WorldWideScience

Sample records for regulatory risk assessments

  1. Hormesis in Regulatory risk assessment - Science and Science Policy.

    Science.gov (United States)

    Gray, George

    2011-01-01

    This brief commentary will argue that whether hormesis is considered in regulatory risk assessment is a matter less of science than of science policy. I will first discuss the distinction between science and science policy and their roles in regulatory risk assessment. Then I will focus on factors that influence science policy, especially as it relates to the conduct of risk assessments to inform regulatory decisions, with a focus on the U.S. Environmental Protection Agency (EPA). The key questions will then be how does hormesis interact with current concepts of science and science policy for risk assessment? Finally, I look ahead to factors that may increase, or decrease, the likelihood of hormesis being incorporated into regulatory risk assessment.

  2. Probabilistic risk assessment methodology for risk management and regulatory applications

    International Nuclear Information System (INIS)

    See Meng Wong; Kelly, D.L.; Riley, J.E.

    1997-01-01

    This paper discusses the development and potential applications of PRA methodology for risk management and regulatory applications in the U.S. nuclear industry. The new PRA methodology centers on the development of This paper discusses the time-dependent configuration risk profile for evaluating the effectiveness of operational risk management programs at U.S. nuclear power plants. Configuration-risk profiles have been used as risk-information tools for (1) a better understanding of the impact of daily operational activities on plant safety, and (2) proactive planning of operational activities to manage risk. Trial applications of the methodology were undertaken to demonstrate that configuration-risk profiles can be developed routinely, and can be useful for various industry and regulatory applications. Lessons learned include a better understanding of the issues and characteristics of PRA models available to industry, and identifying the attributes and pitfalls in the developement of risk profiles

  3. Task-based dermal exposure models for regulatory risk assessment

    NARCIS (Netherlands)

    Warren, N.D.; Marquart, H.; Christopher, Y.; Laitinen, J.; Hemmen, J.J. van

    2006-01-01

    The regulatory risk assessment of chemicals requires the estimation of occupational dermal exposure. Until recently, the models used were either based on limited data or were specific to a particular class of chemical or application. The EU project RISKOFDERM has gathered a considerable number of

  4. The role of risk assessment in the nuclear regulatory process

    International Nuclear Information System (INIS)

    Levine, S.

    1979-01-01

    Since the publication of the Reactor Safety Study in the USA, the basic tasks of which are summarised, the use of quantitative risk-assessment techniques for the safety of nuclear power plants has increased considerably. Some of the viewpoints expressed on the use of these techniques are examined, and their limitations are discussed. Areas where risk-assessment techniques are applied by the NRC are listed and some recent examples are discussed. Risk assessment has also been used as a criteria for deciding the topics for the NRC's recommendations for research programs. It is concluded that the major contribution of risk assessment techniques should be in the form of background analyses that will aid decision making and could also significantly affect the scope and content of regulatory reviews. (UK)

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

    Science.gov (United States)

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

    Fourteen drugs were removed from the market worldwide because their potential to cause torsade de pointes (torsade), a potentially fatal ventricular arrhythmia. The observation that most drugs that cause torsade block the potassium channel encoded by the human ether-à-go-go related gene (hERG) and prolong the heart rate corrected QT interval (QTc) on the ECG, led to a focus on screening new drugs for their potential to block the hERG potassium channel and prolong QTc. This has been a successful strategy keeping torsadogenic drugs off the market, but has resulted in drugs being dropped from development, sometimes inappropriately. This is because not all drugs that block the hERG potassium channel and prolong QTc cause torsade, sometimes because they block other channels. The regulatory paradigm is evolving to improve proarrhythmic risk prediction. ECG studies can now use exposure-response modeling for assessing the effect of a drug on the QTc in small sample size first-in-human studies. Furthermore, the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative is developing and validating a new in vitro paradigm for cardiac safety evaluation of new drugs that provides a more accurate and comprehensive mechanistic-based assessment of proarrhythmic potential. Under CiPA, the prediction of proarrhythmic potential will come from in vitro ion channel assessments coupled with an in silico model of the human ventricular myocyte. The preclinical assessment will be checked with an assessment of human phase 1 ECG data to determine if there are unexpected ion channel effects in humans compared to preclinical ion channel data. While there is ongoing validation work, the heart rate corrected J-T peak interval is likely to be assessed under CiPA to detect inward current block in presence of hERG potassium channel block. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Risk assessment for federal regulatory decisions on organisms produced through biotechnology

    International Nuclear Information System (INIS)

    Payne, John H.; Medley, Terry L.

    1992-01-01

    This article discusses: 1. Purposes and history of risk assessment: application to biotechnology; 2. Framework in the United States for decisions on organisms produced through biotechnology; 3. Choosing from among potential approaches to assessment: a). exposure assessment does not equate to risk assessment: what are the hazards?; b). Setting risk assessment priorities; c). 'Quantitative' environmental and 'quantitative' ecological risk assessments; d). Ecological risk assessments based on biological and ecological principles. 4. The bases for good regulatory decisions

  7. Risk assessment for federal regulatory decisions on organisms produced through biotechnology

    Energy Technology Data Exchange (ETDEWEB)

    Payne, John H; Medley, Terry L [Biotechnology, Biologics and Environmental Protection Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Hyattsville, MD (United States)

    1992-07-01

    This article discusses: 1. Purposes and history of risk assessment: application to biotechnology; 2. Framework in the United States for decisions on organisms produced through biotechnology; 3. Choosing from among potential approaches to assessment: a). exposure assessment does not equate to risk assessment: what are the hazards?; b). Setting risk assessment priorities; c). 'Quantitative' environmental and 'quantitative' ecological risk assessments; d). Ecological risk assessments based on biological and ecological principles. 4. The bases for good regulatory decisions.

  8. Task-based dermal exposure models for regulatory risk assessment.

    Science.gov (United States)

    Warren, Nicholas D; Marquart, Hans; Christopher, Yvette; Laitinen, Juha; VAN Hemmen, Joop J

    2006-07-01

    The regulatory risk assessment of chemicals requires the estimation of occupational dermal exposure. Until recently, the models used were either based on limited data or were specific to a particular class of chemical or application. The EU project RISKOFDERM has gathered a considerable number of new measurements of dermal exposure together with detailed contextual information. This article describes the development of a set of generic task-based models capable of predicting potential dermal exposure to both solids and liquids in a wide range of situations. To facilitate modelling of the wide variety of dermal exposure situations six separate models were made for groupings of exposure scenarios called Dermal Exposure Operation units (DEO units). These task-based groupings cluster exposure scenarios with regard to the expected routes of dermal exposure and the expected influence of exposure determinants. Within these groupings linear mixed effect models were used to estimate the influence of various exposure determinants and to estimate components of variance. The models predict median potential dermal exposure rates for the hands and the rest of the body from the values of relevant exposure determinants. These rates are expressed as mg or microl product per minute. Using these median potential dermal exposure rates and an accompanying geometric standard deviation allows a range of exposure percentiles to be calculated.

  9. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

    The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

  10. Ecological models for regulatory risk assessments of pesticides: Developing a strategy for the future.

    NARCIS (Netherlands)

    Thorbek, P.; Forbes, V.; Heimbach, F.; Hommen, U.; Thulke, H.H.; Brink, van den P.J.

    2010-01-01

    Ecological Models for Regulatory Risk Assessments of Pesticides: Developing a Strategy for the Future provides a coherent, science-based view on ecological modeling for regulatory risk assessments. It discusses the benefits of modeling in the context of registrations, identifies the obstacles that

  11. An ensemble model of QSAR tools for regulatory risk assessment.

    Science.gov (United States)

    Pradeep, Prachi; Povinelli, Richard J; White, Shannon; Merrill, Stephen J

    2016-01-01

    Quantitative structure activity relationships (QSARs) are theoretical models that relate a quantitative measure of chemical structure to a physical property or a biological effect. QSAR predictions can be used for chemical risk assessment for protection of human and environmental health, which makes them interesting to regulators, especially in the absence of experimental data. For compatibility with regulatory use, QSAR models should be transparent, reproducible and optimized to minimize the number of false negatives. In silico QSAR tools are gaining wide acceptance as a faster alternative to otherwise time-consuming clinical and animal testing methods. However, different QSAR tools often make conflicting predictions for a given chemical and may also vary in their predictive performance across different chemical datasets. In a regulatory context, conflicting predictions raise interpretation, validation and adequacy concerns. To address these concerns, ensemble learning techniques in the machine learning paradigm can be used to integrate predictions from multiple tools. By leveraging various underlying QSAR algorithms and training datasets, the resulting consensus prediction should yield better overall predictive ability. We present a novel ensemble QSAR model using Bayesian classification. The model allows for varying a cut-off parameter that allows for a selection in the desirable trade-off between model sensitivity and specificity. The predictive performance of the ensemble model is compared with four in silico tools (Toxtree, Lazar, OECD Toolbox, and Danish QSAR) to predict carcinogenicity for a dataset of air toxins (332 chemicals) and a subset of the gold carcinogenic potency database (480 chemicals). Leave-one-out cross validation results show that the ensemble model achieves the best trade-off between sensitivity and specificity (accuracy: 83.8 % and 80.4 %, and balanced accuracy: 80.6 % and 80.8 %) and highest inter-rater agreement [kappa ( κ ): 0

  12. Bridging the gap between academic research and regulatory health risk assessment of Endocrine Disrupting Chemicals.

    Science.gov (United States)

    Beronius, Anna; Hanberg, Annika; Zilliacus, Johanna; Rudén, Christina

    2014-12-01

    Regulatory risk assessment is traditionally based primarily on toxicity studies conducted according to standardized and internationally validated test guidelines. However, health risk assessment of endocrine disrupting chemicals (EDCs) is argued to rely on the efficient integration of findings from academic research. The aim of this review was to provide an overview of current developments to facilitate the use of academic research in regulatory risk assessment of chemicals and how certain aspects of study design and reporting are particularly important for the risk assessment process. By bridging the gap between academic research and regulatory health risk assessment of EDCs, scientific uncertainty in risk assessment conclusions can be reduced, allowing for better targeted policy decisions for chemical risk reduction. Copyright © 2014. Published by Elsevier Ltd.

  13. Regulatory risk assessment approaches for synthetic mineral fibres.

    Science.gov (United States)

    Harrison, Paul; Holmes, Philip; Bevan, Ruth; Kamps, Klaus; Levy, Leonard; Greim, Helmut

    2015-10-01

    Exposure to synthetic mineral fibres (SMF) may occur in a number of workplace scenarios. To protect worker health, a number of different organisations worldwide have assessed the health risk of these materials and established workplace exposure limits. This paper outlines the basic principles of risk assessment and the scientific methods used to derive valid (justifiable) occupational exposure limits (OELs) and goes on to show how, for SMF, and particularly for refractory ceramic fibre (otherwise known as aluminosilicate wool, RCF/ASW), the methods used and the associated outcomes differ widely. It is argued that the resulting differences in established OELs prevent consistent and appropriate risk management of SMF worldwide, and that development of a transparent and harmonised approach to fibre risk assessment and limit-setting is required. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  14. 77 FR 70846 - Regulatory Guide 1.182, “Assessing and Managing Risk Before Maintenance Activities at Nuclear...

    Science.gov (United States)

    2012-11-27

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0285] Regulatory Guide 1.182, ``Assessing and Managing Risk Before Maintenance Activities at Nuclear Power Plants'' AGENCY: Nuclear Regulatory Commission... withdrawing Regulatory Guide (RG)1.182, Revision (Rev.) 0, ``Assessing and Managing Risk Before Maintenance...

  15. Evolving PBPK applications in regulatory risk assessment: current situation and future goals

    Science.gov (United States)

    The presentation includes current applications of PBPK modeling in regulatory risk assessment and discussions on conflicts between assuring consistency with experimental data in current situation and the desire for animal-free model development.

  16. Nuclear Regulatory Commission probabilistic risk assessment implementation program: A status report

    International Nuclear Information System (INIS)

    Rubin, M.P.; Caruso, M.A.

    1996-01-01

    The US Nuclear Regulatory Commission (NRC) is undertaking a number of activities intended to increase the consideration of risk significance in its decision processes and the effective use of risk-based technologies in its regulatory activities. Although the NRC is moving toward risk-informed regulation throughout its areas of responsibilities, this paper focuses primarily on those issues associated with reactor regulation. As the NRC completed significant milestones in its development of probabilistic risk assessment (PRA) methodology and gained considerable experience in the limited application of risk assessment to selected regulatory activities, it became evident that a much broader use of risk informed approaches offered advantages to both the NRC and the US commercial nuclear industry. This desire to enhance the use of risk assessment is driven by the clear belief that application of PRA methods will result in direct improvements in nuclear power plant operational safety from the perspective of both the regulator and the plant operator. The NRC believed that an overall policy on the use of PRA methods in nuclear regulatory activities should be established so that the many potential applications of PRA could be implemented in a consistent and predictable manner that would promote regulatory stability and efficiency. This paper describes the key activities that the NRC has undertaken to implement the initial stages of an integrated risk-informed regulatory framework

  17. 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.

  18. Assessing and managing regulatory risk in renewable energy: Contrasts between Canada and the United States

    International Nuclear Information System (INIS)

    Holburn, Guy L.F.

    2012-01-01

    Abstact: A challenge for energy firms when considering new investments is to balance expected financial gains against potential risks. However, while investment opportunities in different jurisdictions are often straightforward to identify, the policy or regulatory risks for investors are more difficult to accurately ascertain. Here, I provide a novel conceptual framework for how firms can assess regulatory risk that focuses on the institutional processes governing policy-making. Risks are lower – and policies will subsequently be more stable – in jurisdictions where regulatory agencies have greater autonomy from politicians and where policies are formulated through more ‘rigid’ policy-making processes. The contrasting development patterns of renewable energy policies in Ontario and Texas offer support for the framework. I further develop strategies for how firms can successfully manage regulatory risks in different types of environment. - Highlights: ► The paper provides a conceptual framework for how firms can assess regulatory risk. ► Risks are lower when regulators have greater autonomy from elected politicians. ► Risks are lower when policy-making processes are more ‘rigid’. ► Firms can strategically mitigate regulatory risk in different types of environment.

  19. [GMOs in food: risk assessment, scientific management and regulatory aspects].

    Science.gov (United States)

    Casse, F; Hervieu, F

    2003-03-01

    Genetic transformation constitutes a new tool for improvement of microorganisms, animals and plants used in food. We present foreseeable risks, as well as management measures to avoid unsuspected risks of GMOs. Few risks are specific to GMOs. Present elements of French and European regulations concerning placing on the market and follow up GMOs and other novel foods are described.

  20. Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment.

    Science.gov (United States)

    Abou-El-Enein, Mohamed; Cathomen, Toni; Ivics, Zoltán; June, Carl H; Renner, Matthias; Schneider, Christian K; Bauer, Gerhard

    2017-10-05

    As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Probabilistic risk assessment (PRA): status report and guidance for regulatory application. Draft report for comment

    International Nuclear Information System (INIS)

    1984-02-01

    This document describes the current status of the methodologies used in probabilistic risk assessment (PRA) and provides guidance for the application of the results of PRAs to the nuclear reactor regulatory process. The PRA studies that have been completed or are underway are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed

  2. Relationship between regulatory issues and probabilistic risk assessments

    International Nuclear Information System (INIS)

    Ilberg, D.; Papazoglou, I.

    1985-01-01

    The objective of this study was to obtain some perspective on the characteristics and the relative number of regulatory issues that are PRA related, i.e., can be effectively addressed by plant specific PRA studies. It was also aimed at developing approaches to resolution of regulatory issues as part of plant specific PRAs. Several ongoing NRC programs include a number of safety-related issues which are applicable to operating plants. A number of these issues include aspects that strongly interact with items addressed in PRA studies. The resolution of several generic issues using PRA studies has already started. A review of over 335 issues included in three NRC programs was conducted: Generic Issue Program (GI); Systematic Evaluation Program (SEP); and TMI Action Plan (TMI). The review identifid 240 items related to PRA, 120 of which were judged to have significant effect on core damage frequency. It is believed that these items can be effectively treated in a PRA study that includes internal and external events

  3. Regulatory risk assessments: Is there a need to reduce uncertainty and enhance robustness?

    Science.gov (United States)

    Snodin, D J

    2015-12-01

    A critical evaluation of several recent regulatory risk assessments has been undertaken. These relate to propyl paraben (as a food additive, cosmetic ingredient or pharmaceutical excipient), cobalt (in terms of a safety-based limit for pharmaceuticals) and the cancer Threshold of Toxicological Concern as applied to food contaminants and pharmaceutical impurities. In all cases, a number of concerns can be raised regarding the reliability of the current assessments, some examples being absence of data audits, use of single-dose and/or non-good laboratory practice studies to determine safety metrics, use of a biased data set and questionable methodology and lack of consistency with precedents and regulatory guidance. Drawing on these findings, a set of recommendations is provided to reduce uncertainty and improve the quality and robustness of future regulatory risk assessments. © The Author(s) 2015.

  4. Improved use of workplace exposure data in the regulatory risk assessment of chemicals within Europe.

    Science.gov (United States)

    Money, C D; Margary, S A

    2002-04-01

    The process of risk assessment for human health demands the availability of soundly based effects and exposure information. However, many of the available data, particularly those which seek to describe human exposures to chemicals, are of varying quality and scope. Changing public and regulatory expectations increasingly demand that the outcomes of risk assessments are seen to have duly accounted for these data, in order that their conclusions can be viewed as valid. The challenge for risk assessors, therefore, is how the different grades of data should be integrated within the overall process. A series of core values are identified that govern the relationships and the influence that different types of exposure data have within European Union (EU) regulatory risk assessment for chemicals. Building on these values, an approach is presented for evaluating workplace exposure information in the context of how such data might be used within the EU process for assessing the risks to human health of new and existing substances. The implications of adopting the approach for regulatory risk assessment within the EU and its consequent impact on current occupational hygiene practice are discussed.

  5. Risk assessment: A regulatory strategy for stimulating working environment activities?

    DEFF Research Database (Denmark)

    Jensen, Per Langaa

    2001-01-01

    This paper analyses the Danish approach to workplace assessment (WPA) following European requirements to establish legislation on occupational health and safety. Quantitative studies show that WPA can be interpreted as a success within the larger Danish firms. However, data from qualitative studies...... modify this picture by showing how attention has been focussed on physical working environment problems whilst wider psycho-social problems have been ignored. The paper claims there is no evidence from either the quantitative or the qualitative studies that workplace assessment - even though positively...

  6. Implementing atmospheric fate in regulatory risk assessment of pesticides: (How) can it be done?

    NARCIS (Netherlands)

    Bakker, D.J.; Gilbert, A.J.; Gottschild, D.; Kuchnicki, T.; Laane, R.W.P.M.; Linders, J.B.H.J.; Meent, D. van de; Montforts, M.H.M.M.; Pino, J.; Pol, J.W.; Straalen, N.M. van

    1999-01-01

    Atmospheric fate of pesticides and their possible effects in ecosystems beyond the immediate surrounding of the application site are not actively considered in currently used regulatory, risk assessment schemes. Concern with respect to atmospheric transport and subsequent deposition of pesticides in

  7. Implementing atmospheric fate in regulatory risk assessment of pesticides: (how) can it be done?

    NARCIS (Netherlands)

    Bakker, D.J.; Gilbert, A.J.; Gottschild, D.; Kuchnicki, T.; Laane, R.W.P.M.; Linders, J.B.H.J.; van de Meent, D.; Montforts, M.H.M.M.; Pino, J.; Pol, J.W.; van Straalen, N.M.

    1999-01-01

    Atmospheric fate of pesticides and their possible effects in ecosystems beyond the immediate surrounding of the application site are not actively considered in currently used regulatory, risk assessment schemes. Concern with respect to atmospheric transport and subsequent deposition of pesticides in

  8. Use of probabilistic risk assessments to define areas of possible exemption from regulatory requirements

    International Nuclear Information System (INIS)

    Thompson, C.A.; Carlson, D.; Kolaczkowski, A.; LaChance, J.

    1988-01-01

    The Risk-Based Licensing Program (RBLP) was sponsored by the Department of Energy for the purpose of establishing and demonstrating an approach for identifying potential areas for exemption from current regulatory requirements in the licensing of nuclear power plants. Such an approach could assist in the improvement of the regulatory process for both current and future nuclear plant designs. Use of the methodology could result in streamlining the regulatory process by eliminating unnecessarily detailed reviews of portions of a plant design not important to risk. The RBLP methodology utilizes probabilistic risk assessments, (PRAs), which are required of all future applicants for nuclear power plant licenses. PRA results are used as a screening tool to determine the risk significance of various plant features which are correlated to the risk importance of regulations to identify potential areas for regulatory exemption. Additional consideration is then given to non-risk factors in the final determination of exemption candidates. The RBLP methodology was demonstrated using an existing PRA. The results of the demonstration are highlighted. 10 refs

  9. Work-related stress risk assessment in Italy: a methodological proposal adapted to regulatory guidelines.

    Science.gov (United States)

    Persechino, Benedetta; Valenti, Antonio; Ronchetti, Matteo; Rondinone, Bruna Maria; Di Tecco, Cristina; Vitali, Sara; Iavicoli, Sergio

    2013-06-01

    Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. After close analysis of the Italian and European reference regulatory framework and work-related stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons.

  10. Risk Assessment Review Group report to the U.S. Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Lewis, H.W.; Budnitz, R.J.; Kouts, H.J.C.; Loewenstein, W.B.; Rowe, W.D.; von Hippel, F.; Zachariasen, F.

    1978-09-01

    The Risk Assessment Review Group was organized by the U.S. Nuclear Regulatory Commission on July 1, 1977, with four elements to its charter: clarify the achievements and limitations of WASH-1400, the ''Rasmussen Report''; assess the peer comments thereon, and responses to those comments; study the present state of such risk assessment methodology; and recommend to the Commission how (and whether) such methodology can be used in the regulatory and licensing process. Areas of study include: risk assessment methodologies; statistical issues; completeness; the data base; and the WASH-1400 assessment of the damage to human health from radiation after a postulated accident. Specific items discussed include: Browns Ferry; common cause failure; human factors; format and scrutability; the peer review process; earthquakes; risk perception; allegations by UCS concerning WASH-1400 treatment of quality assurance and quality control; current role of probabilistic methods in the regulatory process; acts of violence; ATWS; influence of design defects in quality assurance failures; and calculation of population doses from given releases of radionuclides

  11. Use of new scientific developments in regulatory risk assessments: challenges and opportunities.

    Science.gov (United States)

    Tarazona, Jose V

    2013-07-01

    Since the 1990s, science based ecological risk assessments constitute an essential tool for supporting decision making in the regulatory context. Using the European REACH Regulation as example, this article presents the challenges and opportunities for new scientific developments within the area of chemical control and environmental protection. These challenges can be sorted out in 3 main related topics (sets). In the short term, the challenges are directly associated with the regulatory requirements, required for facilitating a scientifically sound implementation of the different obligations for industry and authorities. It is important to mention that although the actual tools are different due to the regulatory requirements, the basic needs are still the same as those addressed in the early 1990s: understanding the ecological relevance of the predicted effects, including the uncertainty, and facilitating the link with the socio-economic assessment. The second set of challenges covers the opportunities for getting an added value from the regulatory efforts. The information compiled through REACH registration and notification processes is analyzed as source for new integrative developments for assessing the combined chemical risk at the regional level. Finally, the article discusses the challenge of inverting the process and developing risk assessment methods focusing on the receptor, the individual or ecosystem, instead of on the stressor or source. These approaches were limited in the past due to the lack of information, but the identification and dissemination of standard information, including uses, manufacturing sites, physical-chemical, environmental, ecotoxicological, and toxicological properties as well as operational conditions and risk management measures for thousands of chemicals, combined by the knowledge gathered through large scale monitoring programs and spatial information systems is generating new opportunities. The challenge is liking

  12. Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective.

    Science.gov (United States)

    Johnson, F Reed; Zhou, Mo

    Demands for greater transparency in US regulatory assessments of benefits and risks, together with growing interest in engaging patients in Food and Drug Administration regulatory decision making, have resulted in several recent regulatory developments. Although Food and Drug Administration's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) have established patient-engagement initiatives, CDRH has proposed guidelines for considering quantitative data on patients' benefit-risk perspectives, while CDER has focused on a more qualitative approach. We summarize two significant studies that were developed in collaboration and consultation with CDER and CDRH. CDER encouraged a patient advocacy group to propose draft guidance on engaging patient and caregiver stakeholders in regulatory decision making for Duchenne muscular dystrophy. CDRH sponsored a discrete-choice experiment case study to quantify obese respondents' perspectives on "meaningful benefits." CDRH and CDER issued draft guidance in May and June 2015, respectively, on including patient-preference data in regulatory submissions. Both organizations face challenges. CDER is working on integrating qualitative data into existing evidence-based review processes and is exploring options for therapeutic areas not included on a priority list. CDRH has adopted an approach that requires patient-preference data to satisfy standards of valid scientific evidence. Although that strategy could facilitate integrating patient perspectives directly with clinical data on benefits and harms, generating such data requires building capacity. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  13. Ecological models in support of regulatory risk assessments of pesticides: developing a strategy for the future.

    Science.gov (United States)

    Forbes, Valery E; Hommen, Udo; Thorbek, Pernille; Heimbach, Fred; Van den Brink, Paul J; Wogram, Jörn; Thulke, Hans-Hermann; Grimm, Volker

    2009-01-01

    This brief communication reports on the main findings of the LEMTOX workshop, held from 9 to 12 September 2007, at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. The workshop brought together a diverse group of stakeholders from academia, regulatory authorities, contract research organizations, and industry, representing Europe, the United States, and Asia, to discuss the role of ecological modeling in risk assessments of pesticides, particularly under the European regulatory framework. The following questions were addressed: What are the potential benefits of using ecological models in pesticide registration and risk assessment? What obstacles prevent ecological modeling from being used routinely in regulatory submissions? What actions are needed to overcome the identified obstacles? What recommendations should be made to ensure good modeling practice in this context? The workshop focused exclusively on population models, and discussion was focused on those categories of population models that link effects on individuals (e.g., survival, growth, reproduction, behavior) to effects on population dynamics. The workshop participants concluded that the overall benefits of ecological modeling are that it could bring more ecology into ecological risk assessment, and it could provide an excellent tool for exploring the importance of, and interactions among, ecological complexities. However, there are a number of challenges that need to be overcome before such models will receive wide acceptance for pesticide risk assessment, despite having been used extensively in other contexts (e.g., conservation biology). The need for guidance on Good Modeling Practice (on model development, analysis, interpretation, evaluation, documentation, and communication), as well as the need for case studies that can be used to explore the added value of ecological models for risk assessment, were identified as top priorities. Assessing recovery potential of exposed

  14. Improving the applicability of (Q)SARs for percutaneous penetration in regulatory risk assessment.

    Science.gov (United States)

    Bouwman, T; Cronin, M T D; Bessems, J G M; van de Sandt, J J M

    2008-04-01

    The new regulatory framework REACH (Registration, Evaluation, and Authorisation of Chemicals) foresees the use of non-testing approaches, such as read-across, chemical categories, structure-activity relationships (SARs) and quantitative structure-activity relationships (QSARs). Although information on skin absorption data are not a formal requirement under REACH, data on dermal absorption are an integral part of risk assessment of substances/products to which man is predominantly exposed via the dermal route. In this study, we assess the present applicability of publicly available QSARs on skin absorption for risk assessment purposes. We explicitly did not aim to give scientific judgments on individual QSARs. A total of 33 QSARs selected from the public domain were evaluated using the OECD (Organisation for Economic Co-operation and Development) Principles for the Validation of (Q)SAR Models. Additionally, several pragmatic criteria were formulated to select QSARs that are most suitable for their use in regulatory risk assessment. Based on these criteria, four QSARs were selected. The predictivity of these QSARs was evaluated by comparing their outcomes with experimentally derived skin absorption data (for 62 compounds). The predictivity was low for three of four QSARs, whereas one model gave reasonable predictions. Several suggestions are made to increase the applicability of QSARs for skin absorption for risk assessment purposes.

  15. Regulatory risk coherence

    International Nuclear Information System (INIS)

    Remick, F.J.

    1992-01-01

    As one of the most progressive users of risk assessment in decision making, the US Nuclear Regulatory Commission (NRC) is in a position to play an important role in influencing the development of standard government wide policies for the application of risk assessment in decision making. The NRC, with the support of the nuclear industry, should use the opportunity provided by its experience with risk assessment to actively encourage the adoption of standard national and international health-based safety goals and at the same time accelerate its own efforts to implement the safety goals it has already developed for itself. There are signs of increased recognition of the need for consistency and coherence in the application of risk assessment in government decision making. The NRC and the nuclear industry have recently taken a great step toward establishing a consistant and coherent risk assessment-based culture in the US nuclear industry. As a result of Generic Letter 88-20, which asks each commercial nuclear power plant licensee to perform an individual plant examination by September 1992, for the first time a risk assessment characterizing initiating events in each plant will exist

  16. Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report

    International Nuclear Information System (INIS)

    2000-01-01

    OAK B188 Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report. The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-formed approach for the design and regulation of nuclear power plants. This approach will include the development and/or confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRS) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go further by focusing on the design of new plants

  17. Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-08-01

    OAK B188 Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report. The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-formed approach for the design and regulation of nuclear power plants. This approach will include the development and/or confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRS) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go further by focusing on the design of new plants.

  18. Should the scope of human mixture risk assessment span legislative/regulatory silos for chemicals?

    Science.gov (United States)

    Evans, Richard M; Martin, Olwenn V; Faust, Michael; Kortenkamp, Andreas

    2016-02-01

    Current chemicals regulation operates almost exclusively on a chemical-by-chemical basis, however there is concern that this approach may not be sufficiently protective if two or more chemicals have the same toxic effect. Humans are indisputably exposed to more than one chemical at a time, for example to the multiple chemicals found in food, air and drinking water, and in household and consumer products, and in cosmetics. Assessment of cumulative risk to human health and/or the environment from multiple chemicals and routes can be done in a mixture risk assessment (MRA). Whilst there is a broad consensus on the basic science of mixture toxicology, the path to regulatory implementation of MRA within chemical risk assessment is less clear. In this discussion piece we pose an open question: should the scope of human MRA cross legislative remits or 'silos'? We define silos as, for instance, legislation that defines risk assessment practice for a subset of chemicals, usually on the basis of substance/product, media or process orientation. Currently any form of legal mandate for human MRA in the EU is limited to only a few pieces of legislation. We describe two lines of evidence, illustrated with selected examples, that are particularly pertinent to this question: 1) evidence that mixture effects have been shown for chemicals regulated in different silos and 2) evidence that humans are co-exposed to chemicals from different silos. We substantiate the position that, because there is no reason why chemicals allocated to specific regulatory silos would have non-overlapping risk profiles, then there is also no reason to expect that MRA limited only to chemicals within one silo can fully capture the risk that may be present to human consumers. Finally, we discuss possible options for implementation of MRA and we hope to prompt wider discussion of this issue. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

  19. A review of human biomonitoring data used in regulatory risk assessment under Canada's Chemicals Management Program.

    Science.gov (United States)

    Zidek, Angelika; Macey, Kristin; MacKinnon, Leona; Patel, Mikin; Poddalgoda, Devika; Zhang, Yi

    2017-03-01

    As a part of the Chemicals Management Plan launched in 2006, the Government of Canada is assessing and managing, where appropriate, the potential health and ecological risks associated with approximately 4300 substances under the Canadian Environmental Protection Act (1999). Since that time, nearly 3000 substances have been assessed, with human biomonitoring (HBM) data playing an increasingly important role for some substances. Case studies are presented, including both inorganic and organic substances (i.e., selenium, triclosan, phthalates), which highlight the impact and overall role HBM has had in regulatory decision making in Canada for these three substances as well as criteria used in the application of HBM data in human health risk assessment. An overview of its limitations in terms of how and when HBM data can be applied, when assessing human health in a regulatory setting, is discussed as well as the role HBM data can play in priority setting. Crown Copyright © 2016. Published by Elsevier GmbH. All rights reserved.

  20. Regulatory Forum commentary: alternative mouse models for future cancer risk assessment.

    Science.gov (United States)

    Morton, Daniel; Sistare, Frank D; Nambiar, Prashant R; Turner, Oliver C; Radi, Zaher; Bower, Nancy

    2014-07-01

    International regulatory and pharmaceutical industry scientists are discussing revision of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) S1 guidance on rodent carcinogenicity assessment of small molecule pharmaceuticals. A weight-of-evidence approach is proposed to determine the need for rodent carcinogenicity studies. For compounds with high human cancer risk, the product may be labeled appropriately without conducting rodent carcinogenicity studies. For compounds with minimal cancer risk, only a 6-month transgenic mouse study (rasH2 mouse or p53+/- mouse) or a 2-year mouse study would be needed. If rodent carcinogenicity testing may add significant value to cancer risk assessment, a 2-year rat study and either a 6-month transgenic mouse or a 2-year mouse study is appropriate. In many cases, therefore, one rodent carcinogenicity study could be sufficient. The rasH2 model predicts neoplastic findings relevant to human cancer risk assessment as well as 2-year rodent models, produces fewer irrelevant neoplastic outcomes, and often will be preferable to a 2-year rodent study. Before revising ICH S1 guidance, a prospective evaluation will be conducted to test the proposed weight-of-evidence approach. This evaluation offers an opportunity for a secondary analysis comparing the value of alternative mouse models and 2-year rodent studies in the proposed ICH S1 weight-of-evidence approach for human cancer risk assessment. © 2014 by The Author(s).

  1. Prioritization of chemicals in the aquatic environment based on risk assessment: analytical, modeling and regulatory perspective.

    Science.gov (United States)

    Guillén, D; Ginebreda, A; Farré, M; Darbra, R M; Petrovic, M; Gros, M; Barceló, D

    2012-12-01

    The extensive and intensive use of chemicals in our developed, highly technological society includes more than 100,000 chemical substances. Significant scientific evidence has lead to the recognition that their improper use and release may result in undesirable and harmful side-effects on both the human and ecosystem health. To cope with them, appropriate risk assessment processes and related prioritization schemes have been developed in order to provide the necessary scientific support for regulatory procedures. In the present paper, two of the elements that constitute the core of risk assessment, namely occurrence and hazard effects, have been discussed. Recent advances in analytical chemistry (sample pre-treatment and instrumental equipment, etc.) have allowed for more comprehensive monitoring of environmental pollution reaching limits of detection up to sub ng L(-1). Alternative to analytical measurements, occurrence models can provide risk managers with a very interesting approach for estimating environmental concentrations from real or hypothetical scenarios. The most representative prioritization schemes used for issuing lists of concerning chemicals have also been examined and put in the context of existing environmental policies for protection strategies and regulations. Finally, new challenges in the field of risk-assessment have been outlined, including those posed by new materials (i.e., nanomaterials), transformation products, multi-chemical exposure, or extension of the risk assessment process to the whole ecosystem. Copyright © 2012 Elsevier B.V. All rights reserved.

  2. Development of a Quantitative Framework for Regulatory Risk Assessments: Probabilistic Approaches

    International Nuclear Information System (INIS)

    Wilmot, R.D.

    2003-11-01

    The Swedish regulators have been active in the field of performance assessment for many years and have developed sophisticated approaches to the development of scenarios and other aspects of assessments. These assessments have generally used dose as the assessment end-point and have been based on deterministic calculations. Recently introduced Swedish regulations have introduced a risk criterion for radioactive waste disposal: the annual risk of harmful effects after closure of a disposal facility should not exceed 10 -6 for a representative individual in the group exposed to the greatest risk. A recent review of the overall structure of risk assessments in safety cases concluded that there are a number of decisions and assumptions in the development of a risk assessment methodology that could potentially affect the calculated results. Regulatory understanding of these issues, potentially supported by independent calculations, is important in preparing for review of a proponent's risk assessment. One approach to evaluating risk in performance assessments is to use the concept of probability to express uncertainties, and to propagate these probabilities through the analysis. This report describes the various approaches available for undertaking such probabilistic analyses, both as a means of accounting for uncertainty in the determination of risk and more generally as a means of sensitivity and uncertainty analysis. The report discusses the overall nature of probabilistic analyses and how they are applied to both the calculation of risk and sensitivity analyses. Several approaches are available, including differential analysis, response surface methods and simulation. Simulation is the approach most commonly used, both in assessments for radioactive waste disposal and in other subject areas, and the report describes the key stages of this approach in detail. Decisions relating to the development of input PDFs, sampling methods (including approaches to the treatment

  3. Review of various approaches for assessing public health risks in regulatory decision making: choosing the right approach for the problem.

    Science.gov (United States)

    Dearfield, Kerry L; Hoelzer, Karin; Kause, Janell R

    2014-08-01

    Stakeholders in the public health risk analysis community can possess differing opinions about what is meant by "conduct a risk assessment." In reality, there is no one-size-fits-all risk assessment that can address all public health issues, problems, and regulatory needs. Although several international and national organizations (e.g., Codex Alimentarius Commission, Office International des Epizooties, Food and Agricultural Organization, World Health Organization, National Research Council, and European Food Safety Authority) have addressed this issue, confusion remains. The type and complexity of a risk assessment must reflect the risk management needs to appropriately inform a regulatory or nonregulatory decision, i.e., a risk assessment is ideally "fit for purpose" and directly applicable to risk management issues of concern. Frequently however, there is a lack of understanding by those not completely familiar with risk assessment regarding the specific utility of different approaches for assessing public health risks. This unfamiliarity can unduly hamper the acceptance of risk assessment results by risk managers and may reduce the usefulness of such results for guiding public health policies, practices, and operations. Differences in interpretation of risk assessment terminology further complicate effective communication among risk assessors, risk managers, and stakeholders. This article provides an overview of the types of risk assessments commonly conducted, with examples primarily from the food and agricultural sectors, and a discussion of the utility and limitations of these specific approaches for assessing public health risks. Clarification of the risk management issues and corresponding risk assessment design needs during the formative stages of the risk analysis process is a key step for ensuring that the most appropriate assessment of risk is developed and used to guide risk management decisions.

  4. Improving the relevance and efficiency of human exposure assessments within the process of regulatory risk assessment.

    Science.gov (United States)

    Money, Chris

    2018-01-24

    The process for undertaking exposure assessments varies dependent on its purpose. But for exposure assessments to be relevant and accurate, they are reliant on access to reliable information on key exposure determinants. Acquiring such information is seldom straightforward and can take significant time and resources. This articles examines how the application of tiered and targeted approaches to information acquisition, within the context of European human health risk assessments, can not only lead to improvements in the efficiency and effectiveness of the process but also in the confidence of stakeholders in its outputs. The article explores how the benefits might be further improved through the coordination of such activities, as well as those areas that represent barriers to wider international harmonisation.

  5. Determinants of dermal exposure relevant for exposure modelling in regulatory risk assessment.

    Science.gov (United States)

    Marquart, J; Brouwer, D H; Gijsbers, J H J; Links, I H M; Warren, N; van Hemmen, J J

    2003-11-01

    Risk assessment of chemicals requires assessment of the exposure levels of workers. In the absence of adequate specific measured data, models are often used to estimate exposure levels. For dermal exposure only a few models exist, which are not validated externally. In the scope of a large European research programme, an analysis of potential dermal exposure determinants was made based on the available studies and models and on the expert judgement of the authors of this publication. Only a few potential determinants appear to have been studied in depth. Several studies have included clusters of determinants into vaguely defined parameters, such as 'task' or 'cleaning and maintenance of clothing'. Other studies include several highly correlated parameters, such as 'amount of product handled', 'duration of task' and 'area treated', and separation of these parameters to study their individual influence is not possible. However, based on the available information, a number of determinants could clearly be defined as proven or highly plausible determinants of dermal exposure in one or more exposure situation. This information was combined with expert judgement on the scientific plausibility of the influence of parameters that have not been extensively studied and on the possibilities to gather relevant information during a risk assessment process. The result of this effort is a list of determinants relevant for dermal exposure models in the scope of regulatory risk assessment. The determinants have been divided into the major categories 'substance and product characteristics', 'task done by the worker', 'process technique and equipment', 'exposure control measures', 'worker characteristics and habits' and 'area and situation'. To account for the complex nature of the dermal exposure processes, a further subdivision was made into the three major processes 'direct contact', 'surface contact' and 'deposition'.

  6. 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.

  7. Improving the Clinical Pharmacologic Assessment of Abuse Potential: Part 1: Regulatory Context and Risk Management.

    Science.gov (United States)

    Sellers, Edward M

    2018-02-01

    This article brings to the attention of drug developers the Food and Drug Administration's (FDA's) recent final Guidance to Industry on Assessment of Abuse Potential and provides practical suggestions about compliance with the Guidance. The Guidance areas are reviewed, analyzed, and placed in the context of current scientific knowledge and best practices to mitigate regulatory risk. The Guidance provides substantial new detail on what needs to be done at all stages of drug development for central nervous system-active drugs. However, because many psychopharmacologic agents have unique preclinical and clinical features, the plan for each agent needs to be not only carefully prepared but also reviewed and approved by the FDA. Examples are provided where assumptions about interpretation of the Guidance can delay development. If the expertise and experience needed for assessing abuse potential during drug development do not exist within a company, external preclinical and clinical expert should be involved. Consultation with the FDA is encouraged and important because the specific requirements for each drug will vary.

