WorldWideScience

Sample records for state regulatory systems

  1. Steady-State-Preserving Simulation of Genetic Regulatory Systems

    Directory of Open Access Journals (Sweden)

    Ruqiang Zhang

    2017-01-01

    Full Text Available A novel family of exponential Runge-Kutta (expRK methods are designed incorporating the stable steady-state structure of genetic regulatory systems. A natural and convenient approach to constructing new expRK methods on the base of traditional RK methods is provided. In the numerical integration of the one-gene, two-gene, and p53-mdm2 regulatory systems, the new expRK methods are shown to be more accurate than their prototype RK methods. Moreover, for nonstiff genetic regulatory systems, the expRK methods are more efficient than some traditional exponential RK integrators in the scientific literature.

  2. State Electricity Regulatory Policy and Distributed Resources: Distributed Resources and Electric System Reliability

    Energy Technology Data Exchange (ETDEWEB)

    Cowart, R.; Harrington, C.; Moskovitz, D.; Shirley, W.; Weston, F.; Sedano, R.

    2002-10-01

    Designing and implementing credit-based pilot programs for distributed resources distribution is a low-cost, low-risk opportunity to find out how these resources can help defer or avoid costly electric power system (utility grid) distribution upgrades. This report describes implementation options for deaveraged distribution credits and distributed resource development zones. Developing workable programs implementing these policies can dramatically increase the deployment of distributed resources in ways that benefit distributed resource vendors, users, and distribution utilities. This report is one in the State Electricity Regulatory Policy and Distributed Resources series developed under contract to NREL (see Annual Technical Status Report of the Regulatory Assistance Project: September 2000-September 2001, NREL/SR-560-32733). Other titles in this series are: (1) Accommodating Distributed Resources in Wholesale Markets, NREL/SR-560-32497; (2) Distributed Resources and Electric System Re liability, NREL/SR-560-32498; (3) Distribution System Cost Methodologies for Distributed Generation, NREL/SR-560-32500; (4) Distribution System Cost Methodologies for Distributed Generation Appendices, NREL/SR-560-32501.

  3. 40 CFR 73.86 - State regulatory autonomy.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false State regulatory autonomy. 73.86 Section 73.86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... regulatory autonomy. Nothing in this subpart shall preclude a State or State regulatory authority from...

  4. Jimena: efficient computing and system state identification for genetic regulatory networks.

    Science.gov (United States)

    Karl, Stefan; Dandekar, Thomas

    2013-10-11

    Boolean networks capture switching behavior of many naturally occurring regulatory networks. For semi-quantitative modeling, interpolation between ON and OFF states is necessary. The high degree polynomial interpolation of Boolean genetic regulatory networks (GRNs) in cellular processes such as apoptosis or proliferation allows for the modeling of a wider range of node interactions than continuous activator-inhibitor models, but suffers from scaling problems for networks which contain nodes with more than ~10 inputs. Many GRNs from literature or new gene expression experiments exceed those limitations and a new approach was developed. (i) As a part of our new GRN simulation framework Jimena we introduce and setup Boolean-tree-based data structures; (ii) corresponding algorithms greatly expedite the calculation of the polynomial interpolation in almost all cases, thereby expanding the range of networks which can be simulated by this model in reasonable time. (iii) Stable states for discrete models are efficiently counted and identified using binary decision diagrams. As application example, we show how system states can now be sampled efficiently in small up to large scale hormone disease networks (Arabidopsis thaliana development and immunity, pathogen Pseudomonas syringae and modulation by cytokinins and plant hormones). Jimena simulates currently available GRNs about 10-100 times faster than the previous implementation of the polynomial interpolation model and even greater gains are achieved for large scale-free networks. This speed-up also facilitates a much more thorough sampling of continuous state spaces which may lead to the identification of new stable states. Mutants of large networks can be constructed and analyzed very quickly enabling new insights into network robustness and behavior.

  5. Regulatory authority information system RAIS

    International Nuclear Information System (INIS)

    Ortiz, P.; Mrabit, K.; Miaw, S.

