Comparison of risks due to bisphenol A and radiation with trad-MCN assay

International Nuclear Information System (INIS)

Shin, H. S.; Lee, J. H.; Kim, J. K.; Chon, K. J.; Lee, B. H.

2001-01-01

Many kinds of synthetic chemicals have been being used for various purposes. Some of them are called 'environmental hormones' because they can disturb the endocrine system of organisms. Presently no technique is established for the quantitative assessment of biological risk of the environmental hormones. The pollen mother cells (PMC) of Tradescantia are very sensitive to chemical toxicants or ionizing radiation, and thus can be used as a biological end-point assessing their effect. Micronucleus frequencies in PMC showed a good dose- and concentration-response relationship for radiation and bisphenol A. From the dose-response relationship, it is possible to estimate the equivalent bisphenol A concentration, or vice versa. One μM/ml of bisphenol A is equivalent to 1.8 cGy of radiation in the induction of micronuclei. It is known from the result that Trad-MCN assay can be an excellent tool for detection of biological risk due to environmental toxicants or synthetic chemicals

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

Science.gov (United States)

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

2017-12-01

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

Validation study of a quantitative multigene reverse transcriptase-polymerase chain reaction assay for assessment of recurrence risk in patients with stage II colon cancer.

Science.gov (United States)

Gray, Richard G; Quirke, Philip; Handley, Kelly; Lopatin, Margarita; Magill, Laura; Baehner, Frederick L; Beaumont, Claire; Clark-Langone, Kim M; Yoshizawa, Carl N; Lee, Mark; Watson, Drew; Shak, Steven; Kerr, David J

2011-12-10

We developed quantitative gene expression assays to assess recurrence risk and benefits from chemotherapy in patients with stage II colon cancer. We sought validation by using RNA extracted from fixed paraffin-embedded primary colon tumor blocks from 1,436 patients with stage II colon cancer in the QUASAR (Quick and Simple and Reliable) study of adjuvant fluoropyrimidine chemotherapy versus surgery alone. A recurrence score (RS) and a treatment score (TS) were calculated from gene expression levels of 13 cancer-related genes (n = 7 recurrence genes and n = 6 treatment benefit genes) and from five reference genes with prespecified algorithms. Cox proportional hazards regression models and log-rank methods were used to analyze the relationship between the RS and risk of recurrence in patients treated with surgery alone and between TS and benefits of chemotherapy. Risk of recurrence was significantly associated with RS (hazard ratio [HR] per interquartile range, 1.38; 95% CI, 1.11 to 1.74; P = .004). Recurrence risks at 3 years were 12%, 18%, and 22% for predefined low, intermediate, and high recurrence risk groups, respectively. T stage (HR, 1.94; P < .001) and mismatch repair (MMR) status (HR, 0.31; P < .001) were the strongest histopathologic prognostic factors. The continuous RS was associated with risk of recurrence (P = .006) beyond these and other covariates. There was no trend for increased benefit from chemotherapy at higher TS (P = .95). The continuous 12-gene RS has been validated in a prospective study for assessment of recurrence risk in patients with stage II colon cancer after surgery and provides prognostic value that complements T stage and MMR. The TS was not predictive of chemotherapy benefit.

Development of cultures of the marine sponge Hymeniacidon perleve for genotoxicity assessment using the alkaline comet assay.

Science.gov (United States)

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

2017-12-01

Sponges are a potential alternative model species to bivalves in pollution biomonitoring and environmental risk assessment in the aquatic ecosystem. In the present study, a novel in vivo exposure sponge culture model was developed from field-collected and cryopreserved sponge (Hymeniacidon perleve) cells to investigate the genotoxic effects of environmentally relevant metals in the laboratory. Sponge cell aggregates were cultured and exposed to noncytotoxic concentrations (0-0.4 mg/L) of cadmium chloride, nickel chloride, and sodium dichromate as quantified by the reduction of 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide and DNA-strand breaks assessed by the comet assay. Reactive oxygen species (ROS) formation was quantified by oxidation of 2',7'-dichlorofluorescin diacetate in sponge cell aggregates exposed to the same concentrations of Cd, Cr, and Ni. There was a statistically significant (p sponge cells and demonstrated that exposure to noncytotoxic concentrations of Cd, Cr, and Ni for 12 h results in a concentration-dependent increase in DNA damage and levels of ROS production. In conclusion, we have developed a novel in vivo model based on culture of cryopreserved sponge cells that is compatible with the alkaline comet assay. Genotoxicity in marine sponges measured by the comet assay technique may be a useful tool for biomonitoring research and risk assessment in aquatic ecosystems. Environ Toxicol Chem 2017;36:3314-3323. © 2017 SETAC. © 2017 SETAC.

Folate status in women of reproductive age as basis of neural tube defect risk assessment.

Science.gov (United States)

Bailey, Lynn B; Hausman, Dorothy B

2018-02-01

Reliable folate status data for women of reproductive age (WRA) to assess global risk for neural tube defects (NTDs) are needed. We focus on a recent recommendation by the World Health Organization that a specific "optimal" red blood cell (RBC) folate concentration be used as the sole indicator of NTD risk within a population and discuss how to best apply this guidance to reach the goal of assessing NTD risk globally. We also emphasize the importance of using the microbiologic assay (MBA) as the most reliable assay for obtaining comparable results for RBC folate concentration across time and countries, the need for harmonization of the MBA through use of consistent key reagents and procedures within laboratories, and the requirement to apply assay-matched cutoffs for folate deficiency and insufficiency. To estimate NTD risk globally, the ideal scenario would be to have country-specific population-based surveys of RBC folate in WRA determined utilizing a harmonized MBA, as was done in recent studies in Guatemala and Belize. We conclude with guidance on next steps to best navigate the road map toward the goal of generating reliable folate status data on which to assess NTD risk in WRA in low- and middle-income countries. © 2017 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of New York Academy of Sciences.

Bait-lamina assay as a tool to assess the effects of metal contamination in the feeding activity of soil invertebrates within a uranium mine area

International Nuclear Information System (INIS)

Andre, A.; Antunes, S.C.; Goncalves, F.; Pereira, R.

2009-01-01

As part of the tier 2 of a site-specific risk assessment, this study was the first reporting an intensive in situ application of the bait-lamina assay; two exposure periods (7 and 14 days) were tested during four seasons in ten different sites, within a uranium mine area and at two different depths. The most contaminated sites (by deposition of sludge from the effluent treatment pond) were discriminated after 14 days of exposure because extremely low percentages of feeding activity were recorded. Previous sub-lethal ecotoxicological assays, already had demonstrated that the habitat function of these soils is compromised. Nevertheless, seasonality has proved to have a significant influence on responses. Thus to strength conclusions about the impact of contaminants, the in situ bait-lamina assay should be performed on different annual seasons, at least for temperate regions. It was also found that some environmental parameters (e.g. soil moisture and litter) can act as confounding factors in the bait-lamina assay. - Bait-lamina assay for in situ evaluation of soil functions under site-specific risk assessments.

The kSORT assay to detect renal transplant patients at high risk for acute rejection: results of the multicenter AART study.

Directory of Open Access Journals (Sweden)

Silke Roedder

2014-11-01

Full Text Available 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.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.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.

Alkaline Comet Assay for Assessing DNA Damage in Individual Cells.

Science.gov (United States)

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. Copyright © 2015 John Wiley & Sons, Inc.

Improving risk stratification among veterans diagnosed with prostate cancer: impact of the 17-gene prostate score assay.

Science.gov (United States)

Lynch, Julie A; Rothney, Megan P; Salup, Raoul R; Ercole, Cesar E; Mathur, Sharad C; Duchene, David A; Basler, Joseph W; Hernandez, Javier; Liss, Michael A; Porter, Michael P; Wright, Jonathan L; Risk, Michael C; Garzotto, Mark; Efimova, Olga; Barrett, Laurie; Berse, Brygida; Kemeter, Michael J; Febbo, Phillip G; Dash, Atreya

2018-01-01

Active surveillance (AS) has been widely implemented within Veterans Affairs' medical centers (VAMCs) as a standard of care for low-risk prostate cancer (PCa). Patient characteristics such as age, race, and Agent Orange (AO) exposure may influence advisability of AS in veterans. The 17-gene assay may improve risk stratification and management selection. To compare management strategies for PCa at 6 VAMCs before and after introduction of the Oncotype DX Genomic Prostate Score (GPS) assay. We reviewed records of patients diagnosed with PCa between 2013 and 2014 to identify management patterns in an untested cohort. From 2015 to 2016, these patients received GPS testing in a prospective study. Charts from 6 months post biopsy were reviewed for both cohorts to compare management received in the untested and tested cohorts. Men who just received their diagnosis and have National Comprehensive Cancer Network (NCCN) very low-, low-, and select cases of intermediate-risk PCa. Patient characteristics were generally similar in the untested and tested cohorts. AS utilization was 12% higher in the tested cohort compared with the untested cohort. In men younger than 60 years, utilization of AS in tested men was 33% higher than in untested men. AS in tested men was higher across all NCCN risk groups and races, particular in low-risk men (72% vs 90% for untested vs tested, respectively). Tested veterans exposed to AO received less AS than untested veterans. Tested nonexposed veterans received 19% more AS than untested veterans. Median GPS results did not significantly differ as a factor of race or AO exposure. Men who receive GPS testing are more likely to utilize AS within the year post diagnosis, regardless of age, race, and NCCN risk group. Median GPS was similar across racial groups and AO exposure groups, suggesting similar biology across these groups. The GPS assay may be a useful tool to refine risk assessment of PCa and increase rates of AS among clinically and

Risk assessment

International Nuclear Information System (INIS)

Kinchin, G.H.

1983-01-01

After defining risk and introducing the concept of individual and societal risk, the author considers each of these, restricting considerations to risk of death. Some probabilities of death arising from various causes are quoted, and attention drawn to the care necessary in making comparisons between sets of data and to the distinction between voluntary and involuntary categories and between early and delayed deaths. The presentation of information on societal risk is discussed and examples given. The history of quantified risk assessment is outlined, particularly related to the nuclear industry, the process of assessing risk discussed: identification of hazard causes, the development of accident chains and the use of event trees, the evaluation of probability through the collection of data and their use with fault trees, and the assessment of consequences of hazards in terms of fatalities. Reference is made to the human element and common-made failures, and to studies supporting the development of reliability assessment techniques. Acceptance criteria are discussed for individual and societal risk in the nuclear field, and it is shown that proposed criteria lead to risks conservative by comparison with risks from day-to-day accidents and other potentially hazardous industries. (U.K.)

Risk Assessment Overview

Science.gov (United States)

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.

Introduction to risk assessment

International Nuclear Information System (INIS)

Raina, V.M.

2002-01-01

This paper gives an introduction to risk assessment. It discusses the basic concepts of risk assessment, nuclear risk assessment process and products, the role of risk assessment products in nuclear safety assurance, the relationship between risk assessment and other safety analysis and risk assessment and safe operating envelope

Cumulative Risk Assessment (CRA): transforming the way we assess health risks.

Science.gov (United States)

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

2012-10-16

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

Reliability of plant root comet assay in comparison with human leukocyte comet assay for assessment environmental genotoxic agents.

Science.gov (United States)

Reis, Gabriela Barreto Dos; Andrade-Vieira, Larissa Fonseca; Moraes, Isabella de Campos; César, Pedro Henrique Souza; Marcussi, Silvana; Davide, Lisete Chamma

2017-08-01

Comet assay is an efficient test to detect genotoxic compounds based on observation of DNA damage. The aim of this work was to compare the results obtained from the comet assay in two different type of cells extracted from the root tips from Lactuca sativa L. and human blood. For this, Spent Pot Liner (SPL), and its components (aluminum and fluoride) were applied as toxic agents. SPL is a solid waste generated in industry from the aluminum mining and processing with known toxicity. Three concentrations of all tested solutions were applied and the damages observed were compared to negative and positive controls. It was observed an increase in the frequency of DNA damage for human leukocytes and plant cells, in all treatments. On human leukocytes, SPL induced the highest percentage of damage, with an average of 87.68%. For root tips cells of L. sativa the highest percentage of damage was detected for aluminum (93.89%). Considering the arbitrary units (AU), the average of nuclei with high levels of DNA fragmentation was significant for both cells type evaluated. The tested cells demonstrated equal effectiveness for detection of the genotoxicity induced by the SPL and its chemical components, aluminum and fluoride. Further, using a unique method, the comet assay, we proved that cells from root tips of Lactuca sativa represent a reliable model to detect DNA damage induced by genotoxic pollutants is in agreement of those observed in human leukocytes as model. So far, plant cells may be suggested as important system to assess the toxicological risk of environmental agents. Copyright © 2017 Elsevier Inc. All rights reserved.

Cell Culture Assay for Human Noroviruses [response

Energy Technology Data Exchange (ETDEWEB)

Straub, Tim M.; Honer Zu Bentrup, Kerstin; Orosz Coghlan, Patricia; Dohnalkova, Alice; Mayer, Brooke K.; Bartholomew, Rachel A.; Valdez, Catherine O.; Bruckner-Lea, Cindy J.; Gerba, Charles P.; Abbaszadegan, Morteza A.; Nickerson, Cheryl A.

2007-07-01

We appreciate the comments provided by Leung et al., in response to our recently published article “In Vitro Cell Culture Infectivity Assay for Human Noroviruses” by Straub et al. (1). The specific aim of our project was to develop an in vitro cell culture infectivity assay for human noroviruses (hNoV) to enhance risk assessments when they are detected in water supplies. Reverse transcription (RT) qualitative or quantitative PCR are the primary assays for waterborne NoV monitoring. However, these assays cannot distinguish between infectious vs. non-infectious virions. When hNoV is detected in water supplies, information provided by our infectivity assay will significantly improve risk assessment models and protect human health, regardless of whether we are propagating NoV. Indeed, in vitro cell culture infectivity assays for the waterborne pathogen Cryptosporidium parvum that supplement approved fluorescent microscopy assays, do not result in amplification of the environmentally resistant hard-walled oocysts (2). However, identification of life cycle stages in cell culture provides evidence of infectious oocysts in a water supply. Nonetheless, Leung et al.’s assertion regarding the suitability of our method for the in vitro propagation of high titers of NoV is valid for the medical research community. In this case, well-characterized challenge pools of virus would be useful for developing and testing diagnostics, therapeutics, and vaccines. As further validation of our published findings, we have now optimized RT quantitative PCR to assess the level of viral production in cell culture, where we are indeed finding significant increases in viral titer. The magnitude and time course of these increases is dependent on both virus strain and multiplicity of infection. We are currently preparing a manuscript that will discuss these findings in greater detail, and the implications this may have for creating viral challenge pools

Assessment of combinations of antiandrogenic compounds vinclozolin and flutamide in a yeast based reporter assay.

Science.gov (United States)

Kolle, Susanne N; Melching-Kollmuss, Stephanie; Krennrich, Gerhard; Landsiedel, Robert; van Ravenzwaay, Bennard

2011-08-01

Humans are exposed to a combination of various substances such as cosmetic ingredients, drugs, biocides, pesticides and natural-occurring substances in food. The combined toxicological effects of two or more substances can simply be additive on the basis of response-addition, or it can be greater (synergistic) or smaller (antagonistic) than this. The need to assess combined effects of compounds with endocrine activity is currently discussed for regulatory risk assessment. We have used a well described yeast based androgen receptor transactivation assay YAS to assess the combinatorial effects of vinclozolin and flutamide; both mediating antiandrogenicity via the androgen receptor. Both vinclozolin and flutamide were antiandrogens of similar potency in the YAS assay. In the concentration range tested the two antiandrogens vinclozolin and flutamide did not act synergistically. Concentration additivity was observed in the linear, non-receptor-saturated concentration range. At high concentrations of one of the two substances tested the contribution of the second at lower concentration levels was less than additive. The combined response of both compounds at high concentration levels was also less than additive (saturation effect). At concentration levels which did not elicit a response of the individual compounds, the combination of these compounds also did not elicit a response. Copyright © 2011 Elsevier Inc. All rights reserved.

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

Science.gov (United States)

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

2013-01-01

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

Operational risk assessment.

Science.gov (United States)

McKim, Vicky L

2017-06-01

In the world of risk management, which encompasses the business continuity disciplines, many types of risk require evaluation. Financial risk is most often the primary focus, followed by product and market risks. Another critical area, which typically lacks a thorough review or may be overlooked, is operational risk. This category encompasses many risk exposure types including those around building structures and systems, environmental issues, nature, neighbours, clients, regulatory compliance, network, data security and so on. At times, insurance carriers will assess internal hazards, but seldom do these assessments include more than a cursory look at other types of operational risk. In heavily regulated environments, risk assessments are required but may not always include thorough assessments of operational exposures. Vulnerabilities may linger or go unnoticed, only to become the catalyst for a business disruption at a later time, some of which are so severe that business recovery becomes nearly impossible. Businesses may suffer loss of clients as the result of a prolonged disruption of services. Comprehensive operational risk assessments can assist in identifying such vulnerabilities, exposures and threats so that the risk can be minimised or removed. This paper lays out how an assessment of this type can be successfully conducted.

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

Science.gov (United States)

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. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

Energy Technology Data Exchange (ETDEWEB)

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

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

Science.gov (United States)

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

2013-11-01

Microbial strains are increasingly used for the industrial production of chemicals and biofuels, but the toxicity of components in the feedstock and product streams limits process outputs. Selected or engineered microbes that thrive in the presence of toxic chemicals can be assessed using tolerance assays. Such assays must reasonably represent the conditions the cells will experience during the intended process and measure the appropriate physiological trait for the desired application. We review currently used tolerance assays, and examine the many parameters that affect assay outcomes. We identify and suggest the use of the best-suited assays for each industrial bioreactor operating condition, discuss next-generation assays, and propose a standardized approach for using assays to examine tolerance to toxic chemicals. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

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

2018-01-01

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

Hepatitis Risk Assessment

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

Cyanotoxins: Which detection technique for an optimum risk assessment?

Science.gov (United States)

Gaget, Virginie; Lau, Melody; Sendall, Barbara; Froscio, Suzanne; Humpage, Andrew R

2017-07-01

The presence of toxigenic cyanobacteria (blue-green algae) in drinking water reservoirs poses a risk to human and animal health worldwide. Guidelines and health alert levels have been issued in the Australian Drinking Water Guidelines for three major toxins, which are therefore the subject of routine monitoring: microcystin, cylindrospermopsin and saxitoxin. While it is agreed that these toxic compounds should be monitored closely, the routine surveillance of these bioactive chemicals can be done in various ways and deciding which technique to use can therefore be challenging. This study compared several assays available for the detection of these toxins and their producers in environmental samples: microscopy (for identification and enumeration of cyanobacteria), ELISA (Enzyme-Linked ImmunoSorbant Assay), PPIA (Protein phosphatase inhibition assay), PSI (Protein synthesis inhibition), chemical analysis and PCR (Polymerase Chain Reaction). Results showed that there was generally a good correlation between the presence of potentially toxigenic cyanobacteria and the detection of the toxin by ELISA. Nevertheless data suggest that cell numbers and toxin concentrations measured in bioassays do not necessarily correlate and that enumeration of potentially toxic cyanobacteria by microscopy, while commonly used for monitoring and risk assessment, is not the best indicator of real toxin exposure. The concentrations of saxitoxins quantified by ELISA were significantly different than those measured by LC-MS, while results were comparable in both assays for microcystin and cylindrospermopsin. The evaluation of these analytical methods led to the conclusion that there is no "gold standard" technique for the detection of the aforementioned cyanotoxins but that the choice of detection assay depends on cost, practicality, reliability and comparability of results and essentially on the question to be answered, notably on toxin exposure potential. Copyright © 2017 Elsevier Ltd. All

Mouse Assay for Determination of Arsenic Bioavailability in Contaminated Soils

Science.gov (United States)

Background: Accurate assessment of human exposure estimates from arsenic-contaminated soils depends upon estimating arsenic (As) soil bioavailability. Development of bioavailability assays provides data needed for human health risk assessments and supports development and valida...

GM Risk Assessment

Science.gov (United States)

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.

The local lymph node assay and the assessment of relative potency: status of validation.

Science.gov (United States)

Basketter, David A; Gerberick, Frank; Kimber, Ian

2007-08-01

For the prediction of skin sensitization potential, the local lymph node assay (LLNA) is a fully validated alternative to guinea-pig tests. More recently, information from LLNA dose-response analyses has been used to assess the relative potency of skin sensitizing chemicals. These data are then deployed for risk assessment and risk management. In this commentary, the utility and validity of these relative potency measurements are reviewed. It is concluded that the LLNA does provide a valuable assessment of relative sensitizing potency in the form of the estimated concentration of a chemical required to produce a threefold stimulation of draining lymph node cell proliferation compared with concurrent controls (EC3 value) and that all reasonable validation requirements have been addressed successfully. EC3 measurements are reproducible in both intra- and interlaboratory evaluations and are stable over time. It has been shown also, by several independent groups, that EC3 values correlate closely with data on relative human skin sensitization potency. Consequently, the recommendation made here is that LLNA EC3 measurements should now be regarded as a validated method for the determination of the relative potency of skin sensitizing chemicals, a conclusion that has already been reached by a number of independent expert groups.

Offshore risk assessment

CERN Document Server

Vinnem, Jan-Erik

2014-01-01

  Offshore Risk Assessment was the first book to deal with quantified risk assessment (QRA) as applied specifically to offshore installations and operations. Risk assessment techniques have been used for more than three decades in the offshore oil and gas industry, and their use is set to expand increasingly as the industry moves into new areas and faces new challenges in older regions.   This updated and expanded third edition has been informed by a major R&D program on offshore risk assessment in Norway and summarizes research from 2006 to the present day. Rooted with a thorough discussion of risk metrics and risk analysis methodology,  subsequent chapters are devoted to analytical approaches to escalation, escape, evacuation and rescue analysis of safety and emergency systems.   Separate chapters analyze the main hazards of offshore structures: fire, explosion, collision, and falling objects as well as structural and marine hazards. Risk mitigation and control are discussed, as well as an illustrat...

Discriminating the hemolytic risk of blood type A plasmas using the complement hemolysis using human erythrocytes (CHUHE) assay.

Science.gov (United States)

Cunnion, Kenji M; Hair, Pamela S; Krishna, Neel K; Sass, Megan A; Enos, Clinton W; Whitley, Pamela H; Maes, Lanne Y; Goldberg, Corinne L

2017-03-01

The agglutination-based cross-matching method is sensitive for antibody binding to red blood cells but is only partially predictive of complement-mediated hemolysis, which is important in many acute hemolytic transfusion reactions. Here, we describe complement hemolysis using human erythrocytes (CHUHE) assays that directly evaluate complement-mediated hemolysis between individual serum-plasma and red blood cell combinations. The CHUHE assay is used to evaluate correlations between agglutination titers and complement-mediated hemolysis as well as the hemolytic potential of plasma from type A blood donors. Plasma or serum from each type A blood donor was incubated with AB or B red blood cells in the CHUHE assay and measured for free hemoglobin release. CHUHE assays for serum or plasma demonstrate a wide, dynamic range and high sensitivity for complement-mediated hemolysis for individual serum/plasma and red blood cell combinations. CHUHE results suggest that agglutination assays alone are only moderately predictive of complement-mediated hemolysis. CHUHE results also suggest that plasma from particular type A blood donors produce minimal complement-mediated hemolysis, whereas plasma from other type A blood donors produce moderate to high-level complement-mediated hemolysis, depending on the red blood cell donor. The current results indicate that the CHUHE assay can be used to assess complement-mediated hemolysis for plasma or serum from a type A blood donor, providing additional risk discrimination over agglutination titers alone. © 2016 AABB.

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

Science.gov (United States)

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

2013-11-01

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

Concept of risk: risk assessment and nuclear safety

International Nuclear Information System (INIS)

Thompson, P.B.

1980-01-01

The dissertation is a critical examination of risk assessment and its role in public policy. Nuclear power safety safety issues are selected as the primary source of illustrations and examples. The dissertation examines how risk assessment studies develop a concept of risk which becomes decisive for policy choices. Risk-assessment techniques are interpreted as instruments which secure an evaluation of risk which, in turn, figures prominently in technical reports on nuclear power. The philosophical critique is mounted on two levels. First, an epistemological critique surveys distinctions between the technical concept of risk and more familiar senses of risk. The critique shows that utilization of risk assessment re-structures the concept of risk. The technical concept is contrasted to the function of risk within a decision-maker's conceptual agenda and hierarchy of values. Second, an ethical critique exposes the value commitments of risk assessment recommendations. Although some of these values might be defended for policy decisions, the technical character of risk assessment obfuscates normative issues. Risk assessment is shown to be a form of factual enquiry which, nonetheless, represents a commitment to a specific selection of ethical and social values. Risk assessment should not be interpreted as a primary guide to decision unless the specific values incorporated into its concept of risk are stated explicitly and justified philosophically. Such a statement would allow value questions which have been sublimated by the factual tone of the analytic techniques to be debated on clear, social and ethical grounds

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

Science.gov (United States)

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

2016-05-01

In situ assays based on feeding depression can be powerful ecotoxicological tools that can link physiological organism-level responses to population and/or community-level effects. Amphipods are traditional target species for toxicity tests due to their high sensitivity to contaminants, availability in the field and ease of handling. However, cost-effective in situ assays based on feeding depression are not yet available for amphipods that inhabit estuarine ecosystems. The aim of this work was to assess a short-term in situ assay based on postexposure feeding rates on easily quantifiable food items with an estuarine amphipod. Experiments were carried out under laboratory conditions using juvenile Echinogammarus marinus as the target individual. When 60 Artemia franciscana nauplii (as prey) were provided per individual for a period of 30 min in dark conditions, feeding rates could be easily quantified. As an endpoint, postexposure feeding inhibition in E. marinus was more sensitive to cadmium contamination than mortality. Assay calibration under field conditions demonstrated the relevance of sediment particle size in explaining individual feeding rates in uncontaminated water bodies. An evaluation of the 48-h in situ bioassay based on postexposure feeding rates indicated that it is able to discriminate between unpolluted and polluted estuarine sites. Using the harmonized protocol described here, the in situ postexposure feeding assay with E. marinus was found to be a potentially useful, cost-effective tool for assessing estuarine sediment and water quality. Copyright © 2016 Elsevier Ltd. All rights reserved.

Dutch Risk Assessment tools

NARCIS (Netherlands)

Venema, A.

2015-01-01

The ‘Risico- Inventarisatie- en Evaluatie-instrumenten’ is the name for the Dutch risk assessment (RA) tools. A RA tool can be used to perform a risk assessment including an evaluation of the identified risks. These tools were among the first online risk assessment tools developed in Europe. The

State of risk assessment

International Nuclear Information System (INIS)

Conrad, J.

1978-03-01

In view of the growing importance assumed in recent years by scientific work on the calculation, quantification, evaluation and acceptance as well as behavior in the face of risks in general and more specifically, the risks of large industrial plants, the report attempts to provide a survey of the current situation, results and evaluation of this new branch of research, risk assessment. The emphasis of the report is on the basic discussion and criticism of the theoretical and methodological approaches used in the field of risk assessment (section 3). It is concerned above all with - methodical problems of determining and quantifying risks (3.1) - questions of the possibility of risk evaluation and comp arison (3.1, 3.2) - the premises of normative and empirical studies on decision making under risk (3.2, 3.3) - investigations into society's acceptance of risks involved in the introduction of new technologies (3.4) - attempts to combine various aspects of the field of risk assessment in a unified concept (3.5, 3.6, 3.7). Because risk assessment is embedded in the framework of decision theory and technology assessment, it can be implicitly evaluated at a more general level within this framework, as far as its possibilities and weaknesses of method and application are concerned (section 4). Sections 2 and 5 deal with the social context of origin and utilization of risk assessment. Finally, an attempt is made at a summary indicating the possible future development of risk assessment. (orig./HP) [de

Risk assessment and risk management of mycotoxins.

Science.gov (United States)

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.

A functional assay-based strategy for nanomaterial risk forecasting

Energy Technology Data Exchange (ETDEWEB)

Hendren, Christine Ogilvie, E-mail: christine.hendren@duke.edu [Center for the Environmental Implications of NanoTechnology, Duke University, Durham, NC 27708 (United States); Lowry, Gregory V., E-mail: glowry@andrew.cmu.edu [Center for the Environmental Implications of NanoTechnology, Duke University, Durham, NC 27708 (United States); Department of Civil and Environmental Engineering, Carnegie Mellon University, 119 Porter Hall, Pittsburgh, PA 15213 (United States); Unrine, Jason M., E-mail: jason.unrine@uky.edu [Center for the Environmental Implications of NanoTechnology, Duke University, Durham, NC 27708 (United States); Department of Plant and Soil Sciences, University of Kentucky, Agricultural Science Center, Lexington, KY 40546 (United States); Wiesner, Mark R., E-mail: wiesner@duke.edu [Center for the Environmental Implications of NanoTechnology, Duke University, Durham, NC 27708 (United States); Department of Civil and Environmental Engineering, Duke University, 121 Hudson Hall PO Box 90287, Durham, NC 27708 (United States)

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. - Highlights: • Approaches to predict risk directly from nanomaterial (NM) properties are problematic. • We propose

A functional assay-based strategy for nanomaterial risk forecasting

International Nuclear Information System (INIS)

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

2015-01-01

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. - Highlights: • Approaches to predict risk directly from nanomaterial (NM) properties are problematic. • We propose

Biosafety Risk Assessment Methodology

Energy Technology Data Exchange (ETDEWEB)

Caskey, Susan Adele [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). International Biological Threat Reduction Program; Gaudioso, Jennifer M. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). International Biological Threat Reduction Program; Salerno, Reynolds Mathewson [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). International Biological Threat Reduction Program; Wagner, Stefan M. [Public Health Agency of Canada, Winnipeg, MB (Canada). Canadian Science Centre for Human and Animal Health (CSCHAH); Shigematsu, Mika [National Inst. of Infectious Diseases (NIID), Tokyo (Japan); Risi, George [Infectious Disease Specialists, P.C, Missoula, MT (United States); Kozlovac, Joe [US Dept. of Agriculture (USDA)., Beltsville, MD (United States); Halkjaer-Knudsen, Vibeke [Statens Serum Inst., Copenhagen (Denmark); Prat, Esmeralda [Bayer CropScience, Monheim am Rhein (Germany)

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.

2007 TOXICOLOGY AND RISK ASSESSMENT ...

Science.gov (United States)

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:

Risk Assessment

Science.gov (United States)

How the EPA conducts risk assessment to protect human health and the environment. Several assessments are included with the guidelines, models, databases, state-based RSL Tables, local contacts and framework documents used to perform these assessments.

Performance of a Multiplex Serological Helicobacter pylori Assay on a Novel Microfluidic Assay Platform

Directory of Open Access Journals (Sweden)

Angela Filomena

2017-10-01

Full Text Available Infection with Helicobacter pylori (H. pylori occurs in 50% of the world population, and is associated with the development of ulcer and gastric cancer. Serological diagnostic tests indicate an H. pylori infection by detecting antibodies directed against H. pylori proteins. In addition to line blots, multiplex assay platforms provide smart solutions for the simultaneous analysis of antibody responses towards several H. pylori proteins. We used seven H. pylori proteins (FliD, gGT, GroEL, HpaA, CagA, VacA, and HP0231 and an H. pylori lysate for the development of a multiplex serological assay on a novel microfluidic platform. The reaction limited binding regime in the microfluidic channels allows for a short incubation time of 35 min. The developed assay showed very high sensitivity (99% and specificity (100%. Besides sensitivity and specificity, the technical validation (intra-assay CV = 3.7 ± 1.2% and inter-assay CV = 5.5 ± 1.2% demonstrates that our assay is also a robust tool for the analysis of the H. pylori-specific antibody response. The integration of the virulence factors CagA and VacA allow for the assessment of the risk for gastric cancer development. The short assay time and the performance of the platform shows the potential for implementation of such assays in a clinical setting.

Exploration Health Risks: Probabilistic Risk Assessment

Science.gov (United States)

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

Assessment of Genotoxicity of Ionizing radiation using Tradescantia-Comet assay

Energy Technology Data Exchange (ETDEWEB)

Han, Min; Ryu, Tae Ho; Hyun, Kyung Man; Kim, Jin Kyu [Korea Atomic Energy Research Institute, Jeongeup (Korea, Republic of); Wilhelmova, Nad [Institute of Experimental Botany, Prague (Czech Republic)

2010-05-15

Over the last two decades, several new methodologies for the detection of DNA damage have been developed. The comet assay is currently used in different areas of biological sciences to detect DNA damage. The comet assay, also called the single cell gel electrophoresis (SCGE) was first introduced by Ostling and Johanson as a microelectrophoretic technique for the direct visualization of DNA damage in individual cells. The comet assay, due to its simplicity, sensitivity and need of a few cells, is ideal as a short-term genotoxicity test. The comet assay can theoretically be applied to every type of eukaryotic cell, including plant cells. Plants are very useful as monitors of genetic effects caused by pollution in the atmosphere, water and soil. Although the genotoxic effects detected by Tradescantia tests cannot be associated with mutagenesis or even carcinogenesis in humans, these bioassays are very useful tools for screening the mutagenic potential in the environment. Experiments were conducted to study the genotoxic effects of ionizing radiations on the genome integrity, particularly of Tradescantia. The increasingly frequent use of Tradescantia as a sensitive environmental bioindicator of genotoxic effects. This study was designed to assess the genotoxicity of ionizing radiation using Tradescnatia-comet assay

Electrochemiluminescence assays for insulin and glutamic acid decarboxylase autoantibodies improve prediction of type 1 diabetes risk.