  8. Nanomaterial categorization for assessing risk potential to facilitate regulatory decision-making.

    Science.gov (United States)

    Godwin, Hilary; Nameth, Catherine; Avery, David; Bergeson, Lynn L; Bernard, Daniel; Beryt, Elizabeth; Boyes, William; Brown, Scott; Clippinger, Amy J; Cohen, Yoram; Doa, Maria; Hendren, Christine Ogilvie; Holden, Patricia; Houck, Keith; Kane, Agnes B; Klaessig, Frederick; Kodas, Toivo; Landsiedel, Robert; Lynch, Iseult; Malloy, Timothy; Miller, Mary Beth; Muller, Julie; Oberdorster, Gunter; Petersen, Elijah J; Pleus, Richard C; Sayre, Philip; Stone, Vicki; Sullivan, Kristie M; Tentschert, Jutta; Wallis, Philip; Nel, Andre E

    2015-01-01

    For nanotechnology to meet its potential as a game-changing and sustainable technology, it is important to ensure that the engineered nanomaterials and nanoenabled products that gain entry to the marketplace are safe and effective. Tools and methods are needed for regulatory purposes to allow rapid material categorization according to human health and environmental risk potential, so that materials of high concern can be targeted for additional scrutiny, while material categories that pose the least risk can receive expedited review. Using carbon nanotubes as an example, we discuss how data from alternative testing strategies can be used to facilitate engineered nanomaterial categorization according to risk potential and how such an approach could facilitate regulatory decision-making in the future.

  9. White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.

    Science.gov (United States)

    Wilks, M F; Roth, N; Aicher, L; Faust, M; Papadaki, P; Marchis, A; Calliera, M; Ginebreda, A; Andres, S; Kühne, R; Schüürmann, G

    2015-07-15

    The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more

  10. Where are we in risk assessment of food allergens? The regulatory view

    DEFF Research Database (Denmark)

    Madsen, Charlotte Bernhard

    2001-01-01

    of different allergens in different patient populations is needed. Exposure assessment is possible but may not be easy. Determining the distribution of contamination with an allergen may be crucial. To do risk characterization, and as a consequence to be able to manage risk, knowledge of a threshold for effect...

  11. Heart Rate Variability: New Perspectives on Physiological Mechanisms, Assessment of Self-regulatory Capacity, and Health risk.

    Science.gov (United States)

    McCraty, Rollin; Shaffer, Fred

    2015-01-01

    Heart rate variability, the change in the time intervals between adjacent heartbeats, is an emergent property of interdependent regulatory systems that operates on different time scales to adapt to environmental and psychological challenges. This article briefly reviews neural regulation of the heart and offers some new perspectives on mechanisms underlying the very low frequency rhythm of heart rate variability. Interpretation of heart rate variability rhythms in the context of health risk and physiological and psychological self-regulatory capacity assessment is discussed. The cardiovascular regulatory centers in the spinal cord and medulla integrate inputs from higher brain centers with afferent cardiovascular system inputs to adjust heart rate and blood pressure via sympathetic and parasympathetic efferent pathways. We also discuss the intrinsic cardiac nervous system and the heart-brain connection pathways, through which afferent information can influence activity in the subcortical, frontocortical, and motor cortex areas. In addition, the use of real-time HRV feedback to increase self-regulatory capacity is reviewed. We conclude that the heart's rhythms are characterized by both complexity and stability over longer time scales that reflect both physiological and psychological functional status of these internal self-regulatory systems.

  12. Determinants of Dermal Exposure Relevant for Exposure Modelling in Regulatory Risk Assessment

    NARCIS (Netherlands)

    Marquart, J.; Brouwer, D.H.; Gijsbers, J.H.J.; Links, I.H.M.; Warren, N.; Hemmen, J.J. van

    2003-01-01

    Risk assessment of chemicals requires assessment of the exposure levels of workers. In the absence of adequate specific measured data, models are often used to estimate exposure levels. For dermal exposure only a few models exist, which are not validated externally. In the scope of a large European

  13. Work-Related Stress Risk Assessment in Italy: A Methodological Proposal Adapted to Regulatory Guidelines

    Directory of Open Access Journals (Sweden)

    Benedetta Persechino

    2013-06-01

    Conclusion: This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons.

  14. Default values for assessment of potential dermal exposure of the hands to industrial chemicals in the scope of regulatory risk assessments

    NARCIS (Netherlands)

    Marquart, H.; Warren, N.D.; Laitinen, J.; Hemmen, J.J. van

    2006-01-01

    Dermal exposure needs to be addressed in regulatory risk assessment of chemicals. The models used so far are based on very limited data. The EU project RISKOFDERM has gathered a large number of new measurements on dermal exposure to industrial chemicals in various work situations, together with

  15. How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

    Science.gov (United States)

    Tyner, Katherine M; Zheng, Nan; Choi, Stephanie; Xu, Xiaoming; Zou, Peng; Jiang, Wenlei; Guo, Changning; Cruz, Celia N

    2017-07-01

    The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

  16. 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.

  17. A review of regulatory risk assessment with formaldehyde as an example.

    Science.gov (United States)

    Imbus, H R

    1988-09-01

    Quantitative risk assessment may vary by over a millionfold depending upon the model used. The EPA currently uses models which project the highest potential risk. Furthermore, there is no consideration of the probability that a chemical is a human carcinogen. Such an approach may result in unrealistically high risk at exposures far below current ambient levels. In the case of formaldehyde, three alternative approaches to risk assessment are examined. One uses the maximum likelihood estimate of the multistage model, another uses the no observable adverse effect level divided by a safety factor of 100, and the third uses a probability estimate that the substance is carcinogenic at typical ambient exposures multiplied by EPA's upper bound estimate. The probability estimate is made from considerations of metabolism and pharmacokinetics, toxicology, short-term tests, animal tests, and epidemiology.

  18. Neonicotinoids and bees: The case of the European regulatory risk assessment.

    Science.gov (United States)

    Auteri, Domenica; Arena, Maria; Barmaz, Stefania; Ippolito, Alessio; Linguadoca, Alberto; Molnar, Tunde; Sharp, Rachel; Szentes, Csaba; Vagenende, Benedicte; Verani, Alessia

    2017-02-01

    Neonicotinoid insecticides are systemic pesticides authorised in Europe since 1991. From their introduction on the market, they have received significant attention from the scientific community, particularly regarding the assessment of lethal and sublethal effects on bees. The availability of scientific evidence alongside some concerns raised on the bee health led to the development of more articulate risk assessment methodologies for pesticides. To support the European Commission in its decision-making process, since 2012 EFSA has been requested to evaluate the risk to bees posed by the exposure to neonicotinoids. The outcome of the EFSA evaluations has been used by risk managers to revise the approval conditions of the substances clothianidin, imidacloprid and thiamethoxam and to impose severe restrictions on their use. Meanwhile, a number of new studies have been carried out. EFSA is evaluating these data in order to further support the decision-making process with updated scientific assessments. Copyright © 2016 Elsevier B.V. All rights reserved.

  19. Use of rodent data for cancer risk assessment of smokeless tobacco in the regulatory context.

    Science.gov (United States)

    Nilsson, Robert

    2017-08-01

    To support risk management decisions, information from different fields has been integrated in this presentation to provide a realistic quantitative cancer risk assessment of smokeless tobacco. Smoking among Swedish men is currently below 10%, while about 20% use a special smokeless tobacco (snus) as a substitute for cigarettes. Epidemiological data and molecular biomarkers demonstrate that rodent bioassays with tobacco specific nitrosamines (TSNA) overestimate cancer risk from snus by more than one order of magnitude. The underlying reasons are discussed. DNA damage constitutes a necessary, although not sufficient prerequisite for cancer initiation. Individuals who have not used tobacco exhibit DNA lesions identical with those induced by TSNA. No increase above this adduct background can be shown from snus, and extensive epidemiological studies in Sweden have failed to demonstrate elevated cancer risks even in long term users. A "bench mark" for acceptable risk of 1/10(6) derived from rodent data has been suggested when regulating snus. By relating similarly derived estimates for some food contaminants, the implementation even of a limit of 1/10(4) may be unrealistic. The management of smokeless tobacco products has rarely been based on a scientifically sound risk assessment, where attention is given to the outstandingly higher hazards associated with smoking. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Are Lead Exposures a Risk in European Fresh Waters? A Regulatory Assessment Accounting for Bioavailability.

    Science.gov (United States)

    Peters, Adam; Wilson, Iain; Merrington, Graham; Chowdhury, M Jasim

    2018-01-01

    An indicative compliance assessment of the Europe-wide bioavailable lead Environmental Quality Standard of 1.2 µg L -1 (EQS) was undertaken against regulatory freshwater monitoring data from six European member states and FOREGS database. Bio-met, a user-friendly tool based upon Biotic Ligand Models (BLMs) was used to account for bioavailability, along with the current European Water Framework Directive lead dissolved organic carbon correction approach. The outputs from both approaches were compared to the BLM. Of the 9054 freshwater samples assessed only 0.6% exceeded the EQS of 1.2 µg L -1 after accounting for bioavailability. The data showed that ambient background concentrations of lead across Europe are unlikely to influence general compliance with the EQS, although there may be isolated local issues. The waters showing the greatest sensitivity to potential lead exposures are characterized by relatively low DOC (< 0.5 mg L -1 ), regardless of the pH and calcium concentrations.

  1. MISSING WELL LOCATIONS: AN ENVIRONMENTAL RISK ASSESSMENT AND REGULATORY PROBLEM FOR LOUISIANA

    Energy Technology Data Exchange (ETDEWEB)

    Brian Harder; Chacko John

    2003-04-01

    The focus of this project is to examine 48,953 well permits and create a digital database of the locations from various public records. The Basin Research Institute (BRI), Louisiana State University, in cooperation with the Louisiana Department of Natural Resources, Office of Conservation, will obtain paper records of each well permit. Using various purchased commercial oil and gas, mapping and surveying software and data management programs, (Geographix, Arcview, AutoCad Map and ProCogo) a digital latitude and longitude for each of the missing wells is being obtained. Current status of the project is that all 48,953 permits have been examined. Of that total 48,559 have been completed and digital locations have been obtained, 270 need additional information to be completed, and no determination is possible for 124 well permits. Upon completion each permit is placed in one of the following databases determined by status-Active Producers (11,450) of which 11,444 are complete or 99.99%, Shut-in Producers (2,305) of which 2,300 are complete or 99.78%, Abandoned Previous Producer (17,513) of which 17,332 are complete or 98.96%, Abandoned Dry (9,029) of which 8,883 are complete or 98.38%, Permit Expired (7,083) of which 7,040 are complete or 99.39%, and Miscellaneous Wells (1,573) of which 1,560 are complete or 99.17%. The databases will be available in both digital and hard copy format. The completed database will help Louisiana implement risk-based regulatory policies and streamline existing policies, and provide industry and the public with access to information for all phases of the oil and gas business.

  2. Improving the applicability of (Q)SARs for percutaneous penetration in regulatory risk assessment.

    NARCIS (Netherlands)

    Bouwman, T.; Cronin, M.T.; Bessems, J.G.; Sandt, J.J. van de

    2008-01-01

    The new regulatory framework REACH (Registration, Evaluation, and Authorisation of Chemicals) foresees the use of non-testing approaches, such as read-across, chemical categories, structure-activity relationships (SARs) and quantitative structure-activity relationships (QSARs). Although information

  3. Developing the Regulatory Utility of the Exposome: Mapping Exposures for Risk Assessment through Lifestage Exposome Snapshots (LEnS).

    Science.gov (United States)

    Shaffer, Rachel M; Smith, Marissa N; Faustman, Elaine M

    2017-08-07

    Exposome-related efforts aim to document the totality of human exposures across the lifecourse. This field has advanced rapidly in recent years but lacks practical application to risk assessment, particularly for children's health. Our objective was to apply the exposome to children's health risk assessment by introducing the concept of Lifestage Exposome Snapshots (LEnS). Case studies are presented to illustrate the value of the framework. The LEnS framework encourages organization of exposome studies based on windows of susceptibility for particular target organ systems. Such analyses will provide information regarding cumulative impacts during specific critical periods of the life course. A logical extension of this framework is that regulatory standards should analyze exposure information by target organ, rather than for a single chemical only or multiple chemicals grouped solely by mechanism of action. The LEnS concept is a practical refinement to the exposome that accounts for total exposures during particular windows of susceptibility in target organ systems. Application of the LEnS framework in risk assessment and regulation will improve protection of children's health by enhancing protection of sensitive developing organ systems that are critical for lifelong health and well-being. https://doi.org/10.1289/EHP1250.

  4. Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives.

    Science.gov (United States)

    Leong, James; McAuslane, Neil; Walker, Stuart; Salek, Sam

    2013-09-01

    To explore the current status and need for a universal benefit-risk framework for medicines in regulatory agencies and pharmaceutical companies. A questionnaire was developed and sent to 14 mature regulatory agencies and 24 major companies. The data were analysed using descriptive statistics, for a minority of questions preceded by manual grouping of the responses. Overall response rate was 82%, and study participants included key decision makers from agencies and companies. None used a fully quantitative system, most companies preferring a qualitative method. The major reasons for this group not using semi-quantitative or quantitative systems were lack of a universal and scientifically validated framework. The main advantages of a benefit-risk framework were that it provided a systematic standardised approach to decision-making and that it acted as a tool to enhance quality of communication. It was also reported that a framework should be of value to both agencies and companies throughout the life cycle of a product. They believed that it is possible to develop an overarching benefit-risk framework that should involve relevant stakeholders in the development, validation and application of a universal framework. The entire cohort indicated common barriers to implementing a framework were resource limitations, a lack of knowledge and a scientifically validated and acceptable framework. Stakeholders prefer a semi-quantitative, overarching framework that incorporates a toolbox of different methodologies. A coordinating committee of relevant stakeholders should be formed to guide its development and implementation. Through engaging the stakeholders, these outcomes confirm sentiments and need for developing a universal benefit-risk assessment framework. Copyright © 2013 John Wiley & Sons, Ltd.

  5. Ecological Models in Support of Regulatory Risk Assessments of Pesticides: Developing a Strategy for the Future

    NARCIS (Netherlands)

    Forbes, V.E.; Hommen, U.; Thorbek, P.; Heimbach, F.; Brink, van den P.J.; Wogram, J.; Thulke, H.H.; Grimm, V.

    2009-01-01

    This brief communication reports on the main findings of the LEMTOX workshop, held from 9 to 12 September 2007, at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. The workshop brought together a diverse group of stakeholders from academia, regulatory authorities, contract

  6. Politically Induced Regulatory Risk and Independent Regulatory Agencies

    OpenAIRE

    Strausz, Roland

    2015-01-01

    Uncertainty in election outcomes generates politically induced regulatory risk. Political parties' risk attitudes towards such risk depend on a fluctuation effect that hurts both parties and an output--expansion effect that benefits at least one party. Notwithstanding the parties' risk attitudes, political parties have incentives to negotiate away all regulatory risk by pre-electoral bargaining. Efficient pre-electoral bargaining outcomes fully eliminate politically induced regulatory risk. P...

  7. Quantitative structure-activity relationships for predicting potential ecological hazard of organic chemicals for use in regulatory risk assessments.

    Science.gov (United States)

    Comber, Mike H I; Walker, John D; Watts, Chris; Hermens, Joop

    2003-08-01

    The use of quantitative structure-activity relationships (QSARs) for deriving the predicted no-effect concentration of discrete organic chemicals for the purposes of conducting a regulatory risk assessment in Europe and the United States is described. In the United States, under the Toxic Substances Control Act (TSCA), the TSCA Interagency Testing Committee and the U.S. Environmental Protection Agency (U.S. EPA) use SARs to estimate the hazards of existing and new chemicals. Within the Existing Substances Regulation in Europe, QSARs may be used for data evaluation, test strategy indications, and the identification and filling of data gaps. To illustrate where and when QSARs may be useful and when their use is more problematic, an example, methyl tertiary-butyl ether (MTBE), is given and the predicted and experimental data are compared. Improvements needed for new QSARs and tools for developing and using QSARs are discussed.

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

    DEFF Research Database (Denmark)

    Syberg, Kristian; Hansen, Steffen Foss

    2016-01-01

    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...

  9. Epidemiologic studies of occupational pesticide exposure and cancer: regulatory risk assessments and biologic plausibility.

    Science.gov (United States)

    Acquavella, John; Doe, John; Tomenson, John; Chester, Graham; Cowell, John; Bloemen, Louis

    2003-01-01

    Epidemiologic studies frequently show associations between self-reported use of specific pesticides and human cancers. These findings have engendered debate largely on methodologic grounds. However, biologic plausibility is a more fundamental issue that has received only superficial attention. The purpose of this commentary is to review briefly the toxicology and exposure data that are developed as part of the pesticide regulatory process and to discuss the applicability of this data to epidemiologic research. The authors also provide a generic example of how worker pesticide exposures might be estimated and compared to relevant toxicologic dose levels. This example provides guidance for better characterization of exposure and for consideration of biologic plausibility in epidemiologic studies of pesticides.

  10. The use of probabilistic risk assessment to satisfy the Nuclear Regulatory Commission's maintenance rule

    International Nuclear Information System (INIS)

    Dubord, R.M.

    1993-05-01

    Maintenance and inspection at nuclear power plants consumes a large portion of a utility's resources, making resource allocation for such procedures vital. The NRC Maintenance Rule, due to be implemented in July of 1996, requires utilities to select systems, structures, and components (SSCS) important to safety and to develop a monitoring program to ensure that these SSCs are capable of fulfilling their intended functions. In light of these concerns, two ratios were developed to compare the risk significance of individual components with the amount of plant staff time, or burden, associated with inspecting the component. These risk/burden ratios point out existing disparities between current inspection practices and safety concerns. These ratios can be used to develop new inspection schedules constituting a more equitable risk to burden distribution

  11. Risk-based regulation: A regulatory perspective

    International Nuclear Information System (INIS)

    Scarborough, J.C.

    1993-01-01

    In the early development of regulations for nuclear power plants, risk was implicitly considered through qualitative assessments and engineering reliability principles and practices. Examples included worst case analysis, defense in depth, and the single failure criterion. However, the contributions of various systems, structures, components and operator actions to plant safety were not explicitly assessed since a methodology for this purpose had not been developed. As a consequence of the TMI accident, the use of more quantitative risk methodology and information in regulation such as probabilistic risk analysis (PRA) increased. The use of both qualitative and quantitative consideration of risk in regulation has been a set of regulations and regulatory guides and practices that ensure adequate protection of public health and safety. Presently, the development of PRA techniques has developed to the point that safety goals, expressed in terms of risk, have been established to help guide further regulatory decision making. This paper presents the personal opinions of the author as regards the use of risk today in nuclear power plant regulation, areas of further information needs, and necessary plans for moving toward a more systematic use of risk-based information in regulatory initiatives in the future

  12. The Political Economy of Regulatory Risk

    OpenAIRE

    Strausz, Roland

    2009-01-01

    I investigate the argument that, in a two–party system with different regulatory objectives, political uncertainty generates regulatory risk. I show that this risk has a fluctuation effect that hurts both parties and an output–expansion effect that benefits one party. Consequently, at least one party dislikes regulatory risk. Moreover, both political parties gain from eliminating regulatory risk when political divergence is small or the winning probability of the regulatory–risk–averse party ...

  13. 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.

  14. Nuclear Energy Research Initiative. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants. Annual Report

    International Nuclear Information System (INIS)

    Ritterbusch, S.E.

    2000-01-01

    The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-informed approach for the design and regulation of nuclear power plants. This approach will include the development and.lor confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRs) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go farther by focusing on the design of new plants

  15. Nuclear Energy Research Initiative. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants. Annual Report

    Energy Technology Data Exchange (ETDEWEB)

    Ritterbusch, S.E.

    2000-08-01

    The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-informed approach for the design and regulation of nuclear power plants. This approach will include the development and.lor confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRs) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go farther by focusing on the design of new plants.

  16. Evaluation of spot and passive sampling for monitoring, flux estimation and risk assessment of pesticides within the constraints of a typical regulatory monitoring scheme.

    Science.gov (United States)

    Zhang, Zulin; Troldborg, Mads; Yates, Kyari; Osprey, Mark; Kerr, Christine; Hallett, Paul D; Baggaley, Nikki; Rhind, Stewart M; Dawson, Julian J C; Hough, Rupert L

    2016-11-01

    In many agricultural catchments of Europe and North America, pesticides occur at generally low concentrations with significant temporal variation. This poses several challenges for both monitoring and understanding ecological risks/impacts of these chemicals. This study aimed to compare the performance of passive and spot sampling strategies given the constraints of typical regulatory monitoring. Nine pesticides were investigated in a river currently undergoing regulatory monitoring (River Ugie, Scotland). Within this regulatory framework, spot and passive sampling were undertaken to understand spatiotemporal occurrence, mass loads and ecological risks. All the target pesticides were detected in water by both sampling strategies. Chlorotoluron was observed to be the dominant pesticide by both spot (maximum: 111.8ng/l, mean: 9.35ng/l) and passive sampling (maximum: 39.24ng/l, mean: 4.76ng/l). The annual pesticide loads were estimated to be 2735g and 1837g based on the spot and passive sampling data, respectively. The spatiotemporal trend suggested that agricultural activities were the primary source of the compounds with variability in loads explained in large by timing of pesticide applications and rainfall. The risk assessment showed chlorotoluron and chlorpyrifos posed the highest ecological risks with 23% of the chlorotoluron spot samples and 36% of the chlorpyrifos passive samples resulting in a Risk Quotient greater than 0.1. This suggests that mitigation measures might need to be taken to reduce the input of pesticides into the river. The overall comparison of the two sampling strategies supported the hypothesis that passive sampling tends to integrate the contaminants over a period of exposure and allows quantification of contamination at low concentration. The results suggested that within a regulatory monitoring context passive sampling was more suitable for flux estimation and risk assessment of trace contaminants which cannot be diagnosed by spot

  17. Review of light water reactor regulatory requirements: Assessment of selected regulatory requirements that may have marginal importance to risk: Postaccident sampling system, Turbine missiles, Combustible gas control, Charcoal filters

    International Nuclear Information System (INIS)

    Scott, W.B.; Jamison, J.D.; Stoetzel, G.A.; Tabatabai, A.S.; Vo, T.V.

    1987-05-01

    In a study commissioned by the Nuclear Regulatory Commission (NRC), Pacific Northwest Laboratory (PNL) evaluated the costs and benefits of modifying regulatory requirements in the areas of the postaccident sampling system, turbine rotor design reviews and inspections, combustible gas control for inerted Boiling Water Reactor (BWR) containments, and impregnated charcoal filters in certain plant ventilation systems. The basic framework for the analyses was that presented in the Regulatory Analysis Guidelines (NUREG/BR-0058) and in the Handbook for Value-Impact Assessment (NUREG/CR-3568). The effects of selected modifications to regulations were evaluated in terms of such factors as public risk and costs to industry and NRC. The results indicate that potential modifications of the regulatory requirements in three of the four areas would have little impact on public risk. In the fourth area, impregnated charcoal filters in building ventilation systems do appear to limit risks to the public and plant staff. Revisions in the severe accident source term assumptions, however, may reduce the theoretical value of charcoal filters. The cost analysis indicated that substantial savings in operating costs may be realized by changing the interval of turbine rotor inspections. Small to moderate operating cost savings may be realized through postulated modifications to the postaccident sampling system requirements and to the requirements for combustible gas control in inerted BWR containments. Finally, the use of impregnated charcoal filters in ventilation systems appears to be the most cost-effective method of reducing radioiodine concentrations

  18. Regulatory perspectives of concept assessment

    International Nuclear Information System (INIS)

    Flavelle, Peter A.

    1987-09-01

    The Atomic Energy Control Board is the head agency for the regulatory review of the Assessment of the Canadian Concept for Nuclear Fuel Waste Disposal being done by Atomic Energy of Canada Limited and Ontario Hydro. This paper describes the regulatory perspective of how the Concept Assessment could demonstrate the feasibility of a disposal conforming to regulatory requirements. The long-term aspects of Concept Assessment encourage the use of various predictive techniques for different time scales. Each technique will have a different potential for establishing confidence in the predictions. The predicted performance of a facility during operation should have a very high confidence, as it can be based on standard engineering calculations and the predictions can be validated later by monitoring during operation. The predictions of the transient period following closure of the facility should achieve a medium level of confidence, since they can be based on extrapolations of predictions of operational performance, using models that can be calibrated with monitoring data and with averaged input data derived from natural analog studies. Predictions based on fundamental processes will have a medium level of confidence when made to intermediate times after closure. Long-term predictions using generic or typical input data or Monte Carlo calculations of simplified models will have the least confidence and yet they can still contribute to the confidence that the disposal concept will conform to regulatory requirements

  19. Topic 8 Ecological Risk Assessment and regulatory guidance, radioecological assessment and radioprotection of the territory of Moscow

    Energy Technology Data Exchange (ETDEWEB)

    Polski, O.G.; Shmonov, M.G.; Lakaev, V.S. [Scientific-and-Industrial Association Radon, Moscow (Russian Federation)

    2004-07-01

    Moscow is the historical centre of the atom project of the former USSR. The radiation situation in Moscow has been regularly monitored by 'Radon' Scientific-and-Industrial Association (Moscow) since 1987. In pursuance of conception and Program of the Environmental Radiation Monitoring in Moscow the environmental activity and monitoring of radiation exposure doses in Moscow area have been carried out. The environmental radiation monitoring includes radiation measuring, classification and summarisation of the data file, creation of the data bank, assessment of the general and local radiation situation and it's forecasting. The system for environmental radiation monitoring consists of mobile and stationary monitoring equipment. The mobile equipment includes the automobile, water and aircraft means for monitoring. The stationary equipment includes means for periodical monitoring (134 sites), a network for stationary monitoring of air (4 sites), water areas (64 sites) and a network for automated monitoring of radiation background (MRB) ( 19 sites). MRB are disposed at highways, railroads, large enterprises, at densely populated localities, taking into account the regularity of encompassing all administrative regions. MRB represents a totally automated component for monitoring at the region. It permanently monitors the radiation background in automatic mode, providing for monitoring the preset threshold background values and informing the data processing centre of exceeding the above preset values. The equipment monitors and reports the radiation values twenty four hours a day. The information is provided for the population at indication boards. More than 3000 environmental samples are monitored and studied; about 2500 km of automatic gamma-survey is carried out annually and 300 thermoluminescent dosimeters have been used to monitor the absorbed radiation dose. The major radionuclides monitored in the environmental samples have been the decay products of

  20. Risk-based Regulatory Evaluation Program methodology

    International Nuclear Information System (INIS)

    DuCharme, A.R.; Sanders, G.A.; Carlson, D.D.; Asselin, S.V.

    1987-01-01

    The objectives of this DOE-supported Regulatory Evaluation Progrwam are to analyze and evaluate the safety importance and economic significance of existing regulatory guidance in order to assist in the improvement of the regulatory process for current generation and future design reactors. A risk-based cost-benefit methodology was developed to evaluate the safety benefit and cost of specific regulations or Standard Review Plan sections. Risk-based methods can be used in lieu of or in combination with deterministic methods in developing regulatory requirements and reaching regulatory decisions

  1. 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.)

  2. Regulatory Forum Review*: Utility of in Vitro Secondary Pharmacology Data to Assess Risk of Drug-induced Valvular Heart Disease in Humans: Regulatory Considerations.

    Science.gov (United States)

    Papoian, Thomas; Jagadeesh, Gowraganahalli; Saulnier, Muriel; Simpson, Natalie; Ravindran, Arippa; Yang, Baichun; Laniyonu, Adebayo A; Khan, Imran; Szarfman, Ana

    2017-04-01

    Drug-induced valvular heart disease (VHD) is a serious side effect linked to long-term treatment with 5-hydroxytryptamine (serotonin) receptor 2B (5-HT 2B ) agonists. Safety assessment for off-target pharmacodynamic activity is a common approach used to screen drugs for this undesired property. Such studies include in vitro assays to determine whether the drug is a 5-HT 2B agonist, a necessary pharmacological property for development of VHD. Measures of in vitro binding affinity (IC 50 , K i ) or cellular functional activity (EC 50 ) are often compared to maximum therapeutic free plasma drug levels ( fC max ) from which safety margins (SMs) can be derived. However, there is no clear consensus on what constitutes an appropriate SM under various therapeutic conditions of use. The strengths and limitations of SM determinations and current risk assessment methodology are reviewed and evaluated. It is concluded that the use of SMs based on K i values, or those relative to serotonin (5-HT), appears to be a better predictor than the use of EC 50 or EC 50 /human fC max values for determining whether known 5-HT 2B agonists have resulted in VHD. It is hoped that such a discussion will improve efforts to reduce this preventable serious drug-induced toxicity from occurring and lead to more informed risk assessment strategies.

  3. Systematic identification of regulatory variants associated with cancer risk.

    Science.gov (United States)

    Liu, Song; Liu, Yuwen; Zhang, Qin; Wu, Jiayu; Liang, Junbo; Yu, Shan; Wei, Gong-Hong; White, Kevin P; Wang, Xiaoyue

    2017-10-23

    Most cancer risk-associated single nucleotide polymorphisms (SNPs) identified by genome-wide association studies (GWAS) are noncoding and it is challenging to assess their functional impacts. To systematically identify the SNPs that affect gene expression by modulating activities of distal regulatory elements, we adapt the self-transcribing active regulatory region sequencing (STARR-seq) strategy, a high-throughput technique to functionally quantify enhancer activities. From 10,673 SNPs linked with 996 cancer risk-associated SNPs identified in previous GWAS studies, we identify 575 SNPs in the fragments that positively regulate gene expression, and 758 SNPs in the fragments with negative regulatory activities. Among them, 70 variants are regulatory variants for which the two alleles confer different regulatory activities. We analyze in depth two regulatory variants-breast cancer risk SNP rs11055880 and leukemia risk-associated SNP rs12142375-and demonstrate their endogenous regulatory activities on expression of ATF7IP and PDE4B genes, respectively, using a CRISPR-Cas9 approach. By identifying regulatory variants associated with cancer susceptibility and studying their molecular functions, we hope to help the interpretation of GWAS results and provide improved information for cancer risk assessment.

  4. 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...

  5. 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)...

  6. Integrating process safety with molecular modeling-based risk assessment of chemicals within the REACH regulatory framework: benefits and future challenges.

    Science.gov (United States)

    Lewis, Amanda; Kazantzis, Nikolaos; Fishtik, Ilie; Wilcox, Jennifer

    2007-04-11

    Registration, evaluation and authorization of chemicals (REACH) represents a recent regulatory initiative by the European union commission to protect human health and the environment from potentially hazardous chemicals. Under REACH, all stakeholders must submit (thermo)physical, thermochemical, and toxicological data for certain chemicals. The commission's impact assessment studies estimate that the costs of REACH will be approximately 3-5 billion Euros. The present study advocates the systematic incorporation of computational chemistry and computer-assisted chemical risk assessment methods into REACH to reduce regulatory compliance costs. Currently powerful computer-aided ab initio techniques can be used to generate predictions of key properties of broad classes of chemicals, without resorting to costly experimentation and potentially hazardous testing. These data could be integrated into a centralized IT decision and compliance support system, and stored in a retrievable, easily communicable manner should new regulatory and/or production requirements necessitate the introduction of different uses of chemicals under different conditions. For illustration purposes, ab initio calculations are performed on heterocyclic nitrogen-containing compounds which currently serve as high energy density materials in the chemical industry. Since investigations of these compounds are still in their infancy, stability studies are imperative regarding their safe handling and storage, as well as registration under REACH.

  7. Integrating process safety with molecular modeling-based risk assessment of chemicals within the REACH regulatory framework: Benefits and future challenges

    International Nuclear Information System (INIS)

    Lewis, Amanda; Kazantzis, Nikolaos; Fishtik, Ilie; Wilcox, Jennifer

    2007-01-01

    Registration, evaluation and authorization of chemicals (REACH) represents a recent regulatory initiative by the European union commission to protect human health and the environment from potentially hazardous chemicals. Under REACH, all stakeholders must submit (thermo)physical, thermochemical, and toxicological data for certain chemicals. The commission's impact assessment studies estimate that the costs of REACH will be approximately 3-5 billion Euros. The present study advocates the systematic incorporation of computational chemistry and computer-assisted chemical risk assessment methods into REACH to reduce regulatory compliance costs. Currently powerful computer-aided ab initio techniques can be used to generate predictions of key properties of broad classes of chemicals, without resorting to costly experimentation and potentially hazardous testing. These data could be integrated into a centralized IT decision and compliance support system, and stored in a retrievable, easily communicable manner should new regulatory and/or production requirements necessitate the introduction of different uses of chemicals under different conditions. For illustration purposes, ab initio calculations are performed on heterocyclic nitrogen-containing compounds which currently serve as high energy density materials in the chemical industry. Since investigations of these compounds are still in their infancy, stability studies are imperative regarding their safe handling and storage, as well as registration under REACH

  8. Risk literacy for scientists. Invitation to regulatory science

    International Nuclear Information System (INIS)

    Ono, Kyoko

    2012-01-01

    This paper discusses a regulatory science, which fills a gap between scientific knowledge and regulatory actions. The author provides examples of the regulatory science employed in chemical risk assessment, such as the linear non-threshold theory. In the regulatory science, scientific data as well as scientific reasoning based on scientific knowledge - or regulatory rules - should play an important role. It is important to recognize that the rules facilitate transparent decision making under conditions of uncertainty and time constraints. Furthermore, the development of traditional or pure science results in the validation of regulatory rules, and subsequently, the regulatory science procedure develops more systematically. The concept of this science should be understood by those engaged in governmental decision making. (author)

  9. Assessment of regulatory effectiveness. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    1999-09-01

    This report arises from the seventh series of peer discussions on regulatory practices entitled 'Assessment of Regulatory Effectiveness'. The term 'regulatory effectiveness' covers the quality of the work and level of performance of a regulatory body. In this sense, regulatory effectiveness applies to regulatory body activities aimed at preventing safety degradation and ensuring that an acceptable level of safety is being maintained by the regulated operating organizations. In addition, regulatory effectiveness encompasses the promotion of safety improvements, the timely and cost effective performance of regulatory functions in a manner which ensures the confidence of the operating organizations, the general public and the government, and striving for continuous improvements to performance. Senior regulators from 22 Member States participated in two peer group discussions during March and May 1999. The discussions were focused on the elements of an effective regulatory body, possible indicators of regulatory effectiveness and its assessment. This report presents the outcome of these meetings and recommendations of good practices identified by senior regulators, which do not necessarily reflect those of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. In order to protect people and the environment from hazards associated with nuclear facilities, the main objective of a nuclear regulatory body is to ensure that a high level of safety in the nuclear activities under its jurisdiction is achieved, maintained and within the control of operating organizations. Even if it is possible to directly judge objective safety levels at nuclear facilities, such safety levels would not provide an exclusive indicator of regulatory effectiveness. The way the regulatory body ensures the safety of workers and the public and the way it discharges its responsibilities also determine its effectiveness. Hence the

  10. The treatment of uncertainties in risk for regulatory decision making

    International Nuclear Information System (INIS)

    Baybutt, P.; Cox, D.C.; Denning, R.S.; Kurth, R.E.; Fraley, D.W.; Heaberlin, S.W.

    1982-01-01

    This paper describes research conducted in an ongoing program at Battelle to develop and adapt decision analysis methods for regulatory decision making. A general approach to risk-based decision making is discussed. The nature of uncertainties in risk assessment is described and methods for their inclusion in decision making are proposed. The use of decision analysis methods in regulatory decision making and the consideration of uncertainties is illustrated in a realistic case study

  11. Probabilistic safety assessment - regulatory perspective

    International Nuclear Information System (INIS)

    Solanki, R.B.; Paul, U.K.; Hajra, P.; Agarwal, S.K.

    2002-01-01

    Full text: Nuclear power plants (NPPs) have been designed, constructed and operated mainly based on deterministic safety analysis philosophy. In this approach, a substantial amount of safety margin is incorporated in the design and operational requirements. Additional margin is incorporated by applying the highest quality engineering codes, standards and practices, and the concept of defence-in-depth in design and operating procedures, by including conservative assumptions and acceptance criteria in plant response analysis of postulated initiating events (PIEs). However, as the probabilistic approach has been improved and refined over the years, it is possible for the designer, operator and regulator to get a more detailed and realistic picture of the safety importance of plant design features, operating procedures and operational practices by using probabilistic safety assessment (PSA) along with the deterministic methodology. At present, many countries including USA, UK and France are using PSA insights in their decision making along with deterministic basis. India has also made substantial progress in the development of methods for carrying out PSA. However, consensus on the use of PSA in regulatory decision-making has not been achieved yet. This paper emphasises on the requirements (e.g.,level of details, key modelling assumptions, data, modelling aspects, success criteria, sensitivity and uncertainty analysis) for improving the quality and consistency in performance and use of PSA that can facilitate meaningful use of the PSA insights in the regulatory decision-making in India. This paper also provides relevant information on international scenario and various application areas of PSA along with progress made in India. The PSA perspective presented in this paper may help in achieving consensus on the use of PSA for regulatory / utility decision-making in design and operation of NPPs

  12. Value Assessment in the Regulatory Context.

    Science.gov (United States)

    Miller, Kathleen L; Woodcock, Janet

    2017-02-01

    Value assessments are made on new drugs before they even enter the market. Regulators at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration make a clinical benefit-risk assessment to determine whether to approve a new drug. Benefits of a drug are typically quantified directly, as an assessment of efficacy. CDER defines risk as the intersection of the severity of possible harm and the probability of that harm. For a novel drug to be approved, its benefits and risks must be well understood, and the trade-off between the two must be acceptable. To assist with these benefit-risk value assessments, CDER has two ongoing initiatives: the Patient-Focused Drug Development Initiative that aims to substantially increase the role of patient voice in the regulatory process, and a transparency initiative that focuses on creating a structured framework for benefit-risk assessment. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  13. 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.

  14. High concentrations of protein test substances may have non-toxic effects on Daphnia magna: implications for regulatory study designs and ecological risk assessments for GM crops.

    Science.gov (United States)

    Raybould, Alan; Burns, Andrea; Hamer, Mick

    2014-01-01

    Laboratory testing for possible adverse effects of insecticidal proteins on non-target organisms (NTOs) is an important part of many ecological risk assessments for regulatory decision-making about the cultivation of insect-resistant genetically modified (IRGM) crops. To increase confidence in the risk assessments, regulatory guidelines for effects testing specify that representative surrogate species for NTOs are exposed to concentrations of insecticidal proteins that are in excess of worst-case predicted exposures in the field. High concentrations in effects tests are achieved by using protein test substances produced in microbes, such as Escherichia coli. In a study that exposed Daphnia magna to a single high concentration of a microbial test substance containing Vip3Aa20, the insecticidal protein in MIR162 maize, small reductions in growth were observed. These effects were surprising as many other studies strongly suggest that the activity of Vip3Aa20 is limited to Lepidoptera. A plausible explanation for the effect on growth is that high concentrations of test substance have a non-toxic effect on Daphnia, perhaps by reducing its feeding rate. A follow-up study tested that hypothesis by exposing D. magna to several concentrations of Vip3Aa20, and a high concentration of a non-toxic protein, bovine serum albumin (BSA). Vip3Aa20 and BSA had sporadic effects on the reproduction and growth of D. magna. The pattern of the effects suggests that they result from non-toxic effects of high concentrations of protein, and not from toxicity. The implications of these results for regulatory NTO effects testing and ERA of IRGM crops are discussed.

  15. Use of risk information in regulatory reviews

    International Nuclear Information System (INIS)

    Sagar, B.; Benke, R.; Mohanty, S.

    2004-01-01

    The regulatory framework for licensing any high-level waste repository at Yucca Mountain in the United States, calls for appropriate use of risk information to ensure operational safety during the pre-closure period and long-term safety during the post-closure period. This paper focuses on the post-closure period. Regulations in the Code of Federal Regulations (CFR), Title 10, Part 63, apply to any repository at Yucca Mountain and envision use of probabilistic methods to develop quantitative risk information. Accumulated engineering and scientific experience at Yucca Mountain and analog sites and quantitative risk information from studies conducted by the implementer, regulator, and others are combined to formulate 'risk insights,' which are then used to plan and execute regulatory reviews. The U.S. Nuclear Regulatory Commission (NRC) and the Center for Nuclear Waste Regulatory Analyses (CNWRA) recently consolidated the knowledge gained during several g ears and developed such risk insights for the potential repository at Yucca Mountain. This paper discusses the types of risk information used to generate risk insights and how the risk insights will be used in regulatory reviews. A companion paper presents more details on sensitivity analysis methods used to generate risk information. (authors)

  16. Handbook for value-impact assessments of NRC regulatory actions

    International Nuclear Information System (INIS)

    Mullen, M.F.; DiPalo, A.J.

