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. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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...

  9. 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.

  10. 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

  11. 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)

  12. 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

  13. 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.

  14. 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.

  15. 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

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. 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.

  1. 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...

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  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.; 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

  8. 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

  9. 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...

  10. 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

  11. 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

  12. 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).

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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)

  6. 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 ...

  7. 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

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. 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

  16. 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.

  17. 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

  18. 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...

  19. 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

  20. 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

  1. 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.

  2. 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...

  3. 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.

  4. 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'.

  5. 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)

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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)

  16. 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

  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. 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

  19. 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.

  20. 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)

  1. 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

  2. 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.

  3. 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...

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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)

  11. 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.

  12. 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.

  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. 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

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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

  3. 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...

  4. 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.

  5. 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.

  6. Transparency in risk assessments - Presenting the 'expectation value' of post-closure risks from radioactive waste repositories

    International Nuclear Information System (INIS)

    Wilmot, R.D.; Galson, D.A.; Pollard, S.J.T.; Smith, R.E.; Yearsley, R.A.

    1999-01-01

    The Environment Agency of England and Wales (the 'Agency') has an extremely broad regulatory remit covering aspects of flood defence, integrated pollution control, water quality, waste management, abstraction control, navigation, fisheries, conservation and recreation. Risk assessment, as a regulatory and management tool plays an essential role in the targeting and prioritisation of this activity, as well as in aiding site-specific decisions on authorisations for abstraction, discharge and/or disposal. From a regulatory perspective, the majority of the Agency's risk assessment activity is focused on critically reviewing risk assessments submitted to the Agency in support of requests for authorisation. With increasing calls for openness in all areas of regulatory decision-making, new demands are being placed on risk assessments with a view to allowing far more transparency and traceability of 'process' and 'content' than has historically been the case. The Agency is responsible for the licensing of radioactive waste disposal facilities in England and Wales. It has issued guidance on what is expected of an application for an authorisation to dispose of low and intermediate level radioactive waste to land - the 'Guidance on Requirements for Authorisation' (the 'GRA'). The GRA includes a risk target and places a strong emphasis on confidence-building during the preparation and assessment of post-closure safety cases for such facilities. In this paper we discuss a recent study commissioned by the Agency which has examined the use of expectation value of risk in assessments and considered ways of improving transparency. The study has concluded that the expectation value is an appropriate measure of risk for comparison with a single-value criterion, provided that the scope of the assessment does not involve undue speculation regarding the FEPs (Features, Events and Processes) to be included. Low probability or speculative events and processes for which no data can be

  7. 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

  8. 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

  9. Modern Risk Assessment for Nuclear Power Plants High-Voltage Substations

    International Nuclear Information System (INIS)

    Ioan, S.; Hurdubetiu, S.; Marza, F.; Mocanu, M.; Stefan, M.

    2002-01-01

    The paper describes a first Romanian attempt to set up the methodology for risk assessment and control within high-voltage substations, developed for the Nuclear power plant in Cernavoda (Romania). Considering the present risk assessment methods the MENER Project will develop a new methodology, in line with the European Community legislation and with the specific regional needs. In order to correctly shape the necessary resources required by a risk analysis a large size enterprise (a nuclear power plant) is selected and the following five indicators will be estimated: the economic profit, environmental risk, indirect (future) risk, technology improvement and physic and psychological risk. The results are expected to considerably facilitate risk assessment, by: evaluating project acceptability; evaluating equipment compliance to regulatory criteria; estimating excluding clearances; easing the design of emergency programmes; identifying the equipment use restrictions; identifying the risk sources; selecting the maintenance and risk reduction methods; testing the procedures leading to future regulatory norms; suitability of the risk management system modification. The immediate result of employing modern risk assessment methods could be the decrease by one third of the expenses required by environment protection, staff health and labor safety and quality management. (author)

  10. 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.

  11. 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

  12. Environmental risk assessment of pesticides: state of the art and prospective improvement from science.

    Science.gov (United States)

    Boivin, Arnaud; Poulsen, Véronique

    2017-03-01

    Pesticide risk assessment in the European regulatory framework is mandatory performed for active substances (pesticides) and the plant protection products they are constituents of. The aim is to guarantee that safe use can be achieved for the intended use of the product. This paper provides a feedback on the regulatory environmental risk assessment performed for pesticide registration at the EU and member state levels. The different steps of pesticide registration are addressed considering both exposure and hazard. In this paper, we focus on the environmental fate and behaviour in surface water together with the aquatic ecotoxicity of the substances to illustrate pesticide regulatory risk assessment performed for aquatic organisms. Current methodologies are presented along with highlights on potential improvements. For instance, as regards exposure aspects, moving from field based to landscape risk assessments is promising. Regarding ecotoxicology, ecological models may be valuable tools when applied to chemical risk assessment. In addition, interest and further developments to better take into account mitigation measures in risk assessment and management are also presented.

  13. 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)

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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

  19. 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.

  20. 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

  1. 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.

  2. 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

  3. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. Risk assessment of nanomaterials and nanoproducts – adaptation of traditional approaches

    International Nuclear Information System (INIS)

    Jahnel, J; Fleischer, T; Seitz, S B

    2013-01-01

    Different approaches have been adopted for assessing the potential risks of conventional chemicals and products for human health. In general, the traditional paradigm is a toxicological-driven chemical-by-chemical approach, focusing on single toxic endpoints. Scope and responsibilities for the development and implementation of a risk assessment concept vary across sectors and areas and depends on the specific regulatory environment and the specific protection goals. Thus, risk assessment implication is a complex task based not only on science based knowledge but also on the regulatory context involving different parties and stakeholders. Questions have been raised whether standard paradigms for conventional chemicals would be applicable and adequate for new materials, products and applications of nanotechnology. Most scientists and stakeholders assume that current standard methods are in principle applicable to nanomaterials, but specific aspects require further development. The paper presents additional technical improvements like the complementary use of the life cycle methodology and the support of risk-based classification systems. But also aspects improving the utility of risk assessment with regard to societal impacts on risk governance are discussed.

  9. 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

  10. Relevance and reliability of experimental data in human health risk assessment of pesticides.

    Science.gov (United States)

    Kaltenhäuser, Johanna; Kneuer, Carsten; Marx-Stoelting, Philip; Niemann, Lars; Schubert, Jens; Stein, Bernd; Solecki, Roland

    2017-08-01

    Evaluation of data relevance, reliability and contribution to uncertainty is crucial in regulatory health risk assessment if robust conclusions are to be drawn. Whether a specific study is used as key study, as additional information or not accepted depends in part on the criteria according to which its relevance and reliability are judged. In addition to GLP-compliant regulatory studies following OECD Test Guidelines, data from peer-reviewed scientific literature have to be evaluated in regulatory risk assessment of pesticide active substances. Publications should be taken into account if they are of acceptable relevance and reliability. Their contribution to the overall weight of evidence is influenced by factors including test organism, study design and statistical methods, as well as test item identification, documentation and reporting of results. Various reports make recommendations for improving the quality of risk assessments and different criteria catalogues have been published to support evaluation of data relevance and reliability. Their intention was to guide transparent decision making on the integration of the respective information into the regulatory process. This article describes an approach to assess the relevance and reliability of experimental data from guideline-compliant studies as well as from non-guideline studies published in the scientific literature in the specific context of uncertainty and risk assessment of pesticides. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  11. 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.

  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. 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

  14. 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

  15. 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.

  16. Framework for integrating human and animal data in chemical risk assessment.

    Science.gov (United States)

    Lavelle, Karlene S; Robert Schnatter, A; Travis, Kim Z; Swaen, Gerard M H; Pallapies, Dirk; Money, Chris; Priem, Peter; Vrijhof, Henk

    2012-03-01

    Although regulatory agencies formally encourage the integration of all available data in chemical risk assessment, consistent implementation of this practice has been constrained by the lack of a clear, systematic method for doing so. In this paper, we describe a methodology for evaluating, classifying and integrating human and animal data into the risk assessment process that incorporates: (1) a balanced appraisal of human and animal data, (2) relevance to different stages of the risk assessment process, and (3) accommodation for different data quality requirements. The proposed framework offers a flexible, step-wise approach for determining which set of available data best support the chemical risk assessment that involves the rating and relative ranking of human and animal data quality. The evaluation of human data incorporates seven data quality elements, nature and specificity of the lead effect; evaluation of animal data incorporates data quality and relevance to humans. Results of simulations with selected chemicals previously evaluated in a formal risk assessment generally agreed with existing regulatory guidance. Application of the proposed framework across a wider range of chemical agents will improve transparency of the risk assessment process and validity of results, while informing continuous refinements to this evolving methodology. Copyright © 2012 Elsevier Inc. All rights reserved.

  17. 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.

  18. 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.

  19. 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.

  20. 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...

  1. 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.

  2. Mechanistic effect modeling for ecological risk assessment: where to go from here?

    Science.gov (United States)

    Grimm, Volker; Martin, Benjamin T

    2013-07-01

    Mechanistic effect models (MEMs) consider the mechanisms of how chemicals affect individuals and ecological systems such as populations and communities. There is an increasing awareness that MEMs have high potential to make risk assessment of chemicals more ecologically relevant than current standard practice. Here we discuss what kinds of MEMs are needed to improve scientific and regulatory aspects of risk assessment. To make valid predictions for a wide range of environmental conditions, MEMs need to include a sufficient amount of emergence, for example, population dynamics emerging from what individual organisms do. We present 1 example where the life cycle of individuals is described using Dynamic Energy Budget theory. The resulting individual-based population model is thus parameterized at the individual level but correctly predicts multiple patterns at the population level. This is the case for both control and treated populations. We conclude that the state-of-the-art in mechanistic effect modeling has reached a level where MEMs are robust and predictive enough to be used in regulatory risk assessment. Mechanistic effect models will thus be used to advance the scientific basis of current standard practice and will, if their development follows Good Modeling Practice, be included in a standardized way in future regulatory risk assessments. Copyright © 2013 SETAC.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.)

  8. 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.

  9. 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.

  10. 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.

  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. 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.

  13. 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.

  14. 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...

  15. 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.

  16. 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.

  17. 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

  18. Coordinating ecological risk assessment with natural resource damage assessment: A panel discussion.

    Science.gov (United States)

    Sanders, Brenda; Ammann, Mike; Hoff, Rebecca; Huston, Mark; Jenkins, Kenneth; Palagyi, Tony; Pelto, Karen; Rettig, Todd; Wagner, Anne

    2016-10-01

    Contaminated sites in the United States undergo remediation and restoration through regulatory programs that lead the 2 processes through independent but often parallel pathways with different objectives. The objective of remediation is to reduce risk to human health and the environment, whereas that of restoration is to restore injured resources and compensate the public for lost use of the services that natural resources provide. More complex sites, such as those associated with large river systems and urban waterways, have resulted in increasingly larger-scale ecological risk assessments (ERAs) and natural resource damage assessments (NRDAs) that take many years and involve diverse practitioners including scientists, economists, and engineers. Substantial levels of effort are now frequently required, creating a need for more efficient and cost-effective approaches to data collection, analyses, and assessments. Because there are commonalities in the data needs between ERAs and NRDAs, coordination of the design and implementation of site-specific studies that meet the needs of both programs could result in increased efficiency and lower costs. The Association for Environmental Health and Sciences Foundation convened a panel of environmental practitioners from industry, consulting, and regulatory bodies to examine the benefits and challenges associated with coordinating ERA and NRDA activities in the context of a broad range of regulatory programs. This brief communication presents the opinions and conclusions of the panelists on these issues and reports 2 case studies for which coordinated ERA and NRDA activities produced a positive outcome. Integr Environ Assess Manag 2016;12:616-621. © 2015 SETAC. © 2015 SETAC.

  19. 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

  20. Scientific underpinnings of biotechnology regulatory frameworks.

    Science.gov (United States)

    Gleim, Savannah; Smyth, Stuart J

    2018-05-25

    Part of what is presently missing at domestic regulatory levels (and that is important at the international level as well) is a detailed understanding of what the rules of, and for, regulation should be, who the actors, stakeholders and major decision makers are and finally, how to get agreement about the rules. Greater insights into the system of rules that underpin regulatory frameworks for agri-food and biotechnology products in genetically modified (GM) crop- adopting nations will provide value by clarifying the evidence used to commercialize these technologies. This article examines the public documents available from Canada, the United States, the European Union and the Organisation for Economic Cooperation and Development regarding the development of regulatory risk assessment frameworks for products of biotechnology to determine what science grounds these frameworks. The documentation used to provide the initial structure to the existing regulatory frameworks identifies the linkages, connections and relationships that exist between science, risk assessment and regulatory policy. The relationship between risk and regulation has never been more critical to the commercialization of innovative agricultural products. Documenting the role of science-based risk assessment in regulations and how this has changed over the 20 years of experience in regulating GM crops will identify changes in the risk/regulation relationship. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

  1. 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

  2. Using Discrete Choice Experiments to Inform the Benefit-Risk Assessment of Medicines: Are We Ready Yet?

    Science.gov (United States)

    Vass, Caroline M; Payne, Katherine

    2017-09-01

    There is emerging interest in the use of discrete choice experiments as a means of quantifying the perceived balance between benefits and risks (quantitative benefit-risk assessment) of new healthcare interventions, such as medicines, under assessment by regulatory agencies. For stated preference data on benefit-risk assessment to be used in regulatory decision making, the methods to generate these data must be valid, reliable and capable of producing meaningful estimates understood by decision makers. Some reporting guidelines exist for discrete choice experiments, and for related methods such as conjoint analysis. However, existing guidelines focus on reporting standards, are general in focus and do not consider the requirements for using discrete choice experiments specifically for quantifying benefit-risk assessments in the context of regulatory decision making. This opinion piece outlines the current state of play in using discrete choice experiments for benefit-risk assessment and proposes key areas needing to be addressed to demonstrate that discrete choice experiments are an appropriate and valid stated preference elicitation method in this context. Methodological research is required to establish: how robust the results of discrete choice experiments are to formats and methods of risk communication; how information in the discrete choice experiment can be presented effectually to respondents; whose preferences should be elicited; the correct underlying utility function and analytical model; the impact of heterogeneity in preferences; and the generalisability of the results. We believe these methodological issues should be addressed, alongside developing a 'reference case', before agencies can safely and confidently use discrete choice experiments for quantitative benefit-risk assessment in the context of regulatory decision making for new medicines and healthcare products.

  3. 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.

  4. Risk assessment in long-term storage of spent nuclear fuel

    International Nuclear Information System (INIS)

    Ahn, T.; Guttmann, J.; Mohseni, A.

    2013-01-01

    This paper presents probabilistic risk-informed approaches that the Nuclear Regulatory Commission (NRC) staff is planning to consider in preparing regulatory bases for long-term storage of spent nuclear fuel (SNF) for up to 300 years. Due to uncertainties associated with long-term SNF storage, the NRC is considering a probabilistic risk-informed approach as well as a deterministic design-based approach. The uncertainties considered here are primarily associated with materials aging of the canister and SNF in the cask system during long-term storage of SNF. This paper discusses some potential risk contributors involved in long-term SNF storage. Methods of performance evaluation are presented that assess the various types of risks involved. They include deterministic evaluation, probabilistic evaluation, and consequence assessment under normal conditions and the conditions of accidents and natural hazards. Some potentially important technical issues resulting from the consideration of a probabilistic risk-informed evaluation of the cask system performance are discussed for the canister and SNF integrity. These issues are also discussed in comparison with the deterministic approach for comparison purposes, as appropriate. Probabilistic risk-informed methods can provide insights that deterministic methods may not capture. Two specific examples include stress corrosion cracking of the canister and hydrogen-induced cladding failure. These examples are discussed in more detail, in terms of their effects on radionuclide release and nuclear subcriticality associated with the failure. The plan to consider the probabilistic risk-informed approaches is anticipated to provide helpful regulatory insights for long-term storage of SNF that provide reasonable assurance for public health and safety. (authors)

  5. 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...

  6. Utilizing toxicogenomic data to understand chemical mechanism of action in risk assessment

    Energy Technology Data Exchange (ETDEWEB)

    Wilson, Vickie S., E-mail: wilson.vickie@epa.gov [National Health and Environmental Effects Research Laboratory, Office of Research and Development, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711 (United States); Keshava, Nagalakshmi [National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460 (United States); Hester, Susan [National Health and Environmental Effects Research Laboratory, Office of Research and Development, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711 (United States); Segal, Deborah; Chiu, Weihsueh [National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460 (United States); Thompson, Chad M. [ToxStrategies, Inc., 23501 Cinco Ranch Blvd., Suite G265, Katy, TX 77494 (United States); Euling, Susan Y. [National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460 (United States)

    2013-09-15

    The predominant role of toxicogenomic data in risk assessment, thus far, has been one of augmentation of more traditional in vitro and in vivo toxicology data. This article focuses on the current available examples of instances where toxicogenomic data has been evaluated in human health risk assessment (e.g., acetochlor and arsenicals) which have been limited to the application of toxicogenomic data to inform mechanism of action. This article reviews the regulatory policy backdrop and highlights important efforts to ultimately achieve regulatory acceptance. A number of research efforts on specific chemicals that were designed for risk assessment purposes have employed mechanism or mode of action hypothesis testing and generating strategies. The strides made by large scale efforts to utilize toxicogenomic data in screening, testing, and risk assessment are also discussed. These efforts include both the refinement of methodologies for performing toxicogenomics studies and analysis of the resultant data sets. The current issues limiting the application of toxicogenomics to define mode or mechanism of action in risk assessment are discussed together with interrelated research needs. In summary, as chemical risk assessment moves away from a single mechanism of action approach toward a toxicity pathway-based paradigm, we envision that toxicogenomic data from multiple technologies (e.g., proteomics, metabolomics, transcriptomics, supportive RT-PCR studies) can be used in conjunction with one another to understand the complexities of multiple, and possibly interacting, pathways affected by chemicals which will impact human health risk assessment.

  7. Utilizing toxicogenomic data to understand chemical mechanism of action in risk assessment

    International Nuclear Information System (INIS)

    Wilson, Vickie S.; Keshava, Nagalakshmi; Hester, Susan; Segal, Deborah; Chiu, Weihsueh; Thompson, Chad M.; Euling, Susan Y.

    2013-01-01

    The predominant role of toxicogenomic data in risk assessment, thus far, has been one of augmentation of more traditional in vitro and in vivo toxicology data. This article focuses on the current available examples of instances where toxicogenomic data has been evaluated in human health risk assessment (e.g., acetochlor and arsenicals) which have been limited to the application of toxicogenomic data to inform mechanism of action. This article reviews the regulatory policy backdrop and highlights important efforts to ultimately achieve regulatory acceptance. A number of research efforts on specific chemicals that were designed for risk assessment purposes have employed mechanism or mode of action hypothesis testing and generating strategies. The strides made by large scale efforts to utilize toxicogenomic data in screening, testing, and risk assessment are also discussed. These efforts include both the refinement of methodologies for performing toxicogenomics studies and analysis of the resultant data sets. The current issues limiting the application of toxicogenomics to define mode or mechanism of action in risk assessment are discussed together with interrelated research needs. In summary, as chemical risk assessment moves away from a single mechanism of action approach toward a toxicity pathway-based paradigm, we envision that toxicogenomic data from multiple technologies (e.g., proteomics, metabolomics, transcriptomics, supportive RT-PCR studies) can be used in conjunction with one another to understand the complexities of multiple, and possibly interacting, pathways affected by chemicals which will impact human health risk assessment

  8. 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.

  9. 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

  10. 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.)

  11. 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

  12. 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)

  13. 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.

  14. [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.

  15. 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.

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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.

  3. 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

  4. 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)

  5. 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.

  6. 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...

  7. 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.

  8. Preliminary Consideration for the Development of Regulatory Level 2 PSA Model

    International Nuclear Information System (INIS)

    Lee, Chang-Ju

    2006-01-01

    In order to assess the validity of PSA (probabilistic safety assessment) results and to establish regulatory requirements for relevant safety issues most of the regulators want to develop an independent and convenient risk assessment model including Level 2 PSA area. As this model and framework should be implicitly independent on the licensee's PSA model, it has a primary objective directly for applying to the risk-informed regulatory affairs and for supporting those kinds of works. According this, the regulator can take an objective view for the uncertainty of risk information made by the licensee and keep up the capability and decision-making framework for overall risk assessment results. In addition, the regulatory model may be used to verify and validate the operational risk levels of all engineered safety features of nuclear power plants (NPPs). An issue for plant-specific application of safety goals was previously identified in the US NRC's risk-informed regulatory guidance development activities, and discussed in many Commission papers, e. g. SECY-97-287, which identifies the goal for large early release frequency (LERF). LERF defines a containment performance criteria derived from the quantitative health objectives. As we know, the LERF was chosen to assess risk significance in Regulatory Guide 1.174 (2002) again, which provides one measure of the performance of the containment barrier, and represents a surrogate for early health effects

  9. 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

  10. 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.

  11. 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.

  12. 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

  13. 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)

  14. 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)

  15. Nuclear fuel cycle risk assessment: survey and computer compilation of risk-related literature. [Once-through Cycle and Plutonium Recycle

    Energy Technology Data Exchange (ETDEWEB)

    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.

  16. 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.

  17. 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

  18. 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

  19. 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

  20. 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.

  1. 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.

  2. 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

  3. Considerations regarding the collection of pesticide use information for regulatory purposes

    NARCIS (Netherlands)

    Marquart, J.

    2001-01-01

    Proper use information is necessary to do exposure modelling in the scope of regulatory risk assessments. The legal regime under which the regulatory risk assessment is done influences the need for use information. Different legal regimes lead to more or less possibilities for authorities to define

  4. 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.

  5. 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)

  6. 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.

  7. 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...

  8. 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

  9. The influence of thresholds on the risk assessment of carcinogens in food.

    Science.gov (United States)

    Pratt, Iona; Barlow, Susan; Kleiner, Juliane; Larsen, John Christian

    2009-08-01

    The risks from exposure to chemical contaminants in food must be scientifically assessed, in order to safeguard the health of consumers. Risk assessment of chemical contaminants that are both genotoxic and carcinogenic presents particular difficulties, since the effects of such substances are normally regarded as being without a threshold. No safe level can therefore be defined, and this has implications for both risk management and risk communication. Risk management of these substances in food has traditionally involved application of the ALARA (As Low as Reasonably Achievable) principle, however ALARA does not enable risk managers to assess the urgency and extent of the risk reduction measures needed. A more refined approach is needed, and several such approaches have been developed. Low-dose linear extrapolation from animal carcinogenicity studies or epidemiological studies to estimate risks for humans at low exposure levels has been applied by a number of regulatory bodies, while more recently the Margin of Exposure (MOE) approach has been applied by both the European Food Safety Authority and the Joint FAO/WHO Expert Committee on Food Additives. A further approach is the Threshold of Toxicological Concern (TTC), which establishes exposure thresholds for chemicals present in food, dependent on structure. Recent experimental evidence that genotoxic responses may be thresholded has significant implications for the risk assessment of chemicals that are both genotoxic and carcinogenic. In relation to existing approaches such as linear extrapolation, MOE and TTC, the existence of a threshold reduces the uncertainties inherent in such methodology and improves confidence in the risk assessment. However, for the foreseeable future, regulatory decisions based on the concept of thresholds for genotoxic carcinogens are likely to be taken case-by-case, based on convincing data on the Mode of Action indicating that the rate limiting variable for the development of cancer

  10. 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.

  11. Determining cutoff distances for assessing risks from transportation accident radiation releases

    International Nuclear Information System (INIS)

    Sandquist, G.M.; Slaughter, D.M.; Kimura, C.Y.; Brumburgh, G.

    1995-01-01

    The transportation of radioactive materials throughout the United States and the world is a ubiquitous and sometimes controversial activity. Almost universally, these transportation activities have been performed without major incident, and the safety record for transportation of radioactive material is outstanding compared with the transportation of other hazardous materials. Nevertheless, concerns still exist regarding adequate regulation of radioactive material transportation and accurate assessment of the health risks associated with accidents. These concerns are addressed through certification by the cognizant regulatory authority over the transportation container or the performance of a transportation risk assessment. In a transportation risk assessment, accident situations are examined, frequencies are estimated, and consequences resulting from the accident are analyzed and evaluated for acceptance. A universal question with any transportation risk assessment that examines the radiological consequences from release accidents is, At what distance may the dispersion analysis be terminated? This paper examines cutoff distances and their consequences for assessing health risks from radiological transportation releases

  12. Tolerability of risk, safety assessment principles and their implications for probabilistic safety analysis

    International Nuclear Information System (INIS)

    Ewing, D.J.F.; Campbell, J.F.

    1994-01-01

    This paper gives a regulatory view of probabilistic safety assessment as seen by the Nuclear Installations Inspectorate (NII) and in the light of the general regulatory risk aims set out in the Health and Safety Executive's (HSE) The tolerability of risk from nuclear power stations (TOR) and in Safety assessment principles for nuclear plants (SAPs), prepared by NII on behalf of the HSE. Both of these publications were revised and republished in 1992. This paper describes the SAPs, together with the historical background, the motivation for review, the effects of the Sizewell and Hinkley Point C public inquiries, changes since the original versions, comparison with international standards and use in assessment. For new plant, probabilistic safety analysis (PSA) is seen as an essential tool in balancing the safety of the design and in demonstrating compliance with TOR and the SAPs. (Author)

  13. 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...

