Science.gov

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. ISTA13--international interlaboratory comparative evaluation of microbial assay for risk assessment (MARA).

    PubMed

    Wadhia, K

    2008-10-01

    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-titer plate. Developed for testing the toxicity of chemicals, mixtures, and environmental samples, the assay employs species of a taxonomically diverse range. In addition to 10 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. The performance of MARA was evaluated to ascertain its capability and potential scope in an intralaboratory trial. 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- and nitrification-inhibition tests. MARA's performance was further assessed with the implementation of an international interlaboratory trial. This involved the participation of 13 laboratories ranging from academic establishments to regulatory agencies. The results of the testing will be presented with assessment of the extent of variability and specific assay components. The trial evaluation indicated that performance of the assay was satisfactory and the results were within the acceptable range. MARA is a robust multispecies assay offering scope for toxicity assessment of a diverse range of samples.

  3. An assessment of the potential of the microbial assay for risk assessment (MARA) for ecotoxicological testing.

    PubMed

    Fai, Patricia Bi; Grant, Alastair

    2010-11-01

    Rapid microscale toxicity tests make it possible to screen large numbers of compounds and greatly simplify toxicity identification evaluation and other effect directed chemical analyses of effluents or environmental samples. Tests using Vibrio fischeri (such as Microtox®) detect toxicants that cause non-specific narcosis, but are insensitive to other important classes of contaminants. The microbial assay for risk assessment (MARA) is a 24 h multi-species test that seeks to address this problem by using a battery of ten bacteria and a fungus. But there has been little independent evaluation of this test, and there is no published information on its sensitivity to pesticides. Here, we assess the performance of MARA using a range of toxicants including reference chemicals, fungicides and environmental samples. Mean MARA microbial toxic concentrations and IC(20)s (20% Inhibitory concentrations) indicate the toxicant concentrations affecting the more sensitive micro-organisms, while the mean IC(50) (50% Inhibitory concentration) was found to be the concentration that was toxic to most MARA species. For the two fungicides tested, the yeast (Pichia anomalia) was the most sensitive of the ten MARA species, and was more sensitive than the nine other yeasts tested. The test may be particularly valuable for work with fungicides. Mean MARA IC(50)s were comparable to values for nine other yeast species and the lowest individual IC(50)s for each toxicant were comparable to reported IC(50)s for Daphnia magna, Selenastrum capricornutum and Microtox® bioassays. MARA organisms exhibited more variable sensitivities, with the most sensitive organism being different for different samples, enhancing the likelihood of toxicity detection and giving a toxicity "fingerprint" that may help identify toxicants. The test, therefore, has great potential and would be valuable for ecotoxicological testing of pollutants.

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

    NASA Astrophysics Data System (ADS)

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

    2013-04-01

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

  5. 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. © 2013.

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

    PubMed

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

    2016-01-01

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

  7. Potency values from the local lymph node assay: application to classification, labelling and risk assessment.

    PubMed

    Loveless, S E; Api, A-M; Crevel, R W R; Debruyne, E; Gamer, A; Jowsey, I R; Kern, P; Kimber, I; Lea, L; Lloyd, P; Mehmood, Z; Steiling, W; Veenstra, G; Woolhiser, M; Hennes, C

    2010-02-01

    Hundreds of chemicals are contact allergens but there remains a need to identify and characterise accurately skin sensitising hazards. The purpose of this review was fourfold. First, when using the local lymph node assay (LLNA), consider whether an exposure concentration (EC3 value) lower than 100% can be defined and used as a threshold criterion for classification and labelling. Second, is there any reason to revise the recommendation of a previous ECETOC Task Force regarding specific EC3 values used for sub-categorisation of substances based upon potency? Third, what recommendations can be made regarding classification and labelling of preparations under GHS? Finally, consider how to integrate LLNA data into risk assessment and provide a rationale for using concentration responses and corresponding no-effect concentrations. Although skin sensitising chemicals having high EC3 values may represent only relatively low risks to humans, it is not possible currently to define an EC3 value below 100% that would serve as an appropriate threshold for classification and labelling. The conclusion drawn from reviewing the use of distinct categories for characterising contact allergens was that the most appropriate, science-based classification of contact allergens according to potency is one in which four sub-categories are identified: 'extreme', 'strong', 'moderate' and 'weak'. Since draining lymph node cell proliferation is related causally and quantitatively to potency, LLNA EC3 values are recommended for determination of a no expected sensitisation induction level that represents the first step in quantitative risk assessment.

  8. 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.

  9. Ciguatera risk assessment in two toxic sites of French Polynesia using the receptor-binding assay.

    PubMed

    Darius, H T; Ponton, D; Revel, T; Cruchet, P; Ung, A; Tchou Fouc, M; Chinain, M

    2007-10-01

    Ciguatera Fish Poisoning (CFP) is a tropical syndrome well known in remote archipelagos where the population is still dependent on fish resources. In order to assess the ciguatera risk in two islands of French Polynesia, Tubuai (Australes) and Nuku Hiva (Marquesas), a study was carried out on both Gambierdiscus populations as well as on various fish species using the receptor-binding assay (RBA) to detect and quantify ciguatoxins. Relationship between RBA data and size or weight of fish was evaluated, and when only few individuals for a particular species were available the trophic level was used to help comparisons between studied areas. According to epidemiological data, toxic versus safe areas were explored and compared in both islands. In Tubuai Island, Gambierdiscus cells were surprisingly absent in the north area, considered as a toxic area, but almost 94% of fishes were classified as RBA+. In contrast, the south area, supposed to be safe, was evolving to be a risky area because of the presence of Gambierdiscus cells and 74% of fishes being RBA+. In Nuku Hiva Island, Gambierdiscus cells were present in the toxic areas, Anaho, Taiohae and Taipivei, with two toxic blooms in Anaho Bay, but none in Terre Déserte, the fishing area of this island. With RBA data, fishes were analyzed to be RBA+ at a high percentage in Anaho and Taiohae, higher than in Taipivei and Terre Déserte areas. In general, our findings were congruent with epidemiological data and the knowledge of local people only for risky fish species.

  10. 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

  11. 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

  12. 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.

  13. [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

    The comet assay is a fluorescent microscopic method that is able to detect DNA strand-breaks even in non-proliferative cells in samples with low cell counts. The aim of the authors was to measure genotoxic DNA damage and assess oxidative DNA damage caused by occupational exposure in groups exposed to benzene, polycyclic aromatic carbohydrates and styrene at the workplace in order to clarify whether the comet assay can be used as an effect marker tool in genotoxicology monitoring. In addition to the basic steps of the comet assay, one sample was treated with formamido-pirimidine-DNA-glycolase restriction-enzyme that measures oxidative DNA damage. An increase was observed in tail moments in each group of untreated and Fpg-treated samples compared to the control. It can be concluded that occupational exposure can be detected with the method. The comet assay may prove to be an excellent effect marker and a supplementary technique for monitoring the presence or absence of genotoxic effects.

  14. 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.

  15. Radiation risk assessment in professionals working in dental radiology area using buccal micronucleus cytome assay.

    PubMed

    Sadatullah, Syed; Dawasaz, Ali Azhar; Luqman, Master; Assiry, Ali A; Almeshari, Ahmed A; Togoo, Rafi Ahmad

    2013-11-01

    The aim of this study was to assess the incidence of micronuclei (MN) in buccal mucosal cells of professionals working in radiology area to determine the risk of stochastic effects of radiation. All the professionals and students working in King Khalid University - College of Dentistry radiology area were included in the Risk Group (RG = 27). The Control Group (CG = 27) comprised of healthy individual matching the gender and age of the RG. Buccal mucosal scraping from all the 54 subjects of RG and CG were stained with Papanicolaou stain and observed under oil immersion lens (×100) for the presence of micronuclei (MN) in the exfoliated epithelial cells. There was no significant difference between the incidence of MN in RG and CG (p = >0.05) using t-test. Routine radiation protection protocol does minimize the risk of radiation induced cytotoxicity, however, screening of professionals should be carried out at regular intervals.

  16. Interaction Potency of Single-Walled Carbon Nanotubes with DNAs: A Novel Assay for Assessment of Hazard Risk

    PubMed Central

    Yao, Chunhe; Carlisi, Cristina; Li, Yuning; Chen, Da; Ding, Jianfu; Feng, Yong-Lai

    2016-01-01

    Increasing use of single-walled carbon nanotubes (SWCNTs) necessitates a novel method for hazard risk assessment. In this work, we investigated the interaction of several types of commercial SWCNTs with single-stranded (ss) and double-stranded (ds) DNA oligonucleotides (20-mer and 20 bp). Based on the results achieved, we proposed a novel assay that employed the DNA interaction potency to assess the hazard risk of SWCNTs. It was found that SWCNTs in different sizes or different batches of the same product number of SWCNTs showed dramatically different potency of interaction with DNAs. In addition, the same SWCNTs also exerted strikingly different interaction potency with ss- versus ds- DNAs. The interaction rates of SWCNTs with DNAs were investigated, which could be utilized as the indicator of potential hazard for acute exposure. Compared to solid SWCNTs, the SWCNTs dispersed in liquid medium (2% sodium cholate solution) exhibited dramatically different interaction potency with DNAs. This indicates that the exposure medium may greatly influence the subsequent toxicity and hazard risk produced by SWCNTs. Based on the findings of dose-dependences and time-dependences from the interactions between SWCNTs and DNAs, a new chemistry based assay for hazard risk assessment of nanomaterials including SWCNTs has been presented. PMID:27936089

  17. 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.

  18. Earthworm Comet Assay for Assessing the Risk of Weathered Petroleum Hydrocarbon Contaminated Soils: Need to Look Further than Target Contaminants.

    PubMed

    Ramadass, Kavitha; Palanisami, Thavamani; Smith, Euan; Mayilswami, Srinithi; Megharaj, Mallavarapu; Naidu, Ravi

    2016-11-01

    Earthworm toxicity assays contribute to ecological risk assessment and consequently standard toxicological endpoints, such as mortality and reproduction, are regularly estimated. These endpoints are not enough to better understand the mechanism of toxic pollutants. We employed an additional endpoint in the earthworm Eisenia andrei to estimate the pollutant-induced stress. In this study, comet assay was used as an additional endpoint to evaluate the genotoxicity of weathered hydrocarbon contaminated soils containing 520 to 1450 mg hydrocarbons kg(-1) soil. Results showed that significantly higher DNA damage levels (two to sixfold higher) in earthworms exposed to hydrocarbon impacted soils. Interestingly, hydrocarbons levels in the tested soils were well below site-specific screening guideline values. In order to explore the reasons for observed toxicity, the contaminated soils were leached with rainwater and subjected to earthworm tests, including the comet assay, which showed no DNA damage. Soluble hydrocarbon fractions were not found originally in the soils and hence no hydrocarbons leached out during soil leaching. The soil leachate's Electrical Conductivity (EC) decreased from an average of 1665 ± 147 to 204 ± 20 µS cm(-1). Decreased EC is due to the loss of sodium, magnesium, calcium, and sulphate. The leachate experiment demonstrated that elevated salinity might cause the toxicity and not the weathered hydrocarbons. Soil leaching removed the toxicity, which is substantiated by the comet assay and soil leachate analysis data. The implication is that earthworm comet assay can be included in future eco (geno) toxicology studies to assess accurately the risk of contaminated soils.

  19. 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...

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

    PubMed

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

    2014-06-01

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

  1. Development and validation of a 36-gene sequencing assay for hereditary cancer risk assessment

    PubMed Central

    Wang, Xin; Robertson, Alex D.; Haas, Kevin R.; Theilmann, Mark R.; Spurka, Lindsay; Grauman, Peter V.; Lai, Henry H.; Jeon, Diana; Haliburton, Genevieve; Leggett, Matt; Chu, Clement S.; Iori, Kevin; Maguire, Jared R.; Ready, Kaylene; Evans, Eric A.; Haque, Imran S.

    2017-01-01

    The past two decades have brought many important advances in our understanding of the hereditary susceptibility to cancer. Numerous studies have provided convincing evidence that identification of germline mutations associated with hereditary cancer syndromes can lead to reductions in morbidity and mortality through targeted risk management options. Additionally, advances in gene sequencing technology now permit the development of multigene hereditary cancer testing panels. Here, we describe the 2016 revision of the Counsyl Inherited Cancer Screen for detecting single-nucleotide variants (SNVs), short insertions and deletions (indels), and copy number variants (CNVs) in 36 genes associated with an elevated risk for breast, ovarian, colorectal, gastric, endometrial, pancreatic, thyroid, prostate, melanoma, and neuroendocrine cancers. To determine test accuracy and reproducibility, we performed a rigorous analytical validation across 341 samples, including 118 cell lines and 223 patient samples. The screen achieved 100% test sensitivity across different mutation types, with high specificity and 100% concordance with conventional Sanger sequencing and multiplex ligation-dependent probe amplification (MLPA). We also demonstrated the screen’s high intra-run and inter-run reproducibility and robust performance on blood and saliva specimens. Furthermore, we showed that pathogenic Alu element insertions can be accurately detected by our test. Overall, the validation in our clinical laboratory demonstrated the analytical performance required for collecting and reporting genetic information related to risk of developing hereditary cancers. PMID:28243543

  2. Organ donor screening using parallel nucleic acid testing allows assessment of transmission risk and assay results in real time.

    PubMed

    Baleriola, C; Tu, E; Johal, H; Gillis, J; Ison, M G; Law, M; Coghlan, P; Rawlinson, W D

    2012-06-01

    Expansion of the donor pool may lead to utilization of donors with risk factors for viral infections. Donor laboratory screening relies on serological and nucleic acid testing (NAT). The increased sensitivity of NAT in low prevalence populations may result in false-positive results (FPR) and may cause unnecessary discard of organs.We developed a screening algorithm to deal, in real time, with potential FPR. Three NAT assays: COBAS AmpliScreen assay (CAS), AmpliPrep Total Nucleic Acid Isolation/CAS, and AmpliPrep/TaqMan assays, were validated and used in parallel for prospective screening of increased-risk donors (IRD), and the probability of FPR was calculated. The lower limit of detection of this algorithm was 9.79, 21.02, and 4.31 IU/mL for human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus, respectively, with an average turn-around-time of 7.67 h from sample receipt to result reporting. The probability that a donor is potentially infectious with two NAT concordant results was >90%. NAT screening of 35 IRD within 18 months resulted in transplantation of 102 additional organs that without screening would either not be used or used with restrictions in Australia. Using a parallel testing algorithm, real-time confirmation of seropositive donors allows use of organs from IRD and safer expansion of the donor pool.

  3. Analytical Validation of a Personalized Medicine APOL1 Genotyping Assay for Nondiabetic Chronic Kidney Disease Risk Assessment

    PubMed Central

    Zhang, Jinglan; Fedick, Anastasia; Wasserman, Stephanie; Zhao, Geping; Edelmann, Lisa; Bottinger, Erwin P.; Kornreich, Ruth; Scott, Stuart A.

    2017-01-01

    The incidence of chronic kidney disease (CKD) varies by ancestry, with African Americans (AA) having a threefold to fourfold higher rate than whites. Notably, two APOL1 alleles, termed G1 [c.(1072A>G; 1200T>G)] and G2 (c.1212_1217del6), are strongly associated with higher rates of nondiabetic CKD and an increased risk for hypertensive end-stage renal disease. This has prompted the opportunity to implement APOL1 testing to identify at-risk patients and modify other risk factors to reduce the progression of CKD to end-stage renal disease. We developed an APOL1 genotyping assay using multiplex allele-specific primer extension, and validated using 58 positive and negative controls. Genotyping results were completely concordant with Sanger sequencing, and both triplicate interrun and intrarun genotyping results were completely concordant. Multiethnic APOL1 allele frequencies were also determined by genotyping 7059 AA, Hispanic, and Asian individuals from the New York City metropolitan area. The AA, Hispanic, and Asian APOL1 G1 and G2 allele frequencies were 0.22 and 0.13, 0.037 and 0.025, and 0.013 and 0.004, respectively. Notably, approximately 14% of the AA population carried two risk alleles and are at increased risk for CKD, compared with <1% of the Hispanic and Asian populations. This novel APOL1 genotyping assay is robust and highly accurate, and represents one of the first personalized medicine clinical genetic tests for disease risk prediction. PMID:26773863

  4. 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...

  5. 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...

  6. 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

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

    PubMed

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

    2016-10-01

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

  8. Establishment of in vitro P-glycoprotein inhibition assay and its exclusion criteria to assess the risk of drug-drug interaction at the drug discovery stage.

    PubMed

    Sugimoto, Hiroshi; Matsumoto, Shin-ichi; Tachibana, Miho; Niwa, Shin-ichi; Hirabayashi, Hideki; Amano, Nobuyuki; Moriwaki, Toshiya

    2011-09-01

    The decision tree to determine whether the P-glycoprotein (P-gp)/multidrug resistance protein 1 (MDR1)-mediated drug-drug interaction (DDI) study is recommended has been proposed by the International Transporter Consortium. We, therefore, designed an in vitro P-gp inhibition assay and determined the appropriate risk criteria for P-gp-mediated DDI at the drug discovery stage. Effects of P-gp inhibitors on digoxin transport across a monolayer of MDR1-expressing cells were examined. The IC(50) (half-maximal inhibitory concentration) values generated from the efflux ratio (ER) were smaller than those generated from basolateral-to-apical directional apparent permeability. The difference in IC(50) values was kinetically described in a compartment model analysis. This analysis indicated that ER is a highly sensitive parameter that can be used for the degree of P-gp inhibition. Considering IC(50) values and the increase in digoxin exposure in clinical DDI studies, the risk criteria of [I(2)]/IC(50) = 30 ([I(2)], theoretically maximal gastrointestinal concentration) was the optimal cutoff value to predict a clinically relevant DDI. We also investigated whether the IC(50) value itself is applicable to assess the DDI risk. In conclusion, compounds with IC(50) values less than 2 μM exhibit high risk for P-gp-mediated DDIs. However, compounds with IC(50) values greater than or equal to 2 μM are inconclusive because clinical doses should be considered for the precise DDI risk assessment.

  9. Development of an in vitro cytochrome P450 cocktail inhibition assay for assessing the inhibition risk of drugs of abuse.

    PubMed

    Dinger, Julia; Meyer, Markus R; Maurer, Hans H

    2014-10-01

    Drugs of abuse are not tested for cytochrome P450 (CYP) inhibition potential before distribution. Therefore, a cocktail assay should be developed for testing the inhibition potential for all relevant CYPs. The following CYP test substrates and selective inhibitors were incubated in pooled human liver microsomes: phenacetin (alpha-naphthoflavone for CYP1A2), coumarin (tranylcypromine, CYP2A6), bupropion (sertraline, CYP2B6), amodiaquine (trimethoprim, CYP2C8), diclofenac (sulfaphenazole, CYP2C9), omeprazole (fluconazole, CYP2C19), dextromethorphan (quinidine, CYP2D6), chlorzoxazone (clomethiazole, CYP2E1), testosterone (verapamil, CYP3A). Samples were analyzed after protein precipitation using a Thermo Fisher Q-Exactive LC-high-resolution-MS/MS. The IC50 values were calculated by plotting the concentration of the formed metabolite, relative to the control sample, over the logarithm of the inhibitor concentration. They were determined either for single substrate or the cocktail incubation. Unfortunately, the cocktail assay had to be split because of interferences during incubation caused by substrates or metabolites, but the mixture of both incubates could be analyzed in one analytical run. The IC50 values determined in the single substrate or both cocktail incubations were comparable among themselves and with published data. In conclusion, the new inhibition cocktail assay was reproducible and applicable for testing the inhibition potential of drugs of abuse as exemplified for 2,5-dimethoxy-4-iodo-amfetamine (DOI). Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  10. Neonatal tetanus in Peru: risk assessment with modified enzyme-linked immunosorbent assay and toxoid skin test.

    PubMed Central

    Vernacchio, L; Madico, G; Verastegui, M; Diaz, F; Collins, T S; Gilman, R H

    1993-01-01

    We used a modified enzyme-linked immunosorbent assay (ELISA) to investigate tetanus immunity in 232 pregnant Peruvian women. One hundred forty-two (61.2%) had protective antitoxin titers (> or = 0.01 IU/mL). Protective titers correlated positively with the number of toxoid doses reported during the current pregnancy. A majority of women reporting no toxoid doses during the current pregnancy had at least one prenatal health care visit. We evaluated a toxoid skin test in 44 of the subjects, but it correlated poorly with the ELISA. The modified ELISA is a useful in vitro method for studying tetanus immunity in the developing world. PMID:8259811

  11. 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.

  12. Genotoxic risk assessment in professionals working hairdressers area using buccal micronucleus assay, in Aydın City, Turkey.

    PubMed

    Aslantürk, Özlem Sultan; Aşkin Çelik, Tülay

    2017-06-01

    The aim of this study was to determine the genotoxic risk of professional hairdressers in Aydın City, Turkey, through investigating the micronucleus frequencies in buccal mucosa epithelial cells. All the hairdresser working hairdresser area were included in the genotoxic risk group (GRG = 20) in Aydın City, Turkey. The control group (CG = 20) comprised healthy individuals matching the gender and age of the GRG. Buccal mucosal scraping from all the 40 subjects of GRG (10 women and 10 men) and CG (10 women and 10 men) was stained with Giemsa stain and observed under light microscope (×40) for the presence of micronuclei (M 10 N) and karyolysis, pyknosis, condensed chromatin, karyorrhexis, nuclear bud, and binucleates in the exfoliated epithelial cells. There are significance between the incidence of MN in GRG and CG (P = <0.005) using one-way ANOVA, Kolmogorov-Smirnov Z test, and Spearman Rank Correlation Tests.

  13. 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

  14. 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.

  15. Hepatitis Risk Assessment

    MedlinePlus

    ... please visit this page: About CDC.gov . Hepatitis Risk Assessment Recommend on Facebook Tweet Share Compartir Viral Hepatitis. Are you at risk? Take this 5 minute Hepatitis Risk Assessment developed ...

  16. 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. Copyright © 2014 Elsevier B.V. All rights reserved.

  17. Digestion Assays in Allergenicity Assessment of Transgenic Proteins

    PubMed Central

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

    2006-01-01

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

  18. 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.

  19. RESIDUAL RISK ASSESSMENTS - RESIDUAL RISK ...

    EPA Pesticide Factsheets

    This source category previously subjected to a technology-based standard will be examined to determine if health or ecological risks are significant enough to warrant further regulation for Coke Ovens. These assesments utilize existing models and data bases to examine the multi-media and multi-pollutant impacts of air toxics emissions on human health and the environment. Details on the assessment process and methodologies can be found in EPA's Residual Risk Report to Congress issued in March of 1999 (see web site). To assess the health risks imposed by air toxics emissions from Coke Ovens to determine if control technology standards previously established are adequately protecting public health.

  20. 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.

  1. 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.

  2. 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.

  3. Pollinator Risk Assessment Guidance

    EPA Pesticide Factsheets

    This Guidance is part of a long-term strategy to advance the science of assessing the risks posed by pesticides to honey bees, giving risk managers the means to further improve pollinator protection in our regulatory decisions.

  4. Quantitative microbiological risk assessment.

    PubMed

    Hoornstra, E; Notermans, S

    2001-05-21

    The production of safe food is being increasingly based on the use of risk analysis, and this process is now in use to establish national and international food safety objectives. It is also being used more frequently to guarantee that safety objectives are met and that such guarantees are achieved in a cost-effective manner. One part of the overall risk analysis procedure-risk assessment-is the scientific process in which the hazards and risk factors are identified, and the risk estimate or risk profile is determined. Risk assessment is an especially important tool for governments when food safety objectives have to be developed in the case of 'new' contaminants in known products or known contaminants causing trouble in 'new' products. Risk assessment is also an important approach for food companies (i) during product development, (ii) during (hygienic) process optimalization, and (iii) as an extension (validation) of the more qualitative HACCP-plan. This paper discusses these two different types of risk assessment, and uses probability distribution functions to assess the risks posed by Escherichia coli O157:H7 in each case. Such approaches are essential elements of risk management, as they draw on all available information to derive accurate and realistic estimations of the risk posed. The paper also discusses the potential of scenario-analysis in simulating the impact of different or modified risk factors during the consideration of new or improved control measures.

  5. 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.

  6. 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.

  7. Personal samplers of bioavailable pesticides integrated with a hair follicle assay of DNA damage to assess environmental exposures and their associated risks in children.

    PubMed

    Vidi, Pierre-Alexandre; Anderson, Kim A; Chen, Haiying; Anderson, Rebecca; Salvador-Moreno, Naike; Mora, Dana C; Poutasse, Carolyn; Laurienti, Paul J; Daniel, Stephanie S; Arcury, Thomas A

    2017-10-01

    Agriculture in the United States employs youth ages ten and older in work environments with high pesticide levels. Younger children in rural areas may also be affected by indirect pesticide exposures. The long-term effects of pesticides on health and development are difficult to assess and poorly understood. Yet, epidemiologic studies suggest associations with cancer as well as cognitive deficits. We report a practical and cost-effective approach to assess environmental pesticide exposures and their biological consequences in children. Our approach combines silicone wristband personal samplers and DNA damage quantification from hair follicles, and was tested as part of a community-based participatory research (CBPR) project involving ten Latino children from farmworker households in North Carolina. Our study documents high acceptance among Latino children and their caregivers of these noninvasive sampling methods. The personal samplers detected organophosphates, organochlorines, and pyrethroids in the majority of the participants (70%, 90%, 80%, respectively). Pesticides were detected in all participant samplers, with an average of 6.2±2.4 detections/participant sampler. DNA damage in epithelial cells from the sheath and bulb of plucked hairs follicles was quantified by immunostaining 53BP1-labled DNA repair foci. This method is sensitive, as shown by dose response analyses to γ radiations where the lowest dose tested (0.1Gy) led to significant increased 53BP1 foci density. Immunolabeling of DNA repair foci has significant advantages over the comet assay in that specific regions of the follicles can be analyzed. In this cohort of child participants, significant association was found between the number of pesticide detections and DNA damage in the papilla region of the hairs. We anticipate that this monitoring approach of bioavailable pesticides and genotoxicity will enhance our knowledge of the biological effects of pesticides to guide education programs and

  8. 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)

  9. 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)

  10. Risk assessment [Chapter 9

    Treesearch

    Dennis S. Ojima; Louis R. Iverson; Brent L. Sohngen; James M. Vose; Christopher W. Woodall; Grant M. Domke; David L. Peterson; Jeremy S. Littell; Stephen N. Matthews; Anantha M. Prasad; Matthew P. Peters; Gary W. Yohe; Megan M. Friggens

    2014-01-01

    What is "risk" in the context of climate change? How can a "risk-based framework" help assess the effects of climate change and develop adaptation priorities? Risk can be described by the likelihood of an impact occurring and the magnitude of the consequences of the impact (Yohe 2010) (Fig. 9.1). High-magnitude impacts are always...

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

    PubMed

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

    2016-11-01

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

  12. Risk Assessment Tools

    DTIC Science & Technology

    1994-10-01

    2W0 ww) A number of computer-based risk assessment tools were enhanced or creaited to provide Increased access to risk assessment instruments and...produced an extensible authoring tool , SYNTAS, for test instruments that will simplify the data gathering phase of subsequent work. SYNTAS gives DNA...Ultimately it became a computer-assisted software engineerting (CASE) tool capable of producing a wide variety of assessment instruments . In addition, its

  13. 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.

  14. 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.

  15. 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.

  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. Cardiac Risk Assessment

    MedlinePlus

    ... helpful? Formal name: Cardiac Risk Assessment Related tests: Lipid Profile , VLDL Cholesterol , hs-CRP , Lp(a) Overview | Common ... on Coronary artery disease: Tests and diagnosis .) The lipid profile is the most important blood test for cardiac ...

  18. Schedule Risk Assessment

    NASA Technical Reports Server (NTRS)

    Smith, Greg

    2003-01-01

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

  19. Artificial membrane assays to assess permeability.

    PubMed

    Faller, Bernard

    2008-11-01

    This paper reviews the development of artificial membrane assays in the last decade. Reasons why parallel artificial membrane assays (PAMPA) became widely used are discussed and the various PAMPA assays targeting gastro-intestinal absorption, blood brain barrier and skin penetration are presented. Improvements in the assay technology like the introduction of a paracellular component and the critical factors to get quality data are reviewed. The question how does PAMPA compare with Caco-2 monolayer permeability is being addressed. New dimensions in artificial membrane assays like octanol/water logP measurement, influence of excipients on solubility/permeability and binding constants measurements are introduced. Finally, similarity and differences between partition coefficients and permeability values are discussed.

  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. Guidelines for Carcinogen Risk Assessment

    EPA Pesticide Factsheets

    The Guidelines for Carcinogen Risk Assessment provide EPA staff with guidance for developing and using risk assessments. They also provide basic information to the public about the Agency's risk assessment methods.

  3. Ozone Risk Assessment Utilities

    SciTech Connect

    Whitfield, R. G.; Jusko, M. J.; Clemmons, M. A.

    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 are 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.

  4. 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.

  5. Risk assessment of human myelotoxicity of anticancer drugs: a predictive model and the in vitro colony forming unit granulocyte/macrophage (CFU-GM) assay.

    PubMed

    Masubuchi, N

    2006-02-01

    Myelotoxicity is one of the major limitations to the use of anticancer drugs. It is desirable to evaluate human myelotoxicity before a Phase I study, however, this is difficult because of the differences in susceptibility between humans and animals. The purpose of this study was to establish a reliable method to predict the human maximum tolerated dose (MTD) of five camptothecin derivatives: SN-38, DX-8951f, topotecan (TPT), 9-aminocamptothecin (9-AC), and camptothecin (CAM). The myelotoxicity of camptothecin derivatives was evaluated on bone marrow from mice, dogs, and humans using a 14-day colony-forming unit-granulocyte/macrophage (CFU-GM) assay to determine the 50%, 75%, and 90% inhibitory concentration values (IC50, IC75, and IC90, respectively). Then, using human and murine IC90 values for myelotoxicity of these compounds, in vivo toxicological data, and pharmacokinetic parameters (data referred to the literature), human MTDs were predicted retrospectively. The mechanism-based prediction model which is proposed uses the in vitro CFU-GM assay and in vivo parameters on the basis of free fraction of area under the concentration-curve (AUC) at the MTD (r2 = 0.887) and suggests that the human MTDs were well predicted for the five camptothecin derivatives by this model rather than by other models. The application of this model for in vitro hematotoxicology could be very useful in the development of new anticancer agents.