Science.gov (United States)

Miao, Dongmei; Steck, Andrea K; Zhang, Li; Guyer, K Michelle; Jiang, Ling; Armstrong, Taylor; Muller, Sarah M; Krischer, Jeffrey; Rewers, Marian; Yu, Liping

2015-02-01

We recently developed new electrochemiluminescence (ECL) insulin autoantibody (IAA) and glutamic acid decarboxylase 65 autoantibody (GADA) assays that discriminate high-affinity, high-risk diabetes-specific autoantibodies from low-affinity, low-risk islet autoantibodies (iAbs) detected by radioassay (RAD). Here, we report a further validation of the ECL-IAA and -GADA assays in 3,484 TrialNet study participants. The ECL assay and RAD were congruent in those with prediabetes and in subjects with multiple autoantibodies, but only 24% (P<0.0001) of single RAD-IAA-positive and 46% (P<0.0001) of single RAD-GADA-positive were confirmed by the ECL-IAA and -GADA assays, respectively. During a follow-up (mean, 2.4 years), 51% of RAD-IAA-positive and 63% of RAD-GADA-positive subjects not confirmed by ECL became iAb negative, compared with only 17% of RAD-IAA-positive (P<0.0001) and 15% of RAD-GADA-positive (P<0.0001) subjects confirmed by ECL assays. Among subjects with multiple iAbs, diabetes-free survival was significantly shorter if IAA or GADA was positive by ECL and negative by RAD than if IAA or GADA was negative by ECL and positive by RAD (P<0.019 and P<0.0001, respectively). Both positive and negative predictive values in terms of progression to type 1 diabetes mellitus were superior for ECL-IAA and ECL-GADA, compared with RADs. The prevalence of the high-risk human leukocyte antigen-DR3/4, DQB1*0302 genotype was significantly higher in subjects with RAD-IAA or RAD-GADA confirmed by ECL. In conclusion, both ECL-IAA and -GADA are more disease-specific and better able to predict the risk of progression to type 1 diabetes mellitus than the current standard RADs.

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

DEFF Research Database (Denmark)

Sciascia, Savino; Baldovino, Simone; Schreiber, Karen

2016-01-01

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...

Can in vitro assays account for interactions between inorganic co-contaminants observed during in vivo relative bioavailability assessment?

Science.gov (United States)

Ollson, Cameron J; Smith, Euan; Juhasz, Albert L

2018-02-01

In vitro assays act as surrogate measurements of relative bioavailability (RBA) for inorganic contaminants. The values derived from these assays are routinely used to refine human health risk assessments (HHRA). Extensive in vitro research has been performed on three major inorganic contaminants; As, Cd and Pb. However, the majority of these studies have evaluated the contaminants individually, even in cases when they are found as co-contaminants. Recently, in vivo studies (animal model) have determined that when the three aforementioned contaminants are present in the same soil matrix, they have the ability to influence each other's individual bioavailability. Since in vitro assays are used to inform HHRA, this study investigated whether bioaccessibility methods including the Solubility/Bioavailability Research Consortium (SBRC) assay, and physiologically based extraction test (PBET), have the ability to detect interactions between As, Cd and Pb. Using a similar dosing methodology to recently published in vivo studies, spiked aged (12 years) soil was assessed by evaluating contaminant bioaccessibility individually, in addition to tertiary combinations. In two spiked aged soils (grey and brown chromosols), there was no influence on contaminant bioaccessibility when As, Cd and Pb we present as co-contaminants. However, in a red ferrosol, the presence of As and Pb significantly decreased (p contaminant interactions and bioaccessibility outcomes. Although bioaccessibility methods may not account for interactions between elements as demonstrated in in vivo models, in vitro assessment provides a conservative prediction of contaminant RBA under co-contaminant scenarios. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

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 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.

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

Science.gov (United States)

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

Fluorescence Adherence Inhibition Assay: A Novel Functional Assessment of Blocking Virus Attachment by Vaccine-Induced Antibodies.

Directory of Open Access Journals (Sweden)

Atul Asati

Full Text Available Neutralizing antibodies induced by vaccination or natural infection play a critically important role in protection against the viral diseases. In general, neutralization of the viral infection occurs via two major pathways: pre- and post-attachment modes, the first being the most important for such infections as influenza and polio, the latter being significant for filoviruses. Neutralizing capacity of antibodies is typically evaluated by virus neutralization assays that assess reduction of viral infectivity to the target cells in the presence of functional antibodies. Plaque reduction neutralization test, microneutralization and immunofluorescent assays are often used as gold standard virus neutralization assays. However, these methods are associated with several important prerequisites such as use of live virus requiring safety precautions, tedious evaluation procedure and long assessment time. Hence, there is a need for a robust, inexpensive high throughput functional assay that can be performed rapidly using inactivated virus, without extensive safety precautions. Herein, we report a novel high throughput Fluorescence Adherence Inhibition assay (fADI using inactivated virus labeled with fluorescent secondary antibodies virus and Vero cells or erythrocytes as targets. It requires only few hours to assess pre-attachment neutralizing capacity of donor sera. fADI assay was tested successfully on donors immunized with polio, yellow fever and influenza vaccines. To further simplify and improve the throughput of the assay, we have developed a mathematical approach for calculating the 50% titers from a single sample dilution, without the need to analyze multi-point titration curves. Assessment of pre- and post-vaccination human sera from subjects immunized with IPOL®, YF-VAX® and 2013-2014 Fluzone® vaccines demonstrated high efficiency of the assay. The results correlated very well with microneutralization assay performed independently by the FDA

Hanford Site's Integrated Risk Assessment Program: No-intervention risk assessment

International Nuclear Information System (INIS)

Mahaffey, J.A.; Dukelow, J.S. Jr.; Stenner, R.D.

1994-08-01

The long-term goal of the Integrated Risk Assessment program (IRAP) is to estimate risks to workers, the public, organizations, and groups with reserved rights to Site access, the ecosystem, and natural resources to aid in managing environmental restoration and waste management at the Hanford Site. For each of these, information is needed about current risks, risks during cleanup, and endstate risks. The objective is three-fold: to determine if and when to remediate, and to what extent; to identify information unavailable but needed to make better cleanup decisions; to establish technology performance criteria for achieving desired cleanup levels; to understand costs and benefits of activities from a Site-wide perspective. The no-intervention risk, assessment is the initial evaluation of public health risks conducted under IRAP. The objective is to identify types of activities that the US Department of Energy (DOE) must accomplish for closure of the Hanford Site, defined as no further DOE intervention. There are two primary conclusions from the no-intervention risk assessment. First, some maintenance and operations activities at Hanford must be continued to protect the public from grave risks. However, when large Hanford expenditures are compared to cleanup progress, funds expended for maintenance and operations must be put in proper perspective. Second, stakeholder's emphasis on public risks at Hanford, as indicated by remediation priorities, are not in line with those estimated. The focus currently is on compliance with regulations, and on dealing with issues which are visible to stakeholders

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

Science.gov (United States)

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

Chemical Risk Assessment

Science.gov (United States)

This course is aimed at providing an overview of the fundamental guiding principles and general methods used in chemical risk assessment. Chemical risk assessment is a complex and ever-evolving process. These principles and methods have been organized by the National Research Cou...

An integrated risk assessment approach: Risk assessment in the programmatic environmental impact statement

International Nuclear Information System (INIS)

Morris, J.M.

1994-01-01

The following paper is an informal summary of salient points made in the presentation entitled open-quotes An Integrated Risk Assessment Approach: Risk Assessment in the Programmatic Environmental Impact Statement (PEIS).close quotes. This presentation was given at the U.S. DOE Integrated Planning Workshop in Denver, Colorado on June 2, 1994. Integrated decision analysis is very important in environmental restoration and waste management in the evaluation of such things as land use planning, waste load forecasting, cost analyses, and technology development activities. Integrated risk assessment is an approach that addresses multiple components of risk, including: risks from surplus facilities as well as typical environmental restoration sites, risks to the public, risks to workers, ecological risk, risks before, during and after remediation activities, and others

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

Science.gov (United States)

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

The relation of risk assessment and health impact assessment

DEFF Research Database (Denmark)

Ádám, Balázs; Gulis, Gabriel

2013-01-01

than assessing a present situation. As part of this process, however, methods applied in risk assessment are used. Risk assessment typically characterises relation of a well-defined risk factor to a well-defined health outcome. Within HIA usually several individual risk assessments are needed...... of the causal chain from the proposal through related health determinants and risk factors to health outcomes. The stepwise analysis, systematic prioritization and consideration of horizontal interactions between the causal pathways make it feasible to use widely recognized risk assessment methods in the HIA......The level and distribution of health risks in a society is substantially influenced by measures of various policies, programmes or projects. Risk assessment can evaluate the nature, likelihood and severity of an adverse effect. Health impact assessment (HIA) provides similar function when used...

Assessment of cardiovascular risk.

LENUS (Irish Health Repository)

Cooney, Marie Therese

2010-10-01

Atherosclerotic cardiovascular disease (CVD) is the most common cause of death worldwide. Usually atherosclerosis is caused by the combined effects of multiple risk factors. For this reason, most guidelines on the prevention of CVD stress the assessment of total CVD risk. The most intensive risk factor modification can then be directed towards the individuals who will derive the greatest benefit. To assist the clinician in calculating the effects of these multiple interacting risk factors, a number of risk estimation systems have been developed. This review address several issues regarding total CVD risk assessment: Why should total CVD risk be assessed? What risk estimation systems are available? How well do these systems estimate risk? What are the advantages and disadvantages of the current systems? What are the current limitations of risk estimation systems and how can they be resolved? What new developments have occurred in CVD risk estimation?

Assessing sediment contamination using six toxicity assays

Directory of Open Access Journals (Sweden)

Allen G. BURTON Jr.

2001-08-01

Full Text Available An evaluation of sediment toxicity at Lake Orta, Italy was conducted to compare a toxicity test battery of 6 assays and to evaluate the extent of sediment contamination at various sediment depths. Lake Orta received excessive loadings of copper and ammonia during the 1900’s until a large remediation effort was conducted in 1989-90 using lime addition. Since that time, the lake has shown signs of a steady recovery of biological communities. The study results showed acute toxicity still exists in sediments at a depth of 5 cm and greater. Assays that detected the highest levels of toxicity were two whole sediment exposures (7 d using Hyalella azteca and Ceriodaphnia dubia. The MicrotoxR assay using pore water was the third most sensitive assay. The Thamnotox, Rototox, Microtox solid phase, and Seed Germination-Root Elongation (pore and solid phase assays showed occasional to no toxicity. Based on similarity of responses and assay sensitivity, the two most useful assays were the C. dubia (or H. azteca and Microtox pore water. These assays were effective at describing sediment toxicity in a weight-of-evidence approach.

Personal care product preservatives: risk assessment and mixture toxicities with an industrial wastewater.

Science.gov (United States)

Carbajo, Jose B; Perdigón-Melón, Jose A; Petre, Alice L; Rosal, Roberto; Letón, Pedro; García-Calvo, Eloy

2015-04-01

The aquatic toxicity of eight preservatives frequently used in personal care products (PCPs) (iodopropynyl butylcarbamate, bronopol, diazolidinyl urea, benzalkonium chloride, zinc pyrithione, propylparaben, triclosan and a mixture of methylchloroisothiazolinone and methylisothiazolinone) was assessed by means of two different approaches: a battery of bioassays composed of single species tests of bacteria (Vibrio fischeri and Pseudomonas putida) and protozoa (Tetrahymena thermophila), and a whole biological community resazurin-based assay using activated sludge. The tested preservatives showed considerable toxicity in the studied bioassays, but with a marked difference in potency. In fact, all biocides except propylparaben and diazolidinyl urea had EC50 values lower than 1 mg L(-1) in at least one assay. Risk quotients for zinc pyrithione, benzalkonium chloride, iodopropynyl butylcarbamate and triclosan as well as the mixture of the studied preservatives exceeded 1, indicating a potential risk for the process performance and efficiency of municipal sewage treatment plants (STPs). These four single biocides explained more than 95% of the preservative mixture risk in all bioassays. Each individual preservative was also tested in combination with an industrial wastewater (IWW) from a cosmetics manufacturing facility. The toxicity assessment was performed on binary mixtures (preservative + IWW) and carried out using the median-effect principle, which is a special case of the concept of Concentration Addition (CA). Almost 70% of all experiments resulted in EC50 values within a factor of 2 of the values predicted by the median-effect principle (CI values between 0.5 and 2). The rest of the mixtures whose toxicity was mispredicted by CA were assessed with the alternative concept of Independent Action (IA), which showed higher predictive power for the biological community assay. Therefore, the concept used to accurately predict the toxicity of mixtures of a preservative

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

Energy Technology Data Exchange (ETDEWEB)

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.

Information needs for risk assessment

Energy Technology Data Exchange (ETDEWEB)

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.

Biosafety risk assessment approaches for insect-resistant genetically modified crops

Directory of Open Access Journals (Sweden)

Inaam Ullah

2017-02-01

Full Text Available Background: Environmental risk assessment (ERA is imperative for commercial release of insect resistant, genetically modified crops (IR-GMCs.An insect specific, spider venom peptideω-HXTX-Hv1a (Hvt was successfully expressed in cotton plants. The cotton plants producing Hvt protein have demonstrated resistance against economically important insect pest species. The study was performed to assess the effects of Hvt producing cotton plants on Honey bees (Apis mellifera. Methods: Three approaches were used to evaluate the effects of Hvt protein on adults of honeybees; whole plant assays in flight cages, in vitro assays with pollen of Hvt-cotton, and assays with elevated levels of purified Hvt protein. Pollens of Bt cotton or purified Bt proteins were used as control. Results: The field experiments did not yield any meaningful data due to high rate of mortality in all treatments including the control. However, the laboratory experiments provided conclusive results in which Hvt, purified or in pollens, did not affect the survival or longevity of the bees compared to the control. During the course of study we were able to compare the quality, effectiveness and economics of different experiments. Conclusions: We conclude that Hvt either purified or produced in cotton plants do not affect the survival or longevity of honey bees. We are also of the view that starting at laboratory level assays not only gives meaningful data but also saves a lot of time and money that can be spent on other important questions regarding safety of a particular transgenic crop. Hence, a purpose-based, tiered approach could be the best choice for pre-release ERA of IR-GMCs.

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

International Nuclear Information System (INIS)

Domene, Xavier; Alcaniz, Josep M.; Andres, Pilar

2008-01-01

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

Probabilistic risk assessment as an aid to risk management

International Nuclear Information System (INIS)

Garrick, B.J.

1982-01-01

Probabilistic risk assessments are providing important insights into nuclear power plant safety. Their value is two-fold: first as a means of quantifying nuclear plant risk including contributors to risk, and second as an aid to risk management. A risk assessment provides an analytical plant model that can be the basis for performing meaningful decision analyses for controlling safety. It is the aspect of quantitative risk management that makes probabilistic risk assessment an important technical discipline of the future

Methodology of environmental risk assessment management

Directory of Open Access Journals (Sweden)

Saša T. Bakrač

2012-04-01

Full Text Available Successful protection of environment is mostly based on high-quality assessment of potential and present risks. Environmental risk management is a complex process which includes: identification, assessment and control of risk, namely taking measures in order to minimize the risk to an acceptable level. Environmental risk management methodology: In addition to these phases in the management of environmental risk, appropriate measures that affect the reduction of risk occurrence should be implemented: - normative and legal regulations (laws and regulations, - appropriate organizational structures in society, and - establishing quality monitoring of environment. The emphasis is placed on the application of assessment methodologies (three-model concept, as the most important aspect of successful management of environmental risk. Risk assessment methodology - European concept: The first concept of ecological risk assessment methodology is based on the so-called European model-concept. In order to better understand this ecological risk assessment methodology, two concepts - hazard and risk - are introduced. The European concept of environmental risk assessment has the following phases in its implementation: identification of hazard (danger, identification of consequences (if there is hazard, estimate of the scale of consequences, estimate of consequence probability and risk assessment (also called risk characterization. The European concept is often used to assess risk in the environment as a model for addressing the distribution of stressors along the source - path - receptor line. Risk assessment methodology - Canadian concept: The second concept of the methodology of environmental risk assessment is based on the so-called Canadian model-concept. The assessment of ecological risk includes risk arising from natural events (floods, extreme weather conditions, etc., technological processes and products, agents (chemical, biological, radiological, etc

Strategic Risk Assessment

Science.gov (United States)

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.

Overview of risk assessment

International Nuclear Information System (INIS)

Rimington, J.D.

1992-01-01

The paper begins by defining some terms, and then refer to a number of technical and other difficulties. Finally it attempts to set out why risk assessment is important and what its purposes are. 2) First, risk and risk assessment - what are they?. 3) Risk is a subject of universal significance. Life is very uncertain, and we can achieve no object or benefit in it except by approaching nearer to particular hazards which lie between us and our objects. That approach represents acceptance of risk. 4) Risk assessment is a way of systematising our approach to hazard with a view to determining what is more and what is less risky. It helps us in the end to diminish our exposure while obtaining whatever benefits we have in mind, or to optimise the risks and the benefits

Overview of risk assessment

Energy Technology Data Exchange (ETDEWEB)

Rimington, J D [Health and Safety Executive (United Kingdom)

1992-07-01

The paper begins by defining some terms, and then refer to a number of technical and other difficulties. Finally it attempts to set out why risk assessment is important and what its purposes are. 2) First, risk and risk assessment - what are they?. 3) Risk is a subject of universal significance. Life is very uncertain, and we can achieve no object or benefit in it except by approaching nearer to particular hazards which lie between us and our objects. That approach represents acceptance of risk. 4) Risk assessment is a way of systematising our approach to hazard with a view to determining what is more and what is less risky. It helps us in the end to diminish our exposure while obtaining whatever benefits we have in mind, or to optimise the risks and the benefits.

[Urban ecological risk assessment: a review].

Science.gov (United States)

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.

Nano-immunosafety: issues in assay validation

International Nuclear Information System (INIS)

Boraschi, Diana; Italiani, Paola; Oostingh, Gertie J; Duschl, Albert; Casals, Eudald; Puntes, Victor F; Nelissen, Inge

2011-01-01

Assessing the safety of engineered nanomaterials for human health must include a thorough evaluation of their effects on the immune system, which is responsible for defending the integrity of our body from damage and disease. An array of robust and representative assays should be set up and validated, which could be predictive of the effects of nanomaterials on immune responses. In a trans-European collaborative work, in vitro assays have been developed to this end. In vitro tests have been preferred for their suitability to standardisation and easier applicability. Adapting classical assays to testing the immunotoxicological effects of nanoparticulate materials has raised a series of issues that needed to be appropriately addressed in order to ensure reliability of results. Besides the exquisitely immunological problem of selecting representative endpoints predictive of the risk of developing disease, assay results turned out to be significantly biased by artefactual interference of the nanomaterials or contaminating agents with the assay protocol. Having addressed such problems, a series of robust and representative assays have been developed that describe the effects of engineered nanoparticles on professional and non-professional human defence cells. Two of such assays are described here, one based on primary human monocytes and the other employing human lung epithelial cells transfected with a reporter gene.

[Forensic assessment of violence risk].

Science.gov (United States)

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

2014-03-01

Over the last 20 years there have been steps forward in the field of scientific research on prediction and handling different violent behaviors. In this work we go over the classic concept of "criminal dangerousness" and the more current of "violence risk assessment". We analyze the evolution of such assessment from the practice of non-structured clinical expert opinion to current actuarial methods and structured clinical expert opinion. Next we approach the problem of assessing physical violence risk analyzing the HCR-20 (Assessing Risk for Violence) and we also review the classic and complex subject of the relation between mental disease and violence. One of the most problematic types of violence, difficult to assess and predict, is sexual violence. We study the different actuarial and sexual violence risk prediction instruments and in the end we advise an integral approach to the problem. We also go through partner violence risk assessment, describing the most frequently used scales, especially SARA (Spouse Assault Risk Assessment) and EPV-R. Finally we give practical advice on risk assessment, emphasizing the importance of having maximum information about the case, carrying out a clinical examination, psychopathologic exploration and the application of one of the described risk assessment scales. We'll have to express an opinion about the dangerousness/risk of future violence from the subject and some recommendations on the conduct to follow and the most advisable treatment. Copyright © 2014 Elsevier España, S.L. All rights reserved.

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

DEFF Research Database (Denmark)

Johansson, Clara; Møller, Peter; Forchhammer, Lykke

2010-01-01

The increasing use of single cell gel electrophoresis (the comet assay) highlights its popularity as a method for detecting DNA damage, including the use of enzymes for assessment of oxidatively damaged DNA. However, comparison of DNA damage levels between laboratories can be difficult due...... to differences in assay protocols (e.g. lysis conditions, enzyme treatment, the duration of the alkaline treatment and electrophoresis) and in the end points used for reporting results (e.g. %DNA in tail, arbitrary units, tail moment and tail length). One way to facilitate comparisons is to convert primary comet...... assay end points to number of lesions/10(6) bp by calibration with ionizing radiation. The aim of this study was to investigate the inter-laboratory variation in assessment of oxidatively damaged DNA by the comet assay in terms of oxidized purines converted to strand breaks with formamidopyrimidine DNA...

Environmental risk assessment of chemicals and nanomaterials--The best foundation for regulatory decision-making?

Science.gov (United States)

Syberg, Kristian; Hansen, Steffen Foss

2016-01-15

Environmental risk assessment (ERA) is often considered as the most transparent, objective and reliable decision-making tool for informing the risk management of chemicals and nanomaterials. ERAs are based on the assumption that it is possible to provide accurate estimates of hazard and exposure and, subsequently, to quantify risk. In this paper we argue that since the quantification of risk is dominated by uncertainties, ERAs do not provide a transparent or an objective foundation for decision-making and they should therefore not be considered as a "holy grail" for informing risk management. We build this thesis on the analysis of two case studies (of nonylphenol and nanomaterials) as well as a historical analysis in which we address the scientific foundation for ERAs. The analyses show that ERAs do not properly address all aspects of actual risk, such as the mixture effect and the environmentally realistic risk from nanomaterials. Uncertainties have been recognised for decades, and assessment factors are used to compensate for the lack of realism in ERAs. The assessment factors' values were pragmatically determined, thus lowering the scientific accuracy of the ERAs. Furthermore, the default choice of standard assay for assessing a hazard might not always be the most biologically relevant, so we therefore argue that an ERA should be viewed as a pragmatic decision-making tool among several, and it should not have a special status for informing risk management. In relation to other relevant decision-making tools we discuss the use of chemical alternative assessments (CAAs) and the precautionary principle. Copyright © 2015 Elsevier B.V. All rights reserved.

Bioassay-based risk assessment of hazardous waste

Energy Technology Data Exchange (ETDEWEB)

Donnelly, K.C.; Brown, K.W.; He, L.Y. [Texas A and M Univ., College Station, TX (United States)

1994-12-31

Microbial bioassays have been used to assess the genotoxic hazard at more than 30 different hazardous waste sites. Environmental samples were extracted with dichloromethane and methanol, and the resulting residue tested using GC/MS analysis as well as the Salmonella Microsomal and E. coli Prophage Induction assays. At a munitions wastewater contaminated site, there was no correlation between mutagenicity in bacteria, and the risk as estimated from chemical analysis data of trinitrotoluene. Samples 202 and 204 from a coal gasification site contained 72 mg/kg and 9 mg/kg benzo(a)pyrene, whereas the mutagenic responses of these samples were 231 net revertants/mg and 902 revertants/mg, respectively. The data suggest that microbial bioassays provide a valuable tool for monitoring the interactions of the components of a complex mixture.

Risk assessment of tuberculosis in immunocompromised patients

DEFF Research Database (Denmark)

Sester, Martina; van Leth, Frank; Bruchfeld, Judith

2014-01-01

RATIONALE: In the absence of active tuberculosis, a positive tuberculin skin test (TST) or interferon-γ release assay (IGRA) result defines latent infection with Mycobacterium tuberculosis, although test results may vary depending on immunodeficiency. OBJECTIVES: This study compared the performance...... of TST and IGRAs in five different groups of immunocompromised patients, and evaluated their ability to identify those at risk for development of tuberculosis. METHODS: Immunocompromised patients with HIV infection, chronic renal failure, rheumatoid arthritis, solid-organ or stem-cell transplantation......, and healthy control subjects were evaluated head-to-head by the TST, QuantiFERON-TB-Gold in-tube test (ELISA), and T-SPOT.TB test (enzyme-linked immunospot) at 17 centers in 11 European countries. Development of tuberculosis was assessed during follow-up. MEASUREMENTS AND MAIN RESULTS: Frequencies of positive...

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

Science.gov (United States)

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.

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

Science.gov (United States)

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

2016-02-15

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

Assaying Cellular Viability Using the Neutral Red Uptake Assay.

Science.gov (United States)

Ates, Gamze; Vanhaecke, Tamara; Rogiers, Vera; Rodrigues, Robim M

2017-01-01

The neutral red uptake assay is a cell viability assay that allows in vitro quantification of xenobiotic-induced cytotoxicity. The assay relies on the ability of living cells to incorporate and bind neutral red, a weak cationic dye, in lysosomes. As such, cytotoxicity is expressed as a concentration-dependent reduction of the uptake of neutral red after exposure to the xenobiotic under investigation. The neutral red uptake assay is mainly used for hazard assessment in in vitro toxicology applications. This method has also been introduced in regulatory recommendations as part of 3T3-NRU-phototoxicity-assay, which was regulatory accepted in all EU member states in 2000 and in the OECD member states in 2004 as a test guideline (TG 432). The present protocol describes the neutral red uptake assay using the human hepatoma cell line HepG2, which is often employed as an alternative in vitro model for human hepatocytes. As an example, the cytotoxicity of acetaminophen and acetyl salicylic acid is assessed.

Cutaneous radiation syndrome: applicability of comet assay for early assessment of irradiation consequences

International Nuclear Information System (INIS)

Di Giorgio, Marina; Taja, Maria R.; Bolgiani, A.; Bustos, N.; Cavalieri, H.

2002-01-01

Many accidental overexposures to ionizing radiation lead to an inhomogeneous irradiation of the body. Skin and mucous membranes resulted exposed to very high local radiation doses, which may be survivable because bone marrow is less severely exposed. Under these circumstances, the skin becomes an important organ in determining clinical prognosis, being dosimetric assessment a necessary requirement. There is increasing interest in the assessment of biological markers that permit the detection of radiation induced damage in the localized irradiations. The 'Comet Assay' (single cell gel electrophoresis) is a sensitive, rapid and relatively inexpensive method for measuring DNA damage in individual cells. Single cells are embedded in agarose on microscope slides, lysed to remove the majority of the proteins, electrophoreses, then stained with ethidium bromide in order to visualize the DNA. Following radiation damage, the smaller the fragment size and the grater the number of fragments of DNA, the grater the percentage of DNA that it is able to migrate in an electric field, forming a comet image. The assay can be performed under alkaline conditions to examine DNA single strand breaks (SSBs), or in non denaturing (neutral) conditions to measure double strand breaks (DSBs) in individual cells. In order to get information to be applied on the evaluation of skin biopsies without culture for an early assessment of irradiation consequences in locally irradiated individuals, we have evaluated the alkaline comet assay (for doses 5 Gy), neutral comet assay has been applied to keratinocytes from primary and secondary cultures and to a suspension of epidermal cells obtained from biopsies irradiated in vitro and afterwards processed to obtain the mentioned cellular suspension, in order to reproduce the closest condition to in vivo overexposure. Our results suggest that comet assay can be applied for the early assessment of gamma radiation induced damage in skin biopsies without

Development of an artificial neural network model for risk assessment of skin sensitization using human cell line activation test, direct peptide reactivity assay, KeratinoSens™ and in silico structure alert parameter.

Science.gov (United States)

Hirota, Morihiko; Ashikaga, Takao; Kouzuki, Hirokazu

2018-04-01

It is important to predict the potential of cosmetic ingredients to cause skin sensitization, and in accordance with the European Union cosmetic directive for the replacement of animal tests, several in vitro tests based on the adverse outcome pathway have been developed for hazard identification, such as the direct peptide reactivity assay, KeratinoSens™ and the human cell line activation test. Here, we describe the development of an artificial neural network (ANN) prediction model for skin sensitization risk assessment based on the integrated testing strategy concept, using direct peptide reactivity assay, KeratinoSens™, human cell line activation test and an in silico or structure alert parameter. We first investigated the relationship between published murine local lymph node assay EC3 values, which represent skin sensitization potency, and in vitro test results using a panel of about 134 chemicals for which all the required data were available. Predictions based on ANN analysis using combinations of parameters from all three in vitro tests showed a good correlation with local lymph node assay EC3 values. However, when the ANN model was applied to a testing set of 28 chemicals that had not been included in the training set, predicted EC3s were overestimated for some chemicals. Incorporation of an additional in silico or structure alert descriptor (obtained with TIMES-M or Toxtree software) in the ANN model improved the results. Our findings suggest that the ANN model based on the integrated testing strategy concept could be useful for evaluating the skin sensitization potential. Copyright © 2017 John Wiley & Sons, Ltd.

Validation of an early childhood caries risk assessment tool in a low-income Hispanic population.

Science.gov (United States)

Custodio-Lumsden, Christie L; Wolf, Randi L; Contento, Isobel R; Basch, Charles E; Zybert, Patricia A; Koch, Pamela A; Edelstein, Burton L

2016-03-01

There is a recognized need for valid risk assessment tools for use by both dental and nondental personnel to identify young children at risk for, or with, precavitated stages of early childhood caries (i.e., early stage decalcifications or white spot lesions).The aim of this study is to establish concurrent criterion validity of "MySmileBuddy" (MSB), a novel technology-assisted ECC risk assessment and behavioral intervention tool against four measures of ECC activity: semi-quantitative assays of salivary mutans streptococci levels, visible quantity of dental plaque, visual evidence of enamel decalcifications, and cavitation status (none, ECC, severe ECC). One hundred eight children 2-6 years of age presenting to a pediatric dental clinic were recruited from a predominantly Spanish-speaking, low-income, urban population. All children received a comprehensive oral examination and saliva culture for assessment of ECC indicators. Their caregivers completed the iPad-based MSB assessment in its entirety (15-20 minutes). MSB calculated both diet and comprehensive ECC risk scores. Associations between all variables were determined using ordinal logistic regression. MSB diet risk scores were significantly positively associated with salivary mutans (P valid risk assessment tool for identifying children with early precursors of cavitations but does not add value in identifying children with extant lesions. © 2015 American Association of Public Health Dentistry.

A pseudovirus-based hemagglutination-inhibition assay as a rapid, highly sensitive, and specific assay for detecting avian influenza A (H7N9 antibodies

Directory of Open Access Journals (Sweden)

Anli Zhang

2015-06-01

Full Text Available Background Increased surveillance of avian-origin influenza A (H7N9 virus infection is critical to assess the risk of new outbreaks in China. A high-throughput assay with a good safety profile, sensitivity, and specificity is urgently needed. Methods We used a hemagglutination-inhibition (HI assay based on an H7N9-enveloped pseudovirus to assess serum neutralization antibodies level in 40 H7N9 positive sera and 40 H7N9 negative sera and compared the efficacy of the assay with traditional HI test and micro-neutralization (MN test. Results Spearman’s rank correlation coefficient analysis showed pseudovirus HI (PHI titers correlated well with both HI titers and MN titers. Receiver operating characteristic (ROC curves test revealed using a PHI cut-off titer of 10, the sensitivity and specificity reached 1.0. Conclusions PHI can be used in H7N9-related serological studies. This assay is high-throughput, very sensitive and specific, and cost effective.

In silico tools to aid risk assessment of endocrine disrupting chemicals

International Nuclear Information System (INIS)

Jacobs, M.N.

2004-01-01

In silico or computational tools could be used more effectively in endocrine disruptor risk assessment for prescreening potential endocrine disruptors, improving experimental in vitro screening assay design and facilitating more thorough data analyses. The in silico tools reviewed here are three-fold and include the use of: (1) nuclear receptor (NR) crystal structures and homology models to examine potential modes of ligand binding by different representative compounds; (2) multivariate principal component analyses (PCA) techniques to select best predicted cell lines for endocrine disrupting chemicals (EDC) risk assessment purposes; (3) NR quantitative structure-activity relationships (QSARs) that can be constructed from varied biological data sources, using multivariate partial least squares (PLS) techniques and specific descriptors. The cytosolic and NR examples discussed here include the Ah receptor (AhR), the human oestrogen receptor α (hERα) and the human pregnane X receptor (PXR). The varied biological data sets can be compared to give a more integrated dimension to receptor cross talk mechanisms, with further support from molecular modelling studies

Patient caries risk assessment

DEFF Research Database (Denmark)

Twetman, Svante; Fontana, Margherita

2009-01-01

Risk assessment is an essential component in the decision-making process for the correct prevention and management of dental caries. Multiple risk factors and indicators have been proposed as targets in the assessment of risk of future disease, varying sometimes based on the age group at which...... they are targeted. Multiple reviews and systematic reviews are available in the literature on this topic. This chapter focusses primarily on results of reviews based on longitudinal studies required to establish the accuracy of caries risk assessment. These findings demonstrate that there is a strong body...... of evidence to support that caries experience is still, unfortunately, the single best predictor for future caries development. In young children, prediction models which include a variety of risk factors seem to increase the accuracy of the prediction, while the usefulness of additional risk factors...