  14. 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

  15. Development of multipurpose regulatory PSA model

    International Nuclear Information System (INIS)

    Lee, Chang Ju; Sung, Key Yong; Kim, Hho Jung; Yang, Joon Eon; Ha, Jae Joo

    2004-01-01

    Generally, risk information for nuclear facilities comes from the results of Probabilistic safety assessment (PSA). PSA is a systematic tool to ensure the safety of nuclear facilities, since it is based on thorough and consistent application of probability models. In particular, the PSA has been widely utilized for risk-informed regulation (RIR), including various licensee-initiated risk-informed applications (RIA). In any regulatory decision, the main goal is to make a sound safety decision based on technically defensible information. Also, due to the increased public requests for giving a safety guarantee, the regulator should provide the visible means of safety. The use of PSA by the regulator can give the answer on this problem. Therefore, in order to study the applicability of risk information for regulatory safety management, it is a demanding task to prepare a well-established regulatory PSA model and tool. In 2002, KINS and KAERI together made a research cooperation to form a working group to develop the regulatory PSA model - so-called MPAS model. The MPAS stands for multipurpose probabilistic analysis of safety. For instance, a role of the MPAS model is to give some risk insights in the preparation of various regulatory programs. Another role of this model is to provide an independent risk information to the regulator during regulatory decision-making, not depending on the licensee's information

  16. 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

  17. 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...

  18. Identifying and assessing highly hazardous drugs within quality risk management programs.

    Science.gov (United States)

    Sussman, Robert G; Schatz, Anthony R; Kimmel, Tracy A; Ader, Allan; Naumann, Bruce D; Weideman, Patricia A

    2016-08-01

    Historically, pharmaceutical industry regulatory guidelines have assigned certain active pharmaceutical ingredients (APIs) to various categories of concern, such as "cytotoxic", "hormones", and "steroids". These categories have been used to identify APIs requiring segregation or dedication in order to prevent cross-contamination and protect the quality and safety of drug products. Since these terms were never defined by regulatory authorities, and many novel pharmacological mechanisms challenge these categories, there is a recognized need to modify the historical use of these terms. The application of a risk-based approach using a health-based limit, such as an acceptable daily exposure (ADE), is more appropriate for the development of a Quality Risk Management Program (QRMP) than the use of categories of concern. The toxicological and pharmacological characteristics of these categories are discussed to help identify and prioritize compounds requiring special attention. Controlling airborne concentrations and the contamination of product contact surfaces in accordance with values derived from quantitative risk assessments can prevent adverse effects in workers and patients, regardless of specific categorical designations to which these APIs have been assigned. The authors acknowledge the movement away from placing compounds into categories and, while not yet universal, the importance of basing QRMPs on compound-specific ADEs and risk assessments. Based on the results of a risk assessment, segregation and dedication may also be required for some compounds to prevent cross contamination during manufacture of APIs. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. Influence of the human reliability in the assessment of the impact on the risk of changes of CLO

    International Nuclear Information System (INIS)

    Martorell, P.; Martorell, S.; Marton, I.; Saiz, M.

    2014-01-01

    Treatment and study of epistemic uncertainties is of special importance in the application of the analysis of probabilistic security to informed decision-making in risk, as points out the guide regulatory 1,174 [1] (Regulatory Guide 1,174, RG1.174). Specifically, the RG 1.177 [2] details of the impact on risk assessment concerning changes in the technical operating specifications (ETF). Based on the framework defined by such regulatory guides, will be assessed the effect of uncertainties epistemic associated with the analysis of human reliability in the context of the limit conditions of operation. As an example of application, will be held a sensitivity study of the time of inoperability Completion Time, the Residual heat removal system. (Author)

  20. 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

  1. Actual problems of environmental factors risk assessment on human health and ways to improve it

    Directory of Open Access Journals (Sweden)

    Y.A. Rakhmanin

    2015-06-01

    Full Text Available The article provides an analysis of global trends and new areas of health risk assessment and analysis methodology caused by exposure to chemicals, environmental pollutants, and the contemporary issues of national assessment methodology. Most details are considered: risk assessment evidence base, modern methods and problems of carcinogenic risk assessment, hygienic regulation based on risk assessment, the economic aspects of the methodology. Particular attention is paid to reasons of recent years perceived gaps in the Russian methodological basis of the best foreign samples. The urgent measures to improve the national risk assessment methodology are proposed, the main of which are: legislative consolidation of the basic concepts of risk assessment, a further update of the methodology and the practice of hygienic regulation on the basis of risk assessment, improving the valuation of damage to human health, the tightening of the requirements to the developed regulatory guidance documents on risk assessment, as well as to the training and retraining of personnel in the risk assessment.

  2. 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.

  3. 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.

  4. 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...

  5. A comprehensive approach to benefit-risk assessment in drug development

    DEFF Research Database (Denmark)

    Sarac, Sinan B; Rasmussen, Christian H; Rasmussen, Morten A.

    2012-01-01

    Major regulatory agencies, for example, FDA and EMA, have started to request comprehensive benefit-risk analyses of pharmaceutical products prior to approval or labelling expansion. The purpose of this study is to develop a generally applicable and reliable data-driven benefit-risk assessment......) discussion and formulation of an overall conclusion. To reduce the impact of subjective judgements, scores are assigned to each criterion on the basis of objective information (data) wherever possible. The proposed benefit-risk evaluation approach offers comprehensive, data-driven assessments that can...... method, where two or more drugs/doses can be compared. Our aim is to formulate an approach that is simple to apply, allows direct comparison of different types of risks and benefits, and is tailored for application in different disease areas both during clinical development and in the marketing approval...

  6. A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments.

    Science.gov (United States)

    Heinemann, Jack A; Agapito-Tenfen, Sarah Zanon; Carman, Judy A

    2013-05-01

    Changing the nature, kind and quantity of particular regulatory-RNA molecules through genetic engineering can create biosafety risks. While some genetically modified organisms (GMOs) are intended to produce new regulatory-RNA molecules, these may also arise in other GMOs not intended to express them. To characterise, assess and then mitigate the potential adverse effects arising from changes to RNA requires changing current approaches to food or environmental risk assessments of GMOs. We document risk assessment advice offered to government regulators in Australia, New Zealand and Brazil during official risk evaluations of GM plants for use as human food or for release into the environment (whether for field trials or commercial release), how the regulator considered those risks, and what that experience teaches us about the GMO risk assessment framework. We also suggest improvements to the process. Copyright © 2013 Elsevier Ltd. All rights reserved.

  7. Critical analysis of frameworks and approaches to assess the environmental risks of nanomaterials

    DEFF Research Database (Denmark)

    Grieger, Khara Deanne; Linkov, Igor; Hansen, Steffen Foss

    and approaches which have been developed or proposed by large organizations or regulatory bodies for NM. These frameworks and approaches were evaluated and assessed based on a select number of criteria which have been previously proposed as important parameters for inclusion in successful risk assessment......7.1.7 Critical analysis of frameworks and approaches to assess the environmental risks of nanomaterials Khara D. Grieger1, Igor Linkov2, Steffen Foss Hansen1, Anders Baun1 1Technical University of Denmark, Kgs. Lyngby, Denmark 2Environmental Laboratory, U.S. Army Corps of Engineers, Brookline, USA...... Email: kdg@env.dtu.dk Scientists, organizations, governments, and policy-makers are currently involved in reviewing, adapting, and formulating risk assessment frameworks and strategies to understand and assess the potential environmental risks of engineered nanomaterials (NM). It is becoming...

  8. Recent developments in health risks modeling techniques applied to hazardous waste site assessment and remediation

    International Nuclear Information System (INIS)

    Mendez, W.M. Jr.

    1990-01-01

    Remediation of hazardous an mixed waste sites is often driven by assessments of human health risks posed by the exposures to hazardous substances released from these sites. The methods used to assess potential health risk involve, either implicitly or explicitly, models for pollutant releases, transport, human exposure and intake, and for characterizing health effects. Because knowledge about pollutant fate transport processes at most waste sites is quite limited, and data cost are quite high, most of the models currently used to assess risk, and endorsed by regulatory agencies, are quite simple. The models employ many simplifying assumptions about pollutant fate and distribution in the environment about human pollutant intake, and toxicologic responses to pollutant exposures. An important consequence of data scarcity and model simplification is that risk estimates are quite uncertain and estimates of the magnitude uncertainty associated with risk assessment has been very difficult. A number of methods have been developed to address the issue of uncertainty in risk assessments in a manner that realistically reflects uncertainty in model specification and data limitations. These methods include definition of multiple exposure scenarios, sensitivity analyses, and explicit probabilistic modeling of uncertainty. Recent developments in this area will be discussed, along with their possible impacts on remediation programs, and remaining obstacles to their wider use and acceptance by the scientific and regulatory communities

  9. The importance of data collection for timely and accurate risk assessment

    Science.gov (United States)

    Gilsenan, MB

    2017-09-01

    The European Food Safety Authority (EFSA) is responsible for food safety risk assessments at EU level. It provides independent scientific advice on risks associated with the food chain to support EU risk management decisions. Since its establishment, EFSA has amassed a wealth of data to underpin its risk assessments, such as food consumption data, monitoring data and experimental data. Increasing transparency of its risk assessments is a core objective of EFSA. EFSA aims to enhance the quality and transparency of its outputs by giving insofar as possible access to data and methods underpinning its scientific outputs. This paper provides an overview of the role of EFSA, its core data collections and their regulatory framework, as well as data quality and standardisation aspects. Finally, the paper elaborates on EFSA’s 2020 strategy in relation to data, and describes EFSA scientific data warehouse and Knowledge Junction in this regard.

  10. Nano-TiO₂--feasibility and challenges for human health risk assessment based on open literature.

    Science.gov (United States)

    Christensen, Frans M; Johnston, Helinor J; Stone, Vicki; Aitken, Robert J; Hankin, Steve; Peters, Sheona; Aschberger, Karin

    2011-06-01

    This study aims at investigating feasibility and challenges associated with conducting a human health risk assessment for nano-titanium-dioxide (nano-TiO₂) based on the open literature by following an approach similar to a classical regulatory risk assessment. Gaps in the available data set, both in relation to exposures and hazard, do not allow reaching any definite conclusions that could be used for regulatory decision-making. Results show that repeated inhalation in the workplace and possibly consumer inhalation may cause risks. Also short-term inhalation following spray applications may cause risks. Main future work should focus on generating occupational and consumer inhalation exposure data, as well as toxicity data on absorption following inhalation, repeated dermal contact, and contact with damaged skin. Also relevant seems further information on possible neurotoxicity and genotoxicity/carcinogenicity, as well as establishing a No Observed Adverse Effect Level (NOAEL) for acute inhalation of nano-TiO₂.

  11. 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

  12. Performance Objective for Tank Farm Closure Risk Assessments

    International Nuclear Information System (INIS)

    MANN, F.M.; KNEPP, A.J.; BADDEN, J.

    2003-01-01

    To be meaningful, results from a numeric risk assessment of the consequences of an action must be compared against the standards for such an action. That is, before one disposes of waste or closes a facility with waste, one must show that the disposal or closure action protects the public health and safety and the environment. These standards are called performance objectives. Regulations requiring performing performance assessments, (whether federal ones like the Department of Energy [DOE] Order 435.1, Radioactive Waste Management and its implementing guides or Washington State ones like the regulations implementing the Washington Administrative Code [WAC] 173-340 ''Model Toxics Control Act - Cleanup''), usually require that the determination of performance objectives be one of the first steps performed. These performance objectives not only set comparison level for the numeric results, but also define the media, pathways, exposure scenarios (receptors), spatial locations, and times that the performance assessment must consider. Thus, a performance objective consists of a compliance level, place(s) of compliance, and time(s) of compliance. Performance objectives are not the levels that a regulatory agency will enforce in a permit or authorization. Those levels, often called enforcement levels, will be set in the permit or authorization. Rather, performance objectives are those levels against which the results of the numeric simulation will be compared to judge the success of the proposed cleanup or disposal actions. Additional comparison levels may be requested for information purposes, but are not officially part of the decision on the adequacy of the proposed action. To emphasize that the performance objectives discussed in this document are not regulatory performance objectives, the three components of the performance objective will be renamed in this document as assessment standard, point(s) of assessment, and time(s) of assessment. However, whenever

  13. 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

  14. 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

  15. 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

  16. The risks of risk aversion in drug regulation.

    Science.gov (United States)

    Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Brasseur, Daniel; Breckenridge, Alasdair; Leufkens, Hubert; Raine, June; Salmonson, Tomas; Schneider, Christian K; Rasi, Guido

    2013-12-01

    Drugs are approved by regulatory agencies on the basis of their assessment of whether the available evidence indicates that the benefits of the drug outweigh its risks. In recent years, regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, which reflects the challenge in determining an appropriate balance between benefit and risk with the limited data that is typically available before drug approval. The negative consequences of regulatory tolerance in allowing drugs onto the market that turn out to be unsafe are obvious, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, we discuss the consequences of regulatory risk-aversion for public health and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.

  17. Risk management on nuclear power plant. Application of probabilistic risk assessment

    International Nuclear Information System (INIS)

    Kojima, Shigeo

    2003-01-01

    In U.S.A., nuclear safety regulation is moving to risk-informed regulation (RIR), so necessity of a standard to provide contents of probabilistic risk assessment (PRA) constructing its roots has been discussed for a long time. In 1998, the Committee on Nuclear Risk Management (CNRM) of the American Society of Mechanical Engineers (ASME) began to investigate the standard, of which last edition was published as the Standard for Probabilistic Risk Management for Nuclear Power Plant Applications: RA-S-2002 (PRMA) on April, 2002. As in the Committee, the Nuclear Regulatory Commission (NRC), electric power companies, national institutes, PRA specialists, and so on took parts to carry out many discussions with full energies of participants on risk management in U.S.A., the standard was finished after about four years' efforts. In U.S.A., risk management having already used PRA is successfully practiced, U.S.A. is at a stage with more advancing steps of the risk management than Japan is. Here was described on the standard of PRA and a concrete method of the risk management carried out at nuclear power stations. (G.K.)

  18. A workshop on developing risk assessment methods for medical use of radioactive material. Volume 1: Summary

    Energy Technology Data Exchange (ETDEWEB)

    Tortorelli, J.P. [ed.] [Lockheed Idaho Technologies Co., Idaho Falls, ID (United States)

    1995-08-01

    A workshop was held at the Idaho National Engineering Laboratory, August 16--18, 1994 on the topic of risk assessment on medical devices that use radioactive isotopes. Its purpose was to review past efforts to develop a risk assessment methodology to evaluate these devices, and to develop a program plan and a scoping document for future methodology development. This report contains a summary of that workshop. Participants included experts in the fields of radiation oncology, medical physics, risk assessment, human-error analysis, and human factors. Staff from the US Nuclear Regulatory Commission (NRC) associated with the regulation of medical uses of radioactive materials and with research into risk-assessment methods participated in the workshop. The workshop participants concurred in NRC`s intended use of risk assessment as an important technology in the development of regulations for the medical use of radioactive material and encouraged the NRC to proceed rapidly with a pilot study. Specific recommendations are included in the executive summary and the body of this report. An appendix contains the 8 papers presented at the conference: NRC proposed policy statement on the use of probabilistic risk assessment methods in nuclear regulatory activities; NRC proposed agency-wide implementation plan for probabilistic risk assessment; Risk evaluation of high dose rate remote afterloading brachytherapy at a large research/teaching institution; The pros and cons of using human reliability analysis techniques to analyze misadministration events; Review of medical misadministration event summaries and comparison of human error modeling; Preliminary examples of the development of error influences and effects diagrams to analyze medical misadministration events; Brachytherapy risk assessment program plan; and Principles of brachytherapy quality assurance.

  19. A workshop on developing risk assessment methods for medical use of radioactive material. Volume 1: Summary

    International Nuclear Information System (INIS)

    Tortorelli, J.P.

    1995-08-01

    A workshop was held at the Idaho National Engineering Laboratory, August 16--18, 1994 on the topic of risk assessment on medical devices that use radioactive isotopes. Its purpose was to review past efforts to develop a risk assessment methodology to evaluate these devices, and to develop a program plan and a scoping document for future methodology development. This report contains a summary of that workshop. Participants included experts in the fields of radiation oncology, medical physics, risk assessment, human-error analysis, and human factors. Staff from the US Nuclear Regulatory Commission (NRC) associated with the regulation of medical uses of radioactive materials and with research into risk-assessment methods participated in the workshop. The workshop participants concurred in NRC's intended use of risk assessment as an important technology in the development of regulations for the medical use of radioactive material and encouraged the NRC to proceed rapidly with a pilot study. Specific recommendations are included in the executive summary and the body of this report. An appendix contains the 8 papers presented at the conference: NRC proposed policy statement on the use of probabilistic risk assessment methods in nuclear regulatory activities; NRC proposed agency-wide implementation plan for probabilistic risk assessment; Risk evaluation of high dose rate remote afterloading brachytherapy at a large research/teaching institution; The pros and cons of using human reliability analysis techniques to analyze misadministration events; Review of medical misadministration event summaries and comparison of human error modeling; Preliminary examples of the development of error influences and effects diagrams to analyze medical misadministration events; Brachytherapy risk assessment program plan; and Principles of brachytherapy quality assurance

  20. 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.

  1. 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...

  2. 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.

  3. Report on probabilistic safety assessment (PSA) quality assurance in utilization of risk information

    International Nuclear Information System (INIS)

    2006-12-01

    Recently in Japan, introduction of nuclear safety regulations using risk information such as probabilistic safety assessment (PSA) has been considered and utilization of risk information in the rational and practical measures on safety assurance has made a progress to start with the operation or inspection area. The report compiled results of investigation and studies of PSA quality assurance in risk-informed activities in the USA. Relevant regulatory guide and standard review plan as well as issues and recommendations were reviewed for technical adequacy and advancement of probabilistic risk assessment technology in risk-informed decision making. Useful and important information to be referred as issues in PSA quality assurance was identified. (T. Tanaka)

  4. 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)

  5. Risk-based environmental assessment for uranium mines – some Canadian and Australian experience

    International Nuclear Information System (INIS)

    Phaneuf, M.; Woods, P.; McKee, M.

    2014-01-01

    The uranium producing countries of Canada and Australia have independently developed regulatory frameworks emphasising the importance of human health and ecological risk assessments as core tools for ensuring protection of the environment and public. The value of such an approach is presented as well as practical lessons learned through recent applications of this regulatory model. In May 2000, the Canadian Atomic Energy Control Act was replaced by the Nuclear Safety and Control Act (NSCA). This law created the Canadian Nuclear Safety Commission, whose mission is to protect the health, safety and security of persons and the environment; and to implement Canada’s international commitments on the peaceful use of nuclear energy. From an environmental perspective, the new law added a requirement for the protection of the environment and non-human biota, and a responsibility over hazardous substances in addition to nuclear ones. The NSCA requires the prevention of unreasonable risk to, and adequate provision for the protection of, the environment and the health and safety of the public. It was decided that environmental and public protection would recognize the principles of pollution prevention and ALARA, and that it would be risk based. For Class 1 facilities and uranium mines and mills, Ecological and Human Health Risk Assessments are the core of both the Environmental Assessment process and the licensing process under the Nuclear Safety and Control Act. The Ecological Risk Assessment informs the Effluent and Environmental Monitoring Programs with the resultant monitoring data used to reinforce the risk assessments on a cyclical basis throughout the lifespan of the facility. A number of standards and regulatory documents have been completed supporting this environmental protection framework. In this presentation, a case study is used to illustrate the use of ERA for decision making. In the last decade or so in Australia uranium mining proposals normally require

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

    Science.gov (United States)

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

    2016-01-01

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

  7. Feasibility assessment of a risk-based approach to technical specifications

    International Nuclear Information System (INIS)

    Atefi, B.; Gallagher, D.W.

    1991-05-01

    To assess the potential use of risk and reliability techniques for improving the effectiveness of the technical specifications to control plant operational risk, the Technical Specifications Branch of the Nuclear Regulatory Commission initiated an effort to identify and evaluate alternative risk-based approaches that could bring greater risk perspective to these requirements. In the first phase four alternative approaches were identified and their characteristics were analyzed. Among these, the risk-based approach to technical specifications is the most promising approach for controlling plant operational risk using technical specifications. The second phase of the study concentrated on detailed characteristics of the real time risk-based approach. It is concluded that a real time risk-based approach to technical specifications has the potential to improve both plant safety and availability. 33 figs., 5 figs., 6 tabs

  8. 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

  9. 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

  10. 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)

  11. AUSERA: Large-Scale Automated Security Risk Assessment of Global Mobile Banking Apps

    OpenAIRE

    Chen, Sen; Meng, Guozhu; Su, Ting; Fan, Lingling; Xue, Yinxing; Liu, Yang; Xu, Lihua; Xue, Minhui; Li, Bo; Hao, Shuang

    2018-01-01

    Contemporary financial technology (FinTech) that enables cashless mobile payment has been widely adopted by financial institutions, such as banks, due to its convenience and efficiency. However, FinTech has also made massive and dynamic transactions susceptible to security risks. Given large financial losses caused by such vulnerabilities, regulatory technology (RegTech) has been developed, but more comprehensive security risk assessment is specifically desired to develop robust, scalable, an...

  12. Risk assessment framework of fate and transport models applied to hazardous waste sites

    International Nuclear Information System (INIS)

    Hwang, S.T.

    1993-06-01

    Risk assessment is an increasingly important part of the decision-making process in the cleanup of hazardous waste sites. Despite guidelines from regulatory agencies and considerable research efforts to reduce uncertainties in risk assessments, there are still many issues unanswered. This paper presents new research results pertaining to fate and transport models, which will be useful in estimating exposure concentrations and will help reduce uncertainties in risk assessment. These developments include an approach for (1) estimating the degree of emissions and concentration levels of volatile pollutants during the use of contaminated water, (2) absorption of organic chemicals in the soil matrix through the skin, and (3) steady state, near-field, contaminant concentrations in the aquifer within a waste boundary

  13. Current status of developmental neurotoxicity: regulatory view

    DEFF Research Database (Denmark)

    Hass, Ulla

    2003-01-01

    in the testing strategy for new and existing substances, and biocides. Hopefully, this will lead to an improved database for risk assessment of potential developmental neurotoxicants. However, the regulatory authorities and toxicologists will also be faced with the challenge that decisions have to be made......The need for developmental neurotoxicity testing has been recognized for decades and guidelines are available, as the USEPA guideline and the OECD draft TG 426. Regulatory testing of industrial chemicals for developmental neurotoxicity is required to some extent, especially for pesticides in the US....... Until recently, however, developmental neurotoxicity testing of industrial chemicals has not been a clear regulatory requirement in EU, probably due to the lack of an accepted OECD TG. The revised EU Technical Guidance Document for Risk Assessment (EU-TGD) has now included the OECD draft TG 426...

  14. 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

  15. 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

  16. 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.

  17. Construction scheduled delay risk assessment by using combined AHP-RII methodology for an international NPP project

    Energy Technology Data Exchange (ETDEWEB)

    Hossen, Mufazal Muhammed; Kang, Sun Koo; Kim, Jong Hyun [KEPCO International Nuclear Graduate School (KINGS), Ulsan (Korea, Republic of)

    2015-04-15

    In this study, Nuclear Power Plant (NPP) construction schedule delay risk assessment methodology is developed and the construction delay risk is assessed for turnkey international NPP projects. Three levels of delay factors were selected through literature review and discussions with nuclear industry experts. A questionnaire survey was conducted on the basis of an analytic hierarchy process (AHP) and Relative Importance Index (RII) methods and the schedule delay risk is assessed qualitatively and quantitatively by severity and frequency of occurrence of delay factors. This study assigns four main delay factors to the first level: main contractor, utility, regulatory authority, and financial and country factor. The second and the third levels are designed with 12 sub-factors and 32 sub-sub-factors, respectively. This study finds the top five most important sub-sub-factors, which are as follows: policy changes, political instability and public intervention; uncompromising regulatory criteria and licensing documents conflicting with existing regulations; robust design document review procedures; redesign due to errors in design and design changes; and worldwide shortage of qualified and experienced nuclear specific equipment manufacturers. The proposed combined AHP-RII methodology is capable of assessing delay risk effectively and efficiently. Decision makers can apply risk informed decision making to avoid unexpected construction delays of NPPs.

  18. Construction scheduled delay risk assessment by using combined AHP-RII methodology for an international NPP project

    International Nuclear Information System (INIS)

    Hossen, Mufazal Muhammed; Kang, Sun Koo; Kim, Jong Hyun

    2015-01-01

    In this study, Nuclear Power Plant (NPP) construction schedule delay risk assessment methodology is developed and the construction delay risk is assessed for turnkey international NPP projects. Three levels of delay factors were selected through literature review and discussions with nuclear industry experts. A questionnaire survey was conducted on the basis of an analytic hierarchy process (AHP) and Relative Importance Index (RII) methods and the schedule delay risk is assessed qualitatively and quantitatively by severity and frequency of occurrence of delay factors. This study assigns four main delay factors to the first level: main contractor, utility, regulatory authority, and financial and country factor. The second and the third levels are designed with 12 sub-factors and 32 sub-sub-factors, respectively. This study finds the top five most important sub-sub-factors, which are as follows: policy changes, political instability and public intervention; uncompromising regulatory criteria and licensing documents conflicting with existing regulations; robust design document review procedures; redesign due to errors in design and design changes; and worldwide shortage of qualified and experienced nuclear specific equipment manufacturers. The proposed combined AHP-RII methodology is capable of assessing delay risk effectively and efficiently. Decision makers can apply risk informed decision making to avoid unexpected construction delays of NPPs

  19. 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.