  6. Assessment of Risk in Newborns.

    ERIC Educational Resources Information Center

    Umansky, Warren; Seaton, Jane B.

    1979-01-01

    To assess risk status of newborns, data were collected on 776 newborns using a high risk register. Analysis of high risk characteristics revealed 261 primary risk incidents in the sample and 292 secondary risk factors. (Author/PHR)

  7. Assessment of Risk in Newborns.

    ERIC Educational Resources Information Center

    Umansky, Warren; Seaton, Jane B.

    1979-01-01

    To assess risk status of newborns, data were collected on 776 newborns using a high risk register. Analysis of high risk characteristics revealed 261 primary risk incidents in the sample and 292 secondary risk factors. (Author/PHR)

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. [A new application for the human whole blood test: development of an assay to assess the health risk of air-borne microbial contaminations].

    PubMed

    Fennrich, S; Zucker, B; Hartung, T

    2001-01-01

    The pathogenic properties of environmental microorganisms as well as pyrogens as fragments of those bacteria (especially endotoxins) for humans is increasingly recognised. Various clinical syndromes are described after contact with airborne microbial contaminants via the respiratory tract: Sick-building-syndrome, humidifier lung (a form of hypersensitive pneumonitis), "Monday sickness" etc. Air-conditioning and ventilation systems intensify this problem as well as storage of compost within the household which represents a considerable source of airborne pollutants. In 1995 a new method for the detection of pyrogenic (fever-inducing) hazardous substances was described by Hartung and Wendel. This whole blood assay utilises the natural reaction of the immune system in order to detect a broad spectrum of pyrogens very sensitively in the relevant species. Injectable drugs are the main area of application in which this innovative test has already proven effective and is currently validated for inclusion into European Pharmacopoeia. In co-operation with the FU Berlin we could demonstrate in ventilation systems in animal stables that the whole blood pyrogen test can also detect airborne environmental microorganisms very sensitively. The filtration technique for collection of these germs is an established method for air-conditioning and ventilation systems. In co-operation with the FU Berlin (Institut für Tier-und Umwelthygiene) and the filter producer Sartorius this method is currently developed for the detection of airborne contaminations.

  15. A trial on the quantitative risk assessment of man-made mineral fibers by the rat intraperitoneal administration assay using the JFM standard fibrous samples.

    PubMed

    Adachi, S; Kawamura, K; Takemoto, K

    2001-04-01

    We tried to evaluate the carcinogenic risk of man-made mineral fiber based on the mesothelioma incidence in female F344 rats after intraperitoneal administration. Rats (female F344/ Nslc, 5-week-old, n=330) were observed for 2 years after the intraperitoneal administration of 5 to 20 mg of 9 types of the JFM (Japan Fibrous Material Research Association) standard fiber samples (glass wool, rock wool, micro fiber glass, three types of refractory fiber, potassium titanate whisker, silicon carbide whisker, titanium oxide whisker), wollastonite (natural fiber) and UICC chrysotile B. All rats administered 10 mg of silicon carbide whisker had developed peritoneal mesothelioma within a year. The cumulative incidence of peritoneal mesothelioma at the end of the experiment was 85% for 10 mg UICC chrysotile B, 77% for 10 mg of potassium titanate whisker, 70% for 5 mg of silicon carbide whisker, 20% for 5 mg of potassium titanate whisker, 20% for 20 mg of refractory fiber 2 and 10% for 20 mg of refractory fiber 1. Carcinogenicity was estimated 2.4 times for silicon carbide whisker and 0.23 for potassium titanate whisker in comparison with UICC chrysotile B. It has been well documented from several experimental studies that man-made fibers are safer than asbestos because of the different durability in the lung. Present results consistently suggest that man-made fibers with high durability have similar or higher risk as carcinogen than asbestos.

  16. Falls risk assessment.

    PubMed

    Gallacher, Rose

    2017-02-22

    What was the nature of the CPD activity, practice-related feedback and/or event and/or experience in your practice? The CPD article outlined the causes and consequences of falls for older patients. It discussed the falls risk assessment tools, and falls prevention measures.

  17. Formaldehyde risk assessment

    EPA Science Inventory

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

  18. Formaldehyde risk assessment

    EPA Science Inventory

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

  19. 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). PMID:27757402

  20. 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.

  1. 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.

  2. Risk Assessment in Criminal Sentencing.

    PubMed

    Monahan, John; Skeem, Jennifer L

    2016-01-01

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

  3. 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.

  4. Formaldehyde: assessing the risk

    SciTech Connect

    Hileman, B.

    1984-07-01

    The US Environmental Protection Agency has listed formaldehyde as a priority chemical for regulatory assessment under section 4 (f) of the Toxic Substances Control Act. They will give priority consideration to human formaldehyde exposure in two areas because of the large numbers of people involved: clothing workers who handle textiles treated with formaldehyde-based resins and residents of mobile homes that contain formaldehyde-based resins in construction materials such as foam insulation. Much of the scientific data for determining risks associated with formaldehyde is conflicting and ambiguous, due in part to its presence as a normal metabolite in human biochemistry. Although the chemical induces squamous cell carcinoma in rats, epidemiological studies in occupationally exposed groups show no strong evidence of a causal relationship between formaldehyde and cancer. Dose-response data from an experiment sponsored by the Chemical Industry Institute of Toxicology are used as the primary basis in constructing risk assessments for the human population. The most conservative model and the one chosen by EPA is the linearized multistage model. When the results of this model are examined, most of the groups studied are subject to an unacceptable risk.

  5. 2007 TOXICOLOGY AND RISK ASSESSMENT ...

    EPA Pesticide Factsheets

    EPA has announced The 2007 Toxicology and Risk Assessment Conference Cincinnati Marriott North, West Chester (Cincinnati), OHApril 23- 26, 2007 - Click to register!The Annual Toxicology and Risk Assessment Conference is a unique meeting where several Government Agencies come together to discuss toxicology and risk assessment issues that are not only of concern to the government, but also to a broader audience including academia and industry. The theme of this year's conference is Emerging Issues and Challenges in Risk Assessment and the preliminary agenda includes: Plenary Sessions and prominent speakers (tentative) include: Issues of Emerging Chemical ContaminantsUncertainty and Variability in Risk Assessment Use of Mechanistic data in IARC evaluationsParallel Sessions:Uncertainty and Variability in Dose-Response Assessment Recent Advances in Toxicity and Risk Assessment of RDX The Use of Epidemiologic Data for Risk Assessment Applications Cumulative Health Risk Assessment:

  6. 2007 TOXICOLOGY AND RISK ASSESSMENT ...

    EPA Pesticide Factsheets

    EPA has announced The 2007 Toxicology and Risk Assessment Conference Cincinnati Marriott North, West Chester (Cincinnati), OHApril 23- 26, 2007 - Click to register!The Annual Toxicology and Risk Assessment Conference is a unique meeting where several Government Agencies come together to discuss toxicology and risk assessment issues that are not only of concern to the government, but also to a broader audience including academia and industry. The theme of this year's conference is Emerging Issues and Challenges in Risk Assessment and the preliminary agenda includes: Plenary Sessions and prominent speakers (tentative) include: Issues of Emerging Chemical ContaminantsUncertainty and Variability in Risk Assessment Use of Mechanistic data in IARC evaluationsParallel Sessions:Uncertainty and Variability in Dose-Response Assessment Recent Advances in Toxicity and Risk Assessment of RDX The Use of Epidemiologic Data for Risk Assessment Applications Cumulative Health Risk Assessment:

  7. Risk assessment for safety

    NASA Astrophysics Data System (ADS)

    Hadlock, Charles R.; Glaser, Peter E.

    The application of probabilistic risk-assessment techniques to space missions is discussed, with a focus on the International Space Station. The types of hazards likely to be caused by random events; design, operational, and management errors; and intentional intervention are examined along with their secondary effects; and the top-level safety requirements defined by NASA are considered. It is suggested that such qualitative stipulations be supplemented with more quantitative measures such as used in the nuclear-power industry; the major features of such quantitative methods are reviewed.

  8. Framework for Ecological Risk Assessment

    EPA Pesticide Factsheets

    This is the first step in a long-term effort to develop risk assessment guidelines for ecological effects. Its primary purpose is to offer a simple, flexible structure for conducting and evaluating ecological risk assessment within EPA.

  9. Framework for Metals Risk Assessment

    EPA Pesticide Factsheets

    The Framework for Metals Risk Assessment is a science-based document that addresses the special attributes and behaviors of metals and metal compounds to be considered when assessing their human health and ecological risks.

  10. Ecological risk assessment, prediction, and assessing risk predictions.

    PubMed

    Gibbs, Mark

    2011-11-01

    Ecological risk assessment embodied in an adaptive management framework is becoming the global standard approach for formally assessing and managing the ecological risks of technology and development. Ensuring the continual improvement of ecological risk assessment approaches is partly achieved through the dissemination of not only the types of risk assessment approaches used, but also their efficacy. While there is an increasing body of literature describing the results of general comparisons between alternate risk assessment methods and models, there is a paucity of literature that post hoc assesses the performance of specific predictions based on an assessment of risk and the effectiveness of the particular model used to predict the risk. This is especially the case where risk assessments have been used to grant consent or approval for the construction of major infrastructure projects. While postconstruction environmental monitoring is increasingly commonplace, it is not common for a postconstruction assessment of the accuracy and performance of the ecological risk assessment and underpinning model to be undertaken. Without this "assessment of the assessment," it is difficult for other practitioners to gain insight into the performance of the approach and models used and therefore, as argued here, this limits the rate of improvement of risk assessment approaches.

  11. Risk assessment for carnitine.

    PubMed

    Hathcock, John N; Shao, Andrew

    2006-10-01

    Carnitine is a conditionally essential amino acid-like compound involved in the transport of long-chain fatty acids into the mitochondria during the beta-oxidation process. Carnitine has become an increasingly popular ingredient in dietary supplements, especially weight loss and some sports nutrition products. A number of clinical trials have been conducted examining the effect of carnitine supplementation on weight loss and energy balance. Regarding safety, systematic evaluation of the research designs and data do not provide a basis for risk assessment and the usual safe upper level of intake (UL) derived from it unless the newer methods described as the observed safe level (OSL) or highest observed intake (HOI) are utilized. The OSL risk assessment method indicates that the evidence of safety is strong at intakes up to 2000mg/day l-carnitine equivalents for chronic supplementation, and this level is identified as the OSL. Although much higher levels have been tested without adverse effects and may be safe, the data for intakes above 2000mg/day are not sufficient for a confident conclusion of long-term safety.

  12. Risk assessment in travel medicine.

    PubMed

    Leggat, Peter A

    2006-01-01

    Risk assessment is an integral part of pre-travel and post- assessment. Risk assessment largely determines what health and safety advice and interventions are given within the relevant prevailing travel health guidelines. Risk assessment needs time and depends on information, including that given by the traveller. Risk assessment also needs to be documented. Risk assessment of the traveller preferably starts before they enter the consulting room, where travellers may complete a pre-travel health questionnaire. Armed with this information, risk assessment may be assisted by access to computerised travel health databases and the published literature. Experience of travel to the destination may also assist in risk assessment and the tour operator, overseas employer or agency, the traveller or even the travel health advisers themselves may provide this information.

  13. 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.

  14. Validation of an LDH assay for assessing nanoparticle toxicity.

    PubMed

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

    2011-09-05

    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, 40nm), silver (Ag-35, 35nm; Ag-40, 40nm), and titanium dioxide (TiO(2)-25, 25nm) 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. TiO(2)-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. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  15. 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

  16. 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

  17. 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

  18. Advances in stalking risk assessment.

    PubMed

    McEwan, Troy E; Pathé, Michele; Ogloff, James R P

    2011-01-01

    Over the past 15 years, forensic mental health has become more concerned with the concepts of violence prevention, management, and treatment. The development of specialist tools to aid in the assessment of a range of risks reflects this concern. This article explores contemporary thinking on violence risk assessment and how this knowledge can be applied to the relatively newer field of stalking risk assessment. The role of risk state and risk status are discussed, in addition to the way that standard structured professional judgment procedures need to be adapted to reflect the variety of risks present in stalking situations. The authors go on to describe the development and format of the Stalking Risk Profile, a set of structured professional judgment guidelines for assessing risk in stalkers. Suggestions are made for future research to enhance knowledge and improve practice in the field of stalking risk assessment.

  19. 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.

  20. Defense Programs Transportation Risk Assessment

    SciTech Connect

    Clauss, D.B.

    1994-08-01

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

  1. 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.

  2. Risk assessment for halogenated solvents

    SciTech Connect

    Travis, C.C.

    1988-01-01

    A recent development in the cancer risk area is the advent of biologically based pharmacokinetic and pharmacodynamic models. These models allow for the incorporation of biological and mechanistic data into the risk assessment process. These advances will not only improve the risk assessment process for halogenated solvents but will stimulate and guide basic research in the biological area.

  3. Fact Sheet: Assessing Risks from Flame Retardants

    EPA Pesticide Factsheets

    EPA's assessing and managing risk programs address pollution prevention, risk assessment, hazard and exposure assessment and/or characterization, and risk management for chemicals substances in commercial use.

  4. 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.

  5. 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.

  6. 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.

  7. A Cell-Based Assay to Assess Hemichannel Function

    PubMed Central

    Krishnan, Srinivasan; Fiori, Mariana C.; Cuello, Luis G.; Altenberg, Guillermo A.

    2017-01-01

    Activation of connexin hemichannels is involved in the pathophysiology of disorders that include deafness, stroke, and cardiac infarct. This aspect makes hemichannels an attractive therapeutic target. Unfortunately, most available inhibitors are not selective or isoform specific, which hampers their translational application. The absence of a battery of useful inhibitors is due in part to the absence of simple screening assays for the discovery of hemichannel-active drugs. Here, we present an assay that we have recently developed to assess hemichannel function. The assay is based on the expression of functional human connexins in a genetically modified bacterial strain deficient in K+ uptake. These modified cells do not grow in low-K+ medium, but functional expression of connexin hemichannels allows K+ uptake and growth. This cell-growth-based assay is simple, robust, and easily scalable to high-throughput multi-well platforms. PMID:28356896

  8. 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

  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. Risk Assessment: A Quantitative Approach

    NASA Astrophysics Data System (ADS)

    Baert, K.; Francois, K.; de Meulenaer, B.; Devlieghere, F.

    A risk can be defined as a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard in food (Codex Alimentarius, 1999) . During a risk assessment, an estimate of the risk is obtained. The goal is to estimate the likelihood and the extent of adverse effects occurring to humans due to possible exposure(s) to hazards. Risk assessment is a scientifically based process consisting of the following steps: (1) hazard identification, (2) hazard characterization, (3) exposure assessment and (4) and risk characterization (Codex Alimentarius, 1999).

  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. Copyright © 2014 Elsevier España, S.L. All rights reserved.

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

    PubMed

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

    2015-09-01

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

  13. Models for Pesticide Risk Assessment

    EPA Pesticide Factsheets

    EPA considers the toxicity of the pesticide as well as the amount of pesticide to which a person or the environments may be exposed in risk assessment. Scientists use mathematical models to predict pesticide concentrations in exposure assessment.

  14. Using risk assessment in periodontics.

    PubMed

    Woodman, Alan J

    2014-08-01

    Risk assessment has become a regular feature in both dental practice and society as a whole, and principles used to assess risk in society are similar to those used in a clinical setting. Although the concept of risk assessment as a prognostic indicator for periodontal disease incidence and activity is well established in the management of periodontitis, the use of risk assessment to manage the practical treatment of periodontitis and its sequelae appears to have less foundation. A simple system of initial risk assessment - building on the use of the Basic Periodontal Examination (BPE), clinical, medical and social factors - is described, linked to protocols for delivering care suited to general dental practice and stressing the role of long-term supportive care. The risks of not treating the patient are considered, together with the possible causes of failure, and the problems of successful treatment are illustrated by the practical management of post-treatment recession.

  15. AVLIS Criticality risk assessment

    SciTech Connect

    Brereton, S.J., LLNL

    1998-04-29

    U-235 and uranium depleted in U-235) are cooled and accumulated in solid metallic form in canisters. The collected product and tails material is weighed and transferred into certified, critically safe, shipping containers (DOT specification 6M with 2R containment vessel). These will be temporarily stored, and then shipped offsite either for use by a fuel fabricator, or for disposal. Tails material will be packaged for disposal. A criticality risk assessment was performed for AVLIS IPD runs. In this analysis, the likelihood of occurrence of a criticality was examined. For the AVLIS process, there are a number of areas that have been specifically examined to assess whether or not the frequency of occurrence of a criticality is credible (frequency of occurrence > 10-6/yr). In this paper, we discuss only two of the areas: the separator and canister operations.

  16. 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.

  17. RESIDUAL RISK ASSESSMENT: MAGNETIC TAPE ...

    EPA Pesticide Factsheets

    This document describes the residual risk assessment for the Magnetic Tape Manufacturing source category. For stationary sources, section 112 (f) of the Clean Air Act requires EPA to assess risks to human health and the environment following implementation of technology-based control standards. If these technology-based control standards do not provide an ample margin of safety, then EPA is required to promulgate addtional standards. This document describes the methodology and results of the residual risk assessment performed for the Magnetic Tape Manufacturing source category. The results of this analyiss will assist EPA in determining whether a residual risk rule for this source category is appropriate.

  18. RESIDUAL RISK ASSESSMENT: INDUSTRIAL PROCESS ...

    EPA Pesticide Factsheets

    This document describes the residual risk assessment for the Industrial Process Cooling Towers source category. For stationary sources, section 112 (f) of the Clean Air Act requires EPA to assess risks to human health and the environment following implementation of technology-based control standards. If these technology-based control standards do not provide an ample margin of safety, then EPA is required to promulgate addtional standards. This document describes the methodology and results of the residual risk assessment performed for the Industrial Process Cooling Towers source category. The results of this analyiss will assist EPA in determining whether a residual risk rule for this source category is appropriate.

  19. RESIDUAL RISK ASSESSMENT: ETHYLENE OXIDE ...

    EPA Pesticide Factsheets

    This document describes the residual risk assessment for the Ethylene Oxide Commercial Sterilization source category. For stationary sources, section 112 (f) of the Clean Air Act requires EPA to assess risks to human health and the environment following implementation of technology-based control standards. If these technology-based control standards do not provide an ample margin of safety, then EPA is required to promulgate addtional standards. This document describes the methodology and results of the residual risk assessment performed for the Ethylene Oxide Commercial Sterilization source category. The results of this analyiss will assist EPA in determining whether a residual risk rule for this source category is appropriate.

  20. RESIDUAL RISK ASSESSMENT: ETHYLENE OXIDE ...

    EPA Pesticide Factsheets

    This document describes the residual risk assessment for the Ethylene Oxide Commercial Sterilization source category. For stationary sources, section 112 (f) of the Clean Air Act requires EPA to assess risks to human health and the environment following implementation of technology-based control standards. If these technology-based control standards do not provide an ample margin of safety, then EPA is required to promulgate addtional standards. This document describes the methodology and results of the residual risk assessment performed for the Ethylene Oxide Commercial Sterilization source category. The results of this analyiss will assist EPA in determining whether a residual risk rule for this source category is appropriate.

  1. Risk-Assessment Computer Program

    NASA Technical Reports Server (NTRS)

    Dias, William C.; Mittman, David S.

    1993-01-01

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

  2. Risk Assessment for NOTES

    DTIC Science & Technology

    1991-09-01

    Navy System Safety regulations, NAVOSH regulations (Navy Ocupational , Safety and Health ), and the Environmental Safety regulations. 13 NAVSWC TR 91...significant fields lie over navigable waterways). Health No evidence of long-term health effects of EMP exposure to operating employees has been found, even...34 10 NAVSWC TR 91-328 Identify the risks and controls that would achieve the lowest reasonably achievable risk (consider safety, health , performance

  3. 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…

  4. 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…

  5. High-sensitivity cardiac troponin assays: From improved analytical performance to enhanced risk stratification.

    PubMed

    Kozinski, Marek; Krintus, Magdalena; Kubica, Jacek; Sypniewska, Grazyna

    2017-05-01

    TnI standardization. Finally, we discuss in detail the diagnostic and prognostic value of hs-cTn assays, including non-coronary causes of cTn elevation, the potential benefits and risks of point-of-care testing, and the unjustified skepticism of some clinicians regarding implementation of hs-cTn assays. In everyday clinical practice, hs-cTn assays are an important diagnostic advance, predominantly for patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with suspected non-ST-segment elevation myocardial infarction (NSTEMI). In the NSTE-ACS setting, recently introduced short diagnostic algorithms using hs-cTn assays integrated with careful clinical and ECG assessment were found to substantially reduce the time to final diagnosis, shorten visits to the emergency department and allow earlier safe discharge of low risk subjects. Hs-cTn assays have significantly higher sensitivity and negative predictive value for NSTEMI in comparison to contemporary cTn tests, particularly in early NSTE-ACS presenters. However, due to frequently occurring mild hs-cTn elevations, they are also associated with lower specificity and reduced positive predictive value when compared to previous generations of assays. Our review underscores the need for the education of clinicians and medical laboratory professionals regarding appropriate use and interpretation of hs-cTn assays. Adequate training and clinical experience in using these tests are essential to translate the improved analytical performance of hs-cTn assays into enhanced risk stratification and hopefully better patient outcomes.

  6. RESIDUAL RISK ASSESSMENT: SYNTHETIC ORGANIC ...

    EPA Pesticide Factsheets

    This document describes the residual risk assessment for the Synthetic Organic Chemical Manufacturing Industry source category. For stationary sources, section 112 (f) of the Clean Air Act requires EPA to assess risks to human health and the environment following implementation of technology-based control standards. If these technology-based control standards do not provide an ample margin of safety, then EPA is required to promulgate addtional standards. This document describes the methodology and results of the residual risk assessment performed for the Synthetic Organic Chemical Manufacturing Industry source category. The results of this analyiss will assist EPA in determining whether a residual risk rule for this source category is appropriate. Update 9/19/2006: Proposed Rule June 14, 2006 - Risk Assessment complete September 2005 and only available in the Docket.

  7. Risk assessment of dietary supplements.

    PubMed

    Boobis, Alan R

    2007-01-01

    Risk assessment of dietary supplements shares many of the requirements of that for other chemicals, although there are some important differences. Amongst these is the essential nature of some nutrients so that it may be necessary to balance the need to minimize toxicological risk with the need to avoid deficiency. There may also be limitations on experimental design, in that high doses may not be achievable for nutritional reasons and available human data on toxicological hazard is likely to be very limited. Prior to embarking on a risk assessment the problem needs to be formulated. This involves risk assessors, risk managers and relevant stakeholders. A key decision is whether a risk assessment is necessary and, if so, what is required of the assessment. This will shape the nature and output of the assessment. Risk assessment itself is a scientific process comprising four steps, hazard identification, hazard characterization, exposure assessment and risk characterization. Hazard identification involves determining the range of toxicological effects that might be caused by the substance, whilst hazard characterization establishes dose-response relationships, toxicological and species relevance of the findings and establishes health based guidance values. Exposure assessment involves predicting or measuring the level, pattern and duration of intake of the substance by exposed individuals. This may require dietary consumption data. Finally, risk characterization is the process whereby all of the prior information is integrated to reach conclusions in a form appropriate to the question posed. The nature of the output can take several different forms, and may be qualitative or quantitative. There are some cross-cutting issues in risk assessment, primarily on uncertainty and variability. The sources of uncertainty at each step of the risk assessment should be clearly identified and quantified to the extent possible. Variability requires that the risk assessment should

  8. 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.

  9. 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.

  10. 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...

  11. 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...

  12. 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

    2014-10-16

    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.

  13. 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.

  14. 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.

  15. 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.

  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. 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.

  18. 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. Copyright © 2014 Elsevier B.V. All rights reserved.

  19. PCR assay for screening patients at risk for 22q11.2 deletion.

    PubMed

    Driscoll, D A; Emanuel, B S; Mitchell, L E; Budarf, M L

    1997-01-01

    Deletions of 22q11.2 have been detected in the majority of patients with DiGeorge, velocardiofacial, and conotruncal anomaly face syndromes by either cytogenetic analysis, fluorescence in situ hybridization (FISH), or Southern blot hybridization. However, these techniques may not be the most efficient or cost-effective means of screening large numbers of "at-risk" patients. Therefore, we developed a PCR assay to assess a patient's likelihood of having a 22q11.2 deletion based on homozygosity at consecutive markers in the DiGeorge chromosomal region. The sensitivity and specificity of PCR screening were evaluated in a cohort of cardiac patients. We conclude that a PCR-based assay is a reliable and efficient means of identifying which patients are at greatest risk for a 22q11.2 deletion and should have FISH studies to confirm their deletion status.

  20. APPROACHES FOR INTEGRATED RISK ASSESSMENT

    EPA Science Inventory

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

  1. RESIDUAL RISK ASSESSMENT: HALOGENATED SOLVENTS

    EPA Science Inventory

    This source category previously subjected to a technology-based standard will be examined to determine if health or ecological risks are significant enough to warrant further regulation for Halogenated Solvent Degreasing Facilities. These assessments utilize existing models and d...

  2. APPROACHES FOR INTEGRATED RISK ASSESSMENT

    EPA Science Inventory

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

  3. The risk assessment information system

    SciTech Connect

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

    1998-06-01

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

  4. Anthropic Risk Assessment on Biodiversity

    NASA Astrophysics Data System (ADS)

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

    2013-01-01

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

  5. Improving pandemic influenza risk assessment

    USDA-ARS?s Scientific Manuscript database

    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...

  6. 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.

  7. Groundwater abstraction pollution risk assessment.

    PubMed

    Lytton, L; Howe, S; Sage, R; Greenaway, P

    2003-01-01

    A generic groundwater pollution risk assessment methodology has been developed to enable the evaluation and ranking of the potential risk of pollution to groundwater abstractions. The ranking can then be used to prioritise risk management or mitigation procedures in a robust and quantifiable framework and thus inform business investment decisions. The risk assessment consider the three components of the pollution transport model: source-pathway-receptor. For groundwater abstractions these correspond to land use (with associated pollutants and shallow subsurface characteristics), aquifer and the abstraction borehole. An hierarchical approach was chosen to allow the risk assessment to be successfully carried out with different quality data for different parts of the model. The 400-day groundwater protection zone defines the catchment boundary that form the spatial limit of the land use audit for each receptor. A risk score is obtained for each land use (potential pollution source) within the catchment. These scores are derived by considering the characteristics (such as load, persistence and toxicity) of all pollutants pertaining to each land use, their on-site management and the potential for the unsaturated subsurface to attenuate their effects in the event of a release. Risk scores are also applied to the aquifer characteristics (as pollutant pathway) and to the abstraction borehole (as pollutant receptor). Each risk score is accompanied by an uncertainty score which provides a guide to the confidence in the data used to compile the risk assessment. The application of the methodology has highlighted a number of problems in this type of work and results of initial case studies are being used to trial alternative scoring methods and a more simplified approach to accelerate the process of pollution risk assessment.

  8. Neurotoxicity in risk assessment

    SciTech Connect

    Weiss, B.

    1988-01-01

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

  9. Avalanche risk assessment in Russia

    NASA Astrophysics Data System (ADS)

    Komarov, Anton; Seliverstov, Yury; Sokratov, Sergey; Glazovskaya, Tatiana; Turchaniniva, Alla

    2017-04-01

    The avalanche prone area covers about 3 million square kilometers or 18% of total area of Russia and pose a significant problem in most mountain regions of the country. The constant growth of economic activity, especially in the North Caucasus region and therefore the increased avalanche hazard lead to the demand of the large-scale avalanche risk assessment methods development. Such methods are needed for the determination of appropriate avalanche protection measures as well as for economic assessments during all stages of spatial planning of the territory. The requirement of natural hazard risk assessments is determined by the Federal Law of Russian Federation. However, Russian Guidelines (SP 11-103-97; SP 47.13330.2012) are not clearly presented concerning avalanche risk assessment calculations. A great size of Russia territory, vast diversity of natural conditions and large variations in type and level of economic development of different regions cause significant variations in avalanche risk values. At the first stage of research the small scale avalanche risk assessment was performed in order to identify the most common patterns of risk situations and to calculate full social risk and individual risk. The full social avalanche risk for the territory of country was estimated at 91 victims. The area of territory with individual risk values lesser then 1×10(-6) covers more than 92 % of mountain areas of the country. Within these territories the safety of population can be achieved mainly by organizational activities. Approximately 7% of mountain areas have 1×10(-6) - 1×10(-4) individual risk values and require specific mitigation measures to protect people and infrastructure. Territories with individual risk values 1×10(-4) and above covers about 0,1 % of the territory and include the most severe and hazardous mountain areas. The whole specter of mitigation measures is required in order to minimize risk. The future development of such areas is not recommended

  10. Application of High-Throughput In Vitro Assays for Risk-Based ...

    EPA Pesticide Factsheets

    Multiple drivers shape the types of human-health assessments performed on chemicals by U.S. EPA resulting in chemical assessments are “fit-for-purpose” ranging from prioritization for further testing to full risk assessments. Layered on top of the diverse assessment needs are the resource intensive nature of traditional toxicological studies used to test chemicals and the lack of toxicity information on many chemicals. To address these challenges, the Agency initiated the ToxCast program to screen thousands of chemicals across hundreds of high-throughput screening assays in concentrations-response format. One of the findings of the project has been that the majority of chemicals interact with multiple biological targets within a narrow concentration range and the extent of interactions increases rapidly near the concentration causing cytotoxicity. This means that application of high-throughput in vitro assays to chemical assessments will need to identify both the relative selectivity at chemicals interact with biological targets and the concentration at which these interactions perturb signaling pathways. The integrated analyses will be used to both define a point-of-departure for comparison with human exposure estimates and identify which chemicals may benefit from further studies in a mode-of-action or adverse outcome pathway framework. The application of new technologies in a risk-based, tiered manner provides flexibility in matching throughput and cos

  11. A combination assay for simultaneous assessment of multiple signaling pathways.

    PubMed

    Goetz, A S; Liacos, J; Yingling, J; Ignar, D M

    1999-12-01

    We have developed an assay in which modulation of two or more signaling pathways can be assessed concurrently by combining reporter gene systems with fluorescent probe technology. The validation of this method was achieved by indirect analysis of adenylyl cyclase activation with the use of a cyclic AMP response element (CRE)-luciferase reporter system in combination with the measurement of calcium mobilization by Calcium Green-1 AM fluorescence on a fluorescent imaging plate reader. To demonstrate the utility of the method in studying the pharmacology of receptors that couple to more than one G protein, Chinese hamster ovary (CHO) cells, which stably expressed both the CRE-luciferase reporter gene and the human pituitary adenylyl cyclase-activating peptide (PACAP) receptor, were treated with PACAP 1-27 and 1-38. Calcium mobilization and the induction of adenylyl cyclase activity in response to each concentration of peptide were assessed in individuals wells. This assay may also be used to screen for ligands of two or more unrelated receptors simultaneously without compromising the assessment of either signaling pathway. To illustrate this point, Rat-1 fibroblasts, which expressed human alpha1A receptors, were cocultured with CRE-luciferase CHO cells, which expressed human GLP-1 receptors. Calcium mobilization elicited by phenylephrine agonism of the alpha1A receptor was assessed in the same assay as GLP-1-induced activation of adenylyl cyclase. The pEC(50) for each agonist was similar to that observed when the cell lines were not cocultured. The number of different receptors that can be screened per well is limited only by the ability to distinguish different reporter gene signals and fluorescent indicators.