    2000-01-01

    In this lecture the principles of the regulatory authority information system (RAIS) are presented. RAIS is a tool currently being developed by the IAEA for the Regulatory Authorities. It is a part of a set of supporting actions designed to assist member states in achieving the objectives of the Model project on radiation and waste safety infrastructure. RAIS is a tool that provides the management of the Regulatory Authority with the key information needed for the planning and implementation of activities and to ensure confidence that resources are optimally used. The RAIS contains five modules: Inventory of installations and radiation sources; Authorization process; Inspection and follow-up actions; Information on personal dosimetry; Assessment of effectiveness by means of performance indicators

  6. State/Federal Regulatory Considerations

    Science.gov (United States)

    This page contains presentations from the Brown to Green: Make the Connection to Renewable Energy workshop held in Santa Fe, New Mexico, during December 10-11, 2008, regarding State/Federal Regulatory Considerations.

  7. 78 FR 38053 - Regulatory Systems Strengthening

    Science.gov (United States)

    2013-06-25

    ... current state of medical product regulation globally, including challenges, risks, and emerging trends... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0010... product regulation; generation and analysis of evidence of regulatory systems performance; and provision...

  8. Safety Experts Complete IAEA Nuclear Regulatory Review of the United States

    International Nuclear Information System (INIS)

    2010-01-01

    Full text: An international team of senior nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the United States. The team identified good practices within the U.S. system and offered suggestions for ways the U.S. Nuclear Regulatory Commission (NRC) could improve. The IAEA has conveyed the team's main conclusions to the NRC, and a final report will be submitted to the NRC in about two months. At the request of the United States, the IAEA assembled a team of 19 international experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This mission was a peer review based on the IAEA Safety Standards. It was not an inspection, nor an audit. The experts came from 14 different countries: Canada, China, the Czech Republic, Finland, France, Italy, Japan, Mexico, the Republic of Korea, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. Team leader Jukka Laaksonen of Finland said: ''We found a comprehensive, consistent, and mature regulatory system run by the NRC, which has a strong drive for continuous improvement.' The scope of the mission included the U.S. regulatory framework and the regulation of the nuclear plant operation. The mission was conducted from 18 to 29 October, mainly at NRC headquarters outside of Washington, D.C. To study U.S. regulatory activities, the mission conducted a series of interviews and discussions with NRC staff and other organizations to help assess the effectiveness of the regulatory system. In addition, the team observed regulatory activities at two operating nuclear power reactors and an emergency preparedness exercise. The IAEA's IRRS coordinator Gustavo Caruso said, ''This mission represents a milestone for the IRRS program because the U.S. regulatory system is the largest in the world and many nations look to it. The IRRS is a useful tool that allows host nations to gain guidance from experienced

  9. Regulatory analysis for the resolution of Generic Issue 115, enhancement of the reliability of the Westinghouse Solid State Protection System

    International Nuclear Information System (INIS)

    Basdekas, D.L.

    1989-05-01

    Generic Issue 115 addresses a concern related to the reliability of the Westinghouse reactor protection system for plants using the Westinghouse Solid State Protection System (SSPS). Several options for improving the reliability of the Westinghouse reactor trip function for these plants and their effect on core damage frequency (CDF) and overall risk were evaluated. This regulatory analysis includes a quantitative assessment of the costs and benefits associated with the various options for enhancing the reliability of the Westinghouse SSPS and provides insights for consideration and industry initiatives. No new regulatory requirements are proposed. 25 refs., 11 tabs

  10. Inhibitors Alter the Stochasticity of Regulatory Proteins to Force Cells to Switch to the Other State in the Bistable System.