  20. An approach for using risk assessment in risk-informed decisions on plant-specific changes to the licensing basis

    International Nuclear Information System (INIS)

    Caruso, Mark A.; Cheok, Michael C.; Cunningham, Mark A.; Holahan, Gary M.; King, Thomas L.; Parry, Gareth W.; Ramey-Smith, Ann M.; Rubin, Mark P.; Thadani, Ashok C.

    1999-01-01

    This paper discusses an acceptable approach that the US Nuclear Regulatory Commission staff has proposed for using Probabilistic Risk Assessment in making decisions on changes to the licensing basis of a nuclear power plant. First, the overall philosophy of risk-informed decision-making, and the process framework are described. The philosophy is encapsulated in five principles, one of which states that, if the proposed change leads to an increase in core damage frequency or risk, the increases must be small and consistent with the intent of the Nuclear Regulatory Commission's Safety Goal Policy Statement. The second part of the paper discusses the use of PRA to demonstrate that this principle has been met. The discussion focuses on the acceptance guidelines, and on comparison of the PRA results with those guidelines. The difficulties that arise because of limitations in scope and analytical uncertainties are discussed and approaches to accommodate these difficulties in the decision-making are described

  1. 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

  2. Criteria for waste-related risks to be below regulatory concern

    International Nuclear Information System (INIS)

    Trubatch, S.L.

    1986-01-01

    This paper describes and analyzes the criteria recently established by the US Court of Appeals for the District of Columbia Circuit for determining that a risk is de minimis, i.e., below regulatory concern (BRC), for the purpose of the Atomic Energy Act of 1954, as amended, 42 USC 2011 et seq. The court established these BRC criteria incidentally during its review of intervenors' challenge to the US Nuclear Regulatory Commission's (NRC's) issuance of an operating license for the Diablo Canyon Nuclear Power Plant. In the course of that licensing proceeding, the NRC had determined that its regulations did not require it to consider the complicating effects of earthquakes on emergency planning. Although the legal standard and its quantitation arose in the context of emergency planning, these criteria are equally applicable to waste-related risks cognizable under the Atomic Energy Act. These criteria imply that the NRC, when licensing a waste repository, need not consider the risk of a catastrophic accident having a frequency of occurrence of less than one chance in one hundred thousand per year

  3. Non-Chemical Stressors and Cumulative Risk Assessment: An Overview of Current Initiatives and Potential Air Pollutant Interactions

    Science.gov (United States)

    Lewis, Ari S.; Sax, Sonja N.; Wason, Susan C.; Campleman, Sharan L.

    2011-01-01

    Regulatory agencies are under increased pressure to consider broader public health concerns that extend to multiple pollutant exposures, multiple exposure pathways, and vulnerable populations. Specifically, cumulative risk assessment initiatives have stressed the importance of considering both chemical and non-chemical stressors, such as socioeconomic status (SES) and related psychosocial stress, in evaluating health risks. The integration of non-chemical stressors into a cumulative risk assessment framework has been largely driven by evidence of health disparities across different segments of society that may also bear a disproportionate risk from chemical exposures. This review will discuss current efforts to advance the field of cumulative risk assessment, highlighting some of the major challenges, discussed within the construct of the traditional risk assessment paradigm. Additionally, we present a summary of studies of potential interactions between social stressors and air pollutants on health as an example of current research that supports the incorporation of non-chemical stressors into risk assessment. The results from these studies, while suggestive of possible interactions, are mixed and hindered by inconsistent application of social stress indicators. Overall, while there have been significant advances, further developments across all of the risk assessment stages (i.e., hazard identification, exposure assessment, dose-response, and risk characterization) are necessary to provide a scientific basis for regulatory actions and effective community interventions, particularly when considering non-chemical stressors. A better understanding of the biological underpinnings of social stress on disease and implications for chemical-based dose-response relationships is needed. Furthermore, when considering non-chemical stressors, an appropriate metric, or series of metrics, for risk characterization is also needed. Cumulative risk assessment research will benefit

  4. 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)

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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)

  13. 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

  14. National Strategy for Modernizing the Regulatory System for Biotechnology Products

    Science.gov (United States)

    This National Strategy for Modernizing the Regulatory System for Biotechnology Products sets forth a vision for ensuring that the federal regulatory system is prepared to efficiently assess the risks, if any, of the future products of biotechnology.

  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. What risk assessments of genetically modified organisms can learn from institutional analyses of public health risks.

    Science.gov (United States)

    Rajan, S Ravi; Letourneau, Deborah K

    2012-01-01

    The risks of genetically modified organisms (GMOs) are evaluated traditionally by combining hazard identification and exposure estimates to provide decision support for regulatory agencies. We question the utility of the classical risk paradigm and discuss its evolution in GMO risk assessment. First, we consider the problem of uncertainty, by comparing risk assessment for environmental toxins in the public health domain with genetically modified organisms in the environment; we use the specific comparison of an insecticide to a transgenic, insecticidal food crop. Next, we examine normal accident theory (NAT) as a heuristic to consider runaway effects of GMOs, such as negative community level consequences of gene flow from transgenic, insecticidal crops. These examples illustrate how risk assessments are made more complex and contentious by both their inherent uncertainty and the inevitability of failure beyond expectation in complex systems. We emphasize the value of conducting decision-support research, embracing uncertainty, increasing transparency, and building interdisciplinary institutions that can address the complex interactions between ecosystems and society. In particular, we argue against black boxing risk analysis, and for a program to educate policy makers about uncertainty and complexity, so that eventually, decision making is not the burden that falls upon scientists but is assumed by the public at large.

  17. What Risk Assessments of Genetically Modified Organisms Can Learn from Institutional Analyses of Public Health Risks

    Directory of Open Access Journals (Sweden)

    S. Ravi Rajan

    2012-01-01

    Full Text Available The risks of genetically modified organisms (GMOs are evaluated traditionally by combining hazard identification and exposure estimates to provide decision support for regulatory agencies. We question the utility of the classical risk paradigm and discuss its evolution in GMO risk assessment. First, we consider the problem of uncertainty, by comparing risk assessment for environmental toxins in the public health domain with genetically modified organisms in the environment; we use the specific comparison of an insecticide to a transgenic, insecticidal food crop. Next, we examine normal accident theory (NAT as a heuristic to consider runaway effects of GMOs, such as negative community level consequences of gene flow from transgenic, insecticidal crops. These examples illustrate how risk assessments are made more complex and contentious by both their inherent uncertainty and the inevitability of failure beyond expectation in complex systems. We emphasize the value of conducting decision-support research, embracing uncertainty, increasing transparency, and building interdisciplinary institutions that can address the complex interactions between ecosystems and society. In particular, we argue against black boxing risk analysis, and for a program to educate policy makers about uncertainty and complexity, so that eventually, decision making is not the burden that falls upon scientists but is assumed by the public at large.

  18. Risk analysis methods: their importance for safety assessment of practices using radiation

    International Nuclear Information System (INIS)

    Dumenigo, C; Vilaragut, J.J.; Ferro, R.; Guillen, A.; Ramirez, M.L.; Ortiz Lopez, P.; Rodriguez, M.; McDonnell, J.D.; Papadopulos, S.; Pereira, P.P.; Goncalvez, M.; Morales, J.; Larrinaga, E.; Lopez Morones, R.; Sanchez, R.; Delgado, J.M.; Sanchez, C.; Somoano, F.

    2008-01-01

    Radiation safety has been based for many years on verification of compliance with regulatory requirements, codes of practice and international standards, which can be considered prescriptive methods. Accident analyses have been published, lessons have been learned and safety assessments have incorporated the need to check whether a facility is ready to avoid accidents similar to the reported ones. These approaches can be also called 'reactive methods'. They have in common the fundamental limitation of being restricted to reported experience, but do not take into account other potential events, which were never published or never happened, i.e. latent risks. Moreover, they focus on accident sequences with major consequences and low probability but may not pay enough attention to other sequences leading to lower, but still significant consequences with higher probability. More proactive approaches are, therefore, needed, to assess risk in radiation facilities. They aim at identifying all potential equipment faults and human error, which can lead to predefined unwanted consequences and are based on the general risk equation: Risk = Probability of occurrence of an accidental sequence * magnitude of the consequences. In this work, a review is given of the experience obtained by the countries of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, by applying proactive methods to radiotherapy practice. In particular, probabilistic safety assessment (PSA) used for external beam treatments with linear electron accelerators and two studies, on cobalt 60 therapy and brachytherapy using the risk-matrix approach are presented. The work has identified event sequences, their likelihood of occurrence, the consequences, the efficiency of interlocks and control checks and the global importance in terms of overall risk, to facilitate decision making and implementation of preventive measures. A comparison is presented of advantages and limitations of

  19. 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.

  20. 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.

  1. Insights from Guideline for Performance of Internal Flooding Probabilistic Risk Assessment (IFPRA)

    International Nuclear Information System (INIS)

    Choi, Sun Yeong; Yang, Joo Eon

    2009-01-01

    An internal flooding (IF) risk assessment refers to the quantitative probabilistic safety assessment (PSA) treatment of flooding as a result of pipe and tank breaks inside the plants, as well as from other recognized flood sources. The industry consensus standard for Internal Events Probabilistic Risk Assessment (ASME-RA-Sb-2005) includes high-level and supporting technical requirements for developing internal flooding probabilistic risk assessment (IFPRA). This industry standard is endorsed in Regulatory Guide 1.200, Revision 1 as an acceptable approach for addressing the risk contribution from IF events for risk informed applications that require U.S. Nuclear Regulatory commission (NRC) approval. In 2006, EPRI published a draft report for IFPRA that addresses the requirements of the ASME PRA consensus standard and have made efforts to refine and update the final EPRI IFPRA guideline. Westinghouse has performed an IFPRA analysis for several nuclear power plants (NPPs), such as Watts Bar and Fort Calhoun, using the draft EPRI guidelines for development of an IFPRA. Proprietary methodologies have been developed to apply the EPRI guidelines. The objectives of the draft report for IFPRA guideline are to: · Provide guidance for PSA practitioners in the performance of the elements of a PRA associated with internal flooding events consistent with the current state of the art for internal flooding PRA · Provide guidance regarding acceptable approaches that is sufficient to meeting the requirements of the ASME PRA Standard associated with internal flooding · Incorporate lessons learned in the performance of internal flooding PRAs including those identified as pilot applications of earlier drafts of this procedures guide The purpose of this paper is to present a vision for domestic nuclear power plants' IFPRA by comparing the method of the draft EPRI guidelines with the existing IFPRA method for domestic NPPs

  2. Insights from Guideline for Performance of Internal Flooding Probabilistic Risk Assessment (IFPRA)

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Sun Yeong; Yang, Joo Eon [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2009-10-15

    An internal flooding (IF) risk assessment refers to the quantitative probabilistic safety assessment (PSA) treatment of flooding as a result of pipe and tank breaks inside the plants, as well as from other recognized flood sources. The industry consensus standard for Internal Events Probabilistic Risk Assessment (ASME-RA-Sb-2005) includes high-level and supporting technical requirements for developing internal flooding probabilistic risk assessment (IFPRA). This industry standard is endorsed in Regulatory Guide 1.200, Revision 1 as an acceptable approach for addressing the risk contribution from IF events for risk informed applications that require U.S. Nuclear Regulatory commission (NRC) approval. In 2006, EPRI published a draft report for IFPRA that addresses the requirements of the ASME PRA consensus standard and have made efforts to refine and update the final EPRI IFPRA guideline. Westinghouse has performed an IFPRA analysis for several nuclear power plants (NPPs), such as Watts Bar and Fort Calhoun, using the draft EPRI guidelines for development of an IFPRA. Proprietary methodologies have been developed to apply the EPRI guidelines. The objectives of the draft report for IFPRA guideline are to: {center_dot} Provide guidance for PSA practitioners in the performance of the elements of a PRA associated with internal flooding events consistent with the current state of the art for internal flooding PRA {center_dot} Provide guidance regarding acceptable approaches that is sufficient to meeting the requirements of the ASME PRA Standard associated with internal flooding {center_dot} Incorporate lessons learned in the performance of internal flooding PRAs including those identified as pilot applications of earlier drafts of this procedures guide The purpose of this paper is to present a vision for domestic nuclear power plants' IFPRA by comparing the method of the draft EPRI guidelines with the existing IFPRA method for domestic NPPs.

  3. 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)

  4. 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.

  5. Nanotechnologies in agriculture and food - an overview of different fields of application, risk assessment and public perception.

    Science.gov (United States)

    Grobe, Antje; Rissanen, Mikko E

    2012-12-01

    Nanomaterials in agriculture and food are key issues of public and regulatory interest. Over the past ten years, patents for nanotechnological applications in the field of food and agriculture have become abundant. Uncertainty prevails however regarding their current development status and presence in the consumer market. Thus, the discussion on nanotechnologies in the food sector with its specific public perception of benefits and risks and the patterns of communication are becoming similar to the debate on genetically modified organisms. The food industry's silence in communication increased mistrust of consumer organisations and policy makers. The article discusses the background of the current regulatory debates, starting with the EU recommendation for defining nanomaterials, provides an overview of possible fields of application in agriculture and food industries and discusses risk assessment and the public debate on benefits and risks. Communicative recommendations are directed at researchers, the food industry and regulators in order to increase trust both in stakeholders, risk management and regulatory processes.

  6. Risk assessment of hazardous waste transport - perspectives of GIS application

    International Nuclear Information System (INIS)

    Lazar, R.E.; Dumitrescu, M.; Stefanescu, I.

    2001-01-01

    Due to the increasing public awareness of the potential risks associated with waste transport, the environmental impact assessment of this activity has become an issue of major importance. This paper presents a project proposal, which can establish a national action plan for waste transport evaluation. Such a programme is sustained by the necessity to obtain an adequate method for the rapid and efficient estimation of individual and social risks due to the transport of hazardous substances in Romania. The main objective is to develop regional strategies for risk assessment in comprising: establishing the areas that must be investigated and their particular characteristics; identifying the transport activities in the areas; determining hazards; establishing the analysis criteria and prioritizing the study areas; evaluating continuous emissions; studying major accidents; studying population health; classifying the risks; establishing regional strategies; implementing political and regulatory measures. The project expectation is to provide a decision tool for risk managers and authorities in order to control or limit transportation and the storage of hazardous substances.(author)

  7. Comparison of seismic margin assessment and probabilistic risk assessment in seismic IPE

    International Nuclear Information System (INIS)

    Reed, J.W.; Kassawara, R.P.

    1993-01-01

    A comparison of technical requirements and managerial issues between seismic margin assessment (SMA) and seismic probabilistic risk assessment (SPRA) in a seismic Individual Plant Examination (IPE) is presented and related to requirements for an Unresolved Safety Issue (USI) A-46 review which is required for older nuclear power plants. Advantages and disadvantages are discussed for each approach. Technical requirements reviewed for a seismic IPE include: scope of plants covered, seismic input, scope of review, selection of equipment, required experience and training of engineers, walkdown procedure, evaluation of components, relay review, containment review, quality assurance, products, documentation requirements, and closure procedure. Managerial issues discussed include regulatory acceptability, compatibility with seismic IPE, compliance with seismic IPE requirements, ease of use by utilities, and relative cost

  8. Existing Regulatory Approaches to Reducing Exposures to Chemical- and Product-Based Risk and Their Applicability to Diet-Related Chronic Disease.

    Science.gov (United States)

    Cohen, Deborah A; Knopman, Debra S

    2018-04-17

    We aimed to identify and categorize the types of policies that have been adopted to protect Americans from harmful exposures that could also be relevant for addressing diet-related chronic diseases. This article examines and categorizes the rationales behind government regulation. Our interest in the historical analysis is to inform judgments about how best to address newly emergent risks involving diet-related chronic disease within existing regulatory and information-based frameworks. We assessed exemplars of regulation with respect to harmful exposures from air, water, and food, as well as regulations that are intended to modify voluntary behaviors. Following the comparative analysis, we explored how exposures that lead to diet-related chronic diseases among the general population fit within models of regulation adopted for other comparable risks. We identified five rationales and five approaches that protect people from harmful exposures. Reasons for regulation include: protection from involuntary exposure to risk, high risk of death or chronic illness, ubiquity of risk, counteraction to limit compulsive behaviors, and promotion of population health. Regulatory approaches include: mandatory limits on use, mandatory limits on exposure, mandatory controls on quality, mandatory labeling, and voluntary guidance. In contrast to the use of mandates, the prevention of diet-related chronic diseases thus far has largely relied on information-only approaches and voluntary adoption of guidelines. There is ample precedent for mandatory regulatory approaches that could address harms related to exposure to unhealthy diets, but several barriers to action would need to be overcome. © 2018 Society for Risk Analysis.

  9. 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

  10. Benefit-Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist.

    Science.gov (United States)

    Radawski, Christine; Morrato, Elaine; Hornbuckle, Kenneth; Bahri, Priya; Smith, Meredith; Juhaeri, Juhaeri; Mol, Peter; Levitan, Bennett; Huang, Han-Yao; Coplan, Paul; Li, Hu

    2015-12-01

    Optimizing a therapeutic product's benefit-risk profile is an on-going process throughout the product's life cycle. Different, yet related, benefit-risk assessment strategies and frameworks are being developed by various regulatory agencies, industry groups, and stakeholders. This paper summarizes current best practices and discusses the role of the pharmacoepidemiologist in these activities, taking a life-cycle approach to integrated Benefit-Risk Assessment, Communication, and Evaluation (BRACE). A review of the medical and regulatory literature was performed for the following steps involved in therapeutic benefit-risk optimization: benefit-risk evidence generation; data integration and analysis; decision making; regulatory and policy decision making; benefit-risk communication and risk minimization; and evaluation. Feedback from International Society for Pharmacoepidemiology members was solicited on the role of the pharmacoepidemiologist. The case example of natalizumab is provided to illustrate the cyclic nature of the benefit-risk optimization process. No single, globally adopted benefit-risk assessment process exists. The BRACE heuristic offers a way to clarify research needs and to promote best practices in a cyclic and integrated manner and highlight the critical importance of cross-disciplinary input. Its approach focuses on the integration of BRACE activities for risk minimization and optimization of the benefit-risk profile. The activities defined in the BRACE heuristic contribute to the optimization of the benefit-risk profile of therapeutic products in the clinical world at both the patient and population health level. With interdisciplinary collaboration, pharmacoepidemiologists are well suited for bringing in methodology expertise, relevant research, and public health perspectives into the BRACE process. Copyright © 2015 John Wiley & Sons, Ltd.

  11. Use of PRA in the nuclear regulatory field in South Africa

    International Nuclear Information System (INIS)

    Hill, T.F.

    1994-01-01

    The nuclear regulatory authority in South Africa (since 1988 the Council for Nuclear Safety (CNS)), established in 1973 nuclear safety criteria against which to assess the level of safety of any facility using radioactive material. It is a regulatory requirement in South Africa to develop and maintain a living PRA for each facility and thereby to provide the necessary information to demonstrate compliance against these criteria. All safety submissions to the CNS must include at least a risk statement based on an accepted PRA study. The function of the CNS is to regulate all activities in South Africa involving the use of radioactive material and posing a significant risk to the public or plant personnel. This includes most aspects of the nuclear fuel cycle and the Koeberg NPS (two 2775 MW(th) PWRs). A PRA study including source terms for the two Koeberg units was presented by the contractor in 1979. This included the risk due to power and shutdown states and non reactor related accidents involving spent fuel storage, fuel handling and waste treatment related activities. At least 20 PRA studies have been performed for other nuclear facilities in the country. The CNS maintains an in-house PRA capability to perform independent assessments of licensee submission, to participate in developments of PRA methodology in the regulatory field, to perform pro-active safety work and to assist in regulatory decision making. Present ongoing work includes the development of a risk monitor, a risk management system, improvement in PRA codes, models, data collection and analysis, off-site risk assessment methodology and associated regulatory policy. (author). 1 fig

  12. Potential for the adoption of probabilistic risk assessments by end-users and decision-makers

    DEFF Research Database (Denmark)

    Frewer, Lynn J.; Fischer, Arnout R. H.; van den Brink, Paul J.

    2008-01-01

    -user and regulatory uptake has not been, to date, extensive. A case study, utilizing the Theory of Planned Behavior, was conducted in order to identify potential determinants of end-user adoption of probabilistic risk assessments associated with the ecotoxicological impact of pesticides. Seventy potential end...

  13. 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.

  14. Risk assessment in spent fuel storage and transportation

    International Nuclear Information System (INIS)

    Pandimani, S.

    1989-01-01

    Risk assessment in various stages of nuclear fuel cycle is still an active area of Nuclear safety studies. From the results of risk assessment available in literature, it can be determined that the risk resulting from shipments of plutonium and spent-fuel are much greater than that resulting from the transport of other materials within the nuclear fuel cycle. In India spent fuels are kept in Spent Fuel Storage Pool (SFSP) for about 240-400 days, which is relatively a longer period compared to the usual 120 days as recommended by regulatory authorities. After cooling spent fuels are transported to the reprocessing sites which are mostly situated close to the plants. India has two high level waste treatment facilities, one PREFRE (Plutonium Reprocessing and Fuel Recycling) at Tarapur and the other one, a unit of Nuclear Fuel Complex at Hyderabad. This paper presents the risk associated with spent fuel storage and transportation for the Indian conditions. All calculations are based on a typical CANDU reactor system. Simple fault tree models are evolved for SFSP and for Transportation Accident Mode (TAM) for both road and rail. Fault tree quantification and risk assessment are done to each of these models. All necessary data for SFSP are taken mostly from Reactor Safety Study, (1975). Similarly, the data for rail TAM are taken from Annual Statistical Statements, (1987-8) and that for road TAM from Special Issue on Motor Vehicle Accident Statistics in India, (1986). Simulation method is used wherever necessary. Risk is also estimated for normal/accident free transport

  15. 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.

  16. Use of risk to resolve conflicts in assessing hazards at mixed-waste sites

    International Nuclear Information System (INIS)

    Rechard, R.P.; Chu, M.S.Y.

    1991-01-01

    Two main issues contribute to the assessment of health hazard from mixed waste: the scientific methods to assess these materials and the legislative and regulatory control of these materials. This paper is primarily concerned with the scientific method of assessing hazards from mixed waste (i.e., carcinogenic chemicals, noncarcinogenic chemicals, and radioactive material). This paper discusses SRS, a Site Ranking System, and its use of risk concepts to avoid introducing new inconsistencies when ranking mixed-waste sites. SRS ranks each site by scoring factors that influence the human health risk. The factors are (1) the potentially exposed population, (2) the average amount of exposure to the waste, and (3) the toxicity of the waste. The relative risk of a release is measured as the product of these three factors. The third factor, toxicity, is indexed with a single score, but because methods of measuring toxicity differ for carcinogenic chemicals, noncarcinogenic chemicals, and radionuclides, comparison can be difficult; hence, this paper also summarizes the logic and assumptions used to make toxicity comparisons in SRS. As may be expected, results from a ranking scheme based on risk are different from results generated by the original Hazard Ranking System (HRS), used by the Environmental Protection Agency. This paper briefly discusses these differences for five Superfund sites (no mixed waste). The legislative and regulatory control of these materials to protect human health is also discussed. 37 refs., 1 tab

  17. A European perspective on alternatives to animal testing for environmental hazard identification and risk assessment.

    Science.gov (United States)

    Scholz, Stefan; Sela, Erika; Blaha, Ludek; Braunbeck, Thomas; Galay-Burgos, Malyka; García-Franco, Mauricio; Guinea, Joaquin; Klüver, Nils; Schirmer, Kristin; Tanneberger, Katrin; Tobor-Kapłon, Marysia; Witters, Hilda; Belanger, Scott; Benfenati, Emilio; Creton, Stuart; Cronin, Mark T D; Eggen, Rik I L; Embry, Michelle; Ekman, Drew; Gourmelon, Anne; Halder, Marlies; Hardy, Barry; Hartung, Thomas; Hubesch, Bruno; Jungmann, Dirk; Lampi, Mark A; Lee, Lucy; Léonard, Marc; Küster, Eberhard; Lillicrap, Adam; Luckenbach, Till; Murk, Albertinka J; Navas, José M; Peijnenburg, Willie; Repetto, Guillermo; Salinas, Edward; Schüürmann, Gerrit; Spielmann, Horst; Tollefsen, Knut Erik; Walter-Rohde, Susanne; Whale, Graham; Wheeler, James R; Winter, Matthew J

    2013-12-01

    Tests with vertebrates are an integral part of environmental hazard identification and risk assessment of chemicals, plant protection products, pharmaceuticals, biocides, feed additives and effluents. These tests raise ethical and economic concerns and are considered as inappropriate for assessing all of the substances and effluents that require regulatory testing. Hence, there is a strong demand for replacement, reduction and refinement strategies and methods. However, until now alternative approaches have only rarely been used in regulatory settings. This review provides an overview on current regulations of chemicals and the requirements for animal tests in environmental hazard and risk assessment. It aims to highlight the potential areas for alternative approaches in environmental hazard identification and risk assessment. Perspectives and limitations of alternative approaches to animal tests using vertebrates in environmental toxicology, i.e. mainly fish and amphibians, are discussed. Free access to existing (proprietary) animal test data, availability of validated alternative methods and a practical implementation of conceptual approaches such as the Adverse Outcome Pathways and Integrated Testing Strategies were identified as major requirements towards the successful development and implementation of alternative approaches. Although this article focusses on European regulations, its considerations and conclusions are of global relevance. Copyright © 2013 Elsevier Inc. All rights reserved.