Performance Assessment of a Trypanosoma cruzi Chimeric Antigen in Multiplex Liquid Microarray Assays.

Science.gov (United States)

Santos, Fred Luciano Neves; Celedon, Paola Alejandra Fiorani; Zanchin, Nilson Ivo Tonin; Leitolis, Amanda; Crestani, Sandra; Foti, Leonardo; de Souza, Wayner Vieira; Gomes, Yara de Miranda; Krieger, Marco Aurélio

2017-10-01

Diagnosing chronic Chagas disease (CD) requires antibody-antigen detection methods, which are traditionally based on enzymatic assay techniques whose performance depend on the type and quality of antigen used. Previously, 4 recombinant chimeric proteins from the Instituto de Biologia Molecular do Paraná (IBMP-8.1 to 8.4) comprising immuno-dominant regions of diverse Trypanosoma cruzi antigens showed excellent diagnostic performance in enzyme-linked immunosorbent assays. Considering that next-generation platforms offer improved CD diagnostic accuracy with different T. cruzi -specific recombinant antigens, we assessed the performance of these chimeras in liquid microarrays (LMAs). The chimeric proteins were expressed in Escherichia coli and purified by chromatography. Sera from 653 chagasic and 680 healthy individuals were used to assess the performance of these chimeras in detecting specific anti- T. cruzi antibodies. Accuracies ranged from 98.1 to 99.3%, and diagnostic odds ratio values were 3,548 for IBMP-8.3, 4,826 for IBMP-8.1, 7,882 for IBMP-8.2, and 25,000 for IBMP-8.4. A separate sera bank (851 samples) was employed to assess cross-reactivity with other tropical diseases. Leishmania , a pathogen with high similarity to T. cruzi , showed cross-reactivity rates ranging from 0 to 2.17%. Inconclusive results were negligible (0 to 0.71%). Bland-Altman and Deming regression analysis based on 200 randomly selected CD-positive and negative samples demonstrated interchangeability with respect to CD diagnostic performance in both singleplex and multiplex assays. Our results suggested that these chimeras can potentially replace antigens currently used in commercially available assay kits. Moreover, the use of multiplex platforms, such as LMA assays employing 2 or more IBMP antigens, would abrogate the need for 2 different testing techniques when diagnosing CD. Copyright © 2017 American Society for Microbiology.

Building better environmental risk assessments

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Raymond eLayton

2015-08-01

Full Text Available 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 (ERA 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.

Building Better Environmental Risk Assessments

Science.gov (United States)

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

2015-01-01

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

Building Better Environmental Risk Assessments.

Science.gov (United States)

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.

Pertussis serology: assessment of IgG anti-PT ELISA for replacement of the CHO cell assay*

Science.gov (United States)

DALBY, TINE; SØRENSEN, CHARLOTTE; PETERSEN, JESPER WESTPHAL; KROGFELT, KAREN ANGELIKI

2010-01-01

Dalby T, Sørensen C, Petersen JW, Krogfelt KA. Pertussis serology: assessment of IgG anti-PT ELISA for replacement of the CHO cell assay. APMIS 2010; 118: 968–72. Two types of serological assays are commonly used for the assessment of pertussis vaccine-induced antibodies; the Chinese hamster ovary cell (CHO cell) assay and the immunoglobulin G (IgG) anti pertussis toxin (PT) enzyme-linked immunosorbent assay (IgG anti-PT ELISA). Recently, both the techniques have been modified to improve performance with sera with interfering activity (CHO cell assay) or with heat-treated sera (IgG anti-PT ELISA). These two improved techniques were compared by the analysis of 100 individual serum samples from a previous clinical trial and 213 sera from a longitudinal serum collection from 20 Danish adults recently vaccinated with the Danish acellular pertussis vaccine. The comparison showed a significant linear correlation between the results of the two assays with a p-value of ELISA can be used as a replacement for the often troublesome and time-consuming CHO cell assay for the measurement of vaccine-induced human antibodies to PT. PMID:21091778

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

Science.gov (United States)

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…

Assessment of the predictive capacity of the optimized in vitro comet assay using HepG2 cells.

Science.gov (United States)

Hong, Yoon-Hee; Jeon, Hye Lyun; Ko, Kyung Yuk; Kim, Joohwan; Yi, Jung-Sun; Ahn, Ilyoung; Kim, Tae Sung; Lee, Jong Kwon

2018-03-01

Evaluation of DNA damage is critical during the development of new drugs because it is closely associated with genotoxicity and carcinogenicity. The in vivo comet assay to assess DNA damage is globally harmonized as OECD TG 489. However, a comet test guideline that evaluates DNA damage without sacrificing animals does not yet exist. The goal of this study was to select an appropriate cell line for optimization of the in vitro comet assay to assess DNA damage. We then evaluated the predictivity of the in vitro comet assay using the selected cell line. In addition, the effect of adding S9 was evaluated using 12 test chemicals. For cell line selection, HepG2, Chinese hamster lung (CHL/IU), and TK6 cell lines were evaluated. We employed a method for the in vitro comet assay based on that for the in vivo comet assay. The most appropriate cell line was determined by% tail DNA increase after performing in vitro comet assays with 6 test chemicals. The predictivity of the in vitro comet assay using the selected cell line was measured with 10 test chemicals (8 genotoxins and 2 non-genotoxic chemicals). The HepG2 cell line was found to be the most appropriate, and in vitro comet assays using HepG2 cells exhibited a high accuracy of 90% (9/10). This study suggests that HepG2 is an optimal cell line for the in vitro comet assay to assess DNA damage. Copyright © 2018 Elsevier B.V. All rights reserved.

RISK MANAGEMENT: AN INTEGRATED APPROACH TO RISK MANAGEMENT AND ASSESSMENT

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Szabo Alina

2012-12-01

Full Text Available Purpose: The objective of this paper is to offer an overview over risk management cycle by focusing on prioritization and treatment, in order to ensure an integrated approach to risk management and assessment, and establish the ‘top 8-12’ risks report within the organization. The interface with Internal Audit is ensured by the implementation of the scoring method to prioritize risks collected from previous generated risk report. Methodology/approach: Using evidence from other research in the area and the professional expertise, this article outlines an integrated approach to risk assessment and risk management reporting processes, by separating the risk in two main categories: strategic and operational risks. The focus is on risk prioritization and scoring; the final output will comprise a mix of strategic and operational (‘top 8-12’ risks, which should be used to establish the annual Internal Audit plan. Originality/value: By using an integrated approach to risk assessment and risk management will eliminate the need for a separate Internal Audit risk assessment over prevailing risks. It will reduce the level of risk assessment overlap by different functions (Tax, Treasury, Information System over the same risk categories as a single methodology, is used and will align timings of risk assessment exercises. The risk prioritization by usage of risk and control scoring criteria highlights the combination between financial and non-financial impact criteria allowing risks that do not naturally lend themselves to a financial amount to be also assessed consistently. It is emphasized the usage of score method to prioritize the risks included in the annual audit plan in order to increase accuracy and timelines.

Moving beyond the comprehensive in vitro proarrhythmia assay: Use of human-induced pluripotent stem cell-derived cardiomyocytes to assess contractile effects associated with drug-induced structural cardiotoxicity.

Science.gov (United States)

Yang, Xi; Papoian, Thomas

2018-02-27

Drug-induced cardiotoxicity is a potentially severe side effect that can adversely affect myocardial contractility through structural or electrophysiological changes in cardiomyocytes. Human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) are a promising human cardiac in vitro model system to assess both proarrhythmic and non-proarrhythmic cardiotoxicity of new drug candidates. The scalable differentiation of hiPSCs into cardiomyocytes provides a renewable cell source that overcomes species differences present in current animal models of drug toxicity testing. The Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative represents a paradigm shift for proarrhythmic risk assessment, and hiPSC-CMs are an integral component of that paradigm. The recent advancements in hiPSC-CMs will not only impact safety decisions for possible drug-induced proarrhythmia, but should also facilitate risk assessment for non-proarrhythmic cardiotoxicity, where current non-clinical approaches are limited in detecting this risk before initiation of clinical trials. Importantly, emerging evidence strongly suggests that the use of hiPSC-CMs with cardiac physiological relevant measurements in vitro improves the detection of structural cardiotoxicity. Here we review high-throughput drug screening using the hiPSC-CM model as an experimentally feasible approach to assess potential contractile and structural cardiotoxicity in early phase drug development. We also suggest that the assessment of structural cardiotoxicity can be added to electrophysiological tests in the same platform to complement the Comprehensive in vitro Proarrhythmia Assay for regulatory use. Ideally, application of these novel tools in early drug development will allow for more reliable risk assessment and lead to more informed regulatory decisions in making safe and effective drugs available to the public. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

Risk assessment: 'A consumer's perspective'

International Nuclear Information System (INIS)

Waterhouse, Rachel

1992-01-01

The paper assesses the concept of risk, risk assessment and tolerability of risk from consumer point of view. Review of existing UK and EC directives on certain products and appliances is also covered

Risk assessment: 'A consumer's perspective'

Energy Technology Data Exchange (ETDEWEB)

Waterhouse, Rachel [Consumer' s Association, Health and Safety Commission (United Kingdom)

1992-07-01

The paper assesses the concept of risk, risk assessment and tolerability of risk from consumer point of view. Review of existing UK and EC directives on certain products and appliances is also covered.

Combining Cytotoxicity Assessment and Xenopus laevis Phenotypic Abnormality Assay as a Predictor of Nanomaterial Safety.

Science.gov (United States)

Al-Yousuf, Karamallah; Webster, Carl A; Wheeler, Grant N; Bombelli, Francesca Baldelli; Sherwood, Victoria

2017-08-04

The African clawed frog, Xenopus laevis, has been used as an efficient pre-clinical screening tool to predict drug safety during the early stages of the drug discovery process. X. laevis is a relatively inexpensive model that can be used in whole organism high-throughput assays whilst maintaining a high degree of homology to the higher vertebrate models often used in scientific research. Despite an ever-increasing volume of biomedical nanoparticles (NPs) in development, their unique physico-chemical properties challenge the use of standard toxicology assays. Here, we present a protocol that directly compares the sensitivity of X. laevis development as a tool to assess potential NP toxicity by observation of embryo phenotypic abnormalities/lethality after NP exposure, to in vitro cytotoxicity obtained using mammalian cell lines. In combination with conventional cytotoxicity assays, the X. laevis phenotypic assay provides accurate data to efficiently assess the safety of novel biomedical NPs. © 2017 by John Wiley & Sons, Inc. Copyright © 2017 by John Wiley & Sons, Inc.

Multiplex pyrosequencing assay using AdvISER-MH-PYRO algorithm: a case for rapid and cost-effective genotyping analysis of prostate cancer risk-associated SNPs.

Science.gov (United States)

Ambroise, Jérôme; Butoescu, Valentina; Robert, Annie; Tombal, Bertrand; Gala, Jean-Luc

2015-06-25

Single Nucleotide Polymorphisms (SNPs) identified in Genome Wide Association Studies (GWAS) have generally moderate association with related complex diseases. Accordingly, Multilocus Genetic Risk Scores (MGRSs) have been computed in previous studies in order to assess the cumulative association of multiple SNPs. When several SNPs have to be genotyped for each patient, using successive uniplex pyrosequencing reactions increases analytical reagent expenses and Turnaround Time (TAT). While a set of several pyrosequencing primers could theoretically be used to analyze multiplex amplicons, this would generate overlapping primer-specific pyro-signals that are visually uninterpretable. In the current study, two multiplex assays were developed consisting of a quadruplex (n=4) and a quintuplex (n=5) polymerase chain reaction (PCR) each followed by multiplex pyrosequencing analysis. The aim was to reliably but rapidly genotype a set of prostate cancer-related SNPs (n=9). The nucleotide dispensation order was selected using SENATOR software. Multiplex pyro-signals were analyzed using the new AdvISER-MH-PYRO software based on a sparse representation of the signal. Using uniplex assays as gold standard, the concordance between multiplex and uniplex assays was assessed on DNA extracted from patient blood samples (n = 10). All genotypes (n=90) generated with the quadruplex and the quintuplex pyroquencing assays were perfectly (100 %) concordant with uniplex pyrosequencing. Using multiplex genotyping approach for analyzing a set of 90 patients allowed reducing TAT by approximately 75 % (i.e., from 2025 to 470 min) while reducing reagent consumption and cost by approximately 70 % (i.e., from ~229 US$ /patient to ~64 US$ /patient). This combination of quadruplex and quintuplex pyrosequencing and PCR assays enabled to reduce the amount of DNA required for multi-SNP analysis, and to lower the global TAT and costs of SNP genotyping while providing results as reliable as uniplex

Comparison of Batch Assay and Random Assay Using Automatic Dispenser in Radioimmunoassay

Energy Technology Data Exchange (ETDEWEB)

Moon, Seung Hwan; Jang, Su Jin; Kang, Ji Yeon; Lee, Dong Soo; Chung, June Key; Lee, Myung Chul [Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul (Korea, Republic of); Lee, Ho Young; Shin, Sun Young; Min, Gyeong Sun; Lee, Hyun Joo [Seoul National University college of Medicine, Seoul (Korea, Republic of)

2009-08-15

Radioimmunoassay (RIA) was usually performed by the batch assay. To improve the efficiency of RIA without increase of the cost and time, random assay could be a choice. We investigated the possibility of the random assay using automatic dispenser by assessing the agreement between batch assay and random assay. The experiments were performed with four items; Triiodothyronine (T3), free thyroxine (fT4), Prostate specific antigen (PSA), Carcinoembryonic antigen (CEA). In each item, the sera of twenty patients, the standard, and the control samples were used. The measurements were done 4 times with 3 hour time intervals by random assay and batch assay. The coefficient of variation (CV) of the standard samples and patients' data in T3, fT4, PSA, and CEA were assessed. ICC (Intraclass correlation coefficient) and coefficient of correlation were measured to assessing the agreement between two methods. The CVs (%) of T3, fT4, PSA, and CEA measured by batch assay were 3.2+-1.7%, 3.9+-2.1%, 7.1+-6.2%, 11.2+-7.2%. The CVs by random assay were 2.1+-1.7%, 4.8+-3.1%, 3.6+-4.8%, and 7.4+-6.2%. The ICC between the batch assay and random assay were 0.9968 (T3), 0.9973 (fT4), 0.9996 (PSA), and 0.9901 (CEA). The coefficient of correlation between the batch assay and random assay were 0.9924(T3), 0.9974 (fT4), 0.9994 (PSA), and 0.9989 (CEA) (p<0.05). The results of random assay showed strong agreement with the batch assay in a day. These results suggest that random assay using automatic dispenser could be used in radioimmunoassay

Comparison of Batch Assay and Random Assay Using Automatic Dispenser in Radioimmunoassay

International Nuclear Information System (INIS)

Moon, Seung Hwan; Jang, Su Jin; Kang, Ji Yeon; Lee, Dong Soo; Chung, June Key; Lee, Myung Chul; Lee, Ho Young; Shin, Sun Young; Min, Gyeong Sun; Lee, Hyun Joo

2009-01-01

Radioimmunoassay (RIA) was usually performed by the batch assay. To improve the efficiency of RIA without increase of the cost and time, random assay could be a choice. We investigated the possibility of the random assay using automatic dispenser by assessing the agreement between batch assay and random assay. The experiments were performed with four items; Triiodothyronine (T3), free thyroxine (fT4), Prostate specific antigen (PSA), Carcinoembryonic antigen (CEA). In each item, the sera of twenty patients, the standard, and the control samples were used. The measurements were done 4 times with 3 hour time intervals by random assay and batch assay. The coefficient of variation (CV) of the standard samples and patients' data in T3, fT4, PSA, and CEA were assessed. ICC (Intraclass correlation coefficient) and coefficient of correlation were measured to assessing the agreement between two methods. The CVs (%) of T3, fT4, PSA, and CEA measured by batch assay were 3.2±1.7%, 3.9±2.1%, 7.1±6.2%, 11.2±7.2%. The CVs by random assay were 2.1±1.7%, 4.8±3.1%, 3.6±4.8%, and 7.4±6.2%. The ICC between the batch assay and random assay were 0.9968 (T3), 0.9973 (fT4), 0.9996 (PSA), and 0.9901 (CEA). The coefficient of correlation between the batch assay and random assay were 0.9924(T3), 0.9974 (fT4), 0.9994 (PSA), and 0.9989 (CEA) (p<0.05). The results of random assay showed strong agreement with the batch assay in a day. These results suggest that random assay using automatic dispenser could be used in radioimmunoassay

Clinical Use of Ultrasensitive Cardiac Troponin I Assay in Intermediate- and High-Risk Surgery Patients

Directory of Open Access Journals (Sweden)

Flávia Kessler Borges

2013-01-01

Full Text Available Background. Cardiac troponin levels have been reported to add value in the detection of cardiovascular complications in noncardiac surgery. A sensitive cardiac troponin I (cTnI assay could provide more accurate prognostic information. Methods. This study prospectively enrolled 142 patients with at least one Revised Cardiac Risk Index risk factor who underwent noncardiac surgery. cTnI levels were measured postoperatively. Short-term cardiac outcome predictors were evaluated. Results. cTnI elevation was observed in 47 patients, among whom 14 were diagnosed as having myocardial infarction (MI. After 30 days, 16 patients had major adverse cardiac events (MACE. Excluding patients with a final diagnosis of MI, predictors of cTnI elevation included dialysis, history of heart failure, transoperative major bleeding, and elevated levels of pre- and postoperative N-terminal pro-B-type natriuretic peptide (NT-proBNP. Maximal cTnI values showed the highest sensitivity (94%, specificity (75%, and overall accuracy (AUC 0.89; 95% CI 0.80–0.98 for postoperative MACE. Postoperative cTnI peak level (OR 9.4; 95% CI 2.3–39.2 and a preoperative NT-proBNP level ≥917 pg/mL (OR 3.47; 95% CI 1.05–11.6 were independent risk factors for MACE. Conclusions. cTnI was shown to be an independent prognostic factor for cardiac outcomes and should be considered as a component of perioperative risk assessment.

Using risk assessment in periodontics.

Science.gov (United States)

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.

A total risk assessment methodology for security assessment

International Nuclear Information System (INIS)

Auilar, Richard; Pless, Daniel J.; Kaplan, Paul Garry; Silva, Consuelo Juanita; Rhea, Ronald Edward; Wyss, Gregory Dane; Conrad, Stephen Hamilton

2009-01-01

Sandia National Laboratories performed a two-year Laboratory Directed Research and Development project to develop a new collaborative risk assessment method to enable decision makers to fully consider the interrelationships between threat, vulnerability, and consequence. A five-step Total Risk Assessment Methodology was developed to enable interdisciplinary collaborative risk assessment by experts from these disciplines. The objective of this process is promote effective risk management by enabling analysts to identify scenarios that are simultaneously achievable by an adversary, desirable to the adversary, and of concern to the system owner or to society. The basic steps are risk identification, collaborative scenario refinement and evaluation, scenario cohort identification and risk ranking, threat chain mitigation analysis, and residual risk assessment. The method is highly iterative, especially with regard to scenario refinement and evaluation. The Total Risk Assessment Methodology includes objective consideration of relative attack likelihood instead of subjective expert judgment. The 'probability of attack' is not computed, but the relative likelihood for each scenario is assessed through identifying and analyzing scenario cohort groups, which are groups of scenarios with comparable qualities to the scenario being analyzed at both this and other targets. Scenarios for the target under consideration and other targets are placed into cohort groups under an established ranking process that reflects the following three factors: known targeting, achievable consequences, and the resources required for an adversary to have a high likelihood of success. The development of these target cohort groups implements, mathematically, the idea that adversaries are actively choosing among possible attack scenarios and avoiding scenarios that would be significantly suboptimal to their objectives. An adversary who can choose among only a few comparable targets and scenarios (a

Fluorescence-based assay as a new screening tool for toxic chemicals

Science.gov (United States)

Moczko, Ewa; Mirkes, Evgeny M.; Cáceres, César; Gorban, Alexander N.; Piletsky, Sergey

2016-09-01

Our study involves development of fluorescent cell-based diagnostic assay as a new approach in high-throughput screening method. This highly sensitive optical assay operates similarly to e-noses and e-tongues which combine semi-specific sensors and multivariate data analysis for monitoring biochemical processes. The optical assay consists of a mixture of environmental-sensitive fluorescent dyes and human skin cells that generate fluorescence spectra patterns distinctive for particular physico-chemical and physiological conditions. Using chemometric techniques the optical signal is processed providing qualitative information about analytical characteristics of the samples. This integrated approach has been successfully applied (with sensitivity of 93% and specificity of 97%) in assessing whether particular chemical agents are irritating or not for human skin. It has several advantages compared with traditional biochemical or biological assays and can impact the new way of high-throughput screening and understanding cell activity. It also can provide reliable and reproducible method for assessing a risk of exposing people to different harmful substances, identification active compounds in toxicity screening and safety assessment of drugs, cosmetic or their specific ingredients.

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

Directory of Open Access Journals (Sweden)

Cathryn Clarke Murray

Full Text Available 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.

Probabilistic risk assessment of diuron and prometryn in the Gwydir River catchment, Australia, with the input of a novel bioassay based on algal growth.

Science.gov (United States)

Shi, Yajuan; Burns, Mitchell; Ritchie, Raymond J; Crossan, Angus; Kennedy, Ivan R

2014-08-01

A probabilistic risk assessment of the selected herbicides (diuron and prometryn) in the Gwydir River catchment was conducted, with the input of the EC₅₀ values derived from both literature and a novel bioassay. Laboratory test based on growth of algae exposed to herbicides assayed with a microplate reader was used to examine the toxicity of diuron and prometryn on the growth of Chlorella vulgaris. Both herbicides showed concentration dependent toxicity in inhibiting the growth of Chlorella during the exposure period of 18-72 h. Diuron caused more toxicity as judged by growth rates than prometryn. Thalaba Creek at Merrywinebone was identified as the 'hotspot' for diuron and prometryn risk in the Gwydir catchment. The use of microplate assays coupled with probabilistic risk assessment is recommended for rapid assessment of ecotoxicity of indigenous species, allowing identification of locations in river catchments requiring environmental management. Copyright © 2014 Elsevier Inc. All rights reserved.

24 CFR 35.315 - Risk assessment.

Science.gov (United States)

2010-04-01

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

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

Science.gov (United States)

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

2014-08-01

Current methods for cancer risk assessment result in single values, without any quantitative information on the uncertainties in these values. Therefore, single risk values could easily be overinterpreted. In this study, we discuss a full probabilistic cancer risk assessment approach in which all the generally recognized uncertainties in both exposure and hazard assessment are quantitatively characterized and probabilistically evaluated, resulting in a confidence interval for the final risk estimate. The methodology is applied to three example chemicals (aflatoxin, N-nitrosodimethylamine, and methyleugenol). These examples illustrate that the uncertainty in a cancer risk estimate may be huge, making single value estimates of cancer risk meaningless. Further, a risk based on linear extrapolation tends to be lower than the upper 95% confidence limit of a probabilistic risk estimate, and in that sense it is not conservative. Our conceptual analysis showed that there are two possible basic approaches for cancer risk assessment, depending on the interpretation of the dose-incidence data measured in animals. However, it remains unclear which of the two interpretations is the more adequate one, adding an additional uncertainty to the already huge confidence intervals for cancer risk estimates. © 2014 Society for Risk Analysis.

Nanoparticle-assay marker interaction: effects on nanotoxicity assessment

International Nuclear Information System (INIS)

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

Nanoparticle-assay marker interaction: effects on nanotoxicity assessment

Energy Technology Data Exchange (ETDEWEB)

Zhao, Xinxin; Xiong, Sijing; Huang, Liwen Charlotte; Ng, Kee Woei, E-mail: kwng@ntu.edu.sg; Loo, Say Chye Joachim, E-mail: joachimloo@ntu.edu.sg [Nanyang Technological University, School of Materials Science and Engineering (Singapore)

2015-01-15

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.

Nanoparticle-assay marker interaction: effects on nanotoxicity assessment

Science.gov (United States)

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.

Supporting Risk Assessment: Accounting for Indirect Risk to Ecosystem Components

Science.gov (United States)

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

Avalanche risk assessment in Russia

Science.gov (United States)

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

2017-04-01

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

Risk assessment in international operations

International Nuclear Information System (INIS)

Stricklin, Daniela L.

2008-01-01

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

Implications of probabilistic risk assessment

International Nuclear Information System (INIS)

Cullingford, M.C.; Shah, S.M.; Gittus, J.H.

1987-01-01

Probabilistic risk assessment (PRA) is an analytical process that quantifies the likelihoods, consequences and associated uncertainties of the potential outcomes of postulated events. Starting with planned or normal operation, probabilistic risk assessment covers a wide range of potential accidents and considers the whole plant and the interactions of systems and human actions. Probabilistic risk assessment can be applied in safety decisions in design, licensing and operation of industrial facilities, particularly nuclear power plants. The proceedings include a review of PRA procedures, methods and technical issues in treating uncertainties, operating and licensing issues and future trends. Risk assessment for specific reactor types or components and specific risks (eg aircraft crashing onto a reactor) are used to illustrate the points raised. All 52 articles are indexed separately. (U.K.)

Uncertainties in risk assessment at USDOE facilities

Energy Technology Data Exchange (ETDEWEB)

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.

Uncertainties in risk assessment at USDOE facilities

International Nuclear Information System (INIS)

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 conclusionsclose 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

Advanced Test Reactor outage risk assessment

International Nuclear Information System (INIS)

Thatcher, T.A.; Atkinson, S.A.

1997-01-01

Beginning in 1997, risk assessment was performed for each Advanced Test Reactor (ATR) outage aiding the coordination of plant configuration and work activities (maintenance, construction projects, etc.) to minimize the risk of reactor fuel damage and to improve defense-in-depth. The risk assessment activities move beyond simply meeting Technical Safety Requirements to increase the awareness of risk sensitive configurations, to focus increased attention on the higher risk activities, and to seek cost-effective design or operational changes that reduce risk. A detailed probabilistic risk assessment (PRA) had been performed to assess the risk of fuel damage during shutdown operations including heavy load handling. This resulted in several design changes to improve safety; however, evaluation of individual outages had not been performed previously and many risk insights were not being utilized in outage planning. The shutdown PRA provided the necessary framework for assessing relative and absolute risk levels and assessing defense-in-depth. Guidelines were written identifying combinations of equipment outages to avoid. Screening criteria were developed for the selection of work activities to receive review. Tabulation of inherent and work-related initiating events and their relative risk level versus plant mode has aided identification of the risk level the scheduled work involves. Preoutage reviews are conducted and post-outage risk assessment is documented to summarize the positive and negative aspects of the outage with regard to risk. The risk for the outage is compared to the risk level that would result from optimal scheduling of the work to be performed and to baseline or average past performance

GAR Global Risk Assessment

Science.gov (United States)

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.

Deterministic quantitative risk assessment development

Energy Technology Data Exchange (ETDEWEB)

Dawson, Jane; Colquhoun, Iain [PII Pipeline Solutions Business of GE Oil and Gas, Cramlington Northumberland (United Kingdom)

2009-07-01

Current risk assessment practice in pipeline integrity management is to use a semi-quantitative index-based or model based methodology. This approach has been found to be very flexible and provide useful results for identifying high risk areas and for prioritizing physical integrity assessments. However, as pipeline operators progressively adopt an operating strategy of continual risk reduction with a view to minimizing total expenditures within safety, environmental, and reliability constraints, the need for quantitative assessments of risk levels is becoming evident. Whereas reliability based quantitative risk assessments can be and are routinely carried out on a site-specific basis, they require significant amounts of quantitative data for the results to be meaningful. This need for detailed and reliable data tends to make these methods unwieldy for system-wide risk k assessment applications. This paper describes methods for estimating risk quantitatively through the calibration of semi-quantitative estimates to failure rates for peer pipeline systems. The methods involve the analysis of the failure rate distribution, and techniques for mapping the rate to the distribution of likelihoods available from currently available semi-quantitative programs. By applying point value probabilities to the failure rates, deterministic quantitative risk assessment (QRA) provides greater rigor and objectivity than can usually be achieved through the implementation of semi-quantitative risk assessment results. The method permits a fully quantitative approach or a mixture of QRA and semi-QRA to suit the operator's data availability and quality, and analysis needs. For example, consequence analysis can be quantitative or can address qualitative ranges for consequence categories. Likewise, failure likelihoods can be output as classical probabilities or as expected failure frequencies as required. (author)

Evaluation of thermal risk assessment

International Nuclear Information System (INIS)

Loos, J.J.; Perry, E.S.

1993-01-01

Risk assessment was done in 1983 to estimate the ecological hazard of increasing the generating load and thermal output of an electric generating station. Subsequently, long-term monitoring in the vicinity of the station allowed verification of the predictions made in the risk assessment. This presentation will review the efficacy of early risk assessment methods in producing useful predictions from a resource management point of view. In 1984, the Chalk Point Generating facility of the Potomac Electric Power Company increased it's median generating load by 100%. Prior to this operational change, the Academy of Natural Sciences of Philadelphia synthesized site specific data, model predictions, and results from literature to assess the risk of additional waste heat to the Patuxent River subestuary of Chesapeake Bay. Risk was expressed as the number of days per year that various species of fish and the blue crab would be expected to avoid the discharge vicinity. Accuracy of these predictions is assessed by comparing observed fish and crab distributions and their observed frequencies of avoidance to those predicted. It is concluded that the predictions of this early risk assessment were sufficiently accurate to produce a reliable resource management decision

On risk assessment of energy production

International Nuclear Information System (INIS)

Kunii, Katsuhiko

2005-07-01

Today we cannot ignore the risk of health and/or environment by energy production such as power generation since the risk has been made large enough. In this report an information survey has been done in order to know the outline and points of risk assessment. Based on the information of reports and literature about risk assessment, have been surveyed mainly the external cost assessment of power generation (in which quantification of health and/or environment risk has been done), in addition, risks of disasters, accidents, investments, finance etc. and impacts of those risks on social activities. The remarks obtained by the survey are as follows: 1) Some of external cost assessment of power generation show different results even if the assessment conditions of technology, site, etc. are mostly the same. It is necessary to remark on the information such as basic data, model, background, application limit of assessment considering the reliability. 2) Especially it is considered that the reliability of risk assessment is not enough at present because of the lack of basic data. (author)

Defense Programs Transportation Risk Assessment

International Nuclear Information System (INIS)

Clauss, D.B.

1994-01-01

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

Risk Factor Assessment Branch (RFAB)

Science.gov (United States)

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.

Multipurpose HTS Coagulation Analysis: Assay Development and Assessment of Coagulopathic Snake Venoms

Directory of Open Access Journals (Sweden)

Kristina B. M. Still

2017-11-01

Full Text Available Coagulation assays currently employed are often low throughput, require specialized equipment and/or require large blood/plasma samples. This study describes the development, optimization and early application of a generic low-volume and high-throughput screening (HTS assay for coagulation activity. The assay is a time-course spectrophotometric measurement which kinetically measures the clotting profile of bovine or human plasma incubated with Ca2+ and a test compound. The HTS assay can be a valuable new tool for coagulation diagnostics in hospitals, for research in coagulation disorders, for drug discovery and for venom research. A major effect following envenomation by many venomous snakes is perturbation of blood coagulation caused by haemotoxic compounds present in the venom. These compounds, such as anticoagulants, are potential leads in drug discovery for cardiovascular diseases. The assay was implemented in an integrated analytical approach consisting of reversed-phase liquid chromatography (LC for separation of crude venom components in combination with parallel post-column coagulation screening and mass spectrometry (MS. The approach was applied for the rapid assessment and identification of profiles of haemotoxic compounds in snake venoms. Procoagulant and anticoagulant activities were correlated with accurate masses from the parallel MS measurements, facilitating the detection of peptides showing strong anticoagulant activity.

Risk assessments ensure safer power

Energy Technology Data Exchange (ETDEWEB)

1982-02-19

A growth industry is emerging devoted to the study and comparison of the economic, social and health risks posed by large industrial installations. Electricity generation is one area coming under particularly close scrutiny. Types of risk, ways of assessing risk and the difference between experts' analyses and the public perception of risk are given. An example of improved risk assessment helping to reduce deaths and injuries in coal mining is included.