    1985-01-01

    According to current Nuclear Regulatory Commission (NRC) procedures, value-impact (cost-benefit) assessments must be prepared for all rulemaking actions and for a broad range of other regulatory requirements and guidance. Probabilistic risk assessment (PRA) methods furnish an important part of the information base for these assessments. PRA methods are frequently the principal quantitative tool for estimating the benefits (e.g., public risk reduction) of proposed regulatory actions. In December 1983, the NRC published A Handbook for Value-Impact Assessment, NUREG/CR-3568, which provides a set of systematic procedures for performing value-impact assessments. The Handbook contains methods, data, and sources of information that can assist the regulatory analyst in conducting such assessments. The use of probabilistic risk analysis to estimate the benefits of proposed regulatory actions is described. Procedures and methods are also given for evaluating the costs and other consequences associated with regulatory actions. The Handbook has been adopted by the NRC as the recommended guideline for value impact assessments. This paper presents the background, objectives, and scope of the Handbook, describes the value-impact assessment methods (including the use of probabilistic risk assessment to estimate benefits), and discusses a selection of current and planned applications, with examples to illustrate how the methods are used

  17. Regulatory focus affects physician risk tolerance.

    Science.gov (United States)

    Veazie, Peter J; McIntosh, Scott; Chapman, Benjamin P; Dolan, James G

    2014-01-01

    Risk tolerance is a source of variation in physician decision-making. This variation, if independent of clinical concerns, can result in mistaken utilization of health services. To address such problems, it will be helpful to identify nonclinical factors of risk tolerance, particularly those amendable to intervention-regulatory focus theory suggests such a factor. This study tested whether regulatory focus affects risk tolerance among primary care physicians. Twenty-seven primary care physicians were assigned to promotion-focused or prevention-focused manipulations and compared on the Risk Taking Attitudes in Medical Decision Making scale using a randomization test. Results provide evidence that physicians assigned to the promotion-focus manipulation adopted an attitude of greater risk tolerance than the physicians assigned to the prevention-focused manipulation (p = 0.01). The Cohen's d statistic was conventionally large at 0.92. Results imply that situational regulatory focus in primary care physicians affects risk tolerance and may thereby be a nonclinical source of practice variation. Results also provide marginal evidence that chronic regulatory focus is associated with risk tolerance (p = 0.05), but the mechanism remains unclear. Research and intervention targeting physician risk tolerance may benefit by considering situational regulatory focus as an explanatory factor.

  18. Mission Risk Reduction Regulatory Change Management

    Science.gov (United States)

    Scroggins, Sharon

    2007-01-01

    NASA Headquarters Environmental Management Division supports NASA's mission to pioneer the future in space exploration, scientific discovery, and aeronautics research by integrating environmental considerations into programs and projects early-on, thereby proactively reducing NASA's exposure to institutional, programmatic and operational risk. As part of this effort, NASA established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) as a resource for detecting, analyzing, and communicating environmental regulatory risks to the NASA stakeholder community. The RRAC PC focuses on detecting emerging environmental regulations and other operational change drivers that may pose risks to NASA programs and facilities, and effectively communicating the potential risks. For example, regulatory change may restrict how and where certain activities or operations may be conducted. Regulatory change can also directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Regulatory change can result in significant adverse impacts to NASA programs and facilities due to NASA's stringent performance requirements for materials and components related to human-rated space vehicles. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented a system for proactively managing regulatory change to minimize potential adverse impacts to NASA programs and facilities. This presentation highlights the process utilized by the RRACPC to communicate regulatory change and the associated

  19. Risk perception, safety goals and regulatory decision-making

    International Nuclear Information System (INIS)

    Hoegberg, Lars

    1998-01-01

    Deciding on 'how safe is safe enough?' includes value judgements with implications of an ethical and political nature. As regulators are accountable to governments, parliaments and the general public, regulatory decision-making should be characterized by transparency with respect to how such value judgements are reflected in risk assessments and regulatory decisions. Some approaches in this respect are discussed in the paper, based on more than fifteen years of experience in nuclear regulatory decision-making. Issues discussed include: (1) risk profiles and safety goals associated with severe reactor accidents--individual health risks, societal risks and risk of losing investments; (2) risk profile-based licensing of the Swedish SFR final disposal facility for low and intermediate level radioactive waste

  20. Default values for assessment of potential dermal exposure of the hands to industrial chemicals in the scope of regulatory risk assessments.

    Science.gov (United States)

    Marquart, Hans; Warren, Nicholas D; Laitinen, Juha; van Hemmen, Joop J

    2006-07-01

    Dermal exposure needs to be addressed in regulatory risk assessment of chemicals. The models used so far are based on very limited data. The EU project RISKOFDERM has gathered a large number of new measurements on dermal exposure to industrial chemicals in various work situations, together with information on possible determinants of exposure. These data and information, together with some non-RISKOFDERM data were used to derive default values for potential dermal exposure of the hands for so-called 'TGD exposure scenarios'. TGD exposure scenarios have similar values for some very important determinant(s) of dermal exposure, such as amount of substance used. They form narrower bands within the so-called 'RISKOFDERM scenarios', which cluster exposure situations according to the same purpose of use of the products. The RISKOFDERM scenarios in turn are narrower bands within the so-called Dermal Exposure Operation units (DEO units) that were defined in the RISKOFDERM project to cluster situations with similar exposure processes and exposure routes. Default values for both reasonable worst case situations and typical situations were derived, both for single datasets and, where possible, for combined datasets that fit the same TGD exposure scenario. The following reasonable worst case potential hand exposures were derived from combined datasets: (i) loading and filling of large containers (or mixers) with large amounts (many litres) of liquids: 11,500 mg per scenario (14 mg cm(-2) per scenario with surface of the hands assumed to be 820 cm(2)); (ii) careful mixing of small quantities (tens of grams in default values are considered useful for estimating exposure for similar substances in similar situations with low uncertainty. Several other default values based on single datasets can also be used, but lead to estimates with a higher uncertainty, due to their more limited basis. Sufficient analogy in all described parameters of the scenario, including duration, is needed

  1. Aging and Cardiometabolic Risk in European HEMS Pilots: An Assessment of Occupational Old-Age Limits as a Regulatory Risk Management Strategy.

    Science.gov (United States)

    Bauer, Hans; Nowak, Dennis; Herbig, Britta

    2017-12-11

    Old-age limits are imposed in some occupations in an effort to ensure public safety. In aviation, the "Age 60 Rule" limits permissible flight operations conducted by pilots aged 60 and over. Using a retrospective cohort design, we assessed this rule's validity by comparing age-related change rates of cardiometabolic incapacitation risk markers in European helicopter emergency medical service (HEMS) pilots near age 60 with those in younger pilots. Specifically, individual clinical, laboratory, and electrocardiogram (ECG)-based risk markers and an overall cardiovascular event risk score were determined from aeromedical examination records of 66 German, Austrian, Polish, and Czech HEMS pilots (average follow-up 8.52 years). Risk marker change rates were assessed using linear mixed models and generalized additive models. Body mass index increases over time were slower in pilots near age 60 compared to younger pilots, and fasting glucose levels increased only in the latter. Whereas the lipid profile remained unchanged in the latter, it improved in the former. An ECG-based arrhythmia risk marker increased in younger pilots, which persisted in the older pilots. Six-month risk of a fatal cardiovascular event (in or out of cockpit) was estimated between 0% and 0.3%. Between 41% and 95% of risk marker variability was due to unexplained time-stable between-person differences. To conclude, the cardiometabolic risk marker profile of HEMS pilots appears to improve over time in pilots near age 60, compared to younger pilots. Given large stable interindividual differences, we recommend individualized risk assessment of HEMS pilots near age 60 instead of general grounding. © 2017 Society for Risk Analysis.

  2. Reduction of regulatory risk: a network economic approach

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2007-01-01

    Several definitions of regulatory risk are known from the literature. From the perspective of regulatory reform it is important to differentiate between the impact of a given regulatory scheme on the firm's risk exposure and the risk arising from discretionary behavior of regulatory agencies. Whereas the conse-quences of effective regulation in principle are known and accepted, excessive regulatory discretion may cause a strong need for regulatory reform. Regulatory reform focussing on the re...

  3. 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.

  4. Regulatory cost-risk study

    Energy Technology Data Exchange (ETDEWEB)

    1983-04-01

    This study is intended to provide some quantitative perspective by selecting certain examples of criteria for which estimates of risks and costs can be obtained, and the balance of the various risks, (i.e., internal versus external risks), can be put into perspective. 35 refs., 39 tabs. (JDB)

  5. Regulatory cost-risk study

    International Nuclear Information System (INIS)

    1983-04-01

    This study is intended to provide some quantitative perspective by selecting certain examples of criteria for which estimates of risks and costs can be obtained, and the balance of the various risks, (i.e., internal versus external risks), can be put into perspective. 35 refs., 39 tabs

  6. Systemic Risk and Optimal Regulatory Architecture

    NARCIS (Netherlands)

    Espinosa-Vega, M.A.; Kahn, C.; Matta, R.; Sole, J.

    2011-01-01

    Until the recent financial crisis, the safety and soundness of financial institutions was assessed from the perspective of the individual institution. The financial crisis highlighted the need to take systemic externalities seriously when rethinking prudential oversight and the regulatory

  7. Scenario-targeted toxicity assessment through multiple endpoint bioassays in a soil posing unacceptable environmental risk according to regulatory screening values.

    Science.gov (United States)

    Rodriguez-Ruiz, A; Etxebarria, J; Boatti, L; Marigómez, I

    2015-09-01

    Lanestosa is a chronically polluted site (derelict mine) where the soil (Lanestosa (LA) soil) exceeds screening values (SVs) of regulatory policies in force (Basque Country; Europe) for Zn, Pb and Cd. A scenario-targeted toxicity assessment was carried out on the basis of a multi-endpoint bioassay approach. Acute and chronic toxicity bioassays were conducted with selected test species (Vibrio fischeri, Dictyostelium discoideum, Lactuca sativa, Raphanus sativus and Eisenia fetida) in combination with chemical analysis of soils and elutriates and with bioaccumulation studies in earthworms. Besides, the toxicity profile was compared with that of the mine runoff (RO) soil and of a fresh artificially polluted soil (LAAPS) resembling LA soil pollutant profile. Extractability studies in LA soil revealed that Pb, Zn and Cd were highly available for exchange and/or release into the environment. Indeed, Pb and Zn were accumulated in earthworms and LA soil resulted to be toxic. Soil respiration, V. fischeri, vegetative and developmental cycles of D. discoideum and survival and juvenile production of E. fetida were severely affected. These results confirmed that LA soil had unacceptable environmental risk and demanded intervention. In contrast, although Pb and Zn concentrations in RO soil revealed also unacceptable risk, both metal extractability and toxicity were much lower than in LA soil. Thus, within the polluted site, the need for intervention varied between areas that posed dissimilar risk. Besides, since LAAPS, with a high exchangeable metal fraction, was the most toxic, ageing under in situ natural conditions seemingly contributed to attenuate LA soil risk. As a whole, combining multi-endpoint bioassays with scenario-targeted analysis (including leaching and ageing) provides reliable risk assessment in soils posing unacceptable environmental risk according to SVs, which is useful to optimise the required intervention measures.

  8. Risk assessment

    International Nuclear Information System (INIS)

    1983-01-01

    The report is in sections, entitled: preface; summary and conclusions; introduction (historical and organizational); estimating engineering risks (techniques of risk estimation and forms of expression of risk); laboratory experiments for estimation of biological risks; estimation of risk from observations on man (travel, medical procedures; occupations; sport); the perception of risks; (as an example of attitudes towards a single hazard, studies of nuclear power are considered among other topics in this section); risk management (estimation; perception; acceptability, analysis of risk, costs and benefits; safety standards; decision-making process; possible guidelines). (U.K.)

  9. Food and feed chemical contaminants in the European Union: Regulatory, scientific, and technical issues concerning chemical contaminants occurrence, risk assessment, and risk management in the European Union.

    Science.gov (United States)

    Silano, Marco; Silano, Vittorio

    2017-07-03

    A priority of the European Union is the control of risks possibly associated with chemical contaminants in food and undesirable substances in feed. Following an initial chapter describing the main contaminants detected in food and undesirable substances in feed in the EU, their main sources and the factors which affect their occurrence, the present review focuses on the "continous call for data" procedure that is a very effective system in place at EFSA to make possible the exposure assessment of specific contaminants and undesirable substances. Risk assessment of contaminants in food atances in feed is carried currently in the European Union by the CONTAM Panel of EFSA according to well defined methodologies and in collaboration with competent international organizations and with Member States.

  10. Nuclear energy research initiative, an overview of the cooperative program for the risk-informed assessment of regulatory and design requirements for future nuclear power plants

    International Nuclear Information System (INIS)

    Ritterbusch, Stanley E.

    2000-01-01

    EPRI sstudies have shown that nuclear plant capital costs will have to decrease by about 35% to 40% to be competitive with fossil-generated electricity in the Unite States. Also, the ''first concrete'' to fuel load construction schedule will have to be decreased to less than 40 months. Therefore, the U. S. Department of Energy (DOE) initiate the Nuclear Energy Research Initiative (NERI) and ABB CENP proposed a cooperative program with Sandia National Laboratory (SNL) and Duke Engineering and Services (DE and S) to begin an innovative research effort to drastically cut the cost of new nuclear power plant construction for the U. S. de-regulated market place. This program was approved by the DOE through three separate but coordinated ''cooperative agreements.'' They are the ''Risk-Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants'' (Risk-Informed NPP), the ''Smart Nuclear Power Plant Program'' (Smart-NPP), and ''Design, Procure, Construct, Install and Test'' (DPCIT) Program. DOE funded the three cooperative agreements at a level of $2.6 million for the first year of the program. Funding for the complete program is durrently at a level $6.9 million, however, ABB CENP and all partners anticipate that the scope of the NERI program will be increased as a result of the overall importance of NERI to the U. S. Government. The Risk-Informed NPP program, which is aimed at revising costly regularory and design requirements without reducing overall plant safety, has two basic tasks: ''development of Risk-Informed Methods'' and ''strengthening the Reliability Database.'' The overall objective of the first task is to develop a scientific, risk-informed approach for identifying and simplifying deterministic industry standards, regulatory requirements, and safety systems that do not significantly contribute to nuclear power plant reliability and safety. The second basic task is to develop a means for strengthening the reliability database

  11. A critical appraisal of the process of regulatory implementation of novel in vivo and in vitro methods for chemical hazard and risk assessment.

    Science.gov (United States)

    Piersma, Aldert H; Ezendam, Janine; Luijten, Mirjam; Muller, J J Andre; Rorije, Emiel; van der Ven, Leo T M; van Benthem, Jan

    2014-11-01

    Regulatory toxicology urgently needs applicable alternative test systems that reduce animal use, testing time, and cost. European regulation on cosmetic ingredients has already banned animal experimentation for hazard identification, and public awareness drives toward additional restrictions in other regulatory frameworks as well. In addition, scientific progress stimulates a more mechanistic approach of hazard identification. Nevertheless, the implementation of alternative methods is lagging far behind their development. In search for general bottlenecks for the implementation of alternative methods, this manuscript reviews the state of the art as to the development and implementation of 10 diverse test systems in various areas of toxicological hazard assessment. They vary widely in complexity and regulatory acceptance status. The assays are reviewed as to parameters assessed, biological system involved, standardization, interpretation of results, extrapolation to human hazard, position in testing strategies, and current regulatory acceptance status. Given the diversity of alternative methods in many aspects, no common bottlenecks could be identified that hamper implementation of individual alternative assays in general. However, specific issues for the regulatory acceptance and application were identified for each assay. Acceptance of one-in-one replacement of complex in vivo tests by relatively simple in vitro assays is not feasible. Rather, innovative approaches using test batteries are required together with metabolic information and in vitro to in vivo dose extrapolation to convincingly provide the same level of information of current in vivo tests. A mechanistically based alternative approach using the Adverse Outcome Pathway concept could stimulate further (regulatory) acceptance of non-animal tests.

  12. Scientific and Regulatory Policy Committee (SRPC) Review: Interpretation and Use of Cell Proliferation Data in Cancer Risk Assessment

    Science.gov (United States)

    Increased cell proliferation is a defining feature of carcinogenesis and a central key event in the mode of action for many non-genotoxic carcinogens. Quantitative cell proliferation data thus play an important role in the safety assessment of many pharmaceutical and environment...

  13. 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

  14. A review of the current situation of aflatoxin M1 in cow's milk in Serbia: risk assessment and regulatory aspects.

    Science.gov (United States)

    Milićević, Dragan R; Spirić, Danka; Radičević, Tatjana; Velebit, Branko; Stefanović, Srdjan; Milojević, Lazar; Janković, Saša

    2017-09-01

    The aim of this systematic review is to provide information regarding the incidence and levels of aflatoxin M 1 (AFM 1 ) in raw and heat processed cow's milk in Serbia during 2015-16 and to compare these with collected data on the occurrence of AFM 1 in raw milk and dairy products during the last decade in our region. Estimation of dietary exposure (EDI) and hazard index (HI) calculations for different age groups of the population were also carried out, based on the AFM 1 content of milk samples and on available food consumption data in Serbia. AFM 1 was detected in 69.9% (984/1408) of raw milk samples in 2015 versus 84.9% (3094/3646) in 2016, while in heat-processed milk, AFM 1 was detected in 77.8% (364/468) in 2015 versus 98.5% (753/765) in 2016. On the basis of the obtained results, 450 (9%) of raw and 14 (1.1%) of heat-processed milk samples were contaminated with AFM 1 levels above the maximum permitted level in Serbia (0.25 μg kg -1 ). However, a large percentage of raw and heat processed milk in Serbia (30.1% and 17.3%, respectively) was contaminated with AFM 1 levels above the maximum permitted level regulated in the European Union (0.05 μg kg -1 ). Therefore, in order to protect consumer health, it is extremely important to further control the level of aflatoxins in milk, and this should be considered as a high priority for risk management actions.

  15. Challenges in Risk Assessment: Quantitative Risk Assessment

    OpenAIRE

    Jacxsens, Liesbeth; Uyttendaele, Mieke; De Meulenaer, Bruno

    2016-01-01

    The process of risk analysis consists out of three components, risk assessment, risk management and risk communication. These components are internationally well spread by Codex Alimentarius Commission as being the basis for setting science based standards, criteria on food safety hazards, e.g. setting maximum limits of mycotoxins in foodstuffs. However, the technical component risk assessment is hard to elaborate and to understand. Key in a risk assessment is the translation of biological or...

  16. Initial threat assessment. Radiological risks associated with SevRAO facilities falling within the regulatory supervision responsibilities of FMBA[Russian Federation

    Energy Technology Data Exchange (ETDEWEB)

    Ilin, Leonid; Kochetkov, Oleg; Simakov, Anatoly; Shandala, Natalya; Savkin, Mikhail; Sneve, Malgorzata K.; Boerretzen, Peer; Jaworska, Alicja; Smith, Graham; Barraclough, Ian; Kruse, Phil

    2005-07-01

    The purpose of this initial threat assessment is to obtain a view, from the regulatory perspective of FMBA, of the most important issues which require supervision and regulatory development, regarding work which has to be carried out at the Andreeva Bay and Grcmikha. The main radiological threats have been identified and actions to reduce the threats have been proposed. Situations where regulations and procedures for workers on-site need to be developed have been identified. This will be a basis for further development of Russian regulation and procedures. (Author)

  17. Regulatory review of probabilistic safety assessment (PSA) Level 2

    International Nuclear Information System (INIS)

    2001-07-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

  18. Development of Questionnaire for Self-Assessment of Regulatory Capture

    Energy Technology Data Exchange (ETDEWEB)

    Muhmood, Ul Hassan; Lee, Young Eal [Pakistan Nuclear Regulatory Authority, Islamabad (Pakistan); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-10-15

    Nuclear industry with its evolution in 60s came with a number of pros and cons. In order to avoid any accident or incident, highest safety standards and quality control mechanism were established. The relation of regulator with its licensee is critical in the sense of public safety and welfare. The situation when the regulator starts to work for the interests of the industry instead of the public interest and fails to cling with his mission is known as 'regulatory capture' which may cause a number of serious negative effects like radiological or radiation risk. According to George Stigler, as a rule regulation is acquired by the industry and is designed and operated primarily for its benefit. The phenomenon of regulatory capture may hamper the safety culture and can also be considered as regulatory failure. It is therefore necessary to clearly understand this type of government failure to avoid the happening of serious accidents like TMI and Fukushima in the future. This paper aims to explore whether the regulatory body works independently and effectively to achieve its assigned tasks and objectives. Hence we proposed a questionnaire for the self-assessment of regulatory capture within the regulatory body. It also includes the results of an experimental assessment which was carried out to check the relevance and reliability of the questions to this subject. This assessment survey was conducted with the officers and staff members of Pakistan Nuclear Regulatory Authority (PNRA). We checked the significance of the proposed questionnaire and found some of the questions like Q. 27, 30 and 33 (written in italic) are not directly related to the phenomenon of regulatory capture. However, the existence of the situation which has been asked in these questions may lead towards the hampering of regulatory culture.

  19. Development of Questionnaire for Self-Assessment of Regulatory Capture

    International Nuclear Information System (INIS)

    Muhmood, Ul Hassan; Lee, Young Eal; Choi, Kwang Sik

    2014-01-01

    Nuclear industry with its evolution in 60s came with a number of pros and cons. In order to avoid any accident or incident, highest safety standards and quality control mechanism were established. The relation of regulator with its licensee is critical in the sense of public safety and welfare. The situation when the regulator starts to work for the interests of the industry instead of the public interest and fails to cling with his mission is known as 'regulatory capture' which may cause a number of serious negative effects like radiological or radiation risk. According to George Stigler, as a rule regulation is acquired by the industry and is designed and operated primarily for its benefit. The phenomenon of regulatory capture may hamper the safety culture and can also be considered as regulatory failure. It is therefore necessary to clearly understand this type of government failure to avoid the happening of serious accidents like TMI and Fukushima in the future. This paper aims to explore whether the regulatory body works independently and effectively to achieve its assigned tasks and objectives. Hence we proposed a questionnaire for the self-assessment of regulatory capture within the regulatory body. It also includes the results of an experimental assessment which was carried out to check the relevance and reliability of the questions to this subject. This assessment survey was conducted with the officers and staff members of Pakistan Nuclear Regulatory Authority (PNRA). We checked the significance of the proposed questionnaire and found some of the questions like Q. 27, 30 and 33 (written in italic) are not directly related to the phenomenon of regulatory capture. However, the existence of the situation which has been asked in these questions may lead towards the hampering of regulatory culture

  20. Science, politics, and health in the brave new world of pharmaceutical carcinogenic risk assessment: technical progress or cycle of regulatory capture?

    Science.gov (United States)

    Abraham, John; Ballinger, Rachel

    2012-10-01

    The carcinogenicity (cancer-inducing potential) of pharmaceuticals is an important risk factor for health when considering whether thousands of patients on drug trials or millions/billions of consumers in the marketplace should be exposed to a new drug. Drawing on fieldwork involving over 50 interviews and documentary research spanning 2002-2010 in Europe and the US, and on regulatory capture theory, this article investigates how the techno-regulatory standards for carcinogenicity testing of pharmaceuticals have altered since 1998. It focuses on the replacement of long-term carcinogenicity tests in rodents (especially mice) with shorter-term tests involving genetically-engineered mice (GEM). Based on evidence regarding financial/organizational control, methodological design, and interpretation of the validation and application of these new GEM tests, it is argued that regulatory agencies permitted the drug industry to shape such validation and application in ways that prioritized commercial interests over the need to protect public health. Boundary-work enabling industry scientists to define some standards of public-health policy facilitated such capture. However, as the scientific credibility of GEM tests as tools to protect public health by screening out carcinogens became inescapably problematic, a regulatory resurgence, impelled by reputational concerns, exercised more control over industry's construction and use of the tests, The extensive problems with GEM tests as public-health protective regulatory science raises the spectre that alterations to pharmaceutical carcinogenicity-testing standards since the 1990s may have been boundary-work in which the political project of decreasing the chance that companies' products are defined as carcinogenic has masqueraded as techno-science. Copyright © 2012. Published by Elsevier Ltd.

  1. 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

  2. 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.

  3. Building better environmental risk assessments

    Directory of Open Access Journals (Sweden)

    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.

  4. Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents.

    Science.gov (United States)

    Leong Wai Yeen, James; Salek, Sam; Walker, Stuart

    2014-01-01

    The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template.

  5. Dynamical systems probabilistic risk assessment

    Energy Technology Data Exchange (ETDEWEB)

    Denman, Matthew R. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Ames, Arlo Leroy [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2014-03-01

    Probabilistic Risk Assessment (PRA) is the primary tool used to risk-inform nuclear power regulatory and licensing activities. Risk-informed regulations are intended to reduce inherent conservatism in regulatory metrics (e.g., allowable operating conditions and technical specifications) which are built into the regulatory framework by quantifying both the total risk profile as well as the change in the risk profile caused by an event or action (e.g., in-service inspection procedures or power uprates). Dynamical Systems (DS) analysis has been used to understand unintended time-dependent feedbacks in both industrial and organizational settings. In dynamical systems analysis, feedback loops can be characterized and studied as a function of time to describe the changes to the reliability of plant Structures, Systems and Components (SSCs). While DS has been used in many subject areas, some even within the PRA community, it has not been applied toward creating long-time horizon, dynamic PRAs (with time scales ranging between days and decades depending upon the analysis). Understanding slowly developing dynamic effects, such as wear-out, on SSC reliabilities may be instrumental in ensuring a safely and reliably operating nuclear fleet. Improving the estimation of a plant's continuously changing risk profile will allow for more meaningful risk insights, greater stakeholder confidence in risk insights, and increased operational flexibility.

  6. US EPA - A*Star Partnership - Accelerating the Acceptance of Next-Generation Sciences and Their Application to Regulatory Risk Assessment (A*Star Symposium, Singapore)

    Science.gov (United States)

    The path for incorporating new alternative methods and technologies into quantitative chemical risk assessment poses a diverse set of scientific challenges. Some of these challenges include development of relevant and predictive test systems and computational models to integrate...

  7. Hepatitis Risk Assessment

    Science.gov (United States)

    ... 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 ...

  8. Regulatory review of probabilistic safety assessment (PSA) level 1

    International Nuclear Information System (INIS)

    2000-02-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from the deterministic analysis. Many regulatory authorities consider that the current state of the art in PSA (especially Level 1 PSA) is sufficiently well developed that it can be used centrally in the regulatory decision making process - referred to as 'risk informed regulation'. For these applications to be successful, it will be necessary for regulatory authorities to have a high degree of confidence in PSA. However, at the IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process in 1994 and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' Meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997 the IAEA and OECD Nuclear Energy Agency agreed to produce in co-operation a technical document on the regulatory review of PSA. This publication is intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable standard so that it can be used as the basis for taking risk informed decisions within a regulatory decision making process. The document gives guidance on how to set about reviewing a PSA and on the technical issues that need to be addressed. This publication gives guidance for the review of Level 1 PSA for

  9. 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

  10. 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.

  11. Regulatory Risk Management of Advanced Nuclear Power Plants

    International Nuclear Information System (INIS)

    George, Glenn R.

    2002-01-01

    Regulatory risk reflects both the likelihood of adverse outcomes during regulatory interactions and the severity of those outcomes. In the arena of advanced nuclear power plant licensing and construction, such adverse outcomes may include, for example, required design changes and construction delays. These, in turn, could significantly affect the economics of the plant and the generation portfolio in which it will operate. In this paper, the author addresses these issues through the lens of risk management. The paper considers various tools and techniques of regulatory risk management, including design diversity and hedging strategies. The effectiveness of alternate approaches is weighed and recommendations are made in several regulatory contexts. (author)

  12. Accountability feedback assessments for improving efficiency of nuclear regulatory institutions

    International Nuclear Information System (INIS)

    Lavarenne, Jean; Shwageraus, Eugene; Weightman, Michael

    2016-01-01

    The Fukushima-Daiichi Accident demonstrated the need of assessing and strengthening institutions involved in nuclear safety, including the accountability of regulators. There are a few problems hindering the path towards a greater understanding of accountability systems, the ensemble of mechanisms holding to account the nuclear regulator on behalf of the public. There is no consensus on what it should deliver and no systematic assessment method exists. This article proposes a method of assessing institutions based on defence in depth concepts and inspired from risk-assessment techniques used for nuclear safety. As a first step in testing the proposal, it presents a simple Monte-Carlo simulation, illustrating some of the workings of the method of assessment and demonstrating the kind of results it will be able to supply. This on-going work will assist policy-makers take better informed decisions about the size, structure and organisation of a nuclear regulator and the cost-effective funding of its accountability system. It will assist in striking a balance between efficiency and resilience of regulatory decision-making processes. It will also promote the involvement of stakeholders and allow them to have a more meaningful impact on regulatory decisions, thereby enhancing the robustness of the regulatory system and potentially trust and confidence. - Highlights: •A general introduction to regulatory accountability is given. •A definition of an effective accountability system is proposed. •A method to assess accountability systems is proposed. •A simplified simulation of a regulatory system demonstrates the method’s capabilities.

  13. Genetic toxicology and cancer risk assessment

    National Research Council Canada - National Science Library

    Choy, Wai Nang

    2001-01-01

    ... their risks to humans are obvious goals for the protection of public health. When exposure is unavoidable, an accurate estimation of human risk as a result of exposure is essential for making regulatory decisions. Quantitative cancer risk assessment is an intricate process that utilizes knowledge from many different scien...

  14. INFORMATION SECURITY RISK ASSESSMENT USING EXISTING LEGAL AND METHODOLOGICAL BASE

    Directory of Open Access Journals (Sweden)

    A. I. Trubei

    2015-01-01

    Full Text Available The article provides a survey of the existing regulatory framework for information security riskmanagement. Practical methods for information security risk and vulnerability assessment are proposed.

  15. 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

  16. Pharmacokinetics for regulatory risk analysis: the case of trichloroethylene.

    Science.gov (United States)

    Bogen, K T

    1988-12-01

    Physiologically based pharmacokinetic (PBPK) models describing the uptake, metabolism, and excretion of volatile organic compounds (VOCs) are now proposed for use in regulatory health-risk assessment. A steady-state analysis of one such model is shown to provide simple, convenient predicted relationships between an applied dose and the corresponding toxicologically effective, metabolized dose for certain VOCs like trichloroethylene (TCE). A version of this PBPK model was fit to data on human metabolism of TCE to urinary metabolites in chronically exposed workers, yielding a direct estimate of PBPK parameters governing human capacity to metabolize TCE. It is shown that this estimate is consistent with others based on experimental studies of TCE metabolism in humans exposed to TCE by inhalation for short periods. These results are applied to human cancer-risk assessment using rodent bioassay data on TCE-induced tumorigenesis.

  17. 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.

  18. 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

  19. Risk acceptance criteria of the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Felizia, Eduardo R.

    2005-01-01

    This report describes some of the regulatory and control functions legally conferred upon the Argentine Nuclear Regulatory Authority concerning radiological risks, as well as a critical analysis of the radiological risk acceptance criteria contained in the Argentine regulatory system. A summary of the application of regulatory standards AR 3.1.3. - 'Radiological criteria related to accidents in nuclear power reactors' and AR 4.1.3. - 'Radiological criteria related to accidents in research reactors' to concrete cases is made, while the favourable and unfavourable aspects of the risk acceptance criteria are discussed. The conclusion is that the Argentine regulatory system contains adequate radiological risk acceptance criteria, that the latter are consistent with the radiological protection principles applicable to man and that, for the moment, there is no need to perform any modifications that would broaden the conceptual framework on which such criteria are based. (author) [es

  20. 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?

  1. Hiding the tobacco power wall reduces cigarette smoking risk in adolescents: using an experimental convenience store to assess tobacco regulatory options at retail point-of-sale.

    Science.gov (United States)

    Shadel, William G; Martino, Steven C; Setodji, Claude M; Scharf, Deborah M; Kusuke, Daniela; Sicker, Angela; Gong, Min

    2015-11-23

    This experiment tested whether changing the location or visibility of the tobacco power wall in a life sized replica of a convenience store had any effect on adolescents' susceptibility to future cigarette smoking. The study was conducted in the RAND StoreLab (RSL), a life sized replica of a convenience store that was developed to experimentally evaluate how changing aspects of tobacco advertising displays in retail point-of-sale environments influences tobacco use risk and behaviour. A randomised, between-subjects experimental design with three conditions that varied the location or visibility of the tobacco power wall within the RSL was used. The conditions were: cashier (the tobacco power wall was located in its typical position behind the cash register counter); sidewall (the tobacco power wall was located on a sidewall away from the cash register); or hidden (the tobacco power wall was located behind the cashier but was hidden behind an opaque wall). The sample included 241 adolescents. Hiding the tobacco power wall significantly reduced adolescents' susceptibility to future cigarette smoking compared to leaving it exposed (ie, the cashier condition; p=0.02). Locating the tobacco power wall on a sidewall away from the cashier had no effect on future cigarette smoking susceptibility compared to the cashier condition (p=0.80). Hiding the tobacco power wall at retail point-of-sale locations is a strong regulatory option for reducing the impact of the retail environment on cigarette smoking risk in adolescents. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  2. 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.

  3. Preliminary regulatory assessment of nuclear power plants vulnerabilities

    International Nuclear Information System (INIS)

    Kostadinov, V.; Petelin, S.

    2004-01-01

    Preliminary attempts to develop models for nuclear regulatory vulnerability assessment of nuclear power plants are presented. Development of the philosophy and computer tools could be new and important insight for management of nuclear operators and nuclear regulatory bodies who face difficult questions about how to assess the vulnerability of nuclear power plants and other nuclear facilities to external and internal threats. In the situation where different and hidden threat sources are dispersed throughout the world, the assessment of security and safe operation of nuclear power plants is very important. Capability to evaluate plant vulnerability to different kinds of threats, like human and natural occurrences and terrorist attacks and preparation of emergency response plans and estimation of costs are of vital importance for assurance of national security. On the basis of such vital insights, nuclear operators and nuclear regulatory bodies could plan and optimise changes in oversight procedures, organisations, equipment, hardware and software to reduce risks taking into account security and safety of nuclear power plants operation, budget, manpower, and other limitations. Initial qualitative estimations of adapted assessments for nuclear applications are shortly presented. (author)

  4. 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.

  5. Facts and values in risk assessment

    International Nuclear Information System (INIS)

    Cross, Frank B.

    1998-01-01

    Risk, as commonly understood, is a complex melange of facts, values, and fears. While this complexity of public risk perception is now broadly recognized, its implications are insufficiently explored. Public risk perceptions offer p poor guide for public policymaking. Popular assessments of risk are tainted by misinformation and unreliable heuristics. While subjective considerations, often called values, play a role in public perception of risk, those 'values' are often inappropriate for government decisionmaking. Reliance on public perceptions of risk means more premature deaths. Public risk perception also is systematically skewed contrary to the interests of the disadvantaged. Strict probabilistic risk measures generally provide a superior guide for government regulatory policy

  6. 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...

  7. 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.

  8. 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.

  9. 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...

  10. 77 FR 29391 - An Approach for Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific...

    Science.gov (United States)

    2012-05-17

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0110] An Approach for Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; request for comment. SUMMARY: The U.S. Nuclear Regulatory...

  11. Assessing the effectiveness of nuclear regulatory system in India

    International Nuclear Information System (INIS)

    Gandhia, Sonal; Choi, Kwang Sik

    2012-01-01

    The Fukushima accident brought up the issue of regulatory effectiveness in the fore. One of the causes of the accident has been attributed to the problems in effectiveness of the Japanese regulatory system. Regulatory reform is underway in Japan and in other countries many efforts have also been made to improve the effectiveness and independence of the regulatory bodies. It is important that the regulatory bodies make self-assessment of their weaknesses and strengths, to achieve the ultimate regulatory goal of assuring acceptable level of nuclear safety. In this paper an assessment has been done for the effectiveness of Indian nuclear regulatory system as implemented by the Atomic Energy Regulatory board (AERB). A number of good practices of AERB have been found and some areas have been identified where improvements are necessary

  12. Statement on the suitability of the BEEHAVE model for its potential use in a regulatory context and for the risk assessment of multiple stressors in honeybees at the landscape level

    DEFF Research Database (Denmark)

    EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues); Topping, Christopher John

    2015-01-01

    The Panel has interpreted the Terms of Reference by carrying out a stepwise evaluation of the BEEHAVE simulation model with a view to assessing its suitability for use in a regulatory context and for risk assessment of multiple stressors at the landscape level. The EFSA opinion on good modelling...... practice was used to evaluate the model and its documentation systematically. The overall conclusion is that BEEHAVE performs well in modelling honeybee colony dynamics, and the supporting documentation is generally good but does not fully meet the criteria of the good modelling opinion. BEEHAVE is not yet...... of the effects of interactions of pesticides with multiple stressors. BEEHAVE currently uses a very simple representation of a landscape and this should be extended. There is only one environmental scenario in the present version of BEEHAVE (European central zone—weather scenarios for Germany and the UK...

  13. Expert Views on Regulatory Preparedness for Managing the Risks of Nanotechnologies

    Science.gov (United States)

    Beaudrie, Christian E. H.; Satterfield, Terre; Kandlikar, Milind; Harthorn, Barbara H.

    2013-01-01

    The potential and promise of nanotechnologies depends in large part on the ability for regulatory systems to assess and manage their benefits and risks. However, considerable uncertainty persists regarding the health and environmental implications of nanomaterials, hence the capacity for existing regulations to meet this challenge has been widely questioned. Here we draw from a survey (N=254) of US-based nano-scientists and engineers, environmental health and safety scientists, and regulatory scientists and decision-makers, to ask whether nano experts regard regulatory agencies as prepared for managing nanomaterial risks. We find that all three expert groups view regulatory agencies as unprepared. The effect is strongest for regulators themselves, and less so for scientists conducting basic, applied, or health and safety work on nanomaterials. Those who see nanotechnology risks as novel, uncertain, and difficult to assess are particularly likely to see agencies as unprepared. Trust in regulatory agencies, views of stakeholder responsibility regarding the management of risks, and socio-political values were also found to be small but significant drivers of perceived agency preparedness. These results underscore the need for new tools and methods to enable the assessment of nanomaterial risks, and to renew confidence in regulatory agencies’ ability to oversee their growing use and application in society. PMID:24244662

  14. Expert views on regulatory preparedness for managing the risks of nanotechnologies.

    Directory of Open Access Journals (Sweden)

    Christian E H Beaudrie

    Full Text Available The potential and promise of nanotechnologies depends in large part on the ability for regulatory systems to assess and manage their benefits and risks. However, considerable uncertainty persists regarding the health and environmental implications of nanomaterials, hence the capacity for existing regulations to meet this challenge has been widely questioned. Here we draw from a survey (N=254 of US-based nano-scientists and engineers, environmental health and safety scientists, and regulatory scientists and decision-makers, to ask whether nano experts regard regulatory agencies as prepared for managing nanomaterial risks. We find that all three expert groups view regulatory agencies as unprepared. The effect is strongest for regulators themselves, and less so for scientists conducting basic, applied, or health and safety work on nanomaterials. Those who see nanotechnology risks as novel, uncertain, and difficult to assess are particularly likely to see agencies as unprepared. Trust in regulatory agencies, views of stakeholder responsibility regarding the management of risks, and socio-political values were also found to be small but significant drivers of perceived agency preparedness. These results underscore the need for new tools and methods to enable the assessment of nanomaterial risks, and to renew confidence in regulatory agencies' ability to oversee their growing use and application in society.

  15. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants (Cooperative Agreement DE-FC03-99SF21902, Am. M004) Final Technical Report

    International Nuclear Information System (INIS)

    Ritterbusch, Stanley E.

    2003-01-01

    accidents would be an inherent part of the Probabilistic Safety Assessment for the plant and their evaluation would be probabilistic. Other first year accomplishments include (1) the conversion of an NRC database for cross-referencing NRC criteria and industry codes and standards to Microsoft 2000 software, (2) an assessment of the NRC's hearing process which concluded that the normal cross-examination during public hearings is not actually required by the U.S. Administrative Procedures Act, (3) the identification and listing of reliability data sources, and (4) interfacing with other industry groups (e.g., NEI and IAEA) and NRC at workshops for risk-informing regulations. The major accomplishments during the second year consisted of (1) issuance of the final report for Subtask 1.1, ''Identify Current Applicable Regulatory Requirements [and Industry Standards],'' (2) issuance of the final report for Subtask 1.2,'' Identify Structures, Systems, and Components and Their Associate d Costs for a Typical Plant,'' (3) extension of the new, highly risk-informed design and regulatory framework to non-light-water-reactor technology, (4) completion of more detailed thermal-hydraulic and probabilistic analyses of advanced conceptual reactor system/component designs, (6) initial evaluation and recommendations for improvement of the NRC design review process, and (7) initial development of the software format, procedures and statistical routines needed to store, analyze and retrieve the available reliability data. Final reports for Subtasks 1.1 (regulatory and design criteria) and 1.2 (costs for structures, systems, and components) were prepared and issued. A final report for Subtask 1.3 (Regulatory Framework) was drafted with the aim to issue it in Phase 3 (Year 3). One technical report was produced for Subtask 1.4 (methods development) and two technical reports were produced for Subtask 1.6 (sample problem analysis). An interim report on the NRC design review process (Subtask 1.7) was

  16. Assessing the relevance of ecotoxicological studies for regulatory decision making.

    Science.gov (United States)

    Rudén, Christina; Adams, Julie; Ågerstrand, Marlene; Brock, Theo Cm; Poulsen, Veronique; Schlekat, Christian E; Wheeler, James R; Henry, Tala R

    2017-07-01

    Regulatory policies in many parts of the world recognize either the utility of or the mandate that all available studies be considered in environmental or ecological hazard and risk assessment (ERA) of chemicals, including studies from the peer-reviewed literature. Consequently, a vast array of different studies and data types need to be considered. The first steps in the evaluation process involve determining whether the study is relevant to the ERA and sufficiently reliable. Relevance evaluation is typically performed using existing guidance but involves application of "expert judgment" by risk assessors. In the present paper, we review published guidance for relevance evaluation and, on the basis of the practical experience within the group of authors, we identify additional aspects and further develop already proposed aspects that should be considered when conducting a relevance assessment for ecotoxicological studies. From a regulatory point of view, the overarching key aspect of relevance concerns the ability to directly or indirectly use the study in ERA with the purpose of addressing specific protection goals and ultimately regulatory decision making. Because ERA schemes are based on the appropriate linking of exposure and effect estimates, important features of ecotoxicological studies relate to exposure relevance and biological relevance. Exposure relevance addresses the representativeness of the test substance, environmental exposure media, and exposure regime. Biological relevance deals with the environmental significance of the test organism and the endpoints selected, the ecological realism of the test conditions simulated in the study, as well as a mechanistic link of treatment-related effects for endpoints to the protection goal identified in the ERA. In addition, uncertainties associated with relevance should be considered in the assessment. A systematic and transparent assessment of relevance is needed for regulatory decision making. The relevance

  17. 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.

