models from our research are presented to increase familiarity with this class of models. Use of these models can provide insight into the effect of changing an environmental factor when assessing risk. The usual cautions concerning believing a model, believing causation has been proven, and the assumptions that are required for each model are operative. PMID:2050063

  10. The Current Status of Graduate Training in Suicide Risk Assessment

    ERIC Educational Resources Information Center

    Liebling-Boccio, Dana E.; Jennings, Heather R.

    2013-01-01

    Directors and coordinators (n = 75) of graduate programs in school psychology approved by the National Association of School Psychologists (NASP) were surveyed regarding their training practices in suicide risk assessment. Respondents viewed the assessment of suicide risk as an important part of graduate instruction, and most believed that…

  11. Assessing Fieldwork Risk for Undergraduate Projects. Directions: JGHE Study Guide.

    ERIC Educational Resources Information Center

    Higgitt, David; Bullard, Jo

    1999-01-01

    Discusses the five steps involved in conducting risk assessment for fieldwork using two examples of typical student projects: (1) identity the hazards; (2) identify who might be harmed; (3) evaluate the risks; (4) record the findings; and (5) review the assessment periodically. Addresses expeditions and work overseas. (CMK)

  12. CHILDREN AS A SENSITIVE SUBPOPULATION FOR THE RISK ASSESSMENT PROCESS

    EPA Science Inventory

    Children as a sensitive subpopulation for the risk assessment process
    Abstract
    For cancer risk assessment purposes, it is necessary to consider how to incorporate sensitive subpopulations into the process to ensure that they are appropriately protected. Children represent o...

  13. Systems Biology & Mode of Action Based Risk Assessment

    EPA Science Inventory

    The application of systems biology for risk assessment of environmental chemicals is a national extension of its use in pharmaceutical research. The basis for this is the concept of a key event network that builds on existing mode of action frameworks for risk assessment. The a...

  14. MINI REVIEW - EPIGENETIC PROCESSES AND CANCER RISK ASSESSMENT

    EPA Science Inventory

    Abstract: The U.S. Environmental Protection Agency's Guidelines for Carcinogen Risk Assessment encourages the use of mechanistic data in the assessment of human cancer risk at low (environmental) exposure levels. The key events that define a particular mode of action for tumor fo...

  15. A CRITIQUE OF THE USE OF HORMESIS IN RISK ASSESSMENT

    EPA Science Inventory

    A critique of the use of hormesis in risk assessment.

    Kitchin, KT; and Drane, Wanzer

    Summary:
    There are severe problems and limitations with the use of hormesis as the principal dose-response default assumption in risk assessment. These problems and limitations i...

  16. Regulating by the Numbers: Probabilistic Risk Assessment and Nuclear Power.

    ERIC Educational Resources Information Center

    Nichols, Elizabeth; Wildavsky, Aaron

    1988-01-01

    Probabilistic risk assessment has been promoted within the Nuclear Regulatory Commission as a means of judging risk to the public and of determining regulatory measures. Interviews with engineers and other technically trained personnel reveal the difficulties created by expectations that this form of assessment should be applied. (TJH)

  17. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Risk assessment for candidates. 105.14 Section 105.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIMINAL HISTORY BACKGROUND CHECKS Aviation Training for Aliens and Other Designated Individuals § 105.14 Risk assessment...

  18. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Risk assessment for candidates. 105.14 Section 105.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIMINAL HISTORY BACKGROUND CHECKS Aviation Training for Aliens and Other Designated Individuals § 105.14 Risk assessment...

  19. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Risk assessment for candidates. 105.14 Section 105.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIMINAL HISTORY BACKGROUND CHECKS Aviation Training for Aliens and Other Designated Individuals § 105.14 Risk assessment...