Chemical-based risk assessment and in vitro models of human health effects induced by organic pollutants in soils from the Olona valley

Energy Technology Data Exchange (ETDEWEB)

Baderna, Diego, E-mail: diego.baderna@marionegri.it; Colombo, Andrea; Amodei, Giorgia; Cantù, Stefano; Teoldi, Federico; Cambria, Felice; Rotella, Giuseppe; Natolino, Fabrizio; Lodi, Marco; Benfenati, Emilio

2013-10-01

Risk assessment of soils is usually based on chemical measurements and assuming accidental soil ingestion and evaluating induced toxic and carcinogenic effects. Recently biological tools have been coupled to chemical-based risk assessment since they integrate the biological effects of all xenobiotics in soils. We employed integrated monitoring of soils based on chemical analyses, risk assessment and in vitro models in the highly urbanized semirural area of the Olona Valley in northern Italy. Chemical characterization of the soils indicated low levels of toxic and carcinogenic pollutants such as PAHs, PCDD/Fs, PCBs and HCB and human risk assessment did not give any significant alerts. HepG2 and BALB/c 3T3 cells were used as a model for the human liver and as a tool for the evaluation of carcinogenic potential. Cells were treated with soil extractable organic matters (EOMs) and the MTS assay, LDH release and morphological transformation were selected as endpoints for toxicity and carcinogenicity. Soil EOMs induced dose-dependent inhibition of cell growth at low doses and cytotoxicity after exposure to higher doses. This might be the result of block of cell cycle progression to repair DNA damage caused by oxidative stress; if this DNA damage cannot be repaired, cells die. No significant inductions of foci were recorded after exposure to EOMs. These results indicate that, although the extracts contain compounds with proven carcinogenic potential, the levels of these pollutants in the analyzed soils were too low to induce carcinogenesis in our experimental conditions. In this proposed case study, HepG2 cells were found an appropriate tool to assess the potential harm caused by the ingestion of contaminated soil as they were able to detect differences in the toxicity of soil EOMs. Moreover, the cell transformation assay strengthened the combined approach giving useful information on carcinogenic potential of mixtures. Highlights: • A combined approach for risk

The development and validation of EpiComet-Chip, a modified high-throughput comet assay for the assessment of DNA methylation status.

Science.gov (United States)

Townsend, Todd A; Parrish, Marcus C; Engelward, Bevin P; Manjanatha, Mugimane G

2017-08-01

DNA damage and alterations in global DNA methylation status are associated with multiple human diseases and are frequently correlated with clinically relevant information. Therefore, assessing DNA damage and epigenetic modifications, including DNA methylation, is critical for predicting human exposure risk of pharmacological and biological agents. We previously developed a higher-throughput platform for the single cell gel electrophoresis (comet) assay, CometChip, to assess DNA damage and genotoxic potential. Here, we utilized the methylation-dependent endonuclease, McrBC, to develop a modified alkaline comet assay, "EpiComet," which allows single platform evaluation of genotoxicity and global DNA methylation [5-methylcytosine (5-mC)] status of single-cell populations under user-defined conditions. Further, we leveraged the CometChip platform to create an EpiComet-Chip system capable of performing quantification across simultaneous exposure protocols to enable unprecedented speed and simplicity. This system detected global methylation alterations in response to exposures which included chemotherapeutic and environmental agents. Using EpiComet-Chip on 63 matched samples, we correctly identified single-sample hypermethylation (≥1.5-fold) at 87% (20/23), hypomethylation (≥1.25-fold) at 100% (9/9), with a 4% (2/54) false-negative rate (FNR), and 10% (4/40) false-positive rate (FPR). Using a more stringent threshold to define hypermethylation (≥1.75-fold) allowed us to correctly identify 94% of hypermethylation (17/18), but increased our FPR to 16% (7/45). The successful application of this novel technology will aid hazard identification and risk characterization of FDA-regulated products, while providing utility for investigating epigenetic modes of action of agents in target organs, as the assay is amenable to cultured cells or nucleated cells from any tissue. Environ. Mol. Mutagen. 58:508-521, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Assessing the performance of a Loop Mediated Isothermal Amplification (LAMP) assay for the detection and subtyping of high-risk suptypes of Human Papilloma Virus (HPV) for Oropharyngeal Squamous Cell Carcinoma (OPSCC) without DNA purification.

Science.gov (United States)

Rohatensky, Mitchell G; Livingstone, Devon M; Mintchev, Paul; Barnes, Heather K; Nakoneshny, Steven C; Demetrick, Douglas J; Dort, Joseph C; van Marle, Guido

2018-02-08

Oropharyngeal Squamous Cell Carcinoma (OPSCC) is increasing in incidence despite a decline in traditional risk factors. Human Papilloma Virus (HPV), specifically subtypes 16, 18, 31 and 35, has been implicated as the high-risk etiologic agent. HPV positive cancers have a significantly better prognosis than HPV negative cancers of comparable stage, and may benefit from different treatment regimens. Currently, HPV related carcinogenesis is established indirectly through Immunohistochemistry (IHC) staining for p16, a tumour suppressor gene, or polymerase chain reaction (PCR) that directly tests for HPV DNA in biopsied tissue. Loop mediated isothermal amplification (LAMP) is more accurate than IHC, more rapid than PCR and is significantly less costly. In previous work we showed that a subtype specific HPV LAMP assay performed similar to PCR on purified DNA. In this study we examined the performance of this LAMP assay without DNA purification. We used LAMP assays using established primers for HPV 16 and 18, and new primers for HPV 31 and 35. LAMP reaction conditions were tested on serial dilutions of plasmid HPV DNA to confirm minimum viral copy number detection thresholds. LAMP was then performed directly on different human cell line samples without DNA purification. Our LAMP assays could detect 10 5 , 10 3 , 10 4 , and 10 5 copies of plasmid DNA for HPV 16, 18, 31, and 35, respectively. All primer sets were subtype specific, with no cross-amplification. Our LAMP assays also reliably amplified subtype specific HPV DNA from samples without requiring DNA isolation and purification. The high risk OPSCC HPV subtype specific LAMP primer sets demonstrated, excellent clinically relevant, minimum copy number detection thresholds with an easy readout system. Amplification directly from samples without purification illustrated the robust nature of the assay, and the primers used. This lends further support HPV type specific LAMP assays, and these specific primer sets and assays

CLINICAL PERFORMANCE CHARACTERISTICS OF ELECSYS® FREE-ΒHCG AND PAPP-A FOR FIRST TRIMESTER TRISOMY 21 RISK ASSESSMENT IN GESTATIONAL WEEKS 8+0 TO 14+0

DEFF Research Database (Denmark)

Tørring, Niels; aulesa, C; Eiben, Bernd

2014-01-01

with the Brahms Kryptor®, PerkinElmer AutoDELFIA® and Siemens IMMULITE® assays. Furthermore a clinical validation including generation of assay specific medians from gestational age 8+0 to 14+0 weeks, and clinical test performance of risk assessment was performed. Results The imprecision of the Elecsys free βh...

Risk assessment

DEFF Research Database (Denmark)

Pedersen, Liselotte; Rasmussen, Kirsten; Elsass, Peter

2010-01-01

International research suggests that using formalized risk assessment methods may improve the predictive validity of professionals' predictions of risk of future violence. This study presents data on forensic psychiatric patients discharged from a forensic unit in Denmark in year 2001-2002 (n=107...... and the individual dynamic items strengthen the use of this scheme in clinical practice. (PsycINFO Database Record (c) 2010 APA, all rights reserved) (journal abstract)...

Sudden Cardiac Arrest (SCA) Risk Assessment

Science.gov (United States)

... 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 ...

Integrated climate change risk assessment:

DEFF Research Database (Denmark)

Kaspersen, Per Skougaard; Halsnæs, Kirsten

2017-01-01

Risk assessments of flooding in urban areas during extreme precipitation for use in, for example, decision-making regarding climate adaptation, are surrounded by great uncertainties stemming from climate model projections, methods of downscaling and the assumptions of socioeconomic impact models...... to address the complex linkages between the different kinds of data required in assessing climate adaptation. It emphasizes that the availability of spatially explicit data can reduce the overall uncertainty of the risk assessment and assist in identifying key vulnerable assets. The usefulness...... of such a framework is demonstrated by means of a risk assessment of flooding from extreme precipitation for the city of Odense, Denmark. A sensitivity analysis shows how the presence of particularly important assets, such as cultural and historical heritage, may be addressed in assessing such risks. The output...

Uncertainty Quantification Reveals the Importance of Data Variability and Experimental Design Considerations for in Silico Proarrhythmia Risk Assessment

Directory of Open Access Journals (Sweden)

Kelly C. Chang

2017-11-01

Full Text Available The Comprehensive in vitro Proarrhythmia Assay (CiPA is a global initiative intended to improve drug proarrhythmia risk assessment using a new paradigm of mechanistic assays. Under the CiPA paradigm, the relative risk of drug-induced Torsade de Pointes (TdP is assessed using an in silico model of the human ventricular action potential (AP that integrates in vitro pharmacology data from multiple ion channels. Thus, modeling predictions of cardiac risk liability will depend critically on the variability in pharmacology data, and uncertainty quantification (UQ must comprise an essential component of the in silico assay. This study explores UQ methods that may be incorporated into the CiPA framework. Recently, we proposed a promising in silico TdP risk metric (qNet, which is derived from AP simulations and allows separation of a set of CiPA training compounds into Low, Intermediate, and High TdP risk categories. The purpose of this study was to use UQ to evaluate the robustness of TdP risk separation by qNet. Uncertainty in the model parameters used to describe drug binding and ionic current block was estimated using the non-parametric bootstrap method and a Bayesian inference approach. Uncertainty was then propagated through AP simulations to quantify uncertainty in qNet for each drug. UQ revealed lower uncertainty and more accurate TdP risk stratification by qNet when simulations were run at concentrations below 5× the maximum therapeutic exposure (Cmax. However, when drug effects were extrapolated above 10× Cmax, UQ showed that qNet could no longer clearly separate drugs by TdP risk. This was because for most of the pharmacology data, the amount of current block measured was <60%, preventing reliable estimation of IC50-values. The results of this study demonstrate that the accuracy of TdP risk prediction depends both on the intrinsic variability in ion channel pharmacology data as well as on experimental design considerations that preclude an

Environmental risk assessment of triclosan and ibuprofen in marine sediments using individual and sub-individual endpoints.

Science.gov (United States)

Pusceddu, F H; Choueri, R B; Pereira, C D S; Cortez, F S; Santos, D R A; Moreno, B B; Santos, A R; Rogero, J R; Cesar, A

2018-01-01

The guidelines for the Environmental Risk Assessment (ERA) of pharmaceuticals and personal care products (PPCP) recommend the use of standard ecotoxicity assays and the assessment of endpoints at the individual level to evaluate potential effects of PPCP on biota. However, effects at the sub-individual level can also affect the ecological fitness of marine organisms chronically exposed to PPCP. The aim of the current study was to evaluate the environmental risk of two PPCP in marine sediments: triclosan (TCS) and ibuprofen (IBU), using sub-individual and developmental endpoints. The environmental levels of TCS and IBU were quantified in marine sediments from the vicinities of the Santos submarine sewage outfall (Santos Bay, São Paulo, Brazil) at 15.14 and 49.0 ng g -1 , respectively. A battery (n = 3) of chronic bioassays (embryo-larval development) with a sea urchin (Lytechinus variegatus) and a bivalve (Perna perna) were performed using two exposure conditions: sediment-water interface and elutriates. Moreover, physiological stress through the Neutral Red Retention Time Assay (NRRT) was assessed in the estuarine bivalve Mytella charruana exposed to TCS and IBU spiked sediments. These compounds affected the development of L. variegatus and P. perna (75 ng g -1 for TCS and 15 ng g -1 for IBU), and caused a significant decrease in M. charruana lysosomal membrane stability at environmentally relevant concentrations (0.08 ng g -1 for TCS and 0.15 ng g -1 for IBU). Chemical and ecotoxicological data were integrated and the risk quotient estimated for TCS and IBU were higher than 1.0, indicating a high environmental risk of these compounds in sediments. These are the first data of sediment risk assessment of pharmaceuticals and personal care products of Latin America. In addition, the results suggest that the ERA based only on individual-level and standard toxicity tests may overlook other biological effects that can affect the health of marine organisms

Assessing Your Weight and Health Risk

Science.gov (United States)

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

Clinical Risk Assessment in the Antiphospholipid Syndrome: Current Landscape and Emerging Biomarkers.

Science.gov (United States)

Chaturvedi, Shruti; McCrae, Keith R

2017-07-01

Laboratory criteria for the classification of antiphospholipid syndrome include the detection of a lupus anticoagulant and/or anticardiolipin and anti-β2-glycoprotein I antibodies. However, the majority of patients who test positive in these assays do not have thrombosis. Current risk-stratification tools are largely limited to the antiphospholipid antibody profile and traditional thrombotic risk factors. Novel biomarkers that correlate with disease activity and potentially provide insight into future clinical events include domain 1 specific anti-β 2 GPI antibodies, antibodies to other phospholipids or phospholipid/protein antigens (such as anti-PS/PT), and functional/biological assays such as thrombin generation, complement activation, levels of circulating microparticles, and annexin A5 resistance. Clinical risk scores may also have value in predicting clinical events. Biomarkers that predict thrombosis risk in patients with antiphospholipid antibodies have been long sought, and several biomarkers have been proposed. Ultimately, integration of biomarkers with established assays and clinical characteristics may offer the best chance of identifying patients at highest risk of APS-related complications.

Risk assessment theory, methods, and applications

CERN Document Server

Rausand, Marvin

2011-01-01

With its balanced coverage of theory and applications along with standards and regulations, Risk Assessment: Theory, Methods, and Applications serves as a comprehensive introduction to the topic. The book serves as a practical guide to current risk analysis and risk assessment, emphasizing the possibility of sudden, major accidents across various areas of practice from machinery and manufacturing processes to nuclear power plants and transportation systems. The author applies a uniform framework to the discussion of each method, setting forth clear objectives and descriptions, while also shedding light on applications, essential resources, and advantages and disadvantages. Following an introduction that provides an overview of risk assessment, the book is organized into two sections that outline key theory, methods, and applications. * Introduction to Risk Assessment defines key concepts and details the steps of a thorough risk assessment along with the necessary quantitative risk measures. Chapters outline...

The issue of risk dilution in risk assessments

International Nuclear Information System (INIS)

Wilmot, R.; Robinson, P.

2004-01-01

This paper explores an issue that was first highlighted more than 20 years ago during an inquiry concerning the Sizeweli B nuclear power station in the UK. In the probabilistic safety assessment for this plant, the proponent had apparently reduced its estimates of risk by admitting to increased uncertainty about the timing of certain events. This situation is counter-intuitive, since an increase in uncertainty about the factors contributing to safety would be expected to lead to less confidence and hence to greater risk. This paradoxical situation was termed 'risk dilution' and it has been a topic of interest to reviewers of safety cases since. The recent international peer review of the Yucca Mountain performance assessments concluded that there was a potential for risk dilution in the assumptions and calculations presented. The next section describes how assumptions about the timing of events and other aspects of an assessment may lead to risk dilution, and this is followed by two examples based on recent performance assessments. The final section discusses how potential problems can be identified in safety cases, and the types of response that a regulator might adopt as a result. (authors)

Assaying the effect of levodopa on the evaluation of risk in healthy humans.

Directory of Open Access Journals (Sweden)

Mkael Symmonds

Full Text Available In humans, dopamine is implicated in reward and risk-based decision-making. However, the specific effects of dopamine augmentation on risk evaluation are unclear. Here we sought to measure the effect of 100 mg oral levodopa, which enhances synaptic release of dopamine, on choice behaviour in healthy humans. We use a paradigm without feedback or learning, which solely isolates effects on risk evaluation. We present two studies (n = 20; n = 20 employing a randomised, placebo-controlled, within-subjects design. We manipulated different dimensions of risk in a controlled economic paradigm. We test effects on risk-reward tradeoffs, assaying both aversion to variance (the spread of possible outcomes and preference for relative losses and gains (asymmetry of outcomes--skewness, dissociating this from potential non-specific effects on choice randomness using behavioural modelling. There were no systematic effects of levodopa on risk attitudes, either for variance or skewness. However, there was a drift towards more risk-averse behaviour over time, indicating that this paradigm was sensitive to detect changes in risk-preferences. These findings suggest that levodopa administration does not change the evaluation of risk. One possible reason is that dopaminergic influences on decision making may be due to changing the response to reward feedback.

Risk Assessment in the Maritime Industry

Directory of Open Access Journals (Sweden)

M. Mousavi

2017-02-01

Full Text Available Risk assessment is a well-developed field which many operators are currently applying to improve their operations and reduce their risk exposure. This paper is intended to provide an overview of the risk assessment for mariners in the Maritime transportation. The risks addressed are primarily those affecting the safety of a vessel, facility or operation. The concept of risk is defined, and the methods available to assess the risks associated with an operation are described. Regulatory requirements that have prompted the development of modern risk assessment practices are described, and future regulatory trends are discussed. There are many different analysis techniques and models that have been developed to aid in conducting risk assessments. A key to any successful risk analysis is choosing the right method (or combination of methods for the situation at hand. This is achieved through critical analysis of the available data concerning marine crises. This paper provides a brief introduction to some of the analysis methods available and suggests risk analysis approaches to support different types of decision making within the maritime transportation to cope with crises. Finally, as awareness of risk assessment increases, the benefits which can be realized through its application will continue to increase. Organizations in both the public and the private sector are becoming more and more familiar with the benefits associated with risk-based approaches to managing safety and consequently reducing crisis in maritime transportation.

The MARINA Risk Assessment Strategy: A Flexible Strategy for Efficient Information Collection and Risk Assessment of Nanomaterials.

Science.gov (United States)

Bos, Peter M J; Gottardo, Stefania; Scott-Fordsmand, Janeck J; van Tongeren, Martie; Semenzin, Elena; Fernandes, Teresa F; Hristozov, Danail; Hund-Rinke, Kerstin; Hunt, Neil; Irfan, Muhammad-Adeel; Landsiedel, Robert; Peijnenburg, Willie J G M; Sánchez Jiménez, Araceli; van Kesteren, Petra C E; Oomen, Agnes G

2015-11-27

An engineered nanomaterial (ENM) may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA) a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing) a base set of information is considered, relevant exposure scenarios (RESs) are identified and the scope for Phase 2 (Risk assessment) is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy.

The MARINA Risk Assessment Strategy: A Flexible Strategy for Efficient Information Collection and Risk Assessment of Nanomaterials

Directory of Open Access Journals (Sweden)

Peter M. J. Bos

2015-11-01

Full Text Available An engineered nanomaterial (ENM may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing a base set of information is considered, relevant exposure scenarios (RESs are identified and the scope for Phase 2 (Risk assessment is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy.

Business risks, functions, methods of assessment and ways to reduce risk

Directory of Open Access Journals (Sweden)

A.V. Mihalchuk

2015-06-01

Full Text Available For successful existence in a market economy entrepreneur have to take bold actions, and this increases the risk. The article describes the concept of entrepreneurship and business risk, positive and negative aspects of functions of risk in business. Therefore, it is necessary to assess the risk properly and be able to manage it to achieve the most effective results in the market. In market conditions the problem of assessing and accounting market becomes independent theoretical and practical significance as an important component of the theory and practice of management. Risk - a key element of business activities. Development of risk situations can lead to both the occurrence of adverse effects (losses, lost profits, and positive results for a company in the form of increased profit. This article describes: the concept of entrepreneurship, risk and business risks, characteristic of positive and negative aspects of risk functions in business, methods of assessment and risk reduction, shows formulae and examples you can use to assess risk in an enterprise. Analyzing already established methods of risk assessment a number of rules were proposed in order to reduce business risk.

Risk Assessment

OpenAIRE

Hrdová, Edita

2012-01-01

This diploma thesis is focused on companies risk evaluation before endorsement of Loan deriving from business relationships. The aim of this thesis is not only to describe individual steps of risk assessment, but also perfom analysis of particular companies based on available data, i.e. Balance sheet, Profit and Loss statement and external rating and after that propose solution for each company. My analysis will be based on theoretical knowledge, further on experience related to my job role a...

Development of a nematode offspring counting assay for rapid and simple soil toxicity assessment.

Science.gov (United States)

Kim, Shin Woong; Moon, Jongmin; Jeong, Seung-Woo; An, Youn-Joo

2018-05-01

Since the introduction of standardized nematode toxicity assays by the American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO), many studies have reported their use. Given that the currently used standardized nematode toxicity assays have certain limitations, in this study, we examined the use of a novel nematode offspring counting assay for evaluating soil ecotoxicity based on a previous soil-agar isolation method used to recover live adult nematodes. In this new assay, adult Caenorhabditis elegans were exposed to soil using a standardized toxicity assay procedure, and the resulting offspring in test soils attracted by a microbial food source in agar plates were counted. This method differs from previously used assays in terms of its endpoint, namely, the number of nematode offspring. The applicability of the bioassay was demonstrated using metal-spiked soils, which revealed metal concentration-dependent responses, and with 36 field soil samples characterized by different physicochemical properties and containing various metals. Principal component analysis revealed that texture fraction (clay, sand, and silt) and electrical conductivity values were the main factors influencing the nematode offspring counting assay, and these findings warrant further investigation. The nematode offspring counting assay is a rapid and simple process that can provide multi-directional toxicity assessment when used in conjunction with other standard methods. Copyright © 2018 Elsevier Ltd. All rights reserved.

HTGR accident and risk assessment

International Nuclear Information System (INIS)

Silady, F.A.; Everline, C.J.; Houghton, W.J.

1982-01-01

This paper is a synopsis of the high-temperature gas-cooled reactor probabilistic risk assessments (PRAs) performed by General Atomic Company. Principal topics presented include: HTGR safety assessments, peer interfaces, safety research, process gas explosions, quantitative safety goals, licensing applications of PRA, enhanced safety, investment risk assessments, and PRA design integration

Anthropic Risk Assessment on Biodiversity

Science.gov (United States)

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.

Risk assessment and the environment

International Nuclear Information System (INIS)

Fisk, D.J.

1992-01-01

This paper reviews the use of risk assessment techniques in the field of environment protection. I will argue that in some important instances the development of environment policy has been a source of fruitful development of a risk based methodologies. In other cases the importation of risk assessment techniques has proved much more problematic. As the scope of environmental regulation increases so does the possibility of inconsistent and arbitrary solutions to problems. The need for a more systematic approach to the development of environmental regulation has never been stronger, so it is important to understand the reasons for the mixed success of risk assessment. This applies equally to those nations with long traditions of the regulation of private sector industry and those just beginning on this course. The way ahead may be to extend our ideas of how to express risk and uncertainty. Some of the recent cause celebres of environment policy show this challenge very clearly. As an example, this paper will look at the problem of assessing the risk of man-made climate change

Risk assessment and the environment

Energy Technology Data Exchange (ETDEWEB)

Fisk, D J [Department of the Environment (United Kingdom)

1992-07-01

This paper reviews the use of risk assessment techniques in the field of environment protection. I will argue that in some important instances the development of environment policy has been a source of fruitful development of a risk based methodologies. In other cases the importation of risk assessment techniques has proved much more problematic. As the scope of environmental regulation increases so does the possibility of inconsistent and arbitrary solutions to problems. The need for a more systematic approach to the development of environmental regulation has never been stronger, so it is important to understand the reasons for the mixed success of risk assessment. This applies equally to those nations with long traditions of the regulation of private sector industry and those just beginning on this course. The way ahead may be to extend our ideas of how to express risk and uncertainty. Some of the recent cause celebres of environment policy show this challenge very clearly. As an example, this paper will look at the problem of assessing the risk of man-made climate change.

Nuclear insurance risk assessment using risk-based methodology

International Nuclear Information System (INIS)

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

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

Science.gov (United States)

2013-06-19

... importance of a uniform assay schema. Date and Time: The public workshop will be held on July 23, 2013, from... . SUPPLEMENTARY INFORMATION: This workshop will introduce for discussion a new nonclinical paradigm for assessing... guidelines, and the importance of a uniform assay schema. A description of the planned activities for the...

Risk assessment for halogenated solvents

International Nuclear Information System (INIS)

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

RESIDUAL RISK ASSESSMENT: ETHYLENE OXIDE ...

Science.gov (United States)

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.

The combined use of the PLHC-1 cell line and the recombinant yeast assay to assess the environmental quality of estuarine and coastal sediments.

Science.gov (United States)

Schnell, Sabine; Olivares, Alba; Piña, Benjamin; Echavarri-Erasun, Beatriz; Lacorte, Silvia; Porte, Cinta

2013-12-15

Sediment contamination poses a potential risk for both ecosystems and human health. Risk assessment is troublesome as sediments contain complex mixtures of toxicants, and traditional chemical analyses can neither provide information about potential hazards to organisms nor identify and measure all present contaminants. This work combines the use of the PLHC-1 cell line and the recombinant yeast assay (RYA) to assess the environmental quality of estuarine and coastal sediments. The application of multiple endpoints (cytotoxicity, generation of oxidative stress, presence of CYP1A inducing agents, micronucleus formation and estrogenicity) revealed that the organic extracts of those sediments affected by industrial activities or collected near harbours and untreated urban discharges showed significant cytotoxicity, micronuclei and CYP1A induction. The study highlights the usefulness of the applied bioassays to identify those sediments that could pose risk to aquatic organisms and that require further action to improve their environmental quality. Copyright © 2013 Elsevier Ltd. All rights reserved.

Risk assessment: An employer's perspective

International Nuclear Information System (INIS)

Williams, K.C.

1992-01-01

There is no question that a careful assessment of risk is essential for safe industrial operations. For that reason, a thoughtful analysis of the effectiveness of available risk assessment technologies is prerequisite for responsible corporate decision making. An 'employer's' perspective on risk assessment cannot be constrained by any artificial restrictions which that term may imply. In reality, all those who are involved in the execution of an industrial enterprise: managers, regulators, the affected public, and especially those employees exposed to hazards, are necessarily partners in assessment of risk. The perspective of this paper is that of the oil and gas industry, in which the author's organization, Exxon Company, International, participates. The paper addresses what Exxon requires to assess and manage risk in its worldwide operations. The author is aware, however, through contacts with industry colleagues, that some of Exxon's initiatives are representative of similar actions being taken by others. 1992 is the European Year of Safety, Health and Hygiene, coinciding with the United Kingdom's Presidency of the European Council. It is also the year in which new 'goal-setting' regulations covering safety in the U.K. offshore oil industry were put forward by the Health and Safety Commission. These regulations, based largely on Lord Cullen's recommendations following the Piper Alpha tragedy, set the pace for safety in the British North Sea and will significantly impact the safety of offshore oil installations worldwide. The requirement for risk assessment, using a systematic process of analysing and evaluating risk, is a key component of this safety regime

Risk assessment: An employer's perspective

Energy Technology Data Exchange (ETDEWEB)

Williams, K C [Exxon International (United States)

1992-07-01

There is no question that a careful assessment of risk is essential for safe industrial operations. For that reason, a thoughtful analysis of the effectiveness of available risk assessment technologies is prerequisite for responsible corporate decision making. An 'employer's' perspective on risk assessment cannot be constrained by any artificial restrictions which that term may imply. In reality, all those who are involved in the execution of an industrial enterprise: managers, regulators, the affected public, and especially those employees exposed to hazards, are necessarily partners in assessment of risk. The perspective of this paper is that of the oil and gas industry, in which the author's organization, Exxon Company, International, participates. The paper addresses what Exxon requires to assess and manage risk in its worldwide operations. The author is aware, however, through contacts with industry colleagues, that some of Exxon's initiatives are representative of similar actions being taken by others. 1992 is the European Year of Safety, Health and Hygiene, coinciding with the United Kingdom's Presidency of the European Council. It is also the year in which new 'goal-setting' regulations covering safety in the U.K. offshore oil industry were put forward by the Health and Safety Commission. These regulations, based largely on Lord Cullen's recommendations following the Piper Alpha tragedy, set the pace for safety in the British North Sea and will significantly impact the safety of offshore oil installations worldwide. The requirement for risk assessment, using a systematic process of analysing and evaluating risk, is a key component of this safety regime.

RELEVANCE OF PROCESS RISK ASSESSMENT IN AIRLINES

OpenAIRE

Oksana G. Feoktistova; Igor K. Turkin; Sergey V. Barinov

2017-01-01

The notion of “the concept on assumed risk” that took over from the outdated concept of absolute security is analyzed, the increasing significance of operating risk assessment at the present stage is noted. Some basic risk assessment techniques are considered. Matrix technique of risk assessment is considered more thoroughly, and it may be used in risk assessment of airlines in the context of labour protection management system.The ability to correctly assess risks and develop appropriate pre...

An abuse of risk assessment: how regulatory agencies improperly adopted LNT for cancer risk assessment.

Science.gov (United States)

Calabrese, Edward J

2015-04-01

The Genetics Panel of the National Academy of Sciences' Committee on Biological Effects of Atomic Radiation (BEAR) recommended the adoption of the linear dose-response model in 1956, abandoning the threshold dose-response for genetic risk assessments. This recommendation was quickly generalized to include somatic cells for cancer risk assessment and later was instrumental in the adoption of linearity for carcinogen risk assessment by the Environmental Protection Agency. The Genetics Panel failed to provide any scientific assessment to support this recommendation and refused to do so when later challenged by other leading scientists. Thus, the linearity model used in cancer risk assessment was based on ideology rather than science and originated with the recommendation of the NAS BEAR Committee Genetics Panel. Historical documentation in support of these conclusions is provided in the transcripts of the Panel meetings and in previously unexamined correspondence among Panel members.

A framework for combining social impact assessment and risk assessment

NARCIS (Netherlands)

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

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

A framework for combining social impact assessment and risk assessment

NARCIS (Netherlands)

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

2013-01-01

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

Risk indices in comparative risk assessment studies

International Nuclear Information System (INIS)

Hubert, P.

1984-01-01

More than a decade ago the development of comparative risk assessment studies aroused overwhelming interest. There was no doubt that data on the health and safety aspects of energy systems would greatly benefit, or even end, the debate on nuclear energy. Although such attempts are still strongly supported, the rose-coloured expectations of the early days have faded. The high uncertainties, and the contradictory aspect, of the first results might explain this evolution. The loose connection between the range of computed risk indices and the questions on which the debate was focused is another reason for this decline in interest. Important research work is being carried out aiming at reducing the different kinds of uncertainties. Rather than the uncertainties, the paper considers the meaning of available risk indices and proposes more significant indices with respect to the goals of risk assessment. First, the indices which are of frequent use in comparative studies are listed. The stress is put on a French comparative study from which most examples are drawn. Secondly, the increase in magnitude of the indices and the decrease in the attributability of the risk to a given system is shown to be a consequence of the trend towards more comprehensive analyses. Thirdly, the ambiguity of such indices as the collective occupational risk is underlined, and a possible solution is suggested. Whenever risk assessments are related to pragmatic decision making problems it is possible to find satisfactory risk indices. The development of cost-effectiveness analyses and the proposals for quantitative safety goals clearly demonstrate this point. In the field of comparison of social impacts some proposals are made, but there remain some gaps still to be filled. (author)

Aspects regarding explosion risk assessment

Directory of Open Access Journals (Sweden)

Părăian Mihaela

2017-01-01

Full Text Available Explosive risk occurs in all activities involving flammable substances in the form of gases, vapors, mists or dusts which, in mixture with air, can generate an explosive atmosphere. As explosions can cause human losses and huge material damage, the assessment of the explosion risk and the establishment of appropriate measures to reduce it to acceptable levels according to the standards and standards in force is of particular importance for the safety and health of people and goods.There is no yet a recognized method of assessing the explosion risk, but regardless of the applied method, the likelihood of an explosive atmosphere occurrence has to be determined, together with the occurrence of an efficient ignition source and the magnitude of foreseeable consequences. In assessment processes, consequences analysis has a secondary importance since it’s likely that explosions would always involve considerable damage, starting from important material damages and up to human damages that could lead to death.The purpose of the work is to highlight the important principles and elements to be taken into account for a specific risk assessment. An essential element in assessing the risk of explosion in workplaces where explosive atmospheres may occur is technical installations and personal protective equipment (PPE that must be designed, manufactured, installed and maintained so that they cannot generate a source of ignition. Explosion prevention and protection requirements are governed by specific norms and standards, and a main part of the explosion risk assessment is related to the assessment of the compliance of the equipment / installation with these requirements.

Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies

Directory of Open Access Journals (Sweden)

Michael A. Partridge

2016-01-01

Full Text Available Anti-drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the immunogenicity risk of potential biotherapeutics in producing neutralizing and nonneutralizing anti-drug antibodies, especially in clinical phases of drug development. Different assay methodologies have been used to detect all anti-drug antibodies, including ELISA, radioimmunoassay, surface plasmon resonance, and electrochemiluminescence-based technologies. The most commonly used method is a bridging assay, performed in an ELISA or on the Meso Scale Discovery platform. In this report, we aim to review the emerging new assay technologies that can complement or address challenges associated with the bridging assay format in screening and confirmation of ADAs. We also summarize generic anti-drug antibody assays that do not require drug-specific reagents for nonclinical studies. These generic assays significantly reduce assay development efforts and, therefore, shorten the assay readiness timeline.

Chlorine transportation risk assessment

International Nuclear Information System (INIS)

Lautkaski, Risto; Mankamo, Tuomas.

1977-02-01

An assessment has been made on the toxication risk of the population due to the bulk rail transportation of liquid chlorine in Finland. Fourteen typical rail accidents were selected and their probability was estimated using the accident file of the Finnish State Railways. The probability of a chlorine leak was assessed for each type of accident separately using four leak size categories. The assessed leakage probability was dominated by station accidents, especially by collisions of a chlorine tanker and a locomotive. Toxication hazard areas were estimated for the leak categories. A simple model was constructed to describe the centring of the densely populated areas along the railway line. A comparison was made between the obtained risk and some other risks including those due to nuclear reactor accidents. (author)

Probabilistic risk assessment, Volume I

International Nuclear Information System (INIS)

Anon.

1982-01-01

This book contains 158 papers presented at the International Topical Meeting on Probabilistic Risk Assessment held by the American Nuclear Society (ANS) and the European Nuclear Society (ENS) in Port Chester, New York in 1981. The meeting was second in a series of three. The main focus of the meeting was on the safety of light water reactors. The papers discuss safety goals and risk assessment. Quantitative safety goals, risk assessment in non-nuclear technologies, and operational experience and data base are also covered. Included is an address by Dr. Chauncey Starr

Risk assessment in maritime transportation

International Nuclear Information System (INIS)

Soares, C. Guedes; Teixeira, A.P.