    Science.gov (United States)

    Jhang, Wun-Sin; Lo, Shih-Chiang; Yeh, Chen-Chao; Shu, Che-Chi

    2017-06-30

    The cellular behaviors under the control of genetic circuits are subject to stochastic fluctuations, or noise. The stochasticity in gene regulation, far from a nuisance, has been gradually appreciated for its unusual function in cellular activities. In this work, with Chemical Master Equation (CME), we discovered that the addition of inhibitors altered the stochasticity of regulatory proteins. For a bistable system of a mutually inhibitory network, such a change of noise led to the migration of cells in the bimodal distribution. We proposed that the consumption of regulatory protein caused by the addition of inhibitor is not the only reason for pushing cells to the specific state; the change of the intracellular stochasticity is also the main cause for the redistribution. For the level of the inhibitor capable of driving 99% of cells, if there is no consumption of regulatory protein, 88% of cells were guided to the specific state. It implied that cells were pushed, by the inhibitor, to the specific state due to the change of stochasticity.

  11. Regulatory accessibility and social influences on state self-control.

    Science.gov (United States)

    vanDellen, Michelle R; Hoyle, Rick H

    2010-02-01

    The current work examined how social factors influence self-control. Current conceptions of state self-control treat it largely as a function of regulatory capacity. The authors propose that state self-control might also be influenced by social factors because of regulatory accessibility. Studies 1 through 4 provide evidence that individuals' state self-control is influenced by the trait and state self-control of salient others such that thinking of others with good trait or state self-control leads to increases in state self-control and thinking of others with bad trait or state self-control leads to decreases in state self-control. Study 5 provides evidence that the salience of significant others influences both regulatory accessibility and state self-control. Combined, these studies suggest that the effects of social influences on state self-control occur through multiple mechanisms.

  12. Regulatory issues of digital instrumentation and control system in Lungmen project

    International Nuclear Information System (INIS)

    Chuang, C.F.; Chou, H.P.

    2004-01-01

    The Lungmen Nuclear Power Station (LNPS) is currently under construction in Taiwan, which consists of 2 advanced boiling water reactor (ABWR) units. The instrumentation and control (IC) systems of the LNPS are based on the state-of-the-art modernized fully integrated digital design. These IC systems possess many advantages and distinguished features comparing to traditional analog IC systems, they enjoy set-point stability, self-diagnostic and automatic testing ability, fault tolerance and avoidance, low power requirements, data handling and storage capability, as well as enhanced human-machine interfaces. This paper presents regulatory overviews, regulatory requirements, current major regulatory issues, as well as the areas of regulatory concerns and the lessons learned on the digital IC systems in the Lungmen Project

  13. Regulatory Accessibility and Social Influences on State Self-Control

    OpenAIRE

    vanDellen, Michelle R.; Hoyle, Rick H.

    2009-01-01

    The current work examined how social factors influence self-control. Current conceptions of state self-control treat it largely as a function of regulatory capacity. The authors propose that state self-control might also be influenced by social factors because of regulatory accessibility. Studies 1 through 4 provide evidence that individuals’ state self-control is influenced by the trait and state self-control of salient others such that thinking of others with good trait or state self-contro...

  14. 7 CFR 1710.105 - State regulatory approvals.

    Science.gov (United States)

    2010-01-01

    ... and Basic Policies § 1710.105 State regulatory approvals. (a) In States where a borrower is required... loans are approved by RUS: (1) Loans requiring an Environmental Impact Statement; (2) Loans to finance...

  15. Techniques for analyzing the impacts of certain electric-utility ratemaking and regulatory-policy concepts. Regulatory laws and policies. [State by state

    Energy Technology Data Exchange (ETDEWEB)

    None

    1980-08-01

    This report is a legal study prepared to provide a review of the substantive and procedural laws of each regulatory jurisdiction that may affect implementation of the PURPA standards, and to summarize the current state of consideration and implementation of policies and rate designs similar or identical to the PURPA standards by state regulatory agencies and nonregulated utilities. This report is divided into three sections. The first section, the Introduction, summarizes the standards promulgated by PURPA and the results of the legal study. The second section, State Regulatory Law and Procedure, summarizes for each state or other ratemaking jurisdiction: (1) general constitutional and statutory provisions affecting utility rates and conditions of service; (2) specific laws or decisions affecting policy or rate design issues covered by PURPA standards; and (3) statutes and decisions governing administrative procedures, including judicial review. A chart showing actions taken on the policy and rate design issues addressed by PURPA is also included for each jurisdiction, and citations to relevant authorities are presented for each standard. State statutes or decisions that specifically define a state standard similar or identical to a PURPA standard, or that refer to one of the three PURPA objectives, are noted. The third section, Nonregulated Electric Utilities, summarizes information available on nonregulated utilities, i.e., publicly or cooperatively owned utilities which are specifically exempted from state regulation by state law.