  18. 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...

  19. 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...

  20. 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

  1. 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.

  2. Refinement and cross-validation of nickel bioavailability in PNEC-Pro, a regulatory tool for site-specific risk assessment of metals in surface water.

    Science.gov (United States)

    Verschoor, Anja J; Vijver, Martina G; Vink, Jos P M

    2017-09-01

    The European Water Framework Directive prescribes that the environmental quality standards for nickel in surface waters should be based on bioavailable concentrations. Biotic ligand models (BLMs) are powerful tools to account for site-specific bioavailability within risk assessments. Several BLMs and simplified tools are available. For nickel, most of them are based on the same toxicity dataset and chemical speciation methodology as laid down in the 2008 European Union Environmental Risk Assessment Report (RAR). Since then, further insights into the toxic effects of nickel on aquatic species have been gained, and new data and methodologies have been generated and implemented using the predicted-no-effect-concentration (PNEC)-pro tool. The aim of the present study is to provide maximum transparency on data revisions and how this affects the derived environmental quality standards. A case study with 7 different ecoregions was used to determine differences in species sensitivity distributions and in hazardous concentrations for 5% of the species (HC5) values between the original Ni-RAR BLMs and the PNEC-pro BLMs. The BLM parameters used were pH dependent, which extended the applicability domain of PNEC-pro up to a pH of 8.7 for surface waters. After inclusion of additional species and adjustment for cross-species extrapolation, the HC5s were well within the prediction range of the RAR. Based on the latest data and scientific insights, transfer functions in the user-friendly PNEC-pro tool have been updated accordingly without compromising the original considerations of the Ni-RAR. Environ Toxicol Chem 2017;36:2367-2376. © 2017 SETAC. © 2017 SETAC.

  3. 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

  4. Radiation exposure to natural radioactivity in crude oil and petroleum waste from oil fields in Ghana: modelling, risk assessment and regulatory control

    International Nuclear Information System (INIS)

    Kpeglo, D. O.

    2015-06-01

    In this research work radiological hazards and risks to members of the public and workers from exposure to natural radioactivity as a result of crude oil production activities and waste generation from the Saltpond and Jubilee oilfields of Ghana, have been investigated via several exposure pathways using alpha spectrometry after radiochemical separation, nondestructive gamma spectrometry, Scanning Electron Microscope (SEM) and Inductively Coupled Plasma Quadrupole-Based Mass Spectrometry (ICP-QMS) and other complimentary analytical tools. Additionally, in this study a Human health risk assessment model for cancer risk associated with NORM (Naturally Occurring Radioactive Material) components in produced water was developed. Characterization and determination of specific activities of 234 U, 238 U, 210 Po, 230 Th, 2 3 2 Th, 226 Ra, 210 Pb, 234 Th, 228 Ra, 228 Th, 224 Ra, and 40 K for several environmental and NORM waste samples in different matrices have been established. The elements Al, Ba, Ca, Cl, Cu, Fe, K, Mg, Na, P, Pb S, Si, Sr, and Zn were identified and semi qualitatively quantified by Scanning Electron Microscope for NORM waste samples. The total annual effective dose of 0.35 mSv.y -1 obtained for all exposure pathways for the public in this study was below the International Commission on Radiological Protection (ICRP) recommended dose limit of 1 mSv.y -1 for members of the public, whilst the total annual effective dose of 80.86 mSv.y -1 obtained in this study for workers clearly exceeded the ICRP recommended dose limit for an occupationally exposed worker of 20 mSv.y -1 , averaged over 5 years, but not exceeding 50 mSv.y -1 in any single year. The estimated total lifetime fatality cancer risk and the lifetime hereditary effect values were 1.3 x 10 -3 and 4.9 x 10 -5 for the public, and 23.2 x 10 -2 and 5.7 x 10 -3 for adult workers respectively. In conclusion, radium concentrations obtained in this study for scale, sludge and produced water from the

  5. 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...

  6. Swedish REGULATORY APPROACH TO SAFETY Assessment AND SEVERE ACCIDENT MANAGEMENT

    International Nuclear Information System (INIS)

    Frid, W.; Sandervaag, O.

    1997-01-01

    The Swedish regulatory approach to safety assessment and severe accident management is briefly described. The safety assessment program, which focuses on prevention of incidents and accidents, has three main components: periodic safety reviews, probabilistic safety analysis, and analysis of postulated disturbances and accident progression sequences. Management and man-technology-organisation issues, as well as inspections, play a key role in safety assessment. Basis for severe accident management were established by the Government decisions in 1981 and 1986. By the end of 1988, the severe accident mitigation systems and emergency operating procedures were implemented at all Swedish reactors. The severe accident research has continued after 1988 for further verification of the protection provided by the systems and reduction of remaining uncertainties in risk dominant phenomena

  7. An approach for risk management and regulatory applications

    International Nuclear Information System (INIS)

    Wong, See-Meng

    2000-01-01

    This paper discusses the development and potential applications of a PRA methodology for risk management and regulatory applications in the U.S. nuclear industry. The new PRA methodology centers on the development of time-dependent configuration risk profiles for evaluating the effectiveness of operational risk management programs at U.S. nuclear power plants. Configuration-risk profiles have been used as risk-information tools for (1) a better understanding of the impact of daily operational activities on plant safety and (2) proactive planning of operational activities to manage risk. Trial applications of the methodology were undertaken to demonstrate that configuration-risk profiles can be developed routinely, and can be useful for various industry and regulatory applications. Lessons learned include a better understanding of the issues and characteristics of PRA models available to industry, and identifying the attributes and pitfalls in the development of risk profiles. (author)

  8. Backtesting for Risk-Based Regulatory Capital

    NARCIS (Netherlands)

    Kerkhof, F.L.J.; Melenberg, B.

    2002-01-01

    In this paper we present a framework for backtesting all currently popular risk measurement methods (including value-at-risk and expected shortfall) using the functional delta method.Estimation risk can be taken explicitly into account.Based on a simulation study we provide evidence that tests for

  9. The Future Regulatory Challenges of Liquidity Risk Management

    OpenAIRE

    Petr Teply

    2011-01-01

    Liquidity risk management ranks to key concepts applied in finance. Liquidity is defined as a capacity to obtain funding when needed, while liquidity risk means as a threat to this capacity to generate cash at fair costs. In the paper we present challenges of liquidity risk management resulting from the 2007- 2009 global financial upheaval. We see five main regulatory liquidity risk management issues requiring revision in coming years: liquidity measurement, intra-day and...

  10. 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.

  11. Future regulatory research needs on risk-informed and performance-based regulation

    International Nuclear Information System (INIS)

    Kim, Wong Sik; Kim, Hho Jung

    2004-01-01

    The USNRC has pursued the incorporation of risk-informed and performance-based regulation (RIPBR) into nuclear safety regulatory system, as an alternative to improve existing nuclear safety regulation of nuclear power plants, which is deterministic and prescriptive. It focuses on the use of risk insight from probabilistic safety assessment (PSA). Recently, it becomes necessary to find a way to improve regulatory efficiency and effectiveness in order to cover the increasing regulatory needs in Korea. Also, the utility has optimized design and operation of the plant using PSA insight and equipment performance information. According to the increase of the necessity for regulatory improvement using risk and performance information, KINS (Korea Institute of Nuclear Safety) is developing, as a part of a mid and long-term project of Nuclear R and D program, how to adopt the RIPBR in Korean nuclear regulatory system. As the interim results, three basic directions and several principles that are necessary to implement RIPBR model were already identified from the previous study. This paper suggests a direction to future regulatory research on RIPBR based on the previous studies including the review of international trend of RIPBR and the evaluation of risk-informed regulatory environment

  12. 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

  13. Proposed Regulatory Guideline on the PSA Quality for Risk-informed Applications

    International Nuclear Information System (INIS)

    Lee, Chang Ju; Choi, Jong Soo

    2005-01-01

    In the policy statement on nuclear safety issued by the Korean government in 1994, the introduction of risk-informed regulations in licensing and regulation of nuclear power plants was emphasized for the first time. It also describes the implementation of comprehensive safety assessment utilizing PSA (probabilistic safety assessment). Since then, because risk-informed environment and fundamentals had not been strong, several R and D on PSA and risk-informed regulation have been done even though their application has been delayed. However, today it is not the case. Since the follow-up policy statement (called Severe Accident Policy) was issued, which prescribes strong items such as PSA implementation and its periodic reassessment, reliability database, and risk monitoring program to the utility, we have a chance to easily get all kinds of risk information for improving current regulatory framework. In addition, with the overall availability of PSA results for all operating nuclear power plants, it is expected that many risk-informed applications (RIAs) will be submitted to the regulatory authority. In general, there are a lot of regulatory concerns associated with the quality assurance of licensee's submittals for RIA. It is also noted that making general requirements and touching specific check points are essential for the regulatory decision making process. This paper summarizes the structure and contents of our regulatory guideline for assuring PSA quality

  14. Current products and future plan of regulatory research for risk-informed regulation in Korea

    International Nuclear Information System (INIS)

    Sung, Key Yong; Lee, Chang Ju; Kim, Woong Sik; Kim, Hho Jung

    2003-01-01

    The first phase of a regulatory research project for risk-informed regulation (RIR) and applications (RIA) was finished in March of 2002. Various results that could be useful for preparing Korean RIR system have been developed. One of the remarkable outputs is development of reactor safety goals and acceptance criteria for RIR and RIA in Korea. The Safety Goal has a 4-tier hierarchical structure and each tier has specified goals classified for their usage. Regulatory review guides for probabilistic safety assessment (PSA) including level-1, level-2 and low power and shutdown PSA have been updated by reflecting new information obtained from not only the overseas documents but also experience and insights from regulatory review in Korea. In addition, draft regulatory guides for risk-informed in-service inspection, in-service testing, importance ranking of motor-operated valves, and AOT/STI change of Technical Specifications have been developed for preparing ongoing and future licensing work. Risk-based inspection guides with inspection items selected from a viewpoint of risk importance have been suggested for Korean standard NPPs as well. In the second phase of a research project (April of 2002 to March of 2005), two regulatory research projects on RIR were initiated. One is a study on institutionalization of risk-informed and performance-based regulation. Main topics of this project are evaluation of benefit and characteristics of RIR, development of optimized Korean RIR model, impact analysis for the change of current regulation framework, and suggestion of RIR-related laws and rules. The other is focusing on the development in the areas of a regulatory audit PSA model and regulatory guides for risk monitoring, and application techniques of risk information to the significance determination of plant performance indicators and inspection findings. It is expected that a concrete scheme and detailed regulatory techniques for embodiment of RIR system in Korea will be

  15. Development of Checklist for Self-Assessment of Regulatory Capture in Nuclear Safety Regulation

    International Nuclear Information System (INIS)

    Choi, K. S.; Lee, Y. E.; Chang, H. S.; Jung, S. J.

    2011-01-01

    Regulatory body performs its mission on behalf of the general public. As for nuclear industries, the public delegates the authority to the regulatory body for monitoring the safety in nuclear facilities and for ensuring that it is maintained in the socially and globally acceptable level. However, when the situation that a regulatory body behaves in the interests of industries happens, not working primarily for protecting public health and safety on behalf of the public, it is charged that regulatory body acts as an encouragement for industries which produce negative externalities such as radiation risk or radiation hazards. In this case, the regulatory body is called as 'Captured' or it is called that 'Regulatory Capture' happened. Regulatory capture is important as it may cause regulatory failure, one form of government failure, which is very serious phenomenon: severe nuclear accident at Fukushima nuclear power plants recently occurred in March, 2011. This paper aims to introduce the concept of regulatory capture into nuclear industry field through the literature survey, and suggest the sample checklist developed for self-assessment on the degree of regulatory capture within regulatory body

  16. Regulatory environment of transitioning to risk-informed regulations in U.S.A

    International Nuclear Information System (INIS)

    Choi, C. H.; Kim, C. H.

    1999-01-01

    With the publication of the PRA Policy Statement and recent regulatory guides, the U.S.NRC makes a continuous approach towards risk-informed regulations with the goal of establishing an overall framework for risk-informed decisions in all regulatory activities as well as plant specific licensing issues. Faced with the changing environment of deregulation of the electricity generation market, the licensee's effort to reduce design margins to enhance flexibility and to relieve unnecessary regulatory burdens have been focused on the control and reduction of plant operating costs. The risk-informed approach provides a structured, systematic, and defensible method that can be applied not only to rulemaking, but also to licensing, inspection, enforcement, and performance assessment, as well as provides basis for prioritization in the establishment of programs and the allocation of resources. This report describes the current regulatory environment of transitioning to risk-informed regulations with an emphasis on its background, concepts, regulatory guides, proposed options for modifying the 10CFR50, and risk-informed applications in U.S.A. Review of the risk informed applications utilizing the information provided by the PRAs and their insights in the U.S.NRC and nuclear industry will provide the insights of predicting the expected regulation changes in Korea. Also it could provide the applicable methods or guides for the implementation of the risk-informed applications in plant design and operations. (author)

  17. Policy for setting and assessing regulatory safety goals. Peer discussions on regulatory practices

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-10-01

    This publication pertains to future planning for enhancement of good practices and it describes the experience to date in developing and implementing the policy for setting and assessing regulatory safety goals for nuclear facilities in 22 Member States. Senior regulators from these 22 Member States participated in four Peer Group discussions in 1993/94 which considered the policy used for setting and assessing regulatory safety goals. This publication presents the consensus views reached by the majority of these senior regulators.

  18. Policy for setting and assessing regulatory safety goals. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    1995-10-01

    This publication pertains to future planning for enhancement of good practices and it describes the experience to date in developing and implementing the policy for setting and assessing regulatory safety goals for nuclear facilities in 22 Member States. Senior regulators from these 22 Member States participated in four Peer Group discussions in 1993/94 which considered the policy used for setting and assessing regulatory safety goals. This publication presents the consensus views reached by the majority of these senior regulators

  19. Risk Assessment of Shellfish Toxins

    Directory of Open Access Journals (Sweden)

    Rex Munday

    2013-11-01

    Full Text Available Complex secondary metabolites, some of which are highly toxic to mammals, are produced by many marine organisms. Some of these organisms are important food sources for marine animals and, when ingested, the toxins that they produce may be absorbed and stored in the tissues of the predators, which then become toxic to animals higher up the food chain. This is a particular problem with shellfish, and many cases of poisoning are reported in shellfish consumers each year. At present, there is no practicable means of preventing uptake of the toxins by shellfish or of removing them after harvesting. Assessment of the risk posed by such toxins is therefore required in order to determine levels that are unlikely to cause adverse effects in humans and to permit the establishment of regulatory limits in shellfish for human consumption. In the present review, the basic principles of risk assessment are described, and the progress made toward robust risk assessment of seafood toxins is discussed. While good progress has been made, it is clear that further toxicological studies are required before this goal is fully achieved.

  20. Regulatory Mode and Risk-Taking: The Mediating Role of Anticipated Regret.

    Science.gov (United States)

    Panno, Angelo; Lauriola, Marco; Pierro, Antonio

    2015-01-01

    We propose that decision maker's regulatory mode affects risk-taking through anticipated regret. In the Study 1 either a locomotion or an assessment orientation were experimentally induced, and in the Studies 2 and 3 these different orientations were assessed as chronic individual differences. To assess risk-taking we used two behavioral measures of risk: BART and hot-CCT. The results show that experimentally induced assessment orientation--compared to locomotion--leads to decreased risk-taking through increased anticipated regret (Study 1). People chronically predisposed to be in the assessment state take less risk through increased anticipated regret (Study 2 and Study 3). Study 2 results also show a marginally non-significant indirect effect of chronic locomotion mode on BART through anticipated regret. Differently, Study 3 shows that people chronically predisposed to be in the locomotion state take greater risk through decreased anticipated regret, when play a dynamic risk task triggering stronger emotional arousal. Through all three studies, the average effect size for the relationship of assessment with anticipated regret was in the moderate-large range, whereas for risk-taking was in the moderate range. The average effect size for the relationship of locomotion with anticipated regret was in the moderate range, whereas for risk-taking was in the small-moderate range. These results increase our understanding of human behavior under conditions of risk obtaining novel insights into regulatory mode theory and decision science.

  1. [Fundamentally new electromagnetic pollution and the lack of adequate regulatory framework--on the risk assessment (analysis of modern domestic and foreign data)].

    Science.gov (United States)

    Grigorev, Yu G

    2014-01-01

    On the base of the study of the numerous experimental and epidemiological studies electromagnetic radiation (EMR) of mobile communications were found to adversely affect on the health of the population. Analysis of the influence of radio frequency (RF) radiation from mobile phones (MPs) on the brain of users showed that this organ body is most exposed to this radiation, especially in children. As a result of the performed research there were recorded functional changes in children--MPs users: undue fatiguability (39.7%), decreased performance in the school and at home (50.7%), weakening of the stability of voluntary attention (productivity--14.3%, accuracy 19.4%) and semantic memory (accuracy--19.4% increase in the time--30.1%). In addition, a marked change in the rate of auditory- motor response (55.5%), and disturbances of phonemic perception have been noted. The existing legal framework on the influence of EMR on human health was shown not fully to meet the hygiene requirements in connection with the absence of her normative parameters which determine the impact of complicately modulated radiation from MPs and base stations. The need for additional research on the influence of the modulated RF EMR on the human body and creation of a regulatory framework taking into account the sum of biological effects, especially on the critical organ of human--brain is substantiated by the author. When creating a regulatory framework it must be taken into account the scientific beliefs on the possible development of long-term brain pathologies under the combined effect of EMF, especially in children.

  2. 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)

  3. Risk Assessment Approaches for Carcinogenic Food Contaminants

    OpenAIRE

    Gillespie, Zoe; Pulido, Olga; Vavasour, Elizabeth

    2011-01-01

    Health Canada has identified the need for a standardized department-wide approach for the risk assessment of carcinogens in foods (e.g., pesticides, food chemical contaminants, veterinary therapeutics). A standardized approach would better facilitate and inform risk management strategies for the control of human exposure to food sources of carcinogens. Within the post- market regulatory context, directly DNA-reactive carcinogens are of most concern because any exposure is theoretically assume...

  4. Regulatory approach to risk informed decision making in India

    International Nuclear Information System (INIS)

    Chande, S.K.; Koley, J.

    2001-01-01

    Atomic Energy Regulatory Board (AERB), the authority for licensing and monitoring safety in Indian Nuclear Power Plants (NPPs), makes use of insights gained from PSA together with the results of the other deterministic analyses in taking decisions regarding the acceptability of the safety of the NPPs. PSA provides an estimation of risks; it also gives information on a balanced design by revealing interaction between engineered features and weak areas in a design. For regulatory use, PSA needs to be carried out using standardized methodology and state of the art technology. PSA helps regulators in taking faster and consistent decisions. Keeping in mind the limitations associated with PSA study, AERB has decided to adopt risk-informed decision making in regulatory licensing process. This paper describes the AERB policy regarding PSA and gives an overview of the experience in this area. (author)

  5. 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.

  6. Everyday risk taking as a function of regulatory focus

    NARCIS (Netherlands)

    Hamstra, Melvyn R. W.; Bolderdijk, Jan Willem; Veldstra, Janet L.

    Uncertainty is an inherent aspect of everyday life. However, faced with uncertainty, some individuals take risks more eagerly than others. Regulatory focus theory may explain such differences because risky behavior may arise naturally from the eagerness of promotion focused individuals, while safe

  7. Online versus conventional shopping: Consumers' risk perception and regulatory focus

    NARCIS (Netherlands)

    van Noort, G.; Kerkhof, P.; Fennis, B.M.

    2007-01-01

    In two experiments, the impact of shopping context on consumers' risk perceptions and regulatory focus was examined. We predicted that individuals perceive an online (vs. conventional) shopping environment as more risky and that an online shopping environment, by its risky nature, primes a

  8. Online versus Conventional Shopping: Consumers' Risk Perception and Regulatory Focus

    NARCIS (Netherlands)

    van Noort, Guda; Kerkhof, Peter; Fennis, B.M.

    2007-01-01

    In two experiments, the impact of shopping context on consumers' risk perceptions and regulatory focus was examined. We predicted that individuals perceive an online (vs. conventional) shopping environment as more risky and that an online shopping environment, by its risky nature, primes a

  9. Methodology used by the spanish nuclear regulatory body in the radiological impact assessment

    International Nuclear Information System (INIS)

    Diaz de la Cruz, F.

    1979-01-01

    The radiological risk assessment derived from the operation of a nuclear power plant is done in Spain with methods taken basically from the U.S.N.R.C. regulatory guides. This report presents the way followed by the Spanish Regulatory Body in order to arrive to an official decision on the acceptability of a nuclear plant in the different steps of the licensing. (author)

  10. Regulatory uncertainty and the associated business risk for emerging technologies

    International Nuclear Information System (INIS)

    Hoerr, Robert A.

    2011-01-01

    An oversight system specifically concerned with nanomaterials should be flexible enough to take into account the unique aspects of individual novel materials and the settings in which they might be used, while recognizing that heretofore unrecognized safety issues may require future modifications. This article considers a question not explicitly considered by the project team: what is the risk that uncertainty over how regulatory oversight will be applied to nanomaterials will delay or block the development of this emerging technology, thereby depriving human health of potential and substantial benefits? An ambiguous regulatory environment could delay the availability of valuable new technology and therapeutics for human health by reducing access to investment capital. Venture capitalists list regulatory uncertainty as a major reason not to invest at all in certain areas. Uncertainty is far more difficult to evaluate than risk, which lends itself to quantitative models and can be factored into projections of return on possible investments. Loss of time has a large impact on investment return. An examination of regulatory case histories suggests that an increase in regulatory resting requirement, where the path is well-defined, is far less costly than a delay of a year or more in achieving product approval and market launch.

  11. Regulatory uncertainty and the associated business risk for emerging technologies

    Science.gov (United States)

    Hoerr, Robert A.

    2011-04-01

    An oversight system specifically concerned with nanomaterials should be flexible enough to take into account the unique aspects of individual novel materials and the settings in which they might be used, while recognizing that heretofore unrecognized safety issues may require future modifications. This article considers a question not explicitly considered by the project team: what is the risk that uncertainty over how regulatory oversight will be applied to nanomaterials will delay or block the development of this emerging technology, thereby depriving human health of potential and substantial benefits? An ambiguous regulatory environment could delay the availability of valuable new technology and therapeutics for human health by reducing access to investment capital. Venture capitalists list regulatory uncertainty as a major reason not to invest at all in certain areas. Uncertainty is far more difficult to evaluate than risk, which lends itself to quantitative models and can be factored into projections of return on possible investments. Loss of time has a large impact on investment return. An examination of regulatory case histories suggests that an increase in regulatory resting requirement, where the path is well-defined, is far less costly than a delay of a year or more in achieving product approval and market launch.

  12. 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

  13. 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.

  14. 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

  15. 78 FR 70354 - Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement

    Science.gov (United States)

    2013-11-25

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0254] Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement AGENCY: Nuclear Regulatory Commission. ACTION: Conceptual example of a... ``openness,'' a white paper on a Conceptual Example of a Proposed Risk Management Regulatory Framework (RMRF...

  16. Integral risk assessment

    International Nuclear Information System (INIS)

    Chakraborty, S.; Yadigaroglu, G.

    1991-01-01

    The series of lectures which forms the basis of this book and took place in the winter of 1989/90 at the ETH in Zuerich were held for the purpose of discussing the stage of development of our system of ethics in view of the extremely fast pace of technological progress and the risks which accompany it. Legal, psychological and political aspects of the problem were examined, but the emphasis was placed on ethical aspects. The effects which are examined in conventional risk analyses can be considered as a part of the ethical and social aspects involved, and in turn, the consideration of ethical and social aspects can be viewed as an extension of the conventional form of risk analysis. In any case, among risk experts, the significance of ethical and social factors is uncontested, especially as regards activities which can have far-reaching repurcussions. Some objective difficulties interfere with this goal, however: - No generally acknowledged set of ethical values exists. - Cultural influences and personal motives can interfere. - Normally a risk assessment is carried out in reference to individual facilities and within a small, clearly defined framework. Under certain circumstances, generalizations which are made for complete technological systems can lead to completely different conclusions. One contribution deals with integral views of the risks of atomic energy from an ethical and social perspective. (orig.) [de

  17. Childhood cumulative risk and obesity: the mediating role of self-regulatory ability.

    Science.gov (United States)

    Evans, Gary W; Fuller-Rowell, Thomas E; Doan, Stacey N

    2012-01-01

    We tested whether early childhood risk exposures are related to weight gain in adolescence and evaluate an underlying mechanism, self-regulatory behavior, for the risk-obesity link. Cumulative risk exposure to 9 sociodemographic (eg, poverty), physical (eg, substandard housing), and psychosocial (eg, family turmoil) stressors was assessed in 244 nine-year-old children. BMI was calculated at age 9 and then 4 years later. At age 9, children's ability to delay gratification as an index of self-regulatory behavior was assessed. Path analyses were then estimated to evaluate our mediational model (Cumulative risk → Self-regulation → BMI) over a 4-year period in a prospective, longitudinal design. Nine-year-old children exposed to a greater accumulation of multiple risk factors show larger gains in adiposity over the next four year period, net of their initial BMI. These gains in BMI during early adolescence are largely accounted for by deteriorated self-regulatory abilities among children facing more cumulative risks. Early childhood risk exposure leads to larger gains in BMI in adolescence. Given the importance of childhood adiposity to the development of obesity later in life, understanding the underlying mechanisms that link early experience to weight gain is an essential task. Deficiencies in self-regulation in response to chronic stress appears to be an important agent in the obesity epidemic.

  18. Risk assessment and risk evaluation

    International Nuclear Information System (INIS)

    Niehaus, F.

    1978-01-01

    With the help of results of investigations and model calculations the risk of nuclear energy in routine operation is shown. In this context it is pointed out that the excellent operation results of reactors all over the world have led to the acceptability of risks from local loads no longer being in question. The attention of radiation protection is therefore focused on the emissions of long-living isotopes which collect in the atmosphere. With LWRs the risk of accidents is so minimal that statistical data is, and never will be available. One has to therefore fall back upon the so-called fault tree analyses. On the subject of risk evalution the author referred to a poll in Austria. From the result of this investigation one might conclude that nuclear energy serves as a crystallization point for a discussion of varying concepts for future development. More attention should be paid to this aspect from both sides, in order to objectify the further expansion of this source of energy. (orig./HP) [de

  19. Hazard waste risk assessment

    International Nuclear Information System (INIS)

    Hawley, K.A.; Napier, B.A.

    1986-01-01

    Pacific Northwest Laboratory continued to provide technical assistance to the Department of Energy (DOE) Office of Operational Safety (OOS) in the area of risk assessment for hazardous and radioactive-mixed waste management. The overall objective is to provide technical assistance to OOS in developing cost-effective risk assessment tools and strategies for bringing DOE facilities into compliance with the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) and the Resource Conservation and Recovery Act (RCRA). Major efforts during FY 1985 included (1) completing the modification of the Environmental Protection Agency (EPA) Hazard Ranking System (HRS) and developing training manuals and courses to assist in field office implementation of the modified Hazard Ranking System (mHRS); (2) initiating the development of a system for reviewing field office HRS/mHRS evaluations for appropriate use of data and appropriate application of the methodology; (3) initiating the development of a data base management system to maintain all field office HRS/mHRS scoring sheets and to support the master OOS environmental data base system; (4) developing implementation guidance for Phase I of the DOE CERCLA Program, Installation Assessment; (5) continuing to develop an objective, scientifically based methodology for DOE management to use in establishing priorities for conducting site assessments under Phase II of the DOE CERCLA Program, Confirmation; and (6) participating in developing the DOE response to EPA on the proposed listing of three sites on the National Priorities List

  20. Regulatory review of safety cases and safety assessments - associated challenges

    International Nuclear Information System (INIS)

    Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

    2006-01-01

    Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

  1. Comparative Probabilistic Assessment of Occupational Pesticide Exposures Based on Regulatory Assessments.

    Science.gov (United States)

    Pouzou, Jane G; Cullen, Alison C; Yost, Michael G; Kissel, John C; Fenske, Richard A

    2017-11-06

    Implementation of probabilistic analyses in exposure assessment can provide valuable insight into the risks of those at the extremes of population distributions, including more vulnerable or sensitive subgroups. Incorporation of these analyses into current regulatory methods for occupational pesticide exposure is enabled by the exposure data sets and associated data currently used in the risk assessment approach of the Environmental Protection Agency (EPA). Monte Carlo simulations were performed on exposure measurements from the Agricultural Handler Exposure Database and the Pesticide Handler Exposure Database along with data from the Exposure Factors Handbook and other sources to calculate exposure rates for three different neurotoxic compounds (azinphos methyl, acetamiprid, emamectin benzoate) across four pesticide-handling scenarios. Probabilistic estimates of doses were compared with the no observable effect levels used in the EPA occupational risk assessments. Some percentage of workers were predicted to exceed the level of concern for all three compounds: 54% for azinphos methyl, 5% for acetamiprid, and 20% for emamectin benzoate. This finding has implications for pesticide risk assessment and offers an alternative procedure that may be more protective of those at the extremes of exposure than the current approach. © 2017 Society for Risk Analysis.

  2. The regulatory treatment of liquidity risk in South Africa

    Directory of Open Access Journals (Sweden)

    Johann Jacobs

    2012-08-01

    Full Text Available The Basel accord describes the regulatory capital requirements for credit, market and operational risk. The accord aims to provide guidelines to level the playing field for all internationally active banks and to protect consumers against these risks. Despite the growing significance to bank solvency of liquidity risk, it is omitted from the new accord2. Banks are not required to measure and manage this risk yet they are often considerably exposed to the threat of severely diminished liquidity. This omission from the accord could have dire consequences for banks and the economy in which they operate: liquidity crises can occur without warning and spread quickly to other parts of the financial system. This article critically explores current practices in South Africa and proposes guidelines for effective liquidity risk regulation.

  3. Improving regulatory capacity to manage risks associated with trade agreements.

    Science.gov (United States)

    Walls, Helen L; Smith, Richard D; Drahos, Peter

    2015-03-21

    Modern trade negotiations have delivered a plethora of bilateral and regional preferential trade agreements (PTAs), which involve considerable risk to public health, thus placing demands on governments to strengthen administrative regulatory capacities in regard to the negotiation, implementation and on-going management of PTAs. In terms of risk management, the administrative regulatory capacity requisite for appropriate negotiation of PTAs is different to that for the implementation or on-going management of PTAs, but at all stages the capacity needed is expensive, skill-intensive and requires considerable infrastructure, which smaller and poorer states especially struggle to find. It is also a task generally underestimated. If states do not find ways to increase their capacities then PTAs are likely to become much greater drivers of health inequities. Developing countries especially struggle to find this capacity. In this article we set out the importance of administrative regulatory capacity and coordination to manage the risks to public health associated with PTAs, and suggest ways countries can improve their capacity.

  4. 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

  5. 76 FR 72220 - Incorporation of Risk Management Concepts in Regulatory Programs

    Science.gov (United States)

    2011-11-22

    ... actions? 4. What are the key characteristics for a holistic risk management regulatory structure for... accomplishing the goal of a holistic risk management regulatory structure? How could these challenges be... NUCLEAR REGULATORY COMMISSION [NRC-2011-0269] Incorporation of Risk Management Concepts in...

  6. Online versus conventional shopping: consumers' risk perception and regulatory focus.

    Science.gov (United States)

    van Noort, Guda; Kerkhof, Peter; Fennis, Bob M

    2007-10-01

    In two experiments, the impact of shopping context on consumers' risk perceptions and regulatory focus was examined. We predicted that individuals perceive an online (vs. conventional) shopping environment as more risky and that an online shopping environment, by its risky nature, primes a prevention focus. The findings in Study 1 demonstrate these effects by using self-report measures for risk perception and prevention focus. In Study 2, we replicated these findings and demonstrated that the effect of an online shopping environment carries over to behavior in a domain unrelated to shopping.

  7. 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

  8. 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:

  9. A critical assessment of regulatory triggers for products of biotechnology: Product vs. process

    Science.gov (United States)

    McHughen, Alan

    2016-01-01

    ABSTRACT Regulatory policies governing the safety of genetic engineering (rDNA) and the resulting products (GMOs) have been contentious and divisive, especially in agricultural applications of the technologies. These tensions led to vastly different approaches to safety regulation in different jurisdictions, even though the intent of regulations—to assure public and environmental safety—are common worldwide, and even though the international scientific communities agree on the basic principles of risk assessment and risk management. So great are the political divisions that jurisdictions cannot even agree on the appropriate triggers for regulatory capture, whether product or process. This paper reviews the historical policy and scientific implications of agricultural biotechnology regulatory approaches taken by the European Union, USA and Canada, using their respective statutes and regulations, and then critically assesses the scientific underpinnings of each. PMID:27813691

  10. Promoting and assessment of safety culture within regulatory body

    International Nuclear Information System (INIS)

    Awasthi, Sumit; Bhattacharya, D.; Koley, J.; Krishnamurthy, P.R.

    2015-01-01

    Regulators have an important role to play in assisting organizations under their jurisdiction to develop positive safety cultures. It is therefore essential for the regulator to have a robust safety culture as an inherent strategy and communication of this strategy to the organizations it supervises. Atomic Energy Regulatory Board (AERB) emphasizes every utility to institute a good safety culture during various stages of a NPP. The regulatory requirement for establishing organisational safety culture within utility at different stages are delineated in the various AERB safety codes which are presented in the paper. Although the review and assessment of the safety culture is a part of AERB’s continual safety supervision through existing review mechanism, AERB do not use any specific indicators for safety culture assessment. However, establishing and nurturing a good safety culture within AERB helps in encouraging the utility to institute the same. At the induction level AERB provides training to its staffs for regulatory orientation which include a specific course on safety culture. Subsequently, the junior staffs are mentored by seniors while involving them in various regulatory processes and putting them as observers during regulatory decision making process. Further, AERB established a formal procedure for assessing and improving safety culture within its staff as a management system process. The paper describes as a case study the above safety culture assessment process established within AERB

  11. Probabilistic risk assessment (PRA) reference document. Final report

    International Nuclear Information System (INIS)

    Murphy, J.A.

    1984-09-01

    This document describes the current status of probabilistic risk assessment (PRA) as practiced in the nuclear reactor regulatory process. The PRA studies that have been completed or are under way are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed. This document was issued for comment in February 1984 entitled Probabilistic Risk Assessment (PRA): Status Report and Guidance for Regulatory Application. The comments received on the draft have been considered for this final version of the report

  12. Risk assessment - The future trend

    International Nuclear Information System (INIS)

    Marks, G.A.

    1991-01-01

    Many organizations today are faced with cleaning a site or facility, selecting appropriate remedial alternatives, or explaining the potential effects on human health and the environment caused by the releases of toxic compounds into the air, soil, and water, The use of risk assessment (RA) as a management tool is increasing because it offers an integrated approach to the analysis of toxicological, geological, physio-chemical, meteorological, statistical, and biological parameters that must be evaluated in the assessment of potential impacts to human health. The regulatory atmosphere in the 1990s is leaning toward the adoption of further laws requiring the completion of the RA process. Any industry involved in submitting permit applications to Air Quality Management Districts or complying with California's Proposition 65 and AB 2588 will be required to prepare RAs. Several guidance documents are available that support the RA process including the California Site Mitigation Decision Tree Manual published by the State Department of Health Services (DHS), which bases its approach on developing cleanup objectives (Applied Action Levels) on RA. This presentation focuses on the applications RA can have to the petroleum industry and the kinds of data that each case should develop to make maximum use of the RA process

  13. Comparative Probabilistic Assessment of Occupational Pesticide Exposures Based on Regulatory Assessments

    Science.gov (United States)

    Pouzou, Jane G.; Cullen, Alison C.; Yost, Michael G.; Kissel, John C.; Fenske, Richard A.

    2018-01-01

    Implementation of probabilistic analyses in exposure assessment can provide valuable insight into the risks of those at the extremes of population distributions, including more vulnerable or sensitive subgroups. Incorporation of these analyses into current regulatory methods for occupational pesticide exposure is enabled by the exposure data sets and associated data currently used in the risk assessment approach of the Environmental Protection Agency (EPA). Monte Carlo simulations were performed on exposure measurements from the Agricultural Handler Exposure Database and the Pesticide Handler Exposure Database along with data from the Exposure Factors Handbook and other sources to calculate exposure rates for three different neurotoxic compounds (azinphos methyl, acetamiprid, emamectin benzoate) across four pesticide-handling scenarios. Probabilistic estimates of doses were compared with the no observable effect levels used in the EPA occupational risk assessments. Some percentage of workers were predicted to exceed the level of concern for all three compounds: 54% for azinphos methyl, 5% for acetamiprid, and 20% for emamectin benzoate. This finding has implications for pesticide risk assessment and offers an alternative procedure that may be more protective of those at the extremes of exposure than the current approach. PMID:29105804

  14. 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...

  15. Tritium : health risks, regulatory issues and the nuclear future

    International Nuclear Information System (INIS)

    Chambers, D. B.; Garva, A.

    2010-10-01

    The refurbishment of existing reactors and proposed new build reactors in Canada has resulted in increased public opposition to nuclear power. This opposition has been fuelled by information provided to local groups by highly motivated national and international anti-nuclear groups who foster overstated and often incorrect views on the risks of low doses of radiation. Over the past several years, there has been increased scientific and public interest in the risks of low exposures to tritium. Scientific aspects which have received considerable attention include amongst others, behaviour in the environment, the possibility of increasing the relative biological effectiveness for tritium, the importance of organically bound tritium, and tritium dosimetry. In Canada at least, the perception of harm from exposures to low levels of tritium has been enhanced in the public mind by a proposal in one Province to lower the drinking water standard for tritium from 7,000 Bq/L to 20 Bq/L, which certain non-governmental organizations use to suggest the risks have been greatly underestimated in the past. Actually regulatory environment, the approval of local public of often a requirement for licensing a nuclear facility and thus it is important to ensure that correct information is not only available but available in a technically correct but easily understood form. This paper reviews the currently available scientific information on the risks from exposure to tritium and provides a context of the implications for regulatory actions and communications with the public. (Author)

  16. Assessment of technical risks

    Energy Technology Data Exchange (ETDEWEB)

    Jaeger, T A [Bundesanstalt fuer Materialpruefung, Berlin (Germany, F.R.)

    1978-01-01

    The safety of technical systems is so difficult to assess because the concept 'risk' contains technical-scientific factors as well as components of individual and social psychology. Immediate or short-term hazards of human life as i.e. caused by the operation of industrial plants and mediate and thus long-term hazards have to be distinguished. Characteristic for the second hazard groups is the great time-lag before the effect takes place. Thus a causal relationship can be recognized only late and not definitely. Even when the causes have been obviated the effects still show. The development of a systems-analytical model as a basis of decisive processes for the introduction of highly endangered large-scale technologies seems particularly difficult. A starting point for the quantification of the risk can still be seen in the product of the probability of realization and the extent of the damage. Public opinion, however, does not base its evaluations on an objective concept of risk but tends to have an attitude of aversion against great and disastrous accidents. On the other hand, plenty of slight accidents are accepted much more easily, even when the amount of deadly victims from accidents reaches dimensions beyond those of the rare large-scale accidents. Here, mostly the damage possible but not the probability of its occurence is seen, let alone the general use of the new technology. The value of the mathematical models for estimating risks is mainly due to the fact that they are able to clear up decisions.

  17. Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan.

    Science.gov (United States)

    Wang, Hui-Po; Wang, Chun-Li

    2018-04-01

    The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM). There are thus dual-tract drug approval panels, two GMP controls and two independent adverse drug event reporting systems. This rendered irrational co-medication of WM and TCM undetectable and the standard tools for monitoring pharmacovigilance inapplicable. The bilateral regulatory system is conceptually unscientific in accordance with PVP/RMP and unethical from humanity point of view. The first part of this review delivers (1) social aspects of polypharmacy in Taiwan; (2) regulatory aspects of pharmaceutical administration; (3) risks undermined in the bilateral regulatory system and (4) pharmacoepidemiology in relation to the risk of polypharmacy. As evidence-based medicine (EBM) forms the fundamental risk-benefit assessment on medication, the second part of this review delivers (1) the scientific aspects of the beauty and the odds of biological system that governs host-xenobiotics interaction; (2) conceptual evolution from product management (pharmacovigilance) to risk management (PVP/RMP); (3) non-biased due process is essential for risk-benefit assessment on medicinal products and (4) the opinion of the authors on system building for safe medication. Copyright © 2018. Published by Elsevier B.V.

  18. Use of importance measures in risk-informed regulatory applications

    International Nuclear Information System (INIS)

    Cheok, Michael C.; Parry, Gareth W.; Sherry, Richard R.