2001-01-01

A review is presented of different approaches to quantify the risk in maritime transportation. The discussion of several accident statistics provides a global assessment of the risk levels and its differentiation in ship types and main types of ship losses. Early studies in the probability of ship loss by foundering and capsizing are reviewed. The approaches used to assess the risk of structural design are addressed. Finally a brief account is given of recent development of using formal safety assessments to support decision making on legislation applicable internationally to maritime transportation

Framework for ecological risk assessment

International Nuclear Information System (INIS)

Rodier, D.; Norton, S.

1992-02-01

Increased interest in ecological issues such as global climate change, habitat loss, acid deposition, reduced biological diversity, and the ecological impacts of pesticides and toxic chemicals prompts this U.S. Environmental Protection Agency (EPA) report, A Framework for Ecological Risk Assessment ('Framework Report'). The report describes basic elements, or a framework, for evaluating scientific information on the adverse effects of physical and chemical stressors on the environment. The framework offers starting principles and a simple structure as guidance for current ecological risk assessments and as a foundation for future EPA proposals for risk assessment guidelines

Risk assessment instruments in clinical practice.

Science.gov (United States)

Côté, Gilles; Crocker, Anne G; Nicholls, Tonia L; Seto, Michael C

2012-04-01

To determine whether the items in one of the most widely validated instruments of violence risk assessment, the Historical-Clinical-Risk Management-20 (HCR-20), are used in review board hearings to assess the risk of violence by people found Not Criminally Responsible on account of Mental Disorder (NCRMD). This study was conducted from October 2004 to August 2006 in Quebec's sole forensic psychiatric hospital and 2 large civil psychiatric hospitals designated for the care of people declared NCRMD in the Montreal metropolitan area. The risk assessments presented by clinicians at annual review board hearings and the boards' rationale for the release or detention of people found NCRMD were contrasted with the risk assessments conducted by the research team using the HCR-20. The final sample was comprised of 96 men. Very few of the risk factors identified by prior research (HCR-20 items) were mentioned in the hearing process, whether in clinical reports, discussions during the hearing, or in the disposition justification. The findings confirm that there remains a significant gap between research evidence and risk assessment practice.

Epithelial cells as alternative human biomatrices for comet assay.

Science.gov (United States)

Rojas, Emilio; Lorenzo, Yolanda; Haug, Kristiane; Nicolaissen, Bjørn; Valverde, Mahara

2014-01-01

The comet assay is a valuable experimental tool aimed at mapping DNA damage in human cells in vivo for environmental and occupational monitoring, as well as for therapeutic purposes, such as storage prior to transplant, during tissue engineering, and in experimental ex vivo assays. Furthermore, due to its great versatility, the comet assay allows to explore the use of alternative cell types to assess DNA damage, such as epithelial cells. Epithelial cells, as specialized components of many organs, have the potential to serve as biomatrices that can be used to evaluate genotoxicity and may also serve as early effect biomarkers. Furthermore, 80% of solid cancers are of epithelial origin, which points to the importance of studying DNA damage in these tissues. Indeed, studies including comet assay in epithelial cells have either clear clinical applications (lens and corneal epithelial cells) or examine genotoxicity within human biomonitoring and in vitro studies. We here review improvements in determining DNA damage using the comet assay by employing lens, corneal, tear duct, buccal, and nasal epithelial cells. For some of these tissues invasive sampling procedures are needed. Desquamated epithelial cells must be obtained and dissociated prior to examination using the comet assay, and such procedures may induce varying amounts of DNA damage. Buccal epithelial cells require lysis enriched with proteinase K to obtain free nucleosomes. Over a 30 year period, the comet assay in epithelial cells has been little employed, however its use indicates that it could be an extraordinary tool not only for risk assessment, but also for diagnosis, prognosis of treatments and diseases.

Reevaluating Interrater Reliability in Offender Risk Assessment

NARCIS (Netherlands)

van der Knaap, L.M.; Leenarts, L.E.W.; Born, M.P.; Oosterveld, P.

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

Quantitative risk assessment system (QRAS)

Science.gov (United States)

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.

Ecosystem services as assessment endpoints for ecological risk assessment.

Science.gov (United States)

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

Laboratory assessment of anti-thrombotic therapy in heart failure, atrial fibrillation and coronary artery disease: insights using thrombelastography and a micro-titre plate assay of thrombogenesis and fibrinolysis.

Science.gov (United States)

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

2016-08-01

As heart failure, coronary artery disease and atrial fibrillation all bring a risk of thrombosis, anti-thrombotic therapy is recommended. Despite such treatment, major cardiovascular events such as myocardial infarction and stroke still occur, implying inadequate suppression of thrombus formation. Accordingly, identification of patients whose haemostasis remains unimpaired by treatment is valuable. We compared indices for assessing thrombogenesis and fibrinolysis by two different techniques in patients on different anti-thrombotic agents, i.e. aspirin or warfarin. We determined fibrin clot formation and fibrinolysis by a microplate assay and thromboelastography, and platelet marker soluble P selectin in 181 patients with acute or chronic heart failure, coronary artery disease who were taking either aspirin or warfarin. Five thromboelastograph indices and four microplate assay indices were different on aspirin versus warfarin (p indices rate of clot formation and rate of clot dissolution were independently related to aspirin or warfarin use (p ≤ 0.001). Five microplate assay indices, but no thrombelastograph index, were different (p indices were different (p ≤ 0.002) in warfarin users. The microplate assay indices of lag time and rate of clot formation were abnormal in chronic heart failure patients on aspirin, suggesting increased risk of thrombosis despite anti-platelet use. Soluble P selectin was lower in patients on aspirin (p = 0.0175) but failed to correlate with any other index of haemostasis. The microplate assay shows promise as a tool for dissecting thrombogenesis and fibrinolysis in cardiovascular disease, and the impact of antithrombotic therapy. Prospective studies are required to determine a role in predicting thrombotic risk.

Using toxicokinetic-toxicodynamic modeling as an acute risk assessment refinement approach in vertebrate ecological risk assessment.

Science.gov (United States)

Ducrot, Virginie; Ashauer, Roman; Bednarska, Agnieszka J; Hinarejos, Silvia; Thorbek, Pernille; Weyman, Gabriel

2016-01-01

Recent guidance identified toxicokinetic-toxicodynamic (TK-TD) modeling as a relevant approach for risk assessment refinement. Yet, its added value compared to other refinement options is not detailed, and how to conduct the modeling appropriately is not explained. This case study addresses these issues through 2 examples of individual-level risk assessment for 2 hypothetical plant protection products: 1) evaluating the risk for small granivorous birds and small omnivorous mammals of a single application, as a seed treatment in winter cereals, and 2) evaluating the risk for fish after a pulsed treatment in the edge-of-field zone. Using acute test data, we conducted the first tier risk assessment as defined in the European Food Safety Authority (EFSA) guidance. When first tier risk assessment highlighted a concern, refinement options were discussed. Cases where the use of models should be preferred over other existing refinement approaches were highlighted. We then practically conducted the risk assessment refinement by using 2 different models as examples. In example 1, a TK model accounting for toxicokinetics and relevant feeding patterns in the skylark and in the wood mouse was used to predict internal doses of the hypothetical active ingredient in individuals, based on relevant feeding patterns in an in-crop situation, and identify the residue levels leading to mortality. In example 2, a TK-TD model accounting for toxicokinetics, toxicodynamics, and relevant exposure patterns in the fathead minnow was used to predict the time-course of fish survival for relevant FOCUS SW exposure scenarios and identify which scenarios might lead to mortality. Models were calibrated using available standard data and implemented to simulate the time-course of internal dose of active ingredient or survival for different exposure scenarios. Simulation results were discussed and used to derive the risk assessment refinement endpoints used for decision. Finally, we compared the

Hanford Site baseline risk assessment methodology

International Nuclear Information System (INIS)

1993-03-01

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

RELEVANCE OF PROCESS RISK ASSESSMENT IN AIRLINES

Directory of Open Access Journals (Sweden)

Oksana G. Feoktistova

2017-01-01

Full Text Available The notion of “the concept on assumed risk” that took over from the outdated concept of absolute security is analyzed, the increasing significance of operating risk assessment at the present stage is noted. Some basic risk assessment techniques are considered. Matrix technique of risk assessment is considered more thoroughly, and it may be used in risk assessment of airlines in the context of labour protection management system.The ability to correctly assess risks and develop appropriate precautionary measures will allow airlines to avoid incidents leading to drastic consequences for staff, as well as to direct and indirect costs for the enterprise among which there could be singled out both direct property damage and loss of profit and expenses connected to incident investigation, penalty and compensation payment, loss of business reputation and so on. To reduce the rate of accidents and to develop safe activities skills for airlines staff a risk assessment chart is supposed to be implemented, which will be an efficient accidents prevention involving the staff in the process and making them follow safe working conditions.Process risk assessment is an integral part of assessment of the whole enterprise activity and work efficiency of a department and particular workers evaluation system. Labour protection activity should be based on risk identification and its control. Risk assessment is a keystone of labour protection activity planning.

Uncertainty quantification in flood risk assessment

Science.gov (United States)

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

2017-04-01

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

Reevaluating Interrater Reliability in Offender Risk Assessment

Science.gov (United States)

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…

Enhancing the ecological risk assessment process.

Science.gov (United States)

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

2008-07-01

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

A framework for combining social impact assessment and risk assessment

Energy Technology Data Exchange (ETDEWEB)

Mahmoudi, Hossein, E-mail: mahmoudi@uni-hohenheim.de [Department of Social Sciences in Agriculture, University of Hohenheim (Germany); Environmental Sciences Research Institute, Shahid Beheshti University, G.C. (Iran, Islamic Republic of); Renn, Ortwin [Department of Technology and Environmental Sociology (and DIALOGIK), University of Stuttgart (Germany); Vanclay, Frank [Department of Cultural Geography, Faculty of Spatial Sciences, University of Groningen, Groningen (Netherlands); Hoffmann, Volker [Department of Social Sciences in Agriculture, University of Hohenheim (Germany); Karami, Ezatollah [College of Agriculture, Shiraz University, Shiraz (Iran, Islamic Republic of)

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.

A framework for combining social impact assessment and risk assessment

International Nuclear Information System (INIS)

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

2013-01-01

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

Risk assessment [Chapter 9

Science.gov (United States)

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

2014-01-01

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

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

Science.gov (United States)

Meek, M E Bette; Lipscomb, John C

2015-06-05

Testing strategies are anticipated to increasingly rely on in vitro data as a basis to characterize early steps or key events in toxicity at relevant dose levels in human tissues. Such strategies require quantitative in vitro to in vivo extrapolation to characterize dose-response as a basis for comparison with exposure to estimate risk. Current experience in the incorporation of mechanistic and in vitro data in risk assessment is considered here in the context of identified principles to increase the potential for timely acceptance of more progressive and tailored testing strategies by the regulatory community. These principles are outlined as transitioning in a familiar context, tiering to acquire experience and increase confidence, contextual knowledge transfer to facilitate interpretation and communication, coordination and development of expertise and continuing challenge. A proposed pragmatic tiered data driven framework which includes increasing reliance on in vitro data and quantitative in vitro to in vivo extrapolation is considered in the context of these principles. Based on this analysis, possible additional steps that might facilitate timely evolution and potentially, uptake are identified. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Development of the larval amphibian growth and development assay: Effects of benzophenone-2 exposure in Xenopus laevis from embryo to juvenile

Science.gov (United States)

The Larval Amphibian Growth and Development Assay (LAGDA) is a globally harmonized chemical testing guideline developed by the U.S. Environmental Protection Agency in collaboration with Japan’s Ministry of Environment to support risk assessment. The assay is employed as a ...

Risk assessment - black art or science?

International Nuclear Information System (INIS)

Moore, G.

1988-01-01

Measures of risk can be divided into two categories, those that observe or calculate the risk of a process or project, and those that rely on the level of risk as perceived by the people during the assessment. Collection of data of accidents (where cause and effect are obvious) and experiments on animals which can then be extrapolated to humans, are two ways of risk assessment. Mathematical models and computerized simulations, using either fault tree analysis or Monte Carlo methods are explained simply. Using these methods, experts are able to perceive risk fairly realistically. However, the general public's perception of risk is often quite different, as potential risk is assessed in different ways. The concept of tolerable risk is considered, particularly with reference to nuclear reactors such as Sizewell-B. The need to inform the public of safeguards and safety procedures so they have a better understanding of the risks of nuclear power is stressed. (U.K.)

Concerning ethical risk assessment

International Nuclear Information System (INIS)

Boeckle, F.

1991-01-01

After a fundamental consideration of the concept of responsibility and 'long-term responsibility' for late sequelae, the problems of an ehtical assessment of risks were illustrated: The concept of risk itself poses three problems - predicting the probability of occurrence, assessing the damage = subjective classification of the degree of damage, determining whether the advantages outweigh the risks. It is not possible to weigh the advantages and risks against each other without assessing the goals and the priorities which have been set. Here ethics is called for, because it concerns itself with the reasonableness of evaluative decisions. Its task is to enable us to become aware of and comprehend our system of values in all of its complexity in reference to real life. Ethics can only fulfill its task if it helps us to adopt an integral perspective, i.e. if it centers on the human being. 'One must assess all technical and economic innovations in terms of whether they are beneficial to the development of mankind on a long-term basis. They are only to be legitimized insofar as they prove themselves to be a means of liberating mankind and contributing to his sense of dignity and identity, as a means of bringing human beings together and encouraging them to care for one another, and as a means of protecting the natural basis of our existence. (orig./HSCH) [de

Ecological risk assessment

National Research Council Canada - National Science Library

Suter, Glenn W; Barnthouse, L. W. (Lawrence W)

2007-01-01

Ecological risk assessment is commonly applied to the regulation of chemicals, the remediation of contaminated sites, the monitoring of importation of exotic organisms, the management of watersheds...

Rapid high-throughput assay to assess scavenging capacity index using DPPH.

Science.gov (United States)

Abderrahim, Fatima; Arribas, Silvia M; Gonzalez, M Carmen; Condezo-Hoyos, Luis

2013-11-15

A new microplate-adapted DPPH rapid assay was developed to assess the antioxidant capacity of pure compounds and foods. The assay was carried out in buffered medium (methanol: 10mmol/l Tris buffer pH 7.5, 1:1 v/v) and reaction was completed at 10min. The scavenging capacity index (SCI), a theoretical antioxidant parameter directly related to the antioxidant capacity of samples, was calculated. SCI for pure compounds: gallic acid (6.76±0.08), quercetin (7.89±0.24), catechin (6.05±0.23), trolox (2.32±0.03), ascorbic acid (2.52±0.15) and gluthatione (1.08±0.08) and foods (μmol DPPH scavenged/100ml): tropical juice (655.62±12.18), mediterraneo juice (702.87±11.13), apple juice (212.52±17.22), pomegranate juice (319.83±9.45), red grape nectar (1093.05±18.69), Don Simon orange juice (632.94±17.22) and date syrup (15992.34±250.7) were comparable to those in previous reports using the classic DPPH assay. The relative standard deviation (RSD) for the SCI on the same and different days was less than 8.12% in all cases. Copyright © 2013 Elsevier Ltd. All rights reserved.

A risk communication case study: the Nevada risk assessment/management program

International Nuclear Information System (INIS)

Hechanova, A.E.

2001-01-01

The Nevada Risk Assessment/Management Program is part of a national effort by the U.S. Department of Energy (Grant DE-FG01-96EW56093) to develop new sources of information and approaches to risk assessment, risk management, risk communication and public outreach as these objectives relate to the ecological and human health effects of radioactive and hazardous material management and site remediation activities. This paper reviews the innovation behind the Nevada Risk Assessment/Management Program and presents a synopsis of the effort that began in 1995 and will officially conclude on April 30, 2000. (author)

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

International Nuclear Information System (INIS)

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

2010-01-01

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.

Caries risk assessment in children

DEFF Research Database (Denmark)

Twetman, S

2016-01-01

PURPOSE: To summarise the findings of recent systematic reviews (SR) covering caries risk assessment in children, updated with recent primary studies. METHODS: A search for relevant papers published 2012-2014 was conducted in electronic databases. The systematic reviews were quality assessed...... displayed a high risk of bias. CONCLUSIONS: Based on the present summary of literature, it may be concluded: (1) a caries risk assessment should be carried out at the child's first dental visit and reassessments should be done during childhood (D); (2) multivariate models display a better accuracy than...... the use of single predictors and this is especially true for preschool children (C); (3) there is no clearly superior method to predict future caries and no evidence to support the use of one model, program, or technology before the other (C); and (4) the risk category should be linked to appropriate...

[Regional atmospheric environment risk source identification and assessment].

Science.gov (United States)

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.

OPPT workplan risk assessment for Trichloroethylene ...

Science.gov (United States)

The assessment will focus on uses of TCE as a degreaser and in consumer products used by individuals in the arts/crafts field. Given the range of endpoints (cancer, non-cancer; the latter includes potential effects on the developing fetus), it is expected that susceptible populations would be children (as bystanders physically near the actual consumer use of the products) and adults of all ages (including pregnant women). Thus, the assessment will focus on all human/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 current work on assessment of those specified targeted uses of that chemical. Over time, additional chemicals will be added to the work plan as more data are developed and more chemicals screened.

Tools for Microbiological risk assessment

DEFF Research Database (Denmark)

Bassett, john; Nauta, Maarten; Lindqvist, Roland

can increase the understanding of microbiological risks in foods. It is timely to inform food safety professionals about the availability and utility of MRA tools. Therefore, the focus of this report is to aid the food safety manager by providing a concise summary of the tools available for the MRA......Microbiological Risk Assessment (MRA) has emerged as a comprehensive and systematic approach for addressing the risk of pathogens in specific foods and/or processes. At government level, MRA is increasingly recognised as a structured and objective approach to understand the level of risk in a given...... food/pathogen scenario. Tools developed so far support qualitative and quantitative assessments of the risk that a food pathogen poses to a particular population. Risk can be expressed as absolute numbers or as relative (ranked) risks. The food industry is beginning to appreciate that the tools for MRA...

Modeling for operational event risk assessment

International Nuclear Information System (INIS)

Sattison, M.B.

1997-01-01

The U.S. Nuclear Regulatory Commission has been using risk models to evaluate the risk significance of operational events in U.S. commercial nuclear power plants for more seventeen years. During that time, the models have evolved in response to the advances in risk assessment technology and insights gained with experience. Evaluation techniques fall into two categories, initiating event assessments and condition assessments. The models used for these analyses have become uniquely specialized for just this purpose

Risk assessment of forensic patients: nurses' role.

Science.gov (United States)

Encinares, Maxima; McMaster, Jeff James; McNamee, Jim

2005-03-01

One of the unique roles of forensic nurses is to conduct risk assessments. Establishing a therapeutic nurse-patient relationship helps forensic nurses perform accurate and useful risk assessments. Accurate risk assessments can facilitate formulation of individualized risk management plans, designed to meet patients' needs and ensure public safety. The importance of forensic nurses' knowledge and application of appropriate communication and proper documentation cannot be overemphasized.

Ethical dimensions in assessing technical risks

International Nuclear Information System (INIS)

Birnbacher, D.

1991-01-01

Contrary to the present tendency of partially impact-independent technology assessment, the author does not see a difference between a risk-benefit analysis and an ethical technology assessment. As long as the risk-benefit analysis is truly comprehensive, both fall together. This does not mean that convictions of those who have their doubts about some new technologies, independently of impact assessments, may be disregarded in purely consequential risk evaluations. On the contrary, qualms of representatives of these principles, just as any other stable non-acceptance, have to be included as aggravating negative elements in technology assessments. (orig./HSCH) [de

Total cardiovascular disease risk assessment: a review.

LENUS (Irish Health Repository)

Cooney, Marie Therese

2011-09-01

The high risk strategy for the prevention of cardiovascular disease (CVD) requires an assessment of an individual\\'s total CVD risk so that the most intensive risk factor management can be directed towards those at highest risk. Here we review developments in the assessment and estimation of total CVD risk.

Risk assessment of carcinogens in food

International Nuclear Information System (INIS)

Barlow, Susan; Schlatter, Josef

2010-01-01

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.

Risk assessment of carcinogens in food.

Science.gov (United States)

Barlow, Susan; Schlatter, Josef

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.

Impact of shutdown risk on risk-based assessment of technical specifications

International Nuclear Information System (INIS)

Deriot, S.

1992-10-01

This paper describes the current work performed by the Research and Development Division of EDF concerning risk-based assessment of Operating Technical Specifications (OTS). The current risk-based assessment of OTS at EDF is presented. Then, the level 1 Probabilistic Safety Assessment of unit 3 of the Paluel nuclear power station (called PSA 1300) is described. It is fully computerized and takes into account the risk in shutdown states. A case study is presented. It shows that the fact of considering shutdown risk suggests that the current OTS should be modified

Risk Assessment Uncertainties in Cybersecurity Investments

Directory of Open Access Journals (Sweden)

Andrew Fielder

2018-06-01

Full Text Available When undertaking cybersecurity risk assessments, it is important to be able to assign numeric values to metrics to compute the final expected loss that represents the risk that an organization is exposed to due to cyber threats. Even if risk assessment is motivated by real-world observations and data, there is always a high chance of assigning inaccurate values due to different uncertainties involved (e.g., evolving threat landscape, human errors and the natural difficulty of quantifying risk. Existing models empower organizations to compute optimal cybersecurity strategies given their financial constraints, i.e., available cybersecurity budget. Further, a general game-theoretic model with uncertain payoffs (probability-distribution-valued payoffs shows that such uncertainty can be incorporated in the game-theoretic model by allowing payoffs to be random. This paper extends previous work in the field to tackle uncertainties in risk assessment that affect cybersecurity investments. The findings from simulated examples indicate that although uncertainties in cybersecurity risk assessment lead, on average, to different cybersecurity strategies, they do not play a significant role in the final expected loss of the organization when utilising a game-theoretic model and methodology to derive these strategies. The model determines robust defending strategies even when knowledge regarding risk assessment values is not accurate. As a result, it is possible to show that the cybersecurity investments’ tool is capable of providing effective decision support.

A multi-assay screening approach for assessment of endocrine-active contaminants in wastewater effluent samples

Energy Technology Data Exchange (ETDEWEB)

Metcalfe, Chris D., E-mail: cmetcalfe@trentu.ca [Environmental and Resource Studies, Trent University, Peterborough, ON, K9J 7B8 (Canada); Kleywegt, Sonya [Standards Development Branch, Ontario Ministry of the Environment, 40 St. Clair Ave. West, Toronto, ON, M4V 1M2 (Canada); Letcher, Robert J. [Ecotoxicology and Wildlife Health Division, Science and Technology Branch, Environment Canada, National Wildlife Research Centre, Carleton University, Ottawa, ON, K1A 0H3 (Canada); Topp, Edward [Agriculture and Agri-Food Canada, Southern Crop Protection and Food Research Centre, London, ON, N5V 7T3 (Canada); Wagh, Purva; Trudeau, Vance L.; Moon, Thomas W. [Department of Biology and Centre for Advanced Research in Environmental Genomics, University of Ottawa, Ottawa, ON, K1N 6N5 (Canada)

2013-06-01

Environmental agencies must monitor an ever increasing range of contaminants of emerging concern, including endocrine disrupting compounds (EDCs). An alternative to using ultra-trace chemical analysis of samples for EDCs is to test for biological activity using in vitro screening assays, then use these assay results to direct analytical chemistry approaches. In this study, we used both analytical approaches and in vitro bioassays to characterize the EDCs present in treated wastewater from four wastewater treatment plants (WWTPs) in Ontario, Canada. Estrogen-mediated activity was assessed using a yeast estrogenicity screening (YES) assay. An in vitro competitive binding assay was used to assess capacity to interfere with binding of the thyroid hormone, thyroxine (T4) to the recombinant human thyroid hormone transport protein, transthyretin (i.e. hTTR). An in vitro binding assay with a rat peroxisome proliferator responsive element transfected into a rainbow trout gill cell line was used to evaluate binding and subsequent gene expression via the peroxisome proliferator activated receptor (PPAR). Analyses of a suite of contaminants known to be EDCs in extracts from treated wastewater were conducted using either gas chromatography with mass spectrometry (GC-MS) or liquid chromatography with tandem mass spectrometry (LC-MS/MS). Estrogenic activity was detected in the YES assay only in those extracts that contained detectable amounts of estradiol (E2). There was a positive relationship between the degree of response in the T4-hTTR assay and the amounts of polybrominated diphenyl ether (PBDE) congeners 47 and 99, triclosan and the PBDE metabolite, 4-OH-BDE17. Several wastewater extracts gave a positive response in the PPAR assay, but these responses were not correlated with the amounts of any of the EDCs analyzed by LC-MS/MS. Overall, these data indicate that a step-wise approach is feasible using a combination of in vitro testing and instrumental analysis to monitor for

A multi-assay screening approach for assessment of endocrine-active contaminants in wastewater effluent samples

International Nuclear Information System (INIS)

Metcalfe, Chris D.; Kleywegt, Sonya; Letcher, Robert J.; Topp, Edward; Wagh, Purva; Trudeau, Vance L.; Moon, Thomas W.

2013-01-01

Environmental agencies must monitor an ever increasing range of contaminants of emerging concern, including endocrine disrupting compounds (EDCs). An alternative to using ultra-trace chemical analysis of samples for EDCs is to test for biological activity using in vitro screening assays, then use these assay results to direct analytical chemistry approaches. In this study, we used both analytical approaches and in vitro bioassays to characterize the EDCs present in treated wastewater from four wastewater treatment plants (WWTPs) in Ontario, Canada. Estrogen-mediated activity was assessed using a yeast estrogenicity screening (YES) assay. An in vitro competitive binding assay was used to assess capacity to interfere with binding of the thyroid hormone, thyroxine (T4) to the recombinant human thyroid hormone transport protein, transthyretin (i.e. hTTR). An in vitro binding assay with a rat peroxisome proliferator responsive element transfected into a rainbow trout gill cell line was used to evaluate binding and subsequent gene expression via the peroxisome proliferator activated receptor (PPAR). Analyses of a suite of contaminants known to be EDCs in extracts from treated wastewater were conducted using either gas chromatography with mass spectrometry (GC-MS) or liquid chromatography with tandem mass spectrometry (LC-MS/MS). Estrogenic activity was detected in the YES assay only in those extracts that contained detectable amounts of estradiol (E2). There was a positive relationship between the degree of response in the T4-hTTR assay and the amounts of polybrominated diphenyl ether (PBDE) congeners 47 and 99, triclosan and the PBDE metabolite, 4-OH-BDE17. Several wastewater extracts gave a positive response in the PPAR assay, but these responses were not correlated with the amounts of any of the EDCs analyzed by LC-MS/MS. Overall, these data indicate that a step-wise approach is feasible using a combination of in vitro testing and instrumental analysis to monitor for

Engineering aspects of probabilistic risk assessment

International Nuclear Information System (INIS)

vonHerrmann, J.L.; Wood, P.J.

1984-01-01

Over the last decade, the use of probabilistic risk assessment (PRA) in the nuclear industry has expanded significantly. In these analyses the probabilities of experiencing certain undesired events (for example, a plant accident which results in damage to the nuclear fuel) are estimated and the consequences of these events are evaluated in terms of some common measure. These probabilities and consequences are then combined to form a representation of the risk associated with the plant studied. In the relatively short history of probabilistic risk assessment of nuclear power plants, the primary motivation for these studies has been the quantitative assessment of public risk associated with a single plant or group of plants. Accordingly, the primary product of most PRAs performed to date has been a 'risk curve' in which the probability (or expected frequency) of exceeding a certain consequence level is plotted against that consequence. The most common goal of these assessments has been to demonstrate the 'acceptability' of the calculated risk by comparison of the resultant risk curve to risk curves associated with other plants or with other societal risks. Presented here are brief descriptions of some alternate applications of PRAs, a discussion of how these other applications compare or contrast with the currently popular uses of PRA, and a discussion of the relative benefits of each

Insurance World in Transition: Changes in Global Risk Taking and Risk Assessment

Science.gov (United States)

Michel, Gero; Tiampo, Kristy

2015-04-01

Catastrophe insurance risk assessment, risk taking, and regulation has evolved over the last 20 years and is gearing up for significant further change in the years ahead. Changes in regulation and influx of capital have put profit margins for catastrophe risk products under pressure despite the fact that changes in climate as well as increasing insurance penetration is expected to heighten demand. As a result, reinsurance strategies are moving away from catastrophe risk. In addition, lower margins require cheaper and more efficient risk assessment methods and processes which are contrary to evolving analytical tools and methods that had increased expenses in line with growing margins over the last decade. New capital providers are less familiar with and less willing to accept complex supply chains for risk management, relationship-driven business and tedious data exchange and management processes. Risk takers claim new measures and ask for more flexibility in the use of tools. The current concepts of catastrophe insurance risk assessment are hence under thorough scrutiny. This presentation deals with the changing landscape in catastrophe insurance risk assessment and risk hedging and discusses changes in catastrophe risk assessment products and demand. How likely is it that private, small and nimble hazard and risk consulting groups - increasingly emanating from larger science organizations - will replace large established firms in their role to assess risk? What role do public-private academic partnerships play in assuming risk for catastrophe insurance and what role could they play in the future? What are the opportunities and downsides of the current changes in risk taking and hedging? What is needed from the scientific community in order to fill the gaps in risk management and who is likely to take advantage of the current changes?

Health risk assessment of exposure to ionizing radiation

International Nuclear Information System (INIS)

Ogata, Hiromitsu

2011-01-01

Risk assessment is an essential process for evaluating the human health effects of exposure to ionizing radiation and for determining acceptable levels of exposure. There are two major components of radiation risk assessment: a measure of exposure level and a measure of disease occurrence. For quantitative estimation of health risks, it is important to evaluate the association between exposure and disease occurrence using epidemiological or experimental data. In these approaches, statistical risk models are used particularly for estimating cancer risks related to exposure to low levels of radiation. This paper presents a summary of basic models and methods of risk assessment for studying exposure-risk relationships. Moreover, quantitative risk estimates are subject to several sources of uncertainty due to inherent limitations in risk assessment studies. This paper also discusses the limitations of radiation risk assessment. (author)

Sovereign default risk assessment

NARCIS (Netherlands)

Rijken, H.A.; Altman, E.I.

2013-01-01

We propose a new approach toward assessing sovereign risk by examining rigorously the health and aggregate default risk of a nation's private corporate sector. Models can be utilised to measure the probability of default of the non-financial sector cumulatively for five years, both as an absolute

Safety analysis, risk assessment, and risk acceptance criteria

International Nuclear Information System (INIS)

Jamali, K.

1997-01-01

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

Assessment of DNA damage in car spray painters exposed to organic solvents by the high-throughput comet assay.

Science.gov (United States)

Londoño-Velasco, Elizabeth; Martínez-Perafán, Fabián; Carvajal-Varona, Silvio; García-Vallejo, Felipe; Hoyos-Giraldo, Luz Stella

2016-05-01

Occupational exposure as a painter is associated with DNA damage and development of cancer. Comet assay has been widely adopted as a sensitive and quantitative tool for DNA damage assessment at the individual cell level in populations exposed to genotoxics. The aim of this study was to assess the application of the high-throughput comet assay, to determine the DNA damage in car spray painters. The study population included 52 car spray painters and 52 unexposed subjects. A significant increase in the %TDNA median (p  0.05). The results showed an increase in DNA breaks in car spray painters exposed to organic solvents and paints; furthermore, they demonstrated the application of high-throughput comet assay in an occupational exposure study to genotoxic agents.

PRECIS -- A probabilistic risk assessment system

International Nuclear Information System (INIS)

Peterson, D.M.; Knowlton, R.G. Jr.

1996-01-01

A series of computer tools has been developed to conduct the exposure assessment and risk characterization phases of human health risk assessments within a probabilistic framework. The tools are collectively referred to as the Probabilistic Risk Evaluation and Characterization Investigation System (PRECIS). With this system, a risk assessor can calculate the doses and risks associated with multiple environmental and exposure pathways, for both chemicals and radioactive contaminants. Exposure assessment models in the system account for transport of contaminants to receptor points from a source zone originating in unsaturated soils above the water table. In addition to performing calculations of dose and risk based on initial concentrations, PRECIS can also be used in an inverse manner to compute soil concentrations in the source area that must not be exceeded if prescribed limits on dose or risk are to be met. Such soil contaminant levels, referred to as soil guidelines, are computed for both single contaminants and chemical mixtures and can be used as action levels or cleanup levels. Probabilistic estimates of risk, dose and soil guidelines are derived using Monte Carlo techniques

Risk assessment of soil contamination criteria

International Nuclear Information System (INIS)

King, C.M.; Marter, W.L.; Montaque, D.F.; Holton, G.A.

