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Sample records for risk assessment assays

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

    PubMed Central

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

    2016-01-01

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

  2. 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. 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.

  5. 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.

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

    PubMed

    Sieroslawska, Anna

    2014-07-01

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

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

    PubMed Central

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

    2013-01-01

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

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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...

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

    PubMed

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

    2014-11-23

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

  16. 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

  17. 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.

  18. 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

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

    EPA Science Inventory

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

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

    PubMed

    Martins, Marta; Costa, Pedro M

    2015-01-01

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

  1. Assessment of 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.

  2. 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.

  3. 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.

  4. 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

  5. Hepatitis Risk Assessment

    MedlinePlus

    ... please visit this page: About CDC.gov . Hepatitis Risk Assessment Recommend on Facebook Tweet Share Compartir Viral Hepatitis. ... you at risk? Take this 5 minute Hepatitis Risk Assessment developed by the CDC and get a personalized ...

  6. Risk Assessment: Evidence Base

    NASA Technical Reports Server (NTRS)

    Johnson-Throop, Kathy A.

    2007-01-01

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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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)

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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".

  3. 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.

  4. 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.

  5. 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.

  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. 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.

  8. 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.

  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. 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

  12. 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.

  13. 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...

  14. 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

  15. 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.

  16. Nanotechnologies: Risk assessment model

    NASA Astrophysics Data System (ADS)

    Giacobbe, F.; Monica, L.; Geraci, D.

    2009-05-01

    The development and use of nanomaterials has grown widely in the last years. Hence, it is necessary to carry out a careful and aimed risk assessment for the safety of the workers. The objective of this research is a specific assessment model finalized to the workplaces where the personnel work manipulating nanoparticles. This model mainly takes into account the number of exposed workers, the dimensions of particles, the information found in the safety data sheets and the uncertainties about the danger level coming from the exposition to nanomaterials. The evaluation algorithm considers the normal work conditions, the abnormal (e.g. breakdown air filter) and emergency situations (e.g. package cracking). It has been necessary to define several risk conditions in order to quantify the risk by increasing levels ("low", "middle" and "high" level). Each level includes appropriate behavioural procedures. In particular for the high level, it is advisable that the user carries out urgent interventions finalized to reduce the risk level (e.g. the utilization of vacuum box for the manipulation, high efficiency protection PPE, etc). The model has been implemented in a research laboratory where titanium dioxide and carbon nanotubes are used. The outcomes taken out from such specific evaluation gave a risk level equal to middle.

  17. 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.

  18. 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.

  19. 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.

  20. 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:

  1. [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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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

  1. 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).

  2. [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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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…

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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...

  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. 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...

  4. The risk assessment information system

    SciTech Connect

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

    1998-06-01

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

  5. Anthropic Risk Assessment on Biodiversity

    NASA Astrophysics Data System (ADS)

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

    2013-01-01

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

  6. Improving pandemic influenza risk assessment

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  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. 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.

  9. 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.

  10. Taking the Risk Out of Risk Assessment

    NASA Technical Reports Server (NTRS)

    2005-01-01

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

  11. 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 ...

  12. 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.

  13. 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:

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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)

  19. 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.

  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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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.

  6. 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.

  7. 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…

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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 ...

  13. 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.

  14. 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.

  15. 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.

  16. 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...

  17. 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…

  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. 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

  20. 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

  1. 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.

  2. 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.

  3. 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

  4. [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.

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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…

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. 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...

  5. [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.

  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. 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.

  8. 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.

  9. 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.

  10. 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...

  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 (ERA) and to mark progress toward resource management goals. In late 1997...

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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...

  20. 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.

  1. 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.

  2. 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.

  3. 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.

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

    SciTech Connect

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

    2009-01-15

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

  5. 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.

  6. 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)

  7. Assessing nanoparticle risk poses prodigious challenges

    EPA Science Inventory

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

  8. LINES OF EVIDENCE IN WILDLIFE RISK ASSESSMENTS

    EPA Science Inventory

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

  9. Risk Assessment: 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,…

  10. 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…

  11. 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...

  12. 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.

  13. 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.

  14. 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

  15. 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.

  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. 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.

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  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. 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.

  8. 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.

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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...

  19. 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 ...

  20. 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

  1. 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.

  2. 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

  3. 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…

  4. 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.

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

    PubMed

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

    2016-01-01

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

  6. 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

  7. 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.

  8. TOXICOLOGICAL BASIS FOR DRINKING WATER RISK ASSESSMENT

    EPA Science Inventory

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

  9. 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.

  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. 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)

  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 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.

  14. 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

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

    PubMed Central

    Chung, Young-Shin

    2013-01-01

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

  16. [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.

  17. 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

  18. 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…

  19. 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...

  20. FRAMEWORK FOR INORGANIC METALS RISK ASSESSMENT

    EPA Science Inventory

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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…

  6. 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.

  7. 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

  8. 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

  9. 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...

  10. 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.

  11. 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.

  12. 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...

  13. 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

  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. 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.

  16. 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

  17. 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.

  18. 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

  19. 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...

  20. 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.

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. [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

  13. [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.

  14. Recidivism Risk Assessment for Adult Sexual Offenders.

    PubMed

    Holoyda, Brian J; Newman, William J

    2016-02-01

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

  15. 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

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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

  7. Risk Assessment for Toxic Air Pollutants: A Citizen's Guide

    MedlinePlus

    ... IT ALL UP Public health agencies concerned with air quality perform risk assessments to determine the increased risk of illness from a specific human exposure to a toxic air pollutant. Risk assessment is a four-step process: ( ...

  8. 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.

  9. 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

  10. 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.

  11. 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...

  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. 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...

  14. 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…

  15. 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.

  16. 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...

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 77 FR 58590 - Determining Technical Adequacy of Probabilistic Risk Assessment for Risk-Informed License...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

    ... COMMISSION Determining Technical Adequacy of Probabilistic Risk Assessment for Risk-Informed License...: LWR Edition,'' Section 19.1, ``Determining the Technical Adequacy of Probabilistic Risk Assessment for... Probabilistic Risk Assessment for Risk-Informed License Amendment Requests After Initial Fuel Load''...

  18. 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.

  19. Ecological Risk Assessment Guidance for Superfund: Process for Designing and Conducting Ecological Risk Assessments - Interim Final

    EPA Pesticide Factsheets

    This document provides guidance to site managers and Remedial Project Managers who are legally responsible for the management of a site on how to design and conduct technically defensible ecological risk assessments for the Superfund program.

  20. Asteroid Risk Assessment: A Probabilistic Approach.

    PubMed

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

    2016-02-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

  3. 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...

  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. [Risk assessment of genetically modified organisms].

    PubMed

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

    2011-01-01

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

  6. Supplemental Hazard Analysis and Risk Assessment - Hydrotreater

    SciTech Connect

    Lowry, Peter P.; Wagner, Katie A.

    2015-04-01

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

  7. Assessing the cancer risk from environmental PCBs.

    PubMed Central

    Cogliano, V J

    1998-01-01

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

  8. Risk assessment meta tool LDRD final report.

    SciTech Connect

    Bouchard, Ann Marie; Osbourn, Gordon Cecil

    2006-12-01

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

  9. Chernobyl accident: A comprehensive risk assessment

    SciTech Connect

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

    1999-11-01

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

  10. The Chornobyl accident: A comprehensive risk assessment

    SciTech Connect

    Vargo, G.J.; Poyarkov, V.; Bar`yakhtar, V.; Kukhar, V.; Los, I.; Kholosha, V.; Shestopalov, V.