  16. Transportation of radioactive materials: the legislative and regulatory information system

    International Nuclear Information System (INIS)

    Fore, C.S.

    1982-03-01

    The US Department of Energy is carrying out a national program to assure the safe shipment of radioactive materials. As part of this overall effort, the Hazardous Materials Information Center of Oak Ridge National Laboratory has developed the comprehensive Legislative and Regulatory Information System, which contains information on federal-, state-, and local-level legislative and regulatory actions pertaining primarily to the shipment of radioactive materials. Specific subject areas chosen to highlight particular transportation restrictions include: (1) identification of state agency responsible for regulating transportation, (2) type of escorts required, (3) areas requiring prior notification, (4) areas requiring permits or licenses, and (5) areas totally banning transportation of all radioactive materials. Other legislative information being categorized and of immediate relevance to the transportation issues is covered under the areas of disposal, storage, and management of radioactive materials; establishment of additional regulations; emergency response regulations; moratoriums on power plant construction and siting; radiation safety and control studies; and remedial action studies. The collected information is abstracted, indexed, and input into one of the two data bases developed under this information system - Current Legislation Data Base and Historical Legislation Data Base. An appendix is included which provides a summary of the state and local laws affecting the transportation of radioactive materials throughout the United States. The Legislative and Regulatory Information System is supported by the Transportation Technology Center located at Sandia National Laboratories, Albuquerque, New Mexico

  17. Transportation of radioactive materials: the legislative and regulatory information system

    Energy Technology Data Exchange (ETDEWEB)

    Fore, C.S.

    1982-03-01

    The US Department of Energy is carrying out a national program to assure the safe shipment of radioactive materials. As part of this overall effort, the Hazardous Materials Information Center of Oak Ridge National Laboratory has developed the comprehensive Legislative and Regulatory Information System, which contains information on federal-, state-, and local-level legislative and regulatory actions pertaining primarily to the shipment of radioactive materials. Specific subject areas chosen to highlight particular transportation restrictions include: (1) identification of state agency responsible for regulating transportation, (2) type of escorts required, (3) areas requiring prior notification, (4) areas requiring permits or licenses, and (5) areas totally banning transportation of all radioactive materials. Other legislative information being categorized and of immediate relevance to the transportation issues is covered under the areas of disposal, storage, and management of radioactive materials; establishment of additional regulations; emergency response regulations; moratoriums on power plant construction and siting; radiation safety and control studies; and remedial action studies. The collected information is abstracted, indexed, and input into one of the two data bases developed under this information system - Current Legislation Data Base and Historical Legislation Data Base. An appendix is included which provides a summary of the state and local laws affecting the transportation of radioactive materials throughout the United States. The Legislative and Regulatory Information System is supported by the Transportation Technology Center located at Sandia National Laboratories, Albuquerque, New Mexico.

  18. Management systems for regulatory authorities

    International Nuclear Information System (INIS)

    Mpandanyama, Rujeko Lynette

    2015-02-01

    For a regulatory body to fulfil its statutory obligations, there is need to develop and implement a regulatory management system that has the necessary arrangements for achieving and maintaining high quality performance in regulating the safety of nuclear and radiation facilities under its authority. Hence, the regulatory management system needs to fully integrate the human resources, processes and physical resources of the organization. This study sought to provide an understanding of the concept, principles, policies and fundamentals of management systems as they relate to regulatory systems in the field of radiation protection and to make appropriate recommendations to ensure that an effective management system exists for the control of ionizing radiation and radiation sources and addresses all relevant stakeholders in Zimbabwe. A comparative analysis was done on the current management status and the ideal management system, which led to the identification of the gaps existing. The main key that was found to be of significance was lack of linkages between processes and management tools within the institution. (au)

  19. Improving regulatory effectiveness in Federal/State siting actions: Federal/State regulatory permitting actions in selected nuclear power station licensing cases

    International Nuclear Information System (INIS)

    Baroff, J.