    1998-01-01

    The use of importance measures to analyze PRA results is discussed. Commonly used importance measures are defined. Some issues that have been identified as potentially limiting their usefulness are addressed, namely: there is no simple relationship between importance measures evaluated at the single component level and those evaluated at the level of a group of components, and, as a result, some of the commonly used importance measures are not realistic measures of the sensitivity of the overall risk to parameter value changes; and, importance measures do not typically take into account parameter uncertainties which raises the question of the robustness of conclusions drawn from importance analyses. The issues are explored in the context of both ranking and categorization of structures, systems, and components (SSCs) with respect to risk-significance and safety-significance for use in risk-informed regulatory analyses

  19. Risk Analysis as Regulatory Science: Toward The Establishment of Standards.

    Science.gov (United States)

    Murakami, Michio

    2016-09-01

    Understanding how to establish standards is essential for risk communication and also provides perspectives for further study. In this paper, the concept of risk analysis as regulatory science for the establishment of standards is demonstrated through examples of standards for evacuation and provisional regulation values in foods and drinking water. Moreover, academic needs for further studies related to standards are extracted. The concepts of the traditional 'Standard I', which has a paternalistic orientation, and 'Standard II', established through stakeholder consensus, are then systemized by introducing the current status of the new standards-related movement that developed after the Fukushima nuclear power plant accident, and the perspectives of the standards are discussed. Preparation of standards on the basis of stakeholder consensus through intensive risk dialogue before a potential nuclear power plant accident is suggested to be a promising approach to ensure a safe society and enhance subjective well-being. © The Author 2016. Published by Oxford University Press.

  20. Deposit Insurance and Risk Shifting in a Strong Regulatory Environment

    DEFF Research Database (Denmark)

    Bartholdy, Jan; Justesen, Lene Gilje

    This study provides empirical evidence on the moral hazard implications of introducing deposit insurance into a strong regulatory environment. Denmark offers a unique setting because commercial banks and savings banks have different ownership structures, but are subject to the same set...... of regulations. The ownership structure in savings banks implies that they have no incentive to increase risk after the implementation of a deposit insurance scheme whereas commercial banks have. Also, at the time of introduction, Denmark had high capital requirements and a strict closure policy. Using...... a difference-in-difference framework we show that commercial banks did not increase their risk compared to savings banks when deposit insurance was introduced. The results also hold for large commercial banks, indicating that the systemic risk did not increase either. Thus for a system with high capital...

  1. 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.)

  2. Carbon Capture and Sequestration: A Regulatory Gap Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Lincoln Davies; Kirsten Uchitel; John Ruple; Heather Tanana

    2012-04-30

    Though a potentially significant climate change mitigation strategy, carbon capture and sequestration (CCS) remains mired in demonstration and development rather than proceeding to full-scale commercialization. Prior studies have suggested numerous reasons for this stagnation. This Report seeks to empirically assess those claims. Using an anonymous opinion survey completed by over 200 individuals involved in CCS, it concludes that there are four primary barriers to CCS commercialization: (1) cost, (2) lack of a carbon price, (3) liability risks, and (4) lack of a comprehensive regulatory regime. These results largely confirm previous work. They also, however, expose a key barrier that prior studies have overlooked: the need for comprehensive, rather than piecemeal, CCS regulation. The survey data clearly show that the CCS community sees this as one of the most needed incentives for CCS deployment. The community also has a relatively clear idea of what that regulation should entail: a cooperative federalism approach that directly addresses liability concerns and that generally does not upset traditional lines of federal-state authority.

  3. Caries risk assessment

    DEFF Research Database (Denmark)

    Mejàre, I; Axelsson, S; Dahlén, G

    2014-01-01

    OBJECTIVE: To assess the ability of multivariate models and single factors to correctly identify future caries development in pre-school children and schoolchildren/adolescents. STUDY DESIGN: A systematic literature search for relevant papers was conducted with pre-determined inclusion criteria...... predictors, baseline caries experience had moderate/good accuracy in pre-school children and limited accuracy in schoolchildren/adolescents. The period of highest risk for caries incidence in permanent teeth was the first few years after tooth eruption. In general, the quality of evidence was limited....... CONCLUSIONS: Multivariate models and baseline caries prevalence performed better in pre-school children than in schoolchildren/adolescents. Baseline caries prevalence was the most accurate single predictor in all age groups. The heterogeneity of populations, models, outcome criteria, measures and reporting...

  4. Methods of risk assessment

    International Nuclear Information System (INIS)

    Jones, D.R.

    1981-01-01

    The subject is discussed under the headings: introduction (identification, quantification of risk); some approaches to risk evaluation (use of the 'no risk' principle; the 'acceptable risk' method; risk balancing; comparison of risks, benefits and other costs); cost benefit analysis; an alternative approach (tabulation and display; description and reduction of the data table); identification of potential decision sets consistent with the constraints. Some references are made to nuclear power. (U.K.)

  5. 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.

  6. 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

  7. A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.

    Science.gov (United States)

    Raju, G K; Gurumurthi, Karthik; Domike, Reuben; Kazandjian, Dickran; Landgren, Ola; Blumenthal, Gideon M; Farrell, Ann; Pazdur, Richard; Woodcock, Janet

    2018-01-01

    Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analysis. In this work, a quantitative benefit-risk analysis approach captures regulatory decision-making about new drugs to treat multiple myeloma (MM). MM assessments have been based on endpoints such as time to progression (TTP), progression-free survival (PFS), and objective response rate (ORR) which are different than benefit-risk analysis based on overall survival (OS). Twenty-three FDA decisions on MM drugs submitted to FDA between 2003 and 2016 were identified and analyzed. The benefits and risks were quantified relative to comparators (typically the control arm of the clinical trial) to estimate whether the median benefit-risk was positive or negative. A sensitivity analysis was demonstrated using ixazomib to explore the magnitude of uncertainty. FDA approval decision outcomes were consistent and logical using this benefit-risk framework. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  8. 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

  9. 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.

  10. Integrated systems approach identifies risk regulatory pathways and key regulators in coronary artery disease.

    Science.gov (United States)

    Zhang, Yan; Liu, Dianming; Wang, Lihong; Wang, Shuyuan; Yu, Xuexin; Dai, Enyu; Liu, Xinyi; Luo, Shanshun; Jiang, Wei

    2015-12-01

    Coronary artery disease (CAD) is the most common type of heart disease. However, the molecular mechanisms of CAD remain elusive. Regulatory pathways are known to play crucial roles in many pathogenic processes. Thus, inferring risk regulatory pathways is an important step toward elucidating the mechanisms underlying CAD. With advances in high-throughput data, we developed an integrated systems approach to identify CAD risk regulatory pathways and key regulators. Firstly, a CAD-related core subnetwork was identified from a curated transcription factor (TF) and microRNA (miRNA) regulatory network based on a random walk algorithm. Secondly, candidate risk regulatory pathways were extracted from the subnetwork by applying a breadth-first search (BFS) algorithm. Then, risk regulatory pathways were prioritized based on multiple CAD-associated data sources. Finally, we also proposed a new measure to prioritize upstream regulators. We inferred that phosphatase and tensin homolog (PTEN) may be a key regulator in the dysregulation of risk regulatory pathways. This study takes a closer step than the identification of disease subnetworks or modules. From the risk regulatory pathways, we could understand the flow of regulatory information in the initiation and progression of the disease. Our approach helps to uncover its potential etiology. We developed an integrated systems approach to identify risk regulatory pathways. We proposed a new measure to prioritize the key regulators in CAD. PTEN may be a key regulator in dysregulation of the risk regulatory pathways.

  11. 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

  12. 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.

  13. Methodology for the Systematic Assessment of the Regulatory Competence Needs (SARCoN) for Regulatory Bodies of Nuclear Installations

    International Nuclear Information System (INIS)

    2015-03-01

    A regulatory body’s competence is dependent, among other things, on the competence of its staff. A necessary, but not sufficient, condition for a regulatory body to be competent is that its staff can perform the tasks related to the functions of the regulatory body. In 2001, the IAEA published TECDOC 1254, Training the Staff of the Regulatory Body for Nuclear Facilities: A Competency Framework, which examines the manner in which the recognized regulatory functions of a nuclear regulatory body results in competence needs. Using the internationally recognized systematic approach to training, TECDOC 1254 provides a framework for regulatory bodies for managing training and developing, and maintaining the competence of its staff. It has been successfully used by many regulatory bodies all over the world, including States embarking on a nuclear power programme. The IAEA has also introduced a methodology and an assessment tool — Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) — which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2013, the IAEA published Safety Reports Series No. 79, Managing Regulatory Body Competence, which provides generic guidance based on IAEA safety requirements in the development of a competence management system within a regulatory body’s integrated management system. An appendix in the Safety Report deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an embarking State’s regulatory system. This publication provides guidance for the analysis of required and existing competences to identify those required by the regulatory body to perform its functions and therefore associated needs for acquiring competences. Hence, it is equally applicable to the needs of States embarking on nuclear power

  14. 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

  15. Rosiglitazone, myocardial ischemic risk, and recent regulatory actions.

    Science.gov (United States)

    Bourg, Catherine A; Phillips, Beth Bryles

    2012-02-01

    To review the evidence surrounding rosiglitazone and ischemic cardiovascular risk and discuss the Food and Drug Administration (FDA) decision to revise safety information and restrict access to the drug. A literature search was conducted through MEDLINE (1950-January 2012), PubMed (1966-January 2012), and International Pharmaceutical Abstracts (1970-December 2011) using the search terms rosiglitazone and cardiovascular risk. Regulatory documents from the FDA and the Center for Drug Evaluation and Research, as well as reference citations from publications identified, were reviewed. All articles in English identified from the data sources were evaluated for inclusion. Literature regarding rosiglitazone and ischemic cardiovascular risk has shown inconsistent results. Meta-analyses by the FDA, GlaxoSmithKline, and several independent research groups suggest an increased risk for myocardial infarction (MI), while others have not. Long-term, controlled trials not designed to evaluate cardiovascular outcomes did not find a significant increase in cardiovascular events and had low event rates overall. The RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes) trial is the only prospective randomized trial to date designed to evaluate cardiovascular outcomes of rosiglitazone; the results were limited because of issues with study design and event adjudication. The only direct comparisons between rosiglitazone and pioglitazone are observational studies in which pioglitazone had a more favorable MI risk profile. Data involving rosiglitazone and an association with ischemic cardiovascular risk have yielded variable results. The FDA made the decision to restrict access to rosiglitazone in September 2010 by requiring GlaxoSmithKline to submit a risk evaluation and mitigation strategy (REMS). Drug labeling was revised in February 2011, and the rosiglitazone REMS program took full effect in November 2011.

  16. [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.

  17. Optimising risk reduction: An expected utility approach for marginal risk reduction during regulatory decision making

    International Nuclear Information System (INIS)

    Li Jiawei; Pollard, Simon; Kendall, Graham; Soane, Emma; Davies, Gareth

    2009-01-01

    In practice, risk and uncertainty are essentially unavoidable in many regulation processes. Regulators frequently face a risk-benefit trade-off since zero risk is neither practicable nor affordable. Although it is accepted that cost-benefit analysis is important in many scenarios of risk management, what role it should play in a decision process is still controversial. One criticism of cost-benefit analysis is that decision makers should consider marginal benefits and costs, not present ones, in their decision making. In this paper, we investigate the problem of regulatory decision making under risk by applying expected utility theory and present a new approach of cost-benefit analysis. Directly taking into consideration the reduction of the risks, this approach achieves marginal cost-benefit analysis. By applying this approach, the optimal regulatory decision that maximizes the marginal benefit of risk reduction can be considered. This provides a transparent and reasonable criterion for stakeholders involved in the regulatory activity. An example of evaluating seismic retrofitting alternatives is provided to demonstrate the potential of the proposed approach.

  18. Risk assessment and regulation

    International Nuclear Information System (INIS)

    1981-01-01

    The approach to determining how safe is safe for the nuclear industry is to ensure that the risks are comparable with or less than those of other safe industries. There are some problems in implementing such an approach, because the effects of low levels of radiation are stochastic and assumptions are required in estimating the risks. A conservative approach has generally been adopted. Risk estimates across different activities are a useful indication of where society may be overspending or underspending to reduce risk, but the analysis has to take account of public preferences. Once risks have been estimated, limits may be chosen which the industry is expected to meet under normal and postulated accident conditions. Limits have been set so that nuclear risks do not exceed those in safe industries, and under normal conditions nuclear facilities operate at levels far below these specified limits

  19. Risk Informed Approach for Nuclear Security Measures for Nuclear and Other Radioactive Material out of Regulatory Control. Implementing Guide

    International Nuclear Information System (INIS)

    2015-01-01

    This publication provides guidance to States for developing a risk informed approach and for conducting threat and risk assessments as the basis for the design and implementation of sustainable nuclear security systems and measures for prevention of, detection of, and response to criminal and intentional unauthorised acts involving nuclear and other radioactive material out of regulatory control. It describes concepts and methodologies for a risk informed approach, including identification and assessment of threats, targets, and potential consequences; threat and risk assessment methodologies, and the use of risk informed approaches as the basis for informing the development and implementation of nuclear security systems and measures. The publication is an Implementing Guide within the IAEA Nuclear Security Series and is intended for use by national policy makers, law enforcement agencies and experts from competent authorities and other relevant organizations involved in the establishment, implementation, maintenance or sustainability of nuclear security systems and measures related to nuclear and other radioactive material out of regulatory control

  20. 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.

  1. 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.

  2. A new risk-informed design and regulatory process

    International Nuclear Information System (INIS)

    Apostolakis, George E.; Golay, Michael W.; Camp, Allen L.; Duran, Felicia A.; Finnicum, David; Ritterbusch, Stanley E.

    2001-01-01

    The overall purpose of the new approach, termed Risk-Informed Regulation, is to formulate a method of regulation that is logically consistent and devised so that both the reactor designer and regulator can work together in obtaining systems able to produce economical electricity safely. In this new system the traditional tools (deterministic and probabilistic analyses, tests and expert judgement) and treatments (defense-in-depth, conservatism) of safety regulation would still be employed, but the logic governing their use would be reversed from the current treatment. In the new treatment, probabilistic risk analysis (PRA) would be used as the paramount decision support tool, taking advantage of its ability to integrate all of the elements of system performance and to represent the uncertainties in the results. The latter is the most important reason for this choice, as the most difficult part of safety regulation is the treatment of uncertainties, not the assurance of expected performance. The scope of the PRA would be made as large as that of the reactor system, including all of its performance phenomena. The models and data of the PRA would be supported by deterministic analytical results, and data to the extent feasible. However, as in the current regulatory system, the models and data of the PRA would require being complemented by subjective judgements where the former were inadequate. All of these elements play important roles in the current decision-making structure; the main departure from current practice would be making all of these treatments explicit within the PRA, therefore, decreasing the frequency of sometimes arbitrary judgments. In the intended sense the PRA would be used as a vehicle for stating the beliefs of the designer and regulatory decision-maker; the foundation of their decisions. Thus, the PRA should be viewed as a Bayesian decision tool, and be used in order to take advantage of its capabilities in integration and inclusion of

  3. 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.

  4. Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.

    Science.gov (United States)

    Meyskens, Frank L; Curt, Gregory A; Brenner, Dean E; Gordon, Gary; Herberman, Ronald B; Finn, Olivera; Kelloff, Gary J; Khleif, Samir N; Sigman, Caroline C; Szabo, Eva

    2011-03-01

    This article endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of nonscientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; the use and limitations of biomarkers for developing and the approval of cancer risk reduction drugs; the identification of individuals at a high(er) risk for cancer and who are appropriate candidates for risk reduction drugs; business models that should incentivize pharmaceutical industry investment in cancer risk reduction; a summary of scientific and institutional barriers to development of cancer risk reduction drugs; and a summary of major recommendations that should help facilitate the pathway to regulatory approval for pharmacologic cancer risk reduction drugs.

  5. System Analysis and Risk Assessment (SARA) system

    International Nuclear Information System (INIS)

    Krantz, E.A.; Russell, K.D.; Stewart, H.D.; Van Siclen, V.S.

    1986-01-01

    Utilization of Probabilistic Risk Assessment (PRA) related information in the day-to-day operation of plant systems has, in the past, been impracticable due to the size of the computers needed to run PRA codes. This paper discusses a microcomputer-based database system which can greatly enhance the capability of operators or regulators to incorporate PRA methodologies into their routine decision making. This system is called the System Analysis and Risk Assessment (SARA) system. SARA was developed by EG and G Idaho, Inc. at the Idaho National Engineering Laboratory to facilitate the study of frequency and consequence analyses of accident sequences from a large number of light water reactors (LWRs) in this country. This information is being amassed by several studies sponsored by the United States Nuclear Regulatory Commission (USNRC). To meet the need of portability and accessibility, and to perform the variety of calculations necessary, it was felt that a microcomputer-based system would be most suitable

  6. Switzerland; Financial Sector Assessment Program: Factual Update: Insurance Sector Market and Regulatory Developments

    OpenAIRE

    International Monetary Fund

    2007-01-01

    This paper presents a factual update of the Insurance Core Principles including insurance sector market and regulatory developments for Switzerland. Regulatory reforms since 2003 have updated Switzerland’s regulatory and supervisory regime for the insurance industry to bring it in line with international best practices. The Insurance Supervision Law (ISL) has reoriented the regulatory focus and expanded the regulatory scope to include group/conglomerate supervision, corporate governance, risk...

  7. 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

  8. Nuclear regulatory review of licensee self-assessment (LSA)

    International Nuclear Information System (INIS)

    2003-01-01

    Licensee self-assessment (LSA) by nuclear power plant operators is described as all the activities that a licensee performs in order to identify opportunities for improvements. An LSA is part of an organisation's holistic management system, which must include other process elements. Particularly important elements are: a process for choosing which identified potential improvements should be implemented and a process of project management for implementing the improvements chosen. Nuclear regulators expect the licensee to run an effective LSA programme, which reflects the licensee's 'priority to safety'. Based on contributions from members of the NEA Committee on Nuclear Regulatory Activities (CNRA), this publication provides an overview of the current regulatory philosophy on and approaches to LSA as performed by licensees. The publication's intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  9. 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)

  10. Ecological models and pesticide risk assessment: current modeling practice.

    Science.gov (United States)

    Schmolke, Amelie; Thorbek, Pernille; Chapman, Peter; Grimm, Volker

    2010-04-01

    Ecological risk assessments of pesticides usually focus on risk at the level of individuals, and are carried out by comparing exposure and toxicological endpoints. However, in most cases the protection goal is populations rather than individuals. On the population level, effects of pesticides depend not only on exposure and toxicity, but also on factors such as life history characteristics, population structure, timing of application, presence of refuges in time and space, and landscape structure. Ecological models can integrate such factors and have the potential to become important tools for the prediction of population-level effects of exposure to pesticides, thus allowing extrapolations, for example, from laboratory to field. Indeed, a broad range of ecological models have been applied to chemical risk assessment in the scientific literature, but so far such models have only rarely been used to support regulatory risk assessments of pesticides. To better understand the reasons for this situation, the current modeling practice in this field was assessed in the present study. The scientific literature was searched for relevant models and assessed according to nine characteristics: model type, model complexity, toxicity measure, exposure pattern, other factors, taxonomic group, risk assessment endpoint, parameterization, and model evaluation. The present study found that, although most models were of a high scientific standard, many of them would need modification before they are suitable for regulatory risk assessments. The main shortcomings of currently available models in the context of regulatory pesticide risk assessments were identified. When ecological models are applied to regulatory risk assessments, we recommend reviewing these models according to the nine characteristics evaluated here. (c) 2010 SETAC.

  11. Scientists versus regulators: precaution, novelty & regulatory oversight as predictors of perceived risks of engineered nanomaterials.

    Directory of Open Access Journals (Sweden)

    Christian E H Beaudrie

    Full Text Available Engineered nanoscale materials (ENMs present a difficult challenge for risk assessors and regulators. Continuing uncertainty about the potential risks of ENMs means that expert opinion will play an important role in the design of policies to minimize harmful implications while supporting innovation. This research aims to shed light on the views of 'nano experts' to understand which nanomaterials or applications are regarded as more risky than others, to characterize the differences in risk perceptions between expert groups, and to evaluate the factors that drive these perceptions. Our analysis draws from a web-survey (N = 404 of three groups of US and Canadian experts: nano-scientists and engineers, nano-environmental health and safety scientists, and regulatory scientists and decision-makers. Significant differences in risk perceptions were found across expert groups; differences found to be driven by underlying attitudes and perceptions characteristic of each group. Nano-scientists and engineers at the upstream end of the nanomaterial life cycle perceived the lowest levels of risk, while those who are responsible for assessing and regulating risks at the downstream end perceived the greatest risk. Perceived novelty of nanomaterial risks, differing preferences for regulation (i.e. the use of precaution versus voluntary or market-based approaches, and perceptions of the risk of technologies in general predicted variation in experts' judgments of nanotechnology risks. Our findings underscore the importance of involving a diverse selection of experts, particularly those with expertise at different stages along the nanomaterial lifecycle, during policy development.

  12. Environmental chemicals - how do we assess the risk (question mark)

    International Nuclear Information System (INIS)

    Somers, E.

    Risk assessment is considered as comprising risk identification, risk estimation, and risk evaluation. The methodology of risk estimation is described and the key role of animal experimentation outlined, drawing attention to the inherent problems of extrapolating from animals to humans. The application of risk estimation to regulatory decision-making in Canada is given for chloroform in drinking water; asbestos in dry-wall patching compounds; arsenic emissions in air; nitrogen oxides; mercury in fish; and the food additive saccharin. Risk evaluation represents societal judgement and is ultimately political but a number of techniques can be of value in separating the competing factors, i.e., comparison with natural background or with other risks, balancing risks from alternatives, and risk-benefit analysis. However, the inherent limitations of a completely rational approach to risk assessment must always be recognized. (author)

  13. Preliminary risk assessments of the small HTGR

    International Nuclear Information System (INIS)

    Everline, C.J.; Bellis, E.A.

    1985-05-01

    Preliminary investment and safety risk assessments were performed for a preconceptual design of a four-module 250-MW(t) side-by-side steel-vessel pebble bed HTGR plant. Broad event spectra were analyzed involving component damage resulting in unscheduled plant outages and fission product releases resulting in offsite doses. The preliminary assessment indicates at this stage of the design that two categories of events govern the investment risk envelope: primary coolant leaks which release some circulating and plate-out activity that contaminates the confinement and turbogenerator damage which involves extensive turbine blade failure. Primary coolant leaks are important contributors because associated cleanup and decontamination requirements result in longer outages that arise from other events with comparable frequencies. Turbogenerator damage is the salient low-frequency investment risk accident due to the relatively long outages being experienced in the industry. Thermal transients are unimportant investment risk contributors because pressurized core heatups cause little damage, and depressurized core heatups occur at negligible frequencies relative to the forced outage goal. These preliminary results demonstrate investment and safety risk goal compliance at this stage in the design process. Studies are continuing in order to provide valuable insights into risk-significant events to assure a balanced approach to meeting user and regulatory requirements

  14. 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.)

  15. 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...

  16. 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...

  17. Carcinogen risk assessment

    International Nuclear Information System (INIS)

    Hazelwoold, R.N.

    1987-01-01

    This article describes the methods by which risk factors for carcinogenic hazards are determined and the limitations inherent in the process. From statistical and epidemiological studies, the major identifiable factors related to cancer in the United States were determined to be cigarette smoking, diet, reproductive and sexual behavior, infections, ultraviolet and ionizing radiation, and alcohol consumption. The incidence of lung cancer due to air pollutants was estimated to be less than 2%. Research needs were discussed

  18. Probabilistic risk assessment methodology

    International Nuclear Information System (INIS)

    Shinaishin, M.A.

    1988-06-01

    The objective of this work is to provide the tools necessary for clear identification of: the purpose of a Probabilistic Risk Study, the bounds and depth of the study, the proper modeling techniques to be used, the failure modes contributing to the analysis, the classical and baysian approaches for manipulating data necessary for quantification, ways for treating uncertainties, and available computer codes that may be used in performing such probabilistic analysis. In addition, it provides the means for measuring the importance of a safety feature to maintaining a level of risk at a Nuclear Power Plant and the worth of optimizing a safety system in risk reduction. In applying these techniques so that they accommodate our national resources and needs it was felt that emphasis should be put on the system reliability analysis level of PRA. Objectives of such studies could include: comparing systems' designs of the various vendors in the bedding stage, and performing grid reliability and human performance analysis using national specific data. (author)

  19. Probabilistic risk assessment methodology

    Energy Technology Data Exchange (ETDEWEB)

    Shinaishin, M A

    1988-06-15

    The objective of this work is to provide the tools necessary for clear identification of: the purpose of a Probabilistic Risk Study, the bounds and depth of the study, the proper modeling techniques to be used, the failure modes contributing to the analysis, the classical and baysian approaches for manipulating data necessary for quantification, ways for treating uncertainties, and available computer codes that may be used in performing such probabilistic analysis. In addition, it provides the means for measuring the importance of a safety feature to maintaining a level of risk at a Nuclear Power Plant and the worth of optimizing a safety system in risk reduction. In applying these techniques so that they accommodate our national resources and needs it was felt that emphasis should be put on the system reliability analysis level of PRA. Objectives of such studies could include: comparing systems' designs of the various vendors in the bedding stage, and performing grid reliability and human performance analysis using national specific data. (author)

  20. PRA research and the development of risk-informed regulation at the U.S. nuclear regulatory commission

    International Nuclear Information System (INIS)

    Siu, Nathan; Collins, Dorothy

    2008-01-01

    Over the years, Probabilistic Risk Assessment (PRA) research activities conducted at the U.S. Nuclear Regulatory Commission (NRC) have played an essential role in support of the agency's move towards risk-informed regulation. These research activities have provided the technical basis for NRC's regulatory activities in key areas; provided PRA methods, tools, and data enabling the agency to meet future challenges; supported the implementation of NRC's 1995 PRA Policy Statement by assessing key sources of risk; and supported the development of necessary technical and human resources supporting NRC's risk-informed activities. PRA research aimed at improving the NRC's understanding of risk can positively affect the agency's regulatory activities, as evidenced by three case studies involving research on fire PRA, Human Reliability Analysis (HRA), and Pressurized Thermal Shock (PTS) PRA. These case studies also show that such research can take a considerable amount of time, and that the incorporation of research results into regulatory practice can take even longer. The need for sustained effort and appropriate lead time is an important consideration in the development of a PRA research program aimed at helping the agency address key sources of risk for current and potential future facilities

  1. 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

  2. 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

  3. 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

  4. Combination of the deterministic and probabilistic approaches for risk-informed decision-making in US NRC regulatory guides

    International Nuclear Information System (INIS)

    Patrik, M.; Babic, P.

    2001-06-01

    The report responds to the trend where probabilistic safety analyses are attached, on a voluntary basis (as yet), to the mandatory deterministic assessment of modifications of NPP systems or operating procedures, resulting in risk-informed type documents. It contains a nearly complete Czech translation of US NRC Regulatory Guide 1.177 and presents some suggestions for improving a) PSA study applications; b) the development of NPP documents for the regulatory body; and c) the interconnection between PSA and traditional deterministic analyses as contained in the risk-informed approach. (P.A.)

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. Patient-Focused Benefit-Risk Analysis to Inform Regulatory Decisions: The European Union Perspective.

    Science.gov (United States)

    Mühlbacher, Axel C; Juhnke, Christin; Beyer, Andrea R; Garner, Sarah

    Regulatory decisions are often based on multiple clinical end points, but the perspectives used to judge the relative importance of those end points are predominantly those of expert decision makers rather than of the patient. However, there is a growing awareness that active patient and public participation can improve decision making, increase acceptance of decisions, and improve adherence to treatments. The assessment of risk versus benefit requires not only information on clinical outcomes but also value judgments about which outcomes are important and whether the potential benefits outweigh the harms. There are a number of mechanisms for capturing the input of patients, and regulatory bodies within the European Union are participating in several initiatives. These can include patients directly participating in the regulatory decision-making process or using information derived from patients in empirical studies as part of the evidence considered. One promising method that is being explored is the elicitation of "patient preferences." Preferences, in this context, refer to the individual's evaluation of health outcomes and can be understood as statements regarding the relative desirability of a range of treatment options, treatment characteristics, and health states. Several methods for preference measurement have been proposed, and pilot studies have been undertaken to use patient preference information in regulatory decision making. This article describes how preferences are currently being considered in the benefit-risk assessment context, and shows how different methods of preference elicitation are used to support decision making within the European context. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  11. Assessment and perception of risk

    Energy Technology Data Exchange (ETDEWEB)

    Daglish, J

    1981-01-01

    A recent two-day meeting was called by the Royal Society to discuss all types of risks, but symptomatic of the concerns of most of those present, the discussion centred mainly on the risks inherent in energy production and use. Among the subjects considered were public perception of differing risks, and how these are ranked, and risks versus benefits. Quotations from and summaries of many of the papers presented show that it was generally felt that scientists must be very careful in the way that they use numerical assessments of risk and that they should pay more attention than they have to social and political factors.

  12. NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

    Science.gov (United States)

    Scroggins, Sharon; Duda, Kristen

    2008-01-01

    This viewgraph presentation gives an overview of NASA's risk analysis communication programs associated with changing environmental policies. The topics include: 1) NASA Program Transition; 2) Principal Center for Regulatory Risk Analysis and Communication (RRAC PC); and 3) Regulatory Tracking and Communication Process.

  13. Debate on GMOs health risks after statistical findings in regulatory tests.

    Science.gov (United States)

    de Vendômois, Joël Spiroux; Cellier, Dominique; Vélot, Christian; Clair, Emilie; Mesnage, Robin; Séralini, Gilles-Eric

    2010-10-05

    We summarize the major points of international debate on health risk studies for the main commercialized edible GMOs. These GMOs are soy, maize and oilseed rape designed to contain new pesticide residues since they have been modified to be herbicide-tolerant (mostly to Roundup) or to produce mutated Bt toxins. The debated alimentary chronic risks may come from unpredictable insertional mutagenesis effects, metabolic effects, or from the new pesticide residues. The most detailed regulatory tests on the GMOs are three-month long feeding trials of laboratory rats, which are biochemically assessed. The tests are not compulsory, and are not independently conducted. The test data and the corresponding results are kept in secret by the companies. Our previous analyses of regulatory raw data at these levels, taking the representative examples of three GM maize NK 603, MON 810, and MON 863 led us to conclude that hepatorenal toxicities were possible, and that longer testing was necessary. Our study was criticized by the company developing the GMOs in question and the regulatory bodies, mainly on the divergent biological interpretations of statistically significant biochemical and physiological effects. We present the scientific reasons for the crucially different biological interpretations and also highlight the shortcomings in the experimental protocols designed by the company. The debate implies an enormous responsibility towards public health and is essential due to nonexistent traceability or epidemiological studies in the GMO-producing countries.

  14. Disinfection byproduct regulatory compliance surrogates and bromide-associated risk.

    Science.gov (United States)

    Kolb, Chelsea; Francis, Royce A; VanBriesen, Jeanne M

    2017-08-01

    Natural and anthropogenic factors can alter bromide concentrations in drinking water sources. Increasing source water bromide concentrations increases the formation and alters the speciation of disinfection byproducts (DBPs) formed during drinking water treatment. Brominated DBPs are more toxic than their chlorinated analogs, and thus have a greater impact on human health. However, DBPs are regulated based on the mass sum of DBPs within a given class (e.g., trihalomethanes and haloacetic acids), not based on species-specific risk or extent of bromine incorporation. The regulated surrogate measures are intended to protect against not only the species they directly represent, but also against unregulated DBPs that are not routinely measured. Surrogates that do not incorporate effects of increasing bromide may not adequately capture human health risk associated with drinking water when source water bromide is elevated. The present study analyzes trihalomethanes (THMs), measured as TTHM, with varying source water bromide concentrations, and assesses its correlation with brominated THM, TTHM risk and species-specific THM concentrations and associated risk. Alternative potential surrogates are evaluated to assess their ability to capture THM risk under different source water bromide concentration conditions. The results of the present study indicate that TTHM does not adequately capture risk of the regulated species when source water bromide concentrations are elevated, and thus would also likely be an inadequate surrogate for many unregulated brominated species. Alternative surrogate measures, including THM 3 and the bromodichloromethane concentration, are more robust surrogates for species-specific THM risk at varying source water bromide concentrations. Copyright © 2017. Published by Elsevier B.V.

  15. 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)

  16. Modern biogeochemistry environmental risk assessment

    CERN Document Server

    Bashkin, Vladimir N

    2006-01-01

    Most books deal mainly with various technical aspects of ERA description and calculationsAims at generalizing the modern ideas of both biogeochemical and environmental risk assessment during recent yearsAims at supplementing the existing books by providing a modern understanding of mechanisms that are responsible for the ecological risk for human beings and ecosystem

  17. 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.

  18. Test reactor risk assessment methodology

    International Nuclear Information System (INIS)

    Jennings, R.H.; Rawlins, J.K.; Stewart, M.E.

    1976-04-01

    A methodology has been developed for the identification of accident initiating events and the fault modeling of systems, including common mode identification, as these methods are applied in overall test reactor risk assessment. The methods are exemplified by a determination of risks to a loss of primary coolant flow in the Engineering Test Reactor

  19. 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.

  20. 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.

  1. 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...

  2. Regulatory compliance for a Yucca Mountain Repository: A performance assessment perspective

    International Nuclear Information System (INIS)

    Dyer, J.R.; Van Luik, A.E.; Gil, A.V.; Brocoum, S.J.

    1997-01-01

    The U.S. Department of Energy's Yucca Mountain Site Characterization Project is scheduled to submit a License Application in the year 2002. The License Application is to show compliance with the regulations promulgated by the U.S. Nuclear Regulatory Commission which implement standards promulgated by the U.S. Environmental Protection Agency. These standards are being revised, and it is not certain what their exact nature will be in term of either the performance measure(s) or the time frames that are to be addressed. This paper provides some insights pertaining to this regulatory history, an update on Yucca Mountain performance assessments, and a Yucca Mountain Site Characterization Project perspective on proper standards based on Project experience in performance assessment for its proposed Yucca Mountain Repository system. The Project's performance assessment based perspective on a proper standard applicable to Yucca Mountain may be summarized as follows: a proper standard should be straight forward and understandable; should be consistent with other standards and regulations; and should require a degree of proof that is scientifically supportable in a licensing setting. A proper standard should have several attributes: (1) propose a reasonable risk level as its basis, whatever the quantitative performance measure is chosen to be, (2) state a definite regulatory time frame for showing compliance with quantitative requirements, (3) explicitly recognize that the compliance calculations are not predictions of actual future risks, (4) define the biosphere to which risk needs to be calculated in such a way as to constrain potentially endless speculation about future societies and future human actions, and (5) have as its only quantitative requirement the risk limit (or surrogate performance measure keyed to risk) for the total system

  3. Regulatory review of safety cases and safety assessments for near surface

    International Nuclear Information System (INIS)

    Nys, V.

    2003-01-01

    The activities of the ASAM Regulatory Review Working Group are presented. Regulatory review of the safety assessment is made. It includes the regulatory review of post-closure safety assessment; safety case development and confidence building. The ISAM methodology is reviewed and SA system description is presented. Recommendations on the review process management are given

  4. 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

  5. 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.

  6. Regulatory forum opinion piece*: immunotoxicology assessments in nonhuman primates--challenges and opportunities.

    Science.gov (United States)

    Lebrec, Hervé N

    2013-01-01

    The immune system has been recognized for decades as a potential "target organ" of toxicity. Immune system activation can result in cytokine release resulting in severe systemic toxicity. Immunosuppression can result in impaired host defense and an increase in opportunistic infection, reemergence of latent infection, poor responses to vaccination, or increased risk of certain cancers. Several regulatory documents have addressed various aspects of immunotoxicity assessments. Nonhuman primates (NHPs) and in particular macaques are often the only relevant species for biotechnology-derived investigational new drugs based on cross-reactivity with human and NHP targets. This article reviews the challenges and opportunities associated with monitoring immune function in NHPs in the context of regulatory expectations. The article emphasizes how a comprehensive assessment of immunotoxicity remains a challenge due to interanimal variability associated with certain parameters (e.g., T-dependent antibody response)and it identifies gaps, such as the stage of development of certain assays (e.g., cytotoxic T-cell function). Despite these challenges, a thorough assessment of target biology-driven theoretical risks, in combination with proper integration of all information from the standard toxicology studies, and the refinement of certain assays should enable proper risk assessment. To this effect, emphasis should be placed on leveraging predictive in vitro assays using human cells.

  7. The Cold War legacy of regulatory risk analysis: The Atomic Energy Commission and radiation safety

    Science.gov (United States)

    Boland, Joseph B.

    From its inception in 1946 the Atomic Energy Commission pioneered the use of risk analysis as a mode of regulatory rationality and political rhetoric, yet historical treatments of risk analysis nearly always overlook the important role it played in the administration of atomic energy during the early Cold War. How this absence from history has been achieved and why it characterizes most historical accounts are the subjects of Chapter II. From there, this study goes on to develop the thesis that the advent of the atomic bomb was a world-shattering event that forced the Truman administration to choose between two novel alternatives: (1) movement towards global governance based initially on cooperative control of atomic energy or (2) unsparing pursuit of nuclear superiority. I refer to these as nuclear internationalism and nuclear nationalism, respectively. Each defined a social risk hierarchy. With the triumph of nuclear nationalism, nuclear annihilation was designated the greatest risk and a strong nuclear defense the primary means of prevention. The AEC's mission in the 1950s consisted of the rapid development of a nuclear arsenal, continual improvements in weapons technologies, and the promotion of nuclear power. The agency developed a risk-based regulatory framework through its dominant position within the National Committee on Radiation Protection. It embraced a technocratic model of risk analysis whose articulation and application it controlled, largely in secret. It used this to undergird a public rhetoric of reassurance and risk minimization. In practice, safety officials adjusted exposure levels within often wide parameters and with considerable fluidity in order to prevent safety concerns from interfering with operations. Secrecy, the political climate of the time, and a lack of accountability enabled the agency to meld technical assessments with social value judgments in a manner reflective of nuclear nationalism's risk hierarchy. In the late fifties

  8. Pathology and risk assessment

    International Nuclear Information System (INIS)

    Anon.

    1976-01-01

    Programs for providing basic data for use in evaluating the hazard to man from exposure to radiation and other energy-related pollutants are reviewed. A computer program was developed that takes the existing mortality and fertility data on a given population and applies dose-response coefficients and estimated increments of exposure to chemical or radioactive effluents and derives the excess deaths by age and sex for 5-year intervals. The program was used in an analysis of the health effects of airborne coal combustion effluents. Preliminary results are reported from a study of the influence of products of fossil fuel combustion on the spontaneous activity patterns and daily metabolic cycles of mice as a factor of age, environment, and genetic constitution. Preliminary results are reported from studies on the early and late effects of polycyclic hydrocarbons on the immune competence of mice. Studies to determine the risk to human populations from radionuclides released to the environment from nuclear energy facilities use relative toxicity and dose response data from laboratory animals of different body size and life span and comparisons of the effects of internal exposure with those of external exposure to fission neutrons or gamma sources

  9. 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

  10. 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

  11. Regulatory Assessment Technologies for Aging of Reactor Vessel Internals

    Energy Technology Data Exchange (ETDEWEB)

    Jhung, Myung Jo; Park, Jeong Soon; Ko, Hanok [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2013-10-15

    In order to develop the audit calculation system, it is required to develop crack evaluation, seismic analysis and thermal-hydraulic analysis techniques for RVIs so that integrity of RVIs under the aging environment can be evaluated and be assured. In addition, regulatory requirements including safety review and inspection guides should be developed in order to assure the quality and uniformity of safety reviews and inspections regarding aging assessment and management of RVIs. Since Reactor Vessel Internals (RVIs) are installed within the reactor pressure vessel and surround the fuel assemblies, some of them are exposed to the environment such as high neutron irradiation, high temperature and reactor coolant flow. Those environmental factors can cause damage to RVIs including cracks, loss of material, fatigue, loss of fracture toughness and change of dimension as the operation time of nuclear power plants (NPPs) increases. For long-term operation more than 40 years, aging management of RVIs is important. The final objectives of this study are to establish the audit calculation system for RVIs and to develop regulatory requirements for aging assessment and management of RVIs considering their operating conditions, materials, and possible aging mechanisms.

  12. State risk discourse and the regulatory preservation of traditional medicine knowledge: The case of acupuncture in Ontario, Canada.

    Science.gov (United States)

    Ijaz, Nadine; Boon, Heather; Muzzin, Linda; Welsh, Sandy

    2016-12-01

    Several United Nations bodies have advised countries to actively preserve Traditional Medicine (TM) knowledge and prevent its misappropriation in regulatory structures. To help advance decision-making around this complex regulatory issue, we examine the relationship between risk discourse, epistemology and policy. This study presents a critical, postcolonial analysis of divergent risk discourses elaborated in two contrasting Ontario (Canada) government reports preceding that jurisdiction's regulation of acupuncture, the world's most widely practised TM therapy. The earlier (1996) report, produced when Ontario's regulatory lobby was largely comprised of Chinese medicine practitioners, presents a risk discourse inclusive of biomedical and TM knowledge claims, emphasizing the principle of regulatory 'equity' as well as historical and sociocultural considerations. Reflecting the interests of an increasingly biomedical practitioner lobby, the later (2001) report uses implicit discursive means to exclusively privilege Western scientific perspectives on risk. This report's policy recommendations, we argue, suggest misappropriation of TM knowledge. We advise regulators to consider equitable adaptations to existing policy structures, and to explicitly include TM evidentiary perspectives in their pre-regulatory assessments. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  13. Competing risk theory and radiation risk assessment

    International Nuclear Information System (INIS)

    Groer, P.G.

    1980-01-01

    New statistical procedures are applied to estimate cumulative distribution functions (c.d.f.), force of mortality, and latent period for radiation-induced malignancies. It is demonstrated that correction for competing risks influences the shape of dose response curves, estimates of the latent period, and of the risk from ionizing radiations. The equivalence of the following concepts is demonstrated: force of mortality, hazard rate, and age or time specific incidence. This equivalence makes it possible to use procedures from reliability analysis and demography for radiation risk assessment. Two methods used by reliability analysts - hazard plotting and total time on test plots - are discussed in some detail and applied to characterize the hazard rate in radiation carcinogenesis. C.d.f.'s with increasing, decreasing, or constant hazard rate have different shapes and are shown to yield different dose-response curves for continuous irradiation. Absolute risk is shown to be a sound estimator only if the force of mortality is constant for the exposed and the control group. Dose-response relationships that use the absolute risk as a measure for the effect turn out to be special cases of dose-response relationships that measure the effect with cumulative incidence. (H.K.)