    1999-10-01

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

  11. Chernobyl accident: A comprehensive risk assessment

    SciTech Connect

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

    1999-01-01

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

  12. Degraded environments alter prey risk assessment.

    PubMed

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

    2012-01-01

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

  13. Obsolescence Risk Assessment Process Best Practice

    NASA Astrophysics Data System (ADS)

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

    2012-05-01

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

  14. Depression in primary care: assessing suicide risk

    PubMed Central

    Ng, Chung Wai Mark; How, Choon How; Ng, Yin Ping

    2017-01-01

    Major depression is a common condition seen in the primary care setting. This article describes the suicide risk assessment of a depressed patient, including practical aspects of history-taking, consideration of factors in deciding if a patient requires immediate transfer for inpatient care and measures to be taken if the patient is not hospitalised. It follows on our earlier article about the approach to management of depression in primary care. PMID:28210741

  15. Point Judith, Rhode Island, Breakwater Risk Assessment

    DTIC Science & Technology

    2015-08-01

    cycle of storm events includes both the extreme damaging events as well as the operational events that limit safe navigation. 2.5 Wave and water ...compared to the as-built condition is unknown. This report provides a summary of a life- cycle risk assessment of the Point Judith Main breakwater. The... water level climate, probabilistic characteristics of the historical wave and water level climate, simulated breakwater damage and wave overtopping

  16. Gender, risk assessment, and political ambition.

    PubMed

    Sweet-Cushman, Jennie

    2016-01-01

    In the United States, women have long held the right to vote and can participate fully in the political process, and yet they are underrepresented at all levels of elected office. Worldwide, men's dominance in the realm of politics has also been the norm. To date, scholars have focused on supply-side and demand-side explanations of women's underrepresentation but differences in how men and women assess electoral risk (the risk involved in seeking political office) are not fully explained. To fill this gap, I explore how evolutionary theory offers insights into gendered differences in political ambition and the evaluation of electoral risk. Using the framework of life-history theory, I hypothesize that both cognitive and environmental factors in human evolution, particularly as they relate to sexual selection and social roles, have shaped the psychology of ambition in gendered ways affecting contemporary politics. Cognitive risk-assessment mechanisms evolving in the hominid line came to be expressed differently in females and males, in women and men. These gendered expressions plausibly reflect differentiable environmental pressures in the past and may help explain behaviors in and barriers to women's electoral political activity in the present. If so, then the success of efforts to increase such activity - or, regressively, to suppress it - may be better understood.

  17. Ecological risk assessment benefits environmental management

    SciTech Connect

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

    1994-12-31

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

  18. Natural-technological risk assessment and management

    NASA Astrophysics Data System (ADS)

    Burova, Valentina; Frolova, Nina

    2016-04-01

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

  19. 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

  20. 49 CFR Appendix B to Part 236 - Risk Assessment Criteria

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  1. 49 CFR Appendix B to Part 236 - Risk Assessment Criteria

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Risk Assessment Criteria B Appendix B to Part 236... B to Part 236—Risk Assessment Criteria The safety-critical performance of each product for which risk assessment is required under this part must be assessed in accordance with the following...

  2. 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

  3. 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.

  4. Offshore blowouts, data for risk assessment

    SciTech Connect

    Holand, P.

    1995-12-31

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

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

    PubMed

    Silverman, Morton M

    2014-09-01

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

  6. 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.

  7. Project Fox: Assessing Risks Posed By Asteroids

    NASA Astrophysics Data System (ADS)

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

    2013-12-01

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

  8. 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.

  9. Visual Impairment/Intracranial Pressure Risk Assessment

    NASA Technical Reports Server (NTRS)

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

    2010-01-01

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

  10. Ecological risk assessment of a decommissioned military base

    SciTech Connect

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

    1995-12-31

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

  11. 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.

  12. 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...

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

    EPA Science Inventory

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

  14. Asteroid Airbursts: Risk Assessment and Reduction

    NASA Astrophysics Data System (ADS)

    Boslough, M.

    2015-12-01

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

  15. A classification scheme for risk assessment methods.

    SciTech Connect

    Stamp, Jason Edwin; Campbell, Philip LaRoche

    2004-08-01

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

  16. Spent Nuclear Fuel Alternative Technology Risk Assessment

    SciTech Connect

    Perella, V.F.

    1999-11-29

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

  17. Environmental risk assessment in GMO analysis.

    PubMed

    Pirondini, Andrea; Marmiroli, Nelson

    2010-01-01

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

  18. Environmental risk assessment in GMO analysis.

    PubMed

    Pirondini, Andrea; Marmiroli, Nelson

    2008-01-01

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

  19. Workshop overview: Arsenic research and risk assessment

    SciTech Connect

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

    2007-08-01

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

  20. [Thinking on risk assessment and risk management of post-marketing Chinese medicine].

    PubMed

    Yu, Xueqing; Xie, Yanming; Wang, Yongyan

    2012-01-01

    Drug risk assessment and management is an important measure for reducing the adverse drug reaction and enhancing medication safety of the patient. Based on the concepts of drug risk assessment and risk management, and domestic and international drug risk management situation, this paper discusses the risk management of post-marketing Chinese medicine.

  1. Technical Overview of Ecological Risk Assessment - Analysis Phase: Exposure Characterization

    EPA Pesticide Factsheets

    Exposure Characterization is the second major component of the analysis phase of a risk assessment. For a pesticide risk assessment, the exposure characterization describes the potential or actual contact of a pesticide with a plant, animal, or media.

  2. INTEGRATED RISK ASSESSMENT - RESULTS FROM AN INTERNATIONAL WORKSHOP

    EPA Science Inventory

    The WHO International Programme on Chemical Safety and international partners have developed a framework for integrated assessment of human health and ecological risks and four case studies. An international workshop was convened to consider how ecological and health risk assess...

  3. Considering Environmental and Occupational Stressors in Cumulative Risk Assessments

    EPA Science Inventory

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

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

    EPA Science Inventory

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

  5. Dosimetry and Risk Assessment: Fundamental Concepts

    SciTech Connect

    Fisher, Darrell R.

    2005-12-29

    Radiation dosimetry is important for characterizing radiation exposures and for risk assessment. In a medical setting, dosimetry is important for evaluating the safety of administered radiopharmaceuticals and for planning the safe administration of therapeutic radionuclides. Environmental dosimetry helps establish the safety of radionuclide releases from electric power production and other human activities. Internal and external dosimetry help us understand the consequences of radiation exposure. The absorbed dose is the fundamental quantity in radiation dosimetry from which all other operational values in radiation protection are obtained. Equivalent dose to tissue and effective dose to the whole body are derivatives of absorbed dose and constructs of risk. Mathematical systems supported by computer software facilitate dose calculations and make it possible to estimate internal dose based on bioassay or other biokinetic data. Risk coefficients for radiation-induced cancer rely primarily on data from animal studies and long-term observations of the Hiroshima and Nagasaki bomb survivors. Low-dose research shows that mechanisms of radiation interactions with tissue are dose-dependent, but the resulting biological effects are not necessarily linear with absorbed dose. Thus, the analysis of radiation effects and associated risks must account for the influences of microscopic energy distributions at the cellular level, dose-rate, cellular repair of sub-lethal radiation damage, and modifying factors such as bystander effects, adaptive response, and genomic instability.

  6. Harmonization of international risk assessment protocol.

    PubMed

    Toyofuku, Hajime

    2006-01-01

    For over centuries developments in food production and new food safety management systems in most developed countries have been perceived by many to be efficient in the prevention of food-borne disease. Nevertheless a number of problems remain dominant, one of these being the high level of food-borne microbiological disease which seems, for some pathogens, to have increased over the last decades. The development of an interdisciplinary approach with direct interaction between surveillance and risk analysis systems is described as a potential basis for improved prevention of food-borne disease. Quantitative microbiological risk assessment is a relatively new scientific approach, able to link data from food within the entire food chain and the various data on human disease to provide a clear estimation of risk. Today food safety is one of the WHOs top eleven priorities; the Organization calls for more systematic and aggressive steps to be taken to reduce significantly the risk of microbiological food-borne diseases. Dealing with this challenge is one of the major challenges for the 21st century in regard to food safety, implying a significant re-direction of food microbiology efforts in many parts of the world.

  7. Assessment of cardiovascular risk in hypertensive patients: a comparison of commonly used risk scoring programs.

    PubMed

    Ulusoy, Sükrü

    2013-12-01

    Several calculation modalities are used today for cardiovascular risk assessment. Cardiovascular risk assessment should be performed in all hypertensive patients. Risk assessment methods being based on the population in which the patient lives and the inclusion of factors such as ethnicity variations, socioeconomic status, and medication use will contribute to improvements in risk assessments. The results should be shared with the patient, and modifiable risk factors must be effectively treated.