  20. Selection of Developmental Assessment Techniques for Infants at Risk.

    ERIC Educational Resources Information Center

    Parmelee, Arthur H.; And Others

    This report presents a cumulative risk score system designed to identify high-risk infants through multiple assessments over an extended period of time. The system scores prenatal, natal, and neonatal biological events and neonatal behavioral performance in an additive fashion. Infants are assessed in the first month of life to distinguish those…

  1. Are Risk Assessments of a Terrorist Attack Coherent?

    ERIC Educational Resources Information Center

    Mandel, David R.

    2005-01-01

    Four experiments examined 3 types of violations of coherence criteria in risk assessments of a terrorist attack. First, the requirement that extensionally equivalent descriptions be assigned the same probability (i.e., additivity) was violated. Unpacking descriptions of an attack into subtypes led to an increase in assessed risk. Second,…

  2. Current Challenges in Neurotoxicity Risk Assessment [Poster 2015

    EPA Science Inventory

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

  3. INTERPRETING SPONTANEOUS RENAL LESIONS IN SAFETY AND RISK ASSESSMENT

    EPA Science Inventory

    Interpreting Spontaneous Renal Lesions in Safety and Risk Assessment
    Douglas C. Wolf, D.V.M., Ph.D.

    Introduction

    Risk assessment is a process whereby the potential adverse health effects from exposure to a xenobiotic are predicted after evaluation of the availab...

  4. Status and future of Quantitative Microbiological Risk Assessment in China

    PubMed Central

    Dong, Q.L.; Barker, G.C.; Gorris, L.G.M.; Tian, M.S.; Song, X.Y.; Malakar, P.K.

    2015-01-01

    Since the implementation of the Food Safety Law of the People's Republic of China in 2009 use of Quantitative Microbiological Risk Assessment (QMRA) has increased. QMRA is used to assess the risk posed to consumers by pathogenic bacteria which cause the majority of foodborne outbreaks in China. This review analyses the progress of QMRA research in China from 2000 to 2013 and discusses 3 possible improvements for the future. These improvements include planning and scoping to initiate QMRA, effectiveness of microbial risk assessment utility for risk management decision making, and application of QMRA to establish appropriate Food Safety Objectives. PMID:26089594

  5. Using tsunami deposits to improve assessment of tsunami risk

    USGS Publications Warehouse

    Jaffe, B.E.; Gelfenbaum, G.; ,

    2002-01-01

    In many places in the world the written record of tsunamis is too short to accurately assess the risk of tsunamis. Sedimentary deposits left by tsunamis can be used to extend the record of tsunamis to improve risk assessment. The two primary factors in tsunami risk, tsunami frequency and magnitude, can be addressed through field and modeling studies of tsunami deposits. Recent advances in identification of tsunami deposits and in tsunami sedimentation modeling increase the utility of using tsunami deposits to improve assessment of tsunami risk.

  6. SMALL POPULATIONS REQUIRE SPECIFIC MODELING APPROACHES FOR ASSESSING RISK

    EPA Science Inventory

    All populations face non-zero risks of extinction. However, the risks for small populations, and therefore the modeling approaches necessary to predict them, are different from those of large populations. These differences are currently hindering assessment of risk to small pop...

  7. Scientific Opinion on Risk Assessment of Synthetic Biology.

    PubMed

    Epstein, Michelle M; Vermeire, Theo

    2016-08-01

    In 2013, three Scientific Committees of the European Commission (EC) drafted Scientific Opinions on synthetic biology that provide an operational definition and address risk assessment methodology, safety aspects, environmental risks, knowledge gaps, and research priorities. These Opinions contribute to the international discussions on the risk governance for synthetic biology developments. PMID:27234301

  8. Scientific Opinion on Risk Assessment of Synthetic Biology.

    PubMed

    Epstein, Michelle M; Vermeire, Theo

    2016-08-01

    In 2013, three Scientific Committees of the European Commission (EC) drafted Scientific Opinions on synthetic biology that provide an operational definition and address risk assessment methodology, safety aspects, environmental risks, knowledge gaps, and research priorities. These Opinions contribute to the international discussions on the risk governance for synthetic biology developments.