1987-06-01

Criteria have been developed to select radioactive and nonradioactive contaminants at waste sites detailed analysis and risk assessment. These criteria were based on soil and water quality guidelines developed by various government agencies to determine if the criteria were appropriate. We performed a risk assessment of a hypothetical site which contained radioactive and nonradioactive contaminants at levels equal to the criteria values. Risks to the public from atmospheric, surface water, and groundwater exposure pathways were examined. Health risks to the public from atmospheric releases of radioactive and nonradioactive materials from a waste at soil criteria contamination levels are low. Health risks to the maximally exposed individual to chemical carcinogens are considerably below traditional EPA action levels. And health risks to the maximally exposed individual to atmospherically released radioactive contaminants is 1.88 x 10 -7 , more than a factor of 5 less than 10 -6 . Based on our atmospheric exposure pathways analysis and risk assessment, the applied soil criteria are appropriate for screening out unimportant risk contributors to human health from atmospheric exposure pathways. 13 refs., 3 figs., 7 tabs

Assessing protein oxidation by inorganic nanoparticles with enzyme-linked immunosorbent assay (ELISA).

Science.gov (United States)

Sun, Wenjie; Luna-Velasco, Antonia; Sierra-Alvarez, Reyes; Field, Jim A

2013-03-01

Growth in the nanotechnology industry is leading to increased production of engineered nanoparticles (NPs). This has given rise to concerns about the potential adverse and toxic effects to biological system and the environment. An important mechanism of NP toxicity is oxidative stress caused by the formation of reactive oxygen species (ROS) or via direct oxidation of biomolecules. In this study, a protein oxidation assay was developed as an indicator of biomolecule oxidation by NPs. The oxidation of the protein, bovine serum albumin (BSA) was evaluated with an enzyme-linked immunosorbent assay (ELISA) to measure the protein carbonyl derivatives formed from protein oxidation. The results showed that some NPs such as Cu(0), CuO, Mn(2)O(3), and Fe(0) caused oxidation of BSA; whereas, many of the other NPs tested were not reactive or very slowly reactive with BSA. The mechanisms involved in the oxidation of BSA protein by the reactive NPs could be attributed to the combined effects of ROS-dependent and direct protein oxidation mechanisms. The ELISA assay is a promising method for the assessment of protein oxidation by NPs, which can provide insights on NP toxicity mechanisms. Copyright © 2012 Wiley Periodicals, Inc.

Risk assessment for transport operations

International Nuclear Information System (INIS)

Appleton, P.R.; Miles, J.C.

1990-01-01

The world-wide safety of the transport of radioactive material is based on the IAEA Transport Regulations. Risk assessment can provide quantitative data to help in the demonstration, understanding and improvement of the effectiveness of the Regulations in assuring safety. In this Paper the methodology, data and computer codes necessary and available for transport risk assessment are reviewed. Notable examples of assessments carried out over the past 15 years are briefly described along with current research, and the benefits and limitations of the techniques are discussed. (author)

Assessing Extinction Risk: Integrating Genetic Information

Directory of Open Access Journals (Sweden)

Jason Dunham

1999-06-01

Full Text Available Risks of population extinction have been estimated using a variety of methods incorporating information from different spatial and temporal scales. We briefly consider how several broad classes of extinction risk assessments, including population viability analysis, incidence functions, and ranking methods integrate information on different temporal and spatial scales. In many circumstances, data from surveys of neutral genetic variability within, and among, populations can provide information useful for assessing extinction risk. Patterns of genetic variability resulting from past and present ecological and demographic events, can indicate risks of extinction that are otherwise difficult to infer from ecological and demographic analyses alone. We provide examples of how patterns of neutral genetic variability, both within, and among populations, can be used to corroborate and complement extinction risk assessments.

Risk assessment of metal vapor arcing

Science.gov (United States)

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.

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

Science.gov (United States)

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...

Assessing reservoir operations risk under climate change

Science.gov (United States)

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.

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

International Nuclear Information System (INIS)

Becker, G.; Connolly, M.; McIlwain, M.

1999-01-01

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

NASA Human System Risk Assessment Process

Science.gov (United States)

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

Risk assessment research and technology assessment

International Nuclear Information System (INIS)

Albach, H.; Schade, D.; Sinn, H.

1991-01-01

The concepts and approaches for technology assessment, the targets and scientific principles, as well as recognizable deficits and recommendations concerning purposeful strategies for the promotion of this research field require a dialog between those concerned. Conception, deficits, and the necessary measures for risk assessment research and technology assessment were discussed as well as ethical aspects. The problematic nature of using organisms altered through genetic engineering in the open land, traffic and transport, site restoration, nuclear energy, and isotope applications were subjects particularly dealt with. (DG) [de

Value of a gene signature assay in patients with early breast cancer and intermediate risk: a single institution retrospective study.

Science.gov (United States)

Bonneterre, Jacques; Prat, Aleix; Galván, Patricia; Morel, Pascale; Giard, Sylvia

2016-05-01

Purpose In daily clinical practice, the indication for adjuvant chemotherapy (CT) is relatively easy to make in patients with early hormone-receptor-positive (HR+) breast cancer with either very poor or very good clinicopathological prognostic variables. However, this decision is much more difficult in patients with intermediate clinicopathological prognostic variables. Here, we evaluate the value of a gene-expression profile identified by the Prosigna gene signature assay in guiding treatment decision-making in patients with these intermediate features. Methods A consecutive cohort of 577 HR + breast cancer patients surgically treated in a single institution between January 2012 and December 2012 was evaluated. From this population, pre- and post-menopausal patients with intermediate prognosis clinicopathological variables were identified and indication of adjuvant CT in these patients was recorded. The gene signature assay was performed retrospectively in this intermediate risk group. Descriptive statistics are presented. Results Among 96 intermediate-risk patients, 64 postmenopausal patients underwent gene signature testing. Subtype distribution was as follows: Luminal A (N = 33; 51.6%), Luminal B (N = 31; 48.4%). Risk of recurrence (ROR) distribution was as follows: ROR-low (n = 16; 25%); ROR-intermediate (N = 26; 40.6%); and ROR-high (N = 22; 34.4%). CT was subsequently administered in 18.7%, 53.8% and 59.0% of the ROR-low, ROR-intermediate and ROR-high groups, respectively. With the use of the gene signature assay, 59.4% of the intermediate cases were re-classified to either ROR-low or ROR-high risk categories. In the ROR-intermediate group, 11/26 patients (42.3%) had Luminal A and 15/26 (57.7%) had Luminal B. Due to follow-up time constraints, no patient outcome results were evaluated. Conclusion The gene signature assay provides clinically useful information and improved treatment decision-making in patients with intermediate risk based on

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

Science.gov (United States)

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…

Risk assessment of UVB effects on resistance to infectious diseases

International Nuclear Information System (INIS)

Garssen, J.; Goettsch, W.; Slob, W.; Loveren, H. van; de Gruijl, F.

1996-01-01

The aim of this study was to develop a quantitative risk assessment of lowered resistance to infections in humans due to (solar) ultraviolet B (UVB) exposure. We followed the steps for risk assessment as defined by the U.S. National Academy of Sciences: (1) hazard identification, (2) dose-response assessment, (3) exposure assessment, and (4) risk characterization. For step 1, the suppressory effects of UVB radiation on the immune system has been reviewed, supplemented with new data, and analyzed. Experiments on UV-induced immunosuppression cannot be performed with humans for ethical reasons, but herpes simplex virus infection appears to be the human paradigm. Thus, UVB radiation appears to be a potential hazard to immunologic functions. Step 2 is crucial, but dose-response relationships for infections have never been measured in humans. We used our earlier dose-response rat data for suppression of lymphocyte stimulation and computed that the UVB dose resulting in a 50% reduction of lymphocyte stimulation by Listeria monocytogenes is 6.800 J/m 2 . Using mixed skin lymphocyte response assays we found that humans are 3.8 times less sensitive than rats (interspecies variation [IEV]). To account for the 2.5 percentile of most susceptible individuals in a population, an additional factor (intraspecies variation [IAV]) was introduced (0.5 for humans). Using these data, we computed that 13.100 J/m 2 of UVB radiation emitted by FS40 lamps would suppress 50% of the proliferative response of lymphocytes to L. monocytogenes in most sensitive skin type 2 humans. In step 3, we assumed the action spectrum for the responses analyzed by us as identical to an action spectrum for suppression of contact hypersensitivity that is available in the literature. In step 4, we calculated that approximately 100 min of solar exposure at around noon in Italy or Spain would suppress the resistance to infections by L. monocytogenes in the most sensitive humans. (author)

Risk assessment of UVB effects on resistance to infectious diseases

Energy Technology Data Exchange (ETDEWEB)

Garssen, J.; Goettsch, W.; Slob, W.; Loveren, H. van [National Institute of Public Health and Environment, Bilthoven (Netherlands); de Gruijl, F. [Rijksuniversiteit Utrecht (Netherlands)

1996-08-01

The aim of this study was to develop a quantitative risk assessment of lowered resistance to infections in humans due to (solar) ultraviolet B (UVB) exposure. We followed the steps for risk assessment as defined by the U.S. National Academy of Sciences: (1) hazard identification, (2) dose-response assessment, (3) exposure assessment, and (4) risk characterization. For step 1, the suppressory effects of UVB radiation on the immune system has been reviewed, supplemented with new data, and analyzed. Experiments on UV-induced immunosuppression cannot be performed with humans for ethical reasons, but herpes simplex virus infection appears to be the human paradigm. Thus, UVB radiation appears to be a potential hazard to immunologic functions. Step 2 is crucial, but dose-response relationships for infections have never been measured in humans. We used our earlier dose-response rat data for suppression of lymphocyte stimulation and computed that the UVB dose resulting in a 50% reduction of lymphocyte stimulation by Listeria monocytogenes is 6.800 J/m{sup 2}. Using mixed skin lymphocyte response assays we found that humans are 3.8 times less sensitive than rats (interspecies variation [IEV]). To account for the 2.5 percentile of most susceptible individuals in a population, an additional factor (intraspecies variation [IAV]) was introduced (0.5 for humans). Using these data, we computed that 13.100 J/m{sup 2} of UVB radiation emitted by FS40 lamps would suppress 50% of the proliferative response of lymphocytes to L. monocytogenes in most sensitive skin type 2 humans. In step 3, we assumed the action spectrum for the responses analyzed by us as identical to an action spectrum for suppression of contact hypersensitivity that is available in the literature. In step 4, we calculated that approximately 100 min of solar exposure at around noon in Italy or Spain would suppress the resistance to infections by L. monocytogenes in the most sensitive humans. (author).

Significance of earthquake risk in nuclear power plant probabilistic risk assessments

International Nuclear Information System (INIS)

Sues, R.H.; Amico, P.J.; Campbell, R.D.

1990-01-01

During the last eight years, approximately 25 utility-sponsored probabilistic risk assessments (PRAs) have been conducted for US nuclear reactors. Of these, ten have been published, seven of which have included complete seismic risk assessment. The results of the seven published PRAs are reviewed here in order to ascertain the significance of the risk due to earthquake initiating events. While PRA methodology has been in a state of development over the past seven years, and the results are subject to interpretation (as discussed in the paper), from the review conducted it is clear that earthquake-induced initiating events are important risk contributors. It is concluded that earthquake initiating events should not be dismissed, a priori, in any nuclear plant risk assessment. (orig.)

Chemical Risk Assessment: Traditional vs Public Health ...

Science.gov (United States)

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

Risk-assessment methodology for fast breeder reactors

International Nuclear Information System (INIS)

Ott, K.O.

1976-04-01

The methods applied or proposed for risk assessment of nuclear reactors are reviewed, particularly with respect to their applicability for risk assessment of future commercial fast breeder reactors. All methods are based on the calculation of accident consequences for relatively few accident scenarios. The role and general impact of uncertainties in fast-reactor accident analysis are discussed. The discussion shows the need for improvement of the methodology. A generalized and improved risk-assessment methodology is outlined and proposed (accident-spectra-progression approach). The generalization consists primarily of an explicit treatment of uncertainties throughout the accident progression. The results of this method are obtained in form of consequence distributions. The width and shape of the distributions depend in part on the superposition of the uncertainties. The first moment of the consequence distribution gives an improved prediction of the ''average'' consequence. The higher-consequence moments can be used for consideration of risk aversion. The assessment of the risk of one or a certain number of nuclear reactors can only provide an ''isolated'' risk assessment. The general problem of safety risk assessment and its relation to public acceptance of certain modes of power production is a much broader problem area, which is also discussed

Application of the KeratinoSens™ assay for assessing the skin sensitization potential of agrochemical active ingredients and formulations.

Science.gov (United States)

Settivari, Raja S; Gehen, Sean C; Amado, Ricardo Acosta; Visconti, Nicolo R; Boverhof, Darrell R; Carney, Edward W

2015-07-01

Assessment of skin sensitization potential is an important component of the safety evaluation process for agrochemical products. Recently, non-animal approaches including the KeratinoSens™ assay have been developed for predicting skin sensitization potential. Assessing the utility of the KeratinoSens™ assay for use with multi-component mixtures such as agrochemical formulations has not been previously evaluated and is a significant need. This study was undertaken to evaluate the KeratinoSens™ assay prediction potential for agrochemical formulations. The assay was conducted for 8 agrochemical active ingredients (AIs) including 3 sensitizers (acetochlor, meptyldinocap, triclopyr), 5 non-sensitizers (aminopyralid, clopyralid, florasulam, methoxyfenozide, oxyfluorfen) and 10 formulations for which in vivo sensitization data were available. The KeratinoSens™ correctly predicted the sensitization potential of all the AIs. For agrochemical formulations it was necessary to modify the standard assay procedure whereby the formulation was assumed to have a common molecular weight. The resultant approach correctly predicted the sensitization potential for 3 of 4 sensitizing formulations and all 6 non-sensitizing formulations when compared to in vivo data. Only the meptyldinocap-containing formulation was misclassified, as a result of high cytotoxicity. These results demonstrate the promising utility of the KeratinoSens™ assay for evaluating the skin sensitization potential of agrochemical AIs and formulations. Copyright © 2015 Elsevier Inc. All rights reserved.

The evolution of violence risk assessment.

Science.gov (United States)

Monahan, John; Skeem, Jennifer L

2014-10-01

Many instruments have been published in recent years to improve the ability of mental health clinicians to estimate the likelihood that an individual will behave violently toward others. Increasingly, these instruments are being applied in response to laws that require specialized risk assessments. In this review, we present a framework that goes beyond the "clinical" and "actuarial" dichotomy to describe a continuum of structured approaches to risk assessment. Despite differences among them, there is little evidence that one instrument predicts violence better than another. We believe that these group-based instruments are useful for assessing an individual's risk, and that the instrument should be chosen based on the purpose of the assessment.

Use of an ex vivo local lymph node assay to assess contact hypersensitivity potential.

Science.gov (United States)

Piccotti, Joseph R; Kawabata, Thomas T

2008-07-01

The local lymph node assay (LLNA) is used to assess the contact hypersensitivity potential of compounds. In the standard assay, mice are treated topically with test compound to the dorsum of both ears on Days 1-3. The induction of a hypersensitivity response is assessed on Day 6 by injecting [(3)H]-thymidine into a tail vein and measuring thymidine incorporation into DNA of lymph node cells draining the ears. The ex vivo LLNA is conducted similarly except lymphocyte proliferation is assessed after in vitro incubation of lymph node cells with [(3)H]-thymidine, which significantly reduces the amount of radioactive waste. The current study tested the use of this approach for hazard assessment of contact hypersensitivity and to estimate allergenic potency. Female BALB/c mice were treated on Days 1-3 with two nonsensitizers (4' -methoxyacetophenone, diethyl phthalate), three weak sensitizers (hydroxycitronellal, eugenol, citral), one weak-to-moderate sensitizer (hexylcinnamic aldehyde), two moderate sensitizers (isoeugenol, phenyl benzoate), and one strong sensitizer (dinitrochlorobenzene). On Day 6, isolated lymph node cells were incubated overnight with [(3)H]-thymidine and thymidine incorporation was measured by liquid scintillation spectrophotometry. The ex vivo LLNA accurately distinguished the contact sensitizers from the nonsensitizing chemicals, and correctly ranked the relative potency of the compounds tested. The EC3 values, i.e., the effective concentration of test substance needed to induce a stimulation index of 3, were as follows: 4' -methoxyacetophenone (> 50%), diethyl phthalate (> 50%), hydroxycitronellal (20.4%), eugenol (13.6%), citral (8.9%), isoeugenol (3.8%), hexylcinnamic aldehyde (2.7%), phenyl benzoate (2%), and dinitrochlorobenzene (0.02%). In addition, low inter-animal and inter-experiment variability was seen with 25% hexyl-cinnamic aldehyde (assay positive control). The results of the ex vivo LLNA in the current study were consistent with

Validation of a second-generation multivariate index assay for malignancy risk of adnexal masses.

Science.gov (United States)

Coleman, Robert L; Herzog, Thomas J; Chan, Daniel W; Munroe, Donald G; Pappas, Todd C; Smith, Alan; Zhang, Zhen; Wolf, Judith

2016-07-01

Women with adnexal mass suspected of ovarian malignancy are likely to benefit from consultation with a gynecologic oncologist, but imaging and biomarker tools to ensure this referral show low sensitivity and may miss cancer at critical stages. The multivariate index assay (MIA) was designed to improve the detection of ovarian cancer among women undergoing surgery for a pelvic mass. To improve the prediction of benign masses, we undertook the redesign and validation of a second-generation MIA (MIA2G). MIA2G was developed using banked serum samples from a previously published prospective, multisite registry of patients who underwent surgery to remove an adnexal mass. Clinical validity was then established using banked serum samples from the OVA500 trial, a second prospective cohort of adnexal surgery patients. Based on the final pathology results of the OVA500 trial, this intended-use population for MIA2G testing was high risk, with an observed cancer prevalence of 18.7% (92/493). Coded samples were assayed for MIA2G biomarkers by an external clinical laboratory. Then MIA2G results were calculated and submitted to a clinical statistics contract organization for decoding and comparison to MIA results for each subject. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated, among other measures, and stratified by menopausal status, stage, and histologic subtype. Three MIA markers (cancer antigen 125, transferrin, and apolipoprotein A-1) and 2 new biomarkers (follicle-stimulating hormone and human epididymis protein 4) were included in MIA2G. A single cut-off separated high and low risk of malignancy regardless of patient menopausal status, eliminating potential for confusion or error. MIA2G specificity (69%, 277/401 [n/N]; 95% confidence interval [CI], 64.4-73.4%) and PPV (40%, 84/208; 95% CI, 33.9-47.2%) were significantly improved over MIA (specificity, 54%, 215/401; 95% CI, 48.7-58.4%, and PPV, 31%, 85/271; 95

Environmental Comparative Risk Assessment: A Case Study

International Nuclear Information System (INIS)

Ali, M.M.

2007-01-01

Health and environmental impacts associated with energy production and industrial activities as well as food production and agricultural activities have had great concern in the last decades. Early activities emerged in late 80s of the last century through an Inter- Agency project (lAEA, UNDY, WHO, ... ) on the comparative risk assessment from energy systems and industrial complexes. A work-shop on Risk Assessment and Management in large industrial areas was held in Alexandria Egypt on 20-33 Det 1993, sponsored by IAEA. Several conferences, experts work groups and workshops were held there of Recent trends in determining risks are: 1. Use of probabilistic risk assessment approach to identify hazardous activities and accident scenario. 2. development of data base on failure probabilities and appropriate physical models. 3. Development of related directives and regulations and criteria Comparative risk assessment case study as a tool for comparing risk is emphasized Criteria of exposure to human and ecological risks are addressed

Risk assessment approach for Rokkasho reprocessing plant

International Nuclear Information System (INIS)

Ootou, Y.; Tamauchi, Y.; Hayashi, Y.; Takebe, K.; Miyata, T.

2006-01-01

Full text: It is desirable that the operation and maintenance of Rokkasho Reprocessing Plant (RRP) be established and conducted with maximum effectiveness and efficiency, making the best use of risk information to help the plant achieve further enhanced safety. Risk assessment is applied for RRP, and upgraded risk information is established. In the basic design phase, the potential incidents and accidents that might occur in the plant were identified systematically and exhaustively adopting the HAZOP method. After screening the potential for occurrence, the design basis accidents (DBAs) were identified and it was confirmed that the plant would not put the general public at risk of significant radiation exposure in the case of such accidents, even when assuming the single failure of dynamic apparatus in the prevention and mitigation systems. To support the deterministic safety assessment mentioned above, the risk assessment was conducted during the basic design phase. Of the DBAs and out-of-design basis accidents excluded from DBAs because of extremely rare occurrence possibilities, the risk assessment was conducted for such accidents which might cause relatively high consequence for the general public. The risk assessment was conducted using the PSA method generally used for nuclear power plants. After that, a review of the occurrence frequency assessment for some of the accidents was made, taking into account information relating to detailed design and operation procedures. Typical examples are a loss of the hydrogen scavenging function in the plutonium solution tank and a loss of cooling capability in the high-active liquid waste storage tank. The occurrence frequency for a loss of the hydrogen scavenging function was less than 10 -5 /year. The occurrence frequency for a loss of cooling capability was less than 10 -7 /year. In addition, an importance assessment (FV index, Risk Achievement Worth) was conducted, such as a contribution to the occurrence frequency

The Risk Assessment at the Workplace of Assembly Operation

Directory of Open Access Journals (Sweden)

Marek Burda

2014-01-01

Full Text Available Risk Assessment Process by FMEA method involve hazard identification, risk assessment and risk control processes and their input is fundamental to a successful EH&S system. This Risk assessment tool follows the general process and requirements of the Health and Safety Risk Assessment Procedure.

Comparative tumor promotion assessment of e-cigarette and cigarettes using the in vitro Bhas 42 cell transformation assay.

Science.gov (United States)

Breheny, Damien; Oke, Oluwatobiloba; Pant, Kamala; Gaça, Marianna

2017-05-01

In vitro cell transformation assays (CTA) are used to assess the carcinogenic potential of chemicals and complex mixtures and can detect nongenotoxic as well as genotoxic carcinogens. The Bhas 42 CTA has been developed with both initiation and promotion protocols to distinguish between these two carcinogen classes. Cigarette smoke is known to be carcinogenic and is positive in in vitro genotoxicity assays. Cigarette smoke also contains nongenotoxic carcinogens and is a tumour promoter and cocarcinogen in vivo. We have combined a suite of in vitro assays to compare the relative biological effects of new categories of tobacco and nicotine products with traditional cigarettes. The Bhas promotion assay has been included in this test battery to provide an in vitro surrogate for detecting tumor promoters. The activity of an electronic cigarette (e-cigarette; Vype ePen) was compared to that of a reference cigarette (3R4F) in the promotion assay, using total particulate matter (TPM)/aerosol collected matter (ACM) and aqueous extracts (AqE) of product aerosol emissions. 3R4F TPM was positive in this assay at concentrations ≥6 µg/mL, while e-cigarette ACM did not have any promoter activity. AqE was found to be a lesssuitable test matrix in this assay due to high cytotoxicity. This is the first study to use the Bhas assay to compare tobacco and nicotine products and demonstrates the potential for its future application as part of a product assessment framework. These data add to growing evidence suggesting that e-cigarettes may provide a safer alternative to traditional cigarettes. Environ. Mol. Mutagen. 58:190-198, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Assessing cellulolysis in passive treatment systems for mine drainage: a modified enzyme assay.

Science.gov (United States)

McDonald, Corina M; Gould, W Douglas; Lindsay, Matthew B J; Blowes, David W; Ptacek, Carol J; Condon, Peter D

2013-01-01

A modified cellulase enzyme assay was developed to monitor organic matter degradation in passive treatment systems for mine drainage. This fluorogenic substrate method facilitates assessment of exo-(1,4)-β-D-glucanase, endo-(1,4)-β-D-glucanase, and β-glucosidase, which compose an important cellulase enzyme system. The modified method was developed and refined using samples of organic carbon-amended mine tailings from field experiments where sulfate reduction was induced as a strategy for managing water quality. Sample masses (3 g) and the number of replicates ( ≥ 3) were optimized. Matrix interferences within these metal-rich samples were found to be insignificant. Application of this modified cellulase assay method provided insight into the availability and degradation of organic carbon within the amended tailings. Results of this study indicate that cellulase enzyme assays can be applied to passive treatment systems for mine drainage, which commonly contain elevated concentrations of metals. Copyright © by the American Society of Agronomy, Crop Science Society of America, and Soil Science Society of America, Inc.

Quantitative genotoxicity assays for analysis of medicinal plants: A systematic review.

Science.gov (United States)

Sponchiado, Graziela; Adam, Mônica Lucia; Silva, Caroline Dadalt; Soley, Bruna Silva; de Mello-Sampayo, Cristina; Cabrini, Daniela Almeida; Correr, Cassyano Januário; Otuki, Michel Fleith

2016-02-03

Medicinal plants are known to contain numerous biologically active compounds, and although they have proven pharmacological properties, they can cause harm, including DNA damage. Review the literature to evaluate the genotoxicity risk of medicinal plants, explore the genotoxicity assays most used and compare these to the current legal requirements. A quantitative systematic review of the literature, using the keywords "medicinal plants", "genotoxicity" and "mutagenicity", was undertakenQ to identify the types of assays most used to assess genotoxicity, and to evaluate the genotoxicity potential of medicinal plant extracts. The database searches retrieved 2289 records, 458 of which met the inclusion criteria. Evaluation of the selected articles showed a total of 24 different assays used for an assessment of medicinal plant extract genotoxicity. More than a quarter of those studies (28.4%) reported positive results for genotoxicity. This review demonstrates that a range of genotoxicity assay methods are used to evaluate the genotoxicity potential of medicinal plant extracts. The most used methods are those recommended by regulatory agencies. However, based on the current findings, in order to conduct a thorough study concerning the possible genotoxic effects of a medicinal plant, we indicate that it is important always to include bacterial and mammalian tests, with at least one in vivo assay. Also, these tests should be capable of detecting outcomes that include mutation induction, clastogenic and aneugenic effects, and structural chromosome abnormalities. In addition, the considerable rate of positive results detected in this analysis further supports the relevance of assessing the genotoxicity potential of medicinal plants. Copyright © 2016. Published by Elsevier Ireland Ltd.

Research into specific risk assessment in project financing

Directory of Open Access Journals (Sweden)

Ivana Bestvina Bukvić

2013-12-01

Full Text Available An assessment of investment justification in terms of risk enables the decision maker (investor to select, among available alternatives, the one with the most favourable correlation between the expected profit and assumed risk. At the micro level, the uncertainty of business success is extremely high in production activities, which is an additional incentive for taking a comprehensive approach to the issue of investment decision-making and the development of risk assessment techniques applicable in this particular segment of industry. Given the complexity of the manufacturing process, the length of the production cycle, market conditions, and entity-specific risks (which are difficult to measure, projects in manufacturing industry require a detailed and comprehensive assessment of specific risk factors and their cost-effectiveness. Ne - vertheless, since specific risks can be diversified, investment proposal assessments in practice usually do not cover their quantification and analysis. However, the majority of business entities do not have enough active projects in various industries to be able to fully diversify their business and thus minimize the level of specific risks. The impact of specific factors becomes one of the most important elements for business success. This paper analyses how far risk assessment methods regarding specific risks are used in practice. Furthermore, it analyses the significance of specific risks for total investment risk. This study gives new insi - ghts into the significance of specific risks to the overall investment assessment and the need for permanent development of traditionally used investment assessment models.

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

Science.gov (United States)

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.

Risk assessment of complex accident scenarios

International Nuclear Information System (INIS)

Kluegel, Jens-Uwe

2012-01-01

The use of methods of risk assessment in accidents in nuclear plants is based on an old tradition. The first consistent systematic study is considered to be the Rasmussen Study of the U.S. Nuclear Regulatory Commission, NRC, WASH-1400. Above and beyond the realm of nuclear technology, there is an extensive range of accident, risk and reliability research into technical-administrative systems. In the past, it has been this area of research which has led to the development of concepts of safety precautions of the type also introduced into nuclear technology (barrier concept, defense in depth, single-failure criterion), where they are now taken for granted as trivial concepts. Also for risk analysis, nuclear technology made use of methods (such as event and fault tree analyses) whose origins were outside the nuclear field. One area in which the use of traditional methods of probabilistic safety analysis is encountering practical problems is risk assessment of complex accident scenarios in nuclear technology. A definition is offered of the term 'complex accident scenarios' in nuclear technology. A number of problems are addressed which arise in the use of traditional PSA procedures in risk assessment of complex accident scenarios. Cases of complex accident scenarios are presented to demonstrate methods of risk assessment which allow robust results to be obtained even when traditional techniques of risk analysis are maintained as a matter of principle. These methods are based on the use of conditional risk metrics. (orig.)

Aquatic Macrophyte Risk Assessment for Pesticides

NARCIS (Netherlands)

Maltby, L.; Arnold, D.; Arts, G.H.P.; Davies, J.; Heimbach, F.; Pickl, C.; Poulsen, V.

2009-01-01

Given the essential role that primary producers play in aquatic ecosystems, it is imperative that the potential risk of pesticides to the structure and functioning of aquatic plants is adequately assessed. This book discusses the assessment of the risk of pesticides with herbicidal activity to

Risk assessment and risk transfer from an insurerś point of view

Science.gov (United States)

Ebner, G.

2009-04-01

Risk, a word that causes a lot of associations in human brains. Many of us don't like risks. Since hundreds of years insurance is the most common way to get rid of the financial consequences when risks convert to damages. This article deals with commercial risks and the possibilities of risk transfer, an important task within the field of risk management. For commercial entities it is very important to transfer risks, threatening the competitiveness or even worse the existence of a company. At the beginning of insurance it was more the less a bet between merchants and rich people. Later on mutual societies were taking place. Today we see a complex insurance industry with insurers, reinsurers, self insuring possibilities via captives and much more. This complex system, with all the different ways to deal with risk transfer requires a professional risk assessment! Risk assessment is based on knowledge about the threatened assets, the likelihood that they will be damaged, the threats and the possibilities to protect these assets. Assets may be tangible or intangible. Assessing risks is not a precise calculation that delivers a result without any doubt. But insurers and insured need a basis to fix a premium, both of them can agree. This contribution will present a system to assess risks and to find the right risk-transfer-premiums.

Risk assessment and management in IOR projects

International Nuclear Information System (INIS)

Goodyear, S.G.; Gregory, A.T.

1994-01-01

The application of IOR techniques is one of the investment opportunities open to Exploration and Production companies. A project will only go forward if the perceived balance between the rewards and the risks is acceptable. IOR projects may be ruled out because they are considered to involve significantly higher risks than conventional developments. Therefore, some means of evaluating the actual level of risk may be required if the full economic benefits from IOR techniques are to be realized. Risk assessment is a key element in safety cases, where a well-established methodology for quantifying risk exists. This paper discusses the extension of these methods to IOR project risk assessment. Combining reservoir and IOR technique uncertainties with their impact on project performance allows project risk to be better quantified. The results of the risk assessment are presented in terms of a risk-reward diagram that plots the probability surface for possible project outcomes as a function of NPV (reward) and exposure (risk)

Risk assessment and nuclear power

International Nuclear Information System (INIS)

Bodansky, D.

1982-01-01

The range of risk perceptions involving nuclear power is so great that there is little hope of bridging extreme positions, but a consensus based upon reasoned discussion among uncommitted people could determine a sensible path. Our concerns over the uncertainties of risk assessment have made it increasingly difficult to make responsible decisions fast enough to deal with modern needs. The result is an immobility in energy matters that can point to a 2% reduction in oil use as its only triumph. The risk of nuclear war as a result of military action over energy issues suggests to some that the solution is to abolish nuclear power (however impractical) and to others that a rapid spread of nuclear power will eliminate energy as an incentive for war. If nuclear war is the major risk to consider, risk assessments need to include the risks of war, as well as those of carbon dioxide buildup and socio-economic disruptions, all of which loom larger than the risks of nuclear-plant accidents. Energy choices should be aimed at diminishing these major risks, even if they include the use of nuclear power. 26 references

Risk assessment handbook

International Nuclear Information System (INIS)

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

1990-09-01

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

Risk Assessment of Genetically Modified Microorganisms

DEFF Research Database (Denmark)

Jacobsen, B. L.; Wilcks, Andrea

2001-01-01

the industry, national administration and research institutions were gathered to discuss which elements should be considered in a risk assessment of genetically modified microorganisms used as food or food ingredients. The existing EU and national regulations were presented, together with the experiences......The rapid development of recombinant DNA techniques for food organisms urges for an ongoing discussion on the risk assessment of both new as traditional use of microorganisms in food production. This report, supported by the Nordic Council of Ministers, is the result of a workshop where people from...... with risk assessment of these organisms in each Nordic country....

Subjective risk assessment for planning conservation projects

International Nuclear Information System (INIS)

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

2013-01-01

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. (letter)

INCORPORATING NONCHEMICAL STRESSORS INTO CUMMULATIVE RISK ASSESSMENTS

Science.gov (United States)

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...

A risk communication case study: the Nevada risk assessment/management program

International Nuclear Information System (INIS)

Hechanova, A.E.

2000-01-01

The Nevada Risk Assessment/Management Program (NRAMP) is part of a national effort by the U.S. Department of Energy (DOE) to develop new sources of information and approaches to risk assessment, risk management, risk communication and public outreach as these objectives relate to the ecological and human health effects of radioactive and hazardous material management and site remediation activities. This paper reviews the innovation behind the NRAMP project and presents a synopsis of the NRAMP effort which occurred from 1995 to 2000. The primary goals of the DOE in awarding the cooperative agreement establishing NRAMP were to (I) use a risk-based approach to evaluate the consequences of alternative actions in DOE's Environmental Remediation Programs at sites in Nevada and (2) use a neutral and credible institution outside the DOE to perform the risk assessments and contribute to public education about environmental management issues at the Nevada Test Site. (author)

Approaches to risk assessment in food allergy

DEFF Research Database (Denmark)

Madsen, Charlotte Bernhard; Hattersley, S.; Buck, J.