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

    PubMed

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

    2014-03-01

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

  9. Risk assessment of soybean-based phytoestrogens.

    PubMed

    Kwack, Seung Jun; Kim, Kyu-Bong; Kim, Hyung Sik; Yoon, Kyung Sil; Lee, Byung Mu

    2009-01-01

    Koreans generally consume high quantities of soybean-based foods that contain a variety of phytoestrogens, such as, daidzein, zenistein, and biochalin A. However, phytoestrogens are considered to be potential endocrine-disrupting chemicals (EDC), which interfere with the normal function of the hormonal and reproductive systems. Therefore, dietary exposure to soybean-based phytoestrogens is of concern for Koreans, and comparative dietary risk assessments are required between Japanese (high consumers) versus Americans (low consumers). In this study, a relative risk assessment was conducted based upon daily intake levels of soybean-based foods and phytoestrogens in a Korean cohort, and the risks of photoestrogens were compared with those posed by estradiol and other EDC. Koreans approximately 30-49 yr of age consume on average a total of 135.2 g/d of soy-based foods including soybean, soybean sauce, soybean paste, and soybean oil, and 0.51 mg/kg body weight (bw)/d of phytoestrogens such as daidzein and genistein. Using estimated daily intakes (EDI) and estrogenic potencies (EP), margins of safety (MOS) were calculated where 0.05 is for estradiol (MOS value <1, considered to exert a positive estrogenic effect); thus, MOS values of 1.89 for Japanese, 1.96 for Koreans, and 5.55 for Americans indicate that consumption of soybean-based foods exerted no apparent estrogenic effects, as all MOS values were all higher than 1. For other synthetic EDC used as reference values, MOS values were dieldrin 27, nonylphenol 250, butyl benzyl phthalate 321, bisphenol A 1000, biochanin A 2203, and coumesterol 2898. These results suggest that dietary exposure to phytoestrogens, such as daidzein and genistein, poses a relatively higher health risk for humans than synthetic EDC, although MOS values were all greater than 1.

  10. Twenty Years of Progress in Violence Risk Assessment

    ERIC Educational Resources Information Center

    Hanson, R. Karl

    2005-01-01

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

  11. 78 FR 23901 - Interagency Risk Assessment-Listeria monocytogenes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-23

    ... Food Safety and Inspection Service Interagency Risk Assessment--Listeria monocytogenes in Retail... risk assessment (QRA), ``Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens... and on the FSIS Web site at http://www.fsis.usda.gov/PDF/Listeria-Transcript_062309.pdf ). II....

  12. Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document

    SciTech Connect

    Astuto-Gribble, Lisa M; Caskey, Susan Adele

    2014-07-01

    The purpose of this document is threefold: 1) to describe the laboratory bio safety and biosecurity risk assessment process and its conceptual framework; 2) provide detailed guidance and suggested methodologies on how to conduct a risk assessment; and 3) present some practical risk assessment process strategies using realistic laboratory scenarios.

  13. Assessing risk of solid waste compost

    SciTech Connect

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

    1987-03-01

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

  14. Command hallucinations, compliance, and risk assessment.

    PubMed

    Hersh, K; Borum, R

    1998-01-01

    Command hallucinations are auditory hallucinations that instruct a patient to act in specific ways; these commands can range in seriousness from innocuous to life-threatening. This article summarizes two areas of research regarding command hallucinations: rates of compliance with command hallucinations; and factors associated with compliance. Researchers have reported rates of compliance ranging from 39.2 percent to 88.5 percent. Compliance has not been consistently related to dangerousness of commands. Instead, research suggests that Individuals are more likely to comply with commands if they recognize the hallucinated voice and if their hallucinations are related to a delusion. Implications for risk assessment are discussed in light of the research.

  15. Session: Pre-development project risk assessment

    SciTech Connect

    Curry, Richard; Linehan, Andy

    2004-09-01

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

  16. Anthropometry in cardio-metabolic risk assessment.

    PubMed

    Mišigoj-Duraković, Marjeta; Sorić, Maroje; Duraković, Zijad

    2014-03-01

    High prevalence of obesity, as a major public health problem, is connected with chronic cardiovascular and metabolic diseases. That is why some simple anthropometric parameters were developed to estimate overweight and obesity, and in the primary screening of risk groups. In this field, body mass index (BMI) is the most frequent parameter, both in epidemiological research and in everyday practice. It is a part of the algorithm used in the early detection of overweight and obese persons. However, BMI does not provide any data on body composition. This is why it is particularly insufficient in estimating body mass in physically active persons and in athletes who are often overweight, with a higher proportion of lean body mass but without any excess fat, as well as in those with normal weight but lower than normal lean body mass and/ or gentle skeleton. Over the last few decades, attention has been especially directed to different body fat distribution in relation to chronic cardio-vascular and metabolic diseases. Waist circumference (WC) is the best anthropometric predictor of cardiovascular risk. It is considered an indirect parameter of visceral fat. WC and waist-to-hip ratio are good parameters showing body fat distribution and cardio-metabolic risk. Waist-to-height ratio is suggested by some authors to be an even better parameter of cardio-vascular risk and metabolic syndrome. Hypertriglyceridemia combined with increased WC is considered a marker of atherogenic metabolic risk. The paper also deals with procedures of body composition analysis. Anthropometric assessment of body composition analysis belongs to a group of simple and inexpensive procedures. Development of generalised equations for body density prediction introduced anthropometric methods in the analysis of body composition in everyday practice.

  17. NEUROBEHAVIORAL TESTING IN HUMAN RISK ASSESSMENT

    PubMed Central

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

    2008-01-01

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

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

    PubMed

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

    2014-12-01

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

  19. 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.

  20. Assessments of direct human exposure: the approach of EU risk assessments compared to scenario-based risk assessment.

    PubMed

    Wormuth, Matthias; Demou, Evangelia; Scheringer, Martin; Hungerbühler, Konrad

    2007-08-01

    The awareness of potential risks emerging from the use of chemicals in all parts of daily life has increased the need for risk assessments that are able to cover a high number of exposure situations and thereby ensure the safety of workers and consumers. In the European Union (EU), the practice of risk assessments for chemicals is laid down in a Technical Guidance Document; it is designed to consider environmental and human occupational and residential exposure. Almost 70 EU risk assessment reports (RARs) have been finalized for high-production-volume chemicals during the last decade. In the present study, we analyze the assessment of occupational and consumer exposure to trichloroethylene and phthalates presented in six EU RARs. Exposure scenarios in these six RARs were compared to scenarios used in applications of the scenario-based risk assessment approach to the same set of chemicals. We find that scenarios used in the selected EU RARs to represent typical exposure situations in occupational or private use of chemicals and products do not necessarily represent worst-case conditions. This can be due to the use of outdated information on technical equipment and conditions in workplaces or omission of pathways that can cause consumer exposure. Considering the need for exposure and risk assessments under the new chemicals legislation of the EU, we suggest that a transparent process of collecting data on exposure situations and of generating representative exposure scenarios is implemented to improve the accuracy of risk assessments. Also, the data sets used to assess human exposure should be harmonized, summarized in a transparent fashion, and made accessible for all risk assessors and the public.

  1. 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

  2. Assessing risk factors for periodontitis using regression

    NASA Astrophysics Data System (ADS)

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

    2013-10-01

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

  3. Cyanide analyses for risk and treatability assessments

    SciTech Connect

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

    1994-12-31

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

  4. Hydrogen quantitative risk assessment workshop proceedings.

    SciTech Connect

    Groth, Katrina M.; Harris, Aaron P.

    2013-09-01

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

  5. Simulation Assisted Risk Assessment: Blast Overpressure Modeling

    NASA Technical Reports Server (NTRS)

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

    2006-01-01

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

  6. Actuarial assessment of risk among sex offenders.

    PubMed

    Harris, Grant T; Rice, Marnie E

    2003-06-01

    The appraisal of risk among sex offenders has seen recent advances through the advent of actuarial assessments. Statistics derived from Relative Operating Characteristics (ROCs) permit the comparison of predictive accuracies achieved by different instruments even among samples that exhibit different base rates of recidivism. Such statistics cannot, however, solve problems introduced when items from actuarial tools are omitted, when reliability is low, or when there is high between-subject variability in the duration of the follow-up. We present empirical evidence suggesting that when comprehensive actuarial tools (VRAG and SORAG) are scored with high reliability, without missing items, and when samples of offenders have fixed and equal opportunity for recidivism, predictive accuracies are maximized near ROC areas of 0.90. Although the term "dynamic" has not been consistently defined, such accuracies leave little room for further improvement in long-term prediction by dynamic risk factors. We address the mistaken idea that long-term, static risk levels have little relevance for clinical intervention with sex offenders. We conclude that highly accurate prediction of violent criminal recidivism can be achieved by means of highly reliable and thorough scoring of comprehensive multi-item actuarial tools using historical items (at least until potent therapies are identified). The role of current moods, attitudes, insights, and physiological states in causing contemporaneous behavior notwithstanding, accurate prediction about which sex offenders will commit at least one subsequent violent offense can be accomplished using complete information about past conduct.