  9. Assessing risk from a stakeholder perspective

    NASA Technical Reports Server (NTRS)

    Cooper, L. P.

    2003-01-01

    Planetary exploration missions are subject to a vast array of interpretations of 'success' based on the concerns of multiple stakeholder groups. While project risk management generally focuses on issues of cost/schedule constraints or reliability issues, a broader interpretation of 'risk' as it applies to stakeholders such as sponsors (e.g., NASA), the public at large, the scientific community, the home organization, and the project team itself can provide important insights into the full spectrum of risk that needs to be managed. This paper presents a stakeholder view of risk which is divided into failure, not-a-failure, success, and stunning-success zones. Using the Mars Pathfinder mission as an example, an alternative interpretation of the risks to that mission is presented from the view of key stakeholders. The implications of the stakeholder perspective to project risk management are addressed.

  10. Hanford Site baseline risk assessment methodology. Revision 2

    SciTech Connect

    Not Available

    1993-03-01

    This methodology has been developed to prepare human health and environmental evaluations of risk as part of the Comprehensive Environmental Response, Compensation, and Liability Act remedial investigations (RIs) and the Resource Conservation and Recovery Act facility investigations (FIs) performed at the Hanford Site pursuant to the Hanford Federal Facility Agreement and Consent Order referred to as the Tri-Party Agreement. Development of the methodology has been undertaken so that Hanford Site risk assessments are consistent with current regulations and guidance, while providing direction on flexible, ambiguous, or undefined aspects of the guidance. The methodology identifies Site-specific risk assessment considerations and integrates them with approaches for evaluating human and environmental risk that can be factored into the risk assessment program supporting the Hanford Site cleanup mission. Consequently, the methodology will enhance the preparation and review of individual risk assessments at the Hanford Site.

  11. Cavity degradation risk insurance assessment. Final report

    SciTech Connect

    Hampson, C.; Neill, P.; de Bivort, L.

    1980-01-01

    This study examined the risks and risk management issues involved with the implementation by electric power utilities of compressed air energy storage and underground pumped hydro storage systems. The results are listed in terms of relative risks for the construction and operation of these systems in different geologic deposits, with varying amounts of pressurization, with natural or man-made disasters in the vicinity of the storage equipment, and with different modes of operating the facilities. (LCL)

  12. The in vitro and in vivo genotoxicity of isotretinoin assessed by cytokinesis blocked micronucleus assay and comet assay.

    PubMed

    Silva, F S G; Oliveira, H; Moreiras, A; Fernandes, J C; Bronze-da-Rocha, E; Figueiredo, A; Custódio, J B A; Rocha-Pereira, P; Santos-Silva, A

    2013-03-01

    Isotretinoin is a retinoic acid frequently used in monotherapy or combined with narrow-band ultraviolet B (NBUVB) irradiation to treat patients with acne and psoriasis vulgaris. As both diseases need frequent and/or prolonged therapeutic interventions, the study of the genotoxicity of retinoids becomes important. Our aim was to study the genotoxic effects of isotretinoin alone or combined with NBUVB. In vitro studies were performed in the absence of S9 metabolic activation using blood from five healthy volunteers, incubated 72 h with isotretinoin (1.2-20 μM) (i.e., at concentrations usually achieved in blood with therapeutic doses as well as at higher concentrations). In vivo studies were also performed using blood from two patients with acne and three patients with psoriasis vulgaris treated with isotretinoin in monotherapy (8 or 20mg/day) or combined with NBUVB (20mg isotretinoin/day+NBUVB). The genotoxic effect was evaluated by the cytokinesis-blocked micronucleus and the comet assays. Our studies showed that isotretinoin alone was not genotoxic when tested in human lymphocytes in vitro and in vivo. There was no clear genotoxic effect in psoriatic patients treated with isotretinoin and NBUVB. The in vitro studies showed that isotretinoin induced apoptosis and necrosis in human lymphocytes at higher doses.