  12. 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

  13. Cancer risk assessment of toxaphene.

    PubMed

    Buranatrevedh, Surasak

    2004-07-01

    The primary purpose is to do cancer risk assessment of toxaphene by using four steps of risk assessment proposed by the United States National Academy of Sciences/National Research Council (NAS/NRC). Four steps of risk assessment including hazard identification, dose-response relationship, exposure assessment, and risk characterization were used to evaluate cancer risk of toxaphene. Toxaphene was the most heavily used insecticide in many parts of the world before it was banned in 1982. It increased incidence of neoplasms of liver and uterus in mice and increased incidence of neoplasms of endocrine organs, thyroid, pituitary, adrenal, mammary glands, and reproductive systems in rats. From mice's and rats' study, slope factor for toxaphene is 0.8557 (mg/ kg/day)(-1). Lifetime average daily dose (LADD) of toxaphene from ambient air, surface water, soil, and fish were 1.08 x 10(-6), 5.71 x 10(-6), 3.43 x 10(-7), and 7.96 x 10(-5) mg/kg/day, respectively. Cancer risk of toxaphene for average exposure is 7.42 x 10(-5). From this study, toxaphene might have carcinogenic risk among humans.

  14. 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.

  15. 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:

  16. Development and validation of a new assay for assessing clot integrity.

    PubMed

    Ranjit, P; Lau, Y; Lip, G Y H; Blann, A D

    2015-08-01

    Research and routine laboratory assessment of clot integrity can be time consuming, expensive, and cannot be batched as it is generally performed in real time. To address these issues, we developed and validated a micro-titre based assay to quantify thrombogenesis and fibrinolysis, the purpose being to assess patients at risk of cardiovascular events by virtue of hypercoagulability. In further validation, thrombogenesis results were compared to similar indices from the thrombelastograph (TEG). Our assay determines three indices of thrombogenesis (lag time to the start of thrombus formation (LT), rate of clot formation (RCF), and maximum clot density (MCD)) and two of fibrinolysis (rate of clot dissolution (RCD) and time for 50% of the clot to lyse (T50)). Plasma was tested fresh and again after being frozen at -70°C. Some samples were tested immediately, others after being left at room temperature for up to 24h. The intra-assay coefficients of variation (CVs) of the three thrombogenesis measures (LT, RCF, MCD) and two fibrinolysis measures (RCD, T50) varied between 2.7 and 12.0% in fresh plasma and between 1.3% and 10.8% in frozen plasma respectively. Similarly, the inter-assay coefficients of variation of the thrombogenesis and fibrinolysis measures were 4.9-10.8% in fresh plasma and 2.2-6.5% in frozen plasma respectively. TEG assays intra- and inter assay CVs were around 25%. There were no significant differences in all plate assay indices up to 6h at room temperature. Certain plate assay thrombogenesis data were comparable to TEG indices after analysis by Pearson's correlation. The reagent processing cost per sample is £15 for TEG and £2 for the plate assays. Our micro-titre based assay assessing plasma thrombogenesis and fibrinolysis has good intra- and inter-assay CVs, can assess plasma up to 6h after venepuncture, is more efficient (in terms of throughput) and is more economical than that of the TEG. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. Assessing Your Weight and Health Risk

    MedlinePlus

    ... Health Professional Resources Assessing Your Weight and Health Risk Assessment of weight and health risk involves using ... risk for developing obesity-associated diseases or conditions. Risk Factors for Health Topics Associated With Obesity Along ...

  18. Guidelines for neurotoxicity risk assessment

    SciTech Connect

    1998-04-01

    These Guidelines describe the principles, concepts, and procedures that the US Environmental Protection Agency (EPA) will follow in evaluating data on potential neurotoxicity associated with exposure to environmental toxicants. The procedures outlined are intended to help develop a sound scientific basis for neurotoxicity risk assessment, promote consistency in the Agency`s assessment of toxic effects on the nervous system, and inform others of the approaches used by the Agency in those assessments.

  19. Sudden Cardiac Arrest (SCA) Risk Assessment

    MedlinePlus

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

  20. Risk Assessment for Stonecutting Enterprises

    NASA Astrophysics Data System (ADS)

    Aleksandrova, A. J.; Timofeeva, S. S.

    2017-04-01

    Working conditions at enterprises and artisanal workshops for the processing of jewelry and ornamental stones were considered. The main stages of the technological process for processing of stone raw materials were shown; dangerous processes in the extraction of stone and its processing were identified. The characteristic of harmful and dangerous production factors affecting stonecutters is given. It was revealed that the most dangerous are the increased level of noise and vibration, as well as chemical reagents. The results of a special assessment of the working conditions of stone-cutting plant workers are studied. Professions with high professional risk were identified; an analysis of occupational risks and occupational injuries was carried out. Risk assessment was produced by several methods; professions with high and medium risk indicators were identified by results of the evaluation. The application of risk assessment methods was given the possibility to justify rational measures reducing risks to the lowest possible level. The received quantitative indicators of risk of workers of the stone-cutting enterprises are the result of this work.

  1. 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.

  2. 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.

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

    NASA Technical Reports Server (NTRS)

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

    2005-01-01

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

  4. 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

  5. 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.

  6. 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.

  7. 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)

  8. Caries Risk Assessment Item Importance

    PubMed Central

    Chaffee, B.W.; Featherstone, J.D.B.; Gansky, S.A.; Cheng, J.; Zhan, L.

    2016-01-01

    Caries risk assessment (CRA) is widely recommended for dental caries management. Little is known regarding how practitioners use individual CRA items to determine risk and which individual items independently predict clinical outcomes in children younger than 6 y. The objective of this study was to assess the relative importance of pediatric CRA items in dental providers’ decision making regarding patient risk and in association with clinically evident caries, cross-sectionally and longitudinally. CRA information was abstracted retrospectively from electronic patient records of children initially aged 6 to 72 mo at a university pediatric dentistry clinic (n = 3,810 baseline; n = 1,315 with follow-up). The 17-item CRA form included caries risk indicators, caries protective items, and clinical indicators. Conditional random forests classification trees were implemented to identify and assign variable importance to CRA items independently associated with baseline high-risk designation, baseline evident tooth decay, and follow-up evident decay. Thirteen individual CRA items, including all clinical indicators and all but 1 risk indicator, were independently and statistically significantly associated with student/resident providers’ caries risk designation. Provider-assigned baseline risk category was strongly associated with follow-up decay, which increased from low (20.4%) to moderate (30.6%) to high/extreme risk patients (68.7%). Of baseline CRA items, before adjustment, 12 were associated with baseline decay and 7 with decay at follow-up; however, in the conditional random forests models, only the clinical indicators (evident decay, dental plaque, and recent restoration placement) and 1 risk indicator (frequent snacking) were independently and statistically significantly associated with future disease, for which baseline evident decay was the strongest predictor. In this predominantly high-risk population under caries-preventive care, more individual CRA items

  9. 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

  10. 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.

  11. Where You Live: Risk Assessment

    EPA Pesticide Factsheets

    Where you live page shows visitors to the risk assessment website how to contact their local regional office by state. Since these link to pages maintained by the local offices they will have the most up-to-date contact information.

  12. 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…

  13. 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.

  14. 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.

  15. 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.

  16. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 1 2014-04-01 2014-04-01 false Risk assessment. 35.315 Section 35... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance...

  17. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 1 2012-04-01 2012-04-01 false Risk assessment. 35.315 Section 35... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance...

  18. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 1 2013-04-01 2013-04-01 false Risk assessment. 35.315 Section 35... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance...

  19. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 1 2011-04-01 2011-04-01 false Risk assessment. 35.315 Section 35... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with...

  20. 24 CFR 35.315 - Risk assessment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Risk assessment. 35.315 Section 35... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with...

  1. NUREG-1150 risk assessment methodology

    SciTech Connect

    Benjamin, A.S.; Amos, C.N.; Cunningham, M.A.; Murphy, J.A.

    1987-01-01

    This paper describes the methodology developed in support of the US Nuclear Regulatory Commission's (NCR's) evaluation of severe accident risks in NUREG-1150. After the accident at Three Mile Island, Unit 2, the NRC initiated a sever accident research program to develop an improved understanding of severe accidents and to provide a second technical basis to support regulatory decisions in this area. A key product of this program is NUREG-1150, which provides estimates of risk for several nuclear reactors of different design. The principal technical analyses for NUREG-1150 were performed at Sandia National Labs. under the Severe Accident Risk Reduction Program and the Accident Sequence Evaluation Program. A major aspect of the work was the development of a methodology that improved upon previous full-scale probabilistic risk assessments (PRA) in several areas which are described.

  2. 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.

  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. 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...

  6. Assessing Biases in the Evaluation of Classification Assays for HIV Infection Recency

    PubMed Central

    Patterson-Lomba, Oscar; Wu, Julia W.; Pagano, Marcello

    2015-01-01

    Identifying recent HIV infection cases has important public health and clinical implications. It is essential for estimating incidence rates to monitor epidemic trends and evaluate the effectiveness of interventions. Detecting recent cases is also important for HIV prevention given the crucial role that recently infected individuals play in disease transmission, and because early treatment onset can improve the clinical outlook of patients while reducing transmission risk. Critical to this enterprise is the development and proper assessment of accurate classification assays that, based on cross-sectional samples of viral sequences, help determine infection recency status. In this work we assess some of the biases present in the evaluation of HIV recency classification algorithms that rely on measures of within-host viral diversity. Particularly, we examine how the time since infection (TSI) distribution of the infected subjects from which viral samples are drawn affect performance metrics (e.g., area under the ROC curve, sensitivity, specificity, accuracy and precision), potentially leading to misguided conclusions about the efficacy of classification assays. By comparing the performance of a given HIV recency assay using six different TSI distributions (four simulated TSI distributions representing different epidemic scenarios, and two empirical TSI distributions), we show that conclusions about the overall efficacy of the assay depend critically on properties of the TSI distribution. Moreover, we demonstrate that an assay with high overall classification accuracy, mainly due to properly sorting members of the well-represented groups in the validation dataset, can still perform notoriously poorly when sorting members of the less represented groups. This is an inherent issue of classification and diagnostics procedures that is often underappreciated. Thus, this work underscores the importance of acknowledging and properly addressing evaluation biases when proposing

  7. Assessing Biases in the Evaluation of Classification Assays for HIV Infection Recency.

    PubMed

    Patterson-Lomba, Oscar; Wu, Julia W; Pagano, Marcello

    2015-01-01

    Identifying recent HIV infection cases has important public health and clinical implications. It is essential for estimating incidence rates to monitor epidemic trends and evaluate the effectiveness of interventions. Detecting recent cases is also important for HIV prevention given the crucial role that recently infected individuals play in disease transmission, and because early treatment onset can improve the clinical outlook of patients while reducing transmission risk. Critical to this enterprise is the development and proper assessment of accurate classification assays that, based on cross-sectional samples of viral sequences, help determine infection recency status. In this work we assess some of the biases present in the evaluation of HIV recency classification algorithms that rely on measures of within-host viral diversity. Particularly, we examine how the time since infection (TSI) distribution of the infected subjects from which viral samples are drawn affect performance metrics (e.g., area under the ROC curve, sensitivity, specificity, accuracy and precision), potentially leading to misguided conclusions about the efficacy of classification assays. By comparing the performance of a given HIV recency assay using six different TSI distributions (four simulated TSI distributions representing different epidemic scenarios, and two empirical TSI distributions), we show that conclusions about the overall efficacy of the assay depend critically on properties of the TSI distribution. Moreover, we demonstrate that an assay with high overall classification accuracy, mainly due to properly sorting members of the well-represented groups in the validation dataset, can still perform notoriously poorly when sorting members of the less represented groups. This is an inherent issue of classification and diagnostics procedures that is often underappreciated. Thus, this work underscores the importance of acknowledging and properly addressing evaluation biases when proposing

  8. La Conchita Landslide Risk Assessment

    NASA Astrophysics Data System (ADS)

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

    2009-12-01

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

  9. Development and Validation of a Six-Gene Recurrence Risk Score Assay for Gastric Cancer.

    PubMed

    Lee, Keun-Wook; Lee, Sung Sook; Hwang, Jun-Eul; Jang, Hee-Jin; Lee, Hyun-Sung; Oh, Sang Cheul; Lee, Sang Ho; Sohn, Bo Hwa; Kim, Sang Bae; Shim, Jae-Jun; Jeong, Woojin; Cha, Minse; Cheong, Jae-Ho; Cho, Jae Yong; Lim, Jae Yun; Park, Eun Sung; Kim, Sang Cheol; Kang, Yoon-Koo; Noh, Sung Hoon; Ajani, Jaffer A; Lee, Ju-Seog

    2016-12-15

    This study was aimed at developing and validating a quantitative multigene assay for predicting tumor recurrence after gastric cancer surgery. Gene expression data were generated from tumor tissues of patients who underwent surgery for gastric cancer (n = 267, training cohort). Genes whose expression was significantly associated with activation of YAP1 (a frequently activated oncogene in gastrointestinal cancer), 5-year recurrence-free survival, and 5-year overall survival were first identified as candidates for prognostic genes (156 genes, P < 0.001). We developed the recurrence risk score (RRS) by using quantitative RT-PCR to identify genes whose expression levels were significantly associated with YAP1 activation and patient survival in the training cohort. We based the RRS assay on 6 genes, IGFBP4, SFRP4, SPOCK1, SULF1, THBS, and GADD45B, whose expression levels were significantly associated with YAP1 activation and prognosis in the training cohort. The RRS assay was further validated in an independent cohort of 317 patients. In multivariate analysis, the RRS was an independent predictor of recurrence [HR, 1.6; 95% confidence interval (CI), 1.02-2.4; P = 0.03]. In patients with stage II disease, the RRS had an HR of 2.9 (95% CI, 1.1-7.9; P = 0.03) and was the only significant independent predictor of recurrence. The RRS assay was a valid predictor of recurrence in the two cohorts of patients with gastric cancer. Independent prospective studies to assess the clinical utility of this assay are warranted. Clin Cancer Res; 22(24); 6228-35. ©2016 AACR. ©2016 American Association for Cancer Research.

  10. Risk Assessment Terminology: Risk Communication Part 2.

    PubMed

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

    2016-04-19

    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.

  11. 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

  12. Probabilistic risk assessment of HTGRs

    SciTech Connect

    Fleming, K.N.; Houghton, W.J.; Hannaman, G.W.; Joksimovic, V.

    1980-08-01

    Probabilistic Risk Assessment methods have been applied to gas-cooled reactors for more than a decade and to HTGRs for more than six years in the programs sponsored by the US Department of Energy. Significant advancements to the development of PRA methodology in these programs are summarized as are the specific applications of the methods to HTGRs. Emphasis here is on PRA as a tool for evaluating HTGR design options. Current work and future directions are also discussed.

  13. Applications of Probabilistic Risk Assessment

    SciTech Connect

    Burns, K.J.; Chapman, J.R.; Follen, S.M.; O'Regan, P.J. )

    1991-05-01

    This report provides a summary of potential and actual applications of Probabilistic Risk Assessment (PRA) technology and insights. Individual applications are derived from the experiences of a number of US nuclear utilities. This report identifies numerous applications of PRA techniques beyond those typically associated with PRAs. In addition, believing that the future use of PRA techniques should not be limited to those of the past, areas of plant operations, maintenance, and financial resource allocation are discussed. 9 refs., 3 tabs.

  14. Survey of mental health nurses' attitudes towards risk assessment, risk assessment tools and positive risk.

    PubMed

    Downes, C; Gill, A; Doyle, L; Morrissey, J; Higgins, A

    2016-04-01

    WHAT IS KNOWN ON THE SUBJECT?: Risk assessment and safety planning are a core aspect of the role of the mental health nurse. Conflicting views exist on the value of risk assessment tools. Few studies have examined mental health nurses' attitudes towards risk, including use of tools and the role of positive risk in recovery. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: Mental health nurses view risk assessment as a core dimension of their role and not merely an exercise to fulfil organizational clinical safety and governance obligations. The majority of nurses hold positive attitudes towards therapeutic or positive risk, and consider creative risk taking as vital to people's recovery. The majority of nurses believe that risk assessment tools facilitate professional decision making, however, some are concerned that tools may negatively impact upon therapeutic relationships. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Ongoing education on the use of risk assessment tools is required to minimize views that their use is incompatible with therapeutic engagement, and to enable nurses to develop confidence to engage with positive risk and to allow service users make decisions and take responsibility. Introduction Risk assessment and safety planning are considered core components of the role of the mental health nurse; however, little is known about nurses' attitudes towards risk assessment, use of tools to assess risk or therapeutic risk taking. Aim This study aimed to explore mental health nurses' attitudes towards completing risk assessments, use of tools as an aid, and therapeutic or positive risk. Method An anonymous survey which included 13 attitudinal statements, rated on a five-point Likert scale, was completed by 381 mental health nurses working in adult services in Ireland. Findings Findings indicate strong support for the practice of risk assessment in mental health practice. The vast majority of nurses believe that risk assessment tools facilitate professional

  15. Risk assessment for pulmonary resection.

    PubMed

    Brunelli, Alessandro

    2010-01-01

    Risk assessment for pulmonary resection must include a preliminary cardiac evaluation. Patients deemed at prohibitive cardiac risk should be evaluated and treated as per American Heart Association/American Society of Cardiology guidelines. Those with low cardiac risk or with optimized treatment can proceed with pulmonary assessment. A systematic measurement of lung carbon monoxide diffusing capacity is recommended. In addition, predicted postoperative forced expiratory volume in 1 second should not be used alone for patient selection because it is not an accurate predictor of complications, particularly in patients with chronic obstructive pulmonary disease. The use of exercise testing should be emphasized. Low-technology tests, such as stair climbing, can be used whenever a formal cardiopulmonary exercise test is not readily available. However, in case of suboptimal performance (ie, <22 m in the stair-climbing test) patients should be referred to cardiopulmonary exercise testing with measurement of Vo(2max) for a better definition of their aerobic reserve. A Vo(2max) less than 10 mL/kg/min (or <35% of predicted) indicates a high risk for major lung resection.

  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. 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…

  18. 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…

  19. 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…

  20. 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…

  1. [Risk assessment in pain therapy].

    PubMed

    Schoeffel, D; Casser, H R; Bach, M; Kress, H G; Likar, R; Locher, H; Steinleitner, W; Strohmeier, M; Brunner, H; Treede, R D; Zieglgänsberger, W; Sandkühler, J

    2008-10-01

    Analgesic therapy is not without risk. However, the risk of most analgesic interventions is minor compared to the risk of the inadequate treatment of pain and insufficient treatment may lead to chronic pain.A correct diagnosis should be the basis of any specific treatment of pain disorders. Only a diagnosis which implicates a multi-disciplinary assessment and which considers both the pathoanatomical, functional and biopsychosocial dysfunctions can lead to an adequate therapeutic intervention. Furthermore, therapeutic planning should include the personal needs of the patient and should have realistic aims.Pharmacological treatment is guided by the WHO pain ladder. The risks of the relevant substance groups must be considered. NSAIDs (non-steroidal anti-inflammatory drugs) which are included in all steps of the WHO pain ladder carry specific risks for the gastrointestinal, cardiovascular and renal systems and are contraindicated in many patients in need of analgesic therapy, e.g. in many elderly patients. Opioids which are recommended at steps 2 and 3 of the WHO pain ladder have less organ toxicity but they are still used reluctantly. Coanalgetics, especially antidepressants bear specific risks and the discussion on suicide rates under antidepressant medication is ongoing.Invasive methods such as the intrathecal application of analgesics are valuable procedures if the indication is correct and the treating physician has sufficient experience. Pain therapy is essential and the risks of the procedures are manageable. Considering the current knowledge on the mechanisms of pain sensitisation, the lack of adequate pain control can lead to chronic pain with severe consequences for the patient.

  2. A simple matrix of analytical performance to identify assays that risk patients using External Quality Assurance Program data.

    PubMed

    Mackay, Mark; Hegedus, Gabe; Badrick, Tony

    2016-05-01

    We propose a simple way to reliably rank assays for improvement according to patient risk, based solely on EQA imprecision and biological variation data. Because the underlying technique aligns the imprecision class of an assay from EQA data, peer performance can be used to assess achievable imprecision and the risk ranking can not only prioritise improvement but also highlight laboratory QC operating parameters that are easy to manage and provide reliable, acceptable performance. A modified Failure Modes Effects Analysis (FMEA) is applied to produce an analyte risk rating based on three factors, each of which is graded: 1) the ease of detecting analytical errors based on the ratio of allowable limits of performance to imprecision (Assay Capability) compared to absolute standards and to peers, 2) the predicted frequency of errors in patient monitoring based on the ratio of within-individual biological variation to laboratory imprecision, and 3) the clinical importance of the assay as a surrogate marker for harm arising from an error. We provide laboratory examples to illustrate these models. The proposed models using only EQA data can objectively identify assays at risk of failing against biological variation goals for monitoring patients and suggest parameters for reliable performance. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  3. Assessing blood-brain barrier function using in vitro assays.

    PubMed

    Bressler, Joseph; Clark, Katherine; O'Driscoll, Cliona

    2013-01-01

    The impermeability of the blood-brain barrier (BBB) is due to a number of properties including tight junctions on adjoining endothelial cells, absence of pinocytic vesicles, and expression of multidrug transporters. Although the permeability of many chemicals can be predicted by their polarity, or oil/water partition coefficient, many lipophilic chemicals are not permeable because of multidrug transporters at the luminal and abluminal membranes. In contrast, many nutrients, which are usually polar, cross the BBB more readily than predicted by their oil/water partition coefficients due to the expression of specific nutrient transporters. In vitro models are being developed because rodent models are of low input and relatively expensive. Isolated brain microvessels and cell culture models each offers certain advantages and disadvantages. Isolated brain microvessels are useful in measuring multidrug drug transporters and tight junction integrity, whereas cell culture models allow the investigator to measure directional transport and can be genetically manipulated. In this chapter, we describe how to isolate large batches of brain microvessels from freshly slaughtered cows. The different steps in the isolation procedure include density gradient centrifugations and filtering. Purity is determined microscopically and by marker enzymes. Permeability is assessed by measuring the uptake of fluorescein-labeled dextran in an assay that has been optimized to have a large dynamic range and low inter-day variability. We also describe how to evaluate transendothelial cell electrical resistance and paracellular transport in cell culture models.

  4. Comet assay: a reliable tool for the assessment of DNA damage in different models.

    PubMed

    Dhawan, Alok; Bajpayee, Mahima; Parmar, Devendra

    2009-02-01

    New chemicals are being added each year to the existing burden of toxic substances in the environment. This has led to increased pollution of ecosystems as well as deterioration of the air, water, and soil quality. Excessive agricultural and industrial activities adversely affect biodiversity, threatening the survival of species in a particular habitat as well as posing disease risks to humans. Some of the chemicals, e.g., pesticides and heavy metals, may be genotoxic to the sentinel species and/or to non-target species, causing deleterious effects in somatic or germ cells. Test systems which help in hazard prediction and risk assessment are important to assess the genotoxic potential of chemicals before their release into the environment or commercial use as well as DNA damage in flora and fauna affected by contaminated/polluted habitats. The Comet assay has been widely accepted as a simple, sensitive, and rapid tool for assessing DNA damage and repair in individual eukaryotic as well as some prokaryotic cells, and has increasingly found application in diverse fields ranging from genetic toxicology to human epidemiology. This review is an attempt to comprehensively encase the use of Comet assay in different models from bacteria to man, employing diverse cell types to assess the DNA-damaging potential of chemicals and/or environmental conditions. Sentinel species are the first to be affected by adverse changes in their environment. Determination of DNA damage using the Comet assay in these indicator organisms would thus provide information about the genotoxic potential of their habitat at an early stage. This would allow for intervention strategies to be implemented for prevention or reduction of deleterious health effects in the sentinel species as well as in humans.

  5. Risk assessment for neurobehavioral toxicity

    SciTech Connect

    McMillan, D.E.

    1987-12-01

    A study of the National Academy of Sciences/National Research Council (NAS/NRC) found neurobehavioral toxicity to be one of the areas where almost no data are available for the assessment of toxicity. Using the NAS/NRC report and a data base from the American Conference of Government Industrial Hygienists (ACGIH), an estimate of the number of neurobehavioral toxins in commercial chemicals can be made. Although the assumption made in making such a calculation may be invalid, the exercise suggests that the number of neurobehavioral toxins may be quite large. There does seem to be general agreement as to what type of neurobehavioral test procedures are appropriate for regulatory purposes. Select committees have consistently recommended the use of test batteries that include schedule-controlled behavior, motor activity, and neuropathological examination following in vivo perfusion, for regulatory purposes. Alkyltin data developed from such a battery were applied to the risk assessment model employed by the United States Environmental Protection Agency (EPA) in their calculations of acceptable daily intake. Using this test battery and the EPA risk assessment model, the acceptable daily intake calculated is of the same order of magnitude as the total limit values established by the ACGIH. A number of special issues in neurobehavioral toxicity also are discussed, including the definition of adverse neurobehavioral toxic effect, species extrapolation, correlation of behavior and neuropathology, alternative methods, and quality of life issues.

  6. 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.

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

    PubMed

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

    2015-08-14

    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.

  8. Assessment of bacterial biodetoxification of herbicide atrazine using Aliivibrio fischeri cytotoxicity assay with prolonged contact time.

    PubMed

    Háhn, Judit; Szoboszlay, Sándor; Tóth, Gergő; Kriszt, Balázs

    2017-07-01

    In our study, we determined and compared the atrazine-biodetoxification ability of 41 bacterial strains and 21 consortia created of those with over 50% degradation rate in pure cultures. Biodegradation capacity was measured with GC-MS. Detoxification was assessed based on the cytotoxic effect of end-products to Aliivibrio fischeri in chronic bioluminescence inhibition assay with 25 h contact time. Chronic A. fischeri assay adapted to a microplate, which is suitable for examine numerous residues simultaneously, also appeared to be significantly more sensitive to atrazine compared to the standard acute (30 min) test. Due to its sensitivity, the chronic assay could be a valuable tool to provide a more comprehensive view of the ecological risks of atrazine and other chemicals. Thirteen strains were able to degrade more than 50% of 50 ppm atrazine. Four of these belong to Rhodococcus aetherivorans, R. qingshengii, Serratia fonticola and Olivibacter oleidegradans which species' atrazine degrading ability has never been reported before. Four consortia degrading ability was more effective than that of the creating individual strains; moreover, their residues did not show cytotoxic effects to A. fischeri. However, in several cases, the degradation products of sole strains and consortia resulted in significant bioluminescence inhibition. Thus high biodegradation (>90%) does not certainly mean the reduction or cessation of toxicity highlighting the importance of the evaluation of biological effects of degradation residues to improve the efficiency and abate the ecological risks of bioremediation techniques.

  9. Nanoparticle-assay marker interaction: effects on nanotoxicity assessment

    NASA Astrophysics Data System (ADS)

    Zhao, Xinxin; Xiong, Sijing; Huang, Liwen Charlotte; Ng, Kee Woei; Loo, Say Chye Joachim

    2015-01-01

    Protein-based cytotoxicity assays such as lactate dehydrogenase (LDH) and tumor necrosis factor-alpha (TNF-α) are commonly used in cytotoxic evaluation of nanoparticles (NPs) despite numerous reports on possible interactions with protein markers in these assays that can confound the results obtained. In this study, conventional cytotoxicity assays where assay markers may (LDH and TNF- α) or may not (PicoGreen and WST-8) come into contact with NPs were used to evaluate the cytotoxicity of NPs. The findings revealed selective interactions between negatively charged protein assay markers (LDH and TNF- α) and positively charged ZnO NPs under abiotic conditions. The adsorption and interaction with these protein assay markers were strongly influenced by surface charge, concentration, and specific surface area of the NPs, thereby resulting in less than accurate cytotoxic measurements, as observed from actual cell viability measurements. An improved protocol for LDH assay was, therefore, proposed and validated by eliminating any effects associated with protein-particle interactions. In view of this, additional measures and precautions should be taken when evaluating cytotoxicity of NPs with standard protein-based assays, particularly when they are of opposite charges.