2009-01-01

modelling is considered to be the most promising approach for use in population risk assessment (which is a particular focus for risk managers). For all approaches, further improvement of input data is desirable, particularly data on consumption patterns/food choices in food allergic consumers, data...... models. The workshop concluded that all the three approaches to safety and risk assessment of allergenic foods should continue to be considered. A particular strength of the MoE and probabilistic approaches is that they do not rely on low-dose extrapolations with its inherent issues. Probabilistic......A workshop was organised to investigate whether risk assessment strategies and methodologies used in classical/conventional toxicology may be used for risk assessment of allergenic foods. to discuss the advantages and limitations of different approaches and to determine the research needed to move...

Hanford waste vitrification systems risk assessment

International Nuclear Information System (INIS)

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

Analysis of existing risk assessments, and list of suggestions

CERN Document Server

Heimsch, Laura

2016-01-01

The scope of this project was to analyse risk assessments made at CERN and extracting some crucial information about the different methodologies used, profiles of people who make the risk assessments, and gathering information of whether the risk matrix was used and if the acceptable level of risk was defined. Second step of the project was to trigger discussion inside HSE about risk assessment by suggesting a risk matrix and a risk assessment template.

Risk monitor-a tool for computer aided risk assessment for NPPs

International Nuclear Information System (INIS)

Vinod, Gopika; Saraf, R.K.; Babar, A.K.; Kushwaha, H.S.; Hadap, Nikhil

2001-01-01

Considerable changes occur in components status and system design and subsequent operation due to changes in plant configuration and their operating procedures. These changes are organised because some components are randomly down and other can be planned for test, maintenance and repair. This results in a fluctuation of risk level over operating time, which is termed as risk profile. Probabilistic Safety Assessment (PSA) is an analytical technique for assessing the risk by integrating diverse aspects of design and operation of a Nuclear Power Plant. Risk can be defined as the product of the probability of an accident and the consequences from that accident. Reactor Safety Division of BARC has developed PC based tool, which can assess the risk profile. This package can be used to optimise the operation in Nuclear Power Plants with respect to a minimum risk level over the operating time, and is termed as Risk Monitor. Risk Monitor is user friendly and can re-evaluate core damage frequency for changes in component status, test interval, initiating event frequency etc. Plant restoration advice, when the plant is in high risk configuration, current status of all plant equipment, and equipment prioritization are also provided by the package. (author)

Site remediation guided by risk assessment

International Nuclear Information System (INIS)

McBean, E.A.; Gowing, A.; Pieczonka, G.

2002-01-01

'Full text:' Risk assessment (RA) provides an effective tool for identifying hazards with respect to human health and ecological receptors, hazards that arise from contaminants in the environment. Risk assessment relies upon: hazard identification/problem formulation; toxicity assessment; exposure assessment; and risk characterization. Hence, risk assessment provides an effective guide for site remediation through the identification of the associated risks arising from pre- and potential post-remediation activities. As a demonstration of this decision-making process, a site-specific risk assessment (SSRA) was performed on a chemical producing facility. Historical waste practices during the production of DDT compounds resulted in impacted site soils and sediment and soils of the creek passing through the facility. The purpose of the SSRA was to derive site-specific cleanup values for the impacted on-site soils, creek sediments, and embankment soils, incorporating human and ecological receptors associated with the environmental media. The human exposure pathways considered were dermal contact, incidental ingestion, and inhalation of the various soils. The potential human receptors were industrial workers, construction workers, trespassers, and off-site residents. Ingestion of fish from the creek by residents was also evaluated in the human health risk assessment (HHRA). Food web analyses were used to evaluate the impact of exposure to chemical compounds in aquatic sediments and related soils by ecological receptors such as the great blue heron, raccoon, and mink. The SSRA involved modelling the daily chemical intake by receptors and the transfer of chemicals to identified secondary media (e.g., ambient air or animal tissues) that are also potential exposure media. These models, while using the site-specific chemical data in the source media, possess uncertainties associated with default parameters that are only approximations and not site-specific (e.g., soil

Surgery Risk Assessment (SRA) Database

Data.gov (United States)

Department of Veterans Affairs — The Surgery Risk Assessment (SRA) database is part of the VA Surgical Quality Improvement Program (VASQIP). This database contains assessments of selected surgical...

Cultural heuristics in risk assessment of HIV/AIDS

NARCIS (Netherlands)

Bailey, A.; Hutter, I.

2006-01-01

Behaviour change models in HIV prevention tend to consider that risky sexual behaviours reflect risk assessments and that by changing risk assessments behaviour can be changed. Risk assessment is however culturally constructed. Individuals use heuristics or bounded cognitive devices derived from

Defining Probability in Sex Offender Risk Assessment.

Science.gov (United States)

Elwood, Richard W

2016-12-01

There is ongoing debate and confusion over using actuarial scales to predict individuals' risk of sexual recidivism. Much of the debate comes from not distinguishing Frequentist from Bayesian definitions of probability. Much of the confusion comes from applying Frequentist probability to individuals' risk. By definition, only Bayesian probability can be applied to the single case. The Bayesian concept of probability resolves most of the confusion and much of the debate in sex offender risk assessment. Although Bayesian probability is well accepted in risk assessment generally, it has not been widely used to assess the risk of sex offenders. I review the two concepts of probability and show how the Bayesian view alone provides a coherent scheme to conceptualize individuals' risk of sexual recidivism.

Completion of risk assessment and monitoring within forensic psychiatry.

Science.gov (United States)

Galappathie, Nuwan; Heeramun, Ragini; Jethwa, Krishma

2009-04-01

There is a clear need for high standards of risk assessment and monitoring within forensic psychiatry. This has been highlighted by a number of high profile homicide enquires which have called for better standards of multidisciplinary risk assessment and monitoring. There are no national standards for risk assessment. We conducted a study to audit electronically the completion rate of a service-designed risk assessment document within Fromside, a medium secure unit in the UK. The completion rates for key sections of 64 risk assessment documents were assessed. Only 48 of the 64 (75%) documents were electronically available. The completion rates ranged from 59/64 (92%) for the retrospective risk review to 46/64 (72%) for relapse indicators. Only 35/64 (55%) risk documents were updated within the last three months. We found that the use of risk profile documents has helped achieve good standards of risk assessment, however greater priority needs to be given to ongoing monitoring. We recommend that consideration is given to the development of national guidelines for multidisciplinary risk assessment and monitoring.

Quantifying risk and accuracy in cancer risk assessment: the process and its role in risk management problem-solving.

Science.gov (United States)

Turturro, A; Hart, R W

1987-01-01

A better understanding of chemical-induced cancer has led to appreciation of similarities to problems addressed by risk management of radiation-induced toxicity. Techniques developed for cancer risk assessment of toxic substances can be generalized to toxic agents. A recent problem-solving approach for risk management of toxic substances developed for the U.S. Department of Health and Human Services, and the role of risk assessment and how uncertainty should be treated within the context of this approach, is discussed. Finally, two different methods, research into the assumptions underlying risk assessment and the modification of risk assessment/risk management documents, are used to illustrate how the technique can be applied.

Risk Assessment for an Unmanned Merchant Ship

Directory of Open Access Journals (Sweden)

Ø.J. Rødseth

2015-09-01

Full Text Available The MUNIN project is doing a feasibility study on an unmanned bulk carrier on an intercontinental voyage. To develop the technical and operational concepts, MUNIN has used a risk-based design method, based on the Formal Safety Analysis method which is also recommended by the International Mari-time Organization. Scenario analysis has been used to identify risks and to simplify operational scope. Systematic hazard identification has been used to find critical safety and security risks and how to address these. Technology and operational concept testing is using a hypothesis-based test method, where the hypotheses have been created as a result of the risk assessment. Finally, the cost-benefit assessment will also use results from the risk assessment. This paper describes the risk assessment method, some of the most important results and also describes how the results have been or will be used in the different parts of the project.

Hanford Site Risk Assessment Methodology. Revision 3

International Nuclear Information System (INIS)

1995-05-01

This methodology has been developed to prepare human health and ecological evaluations of risk as part of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) remedial investigations (RI) and the Resource conservation and Recovery Act of 1976 (RCRA) facility investigations (FI) performed at the Hanford Site pursuant to the hanford Federal Facility Agreement and Consent Order (Ecology et al. 1994), referred to as the Tri-Party Agreement. Development of the methodology has been undertaken so that Hanford Site risk assessments are consistent with current regulations and guidance, while providing direction on flexible, ambiguous, or undefined aspects of the guidance. The methodology identifies site-specific risk assessment considerations and integrates them with approaches for evaluating human and ecological risk that can be factored into the risk assessment program supporting the Hanford Site cleanup mission. Consequently, the methodology will enhance the preparation and review of individual risk assessments at the Hanford Site

Assessment and uncertainty analysis of groundwater risk.

Science.gov (United States)

Li, Fawen; Zhu, Jingzhao; Deng, Xiyuan; Zhao, Yong; Li, Shaofei

2018-01-01

Groundwater with relatively stable quantity and quality is commonly used by human being. However, as the over-mining of groundwater, problems such as groundwater funnel, land subsidence and salt water intrusion have emerged. In order to avoid further deterioration of hydrogeological problems in over-mining regions, it is necessary to conduct the assessment of groundwater risk. In this paper, risks of shallow and deep groundwater in the water intake area of the South-to-North Water Transfer Project in Tianjin, China, were evaluated. Firstly, two sets of four-level evaluation index system were constructed based on the different characteristics of shallow and deep groundwater. Secondly, based on the normalized factor values and the synthetic weights, the risk values of shallow and deep groundwater were calculated. Lastly, the uncertainty of groundwater risk assessment was analyzed by indicator kriging method. The results meet the decision maker's demand for risk information, and overcome previous risk assessment results expressed in the form of deterministic point estimations, which ignore the uncertainty of risk assessment. Copyright © 2017 Elsevier Inc. All rights reserved.

Risk assessment using probabilistic standards

International Nuclear Information System (INIS)

Avila, R.

2004-01-01

A core element of risk is uncertainty represented by plural outcomes and their likelihood. No risk exists if the future outcome is uniquely known and hence guaranteed. The probability that we will die some day is equal to 1, so there would be no fatal risk if sufficiently long time frame is assumed. Equally, rain risk does not exist if there was 100% assurance of rain tomorrow, although there would be other risks induced by the rain. In a formal sense, any risk exists if, and only if, more than one outcome is expected at a future time interval. In any practical risk assessment we have to deal with uncertainties associated with the possible outcomes. One way of dealing with the uncertainties is to be conservative in the assessments. For example, we may compare the maximal exposure to a radionuclide with a conservatively chosen reference value. In this case, if the exposure is below the reference value then it is possible to assure that the risk is low. Since single values are usually compared; this approach is commonly called 'deterministic'. Its main advantage lies in the simplicity and in that it requires minimum information. However, problems arise when the reference values are actually exceeded or might be exceeded, as in the case of potential exposures, and when the costs for realizing the reference values are high. In those cases, the lack of knowledge on the degree of conservatism involved impairs a rational weighing of the risks against other interests. In this presentation we will outline an approach for dealing with uncertainties that in our opinion is more consistent. We will call it a 'fully probabilistic risk assessment'. The essence of this approach consists in measuring the risk in terms of probabilities, where the later are obtained from comparison of two probabilistic distributions, one reflecting the uncertainties in the outcomes and one reflecting the uncertainties in the reference value (standard) used for defining adverse outcomes. Our first aim

Aggregate Exposure and Cumulative Risk Assessment--Integrating Occupational and Non-occupational Risk Factors.

Science.gov (United States)

Lentz, T J; Dotson, G S; Williams, P R D; Maier, A; Gadagbui, B; Pandalai, S P; Lamba, A; Hearl, F; Mumtaz, M

2015-01-01

Occupational exposure limits have traditionally focused on preventing morbidity and mortality arising from inhalation exposures to individual chemical stressors in the workplace. While central to occupational risk assessment, occupational exposure limits have limited application as a refined disease prevention tool because they do not account for all of the complexities of the work and non-occupational environments and are based on varying health endpoints. To be of greater utility, occupational exposure limits and other risk management tools could integrate broader consideration of risks from multiple exposure pathways and routes (aggregate risk) as well as the combined risk from exposure to both chemical and non-chemical stressors, within and beyond the workplace, including the possibility that such exposures may cause interactions or modify the toxic effects observed (cumulative risk). Although still at a rudimentary stage in many cases, a variety of methods and tools have been developed or are being used in allied risk assessment fields to incorporate such considerations in the risk assessment process. These approaches, which are collectively referred to as cumulative risk assessment, have potential to be adapted or modified for occupational scenarios and provide a tangible path forward for occupational risk assessment. Accounting for complex exposures in the workplace and the broader risks faced by the individual also requires a more complete consideration of the composite effects of occupational and non-occupational risk factors to fully assess and manage worker health problems. Barriers to integrating these different factors remain, but new and ongoing community-based and worker health-related initiatives may provide mechanisms for identifying and integrating risk from aggregate exposures and cumulative risks from all relevant sources, be they occupational or non-occupational.

Systems Toxicology: The Future of Risk Assessment.

Science.gov (United States)

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

2015-01-01

Risk assessment, in the context of public health, is the process of quantifying the probability of a harmful effect to individuals or populations from human activities. With increasing public health concern regarding the potential risks associated with chemical exposure, there is a need for more predictive and accurate approaches to risk assessment. Developing such an approach requires a mechanistic understanding of the process by which xenobiotic substances perturb biological systems and lead to toxicity. Supplementing the shortfalls of traditional risk assessment with mechanistic biological data has been widely discussed but not routinely implemented in the evaluation of chemical exposure. These mechanistic approaches to risk assessment have been generally referred to as systems toxicology. This Symposium Overview article summarizes 4 talks presented at the 35th Annual Meeting of the American College of Toxicology. © The Author(s) 2015.

Risk assessment in support of plant health

DEFF Research Database (Denmark)

Jeger, Michael; Schans, Jan; Lövei, Gabor L.

2012-01-01

environmental risk assessment and the evaluation of risk reducing options. Quantitative approaches have become increasingly important during this time. The Panel has developed such methods in climatic mapping (in association with the Joint Research Councils), application of spatial spread models, re......With the establishment of the Plant Health Panel in 2006, EFSA became the body responsible for risk assessment in the plant health area for the European Union (EU). Since then more than 70 outputs have been produced dealing with the full range of organisms harmful to plant health across all crop...... types and plants in the environment. There has been an increasing trend towards producing scientific opinions which are full pest risk assessments for the whole EU territory. In its work, and as a contribution to the wider development of risk assessment methodology, the Panel has developed a series...

Performing the lockout/tagout risk assessment.

Science.gov (United States)

Wallace, W Jon

2007-03-01

Lockout/tagout provides the greatest level routine, repetitive, and integral to the production process, a risk assessment should be performed. If the task performed poses an unacceptable risk, acceptable risk reduction methods should be implemented to reduce the risk to acceptable levels.

Bioassay-based risk assessment of complex mixtures

International Nuclear Information System (INIS)

Donnelly, K.C.; Huebner, H.J.

1996-01-01

The baseline risk assessment often plays an integral role in various decision-making processes at Superfund sites. The present study reports on risk characterizations prepared for seven complex mixtures using biological and chemical analysis. Three of the samples (A, B, and C) were complex mixtures of polycyclic aromatic hydrocarbons (PAHs) extracted from coal tar; while four samples extracted from munitions-contaminated soil contained primarily nitroaromatic hydrocarbons. The chemical-based risk assessment ranked sample C as least toxic, while the risk associated with samples A and B was approximately equal. The microbial bioassay was in general agreement for the coal tar samples. The weighted activity of the coal tar extracts in Salmonella was 4,960 for sample C, and 162,000 and 206,000 for samples A and B, respectively. The bacterial mutagenicity of 2,4,6-trinitrotoluene contaminated soils exhibited an indirect correlation with chemical-based risk assessment. The aqueous extract of sample 004 induced 1,292 net revertants in Salmonella, while the estimated risk to ingestion and dermal adsorption was 2E-9. The data indicate that the chemical-based risk assessment accurately predicted the genotoxicity of the PAHs, while the accuracy of the risk assessment for munitions contaminated soils was limited due to the presence of metabolites of TNT degradation. The biological tests used in this research provide a valuable compliment to chemical analysis for characterizing the genotoxic risk of complex mixtures

Dose assessment of SiC nanoparticle dispersions during in vitro assays

International Nuclear Information System (INIS)

Mejia, Jorge; Piret, Jean-Pascal; Noël, Florence; Masereel, Bernard; Toussaint, Olivier; Lucas, Stéphane

2013-01-01

Here, we show that key physicochemical parameters of commercial Silicon Carbide nanoparticles, such as the primary particles of about 53 nm in size, the agglomerates size, and the surface composition, are considerably modified with respect to the pristine conditions, during in vitro assessment. The use of sample conditioning stages, such as the pre-dispersion in aqueous media and the subsequent dispersion in a culture medium specific to the in vitro assay, produce modifications as the absorption of N, C, and O, from the culture medium, in the nanoparticles surface. Our results show that the sedimented dose, fraction of sedimented NPs during incubation and consequently in contact with cells seeded at the bottom, of Silicon Carbide nanoparticles can be measured from the particle size distribution obtained using a centrifugal liquid sedimentation technique. It is underlined that the variations observed in the physicochemical properties are related to the in vitro assay conditions. Culture medium and incubation time are found to influence the most the sedimented dose and consequently the cells dose uptake

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

Science.gov (United States)

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

2016-09-01

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

An integrated framework for health and ecological risk assessment

International Nuclear Information System (INIS)

Suter, Glenn W.; Vermeire, Theo; Munns, Wayne R.; Sekizawa, Jun

2005-01-01

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

Risk assessment of radiation carcinogenesis

International Nuclear Information System (INIS)

Kai, Michiaki

2012-01-01

This commentary describes the radiation cancer risk assessed by international organizations other than ICRP, assessed for radon and for internal exposure, in the series from the aspect of radiation protection of explaining the assessments done until ICRP Pub. 103. Statistic significant increase of cancer formation is proved at higher doses than 100-200 mSv. At lower doses, with use of mathematical model, United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) reported the death probability due to the excess lifetime risk (ELR) at 100 mSv of 0.36-0.77% for solid tumors and 0.03-0.05% for leukemia, and NRC in US, the risk of exposure-induced prevalence and death (REID) per 100 thousands persons of 800 (male)/1,310 (female) and 410/610, respectively. Both are essentially based on findings in A-bomb survivors. The assessment for Rn is described here not on dose. UK and US analyses of pooled raw data in case control studies revealed the significant increase of lung cancer formation at as low level as 100 Bq Rn/m3. Their analyses also showed the significance of smoking, which had been realized as a confounding factor in risk analysis of Rn for uranium miners. The death probability until the age of 85 y was found to be 1.2 x 10 -4 in non-smokers and 24 x 10 -4 in smokers/ Working Level Month (WLM). Increased thyroid cancer incidence has been known in Chernobyl Accident, which is realized as a result of internal exposure of radioiodine; however, the relationship between the internal dose to thyroid and its cancer prevalence resembles that in the case of external exposure. There is no certain evidence against the concept that risk of internal exposure is similar to and/or lower than, the external one although assessment of the internal exposure risk accompanies uncertainty depending on the used model and ingested dose. International Commission on Radiological Protection (ICRP) recommendations hitherto have been important and precious despite

Contribution for tier 1 of the ecological risk assessment of Cunha Baixa uranium mine (Central Portugal): I Soil chemical characterization

International Nuclear Information System (INIS)

Pereira, R.; Antunes, S.C.; Marques, S.M.; Goncalves, F.

2008-01-01

Within the tier 1 of a site specific risk assessment, the pseudo-total concentrations (extracted with aqua regia) and the potential mobile fractions of metals were determined to perform a preliminary evaluation of risks posed by contaminated soils from an abandoned uranium mine (Mangualde, Central Portugal). Considering the mobile fractions of metals, extracted with artificial rain water, aluminium and uranium were the most concerning elements, since their concentrations were above soil quality criteria values (SQGVs) established for both elements. However, according to the evaluation based on potential mobile fractions of elements, rather than on pseudo-total metal concentrations the risks were limited to sites within the exploitation area, where contamination derives mainly from past in-situ leaching activities of pore ore as well as from the deposition of sludge from the effluent pond. The exclusion of other sites under evaluation, from the risk assessment process, requires additional data provided by soil screening ecotoxicological assays

Ethics of Risk. Kristin Shrader-Frechette's Philosophical Critique of Risk Assessment

International Nuclear Information System (INIS)

Heikkeroe, Topi

2006-01-01

This paper addresses risk assessment from a philosophical point of view. It presents and critically reviews the work of Kristin Shrader-Frechette. It introduces the ethical, epistemological, and methodological issues related to risk assessment. The paper focuses on the ethical questions of justice in risk decisions. It opens by framing the relationship between ethics and technology in the modern world. Then the paper turns to a brief description of risk assessment as a central method in technological decision making. It proceeds to show how Shrader-Frechette analyzes ethical and political aspects of risk assessment. The central argumentation In her critique follows RawIsian lines: distributive and participatory inequalities in creating technological constructions need to be justified. To clarify this requirement she formulates the Principle of Prima Facie Political Equity (PPFPE), which is her central tool in most of her ethical criticism, for instance, in relation to the future generations: prima facie. all generations should be treated equally. Brief critical remarks conclude the paper. They touch upon placing Shrader-Frechette's project on the academic chart and her liberal individualist anthropology

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

Science.gov (United States)

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.

Assessing individual risk for AMD with genetic counseling, family history, and genetic testing.

Science.gov (United States)

Cascella, R; Strafella, C; Longo, G; Manzo, L; Ragazzo, M; De Felici, C; Gambardella, S; Marsella, L T; Novelli, G; Borgiani, P; Sangiuolo, F; Cusumano, A; Ricci, F; Giardina, E

2018-02-01

PurposeThe goal was to develop a simple model for predicting the individual risk profile for age-related macular degeneration (AMD) on the basis of genetic information, disease family history, and smoking habits.Patients and methodsThe study enrolled 151 AMD patients following specific clinical and environmental inclusion criteria: age >55 years, positive family history for AMD, presence of at least one first-degree relative affected by AMD, and smoking habits. All of the samples were genotyped for rs1061170 (CFH) and rs10490924 (ARMS2) with a TaqMan assay, using a 7500 Fast Real Time PCR device. Statistical analysis was subsequently employed to calculate the real individual risk (OR) based on the genetic data (ORgn), family history (ORf), and smoking habits (ORsm).Results and conclusionThe combination of ORgn, ORf, and ORsm allowed the calculation of the Ort that represented the realistic individual risk for developing AMD. In this report, we present a computational model for the estimation of the individual risk for AMD. Moreover, we show that the average distribution of risk alleles in the general population and the knowledge of parents' genotype can be decisive to assess the real disease risk. In this contest, genetic counseling is crucial to provide the patients with an understanding of their individual risk and the availability for preventive actions.

Impaired DNA repair as assessed by the ``comet`` assay in patients developing thyroid carcinoma after radiotherapy

Energy Technology Data Exchange (ETDEWEB)

Leprat, F.; Sarasin, A.; Suarez, H.G. [Institut de Recherches sur le Cancer, 94 - Villesuif (France); Leprat, F.; Alapetite, C.; Rosselli, F.; Ridet, A.; Moustacch, E.; Alapetite, C. [Institut Curie, 75 - Paris (France); Schlumberger, M. [Institut Gustave Roussy, 94 - Villejuif (France)

1997-03-01

A defective cellular response to DNA lesions induced be genotoxic agents may be associated to an increased cancer proneness. This has been clearly identified in some rare but extensively studied genetic diseases such as xeroderma pigmentosum (XP), ataxia telangiectasia (AT) and Fanconi anemia (FA). In practical oncology, most patients receive genotoxic therapeutic agents and the presence of so far unidentified sensitive genotypes could account for an increased susceptibility to cancer in a subgroup of exposed patients. The thyroid gland of children is especially sensitive to the carcinogenic effect of ionizing radiation. Evidence for risk is reported even at doses as low as 0.1 Gy, and the excess relative risk to develop a thyroid tumor following a radiation dose of 1 Gy in childhood is of 7.7 [l]. In order to determine if a defect in repair of DNA strand breaks could be involved, as an early step, in the development of secondary thyroid tumors after radiotherapy, we examined, using the alkaline single cell gel electrophoresis assay (SCGE or `comet`), the response to in vitro {gamma}-rays exposure of lymphocytes of a small group of patients who developed thyroid carcinoma after radiotherapy for a primary tumor. Because of its practical advantages, the alkaline comet assay offers the opportunity to question the role of DNA strand beaks rejoining capacity of the individual in the radiation induced carcinogenesis of thyroid tumors. This preliminary study of a small group of patients with therapeutic irradiation at childhood for a primary tumor indicates that, at the time of blood sampling, lymphocytes of some of these patients demonstrated reduced rejoining capacity. These results suggest that the comet assay might help to distinguish a subgroup of individuals at risk for radiation induced genomic instability and encourage further investigation. (authors)

Risk assessment and multi-criteria decision-making

International Nuclear Information System (INIS)

Segerstaahl, Boris

1989-01-01

Risk assessment and analysis is connected to the policy framework used in decision-making on issues concerning technological risk. A review of the problems created by different views concerning the fundamental structure of risk concepts is used as a way to describe the structure of risk assessment studies as used in decision-making. The fundamental difference between judgments based on assessments and on perceptions is analyzed in order to explain the dynamics of the decision making process. A proposed effort to study the energy sector as a dynamic endless game implementing a mixed strategy is suggested. (author)

Comparative Risk Assessment to Inform Adaptation Priorities for the Natural Environment: Observations from the First UK Climate Change Risk Assessment

Directory of Open Access Journals (Sweden)

Iain Brown

2015-11-01

Full Text Available Risk assessment can potentially provide an objective framework to synthesise and prioritise climate change risks to inform adaptation policy. However, there are significant challenges in the application of comparative risk assessment procedures to climate change, particularly for the natural environment. These challenges are evaluated with particular reference to the first statutory Climate Change Risk Assessment (CCRA and evidence review procedures used to guide policy for the UK government. More progress was achieved on risk identification, screening and prioritisation compared to risk quantification. This was due to the inherent complexity and interdependence of ecological risks and their interaction with socio-economic drivers as well as a climate change. Robust strategies to manage risk were identified as those that coordinate organisational resources to enhance ecosystem resilience, and to accommodate inevitable change, rather than to meet specific species or habitats targets. The assessment also highlighted subjective and contextual components of risk appraisal including ethical issues regarding the level of human intervention in the natural environment and the proposed outcomes of any intervention. This suggests that goals for risk assessment need to be more clearly explicated and assumptions on tolerable risk declared as a primer for further dialogue on expectations for managed outcomes. Ecosystem-based adaptation may mean that traditional habitats and species conservation goals and existing regulatory frameworks no longer provide the best guide for long-term risk management thereby challenging the viability of some existing practices.

Assessment of health risks of policies

International Nuclear Information System (INIS)

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

2014-01-01

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

Assessment of health risks of policies

Energy Technology Data Exchange (ETDEWEB)

Ádám, Balázs, E-mail: badam@cmss.sdu.dk [Unit for Health Promotion Research, Faculty of Health Sciences, University of Southern Denmark, Niels Bohrs Vej 9, DK-6700 Esbjerg (Denmark); Department of Preventive Medicine, Faculty of Public Health, University of Debrecen, P.O. Box 9, H-4012 Debrecen (Hungary); Molnár, Ágnes, E-mail: MolnarAg@smh.ca [Department of Preventive Medicine, Faculty of Public Health, University of Debrecen, P.O. Box 9, H-4012 Debrecen (Hungary); Centre for Research on Inner City Health, Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael' s Hospital, Victoria 209, Rm. 3-26.22, M5B 1C6 Toronto, Ontario (Canada); Ádány, Róza, E-mail: adany.roza@sph.unideb.hu [Department of Preventive Medicine, Faculty of Public Health, University of Debrecen, P.O. Box 9, H-4012 Debrecen (Hungary); Bianchi, Fabrizio, E-mail: Fabriepi@ifc.cnr.it [Unit of Environmental Epidemiology, Institute of Clinical Physiology, National Council of Research, Moruzzi 1, 56124 Pisa (Italy); Bitenc, Katarina, E-mail: katarina.bitenc@ivz-rs.si [National Institute of Public Health, Trubarjeva 2, SI-1000 Ljubljana (Slovenia); Chereches, Razvan, E-mail: razvan.m.chereches@gmail.com [Faculty of Political, Administrative and Communication Sciences, Babes-Bolyai University, Strada Mihail Kogalniceanu 1, 3400 Cluj (Romania); Cori, Liliana, E-mail: liliana.cori@ifc.cnr.it [Unit of Environmental Epidemiology, Institute of Clinical Physiology, National Council of Research, Moruzzi 1, 56124 Pisa (Italy); Fehr, Rainer, E-mail: rainer.fehr@uni-bielefeld.de [NRW Centre for Health, Westerfeldstr. 35-37, 33611 Bielefeld (Germany); Kobza, Joanna, E-mail: koga1@poczta.onet.pl [Public Health Department, Silesian Medical University, 18 Medykow Street, 40-752 Katowice (Poland); Kollarova, Jana, E-mail: janakollarova@yahoo.com [Department of Health Promotion, Regional Public Health Authority, Ipelska 1, 04011 Kosice (Slovakia); 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.

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

Science.gov (United States)

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

Risk assessment and risk management in managed aquifer recharge

CSIR Research Space (South Africa)

Page, D

2012-06-01

Full Text Available This chapter presents the methodologies used for risk assessment and risk management in MAR in Australia and the European Union, qualitative and quantitative approaches adopted within the RECLAIM Water project and case studies where the outcomes...

Cloud computing assessing the risks

CERN Document Server

Carstensen, Jared; Golden, Bernard

2012-01-01

Cloud Computing: Assessing the risks answers these questions and many more. Using jargon-free language and relevant examples, analogies and diagrams, it is an up-to-date, clear and comprehensive guide the security, governance, risk, and compliance elements of Cloud Computing.

Quantified risk assessment - a nuclear industry viewpoint

International Nuclear Information System (INIS)

Thomson, J.R.

1994-01-01

This paper presents a brief summary of the methodology used for the assessment of risk arising from fuel handling and dismantling operations in advanced gas-cooled reactor power stations. The difficulties with and problems arising from such risk assessments are discussed. In particular, difficulties arise from (i) the onerous risk criteria that nuclear plants are expected to satisfy, (ii) the necessary complexity of the plant, (iii) the conflicting requirements for the fault consequence assessments to be bounding but not grossly pessimistic, and (iv) areas of fault frequency assessment which contain possibly subjective considerations such as software and common mode failure. (author)

SPECIFIC METHOD OF RISK ASSESSMENT IN TOURISM ENTERPRISES

Directory of Open Access Journals (Sweden)

Andreea ARMEAN

2014-12-01

Full Text Available The objective of this paper is to present an innovative method of risk assessment for tourism businesses. The contribution to literature is the novelty of this method of following paths: is an ante-factum assessment not post-factum; risk assessment is based on perception rather than results; is based on specific risks tourism enterprises not on the overall risks. Is an asset-research methodology and consists in generating its own method of risk assessment based on the ideas summarized from the literature studied. The aim established is tourism enterprises from Romania. The data necessary for the application of this method will result from applying to top level management of tourism enterprises, a questionnaire about risk perception. The results from this study will help identify and measure the risks specific to tourism enterprises. The applicability of the results is to improve risk management in these enterprises.

New approaches for improving cardiovascular risk assessment.

Science.gov (United States)

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

2016-01-01

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

Environmental Risk Communication through Qualitative Risk Assessment

Directory of Open Access Journals (Sweden)

Sabre J. Coleman

2014-06-01

Full Text Available Environmental analysts are often hampered in communicating the risks of environmental contaminants due to the myriad of regulatory requirements that are applicable. The use of a qualitative, risk-based control banding strategy for assessment and control of potential environmental contaminants provides a standardized approach to improve risk communication. Presented is a model that provides an effective means for determining standardized responses and controls for common environmental issues based on the level of risk. The model is designed for integration within an occupational health and safety management system to provide a multidisciplinary environmental and occupational risk management approach. This environmental model, which utilizes multidisciplinary control banding strategies for delineating risk, complements the existing Risk Level Based Management System, a proven method in a highly regulated facility for occupational health and safety. A simplified environmental risk matrix is presented that is stratified over four risk levels. Examples of qualitative environmental control banding strategies are presented as they apply to United States regulations for construction, research activities, facility maintenance, and spill remediation that affect air, water, soil, and waste disposal. This approach offers a standardized risk communication language for multidisciplinary issues that will improve communications within and between environmental health and safety professionals, workers, and management.

Can we (actually) assess global risk?

Science.gov (United States)

Di Baldassarre, Giuliano

2013-04-01

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

Operationalization Of The Professional Risks Assessment Activity

Science.gov (United States)

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.

Methodology for technical risk assessment

International Nuclear Information System (INIS)

Waganer, L.M.; Zuckerman, D.S.