  14. 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...

  15. Assessing Risk of Innovation

    International Nuclear Information System (INIS)

    Allgood, GO

    2001-01-01

    Today's manufacturing systems and equipment must perform at levels thought impossible a decade ago. Companies must push operations, quality, and efficiencies to unprecedented levels while holding down costs. In this new economy, companies must be concerned with market shares, equity growth, market saturation, and profit. U.S. manufacturing is no exception and is a prime example of businesses forced to adapt to constant and rapid changes in customer needs and product mixes, giving rise to the term ''Agile Manufacturing''. The survival and ultimate success of the American Manufacturing economy may depend upon its ability to create, innovate, and quickly assess the impact that new innovations will have on its business practices. Given the need for flexibility, companies need proven methods to predict and measure the impact that new technologies and strategies will have on overall plant performance from an enterprise perspective. The Value-Derivative Model provides a methodology and approach to assess such impacts in terms of energy savings, production increases, quality impacts, emission reduction, and maintenance and operating costs as they relate to enabling and emerging technologies. This is realized by calculating a set of first order sensitivity parameters obtained from expanding a Taylor Series about the system's operating point. These sensitivity parameters are invariant economic and operational indicators that quantify the impact of any proposed technology in terms of material throughput, efficiency, energy usage, environmental effects, and costs. These parameters also provide a mechanism to define metrics and performance measures that can be qualified in terms of real economic impact. Value-Derivative Analysis can be applied across all manufacturing and production segments of our economy and has found specific use in steel and textiles. Where economic models give the cost of conducting a business, Value-Derivative Analysis provides the cost to conduct

  16. 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

  17. 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

  18. Dealing with uncertainty arising out of probabilistic risk assessment

    International Nuclear Information System (INIS)

    Solomon, K.A.; Kastenberg, W.E.; Nelson, P.F.

    1984-03-01

    In addressing the area of safety goal implementation, the question of uncertainty arises. This report suggests that the Nuclear Regulatory Commission (NRC) should examine how other regulatory organizations have addressed the issue. Several examples are given from the chemical industry, and comparisons are made to nuclear power risks. Recommendations are made as to various considerations that the NRC should require in probabilistic risk assessments in order to properly treat uncertainties in the implementation of the safety goal policy. 40 references, 7 figures, 5 tables

  19. Performance-Based (Risk-Informed) Regulation: A Regulatory Perspective

    International Nuclear Information System (INIS)

    Kadambi, N. Prasad

    2005-01-01

    Performance-based regulation (PBR) has been mandated at the national level in the United States and at the agency level, where appropriate, at the U.S. Nuclear Regulatory Commission (USNRC). Guidance has been developed that implements the USNRC's definitions of PBR and other such conceptual regulatory improvements. This paper describes why PBR is important, what constitutes PBR in the context of direction provided at the USNRC, and how PBR can be implemented using a five-step process. The process steps articulate questions to be posed by the analyst regarding various aspects of a regulatory issue so that a suitably performance-based resolution can be developed. A regulatory alternative thus developed can be included among other options to be considered as part of the regulatory decision-making process

  20. Microbiological risk assessment for personal care products.

    Science.gov (United States)

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

    2016-12-01

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

  1. 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)

  2. Quantum chemistry in environmental pesticide risk assessment.

    Science.gov (United States)

    Villaverde, Juan J; López-Goti, Carmen; Alcamí, Manuel; Lamsabhi, Al Mokhtar; Alonso-Prados, José L; Sandín-España, Pilar

    2017-11-01

    The scientific community and regulatory bodies worldwide, currently promote the development of non-experimental tests that produce reliable data for pesticide risk assessment. The use of standard quantum chemistry methods could allow the development of tools to perform a first screening of compounds to be considered for the experimental studies, improving the risk assessment. This fact results in a better distribution of resources and in better planning, allowing a more exhaustive study of the pesticides and their metabolic products. The current paper explores the potential of quantum chemistry in modelling toxicity and environmental behaviour of pesticides and their by-products by using electronic descriptors obtained computationally. Quantum chemistry has potential to estimate the physico-chemical properties of pesticides, including certain chemical reaction mechanisms and their degradation pathways, allowing modelling of the environmental behaviour of both pesticides and their by-products. In this sense, theoretical methods can contribute to performing a more focused risk assessment of pesticides used in the market, and may lead to higher quality and safer agricultural products. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

  3. Can systematic reviews inform GMO risk assessment and risk management?

    Directory of Open Access Journals (Sweden)

    Christian eKohl

    2015-08-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

  5. 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

  6. 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.

  7. 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 ...

  8. Risk Management And Liability For EnvironmentalL Harm Caused By GMOS – The South African Regulatory Framework

    Directory of Open Access Journals (Sweden)

    L Feris

    2006-05-01

    Full Text Available Biotechnology is still relatively new and as with any new technology, it carries some level of risk. This necessitates appropriate risk assessments and appropriate risk management. One element of risk management however, is taking into account that during the production, development, transport or release of a GMO it may cause injury to person, property or the environment, regardless of risk management procedures. This calls for the existence of a liability regime that will place some legal responsibility on the party responsible for the harm. This paper assesses the South African regulatory framework of relevance to GMOs, which is composed of a fragmented set of laws that deals with risk assessment, risk management and liability for damage to the environment. It discusses the GMO Act as the principle legislation regulation GMOs and also the recent amendment thereof and also consider other legislation such as the ECA, NEMA and NEMA Biodiversity Act in an attempt to determine whether the regulatory framework addresses risk management and liability in an effective and adequate manner. It comes to the conclusion that South Africa does not as yet have a satisfactory legal regime that provides for risk management and liability in the context of GMOs.

  9. Assessment of compliance with regulatory requirements for a best estimate methodology for evaluation of ECCS

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Un Chul; Jang, Jin Wook; Lim, Ho Gon; Jeong, Ik [Seoul National Univ., Seoul (Korea, Republic of); Sim, Suk Ku [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

    2000-03-15

    Best estimate methodology for evaluation of ECCS proposed by KEPCO(KREM) os using thermal-hydraulic best-estimate code and the topical report for the methodology is described that it meets the regulatory requirement of USNRC regulatory guide. In this research the assessment of compliance with regulatory guide. In this research the assessment of compliance with regulatory requirements for the methodology is performed. The state of licensing procedure of other countries and best-estimate evaluation methodologies of Europe is also investigated, The applicability of models and propriety of procedure of uncertainty analysis of KREM are appraised and compliance with USNRC regulatory guide is assessed.

  10. Balancing risk in regulatory decision making: the Port Granby Project case study

    International Nuclear Information System (INIS)

    Benitez, L.; Kleb, H.

    2011-01-01

    The purpose of this paper is to review the trade-offs that are routinely considered in regulatory decision making, and the policy basis and methods for making those trade-offs. Regulatory decisions under the Canadian Environmental Assessment Act (CEAA) and the Nuclear Safety and Control Act (NSCA) normally consider potential risks to the environment, human health and safety, if a project were to proceed. There is only limited consideration, under such circumstances, of the risks to the environment, human health and safety if the project were not to proceed. The focus is on the potential adverse effects of the project, except in the event of an emergency, where the focus shifts to the economic and other beneficial effects. The Port Granby long-term low-level radioactive waste management project is a project to clean up and provide appropriate local, long-term management of historic low-level radioactive waste (LLRW) in the Port Granby, Ontario area. Approximately 0.4 M m 3 of LLRW, presently located at the Port Granby Waste Management Facility, is to be transported to a newly constructed long-term waste management facility ~700 m north of the bluff face where the facility is located. Accordingly, the project is subject to environmental assessment and licensing processes under the CEAA and the NSCA, respectively. While the Port Granby Project does not represent an emergency situation, it does represent a situation that could result in a significant degree of environmental risk if the project were not to proceed. Over the course of the various studies that have been undertaken at the Waste Management Facility, it has become apparent that the facility is subject to erosion and gullying along the bluff face. The potential for the leaching of contaminants from the existing facility and the erosion of the Lake Ontario bluffs are recognized as ongoing risks that will continue and potentially worsen if the project does not proceed. The economic and other considerations that

  11. 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.

  12. 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

  13. 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 ...

  14. U.S. Nuclear Regulatory Commission Process for Risk-Informing the Nuclear Waste Arena

    International Nuclear Information System (INIS)

    Leslie, B. W.

    2003-01-01

    The U.S. Nuclear Regulatory Commission (NRC) is increasing the use of risk insights and information in its regulation of nuclear materials and waste. The objective of this risk-informed regulatory effort is to improve the effectiveness and efficiency of the agency, while maintaining or increasing its focus on safety. The agency's Office of Nuclear Material Safety and Safeguards (NMSS) proposed a five-step process to carry out a framework for increasing the use of risk information and insights in its regulation of nuclear materials and waste. The office is carrying out the five-step process to risk-inform the nuclear materials and waste arenas. NMSS's actions included forming a Risk Task Group and the use of case studies to test and complete screening criteria for identifying candidate regulatory applications amenable for risk-informing. Other actions included involving stakeholders through enhanced public participation, developing safety goals for materials and waste regulatory applications, and establishing a risk training program for staff. Through the case studies, NRC staff found the draft screening criteria to be effective in deciding regulatory areas that may be amenable to an increased use of risk insights. NRC staff also found that risk information may have the potential to reduce regulatory burden and improve staff's efficiency in making decisions, while maintaining safety. Finally, staff found that it would be possible to develop safety goals for the nuclear materials and waste arenas

  15. 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.

  16. Development of regulatory guidance for risk-informing digital system reviews

    International Nuclear Information System (INIS)

    Arndt, S. A.

    2006-01-01

    In 1995, the U.S. Nuclear Regulatory Commission (NRC) issued the Probabilistic Risk Assessment (PRA) Policy Statement, which encourages the increased use of PRA and associated analyses in all regulatory matters to the extent supported by the state-of-the-art in PRA and the data. This policy applies, in part, to the review of digital systems, which offer the potential to improve plant safety and reliability through such features as increased hardware reliability and stability and improved failure detection capability. However, there are presently no universally accepted methods for modeling digital systems in current-generation PRAs. Further, there are ongoing debates among the PRA technical community regarding the level of detail that any digital system reliability model must have to adequately model the complex system interactions that can contribute to digital system failure modes. Moreover, for PRA modeling of digital reactor protection and control systems, direct interactions between system components and indirect interactions through controlled/supervised plant processes may necessitate the use of dynamic PRA methodologies. This situation has led the NRC to consider developing performance based rather than prescriptive regulatory guidance in this area. This paper will discuss the development of this guidance and some preliminary concepts. (authors)

  17. Human reliability assessment and probabilistic risk assessment

    International Nuclear Information System (INIS)

    Embrey, D.E.; Lucas, D.A.

    1989-01-01

    Human reliability assessment (HRA) is used within Probabilistic Risk Assessment (PRA) to identify the human errors (both omission and commission) which have a significant effect on the overall safety of the system and to quantify the probability of their occurrence. There exist a variey of HRA techniques and the selection of an appropriate one is often difficult. This paper reviews a number of available HRA techniques and discusses their strengths and weaknesses. The techniques reviewed include: decompositional methods, time-reliability curves and systematic expert judgement techniques. (orig.)

  18. Environmental Risk Assessment of Nanomaterials

    Science.gov (United States)

    Bayramov, A. A.

    In this paper, various aspects of modern nanotechnologies and, as a result, risks of nanomaterials impact on an environment are considered. This very brief review of the First International Conference on Material and Information Sciences in High Technologies (2007, Baku, Azerbaijan) is given. The conference presented many reports that were devoted to nanotechnology in biology and business for the developing World, formation of charged nanoparticles for creation of functional nanostructures, nanoprocessing of carbon nanotubes, magnetic and optical properties of manganese-phosphorus nanowires, ultra-nanocrystalline diamond films, and nanophotonics communications in Azerbaijan. The mathematical methods of simulation of the group, individual and social risks are considered for the purpose of nanomaterials risk reduction and remediation. Lastly, we have conducted studies at a plant of polymeric materials (and nanomaterials), located near Baku. Assessments have been conducted on the individual risk of person affection and constructed the map of equal isolines and zones of individual risk for a plant of polymeric materials (and nanomaterials).

  19. 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)

  20. Protection of people and environment from radiation risk through good regulatory practice

    Science.gov (United States)

    Jais, Azlina Mohammad; Hassan, Najwa

    2017-01-01

    The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be

  1. Enrichment of risk SNPs in regulatory regions implicate diverse tissues in Parkinson's disease etiology.

    Science.gov (United States)

    Coetzee, Simon G; Pierce, Steven; Brundin, Patrik; Brundin, Lena; Hazelett, Dennis J; Coetzee, Gerhard A

    2016-07-27

    Recent genome-wide association studies (GWAS) of Parkinson's disease (PD) revealed at least 26 risk loci, with associated single nucleotide polymorphisms (SNPs) located in non-coding DNA having unknown functions in risk. In order to explore in which cell types these SNPs (and their correlated surrogates at r(2) ≥ 0.8) could alter cellular function, we assessed their location overlap with histone modification regions that indicate transcription regulation in 77 diverse cell types. We found statistically significant enrichment of risk SNPs at 12 loci in active enhancers or promoters. We investigated 4 risk loci in depth that were most significantly enriched (-logeP > 14) and contained 8 putative enhancers in the different cell types. These enriched loci, along with eQTL associations, were unexpectedly present in non-neuronal cell types. These included lymphocytes, mesendoderm, liver- and fat-cells, indicating that cell types outside the brain are involved in the genetic predisposition to PD. Annotating regulatory risk regions within specific cell types may unravel new putative risk mechanisms and molecular pathways that contribute to PD development.

  2. Enrichment of risk SNPs in regulatory regions implicate diverse tissues in Parkinson’s disease etiology

    Science.gov (United States)

    Coetzee, Simon G.; Pierce, Steven; Brundin, Patrik; Brundin, Lena; Hazelett, Dennis J.; Coetzee, Gerhard A.

    2016-01-01

    Recent genome-wide association studies (GWAS) of Parkinson’s disease (PD) revealed at least 26 risk loci, with associated single nucleotide polymorphisms (SNPs) located in non-coding DNA having unknown functions in risk. In order to explore in which cell types these SNPs (and their correlated surrogates at r2 ≥ 0.8) could alter cellular function, we assessed their location overlap with histone modification regions that indicate transcription regulation in 77 diverse cell types. We found statistically significant enrichment of risk SNPs at 12 loci in active enhancers or promoters. We investigated 4 risk loci in depth that were most significantly enriched (−logeP > 14) and contained 8 putative enhancers in the different cell types. These enriched loci, along with eQTL associations, were unexpectedly present in non-neuronal cell types. These included lymphocytes, mesendoderm, liver- and fat-cells, indicating that cell types outside the brain are involved in the genetic predisposition to PD. Annotating regulatory risk regions within specific cell types may unravel new putative risk mechanisms and molecular pathways that contribute to PD development. PMID:27461410

  3. The regulatory treatment of liquidity risk in South Africa / Johann R.G. Jacobs

    OpenAIRE

    Jacobs, Johann Renier Gabriel

    2008-01-01

    South Africa will be implementing Basel II on 1 January 2008. Basel II provides regulatory capital requirements for credit risk, market risk and operational risk. The purpose of capital requirements is to level the playing field for all internationally active banks and to protect consumers against these risks. Although there is an obvious threat of liquidity risk and it is important to correctly measure and manage liquidity risk, it is almost glaringly omitted from Basel II. The result of...

  4. The US FDA and animal cloning: risk and regulatory approach.

    Science.gov (United States)

    Rudenko, Larisa; Matheson, John C

    2007-01-01

    The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.

  5. Uncovering transcription factor and microRNA risk regulatory pathways associated with osteoarthritis by network analysis.

    Science.gov (United States)

    Song, Zhenhua; Zhang, Chi; He, Lingxiao; Sui, Yanfang; Lin, Xiafei; Pan, Jingjing

    2018-05-01

    Osteoarthritis (OA) is the most common form of joint disease. The development of inflammation have been considered to play a key role during the progression of OA. Regulatory pathways are known to play crucial roles in many pathogenic processes. Thus, deciphering these risk regulatory pathways is critical for elucidating the mechanisms underlying OA. We constructed an OA-specific regulatory network by integrating comprehensive curated transcription and post-transcriptional resource involving transcription factor (TF) and microRNA (miRNA). To deepen our understanding of underlying molecular mechanisms of OA, we developed an integrated systems approach to identify OA-specific risk regulatory pathways. In this study, we identified 89 significantly differentially expressed genes between normal and inflamed areas of OA patients. We found the OA-specific regulatory network was a standard scale-free network with small-world properties. It significant enriched many immune response-related functions including leukocyte differentiation, myeloid differentiation and T cell activation. Finally, 141 risk regulatory pathways were identified based on OA-specific regulatory network, which contains some known regulator of OA. The risk regulatory pathways may provide clues for the etiology of OA and be a potential resource for the discovery of novel OA-associated disease genes. Copyright © 2018 Elsevier Inc. All rights reserved.

  6. Animal testing, 3R models and regulatory acceptance : Technology transition in a risk-averse context

    NARCIS (Netherlands)

    Schiffelers, M.J.W.A.

    2016-01-01

    Risk avoidance has resulted in a broad range of regulations to guarantee the safety of products such as pharmaceuticals and chemicals. Many of these regulations rely on animal tests. About 3 million laboratory animals are used annually in Europe to meet such regulatory requirements.Regulatory animal

  7. 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

  8. Scientists versus Regulators: Precaution, Novelty & Regulatory Oversight as Predictors of Perceived Risks of Engineered Nanomaterials

    Science.gov (United States)

    Beaudrie, Christian E. H.; Satterfield, Terre; Kandlikar, Milind; Harthorn, Barbara H.

    2014-01-01

    Engineered nanoscale materials (ENMs) present a difficult challenge for risk assessors and regulators. Continuing uncertainty about the potential risks of ENMs means that expert opinion will play an important role in the design of policies to minimize harmful implications while supporting innovation. This research aims to shed light on the views of ‘nano experts’ to understand which nanomaterials or applications are regarded as more risky than others, to characterize the differences in risk perceptions between expert groups, and to evaluate the factors that drive these perceptions. Our analysis draws from a web-survey (N = 404) of three groups of US and Canadian experts: nano-scientists and engineers, nano-environmental health and safety scientists, and regulatory scientists and decision-makers. Significant differences in risk perceptions were found across expert groups; differences found to be driven by underlying attitudes and perceptions characteristic of each group. Nano-scientists and engineers at the upstream end of the nanomaterial life cycle perceived the lowest levels of risk, while those who are responsible for assessing and regulating risks at the downstream end perceived the greatest risk. Perceived novelty of nanomaterial risks, differing preferences for regulation (i.e. the use of precaution versus voluntary or market-based approaches), and perceptions of the risk of technologies in general predicted variation in experts' judgments of nanotechnology risks. Our findings underscore the importance of involving a diverse selection of experts, particularly those with expertise at different stages along the nanomaterial lifecycle, during policy development. PMID:25222742

  9. 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

  10. 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

  11. Ecological risk assessment: Lessons learned?

    International Nuclear Information System (INIS)

    Anon.

    1993-01-01

    This conference was held November 14--18, 1993 in Houston, Texas for the purpose of providing a forum for exchange of state-of-the-art information on ecological risk assessment. This book is comprised of the abstracts of the presentations at this symposium. Individual abstracts have been processed separately for inclusion in the appropriate data bases

  12. Where You Live: Risk Assessment

    Science.gov (United States)

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

  13. Accountability Feedback Assessments for Improving Efficiency of Nuclear Regulatory Institutions

    International Nuclear Information System (INIS)

    Lavarenne, J.

    2016-01-01

    The Fukushima-Daiichi Disaster demonstrated the need of assessing and strengthening institutions involved in nuclear safety, including the accountability of nuclear regulators. There are a few problems hindering the path towards a greater understanding of systems of accountability, the ensemble of mechanisms holding to account the nuclear regulator on behalf of the public. There is no consensus on what it should deliver and no systematic method of assessment exists. This poster proposes a definition of an effective accountability system and a method of assessment of institutions based on defence in depth concepts and inspired from risk-assessment techniques used in the nuclear industry. Finally it presents a simple Monte-Carlo simulation that illustrates the inner workings of the method of assessment and shows the kind of results it will be able to supply. (author)

  14. An approach to risk assessment

    DEFF Research Database (Denmark)

    Simonsen, L.; Lund, S. P.; Hass, Ulla

    1998-01-01

    of Ministers with the task to propose criteria for neurotoxicity. Functional effects on the nervous system, such as reduction in memory and learning ability, decrease in attention, and alteration of behavior due to toxic chemicals in the environment is now being acknowledged as an important public health...... indicate that numerous persons are exposed in the working as well as in the general environment to several chemicals, for which almost no data on the effect on subtle neurophysiological functions are available. Development of an approach to risk assessment dealing with this problem is a major challenge...... in the nineties. Different approaches to risk assessment are discussed, the quality of the databases available for hazard assessment are evaluated, and the needs for further research are identified. (C) 1996 Intox Press, Inc....

  15. EU Regulatory Risk Management of Marine Biotoxins in the Marine Bivalve Mollusc Food-Chain

    Directory of Open Access Journals (Sweden)

    Micheál O’Mahony

    2018-03-01

    Full Text Available Food safety risk assessment in the European Union (EU recognises consumer illness that arises from marine biotoxins as a risk associated with bivalve mollusc consumption. EU food regulations contain various general food safety obligations, which should contribute significantly to managing this risk. EU food regulations additionally impose various specific obligations on both Food Business Operators and Competent Authorities in order to manage the marine biotoxin food safety risk in the bivalve mollusc food-chain. These have a particular focus on the pre-harvest component of the food-chain. A central component of these specific systems is the requirement for ongoing monitoring of phytoplankton and biotoxin concentrations in water and molluscs, respectively. This monitoring explicitly brings a potential outcome of closing production areas delineated by classification to prohibit the harvest of bivalve molluscs as food from those areas when acceptable biotoxin concentrations are exceeded. This review considers the utility of these systems, at conceptual and practical levels, and explores their contribution to an effective regulatory risk management approach.

  16. EU Regulatory Risk Management of Marine Biotoxins in the Marine Bivalve Mollusc Food-Chain.

    Science.gov (United States)

    O'Mahony, Micheál

    2018-03-10

    Food safety risk assessment in the European Union (EU) recognises consumer illness that arises from marine biotoxins as a risk associated with bivalve mollusc consumption. EU food regulations contain various general food safety obligations, which should contribute significantly to managing this risk. EU food regulations additionally impose various specific obligations on both Food Business Operators and Competent Authorities in order to manage the marine biotoxin food safety risk in the bivalve mollusc food-chain. These have a particular focus on the pre-harvest component of the food-chain. A central component of these specific systems is the requirement for ongoing monitoring of phytoplankton and biotoxin concentrations in water and molluscs, respectively. This monitoring explicitly brings a potential outcome of closing production areas delineated by classification to prohibit the harvest of bivalve molluscs as food from those areas when acceptable biotoxin concentrations are exceeded. This review considers the utility of these systems, at conceptual and practical levels, and explores their contribution to an effective regulatory risk management approach.

  17. Toward refined environmental scenarios for ecological risk assessment of down-the-drain chemicals in freshwater environments

    NARCIS (Netherlands)

    Franco, Antonio; Price, Oliver R.; Marshall, Stuart; Jolliet, Olivier; Brink, van den Paul J.; Rico Artero, Andreu; Focks, Andreas; Laender, De Frederik; Ashauer, Roman

    2017-01-01

    Current regulatory practice for chemical risk assessment suffers from the lack of realism in conventional frameworks. Despite significant advances in exposure and ecological effect modeling, the implementation of novel approaches as high-tier options for prospective regulatory risk assessment

  18. 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...

  19. Use of traits-based bioassessment approaches in biomonitoring and ecological risk assessment

    NARCIS (Netherlands)

    Brink, van den P.J.; Alexander, A.; Desrosiers, M.; Goedkoop, W.; Goethals, P.L.M.; Liess, M.; Dyer, S.

    2011-01-01

    We discuss the application of traits-based bioassessment approaches in retrospective bioassessment as well as in prospective ecological risk assessments in regulatory frameworks. Both approaches address the interaction between species and stressors and their consequences at different levels of

  20. 76 FR 69726 - Pyrethrins/Pyrethroid Cumulative Risk Assessment; Notice of Availability

    Science.gov (United States)

    2011-11-09

    ... exposure to multiple chemicals that have a common mechanism of toxicity when making regulatory decisions... stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical... Cumulative Risk Assessment; Notice of Availability AGENCY: Environmental Protection Agency (EPA). ACTION...

  1. Systematic Assessment of Regulatory Competences (SARCON) V18a

    International Nuclear Information System (INIS)

    Zimmermann, Moritz

    2014-01-01

    Why Competence Management? • Arrangements for competence management is a key factor to: • Support the implementation of article 8 of CNS (Convention on Nuclear Safety – “regulatory body with adequate competence and human resources”); • Support the implementation of Modules 3 and 4 of the IRRS and other IAEA Safety Standards (Module 3: “Responsibilities and functions of the regulatory body”, Module 4: “Management system of the regulatory body”); • Identify gaps between regulatory required competences and the existing resources; • Develop and implement tools and programmes to fill the gaps; • Review periodically the competence needs and training programmes

  2. 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

  3. 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.

  4. Performance assessment - risk assessment vive la differences

    International Nuclear Information System (INIS)

    Nitschke, R.L.

    1997-01-01

    In the sister worlds of radioactive waste management disposal and environmental restoration, there are two similar processes and computational approaches for determining the acceptability of the proposed activities. While similar, these two techniques can lead to confusion and misunderstanding if the differences are not recognized and appreciated. In the case of radioactive waste management, the performance assessment process is used to determine compliance with certain prescribed 'performance objectives'. These objectives are designed to ensure that the disposal of radioactive (high-level, low-level, and/or transuranic) waste will be protective of human health and the environment. The environmental link is primarily through assuring protection of the groundwater as a resource. In the case of environmental restoration, the risk assessment process is used to determine the proper remedial action response, if any, for a past hazardous waste release. The process compares the 'no action' or 'leave as is' option with both carcinogenic and noncarcinogenic values for human health to determine the need for any action and to help to help determine just what the appropriate action would need to be. The impacts to the ecological system are evaluated in a slightly, different but similar fashion. Now the common objectives between these two processes notwithstanding. There are some key and fundamental differences that need to be answered that make direct comparisons or a common approach inappropriate. Failure to recognize this can lead to confusion and misunderstanding. This can be particularly problematic when one is faced with an active disposal facility located within the boundaries of an environmental restoration site as is the case at the Idaho National Engineering Laboratory (INEL). Through a critical evaluation of the performance assessment and risk assessment processes, highlighting both similarities and differences, it is hoped that greater understanding and appreciation

  5. 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...

  6. Probabilistic risk assessment in nuclear power plant regulation

    Energy Technology Data Exchange (ETDEWEB)

    Wall, J B

    1980-09-01

    A specific program is recommended to utilize more effectively probabilistic risk assessment in nuclear power plant regulation. It is based upon the engineering insights from the Reactor Safety Study (WASH-1400) and some follow-on risk assessment research by USNRC. The Three Mile Island accident is briefly discussed from a risk viewpoint to illustrate a weakness in current practice. The development of a probabilistic safety goal is recommended with some suggestions on underlying principles. Some ongoing work on risk perception and the draft probabilistic safety goal being reviewed on Canada is described. Some suggestions are offered on further risk assessment research. Finally, some recent U.S. Nuclear Regulatory Commission actions are described.

  7. Telemental Health for Children and Adolescents: An Overview of Legal, Regulatory, and Risk Management Issues.

    Science.gov (United States)

    Kramer, Gregory M; Luxton, David D

    2016-04-01

    The use of technology to provide telemental healthcare continues to increase; however, little has been written about the legal and regulatory issues involved in providing this form of care to children and adolescents. This article reviews existing laws and regulations to summarize the risk management issues relevant to providing telemental healthcare to children and adolescents. There are several legal and regulatory areas in which telemental health clinicians need to have awareness. These areas include: 1) Licensure, 2) malpractice liability, 3) credentialing and privileging, 4) informed consent, 5) security and privacy, and 6) emergency management. Although legal and regulatory challenges remain in providing telemental healthcare to children and adolescents, it is possible to overcome these challenges with knowledge of the issues and appropriate risk management strategies. We provide general knowledge of these key legal and regulatory issues, along with some risk management recommendations.

  8. Health physics self-assessment and the nuclear regulatory oversight process at a nuclear power plant

    International Nuclear Information System (INIS)

    Schofield, R.S.

    2003-01-01

    The U.S. Nuclear Regulatory Commission has developed improvements in their Nuclear Power Plant inspection, assessment and enforcement practices. The objective of these changes was to link regulatory action with power plant performance through a risk- informed process which is intended to enhance objectivity. One of the Strategic Performance Areas of focus by the U.S. NRC is radiation safety. Two cornerstones, Occupational Radiation Safety and Public Radiation Safety, make up this area. These cornerstones are being evaluated through U.S. NRC Performance Indicators (PI) and baseline site inspections. Key to the U.S. NRC's oversight program is the ability of the licensee to implement a self-assessment program which pro-actively identifies potential problems and develops improvements to enhance management's effectiveness. The Health Physics Self-Assessment Program at San Onofre Nuclear Generating Station (SONGS) identifies radiation protection-related weakness or negative trends. The intended end result is improved performance through rapid problem identification, timely evaluation, corrective action and follow-up effectiveness reviews. A review of the radiation protection oversight process and the SONGS Health Physics Self-Assessment Program will be presented. Lessons learned and management tools, which evaluate workforce and Health Physics (HP) staff performance to improve radiological practices, are discussed. (author)

  9. Risk assessment and societal choices

    Energy Technology Data Exchange (ETDEWEB)

    Otway, H J

    1975-02-15

    Many countries are experiencing a period in which traditional values are being questioned; plans for further technological progress are being met by a variety of demands for a closer examination of the benefits and risks of large-scale technologies. In this paper the concepts of risk assessment are presented and a model is proposed which illustrates the importance of socio-psychological mechanisms in the acceptance of technological risks. The research plan of the Joint IAEA/IIASA Research Project is outlined: this work is directed toward gaining an improved understanding of how societies judge the acceptability of technologies and how societal attitudes and anticipated responses may be better integrated into the decision-making process. Some preliminary results are reported. (author)

  10. Risk assessment and societal choices

    International Nuclear Information System (INIS)

    Otway, H.J.

    1975-01-01

    Many countries are experiencing a period in which traditional values are being questioned; plans for further technological progress are being met by a variety of demands for a closer examination of the benefits and risks of large-scale technologies. In this paper the concepts of risk assessment are presented and a model is proposed which illustrates the importance of socio-psychological mechanisms in the acceptance of technological risks. The research plan of the Joint IAEA/IIASA Research Project is outlined: this work is directed toward gaining an improved understanding of how societies judge the acceptability of technologies and how societal attitudes and anticipated responses may be better integrated into the decision-making process. Some preliminary results are reported. (author)

  11. Fire Risk Assessment in Germany

    International Nuclear Information System (INIS)

    Berg, H. P.

    2000-01-01

    Quantitative fire risk assessment can serve as an additional tool to assess the safety level of a nuclear power plant (NPP) and to set priorities for fire protection improvement measures. The recommended approach to be applied within periodic safety reviews of NPPs in Germany starts with a screening process providing critical fire zones in which a fully developed fire has the potential to both cause an initiating event and impair the function of at least one component or system critical to safety. The second step is to perform a quantitative analysis using a standard event tree has been developed with elements for fire initiation, ventilation of the room, fire detection, fire suppression, and fire propagation. In a final step, the fire induced frequency of initiating events, the main contributors and the calculated hazard state frequency for the fire event are determined. Results of the first quantitative fire risk studies performed in Germany are reported. (author)

  12. Hydrocarbons pipeline transportation risk assessment

    Science.gov (United States)

    Zanin, A. V.; Milke, A. A.; Kvasov, I. N.

    2018-04-01

    The pipeline transportation applying risks assessment issue in the arctic conditions is addressed in the paper. Pipeline quality characteristics in the given environment has been assessed. To achieve the stated objective, the pipelines mathematical model was designed and visualized by using the software product SOLIDWORKS. When developing the mathematical model the obtained results made possible to define the pipeline optimal characteristics for designing on the Arctic sea bottom. In the course of conducting the research the pipe avalanche collapse risks were examined, internal longitudinal and circular loads acting on the pipeline were analyzed, as well as the water impact hydrodynamic force was taken into consideration. The conducted calculation can contribute to the pipeline transport further development under the harsh climate conditions of the Russian Federation Arctic shelf territory.

  13. Risk assessment - The perspective and experience of US environmentalists

    Energy Technology Data Exchange (ETDEWEB)

    Silbergeld, Ellen [University of Maryland, Baltimore (United States)

    1992-07-01

    Since 1981, risk assessment has formed the methodological basis for much public policy related to occupational and environmental chemicals in the US. Risk assessment rose to prominence out of public concern over the potential contribution of chemical exposures to cancer and out of public frustration with delays in regulation by the Environmental Agency (EPA) and the Occupational Safety and Health Administration (OSHA). In addition, pressures from industry required EPA and OSHA to provide a scientific rationale for specific regulatory decisions. The past decade provides a convenient body of evidence upon which to consider the value of risk assessment as a method for reaching public policy decisions. This paper will provide such an evaluation; from the environmentalist perspective. My criteria include: the efficiency, adequacy, clarity, enforceability, and public acceptability of regulation during this period. In addition, the scientific validity of risk assessment is of concern to environmentalists, as it is to others.

  14. Risk assessment - The perspective and experience of US environmentalists

    International Nuclear Information System (INIS)

    Silbergeld, Ellen

    1992-01-01

    Since 1981, risk assessment has formed the methodological basis for much public policy related to occupational and environmental chemicals in the US. Risk assessment rose to prominence out of public concern over the potential contribution of chemical exposures to cancer and out of public frustration with delays in regulation by the Environmental Agency (EPA) and the Occupational Safety and Health Administration (OSHA). In addition, pressures from industry required EPA and OSHA to provide a scientific rationale for specific regulatory decisions. The past decade provides a convenient body of evidence upon which to consider the value of risk assessment as a method for reaching public policy decisions. This paper will provide such an evaluation; from the environmentalist perspective. My criteria include: the efficiency, adequacy, clarity, enforceability, and public acceptability of regulation during this period. In addition, the scientific validity of risk assessment is of concern to environmentalists, as it is to others

  15. Probabilistic risk assessment of HTGRs

    International Nuclear Information System (INIS)

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

    1980-08-01

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

  16. Probabilistic risk assessment of HTGRs

    International Nuclear Information System (INIS)

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

    1981-01-01

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

  17. 78 FR 27235 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Science.gov (United States)

    2013-05-09

    ... Justice in Regulatory Analysis.'' The purpose of this guidance is to provide EPA analysts with technical...-566-2363. Mail: Technical Guidance for Assessing Environmental Justice in Regulatory Analysis... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2013-0320; FRL-9810-5] Technical Guidance for Assessing...

  18. Water risk assessment in China based on the improved Water Risk Filter

    Science.gov (United States)

    Hong, G.; Yaqin, Q.; Qiong, L.; Cunwen, N.; Na, W.; Jiajia, L.; Jongde, G.; Na, Z.; Xiangyi, D.

    2014-09-01

    Finding an effective way to deal with the water crisis and the relationship between water and development is a major issue for all levels of government and different economic sectors across the world. Scientific understanding of water risk is the basis for achieving a scientific relationship between water and development, and water risk assessment is currently an important research focus. To effectively deal with the global water crisis, the World Wide Fund for Nature and German Investment and Development Company Limited proposed the concept of water risk and released an online Water Risk Filter in March 2012, which has been applied to at least 85 countries. To comprehensively and accurately reflect the situation of water risk in China, this study adjusts the water risk assessment indicators in the Water Risk Filter, taking the actual situation in China and the difficulty of obtaining the information about the indicators into account, and proposes an index system for water risk evaluation for China which consists of physical risk, regulatory risk and reputational risk. The improved Water Risk Filter is further used to assess the sources and causes of the water risks in 10 first-class and seven second-class water resource areas (WRAs). The results indicate that the water risk for the whole country is generally medium and low, while those for different regions in the country vary greatly, and those for southern regions are generally lower than those for northern regions. Government regulatory and policy implementation as well as media supervision in northern regions should be strengthened to reduce the water risk. The research results may provide decision support and references for both governments and industrial enterprises in identifying water risks, formulating prevention and control policies, and improving water resources management in China.

  19. Water risk assessment in China based on the improved Water Risk Filter

    Directory of Open Access Journals (Sweden)

    G. Hong

    2014-09-01

    Full Text Available Finding an effective way to deal with the water crisis and the relationship between water and development is a major issue for all levels of government and different economic sectors across the world. Scientific understanding of water risk is the basis for achieving a scientific relationship between water and development, and water risk assessment is currently an important research focus. To effectively deal with the global water crisis, the World Wide Fund for Nature and German Investment and Development Company Limited proposed the concept of water risk and released an online Water Risk Filter in March 2012, which has been applied to at least 85 countries. To comprehensively and accurately reflect the situation of water risk in China, this study adjusts the water risk assessment indicators in the Water Risk Filter, taking the actual situation in China and the difficulty of obtaining the information about the indicators into account, and proposes an index system for water risk evaluation for China which consists of physical risk, regulatory risk and reputational risk. The improved Water Risk Filter is further used to assess the sources and causes of the water risks in 10 first-class and seven second-class water resource areas (WRAs. The results indicate that the water risk for the whole country is generally medium and low, while those for different regions in the country vary greatly, and those for southern regions are generally lower than those for northern regions. Government regulatory and policy implementation as well as media supervision in northern regions should be strengthened to reduce the water risk. The research results may provide decision support and references for both governments and industrial enterprises in identifying water risks, formulating prevention and control policies, and improving water resources management in China.

  20. 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

  1. 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…

  2. 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.

  3. [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.

  4. Risk communication and environmental risk assessment

    International Nuclear Information System (INIS)

    Petts, J.

    1994-01-01

    This paper attempts to provide a broad context for consideration of appropriate risk communication approaches. It examines the basis of public concerns and in particular the non-risk dimensions. The latter are so important in any risk decision that means of communication which can deal with them are required which extend beyond understanding how to present risk estimates. These means relate to (a) the decision processes themselves and the extent to which they provide for involvement of the public in decisions, (b) the communication skills of experts, and (c) the robustness of the risk information which is available. (Author)

  5. Outlook for risk assessment and risk-informed regulations

    International Nuclear Information System (INIS)

    Chakraborty, S.; Breutel, C.; Khatib-Rahbar, M.

    2000-01-01

    The Western nuclear regulatory process has evolved from the initial engineering judgment' framework of the 1960's, the prescriptive deterministic requirements of the 1970s, the transition years of the 1980s, to the present day movement toward risk-informed approaches. In this paper, a short overview of the historic development of safety regulation is provided. The critique of traditional regulatory practice will be summarized and the features of risk-informed regulation will be discussed. The implementation of risk-informed regulation is considered on the basis of general legal principles common to many member states of the NEA and IAEA. In a process to risk-inform regulation, principles such as equal treatment, proportionality of rules and predictability of administrative action are found to be important. (author)

  6. Special committee review of the Nuclear Regulatory Commission's severe accident risks report (NUREG--1150)

    International Nuclear Information System (INIS)

    Kouts, H.J.C.; Apostolakis, G.; Kastenberg, W.E.; Birkhofer, E.H.A.; Hoegberg, L.G.; LeSage, L.G.; Rasmussen, N.C.; Teague, H.J.; Taylor, J.J.

    1990-08-01

    In April 1989, the Nuclear Regulatory Commission's (NRC) Office of Nuclear Regulatory Research (RES) published a draft report ''Severe Accident Risks: An Assessment for Five US Nuclear Power Plants,'' NUREG-1150. This report updated, extended and improved upon the information presented in the 1974 ''Reactor Safety Study,'' WASH-1400. Because the information in NUREG-1150 will play a significant role in implementing the NRC's Severe Accident Policy, its quality and credibility are of critical importance. Accordingly, the Commission requested that the RES conduct a peer review of NUREG-1150 to ensure that the methods, safety insights and conclusions presented are appropriate and adequately reflect the current state of knowledge with respect to reactor safety. To this end, RES formed a special committee in June of 1989 under the provisions of the Federal Advisory Committee Act. The Committee, composed of a group of recognized national and international experts in nuclear reactor safety, was charged with preparing a report reflecting their review of NUREG-1150 with respect to the adequacy of the methods, data, analysis and conclusions it set forth. The report which precedes reflects the results of this peer review

  7. Molecular radiobiology and risk assessment

    International Nuclear Information System (INIS)

    Georgieva, R.