  10. 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

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

    PubMed Central

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

    2013-01-01

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

  12. Risk Assessment-- A Science in Controversy.

    ERIC Educational Resources Information Center

    Ravetz, J. R.

    1982-01-01

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

  13. Risk Assessment-- A Science in Controversy.

    ERIC Educational Resources Information Center

    Ravetz, J. R.

    1982-01-01

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

  14. 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.

  15. 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

  16. Viral factors in influenza pandemic risk assessment

    PubMed Central

    Lipsitch, Marc; Barclay, Wendy; Raman, Rahul; Russell, Charles J; Belser, Jessica A; Cobey, Sarah; Kasson, Peter M; Lloyd-Smith, James O; Maurer-Stroh, Sebastian; Riley, Steven; Beauchemin, Catherine AA; Bedford, Trevor; Friedrich, Thomas C; Handel, Andreas; Herfst, Sander; Murcia, Pablo R; Roche, Benjamin; Wilke, Claus O; Russell, Colin A

    2016-01-01

    The threat of an influenza A virus pandemic stems from continual virus spillovers from reservoir species, a tiny fraction of which spark sustained transmission in humans. To date, no pandemic emergence of a new influenza strain has been preceded by detection of a closely related precursor in an animal or human. Nonetheless, influenza surveillance efforts are expanding, prompting a need for tools to assess the pandemic risk posed by a detected virus. The goal would be to use genetic sequence and/or biological assays of viral traits to identify those non-human influenza viruses with the greatest risk of evolving into pandemic threats, and/or to understand drivers of such evolution, to prioritize pandemic prevention or response measures. We describe such efforts, identify progress and ongoing challenges, and discuss three specific traits of influenza viruses (hemagglutinin receptor binding specificity, hemagglutinin pH of activation, and polymerase complex efficiency) that contribute to pandemic risk. DOI: http://dx.doi.org/10.7554/eLife.18491.001 PMID:27834632

  17. 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

  18. Troponin assays in the assessment of the equine myocardium.

    PubMed

    Rossi, T M; Pyle, W G; Maxie, M G; Pearl, D L; Physick-Sheard, P W

    2014-05-01

    In 2000, troponin assays were adopted as the test of choice for detection of myocardial injury in man. This decision was made after extensive testing and followed a 60 year search for a biomarker of myocardial damage with sufficient analytical sensitivity and specificity. This has led to proliferation of assays for use in human medicine, each requiring extensive testing and validation before it could be made available on the open market for human use. The search for ever-more analytically sensitive assays and for a standard reference material continues. The adoption of troponin testing in veterinary medicine followed shortly after its development for use in man, providing a much-needed means of detecting and monitoring myocardial damage in horses. However, application of these tests in veterinary medicine has exclusively involved use of assays designed for and clinically validated in human patients. There is no mandated requirement for test validation in veterinary medicine and, while many of these assays have been shown to be capable of detecting equine troponin, the wide diversity of available tests, lack of validation, absence of protocols for their use and lack of standardisation make their application problematic. The objective of this review article is to address this issue, offering guidance where data are available and encouraging caution where there are none. Ultimately, the overall goal of this review is to examine critically the use of troponin assays in the horse and to promote the accurate and appropriate interpretation of valid results.

  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. 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.

  1. The Genomic Grade Assay Compared With Ki67 to Determine Risk of Distant Breast Cancer Recurrence.

    PubMed

    Ignatiadis, Michail; Azim, Hatem A; Desmedt, Christine; Veys, Isabelle; Larsimont, Denis; Salgado, Roberto; Lyng, Maria B; Viale, Giuseppe; Leyland-Jones, Brian; Giobbie-Hurder, Anita; Kammler, Rosita; Dell'Orto, Patrizia; Rothé, Françoise; Laïos, Ioanna; Ditzel, Henrik J; Regan, Meredith M; Piccart, Martine; Michiels, Stefan; Sotiriou, Christos

    2016-02-01

    The Genomic Grade Index (GGI) was previously developed, evaluated on frozen tissue, and shown to be prognostic in early breast cancer. To test the GGI in formalin-fixed, paraffin-embedded breast cancer tumors, a quantitative reverse transcriptase polymerase chain reaction assay was developed and named the Genomic Grade (GG). The GG assay has the potential to increase the clinical application of the GGI, but robust demonstration of the clinical validity of the GG assay is required. To evaluate the prognostic ability of the GG assay to detect breast cancer recurrence compared with centrally reviewed immunohistochemical testing of Ki67 antigen proliferation. This is an internationally collaborative substudy of a large phase 3 4-arm adjuvant trial. Patients had endocrine receptor-positive, node-positive, or node-negative nonmetastatic primary breast cancer. Patients included in this study had available formalin-fixed, paraffin-embedded samples of their primary tumors and were randomized to either a 5-year tamoxifen monotherapy arm or a 5-year letrozole monotherapy arm. Associations between either GG assay results or log2-transformed Ki67 data and survival end points were evaluated using Cox regression models stratified for chemotherapy use; the 2 vs 4 arm randomization option; and endocrine therapy assignment with and without adjustment for clinicopathological parameters, including centrally reviewed histological grade, hormone receptors, and ERBB2 (formerly HER2 or HER2/neu). The likelihood ratio statistic was used to assess the added prognostic value. Central evaluation and comparison, blinded for clinical information, of the GG assay, breast cancer histological grade, and Ki67. Distant recurrence-free interval (DRFI). Genomic Grade assay data were obtained in 883 breast cancer samples (62%). At a median follow-up of 8.1 years, 84 (10%) had distant recurrences. Increasing GG or Ki67 were both significantly associated with lower DRFI and added independent prognostic

  2. Getting fire risk assessment right.

    PubMed

    Charters, David

    2012-06-01

    The NHS has one of the world's largest and most varied estates, which at any time accommodates many of the most dependent people in society. With around 6,000 fires occurring in NHS premises each year, its duty of care--and that of other healthcare providers--demands very close attention to fire safety. Here Dr David Charters BSc, PhD, CEng, FIFireE, MIMechE, MSFPE, director of Fire Engineering at BRE Global, an independent third party approvals body offering certification of fire, security, and sustainability products and services, examines the critical role of fire risk assessment, and explains why the process should provide the 'foundation' for effective fire safety measures.

  3. 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.

  4. Quantitative Lateral Flow Assays for Salivary Biomarker Assessment: A Review

    PubMed Central

    Miočević, Olga; Cole, Craig R.; Laughlin, Mary J.; Buck, Robert L.; Slowey, Paul D.; Shirtcliff, Elizabeth A.

    2017-01-01

    Saliva is an emerging biofluid with a significant number of applications in use across research and clinical settings. The present paper explores the reasons why saliva has grown in popularity in recent years, balancing both the potential strengths and weaknesses of this biofluid. Focusing on reasons why saliva is different from other common biological fluids such as blood, urine, or tears, we review how saliva is easily obtained, with minimal risk to the donor, and reduced costs for collection, transportation, and analysis. We then move on to a brief review of the history and progress in rapid salivary testing, again reviewing the strengths and weaknesses of rapid immunoassays (e.g., lateral flow immunoassay) compared to more traditional immunoassays. We consider the potential for saliva as an alternative biofluid in a setting where rapid results are important. We focus the review on salivary tests for small molecule biomarkers using cortisol as an example. Such salivary tests can be applied readily in a variety of settings and for specific measurement purposes, providing researchers and clinicians with opportunities to assess biomarkers in real time with lower transportation, collection, and analysis costs, faster turnaround time, and minimal training requirements. We conclude with a note of cautious optimism that the field will soon gain the ability to collect and analyze salivary specimens at any location and return viable results within minutes. PMID:28660183

  5. Enzymatic reactive oxygen species assay to evaluate phototoxic risk of metabolites.

    PubMed

    Kato, Masashi; Ohtake, Hiroto; Sato, Hideyuki; Seto, Yoshiki; Onoue, Satomi

    2017-08-15

    The present study aimed to verify the feasibility of an enzymatic reactive oxygen species (eROS) assay to evaluate the phototoxic risk of compounds after their metabolization. The eROS assay was designed based on the combined use of an in vitro drug metabolism system and a ROS assay. The incubation time of compounds with human hepatic S9 fractions was optimized with the use of fenofibrate (FF), a typical phototoxicant with metabolite-related phototoxicity, and the reproducibility and robustness of the eROS assay were examined using FF. The eROS assay was applied to 12 phototoxic compounds, including 7 phototoxicants with metabolite-related phototoxicity, to clarify the assay performance. According to the eROS data on singlet oxygen generation from FF and metabolic conversion profiles of FF and fenofibric acid, the incubation time of chemicals with human hepatic S9-mix was determined to be 4min. The singlet oxygen-based evaluation system in the eROS assay was found to be acceptable as a high-throughput assay because of its favorable intra-/inter-day reproducibility (coefficient of variation: ca. 8%) and robustness (Z'-factor: 0.23). Singlet oxygen data on phototoxicants with phototoxic metabolites tended to exceed 120% of control, suggesting the feasibility of the eROS assay to evaluate metabolite-related phototoxic potentials. However, further data accumulation is still needed to improve the assay performance because the eROS assay provided false predictions for some compounds. The present eROS assay may be applicable in part for evaluating the phototoxic risk of drug candidates after their metabolization in the early stage of drug discovery. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. 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.

  7. 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

  8. Fuzzy based risk register for construction project risk assessment

    NASA Astrophysics Data System (ADS)

    Kuchta, Dorota; Ptaszyńska, Ewa

    2017-07-01

    The paper contains fuzzy based risk register used to identify risks which appear in construction projects and to assess their attributes. Risk is considered here as a possible event with negative consequences for the project [4]. We use different risk attributes in the proposed risk register. Values of risk attributes are generated by using fuzzy numbers. Specific risk attributes have different importance for project managers of construction projects. To compare specific risk attributes we use methods of fuzzy numbers ranking. The main strengths of the proposed concept in managing construction projects are also presented in the paper.

  9. Advances in the assessment of suicide risk.

    PubMed

    Bryan, Craig J; Rudd, M David

    2006-02-01

    This article reviews and integrates empirically grounded advances in the assessment of suicidality. The practices discussed are consistent with existing standards of care, practice guidelines, and applicable research. The authors differentiate between risk assessment and prediction and then emphasize the important role of time in risk assessment. We present and illustrate a continuum of suicidality for risk assessment and offer practical recommendations for clinical decision making and treatment. (c) 2005 Wiley Periodicals, Inc.

  10. Assessing the toxicity of TBBPA and HBCD by zebrafish embryo toxicity assay and biomarker analysis.

    PubMed

    Hu, Jun; Liang, Yong; Chen, Minjie; Wang, Xiaorong

    2009-08-01

    Tetrabromobisphenol A (TBBPA) and hexabromocyclododecane (HBCD) are two of the most widely used brominated flame retardants (BFRs). The biological toxicity effect of TBBPA and HBCD was studied by means of zebrafish embryo toxicity assays in combination with three biomarkers, including superoxide dismutase (SOD), lipid peroxidation, (LPO), and heat shock protein (Hsp70). The standard zebrafish embryo assay showed that high concentrations of TBBPA (> or =0.75 mg/L) can cause lethality or malformation. For HBCD within the concentration range (0.002-10 mg/L), no endpoint was observed. Furthermore, SOD activities of zebrafish embryos exposed to TBBPA were increased with the increasing concentrations. SOD activities in the group treated by HBCD showed an increase followed by a decline. Regardless of TBBPA or HBCD, LPO were increased along with the increase of the concentration. The change pattern of Hsp70 levels was the same with LPO. All these results showed that TBBPA and HBCD could cause oxidative stress and Hsp70 overexpression, inducing acute toxicity to zebrafish embryo in a short-term exposure. The study also indicates that the zebrafish embryo assay in combination with the biomarkers is effective in aquatic environmental toxicology and risk assessment.

  11. Radiological safety and risk assessment

    SciTech Connect

    Hunter, P.H.; Barg, D.C.; Baird, R.D.; Card, D.H.; de Souza, F.; Elder, J.; Felthauser, K.; Jensen, C.; Winkler, V.

    1982-02-01

    A brief radiological safety and risk assessment of a nuclear power generation center with an adjacent on-site waste disposal facility at a specific site in the State of Utah is presented. The assessment was conducted to assist in determining the feasibility and practicality of developing a nuclear energy center (NEC) in Utah consisting of nine 1250 MWe nuclear pressurized water reactor (PWR) electrical generating units arranged in 3 clusters of 3 units each known as triads. The site selected for this conceptual study is in the Horse Bench area about 15 miles directly south of the town of Green River, Utah. The radiological issues included direct radiation exposures to on-site workers and the off-site population, release of radioactive material, and effects of these releases for both normal operations and accidental occurrences. The basic finding of this study is that the concept of an NEC in the Green River area, specifically at the Horse Bench site, is radiologically feasible.

  12. Bilastine: an environmental risk assessment.

    PubMed

    Lucero, María Luisa; Peither, Armin; Ledo, Francisco

    2015-10-01

    Bilastine is a new oral selective, non-sedating histamine H1 antagonist for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. The European Medicines Agency requires an Environmental Risk Assessment (ERA) for all novel medicines for human use. To calculate the bilastine predicted environmental concentration in surface water (PECsw; phase I ERA), and to determine the effects of bilastine on aquatic systems (phase II [tier A]). Bilastine PECsw was calculated using the maximum daily dosage (20 mg), assuming that all administered bilastine was released into the aquatic environment. A persistence, bioaccumulation and toxicity assessment was conducted using the log Kow from the molecular structure. In phase II (tier A), a ready biodegradability test was performed, and bilastine's potential toxicity to various aquatic and sediment-dwelling micro-organisms was evaluated. Bilastine PECSW was calculated as 0.1 μg L(-1), and the compound was not readily biodegradable. Bilastine had no significant effects on Chironomus riparius midges, or on the respiration rate of activated sludge. For green algae, the bilastine no observed effect concentration (NOEC) was 22 mg L(-1); bilastine had no effect on zebra fish development, or on the reproduction rate of daphnids. Bilastine NOEC values against zebra fish, algae, daphnids, and aerobic organisms in activated sludge were at least 130 000-fold greater than the calculated PECSW value. No environmental concerns exist from bilastine use in patients with allergic rhinoconjunctivitis or urticaria.

  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.

  14. 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.

  15. Genotoxicity assessment of deoxynivalenol in the Caco-2 cell line model using the Comet assay.

    PubMed

    Bony, Sylvie; Carcelen, Monique; Olivier, Laurence; Devaux, Alain

    2006-09-30

    The genotoxic risk associated with deoxynivalenol (DON), a prevalent trichothecene mycotoxin which contaminates cereal-based products has not yet been deeply explored. In this work, the alkaline version of the Comet assay was used to evaluate DNA damage stemming from DON exposure in both dividing and differentiated Caco-2 cells, an epithelial intestinal cell line. To avoid false positive results, cytotoxic and apoptotic thresholds were firstly established using the MTS and neutral red assays and the Hoestch staining method, respectively. Dividing cells were found to be more sensitive to DON than differentiated cells and the lowest IC(10) (0.5 microM) obtained for dividing cells exposed for 72 h was used as the highest working concentration in the genotoxicity study. Both differentiated and dividing cells responded with a dose-dependent relationship to DON in terms of DNA damage in the 0.01-0.5 microM range. These results demonstrated the existence of a genotoxic potential for DON at low concentrations compatible with actual exposure situations and calls for additional studies to determine the functional consequences which could be taken into account for the risk assessment of this food contaminant.

  16. Pressure sore risk assessment in palliative care.

    PubMed

    Chaplin, J

    2000-01-01

    Pressure sore prevention in palliative care is recognized as being an essential element of holistic care, with the primary goal of promoting quality of life for patient and family. Little is known about the incidence of pressure sore development and the use of pressure sore risk assessment tools in palliative care settings. The development of a risk assessment tool specifically for palliative care patients in a 41-bedded specialist palliative care unit is described. The risk assessment tool was developed as part of a tissue viability practice development initiative. The approach adopted in the validation of the Hunters Hill Marie Curie Centre pressure sore risk assessment tool was the comparative analysis of professional judgment of experienced palliative care nurses with the numerical scores achieved during the assessment of risk on 291 patients (529 risk assessment events). This comparative analysis identified the threshold for different degrees of risk for the patient group involved: low risk, medium risk, high risk and very high risk. Further work is being undertaken to evaluate the inter-rater reliability of the new tool. A number of issues are explored in this paper in relation to pressure sore prevention in palliative care: the role of risk assessment tools, the sometimes conflicting aims of trying to ensure comfort and prevent pressure sore damage, and the uncertainties faced by palliative care nurses when they are trying to maintain quality of life for the dying.

  17. 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...

  18. 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...

  19. 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

  20. 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.

  1. [Application of three risk assessment models in occupational health risk assessment of dimethylformamide].

    PubMed

    Wu, Z J; Xu, B; Jiang, H; Zheng, M; Zhang, M; Zhao, W J; Cheng, J

    2016-08-20

    Objective: To investigate the application of United States Environmental Protection Agency (EPA) inhalation risk assessment model, Singapore semi-quantitative risk assessment model, and occupational hazards risk assessment index method in occupational health risk in enterprises using dimethylformamide (DMF) in a certain area in Jiangsu, China, and to put forward related risk control measures. Methods: The industries involving DMF exposure in Jiangsu province were chosen as the evaluation objects in 2013 and three risk assessment models were used in the evaluation. EPA inhalation risk assessment model: HQ=EC/RfC; Singapore semi-quantitative risk assessment model: Risk= (HR×ER) (1/2); Occupational hazards risk assessment index=2(Health effect level)×2(exposure ratio)×Operation condition level. Results: The results of hazard quotient (HQ>1) from EPA inhalation risk assessment model suggested that all the workshops (dry method, wet method and printing) and work positions (pasting, burdening, unreeling, rolling, assisting) were high risk. The results of Singapore semi-quantitative risk assessment model indicated that the workshop risk level of dry method, wet method and printing were 3.5 (high) , 3.5 (high) and 2.8 (general) , and position risk level of pasting, burdening, unreeling, rolling, assisting were 4 (high) , 4 (high) , 2.8 (general) , 2.8 (general) and 2.8 (general) . The results of occupational hazards risk assessment index method demonstrated that the position risk index of pasting, burdening, unreeling, rolling, assisting were 42 (high) , 33 (high) , 23 (middle) , 21 (middle) and 22 (middle) . The results of Singapore semi-quantitative risk assessment model and occupational hazards risk assessment index method were similar, while EPA inhalation risk assessment model indicated all the workshops and positions were high risk. Conclusion: The occupational hazards risk assessment index method fully considers health effects, exposure, and operating conditions

  2. [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.

  3. 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

  4. Assessing Human Health Risk from Pesticides

    EPA Pesticide Factsheets

    EPA protects human health and the environment by evaluating the risk associated with pesticides before allowing them to be used in the United States. Learn about the tools and processes used in risk assessment for pesticides.

  5. Revised Methods for Worker Risk Assessment

    EPA Pesticide Factsheets

    EPA is updating and changing the way it approaches pesticide risk assessments. This new approach will result in more comprehensive and consistent evaluation of potential risks of food use pesticides, non-food use pesticides, and occupational exposures.

  6. 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.

  7. ECOLOGICAL INDICATORS IN RISK ASSESSMENT WORKSHOP SUMMARY

    EPA Science Inventory

    Ecological indicators can be defined as relatively simple measurements that relay scientific information about complex ecosystems. Such indicators are used to characterize risk in ecological risk assessment (ERA) and to mark progress toward resource management goals. In late 1997...

  8. ECOLOGICAL INDICATORS IN RISK ASSESSMENT: WORKSHOP SUMMARY

    EPA Science Inventory

    Ecological indicators can be defined as relatively simple measurements that relay scientific information about complex ecosystems. Such indicators are used to characterize risk in ecological risk assessment and to mark progress toward resource management goals. In late 1997 scien...

  9. 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.

  10. Cumulative Assessment of Risk from Pesticides

    EPA Pesticide Factsheets

    EPA protects human health and the environment by evaluating the risk associated with pesticides before allowing them to be used in the United States. Learn about the tools and processes used in risk assessment for pesticides.

  11. ECOLOGICAL INDICATORS IN RISK ASSESSMENT: WORKSHOP SUMMARY

    EPA Science Inventory

    Ecological indicators can be defined as relatively simple measurements that relay scientific information about complex ecosystems. Such indicators are used to characterize risk in ecological risk assessment and to mark progress toward resource management goals. In late 1997 scien...

  12. ECOLOGICAL INDICATORS IN RISK ASSESSMENT WORKSHOP SUMMARY

    EPA Science Inventory

    Ecological indicators can be defined as relatively simple measurements that relay scientific information about complex ecosystems. Such indicators are used to characterize risk in ecological risk assessment (ERA) and to mark progress toward resource management goals. In late 1997...

  13. Integrated risk assessment and endocrine disrupters.

    PubMed

    Bridges, J W; Bridges, Olga

    2004-12-01

    1. The procedures currently employed for risk assessment are unlikely to be sustainable in the future for a variety of reasons. A number of actions are needed to remedy the situation and the most important of these actions are: * to improve access to existing data; * to introduce a prioritisation system based on exposure assessment; * to co-ordinate and harmonise approaches of different organisations involved in risk assessment. 2. Integration of information and methodologies between human health risk assessment and ecological risk assessment (integrated risk assessment) is advocated in this paper as one of the most important steps towards a holistic and effective way of conducting a risk assessment. 3. A framework is proposed for identification of agents for which an integrated risk assessment would be of particular value. Close collaboration across disciplines and across countries is necessary for the potential of integrated risk assessment to be realised in practice. The practicality of applying integrated risk assessment to endocrine disrupting agents is presently being investigated in an EU funded multi-laboratory collaborative study (CREDO).

  14. 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.

  15. 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.

  16. Proceedings of the 2006 Toxicology and Risk Assessment Conference: Applying Mode of Action in Risk Assessment

    DTIC Science & Technology

    2006-07-01

    Ecological Risk Assessment; Benchmark Dose Methods ; Fundamentals of Risk Assessment; and Multi-Criteria Decision Analysis Tools for Managing Complex...Tomato; I Say Lampshade - Different Methods and Mechanisms for Health Risk Assessment.” The program, which is included in this report, gives an...cutting edge chemical mixture health risk assessment risk issues, explanation of state-of-the-art methods , and hands on exercises for several

  17. Issues in risk assessment. Final report

    SciTech Connect

    Not Available

    1993-01-01

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

  18. Prediction of the Clinical Risk of Drug-Induced Cholestatic Liver Injury Using an In Vitro Sandwich Cultured Hepatocyte Assay.

    PubMed

    Susukida, Takeshi; Sekine, Shuichi; Nozaki, Mayuka; Tokizono, Mayuko; Ito, Kousei

    2015-11-01

    Drug-induced liver injury (DILI) is of concern to the pharmaceutical industry, and reliable preclinical screens are required. Previously, we established an in vitro bile acid-dependent hepatotoxicity assay that mimics cholestatic DILI in vivo. Here, we confirmed that this assay can predict cholestatic DILI in clinical situations by comparing in vitro cytotoxicity data with in vivo risk. For 38 drugs, the frequencies of abnormal increases in serum alkaline phosphatase (ALP), transaminases, gamma glutamyltranspeptidase (γGT), and bilirubin were collected from interview forms. Drugs with frequencies of serum marker increases higher than 1% were classified as high DILI risk compounds. In vitro cytotoxicity was assessed by monitoring lactate dehydrogenase release from rat and human sandwich-cultured hepatocytes (SCRHs and SCHHs) incubated with the test drugs (50 μM) for 24 hours in the absence or presence of a bile acids mixture. Receiver operating characteristic analyses gave optimal cutoff toxicity values of 19.5% and 9.2% for ALP and transaminases in SCRHs, respectively. Using this cutoff, high- and low-risk drugs were separated with 65.4-78.6% sensitivity and 66.7-79.2% specificity. Good separation was also achieved using SCHHs. In conclusion, cholestatic DILI risk can be successfully predicted using a sandwich-cultured hepatocyte-based assay. Copyright © 2015 by The American Society for Pharmacology and Experimental Therapeutics.

  19. Earthworm biomarkers in ecological risk assessment.

    PubMed

    Sanchez-Hernandez, J C

    2006-01-01

    Earthworms have had a notable contribution in terrestrial ecotoxicology. They have been broadly used to assess environmental impact from metal pollution, and they are typical test organisms (e.g., Eisenia) in standardized toxicity tests. Several reviews and international workshops have stressed the need for increasing the understanding and applicability of earthworm biomarkers in the ecological risk assessment (ERA) process. This review summarizes recent available information concerning the most investigated earthworm biomarkers. In earthworms, the use of biomarkers has been focused on assessing metal pollution, and available data on biomarker responses to organic contaminants are rather limited. The potential for applying earthworm biomarkers in the standardized toxicity tests is suggested in view of their significant contribution to the risk assessment of contaminated soils (e.g., estimation of bioavailable and bioactive fraction or sublethal effects). Field studies involving earthworm biomarkers are still scarce and are summarized according to their main practical approaches in retrospective ERA: biological surveys, laboratory tests of the soil, simulated field studies, and in situ exposure bioassays. Despite the great volume of laboratory studies on earthworm biomarkers, future lines of research are suggested besides the recommendations made by others: (1) the potential and limitations of the inclusion of biomarkers in the standardized toxicity tests should be examined under a well-defined weight-of-evidence framework; (2) it is necessary to develop operating guidelines to standardize earthworm biomarker assays, an important step to apply biomarkers in a regulatory context; (3) molecular and physiological biomarkers should be directly linked to behavioral changes with significant ecological implications, an important step in considering them as ecotoxicological biomarkers; and (4) biomarkers to organic pollutants of current concern (e.g., polycyclic aromatic

  20. [Risk assessment on laboratory biosafety of Leishmania].

    PubMed

    Xiong, Yan-Hong; Guan, Ya-Yi; Cao, Jian-Ping

    2012-06-01

    To provide the evidence for improving the risk assessment and personal protective equipment and techniques to laboratory staff related to Leishmania. The laboratory biosafety of Leishmania was preliminarily assessed based on the biological background information, potential hazards in experimental activities, the risk analyses of laboratory personnel and other relevant factors. The risk assessment on laboratory biosafety of Leishmania was helpful for the establishment of the laboratory standard operating procedure, and was helpful for protecting the staff from infection of Leishmania. The risk assessment on laboratory biosafety is important to the safety of laboratory activity related to Leishmania, and is of a great significance to protect the laboratory staff.

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

    PubMed

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

    2015-09-01

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

  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. Advances in risk assessment and communication.

    PubMed

    Goldstein, Bernard D

    2005-01-01

    Risk analysis continues to evolve. There is increasing depth and breadth to each component of the four-step risk-assessment paradigm of hazard identification, dose-response analysis, exposure assessment, and risk characterization. Basic conceptual approaches to understanding how people perceive risk are being tested against a growing body of empirical observations, many involving stakeholders. Emerging ideas such as the precautionary principle have provided challenges that have led to a rethinking of the role of risk assessment in environmental health. Newer problems, such as intergenerational issues posed by long-lasting radiation pollution, environmental justice, and the assessment and communication of risks related to terrorism, have spurred innovative approaches to risk analysis.

  4. 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...

  5. Revised Human Health Risk Assessment on Chlorpyrifos

    EPA Pesticide Factsheets

    We have revised our human health risk assessment and drinking water exposure assessment for chlorpyrifos that supported our October 2015 proposal to revoke all food residue tolerances for chlorpyrifos. Learn about the revised analysis.

  6. Quantitative Microbial Risk Assessment Tutorial - Primer

    EPA Science Inventory

    This document provides a Quantitative Microbial Risk Assessment (QMRA) primer that organizes QMRA tutorials. The tutorials describe functionality of a QMRA infrastructure, guide the user through software use and assessment options, provide step-by-step instructions for implementi...

  7. 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...

  8. Multiple-endpoints gene alteration-based (MEGA) assay: A toxicogenomics approach for water quality assessment of wastewater effluents.

    PubMed

    Fukushima, Toshikazu; Hara-Yamamura, Hiroe; Nakashima, Koji; Tan, Lea Chua; Okabe, Satoshi

    2017-08-21

    Wastewater effluents contain a significant number of toxic contaminants, which, even at low concentrations, display a wide variety of toxic actions. In this study, we developed a multiple-endpoints gene alteration-based (MEGA) assay, a real-time PCR-based transcriptomic analysis, to assess the water quality of wastewater effluents for human health risk assessment and management. Twenty-one genes from the human hepatoblastoma cell line (HepG2), covering the basic health-relevant stress responses such as response to xenobiotics, genotoxicity, and cytotoxicity, were selected and incorporated into the MEGA assay. The genes related to the p53-mediated DNA damage response and cytochrome P450 were selected as markers for genotoxicity and response to xenobiotics, respectively. Additionally, the genes that were dose-dependently regulated by exposure to the wastewater effluents were chosen as markers for cytotoxicity. The alterations in the expression of an individual gene, induced by exposure to the wastewater effluents, were evaluated by real-time PCR and the results were validated by genotoxicity (e.g., comet assay) and cell-based cytotoxicity tests. In summary, the MEGA assay is a real-time PCR-based assay that targets cellular responses to contaminants present in wastewater effluents at the transcriptional level; it is rapid, cost-effective, and high-throughput and can thus complement any chemical analysis for water quality assessment and management. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Assessing reservoir operations risk under climate change

    NASA Astrophysics Data System (ADS)

    Brekke, Levi D.; Maurer, Edwin P.; Anderson, Jamie D.; Dettinger, Michael D.; Townsley, Edwin S.; Harrison, Alan; Pruitt, Tom

    2009-04-01

    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.

  10. 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.

  11. 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.