  7. Classification accuracy of actuarial risk assessment instruments.

    PubMed

    Neller, Daniel J; Frederick, Richard I

    2013-01-01

    Users of commonly employed actuarial risk assessment instruments (ARAIs) hope to generate numerical probability statements about risk; however, ARAI manuals often do not explicitly report data that are essential for understanding the classification accuracy of the instruments. In addition, ARAI manuals often contain data that have the potential for misinterpretation. The authors of the present article address the accurate generation of probability statements. First, they illustrate how the reporting of numerical probability statements based on proportions rather than predictive values can mislead users of ARAIs. Next, they report essential test characteristics that, to date, have gone largely unreported in ARAI manuals. Then they discuss a graphing method that can enhance the practice of clinicians who communicate risk via numerical probability statements. After the authors review several strategies for selecting optimal cut-off scores, they show how the graphing method can be used to estimate positive predictive values for each cut-off score of commonly used ARAIs, across all possible base rates. They also show how the graphing method can be used to estimate base rates of violent recidivism in local samples.

  8. VOLCANIC RISK ASSESSMENT - PROBABILITY AND CONSEQUENCES

    SciTech Connect

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

    2005-08-26

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

  9. 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.

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

    ERIC Educational Resources Information Center

    Campbell, Martin; McCue, Michael

    2013-01-01

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

  11. 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.

  12. 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.

  13. 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

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

    PubMed

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

    2015-01-01

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

  15. 78 FR 36787 - Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia... the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without...

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

    PubMed

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

    2012-12-01

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

  17. Quantitative Risk Assessment for Enhanced Geothermal Systems

    NASA Astrophysics Data System (ADS)

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

    2011-12-01

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

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

    NASA Technical Reports Server (NTRS)

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

    2008-01-01

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

  19. [Risk assessment of periodontal disease in Hungary].

    PubMed

    Hermann, Péter; Borbély, Judit; Gera, István; Fejérdy, Pál; Soós, Borbála; Madléna, Melinda

    2011-06-01

    In this study, risk determinants were assessed for periodontal disease in the oral health survey of a representative Hungarian adult population sample. 4153 individuals participated in the study after formal consent. Participants were questionned on level of education, dental office attendance, smoking habits, oral hygiene habits and general health conditions. Quality of fixed partial dentures (FPD) were evaluated. Periodontal health status was assessed with the CPI method according to WHO criteria. When the prevalence of CPI scores was assessed by educational level, significant differences were found between groups. With increasing levels of education, a significantly higher percentage of subjects visited the dental office regularly. Higher prevalence of CPI 0 was found among those with higher level of education but there was also high prevalence of CPI 2, representing bad oral hygiene in the highly educated group. Findings of our study showed high percentage (66%) of the population attending the dental office only in case of emergency. The investigation revealed destructive effect of unsatisfactory construction of FPD on the periodontium. Healthy periodontium (CPI 0) was found among 16% of those wearing no FPD and 9% among FPD-wearers. The prevalence of deep periodontal pockets (CPI 4) was 1,6 times higher among smokers as non-smokers. Oral health statistics play an important role in planning for improvement of dental health care. Hungary needs effective prevention programs and emphasize on regular dental office attendance of individuals to improve the nation's oral health status.

  20. A Successful ED Fall Risk Program Using the KINDER 1 Fall RiskAssessment Tool.

    PubMed

    Townsend, Ann B; Valle-Ortiz, Marisol; Sansweet, Tracy

    2016-11-01

    Emergency nurses did not perform falls risk assessments routinely on our ED patients; the instrument used was aimed at inpatients. We identified a need to revise fall assessment practices specific to our emergency department. The purpose of the performance improvement project was to reduce ED falls and evaluate the use of an ED-specific fall risk tool, the KINDER 1 Fall Risk Assessment. The plan was to establish fall risk assessment practices at point of ED entry and to decrease total falls.

  1. Assessing and Managing Multiple Risks in a Changing World ...

    EPA Pesticide Factsheets

    Roskilde University hosted a November 2015 workshop on “Environmental RiskAssessing and Managing Multiple Risks in a Changing World”. Thirty attendees from 9 countries developed consensus recommendations regarding: implementation of a common currency (ecosystem services) for holistic environmental risk assessment and management; improvements to risk assessment and management in a complex, human-modified, and changing world; appropriate development of protection goals in a 2-stage process involving both universal and site-, region-, or problem-specific protection goals; addressing societal issues; risk management information needs; conducting risk assessment of risk management; and development of adaptive and flexible regulatory systems. We encourage both cross- and inter-disciplinary approaches to address 10 recommendations: 1) adopt ecosystem services as a common currency for risk assessment and management; 2) consider cumulative stressors (chemical and non-chemical) and determine which dominate to best manage and restore ecosystem services; 3) fully integrate risk managers and communities of interest into the risk assessment process; 4) fully integrate risk assessors and communities of interest into the risk management process; 5) consider socio-economics and increase transparency in both risk assessment and risk management; 6) recognize the ethical rights of humans and ecosystems to an adequate level of protection; 7) determine relevant reference con

  2. Nanomaterials: a challenge for toxicological risk assessment?

    PubMed

    Haase, Andrea; Tentschert, Jutta; Luch, Andreas

    2012-01-01

    Nanotechnology has emerged as one of the central technologies in the twenty-first century. This judgment becomes apparent by considering the increasing numbers of people employed in this area; the numbers of patents, of scientific publications, of products on the market; and the amounts of money invested in R&D. Prospects originating from different fields of nanoapplication seem unlimited. However, nanotechnology certainly will not be able to meet all of the ambitious expectations communicated, yet has high potential to heavily affect our daily life in the years to come. This might occur in particular in the field of consumer products, for example, by introducing nanomaterials in cosmetics, textiles, or food contact materials. Another promising area is the application of nanotechnology in medicine fueling hopes to significantly improve diagnosis and treatment of all kinds of diseases. In addition, novel technologies applying nanomaterials are expected to be instrumental in waste remediation and in the production of efficient energy storage devices and thus may help to overcome world's energy problems or to revolutionize computer and data storage technologies. In this chapter, we will focus on nanomaterials. After a brief historic and general overview, current proposals of how to define nanomaterials will be summarized. Due to general limitations, there is still no single, internationally accepted definition of the term "nanomaterial." After elaborating on the status quo and the scope of nanoanalytics and its shortcomings, the current thinking about possible hazards resulting from nanoparticulate exposures, there will be an emphasis on the requirements to be fulfilled for appropriate health risk assessment and regulation of nanomaterials. With regard to reliable risk assessments, until now there is still the remaining issue to be resolved of whether or not specific challenges and unique features exist on the nanoscale that have to be tackled and distinctively

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

    SciTech Connect

    Marcy, S.K.M.

    1994-12-31

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

  4. Evolving regulatory paradigm for proarrhythmic risk assessment for new drugs.

    PubMed

    Vicente, Jose; Stockbridge, Norman; Strauss, David G

    Fourteen drugs were removed from the market worldwide because their potential to cause torsade de pointes (torsade), a potentially fatal ventricular arrhythmia. The observation that most drugs that cause torsade block the potassium channel encoded by the human ether-à-go-go related gene (hERG) and prolong the heart rate corrected QT interval (QTc) on the ECG, led to a focus on screening new drugs for their potential to block the hERG potassium channel and prolong QTc. This has been a successful strategy keeping torsadogenic drugs off the market, but has resulted in drugs being dropped from development, sometimes inappropriately. This is because not all drugs that block the hERG potassium channel and prolong QTc cause torsade, sometimes because they block other channels. The regulatory paradigm is evolving to improve proarrhythmic risk prediction. ECG studies can now use exposure-response modeling for assessing the effect of a drug on the QTc in small sample size first-in-human studies. Furthermore, the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative is developing and validating a new in vitro paradigm for cardiac safety evaluation of new drugs that provides a more accurate and comprehensive mechanistic-based assessment of proarrhythmic potential. Under CiPA, the prediction of proarrhythmic potential will come from in vitro ion channel assessments coupled with an in silico model of the human ventricular myocyte. The preclinical assessment will be checked with an assessment of human phase 1 ECG data to determine if there are unexpected ion channel effects in humans compared to preclinical ion channel data. While there is ongoing validation work, the heart rate corrected J-Tpeak interval is likely to be assessed under CiPA to detect inward current block in presence of hERG potassium channel block.