  18. Review insights on the probabilistic risk assessment for the Limerick Generating Station

    International Nuclear Information System (INIS)

    1984-08-01

    In recognition of the high population density around the Limerick Generating Station site and the proposed power level, the Philadelphia Electric Company, in response to NRC staff requests, conducted and submitted between March 1981 and November 1983 a probabilistic risk assessment (PRA) on internal event contributors and a severe accident risk assessment on external event contributors to assess risks posed by operation of the plant. The applicant has developed perspectives using PRA models on the safety profile of the Limerick plant and has altered the plant design to reduce accident vulnerabilities identified in these PRAs. The staff's review of the Limerick PRA has particularly emphasized the dominant accident sequences and the resulting insights into demonstration of compliance with regulatory requirments, unique design features and major plant vulnerabilities to assess the need for any additional measures to further improve the safety of the LGS. The staff's review insights and PRA safety review conclusions are presented in this report

  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. 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...

  2. Legal precedents regarding use and defensibility of risk assessment in Federal transportation of SNF and HLW

    International Nuclear Information System (INIS)

    Bentz, E.J. Jr.; Bentz, C.B.; O'Hora, T.D.; Chen, S.Y.

    1997-01-01

    Risk assessment has become an increasingly important and essential tool in support of Federal decision-making regarding the handling, storage, disposal, and transportation of spent nuclear fuel (SNF) and high-level radioactive waste (HLW). This paper analyzes the current statutory and regulatory framework and related legal precedents with regard to SNF and HLW transportation. The authors identify key scientific and technical issues regarding the use and defensibility of risk assessment in Federal decision-making regarding anticipated shipments

  3. Nanometer-sized emissions from municipal waste incinerators: A qualitative risk assessment

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, David R., E-mail: david.r.johnson@ghd.com

    2016-12-15

    Municipal waste incinerators (MWI) are beneficial alternatives to landfills for waste management. A recent constituent of concern in emissions from these facilities is incidental nanometer-sized particles (INP{sub MWI}), i.e., particles smaller than 1 micrometer in size that may deposit in the deepest parts of the lungs, cross into the bloodstream, and affect different regions of the body. With limited data, the public may fear INP{sub MWI} due to uncertainty, which may affect public acceptance, regulatory permitting, and the increased lowering of air quality standards. Despite limited data, a qualitative risk assessment paradigm can be applied to determine the relative risk due to INP{sub MWI} emissions. This review compiles existing data on nanometer-sized particle generation by MWIs, emissions control technologies used at MWIs, emission releases into the atmosphere, human population exposure, and adverse health effects of nanometer-sized particles to generate a qualitative risk assessment and identify data gaps. The qualitative risk assessment conservatively concludes that INP{sub MWI} pose a low to moderate risk to individuals, primarily due to the lack of relevant toxicological data on INP{sub MWI} mixtures in ambient particulate matter.

  4. Risk-based regulation - an NRC perspective and status

    International Nuclear Information System (INIS)

    King, T.L.; Murphy, J.A.

    1993-01-01

    The consideration of risk in regulatory decision making has traditionally been part of the US Nuclear Regulatory Commission's (NRC's) policy and practice. In the early days of regulation, this consideration was more qualitative in nature and was reflected in prescriptive/deterministic regulatory requirements. However, with the development of quantitative risk assessment methods, more detailed and comprehensive (although not complete) risk information on nuclear power plants is available to the designer, operator, and regulator. The availability of such information provides an opportunity to assess the need for change in the current regulatory structure and to develop future regulatory requirements in a less prescriptive, more performance-oriented fashion

  5. 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.)

  6. 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...

  7. 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.

  8. 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.

  9. Risk assessments for energy systems and role of preliminary degree-of-hazard evaluations

    International Nuclear Information System (INIS)

    Habegger, L.J.; Fingleton, D.J.

    1985-11-01

    The appropriate approach to risk or hazard assessment can vary considerably, depending on various factors, including the intended application of the results and the time other resources available to conduct the assessment. This paper illustrates three types of interrelated assessments. Although they can be mutually supportive, they have fundamentally different objectives, which require major differences in approach. The example of the overall risk assessment of alternative major energy technologies illustrates the compilation of a wide range of available risk data applicable to these systems. However, major uncertainties exist in the assessments, and public perception of their importance could play an important role in final system evaluations. A more narrowly defined risk assessment, often focusing on an individual component of a larger system, is the most commonly used approach in regulatory applications. The narrow scope allows in-depth analysis of risks and associated uncertainties, but it may also contribute to a loss of perspective on the magnitude of the assessed risk relative to that of the unassessed risks. In some applications, it is useful to conduct semiquantitative degree-of-hazard evaluations as a means of setting priorities for detailed risk assessment. The MAHAS procedure described in this paper provides a means of rapidly ranking relative hazards from various sources using easily accessible data. However, these rankings should not be used as definitive input for selecting technology alternatives or developing regulations. 25 refs., 6 tabs

  10. 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

  11. 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)

  12. 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.

  13. 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

  14. Current developments in the assessment of petroleum hydrocarbon contaminated sites: Analysis, interpretation, and use of the TPH parameter for quantitative risk assessment

    International Nuclear Information System (INIS)

    Garcia-Surette, M.; Maynard, P.; Lamie, P.O.; Kaslick, C.

    1995-01-01

    In 1994, the Massachusetts Department of Environmental Protection (MDEP) estimated that petroleum-only cases comprised approximately one-half of the state's hazardous waste sites currently under investigation and/or remediation. Because of this significant percentage, it became clear that assessing petroleum sites more efficiently in terms of risk and cleanup alternatives was necessary. One of these key MDEP policies describes an alternative risk assessment approach enabling the quantitative characterization of total petroleum hydrocarbon (TPH)-related health risks. The approach relies on the use of an analytical technique by which the mass of petroleum hydrocarbons within specified carbon ranges is quantified. MDEP's TPH risk assessment approach was successfully employed at a residential site contaminated with No. 2 fuel oil. The combined use of MDEP's suggested analytical methods, alternative reference compounds and toxicity values, as well as chromatograms, standard dose equations, and an EPA-approved box model, facilitated the performance of a more realistic and cost-effective assessment of risk. Such assessment provided key management information to regulatory agencies, and project managers, as well as property owners concerned with potential property value loss

  15. Risk-based approach to long-term safety assessment for near surface disposal of radioactive waste in Korea

    International Nuclear Information System (INIS)

    Jeong, C.W.; Kim, K.I.; Lee, J.I.

    2000-01-01

    This paper presents the Korean regulatory approach to safety assessment consistent with probabilistic, risk-based long-term safety requirements for near surface disposal facilities. The approach is based on: (1) From the standpoint of risk limitation, normal processes and probabilistic disruptive events should be integrated in a similar manner in terms of potential exposures; and (2) The uncertainties inherent in the safety assessment should be reduced using appropriate exposure scenarios. In addition, this paper emphasizes the necessity of international guidance for quantifying potential exposures and the corresponding risks from radioactive waste disposal. (author)

  16. Capacities for the Risk Assessment of GMOs: Challenges to Build Sustainable Systems

    Directory of Open Access Journals (Sweden)

    Danilo Fernández Ríos

    2018-04-01

    Full Text Available The need for functional risk assessment bodies in general, and in the biosafety field in particular, demands continued efforts and commitment from regulatory agencies, if results that are sustainable in time are to be achieved. The lack of formal processes that ensure continuity in the application of state of the art scientific criteria, the high rotation in some cases or the lack of experienced professionals, in others, is a challenge to be addressed. Capacity building initiatives with different approaches and degrees of success have been implemented in many countries over the years, supported by diverse governmental and non-governmental organizations. This document summarizes some capacity building experiences in developing countries and concludes that risk assessors taking ownership and regulatory authorities fully committed to developing and retaining highly qualified bodies are a sine qua non to achieve sustainable systems. To this end, it is essential to implement “in-house” continuing education mechanisms supported by external experts and organizations, and inter-institutional cooperation. It has to be noted that these recommendations could only be realized if policy makers understand and appreciate the value of professional, independent regulatory bodies.

  17. Capacities for the Risk Assessment of GMOs: Challenges to Build Sustainable Systems.

    Science.gov (United States)

    Fernández Ríos, Danilo; Rubinstein, Clara; Vicién, Carmen

    2018-01-01

    The need for functional risk assessment bodies in general, and in the biosafety field in particular, demands continued efforts and commitment from regulatory agencies, if results that are sustainable in time are to be achieved. The lack of formal processes that ensure continuity in the application of state of the art scientific criteria, the high rotation in some cases or the lack of experienced professionals, in others, is a challenge to be addressed. Capacity building initiatives with different approaches and degrees of success have been implemented in many countries over the years, supported by diverse governmental and non-governmental organizations. This document summarizes some capacity building experiences in developing countries and concludes that risk assessors taking ownership and regulatory authorities fully committed to developing and retaining highly qualified bodies are a sine qua non to achieve sustainable systems. To this end, it is essential to implement "in-house" continuing education mechanisms supported by external experts and organizations, and inter-institutional cooperation. It has to be noted that these recommendations could only be realized if policy makers understand and appreciate the value of professional, independent regulatory bodies.

  18. 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

  19. 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.

  20. 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)

  1. Genetic toxicology at the crossroads-from qualitative hazard evaluation to quantitative risk assessment.

    Science.gov (United States)

    White, Paul A; Johnson, George E

    2016-05-01

    Applied genetic toxicology is undergoing a transition from qualitative hazard identification to quantitative dose-response analysis and risk assessment. To facilitate this change, the Health and Environmental Sciences Institute (HESI) Genetic Toxicology Technical Committee (GTTC) sponsored a workshop held in Lancaster, UK on July 10-11, 2014. The event included invited speakers from several institutions and the contents was divided into three themes-1: Point-of-departure Metrics for Quantitative Dose-Response Analysis in Genetic Toxicology; 2: Measurement and Estimation of Exposures for Better Extrapolation to Humans and 3: The Use of Quantitative Approaches in Genetic Toxicology for human health risk assessment (HHRA). A host of pertinent issues were discussed relating to the use of in vitro and in vivo dose-response data, the development of methods for in vitro to in vivo extrapolation and approaches to use in vivo dose-response data to determine human exposure limits for regulatory evaluations and decision-making. This Special Issue, which was inspired by the workshop, contains a series of papers that collectively address topics related to the aforementioned themes. The Issue includes contributions that collectively evaluate, describe and discuss in silico, in vitro, in vivo and statistical approaches that are facilitating the shift from qualitative hazard evaluation to quantitative risk assessment. The use and application of the benchmark dose approach was a central theme in many of the workshop presentations and discussions, and the Special Issue includes several contributions that outline novel applications for the analysis and interpretation of genetic toxicity data. Although the contents of the Special Issue constitutes an important step towards the adoption of quantitative methods for regulatory assessment of genetic toxicity, formal acceptance of quantitative methods for HHRA and regulatory decision-making will require consensus regarding the

  2. Ecological risk assessment of radionuclides in the Columbia River System ''a historical assessment''

    International Nuclear Information System (INIS)

    Friant, S.L.; Brandt, C.A.; Probasco, K.M.

    1993-01-01

    The US Department of Energy's (DOE) Hanford Site in southcentral Washington State has been the location of nuclear production activities since 1943. Radioactive effluents were discharged to the Columbia River, which runs through the northern portion of the Site and borders it on the east (the Hanford Reach). The assessment was conducted using historical Hanford Site monitoring data for the aquatic environment of the Columbia River over the time period from 1963 to 1964. The time period was chosen because it was then that peak production of nuclear material was occurring and the maximum number of reactors were operational. Exposure characterization consisted of measured radioactivity in water, sediments, and biota. Two approaches were used in assessing ecological risk to Columbia River organisms. In the first approach, environmental exposure data were used to calculate internal dose to a variety of aquatic organisms, including the most sensitive receptors (fish). In the second approach, measured tissue concentrations were used for selected aquatic organisms to calculate organism internal dose directly. Organism dose was used to assess potential toxic effects and assess regulatory compliance. Risk characterization was developed by comparing dose levels in fish and other organisms found in the Columbia River to known concentrations through a hazard quotient for acute dose and developmental effects

  3. 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

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

    Science.gov (United States)

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

    2017-03-01

    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 remains limited, particularly among general chemicals such as down-the-drain ingredients. While reviewing the current state of the art in environmental exposure and ecological effect modeling, we propose a scenario-based framework that enables a better integration of exposure and effect assessments in a tiered approach. Global- to catchment-scale spatially explicit exposure models can be used to identify areas of higher exposure and to generate ecologically relevant exposure information for input into effect models. Numerous examples of mechanistic ecological effect models demonstrate that it is technically feasible to extrapolate from individual-level effects to effects at higher levels of biological organization and from laboratory to environmental conditions. However, the data required to parameterize effect models that can embrace the complexity of ecosystems are large and require a targeted approach. Experimental efforts should, therefore, focus on vulnerable species and/or traits and ecological conditions of relevance. We outline key research needs to address the challenges that currently hinder the practical application of advanced model-based approaches to risk assessment of down-the-drain chemicals. Integr Environ Assess Manag 2017;13:233-248. © 2016 SETAC. © 2016 SETAC.

  5. Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

    Science.gov (United States)

    Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

    2012-07-01

    Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

  6. Influence of early regulatory problems in infants on their development at 12 months: a longitudinal study in a high-risk sample.

    Science.gov (United States)

    Sidor, Anna; Fischer, Cristina; Eickhorst, Andreas; Cierpka, Manfred

    2013-10-12

    This study examined the extent to which regulatory problems in infants at 4 and 6 months influence childhood development at 12 months. The second aim of the study was to examine the influence maternal distress has on 4-month-old children's subsequent development as well as gender differences with regard to regulatory problems and development. 153 mother-child dyads enrolled in the family support research project "Nobody slips through the net" constituted the comparison group. These families faced psychosocial risks (e.g. poverty, excessive demands on the mother, and mental health disorders of the mother, measured with the risk screening instrument Heidelberger Belastungsskala - HBS) and maternal stress, determined with the Parental Stress Index (PSI-SF). The children's developmental levels and possible early regulatory problems were evaluated by means of the Ages and Stages Questionnaires (ASQ) and a German questionnaire assessing problems of excessive crying along with sleeping and feeding difficulties (SFS). A statistically significant but only low, inverse association between excessive crying, whining and sleep problems at 4 and 6 months and the social development of one-year-olds (accounting for 5% and 8% of the variance respectively) was found. Feeding problems had no effect on development. Although regulatory problems in infants were accompanied by increased maternal stress level, these did not serve as a predictor of the child's social development at 12 months. One-year-old girls reached a higher level of development in social and fine motor skills. No gender differences were found with regard to regulatory problems, nor any moderating effect of gender on the relation between regulatory problems and level of development. Our results reinforce existing knowledge pertaining to the transactional association between regulatory problems in infants, maternal distress and dysfunctionality of mother-child interactions. They also provide evidence of a slight but

  7. Oil spill risk assessment in maritime transportation networks

    International Nuclear Information System (INIS)

    Yudhbir, L.; Iakovou, E.

    2005-01-01

    Commercial shippers and regulatory agencies face the challenge of evaluating the merits of various alternative policies for the transportation of crude oil and petroleum products. This paper presented a new risk estimation and assignment methodology that assesses the risk costs for the bodies of water where shipping lanes exist. The methodology is based on historical spills and uses causal data to estimate risk cost between 2 points of reference for numerous products transported by a variety of vessels. In response to public concerns regarding the environmental impacts of accidental spills from tanker ships, laws have been imposed on companies for all costs relating to environmental damage. This measure has prompted the oil industry to take greater responsibility, but a better understanding of tanker re-routing on environmental sensitive areas is needed in order to implement detailed emergency response plans and greater safety precautions. This methodology addressed the need for an efficient maritime transportation system that provides routing for various vessels carrying different petroleum products. The risk estimation methodology successfully modeled a multi-objective, multi-commodity routing problem. 23 refs., 3 figs

  8. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    Wieland, Patricia; Almeida, Ivan Pedro Salati de

    2011-01-01

    The scientific considerations upon which the nuclear regulations are based provide objective criteria for decisions on nuclear safety matters. However, the decisions that a regulatory agency takes go far beyond granting or not an operating license based on assessment of compliance. It may involve decisions about hiring experts or research, appeals, responses to other government agencies, international agreements, etc.. In all cases, top management of the regulatory agency should hear and decide the best balance between the benefits of regulatory action and undue risks and other associated impacts that may arise, including issues of credibility and reputation. The establishment of a decision framework based on well established principles and criteria ensures performance stability and consistency, preventing individual subjectivity. This article analyzes the challenges to the decision-making by regulatory agencies to ensure coherence and consistency in decisions, even in situations where there is uncertainty, lack of reliable information and even divergence of opinions among experts. The article explores the basic elements for a framework for regulatory decision-making. (author)

  9. Survey and evaluation of aging risk assessment methods and applications

    International Nuclear Information System (INIS)

    Sanzo, D.; Kvam, P.; Apostolakis, G.; Wu, J.; Milici, T.; Ghoniem, N.; Guarro, S.

    1994-11-01

    The US Nuclear Regulatory Commission initiated the nuclear power plant aging research program about 6 years ago to gather information about nuclear power plant aging. Since then, this program has collected a significant amount of information, largely qualitative, on plant aging and its potential effects on plant safety. However, this body of knowledge has not yet been integrated into formalisms that can be used effectively and systematically to assess plant risk resulting from aging, although models for assessing the effect of increasing failure rates on core damage frequency have been proposed. This report surveys the work on the aging of systems, structures, and components (SSCs) of nuclear power plants, as well as associated data bases. We take a critical look at the need to revise probabilistic risk assessments (PRAs) so that they will include the contribution to risk from plant aging, the adequacy of existing methods for evaluating this contribution, and the adequacy of the data that have been used in these evaluation methods. We identify a preliminary framework for integrating the aging of SSCs into the PRA and include the identification of necessary data for such an integration

  10. Development of Risk Insights for Regulatory Review of a Near-Surface Disposal Facility for Radioactive Waste

    International Nuclear Information System (INIS)

    Esh, D.W.; Ridge, A.C.; Thaggard, M.

    2006-01-01

    Section 3116 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (NDAA) requires the Department of Energy (DOE) to consult with the Nuclear Regulatory Commission (NRC) about non-High Level Waste (HLW) determinations. In its consultative role, NRC performs technical reviews of DOE's waste determinations but does not have regulatory authority over DOE's waste disposal activities. The safety of disposal is evaluated by comparing predicted disposal facility performance to the performance objectives specified in NRC regulations for the disposal of low-level waste (10 CFR Part 61 Subpart C). The performance objectives contain criteria for protection of the public, protection of inadvertent intruders, protection of workers, and stability of the disposal site after closure. The potential radiological dose to receptors typically is evaluated with a performance assessment (PA) model that simulates the release of radionuclides from the disposal site, transport of radionuclides through the environment, and exposure of potential receptors to residual contamination for thousands of years. This paper describes NRC's development and use of independent performance assessment modeling to facilitate review of DOE's non-HLW determination for the Saltstone Disposal Facility (SDF) at the Savannah River Site. NRC's review of the safety of near-surface disposal of radioactive waste at the SDF was facilitated and focused by risk insights developed with an independent PA model. The main components of NRC's performance assessment model are presented. The development of risk insights that allow the staff to focus review efforts on those areas that are most important to satisfying the performance objectives is discussed. Uncertainty analysis was performed of the full stochastic model using genetic variable selection algorithms. The results of the uncertainty analysis were then used to guide the development of simulations of other scenarios to understand the key risk

  11. 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.

  12. The California Multimedia Risk Assessment Protocol for Alternative Fuels

    Science.gov (United States)

    Hatch, T.; Ginn, T. R.; McKone, T. E.; Rice, D. W.

    2013-12-01

    Any new fuel in California requires approval by the state agencies overseeing human and environmental health. In order to provide a systematic evaluation of new fuel impacts, California now requires a multimedia risk assessment (MMRA) for fuel approval. The fuel MMRA involves all relevant state agencies including: the California Air Resources Board (CARB), the State Water Resources Control Board (SWRCB), the Office of Environmental Health Hazards Assessment (OEHHA), and the Department of Toxic Substances Control (DTSC) overseen by the California Environmental Protection Agency (CalEPA). The lead agency for MMRAs is the CARB. The original law requiring a multimedia assessment is California Health and Safety Code 43830.8. In addition, the low carbon fuel standard (LCFS), the Global Warming Solutions Act (AB32), and the Verified Diesel Emission Control Strategy (VDECS) have provisions that can require a multimedia assessment. In this presentation, I give an overview of the California multimedia risk assessment (MMRA) for new fuels that has been recently developed and applied to several alternative fuels. The objective of the California MMRA is to assess risk of potential impacts of new fuels to multiple environmental media including: air, water, and soil. Attainment of this objective involves many challenges, including varying levels of uncertainty, relative comparison of incommensurate risk factors, and differing levels of priority assigned to risk factors. The MMRA is based on a strategy of relative risk assessment and flexible accommodation of distinct and diverse fuel formulations. The approach is tiered by design, in order to allow for sequentially more sophisticated investigations as knowledge gaps are identified and re-prioritized by the ongoing research. The assessment also involves peer review in order to provide coupling between risk assessment and stakeholder investment, as well as constructive or confrontational feedback. The multimedia assessment

  13. Benefit-Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products : overall perspective and role of the pharmacoepidemiologist

    NARCIS (Netherlands)

    Radawski, Christine; Morrato, Elaine; Hornbuckle, Kenneth; Bahri, Priya; Smith, Meredith; Juhaeri, Juhaeri; Mol, Peter; Levitan, Bennett; Huang, Han-Yao; Coplan, Paul; Li, Hu

    2015-01-01

    Purpose Optimizing a therapeutic product's benefit-risk profile is an on-going process throughout the product's life cycle. Different, yet related, benefit-risk assessment strategies and frameworks are being developed by various regulatory agencies, industry groups, and stakeholders. This paper

  14. Principles of resource-effectiveness and regulatory-effectiveness for risk-informed applications: Reducing burdens by improving effectiveness

    International Nuclear Information System (INIS)

    Vesely, W.E.

    1999-01-01

    Principles of resource-effectiveness and regulatory-effectiveness are presented which systematically compare the resources expended on a requirement or activity versus its risk importance. To evaluate resource-effectiveness and regulatory-effectiveness, cost-benefit analysis principles are generalized to resource versus risk importance principles. It is shown that by applying resource-importance analyses, current requirements and activities can be systematically evaluated for their resource-effectiveness and their risk-consistency. Strategies can then be developed to maximize both resource-effectiveness and risk-consistency which reduces unnecessary burdens while maintaining risk or reducing risk. The principles, approaches, and implementation schemes which are presented provide a systematic process for evaluating and optimizing resource-effectiveness and regulatory-effectiveness. The illustrations that are presented show that current NRC and industry actions are not resource-effective. By improving their resource-effectiveness and risk-consistency, significant burden reductions are achievable while risk, e.g. core damage frequency, is maintained or is reduced. The illustrations show that by optimizing industry resources and NRC resources with regard to their risk-effectiveness, significant burden reductions are achievable for both the industry and NRC. Algorithms and software exist for broad-scale implementations. Because of the burden reductions which are identified and the improvements in risk-consistency which result, resource-importance analysis should be the first step in risk-informed applications. Resource-importance analysis is so important and can provide such large benefits that it needs to be carried out on all current requirements that are addressed by risk-informed applications

  15. Development of risk-informed assessment (RIA) design methodology

    International Nuclear Information System (INIS)

    Ji, S. K.; Park, S. J.; Park, B. R.; Kim, M. R.; Choi, C. J.

    2001-01-01

    It has been assessed that the capital cost for future nuclear power plants needs to be reduced on the order of 35% to 40% for Advanced Light Water Reactors such as KNGR and System 80+. Such reduction in the capital cost will require a fundamental re-evaluation of the industry standards and regulatory basis under which nuclear plants are designed and licensed. The objective of this study is to develop the risk-informed assessment (RIA) design methodology for future nuclear power plants. In order to meet this objective, the design simplification method is developed and RIA design methodology exercised for conceptual system. For the methodology verification, simplified conceptual ECCS and feedwater system are developed, then LOCA sensitivity analyses and agressive secondary cooldown analyses for these systems are performed. In addition, the probability safety assessment (PSA) model for LOCA is developed and the validation of RIA design methodology is demonstrated

  16. Human exposure to chemical mixtures: Challenges for the integration of toxicology with epidemiology data in risk assessment.