    1977-06-01

    The Federal/State regulatory permitting actions in 12 case histories of nuclear power station licensing in nine different states are documented. General observations regarding Federal/State siting roles in the siting process are included. Eleven of the case histories are illustrated with a logic network that gives the actions of the utilities in addition to the Federal/State permits

  20. Information resources in state regulatory agencies-a California perspective

    Energy Technology Data Exchange (ETDEWEB)

    DiZio, S.M. [California Environmental Protection Agency, Sacramento (United States)

    1990-12-31

    Various state regulatory agencies have expressed a need for networking with information gatherers/researchers to produce a concise compilation of primary information so that the basis for regulatory standards can be scientifically referenced. California has instituted several programs to retrieve primary information, generate primary information through research, and generate unique regulatory standards by integrating the primary literature and the products of research. This paper describes these programs.

  1. Unsolved problems in applying U.S. regulatory guides to control system equipment

    International Nuclear Information System (INIS)

    Stade, R.E.

    1978-01-01

    Two current problems encountered when designing control systems to the United States Regulatory Guide requirements are discussed. They are: 1) Level of surge voltages that should be specified when procuring solid state control and instrumentation systems and equipment. 2) The approach to be used qualifying equipment that must meet the aging requirements. (author)

  2. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in the United States. Preliminary background report

    Energy Technology Data Exchange (ETDEWEB)

    Feurer, D.A.; Weaver, C.L.; Gallagher, K.C.; Hejna, D.; Rielley, K.J.

    1980-01-01

    This report is one of a series of preliminary reports describing the laws and regulatory programs of the United States and each of the 50 states affecting the siting and operation of energy generating facilities likely to be used in Integrated Community Energy Systems (ICES). Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES. This report describes laws and regulatory programs in the United States. Subsequent reports will (1) describe public utility rate regulatory procedures and practices as they might affect an ICES, (2) analyze each of the aforementioned regulatory programs to identify impediments to the development of ICES, and (3) recommend potential changes in legislation and regulatory practices and procedures to overcome such impediments.

  3. Sociotechnical systems as a framework for regulatory system design and evaluation: Using Work Domain Analysis to examine a new regulatory system.

    Science.gov (United States)

    Carden, Tony; Goode, Natassia; Read, Gemma J M; Salmon, Paul M

    2017-03-15

    Like most work systems, the domain of adventure activities has seen a series of serious incidents and subsequent calls to improve regulation. Safety regulation systems aim to promote safety and reduce accidents. However, there is scant evidence they have led to improved safety outcomes. In fact there is some evidence that the poor integration of regulatory system components has led to adverse safety outcomes in some contexts. Despite this, there is an absence of methods for evaluating regulatory and compliance systems. This article argues that sociotechnical systems theory and methods provide a suitable framework for evaluating regulatory systems. This is demonstrated through an analysis of a recently introduced set of adventure activity regulations. Work Domain Analysis (WDA) was used to describe the regulatory system in terms of its functional purposes, values and priority measures, purpose-related functions, object-related processes and cognitive objects. This allowed judgement to be made on the nature of the new regulatory system and on the constraints that may impact its efficacy following implementation. Importantly, the analysis suggests that the new system's functional purpose of ensuring safe activities is not fully supported in terms of the functions and objects available to fulfil them. Potential improvements to the design of the system are discussed along with the implications for regulatory system design and evaluation across the safety critical domains generally. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. 30 CFR 906.10 - State regulatory program approval.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false State regulatory program approval. 906.10 Section 906.10 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE COLORADO § 906.10 State...