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

    PubMed

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

    2013-01-20

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

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

    SciTech Connect

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

    2010-03-15

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

  7. Radiological risk assessment of environmental radon

    SciTech Connect

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

    2013-11-27

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

  8. Radiological risk assessment of environmental radon

    NASA Astrophysics Data System (ADS)

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

    2013-11-01

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

  9. Risk assessment of malicious biocontamination of food.

    PubMed

    Elad, Daniel

    2005-06-01

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

  10. Performing Probabilistic Risk Assessment Through RAVEN

    SciTech Connect

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

    2013-06-01

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

  11. Impact assessment of risk management interventions.

    PubMed

    Shryock, T R

    2012-04-01

    Much effort has been invested in the development and implementation of international recommendations to manage the risk of foodborne antimicrobial resistance, and monitoring programmes to measure bacterial antimicrobial resistance and antimicrobial product volumes. A variety of approaches have been recommended for various stakeholders in the food animal and food production sectors. Interestingly, much less consideration has been given to the establishment of success criteria for the individual interventions and even less for the cumulative effects, when all interventions are considered together as consecutive 'hurdles' along the food chain. The author explores the outcome and unforeseen consequences of these various interventions and appropriate methods that could provide data to assess their impact, as well as key learning experiences that should lead to refinements of such interventions in the future.

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

    PubMed

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

    2015-06-01

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

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

    SciTech Connect

    Lamuro, R.J.

    1992-09-30

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

  14. Risk Assessment of the Carbon Nanotube Group

    PubMed Central

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

    2015-01-01

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

  15. Inhalation cancer risk assessment of cobalt metal.

    PubMed

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

    2016-08-01

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

  16. Evolutionary Consequences for Ecological Risk Assessment and Management.

    ERIC Educational Resources Information Center

    Gochfeld, Michael; Burger, Joanna

    1993-01-01

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

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

    EPA Science Inventory

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

  18. Assessing and managing multiple risks in a changing world ...

    EPA Pesticide Factsheets

    Roskilde University (Denmark) hosted a November 2015 workshop, Environmental Risk—Assessing and Managing Multiple Risks in a Changing World. This Focus article presents the consensus recommendations of 30 attendees from 9 countries regarding implementation of a common currency (ecosystem services) for holistic environmental risk assessment and management; improvements to risk assessment and management in a complex, human-modified, and changing world; appropriate development of protection goals in a 2-stage process; dealing with societal issues; risk-management information needs; conducting risk assessment of risk management; and development of adaptive and flexible regulatory systems. The authors encourage both cross-disciplinary and interdisciplinary approaches to address their 10 recommendations: 1) adopt ecosystem services as a common currency for risk assessment and management; 2) consider cumulative stressors (chemical and nonchemical) and determine which dominate to best manage and restore ecosystem services; 3) fully integrate risk managers and communities of interest into the risk-assessment process; 4) fully integrate risk assessors and communities of interest into the risk-management process; 5) consider socioeconomics and increased transparency in both risk assessment and risk management; 6) recognize the ethical rights of humans and ecosystems to an adequate level of protection; 7) determine relevant reference conditions and the proper ecological c

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed

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

    2016-10-01

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

  1. Risk Assessment Document for Coke Oven MACT Residual Risk

    EPA Pesticide Factsheets

    The residual risk analysis described in this report addresses four coke plants subject to the 1993coke oven MACT standards (40 CFR Part 63 Subpart L) and estimates potential risks due to HAPsemissions from facilities involved in coking operations.

  2. Using Touch-evoked Response and Locomotion Assays to Assess Muscle Performance and Function in Zebrafish

    PubMed Central

    Williams, Caitlin; Bryson-Richardson, Robert J.

    2016-01-01

    Zebrafish muscle development is highly conserved with mammalian systems making them an excellent model to study muscle function and disease. Many myopathies affecting skeletal muscle function can be quickly and easily assessed in zebrafish over the first few days of embryogenesis. By 24 hr post-fertilization (hpf), wildtype zebrafish spontaneously contract their tail muscles and by 48 hpf, zebrafish exhibit controlled swimming behaviors. Reduction in the frequency of, or other alterations in, these movements may indicate a skeletal muscle dysfunction. To analyze swimming behavior and assess muscle performance in early zebrafish development, we utilize both touch-evoked escape response and locomotion assays. Touch-evoked escape response assays can be used to assess muscle performance during short burst movements resulting from contraction of fast-twitch muscle fibers. In response to an external stimulus, which in this case is a tap on the head, wildtype zebrafish at 2 days post-fertilization (dpf) typically exhibit a powerful burst swim, accompanied by sharp turns. Our method quantifies skeletal muscle function by measuring the maximum acceleration during a burst swimming motion, the acceleration being directly proportional to the force produced by muscle contraction. In contrast, locomotion assays during early zebrafish larval development are used to assess muscle performance during sustained periods of muscle activity. Using a tracking system to monitor swimming behavior, we obtain an automated calculation of the frequency of activity and distance in 6-day old zebrafish, reflective of their skeletal muscle function. Measurements of swimming performance are valuable for phenotypic assessment of disease models and high-throughput screening of mutations or chemical treatments affecting skeletal muscle function. PMID:27842370

  3. Assessing uncertainty in published risk estimates using ...

    EPA Pesticide Factsheets

    Introduction: The National Research Council recommended quantitative evaluation of uncertainty in effect estimates for risk assessment. This analysis considers uncertainty across model forms and model parameterizations with hexavalent chromium [Cr(VI)] and lung cancer mortality as an example. The objective is to characterize model uncertainty by evaluating estimates across published epidemiologic studies of the same cohort.Methods: This analysis was based on 5 studies analyzing a cohort of 2,357 workers employed from 1950-74 in a chromate production plant in Maryland. Cox and Poisson models were the only model forms considered by study authors to assess the effect of Cr(VI) on lung cancer mortality. All models adjusted for smoking and included a 5-year exposure lag, however other latency periods and model covariates such as age and race were considered. Published effect estimates were standardized to the same units and normalized by their variances to produce a standardized metric to compare variability within and between model forms. A total of 5 similarly parameterized analyses were considered across model form, and 16 analyses with alternative parameterizations were considered within model form (10 Cox; 6 Poisson). Results: Across Cox and Poisson model forms, adjusted cumulative exposure coefficients (betas) for 5 similar analyses ranged from 2.47 to 4.33 (mean=2.97, σ2=0.63). Within the 10 Cox models, coefficients ranged from 2.53 to 4.42 (mean=3.29, σ2=0.

  4. Assessing the applicability of FISH-based prematurely condensed dicentric chromosome assay in triage biodosimetry.

    PubMed

    Suto, Yumiko; Gotoh, Takaya; Noda, Takashi; Akiyama, Miho; Owaki, Makiko; Darroudi, Firouz; Hirai, Momoki

    2015-03-01

    The dicentric chromosome assay (DCA) has been regarded as the gold standard of radiation biodosimetry. The assay, however, requires a 2-d peripheral blood lymphocyte culture before starting metaphase chromosome analyses to estimate biological doses. Other biological assays also have drawbacks with respect to the time needed to obtain dose estimates for rapid decision on the correct line of medical treatment. Therefore, alternative technologies that suit requirements for triage biodosimetry are needed. Radiation-induced DNA double strand breaks in G0 lymphocytes can be detected as interphase chromosome aberrations by the cell fusion-mediated premature chromosome condensation (PCC) method. The method, in combination with fluorescence in situ hybridization (FISH) techniques, has been proposed in early studies as a powerful tool for obtaining biological dose estimates without 2-d lymphocyte culture procedures. The present work assesses the applicability of FISH-based PCC techniques using pan-centromeric and telomeric peptide nucleic acid (PNA) probes in triage mode biodosimetry and demonstrates that an improved rapid procedure of the prematurely condensed dicentric chromosome (PCDC) assay has the potential for evaluating exposed radiation doses in as short as 6 h after the collection of peripheral blood specimens.

  5. Gasbuggy Site Assessment and Risk Evaluation

    SciTech Connect

    2011-03-01

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

  6. Risk Assessment for Human Immunodeficiency Virus among Pregnant Hispanic Adolescents.

    ERIC Educational Resources Information Center

    Berger, David K.; And Others

    1993-01-01

    Assessed human immunodeficiency virus (HIV) risk status of pregnant Hispanic adolescents in New York City. One-third of 87 adolescents were identified as being at increased risk for HIV infection. Sexual risk-taking behavior was most common factor that increased HIV risk. Birthplace and nationality were significantly associated with HIV risk…

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

    ERIC Educational Resources Information Center

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

    2003-01-01

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

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

    SciTech Connect

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

    1999-07-01

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

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

    ERIC Educational Resources Information Center

    Kroner, Daryl G.