  13. Risk assessment technique for evaluating research laboratories

    SciTech Connect

    Bolander, T.W.; Meale, B.M.; Eide, S.A.

    1992-01-01

    A technique has been developed to evaluate research laboratories according to risk, where risk is defined as the product of frequency and consequence. This technique was used to evaluate several laboratories at the Idaho National Engineering Laboratory under the direction of the Department of Energy, Idaho Field Office to assist in the risk management of the Science and Technology Department laboratories. With this technique, laboratories can be compared according to risk, and management can use the results to make cost effective decisions associated with the operation of the facility.

  14. Risk assessment technique for evaluating research laboratories

    SciTech Connect

    Bolander, T.W.; Meale, B.M.; Eide, S.A.

    1992-09-01

    A technique has been developed to evaluate research laboratories according to risk, where risk is defined as the product of frequency and consequence. This technique was used to evaluate several laboratories at the Idaho National Engineering Laboratory under the direction of the Department of Energy, Idaho Field Office to assist in the risk management of the Science and Technology Department laboratories. With this technique, laboratories can be compared according to risk, and management can use the results to make cost effective decisions associated with the operation of the facility.

  15. Assessing leukocyte-endothelial interactions under flow conditions in an ex vivo autoperfused microflow chamber assay.

    PubMed

    Mulki, Lama; Sweigard, J Harry; Connor, Kip M

    2014-01-01

    Leukocyte-endothelial interactions are early and critical events in acute and chronic inflammation and can, when dysregulated, mediate tissue injury leading to permanent pathological damage. Existing conventional assays allow the analysis of leukocyte adhesion molecules only after the extraction of leukocytes from the blood. This requires the blood to undergo several steps before peripheral blood leukocytes (PBLs) can be ready for analysis, which in turn can stimulate PBLs influencing the research findings. The autoperfused micro flow chamber assay, however, allows scientists to study early leukocytes functional dysregulation using the systemic flow of a live mouse while having the freedom of manipulating a coated chamber. Through a disease model, the functional expression of leukocyte adhesion molecules can be assessed and quantified in a micro-glass chamber coated with immobilized endothelial adhesion molecules ex vivo. In this model, the blood flows between the right common carotid artery and left external jugular vein of a live mouse under anesthesia, allowing the interaction of native PBLs in the chamber. Real-time experimental analysis is achieved with the assistance of an intravital microscope as well as a Harvard Apparatus pressure device. The application of a flow regulator at the input point of the glass chamber allows comparable physiological flow conditions amongst the experiments. Leukocyte rolling velocity is the main outcome and is measured using the National Institutes of Health open-access software ImageJ. In summary, the autoperfused micro flow chamber assay provides an optimal physiological environment to study leukocytes endothelial interaction and allows researchers to draw accurate conclusions when studying inflammation.

  16. Quantitative risk assessment: an emerging tool for emerging foodborne pathogens.

    PubMed Central

    Lammerding, A. M.; Paoli, G. M.

    1997-01-01

    New challenges to the safety of the food supply require new strategies for evaluating and managing food safety risks. Changes in pathogens, food preparation, distribution, and consumption, and population immunity have the potential to adversely affect human health. Risk assessment offers a framework for predicting the impact of changes and trends on the provision of safe food. Risk assessment models facilitate the evaluation of active or passive changes in how foods are produced, processed, distributed, and consumed. PMID:9366601

  17. HVAC fault tree analysis for WIPP integrated risk assessment

    SciTech Connect

    Kirby, P.; Iacovino, J.

    1990-01-01

    In order to evaluate the public health risk from operation of the Waste Isolation Pilot Plant (WIPP) due to potential radioactive releases, a probabilistic risk assessment of waste handling operations was conducted. One major aspect of this risk assessment involved fault tree analysis of the plant heating, ventilation, and air conditioning (HVAC) systems, which comprise the final barrier between waste handling operations and the environment. 1 refs., 1 tab.