  5. Regulatory approaches in the United States of America for safe management and disposal of long-lived radionuclides

    International Nuclear Information System (INIS)

    Greeves, J.T.; Bell, M.J.; Nelson, R.A.

    1998-01-01

    Regulation of the safe management and disposal of commercial, man-made, long-lived radioactive wastes in the United States is the responsibility of the US Nuclear Regulatory Commission (NRC). In some instances, state regulatory authorities have entered into agreements with the NRC to exercise regulatory authority over management and disposal of low-level radioactive wastes and uranium mill tailings within their borders. The legal and regulatory framework employed to achieve safe management and disposal of long-lived radioactive wastes in the US regulatory system is quite detailed, and in many cases the requirements are considerably prescriptive. The NRC has undertaken an initiative to move in the direction of adopting risk-informed, performance-based and risk-informed, less-prescriptive regulations. The current status and future direction of the legal and regulatory framework for management and disposal of commercial long-lived radioactive waste in the US is described. (author)

  6. Below regulatory concern standards: The limits of state and local authority

    International Nuclear Information System (INIS)

    Silverman, D.J.

    1990-01-01

    The paper discusses: (1) the scope of the Nuclear Regulatory Commission's authority to develop and implement below regulatory concern or BRC standards; and (2) the limitations on the legal authority of states and local governments to create impediments to full implementation of such standards. The paper demonstrates that the NRC is acting well within its statutory authority in developing BRC regulations and guidelines, and that the ability of state and local governments to impede generators' use of those regulations and guidelines on the basis of legal or regulatory initiatives is substantially circumscribed. While some generators may be reluctant, as a result of political factors, to utilize BRC standards, the decision whether or not to use such standards should not be made without careful consideration of the applicable legal and regulatory limitations on state and local authority

  7. Assistance to Oil and Gas State Agencies and Industry through Continuation of Environmental and Production Data Management and a Water Regulatory Initiative

    Energy Technology Data Exchange (ETDEWEB)

    Grunewald, Ben; Arthur, Dan; Langhus, Bruce; Gillespie, Tom; Binder, Ben; Warner, Don; Roberts, Jim; Cox, D.O.

    2002-05-31

    This grant project was a major step toward completion of the Risk Based Data Management System (RBDMS) project. Additionally the project addresses the needs identified during the projects initial phases. By implementing this project, the following outcomes were sought: (1) State regulatory agencies implemented more formalized environmental risk management practices as they pertain to the production of oil and gas, and injection via Class II wells. (2) Enhancement of oil and gas production by implementing a management system supporting the saving of abandoned or idle wells located in areas with a relatively low environmental risk of endangering underground sources of drinking water (USDWs) in a particular state. (3) Verification that protection of USDWs is adequate and additional restrictions of requirements are not necessary in areas with a relatively low environmental risk. (4) Standardization of data and information maintained by state regulatory agencies and decrease the regulatory cost burden on producers operating in multiple states, and (5) Development of a system for electronic data transfer among operators and state regulatory agencies and reduction of overall operator reporting burdens.

  8. Managing Regulatory Body Competence

    International Nuclear Information System (INIS)

    2013-01-01

    In 2001, the IAEA published TECDOC 1254, which examined the way in which the recognized functions of a regulatory body for nuclear facilities results in competence needs. Using the systematic approach to training (SAT), TECDOC 1254 provided a framework for regulatory bodies for managing training and developing and their maintaining their competence. It has been successfully used by many regulators. 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 2009, the IAEA established a steering committee (supported by a bureau) with the mission to advise the IAEA on how it could best assist Member States to develop suitable competence management systems for their regulatory bodies. The committee recommended the development of a safety report on managing staff competence as an integral part of a regulatory body's management system. This Safety Report was developed in response to this request. It supersedes TECDOC 1254, broadens its application to regulatory bodies for all facilities and activities, and builds upon the experience gained through the application of TECDOC 1254 and SARCoN and the feedback received from Member States. This Safety Report applies to the management of adequate competence as needs change, and as such is equally applicable to the needs of States 'embarking' on a nuclear power programme. It also 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