    2005-01-01

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

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

    ERIC Educational Resources Information Center

    Granello, Darcy Haag

    2010-01-01

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

  11. Dynamic Attack Tree Tool for Risk Assessments

    SciTech Connect

    Black, Karl

    2012-03-13

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

  12. Ozone Health Risk Assessment for Selected Urban Areas

    EPA Pesticide Factsheets

    The health risk assessment described in this report estimated various health effects associated with O3 exposures as well as the reduced risks for one O3 season associated with just meeting the current O3 NAAQS.

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

    Cancer.gov

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

  14. Probabilistic Risk Assessment to Inform Decision Making: Frequently Asked Questions

    EPA Pesticide Factsheets

    General concepts and principles of Probabilistic Risk Assessment (PRA), describe how PRA can improve the bases of Agency decisions, and provide illustrations of how PRA has been used in risk estimation and in describing the uncertainty in decision making.

  15. Ecological Risk Assessment Process under the Endangered Species Act

    EPA Pesticide Factsheets

    This document provides an overview of the Environmental Protection Agency’s (EPA) ecological risk assessment process for the evaluation of potential risk to endangered and threatened (listed) species from exposure to pesticides.

  16. FIFRA Peer Review: Proposed Risk Assessment Methods Process

    EPA Pesticide Factsheets

    From September 11-14, 2012, EPA participated in a Federal Insecticide, Fungicide and Rodenticide Act Scientific Advisory Panel (SAP) meeting on a proposed pollinator risk assessment framework for determining the potential risks of pesticides to honey bees.

  17. Assessment of a dye permeability assay for determination of inactivation rates of Cryptosporidium parvum oocysts.

    PubMed Central

    Jenkins, M B; Anguish, L J; Bowman, D D; Walker, M J; Ghiorse, W C

    1997-01-01

    The ability to determine inactivation rates of Cryptosporidium parvum oocysts in environmental samples is critical for assessing the public health hazard of this gastrointestinal parasite in watersheds. We compared a dye permeability assay, which tests the differential uptake of the fluorochromes 4'-6-diamidino-2-phenylindole (DAPI) and propidium iodide (PI) by the oocysts (A. T. Campbell, L. J. Robertson, and H. V. Smith, Appl. Environ. Microbiol. 58:3488-3493, 1992), with an in vitro excystation assay, which tests their ability to excyst and, thus, their metabolic potential and potential for infectivity (J.B. Rose, H. Darbin, and C.P. Gerba, Water Sci. Technol. 20:271-276, 1988). Formaldehyde-fixed (killed) oocysts and untreated oocysts were permeabilized with sodium hypochlorite and subjected to both assays. The results of the dye permeability assays were the same, while the excystation assay showed that no excystation occurred in formaldehyde-fixed oocysts. This confirmed that oocyst wall permeability, rather than metabolic activity potential, was the basis of the dye permeability viability assessment. A previously developed protocol (L. J. Anguish and W. C. Ghiorse, Appl. Environ. Microbiol. 63:724-733, 1997) for determining viability of oocysts in soil and sediment was used to examine further the use of oocyst permeability status as an indicator of oocyst viability in fecal material stored at 4 degrees C and in water at various temperatures. Most of the oocysts in fresh calf feces were found to be impermeable to the fluorochromes. They were also capable of excystation, as indicated by the in vitro excystation assay, and were infective, as indicated by a standard mouse infectivity assay. The dye permeability assay further showed that an increase in the intermediate population of oocysts permeable to DAPI but not to PI occurred over time. There was also a steady population of oocysts permeable to both dyes. Further experiments with purified oocysts suspended in

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

    SciTech Connect

    1995-03-01

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

  19. Assessment of environmental contamination associated with a mammalian cell transformation assay.

    PubMed

    Sansone, E B; Losikoff, A M; Lebherz, W B; Poiley, J A

    1981-09-01

    To estimate worker exposures to, and environmental contamination from, test chemicals and organic solvents used in an in vitro assay to assess the carcinogenic potential of chemicals, sodium fluorescein, a noncarcinogenic fluorescent material, was dissolved in tissue culture medium used to maintain early passage hamster embryo cells. Personal an environmental samples were taken over a 14-d period. The assay was performed according to standard procedures in a ventilated glove box or laminar flow safety cabinet. Considerably more than 99% of the chemical contamination found was recovered from the interiors of the glove box and hood and from disposable equipment. Contamination outside the containment units (less than 1 microgram) resulted from intralaboratory transport of chemicals, treated cultures, and contaminated equipment. We conclude that the standard operating particles and procedures provided adequate safeguards for personnel and the environment.

  20. Risk assessment and toxicology databases for health effects assessment

    SciTech Connect

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

    1990-12-31

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

  1. Assessing human health risk in the USDA forest service

    SciTech Connect

    Hamel, D.R.

    1990-12-31

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

  2. Cancer Risk Assessment for Space Radiation

    NASA Technical Reports Server (NTRS)

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

    2002-01-01

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

  3. Risk assessment of Pseudomonas aeruginosa in water.

    PubMed

    Mena, Kristina D; Gerba, Charles P

    2009-01-01

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

  4. Overcoming barriers to integrating economic analysis into risk assessment.

    PubMed

    Hoffmann, Sandra

    2011-09-01

    Regulatory risk analysis is designed to provide decisionmakers with a clearer understanding of how policies are likely to affect risk. The systems that produce risk are biological, physical, and social and economic. As a result, risk analysis is an inherently interdisciplinary task. Yet in practice, risk analysis has been interdisciplinary in only limited ways. Risk analysis could provide more accurate assessments of risk if there were better integration of economics and other social sciences into risk assessment itself. This essay examines how discussions about risk analysis policy have influenced the roles of various disciplines in risk analysis. It explores ways in which integrated bio/physical-economic modeling could contribute to more accurate assessments of risk. It reviews examples of the kind of integrated economics-bio/physical modeling that could be used to enhance risk assessment. The essay ends with a discussion of institutional barriers to greater integration of economic modeling into risk assessment and provides suggestions on how these might be overcome.

  5. [Statistical prediction methods in violence risk assessment and its application].

    PubMed

    Liu, Yuan-Yuan; Hu, Jun-Mei; Yang, Min; Li, Xiao-Song

    2013-06-01

    It is an urgent global problem how to improve the violence risk assessment. As a necessary part of risk assessment, statistical methods have remarkable impacts and effects. In this study, the predicted methods in violence risk assessment from the point of statistics are reviewed. The application of Logistic regression as the sample of multivariate statistical model, decision tree model as the sample of data mining technique, and neural networks model as the sample of artificial intelligence technology are all reviewed. This study provides data in order to contribute the further research of violence risk assessment.

  6. Risk assessment of thyroid follicular cell tumors.

    PubMed Central

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

    1998-01-01

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

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

    SciTech Connect

    Altenbach, T.J.

    1995-02-13

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

  8. An Integrated Approach to Risk Assessment for Concurrent Design

    NASA Technical Reports Server (NTRS)

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

    2005-01-01

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

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

    ERIC Educational Resources Information Center

    Pouls, Claudia; Jeandarme, Inge

    2015-01-01

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

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

    SciTech Connect

    G. Becker; M. Connolly; M. McIlwain

    1999-02-01

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

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

    PubMed

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

    2015-07-06

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

  12. Risk assessment compatible fire models (RACFMs)

    SciTech Connect

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

    1998-07-01

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

  13. Quality assessment of vitamin D metabolite assays used by clinical and research laboratories.

    PubMed

    Carter, G D; Berry, J; Durazo-Arvizu, R; Gunter, E; Jones, G; Jones, J; Makin, H L J; Pattni, P; Phinney, K W; Sempos, C T; Williams, E L

    2017-03-15

    The Vitamin D External Quality Assessment Scheme (DEQAS) was launched in 1989 and monitors the performance of 25-hydroxyvitamin D (25-OHD) and 1,25- dihydroxyvitamin D (1,25(OH)2D) assays. In April 2015 a pilot scheme for 24,25-dihydroxyvitamin D (24,25(OH)2D) was introduced. The 25-OHD scheme is accuracy - based with target values assigned by the NIST Reference Measurement Procedure (RMP) for 25-OHD2 and 25-OHD3. A similar method is used to assign values for 3-epi-25-OHD. Five samples of human serum are distributed quarterly to over 1000 participants in 58 countries (April 2016) and clinical laboratories are expected to submit results within approximately 5 weeks. Research laboratories with assays run less frequently are not given a deadline. Archived samples with NIST- assigned values are also available. Performance is assessed on the first four samples with the fifth reserved for investigations e.g. recovery experiments or to assess the influence of other serum constituents such as lipids. DEQAS provides rapid feedback, with an on-line preliminary report available immediately after a participant submits results and a comprehensive report soon after the results deadline. In 2015, DEQAS investigations revealed that several 25-OHD immunoassays under-recovered 25-OHD2 and 25-OHD results were falsely low on a sample with a modestly raised triglyceride concentration. An RMP for 1,25 (OH)2D is not yet available and results are judged against the Method Mean. Free advice is available from the DEQAS Advisory Panel which includes experts on methodology and biostatistics. DEQAS collaborates closely with the Vitamin D Standardization Program (VDSP) and both organizations have successfully worked with participants and manufacturers to improve the accuracy of vitamin D assays.