    Science.gov (United States)

    Hernández, Antonio F; Tsatsakis, Aristidis M

    2017-05-01

    Little is known about the potential adverse effects from longterm exposure to complex mixtures at low doses, close to health-based reference values. Traditional chemical-specific risk assessment based on animal testing may be insufficient and the lack of toxicological studies on chemical mixtures remains a major regulatory challenge. Hence, new methodologies on cumulative risk assessment are being developed but still present major limitations. Evaluation of chemical mixture effects requires an integrated and systematic approach and close collaboration across different scientific fields, particularly toxicology, epidemiology, exposure science, risk assessment and statistics for a proper integration of data from all these disciplines. Well designed and conducted epidemiological studies can take advantage of this new paradigm and can provide insight to support the correlation between humans low-dose exposures and diseases, thus avoiding the uncertainty associated with extrapolation across species. In this regard, human epidemiology studies may play a significant role in the new vision of toxicity testing. However, this type of information has not been fully considered in risk assessment, mainly due to the inherent limitations of epidemiologic studies. An integrated approach of in vivo, in vitro and in silico data, together with systematic reviews or meta-analysis of high quality epidemiological studies will improve the robustness of risk assessment of chemical mixtures and will provide a stronger basis for regulatory decisions. The ultimate goal is that experimental and mechanistic data can lend support and biological plausibility to the human epidemiological observations. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. Regulatory cross-cutting topics for fuel cycle facilities.

    Energy Technology Data Exchange (ETDEWEB)

    Denman, Matthew R.; Brown, Jason; Goldmann, Andrew Scott; Louie, David

    2013-10-01

    This report overviews crosscutting regulatory topics for nuclear fuel cycle facilities for use in the Fuel Cycle Research & Development Nuclear Fuel Cycle Evaluation and Screening study. In particular, the regulatory infrastructure and analysis capability is assessed for the following topical areas: Fire Regulations (i.e., how applicable are current Nuclear Regulatory Commission (NRC) and/or International Atomic Energy Agency (IAEA) fire regulations to advance fuel cycle facilities) Consequence Assessment (i.e., how applicable are current radionuclide transportation tools to support risk-informed regulations and Level 2 and/or 3 PRA) While not addressed in detail, the following regulatory topic is also discussed: Integrated Security, Safeguard and Safety Requirement (i.e., how applicable are current Nuclear Regulatory Commission (NRC) regulations to future fuel cycle facilities which will likely be required to balance the sometimes conflicting Material Accountability, Security, and Safety requirements.)

  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. Depressive symptoms, post-traumatic stress symptoms and suicide risk among graduate students: The mediating influence of emotional regulatory self-efficacy.

    Science.gov (United States)

    Zeng, Baoer; Zhao, Jiubo; Zou, Laiquan; Yang, Xueling; Zhang, Xiaoyuan; Wang, Wanjun; Zhao, Jingbo; Chen, Jie

    2018-06-01

    The current study was to examine the relationship among depressive symptoms, post-traumatic stress symptoms, emotion regulatory self-efficacy and suicide risk. A cross-sectional survey was conducted among 3257 graduate students from a medical college of China. Lifetime prevalence of suicidal ideation, plan and attempt were 25.7%, 1.6%, 1.1%, respectively, with one-year suicidal ideation showing at 6.3%. Structural equation modeling was employed to examine the relative contribution of depressive symptoms, post-traumatic stress symptoms and emotion regulatory self-efficacy on suicide risk. Structural equation model had a highly satisfactory fit [χ 2  = 7.782, df = 4, p = 0.096; RMSEA = 0.021; CFI = 0.992; GFI = 0.997]. Post-traumatic stress symptoms had a direct effect and an indirect effect on suicide risk via emotion regulatory self-efficacy. Depressive symptoms also had a direct effect and an indirect effect on suicide risk via emotion regulatory self-efficacy. The depressive and post-traumatic stress symptoms increased the risk of suicide risk, but the variable of emotion regulatory self-efficacy would be served as a buffering factor, decreasing the risk of suicide. The interaction term of depressive symptoms and post-traumatic stress symptoms had a direct effect on suicide risk. A significant interactive effect of depressive and post-traumatic stress symptoms on suicide risk was found. Copyright © 2018 Elsevier B.V. All rights reserved.

  20. 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

  1. A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer.

    Science.gov (United States)

    Raju, G K; Gurumurthi, K; Domike, R; Kazandjian, D; Blumenthal, G; Pazdur, R; Woodcock, J

    2016-12-01

    Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analyses. There is much interest in quantifying regulatory approaches to benefit and risk. In this work the use of a quantitative benefit-risk analysis was applied to regulatory decision-making about new drugs to treat advanced non-small cell lung cancer (NSCLC). Benefits and risks associated with 20 US Food and Drug Administration (FDA) decisions associated with a set of candidate treatments submitted between 2003 and 2015 were analyzed. For benefit analysis, the median overall survival (OS) was used where available. When not available, OS was estimated based on overall response rate (ORR) or progression-free survival (PFS). Risks were analyzed based on magnitude (or severity) of harm and likelihood of occurrence. Additionally, a sensitivity analysis was explored to demonstrate analysis of systematic uncertainty. FDA approval decision outcomes considered were found to be consistent with the benefit-risk logic. © 2016 American Society for Clinical Pharmacology and Therapeutics.

  2. Health risk assessment of dichloromethane (methylene chloride) in California ground water

    International Nuclear Information System (INIS)

    Bogen, K.T.; Hall, L.C.; Wright, K.; McKone, T.E.

    1992-01-01

    This document presents an assessment of potential health risks associated with exposure to dichloromethane (DCM) dissolved in California drinking water, focusing primarily on information relevant to a determination of potential cancer risk that may be associated with such exposures to DCM. This assessment is being provided to the California Environmental Protection Agency for the development of drinking-water standards to manage the health risks of DCM exposures. Other assessments required in the risk-management process include analyses of the technical and economic feasibilities of treating water supplies contaminated with DCM. The primary goal of this health-risk assessment is to evaluate scientifically plausible dose-response relationships for observed and potential DCM-induced cancer in order to define dose rates that can be used to establish standards that win protect members of the general public from this chronic toxicity endpoint resulting solely from groundwater-based exposures to DCM, based on information obtained from the scientific literature. The document consists of seven sections, plus one supporting appendix. Each section provides information that can be used to develop DCM drinking-water standards that will safeguard human health. Evaluation of this information in support of specific groundwater safety standards for DCM was not conducted in this report; rather, the basis for selection of alternative standards, along with a narrative description of certain key sources of underlying uncertainty, are presented for evaluation through the regulatory risk-management process

  3. Rethinking risk assessment for emerging technology first-in-human trials.

    Science.gov (United States)

    Genske, Anna; Engel-Glatter, Sabrina

    2016-03-01

    Recent progress in synthetic biology (SynBio) has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials (FIH) will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including 'risk' minimization. These concerns are associated with any FIH trial, however, due to the novelty of the approach, they become more pronounced for medical applications of emerging technologies (emTech) like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using 'risk assessment' as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as 'risk' and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue.

  4. Use of reliability engineering tools in safety and risk assessment of nuclear facilities

    Energy Technology Data Exchange (ETDEWEB)

    Raso, Amanda Laureano; Vasconcelos, Vanderley de; Marques, Raíssa Oliveira; Soares, Wellington Antonio; Mesquita, Amir Zacarias, E-mail: amandaraso@hotmail.com, E-mail: vasconv@cdtn.br, E-mail: raissaomarques@gmail.com, E-mail: soaresw@cdtn.br, E-mail: amir@cdtn.br [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte, MG (Brazil). Serviço de Tecnologia de Reatores

    2017-07-01

    Safety, reliability and availability are fundamental criteria in design, construction and operation of nuclear facilities, as nuclear power plants. Deterministic and probabilistic risk assessments of such facilities are required by regulatory authorities in order to meet licensing regulations, contributing to assure safety, as well as reduce costs and environmental impacts. Probabilistic Risk Assessment has become an important part of licensing requirements of the nuclear power plants in Brazil and in the world. Risk can be defined as a qualitative and/or quantitative assessment of accident sequence frequencies (or probabilities) and their consequences. Risk management is a systematic application of management policies, procedures and practices to identify, analyze, plan, implement, control, communicate and document risks. Several tools and computer codes must be combined, in order to estimate both probabilities and consequences of accidents. Event Tree Analysis (ETA), Fault Tree Analysis (FTA), Reliability Block Diagrams (RBD), and Markov models are examples of evaluation tools that can support the safety and risk assessment for analyzing process systems, identifying potential accidents, and estimating consequences. Because of complexity of such analyzes, specialized computer codes are required, such as the reliability engineering software develop by Reliasoft® Corporation. BlockSim (FTA, RBD and Markov models), RENO (ETA and consequence assessment), Weibull++ (life data and uncertainty analysis), and Xfmea (qualitative risk assessment) are some codes that can be highlighted. This work describes an integrated approach using these tools and software to carry out reliability, safety, and risk assessment of nuclear facilities, as well as, and application example. (author)

  5. Use of reliability engineering tools in safety and risk assessment of nuclear facilities

    International Nuclear Information System (INIS)

    Raso, Amanda Laureano; Vasconcelos, Vanderley de; Marques, Raíssa Oliveira; Soares, Wellington Antonio; Mesquita, Amir Zacarias

    2017-01-01

    Safety, reliability and availability are fundamental criteria in design, construction and operation of nuclear facilities, as nuclear power plants. Deterministic and probabilistic risk assessments of such facilities are required by regulatory authorities in order to meet licensing regulations, contributing to assure safety, as well as reduce costs and environmental impacts. Probabilistic Risk Assessment has become an important part of licensing requirements of the nuclear power plants in Brazil and in the world. Risk can be defined as a qualitative and/or quantitative assessment of accident sequence frequencies (or probabilities) and their consequences. Risk management is a systematic application of management policies, procedures and practices to identify, analyze, plan, implement, control, communicate and document risks. Several tools and computer codes must be combined, in order to estimate both probabilities and consequences of accidents. Event Tree Analysis (ETA), Fault Tree Analysis (FTA), Reliability Block Diagrams (RBD), and Markov models are examples of evaluation tools that can support the safety and risk assessment for analyzing process systems, identifying potential accidents, and estimating consequences. Because of complexity of such analyzes, specialized computer codes are required, such as the reliability engineering software develop by Reliasoft® Corporation. BlockSim (FTA, RBD and Markov models), RENO (ETA and consequence assessment), Weibull++ (life data and uncertainty analysis), and Xfmea (qualitative risk assessment) are some codes that can be highlighted. This work describes an integrated approach using these tools and software to carry out reliability, safety, and risk assessment of nuclear facilities, as well as, and application example. (author)

  6. 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 ...

  7. Does flood risk information held within at risk population always have a positive impact? An evaluation of the effects of French regulatory tools in Orleans

    Directory of Open Access Journals (Sweden)

    Jadot Julien

    2016-01-01

    Full Text Available French law on major risk preventive information for population setup the objective to make the citizen able to act for his own safety and to participate through his behaviour to the civil security. To reach this objective, the policymakers developed 4 regulatory tools that have to be implemented by the local authorities. These 4 tools do not meet the success factors of risk communication measures aiming at inducing behavioural adaptation to face risks. This, added to the fact that people who die in the last floods events in France lost their lives due to either a lack of knowledge of the risk or to a risk taking behaviour, led us to question the impact of the preventive information regulatory tools. For the needs of our study we developed a risk perception and behaviour scale, helping us to classify the people of our sample. Our evaluation in Orléans shows that very few people know the regulatory tools and that their impact is quite low, far from the policymakers’ expectations. This highlight the real necessity to innovate in the field of flood risk communication.

  8. Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines : Current Status and Possible Future Directions

    NARCIS (Netherlands)

    Pignatti, F.; Ashby, D.; Brass, E. P.; Eichler, H-G; Frey, P.; Hillege, H. L.; Hori, A.; Levitan, B.; Liberti, L.; Loefstedt, R. E.; McAuslane, N.; Micaleff, A.; Noel, R. A.; Postmus, D.; Renn, O.; Sabourin, B. J.; Salmonson, T.; Walker, S.

    2015-01-01

    Structured frameworks for benefit-risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of these frameworks is to aid the analysis and communication of the benefit-risk assessment throughout the development, evaluation, and

  9. Study on risk factors of PWR accidents beyond design basis

    International Nuclear Information System (INIS)

    Ahn, Seung Hoon; Nah, W. J.; Bang, Y. S.; Oh, D. Y.; Oh, S. H.

    2005-01-01

    Development of the regulatory guidelines for Beyond Design Basis Accidents (BDBA) with high risk requires a detailed investigation of major factors contributing to the event risk. In this study, each event was classified by the level of risk, based on the probabilistic safety assessment results, so that BDBA with high risk could be selected, with consideration of foreign and domestic regulations, and operating experiences. The regulatory requirements and technical backgrounds for the selected accidents were investigated, and effective regulatory approaches for risk reduction of the accidents. The following conclusions were drawn from this study: - Selected high risk BDBA is station blackout, anticipated without scram, total loss of feedwater. - Major contributors to the risk of selected events were investigated, and appropriate assessment of them was recommended for development of the regulatory guidelines

  10. 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.

  11. 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.

  12. 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...

  13. 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

  14. 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)

  15. Risk assessment of severe accident-induced steam generator tube rupture

    International Nuclear Information System (INIS)

    1998-03-01

    This report describes the basis, results, and related risk implications of an analysis performed by an ad hoc working group of the U.S. Nuclear Regulatory Commission (NRC) to assess the containment bypass potential attributable to steam generator tube rupture (SGTR) induced by severe accident conditions. The SGTR Severe Accident Working Group, comprised of staff members from the NRC's Offices of Nuclear Reactor Regulation (NRR) and Nuclear Regulatory Research (RES), undertook the analysis beginning in December 1995 to support a proposed steam generator integrity rule. The work drew upon previous risk and thermal-hydraulic analyses of core damage sequences, with a focus on the Surry plant as a representative example. This analysis yielded new results, however, derived by predicting thermal-hydraulic conditions of selected severe accident scenarios using the SCDAP/RELAP5 computer code, flawed tube failure modeling, and tube failure probability estimates. These results, in terms of containment bypass probability, form the basis for the findings presented in this report. The representative calculation using Surry plant data indicates that some existing plants could be vulnerable to containment bypass resulting from tube failure during severe accidents. To specifically identify the population of plants that may pose a significant bypass risk would require more definitive analysis considering uncertainties in some assumptions and plant- and design-specific variables. 46 refs., 62 figs., 37 tabs

  16. 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.

  17. 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

  18. Regulatory Impact Assessment (RIA and Rationality of Law – Legal Aspects

    Directory of Open Access Journals (Sweden)

    Jan Chmielewski

    2015-06-01

    Full Text Available Purpose: The fundamental aim of this article is to verify an assumption according to which the proper Regulatory Impact Assessment (RIA is a key factor in the rationality of law. Rational law is a law which is effective and able to realize and achieve social, economic and environmental aims determined and established by the lawmaker. Methodology: The scope of this paper – which determines its structure – encompasses the definition of RIA, including its specific (but non-legal forms such as benchmarking and evaluation. As far as we are concerned, these methods can provide – as a kind of Regulatory Impact Assessment a significant tool for measuring the rationality of regulations. Furthermore, the usefulness of benchmarking and evaluation has been recognised by representatives of jurisprudence. We will also explain the concept and the assumptions of the rationality of law on the grounds and in the light of the case law of the Polish Constitutional Tribunal and the Supreme Administrative Court. This should allow to countercheck the main thesis of this paper. The methodology encompasses primary legal methods such as literature, case law and legislation analysis. Findings: An indispensable condition of the rationality of law is actual elimination of irrational regulations which were not subjected to the Regulatory Impact Assessment. Practical implications: Although RIA is a problematic issue (in terms of its practical application,it is necessary to carry it out in order to assure the rationality of law. A good and desirable complement to Regulatory Impact Assessment are non-legal methods such as benchmarking and evaluation. Originality: Originality and value of this survey lies in taking into account the case law of the Polish Constitutional Tribunal and the Supreme Administrative Court. Additionally, this paper is original in that it considers non-legal methods in the examination of the rationality of law.

  19. 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

  20. 75 FR 53998 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-09-02

    ... characteristics and risks of security futures. \\6\\ 15 U.S.C. 78o-3(b)(6). B. Self-Regulatory Organization's...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Security Futures Risk Disclosure Statement August 27, 2010...

  1. Lessons learned from first generation nuclear plant probabalistic risk assessments

    International Nuclear Information System (INIS)

    Garrick, B.J.

    1984-01-01

    The paper by Garrick summarizes the state-of-the-art in what are perhaps the most archetypical probabilistic risk assessments (PRAs). Because of its unique regulatory environment and because of the high levels of perceived (not necessarily actual) risk, the nuclear industry more than any other has been concerned with quantitative risk analysis. Garrick's paper summarizes the lessons learned from ten PRA's conducted in the nuclear industry, including six that can be characterized as full-scope risk studies. Most of the quantitative data, though, came from two especially thorough studies done for the Zion and Indian Point power plants, operated by Commonwealth Edison and Consolidated Edison respectively. The principal conclusions of the Garrick survey are that the public risk (from radiation release) is now known to be very small for commercial nuclear power plants, but that the risk to utilities (from core damage) is somewhat larger. Significant radiation releases require both core meltdown -- an event occurring only about once every 10,000 reactor-years -- and containment failure, occurring only about once in every hundred meltdowns

  2. Radio-ecological characterization and radiological assessment in support of regulatory supervision of legacy sites in northwest Russia

    International Nuclear Information System (INIS)

    Sneve, M.K.; Kiselev, M.; Shandala, N.K.

    2014-01-01

    The Norwegian Radiation Protection Authority has been implementing a regulatory cooperation program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective has been the enhancement of safety culture and includes a special focus on regulatory supervision of nuclear legacy sites. The initial project outputs included appropriate regulatory threat assessments, to determine the hazardous situations and activities which are most in need of enhanced regulatory supervision. In turn, this has led to the development of new and updated norms and standards, and related regulatory procedures, necessary to address the often abnormal conditions at legacy sites. This paper presents the experience gained within the above program with regard to radio-ecological characterization of Sites of Temporary Storage for spent nuclear fuel and radioactive waste at Andreeva Bay and Gremikha in the Kola Peninsula in northwest Russia. Such characterization is necessary to support assessments of the current radiological situation and to support prospective assessments of its evolution. Both types of assessments contribute to regulatory supervision of the sites. Accordingly, they include assessments to support development of regulatory standards and guidance concerning: control of radiation exposures to workers during remediation operations; emergency preparedness and response; planned radionuclide releases to the environment; development of site restoration plans, and waste treatment and disposal. Examples of characterization work are presented which relate to terrestrial and marine environments at Andreeva Bay. The use of this data in assessments is illustrated by means of the visualization and assessment tool (DATAMAP) developed as part of the regulatory cooperation program, specifically to help control radiation exposure in operations and to support

  3. 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...

  4. Risk-Informed Assessment Methodology Development and Application

    International Nuclear Information System (INIS)

    Sung Goo Chi; Seok Jeong Park; Chul Jin Choi; Ritterbusch, S.E.; Jacob, M.C.

    2002-01-01

    Westinghouse Electric Company (WEC) has been working with Korea Power Engineering Company (KOPEC) on a US Department of Energy (DOE) sponsored Nuclear Energy Research Initiative (NERI) project through a collaborative agreement established for the domestic NERI program. The project deals with Risk-Informed Assessment (RIA) of regulatory and design requirements of future nuclear power plants. An objective of the RIA project is to develop a risk-informed design process, which focuses on identifying and incorporating advanced features into future nuclear power plants (NPPs) that would meet risk goals in a cost-effective manner. The RIA design methodology is proposed to accomplish this objective. This paper discusses the development of this methodology and demonstrates its application in the design of plant systems for future NPPs. Advanced conceptual plant systems consisting of an advanced Emergency Core Cooling System (ECCS) and Emergency Feedwater System (EFWS) for a NPP were developed and the risk-informed design process was exercised to demonstrate the viability and feasibility of the RIA design methodology. Best estimate Loss-of-Coolant Accident (LOCA) analyses were performed to validate the PSA success criteria for the NPP. The results of the analyses show that the PSA success criteria can be met using the advanced conceptual systems and that the RIA design methodology is a viable and appropriate means of designing key features of risk-significant NPP systems. (authors)

  5. 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

  6. 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

  7. Current products and future plan of regulatory technology R and D for risk-informed regulation and applications

    International Nuclear Information System (INIS)

    Song, K. Y.; Lee, C. J.; Kim, W. S.; Jeong, D. W.; Kim, H. J.

    2002-01-01

    The first phase of a R and D project for risk-informed regulation (RIR) and applications (RIA) has been finished. Various results which would be useful for preparing domestic RIR system were accomplished, in areas of safety goals and general principles of RIR, which provide fundamental bases for establishment of RIR system as well as regulatory review guides, which ensure the quality for PSA. RIA guidelines for ISI, IST, MOV, Tech.-Sepc. also have been developed, implementing some pilot plant applications. As essential documents for actual RIR inspection, risk-informed inspection guides and implementation guide for maintenance effectiveness were prepared. In the second phase of R and D, two projects on RIR area will be performed. One is to study on institutionalization of RIR and performance-based regulation, another is to develop a PSA model for regulatory audit as well as regulatory technology for risk monitoring

  8. [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.

  9. 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

  10. Radio-ecological characterization and radiological assessment in support of regulatory supervision of legacy sites in northwest Russia.

    Science.gov (United States)

    Sneve, M K; Kiselev, M; Shandala, N K

    2014-05-01

    The Norwegian Radiation Protection Authority has been implementing a regulatory cooperation program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective has been the enhancement of safety culture and includes a special focus on regulatory supervision of nuclear legacy sites. The initial project outputs included appropriate regulatory threat assessments, to determine the hazardous situations and activities which are most in need of enhanced regulatory supervision. In turn, this has led to the development of new and updated norms and standards, and related regulatory procedures, necessary to address the often abnormal conditions at legacy sites. This paper presents the experience gained within the above program with regard to radio-ecological characterization of Sites of Temporary Storage for spent nuclear fuel and radioactive waste at Andreeva Bay and Gremikha in the Kola Peninsula in northwest Russia. Such characterization is necessary to support assessments of the current radiological situation and to support prospective assessments of its evolution. Both types of assessments contribute to regulatory supervision of the sites. Accordingly, they include assessments to support development of regulatory standards and guidance concerning: control of radiation exposures to workers during remediation operations; emergency preparedness and response; planned radionuclide releases to the environment; development of site restoration plans, and waste treatment and disposal. Examples of characterization work are presented which relate to terrestrial and marine environments at Andreeva Bay. The use of this data in assessments is illustrated by means of the visualization and assessment tool (DATAMAP) developed as part of the regulatory cooperation program, specifically to help control radiation exposure in operations and to support

  11. 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.

  12. 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

  13. 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.

  14. A method of quantitative risk assessment for transmission pipeline carrying natural gas

    International Nuclear Information System (INIS)

    Jo, Young-Do; Ahn, Bum Jong

    2005-01-01

    Regulatory authorities in many countries are moving away from prescriptive approaches for keeping natural gas pipelines safe. As an alternative, risk management based on a quantitative assessment is being considered to improve the level of safety. This paper focuses on the development of a simplified method for the quantitative risk assessment for natural gas pipelines and introduces parameters of fatal length and cumulative fatal length. The fatal length is defined as the integrated fatality along the pipeline associated with hypothetical accidents. The cumulative fatal length is defined as the section of pipeline in which an accident leads to N or more fatalities. These parameters can be estimated easily by using the information of pipeline geometry and population density of a Geographic Information Systems (GIS). To demonstrate the proposed method, individual and societal risks for a sample pipeline have been estimated from the historical data of European Gas Pipeline Incident Data Group and BG Transco. With currently acceptable criteria taken into account for individual risk, the minimum proximity of the pipeline to occupied buildings is approximately proportional to the square root of the operating pressure of the pipeline. The proposed method of quantitative risk assessment may be useful for risk management during the planning and building stages of a new pipeline, and modification of a buried pipeline

  15. 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

  16. 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

  17. 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

  18. Application of probabilistic risk assessment to advanced liquid metal reactor designs

    International Nuclear Information System (INIS)

    Carroll, W.P.; Temme, M.I.

    1987-01-01

    The United States Department of Energy (US DOE) has been active in the development and application of probabilistic risk assessment methods within its liquid metal breeder reactor development program for the past eleven years. These methods have been applied to comparative risk evaluations, the selection of design features for reactor concepts, the selection and emphasis of research and development programs, and regulatory discussions. The application of probabilistic methods to reactors which are in the conceptual design stage presents unique data base, modeling, and timing challenges, and excellent opportunities to improve the final design. We provide here the background and insights on the experience which the US DOE liquid metal breeder reactor program has had in its application of probabilistic methods to the Clinch River Breeder Reactor Plant project, the Conceptual Design State of the Large Development Plant, and updates on this design. Plans for future applications of probabilistic risk assessment methods are also discussed. The US DOE is embarking on an innovative design program for liquid metal reactors. (author)

  19. 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.

  20. A workshop on developing risk assessment methods for medical use of radioactive material. Volume 2: Supporting documents

    Energy Technology Data Exchange (ETDEWEB)

    Tortorelli, J.P. [ed.] [Lockheed Idaho Technologies Co., Idaho Falls, ID (United States)

    1995-08-01

    A workshop was held at the Idaho National Engineering Laboratory, August 16--18, 1994 on the topic of risk assessment on medical devices that use radioactive isotopes. Its purpose was to review past efforts to develop a risk assessment methodology to evaluate these devices, and to develop a program plan and a scoping document for future methodology development. This report contains presentation material and a transcript of the workshop. Participants included experts in the fields of radiation oncology, medical physics, risk assessment, human-error analysis, and human factors. Staff from the US Nuclear Regulatory Commission (NRC) associated with the regulation of medical uses of radioactive materials and with research into risk-assessment methods participated in the workshop. The workshop participants concurred in NRC`s intended use of risk assessment as an important technology in the development of regulations for the medical use of radioactive material and encouraged the NRC to proceed rapidly with a pilot study. Specific recommendations are included in the executive summary and the body of this report.