    2009-01-01

    Full text: Attitudes towards the radiation protection standards on in Europe and the world largely depends on scientific knowledge, periodically published by the United Nations Scientific Committee (UNSCEAR) and the recommendations of the International Commission on Radiation Protection (ICRP), which also comply with the research. The new scientific evidence by conducting an additional research is a crucial element in the process of protection of people, workers and patients in medicine from the adverse health effects. Although these standards are clear and easy to apply, there is serious doubt from a scientific perspective about the level of health risk at low doses, which keep up a fierce debate, both eight scientific and political society. The answer to this question requires the integrated efforts of many scientific disciplines. Increasingly rapid advances in biological and medical knowledge provide the necessary conditions for achieving this aim. This lecture tries to shed light on the current state of knowledge, the main unresolved problems in science in the context of radiation protection and risk assessment, and on those lines of research that have the greatest potential to address the issues. They mainly concern issues of doses and biological effects of different types of ionisation radiation, biological effects in cells/tissues which initiate health effects at low doses, individual variability and direct health risk assessment by epidemiological studies of groups exposed to lower doses irradiation

  8. Understanding and acknowledging the ice throw hazard - consequences for regulatory frameworks, risk perception and risk communication

    Science.gov (United States)

    Bredesen, R. E.; Drapalik, M.; Butt, B.

    2017-11-01

    This study attempts to provide the necessary framework required to make sufficiently informed decisions regarding the safety implications of ice throw. The framework elaborates on how to cope with uncertainties, and how to describe results in a meaningful and useful manner to decision makers. Moreover, it points out the moral, judicial and economical obligations of wind turbine owners such that they are able to minimize risk of ice throws as much as possible. Building on the strength of knowledge as well as accounting for uncertainty are also essential in enabling clear communication with stakeholders on the most important/critical/vital issues. With increasing empirical evidence, one can assign a higher confidence level on the expert opinions on safety. Findings regarding key uncertainties of ice risk assessments are presented here to support the ongoing IEA Wind Task 19's work on creating the international guidelines on ice risk assessment due in 2018 (Krenn et al. 2017)[1-6]. In addition the study also incorporates the findings of a Norwegian information project, which focuses on the ice throw hazard for the public (Bredesen, Flage, Butt, Winterwind 2018)[7-9]. This includes measures to reduce damage and hazard from wind turbines for the general public. Recent theory of risk assessment questions the use of risk criteria for achieving optimum risk reduction and favours the use of the ALARA (as low as reasonably achievable) principle. Given the several practical problems associated with the ALARA approach (e.g. judicial realization), a joint approach, which uses a minimum set of criteria as well as the obligation to meet ALARA is suggested (associated with acceptable cost). The actual decision about acceptance criteria or obligations is a societal one, thus suggestions can be made at best. Risk acceptance, risk perception and risk communication are inextricably linked and should thus never be considered separately. Risk communication can shape risk perception

  9. Identifying noncoding risk variants using disease-relevant gene regulatory networks.

    Science.gov (United States)

    Gao, Long; Uzun, Yasin; Gao, Peng; He, Bing; Ma, Xiaoke; Wang, Jiahui; Han, Shizhong; Tan, Kai

    2018-02-16

    Identifying noncoding risk variants remains a challenging task. Because noncoding variants exert their effects in the context of a gene regulatory network (GRN), we hypothesize that explicit use of disease-relevant GRNs can significantly improve the inference accuracy of noncoding risk variants. We describe Annotation of Regulatory Variants using Integrated Networks (ARVIN), a general computational framework for predicting causal noncoding variants. It employs a set of novel regulatory network-based features, combined with sequence-based features to infer noncoding risk variants. Using known causal variants in gene promoters and enhancers in a number of diseases, we show ARVIN outperforms state-of-the-art methods that use sequence-based features alone. Additional experimental validation using reporter assay further demonstrates the accuracy of ARVIN. Application of ARVIN to seven autoimmune diseases provides a holistic view of the gene subnetwork perturbed by the combinatorial action of the entire set of risk noncoding mutations.

  10. Regulatory requirements related to risk-based inspection and maintenance

    International Nuclear Information System (INIS)

    Schroeder, H.C.; Kauer, R.

    2003-01-01

    By asking the question why new inspection and maintenance strategies have to be developed one can often be made aware that there is always a continue demand for cost reduction and optimisation. In this framework, general trends involving staff reduction, outsourcing, benchmarking etc. can often be observed nearly everywhere. Since inspection and maintenance are amongst the few cost factors, which could be actively influenced in the short term, and in combination with the recent regulatory fundamental changes (e.g. PED) yielding to considerably greater responsibilities for the operator of a plant, also the demand for documentation and comprehensibility of measures will increase. (orig.)

  11. Using Risk Assessment Methodologies to Meet Management Objectives

    Science.gov (United States)

    DeMott, D. L.

    2015-01-01

    Corporate and program objectives focus on desired performance and results. ?Management decisions that affect how to meet these objectives now involve a complex mix of: technology, safety issues, operations, process considerations, employee considerations, regulatory requirements, financial concerns and legal issues. ?Risk Assessments are a tool for decision makers to understand potential consequences and be in a position to reduce, mitigate or eliminate costly mistakes or catastrophic failures. Using a risk assessment methodology is only a starting point. ?A risk assessment program provides management with important input in the decision making process. ?A pro-active organization looks to the future to avoid problems, a reactive organization can be blindsided by risks that could have been avoided. ?You get out what you put in, how useful your program is will be up to the individual organization.

  12. 76 FR 28102 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2011-05-13

    ..., Probabilistic Risk Assessment Branch, Division of Risk Analysis, Office of Nuclear Regulatory Research, U.S... results of risk analyses are used to help justify regulatory action. As such, the principles, process, and... NUCLEAR REGULATORY COMMISSION [NRC-2009-0385] Notice of Issuance of Regulatory Guide AGENCY...

  13. A survey of ecological risk assessment at DOE facilities

    International Nuclear Information System (INIS)

    Barnthouse, L.W.; Bascietto, J.; Joseph, T.; Bilyard, G.

    1992-01-01

    The US Department of Energy (DOE) Risk-Based Standards Working Group is studying standard-setting and remedial action based on realistic estimates of human health and ecological risks. Federal and state regulations require DOE to assess ecological risks due to present and past operation of DOE facilities and ecological damage caused by remedial actions. Unfortunately, little technical guidance has been provided by regulatory agencies about how these assessments should be performed or what constitutes an adequate assessment. Active ecological research, environmental characterization, and ecological risk assessment programs are already underway at many locations. Some of these programs were established more than 30 years ago. Because of the strength of its existing programs and the depth of expertise available within the DOE complex, the agency is in a position to lead in developing ecological risk assessment procedures that are fully consistent with the general principles defined by EPA and that will ensure environmentally sound and cost-effective restoration of its sites. As a prelude to guidance development, the working group conducted a survey of ecological risk assessment activities at a subset of major DOE facilities. The survey was intended to (1) identify approaches now being used in ecological risk assessments performed by DOE staff and contractors at each site, (2) record successes and failures of these approaches, (3) identify new technical developments with potential for general application to many DOE facilities, and (4) identify major data needs, data resources, and methodological deficiencies

  14. Use of probabilistic risk assessment in fuel cycle facilities

    International Nuclear Information System (INIS)

    Gonzalez, Felix; Gonzalez, Michelle; Wagner, Brian

    2013-01-01

    As expressed in its Policy Statement on the Use of Probabilistic Risk Assessment (PRA) Methods in Nuclear Regulatory Activities, the U.S Nuclear Regulatory Commission has been working for decades to increase the use of PRA technology in its regulatory activities. Since the policy statement was issued in 1995, PRA has become a core component of the nuclear power plant (NPP) licensing and oversight processes. In the last several years, interest has increased in PRA technologies and their possible application to other areas including, but not limited to, spent fuel handling, fuel cycle facilities, reprocessing facilities, and advanced reactors. This paper describes the application of PRA technology currently used in NPPs and its application in other areas such as fuel cycle facilities and advanced reactors. It describes major challenges that are being faced in the application of PRA into new technical areas and possible ways to resolve them. (authors)

  15. Deregulation in the electricity sector: Understanding strategic and regulatory risk

    Energy Technology Data Exchange (ETDEWEB)

    Larsen, E.R. [City Univ. Business School, Dept. Management Systems and Information, London (United Kingdom); Bunn, D.W. [London Business School, London (United Kingdom)

    1999-08-01

    This paper is motivated by our experiences since 1990 with developing system simulation models to help UK companies in the restructured electricity industry understand the radically different market within which they must become competitive. When public utilities such as electricity have been restructured, deregulated and/or privatised, the process has often been associated with a major change in the competitive environment. As a consequence, the strategic and regulatory uncertainties ahead for these companies are unprecedented. In such a market there has been no historical evolution and all the participants including the regulatory institutions have very little understanding of how it will operate in the short term and evolve in the future. In this situation, the use of systems dynamic models appears to offer an attractive way of gaining insights into how aspects of the competitive market might evolve. In the absence of real experience and relevant analogies, learning from models assumes a key role. Such models cannot be validated empirically, but can be developed to represent how the system is designed to operate. From such a prototypical basis, sensitivity analysis can generate insights on the strategic opportunities created failings in the market design, or its potential instability to shocks and market imperfections. (au)

  16. 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

  17. Development of infrastructure for the regulatory authority to implement risk-informed regulation

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    It is important to assure the technical adequacy of probabilistic risk assessment (PRA) to implement risk-informed regulation of nuclear power plants (NPPs). JNES has been conducting various activities, such as development of PRA model, method, and data base, in order to assure the technical adequacy of PRA as development of the infrastructure for the regulatory authority to implement risk-informed regulation. In 2012, JNES updated the reliability data base used in PRA and improved PRA models to enhance the technical bases of PRA. In addition, JNES has been establishing the PRA model for fuel damage in the spent fuel storage pool in NPPs. As for improvement of PRA model for core damage in reactor, JNES conducted the study including feasibility of a simplified reliability model for digital I and C system developed by the digital I and C task group of OECD/NEA CSNI WGRISK by reproducing the sample calculation, and improvement of PRA models of individual NPPs in Japan. JNES is making effort to develop the procedures of internal fire PRA and internal flooding PRA. To improve the internal fire PRA, JNES is participating in OECD/NEA FIRE project to obtain the latest information and to validate and improve the fire propagation analysis codes and the parameters. JNES is establishing a method for analyzing internal influence due to flooding in NPPs, and this method is the base to develop the procedure of internal flooding PRA. (author)

  18. Risk assessment terminology: risk communication part 1

    Directory of Open Access Journals (Sweden)

    Gaetano Liuzzo

    2016-03-01

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

  19. Risk Assessment and Risk Governance of Liquefied Natural Gas Development in Gladstone, Australia.

    Science.gov (United States)

    van der Vegt, R G

    2018-02-26

    This article is a retrospective analysis of liquefied natural gas development (LNG) in Gladstone, Australia by using the structure of the risk governance framework developed by the International Risk Governance Council (IRGC). Since 2010 the port of Gladstone has undergone extensive expansion to facilitate the increasing coal export as well as the new development of three recently completed LNG facilities. Significant environmental and socio-economic impacts and concerns have occurred as a result of these developments. The overall aim of the article, therefore, is to identify the risk governance deficits that arose and to formulate processes capable of improving similar decision-making problems in the future. The structure of the IRGC framework is followed because it represents a broad analytical approach for considering risk assessment and risk governance in Gladstone in ways that include, but also go beyond, the risk approach of the ISO 31000:2009 standard that was employed at the time. The IRGC risk framework is argued to be a consistent and comprehensive risk governance framework that integrates scientific, economic, social, and cultural aspects and advocates the notion of inclusive risk governance through stakeholder communication and involvement. Key aspects related to risk preassessment, risk appraisal, risk tolerability and acceptability, risk management, and stakeholder communication and involvement are considered. The results indicate that the risk governance deficits include aspects related to (i) the risk matrix methodology, (ii) reflecting uncertainties, (iii) cumulative risks, (iv) the regulatory process, and (v) stakeholder communication and involvement. © 2018 Society for Risk Analysis.

  20. Pesticide risk assessment in the United States

    Energy Technology Data Exchange (ETDEWEB)

    Hill, Richard N [Environmental Protection Agency, Washington, DC (United States)

    1992-07-01

    ,000 products, and implementing other aspects of the statute, EPA employs about 900 people. Unlike the approval process and actions to cancel pesticides in some countries, in the U.S. they are generally much more transparent. The need for specific test guidelines and the nature of the protocols are debated in the scientific community. Test data adequacy is evaluated according to objective criteria, and study findings are reviewed using standard evaluation procedures and risk assessment guidelines that have been through public comment. Agency risk concerns for a registered pesticide are vetted at a meeting of its Scientific Advisory Panel, a group of technical experts outside of government, where the potential risk case is reviewed and discussed. The meeting is open to the public with opportunity for input from industry, public interest groups, and other parties. Formal Agency regulatory proposals to cancel registered pesticides are published for public review and comment, and there may be several rounds of public involvement before a final decision is reached. Even after a regulatory decision has been made, and unless a settlement has been reached, the Agency is often sued by an environmental group or industry that questions the EPA position; in such situations, the case is then transferred to the court for deliberation. Risks are evaluated for a host of different effects by the pesticide program: acute and chronic, human health and ecological.

  1. Pesticide risk assessment in the United States

    International Nuclear Information System (INIS)

    Hill, Richard N.

    1992-01-01

    ,000 products, and implementing other aspects of the statute, EPA employs about 900 people. Unlike the approval process and actions to cancel pesticides in some countries, in the U.S. they are generally much more transparent. The need for specific test guidelines and the nature of the protocols are debated in the scientific community. Test data adequacy is evaluated according to objective criteria, and study findings are reviewed using standard evaluation procedures and risk assessment guidelines that have been through public comment. Agency risk concerns for a registered pesticide are vetted at a meeting of its Scientific Advisory Panel, a group of technical experts outside of government, where the potential risk case is reviewed and discussed. The meeting is open to the public with opportunity for input from industry, public interest groups, and other parties. Formal Agency regulatory proposals to cancel registered pesticides are published for public review and comment, and there may be several rounds of public involvement before a final decision is reached. Even after a regulatory decision has been made, and unless a settlement has been reached, the Agency is often sued by an environmental group or industry that questions the EPA position; in such situations, the case is then transferred to the court for deliberation. Risks are evaluated for a host of different effects by the pesticide program: acute and chronic, human health and ecological

  2. RISK MANAGEMENT: AN INTEGRATED APPROACH TO RISK MANAGEMENT AND ASSESSMENT

    Directory of Open Access Journals (Sweden)

    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.

  3. Risks, risk assessment and risk competence in toxicology

    Science.gov (United States)

    Stahlmann, Ralf; Horvath, Aniko

    2015-01-01

    Understanding the toxic effects of xenobiotics requires sound knowledge of physiology and biochemistry. The often described lack of understanding pharmacology/toxicology is therefore primarily caused by the general absence of the necessary fundamental knowledge. Since toxic effects depend on exposure (or dosage) assessing the risks arising from toxic substances also requires quantitative reasoning. Typically public discussions nearly always neglect quantitative aspects and laypersons tend to disregard dose-effect-relationships. One of the main reasons for such disregard is the fact that exposures often occur at extremely low concentrations that can only be perceived intellectually but not by the human senses. However, thresholds in the low exposure range are often scientifically disputed. At the same time, ignorance towards known dangers is wide-spread. Thus, enhancing the risk competence of laypersons will have to be initially restricted to increasing the awareness of existing problems. PMID:26195922

  4. Risks, risk assessment and risk competence in toxicology.

    Science.gov (United States)

    Stahlmann, Ralf; Horvath, Aniko

    2015-01-01

    Understanding the toxic effects of xenobiotics requires sound knowledge of physiology and biochemistry. The often described lack of understanding pharmacology/toxicology is therefore primarily caused by the general absence of the necessary fundamental knowledge. Since toxic effects depend on exposure (or dosage) assessing the risks arising from toxic substances also requires quantitative reasoning. Typically public discussions nearly always neglect quantitative aspects and laypersons tend to disregard dose-effect-relationships. One of the main reasons for such disregard is the fact that exposures often occur at extremely low concentrations that can only be perceived intellectually but not by the human senses. However, thresholds in the low exposure range are often scientifically disputed. At the same time, ignorance towards known dangers is wide-spread. Thus, enhancing the risk competence of laypersons will have to be initially restricted to increasing the awareness of existing problems.

  5. Risks, risk assessment and risk competence in toxicology

    Directory of Open Access Journals (Sweden)

    Stahlmann, Ralf

    2015-07-01

    Full Text Available Understanding the toxic effects of xenobiotics requires sound knowledge of physiology and biochemistry. The often described lack of understanding pharmacology/toxicology is therefore primarily caused by the general absence of the necessary fundamental knowledge. Since toxic effects depend on exposure (or dosage assessing the risks arising from toxic substances also requires quantitative reasoning. Typically public discussions nearly always neglect quantitative aspects and laypersons tend to disregard dose-effect-relationships. One of the main reasons for such disregard is the fact that exposures often occur at extremely low concentrations that can only be perceived intellectually but not by the human senses. However, thresholds in the low exposure range are often scientifically disputed. At the same time, ignorance towards known dangers is wide-spread. Thus, enhancing the risk competence of laypersons will have to be initially restricted to increasing the awareness of existing problems.

  6. Risk Profile Indicators and Spanish Banks’ Probability of Default from a Regulatory Approach

    Directory of Open Access Journals (Sweden)

    Pilar Gómez-Fernández-Aguado

    2018-04-01

    Full Text Available This paper analyses the relationships between the traditional bank risk profile indicators and a new measure of banks’ probability of default that considers the Basel regulatory framework. First, based on the SYstemic Model of Bank Originated Losses (SYMBOL, we calculated the individual probabilities of default (PD of a representative sample of Spanish credit institutions during the period of 2008–2016. Then, panel data regressions were estimated to explore the influence of the risk indicators on the PD. Our findings on the Spanish banking system could be important to regulatory and supervisory authorities. First, the PD based on the SYMBOL model could be used to analyse bank risk from a regulatory approach. Second, the results might be useful for designing new regulations focused on the key factors that affect the banks’ probability of default. Third, our findings reveal that the emphasis on regulation and supervision should differ by type of entity.

  7. 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

  8. 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

  9. The assessment of technical risks

    International Nuclear Information System (INIS)

    Jaeger, T.A.

    1978-01-01

    The safety of technical systems is so difficult to assess because the concept 'risk' contains technical-scientific factors as well as components of individual and social psychology. Immediate or short-term hazards of human life as i.e. caused by the operation of industrial plants and mediate and thus long-term hazards have to be distinguished. Characteristic for the second hazard groups is the great time-lag before the effect takes place. Thus a causal relationship can be recognized only late and not definitely. Even when the causes have been obviated the effects still show. The development of a systems-analytical model as a basis of decisive processes for the introduction of highly endangered large-scale technologies seems particularly difficult. A starting point for the quantification of the risk can still be seen in the product of the probability of realization and the extent of the damage. Public opinion, however, does not base its evaluations on an objective concept of risk but tends to have an attitude of aversion against great and disastrous accidents. On the other hand, plenty of slight accidents are accepted much more easily, even when the amount of deadly victims from accidents reaches dimensions beyond those of the rare large-scale accidents. Here, mostly the damage possible but not the probability of its occurence is seen, let alone the general use of the new technology. The value of the mathematical models for estimating risks is mainly due to the fact that they are able to clear up decisions. (orig./HP) [de

  10. Inter-system LOCA risk assessment

    International Nuclear Information System (INIS)

    Galyean, W.J.; Kelly, D.L.; Schroeder, J.A.

    1991-01-01

    Inter-systems loss-of-coolant accidents (ISLOCAs) have been included in probabilistic risk assessments (PRAs) since WASH-1400. While estimated as being relatively low contributors to core damage frequency, ISLOCAs have been identified as major contributors to risk at nuclear power plants (NPPs). They have the potential to result in core melt and containment bypass, which may lead to the early release of large quantities of fission products. Recent events at several operating reactors have been identified as ISLOCA precursors. The occurrence of these events have raised concerns that the frequency of ISLOCA sequences might be underestimated in current state-of-the-art PRAs. In order to expand the current state-of-the-art, a Nuclear Regulatory Commission research program is being conducted by ED and G Idaho, Inc. at the Idaho National Engineering Laboratory. The objective of the ISLOCA research program is to generate qualitative and quantitative information on the hardware, human factors, and accident consequence issues that dominate nuclear power plant risks for ISLOCA. To meet this objective, the approach being taken includes analysis of all interfaces between the primary reactor coolant system and other, lower pressure systems. This historical experience (primarily, licensee event reports) has provided the basis for determining the scope of the analysis with respect to potential failure mechanisms of the pressure isolation boundary. It is important to note that in the vast majority of these events, the dominant failure was a human error. Because of their significance, human errors are given particular attention in the present analysis

  11. Probabilistic risk analysis and its role in regulatory activity in a developing country

    International Nuclear Information System (INIS)

    Arredondo-Sanchez, C.

    1985-01-01

    The author discusses the criterion adopted for regulatory activity in a developing country with a nuclear power plant. He describes the problems that have to be overcome as a result of changes in the regulations during construction of the plant. There is discussion of the action taken by the regulatory body when introducing the method of probabilistic risk analysis. The part played by this form of analysis in quantifying the safety objectives proposed in the USA together with its limitations and the problems involved in this methodology are examined. Lastly, the author gives an opinion on the use that probabilistic risk analysis should be put to in developing countries such as Mexico. (author)

  12. Environmental risk assessments for transgenic crops producing output trait enzymes

    Science.gov (United States)

    Tuttle, Ann; Shore, Scott; Stone, Terry

    2009-01-01

    The environmental risks from cultivating crops producing output trait enzymes can be rigorously assessed by testing conservative risk hypotheses of no harm to endpoints such as the abundance of wildlife, crop yield and the rate of degradation of crop residues in soil. These hypotheses can be tested with data from many sources, including evaluations of the agronomic performance and nutritional quality of the crop made during product development, and information from the scientific literature on the mode-of-action, taxonomic distribution and environmental fate of the enzyme. Few, if any, specific ecotoxicology or environmental fate studies are needed. The effective use of existing data means that regulatory decision-making, to which an environmental risk assessment provides essential information, is not unnecessarily complicated by evaluation of large amounts of new data that provide negligible improvement in the characterization of risk, and that may delay environmental benefits offered by transgenic crops containing output trait enzymes. PMID:19924556

  13. 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...

  14. Formulation and Presentation of Risk Assessments to Address Risk Targets for Radioactive Waste Disposal

    International Nuclear Information System (INIS)

    Wilmot, R.D.

    2002-10-01

    The Swedish regulators have been active in the field of performance assessment of radioactive waste disposal facilities for many years and have developed sophisticated approaches to the development of scenarios and other aspects of assessments. These assessments have generally used dose as the assessment end-point. Regulations recently established in Sweden (SSI FS 1998:1) have introduced a risk criterion for radioactive waste disposal: the annual risk of harmful effects after closure of a disposal facility should not exceed 10 -6 for a representative individual in the group exposed to the greatest risk. This report evaluates different approaches to the definition and use of probabilities in the context of risk assessments, and examines the presentation of the results of risk assessments in safety cases to meet risk targets. The report illustrates the strengths and weaknesses of different possible approaches to risk assessment by reference to assessments in other countries, and provides suggestions for future activity and development in this area by the Swedish regulators. The review of experience in other countries has led to a number of key observations relevant to the conduct of regulatory work on risk assessments and preparations for review. These highlight the importance of developing a protocol for conducting calculations, and linking such a protocol to the requirements of risk assessment calculations and to existing code and model capabilities. There are a number of decisions and assumptions required in developing a risk assessment methodology that could potentially affect the calculated results. These assumptions are independent of the analysis of performance, and relate to issues such as the expectation value of risk, risk dilution, the definition of probability density functions and achieving convergence. A review of a proponent's risk assessment should address these issues in determining the appropriateness and validity of the results presented

  15. Formulation and Presentation of Risk Assessments to Address Risk Targets for Radioactive Waste Disposal

    Energy Technology Data Exchange (ETDEWEB)

    Wilmot, R.D. [Galson Sciences Ltd, Oakham (United Kingdom)

    2002-10-01

    The Swedish regulators have been active in the field of performance assessment of radioactive waste disposal facilities for many years and have developed sophisticated approaches to the development of scenarios and other aspects of assessments. These assessments have generally used dose as the assessment end-point. Regulations recently established in Sweden (SSI FS 1998:1) have introduced a risk criterion for radioactive waste disposal: the annual risk of harmful effects after closure of a disposal facility should not exceed 10{sup -6} for a representative individual in the group exposed to the greatest risk. This report evaluates different approaches to the definition and use of probabilities in the context of risk assessments, and examines the presentation of the results of risk assessments in safety cases to meet risk targets. The report illustrates the strengths and weaknesses of different possible approaches to risk assessment by reference to assessments in other countries, and provides suggestions for future activity and development in this area by the Swedish regulators. The review of experience in other countries has led to a number of key observations relevant to the conduct of regulatory work on risk assessments and preparations for review. These highlight the importance of developing a protocol for conducting calculations, and linking such a protocol to the requirements of risk assessment calculations and to existing code and model capabilities. There are a number of decisions and assumptions required in developing a risk assessment methodology that could potentially affect the calculated results. These assumptions are independent of the analysis of performance, and relate to issues such as the expectation value of risk, risk dilution, the definition of probability density functions and achieving convergence. A review of a proponent's risk assessment should address these issues in determining the appropriateness and validity of the results presented

  16. Getting fire risk assessment right.

    Science.gov (United States)

    Charters, David

    2012-06-01

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

  17. 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.

  18. Risk management of biologicals: a regulatory and clinical perspective

    NARCIS (Netherlands)

    Giezen, T.J.|info:eu-repo/dai/nl/304823112

    2011-01-01

    Biologicals are a relatively new class of drugs and are important treatment options for a variety of chronic and/or serious conditions. Biologicals have different characteristics as compared to the traditional chemically synthesised drugs, which may result in different risk profiles and the need for

  19. Social aspects of risk assessment

    International Nuclear Information System (INIS)

    Otway, H.J.; Linnerooth, J.; Niehaus, F.

    1977-01-01

    Plans for technological development have often been met by demands for a closer examination of the associated benefits and risks and the consideration of social values in public planning and decision processes. A theoretical framework for inter-disciplinary risk assessment studies is presented to aid the balancing of technical data with social values in decision making. Methods for obtaining value measures are reviewed and an attitude-based method is developed in detail; this model allows identification of the relative importance of the technical, psychological and social factors which underlie attitudes and indicates which factors differentiate between social groups. Results of a pilot application to nuclear power are summarized. For these subjects, different attitudes between pro and con were primarily due to strongly differing beliefs about the benefits of nuclear power. Preliminary results are reported of an application of this model with a heterogeneous sample drawn from the general public. The cognitive limitations which affect rationality in intuitive decision making are summarized as background to introduce formal decision methodologies for the use of attitude data in public decision making

  20. Colorectal Cancer Risk Assessment Tool

    Science.gov (United States)

    ... 11/12/2014 Risk Calculator About the Tool Colorectal Cancer Risk Factors Download SAS and Gauss Code Page ... Rectal Cancer: Prevention, Genetics, Causes Tests to Detect Colorectal Cancer and Polyps Cancer Risk Prediction Resources Update November ...

  1. Managing carbon regulatory risk in utility resource planning: Current practices in the Western United States

    International Nuclear Information System (INIS)

    Barbose, Galen; Wiser, Ryan; Phadke, Amol; Goldman, Charles

    2008-01-01

    Concerns about global climate change have substantially increased the likelihood that future policy will seek to minimize carbon dioxide emissions. As such, even today, electric utilities are making resource planning and investment decisions that consider the possible implications of these future carbon regulations. In this article, we examine the manner in which utilities assess the financial risks associated with future carbon regulations within their long-term resource plans. We base our analysis on a review of the most recent resource plans filed by 15 electric utilities in the Western United States. Virtually all of these utilities made some effort to quantitatively evaluate the potential cost of future carbon regulations when analyzing alternate supply- and demand-side resource options for meeting customer load. Even without federal climate regulation in the US, the prospect of that regulation is already having an impact on utility decision-making and resource choices. That said, the methods and assumptions used by utilities to analyze carbon regulatory risk, and the impact of that analysis on their choice of a particular resource strategy, vary considerably, revealing a number of opportunities for analytic improvement. Though our review focuses on a subset of US electric utilities, this work holds implications for all electric utilities and energy policymakers who are seeking to minimize the compliance costs associated with future carbon regulations

  2. Applying quantitative benefit-risk analysis to aid regulatory decision making in diagnostic imaging: methods, challenges, and opportunities.

    Science.gov (United States)

    Agapova, Maria; Devine, Emily Beth; Bresnahan, Brian W; Higashi, Mitchell K; Garrison, Louis P

    2014-09-01

    Health agencies making regulatory marketing-authorization decisions use qualitative and quantitative approaches to assess expected benefits and expected risks associated with medical interventions. There is, however, no universal standard approach that regulatory agencies consistently use to conduct benefit-risk assessment (BRA) for pharmaceuticals or medical devices, including for imaging technologies. Economics, health services research, and health outcomes research use quantitative approaches to elicit preferences of stakeholders, identify priorities, and model health conditions and health intervention effects. Challenges to BRA in medical devices are outlined, highlighting additional barriers in radiology. Three quantitative methods--multi-criteria decision analysis, health outcomes modeling and stated-choice survey--are assessed using criteria that are important in balancing benefits and risks of medical devices and imaging technologies. To be useful in regulatory BRA, quantitative methods need to: aggregate multiple benefits and risks, incorporate qualitative considerations, account for uncertainty, and make clear whose preferences/priorities are being used. Each quantitative method performs differently across these criteria and little is known about how BRA estimates and conclusions vary by approach. While no specific quantitative method is likely to be the strongest in all of the important areas, quantitative methods may have a place in BRA of medical devices and radiology. Quantitative BRA approaches have been more widely applied in medicines, with fewer BRAs in devices. Despite substantial differences in characteristics of pharmaceuticals and devices, BRA methods may be as applicable to medical devices and imaging technologies as they are to pharmaceuticals. Further research to guide the development and selection of quantitative BRA methods for medical devices and imaging technologies is needed. Copyright © 2014 AUR. Published by Elsevier Inc. All rights

  3. Cell-type-specific enrichment of risk-associated regulatory elements at ovarian cancer susceptibility loci.

    Science.gov (United States)

    Coetzee, Simon G; Shen, Howard C; Hazelett, Dennis J; Lawrenson, Kate; Kuchenbaecker, Karoline; Tyrer, Jonathan; Rhie, Suhn K; Levanon, Keren; Karst, Alison; Drapkin, Ronny; Ramus, Susan J; Couch, Fergus J; Offit, Kenneth; Chenevix-Trench, Georgia; Monteiro, Alvaro N A; Antoniou, Antonis; Freedman, Matthew; Coetzee, Gerhard A; Pharoah, Paul D P; Noushmehr, Houtan; Gayther, Simon A

    2015-07-01

    Understanding the regulatory landscape of the human genome is a central question in complex trait genetics. Most single-nucleotide polymorphisms (SNPs) associated with cancer risk lie in non-protein-coding regions, implicating regulatory DNA elements as functional targets of susceptibility variants. Here, we describe genome-wide annotation of regions of open chromatin and histone modification in fallopian tube and ovarian surface epithelial cells (FTSECs, OSECs), the debated cellular origins of high-grade serous ovarian cancers (HGSOCs) and in endometriosis epithelial cells (EECs), the likely precursor of clear cell ovarian carcinomas (CCOCs). The regulatory architecture of these cell types was compared with normal human mammary epithelial cells and LNCaP prostate cancer cells. We observed similar positional patterns of global enhancer signatures across the three different ovarian cancer precursor cell types, and evidence of tissue-specific regulatory signatures compared to non-gynecological cell types. We found significant enrichment for risk-associated SNPs intersecting regulatory biofeatures at 17 known HGSOC susceptibility loci in FTSECs (P = 3.8 × 10(-30)), OSECs (P = 2.4 × 10(-23)) and HMECs (P = 6.7 × 10(-15)) but not for EECs (P = 0.45) or LNCaP cells (P = 0.88). Hierarchical clustering of risk SNPs conditioned on the six different cell types indicates FTSECs and OSECs are highly related (96% of samples using multi-scale bootstrapping) suggesting both cell types may be precursors of HGSOC. These data represent the first description of regulatory catalogues of normal precursor cells for different ovarian cancer subtypes, and provide unique insights into the tissue specific regulatory variation with respect to the likely functional targets of germline genetic susceptibility variants for ovarian cancer. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. 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.

  5. 77 FR 61446 - Proposed Revision Probabilistic Risk Assessment and Severe Accident Evaluation for New Reactors

    Science.gov (United States)

    2012-10-09

    ... Severe Accident Evaluation for New Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Standard... its Standard Review Plan (SRP), Section 19.0, ``Probabilistic Risk Assessment and Severe Accident... assessment (PRA) information and severe accident assessments for new reactors submitted to support design...

  6. Radiological safety and risk assessment

    International Nuclear Information System (INIS)

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

    1982-02-01

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

  7. Gender differences in risk assessment

    Directory of Open Access Journals (Sweden)

    Christine R. Harris

    2006-07-01

    Full Text Available Across many real-world domains, men engage in more risky behaviors than do women. To examine some of the beliefs and preferences that underlie this difference, 657 participants assessed their likelihood of engaging in various risky activities relating to four different domains (gambling, health, recreation, and social, and reported their perceptions of (1 probability of negative outcomes, (2 severity of potential negative outcomes, and (3 enjoyment expected from the risky activities. Women's greater perceived likelihood of negative outcomes and lesser expectation of enjoyment partially mediated their lower propensity toward risky choices in gambling, recreation, and health domains. Perceptions of severity of potential outcomes was a partial mediator in the gambling and health domains. The genders did not differ in their propensity towards taking social risks. A fifth domain of activities associated with high potential payoffs and fixed minor costs was also assessed. In contrast to other domains, women reported being more likely to engage in behaviors in this domain. This gender difference was partially mediated by women's more optimistic judgments of the probability of good outcomes and of

  8. 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

  9. 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...

  10. 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...

  11. An industry approach to the risk assessment of pesticides

    International Nuclear Information System (INIS)

    Thomas, Barry

    1992-01-01

    The regulatory control of pesticides has developed over the last 40 years during which time major changes have occurred, not only in the scientific basis of risk assessment but also in the socio-political perception of pesticides and of the agricultural and chemical industries. Traditionally, and logically, the registration of pesticides has been based on a pre-marketing risk-benefit assessment by but changes have occurred in the relative importance associated with the two elements of this assessment. These potential risks have assumed a greater importance as has the acceptability of such risks. By contrast the benefits of using plant protection products to increase agricultural productivity and production has assumed less importance in the light of perceived agricultural surpluses, at least in the Developed Countries. This paper will consider current and future regulatory requirements for pesticides and identify some of the key areas which are of importance to the Plant Protection Industry. It will also discuss initiatives, by both the Industry and Government, aimed at ensuring the safe use of plant protection products, how such initiatives are likely to impact on new product developments and the consequential effects on global food supplies

  12. An industry approach to the risk assessment of pesticides

    Energy Technology Data Exchange (ETDEWEB)

    Thomas, Barry [Schering Agrochemicals Ltd., Chesterford Park Research Station, Saffron Walder, Essex (United Kingdom)

    1992-07-01

    The regulatory control of pesticides has developed over the last 40 years during which time major changes have occurred, not only in the scientific basis of risk assessment but also in the socio-political perception of pesticides and of the agricultural and chemical industries. Traditionally, and logically, the registration of pesticides has been based on a pre-marketing risk-benefit assessment by but changes have occurred in the relative importance associated with the two elements of this assessment. These potential risks have assumed a greater importance as has the acceptability of such risks. By contrast the benefits of using plant protection products to increase agricultural productivity and production has assumed less importance in the light of perceived agricultural surpluses, at least in the Developed Countries. This paper will consider current and future regulatory requirements for pesticides and identify some of the key areas which are of importance to the Plant Protection Industry. It will also discuss initiatives, by both the Industry and Government, aimed at ensuring the safe use of plant protection products, how such initiatives are likely to impact on new product developments and the consequential effects on global food supplies.

  13. Approach for assessing the effectiveness of regulatory control in Peru using performance indicators

    International Nuclear Information System (INIS)

    Ramirez Quijada, R.

    1998-01-01

    The paper is intended to make an approach for assessing the effectiveness of regulatory activities in Peru by using of performance indicators for each of the activities developed pursuant their responsibilities. So inspections, authorizations, enforcement and regulation activities are qualified by levels of attainments and then assessed independently to rise specific issues. The general conclusion is that regulatory activities seems to be acceptable but some improvements are needed in order to reach a good level of performance. (author)

  14. Regulatory use of risk information - initial developments at Slovenian Nuclear Safety Administration

    International Nuclear Information System (INIS)

    Muehleisen, A.; Koncar, M.; Vojnovic, D.; Persic, A.

    2004-01-01

    Similarly to other regulators worldwide, the SNSA intends to enhance the use of PSA and risk insights in its activities in order to ensure a better and more focused regulatory oversight as well as improved interface with a licensee. The main aim of the SNSA is to establish PSA as a standard tool to complement the deterministic based regulation for a variety of regulatory tasks. The PSA applications should, in particular, support the decision making process as well as the interactions with the Krsko NPP. As a first step in the internal use of PSA, PSA event analysis and risk based performance indicators are being introduced. In 2004, the SNSA will start introducing risk follow up and risk informed inspections. By mid 2005 the legal basis for the use of PSA will be also established in Slovenian legislation. (author)

  15. [International trend of guidance for nanomaterial risk assessment].

    Science.gov (United States)

    Hirose, Akihiko

    2013-01-01

    In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

  16. EU risk governance of 'cloned food': regulatory uncertainty between trade and non-trade

    NARCIS (Netherlands)

    Weimer, M.; van Asselt, M.B.A.; Versluis, E.; Vos, E.

    2013-01-01

    This chapter analyzes the difficulties of creating a viable legal framework for ‘cloned food’ in the EU combining a legal perspective with insights from the interdisciplinary research on risk governance. Animal cloning offers an instructive example for the challenges of designing regulatory

  17. Developmental Risk and Young Children's Regulatory Strategies: Predicting Behavior Problems at Age Five

    Science.gov (United States)

    Gerstein, Emily D.; Pedersen y Arbona, Anita; Crnic, Keith A.; Ryu, Ehri; Baker, Bruce L.; Blacher, Jan

    2011-01-01

    Children with early developmental delays are at heightened risk for behavior problems and comorbid psychopathology. This study examined the trajectories of regulatory capabilities and their potentially mediating role in the development of behavior problems for children with and without early developmental delays. A sample of 231 children comprised…

  18. Bank Risk Taking and Liquidity Creation Following Regulatory Interventions and Capital Support

    NARCIS (Netherlands)

    Berger, A.N.; Bouwman, C.H.S.; Kick, T.; Schaeck, K.

    2011-01-01

    During times of bank distress, authorities often engage in regulatory interventions and provide capital support to reduce bank risk taking. An unintended effect of such actions may be a reduction in bank liquidity creation, with possible adverse consequences for the economy as a whole. This paper

  19. Bank risk taking and liquidity creation following regulatory interventions and capital support

    NARCIS (Netherlands)

    Berger, A.N.; Bouwman, C.H.S.; Kick, T.; Schaeck, K.

    2011-01-01

    During times of bank distress, authorities often engage in regulatory interventions and provide capital support to reduce bank risk taking. An unintended effect of such actions may be a reduction in bank liquidity creation, with possible adverse consequences for the economy as a whole. This paper

  20. New approach to weight-of-evidence assessment of ecotoxicological effects in regulatory decision-making.

    Science.gov (United States)

    Hall, A Tilghman; Belanger, Scott E; Guiney, Pat D; Galay-Burgos, Malyka; Maack, Gerd; Stubblefield, William; Martin, Olwenn

    2017-07-01

    Ecological risk assessments and risk management decisions are only as sound as the underlying information and processes to integrate them. It is important to develop transparent and reproducible procedures a priori to integrate often-heterogeneous evidence. Current weight-of-evidence (WoE) approaches for effects or hazard assessment tend to conflate aspects of the assessment of the quality of the data with the strength of the body of evidence as a whole. We take forward recent developments in the critical appraisal of the reliability and relevance of individual ecotoxicological studies as part of the effect or hazard assessment of prospective risk assessments and propose a streamlined WoE approach. The aim is to avoid overlap and double accounting of criteria used in reliability and relevance with that used in current WoE methods. The protection goals, problem formulation, and evaluation process need to be clarified at the outset. The data are first integrated according to lines of evidence (LoEs), typically mechanistic insights (e.g., cellular, subcellular, genomic), in vivo experiments, and higher-tiered field or observational studies. Data are then plotted on the basis of both relevance and reliability scores or categories. This graphical approach provides a means to visually assess and communicate the credibility (reliability and relevance of available individual studies), quantity, diversity, and consistency of the evidence. In addition, the external coherence of the body of evidence needs to be considered. The final step in the process is to derive an expression of the confidence in the conclusions of integrating the information considering these 5 aspects in the context of remaining uncertainties. We suggest that this streamlined approach to WoE for the effects or hazard characterization should facilitate reproducible and transparent assessments of data across different regulatory requirements. Integr Environ Assess Manag 2017;13:573-579. © 2017 The Authors

  1. Assessing Risk and Driving Risk Mitigation for First-of-a-Kind Advanced Reactors

    Energy Technology Data Exchange (ETDEWEB)

    John W. Collins

    2011-09-01

    Planning and decision making amidst programmatic and technological risks represent significant challenges for projects. This presentation addresses the four step risk-assessment process needed to determine clear path forward to mature needed technology and design, license, and construct advanced nuclear power plants, which have never been built before, including Small Modular Reactors. This four step process has been carefully applied to the Next Generation Nuclear Plant. STEP 1 - Risk Identification Risks are identified, collected, and categorized as technical risks, programmatic risks, and project risks, each of which result in cost and schedule impacts if realized. These include risks arising from the use of technologies not previously demonstrated in a relevant application. These risks include normal and accident scenarios which the SMR could experience including events that cause the disablement of engineered safety features (typically documented in Phenomena Identification Ranking Tables (PIRT) as produced with the Nuclear Regulatory Commission) and design needs which must be addressed to further detail the design. Product - Project Risk Register contained in a database with sorting, presentation, rollup, risk work off functionality similar to the NGNP Risk Management System . STEP 2 - Risk Quantification The risks contained in the risk register are then scored for probability of occurrence and severity of consequence, if realized. Here the scoring methodology is established and the basis for the scoring is well documented. Product - Quantified project risk register with documented basis for scoring. STEP 3 - Risk Handling Strategy Risks are mitigated by applying a systematic approach to maturing the technology through Research and Development, modeling, test, and design. A Technology Readiness Assessment is performed to determine baseline Technology Readiness Levels (TRL). Tasks needed to mature the technology are developed and documented in a roadmap

  2. Assessing Risk and Driving Risk Mitigation for First-of-a-Kind Advanced Reactors

    International Nuclear Information System (INIS)

    Collins, John W.