  12. Development of a STAT5 phosphorylation assay as a rapid bioassay to assess interleukin-7 potency.

    PubMed

    Zumpe, C; Engel, K; Wiedemann, N; Metzger, A U; Pischetsrieder, M; Bachmann, C L

    2011-10-01

    Interleukin (IL)-7 is a cytokine inducing the Janus Kinase (JAK)/Signal Transducer and Activator of Transcription (STAT) pathway. As a consequence of IL-7 activating this pathway, STAT5 is phosphorylated. In pharmaceutical quality control, the potency of biopharmaceuticals is commonly assessed by proliferation assays. This is also possible for IL-7 conjugates. However, the disadvantage of these classical "endpoint-assays" is that they require very long incubation times, up to several days, since they measure the downstream events of a cellular response. As an alternative to this, we developed a rapid intracellular phosphorylation assay, measuring IL-7 induced STAT5 phosphorylation in Kit 225 cells. The Kit 225 human T cell line expresses the IL-7 receptor and is responsive to IL-7, therefore making it a good candidate cell line for assay development. Like the Kinase receptor activation (KIRA) assay, developed by Sadick et al. [1], the STAT5 phosphorylation assay was performed using two separate microtiter plates: the first one for cell stimulation and lysis, the second one for enzyme-linked immuno sorbent assay (ELISA). The assay showed a high accuracy and precision with a mean recovery of 102% and a mean coefficient of variation of 9%. In comparison to the classical proliferation assay, the phosphorylation assay is much faster. Thus, the assay procedure time can at least be reduced from six to three days by using STAT5 phosphorylation instead of proliferation as an endpoint due to the shorter incubation time with IL-7. Moreover, the phosphorylation assay shows a wider dynamic range and higher signal to noise ratios and is thus more robust than the proliferation assay.mAs a consequence, this assay could serve as reliable, accurate, precise and fast alternative to the classical proliferation assay for IL-7. This study also serves as an example for the typical steps during development and qualification / validation of a potency assay for quality control testing.

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

    PubMed

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

    2015-01-01

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

  14. 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. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. Production Risk Assessing Methodology (PRAM).

    DTIC Science & Technology

    1982-05-01

    the price up five-fold which translates to $30.M. On the optimistic side,this same commodity market could bring the price down to one half of the price...57 PWMIW- A recognitinn that past product ion probl ems represent f ut ri , producto ; risk areas suggested an empirically developed risk structure

  16. Summary Report: Risk Assessment Forum Technical Workshop on Population-level Ecological Risk Assessment

    EPA Pesticide Factsheets

    2008 technical workshop regarding development of additional guidelines or best practices for planning, implementing and interpreting ecological risk assessments that involve population-level assessment endpoints.

  17. Cumulative Risk Assessment (CRA): Transforming the Way We Assess Health Risks

    PubMed Central

    Williams, Pamela R. D.; Dotson, G. Scott; Maier, Andrew

    2016-01-01

    Human health risk assessments continue to evolve and now focus on the need for cumulative risk assessment (CRA). CRA involves assessing the combined risk from coexposure to multiple chemical and nonchemical stressors for varying health effects. CRAs are broader in scope than traditional chemical risk assessments because they allow for a more comprehensive evaluation of the interaction between different stressors and their combined impact on human health. Future directions of CRA include greater emphasis on local-level community-based assessments; integrating environmental, occupational, community, and individual risk factors; and identifying and implementing common frameworks and risk metrics for incorporating multiple stressors. PMID:22938698

  18. Site-Specific Rules for Risk Assessment.

    ERIC Educational Resources Information Center

    Tucker, William; And Others

    1994-01-01

    This article examines the development of regulatory guidance upon which the technology of risk assessment has matured into a decision-making method of choice. It examines in particular the role of site-specific risk assessment at Superfund sites. (LZ)

  19. 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 ...

  20. 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…

  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…

  2. Site-Specific Rules for Risk Assessment.

    ERIC Educational Resources Information Center

    Tucker, William; And Others

    1994-01-01

    This article examines the development of regulatory guidance upon which the technology of risk assessment has matured into a decision-making method of choice. It examines in particular the role of site-specific risk assessment at Superfund sites. (LZ)

  3. 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,…

  4. 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,…

  5. 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 ...

  6. 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...

  7. 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...

  8. RESIDUAL RISK ASSESSMENT: PCE DRY CLEANERS ...

    EPA Pesticide Factsheets

    This document describes the residual risk assessement for the Perchloroethylene Dry Cleaners source category. For stationary sources, section 112(f) of the Clean Air Act requires EPA to assess risks to human health and the environment following implementation of technology-based control standards. If these technology-based control standards do not provide an ample margin of safety, then EPA is required to promulgate additional standards. The purpose of this document is to describe the methodology and results of teh residual risk assessment performed for the Perchloroethylene Dry Cleaners source category. The results of this analysis will assist EPA in determining whether a residual risk rule for this source category is appropriate.

  9. 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...

  10. 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...

  11. Comparison of the Third Wave Invader Human Papillomavirus (HPV) Assay and the Digene HPV Hybrid Capture 2 Assay for Detection of High-Risk HPV DNA▿

    PubMed Central

    Ginocchio, C. C.; Barth, D.; Zhang, F.

    2008-01-01

    This study compared the clinical performance of the Digene Hybrid Capture 2 (HC2) assay to that of a prototype Third Wave Invader human papillomavirus (HPV) (IHPV) analyte-specific reagent-based assay for the detection of oncogenic or “high-risk” (HR) HPV DNA using liquid-based cytology specimens. In total, 821 ThinPrep vials were tested using both assays. In accordance with the type-specific probes contained within each test, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the IHPV assay were 95.9%, 97.6%, 97.5%, and 96.1%, respectively, and those for the HC2 assay were 98.1%, 86.2%, 87.1%, and 97.9%. Overall, the sensitivity and NPV were comparable between the assays, but the IHPV assay demonstrated a better specificity and PPV, since the IHPV assay had fewer false-positive HR HPV results. The incorporation of an internal control to evaluate the cellularity of the test material is an important feature of the IHPV assay and should reduce the risk of false-negative results due to insufficient sample collection rather than the lack of HR HPV DNA. An additional benefit of the IHPV assay was the smaller sample volume required (1 ml versus 4 ml for the HC2 assay). PMID:18367578

  12. 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.

  13. 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.

  14. 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

  15. 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...

  16. 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...

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

    PubMed Central

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

    2014-01-01

    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. PMID:25355292

  18. Guidelines for Neurotoxicity Risk Assessment

    EPA Pesticide Factsheets

    These Guidelines set forth principles and procedures to guide EPA scientists in evaluating environmental contaminants that may pose neurotoxic risks, and inform Agency decision makers and the public about these procedures.

  19. Colorectal Cancer Risk Assessment Tool

    MedlinePlus

    ... Colorectal Cancer Risk Factors Download SAS and Gauss Code Page Options Print Page Quick Links Colon and Rectal Cancer Home Page Colon and Rectal Cancer: Prevention, Genetics, Causes Tests to Detect Colorectal Cancer and Polyps ...

  20. 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.

  1. Cardiovascular risk assessment: a global perspective.

    PubMed

    Zhao, Dong; Liu, Jing; Xie, Wuxiang; Qi, Yue

    2015-05-01

    An important strategy in primary prevention of cardiovascular diseases (CVD) is the early identification of high-risk individuals. Effective implementation of a strategy to identify these individuals in a clinical setting is reliant on the availability of appropriate CVD risk-assessment models and guideline recommendations. Several well-known models for CVD risk assessment have been developed and utilized in the USA and Europe, but might not be suitable for use in other regions or countries. Very few reports have discussed the development of risk-assessment models and recommendations from a global perspective. In this Review, we discuss why risk-assessment methods developed from studies in one geographical region or ethnic population might not be suitable for other regions or populations, and examine the availability and characteristics of predictive models in areas beyond the USA or Europe. In addition, we compare the differences in risk-assessment recommendations outlined in CVD clinical guidelines from developed and developing countries, and consider their potential effect on clinical practice. This overview of cardiovascular risk assessment from a global perspective can potentially guide low-to-middle-income countries in the development or validation of their own CVD risk-assessment models, and the formulation of recommendations in their own clinical guidelines according to local requirements.

  2. Values in science and risk assessment.

    PubMed

    Wandall, Birgitte

    2004-09-25

    It is a widely accepted claim that scientific practice contains value judgments, i.e. decisions made on the basis of values. This paper clarifies the concepts involved in this claim and explains its implications for risk assessment. It is explained why values are necessarily a part of science and of risk assessment. A certain type of values that contribute to the aim of science, so-called epistemic values, are identified as rationally justified as basis for judgment in science. It is argued that the aims of pure science and risk assessment differ in some aspects and that consequently pure science's epistemic values are not sufficient for risk assessment. I suggest how the epistemic values may be supplemented in order to align better with the aim of risk assessment. It is concluded that since risk assessment is no less value-laden than pure science, it is important (a) that risk assessors become aware of what values they are (often implicitly) relying on, (b) that the values are justifiable, and (c) that transparency is ensured, i.e. that the values and value-based assumptions applied in particular risk assessments are explicitly acknowledged.

  3. 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

  4. 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...

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

    EPA Science Inventory

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

  6. 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. Rapid Assay to Assess Bacterial Adhesion on Textiles

    PubMed Central

    Schmidt-Emrich, Sabrina; Stiefel, Philipp; Rupper, Patrick; Katzenmeier, Heinz; Amberg, Caroline; Maniura-Weber, Katharina; Ren, Qun

    2016-01-01

    Textiles are frequently colonized by microorganisms leading to undesired consequences like hygienic problems. Biocidal coatings often raise environmental and health concerns, thus sustainable, biocide-free coatings are of interest. To develop novel anti-adhesive textile coatings, a rapid, reliable, and quantitative high-throughput method to study microbial attachment to fabrics is required, however currently not available. Here, a fast and reliable 96-well plate-based screening method is developed. The quantification of bacterial adhesion is based on nucleic acid staining by SYTO9, with Pseudomonas aeruginosa and Staphylococcus aureus as the model microorganisms. Subsequently, 38 commercially available and novel coatings were evaluated for their anti-bacterial adhesion properties. A poly(l-lysine)-g-poly(ethylene glycol) coating on polyester textile substratum revealed an 80% reduction of bacterial adhesion. Both the coating itself and the anti-adhesive property were stable after 20 washing cycles, confirmed by X-ray analysis. The assay provides an efficient tool to rapidly screen for non-biocidal coatings reducing bacterial attachment. PMID:28773373

  9. 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

  10. 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.

  11. 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.

  12. Risk Assessment: Perchloroethylene Dry Cleaners Refined Human Health Risk Characterization

    EPA Pesticide Factsheets

    This November 2005 memo and appendices describe the methods by which EPA conducted its refined risk assessment of the Major Source and Area Source facilities within the perchloroethylene (perc) dry cleaners source category.

  13. Health Risk Assessments for Alumina Refineries

    PubMed Central

    Coffey, Patrick S.

    2014-01-01

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

  14. Health risk assessments for alumina refineries.

    PubMed

    Donoghue, A Michael; Coffey, Patrick S

    2014-05-01

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

  15. 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.

  16. Genotoxicity of citrate-coated silver nanoparticles to human keratinocytes assessed by the comet assay and cytokinesis blocked micronucleus assay.

    PubMed

    Bastos, V; Duarte, I F; Santos, C; Oliveira, H

    2017-02-01

    Silver nanoparticles (AgNPs) are widely used in industrial, cosmetic, and biomedical products, and humans are frequently exposed to these products through the skin. It is widely recognized that the characteristics of AgNPs (e.g., size, coating) may influence their cytotoxic effects, but their correlation with DNA damage and mitotic disorders remains poorly explored. In this study, human keratinocytes (HaCaT cell line) were exposed to well-characterized 30 nm AgNPs coated with citrate, and their effects on viability, DNA fragmentation (assessed by the comet assay), and micronuclei (MNi) induction (assessed by the cytokinesis-block micronucleus cytome assays, CBMN) were investigated. The results showed that 10 and 40 μg/mL AgNPs decreased cell proliferation and viability, and induced a significant genetic damage. This was observed by an increase of DNA amount in comet tail, which linearly correlated with dose and time of exposure. Also, cytostaticity (increase of mononucleated cells) and MNi rates increased in treated cells. In contrast, no significant changes were observed in nucleoplasmatic bridges (NPBs) or nuclear buds (NBUDs), although NBUDs tended to increase in all conditions and periods. The cytostatic effects on HaCaT cells were also shown by the decrease of their nuclear division index. Thus, both comet and CBMN assays supported the observation that citrate-AgNPs induced genotoxic effects on HaCaT cells. Considering that AgNPs are present in a vast number of consumer products and also in multiple nanomedicine skin applications and formulations, more research is needed to determine the properties that confer less toxicity of AgNPs to different cell lines.

  17. Technical Overview of Ecological Risk Assessment: Problem Formulation

    EPA Pesticide Factsheets

    Before the ecological risk assessment is conducted, risk assessors and risk managers engage in a planning dialogue to ensure that the risk assessment will enable the risk managers to make informed environmental decisions.

  18. 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.

  19. 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

  20. [Study on application of two risk assessment methods in coal dust occupational health risk assessment].

    PubMed

    Wu, B; Zhang, Y L; Chen, Y Q

    2017-04-20

    Objective: To evaluate the applicability of quantitative grading method (GBZ/T 229.1-2010) and occupational hazard risk index method in coal dust occupational health risk assessment. Methods: Taking 4 coal mines as the research object of risk assessment and making occupational health field testing and investigation. Based on two risk assessment methods, we analysed the health risk levels of 20 occupations which were exposed to coal dust in workplaces. Results: Coal dust working post had different risk levels in 4 coal mines, the post of higher risk level were mainly concentrated in the underground workplace of coal mine, especially the post of coal mining and tunneling system. The two risk assessment results showed that the risk levels of coal-mining machine drivers and tunneling machine drivers were the highest. The risk levels of coal dust working post used by two risk assessment methods had no significant difference (P>0.05) and were highly correlated (r=0.821, P<0.001) . Evaluation results of two risk assessment methods were supported by the field investigation and literatures. Conclusion: The two risk assessment methods can be used in coal dust occupational health risk assessment.

  1. Enhancing the ecological risk assessment process.

    PubMed

    Dale, Virginia H; Biddinger, Gregory R; Newman, Michael C; Oris, James T; Suter, Glenn W; Thompson, Timothy; Armitage, Thomas M; Meyer, Judith L; Allen-King, Richelle M; Burton, G Allen; Chapman, Peter M; Conquest, Loveday L; Fernandez, Ivan J; Landis, Wayne G; Master, Lawrence L; Mitsch, William J; Mueller, Thomas C; Rabeni, Charles F; Rodewald, Amanda D; Sanders, James G; van Heerden, Ivor L

    2008-07-01

    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) through 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 would

  2. 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

  3. Prospective actuarial risk assessment: a comparison of five risk assessment instruments in different sexual offender subtypes.

    PubMed

    Rettenberger, Martin; Matthes, Anna; Boer, Douglas P; Eher, Reinhard

    2010-04-01

    This study examines the predictive validity of the most commonly used risk assessment instruments for sexual offenders: Static-99, Rapid Risk Assessment for Sexual Offense Recidivism, Sex Offender Risk Appraisal Guide, Sexual Violence Risk-20, and Psychopathy Checklist-Revised in a prospective research design. Although risk assessment is part of a regime leading to various efforts to reduce risk by treatment and aftercare, all instruments show good predictive validity. However, depending on the instrument, recidivism category, and subgroup, the predictive accuracy varies markedly. Furthermore, the authors fail to demonstrate predictive validity for sexual violent reoffences-for the whole sample and for all subgroups. The results, nevertheless, support the utility and predictive validity of actuarial risk assessment complementary to treatment efforts to reduce risk. On the other hand, forensic practitioners have to be aware of the limitations of actuarial risk assessment methods, in particular as regards to variable predictive accuracy for different sexual offender subgroups and reoffence categories.

  4. 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. Copyright © 2016 Elsevier B.V. All rights reserved.

  5. 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 ...

  6. CANCER RISK ASSESSMENT FOR CHLOROFORM

    EPA Science Inventory

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

  7. ASSESSING WATERBORNE RISKS: AN INTRODUCTION

    EPA Science Inventory

    Information in this article can help readers evaluate the results of epidemiologic studies of

    waterborne disease risks. It is important that readers understand the various epidemiologic study

    designs, their strengths and limitations, and potential biases. Terminolog...

  8. Comparison of solid-phase and eluate assays to gauge the ecotoxicological risk of organic wastes on soil organisms.

    PubMed

    Domene, Xavier; Alcañiz, Josep M; Andrés, Pilar

    2008-02-01

    Development of methodologies to assess the safety of reusing polluted organic wastes in soil is a priority in Europe. In this study, and coupled with chemical analysis, seven organic wastes were subjected to different aquatic and soil bioassays. Tests were carried out with solid-phase waste and three different waste eluates (water, methanol, and dichloromethane). Solid-phase assays were indicated as the most suitable for waste testing not only in terms of relevance for real situations, but also because toxicity in eluates was generally not representative of the chronic effects in solid-phase. No general correlations were found between toxicity and waste pollutant burden, neither in solid-phase nor in eluate assays, showing the inability of chemical methods to predict the ecotoxicological risks of wastes. On the contrary, several physicochemical parameters reflecting the degree of low organic matter stability in wastes were the main contributors to the acute toxicity seen in collembolans and daphnids.

  9. Vehicle emission unit risk factors for transportation risk assessments

    SciTech Connect

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

    1999-12-01

    When the transportation risk posed by shipments of hazardous chemical and radioactive materials is being assessed, it is necessary to evaluate the risks associated with both vehicle emissions and cargo-related risks. Diesel exhaust and fugitive dust emissions from vehicles transporting hazardous shipments lead to increased air pollution, which increases the risk of latent fatalities in the affected population along the transport route. The estimated risk from these vehicle-related sources can often by as large or larger than the estimated risk associated with the material being transported. In this paper, data from the US Environmental Protection Agency's Motor Vehicle-Related Air Toxics Study are first used to develop latent cancer fatality estimates per kilometer of travel in rural and urban areas for all diesel truck classes. These unit risk factors are based on studies investigating the carcinogenic nature of diesel exhaust. With the same methodology, the current per=kilometer latent fatality risk factor used in transportation risk assessment for heavy diesel trucks in urban areas is revised and the analysis expanded to provide risk factors for rural areas and all diesel truck classes. These latter fatality estimates may include, but are not limited to, cancer fatalities and are based primarily on the most recent epidemiological data available on mortality rates associated with ambient air PM-10 concentrations.

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

    PubMed

    Biwer, B M; Butler, J P

    1999-12-01

    When the transportation risk posed by shipments of hazardous chemical and radioactive materials is being assessed, it is necessary to evaluate the risks associated with both vehicle emissions and cargo-related risks. Diesel exhaust and fugitive dust emissions from vehicles transporting hazardous shipments lead to increased air pollution, which increases the risk of latent fatalities in the affected population along the transport route. The estimated risk from these vehicle-related sources can often be as large or larger than the estimated risk associated with the material being transported. In this paper, data from the U.S. Environmental Protection Agency's Motor Vehicle-Related Air Toxics Study are first used to develop latent cancer fatality estimates per kilometer of travel in rural and urban areas for all diesel truck classes. These unit risk factors are based on studies investigating the carcinogenic nature of diesel exhaust. With the same methodology, the current per-kilometer latent fatality risk factor used in transportation risk assessments for heavy diesel trucks in urban areas is revised and the analysis expanded to provide risk factors for rural areas and all diesel truck classes. These latter fatality estimates may include, but are not limited to, cancer fatalities and are based primarily on the most recent epidemiological data available on mortality rates associated with ambient air PM-10 concentrations.

  11. Assessing Risk in Graphically Presented Financial Series.

    PubMed

    Sobolev, Daphne; Harvey, Nigel

    2016-12-01

    It has been argued that traders use their natural sensitivity to the fractal properties of price graphs to assess risk and that they are better able to do this when given price change as well as price level information. This approach implies that risk assessments should be higher when the Hurst exponents are lower, that this relationship should be stronger in the presence of price change information and that risk assessment should depend more strongly on the Hurst exponent than on the standard deviation of the series. Participants in Experiment 1 decided which of two assets was riskier by inspecting graphs of their price series. Graphs with lower Hurst exponents were selected only by those who were less emotionally stable and hence more sensitive to risk. However, when both price series and price change series were presented, the assets with lower Hurst exponents were selected by all participants. In a second experiment, participants were given both price level and price change series for a number of assets and rated the risk of trading in each one. Ratings depended more strongly on Hurst exponents than on other measures of volatility. They also depended on indicators of potential loss. Human risk assessment deviates from the way that risk is measured in modern finance theory: it requires integration of information relevant to both uncertainty and loss aversion, thereby imposing high attentional demands on traders. These demands may impair risk assessment but they can be eased by adding displays of price change information.

  12. 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.

  13. Subjective risk assessment for planning conservation projects

    NASA Astrophysics Data System (ADS)

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

    2013-12-01

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

  14. Chemical Risk Assessment: Traditional vs Public Health ...

    EPA Pesticide Factsheets

    Preventing adverse health impacts from exposures to environmental chemicals is fundamental to protecting individual and public health. When done efficiently and properly, chemical risk assessment enables risk management actions that minimize the incidence and impacts of environmentally-induced diseases related to chemical exposure. However, traditional chemical risk assessment is faced with multiple challenges with respect to predicting and preventing disease in human populations, and epidemiological studies increasingly report observations of adverse health effects at exposure levels predicted from animal studies to be safe for humans. This discordance reinforces concerns about the adequacy of contemporary risk assessment practices (Birnbaum, Burke, & Jones, 2016) for protecting public health. It is becoming clear that to protect public health more effectively, future risk assessments will need to use the full range of available data, draw on innovative methods to integrate diverse data streams, and consider health endpoints that also reflect the range of subtle effects and morbidities observed in human populations. Given these factors, there is a need to reframe chemical risk assessment to be more clearly aligned with the public health goal of minimizing environmental exposures associated with disease. Preventing adverse health impacts from exposures to environmental chemicals is fundamental to protecting individual and public health. Chemical risk assessments

  15. USE OF TOXICOGENOMICS DATA IN RISK ASSESSMENT ...

    EPA Pesticide Factsheets

    The goal of this project is to address the question, “Can existing toxicogenomics (TG) data improve Environmental Protection Agency (EPA) chemical health or risk assessments?” Although genomics data promises to impact multiple areas of science, medicine, law, and policy, there are only a few areas where genomics data currently has application (e.g., biomarkers of disease). As the technology continues to advance, EPA will need to prepare for genomics data availability and submission by: 1) identifying areas of risk assessment where such data may be particularly useful; 2) developing acceptance criteria for inclusion of toxicogenomics data in risk assessment; and 3) developing approaches for the use of toxicogenomics in risk assessment. These needs will likely require an iterative and collaborative research process between risk assessors and scientists (inside and outside the Agency). At the NCEA sponsored Genomics and Risk Assessment Colloquium in 2003, one of the recommendations was to conduct case studies that could provide a practical attempt to incorporate currently available toxicogenomics data that would illuminate issues and the methods development. This project is responds to this recommendation. To address the question of whether TG data can improve health risk assessments, a case study will be performed in which TG data for one chemical will be incorporated qualitatively within the hazard characterization step of a recent or ongoing EPA chemical he

  16. Phthalates and Cumulative Risk Assessment (NAS Final ...

    EPA Pesticide Factsheets

    On December 18, 2008, the National Academy of Sciences' National Research Council released a final report, requested and sponsored by the EPA, entitled Phthalates and Cumulative Risk Assessment: The Task Ahead. Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. People are exposed to a variety of chemicals throughout their daily lives. To protect public health, regulators use risk assessments to examine the effects of chemical exposures. This book provides guidance for assessing the risk of phthalates, chemicals found in many consumer products that have been shown to affect the development of the male reproductive system of laboratory animals. Because people are exposed to multiple phthalates and other chemicals that affect male reproductive development, a cumulative risk assessment should be conducted that evaluates the combined effects of exposure to all these chemicals. The book suggests an approach for cumulative risk assessment that can serve as a model for evaluating the health risks of other types of chemicals.

  17. A Bioluminescent Cytotoxicity Assay for Assessment of Membrane Integrity Using a Proteolytic Biomarker

    PubMed Central

    Cho, Ming-Hsuang; Niles, Andrew; Huang, Ruili; Inglese, James; Austin, Christopher P.; Riss, Terry; Xia, Menghang

    2008-01-01

    Measurement of cell membrane integrity has been widely used to assess chemical cytotoxity. Several assays are available for determining cell membrane integrity including differential labeling techniques using neutral red and trypan blue dyes or fluorescent compounds such as propidium iodide. Other common methods for assessing cytotoxicity are enzymatic “release” assays which measure the extracellular activities of lactate dehydrogenase (LDH), adenylate kinase (AK), or glyceraldehyde-3-phosphate dehydrogenase (GAPDH) in culture medium. However, all these assays suffer from several practical limitations, including multiple reagent additions, scalability, low sensitivity, poor linearity, or requisite washes and medium exchanges. We have developed a new cytotoxicity assay which measures the activity of released intracellular proteases as a result of cell membrane impairment. It allows for a homogenous, one-step addition assay with a luminescent readout. We have optimized and miniaturized this assay into a 1536-well format, and validated it by screening a library of known toxins from the National Toxicology Program (NTP) using HEK 293 and human renal mesangial cells by quantitative high-throughput screening (qHTS). Several known and novel membrane disrupters were identified from the library, which indicates that the assay is robust and suitable for large scale library screening. This cytotoxicity assay, combined with the qHTS platform, allowed us to quickly and efficiently evaluate compound toxicities related to cell membrane integrity. PMID:18400464

  18. Uncertainty and sensitivity assessment of flood risk assessments

    NASA Astrophysics Data System (ADS)

    de Moel, H.; Aerts, J. C.

    2009-12-01

    Floods are one of the most frequent and costly natural disasters. In order to protect human lifes and valuable assets from the effect of floods many defensive structures have been build. Despite these efforts economic losses due to catastrophic flood events have, however, risen substantially during the past couple of decades because of continuing economic developments in flood prone areas. On top of that, climate change is expected to affect the magnitude and frequency of flood events. Because these ongoing trends are expected to continue, a transition can be observed in various countries to move from a protective flood management approach to a more risk based flood management approach. In a risk based approach, flood risk assessments play an important role in supporting decision making. Most flood risk assessments assess flood risks in monetary terms (damage estimated for specific situations or expected annual damage) in order to feed cost-benefit analysis of management measures. Such flood risk assessments contain, however, considerable uncertainties. This is the result from uncertainties in the many different input parameters propagating through the risk assessment and accumulating in the final estimate. Whilst common in some other disciplines, as with integrated assessment models, full uncertainty and sensitivity analyses of flood risk assessments are not so common. Various studies have addressed uncertainties regarding flood risk assessments, but have mainly focussed on the hydrological conditions. However, uncertainties in other components of the risk assessment, like the relation between water depth and monetary damage, can be substantial as well. This research therefore tries to assess the uncertainties of all components of monetary flood risk assessments, using a Monte Carlo based approach. Furthermore, the total uncertainty will also be attributed to the different input parameters using a variance based sensitivity analysis. Assessing and visualizing the

  19. 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.

  20. 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.

  1. NUREG-1150 risk assessment results

    SciTech Connect

    Benjamin, A.S.; Kunsman, D.M.; Boyd, G.J.; Lewis, S.R.; Amos, C.N.; Smith, L.N.

    1987-01-01

    The methodology developed in support of the US Nuclear Regulatory Commission's (NRC's) evaluation of severe accident risks in NUREG-1150 is noted. This paper discusses the results. The principal technical analyses for NUREG-1150 were performed at Sandia National Labs. under the Severe Accident Risk Reduction Program and the Accident Sequence Evaluation Program. The analyses have been completed so far for four reference plants: (a) a pressurized water reactor (PWR) with a dry, subatmospheric containment (Surry Unit 1), (b) a PWR with an ice condenser containment (Sequoyah Unit 1), (c) a boiling water reactor (BWR) with a Mark I containment (Peach Bottom Unit 2), and (d) a BWR with a Mark III containment (Grand Gulf Unit 1). A fifth NUREG-1150 plant, a PWR with a large, dry containment (Zion Unit 1), has been evaluated separately by Brookhaven National Lab. Sample risk results for one of the plants (Surry) are presented. The results for Sequoyah, Peach Bottom, and Grand Gulf are broadly compared with those for Surry.

  2. 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

  3. 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.

  4. Assessing risk assessment: genetic testing and screening for complex disease.

    PubMed

    Cox, S M

    2006-11-01

    This paper reports on the presentations from the second session of a 2-day workshop on genetic diversity and science communication, organized by the Institute of Genetics. The four talks in this session (by Sarah Cunningham-Burley, Gail Geller, Michael Hayden, and Theresa Marteau) focused on the topic of risk assessment in the context of genetic testing, screening and preventive medicine for complex disease. Each talk underscored the urgency and importance of evaluating when and for whom risk assessment may be useful. A recurrent theme was the need to attend closely to the diverse ways that risk is constructed, perceived and communicated in a variety of contexts and the significant implications of this for laypersons as well as experts. Although there was no consensus on when genetic risk assessment ceases (or might begin) to be useful, ensuing dialogue between presenters and participants reflected what is perhaps a new and critical engagement with how risk assessment itself is assessed. In response to this impetus, I use the word RISK as a heuristic to identify, extract and amplify four tendencies that appear to advance understandings of risk assessment towards a more explicitly reflexive, interpretive, and situated form of knowing.

  5. Army Independent Risk Assessment Guidebook

    DTIC Science & Technology

    2014-04-01

    RFI - Request for Information...Cost Uncertainty S&T Community • Identify Technologies • Assess Readiness Levels PM •System Concepts •Program ScheduleIn p u ts to R is k A ss...es sm en t Develop Cost Estimate S u m m a ri ze R is k A s s e s s m e n ts In te rd e p e n d e n c ie s 14 o Assess the transition times

  6. How We Assess Risks to Pollinators

    EPA Pesticide Factsheets

    EPA has a new risk assessment framework for bees as part of its regulatory decision-making process for all pesticides, which relies on a tiered process, focuses on major routes of exposure, and distinguishes different types of pesticide treatment.