  1. A workshop on developing risk assessment methods for medical use of radioactive material. Volume 2: Supporting documents

    International Nuclear Information System (INIS)

    Tortorelli, J.P.

    1995-08-01

    A workshop was held at the Idaho National Engineering Laboratory, August 16--18, 1994 on the topic of risk assessment on medical devices that use radioactive isotopes. Its purpose was to review past efforts to develop a risk assessment methodology to evaluate these devices, and to develop a program plan and a scoping document for future methodology development. This report contains presentation material and a transcript of the workshop. Participants included experts in the fields of radiation oncology, medical physics, risk assessment, human-error analysis, and human factors. Staff from the US Nuclear Regulatory Commission (NRC) associated with the regulation of medical uses of radioactive materials and with research into risk-assessment methods participated in the workshop. The workshop participants concurred in NRC's intended use of risk assessment as an important technology in the development of regulations for the medical use of radioactive material and encouraged the NRC to proceed rapidly with a pilot study. Specific recommendations are included in the executive summary and the body of this report

  2. Spatial interactions database development for effective probabilistic risk assessment

    International Nuclear Information System (INIS)

    Liming, J. K.; Dunn, R. F.

    2008-01-01

    In preparation for a subsequent probabilistic risk assessment (PRA) fire risk analysis update, the STP Nuclear Operating Company (STPNOC) is updating its spatial interactions database (SID). This work is being performed to support updating the spatial interactions analysis (SIA) initially performed for the original South Texas Project Electric Generating Station (STPEGS) probabilistic safely assessment (PSA) and updated in the STPEGS Level 2 PSA and IPE Report. S/A is a large-scope screening analysis performed for nuclear power plant PRA that serves as a prerequisite basis for more detailed location-dependent, hazard-spec analyses in the PRA, such as fire risk analysis, flooding risk analysis, etc. SIA is required to support the 'completeness' argument for the PRA scope. The objectives of the current SID development effort are to update the spatial interactions analysis data, to the greatest degree practical, to be consistent with the following: the as-built plant as of December 31, 2007 the in-effect STPNOC STPEGS Units 1 and 2 PRA the current technology and intent of NUREG/CR-6850 guidance for lire risk analysis database support the requirements for PRA SIA, including fire and flooding risk analysis, established by NRC Regulatory Guide 1.200 and the ASME PRA Standard (ASME RA-S-2002 updated through ASME RA-Sc-2007,) This paper presents the approach and methodology for state-of-the-art SID development and applications, including an overview of the SIA process for nuclear power plant PRA. The paper shows how current relational database technology and existing, conventional station information sources can be employed to collect, process, and analyze spatial interactions data for the plant in an effective and efficient manner to meet the often challenging requirements of industry guidelines and standards such as NUREG/CR-6850, NRC Regulatory Guide 1.200, and ASME RA-S-2002 (updated through ASME RA-Sc 2007). This paper includes tables and figures illustrating how SIA

  3. A quantitative assessment of risks of heavy metal residues in laundered shop towels and their use by workers.

    Science.gov (United States)

    Connor, Kevin; Magee, Brian

    2014-10-01

    This paper presents a risk assessment of exposure to metal residues in laundered shop towels by workers. The concentrations of 27 metals measured in a synthetic sweat leachate were used to estimate the releasable quantity of metals which could be transferred to workers' skin. Worker exposure was evaluated quantitatively with an exposure model that focused on towel-to-hand transfer and subsequent hand-to-food or -mouth transfers. The exposure model was based on conservative, but reasonable assumptions regarding towel use and default exposure factor values from the published literature or regulatory guidance. Transfer coefficients were derived from studies representative of the exposures to towel users. Contact frequencies were based on assumed high-end use of shop towels, but constrained by a theoretical maximum dermal loading. The risk estimates for workers developed for all metals were below applicable regulatory risk benchmarks. The risk assessment for lead utilized the Adult Lead Model and concluded that predicted lead intakes do not constitute a significant health hazard based on potential worker exposures. Uncertainties are discussed in relation to the overall confidence in the exposure estimates developed for each exposure pathway and the likelihood that the exposure model is under- or overestimating worker exposures and risk. Copyright © 2014 Elsevier Inc. All rights reserved.

  4. Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

    Science.gov (United States)

    Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

    2016-01-01

    Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

  5. Risk assessment of nonhazardous oil-field waste disposal in salt caverns.

    Energy Technology Data Exchange (ETDEWEB)

    Elcock, D.

    1998-03-10

    that if caverns are sited and designed well, operated carefully, closed properly, and monitored routinely, they could, from technical and legal perspectives, be suitable for disposing of oil-field wastes. On the basis of these findings, ANL subsequently conducted a preliminary risk assessment on the possibility that adverse human health effects (carcinogenic and noncarcinogenic) could result from exposure to contaminants released from the NOW disposed of in salt caverns. The methodology for the risk assessment included the following steps: identifying potential contaminants of concern; determining how humans could be exposed to these contaminants; assessing contaminant toxicities; estimating contaminant intakes; and estimating human cancer and noncancer risks. To estimate exposure routes and pathways, four postclosure cavern release scenarios were assessed. These were inadvertent cavern intrusion, failure of the cavern seal, failure of the cavern through cracks, failure of the cavern through leaky interbeds, and partial collapse of the cavern roof. Assuming a single, generic, salt cavern and generic oil-field wastes, potential human health effects associated with constituent hazardous substances (arsenic, benzene, cadmium, and chromium) were assessed under each of these scenarios. Preliminary results provided excess cancer risk and hazard index (for noncancer health effects) estimates that were well within the EPA target range for acceptable exposure risk levels. These results lead to the preliminary conclusion that from a human health perspective, salt caverns can provide an acceptable disposal method for nonhazardous oil-field wastes.

  6. Risk assessment of nonhazardous oil-field waste disposal in salt caverns

    International Nuclear Information System (INIS)

    Elcock, D.

    1998-01-01

    that if caverns are sited and designed well, operated carefully, closed properly, and monitored routinely, they could, from technical and legal perspectives, be suitable for disposing of oil-field wastes. On the basis of these findings, ANL subsequently conducted a preliminary risk assessment on the possibility that adverse human health effects (carcinogenic and noncarcinogenic) could result from exposure to contaminants released from the NOW disposed of in salt caverns. The methodology for the risk assessment included the following steps: identifying potential contaminants of concern; determining how humans could be exposed to these contaminants; assessing contaminant toxicities; estimating contaminant intakes; and estimating human cancer and noncancer risks. To estimate exposure routes and pathways, four postclosure cavern release scenarios were assessed. These were inadvertent cavern intrusion, failure of the cavern seal, failure of the cavern through cracks, failure of the cavern through leaky interbeds, and partial collapse of the cavern roof. Assuming a single, generic, salt cavern and generic oil-field wastes, potential human health effects associated with constituent hazardous substances (arsenic, benzene, cadmium, and chromium) were assessed under each of these scenarios. Preliminary results provided excess cancer risk and hazard index (for noncancer health effects) estimates that were well within the EPA target range for acceptable exposure risk levels. These results lead to the preliminary conclusion that from a human health perspective, salt caverns can provide an acceptable disposal method for nonhazardous oil-field wastes

  7. Recent developments in the external hazard risk assessment in Ukraine

    International Nuclear Information System (INIS)

    2000-01-01

    Ukrainian legislation prescribes safety analysis reports for all operating and future NPPs. Apart from main report they must include: safety analysis supplement; design basis accident analysis; beyond design basis accident analysis; probabilistic safety assessment (PSA); technical; substantiation of safety. Regulatory requirements to PSA contents cover the criteria for core damage frequency and large radioactive release frequency. Initiating events taken into account are internal events; internal hazards and external hazards. External hazards to be considered are seismic events, external fires, external floods, extreme ambient temperatures, aircraft crashes, etc. Current status of PSA development is related to operating WWER-440 and WWER-1000 NPPs and NPPs under construction. This presentation describes in detail the external hazard risk assessment for South Ukraine including methodology applied and expected future activities

  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. 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

  10. 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...

  11. 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.

  12. Evolution in performance assessment modeling as a result of regulatory review

    Energy Technology Data Exchange (ETDEWEB)

    Rowat, J.H.; Dolinar, G.M.; Stephens, M.E. [AECL Chalk River Labs., Ontario (Canada)] [and others

    1995-12-31

    AECL is planning to build the IRUS (Intrusion Resistant Underground Structure) facility for near-surface disposal of LLRW. The PSAR (preliminary safety assessment report) was subject to an initial regulatory review during mid-1992. The regulatory authority provided comments on many aspects of the safety assessment documentation including a number of questions on specific PA (Performance Assessment) modelling assumptions. As a result of these comments as well as a separate detailed review of the IRUS disposal concept, changes were made to the conceptual and mathematical models. The original disposal concept included a non-sorbing vault backfill, with a strong reliance on the wasteform as a barrier. This concept was altered to decrease reliance on the wasteform by replacing the original backfill with a sand/clinoptilolite mix, which is a better sorber of metal cations. This change lead to changes in the PA models which in turn altered the safety case for the facility. This, and other changes that impacted performance assessment modelling are the subject of this paper.

  13. 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

  14. Application of omics data in regulatory toxicology: report of an international BfR expert workshop.

    Science.gov (United States)

    Marx-Stoelting, P; Braeuning, A; Buhrke, T; Lampen, A; Niemann, L; Oelgeschlaeger, M; Rieke, S; Schmidt, F; Heise, T; Pfeil, R; Solecki, R

    2015-11-01

    Advances in omics techniques and molecular toxicology are necessary to provide new perspectives for regulatory toxicology. By the application of modern molecular techniques, more mechanistic information should be gained to support standard toxicity studies and to contribute to a reduction and refinement of animal experiments required for certain regulatory purposes. The relevance and applicability of data obtained by omics methods to regulatory purposes such as grouping of chemicals, mode of action analysis or classification and labelling needs further improvement, defined validation and cautious expert judgment. Based on the results of an international expert workshop organized 2014 by the Federal Institute for Risk Assessment in Berlin, this paper is aimed to provide a critical overview of the regulatory relevance and reliability of omics methods, basic requirements on data quality and validation, as well as regulatory criteria to decide which effects observed by omics methods should be considered adverse or non-adverse. As a way forward, it was concluded that the inclusion of omics data can facilitate a more flexible approach for regulatory risk assessment and may help to reduce or refine animal testing.

  15. Transcriptomic resources for environmental risk assessment: a case study in the Venice lagoon

    International Nuclear Information System (INIS)

    Milan, M.; Pauletto, M.; Boffo, L.; Carrer, C.; Sorrentino, F.; Ferrari, G.; Pavan, L.; Patarnello, T.; Bargelloni, L.

    2015-01-01

    The development of new resources to evaluate the environmental status is becoming increasingly important representing a key challenge for ocean and coastal management. Recently, the employment of transcriptomics in aquatic toxicology has led to increasing initiatives proposing to integrate eco-toxicogenomics in the evaluation of marine ecosystem health. However, several technical issues need to be addressed before introducing genomics as a reliable tool in regulatory ecotoxicology. The Venice lagoon constitutes an excellent case, in which the assessment of environmental risks derived from the nearby industrial activities represents a crucial task. In this context, the potential role of genomics to assist environmental monitoring was investigated through the definition of reliable gene expression markers associated to chemical contamination in Manila clams, and their subsequent employment for the classification of Venice lagoon areas. Overall, the present study addresses key issues to evaluate the future outlooks of genomics in the environmental monitoring and risk assessment. - Highlights: • Growing need to develop new resources for the evaluation of the environmental status. • Identification of gene expression markers associated to chemical contamination. • Employment of genomics to evaluate the environmental status of Venice lagoon areas. • Hurdles and future outlooks of genomic tools in environmental risk assessment. - Genomics in risk assessment of Venice lagoon

  16. 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)

  17. 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

  18. Risk Perceptions in Diabetic Patients Who Have Experienced Adverse Events: Implications for Patient Involvement in Regulatory Decisions.

    Science.gov (United States)

    Sachs, Mikkel Lindskov; Sporrong, Sofia Kälvemark; Colding-Jørgensen, Morten; Frokjaer, Sven; Helboe, Per; Jelic, Katarina; Kaae, Susanne

    2017-01-01

    Increasingly, patients are expected to influence decisions previously reserved for regulatory agencies, pharmaceutical companies, and healthcare professionals. Individual patients have previously represented their patient population when rare, serious adverse events (AEs) were weighed as part of a benefit-risk assessment. However, the degree of heterogeneity of the patient population is critical for how accurately they can be represented by individuals. This study aims to explore patients' risk perception of rare, serious adverse effects of medicines with regard to blood glucose-lowering antidiabetics used by the individual patient. Semi-structured interviews were conducted with 18 patients with diabetes with self-perceived serious, but not necessarily rare, AEs (e.g. stroke or valve or bypass surgery). The interviews explored the patients' history of disease, perceptions of the terms rare and serious, and overall levels of risk aversion. A thematic analysis of the interviews, including a consensus discussion, was carried out. Interestingly, respondents rarely made a clear distinction between medicines-induced AEs and complications related to disease progression. Concerns regarding AEs were apparently diverse but were systematically related to the personal experiences of the respondents. Respondents routinely ignored information about possible rare, serious AEs, unless it could be related to personal experience. In the absence of experience, concerns were focused on common and less serious AEs, thus disregarding rare and more serious events. The study suggests that experience of AEs, related to either medicines or disease, constitutes an important factor of patient risk perception. We therefore propose that serious adverse experiences should be added to the traditional panel of socioeconomic factors that are accounted for when patients are invited to give input on regulatory decisions.

  19. 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

  20. 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.

  1. 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

  2. Mapping knowledge investments in the aftermath of Hurricane Katrina: a new approach for assessing regulatory agency responses to environmental disaster

    International Nuclear Information System (INIS)

    Frickel, Scott; Campanella, Richard; Vincent, M. Bess

    2009-01-01

    In the aftermath of large-scale disasters, the public's dependency on federal and state agencies for information about public safety and environmental risk is acute. While formal rules and procedures are in place to guide policy decisions in environmental risk assessment of spatially concentrated hazards such as regulated waste sites or vacant city lots, standard procedures for risk assessment seem potentially less well-suited for urban-scale disaster zones where environmental hazards may be widely dispersed and widely varying. In this paper we offer a new approach for the social assessment of regulatory science in response to large-scale disaster, illustrating our methodology through a socio-spatial analysis of the U.S. Environmental Protection Agency's (EPA) hazard assessment in New Orleans, Louisiana, following Hurricane Katrina in 2005. We find that the agency's commitment of epistemic resources or 'knowledge investments' varied considerably across the flood-impacted portion of the city, concentrating in poorer and disproportionately African American neighborhoods previously known to be heavily contaminated. We address some of the study's social and policy implications, noting the multidimensionality and interactive nature of knowledge investments and the prospects for deepening and extending this approach through comparative research

  3. Focal species candidates for pesticide risk assessment in European rice fields: A review.

    Science.gov (United States)

    Vallon, Martin; Dietzen, Christian; Laucht, Silke; Ludwigs, Jan-Dieter

    2018-04-25

    An assessment of potential risks of pesticides on wildlife is required during the process of product registration within Europe because of the importance of agricultural landscapes as wildlife habitats. Despite their peculiarity and their specific role as artificial wetlands, rice paddies are to date pooled with cereals in guidance documents on how to conduct risk assessments for birds and mammals in Europe. Hence, the focal species currently considered in risk assessments for rice paddies are those known from cereal fields and can therefore be expected to differ significantly from the species actually occurring in the wet environments of rice paddies. We present results of a comprehensive review on bird and mammal species regularly occurring in rice paddies during a time of potential pesticide exposure to identify appropriate focal species candidates for ecotoxicological pesticide risk assessment according to the European Food Safety Authority (EFSA). In addition, we present data on rice cultivation areas and agricultural practices in Europe to give background information supporting the species selection process. Our literature search identified a general scarcity of relevant data, particularly for mammals, which highlights the need for crop-specific focal species studies. However, our results clearly indicate that the relevant bird and mammal species in rice fields indeed differ strongly from the focal species used for the cereal risk assessment. They can thus be used as a baseline for more realistic wildlife risk assessments specific to rice and the development of a revised guidance document to bridge the gap for regulatory decision makers. Integr Environ Assess Manag 2018;00:000-000. © 2018 SETAC. © 2018 SETAC.

  4. 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

  5. Physiologically Based Toxicokinetic Modelling as a Tool to Support Risk Assessment: Three Case Studies

    Directory of Open Access Journals (Sweden)

    Hans Mielke

    2012-01-01

    Full Text Available In this contribution we present three case studies of physiologically based toxicokinetic (PBTK modelling in regulatory risk assessment. (1 Age-dependent lower enzyme expression in the newborn leads to bisphenol A (BPA blood levels which are near the levels of the tolerated daily intake (TDI at the oral exposure as calculated by EFSA. (2 Dermal exposure of BPA by receipts, car park tickets, and so forth, contribute to the exposure towards BPA. However, at the present levels of dermal exposure there is no risk for the adult. (3 Dermal exposure towards coumarin via cosmetic products leads to external exposures of two-fold the TDI. PBTK modeling helped to identify liver peak concentration as the metric for liver toxicity. After dermal exposure of twice the TDI, the liver peak concentration was lower than that present after oral exposure with the TDI dose. In the presented cases, PBTK modeling was useful to reach scientifically sound regulatory decisions.

  6. Tissue-Specific Enrichment of Lymphoma Risk Loci in Regulatory Elements.

    Science.gov (United States)

    Hayes, James E; Trynka, Gosia; Vijai, Joseph; Offit, Kenneth; Raychaudhuri, Soumya; Klein, Robert J

    2015-01-01

    Though numerous polymorphisms have been associated with risk of developing lymphoma, how these variants function to promote tumorigenesis is poorly understood. Here, we report that lymphoma risk SNPs, especially in the non-Hodgkin's lymphoma subtype chronic lymphocytic leukemia, are significantly enriched for co-localization with epigenetic marks of active gene regulation. These enrichments were seen in a lymphoid-specific manner for numerous ENCODE datasets, including DNase-hypersensitivity as well as multiple segmentation-defined enhancer regions. Furthermore, we identify putatively functional SNPs that are both in regulatory elements in lymphocytes and are associated with gene expression changes in blood. We developed an algorithm, UES, that uses a Monte Carlo simulation approach to calculate the enrichment of previously identified risk SNPs in various functional elements. This multiscale approach integrating multiple datasets helps disentangle the underlying biology of lymphoma, and more broadly, is generally applicable to GWAS results from other diseases as well.

  7. Approach and strategy for performing ecological risk assessments for the U.S. Department of Energy's Oak Ridge Reservation: 1994 revision

    International Nuclear Information System (INIS)

    Suter, G.W. II; Sample, B.E.; Jones, D.S.; Ashwood, T.L.

    1994-08-01

    This report provides guidance for planning and performing ecological risk assessments on the Oak Ridge Reservation (ORR). The tiered approach to ecological risk assessment has been implemented, generic conceptual models have been developed, and a general approach for developing ecological assessment endpoints and measurement endpoints has been agreed upon. The document also includes changes in terminology to agree with the terminology in the US Environmental Protection Agency's (EPA's) framework for ecological risk assessment. Although ecological risks are equal in regulatory importance to human health risks, formal procedures for ecological risk assessment are poorly developed. This report will provide specific guidance and promote the use of consistent approaches for ecological risk assessments at individual sites on the ORR. The strategy discussed in this report is consistent with the overall strategy for site management and Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) compliance and with relevant EPA guidance. The general approach and strategy presented herein was developed for the ORR, but it should be applicable to other complex CERCLA sites that possess significant ecological resources

  8. 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)

  9. Cyber Security Risk Assessment for the KNICS Safety Systems

    International Nuclear Information System (INIS)

    Lee, C. K.; Park, G. Y.; Lee, Y. J.; Choi, J. G.; Kim, D. H.; Lee, D. Y.; Kwon, K. C.

    2008-01-01

    In the Korea Nuclear I and C Systems Development (KNICS) project the platforms for plant protection systems are developed, which function as a reactor shutdown, actuation of engineered safety features and a control of the related equipment. Those are fully digitalized through the use of safety-grade programmable logic controllers (PLCs) and communication networks. In 2006 the Regulatory Guide 1.152 (Rev. 02) was published by the U.S. NRC and it describes the application of a cyber security to the safety systems in the Nuclear Power Plant (NPP). Therefore it is required that the new requirements are incorporated into the developed platforms to apply to NPP, and a cyber security risk assessment is performed. The results of the assessment were input for establishing the cyber security policies and planning the work breakdown to incorporate them

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

    International Nuclear Information System (INIS)

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

    1994-08-01

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

  11. Innovations in the Delivery of Regulatory Services in Australia

    International Nuclear Information System (INIS)

    Dillich, J.

    2016-01-01

    The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) is the country’s primary authority on radiation protection and nuclear safety. ARPANSA aims to promote safety, security, and emergency preparedness through efficient and effective regulation of nuclear installations, controlled facilities, and radiation sources. Recent initiatives to improve regulation by ‘cutting red tape’ and reducing regulatory burden have been introduced. ARPANSA’s Regulatory Delivery Model emphasises the key elements to good regulation and describes initiatives such as baseline inspection schedule, Performance Objectives and Criteria, and performance deficiencies. These and other initiatives have streamlined inspection efforts, increased risk-based oversight and risk-informed decision making, leading to increased efficiencies for both regulator and licence holder. In addition, ARPANSA has introduced 12 key performance indicators in its self-assessment of regulatory performance against the Australian Government’s Regulator Performance Framework. (author)

  12. 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

  13. Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.

    Science.gov (United States)

    Buchholzer, Marie-Luise; Werner, Christine; Knoess, Werner

    2014-03-01

    For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Behavioral Economic Laboratory Research in Tobacco Regulatory Science.

    Science.gov (United States)

    Tidey, Jennifer W; Cassidy, Rachel N; Miller, Mollie E; Smith, Tracy T

    2016-10-01

    Research that can provide a scientific foundation for the United States Food and Drug Administration (FDA) tobacco policy decisions is needed to inform tobacco regulatory policy. One factor that affects the impact of a tobacco product on public health is its intensity of use, which is determined, in part, by its abuse liability or reinforcing efficacy. Behavioral economic tasks have considerable utility for assessing the reinforcing efficacy of current and emerging tobacco products. This paper provides a narrative review of several behavioral economic laboratory tasks and identifies important applications to tobacco regulatory science. Behavioral economic laboratory assessments, including operant self-administration, choice tasks and purchase tasks, can be used generate behavioral economic data on the effect of price and other constraints on tobacco product consumption. These tasks could provide an expedited simulation of the effects of various tobacco control policies across populations of interest to the FDA. Tobacco regulatory research questions that can be addressed with behavioral economic tasks include assessments of the impact of product characteristics on product demand, assessments of the abuse liability of novel and potential modified risk tobacco products (MRTPs), and assessments of the impact of conventional and novel products in vulnerable populations.

  15. 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...

  16. Rationales for regulatory activity

    Energy Technology Data Exchange (ETDEWEB)

    Perhac, R.M. [Univ. of Tennessee, Knoxville, TN (United States)

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  17. 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.

  18. Drug interactions evaluation: An integrated part of risk assessment of therapeutics

    International Nuclear Information System (INIS)

    Zhang, Lei; Reynolds, Kellie S.; Zhao, Ping; Huang, Shiew-Mei

    2010-01-01

    Pharmacokinetic drug interactions can lead to serious adverse events or decreased drug efficacy. The evaluation of a new molecular entity's (NME's) drug-drug interaction potential is an integral part of risk assessment during drug development and regulatory review. Alteration of activities of enzymes or transporters involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by concomitant drugs may alter drug exposure, which can impact response (safety or efficacy). The recent Food and Drug Administration (FDA) draft drug interaction guidance ( (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf)) highlights the methodologies and criteria that may be used to guide drug interaction evaluation by industry and regulatory agencies and to construct informative labeling for health practitioner and patients. In addition, the Food and Drug Administration established a 'Drug Development and Drug Interactions' website to provide up-to-date information regarding evaluation of drug interactions ( (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm)). This review summarizes key elements in the FDA drug interaction guidance and new scientific developments that can guide the evaluation of drug-drug interactions during the drug development process.

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

    International Nuclear Information System (INIS)

    Morris, J.M.

    1994-01-01

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

  20. Global Banking System Regulatory Environment

    Directory of Open Access Journals (Sweden)

    Oleh Mozhovyi

    2017-03-01

    Full Text Available The international and domestic experience shows that the main factors of financial destabilization during the financial crises are in the banking sector. The article reveals that the vulnerability of the financial system is connected with functions, deposit and credit transactions, risks distribution and ensuring liquidity; banks act as a major factor in stabilisation measures in the current context of globalization processes, since the economic stability of banking activities relates directly to all the entities and only stable banking system can withstand the crisis phenomena. Therefore, as a result of the analysis, it is proved that not only reduction of risks of banks is needed, but also introduction of the effective supervision system over implementation of the requirements and standards to prevent these risks. According to modern international approaches, banks use the so-called prudential supervision, which is based on the risk management assessment policy on the part of the Bank’s management, and regulatory bodies contribute to implementation of such policy. The authors have concluded that not only modern specificity of banks, but also the impact of supervision systems and regulation of modern trends in development of the banking should be analysed. Application of the general regulatory principles and banking risks methodology is required. The task of supervision is distribution of reliable risk management practices in the banking system, taking into account national peculiarities of development.