    2011-01-01

    Planning and decision making amidst programmatic and technological risks represent significant challenges for projects. This presentation addresses the four step risk-assessment process needed to determine clear path forward to mature needed technology and design, license, and construct advanced nuclear power plants, which have never been built before, including Small Modular Reactors. This four step process has been carefully applied to the Next Generation Nuclear Plant. STEP 1 - Risk Identification Risks are identified, collected, and categorized as technical risks, programmatic risks, and project risks, each of which result in cost and schedule impacts if realized. These include risks arising from the use of technologies not previously demonstrated in a relevant application. These risks include normal and accident scenarios which the SMR could experience including events that cause the disablement of engineered safety features (typically documented in Phenomena Identification Ranking Tables (PIRT) as produced with the Nuclear Regulatory Commission) and design needs which must be addressed to further detail the design. Product - Project Risk Register contained in a database with sorting, presentation, rollup, risk work off functionality similar to the NGNP Risk Management System . STEP 2 - Risk Quantification The risks contained in the risk register are then scored for probability of occurrence and severity of consequence, if realized. Here the scoring methodology is established and the basis for the scoring is well documented. Product - Quantified project risk register with documented basis for scoring. STEP 3 - Risk Handling Strategy Risks are mitigated by applying a systematic approach to maturing the technology through Research and Development, modeling, test, and design. A Technology Readiness Assessment is performed to determine baseline Technology Readiness Levels (TRL). Tasks needed to mature the technology are developed and documented in a roadmap

  3. 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.

  4. Model of MSD Risk Assessment at Workplace

    OpenAIRE

    K. Sekulová; M. Šimon

    2015-01-01

    This article focuses on upper-extremity musculoskeletal disorders risk assessment model at workplace. In this model are used risk factors that are responsible for musculoskeletal system damage. Based on statistic calculations the model is able to define what risk of MSD threatens workers who are under risk factors. The model is also able to say how MSD risk would decrease if these risk factors are eliminated.

  5. 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)

  6. 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

  7. Risk assessment to an integrated planning model for UST programs

    International Nuclear Information System (INIS)

    Ferguson, K.W.

    1993-01-01

    The US Postal Service maintains the largest civilian fleet in the United States totaling approximately 180,000 vehicles. To support the fleets daily energy requirements, the Postal Service also operates one of the largest networks of underground storage tanks nearly 7,500 nationwide. A program to apply risk assessment to planning, budget development and other management actions was implemented during September, 1989. Working closely with a consultant, the postal service developed regulatory and environmental risk criteria and weighting factors for a ranking model. The primary objective was to identify relative risks for each underground tank at individual facilities. Relative risks at each facility were determined central to prioritizing scheduled improvements to the tank network. The survey was conducted on 302 underground tanks in the Northeast Region of the US. An environmental and regulatory risk score was computed for each UST. By ranking the tanks according to their risk score, tanks were classified into management action categories including, but the limited to, underground tank testing, retrofit, repair, replacement and closure

  8. Apperception and assessment of technological risks

    International Nuclear Information System (INIS)

    Hoyos, C.; Hauke, G.

    1986-01-01

    Risk is defined to be the possibility to induce damage or loss. Any person confronted with risk in his activities has to assess the risk in every case. The author explains a number of actions and events that have been worked out to train people in better management of risk, especially in the working environment. (DG) [de

  9. 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.

  10. Risk communication in environmental assessment

    Energy Technology Data Exchange (ETDEWEB)

    Rahm-Crites, L. [Lawrence Livermore National Lab., Germantown, MD (United States). Washington Operations Office

    1996-08-26

    Since the enactment of NEPA and other environmental legislation, the concept of `risk communication` has expanded from simply providing citizens with scientific information about risk to exploring ways of making risk information genuinely meaningful to the public and facilitating public involvement in the very processes whereby risk is analyzed and managed. Contemporary risk communication efforts attempt to find more effective ways of conveying increasingly complex risk information and to develop more democratic and proactive approaches to community involvement, in particular to ensuring the participation of diverse populations in risk decisions. Although considerable progress has been made in a relatively short time, risk communication researchers and practitioners currently face a number of challenges in a time of high expectations, low trust, and low budgets.

  11. Thyroid Cancer Risk Assessment Tool

    Science.gov (United States)

    The R package thyroid implements a risk prediction model developed by NCI researchers to calculate the absolute risk of developing a second primary thyroid cancer (SPTC) in individuals who were diagnosed with a cancer during their childhood.

  12. 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...

  13. Groundwater contamination from waste management sites: The interaction between risk-based engineering design and regulatory policy: 1. Methodology

    Science.gov (United States)

    Massmann, Joel; Freeze, R. Allan

    1987-02-01

    This paper puts in place a risk-cost-benefit analysis for waste management facilities that explicitly recognizes the adversarial relationship that exists in a regulated market economy between the owner/operator of a waste management facility and the government regulatory agency under whose terms the facility must be licensed. The risk-cost-benefit analysis is set up from the perspective of the owner/operator. It can be used directly by the owner/operator to assess alternative design strategies. It can also be used by the regulatory agency to assess alternative regulatory policy, but only in an indirect manner, by examining the response of an owner/operator to the stimuli of various policies. The objective function is couched in terms of a discounted stream of benefits, costs, and risks over an engineering time horizon. Benefits are in the form of revenues for services provided; costs are those of construction and operation of the facility. Risk is defined as the cost associated with the probability of failure, with failure defined as the occurrence of a groundwater contamination event that violates the licensing requirements established for the facility. Failure requires a breach of the containment structure and contaminant migration through the hydrogeological environment to a compliance surface. The probability of failure can be estimated on the basis of reliability theory for the breach of containment and with a Monte-Carlo finite-element simulation for the advective contaminant transport. In the hydrogeological environment the hydraulic conductivity values are defined stochastically. The probability of failure is reduced by the presence of a monitoring network operated by the owner/operator and located between the source and the regulatory compliance surface. The level of reduction in the probability of failure depends on the probability of detection of the monitoring network, which can be calculated from the stochastic contaminant transport simulations. While

  14. [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.

  15. Colon Cancer Risk Assessment - Gauss Program

    Science.gov (United States)

    An executable file (in GAUSS) that projects absolute colon cancer risk (with confidence intervals) according to NCI’s Colorectal Cancer Risk Assessment Tool (CCRAT) algorithm. GAUSS is not needed to run the program.

  16. 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...

  17. Overcoming regulatory fear of public perceptions of mobile phone health risks

    International Nuclear Information System (INIS)

    Mercer, D.

    2001-01-01

    In the following discussion I will critique the images of the public, the mass media and science that permeate much of the regulatory discourse on RF and risk. These images are sometimes explicitly articulated but on other occasions merely implied. These images can be described as the mythical RF triad. Some examples are provided illustrating why the current approach represents a misleading oversimplification of the social and scientific context relevant to formulating a fair and scientifically accountable RF health policy. a number of suggestions are made for broadening the regulatory imagination and stimulate constructive debate on the RF question. Copyright (2001) Australasian Radiation Protection Society Inc

  18. 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.)

  19. 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

  20. 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

  1. Life Cycle Assessment and Risk Assessment

    DEFF Research Database (Denmark)

    Olsen, Stig Irving

    Life Cycle Assessment (LCA) is a tool for environmental assessment of product and systems – over the whole life cycle from acquisition of raw materials to the end-of-life of the product – and encompassing all environmental impacts of emissions and resource usage, e.g. global warming, acidification...... cycle. The models for assessing toxic impacts in LCA are to a large extent based on those developed for RA, e.g. EUSES, and require basic information about the inherent properties of the emissions like solubility, LogKow,ED50 etc. Additionally, it is a prerequisite to know how to characterize...

  2. 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.

  3. Intersystem LOCA risk assessment: methodology and results

    International Nuclear Information System (INIS)

    Galyean, W.J.; Kelly, D.L.; Schroeder, J.A.; Auflick, L.J.; Blackman, H.S.; Gertman, D.I.; Hanley, L.N.

    1994-01-01

    The United States Nuclear Regulatory Commission is sponsoring a research program to develop an improved understanding of the human factors, hardware and accident consequence issues that dominate the risk from an intersystem loss-of-coolant accident (ISLOCA) at a nuclear power plant. To accomplish the goals of this program, a mehtodology has been developed for estimating ISLOCA core damage frequency and risk. The steps in this methodology are briefly described, along with the results obtained from an application of the methodology at three pressurized water reactors. Also included are the results of a screening study of boiling water reactors. ((orig.))

  4. 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

  5. Regulatory activity based risk model identifies survival of stage II and III colorectal carcinoma.

    Science.gov (United States)

    Liu, Gang; Dong, Chuanpeng; Wang, Xing; Hou, Guojun; Zheng, Yu; Xu, Huilin; Zhan, Xiaohui; Liu, Lei

    2017-11-17

    Clinical and pathological indicators are inadequate for prognosis of stage II and III colorectal carcinoma (CRC). In this study, we utilized the activity of regulatory factors, univariate Cox regression and random forest for variable selection and developed a multivariate Cox model to predict the overall survival of Stage II/III colorectal carcinoma in GSE39582 datasets (469 samples). Patients in low-risk group showed a significant longer overall survival and recurrence-free survival time than those in high-risk group. This finding was further validated in five other independent datasets (GSE14333, GSE17536, GSE17537, GSE33113, and GSE37892). Besides, associations between clinicopathological information and risk score were analyzed. A nomogram including risk score was plotted to facilitate the utilization of risk score. The risk score model is also demonstrated to be effective on predicting both overall and recurrence-free survival of chemotherapy received patients. After performing Gene Set Enrichment Analysis (GSEA) between high and low risk groups, we found that several cell-cell interaction KEGG pathways were identified. Funnel plot results showed that there was no publication bias in these datasets. In summary, by utilizing the regulatory activity in stage II and III colorectal carcinoma, the risk score successfully predicts the survival of 1021 stage II/III CRC patients in six independent datasets.

  6. Metal Vapor Arcing Risk Assessment Tool

    Science.gov (United States)

    Hill, Monika C.; Leidecker, Henning W.

    2010-01-01

    The Tin Whisker Metal Vapor Arcing Risk Assessment Tool has been designed to evaluate the risk of metal vapor arcing and to help facilitate a decision toward a researched risk disposition. Users can evaluate a system without having to open up the hardware. This process allows for investigating components at risk rather than spending time and money analyzing every component. The tool points to a risk level and provides direction for appropriate action and documentation.

  7. Energy and environment: Risk assessment

    International Nuclear Information System (INIS)

    Colombo, U.

    1993-01-01

    Two problems connected to the concept of 'risk' were analyzed: nuclear power production and global climate changes. In fact, nuclear power, despite of the risk management of the plants, does not produce gaseous emissions and can be used to reduce environmental risks. Even if a cost benefit analysis of nuclear power is very difficult, to perform it is author's opinion that, very probably, industrial countries will continue to use this form of energy

  8. CEA: risk management assessment 2011

    International Nuclear Information System (INIS)

    Bigot, Bernard; Bonnevie, Edwige; Maillot, Bernard

    2012-01-01

    This report proposes a qualitative and quantitative overview of CEA activities in the field of risk management during 2011. These activities concerned the impact on the environment, the safety of installations, the management of professional risks (safety and health at work), the radiological protection of workers, the transports of hazardous materials, waste management, protection of sites, installations and heritage, the management of emergency situations, the management of law risks, controls and audits

  9. Nuclear fuel cycle risk assessment: survey and computer compilation of risk-related literature

    International Nuclear Information System (INIS)

    Yates, K.R.; Schreiber, A.M.; Rudolph, A.W.

    1982-10-01

    The US Nuclear Regulatory Commission has initiated the Fuel Cycle Risk Assessment Program to provide risk assessment methods for assistance in the regulatory process for nuclear fuel cycle facilities other than reactors. Both the once-through cycle and plutonium recycle are being considered. A previous report generated by this program defines and describes fuel cycle facilities, or elements, considered in the program. This report, the second from the program, describes the survey and computer compilation of fuel cycle risk-related literature. Sources of available information on the design, safety, and risk associated with the defined set of fuel cycle elements were searched and documents obtained were catalogued and characterized with respect to fuel cycle elements and specific risk/safety information. Both US and foreign surveys were conducted. Battelle's computer-based BASIS information management system was used to facilitate the establishment of the literature compilation. A complete listing of the literature compilation and several useful indexes are included. Future updates of the literature compilation will be published periodically. 760 annotated citations are included

  10. CEA - 2014 risk management assessment

    International Nuclear Information System (INIS)

    Bonnevie, Edwige; Verwaerde, Daniel; Maillot, Bernard

    2015-06-01

    After introducing presentations of CEA managers in charge of risk management and controls, this document presents and comments the actions undertaken by the CEA and the obtained results in terms of risk management in different fields: protection and control of the environment, installation safety, health, safety and radiation protection, transport of hazardous materials, waste management, protection of sites, installations and heritage, management of emergency situations, management of legal risks, internal audits and controls. Other topics are addressed like the presentation of the risk management department, and the role of the CEA in the relationship between research and industry

  11. 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

  12. Revised Human Health Risk Assessment on Chlorpyrifos

    Science.gov (United States)

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

  13. Quantitative Microbial Risk Assessment Tutorial - Primer

    Science.gov (United States)

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

  14. Health risk assessment and the practice of industrial hygiene.

    Science.gov (United States)

    Paustenbach, D J

    1990-07-01

    It has been claimed that there may be as many as 2000 airborne chemicals to which persons could be exposed in the workplace and in the community. Of these, occupational exposure limits have been set for approximately 700 chemicals, and only about 30 chemicals have limits for the ambient air. It is likely that some type of health risk assessment methodology will be used to establish limits for the remainder. Although these methods have been used for over 10 yr to set environmental limits, each step of the process (hazard identification, dose-response assessment, exposure assessment, and risk characterization) contains a number of traps into which scientists and risk managers can fall. For example, regulatory approaches to the hazard identification step have allowed little discrimination between the various animal carcinogens, even though these chemicals can vary greatly in their potency and mechanisms of action. In general, epidemiology data have been given little weight compared to the results of rodent bioassays. The dose-response extrapolation process, as generally practiced, often does not present the range of equally plausible values. Procedures which acknowledge and quantitatively account for some or all of the different classes of chemical carcinogens have not been widely adopted. For example, physiologically based pharmacokinetic (PB-PK) and biologically based models need to become a part of future risk assessments. The exposure evaluation portion of risk assessments can now be significantly more valid because of better dispersion models, validated exposure parameters, and the use of computers to account for complex environmental factors. Using these procedures, industrial hygienists are now able to quantitatively estimate the risks caused not only by the inhalation of chemicals but also those caused by dermal contact and incidental ingestion. The appropriate use of risk assessment methods should allow scientists and risk managers to set scientifically valid

  15. 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.

  16. Regulatory Risk Reduction for Advanced Reactor Technologies - FY2016 Status and Work Plan Summary

    International Nuclear Information System (INIS)

    Moe, Wayne Leland

    2016-01-01

    Millions of public and private sector dollars have been invested over recent decades to realize greater efficiency, reliability, and the inherent and passive safety offered by advanced nuclear reactor technologies. However, a major challenge in experiencing those benefits resides in the existing U.S. regulatory framework. This framework governs all commercial nuclear plant construction, operations, and safety issues and is highly large light water reactor (LWR) technology centric. The framework must be modernized to effectively deal with non-LWR advanced designs if those designs are to become part of the U.S energy supply. The U.S. Department of Energy's (DOE) Advanced Reactor Technologies (ART) Regulatory Risk Reduction (RRR) initiative, managed by the Regulatory Affairs Department at the Idaho National Laboratory (INL), is establishing a capability that can systematically retire extraneous licensing risks associated with regulatory framework incompatibilities. This capability proposes to rely heavily on the perspectives of the affected regulated community (i.e., commercial advanced reactor designers/vendors and prospective owner/operators) yet remain tuned to assuring public safety and acceptability by regulators responsible for license issuance. The extent to which broad industry perspectives are being incorporated into the proposed framework makes this initiative unique and of potential benefit to all future domestic non-LWR applicants

  17. Regulatory Risk Reduction for Advanced Reactor Technologies – FY2016 Status and Work Plan Summary

    Energy Technology Data Exchange (ETDEWEB)

    Moe, Wayne Leland [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-08-01

    Millions of public and private sector dollars have been invested over recent decades to realize greater efficiency, reliability, and the inherent and passive safety offered by advanced nuclear reactor technologies. However, a major challenge in experiencing those benefits resides in the existing U.S. regulatory framework. This framework governs all commercial nuclear plant construction, operations, and safety issues and is highly large light water reactor (LWR) technology centric. The framework must be modernized to effectively deal with non-LWR advanced designs if those designs are to become part of the U.S energy supply. The U.S. Department of Energy’s (DOE) Advanced Reactor Technologies (ART) Regulatory Risk Reduction (RRR) initiative, managed by the Regulatory Affairs Department at the Idaho National Laboratory (INL), is establishing a capability that can systematically retire extraneous licensing risks associated with regulatory framework incompatibilities. This capability proposes to rely heavily on the perspectives of the affected regulated community (i.e., commercial advanced reactor designers/vendors and prospective owner/operators) yet remain tuned to assuring public safety and acceptability by regulators responsible for license issuance. The extent to which broad industry perspectives are being incorporated into the proposed framework makes this initiative unique and of potential benefit to all future domestic non-LWR applicants

  18. A comparison of integrated safety analysis and probabilistic risk assessment

    International Nuclear Information System (INIS)

    Damon, Dennis R.; Mattern, Kevin S.

    2013-01-01

    The U.S. Nuclear Regulatory Commission conducted a comparison of two standard tools for risk informing the regulatory process, namely, the Probabilistic Risk Assessment (PRA) and the Integrated Safety Analysis (ISA). PRA is a calculation of risk metrics, such as Large Early Release Frequency (LERF), and has been used to assess the safety of all commercial power reactors. ISA is an analysis required for fuel cycle facilities (FCFs) licensed to possess potentially critical quantities of special nuclear material. A PRA is usually more detailed and uses more refined models and data than an ISA, in order to obtain reasonable quantitative estimates of risk. PRA is considered fully quantitative, while most ISAs are typically only partially quantitative. The extension of PRA methodology to augment or supplant ISAs in FCFs has long been considered. However, fuel cycle facilities have a wide variety of possible accident consequences, rather than a few surrogates like LERF or core damage as used for reactors. It has been noted that a fuel cycle PRA could be used to better focus attention on the most risk-significant structures, systems, components, and operator actions. ISA and PRA both identify accident sequences; however, their treatment is quite different. ISA's identify accidents that lead to high or intermediate consequences, as defined in 10 Code of Federal Regulations (CFR) 70, and develop a set of Items Relied on For Safety (IROFS) to assure adherence to performance criteria. PRAs identify potential accident scenarios and estimate their frequency and consequences to obtain risk metrics. It is acceptable for ISAs to provide bounding evaluations of accident consequences and likelihoods in order to establish acceptable safety; but PRA applications usually require a reasonable quantitative estimate, and often obtain metrics of uncertainty. This paper provides the background, features, and methodology associated with the PRA and ISA. The differences between the

  19. Information security risk assessment, aggregation, and mitigation

    NARCIS (Netherlands)

    Lenstra, A.K.; Voss, T.; Wang, H.; Pieprzyk, J.; Varadharajan, V.

    2004-01-01

    As part of their compliance process with the Basel 2 operational risk management requirements, banks must define how they deal with information security risk management. In this paper we describe work in progress on a new quantitative model to assess and aggregate information security risks that is

  20. Bahia State, Brazil : Ariculture Sector Risk Assessment

    OpenAIRE

    Arias, Diego; Caballero, Jorge

    2015-01-01

    The present study is part of an effort by the World Bank and the State of Bahia to assess agriculture sector risks as a contribution to the strategic economic development and poverty reduction agenda of the state government. It is composed of two phases: an agricultural sector risk identification and prioritization (volume one) and a risk management strategy and action plan (volume two). T...

  1. 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

  2. Evaluation of a constipation risk assessment scale.

    Science.gov (United States)

    Zernike, W; Henderson, A

    1999-06-01

    This project was undertaken in order to evaluate the utility of a constipation risk assessment scale and the accompanying bowel management protocol. The risk assessment scale was primarily introduced to teach and guide staff in managing constipation when caring for patients. The intention of the project was to reduce the incidence of constipation in patients during their admission to hospital.

  3. Recovery in environmental risk assessment at EFSA

    NARCIS (Netherlands)

    Brock, T.C.M.

    2016-01-01

    EFSA performs environmental risk assessments (ERAs) for single potential stressors such as plant protection products, genetically modified organisms and feed additives and for invasive alien species that are harmful for plant health. In this risk assessment domain, the EFSA Scientific Committee

  4. Explaining probalistic risk assessment in common language

    International Nuclear Information System (INIS)

    Wong, J.W.

    1994-01-01

    Probabilistic human health risk assessment is explained in ordinary language using a hypothetical example and the ingestion equation from EPA's Risk Assessment Guidance for Superfund. A section on understanding probabilities and probability distributions used in a Monte Carlo simulation is included as well as an appendix showing the computer run and the technical assumptions behind it

  5. 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

  6. Common and rare variants in the exons and regulatory regions of osteoporosis-related genes improve osteoporotic fracture risk prediction.

    Science.gov (United States)

    Lee, Seung Hun; Kang, Moo Il; Ahn, Seong Hee; Lim, Kyeong-Hye; Lee, Gun Eui; Shin, Eun-Soon; Lee, Jong-Eun; Kim, Beom-Jun; Cho, Eun-Hee; Kim, Sang-Wook; Kim, Tae-Ho; Kim, Hyun-Ju; Yoon, Kun-Ho; Lee, Won Chul; Kim, Ghi Su; Koh, Jung-Min; Kim, Shin-Yoon

    2014-11-01

    Osteoporotic fracture risk is highly heritable, but genome-wide association studies have explained only a small proportion of the heritability to date. Genetic data may improve prediction of fracture risk in osteopenic subjects and assist early intervention and management. To detect common and rare variants in coding and regulatory regions related to osteoporosis-related traits, and to investigate whether genetic profiling improves the prediction of fracture risk. This cross-sectional study was conducted in three clinical units in Korea. Postmenopausal women with extreme phenotypes (n = 982) were used for the discovery set, and 3895 participants were used for the replication set. We performed targeted resequencing of 198 genes. Genetic risk scores from common variants (GRS-C) and from common and rare variants (GRS-T) were calculated. Nineteen common variants in 17 genes (of the discovered 34 functional variants in 26 genes) and 31 rare variants in five genes (of the discovered 87 functional variants in 15 genes) were associated with one or more osteoporosis-related traits. Accuracy of fracture risk classification was improved in the osteopenic patients by adding GRS-C to fracture risk assessment models (6.8%; P risk in an osteopenic individual.

  7. Review of probabilistic safety assessments by regulatory bodies

    International Nuclear Information System (INIS)

    2002-01-01

    This report provides guidance to assist regulatory bodies in carrying out reviews of the PSAs produced by utilities. In following this guidance, it is important that the regulatory body is able to satisfy itself that the PSA has been carried out to an acceptable standard and that it can be used for its intended applications. The review process becomes an important phase in determining the acceptability of the PSA since this provides a degree of assurance of the PSA scope, validity and limitations, as well as a better understanding of plants themselves. This report is also intended to assist technical experts managing or performing PSA reviews. A particular aim is to promote a standardized framework, terminology and form of documentation for the results of PSA reviews. The information presented in this report supports IAEA Safety Guide No. GS-G-1.2. Recommendations on the scope and methods to be used by the utility in the preparation of a PSA study is provided in IAEA Safety Guide No. NSG- 1.2. Information on these Safety Guides and other IAEA safety standards for nuclear power plants can be found on the following Internet site: http://www.iaea.org/ns/coordinet. The scope of this report covers the review of Level 1, 2 and 3 PSAs for event sequences occurring in all modes of plant operation (including full power, low power and shutdown). Where the scope of the analysis is narrower than this, a subset of the guidance can be identified and used. Information is provided on carrying out the review of a PSA throughout the PSA production process, i.e. from the initial decision to carry out the PSA through to the completion of the study and the production of the final PSA report. However, the same procedure can be applied to a completed PSA or to one already in progress. As a result of the performance of a PSA, changes to the design or operation of the plant are often identified that would increase the level of safety. This might include the addition of further safety

  8. 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

  9. 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.

  10. 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

  11. Bt rice in China - focusing the nontarget risk assessment.

    Science.gov (United States)

    Li, Yunhe; Zhang, Qingling; Liu, Qingsong; Meissle, Michael; Yang, Yan; Wang, Yanan; Hua, Hongxia; Chen, Xiuping; Peng, Yufa; Romeis, Jörg

    2017-10-01

    Bt rice can control yield losses caused by lepidopteran pests but may also harm nontarget species and reduce important ecosystem services. A comprehensive data set on herbivores, natural enemies, and their interactions in Chinese rice fields was compiled. This together with an analysis of the Cry protein content in arthropods collected from Bt rice in China indicated which nontarget species are most exposed to the insecticidal protein and should be the focus of regulatory risk assessment. © 2017 The Authors. Plant Biotechnology Journal published by Society for Experimental Biology and The Association of Applied Biologists and John Wiley & Sons Ltd.

  12. Percutaneous penetration studies for risk assessment

    DEFF Research Database (Denmark)

    Sartorelli, Vittorio; Andersen, Helle Raun; Angerer, Jürgen

    2000-01-01

    . In order to predict the systemic risk of dermally absorbed chemicals and to enable agencies to set safety standards, data is needed on the rates of percutaneous penetration of important chemicals. Standardization of in vitro tests and comparison of their results with the in vivo data could produce...... internationally accepted penetration rates and/or absorption percentages very useful for regulatory toxicology. The work of the Percutaneous Penetration Subgroup of EC Dermal Exposure Network has been focussed on the standardization and validation of in vitro experiments, necessary to obtain internationally...... accepted penetration rates for regulatory purposes. The members of the Subgroup analyzed the guidelines on percutaneous penetration in vitro studies presented by various organizations and suggested a standardization of in vitro models for percutaneous penetration taking into account their individual...

  13. 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.

  14. Assessment of safety culture: Changing regulatory approach in Hungary

    International Nuclear Information System (INIS)

    Ronaky, Jozsef; Toth, Andras

    2002-01-01

    Hungarian Atomic Energy Authority (HAEA) is changing its inspection practice and assessment methods of safety performance and safety culture in operating nuclear facilities. The new approach emphasises integrated team inspection of safety cornerstones and systematic assessment of safety performance of operators. (author)

  15. Regulatory Guide on Conducting a Security Vulnerability Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Ek, David R. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2016-01-01

    This document will provide guidelines on conducting a security vulnerability assessment at a facility regulated by the Radiation Protection Centre. The guidelines provide a performance approach assess security effectiveness. The guidelines provide guidance for a review following the objectives outlined in IAEA NSS#11 for Category 1, 2, & 3 sources.

  16. The Role of Regulatory Pressure in Banks’ Capital and Risk Decisions

    Directory of Open Access Journals (Sweden)

    Alessandra Tanda

    2015-06-01

    Full Text Available Capital regulation represents the core of prudential regulation in banking. Despite the aim of the regulators to have a safer and more robust banking industry, the effects of capital regulation on banks’ capital and risk decisions appear ambiguous. The paper analyses the relationship between capital and risk changes and the impact of regulatory pressure for a sample of European banks during the period 2006–2010, which encompasses the start of the latest financial crisis. Results highlight that banks tend to adopt a different behaviour depending on the capital ratio considered, supporting the so-called ‘gamble for resurrection’ hypothesis. Evidence supports the rethinking of the regulatory framework, especially with reference to higher and stricter capital requirements.

  17. Techno-economic viability assessments of greener propulsion technology under potential environmental regulatory policy scenarios

    International Nuclear Information System (INIS)

    Nalianda, D.K.; Kyprianidis, K.G.; Sethi, V.; Singh, R.

    2015-01-01

    Highlights: • An advanced method is presented for techno-economic assessment under potential environmental regulatory policy scenarios. • The viability of the contra-rotating open rotor concept is investigated under various environmental policies. • CO_2 taxation is needed to drive the aerospace industry towards greener solutions. - Abstract: Sustainability of the aviation industry, as any other industry, depends on the elasticity of demand for the product and profitability through minimising operating costs. Of paramount importance is assessing and understanding the interdependency and effects of environmentally optimised solutions and emission mitigation policies. This paper describes the development and application of assessment methodologies to better understand the effects of environmental taxation/energy policies aimed at environmental pollution reduction and the future potential economic impact they may have on the adaptation of “greener” novel technologies. These studies are undertaken using a Techno-economic Environmental Risk Assessment approach. The methodology demonstrated allows the assessment of the economic viability of new technologies compared to conventional technologies, for various CO_2 emission taxation and fuel price scenarios. It considers relative increases in acquisition price and maintenance costs. A study undertaken as a ‘proof of concept’ compares a Counter Rotating Open Rotor aircraft with a conventional aircraft for short range operations. It indicates that at current fuel price and with no carbon taxation, a highly fuel efficient technology, such as the one considered, could be rendered economically unviable. The work goes on to demonstrate that in comparison to the conventional aircraft, any economic benefits that may be accrued from improvement in fuel consumption through such a technology, may well be negated through increases in acquisition price and maintenance costs. The work further demonstrates that if policy

  18. 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

  19. 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)

  20. 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.

  1. Modeling disease risk through analysis of physical interactions between genetic variants within chromatin regulatory circuitry.

    Science.gov (United States)

    Corradin, Olivia; Cohen, Andrea J; Luppino, Jennifer M; Bayles, Ian M; Schumacher, Fredrick R; Scacheri, Peter C

    2016-11-01

    SNPs associated with disease susceptibility often reside in enhancer clusters, or super-enhancers. Constituents of these enhancer clusters cooperate to regulate target genes and often extend beyond the linkage disequilibrium (LD) blocks containing risk SNPs identified in genome-wide association studies (GWAS). We identified 'outside variants', defined as SNPs in weak LD with GWAS risk SNPs that physically interact with risk SNPs as part of a target gene's regulatory circuitry. These outside variants further explain variation in target gene expression beyond that explained by GWAS-associated SNPs. Additionally, the clinical risk associated with GWAS SNPs is considerably modified by the genotype of outside variants. Collectively, these findings suggest a potential model in which outside variants and GWAS SNPs that physically interact in 3D chromatin collude to influence target transcript levels as well as clinical risk. This model offers an additional hypothesis for the source of missing heritability for complex traits.

  2. 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)

  3. RISK MANAGEMENT: AN INTEGRATED APPROACH TO RISK MANAGEMENT AND ASSESSMENT

    OpenAIRE

    Szabo Alina

    2012-01-01

    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 ...

  4. Approaches and methods of risk assessment

    International Nuclear Information System (INIS)

    Rowe, W.D.

    1983-01-01

    The classification system of risk assessment includes the categories: 1) risk comparisons, 2) cost-effectiveness of risk reduction, 3) balancing of costs, risks and benefits against one another, 4. Metasystems. An overview of methods and systems reveals that no single method can be applied to all cases and situations. The visibility of the process and the absolute consideration of all aspects of judging are, however, of first and fore most importance. (DG) [de

  5. Regulatory assessment of safety culture in nuclear organisations - current trends and challenges

    International Nuclear Information System (INIS)

    Tronea, M.

    2010-01-01

    The paper gives an overview of the current practices in the area of regulatory assessment of safety culture in nuclear organisations and of the associated challenges. While the assessment and inspection procedures currently in use by regulatory authorities worldwide are directed primarily at verifying compliance with the licensing basis, there is a recognised need for a more systematic approach to the identification, collection and review of data relevant to the safety culture in licensees' organisations. The paper presents a proposal for using the existing regulatory inspection practices for gathering information relevant to safety culture and for assessing it in an integrated manner. The proposal is based on the latest requirements and guidance issued by the International Atomic Energy Agency (IAEA) on management systems for nuclear facilities and activities, particularly as regards the attributes needed for a strong nuclear safety culture. (author)

  6. Risk assessment: A regional approach

    Energy Technology Data Exchange (ETDEWEB)

    Palecek, M [Occupational Safety Research Institute, Prague (Czech Republic)

    1992-07-01

    An assessment of the region of North Bohemia which suffered from forty years socialist economy and heavy emissions from German and Polish factories and power stations is presented. The case strongly underlines the need for regional and international cooperation both in the assessment of hazards and finding solution to public health and environmental problems.

  7. Risk assessment: A regional approach

    International Nuclear Information System (INIS)

    Palecek, M.

    1992-01-01

    An assessment of the region of North Bohemia which suffered from forty years socialist economy and heavy emissions from German and Polish factories and power stations is presented. The case strongly underlines the need for regional and international cooperation both in the assessment of hazards and finding solution to public health and environmental problems

  8. Using a risk assessment protocol to develop soil cleanup criteria for petroleum contaminated sites

    International Nuclear Information System (INIS)

    Asante-Duah, D.K.

    1991-01-01

    Petroleum contaminated site may prose significant risks to the public because of potential health and environmental effects, and to Potentially Responsible Parties (PRPs) because of financial liabilities that could result from such effects. The effective management of petroleum contaminated sites has therefore become an important environmental priority and will be a growing challenge for years to come. It has also become evident that the proper management of such sites poses great challenges. Risk assessment seems to be one of the fastest evolving tools for developing appropriate management decisions, including those relating to the levels of cleanup warranty under specific scenarios. This paper reports that the U.S. Environmental Protection Agency (U.S. EPA) recognizes the use of risk assessment to facilitate decisions on whether or not remedial actions are needed to abate site-related risks, and also in the enforcement of regulatory standards. Risk assessment techniques have been used in various regulatory programs employed by federal, state, and local agencies

  9. Multi-Hazard Advanced Seismic Probabilistic Risk Assessment Tools and Applications

    International Nuclear Information System (INIS)

    Coleman, Justin L.; Bolisetti, Chandu; Veeraraghavan, Swetha; Parisi, Carlo; Prescott, Steven R.; Gupta, Abhinav

    2016-01-01

    Design of nuclear power plant (NPP) facilities to resist natural hazards has been a part of the regulatory process from the beginning of the NPP industry in the United States (US), but has evolved substantially over time. The original set of approaches and methods was entirely deterministic in nature and focused on a traditional engineering margins-based approach. However, over time probabilistic and risk-informed approaches were also developed and implemented in US Nuclear Regulatory Commission (NRC) guidance and regulation. A defense-in-depth framework has also been incorporated into US regulatory guidance over time. As a result, today, the US regulatory framework incorporates deterministic and probabilistic approaches for a range of different applications and for a range of natural hazard considerations. This framework will continue to evolve as a result of improved knowledge and newly identified regulatory needs and objectives, most notably in response to the NRC activities developed in response to the 2011 Fukushima accident in Japan. Although the US regulatory framework has continued to evolve over time, the tools, methods and data available to the US nuclear industry to meet the changing requirements have not kept pace. Notably, there is significant room for improvement in the tools and methods available for external event probabilistic risk assessment (PRA), which is the principal assessment approach used in risk-informed regulations and risk-informed decision-making applied to natural hazard assessment and design. This is particularly true if PRA is applied to natural hazards other than seismic loading. Development of a new set of tools and methods that incorporate current knowledge, modern best practice, and state-of-the-art computational resources would lead to more reliable assessment of facility risk and risk insights (e.g., the SSCs and accident sequences that are most risk-significant), with less uncertainty and reduced conservatisms.

  10. Multi-Hazard Advanced Seismic Probabilistic Risk Assessment Tools and Applications

    Energy Technology Data Exchange (ETDEWEB)

    Coleman, Justin L. [Idaho National Lab. (INL), Idaho Falls, ID (United States); Bolisetti, Chandu [Idaho National Lab. (INL), Idaho Falls, ID (United States); Veeraraghavan, Swetha [Idaho National Lab. (INL), Idaho Falls, ID (United States); Parisi, Carlo [Idaho National Lab. (INL), Idaho Falls, ID (United States); Prescott, Steven R. [Idaho National Lab. (INL), Idaho Falls, ID (United States); Gupta, Abhinav [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-09-01

    Design of nuclear power plant (NPP) facilities to resist natural hazards has been a part of the regulatory process from the beginning of the NPP industry in the United States (US), but has evolved substantially over time. The original set of approaches and methods was entirely deterministic in nature and focused on a traditional engineering margins-based approach. However, over time probabilistic and risk-informed approaches were also developed and implemented in US Nuclear Regulatory Commission (NRC) guidance and regulation. A defense-in-depth framework has also been incorporated into US regulatory guidance over time. As a result, today, the US regulatory framework incorporates deterministic and probabilistic approaches for a range of different applications and for a range of natural hazard considerations. This framework will continue to evolve as a result of improved knowledge and newly identified regulatory needs and objectives, most notably in response to the NRC activities developed in response to the 2011 Fukushima accident in Japan. Although the US regulatory framework has continued to evolve over time, the tools, methods and data available to the US nuclear industry to meet the changing requirements have not kept pace. Notably, there is significant room for improvement in the tools and methods available for external event probabilistic risk assessment (PRA), which is the principal assessment approach used in risk-informed regulations and risk-informed decision-making applied to natural hazard assessment and design. This is particularly true if PRA is applied to natural hazards other than seismic loading. Development of a new set of tools and methods that incorporate current knowledge, modern best practice, and state-of-the-art computational resources would lead to more reliable assessment of facility risk and risk insights (e.g., the SSCs and accident sequences that are most risk-significant), with less uncertainty and reduced conservatisms.

  11. Hazard classification or risk assessment

    DEFF Research Database (Denmark)

    Hass, Ulla

    2013-01-01

    The EU classification of substances for e.g. reproductive toxicants is hazard based and does not to address the risk suchsubstances may pose through normal, or extreme, use. Such hazard classification complies with the consumer's right to know. It is also an incentive to careful use and storage...

  12. [Regulatory radiation risks' for the population and natural objects within the Semipalatinsk Test Site].

    Science.gov (United States)

    Spiridonov, S I; Teten'kin, V L; Mukusheva, M K; Solomatin, V M

    2008-01-01

    Advisability of using risks as indicators for estimating radiation impacts on environmental objects and humans has been jusified. Results are presented from identification of dose burdens distribution to various cohorts of the population living within the Semipalatinsk Test Site (STS) and consuming contaminated farm products. Parameters of dose burden distributions are estimated for areas of livestock grazing and the most contaminated sectors within these areas. Dose distributions to meadow plants for the above areas have been found. Regulatory radiation risks for the STS population and meadow ecosystem components have been calculated. Based on the parameters estimated, levels of radiation exposure of the population and herbaceous plants have been compared.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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...

  18. 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...

  19. Assessing and managing multiple risks in a changing world-The Roskilde recommendations.

    Science.gov (United States)

    Selck, Henriette; Adamsen, Peter B; Backhaus, Thomas; Banta, Gary T; Bruce, Peter K H; Burton, G Allen; Butts, Michael B; Boegh, Eva; Clague, John J; Dinh, Khuong V; Doorn, Neelke; Gunnarsson, Jonas S; Hauggaard-Nielsen, Henrik; Hazlerigg, Charles; Hunka, Agnieszka D; Jensen, John; Lin, Yan; Loureiro, Susana; Miraglia, Simona; Munns, Wayne R; Nadim, Farrokh; Palmqvist, Annemette; Rämö, Robert A; Seaby, Lauren P; Syberg, Kristian; Tangaa, Stine R; Thit, Amalie; Windfeld, Ronja; Zalewski, Maciej; Chapman, Peter M

    2017-01-01

    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 context for assessments in human-modified systems; 8) assess risks and benefits to humans and the ecosystem and consider unintended consequences of management actions; 9) avoid excessive conservatism or possible underprotection resulting from sole reliance on binary, numerical benchmarks; and 10) develop adaptive risk-management and regulatory goals based on ranges of uncertainty. Environ Toxicol Chem 2017;36:7-16. © 2016 SETAC. © 2016 SETAC.

  20. On-farm welfare assessment for regulatory purposes: Issues and possible solutions

    DEFF Research Database (Denmark)

    Sørensen, Jan Tind; Fraser, David

    2010-01-01

    On-farm welfare assessment has been used mainly for non-regulatory purposes such as producer education or to qualify for voluntary welfare-assurance programs. The application of on-farm assessments in regulatory programs would require four issues to be addressed: (1) selecting criteria...... solution. Issues 3 and 4 (fairness and efficiency) require scientific data on the precision, repeatability, independence, and cost-of-scoring for the various candidate criteria. A process is also needed to bring the scientific information into the deliberative process, either as formal recommendations and...