1983-01-01

A methodology has been developed for and applied to the assessment of the technical risks associated with an evolving technology. This methodology, originally developed for fusion by K. W. Billman and F. R. Scott at EPRI, has been applied to assess the technical risk of a fuel system for a fusion reactor. Technical risk is defined as the risk that a particular technology or component which is currently under development will not achieve a set of required technical specifications (i.e. probability of failure). The individual steps in the technical risk assessment are summarized. The first step in this methodology is to clearly and completely quantify the technical requirements for the particular system being examined. The next step is to identify and define subsystems and various options which appear capable of achieving the required technical performance. The subsystem options are then characterized regarding subsystem functions, interface requirements with the subsystems and systems, important components, developmental obstacles and technical limitations. Key technical subsystem performance parameters are identified which directly or indirectly relate to the system technical specifications. Past, existing and future technical performance data from subsystem experts are obtained by using a Bayesian Interrogation technique. The input data is solicited in the form of probability functions. Thus the output performance of the system is expressed as probability functions

Overcoming barriers to integrating economic analysis into risk assessment.

Science.gov (United States)

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. © 2011 Society for Risk Analysis.

Regional scale ecological risk assessment: using the relative risk model

National Research Council Canada - National Science Library

Landis, Wayne G

2005-01-01

...) in the performance of regional-scale ecological risk assessments. The initial chapters present the methodology and the critical nature of the interaction between risk assessors and decision makers...

Sensitive assays enable detection of serum IgG antibodies against Clostridium difficile toxin A and toxin B in healthy subjects and patients with Clostridium difficile infection.

Science.gov (United States)

Zhao, Xuemei; Bender, Florent; Shukla, Rajiv; Kang, John J; Caro-Aguilar, Ivette; Laterza, Omar F

2016-04-01

Pathogenic Clostridium difficile produces two proinflammatory exotoxins, toxin A and toxin B. Low level of serum antitoxin IgG antibodies is a risk factor for the development of primary and recurrent C. difficile infection (CDI). We developed and validated two sensitive, titer-based electrochemiluminescence assays for the detection of serum antibody levels against C. difficile toxins A and B. These assays demonstrated excellent precision. The sensitivity of the assays allowed the detection of antitoxin A and antitoxin B IgG antibodies in all tested serum samples during assay validation. The validated titer-based assays enable assessment of antitoxin A and antitoxin B IgG antibodies as potential biomarkers to identify patients with CDI at increased risk for CDI recurrence.

Risk assessment future cash flows

OpenAIRE

Chachina H. G.

2012-01-01

This article is about risk assessment in planning future cash flows. Discount rate in DCF-model must include four factors: risk cash flow, inflation, value of investments, turnover assets. This has an influence net present value cash flow and make his incomparable.

Improving pandemic influenza risk assessment

Science.gov (United States)

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...

Framework for Shared Drinking Water Risk Assessment.

Energy Technology Data Exchange (ETDEWEB)

Lowry, Thomas Stephen [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Tidwell, Vincent C. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Peplinski, William John [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Mitchell, Roger [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Binning, David [AEM Corp., Herndon, VA (United States); Meszaros, Jenny [AEM Corp., Herndon, VA (United States)

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.

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

Science.gov (United States)

2011-07-27

...] Monsanto Co.; Availability of Petition, Plant Pest Risk Assessment, and Environmental Assessment for... Monsanto petition, our plant pest risk assessment, and our draft environmental assessment for the proposed...-2817 before coming. The petition, draft environmental assessment, and plant pest risk assessment are...

The Next Generation of Risk Assessment Multi-Year Study—Highlights of Findings, Applications to Risk Assessment, and Future Directions

Science.gov (United States)

Cote, Ila; Andersen, Melvin E.; Ankley, Gerald T.; Barone, Stanley; Birnbaum, Linda S.; Boekelheide, Kim; Bois, Frederic Y.; Burgoon, Lyle D.; Chiu, Weihsueh A.; Crawford-Brown, Douglas; Crofton, Kevin M.; DeVito, Michael; Devlin, Robert B.; Edwards, Stephen W.; Guyton, Kathryn Z.; Hattis, Dale; Judson, Richard S.; Knight, Derek; Krewski, Daniel; Lambert, Jason; Maull, Elizabeth Anne; Mendrick, Donna; Paoli, Gregory M.; Patel, Chirag Jagdish; Perkins, Edward J.; Poje, Gerald; Portier, Christopher J.; Rusyn, Ivan; Schulte, Paul A.; Simeonov, Anton; Smith, Martyn T.; Thayer, Kristina A.; Thomas, Russell S.; Thomas, Reuben; Tice, Raymond R.; Vandenberg, John J.; Villeneuve, Daniel L.; Wesselkamper, Scott; Whelan, Maurice; Whittaker, Christine; White, Ronald; Xia, Menghang; Yauk, Carole; Zeise, Lauren; Zhao, Jay; DeWoskin, Robert S.

2016-01-01

Background: The Next Generation (NexGen) of Risk Assessment effort is a multi-year collaboration among several organizations evaluating new, potentially more efficient molecular, computational, and systems biology approaches to risk assessment. This article summarizes our findings, suggests applications to risk assessment, and identifies strategic research directions. Objective: Our specific objectives were to test whether advanced biological data and methods could better inform our understanding of public health risks posed by environmental exposures. Methods: New data and methods were applied and evaluated for use in hazard identification and dose–response assessment. Biomarkers of exposure and effect, and risk characterization were also examined. Consideration was given to various decision contexts with increasing regulatory and public health impacts. Data types included transcriptomics, genomics, and proteomics. Methods included molecular epidemiology and clinical studies, bioinformatic knowledge mining, pathway and network analyses, short-duration in vivo and in vitro bioassays, and quantitative structure activity relationship modeling. Discussion: NexGen has advanced our ability to apply new science by more rapidly identifying chemicals and exposures of potential concern, helping characterize mechanisms of action that influence conclusions about causality, exposure–response relationships, susceptibility and cumulative risk, and by elucidating new biomarkers of exposure and effects. Additionally, NexGen has fostered extensive discussion among risk scientists and managers and improved confidence in interpreting and applying new data streams. Conclusions: While considerable uncertainties remain, thoughtful application of new knowledge to risk assessment appears reasonable for augmenting major scope assessments, forming the basis for or augmenting limited scope assessments, and for prioritization and screening of very data limited chemicals. Citation: Cote I

Probabilistic risk assessment: Number 219

International Nuclear Information System (INIS)

Bari, R.A.

1985-01-01

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)

Risk assessment under deep uncertainty: A methodological comparison

International Nuclear Information System (INIS)

Shortridge, Julie; Aven, Terje; Guikema, Seth

2017-01-01

Probabilistic Risk Assessment (PRA) has proven to be an invaluable tool for evaluating risks in complex engineered systems. However, there is increasing concern that PRA may not be adequate in situations with little underlying knowledge to support probabilistic representation of uncertainties. As analysts and policy makers turn their attention to deeply uncertain hazards such as climate change, a number of alternatives to traditional PRA have been proposed. This paper systematically compares three diverse approaches for risk analysis under deep uncertainty (qualitative uncertainty factors, probability bounds, and robust decision making) in terms of their representation of uncertain quantities, analytical output, and implications for risk management. A simple example problem is used to highlight differences in the way that each method relates to the traditional risk assessment process and fundamental issues associated with risk assessment and description. We find that the implications for decision making are not necessarily consistent between approaches, and that differences in the representation of uncertain quantities and analytical output suggest contexts in which each method may be most appropriate. Finally, each methodology demonstrates how risk assessment can inform decision making in deeply uncertain contexts, informing more effective responses to risk problems characterized by deep uncertainty. - Highlights: • We compare three diverse approaches to risk assessment under deep uncertainty. • A simple example problem highlights differences in analytical process and results. • Results demonstrate how methodological choices can impact risk assessment results.

Participatory Risk Assessment for Environmental Decision-Making

International Nuclear Information System (INIS)

Homan, Jacqueline; Petts, Judith

2001-01-01

Recent research, discussion and practice in the role environmental decision-making as an integral part of a democratic society have resulted in legislation, policy and guidance that encourage, and indeed may require, greater participation. The focus of this research paper is to explore these participatory ideas in the context of environmental risk assessment. Participation methods have generic application. However, the importance of fitting method to purpose requires that different contexts and issues relative to the objectives be addressed. In relation to environmental risk assessment these issues include: the complexity of risk issues per se; the inherent uncertainty that dominates any risk assessment; the quantitative nature of many risk assessments and the difficulty of dealing with low probability-high consequence outconies; the possibility of controversy in relation to decisions involving risk and thus the careful attention needed to the process and identification of participants; the traditional role and culture of experts in risk decisions and the challenge of reconciling this with the role of lay knowledge and the potential for the public to act as quality assurers in the risk decision process; the tendency for people to need reassurance when confronted with risk, even during a participation process; the need to acknowledge the public's ability to deal with complex technical issues and the need for information and data to respond to their questions, and the fact that 'risk' per se will often not be the only issue of public concern. The contributions to the risk debate from the social sciences are having considerable influence on the practice of environmental decision-making. Calls for increased stakeholder involvement in risk decisions are requiring greater access to and engagement with environmental risk assessments. Mechanisms for this level of involvement, however, are not well defined. For these aspirational calls to be realised in practice, decision

Participatory Risk Assessment for Environmental Decision-Making

Energy Technology Data Exchange (ETDEWEB)

Homan, Jacqueline; Petts, Judith [Univ. of Birmingham (United Kingdom). Centre for Environmental Research and Training; Pollard, Simon; Twigger-Ross, Clare [National Centre for Risk Analysis and Options Appraisal, London (United Kingdom)

2001-07-01

Recent research, discussion and practice in the role environmental decision-making as an integral part of a democratic society have resulted in legislation, policy and guidance that encourage, and indeed may require, greater participation. The focus of this research paper is to explore these participatory ideas in the context of environmental risk assessment. Participation methods have generic application. However, the importance of fitting method to purpose requires that different contexts and issues relative to the objectives be addressed. In relation to environmental risk assessment these issues include: the complexity of risk issues per se; the inherent uncertainty that dominates any risk assessment; the quantitative nature of many risk assessments and the difficulty of dealing with low probability-high consequence outconies; the possibility of controversy in relation to decisions involving risk and thus the careful attention needed to the process and identification of participants; the traditional role and culture of experts in risk decisions and the challenge of reconciling this with the role of lay knowledge and the potential for the public to act as quality assurers in the risk decision process; the tendency for people to need reassurance when confronted with risk, even during a participation process; the need to acknowledge the public's ability to deal with complex technical issues and the need for information and data to respond to their questions, and the fact that 'risk' per se will often not be the only issue of public concern. The contributions to the risk debate from the social sciences are having considerable influence on the practice of environmental decision-making. Calls for increased stakeholder involvement in risk decisions are requiring greater access to and engagement with environmental risk assessments. Mechanisms for this level of involvement, however, are not well defined. For these aspirational calls to be realised in

Advances in risk assessment for climate change adaptation policy

Science.gov (United States)

Adger, W. Neil; Brown, Iain; Surminski, Swenja

2018-01-01

Climate change risk assessment involves formal analysis of the consequences, likelihoods and responses to the impacts of climate change and the options for addressing these under societal constraints. Conventional approaches to risk assessment are challenged by the significant temporal and spatial dynamics of climate change; by the amplification of risks through societal preferences and values; and through the interaction of multiple risk factors. This paper introduces the theme issue by reviewing the current practice and frontiers of climate change risk assessment, with specific emphasis on the development of adaptation policy that aims to manage those risks. These frontiers include integrated assessments, dealing with climate risks across borders and scales, addressing systemic risks, and innovative co-production methods to prioritize solutions to climate challenges with decision-makers. By reviewing recent developments in the use of large-scale risk assessment for adaptation policy-making, we suggest a forward-looking research agenda to meet ongoing strategic policy requirements in local, national and international contexts. This article is part of the theme issue ‘Advances in risk assessment for climate change adaptation policy’. PMID:29712800

Advances in risk assessment for climate change adaptation policy.

Science.gov (United States)

Adger, W Neil; Brown, Iain; Surminski, Swenja

2018-06-13

Climate change risk assessment involves formal analysis of the consequences, likelihoods and responses to the impacts of climate change and the options for addressing these under societal constraints. Conventional approaches to risk assessment are challenged by the significant temporal and spatial dynamics of climate change; by the amplification of risks through societal preferences and values; and through the interaction of multiple risk factors. This paper introduces the theme issue by reviewing the current practice and frontiers of climate change risk assessment, with specific emphasis on the development of adaptation policy that aims to manage those risks. These frontiers include integrated assessments, dealing with climate risks across borders and scales, addressing systemic risks, and innovative co-production methods to prioritize solutions to climate challenges with decision-makers. By reviewing recent developments in the use of large-scale risk assessment for adaptation policy-making, we suggest a forward-looking research agenda to meet ongoing strategic policy requirements in local, national and international contexts.This article is part of the theme issue 'Advances in risk assessment for climate change adaptation policy'. © 2018 The Author(s).

Advances in risk assessment for climate change adaptation policy

Science.gov (United States)

Adger, W. Neil; Brown, Iain; Surminski, Swenja

2018-06-01

Climate change risk assessment involves formal analysis of the consequences, likelihoods and responses to the impacts of climate change and the options for addressing these under societal constraints. Conventional approaches to risk assessment are challenged by the significant temporal and spatial dynamics of climate change; by the amplification of risks through societal preferences and values; and through the interaction of multiple risk factors. This paper introduces the theme issue by reviewing the current practice and frontiers of climate change risk assessment, with specific emphasis on the development of adaptation policy that aims to manage those risks. These frontiers include integrated assessments, dealing with climate risks across borders and scales, addressing systemic risks, and innovative co-production methods to prioritize solutions to climate challenges with decision-makers. By reviewing recent developments in the use of large-scale risk assessment for adaptation policy-making, we suggest a forward-looking research agenda to meet ongoing strategic policy requirements in local, national and international contexts. This article is part of the theme issue `Advances in risk assessment for climate change adaptation policy'.

General approaches to the risk assessment of chemicals

Energy Technology Data Exchange (ETDEWEB)

Murphy, Patrick [Commission of the European Communities, Directorate General XI, Environment, Nuclear Safety and Civil Protection (Belgium)

1992-07-01

In the context of the UNCED 92 'Earth Summit' in Rio, the following definition of chemical risk assessment has been developed: 'Chemical risk assessment is a scientific process that identifies and quantifies the potential adverse effects on human health or ecosystems of defined exposures to chemical substances, to mixtures that include chemicals, or to chemically hazardous processes or situations. Risk itself is the probability of the occurrence of a defined adverse effect in a defined group and in defined circumstances'. I would not be so impertinent as to try and improve upon a definition that has the tacit endorsement of the majority of world-leaders. Furthermore, I consider that too many man-years have been spent discussing this topic. Thankfully the UNCED definition recognises chemical risk assessment as being a process and not some immutable physical law. In this presentation I will attempt to explain some of the details and mechanisms of that process but first of all it is worthwhile to spend a few moments putting chemical risk assessment in its proper context and asking the simple question: why do we want/need to assess the potential risk of chemicals?. In general terms, chemicals risk assessment is carried out in order to ensure that neither man (consumer/worker/general public) nor the environment are exposed to unacceptable risks arising from the production, use and disposal of chemicals. At a national and/or international level, risk assessments are performed by the regulatory authorities before they accept notification dossiers (e.g. new industrial chemicals) or grant authorizations (e.g. pharmaceuticals, pesticides, cosmetics, food additives). At the local level, plant-operators must carry out risk assessments to ensure that in the particular circumstances of their factory the workers are adequately protected and that satisfactory accident prevention and contingency plans are prepared. Similarly, local authorities must carry out risk assessments before

General approaches to the risk assessment of chemicals

International Nuclear Information System (INIS)

Murphy, Patrick

1992-01-01

In the context of the UNCED 92 'Earth Summit' in Rio, the following definition of chemical risk assessment has been developed: 'Chemical risk assessment is a scientific process that identifies and quantifies the potential adverse effects on human health or ecosystems of defined exposures to chemical substances, to mixtures that include chemicals, or to chemically hazardous processes or situations. Risk itself is the probability of the occurrence of a defined adverse effect in a defined group and in defined circumstances'. I would not be so impertinent as to try and improve upon a definition that has the tacit endorsement of the majority of world-leaders. Furthermore, I consider that too many man-years have been spent discussing this topic. Thankfully the UNCED definition recognises chemical risk assessment as being a process and not some immutable physical law. In this presentation I will attempt to explain some of the details and mechanisms of that process but first of all it is worthwhile to spend a few moments putting chemical risk assessment in its proper context and asking the simple question: why do we want/need to assess the potential risk of chemicals?. In general terms, chemicals risk assessment is carried out in order to ensure that neither man (consumer/worker/general public) nor the environment are exposed to unacceptable risks arising from the production, use and disposal of chemicals. At a national and/or international level, risk assessments are performed by the regulatory authorities before they accept notification dossiers (e.g. new industrial chemicals) or grant authorizations (e.g. pharmaceuticals, pesticides, cosmetics, food additives). At the local level, plant-operators must carry out risk assessments to ensure that in the particular circumstances of their factory the workers are adequately protected and that satisfactory accident prevention and contingency plans are prepared. Similarly, local authorities must carry out risk assessments before

Assessment of a New Lower-Cost Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus: Useful for Cervical Screening in Limited-Resource Settings?

Science.gov (United States)

Fokom Domgue, Joel; Schiffman, Mark; Wentzensen, Nicolas H; Gage, Julia C; Castle, Philip E; Raine-Bennett, Tina R; Fetterman, Barbara; Lorey, Thomas; Poitras, Nancy E; Befano, Brian; Xie, Yi; Miachon, Lais S; Dean, Michael

2017-08-01

Inexpensive and easy-to-perform human papillomavirus (HPV) tests are needed for primary cervical cancer screening in lower-resource regions. In a convenience sample of 516 residual exfoliative cervical specimens from the Kaiser Permanente Northern California and U.S. National Cancer Institute Persistence and Progression Study, we assessed the agreement and clinical performance of a simple, inexpensive real-time PCR assay for the detection of 13 carcinogenic HPV types (the H13 assay; Hybribio, Hong Kong) that is marketed in limited-resource settings compared to previous testing by the Hybrid Capture 2 assay (HC2; Qiagen, Germantown, MD) and the Onclarity assay (BD Diagnostics, Sparks, MD). The test set was chosen to include many HPV-positive specimens. The reference standard was a combination of HC2 and Onclarity results for HPV detection and histologic diagnosis of controls (less than cervical intraepithelial neoplasia grade 2 [

The potential value of the neutral comet assay and the expression of genes associated with DNA damage in assessing the radiosensitivity of tumor cells.

Science.gov (United States)

Jayakumar, Sundarraj; Bhilwade, Hari N; Pandey, Badri N; Sandur, Santosh K; Chaubey, Ramesh C

2012-10-09

The assessment of tumor radiosensitivity would be particularly useful in optimizing the radiation dose during radiotherapy. Therefore, the degree of correlation between radiation-induced DNA damage, as measured by the alkaline and the neutral comet assays, and the clonogenic survival of different human tumor cells was studied. Further, tumor radiosensitivity was compared with the expression of genes associated with the cellular response to radiation damage. Five different human tumor cell lines were chosen and the radiosensitivity of these cells was established by clonogenic assay. Alkaline and neutral comet assays were performed in γ-irradiated cells (2-8Gy; either acute or fractionated). Quantitative PCR was performed to evaluate the expression of DNA damage response genes in control and irradiated cells. The relative radiosensitivity of the cell lines assessed by the extent of DNA damage (neutral comet assay) immediately after irradiation (4Gy or 6Gy) was in agreement with radiosensitivity pattern obtained by the clonogenic assay. The survival fraction of irradiated cells showed a better correlation with the magnitude of DNA damage measured by the neutral comet assay (r=-0.9; Pcomet assay (r=-0.73; Pcomet assay was better than alkaline comet assay for assessment of radiosensitivities of tumor cells after acute or fractionated doses of irradiation. © 2012 Elsevier B.V. All rights reserved.

Development of a rapid loop-mediated isothermal amplification assay for diagnosis and assessment of cure of Leishmania infection.

Science.gov (United States)

Verma, Sandeep; Singh, Ruchi; Sharma, Vanila; Bumb, Ram Avtar; Negi, Narendra Singh; Ramesh, V; Salotra, Poonam

2017-03-23

Leishmaniasis is a spectrum of diseases with great relevance to public health. Conventional diagnostic methods are time consuming, needing trained personnel. A robust, rapid and cost effective diagnostic test is warranted for on-time diagnosis and field application. We have developed a loop mediated isothermal amplification (LAMP) assay with primers (n = 6) based on Leishmania donovani kDNA for detection of Leishmania infection, using a closed tube to prevent cross-contamination. The assay was used to detect Leishmania infection in biological samples obtained from patients of visceral leishmaniasis (VL), post kala-azar dermal leishmaniasis (PKDL) and cutaneous leishmaniasis (CL). The assay was positive for L. donovani, L. tropica and L. major parasites, with the highest sensitivity towards L. donovani (1 fg DNA). The high sensitivity of the assay for detection of L. donovani was reflected in its ability to detect parasite DNA within 30 min of amplification time with a threshold detection limit of ≥25 copies per reaction. The assay detected parasite in 64 of 66 VL blood samples (sensitivity, 96.9%; 95% CI: 89.6-99.2%), 15 of 15 VL bone marrow aspirate samples (sensitivity, 100%; 95% CI:79.6-100%), 65 of 67 PKDL tissue biopsy samples (sensitivity, 97%; 95% CI:89.7-99.2%). The assay was evaluated in a few cases of CL wherein it was found positive in 8 of 10 tissue biopsies (sensitivity, 80%; 95% CI: 49-94.3%). The assay was negative in all control blood (n = 76) and tissue biopsy (n = 24) samples (specificity, 100%; 95% CI: 96.3-100%). Further, the assay was evaluated for its utility in assessment of cure in treated VL and PKDL patients. The assay detected parasite DNA in 2 of 20VL blood samples and 2 of 21 PKDL tissue samples. Out of 4 cases that were positive for parasite DNA at post treatment stage, 2 patients (1VL and 1 PKDL) returned with relapse. The study demonstrated a Leishmania genus specific closed tube LAMP assay for reliable and rapid

New method for assessing risks of email

Science.gov (United States)

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.

Advancing environmental risk assessment for transgenic biofeedstock crops

Directory of Open Access Journals (Sweden)

Wolt Jeffrey D

2009-11-01

Full Text Available Abstract 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.

Models for Pesticide Risk Assessment

Science.gov (United States)

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.

Low-frequency fields - health risk assessment

International Nuclear Information System (INIS)

Bernhardt, J.

1993-01-01

The author briefly reviews the biological actions and effects of low-frequency fields, epidemiological studies and discusses health risks in detail. He describes the assessment principles of the International Commission on Non-ionizing Radiation Protection (ICNIRP), medical principles for risk assessment, determination of limits and thesholds, and aspects of prevention. This is supplemented to by several fables and literature list. (Uhe) [de

Improving antenatal risk assessment in women exposed to high risks.

Science.gov (United States)

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

2015-01-01

Antenatal substance use and related psychosocial risk factors are known to increase the likelihood of child protection involvement; less is known about the predictive nature of maternal reflective functioning (RF) in this population. This preliminary study assessed psychosocial and psychological risk factors for a group of substance dependent women exposed to high risks in pregnancy, and their impact on child protection involvement. Pregnant women on opiate substitution treatment (n = 11) and a comparison group (n = 15) were recruited during their third trimester to complete measures of RF (Pregnancy Interview), childhood trauma, mental health and psychosocial assessments. At postnatal follow-up, RF was reassessed (Parent Development Interview - Revised Short Version) and mother-infant dyads were videotaped to assess emotional availability (EA). Child protection services were contacted to determine if any concerns had been raised for infant safety. Significant between-group differences were observed for demographics, psychosocial factors, trauma and mental health symptoms. Unexpectedly, no significant differences were found for RF or EA between groups. Eight women in the 'exposed to high risks' group became involved with child protection services. Reflective functioning was not significantly associated with psychosocial risk factors, and therefore did not mediate the outcome of child protection involvement. Women 'exposed to high risks' were equally able to generate a model of their own and their infants' mental states and should not be seen within a deficit perspective. Further research is required to better understand the range of risk factors that predict child protection involvement in high risk groups. © The Author(s) 2013.

78 FR 15894 - Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside...

Science.gov (United States)

2013-03-13

.... FDA-2012-N-1258] Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for... comment period for a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/ [[Page... ``Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm...

Assessment of risk from radiation sources

International Nuclear Information System (INIS)

Subbaratnam, T.; Madhvanath, U.; Somasundaram, S.

1976-01-01

Assessment of risk from exposure to ionizing radiations from man-made radiation sources and nuclear installations has to be viewed from three aspects, namely, dose-effect relationship (genetic and somatic) for humans, calculation of doses or dose-commitments to population groups, assessment of risk to radiation workers and the population at large from the current levels of exposure from nuclear industry and comparison of risk estimates with other industries in a modern society. These aspects are discussed in brief. On the basis of available data, it is shown that estimated incidence of genetic diseases and cancers due to exposure of population to radiation from nuclear industry is negligible in comparison with their natural incidence, and radiation risks to the workers in nuclear industry are much lower than the risks in other occupations. (M.G.B.)

Assessment of fracture risk

International Nuclear Information System (INIS)

Kanis, John A.; Johansson, Helena; Oden, Anders; McCloskey, Eugene V.

2009-01-01

Fractures are a common complication of osteoporosis. Although osteoporosis is defined by bone mineral density at the femoral neck, other sites and validated techniques can be used for fracture prediction. Several clinical risk factors contribute to fracture risk independently of BMD. These include age, prior fragility fracture, smoking, excess alcohol, family history of hip fracture, rheumatoid arthritis and the use of oral glucocorticoids. These risk factors in conjunction with BMD can be integrated to provide estimates of fracture probability using the FRAX tool. Fracture probability rather than BMD alone can be used to fashion strategies for the assessment and treatment of osteoporosis.

Taking the Risk Out of Risk Assessment

Science.gov (United States)

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

Research on risk assessment for maritime transport of radioactive materials. Preparation of maritime accident data for risk assessment

International Nuclear Information System (INIS)

Odano, Naoteru; Sawada, Ken-ichi; Mochiduki, Hiromitsu; Hirao, Yoshihiro; Asami, Mitsufumi

2010-01-01

Maritime transport of radioactive materials has been playing an important role in the nuclear fuel cycle in Japan. Due to recent increase of transported radioactive materials and diversification of transport packages with enlargement of nuclear research, development and utilization, safety securement for maritime transport of radioactive materials is one of important issues in the nuclear fuel cycle. Based squarely on the current circumstances, this paper summarizes discussion on importance of utilization of results of risk assessment for maritime transport of radioactive materials. A plan for development of comprehensive methodology to assess risks in maritime transport of radioactive materials is also described. Preparations of database of maritime accident to be necessary for risk assessment are also summarized. The prepared data could be utilized for future quantitative risk assessment, such as the event trees and fault trees analyses, for maritime transport of radioactive materials. The frequency of severe accident that the package might be damaged is also estimated using prepared data. (author)

Reducing the harms associated with risk assessments

International Nuclear Information System (INIS)

Montague, Peter

2004-01-01

Risk assessments are the intellectual products of dedicated public health and environmental professionals. Like many other products, risk assessments carry with them the potential for both good and harm. This paper briefly examines some of the harms to which risk assessments have contributed, and then suggests that the legal 'duty to warn' doctrine offers a logical and practical way to reduce some of these harms. The paper suggests concepts that could be incorporated into warnings accompanying every formal risk assessment as routine 'boiler plate' addenda, just as other potentially harmful products, such as lawn mowers and cook stoves, are accompanied by warnings. Finally, the paper briefly examines the 'Code of Ethics and Standards of Practice for Environmental Professionals' (promulgated by the National Association of Environmental Professionals) and shows that the suggested warnings are consistent with recommended practices for environmental professionals

Toxicity screening of soils from different mine areas—A contribution to track the sensitivity and variability of Arthrobacter globiformis assay

Energy Technology Data Exchange (ETDEWEB)

Marques, Catarina R., E-mail: crmarques@ua.pt [Departamento de Biologia and CESAM (Centro de Estudos do Ambiente e do Mar), Universidade de Aveiro, Campus Universitário de Santiago, 3810-193 Aveiro (Portugal); Caetano, Ana L. [Departamento de Biologia and CESAM (Centro de Estudos do Ambiente e do Mar), Universidade de Aveiro, Campus Universitário de Santiago, 3810-193 Aveiro (Portugal); Haller, Andreas [ECT Oekotoxikologie GmbH, Böttgerstraße 2–14, D-65439 Flörsheim a. M. (Germany); Gonçalves, Fernando [Departamento de Biologia and CESAM (Centro de Estudos do Ambiente e do Mar), Universidade de Aveiro, Campus Universitário de Santiago, 3810-193 Aveiro (Portugal); Pereira, Ruth [Faculdade de Ciências da Universidade do Porto, Rua do Campo Alegre, s/n, 4169-007 Porto (Portugal); Interdisciplinary Centre of Marine and Environmental Research (CIIMAR/CIMAR), Universidade do Porto, Rua dos Bragas 289, P 4050-123 Porto (Portugal); Römbke, Jörg [ECT Oekotoxikologie GmbH, Böttgerstraße 2–14, D-65439 Flörsheim a. M. (Germany)

2014-06-01

Highlights: • The assay gave rapid and feasible discrimination of toxic soils to A. globiformis. • Sensitive and low variability response to soils from different regions. • Soil properties may interfere with metal toxicity and fluorescence measurements. • Proposal of a toxicity threshold for the contact assay regarding soils. • A. globiformis assay should be included in the Tier I of risk assessment frameworks. - Abstract: This study used the Arthrobacter globiformis solid-contact test for assessing the quality of soils collected in areas subjected to past and present mine activities in Europe (uranium mine, Portugal) and North Africa (phosphogypsum pile, Tunisia; iron mine, Morocco). As to discriminate the influence of soils natural variability from the effect of contaminants, toxicity thresholds were derived for this test, based on the dataset of each study area. Furthermore, the test sensitivity and variability was also evaluated. As a result, soils that inhibited A. globiformis dehydrogenase activity above 45% or 50% relatively to the control, were considered to be toxic. Despite the soil metal content determined, the properties of soils seemed to influence dehydrogenase activity. Overall, the contact test provided a coherent outcome comparing to other more time-consuming and effort-demanding ecotoxicological assays. Our results strengthened the feasibility and ecological relevance of this assay, which variability was quite reduced hence suggesting its potential integration within the test battery of tier 1 of soil risk assessment schemes.

Toxicity screening of soils from different mine areas—A contribution to track the sensitivity and variability of Arthrobacter globiformis assay

International Nuclear Information System (INIS)

Marques, Catarina R.; Caetano, Ana L.; Haller, Andreas; Gonçalves, Fernando; Pereira, Ruth; Römbke, Jörg

2014-01-01

Highlights: • The assay gave rapid and feasible discrimination of toxic soils to A. globiformis. • Sensitive and low variability response to soils from different regions. • Soil properties may interfere with metal toxicity and fluorescence measurements. • Proposal of a toxicity threshold for the contact assay regarding soils. • A. globiformis assay should be included in the Tier I of risk assessment frameworks. - Abstract: This study used the Arthrobacter globiformis solid-contact test for assessing the quality of soils collected in areas subjected to past and present mine activities in Europe (uranium mine, Portugal) and North Africa (phosphogypsum pile, Tunisia; iron mine, Morocco). As to discriminate the influence of soils natural variability from the effect of contaminants, toxicity thresholds were derived for this test, based on the dataset of each study area. Furthermore, the test sensitivity and variability was also evaluated. As a result, soils that inhibited A. globiformis dehydrogenase activity above 45% or 50% relatively to the control, were considered to be toxic. Despite the soil metal content determined, the properties of soils seemed to influence dehydrogenase activity. Overall, the contact test provided a coherent outcome comparing to other more time-consuming and effort-demanding ecotoxicological assays. Our results strengthened the feasibility and ecological relevance of this assay, which variability was quite reduced hence suggesting its potential integration within the test battery of tier 1 of soil risk assessment schemes

Rapid in situ assessment for predicting soil quality using an algae-soaked disc seeding assay.

Science.gov (United States)

Nam, Sun-Hwa; Moon, Jongmin; Kim, Shin Woong; Kim, Hakyeong; Jeong, Seung-Woo; An, Youn-Joo

2017-11-16

The soil quality of remediated land is altered and this land consequently exerts unexpected biological effects on terrestrial organisms. Therefore, field evaluation of such land should be conducted using biological indicators. Algae are a promising new biological indicator since they are a food source for organisms in higher soil trophic levels and easily sampled from the soil. Field evaluation of soil characteristics is preferred to be testing in laboratory conditions because many biological effects cannot be duplicated during laboratory evaluations. Herein, we describe a convenient and rapid algae-soaked disc seeding assay for assessing soil quality in the field based on soil algae. The collection of algae is easy and rapid and the method predicts the short-term quality of contaminated, remediated, and amended farm and paddy soils. The algae-soaked disc seeding assay is yet to be extensively evaluated, and the method cannot be applied to loamy sand soil in in situ evaluations. The algae-soaked disc seeding assay is recommended for prediction of soil quality in in situ evaluations because it reflects all variations in the environment. The algae-soaked disc seeding assay will help to develop management strategies for in situ evaluation.

Response to challenging dose of x-rays as a predictive assay for molecular epidemiology