  1. 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...

  2. 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?

  3. 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…

  4. 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.

  5. Leaching characteristics, ecotoxicity, and risk assessment based management of mine wastes

    Science.gov (United States)

    Kim, J.; Ju, W. J.; Jho, E. H.; Nam, K.; Hong, J. K.

    2016-12-01

    Mine wastes generated during mining activities in metal mines generally contain high concentrations of metals that may impose toxic effects to surrounding environment. Thus, it is necessary to properly assess the mining-impacted landscapes for management. The study investigated leaching characteristics, potential environmental effects, and human health risk of mine wastes from three different metal mines in South Korea (molybdenum mine, lead-zinc mine, and magnetite mine). The heavy metal concentrations in the leachates obtained by using the Korean Standard Test Method for Solid Wastes (STM), Toxicity Characteristics Leaching Procedure (TCLP), and Synthetic Precipitation Leaching Procedure (SPLP) met the Korea Waste Control Act and the USEPA region 3 regulatory levels accordingly, even though the mine wastes contained high concentrations of metals. Assuming that the leachates may get into nearby water sources, the leachate toxicity was tested using Daphnia Magna. The toxic unit (TU) values after 24 h and 48 h exposure of all the mine wastes tested met the Korea Allowable Effluent Water Quality Standards (TUwaste may have long-term toxic effects (TU>1 for the eluent at L/S of 30) implying that the long-term effect of mine wastes left in mining areas need to be assessed. Considering reuse of mine wastes as a way of managing mine wastes, the human health risk assessment of reusing the lead-zinc mine waste in industrial areas was carried out using the bioavailable fraction of the heavy metals contained in the mine wastes, which was determined by using the Solubility/Bioavailability Research Consortium method. There may be potential carcinogenic risk (9.7E-05) and non-carcinogenic risk (HI, Hazard Index of 1.0E+00) as CR≧1.0E-05 has carcinogenic risk and HI≧1.0E+00 has non-carcinogenic risk. Overall, this study shows that not only the concentration-based assessment but ecological toxic effect and human health risk based assessments can be utilized for mining

  6. The Assessment of Systemic Risk in the Kenyan Banking Sector

    Directory of Open Access Journals (Sweden)

    Hong Fan

    2018-01-01

    Full Text Available The present paper aims to assess the systemic risk of the Kenyan banking system. We propose a theoretical framework to reveal the time evolution of the systemic risk using sequences of financial data and use the framework to assess the systemic risk of the Kenyan banking system that is regarded as the largest in the East and Central African region. Firstly, we estimate the bilateral exposures matrix using aggregate financial data on loans and deposits from annual reports and analyze the interconnectedness in the market using network centrality measures. Next, we extend the Eisenberg–Noe method to a multiperiod setting to the systemic risk of the Kenyan banking system, in which the multiperiod includes the dynamic evolutions of the Kenyan banking system of every bank and the structure of the interbank network system. We apply this framework to assess dynamically the systemic risk of the Kenyan banking system between 2009 and 2015. The main findings are the following. The theoretical network analysis using network centrality measures showed several banks displaying characteristics of systematically important banks (SIBs. The theoretical default analysis showed that a bank suffering a basic default will trigger a contagious default that caused several other banks in the sector to go bankrupt. Further stress test proved that the KCB bank theoretically caused a few contagious defaults due to an unusually high interconnectedness. This methodology can contribute by being part of monitoring system of the Central Bank of Kenya (regulatory body as well as the implementation of policies (such as bank-internal stress tests that assist in preventing default contagion.

  7. Safety Culture Assessment at Regulatory Body - PNRA Experience of Implementing IAEA Methodology for Safety Culture Self Assessment

    International Nuclear Information System (INIS)

    Bhatti, S.A.N.; Arshad, N.

    2016-01-01

    The prevalence of a good safety culture is equally important for all kind of organizations involved in nuclear business including operating organizations, designers, regulator, etc., and this should be reflected through all the processes and activities of these organizations. The need for inculcating safety culture into regulatory processes and practices is gradually increasing since the major accident at Fukushima. Accordingly, several international fora in last few years repeatedly highlighted the importance of prevalence of safety culture in regulatory bodies as well. The utilisation of concept of safety culture always remained applicable in regulatory activities of PNRA in the form of core values. After the Fukushima accident, PNRA considered it important to check the extent of utilisation of safety culture concept in organizational activities and decided to conduct its “Safety Culture Self-Assessment (SCSA)” for presenting itself as a role model in-order to endorse the fact that safety culture at regulatory authority plays an important role to influence safety culture at licenced facilities.

  8. 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.

  9. Risk approaches in setting radiation standards

    International Nuclear Information System (INIS)

    Whipple, C.

    1984-01-01

    This paper discusses efforts to increase the similarity of risk regulation approaches for radiation and chemical carcinogens. The risk assessment process in both cases involves the same controversy over the extrapolation from high to low doses and dose rates, and in both cases the boundaries between science and policy in risk assessment are indistinct. Three basic considerations are presented to approach policy questions: the economic efficiency of the regulatory approach, the degree of residual risk, and the technical opportunities for risk control. It is the author's opinion that if an agency can show that its standard-setting policies are consistent with those which have achieved political and judicial acceptance in other contexts, the greater the predictability of the regulatory process and the stability of this process

  10. 75 FR 21686 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-04-26

    ... to pay arbitration awards to remain in the securities industry presents regulatory risks and is...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule... Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC'' or...

  11. Application of ecological risk assessment to establish nonhuman environmental protection at nuclear generating stations in Ontario, Canada

    International Nuclear Information System (INIS)

    Wismer, D.A.

    2004-01-01

    A screening ecological risk assessment was performed for regulatory compliance at three Ontario nuclear generating station sites to establish design requirements for a routine contaminant monitoring program and to address the need for non-contaminant stressor management. Site specific assessments went beyond traditional contaminant risk assessment to include stressors associated with land-use change, cooling water systems and site storm water runoff. Valued terrestrial and aquatic ecosystem components were selected from species lists after stakeholder consultation, and contaminants of concern were selected based on their relative loadings, and with respect to regulatory and literature-based benchmarks. Predictive modeling was used to estimate chemical and radionuclide exposures and likelihood of effects. Adverse effects on individual biota were predicted for aqueous emissions of chlorine and storm water but not for radionuclides. Retrospective analyses of past field monitoring were used to determine likelihood of effects from non-contaminant stressors. Individual-level adverse effects were observed for fish losses from cooling water withdrawal. Depending on the site and the biological species, either beneficial or adverse effects from thermal discharge and land-use change were observed. Followup studies include monitoring, laboratory study, computer modeling and mitigation. Field monitoring will generate more precise species-level estimates of intake fish losses, magnitude of fish response to thermal discharge and chlorine concentrations in near-field discharge waters. Laboratory study is determining the effectiveness of intake fish loss mitigation technology. Computer fish population models are being used to design field studies and interpret individual level effects. Mitigation includes storm water controls and habitat biodiversity management projects to offset past losses from site development and construction. Routine contaminant monitoring is planned to

  12. Approach and strategy for performing ecological risk assessments for the U.S. Department of Energy`s Oak Ridge Reservation: 1994 revision

    Energy Technology Data Exchange (ETDEWEB)

    Suter, G.W. II; Sample, B.E.; Jones, D.S.; Ashwood, T.L.

    1994-08-01

    This report provides guidance for planning and performing ecological risk assessments on the Oak Ridge Reservation (ORR). The tiered approach to ecological risk assessment has been implemented, generic conceptual models have been developed, and a general approach for developing ecological assessment endpoints and measurement endpoints has been agreed upon. The document also includes changes in terminology to agree with the terminology in the US Environmental Protection Agency`s (EPA`s) framework for ecological risk assessment. Although ecological risks are equal in regulatory importance to human health risks, formal procedures for ecological risk assessment are poorly developed. This report will provide specific guidance and promote the use of consistent approaches for ecological risk assessments at individual sites on the ORR. The strategy discussed in this report is consistent with the overall strategy for site management and Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) compliance and with relevant EPA guidance. The general approach and strategy presented herein was developed for the ORR, but it should be applicable to other complex CERCLA sites that possess significant ecological resources.

  13. Induced seismicity and carbon storage: Risk assessment and mitigation strategies

    Energy Technology Data Exchange (ETDEWEB)

    White, Joshua A. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Foxall, William [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Bachmann, Corinne [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Chiaramonte, Laura [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Daley, Thomas M. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2016-01-28

    assessment and mitigation approach. A phased approach to risk management is then introduced. The basic goal of the phased approach is to constantly adapt site operations to current conditions and available characterization data. The remainder of the report then focuses in detail on different components of the monitoring, risk assessment, and mitigation strategies. Issues in current seismic risk assessment methods that must be modified to address induce seismicity are highlighted. The report then concludes with several specific recommendations for operators and regulatory authorities to consider when selecting, permitting, and operating a storage project.

  14. 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.

  15. Radiation safety assessment of cobalt 60 external beam radiotherapy using the risk-matrix method

    International Nuclear Information System (INIS)

    Dumenigo, C; Vilaragut, J.J.; Ferro, R.; Guillen, A.; Ramirez, M.L.; Ortiz Lopez, P.; Rodriguez, M.; McDonnell, J.D.; Papadopulos, S.; Pereira, P.P.; Goncalvez, M.; Morales, J.; Larrinaga, E.; Lopez Morones, R.; Sanchez, R.; Delgado, J.M.; Sanchez, C.; Somoano, F.

    2008-01-01

    External beam radiotherapy is the only practice in which humans are placed directly in a radiation beam with the intention to deliver a very high dose. This is why safety in radiotherapy is very critical, and is a matter of interest to both radiotherapy departments and regulatory bodies. Accidental exposures have occurred throughout the world, thus showing the need for systematic safety assessments, capable to identify preventive measures and to minimize consequences of accidental exposure. Risk-matrix is a systematic approach which combines the relevant event features to assess the overall risk of each particular event. Once an event sequence is identified, questions such as how frequent the event, how severe the potential consequences and how reliable the existing safety measures are answered in a risk-matrix table. The ultimate goal is to achieve that the overall risk for events with severe consequences should always be low o very low. In the present study, the risk-matrix method has been applied to an hypothetical radiotherapy department, which could be equivalent to an upper level hospital of the Ibero American region, in terms of safety checks and preventive measures. The application of the method has identified 76 event sequences and revealed that the hypothetical radiotherapy department is sufficiently protected (low risk) against them, including 23 event sequences with severe consequences. The method has revealed that the risk of these sequences could grow to high level if certain specific preventive measures were degraded with time. This study has identified these preventive measures, thus facilitating a rational allocation of resources in regular controls to detect any loss of reliability. The method has proven to have an important practical value and is affordable at hospital level. The elaborated risk-matrix can be easily adapted to local circumstances, in terms of existing controls and safety measures. This approach can help hospitals to identify

  16. 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

  17. Regulatory Compliance in Multi-Tier Supplier Networks

    Science.gov (United States)

    Goossen, Emray R.; Buster, Duke A.

    2014-01-01

    Over the years, avionics systems have increased in complexity to the point where 1st tier suppliers to an aircraft OEM find it financially beneficial to outsource designs of subsystems to 2nd tier and at times to 3rd tier suppliers. Combined with challenging schedule and budgetary pressures, the environment in which safety-critical systems are being developed introduces new hurdles for regulatory agencies and industry. This new environment of both complex systems and tiered development has raised concerns in the ability of the designers to ensure safety considerations are fully addressed throughout the tier levels. This has also raised questions about the sufficiency of current regulatory guidance to ensure: proper flow down of safety awareness, avionics application understanding at the lower tiers, OEM and 1st tier oversight practices, and capabilities of lower tier suppliers. Therefore, NASA established a research project to address Regulatory Compliance in a Multi-tier Supplier Network. This research was divided into three major study efforts: 1. Describe Modern Multi-tier Avionics Development 2. Identify Current Issues in Achieving Safety and Regulatory Compliance 3. Short-term/Long-term Recommendations Toward Higher Assurance Confidence This report presents our findings of the risks, weaknesses, and our recommendations. It also includes a collection of industry-identified risks, an assessment of guideline weaknesses related to multi-tier development of complex avionics systems, and a postulation of potential modifications to guidelines to close the identified risks and weaknesses.

  18. Draft CSA standard on environmental risk assessments at class I nuclear facilities and uranium mines and mills

    International Nuclear Information System (INIS)

    Hart, D.; Garisto, N.; Parker, R.; Kovacs, R.; Thompson, B.

    2012-01-01

    The Canadian Standards Association (CSA) is preparing a draft Standard on environmental risk assessments (ERAs) at Class I nuclear facilities and uranium mines and mills (CSA N288.6). It is being prepared by a technical subcommittee of the CSA N288 Technical Committee, including experts from across the nuclear industry, government and regulatory authorities, and environmental service providers, among others. It addresses the design, implementation, and management of environmental risk assessment programs, and is intended to standardize practice across the industry. This paper outlines the scope of the draft Standard and highlights key features. It is under development and subject to change. (author)

  19. 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.

  20. 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

  1. Performance as a basic regulatory rule

    International Nuclear Information System (INIS)

    Spano, F.; Rudelli, M.D.; Telleria, D.M.

    1998-01-01

    In Argentina, the Nuclear Regulatory Authority has been sustained, from beginning by a normative system whose fundamental features are its requirements for performance. The Authority has defined indicators for carrying out the classification of practices as major o minor. (As a function of the complexity of processes and operation, equipment, associate risks and type of consequences, etc.). An example is given base on the requirements of standards related with the practice of gammagraphy in Argentina. From the Authority records we know that the effective dose of operators registered do not exceed 5 mSv per year. The associate risk is lower than 2 10 -4 per year. Risk assessment in scenarios resulting in a potential exposure, taken into account the Argentine standards gives a total risk per year in the order of 10 -4 for workers and 4 10 -5 for members of the public. The contents and requirements of system that sustains the regulatory authority can be prescriptive or just based in performance. A decision in favour of one of them should not only reflect the technical-scientific reality of the country implementing it but also other factors like social and economic issues. (author)

  2. Waste convention regulatory impact on planning safety assessment for LILW disposal in Croatia

    International Nuclear Information System (INIS)

    Valcic, I.; Subasic, D.; Lokner, V.

    2000-01-01

    Preparations for establishment of a LILW repository in Croatia have reached a point where a preliminary safety assessment for the prospective facility is being planned. The planning is not based upon the national regulatory framework, which does not require such an assessment at this early stage, but upon the interagency BSS and the IAEA RADWASS programme recommendations because the national regulations are being revised with express purpose to conform to the most recent international standards and good practices. The Waste Convention, which Croatia has ratified in the meantime, supports this approach in principle, but does not appear to have more tangible regulatory relevance for the safety assessment planning. Its actual requirements regarding safety analyses for a repository fall short of the specific assessment concepts practiced in this decade, and could have well been met by the old Croatian regulations from the mid-eighties. (author)

  3. Application of PSA in risk informed decision making

    International Nuclear Information System (INIS)

    Hari Prasad, M.; Vinod, Gopika; Saraf, R.K.; Ghosh, A.K.; Kushwaha, H.S.

    2006-01-01

    Probabilistic Safety Assessment (PSA) models have been successfully employed during design evaluation to assess weak links and carry out design modifications to improve system reliability and safety. Recently, studies are directed towards applying PSA in various decision making issues concerned with plant operations and safety regulations. This necessitates development of software tools like Living PSA, Risk Monitor etc. Risk Monitor is a PC based tool developed to assess the risk, based on the actual status of systems and components. Such tools find wide application with plant personnel and regulatory authorities since they can provide solutions to various plant issues and regulatory decision making issues respectively. (author)

  4. MicroRNA-related genetic variants in iron regulatory genes, dietary iron intake, microRNAs and lung cancer risk.

    Science.gov (United States)

    Zhang, L; Ye, Y; Tu, H; Hildebrandt, M A; Zhao, L; Heymach, J V; Roth, J A; Wu, X

    2017-05-01

    Genetic variations in MicroRNA (miRNA) binding sites may alter structural accessibility of miRNA binding sites to modulate risk of cancer. This large-scale integrative multistage study was aimed to evaluate the interplay of genetic variations in miRNA binding sites of iron regulatory pathway, dietary iron intake and lung cancer (LC) risk. The interplay of genetic variant, dietary iron intake and LC risk was assessed in large-scale case-control study. Functional characterization of the validated SNP and analysis of target miRNAs were performed. We found that the miRNA binding site SNP rs1062980 in 3' UTR of Iron-Responsive Element Binding protein 2 gene (IREB2) was associated with a 14% reduced LC risk (P value = 4.9×10 - 9). Comparing to AA genotype, GG genotype was associated with a 27% reduced LC risk. This association was evident in males and ever-smokers but not in females and never-smokers. Higher level of dietary iron intake was significantly associated with 39% reduced LC risk (P value = 2.0×10 - 8). This association was only present in individuals with AG + AA genotypes with a 46% reduced risk (P value = 1.0×10 - 10), but not in GG genotype. The eQTL-analysis showed that rs1062980 significantly alters IREB2 expression level. Rs1062980 is predicted to alter a miR-29 binding site on IREB2 and indeed the expression of miR-29 is inversely correlated with IREB2 expression. Further, we found that higher circulating miR-29a level was significantly associated with 78% increased LC risk. The miRNA binding site SNP rs1062980 in iron regulatory pathway, which may alter the expression of IREB2 potentially through modulating the binding of miR-29a, together with dietary iron intake may modify risk of LC both individually and jointly. These discoveries reveal novel pathway for understanding lung cancer tumorigenesis and risk stratification. © The Author 2017. Published by Oxford University Press on behalf of the European Society for

  5. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

    International Nuclear Information System (INIS)

    2002-06-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

  6. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

    International Nuclear Information System (INIS)

    2001-05-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

  7. Risk assessment for nickel and nickel compounds in the ambient air from exposure by inhalation. Review of the European situation

    Energy Technology Data Exchange (ETDEWEB)

    Lepicard, S; Schneider, T [Centre d` Etude sur l` Evaluation de la Protection dans le Domaine Nucleaire, 92 - Fontenay-aux-Roses (France); Fritsch, P; Maximilien, R [Commissariat a l` Energie Atomique, Brussels (Belgium). Dept. des Sciences du Vivant; Deloraine, A [Centre Rhone-Alpes d` Epidemiologie et de Prevention Sanitaire (France)

    1997-12-01

    The objective of this report is to evaluate the risk associated with exposure to nickel in the ambient air, for the general public. The document is divided into three parts, comprising: A review of the regulatory context, a description of the physical and chemical characteristics of nickel and certain nickel compounds, a description of certain industrial processes involving nickel, and the characterization of human exposure (emissions, immissions, transport in the atmosphere); a risk assessment on the basis of human (occupational exposure) and animal data related to the presumed risk of lung cancer; an assessment of the risk associated with exposure to nickel in the ambient air for the general public. (R.P.) 55 refs.

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. ILK statement about the regulatory authorities' perception of operators' self-assessment of safety culture

    International Nuclear Information System (INIS)

    2005-01-01

    Over the past few years, German licensing and supervisory authorities have devoted increasing attention to safety management and safety culture issues. At present, German plant operators are introducing systems for self-assessment of the safety culture in their plants, such as the Safety Culture Assessment System developed by VGB Power Tech (VGB-SBS). In its statement, the International Committee on Nuclear Technology (ILK) addresses an effective approach of the authorities in evaluating the self-assessment of safety culture conducted by operators. ILK proposes a total of ten recommendations for evaluating the self-assessment system of the operators by the authority. The regulatory authorities should see to it that the operators establish a self-assessment system for aspects of organization and personnel, and use it continuously. The measures derived from this self-assessment by the operators, and the reasons underlying them, should be discussed with the authorities. In addition to the operators, also the regulatory authorities and the technical expert organizations commissioned by them should carry out self-assessments of their respective supervisory activities, taking into account also special events, such as changes in government, and develop appropriate programs of measures to be taken. In evaluating safety culture, the regulatory authorities should strive to support the activities of operators in improving their safety culture. A spirit of mutual confidence and cooperation should exist between operators and authorities. The recommendations expressed in the statement deliberately leave room for detailed implementation by the parties concerned. (orig.)

  13. [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.

  14. Probabilistic commentary: the rise and fall, and rise again, of risk assessment

    International Nuclear Information System (INIS)

    Hendrie, J.M.

    1985-02-01

    Probabilistic risk assessment is mainly concerned with assessing the risks of nuclear power plants. Historically, the field of PRA began with a Senate request for a report on the safety of nuclear reactors in 1972. A quantitative report called WASH-1400 was eventually prepared and published in 1975, and in summary, it stated that nuclear reactors warranted only a low-grade concern in modern society. Criticism of this report and public perception of its results were highly visible subjects in the media, and the criticism led to the fact that PRA fell into disfavor. After Three Mile Island, it was recognized that PRA was a valuable tool for understanding such accidents, and PRA became a bit more popular again by the end of 1979. The usefulness of PRA was also supported by a German study in 1979. PRA played a significant role in the hearings on the Indian Point reactor. The present NRC regards PRA as an important tool in regulatory practice

  15. [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.

  16. Incorporating biomarkers in ecological risk assessment of chemical contaminants of soils

    Directory of Open Access Journals (Sweden)

    A. J. Reinecke

    2007-09-01

    Full Text Available Soil is an important but complex natural resource which is increasingly used as sink for chemicals. The monitoring of soil quality and the assessment of risks posed by contaminants have become crucial. This study deals with the potential use of biomarkers in the monitoring of soils and the assessment of risk resulting from contamination. Apart from an overview of the existing literature on biomarkers, the results of various of our field experiments in South African soils are discussed. Biomarkers may have potential in the assessment of risk because they can indicate at an early stage that exposure has taken place and that a toxic response has been initiated. It is therefore expected that early biomarkers will play an increasing role as diagnostic tools for determining exposure to chemicals and the resulting effects. They may have predictive value that can assist in the prevention or minimising of risks. The aim of this study was to investigate the possibilities of using our results on biomarker responses of soil dwelling organisms to predict changes at higher organisational levels (which may have ecological implications. Our recent experimental results on the evaluation of various biomarkers in both the laboratory and the field are interpreted and placed in perspective within the broader framework of response biology. The aim was further to contribute to the development and application of biomarkers in regulatory risk assessment schemes of soils. This critical review of our own and recent literature on biomarkers in ecotoxicology leads to the conclusion that biomarkers can, under certain conditions, be useful tools in risk assessment. Clear relationships between contamination loads in soil organisms and certain biomarker responses were determined in woodlice, earthworms and terrestrial snails. Clear correlations were also established in field experiments between biomarker responses and changes at the population level. This indicated that, in

  17. The changing face of nanomaterials: Risk assessment challenges along the value chain.

    Science.gov (United States)

    Mattsson, Mats-Olof; Simkó, Myrtill

    2017-03-01

    Risk assessment (RA) of manufactured nanomaterials (MNM) is essential for regulatory purposes and risk management activities. Similar to RA of "classical" chemicals, MNM RA requires knowledge about exposure as well as of hazard potential and dose response relationships. What makes MNM RA especially challenging is the multitude of materials (which is expected to increase substantially in the future), the complexity of MNM value chains and life cycles, the accompanying possible changes in material properties over time and in contact with various environmental and organismal milieus, and the difficulties to obtain proper exposure data and to consider the proper dose metric. This article discusses these challenges and also critically overviews the current state of the art regarding MNM RA approaches. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Advancing Dose-Response Assessment Methods for Environmental Regulatory Impact Analysis: A Bayesian Belief Network Approach Applied to Inorganic Arsenic.

    Science.gov (United States)

    Zabinski, Joseph W; Garcia-Vargas, Gonzalo; Rubio-Andrade, Marisela; Fry, Rebecca C; Gibson, Jacqueline MacDonald

    2016-05-10

    Dose-response functions used in regulatory risk assessment are based on studies of whole organisms and fail to incorporate genetic and metabolomic data. Bayesian belief networks (BBNs) could provide a powerful framework for incorporating such data, but no prior research has examined this possibility. To address this gap, we develop a BBN-based model predicting birthweight at gestational age from arsenic exposure via drinking water and maternal metabolic indicators using a cohort of 200 pregnant women from an arsenic-endemic region of Mexico. We compare BBN predictions to those of prevailing slope-factor and reference-dose approaches. The BBN outperforms prevailing approaches in balancing false-positive and false-negative rates. Whereas the slope-factor approach had 2% sensitivity and 99% specificity and the reference-dose approach had 100% sensitivity and 0% specificity, the BBN's sensitivity and specificity were 71% and 30%, respectively. BBNs offer a promising opportunity to advance health risk assessment by incorporating modern genetic and metabolomic data.

  19. 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.

  20. [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.

  1. Evaluation of FOCUS surface water pesticide concentration predictions and risk assessment of field-measured pesticide mixtures-a crop-based approach under Mediterranean conditions.