  14. Pollinator Risk Assessment: an International Workshop

    EPA Pesticide Factsheets

    This 2011 Society of Environmental Toxicology and Chemistry (SETAC) workshop brought together statisticians, bee biologists, modelers, beekeepers, risk assessors and risk managers to develop exposure measurement methods and identify pesticide effects.

  15. Bioluminescent Vibrio fischeri Assays in the Assessment of Seasonal and Spatial Patterns in Toxicity of Contaminated River Sediments

    PubMed Central

    Jarque, Sergio; Masner, Petr; Klánová, Jana; Prokeš, Roman; Bláha, Ludek

    2016-01-01

    Several bacteria-based assays, notably Vibrio fischeri luminescence assays, are often used as environmental monitoring tool for toxicity in sediments that may serve as both sinks and secondary source of contamination in aquatic ecosystems. In this study, we used 30-s kinetic bioassays based on V. fischeri to evaluate the toxicity associated to sediments from five localities with different contamination inputs (Morava River and its tributary Drevnice River in the south-eastern part of the Czech Republic). Toxicity assessed as half maximal inhibitory concentration (IC50) over the course of a year-long sampling was compared in bottom sediments and freshly trapped particulate material. Standard approach based on testing of aqueous elutriates was compared with toxicity of whole sediments (contact suspension toxicity). Bottom sediments showed lower toxicity compared to freshly trapped suspended materials in all cases. On the other hand, standardized elutriates induced generally weaker effects than suspended sediments likely due to losses during the extraction process. Toxicity generally increased during winter reaching maximum peaks in early spring months in all five sites. Total organic carbon (TOC) was found to be highly correlated with toxic effects. Toxicity from sites with direct industrial and agricultural water inputs also correlated with concentrations of metals, polycyclic aromatic hydrocarbons (PAHs), and polychlorinated biphenyls (PCBs). Single time point sampling followed by the extraction and testing of elutriates, do not truly reflect the spatial and temporal variability in natural sediments and may lead to underestimation of ecotoxic risks. PMID:27872614

  16. Human Health Toxicity Values in Superfund Risk Assessments

    EPA Pesticide Factsheets

    This memorandum revises the hierarchy of human health toxicity values generally recommended for use inr isk assessments, originally presented in Risk Assessment Guidance for Superfund Volume I, Part A.

  17. THE ROLE OF EXPOSURE ANALYSIS IN HUMAN HEALTH RISK ASSESSMENT

    EPA Science Inventory

    This presentation will cover the basic methodologies used for assessing human exposures to environmental pollutants, and some of the scientific challenges involved in conducting exposure and risk assessments in support of regulatory evaluations.

  18. Advancing environmental risk assessment for transgenic biofeedstock crops.

    PubMed

    Wolt, Jeffrey D

    2009-11-02

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

  19. Analysis of Alternatives for Risk Assessment Methodologies and Tools

    SciTech Connect

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

    2013-10-01

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

  20. Advancing environmental risk assessment for transgenic biofeedstock crops

    PubMed Central

    Wolt, Jeffrey D

    2009-01-01

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

  1. AIDS: Assessing the Risk among Athletes.

    ERIC Educational Resources Information Center

    Hamel, Ruth

    1992-01-01

    Since Magic Johnson's retirement, athletes and sports organizations are more interested in HIV and AIDS. Many seek answers from physicians about the risk of transmission through athletic competition and the rights of HIV-positive players. Physicians can counsel patients about reducing risk. The article discusses risk, testing, policies, education,…

  2. Managing Risk Assessment in Science Departments.

    ERIC Educational Resources Information Center

    Forlin, Peter; Forlin, Chris

    1997-01-01

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

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

    PubMed Central

    Zacharewski, T

    1998-01-01

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

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

    PubMed

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

    2016-04-01

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

  5. In vivo genotoxicity assessment of sertraline by using alkaline comet assay and the cytokinesis-block micronucleus assay.

    PubMed

    Battal, Dilek; Aktas, Ayca; Sungur, Mehmet Ali; Kadioglu, Ela; Eker, Ebru Derici; Sahin, Nefise Ozlen; Saygi, Sahan

    2013-11-01

    Sertraline, a leading antidepressant in the selective serotonin reuptake inhibitor (SSRI) group of medicine, is the most frequently prescribed drug. In this study, the alkaline comet assay and the cytokinesis-block micronucleus (CBMN) assay were used to investigate genotoxicity potential of sertraline in the peripheral blood lymphocytes (PBLs) of acute and chronic sertraline-treated Wistar albino rats. Male Wistar albino rats (n = 48) were administered low, medium and high doses of sertraline (10, 40, 80 mg/kg) for acute and chronic treatment by employing the gavage method to investigate genotoxicity of the administered drug. The data (tail length, tail intensity and tail moment) were analysed and indicated that there was no statistically significant difference between sertraline-treated groups and the negative control group with respect to DNA damage (p > 0.05). However, it was observed that acute sertraline administration had caused much more DNA damage in comparison with chronic treatment (p < 0.05). According to the data obtained from the CBMN test, an increase in the micronucleus (MN) frequency was detected at chronic and high-dose acute sertraline treatment. Based on the outcome of comet assay, detection of statistically insignificant DNA damage may be due to the fact that sertraline did not cause damage on DNA. Also, increase in frequency of MN in chronic sertraline treatment suggests that chronic sertraline administration might influence some mechanisms of cell division. Therefore, dose adjustment in depressed patients seems significant as it may help prevent further prognosis of the diseases.

  6. Screening of endocrine disrupting chemicals with MELN cells, an ER-transactivation assay combined with cytotoxicity assessment.

    PubMed

    Berckmans, P; Leppens, H; Vangenechten, C; Witters, H

    2007-10-01

    There is growing concern that some chemicals can cause endocrine disrupting effects to wild animals and humans. Therefore a rapid and reliable screening assay to assess the activity of endocrine disrupting chemicals (EDCs) is required. These EDCs can act at multiple sites. Most studied mechanism is direct interaction with the hormone receptors, e.g. estrogen receptor. In this study the luciferase reporter gene assay using transgenic human MELN cells was used. Since cytotoxicity of the chemicals can decrease the luminescent signal in the transactivation assays, a cytotoxicity assay must be implemented. Mostly the neutral red (NR) assay is performed in parallel with the estrogenicity assay. To increase the reliability and cost-efficiency of the test, a method to measure estrogenicity and cytotoxicity in the same cell culture plate instead of in parallel plates was developed and evaluated. Therefore the NR-assay was compared with the CytoTox-ONE homogeneous membrane integrity assay. The latter measures LDH (lactate dehydrogenase) leakage based on a fluorometric method. For all compounds tested, the CytoTox-ONE test showed comparable curves and EC50-values to those obtained by the NR-assay. So the CytoTox-ONE kit, which seemed more sensitive than measurements of LDH-leakage based on a colorimetric method, is recommended to test cytotoxicity to MELN cells, with the advantage to use the same cells for ER-transactivation measurements. The chemicals tested in the optimised MELN assay showed estrogenic potencies comparable to those reported for several other transactivation assays.