  7. Guidelines for Reproductive Toxicity Risk Assessment

    EPA Pesticide Factsheets

    These guidelines discuss the scientific basis for concern about exposure to agents that cause reproductive toxicity and describe the principles and procedures to be followed in conducting risk assessments for reproductive toxicity.

  8. Framework for Shared Drinking Water Risk Assessment.

    SciTech Connect

    Lowry, Thomas Stephen; Tidwell, Vincent C.; Peplinski, William John; Mitchell, Roger; Binning, David; Meszaros, Jenny

    2017-01-01

    Central to protecting our nation's critical infrastructure is the development of methodologies for prioritizing action and supporting resource allocation decisions associated with risk-reduction initiatives. Toward this need a web-based risk assessment framework that promotes the anonymous sharing of results among water utilities is demonstrated. Anonymous sharing of results offers a number of potential advantages such as assistance in recognizing and correcting bias, identification of 'unknown, unknowns', self-assessment and benchmarking for the local utility, treatment of shared assets and/or threats across multiple utilities, and prioritization of actions beyond the scale of a single utility. The constructed framework was demonstrated for three water utilities. Demonstration results were then compared to risk assessment results developed using a different risk assessment application by a different set of analysts.

  9. 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

  10. 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.

  11. 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<...

  12. 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<...

  13. 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.

  14. 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)

  15. 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)

  16. 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…

  17. 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…

  18. 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…

  19. [Risk assessment in upper limb overload].

    PubMed

    Martinelli, R; Casilli, A; Fanelli, C; Pizzuti, S; Tarquini, M; Tobia, L; Paoletti, A

    2007-01-01

    One of the most important factors of the work-related musculoskeletal disorders of the upper extremities (WMSDs) is the biomechanical overload. The purpose of this study is to evaluate the possibility to predict the upper limb repetitive stress, according to risk assessment procedures. In order to this aim, we gathered clinical-anamnestic data and risk assessment considerations of a cohort of workers in a car industry.

  20. Risk assessment as standard work in design.

    PubMed

    Morrill, Patricia W

    2013-01-01

    This case study article examines a formal risk assessment as part of the decision making process for design solutions in high risk areas. The overview of the Failure Modes and Effects Analysis (FMEA) tool with examples of its application in hospital building projects will demonstrate the benefit of those structured conversations. This article illustrates how two hospitals used FMEA when integrating operational processes with building projects: (1) adjacency decision for Intensive Care Unit (ICU); and (2) distance concern for handling of specimens from Surgery to Lab. Both case studies involved interviews that exposed facility solution concerns. Just-in-time studies using the FMEA followed the same risk assessment process with the same workshop facilitator involving structured conversations in analyzing risks. In both cases, participants uncovered key areas of risk enabling them to take the necessary next steps. While the focus of this article is not the actual design solution, it is apparent that the risk assessment brought clarity to the situations resulting in prompt decision making about facility solutions. Hospitals are inherently risky environments; therefore, use of the formal risk assessment process, FMEA, is an opportunity for design professionals to apply more rigor to design decision making when facility solutions impact operations in high risk areas. Case study, decision making, hospital, infection control, strategy, work environment.

  1. 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…

  2. FRAMEWORK FOR INORGANIC METALS RISK ASSESSMENT

    EPA Science Inventory

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

  3. Threat Based Risk Assessment for Enterprise Networks

    DTIC Science & Technology

    2016-02-15

    Threat-Based Risk Assessment for Enterprise Networks Richard P. Lippmann and James F. Riordan Protecting enterprise networks requires... enterprises to make sure that risks from all current threats are addressed, many organizations adopt a best-practices approach by installing popular...effective when performed by skilled security practitioners who understand an enterprise network, can enumerate all threats and their likelihoods, and

  4. 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...

  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. 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...

  7. Risk assessment in Finland: theory and practice.

    PubMed

    Anttonen, Hannu; Pääkkönen, Rauno

    2010-09-01

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

  8. Uncertainty quantification in flood risk assessment

    NASA Astrophysics Data System (ADS)

    Blöschl, Günter; Hall, Julia; Kiss, Andrea; Parajka, Juraj; Perdigão, Rui A. P.; Rogger, Magdalena; Salinas, José Luis; Viglione, Alberto

    2017-04-01

    Uncertainty is inherent to flood risk assessments because of the complexity of the human-water system, which is characterised by nonlinearities and interdependencies, because of limited knowledge about system properties and because of cognitive biases in human perception and decision-making. On top of the uncertainty associated with the assessment of the existing risk to extreme events, additional uncertainty arises because of temporal changes in the system due to climate change, modifications of the environment, population growth and the associated increase in assets. Novel risk assessment concepts are needed that take into account all these sources of uncertainty. They should be based on the understanding of how flood extremes are generated and how they change over time. They should also account for the dynamics of risk perception of decision makers and population in the floodplains. In this talk we discuss these novel risk assessment concepts through examples from Flood Frequency Hydrology, Socio-Hydrology and Predictions Under Change. We believe that uncertainty quantification in flood risk assessment should lead to a robust approach of integrated flood risk management aiming at enhancing resilience rather than searching for optimal defense strategies.

  9. Preoperative optimization and risk assessment.

    PubMed

    Nicholas, Joseph A

    2014-05-01

    Because most older adults with hip fractures require urgent surgical intervention, the preoperative medical evaluation focuses on the exclusion of the small number of contraindications to surgery, and rapid optimization of patients for operative repair. Although many geriatric fracture patients have significant chronic medical comorbidities, most patients can be safely stabilized for surgery with medical and orthopedic comanagement by anticipating a small number of common physiologic responses and perioperative complications. In addition to estimating perioperative risk, the team should focus on intravascular volume restoration, pain control, and avoidance of perioperative hypotension. Copyright © 2014 Elsevier Inc. All rights reserved.

  10. 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.

  11. Comparison of the performance of IFA, CFA, and ELISA assays for the serodiagnosis of acute Q fever by quality assessment.

    PubMed

    Herremans, Tineke; Hogema, Boris M; Nabuurs, Marrigje; Peeters, Marcel; Wegdam-Blans, Marjolijn; Schneeberger, Peter; Nijhuis, Carla; Notermans, Daan W; Galama, Joep; Horrevorts, Anton; van Loo, Inge H M; Vlaminckx, Bart; Zaaijer, Hans L; Koopmans, Marion P; Berkhout, Hanneke; Socolovschi, Cristina; Raoult, Didier; Stenos, John; Nicholson, William; Bijlmer, Henk

    2013-01-01

    The indirect immunofluorescence assay (IFA) is considered the reference method for diagnosing Q fever, but serology is also performed by complement fixation assay (CFA) or enzyme-linked immunosorbent assay (ELISA). However, comparability between these assays is not clear, and therefore a quality assessment was performed. A total of 25 serum samples from negative controls, Q fever patients, and a serial diluted high-positive sample were analyzed in 10 Dutch laboratories. Six laboratories performed CFA, 5 performed IFA, and 5 performed ELISAs. Three international reference laboratories from Australia, France, and the USA also participated in this study. Qualitative values between laboratories using the same methods were within close range, and all 3 methods correctly identified acute Q fever patients. The IFA, ELISA, and CFA are all suitable serodiagnostic assays to diagnose acute Q fever, but the IFA remains an important tool in the follow-up of patients and in identifying patients at risk for developing chronic Q fever. Copyright © 2013 Elsevier Inc. All rights reserved.

  12. Analytical and assay issues for use of cardiac troponin testing for risk stratification in primary care.

    PubMed

    Wu, Alan H B; Christenson, Robert H

    2013-08-01

    Cardiac troponin is the standard marker for diagnosis of acute myocardial infarction and risk stratification of patients who present to an emergency department with signs and symptoms of acute cardiac ischemia. Over the past few years, the analytical sensitivity of assays for cardiac troponin has improved significantly to the point where a detectable amount of troponin can be measured in essentially all healthy subjects. Recent studies have shown that use of a highly sensitive troponin assays may provide value to traditional markers of primary disease risk for patients, i.e., for those who have no history of heart disease. There are barriers to the adoption of cardiac troponin for screening high risk cohorts such as the elderly, diabetics and perhaps even the asymptomatic population. Strategies used for the assignment of cutoff concentrations in acute care, i.e., the 99 th percentile, may not be appropriate for primary care as changes over baseline levels may provide more accurate information of risk than cross-sectional results. A review of biological variation has shown that cardiac troponin as a biomarker has low index of individuality, indicating that reference values are of little utility. Whether or not cardiac troponin can be released in reversible injury is a debate that could have significance for detecting minor myocardial injury. A major hurdle for use of troponin in primary care is the lack of assay standardization and nomenclature for the different generations of troponin assays. Standardization requires knowledge of what is released after cardiac injury and what the various cardiac troponin assays are measuring. Currently it is not clear if the cardiac troponin release after ischemic injury is identical to that in circulation of healthy individuals. This may affect the design of future assays and standardization approaches. There is potential that a marker of myocardial injury such as troponin can add to the value of existing indicators and biomarkers

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

    PubMed

    Desbois, Andrew P; Smith, Valerie J

    2015-01-01

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

  14. A modified multiparametric assay using HepaRG cells for predicting the degree of drug-induced liver injury risk.

    PubMed

    Tomida, Takafumi; Okamura, Hayao; Yokoi, Tsuyoshi; Konno, Yoshihiro

    2017-03-01

    The approach for predicting the degree of drug-induced liver injury (DILI) risk was investigated quantitatively in a modified multiparametric assay using HepaRG cells. Thirty-eight drugs were classified by DILI risk into five categories based on drug labels approved by the Food and Drug Administration (FDA) as follows: withdrawn (WDN), boxed warning (BW), warnings and precautions (WP), adverse reactions (AR), and no match (NM). Also, WP was classified into two categories: high and low concern. Differentiated HepaRG cells were treated with drugs for 24 h. The maximum concentration was set at 100-fold the therapeutic maximum plasma concentration (Cmax ). After treatment with drugs, the cell viability, glutathione content, caspase 3/7 activity, lactate dehydrogenase leakage and albumin secretion were measured. As modified cut-off values of each parameter, the TC50 (toxic concentration that decreased the response by 50%) and EC200 (effective concentration giving a response equal to 200% of controls) were calculated. In addition, the toxicity score (total sum score of the cytotoxic level of each parameter) was calculated. This modified multiparametric assay showed an 87% sensitivity and 87% specificity for predicting the DILI risk. The toxicity score showed a good predictive performance for WDN, BW and WP (high concern) categories [cut-off: score ≥ 1; area under a receiver operating characteristic curve (ROC-AUC): 0.88], and for WDN and BW categories (cut-off: score ≥ 3; ROC-AUC: 0.88). This study newly indicated that the degree of DILI risk might be predictable quantitatively by assessing the toxicity score in the modified multiparametric assay using HepaRG cells. Copyright © 2016 John Wiley & Sons, Ltd.

  15. 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.

  16. New Methodology for Rapid Seismic Risk Assessment

    NASA Astrophysics Data System (ADS)

    Melikyan, A. E.; Balassanian, S. Y.

    2002-05-01

    Seismic risk is growing worldwide and is, increasingly, a problem of developing countries. Along with growing urbanization future earthquakes will have more disastrous social and economic consequences. Seismic risk assessment and reduction are important goals for each country located in seismically active zone. For Armenia these goals are of primary importance because the results of studies carried out by Armenian NSSP for assessment of the losses caused by various types of disasters in Armenia had shown that earthquakes are the most disastrous hazard for Armenia. The strategy for seismic risk reduction in 1999 was adopted by the Government of Armenia as a high priority state program. The world experience demonstrates that for efficient response the rapid assessment of seismic losses is necessary. There are several state-of-the-art approaches for seismic risk assessment (Radius, Hazus, etc.). All of them required large amount of various input data, which is impossible to collect in many developing countries, in particular in Armenia. Taking into account this very serious problem existing for developing countries, as well as rapid seismic risk assessment need immediately after strong earthquake the author undertake the attempt to contribute into a new approach for rapid seismic risk assessment under the supervision of Prof. S. Balassanian. The analysis of numerous factors influencing seismic risk in Armenia shows that the following elements contribute most significantly to the possible losses: seismic hazard; density of population; vulnerability of structures. Proposed approach for rapid seismic risk assessment based on these three factors has been tested for several seismic events. These tests have shown that such approach might represent from 80 to 90 percent of real losses.

  17. 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.

  18. 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.

  19. Application of a microplate scale fluorochrome staining assay for the assessment of viability of probiotic preparations.

    PubMed

    Alakomi, H-L; Mättö, J; Virkajärvi, I; Saarela, M

    2005-07-01

    Cell viability in probiotic preparations is traditionally assessed by the plate count technique. Additionally, fluorescent staining combined with epifluorescence microscopy or flow cytometry has been developed for the viability assessment, but the currently available assays are either laborious or require highly sophisticated equipment. The aim of this study was to investigate the applicability of a microplate scale fluorochrome assay for predicting the cell state of freeze-dried Lactobacillus rhamnosus and Bifidobacterium animalis subsp. lactis preparations. In addition to viability assessment with LIVE/DEAD BacLight Bacterial Viability Kit, DiBAC(4)3 stain was used for the kinetic measurement of changes in bifidobacterial cell membrane functions during exposure to low pH. The microplate scale fluorochrome assay results on the viability and cell numbers of probiotic preparations correlated well with the results obtained with the culture-based technique and (with few exceptions) with epifluorescence microscopy. The assay was applicable also for the viability assessment of stressed (acid-treated) cells provided that the cell density in treatments was adjusted to the optimal measurement level of the fluorometer. The microplate scale fluorochrome assay offers a rapid and robust tool for the viability assessment of probiotic preparations, and enables also kinetic measurements.

  20. General principles for risk assessment of living modified organisms: lessons from chemical risk assessment.

    PubMed

    Hill, Ryan A; Sendashonga, Cyrie

    2003-01-01

    Modern biotechnology has led to the development and use of Living Modified Organisms (LMOs) for agriculture and other purposes. Regulators at the national level are increasingly depending on risk assessment as a tool for assessing potential adverse effects of LMOs on the environment and human health. In addition, the Cartagena Protocol on Biosafety, an international agreement expected to enter into force in the near future, requires risk assessment as the basis for decision-making regarding import of some LMOs. While LMO risk assessment is relatively new, there are other risk assessment disciplines which have developed over longer time periods. The field of assessment of the environmental and human health risks of chemicals is particularly well developed, and is similar in application to LMO risk assessment. This paper aims to draw lessons for LMO risk assessment from the vast experience with chemical risk assessment. Seven general principles are outlined which should serve as a useful checklist to guide assessments of risks posed by LMOs.

  1. Multiplexed assays by high-content imaging for assessment of GPCR activity.

    PubMed

    Ross, D A; Lee, S; Reiser, V; Xue, J; Alves, K; Vaidya, S; Kreamer, A; Mull, R; Hudak, E; Hare, T; Detmers, P A; Lingham, R; Ferrer, M; Strulovici, B; Santini, F

    2008-07-01

    G-protein-coupled receptors (GPCR) participate in many disease pathways and represent the largest family of therapeutic targets. Thus, great investments are made to discover drugs modulating GPCR-mediated events. Among functional assays for screening GPCRs, the Transfluor imaging assay is based on redistribution of cytosolic beta-arrestin to an activated GPCR and has become widely used in high-content screening. However, assessing Transfluor alone has limitations: relying on a single mechanistic step of beta-arrestin redistribution during GPCR activation, providing no information on the stimulated GPCR's intracellular fate, and using only a single fluorescent color (green fluorescent protein). Taking full advantage of high-content imaging to screen approximately 2000 compounds, the authors multiplexed the Transfluor assay with an immunofluorescence-based quantification of GPCR internalization. This approach identified and classified 377 compounds interfering with agonist-induced activation of the Transfluor assay, receptor internalization, or both. In addition, a subset of compounds was analyzed for their performance across imaging, cell-based calcium release (fluorometric imaging plate reader [FLIPR]), and biochemical receptor binding assays (scintillation proximity assay). This indicated that the imaging assays have even better predictive power for direct inhibition of receptor binding than the FLIPR assay. In conclusion, compounds inducing unique responses can suggest novel mechanisms of action and be used as tools to study GPCR activation and internalization.

  2. Probabalistic Risk Assessment of a Turbine Disk

    NASA Astrophysics Data System (ADS)

    Carter, Jace A.; Thomas, Michael; Goswami, Tarun; Fecke, Ted

    Current Federal Aviation Administration (FAA) rotor design certification practices risk assessment using a probabilistic framework focused on only the life-limiting defect location of a component. This method generates conservative approximations of the operational risk. The first section of this article covers a discretization method, which allows for a transition from this relative risk to an absolute risk where the component is discretized into regions called zones. General guidelines were established for the zone-refinement process based on the stress gradient topology in order to reach risk convergence. The second section covers a risk assessment method for predicting the total fatigue life due to fatigue induced damage. The total fatigue life incorporates a dual mechanism approach including the crack initiation life and propagation life while simultaneously determining the associated initial flaw sizes. A microstructure-based model was employed to address uncertainties in material response and relate crack initiation life with crack size, while propagation life was characterized large crack growth laws. The two proposed methods were applied to a representative Inconel 718 turbine disk. The zone-based method reduces the conservative approaches, while showing effects of feature-based inspection on the risk assessment. In the fatigue damage assessment, the predicted initial crack distribution was found to be the most sensitive probabilistic parameter and can be used to establish an enhanced inspection planning.

  3. 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.

  4. Assessing wildfire risks at multiple spatial scales

    Treesearch

    Justin Fitch

    2008-01-01

    In continuation of the efforts to advance wildfire science and develop tools for wildland fire managers, a spatial wildfire risk assessment was carried out using Classification and Regression Tree analysis (CART) and Geographic Information Systems (GIS). The analysis was performed at two scales. The small-scale assessment covered the entire state of New Mexico, while...

  5. 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...

  6. 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...

  7. OPPT workplan risk assessment Methylene Chloride ...

    EPA Pesticide Factsheets

    These assessments will focus on the use of DCM and NMP in paint stripping. NMP exposures scenarios for this use result in inhalation and dermal exposure to consumers and workers. The low concern for environmental effects of NMP will be discussed in the assessment. In the case of DCM, there are human health concerns for both cancer and non-cancer effects. This DCM assessment of paint stripping uses will focus only on inhalation exposure to consumers and workers. The low concern for environmental effects of DCM will be discussed in the assessment. EPA anticipates issuing draft risk assessments for public review and comment as they are completed. At the conclusion of the review process, if an assessment of specific uses indicates significant risk, EPA will evaluate and pursue appropriate risk reduction actions, as warranted. If an assessment indicates no significant risk, EPA will conclude its current work on assessment of those specified targeted uses of that chemical. Over time, additional chemicals will be added to the work plan as more data are developed and more chemicals screened.

  8. 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

  9. 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.

  10. 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

  11. [Assessment of dynamic violent behavior risk factors].

    PubMed

    Folino, Jorge Oscar; Cáceres, María Soledad; Campos, María Laura; Silveri, Marina; Ucín, Silvana; Ascazibar, Mariel

    2005-01-01

    Dynamic violent behavior risk factors have special significance since they constitute the main target for preventive intervention. Different dynamic factors as well as violent recidivism were assessed with, among other instruments, the environmental risk (Risk Management) section of the Argentinean version of the HCR-20 in 25 parolees from the Province of Buenos Aires Penitentiary System. Among other findings, the prevalence of the risk factors linked to substance abuse and socioeconomic deprivation, and the heterogeneous perception of the official institutions are very significant. Exposure to destabilizers was the factor most associated with violent recidivism.

  12. New approaches for improving cardiovascular risk assessment.

    PubMed

    Paredes, Simão; Rocha, Teresa; Mendes, Diana; Carvalho, Paulo; Henriques, Jorge; Morais, João; Ferreira, Jorge; Mendes, Miguel

    2016-01-01

    Clinical guidelines recommend the use of cardiovascular risk assessment tools (risk scores) to predict the risk of events such as cardiovascular death, since these scores can aid clinical decision-making and thereby reduce the social and economic costs of cardiovascular disease (CVD). However, despite their importance, risk scores present important weaknesses that can diminish their reliability in clinical contexts. This study presents a new framework, based on current risk assessment tools, that aims to minimize these limitations. Appropriate application and combination of existing knowledge is the main focus of this work. Two different methodologies are applied: (i) a combination scheme that enables data to be extracted and processed from various sources of information, including current risk assessment tools and the contributions of the physician; and (ii) a personalization scheme based on the creation of patient groups with the purpose of identifying the most suitable risk assessment tool to assess the risk of a specific patient. Validation was performed based on a real patient dataset of 460 patients at Santa Cruz Hospital, Lisbon, Portugal, diagnosed with non-ST-segment elevation acute coronary syndrome. Promising results were obtained with both approaches, which achieved sensitivity, specificity and geometric mean of 78.79%, 73.07% and 75.87%, and 75.69%, 69.79% and 72.71%, respectively. The proposed approaches present better performances than current CVD risk scores; however, additional datasets are required to back up these findings. Copyright © 2015 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

  13. DEVELOPMENT OF CULTURES OF THE MARINE SPONGE HYMENIACIDON PERLEVE FOR GENOTOXICITY ASSESSMENT USING THE ALKALINE COMET ASSAY.

    PubMed

    Akpiri, Rachael U; Konya, Roseline S; Hodges, Nikolas J

    2017-07-10

    Sponges are a potential alternative model species to bivalves in pollution biomonitoring and environmental risk assessment in the aquatic ecosystem. Here, a novel in vivo exposure sponge culture model was developed from field collected and cryopreserved sponge (Hymeniacidon perleve) cells to investigate the genotoxic effects of environmentally relevant metals in the laboratory. Sponge cell aggregates were cultured and exposed to non-cytotoxic concentrations (0-0.4 mg/L) of cadmium chloride, nickel chloride, and sodium dichromate as quantified by the reduction of 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide and DNA-strand breaks assessed by the comet assay. Reactive oxygen species (ROS) formation was quantified by oxidation of 2',7'-dichlorofluorescin diacetate in sponge cell aggregates exposed to the same concentrations of Cd, Cr, and Ni. There was a statistically significant (P < 0.05) concentration-dependent increase in the level of DNA strand breaks and ROS formation in all of the metals investigated. To thebest of our knowledge we have utilised for the first time the alkaline comet assay to detect DNA-strand breaks in marine sponge cells, and demonstrated that exposure to non-cytotoxic concentrations of Cd, Cr, and Ni for 12 h results in a concentration-dependent increase in DNA damage and levels of ROS production. In conclusion, we have developed a novel in vivo model based on culture of cryopreserved sponge cells that is compatible with the alkaline comet assay. Genotoxicity in marine sponges measured by the comet assay technique may be a useful tool for biomonitoring research and risk assessment in aquatic ecosystems. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  14. TSCA Work Plan Chemical Risk Assessment: 1 ...

    EPA Pesticide Factsheets

    1-Bromopropane (CASRN 106-94-5): or 1-BP is a volatile organic chemical that is considered moderately persistent in the environment but does not have the potential to bioaccumulate in fish or other animals. The majority of the 1-BP production volume (~ 47%) is used as a vapor degreaser for optics electronics, plastics, and metals. 1-BP also is used as an aerosol solvent in cleaning products, as a spray fixative in arts and crafts, and as a spot cleaner in various industrial/commercial/consumer sectors. Focus of the Risk Assessment: The assessment will focus on uses of 1-BP in commercial (i.e., vapor degreasing, spray adhesives, and dry cleaning) and consumer applications (i.e., aerosol solvent cleaners and spray adhesives). Given the range of endpoints (i.e., cancer, non-cancer; the latter includes potential effects on the developing fetus), susceptible populations are expected to include adults (including pregnant women) in commercial uses and children (as bystanders) and adults of all ages (including pregnant women) for consumer uses. Thus, the assessment will focus on all humans/lifestages. EPA anticipates issuing draft risk assessments for public review and comment as they are completed. At the conclusion of the review process, if an assessment of specific uses indicates significant risk, EPA will evaluate and pursue appropriate risk reduction actions, as warranted. If an assessment indicates no significant risk, EPA will conclude its work on the a

  15. TSCA Work Plan Chemical Risk Assessment: 1 ...

    EPA Pesticide Factsheets

    1-Bromopropane (CASRN 106-94-5): or 1-BP is a volatile organic chemical that is considered moderately persistent in the environment but does not have the potential to bioaccumulate in fish or other animals. The majority of the 1-BP production volume (~ 47%) is used as a vapor degreaser for optics electronics, plastics, and metals. 1-BP also is used as an aerosol solvent in cleaning products, as a spray fixative in arts and crafts, and as a spot cleaner in various industrial/commercial/consumer sectors. Focus of the Risk Assessment: The assessment will focus on uses of 1-BP in commercial (i.e., vapor degreasing, spray adhesives, and dry cleaning) and consumer applications (i.e., aerosol solvent cleaners and spray adhesives). Given the range of endpoints (i.e., cancer, non-cancer; the latter includes potential effects on the developing fetus), susceptible populations are expected to include adults (including pregnant women) in commercial uses and children (as bystanders) and adults of all ages (including pregnant women) for consumer uses. Thus, the assessment will focus on all humans/lifestages. EPA anticipates issuing draft risk assessments for public review and comment as they are completed. At the conclusion of the review process, if an assessment of specific uses indicates significant risk, EPA will evaluate and pursue appropriate risk reduction actions, as warranted. If an assessment indicates no significant risk, EPA will conclude its work on the a

  16. Risk assessment of mixed waste sites

    SciTech Connect

    Montague, D.F.; Holton, G.A.; King, C.M.

    1987-12-31

    As part of its ongoing efforts to ensure environmental regulation compliance at DOE facilities, DOE published on April 26, 1985, a notice of intent to write an Environmental Impact Statement on Waste Management Activities for Groundwater Protection (Groundwater EIS) at the Savannah River Plant (SRP). To perform a human health risk assessment of each waste site for each closure action considered, DuPont organized a project team led by personnel from the Savannah River Laboratory (SRL) and supported by outside contractors specializing in risk assessment work. As part of that team, JBF Associates, Inc. (JBFA) performed an atmospheric containment transport analysis and human health risk assessment of nonradioactive contaminants from SRP waste sites. For each waste site, three closure actions were examined: (1) excavate the site, backfill it, and cap it followed by regular groundwater monitoring (Option 1); (2) backfill and cap the site followed by regular groundwater monitoring (Option 2); and (3) no remedial action, regular groundwater monitoring, and some site maintenance work (Option 3). The human health risk assessment performed by JBFA estimated the public and worker risks from contaminants released to the atmosphere from each waste site for each closure option. This paper first presents the methodology JBFA used to estimate the public and worker risks attributable to the inhalation and ingestion of airborne, nonradioactive contaminants. Following the description of the analysis methodology, the authors present the risk results for the waste sites that were due to atmospherically released nonradioactive contaminants. Both worker risks and public risks are presented. Finally, the authors present the results and conclusions derived from their analysis of the risk from airborne, nonradioactive contaminants.

  17. 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.

  18. Postural risk assessment of mechanised firewood processing.

    PubMed

    Spinelli, Raffaele; Aminti, Giovanni; De Francesco, Fabio

    2017-03-01

    The study assessed the postural risk of mechanised firewood processing with eight machines, representing the main technology solutions available on the market. Assessment was conducted with the Ovako Working posture Analysis System (OWAS) on 1000 still frames randomly extracted from videotaped work samples. The postural risk associated with firewood processing was variable and associated with technology type. Simple, manually operated new machines incurred a higher postural risk compared with semi- or fully automatic machines. In contrast, new semi-automatic and automatic machines were generally free from postural risk. In all cases, attention should be paid to postural risk that may occur during blockage resolution. The study did not cover the postural risk of firewood processing sites as a whole. The study provided useful information for selecting firewood processing machinery and for improving firewood machinery design, as part of a more articulate strategy aimed at enhancing the safety of firewood processing work sites. Practitioner Summary: The postural risk associated with mechanised firewood processing (eg cutting and splitting) depends on the type of equipment. Postural risk is highest (OWAS Action Category 2) with new in-line machines, designed for operation by a single worker. Fully automatic machines present minimum postural risk, except during blockage resolution.

  19. 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...

  20. Risk Assessment Guidance for Superfund (RAGS) Volume III: Part A

    EPA Pesticide Factsheets

    EPA's Risk Assessment Guidance for Superfund (RAGS) Volume 3A provides policies and guiding principles on the application of probabilistic risk assessment (PRA) methods to human health and ecological risk assessment in the EPA Superfund Program.

  1. 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...

  2. Distinguishing persistent insulin autoantibodies with differential risk: nonradioactive bivalent proinsulin/insulin autoantibody assay.

    PubMed

    Yu, Liping; Miao, Dongmei; Scrimgeour, Laura; Johnson, Kelly; Rewers, Marian; Eisenbarth, George S

    2012-01-01

    A subset of children develops persistent insulin autoantibodies (IAA; almost always as the only islet autoantibody) without evidence of progression to diabetes. The aim of the current study was the development and characterization of the performance of a nonradioactive fluid phase IAA assay in relation to standard IAA radioassay. We developed a nonradioactive IAA assay where bivalent IAA cross-link two insulin moieties in a fluid phase. The serum samples positive for anti-islet autoantibodies from 150 newly diagnosed patients with diabetes (Barbara Davis Center plus Diabetes Autoantibody Standardization Program [DASP] workshop) and 70 prediabetic subjects who were followed to diabetes were studied. In addition, sequential samples from 64 nondiabetic subjects who were persistently IAA(+) were analyzed. With 99th percentile of specificity, the new assay with the technology from Meso Scale Discovery Company (MSD-IAA) detects as positive 61% (61 of 100) of new-onset patients and 80% (56 of 70) of prediabetic patients compared with our current fluid phase micro-IAA radioassay (mIAA; 44 and 74%, respectively). In addition, MSD-IAA demonstrated better sensitivity than our mIAA from blinded DASP workshop (68 vs. 56% with the same 99% specificity). Of 64 IAA(+) nondiabetic subjects, 25% (8 of 32) who had only IAA and thus the low risk for progression to diabetes were positive with MSD-IAA assay. In contrast, 100% (32 of 32) high-risk children (IAA plus other islet autoantibodies) were positive with MSD-IAA. The IAA detectable by radioassay, but not MSD-IAA, were usually of lower affinity compared with the IAA of the high-risk children. These data suggest that a subset of IAA with current radioassay (not MSD-IAA) represents biologic false positives in terms of autoimmunity leading to diabetes. We hypothesize that factors related to the mechanism of loss of tolerance leading to diabetes determine high affinity and MSD-IAA reactivity.