  18. A method for assessing the risks of pipeline operations

    SciTech Connect

    Gloven, M.P.

    1996-09-01

    This paper presents a method for assessing the risks of hazardous liquid and natural gas pipeline systems. The method assesses risk by measuring historical and projected performance data against selected benchmarks, which if exceeded, may indicate that the pipeline may have a greater potential for failure or adverse consequence at certain points. Once these areas are determined, plans are developed and implemented to minimize risk.

  19. Assessment of weather risk on chestnut production

    NASA Astrophysics Data System (ADS)

    Pereira, M. G.; Gomes-Laranjo, J.; Caramelo, L.

    2009-04-01

    to March) precipitation, the number of days with maximum temperature between 24°C and 28°C and the number of days of May with minimum temperature below 0°C is able to model the chestnut productivity with r2 equal to 0.79. It should be pointed out that the relation between weather/climate and chestnut productivity may change over time. Finally, it is important to express objectively the effects of temperature and precipitation extremes on the chestnut productivity since temperature is one of the global circulation models predicted variables with less uncertainty. With these tools will be possible to assess the weather related risk on chestnut production as well as infer about evolution of the adequate conditions to the chestnut trees in the actual plantations and about the expansion of this specie. Bounous, G. (2002) "Il castagno" [Chestnut.] - Edagricole, Bologna. [In Ital.] Gomes-Laranjo, J., Coutinho, J.P., Ferreira-Cardoso, J., Pimentel-Pereira, M., Ramos, C., Torres-Pereira, J.(2005) "Assessment to a new concept of chestnut orchard management in vegetative wall.". Acta Hort. 693: 707-712. Gomes-Laranjo, J.C.E., Peixoto, F., Wong Fong Sang, H.W., Torres-Pereira, J.M.G.(2006) "Study of the temperature effect in three chestnut (Castanea sativa Mill.) cultivars' behavior". J. Plant Physiol. 163: 945-955.

  20. Hurricane flood risk in New York City - a detailed risk assessment of future risks and validation

    NASA Astrophysics Data System (ADS)

    de Moel, Hans; Lin, Ning; Emanuel, Kerry; Botzen, Wouter; Aerts, Jeroen

    2014-05-01

    Hurricane Irene in 2011 and hurricane Sandy in 2012 showed all too clearly how vulnerable New York City (NYC) and the east coast of continental USA is to the devastating effects of coastal flooding. Total repair and recovery costs caused by Sandy in the States of New Jersey and New York totaled around 60 billion. The wake of hurricane Sandy has seen a lively debate on how to cope with this now apparent flood risk, and how it may change in the future. In this research, we developed an integrated flood risk model to assess the flood risk to buildings and vehicles by combining more than 500 synthetic hurricane events with the Hazus-MH4 damage model. Risk is estimated on a refined spatial scale for the current situation, as well as for future conditions around 2050 and 2080 by including population growth and climate change. Climate change is included based on synthetic storms using boundary conditions of 4 different GCMs, representing the effect of sea-level rise as well as a possible increase in storm frequency. The effect of uncertainty in storm water levels and damage estimation is also illustrated. The model results are validated using observations of damage caused by Hurricane Sandy in the region, yielding good agreement, giving confidence in the capacities of the modeling framework. The model results illustrate the spatial extent of the flood risk in New York (at the census block level), yielding an aggregate of 71 million/year for buildings and vehicles (total risk including e.g. infrastructure would roughly be double). The population growth projected by the city will result in a moderate increase in risk (~17%). Climate change, on the other hand, will have a much more profound impact on risk in NYC. Sea-level rise will already have a considerable impact (+60% in 2050s; +150% in 2080s), but coupled with a possible increase in storm frequency, as present in two of the four GCMs, will make for a large increase (+440% in 2050s, +1160%). A future flood risk of up to