  7. Embedding climate change risk assessment within a governance context

    SciTech Connect

    Preston, Benjamin L

    2011-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  9. Seismic vulnerability assessments in risk analysis

    NASA Astrophysics Data System (ADS)

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

    2013-04-01

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

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

    ERIC Educational Resources Information Center

    Chan, Ko Ling

    2012-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-07-21

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

  13. Validity of Thermal Ramping Assays Used to Assess Thermal Tolerance in Arthropods

    PubMed Central

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

    2012-01-01

    Proper assessment of environmental resistance of animals is critical for the ability of researchers to understand how variation in environmental conditions influence population and species abundance. This is also the case for studies of upper thermal limits in insects, where researchers studying animals under laboratory conditions must select appropriate methodology on which conclusions can be drawn. Ideally these methods should precisely estimate the trait of interest and also be biological meaningful. In an attempt to develop such tests it has been proposed that thermal ramping assays are useful assays for small insects because they incorporate an ecologically relevant gradual temperature change. However, recent model-based papers have suggested that estimates of thermal resistance may be strongly confounded by simultaneous starvation and dehydration stress. In the present study we empirically test these model predictions using two sets of independent experiments. We clearly demonstrate that results from ramping assays of small insects (Drosophila melanogaster) are not compromised by starvation- or dehydration-stress. Firstly we show that the mild disturbance of water and energy balance of D. melanogaster experienced during the ramping tests does not confound heat tolerance estimates. Secondly we show that flies pre-exposed to starvation and dehydration have “normal” heat tolerance and that resistance to heat stress is independent of the energetic and water status of the flies. On the basis of our results we discuss the assumptions used in recent model papers and present arguments as to why the ramping assay is both a valid and ecologically relevant way to measure thermal resistance in insects. PMID:22427876

  14. An optimized SYBR Green I/PI assay for rapid viability assessment and antibiotic susceptibility testing for Borrelia burgdorferi.

    PubMed

    Feng, Jie; Wang, Ting; Zhang, Shuo; Shi, Wanliang; Zhang, Ying

    2014-01-01

    Lyme disease caused by Borrelia burgdorferi is the most common tick-borne disease in the US and Europe. Unlike most bacteria, measurements of growth and viability of B. burgdorferi are challenging. The current B. burgdorferi viability assays based on microscopic counting and PCR are cumbersome and tedious and cannot be used in a high throughput format. Here, we evaluated several commonly used viability assays including MTT and XTT assays, fluorescein diacetate assay, Sytox Green/Hoechst 33342 assay, the commercially available LIVE/DEAD BacLight assay, and SYBR Green I/PI assay by microscopic counting and by automated 96-well plate reader for rapid viability assessment of B. burgdorferi. We found that the optimized SYBR Green I/PI assay based on green to red fluorescence ratio is superior to all the other assays for measuring the viability of B. burgdorferi in terms of sensitivity, accuracy, reliability, and speed in automated 96-well plate format and in comparison with microscopic counting. The BSK-H medium which produced a high background for the LIVE/DEAD BacLight assay did not affect the SYBR Green I/PI assay, and the viability of B. burgdorferi culture could be directly measured using a microtiter plate reader. The SYBR Green I/PI assay was found to reliably assess the viability of planktonic as well as biofilm B. burgdorferi and could be used as a rapid antibiotic susceptibility test. Thus, the SYBR Green I/PI assay provides a more sensitive, rapid and convenient method for evaluating viability and antibiotic susceptibility of B. burgdorferi and can be used for high-throughput drug screens.

  15. Population-scale assessment endpoints in ecological risk assessment part II: selection of assessment endpoint attributes.

    PubMed

    Landis, Wayne G; Kaminski, Laurel A

    2007-07-01

    Because ecological services often are tied to specific species, the risk to populations is a critical endpoint and important feature of ecological risk assessments. In Part 1 of this series it was demonstrated that population scale assessment endpoints are important expressions of the valued components of ecological structures. This commentary reviews several of the characteristics of populations that can be evaluated and used in population scale risk assessments. Two attributes are evaluated as promising. The 1st attribute is the change in potential productivity of the population over a specified time period. The 2nd attribute is the change in the age structure of a population, expressed graphically or as a normalized effects vector (NEV). The NEV is a description of the change in age structure due to a toxicant or other stressor and appears to be characteristic of specific stressor effects.

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

    ERIC Educational Resources Information Center

    Unks, Ruth A.; Thor, Linda

    2008-01-01

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

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

    EPA Science Inventory

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

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

    SciTech Connect

    Andrews, W.B.

    1980-03-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2014-05-01

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

  20. Assessing risk: the role of probabilistic risk assessment (PRA) in patient safety improvement.

    PubMed

    Wreathall, J; Nemeth, C

    2004-06-01

    Morbidity and mortality due to "medical errors" compel better understanding of health care as a system. Probabilistic risk assessment (PRA) has been used to assess the designs of high hazard, low risk systems such as commercial nuclear power plants and chemical manufacturing plants and is now being studied for its potential in the improvement of patient safety. PRA examines events that contribute to adverse outcomes through the use of event tree analysis and determines the likelihood of event occurrence through fault tree analysis. It complements tools already in use in patient safety such as failure modes and effects analyses (FMEAs) and root cause analyses (RCAs). PRA improves on RCA by taking account of the more complex causal interrelationships that are typical in health care. It also enables the analyst to examine potential solution effectiveness by direct graphical representations. However, PRA simplifies real world complexity by forcing binary conditions on events, and it lacks adequate probability data (although recent developments help to overcome these limitations). Its reliance on expert assessment calls for deep domain knowledge which has to come from research performed at the "sharp end" of acute care.

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

    SciTech Connect

    EVANS, C B

    2004-12-21

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

  2. Structural equation modeling in environmental risk assessment.

    PubMed Central

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

    1991-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  4. INTERPRETING SPONTANEOUS RENAL LESIONS IN SAFETY AND RISK ASSESSMENT

    EPA Science Inventory

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

    Introduction

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

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

    EPA Science Inventory

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

  6. MINI REVIEW - EPIGENETIC PROCESSES AND CANCER RISK ASSESSMENT

    EPA Science Inventory

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

  7. Recognizing Success: Assessing Arts Residencies for "At Risk" Populations

    ERIC Educational Resources Information Center

    Davidoff, Paula

    2007-01-01

    Assessing the success of a residency with an at-risk population requires an expanded set of standards. While ultimate goals may be the same, one needs a longer time to achieve them. In this article, the author, a teaching artist with long experience working in at-risk settings, argues for a deeper and broader understanding of assessment and…

  8. Are Risk Assessments of a Terrorist Attack Coherent?

    ERIC Educational Resources Information Center

    Mandel, David R.

    2005-01-01

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

  9. Recent methods for assessing osteoporosis and fracture risk.

    PubMed

    Imai, Kazuhiro

    2014-01-01

    In the management and treatment of osteoporosis, the target is to assess fracture risk and the end-point is to prevent fractures. Traditionally, measurement of bone mineral density (BMD) by dual energy X-ray absorptiometry (DXA) has been the standard method for diagnosing osteoporosis, in addition to assessing fracture risk and therapeutic effects. Quantitative computed tomography (QCT) can quantify volumetric BMD, and cancellous bone can be measured independently of surrounding cortical bone and aortic calcification. Hip structure analysis (HSA) is a method using the DXA scan image and provides useful data for assessing hip fracture risk. Recently, new tools to assess osteoporosis and fracture risk have been developed. One of the recent advances has been the development of the FRAX (Fracture Risk Assessment Tool), which is helpful in conveying fracture risk to patients and providing treatment guidance to clinicians. Another advance is the finite element (FE) method based on data from computed tomography (CT), which is useful for assessing bone strength, fracture risk, and therapeutic effects on osteoporosis. In selecting the most appropriate drug for osteoporosis treatment, assessment by bone metabolic markers is an important factor. In this review, recent patents for assessing osteoporosis and fracture risk are discussed.

  10. Integratively Assessing Risk and Protective Factors for Adolescent Suicide

    ERIC Educational Resources Information Center

    Gutierrez, Peter M.

    2006-01-01

    This article briefly reviews key issues in adolescent suicide risk assessment and proposes that assessing risk and protective factors in combination has the best probability of informing the field's understanding of this complex problem. Several newer measures are described along with summaries of their psychometric properties. A recommended…

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

    EPA Science Inventory

    A critique of the use of hormesis in risk assessment.

    Kitchin, KT; and Drane, Wanzer

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

  12. Systems Biology & Mode of Action Based Risk Assessment

    EPA Science Inventory

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

  13. Phthalates and Cumulative Risk Assessment (NAS Final Report)

    EPA Science Inventory

    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 ...

  14. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Risk assessment for candidates. 105.14 Section 105.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIMINAL HISTORY BACKGROUND CHECKS Aviation Training for Aliens and Other Designated Individuals § 105.14 Risk assessment...

  15. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  16. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Risk assessment for candidates. 105.14 Section 105.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIMINAL HISTORY BACKGROUND CHECKS Aviation Training for Aliens and Other Designated Individuals § 105.14 Risk assessment...

  17. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  18. 28 CFR 105.14 - Risk assessment for candidates.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

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

    ERIC Educational Resources Information Center

    Nichols, Elizabeth; Wildavsky, Aaron

    1988-01-01

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