  3. Risk propensity assessment in military special operations.

    PubMed

    Sicard, B; Jouve, E; Blin, O

    2001-10-01

    Risk taking, decision making, and stress factors are strongly associated in military operations. The authors used the Bond and Lader mood and alertness scale and a new scale, Evaluation of Risks (EVAR), to assess risk proneness in a maritime counter-terrorism exercise. EVAR items are distributed among five factors: self-control, danger seeking, energy, impulsiveness, and invincibility. In the study, 10 pilots were submitted to strenuous night flights with limited sleep deprivation. Compared with baseline data, pilots reported an increase in impulsiveness, whereas EVAR factors were consistent in a control group composed of 9 navy crew member. Correlations were observed between mood and alertness and risk factors. These results illustrate how EVAR can be used to evaluate change in risk proneness in individuals submitted to various stressors. But further studies are required to weigh stress factors and environmental conditions in risk propensity with a larger population of various age and personality traits.

  4. Lymphocyte proliferation response during Eimeria tenella infection assessed by a new, reliable, nonradioactive colorimetric assay.

    PubMed

    Miyamoto, Tadashi; Min, Wongi; Lillehoj, Hyun S

    2002-01-01

    The application of a tetrazolium salt, WST-8,2-(2-methoxy-4-nitrophenyl)-3-(4-nitrophenyl)-5-(2,4-disulfophenyl)-2H tetrazolium, monosodium salt to the lymphocyte proliferation assay in the chicken system was evaluated. Proliferation of concanavalin (Con A)-induced splenic lymphocytes and peripheral blood lymphocytes (PBL) was evaluated with WST-8 and 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT). Coefficients of correlation (r) between these two reagents were 0.98 and 0.97 in splenic lymphocytes and PBL, respectively. In general, the sensitivity of the WST-8 assay was significantly higher than that of the MTT assay, and the standard deviations of the WST-8 assay were significantly lower than those of the MTT assay. The WST-8 assay was fast and highly reproducible and provided a good indication of mitogen-induced proliferation of spleen cells induced by Con A. With the use of the WST-8 assay, splenic mitogenic response of chickens infected with Eimeria decreased transiently at 7 days but increased significantly at 10 days after primary infection compared with that of uninfected chickens. Additionally, the measurement of interleukin (IL)-2 production with WST-8 was highly reproducible and showed a significant increase in IL-2 production upon stimulation of Eimeria tenella-immune spleen cells with Con A. After E. tenella infection, splenic IL-2 production increased significantly at 7 days post-primary and at 2 days post-secondary infection. The WST-8 assay is fast, simple, and more reproducible and sensitive than the MTT assay. This study demonstrates the effectiveness of the WST-8 assay to assess cell-mediated immune response of chickens in normal and disease states.

  5. Current Challenges in Neurotoxicity Risk Assessment ...

    EPA Pesticide Factsheets

    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 complex animal models that better replicate human behavior and a wider array of molecular and mechanistic data relevant to interpreting the underlying cause(s) of toxicity. However, modern neurotoxicology studies are often more nuanced and complicated than traditional studies, and they often vary considerably in evaluation methods from one study to the next, impeding comparisons. This can pose particular difficulties for risk assessors, especially given the recent demand for chemical risk assessments to be more systematic and transparent. This presentation will introduce and provide some examples of specific challenges in neurotoxicity assessments of environmental chemicals. Some of these challenges are relatively new to the field, such as the incorporation of data on neuron-supportive glial cells into hazard characterization, while other challenges have persisted for several decades, but only recently are studies being designed to evaluate them, including analyses of latent neurotoxicity. The examples provided illustrate some future research areas of interest for scientists and risk assessors examining human neurotoxicity risk. This abstract will be presented to internal U.S. Food and Drug A

  6. Current Challenges in Neurotoxicity Risk Assessment ...

    EPA Pesticide Factsheets

    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 complex animal models that better replicate human behavior and a wider array of molecular and mechanistic data relevant to interpreting the underlying cause(s) of toxicity. However, modern neurotoxicology studies are often more nuanced and complicated than traditional studies, and they often vary considerably in evaluation methods from one study to the next, impeding comparisons. This can pose particular difficulties for risk assessors, especially given the recent demand for chemical risk assessments to be more systematic and transparent. This presentation will introduce and provide some examples of specific challenges in neurotoxicity assessments of environmental chemicals. Some of these challenges are relatively new to the field, such as the incorporation of data on neuron-supportive glial cells into hazard characterization, while other challenges have persisted for several decades, but only recently are studies being designed to evaluate them, including analyses of latent neurotoxicity. The examples provided illustrate some future research areas of interest for scientists and risk assessors examining human neurotoxicity risk. This abstract will be presented to internal U.S. Food and Drug A

  7. Comparison of the performance in detection of HPV infections between the high-risk HPV genotyping real time PCR and the PCR-reverse dot blot assays.

    PubMed

    Zhang, Lahong; Dai, Yibei; Chen, Jiahuan; Hong, Liquan; Liu, Yuhua; Ke, Qiang; Chen, Yiwen; Cai, Chengsong; Liu, Xia; Chen, Zhaojun

    2017-08-29

    A new multiplex real-time PCR assay, the high-risk HPV genotyping real time PCR assay (HR HPV RT-PCR), has been developed to detect 15 high-risk HPV types with respective viral loads. In this report, a total of 684 cervical specimens from women diagnosed with vaginitis were assessed by the HR HPV RT-PCR and the PCR reaction and reverse dot blot (PCR-RDB) assays, using a PCR-sequencing method as a reference standard. A total coincidence of 97.7% between the HR HPV RT PCR and the PCR-RDB assays was determined with a Kappa value of 0.953. The HR HPV RT PCR assay had sensitivity, specificity, and concordance rates (accuracy) of 99.7%, 99.7%, and 99.7%, respectively, as confirmed by PCR-sequencing, while the PCR-RDB assay had respective rates of 98.8%, 97.1%, and 98.0%. The overall rate of HPV infection, determined by PCR-sequencing, in women diagnosed with vaginitis was 49.85%, including 36.26% of single infection and 13.6% of multiple infections. The most common infections among the 15 high-risk HPV types in women diagnosed with vaginitis were HPV-52, HPV-16, and HPV-58, with a total detection rate of 10.23%, 7.75%, and 5.85%, respectively. We conclude that the HR HPV RT PCR assay exhibits better clinical performance than the PCR-RDB assay, and is an ideal alternative method for HPV genotyping. In addition, the HR HPV RT PCR assay provides HPV DNA viral loads, and could serve as a quantitative marker in the diagnosis and treatment of single and multiple HPV infections. © 2017 Wiley Periodicals, Inc.

  8. ORAMUS(WINDOWS). Ozone Risk AssessMent Utilities

    SciTech Connect

    Whitfield, R.G.; Jusko, M.J.; Biller, W.F.

    1998-12-01

    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 are 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.

  9. ORAMUS(DOS). Ozone Risk AssessMent Utilities

    SciTech Connect

    Whitfield, R.G.; Jusko, M.J.; Biller, W.F.

    1998-12-01

    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 are 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 acute health endpoints, and 4 chronic health endpoints can be calculated.

  10. Update earthquake risk assessment in Cairo, Egypt

    NASA Astrophysics Data System (ADS)

    Badawy, Ahmed; Korrat, Ibrahim; El-Hadidy, Mahmoud; Gaber, Hanan

    2017-07-01

    The Cairo earthquake (12 October 1992; m b = 5.8) is still and after 25 years one of the most painful events and is dug into the Egyptians memory. This is not due to the strength of the earthquake but due to the accompanied losses and damages (561 dead; 10,000 injured and 3000 families lost their homes). Nowadays, the most frequent and important question that should rise is "what if this earthquake is repeated today." In this study, we simulate the same size earthquake (12 October 1992) ground motion shaking and the consequent social-economic impacts in terms of losses and damages. Seismic hazard, earthquake catalogs, soil types, demographics, and building inventories were integrated into HAZUS-MH to produce a sound earthquake risk assessment for Cairo including economic and social losses. Generally, the earthquake risk assessment clearly indicates that "the losses and damages may be increased twice or three times" in Cairo compared to the 1992 earthquake. The earthquake risk profile reveals that five districts (Al-Sahel, El Basateen, Dar El-Salam, Gharb, and Madinat Nasr sharq) lie in high seismic risks, and three districts (Manshiyat Naser, El-Waily, and Wassat (center)) are in low seismic risk level. Moreover, the building damage estimations reflect that Gharb is the highest vulnerable district. The analysis shows that the Cairo urban area faces high risk. Deteriorating buildings and infrastructure make the city particularly vulnerable to earthquake risks. For instance, more than 90 % of the estimated buildings damages are concentrated within the most densely populated (El Basateen, Dar El-Salam, Gharb, and Madinat Nasr Gharb) districts. Moreover, about 75 % of casualties are in the same districts. Actually, an earthquake risk assessment for Cairo represents a crucial application of the HAZUS earthquake loss estimation model for risk management. Finally, for mitigation, risk reduction, and to improve the seismic performance of structures and assure life safety

  11. Update earthquake risk assessment in Cairo, Egypt

    NASA Astrophysics Data System (ADS)

    Badawy, Ahmed; Korrat, Ibrahim; El-Hadidy, Mahmoud; Gaber, Hanan

    2016-12-01

    The Cairo earthquake (12 October 1992; m b = 5.8) is still and after 25 years one of the most painful events and is dug into the Egyptians memory. This is not due to the strength of the earthquake but due to the accompanied losses and damages (561 dead; 10,000 injured and 3000 families lost their homes). Nowadays, the most frequent and important question that should rise is "what if this earthquake is repeated today." In this study, we simulate the same size earthquake (12 October 1992) ground motion shaking and the consequent social-economic impacts in terms of losses and damages. Seismic hazard, earthquake catalogs, soil types, demographics, and building inventories were integrated into HAZUS-MH to produce a sound earthquake risk assessment for Cairo including economic and social losses. Generally, the earthquake risk assessment clearly indicates that "the losses and damages may be increased twice or three times" in Cairo compared to the 1992 earthquake. The earthquake risk profile reveals that five districts (Al-Sahel, El Basateen, Dar El-Salam, Gharb, and Madinat Nasr sharq) lie in high seismic risks, and three districts (Manshiyat Naser, El-Waily, and Wassat (center)) are in low seismic risk level. Moreover, the building damage estimations reflect that Gharb is the highest vulnerable district. The analysis shows that the Cairo urban area faces high risk. Deteriorating buildings and infrastructure make the city particularly vulnerable to earthquake risks. For instance, more than 90 % of the estimated buildings damages are concentrated within the most densely populated (El Basateen, Dar El-Salam, Gharb, and Madinat Nasr Gharb) districts. Moreover, about 75 % of casualties are in the same districts. Actually, an earthquake risk assessment for Cairo represents a crucial application of the HAZUS earthquake loss estimation model for risk management. Finally, for mitigation, risk reduction, and to improve the seismic performance of structures and assure life safety

  12. 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...

  13. 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...

  14. Assessing Assay Variability of Pesticide Metabolites in the Presence of Heavy Left-Censoring

    PubMed Central

    Chen, Haiying; Quandt, Sara A.; Barr, Dana Boyd; Arcury, Thomas A.

    2015-01-01

    Assessing assay variability for field samples in environmental research is challenging, since a quantitative assay is typically constrained by a lower limit of detection. The purpose of this paper is to compare three parametric models for assessing assay variability using duplicate data subject to heavy left-censoring. Efron information criterion (EIC) and Bayesian information criterion (BIC) are used to aid in model selections. Distributional parameter estimates are obtained using maximum likelihood estimation for bivariate lognormal, bivariate zero-inflated lognormal, and bivariate 3-component mixture models. We illustrate a practical application using duplicate pesticide data from the Community Participatory Approach to Measuring Farmworker Pesticide Exposure (PACE3) study. Furthermore, a simulation study is conducted to empirically evaluate the performance of the three models. The results from PACE3 indicate that the bivariate zero-inflated lognormal model is fairly competitive based on EIC or BIC. Further, total variability for the lognormal component can be decomposed into between-subject and within-subject variance based on this model. Assay variability estimates such as within-subject coefficient variation, minimum detectable change, and probability of k-fold difference can be easily derived under the bivariate zero-inflated lognormal model. Additionally, the assay variability is rather large for the PACE3 data. Therefore, apparent longitudinal change in pesticide exposure should be examined cautiously in the context of substantial assay variability. PMID:26023279

  15. 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

  16. 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.

  17. 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.

  18. Cytotoxicity and genotoxicity assessment of Euphorbia hirta in MCF-7 cell line model using comet assay

    PubMed Central

    Ping, Kwan Yuet; Darah, Ibrahim; Chen, Yeng; Sasidharan, Sreenivasan

    2013-01-01

    Objective To evaluate the cytotoxicity and genotoxicity activity of Euphorbia hirta (E. hirta) in MCF-7 cell line model using comet assay. Methods The cytotoxicity of E. hirta extract was investigated by employing brine shrimp lethality assay and the genotoxicity of E. hirta was assessed by using Comet assay. Results Both toxicity tests exhibited significant toxicity result. In the comet assay, the E. hirta extract exhibited genotoxicity effects against MCF-7 DNA in a time-dependent manner by increasing mean percentage of DNA damage. The extract of E. hirta showed significant toxicity against brine shrimp with an LC50 value of 620.382 µg/mL (24 h). Comparison with positive control potassium dichromate signifies that cytotoxicity exhibited by the methanol extract might have moderate activity. Conclusion The present work confirmed the cytotoxicity and genotoxicity of E. hirta. However, the observed toxicity of E. hirta extracts needs to be confirmed in additional studies. PMID:23998008

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

    PubMed

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

    2013-11-01

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

  20. 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.

  1. 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.

  2. 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.

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

    PubMed Central

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

    2015-01-01

    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. PMID:25810005

  4. Development of an assay to assess genotoxicity by particulate matter extract

    PubMed Central

    Priftis, Alexandros; Papikinos, Konstantinos; Koukoulanaki, Marina; Kerasioti, Efthalia; Stagos, Dimitrios; Konstantinopoulos, Konstantinos; Spandidos, Demetrios A.; Kermenidou, Marianthi; Karakitsios, Spyros; Sarigiannis, Dimosthenis; Tsatsakis, Aristides M.; Kouretas, Demetrios

    2017-01-01

    The current study describes a method for assessing the oxidative potential of common environmental stressors (ambient air particulate matter), using a plasmid relaxation assay where the extract caused single-strand breaks, easily visualised through electrophoresis. This assay utilises a miniscule amount (11 µg) of particulate matter (PM) extract compared to other, cell-based methods (~3,000 µg). The negative impact of air pollution on human health has been extensively recognised. Among the air pollutants, PM plays an eminent role, as reflected in the broad scientific interest. PM toxicity highly depends on its composition (metals and organic compounds), which in turn has been linked to multiple health effects (such as cardiorespiratory diseases and cancer) through multiple toxicity mechanisms; the induction of oxidative stress is considered a major mechanism among these. In this study, the PM levels, oxidative potential, cytotoxicity and genotoxicity of PM in the region of Larissa, Greece were examined using the plasmid relaxation assay. Finally, coffee extracts from different varieties, derived from both green and roasted seeds, were examined for their ability to inhibit PM-induced DNA damage. These extracts also exerted an inhibitory effect on xanthine oxidase and catalase, but had no effect against superoxide dismutase. Overall, this study highlights the importance of assays for assessing the oxidative potential of widespread environmental stressors (PM), as well as the antioxidant capacity of beverages and food items, with the highlight being the development of a plasmid relaxation assay to assess the genotoxicity caused by PM using only a miniscule amount. PMID:28260086

  5. [Patient safety in antibiotics administration: Risk assessment].

    PubMed

    Maqueda Palau, M; Pérez Juan, E

    To determine the level of risk in the preparation and administration of antibiotics frequently used in the Intensive Care Unit using a risk matrix. A study was conducted using situation analysis and literature review of databases, protocols and good practice guidelines on intravenous therapy, drugs, and their administration routes. The most used antibiotics in the ICU registered in the ENVIN-HELICS program from 1 April to 30 June 2015 were selected. In this period, 257 patients received antimicrobial treatment and 26 antibiotics were evaluated. Variables studied: A risk assessment of each antibiotic using the scale Risk Assessment Tool, of the National Patient Safety Agency, as well as pH, osmolarity, type of catheter recommended for administration, and compatibility and incompatibility with other antibiotics studied. Almost two-thirds (65.3%) of antibiotics had more than 3 risk factors (represented by a yellow stripe), with the remaining 34.7% of antibiotics having between 0 and 2 risk factors (represented by a green stripe). There were no antibiotics with 6 or more risk factors (represented by a red stripe). Most drugs needed reconstitution, additional dilution, and the use of part of the vial to administer the prescribed dose. More than half of the antibiotics studied had a moderate risk level; thus measures should be adopted in order to reduce it. The risk matrix is a useful tool for the assessment and detection of weaknesses associated with the preparation and administration of intravenous antibiotics. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  6. [Monitoring and risk assessment of campylobacter infections].

    PubMed

    Bartelt, E

    2004-08-01

    The aim of a national study of a "Quantitative Risk Assessment of Campylobacter infections and broiler chicken" at the Federal Institute for Risk Assessment is to estimate the chicken meat associated risk of Campylobacteriosis in Germany by using probabilistic models. Furthermore, process parameters (modelling parameters) with the most vital impact on the risk of Campylobacteriosis due to chicken meat have to be elaborated to give recommendations for risk management options in the whole food chain. The outcome of Joint FAO/WHO Expert Consultations on Risk Assessment of Microbiological Hazards in Foods (JEMRA) with respect to Campylobacter spp. in broiler chickens are the baseline for the national approach. In addition, national studies from Canada, Denmark and The Netherlands have to be considered. Typical regional data with respect to the disease, to risk factors in Germany and to the qualitative and quantitative occurrence of Campylobacter in broiler chickens along the "farm-to-fork" continuum have to be collected and validated for elaboration of the four elements of a risk assessment. Data on the prevalence of the agent at different stages of the food chain given in available surveillance systems in Germany are limited with respect to their suitability as incoming parameters for the models. A monitoring programme, as required in the Directive 2003/99/EC on the monitoring of zoonoses and zoonotic agents, as well as coordinated programmes for the official food control authorities, could improve the data baseline for risk assessment studies for instance. To collect all necessary information on the quantitative load of Camylobacter in broiler chickens will go beyond the scope of any existing or future monitoring systems. Results can only be achieved by detailed studies. Beside this, regional data on production and processing of broiler chicken, consumption data and information on the behaviour of consumers in households when preparing broiler chicken products are

  7. 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. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  8. [Benefit-risk assessment of vaccination strategies].

    PubMed

    Hanslik, Thomas; Boëlle, Pierre Yves

    2007-04-01

    This article summarises the various stages of the risk/benefit assessment of vaccination strategies. Establishing the awaited effectiveness of a vaccination strategy supposes to have an epidemiologic description of the disease to be prevented. The effectiveness of the vaccine strategy will be thus expressed in numbers of cases, hospitalizations or deaths avoided. The effectiveness can be direct, expressed as the reduction of the incidence of the infectious disease in the vaccinated subjects compared to unvaccinated subjects. It can also be indirect, the unvaccinated persons being protected by the suspension in circulation of the pathogenic agent, consecutive to the implementation of the vaccination campaign. The risks of vaccination related to the adverse effects detected during the clinical trials preceding marketing are well quantified, but other risks can occur after marketing: e.g., serious and unexpected adverse effects detected by vaccinovigilance systems, or risk of increase in the age of cases if the vaccination coverage is insufficient. The medico-economic evaluation forms a part of the risks/benefit assessment, by positioning the vaccine strategy comparatively with other interventions for health. Epidemiologic and vaccinovigilance informations must be updated very regularly, which underlines the need for having an operational and reliable real time monitoring system to accompany the vaccination strategies. Lastly, in the context of uncertainty which often accompanies the risks/benefit assessments, it is important that an adapted communication towards the public and the doctors is planned.

  9. 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.

  10. Health Risk Assessment of Chemical Mixtures | Science ...

    EPA Pesticide Factsheets

    The implementation of Superfund requires a methodology for estimating health risk from multi-chemical contamination at ambient levels. Most often, the chemical composition of these mixtures is poorly characterized, exposure data are uncertain and toxicologic data on the known components of the mixture are limited. However, a potential human health hazard may exist and the U.S.EPA, state and local governments need to be able to assess the total hazard in order to make decisions on appropriate action. This report describes a procedure for assessing the risks from chemical mixtures that includes options when different kinds of data are available. Good-quality information on the mixture of concern or a similar mixture should always be used. Less desirable, but still useful approach, is to utilize data on components and their interactions. The quality of exposure and toxicity data must be determined and the uncertainties involved in each risk assessment must be thoroughly discussed. ater contamination is briefly discussed since it is of vital concern as the primary exposure medium for chemical mixtures. The methodology for estimating the human health risk from single chemicals, both carcinogens and systemic toxicants, is reviewed as it forms the basis for the assessment of mixtures. The Implementation of Superfund requires a methodology for estimating health risk from multi-chemical contamination at ambient levels. Most often, the chemical composition of these mix

  11. 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.

  12. Occupational risk assessment of paint industry workers

    PubMed Central

    de Oliveira, Hugo M.; Dagostim, Gracilene P.; da Silva, Arielle Mota; Tavares, Priscila; da Rosa, Luiz A. Z. C.; de Andrade, Vanessa M.

    2011-01-01

    Background: Thousands of chemical compounds are used in paint products, like pigments, extenders, binders, additives, and solvents (toluene, xylene, ketones, alcohols, esters, and glycol ethers). Paint manufacture workers are potentially exposed to the chemicals present in paint products although the patterns and levels of exposure to individual agents may differ from those of painters. The aim of the present study was to evaluate genome damage induced in peripheral blood lymphocytes and oral mucosa cells of paint industry workers. Materials and Methods: Genotoxicity was evaluated using the alkaline Comet assay in blood lymphocytes and oral mucosa cells, and the Micronucleus test in oral mucosa cells. For the micronucleus test in exfoliated buccal cells, no significant difference was detected between the control and paint industry workers. Results: The Comet assay in epithelia buccal cells showed that the damage index (DI) and damage frequency (DF) observed in the exposed group were significantly higher relative to the control group (P≤0.05). In the same way, the Comet assay data in peripheral blood leukocytes showed that both analysis parameters (DI and DF) were significantly greater than that for the control group (P≤0.05). Conclusions: Chronic occupational exposure to paints may lead to a slightly increased risk of genetic damage among paint industry workers. PMID:22223950

  13. Sensitivity analysis in quantitative microbial risk assessment.

    PubMed

    Zwieterin, M H; van Gerwen, S J

    2000-07-15

    The occurrence of foodborne disease remains a widespread problem in both the developing and the developed world. A systematic and quantitative evaluation of food safety is important to control the risk of foodborne diseases. World-wide, many initiatives are being taken to develop quantitative risk analysis. However, the quantitative evaluation of food safety in all its aspects is very complex, especially since in many cases specific parameter values are not available. Often many variables have large statistical variability while the quantitative effect of various phenomena is unknown. Therefore, sensitivity analysis can be a useful tool to determine the main risk-determining phenomena, as well as the aspects that mainly determine the inaccuracy in the risk estimate. This paper presents three stages of sensitivity analysis. First, deterministic analysis selects the most relevant determinants for risk. Overlooking of exceptional, but relevant cases is prevented by a second, worst-case analysis. This analysis finds relevant process steps in worst-case situations, and shows the relevance of variations of factors for risk. The third, stochastic analysis, studies the effects of variations of factors for the variability of risk estimates. Care must be taken that the assumptions made as well as the results are clearly communicated. Stochastic risk estimates are, like deterministic ones, just as good (or bad) as the available data, and the stochastic analysis must not be used to mask lack of information. Sensitivity analysis is a valuable tool in quantitative risk assessment by determining critical aspects and effects of variations.

  14. Pressure sore risk assessment in children.

    PubMed

    Waterlow, J A

    1997-07-01

    A multi-centred study was undertaken involving 300 children ranging from neonates to children aged 16 years. The purpose of the study was to investigate the possibility of designing a pressure sore risk assessment scoring system suitable for the paediatric area of care. It was found that the following conclusions can be drawn: (i) Children are at risk of developing pressure sores; (ii) A version of the adult Waterlow card was not appropriate, especially at the younger end of the scale; (iii) There are identifiable situations and treatments which do pose a risk of pressure sore development. Admission documentation and a care plan within a hospital policy is recommended as the best method of drawing nurses' attention to the risk factors involved and the measures which need to be taken to alleviate the risk of tissue damage.

  15. RISK ASSESSMENT FOR THE DYE AND PIGMENT ...

    EPA Pesticide Factsheets

    This risk assessment calculates the maximum loadings of constituents found in dyes and pigment industries waste streams which can be disposed in different types of waste management units without causing health benchmarks to be exceeded at plausible receptor locations. The assessment focuses on potential risks from volatilization and leaching to groundwater of constituents disposed in surface impoundments and landfills with either clay liners or composite liners. This product will be used by EPA decision makers to assist in determining whether certain waste streams generated by the dyes and pigments industries should be designated as hazardous.

  16. 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.

  17. New method for assessing risks of email

    NASA Astrophysics Data System (ADS)

    Raja, Seyyed H.; Afrooz, Farzad

    2013-03-01

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

  18. Application of geostatistics to risk assessment.

    PubMed

    Thayer, William C; Griffith, Daniel A; Goodrum, Philip E; Diamond, Gary L; Hassett, James M

    2003-10-01

    Geostatistics offers two fundamental contributions to environmental contaminant exposure assessment: (1) a group of methods to quantitatively describe the spatial distribution of a pollutant and (2) the ability to improve estimates of the exposure point concentration by exploiting the geospatial information present in the data. The second contribution is particularly valuable when exposure estimates must be derived from small data sets, which is often the case in environmental risk assessment. This article addresses two topics related to the use of geostatistics in human and ecological risk assessments performed at hazardous waste sites: (1) the importance of assessing model assumptions when using geostatistics and (2) the use of geostatistics to improve estimates of the exposure point concentration (EPC) in the limited data scenario. The latter topic is approached here by comparing design-based estimators that are familiar to environmental risk assessors (e.g., Land's method) with geostatistics, a model-based estimator. In this report, we summarize the basics of spatial weighting of sample data, kriging, and geostatistical simulation. We then explore the two topics identified above in a case study, using soil lead concentration data from a Superfund site (a skeet and trap range). We also describe several areas where research is needed to advance the use of geostatistics in environmental risk assessment.

  19. Risk Assessment in the 21st Century | Science Inventory | US ...

    EPA Pesticide Factsheets

    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 approach is no longer adequate. This presentation provides an update on current progress in achieving the goals outlined in the NAS report on Toxicology Testing in the 21st Century, highlighting many of the advances lead by the EPA. Topics covered include the evolution of the mode of action framework into a chemically agnostic, adverse outcome pathway (AOP), a systems-based data framework that facilitates integration of modifiable factors (e.g., genetic variation, life stages), and an understanding of networks, and mixtures. Further, the EDSP pivot is used to illustrate how AOPs drive development of predictive models for risk assessment based on assembly of high throughput assays representing AOP key elements. The birth of computational exposure science, capable of large-scale predictive exposure models, is reviewed. Although still in its infancy, development of non-targeted analysis to begin addressing exposome also is presented. Finally, the systems-based AEP is described that integrates exposure, toxicokinetics and AOPs into a comprehensive framework. For the past ~50 years, risk assessment depended almost exclusively on animal testing for hazard identification and dose-response as

  20. Microbiological risk assessment for personal care products.

    PubMed

    Stewart, S E; Parker, M D; Amézquita, A; Pitt, T L

    2016-12-01

    Regulatory decisions regarding microbiological safety of cosmetics and personal care products are primarily hazard-based, where the presence of a potential pathogen determines decision-making. This contrasts with the Food industry where it is a commonplace to use a risk-based approach for ensuring microbiological safety. A risk-based approach allows consideration of the degree of exposure to assess unacceptable health risks. As there can be a number of advantages in using a risk-based approach to safety, this study explores the Codex Alimentarius (Codex) four-step Microbiological Risk Assessment (MRA) framework frequently used in the Food industry and examines how it can be applied to the safety assessment of personal care products. The hazard identification and hazard characterization steps (one and two) of the Codex MRA framework consider the main microorganisms of concern. These are addressed by reviewing the current industry guidelines for objectionable organisms and analysing reports of contaminated products notified by government agencies over a recent 5-year period, together with examples of reported outbreaks. Data related to estimation of exposure (step three) are discussed, and examples of possible calculations and references are included. The fourth step, performed by the risk assessor (risk characterization), is specific to each assessment and brings together the information from the first three steps to assess the risk. Although there are very few documented uses of the MRA approach for personal care products, this study illustrates that it is a practicable and sound approach for producing products that are safe by design. It can be helpful in the context of designing products and processes going to market and with setting of microbiological specifications. Additionally, it can be applied reactively to facilitate decision-making when contaminated products are released on to the marketplace. Currently, the knowledge available may only allow a

  1. 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.