    Science.gov (United States)

    Pereira, Ana Santos; Daam, Michiel A; Cerejeira, Maria José

    2017-07-01

    FOCUS models are used in the European regulatory risk assessment (RA) to predict individual pesticide concentrations in edge-of-field surface waters. The scenarios used in higher tier FOCUS simulations were mainly based on Central/North European, and work is needed to underpin the validity of simulated exposure profiles for Mediterranean agroecosystems. In addition, the RA of chemicals are traditionally evaluated on the basis of single substances although freshwater life is generally exposed to a multitude of pesticides. In the present study, we monitored 19 pesticides in surface waters of five locations in the Portuguese 'Lezíria do Tejo' agricultural area. FOCUS step 3 simulations were performed for the South European scenarios to estimate predicted environmental concentrations (PECs). We verified that 44% of the PECs underestimated the measured environmental concentrations (MEC) of the pesticides, showing a non-compliance with the field data. Risk was assessed by comparing the environmental quality standards (EQS) and regulatory acceptable concentrations with their respective MECs. Risk of mixtures was demonstrated in 100% of the samples with insecticides accounting for 60% of the total risk identified. The overall link between the RA and the actual situation in the field must be considerably strengthened, and field studies on pesticide exposure and effects should be carried out to assist the improvement of predictive approaches used for regulatory purposes.

  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. 77 FR 9273 - WORKSHOP Sponsored by the Nuclear Regulatory Commission and the Electric Power Research Institute...

    Science.gov (United States)

    2012-02-16

    ... Commission and the Electric Power Research Institute on the Treatment of Probabilistic Risk Assessment.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC), Office of Nuclear Regulatory Research (RES), in cooperation with the Electric Power Research Institute (EPRI), will hold a joint workshop on the Treatment of...

  4. Validation of innovative technologies and strategies for regulatory safety assessment methods: challenges and opportunities.

    Science.gov (United States)

    Stokes, William S; Wind, Marilyn

    2010-01-01

    Advances in science and innovative technologies are providing new opportunities to develop test methods and strategies that may improve safety assessments and reduce animal use for safety testing. These include high throughput screening and other approaches that can rapidly measure or predict various molecular, genetic, and cellular perturbations caused by test substances. Integrated testing and decision strategies that consider multiple types of information and data are also being developed. Prior to their use for regulatory decision-making, new methods and strategies must undergo appropriate validation studies to determine the extent that their use can provide equivalent or improved protection compared to existing methods and to determine the extent that reproducible results can be obtained in different laboratories. Comprehensive and optimal validation study designs are expected to expedite the validation and regulatory acceptance of new test methods and strategies that will support improved safety assessments and reduced animal use for regulatory testing.

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

    Science.gov (United States)

    Schwalbe, Craig S.

    2009-01-01

    The actuarial method is the gold standard for risk assessment in child welfare, juvenile justice, and criminal justice. It produces risk classifications that are highly predictive and that may be robust to sampling error. This article reports a revalidation study of the Arizona Risk/Needs Assessment instrument, an actuarial instrument for juvenile…

  7. 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.

  8. Hazard risk and vulnerability assessment : Regional District of Nanaimo : final report

    International Nuclear Information System (INIS)

    2006-06-01

    A Hazard Risk and Vulnerability Assessment (HRVA) is a mandated regulatory requirement in British Columbia that requires local authorities to prepare emergency plans that reflect the local authority's assessment of the relative risk of occurrence and the potential impact on people and property of the hazards, emergencies or disasters that could affect the jurisdictional area for which the local authority has responsibility. This report constituted an HRVA for the Regional District of Nanaimo, British Columbia. It presented the study scope and methodology and provided an overview of the Regional District of Nanaimo. This included information on the setting, demographics, and economy. Next, it discussed social vulnerability; critical response and recovery facilities; and critical infrastructure such as water, energy, telecommunications and transportation. A summary of the Regional District of Nanaimo's response capabilities that were considered when assessing the Regional District's overall risk to the hazards was also presented. Response capabilities were discussed with reference to fire and rescue; police; ambulance; and search and rescue. Emergency support and preparedness organizations were also identified. These included the Emergency Coordination Centre, environmental services, emergency social services, amateur radio and health authorities. Last, 33 hazards that could affect the Regional District of Nanaimo were identified and discussed. The study identified the following hazards as high risk: flooding; forest fires and wildland urban interface fires; and human diseases and pandemic. It was recommended that the advancement of business continuity planning in the Regional District of Nanaimo would help to reduce the impact of a possible human disease and pandemic risk outbreak affecting the population. 75 refs., 25 figs., 14 tabs., 2 appendices

  9. Research needs for risk-informed, performance-based regulations

    International Nuclear Information System (INIS)

    Thadani, A.C.

    1997-01-01

    This article summarizes the activities of the Office of Research of the NRC, both from a historical aspect as well as it applies to the application of risk-based decision making. The office has been actively involved in problems related to understanding risks related to core accidents, to understanding the problem of aging of reactor components and materials from years of service, and toward the understanding and analysis of severe accidents. In addition new policy statements regarding the role of risk assessment in regulatory applications has given focus for the need of further work. The NRC has used risk assessment in regulatory questions in the past but in a fairly ad hoc sort of manner. The new policies will clearly require a better defined application of risk assessment, and help for people evaluating applications in judging the applicability of such applications when a component of them is based on risk-based decision making. To address this, standard review plans are being prepared to serve as guides for such questions. In addition, with regulatory decisions being allowed to be based upon risk-based decisions, it is necessary to have an adequate data base prepared, and made publically available, to support such a position

  10. 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.

  11. 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

  12. Monitoring emerging contaminants in the drinking water of Milan and assessment of the human risk.

    Science.gov (United States)

    Riva, Francesco; Castiglioni, Sara; Fattore, Elena; Manenti, Angela; Davoli, Enrico; Zuccato, Ettore

    2018-04-01

    Emerging Contaminants (ECs) are ubiquitous in waters, arousing concern because of their potential risks for human health and the environment. This study investigated the presence of multiple classes of ECs in 21 wells over the drinking water network of Milan, in the most inhabited and industrialized area of Italy, and assessed the risks for consumers. Samples were analyzed using liquid chromatography coupled to mass spectrometry. Human risk assessment (HRA) was conducted by comparing the measured concentrations with drinking water thresholds from guidelines or calculated in this study; first considering the exposure to each single EC and then the entire mixture. Thirteen ECs were measured in the low ng/L range, and were generally detected in less than half of the wells. Pharmaceuticals, perfluorinated substances, personal care products, and anthropogenic markers were the most frequently detected. The results of the HRA excluded any risks for consumers in each scenario considered. This is one of the most comprehensive studies assessing the presence of a large number of ECs in the whole drinking water network of a city, and the risks for human health. Results improve the limited information on ECs sources and occurrence in drinking water and help establishing guidelines for regulatory purposes. Copyright © 2018 Elsevier GmbH. All rights reserved.

  13. 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.

  14. Oseltamivir prescription and regulatory actions vis-à-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database.

    Science.gov (United States)

    Urushihara, Hisashi; Doi, Yuko; Arai, Masaru; Matsunaga, Toshiyuki; Fujii, Yosuke; Iino, Naoko; Kawamura, Takashi; Kawakami, Koji

    2011-01-01

    In March 2007, a regulatory advisory was issued in Japan to restrict oseltamivir use in children aged 10-19 years because of safety concerns over abnormal behavior. The effectiveness and validity of regulatory risk minimization actions remain to be reviewed, despite their significant public health implications. To assess the impact of the regulatory actions on prescribing practices and safety reporting. METHODOLOY/PRINICPAL FINDINGS: In this retrospective review of a nationwide pharmacy database, we analyzed 100,344 dispensation records for oseltamivir and zanamivir for the period from November 2006 to March 2009. The time trend in dispensations for these antiviral agents was presented before and after the regulatory actions, contrasted with intensity of media coverage and the numbers of spontaneous adverse reaction reports with regard to antivirals. The 2007 regulatory actions, together with its intense media coverage, reduced oseltamivir dispensation in targeted patients in fiscal year 2008 to 20.4% of that in fiscal year 2006, although influenza activities were comparable between these fiscal years. In contrast, zanamivir dispensation increased approximately nine-fold across all age groups. The number of abnormal behavior reports associated with oseltamivir in children aged 10-19 years decreased from fiscal year 2006 to 2008 (24 to 9 cases); this decline was offset by the increased number of reports of abnormal behavior in children under age 10 (12 to 28 cases). The number of reports associated with zanamivir increased in proportion to increased dispensation of this drug (11 to 114 cases). The 2007 actions effectively reduced oseltamivir prescriptions and the number of reports of abnormal behavior in the targeted group. The observed increase in abnormal behavior reports in oseltamivir patients under age 10 and in zanamivir patients suggests that these patient groups may also be at risk, calling into question the validity of the current discrimination by age and

  15. Oseltamivir prescription and regulatory actions vis-à-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database.

    Directory of Open Access Journals (Sweden)

    Hisashi Urushihara

    Full Text Available BACKGROUND: In March 2007, a regulatory advisory was issued in Japan to restrict oseltamivir use in children aged 10-19 years because of safety concerns over abnormal behavior. The effectiveness and validity of regulatory risk minimization actions remain to be reviewed, despite their significant public health implications. To assess the impact of the regulatory actions on prescribing practices and safety reporting. METHODOLOY/PRINICPAL FINDINGS: In this retrospective review of a nationwide pharmacy database, we analyzed 100,344 dispensation records for oseltamivir and zanamivir for the period from November 2006 to March 2009. The time trend in dispensations for these antiviral agents was presented before and after the regulatory actions, contrasted with intensity of media coverage and the numbers of spontaneous adverse reaction reports with regard to antivirals. The 2007 regulatory actions, together with its intense media coverage, reduced oseltamivir dispensation in targeted patients in fiscal year 2008 to 20.4% of that in fiscal year 2006, although influenza activities were comparable between these fiscal years. In contrast, zanamivir dispensation increased approximately nine-fold across all age groups. The number of abnormal behavior reports associated with oseltamivir in children aged 10-19 years decreased from fiscal year 2006 to 2008 (24 to 9 cases; this decline was offset by the increased number of reports of abnormal behavior in children under age 10 (12 to 28 cases. The number of reports associated with zanamivir increased in proportion to increased dispensation of this drug (11 to 114 cases. CONCLUSIONS/SIGNIFICANCE: The 2007 actions effectively reduced oseltamivir prescriptions and the number of reports of abnormal behavior in the targeted group. The observed increase in abnormal behavior reports in oseltamivir patients under age 10 and in zanamivir patients suggests that these patient groups may also be at risk, calling into question

  16. Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

    International Nuclear Information System (INIS)

    Wilmot, Roger D.

    2011-02-01

    The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

  17. Managing motivational conflict: how self-esteem and executive resources influence self-regulatory responses to risk.

    Science.gov (United States)

    Cavallo, Justin V; Holmes, John G; Fitzsimons, Gráinne M; Murray, Sandra L; Wood, Joanne V

    2012-09-01

    This article explores how self-esteem and executive resources interact to determine responses to motivational conflict. One correlational and 3 experimental studies investigated the hypothesis that high and low self-esteem people undertake different self-regulatory strategies in "risky" situations that afford opportunity to pursue competing goals and that carrying out these strategies requires executive resources. When such resources are available, high self-esteem people respond to risk by prioritizing and pursuing approach goals, whereas low self-esteem people prioritize avoidance goals. However, self-esteem does not influence responses to risk when executive resources are impaired. In these studies, risk was operationalized by exposing participants to a relationship threat (Studies 1 and 2), by using participants' self-reported marital conflict (Study 3), and by threatening academic competence (Study 4). Executive resources were operationalized as cognitive load (Studies 1 and 2), working memory capacity (Study 3), and resource depletion (Study 4). When executive resources were ample, high self-esteem people responded to interpersonal risk by making more positive relationship evaluations (Studies 1, 2, and 3) and making more risky social comparisons following a personal failure (Study 4) than did low self-esteem people. Self-esteem did not predict participants' responses when executive resources were impaired or when risk was absent. The regulatory function of self-esteem may be more resource-dependent than has been previously theorized.

  18. 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...

  19. Self-assessment of the Nuclear Regulatory Authority of the Slovak Republic and a subsequent partner IAEA IRRS mission

    International Nuclear Information System (INIS)

    Husarcek, Jan

    2012-01-01

    A self-assessment exercise performed by the Nuclear Regulatory Authority of the Slovak Republic based on the IAEA Integrated Regulatory Review Service (IRRS) methodology, and the follow-up IAEA mission are described. The self-assessment methodology is outlined. The purpose, scope, area, content and process of the self-assessment are explained. The work done, the summary results of the IAEA IRRS mission, and proposed improvements are described. (orig.)

  20. 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

  1. 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.

  2. Self-assessment of the Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    Husarcek, J.; Grebeciova, J.

    2006-01-01

    The major results are presented of the self-assessment procedure which was carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD) in 2005 based on the Common Assessment Framework (CAF) model. An overview is given of the most important preconditions and results and their interactions in the nine areas of assessment as follows: leadership, strategy and planning, human resource management, partnership and resources, process management and changes, customer and public oriented results, people results, society results, and key performance results. UJD's strengths and opportunities as emerged from the self-assessment are highlighted. The self-assessment process will be followed by the preparation and implementation of an Action Plan. (author)

  3. Risk assessment of flavouring substances used in foods

    DEFF Research Database (Denmark)

    Norby, Karin; Beltoft, Vibe Meister; Greve, Krestine

    2006-01-01

    not to present a safety concern, have been specified. In the project a very comprehensive database (the FLAVIS database) has been developed for the evaluation. It compiles information on the about 2800 flavouring substances used in Europe: specifications, structural class, food categories used in, intake data......The aim of the present project, the FLAVIS project, is to perform risk assessment of chemically defined flavouring substances. The evaluations are then presented to the European Food Safety Authority (EFSA) for final adoption in its Scientific Panel on food additives, flavourings, processing aids...... and materials in contact with food. The regulatory background for the work is found in the European Parliament and Council Regulation No. 2232/96 laying down a procedure for the establishment of a list of flavouring substances the use of which will be authorised to the exclusion of all others in the EU...

  4. 78 FR 39284 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Science.gov (United States)

    2013-07-01

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2013-0320; FRL-9830-1] Technical Guidance for Assessing Environmental Justice in Regulatory Analysis AGENCY: Environmental Protection Agency (EPA). ACTION: Notice... Environmental Protection Agency (EPA) issued for public comment a document entitled, ``Technical Guidance for...

  5. Assessing the assessments: Pharmaceuticals in the environment

    International Nuclear Information System (INIS)

    Enick, O.V.; Moore, M.M.

    2007-01-01

    The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development

  6. Nuclear energy and Indian society: Public engagement, risk assessment and legal frameworks - Summary of the proceedings

    International Nuclear Information System (INIS)

    Kini, Els Reynaers; Dipankar Bandyopadhyay, I.; Kanwar, Bhanudey

    2014-01-01

    The Nuclear Law Association (NLA) has organised its 3. Annual Meeting with the specific aim to deliberate on public engagement, consultation and acceptance of nuclear energy projects. The meeting further aimed to seek a better understanding of the necessary legal framework for a safe nuclear energy program in India. The themes covered by the conference were: Public engagement, consultation and acceptance; Nuclear energy safety and public discourse; Case studies from India on public engagement; Land acquisition and EIA in India; Safety regulations and its enforcement; Nuclear regulatory institutions; Siting, consent and project execution; Nuclear liability and compensation. The meeting was organised in 3 sessions dealing with: 1 - Public engagement, consultation and acceptance of nuclear projects: - Sociological context of public engagement and consultation, - Current state of affairs and new approaches to public consultation, - Case studies from new green field nuclear project sites, - Public opinion and acceptability for nuclear energy projects, - Role of State, NGOs and Public; 2 - Vales, Attitudes and Acceptability - Lessons from other countries: - Fukushima and nuclear energy choices, - Social dimensions of nuclear power, - Public engagement, acceptance and regulatory process, - Management of HLW. 3 - Legal Framework for a Safe and Secure Nuclear Energy Program: - Safety regulations and its enforcement, - Nuclear regulatory institutions, - Siting, consent and project execution, - Environmental impact assessments and plans, - Nuclear liability and compensation. Several of the papers presented will be published in the Journal of Risk Research in early 2015 as part of the Special Issue on Nuclear Energy and Indian Society: Public Engagement, Risk Assessment and Legal Frameworks. This article is the summary of the proceedings

  7. Assessment of Transportation Risk of Radioactive Materials in Uganda

    International Nuclear Information System (INIS)

    Richard, Menya; Kim, Jonghyun

    2014-01-01

    Radioactive materials refer to any materials that spontaneously emit ionizing radiation and of which the radioactivity per gram is greater than 0.002 micro-curie. They include: spent nuclear fuel, nuclear wastes, medical sources i.e. Co-60, industrial sources i.e. Cs-137, Am-241:Be, Ra-226, and sources for research. In view of the rising reported cancer cases in Uganda, which might be as a result of radiation exposure due to constant transportation of radioactive materials i.e. industrial sources, a risk analysis was thought of and undertaken for the country's safety evaluation and improvement. It was therefore important to undertake a risk assessment of the actual and potential radiation exposure during the transportation process. This paper explains a study undertaken for transport risk assessment of the impact on the environment and the people living in it, from exposure to radioactivity during transportation of the industrial sources in Uganda. It provides estimates of radiological risks associated with visualized transport scenarios for the highway transport mode. This is done by calculating the human health impact and radiological risk from transportation of the sources along Busia transport route to Hoima. Busia is the entry port for the sources whilst Hoima, where various industrial practices that utilize sources like oil explorations are centered. During the study, a computer code RADTRAN-6 was used. The overall collective dose for population and package transport crew are 3.72E-4 and 1.69E-4 person-sievert respectively. These are less than the exemption value recommended by the IAEA and Uganda Regulatory Authority for public implying that no health effects like cancer are to be expected. Hence the rising cancer cases in the country are not as a result of increased transportation of radioactive materials in the Industrial sector

  8. Assessment of Transportation Risk of Radioactive Materials in Uganda

    Energy Technology Data Exchange (ETDEWEB)

    Richard, Menya; Kim, Jonghyun [KEPCO International Nuclear Graduate School, Ulsan (Korea, Republic of)

    2014-10-15

    Radioactive materials refer to any materials that spontaneously emit ionizing radiation and of which the radioactivity per gram is greater than 0.002 micro-curie. They include: spent nuclear fuel, nuclear wastes, medical sources i.e. Co-60, industrial sources i.e. Cs-137, Am-241:Be, Ra-226, and sources for research. In view of the rising reported cancer cases in Uganda, which might be as a result of radiation exposure due to constant transportation of radioactive materials i.e. industrial sources, a risk analysis was thought of and undertaken for the country's safety evaluation and improvement. It was therefore important to undertake a risk assessment of the actual and potential radiation exposure during the transportation process. This paper explains a study undertaken for transport risk assessment of the impact on the environment and the people living in it, from exposure to radioactivity during transportation of the industrial sources in Uganda. It provides estimates of radiological risks associated with visualized transport scenarios for the highway transport mode. This is done by calculating the human health impact and radiological risk from transportation of the sources along Busia transport route to Hoima. Busia is the entry port for the sources whilst Hoima, where various industrial practices that utilize sources like oil explorations are centered. During the study, a computer code RADTRAN-6 was used. The overall collective dose for population and package transport crew are 3.72E-4 and 1.69E-4 person-sievert respectively. These are less than the exemption value recommended by the IAEA and Uganda Regulatory Authority for public implying that no health effects like cancer are to be expected. Hence the rising cancer cases in the country are not as a result of increased transportation of radioactive materials in the Industrial sector.

  9. 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.

  10. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  11. A total risk assessment methodology for security assessment

    International Nuclear Information System (INIS)

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

    2009-01-01

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

  12. Uncertainties in human health risk assessment of environmental contaminants: A review and perspective.

    Science.gov (United States)

    Dong, Zhaomin; Liu, Yanju; Duan, Luchun; Bekele, Dawit; Naidu, Ravi

    2015-12-01

    Addressing uncertainties in human health risk assessment is a critical issue when evaluating the effects of contaminants on public health. A range of uncertainties exist through the source-to-outcome continuum, including exposure assessment, hazard and risk characterisation. While various strategies have been applied to characterising uncertainty, classical approaches largely rely on how to maximise the available resources. Expert judgement, defaults and tools for characterising quantitative uncertainty attempt to fill the gap between data and regulation requirements. The experiences of researching 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) illustrated uncertainty sources and how to maximise available information to determine uncertainties, and thereby provide an 'adequate' protection to contaminant exposure. As regulatory requirements and recurring issues increase, the assessment of complex scenarios involving a large number of chemicals requires more sophisticated tools. Recent advances in exposure and toxicology science provide a large data set for environmental contaminants and public health. In particular, biomonitoring information, in vitro data streams and computational toxicology are the crucial factors in the NexGen risk assessment, as well as uncertainties minimisation. Although in this review we cannot yet predict how the exposure science and modern toxicology will develop in the long-term, current techniques from emerging science can be integrated to improve decision-making. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Transcriptomic resources for environmental risk assessment: a case study in the Venice lagoon.

    Science.gov (United States)

    Milan, M; Pauletto, M; Boffo, L; Carrer, C; Sorrentino, F; Ferrari, G; Pavan, L; Patarnello, T; Bargelloni, L

    2015-02-01

    The development of new resources to evaluate the environmental status is becoming increasingly important representing a key challenge for ocean and coastal management. Recently, the employment of transcriptomics in aquatic toxicology has led to increasing initiatives proposing to integrate eco-toxicogenomics in the evaluation of marine ecosystem health. However, several technical issues need to be addressed before introducing genomics as a reliable tool in regulatory ecotoxicology. The Venice lagoon constitutes an excellent case, in which the assessment of environmental risks derived from the nearby industrial activities represents a crucial task. In this context, the potential role of genomics to assist environmental monitoring was investigated through the definition of reliable gene expression markers associated to chemical contamination in Manila clams, and their subsequent employment for the classification of Venice lagoon areas. Overall, the present study addresses key issues to evaluate the future outlooks of genomics in the environmental monitoring and risk assessment. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. The impact of biology on risk assessment -- Workshop of the National Research Council's board on radiation effects research. Meeting report

    International Nuclear Information System (INIS)

    Fry, R.J.M.; Grosovsky, A.; Hanawalt, P.C.; Ullrich, R.L.

    1997-01-01

    The linear, nonthreshold extrapolation from a dose-response relationship for ionizing radiation derived at higher doses to doses for which regulatory standards are proposed is being challenged by some scientists and defended by others. It appears that the risks associated with exposures to doses of interest are below the risks that can be measured with epidemiologic studies. Therefore, many have looked to biology to provide information relevant to risk assessment. The workshop reported here, ''The Impact of biology on Risk Assessment,'' was planned to address the need for further information by bringing together scientists who have been working in key fields of biology and others who have been contemplating the issues associated specifically with this question. The goals of the workshop were to summarize and review the status of the relevant biology, to determine how the reported biologic data might influence risk assessment, and to identify subjects on which more data is needed

  15. Horses for courses: risk information and decision making in the regulation of nanomaterials

    International Nuclear Information System (INIS)

    Beaudrie, Christian E. H.; Kandlikar, Milind

    2011-01-01

    Despite the widespread commercial use of nanomaterials, regulators currently have a limited ability to characterize and manage risks. There is a paucity of data available on the current production and use of nanomaterials and extreme scientific uncertainty on most aspects of the risk assessment “causal chain.” Regulatory decisions will need to be made in the near-term in the absence formal quantitative risk assessments. The article draws on examples from three different regulatory contexts—baseline data monitoring efforts of the U.S. Environmental Protection Agency and California Department of Toxic Substances Control, prioritization of risk information in the context of environmental releases, and mitigation of occupational risks—to argue for the use of decision-analytic tools in lieu of formal risk assessment to help regulatory bodies. We advocate a “horses for courses” approach whereby existing analytical tools (such as risk ranking, multi-criteria decision analysis, and “control banding” approaches) might be adapted to regulators’ goals in particular decision contexts. While efforts to build new and modify existing tools are underway, they need greater support from funding and regulatory agencies because innovative approaches are needed for the “extreme” uncertainty problems that nanomaterials pose.

  16. 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.

  17. Influence of the human reliability in the assessment of the impact on the risk of changes of CLO; Influencia de la fiabilidad humana en la evaluacion del impacto en el riesgo de cambios de CLO

    Energy Technology Data Exchange (ETDEWEB)

    Martorell, P.; Martorell, S.; Marton, I.; Saiz, M.

    2014-07-01

    Treatment and study of epistemic uncertainties is of special importance in the application of the analysis of probabilistic security to informed decision-making in risk, as points out the guide regulatory 1,174 [1] (Regulatory Guide 1,174, RG1.174). Specifically, the RG 1.177 [2] details of the impact on risk assessment concerning changes in the technical operating specifications (ETF). Based on the framework defined by such regulatory guides, will be assessed the effect of uncertainties epistemic associated with the analysis of human reliability in the context of the limit conditions of operation. As an example of application, will be held a sensitivity study of the time of inoperability Completion Time, the Residual heat removal system. (Author)

  18. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

    Science.gov (United States)

    Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

    2007-01-01

    Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

  19. 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...

  20. Assessing Pesticides under the Endangered Species Act

    Science.gov (United States)

    EPA’s pesticide risk assessment and regulatory processes ensure that protections are in place for all populations of non-target species. We have developed risk assessment procedures to determine potential for harm to individuals of a listed species.