  2. Ecological risk assessment: implications of hormesis.

    PubMed

    van der Schalie, W H; Gentile, J H

    2000-01-01

    Hormesis is a widespread phenomenon across many taxa and chemicals, and, at the single species level, issues regarding the application of hormesis to human health and ecological risk assessment are similar. For example, convincing the public of a 'beneficial' effect of environmental chemicals may be problematic, and the design and analysis of laboratory studies may require modifications to detect hormesis. However, interpreting the significance of hormesis for even a single species in an ecological risk assessment can be complicated by considerations of competition with other species, predation effects, etc. Ecological risk assessments involve more than a single species; they may involve communities of hundreds or thousands of species as well as a range of ecological processes. Applying hormetic adjustments to threshold effect levels for chemicals derived from sensitivity distributions for a large number of species is impractical. For ecological risks, chemical stressors are frequently of lessor concern than physical stressors such as habitat alteration or biological stressors such as introduced species, but the relevance of hormesis to non-chemical stressors is unclear. Although ecological theories such as the intermediate disturbance hypothesis offer some intriguing similarities between chemical hormesis and hormetic-like responses resulting from physical disturbances, mechanistic explanations are lacking. Further exploration of the relevance of hormesis to ecological risk assessment is desirable. Aspects deserving additional attention include developing a better understanding of the hormetic effects of chemical mixtures, the relevance of hormesis to physical and biological stressors and the development of criteria for determining when hormesis is likely to be relevant to ecological risk assessments.

  3. Assessing the Developmental Neurotoxicity of 27 Organophosphorus Pesticides Using a Zebrafish Behavioral Assay

    EPA Science Inventory

    Assessing the Developmental Neurotoxicity of 27 Organophosphorus Pesticides Using a Zebrafish Behavioral Assay, Waalkes, M., Hunter, D.L., Jarema, K., Mundy, W., and S. Padilla. The U.S. Environmental Protection Agency is evaluating methods to screen and prioritize organophosphor...

  4. Assessing the Developmental Neurotoxicity of 27 Organophosphorus Pesticides Using a Zebrafish Behavioral Assay

    EPA Science Inventory

    Assessing the Developmental Neurotoxicity of 27 Organophosphorus Pesticides Using a Zebrafish Behavioral Assay, Waalkes, M., Hunter, D.L., Jarema, K., Mundy, W., and S. Padilla. The U.S. Environmental Protection Agency is evaluating methods to screen and prioritize organophosphor...

  5. Dose assessment intercomparisons within the RENEB network using G0-lymphocyte prematurely condensed chromosomes (PCC assay).

    PubMed

    Terzoudi, Georgia I; Pantelias, Gabriel; Darroudi, Firouz; Barszczewska, Katarzyna; Buraczewska, Iwona; Depuydt, Julie; Georgieva, Dimka; Hadjidekova, Valeria; Hatzi, Vasiliki I; Karachristou, Ioanna; Karakosta, Maria; Meschini, Roberta; M'Kacher, Radhia; Montoro, Alegria; Palitti, Fabrizio; Pantelias, Antonio; Pepe, Gaetano; Ricoul, Michelle; Sabatier, Laure; Sebastià, Natividad; Sommer, Sylwester; Vral, Anne; Zafiropoulos, Demetre; Wojcik, Andrzej

    2017-01-01

    Dose assessment intercomparisons within the RENEB network were performed for triage biodosimetry analyzing G0-lymphocyte PCC for harmonization, standardization and optimization of the PCC assay. Comparative analysis among different partners for dose assessment included shipment of PCC-slides and captured images to construct dose-response curves for up to 6 Gy γ-rays. Accident simulation exercises were performed to assess the suitability of the PCC assay by detecting speed of analysis and minimum number of cells required for categorization of potentially exposed individuals. Calibration data based on Giemsa-stained fragments in excess of 46 PCC were obtained by different partners using galleries of PCC images for each dose-point. Mean values derived from all scores yielded a linear dose-response with approximately 4 excess-fragments/cell/Gy. To unify scoring criteria, exercises were carried out using coded PCC-slides and/or coded irradiated blood samples. Analysis of samples received 24 h post-exposure was successfully performed using Giemsa staining (1 excess-fragment/cell/Gy) or centromere/telomere FISH-staining for dicentrics. Dose assessments by RENEB partners using appropriate calibration curves were mostly in good agreement. The PCC assay is quick and reliable for whole- or partial-body triage biodosimetry by scoring excess-fragments or dicentrics in G0-lymphocytes. Particularly, analysis of Giemsa-stained excess PCC-fragments is simple, inexpensive and its automation could increase throughput and scoring objectivity of the PCC assay.

  6. 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

  7. 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. © 2014 Society for Risk Analysis.

  8. Ecosystem services in risk assessment and management. ...

    EPA Pesticide Factsheets

    The ecosystem services (ES) concept holds much promise for environmental decision making. Even so, the concept has yet to gain full traction in the decisions and policies of environmental agencies in the United States, Europe, and elsewhere. Here we examine the opportunities for and implications of including ES in risk assessments and the risk management decisions that they inform. We assert that use of ES will: 1) lead to more comprehensive environmental protection; 2) help to articulate the benefits of environmental decisions, policies, and actions; 3) better inform the derivation of environmental quality standards; 4) enable integration of human health and ecological risk assessment; and 5) facilitate horizontal integration of policies, regulations, and programs. We provide the technical basis and supporting rationale for each assertion, relying on examples taken from experiences in the United States and European Union. Specific recommendations are offered for use of ES in risk assessment and risk management, and issues and challenges to advancing use of ES are described along with some of the science needed to improve the value of the ES concept to environmental protection. This paper is one of 4 papers generated from the 2014 Pellston Workshop “Ecosystem Services, Environmental Stressors and Decision Making,” organized jointly by the Society of Environmental Toxicology and Chemistry and the Ecological Society of America. The main workshop objective was

  9. 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...

  10. Methodology for qualitative urban flooding risk assessment.

    PubMed

    Leitão, João P; Almeida, Maria do Céu; Simões, Nuno E; Martins, André

    2013-01-01

    Pluvial or surface flooding can cause significant damage and disruption as it often affects highly urbanised areas. Therefore it is essential to accurately identify consequences and assess the risks associated with such phenomena. The aim of this study is to present the results and investigate the applicability of a qualitative flood risk assessment methodology in urban areas. This methodology benefits from recent developments in urban flood modelling, such as the dual-drainage modelling concept, namely one-dimensional automatic overland flow network delineation tools (e.g. AOFD) and 1D/1D models incorporating both surface and sewer drainage systems. To assess flood risk, the consequences can be estimated using hydraulic model results, such as water velocities and water depth results; the likelihood was estimated based on the return period of historical rainfall events. To test the methodology two rainfall events with return periods of 350 and 2 years observed in Alcântara (Lisbon, Portugal) were used and three consequence dimensions were considered: affected public transportation services, affected properties and pedestrian safety. The most affected areas in terms of flooding were easily identified; the presented methodology was shown to be easy to implement and effective to assess flooding risk in urban areas, despite the common difficulties in obtaining data.

  11. 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…

  12. 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...

  13. ECOTOXICOLOGY AND RISK ASSESSMENT FOR WETLANDS

    EPA Science Inventory

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

  14. Soil Erosion Risk Assessment and Modelling

    NASA Astrophysics Data System (ADS)

    Fister, Wolfgang; Kuhn, Nikolaus J.; Heckrath, Goswin

    2013-04-01

    Soil erosion is a phenomenon with relevance for many research topics in the geosciences. Consequently, PhD students with many different backgrounds are exposed to soil erosion related questions during their research. These students require a compact, but detailed introduction to erosion processes, the risks associated with erosion, but also tools to assess and study erosion related questions ranging from a simple risk assessment to effects of climate change on erosion-related effects on geochemistry on various scales. The PhD course on Soil Erosion Risk Assessment and Modelling offered by the University of Aarhus and conducted jointly with the University of Basel is aimed at graduate students with degrees in the geosciences and a PhD research topic with a link to soil erosion. The course offers a unique introduction to erosion processes, conventional risk assessment and field-truthing of results. This is achieved by combing lectures, mapping, erosion experiments, and GIS-based erosion modelling. A particular mark of the course design is the direct link between the results of each part of the course activities. This ensures the achievement of a holistic understanding of erosion in the environment as a key learning outcome.

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. An approach to security risk assessment.

    PubMed

    Engells, Thomas E

    2012-01-01

    Use of a brief survey instrument described in this article can be a useful means of obtaining actionable information in regards to risk assessment and crime prevention, the author points out. The survey yields data that assists in the prioritization of effort that can enhance the impact of a limited pool of qualified specialists.

  20. 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...

  1. 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...

  2. Bayesian Networks for enterprise risk assessment

    NASA Astrophysics Data System (ADS)

    Bonafede, C. E.; Giudici, P.

    2007-08-01

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

  3. Simulation modeling for microbial risk assessment.

    PubMed

    Cassin, M H; Paoli, G M; Lammerding, A M

    1998-11-01

    Quantitative microbial risk assessment implies an estimation of the probability and impact of adverse health outcomes due to microbial hazards. In the case of food safety, the probability of human illness is a complex function of the variability of many parameters that influence the microbial environment, from the production to the consumption of a food. The analytical integration required to estimate the probability of foodborne illness is intractable in all but the simplest of models. Monte Carlo simulation is an alternative to computing analytical solutions. In some cases, a risk assessment may be commissioned to serve a larger purpose than simply the estimation of risk. A Monte Carlo simulation can provide insights into complex processes that are invaluable, and otherwise unavailable, to those charged with the task of risk management. Using examples from a farm-to-fork model of the fate of Escherichia coli O157:H7 in ground beef hamburgers, this paper describes specifically how such goals as research prioritization, risk-based characterization of control points, and risk-based comparison of intervention strategies can be objectively achieved using Monte Carlo simulation.

  4. 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.

  5. Bacterial Bioburden Decrease in Orthokeratology Lens Storage Cases After Forewarning: Assessment by the DNA Dot Hybridization Assay.

    PubMed

    Fang, Po-Chiung; Lo, Jung; Chang, Tsung C; Chien, Chun-Chih; Hsiao, Chang-Chun; Tseng, Shin-Ling; Lai, Yu-Hsuan; Kuo, Ming-Tse

    2017-05-01

    The aim of this study was to measure the changes in the bacterial bioburden in orthokeratology (OK) lens storage cases using the DNA dot hybridization assay (DHA) after forewarning patients about their bacterial contamination severity. Thirty-one OK lens wearers were prospectively enrolled in this study. Dot hybridization assay was used for serial measurements of bacterial bioburden in OK storage cases after lenses had been soaked for approximately 6 hr. After the first assessment, the lens wearers were informed of the extent of case contamination and the possible risk of microbial keratitis (MK), and best practices for lens care and lens case hygiene were reviewed and reinforced. A second assessment by the same DHA method was performed after approximately 6 months. Two universal bacterial probes confirmed a significant decrease in bacterial bioburden at the second assessment (P<0.01 and P<0.001). Genus-specific probes showed significant reductions in Acinetobacter and Klebsiella (P=0.02 and P=0.01), but not in Pseudomonas (P=0.42). Making OK lens wearers aware of the bacterial bioburden in their lens cases resulted in improved quality of case care and reduced bioburden. Our results suggest that a strategy of bioburden assessment with forewarning could be a useful method to decrease the incidence of OK-related MK.

  6. exLOPA for explosion risks assessment.

    PubMed

    Markowski, Adam S

    2007-04-11

    The European Union regulations require safety and health protection of workers who are potentially at risk from explosive atmosphere areas. According to the requirements, the operators of installations where potentially explosive atmosphere can occur are obliged to produce an explosion protection document. The key objective of this document is the assessment of explosion risks. This paper is concerned with the so-called explosion layer of protection analysis (exLOPA), which allows for semi-quantitative explosion risk assessment for process plants where explosive atmospheres occur. The exLOPA is based on the original work of CCPS for LOPA but takes into account some typical factors appropriate for explosion, like the probability that an explosive atmosphere will occur, probability that sources of ignition will be present and become effective as well as the probability of failure on demand for appropriate explosion prevention and mitigation means.

  7. Statistics for risk assessment of chemical carcinogens.

    PubMed

    Chen, James J; Chen, Yi-Ju; Cheng, Kuang Fu

    2007-01-01

    Risk assessment is a scientific process of evaluation of potential health risks of chemical exposures to humans from available information. It involves analysis of the relationship between exposure and health related outcomes to derive an allowable exposure level. Because of lack of human exposure data, the major source of information for studying potential health effects of chemicals on humans is generally obtained from animal dose response experiments. Animal data are often evaluated in two aspects via statistical analysis: qualitative testing and quantitative estimation. The qualitative testing is to determine if the chemical causes an adverse health effect, i.e., if there is a statistically significant difference between treated and control animals. Quantitative estimation involves fitting a dose-response model to derive an allowable exposure level for humans. This paper reviews statistical principles and procedures for qualitative and quantitative approaches to human risk assessment.

  8. RESIDUAL RISK ASSESSMENTS | Science Inventory | US ...

    EPA Pesticide Factsheets

    Each source category previously subjected to a technology-based standard will be examined to determine if health or ecological risks are significant enough to warrant further regulation. These assesments utilize existing models and data bases to examine the multi-media and multi-pollutant impacts of air toxics emissions on human health and the environment. Details on the assessment process and methodologies can be found in EPA's Residual Risk Report to Congress issued in March of 1999 (see web site). To assess the health risks imposed by sources of air toxics emissions, on a source category basis, to determine if control technology standards previously established for that source category are adequately protecting public health.

  9. 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

  10. New approaches in human health risk assessment

    PubMed Central

    Abass, Khaled; Carlsen, Anders; Rautio, Arja

    2016-01-01

    Studies on the precise impact of environmental pollutants on human health are difficult to undertake and interpret, because many genetic and environmental factors influence health at the same time and to varying degrees. Our chapter in the AMAP report was based on new approaches to describe risks and future needs. In this paper, we will introduce the issues associated with risk assessment of single chemicals, and present suggestions for future studies as well as a summary of lessons learned during the health-related parts of the European Union-funded FP7 project ArcRisk (Arctic Health Risks: Impacts on health in the Arctic and Europe owing to climate-induced changes in contaminant cycling, 2009–2014; www.arcrisk.eu). PMID:27974141

  11. 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

  12. 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.

  13. Seismic Risk Assessment for the Kyrgyz Republic

    NASA Astrophysics Data System (ADS)

    Pittore, Massimiliano; Sousa, Luis; Grant, Damian; Fleming, Kevin; Parolai, Stefano; Fourniadis, Yannis; Free, Matthew; Moldobekov, Bolot; Takeuchi, Ko

    2017-04-01

    The Kyrgyz Republic is one of the most socially and economically dynamic countries in Central Asia, and one of the most endangered by earthquake hazard in the region. In order to support the government of the Kyrgyz Republic in the development of a country-level Disaster Risk Reduction strategy, a comprehensive seismic risk study has been developed with the support of the World Bank. As part of this project, state-of-the-art hazard, exposure and vulnerability models have been developed and combined into the assessment of direct physical and economic risk on residential, educational and transportation infrastructure. The seismic hazard has been modelled with three different approaches, in order to provide a comprehensive overview of the possible consequences. A probabilistic seismic hazard assessment (PSHA) approach has been used to quantitatively evaluate the distribution of expected ground shaking intensity, as constrained by the compiled earthquake catalogue and associated seismic source model. A set of specific seismic scenarios based on events generated from known fault systems have been also considered, in order to provide insight on the expected consequences in case of strong events in proximity of densely inhabited areas. Furthermore, long-span catalogues of events have been generated stochastically and employed in the probabilistic analysis of expected losses over the territory of the Kyrgyz Republic. Damage and risk estimates have been computed by using an exposure model recently developed for the country, combined with the assignment of suitable fragility/vulnerability models. The risk estimation has been carried out with spatial aggregation at the district (rayon) level. The obtained results confirm the high level of seismic risk throughout the country, also pinpointing the location of several risk hotspots, particularly in the southern districts, in correspondence with the Ferghana valley. The outcome of this project will further support the local

  14. 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.

  15. 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.

  16. 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

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

    PubMed

    Yohrling, Jennifer

    2009-06-01

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

  18. Risk Assessment in the 21st Century - Conference Abstract ...

    EPA Pesticide Factsheets

    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 approach is no longer sufficient. This presentation provides an update on current progress in achieving the goals outlined in the NAS reports: “Toxicology Testing in the 21st Century”, “Exposure Science in the 21st Century”, and most recently, “Using 21st Century Science to Improve Risk-Related Evaluations.” The presentation highlights many of the advances lead by the EPA. Topics covered include the evolution of the mode of action concept into the chemically agnostic, adverse outcome pathway (AOP), a systems-based data framework that facilitates integration of modifiable factors (e.g., genetic variation, life stages), and an understanding of networks, and mixtures. Further, the EDSP pivot is used to illustrate how AOPs drive development of predictive models for risk assessment based on assembly of high throughput assays representing AOP key elements. The birth of computational exposure science, capable of large-scale predictive exposure models, is reviewed. Although still in its infancy, development of non-targeted analysis to begin addressing the exposome is presented, as is the systems-based AEP that integrates exposure, toxicokinetics and AOPs into a comprehensive framework

  19. A 21st Century Update on Neurotoxicity Risk Assessment ...

    EPA Pesticide Factsheets

    In 1998, EPA published Guidelines for Neurotoxicity Risk Assessment as the basis for interpreting neurotoxicity results. At that time, the focus was on traditional toxicity testing and human clinical /epidemiological data. More recently, a change in approach to toxicity testing was proposed in “A 21st Century Update on Neurotoxicity Risk Assessment “ (NRC, 2007), stating that traditional toxicity testing was too slow and expensive to develop information on the potential toxicity of the large number of untested chemicals already used in commerce. In addition, new technologies have compounded the problem as new materials, such as engineered nanomaterials, are introduced at a rate exceeding traditional testing capacity. There is currently much effort to develop higher throughput neurotoxicity testing capabilities, especially for developmental neurotoxicity, but there is no general consensus regarding how alternative testing data should be interpreted for neurotoxicity risk assessment. The dependence of critical functions, such as learning, memory or sensory perception, on the operation of integrated neural systems makes the interpretation of data from simple test assays particularly difficult. The concept of Adverse Outcome Pathways (AOP), in which molecular initiating events (MIE) trigger a sequence of steps leading to an adverse outcome, may provide a conceptual framework in which simple alternative testing data indicative of MIEs can be used to predict neur

  20. A 21st Century Update on Neurotoxicity Risk Assessment ...

    EPA Pesticide Factsheets

    In 1998, EPA published Guidelines for Neurotoxicity Risk Assessment as the basis for interpreting neurotoxicity results. At that time, the focus was on traditional toxicity testing and human clinical /epidemiological data. More recently, a change in approach to toxicity testing was proposed in “A 21st Century Update on Neurotoxicity Risk Assessment “ (NRC, 2007), stating that traditional toxicity testing was too slow and expensive to develop information on the potential toxicity of the large number of untested chemicals already used in commerce. In addition, new technologies have compounded the problem as new materials, such as engineered nanomaterials, are introduced at a rate exceeding traditional testing capacity. There is currently much effort to develop higher throughput neurotoxicity testing capabilities, especially for developmental neurotoxicity, but there is no general consensus regarding how alternative testing data should be interpreted for neurotoxicity risk assessment. The dependence of critical functions, such as learning, memory or sensory perception, on the operation of integrated neural systems makes the interpretation of data from simple test assays particularly difficult. The concept of Adverse Outcome Pathways (AOP), in which molecular initiating events (MIE) trigger a sequence of steps leading to an adverse outcome, may provide a conceptual framework in which simple alternative testing data indicative of MIEs can be used to predict neur

  1. Risk Assessment in the 21st Century - Conference Abstract ...

    EPA Pesticide Factsheets

    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 approach is no longer sufficient. This presentation provides an update on current progress in achieving the goals outlined in the NAS reports: “Toxicology Testing in the 21st Century”, “Exposure Science in the 21st Century”, and most recently, “Using 21st Century Science to Improve Risk-Related Evaluations.” The presentation highlights many of the advances lead by the EPA. Topics covered include the evolution of the mode of action concept into the chemically agnostic, adverse outcome pathway (AOP), a systems-based data framework that facilitates integration of modifiable factors (e.g., genetic variation, life stages), and an understanding of networks, and mixtures. Further, the EDSP pivot is used to illustrate how AOPs drive development of predictive models for risk assessment based on assembly of high throughput assays representing AOP key elements. The birth of computational exposure science, capable of large-scale predictive exposure models, is reviewed. Although still in its infancy, development of non-targeted analysis to begin addressing the exposome is presented, as is the systems-based AEP that integrates exposure, toxicokinetics and AOPs into a comprehensive framework

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. Flood risk assessment of land pollution hotspots

    NASA Astrophysics Data System (ADS)

    Masi, Matteo; Arrighi, Chiara; Iannelli, Renato

    2017-04-01

    Among the risks caused by extreme events, the potential spread of pollutants stored in land hotspots due to floods is an aspect that has been rarely examined with a risk-based approach. In this contribution, an attempt to estimate pollution risks related to flood events of land pollution hotspots was carried out. Flood risk has been defined as the combination of river flood hazard, hotspots exposure and vulnerability to contamination of the area, i.e. the expected severity of the environmental impacts. The assessment was performed on a geographical basis, using geo-referenced open data, available from databases of land management institutions, authorities and agencies. The list of land pollution hotspots included landfills and other waste handling facilities (e.g., temporary storage, treatment and recycling sites), municipal wastewater treatment plants, liquid waste treatment facilities and contaminated sites. The assessment was carried out by combining geo-referenced data of pollution hotspots with flood hazard maps. We derived maps of land pollution risk based on geographical and geological properties and source characteristics available from environmental authorities. These included information about soil particle size, soil hydraulic conductivity, terrain slope, type of stored pollutants, the type of facility, capacity, size of the area, land use, etc. The analysis was carried out at catchment scale. The case study of the Arno river basin in Tuscany (central Italy) is presented.

  10. Biostatistics Series Module 8: Assessing Risk

    PubMed Central

    Hazra, Avijit; Gogtay, Nithya

    2017-01-01

    In observational studies, as well as in interventional ones, it is frequently necessary to estimate risk that is the association between an observed outcome or event and exposure to one or more factors that may be contributing to the event. Understanding incidence and prevalence are the starting point in any discussion of risk assessment. Incidence rate uses person-time as the denominator rather than a simple count. Ideally, rates and ratios estimated from samples should be presented with their corresponding 95% confidence intervals (CIs). To assess the importance of an individual risk factor, it is necessary to compare the risk of the outcome in the exposed group with that in the nonexposed group. A comparison between risks in different groups can be made by examining either their ratio or the difference between them. The 2 × 2 contingency table comes in handy in the calculation of ratios. Odds ratio (OR) is the ratio of the odds of an event in the exposed group, to the odds of the same event in the nonexposed group. It can range from zero to infinity. When the odds of an outcome in the two groups are identical, then the OR equals one. OR >1 indicates exposure increases risk while OR <1 indicates that exposure is protecting against risk. The OR should be presented with its 95% CI to enable more meaningful interpretation – if this interval includes 1, then even a relatively large OR will not carry much weight. The relative risk (RR) denotes the ratio of risk (probability) of event in exposed group to risk of same event in the nonexposed group. Its interpretation is similar (but not identical) to the OR. If the event in question is relatively uncommon, values of OR and RR tend to be similar. Absolute risk reduction (ARR) is a measure of the effectiveness of an intervention with respect to a dichotomous event. It is calculated as proportion experiencing the event in control group minus the proportion experiencing the event in treated group. It is often used to

  11. Oncotype DX(®) colon cancer assay for prediction of recurrence risk in patients with stage II and III colon cancer: A review of the evidence.

    PubMed

    You, Y Nancy; Rustin, Rudolph B; Sullivan, James D

    2015-06-01

    Advances in molecular biology have enabled identification of tumor biomarkers that allow for individualized risk assessment for patients with cancer. Molecular predictors of clinical outcome can help inform discussion regarding the role of adjuvant chemotherapy in patients with resected colon cancer, such as those with stage II colon cancer in which the benefit of adjuvant therapy is controversial or those with stage III colon cancer who may have a lower risk of recurrence and less absolute benefit from oxaliplatin therapy. This article summarizes the data surrounding the development, validation, and clinical and economic utility of the Oncotype DX(®) colon cancer assay, a multigene expression assay validated to independently predict recurrence risk in patients with stage II and III colon cancer beyond traditional factors.

  12. Toxicity assessment of reference and natural freshwater sediments with the LuminoTox assay.

    PubMed

    Dellamatrice, P M; Monteiro, R T R; Blaise, C; Slabbert, J L; Gagné, F; Alleau, S

    2006-08-01

    We examined the possibility of adapting the LuminoTox, a recently-commercialized bioanalytical testing procedure initially developed for aqueous samples, to assess the toxic potential of sediments. This portable fluorescent biosensor uses photosynthetic enzyme complexes (PECs) to rapidly measure photosynthetic efficiency. LuminoTox testing of 14 CRM (Certified Reference Material) sediments was first undertaken with (1) a "solid phase assay" (Lum-SPA) in which PECs are in intimate contact with sediment slurries for a 15 min exposure period and (2) an elutriate assay (Lum-ELU) in which PECs are exposed for 15 min to sediment water elutriates. CRM sediment toxicity data were then compared with those generated with the Microtox Solid Phase Assay (Mic-SPA). A significant correlation (P < 0.05) was shown to exist between Lum-SPA and Mic-SPA, indicating that both tests display a similar toxicity response pattern for CRM sediments having differing contaminant profiles. The sediment elutriate Lum-ELU assay displayed toxicity responses (i.e. measurable IC20s) for eight of the 14 CRM sediments, suggesting that it is capable of determining the presence of sediment contaminants that are readily soluble in an aqueous elutriate. Lum-SPA and Mic-SPA bioassays were further conducted on 12 natural freshwater sediments and their toxicity responses were more weakly, yet significantly, correlated. Finally, Lum-SPA testing undertaken with increasing mixtures of kaolin clay confirmed that its toxicity responses, in a manner similar to those reported for the Mic-SPA assay, are also subject to the influence of grain size. While further studies will be required to more fully understand the relationship between Lum-SPA assay responses and the physicochemical makeup of sediments (e.g., grain size, combined presence of natural and anthropogenic contaminants), these preliminary results suggest that LuminoTox testing could be a useful screen to assess the toxic potential of solid media.

  13. Assessing cytogenotoxicity of cigarette smoke condensates using three in vitro assays.

    PubMed

    Jianlin, Lou; Guohai, Chu; Guojun, Zhou; Jian, Jiang; Fangfang, Huang; Juanjuan, Xu; Shu, Zheng; Zhijian, Chen; Wei, Jiang; Yezhen, Lu; Xiaoxue, Li; Jiliang, He

    2009-01-01

    Cigarette smoke condensates (CSCs) are complex mixed compounds that contain both direct and indirect mutagens/carcinogens. To detect genotoxicity of CSCs in vitro, a combination of various enzymes (e.g. activation and detoxification enzymes) called S9 is usually added. However, as S9 may induce cytotoxicity in target cells, it is unclear whether the addition of S9 can impact CSC-induced toxicity. Here, differences in cytogenotoxicity between CSCs in the presence or absence of S9 were studied using three in vitro assays (neutral red uptake assay, comet assay, and TCR gene mutation test) in human peripheral lymphocytes, which were exposed to CSCs at doses of 25, 50, 75, 100 and 125 microg/ml for 4 h. Assay results showed that both CSCs + S9 or CSCs - S9 could induce a dose-dependent elevation of cytogenotoxic effects in human lymphocytes with some differences between the two groups. The cytogenotoxicity induced by CSCs - S9 was significantly higher than that induced by CSCs + S9 in all three assays. The comet and NRU assays revealed that a dose-response relationship of cytogenotoxicity induced by CSCs + S9 was less typical than that induced by CSCs - S9, possibly due to specific cytogenotoxic agents in CSCs and enzymes contained in the S9 mixture. Thus, the three in vitro assays used in the present study are suitable for detecting cytogenotoxic effects in human lymphocytes induced by CSCs. Furthermore, the cytogenotoxicity induced by both CSCs + S9 and CSCs - S9 should be measured simultaneously when assessing and comparing the biological activity of different CSCs.

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

    PubMed

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

    2016-09-01

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

  15. 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

    2015-05-05

    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.

  16. 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.

  17. Assessing Transmissible Spongiform Encephalopathy Species Barriers with an In Vitro Prion Protein Conversion Assay

    PubMed Central

    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. In vitro comparative assessment of different viability assays in Acanthamoeba castellanii and Acanthamoeba polyphaga trophozoites.

    PubMed

    Heredero-Bermejo, I; Copa-Patiño, J L; Soliveri, J; Gómez, R; de la Mata, F J; Pérez-Serrano, J

    2013-12-01

    The species of the genus Acanthamoeba are opportunistic protozoan parasites that cause different diseases in humans, such as amoebic keratitis and granulomatous encephalitis. The rise in the rate of Acanthamoeba keratitis, mainly due to the increase in contact lens wearers, turns the development of viability assays using a multi-well plate reader as a tool for screening new antiamoebic agents in vitro into an important goal. In our study, the viability assays PrestoBlue®, resazurin sodium salt, 3-(4,5-dimethylthiazol-2yl)-2,5-diphenyltetrazolium bromide (MTT) and CellTiter96® were tested for their suitability as time-saving alternatives to the classical manual or direct-counting method, assessing the effect of the antiamoebic agent chlorhexidine digluconate and temperature on Acanthamoeba castellanii (ATCC® 30234™) and Acanthamoeba polyphaga 2961. Although resazurin and MTT have already been previously used in amoeba viability assays to test the activities of antiamoebic agents in vitro, it is the first time that PrestoBlue® and CellTiter96® are used for this purpose. Results indicated that the viability assays were strain-dependent leading in some cases to an overestimation of the real situation of viable cells. This implies that each viability assay ought to be set up for each amoeba strain studied.