  9. Discourse-voice regulatory strategies in the psychotherapeutic interaction: a state-space dynamics analysis.

    Science.gov (United States)

    Tomicic, Alemka; Martínez, Claudio; Pérez, J Carola; Hollenstein, Tom; Angulo, Salvador; Gerstmann, Adam; Barroux, Isabelle; Krause, Mariane

    2015-01-01

    This study seeks to provide evidence of the dynamics associated with the configurations of discourse-voice regulatory strategies in patient-therapist interactions in relevant episodes within psychotherapeutic sessions. Its central assumption is that discourses manifest themselves differently in terms of their prosodic characteristics according to their regulatory functions in a system of interactions. The association between discourse and vocal quality in patients and therapists was analyzed in a sample of 153 relevant episodes taken from 164 sessions of five psychotherapies using the state space grid (SSG) method, a graphical tool based on the dynamic systems theory (DST). The results showed eight recurrent and stable discourse-voice regulatory strategies of the patients and three of the therapists. Also, four specific groups of these discourse-voice strategies were identified. The latter were interpreted as regulatory configurations, that is to say, as emergent self-organized groups of discourse-voice regulatory strategies constituting specific interactional systems. Both regulatory strategies and their configurations differed between two types of relevant episodes: Change Episodes and Rupture Episodes. As a whole, these results support the assumption that speaking and listening, as dimensions of the interaction that takes place during therapeutic conversation, occur at different levels. The study not only shows that these dimensions are dependent on each other, but also that they function as a complex and dynamic whole in therapeutic dialog, generating relational offers which allow the patient and the therapist to regulate each other and shape the psychotherapeutic process that characterizes each type of relevant episode.

  10. Discourse-Voice Regulatory Strategies in the Psychotherapeutic Interaction: A State-Space Dynamics Analysis

    Directory of Open Access Journals (Sweden)

    Alemka eTomicic

    2015-04-01

    Full Text Available This study seeks to provide evidence of the dynamics associated with the configurations of discourse-voice regulatory strategies in patient-therapist interactions in relevant episodes within psychotherapeutic sessions. Its central assumption is that discourses manifest themselves differently in terms of their prosodic characteristics according to their regulatory functions in a system of interactions. The association between discourse and vocal quality in patients and therapists was analyzed in a sample of 153 relevant episodes taken from 164 sessions of five psychotherapies using the State Space Grid (SSG method, a graphical tool based on the Dynamic Systems Theory (DST. The results showed eight recurrent and stable discourse-voice regulatory strategies of the patients and three of the therapists. Also, four specific groups of these discourse-voice strategies were identified. The latter were interpreted as regulatory configurations, that is to say, as emergent self-organized groups of discourse-voice regulatory strategies constituting specific interactional systems. Both regulatory strategies and their configurations differed between two types of relevant episodes: Change Episodes and Rupture Episodes. As a whole, these results support the assumption that speaking and listening, as dimensions of the interaction that takes place during therapeutic conversation, occur at different levels. The study not only shows that these dimensions are dependent on each other, but also that they function as a complex and dynamic whole in therapeutic dialogue, generating relational offers which allow the patient and the therapist to regulate each other and shape the psychotherapeutic process that characterizes each type of relevant episode.

  11. 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)

  12. State regulatory issues in acid rain compliance

    International Nuclear Information System (INIS)

    Solomon, B.D.; Brick, S.

    1992-01-01

    This article discusses the results of a US EPA workshop for state regulators and commission staff on acid rain compliance concerns. The topics of the article include the results of market-based emissions control, how emissions trading is expected to reduce emissions, public utility commissions approval of compliance plans, the purposes of the workshop, market information, accounting issues, regulatory process and utility planning, multi-state compliance planning, and relationship to other compliance issues

  13. Nuclear Experts Complete IAEA Follow-up Review of German Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear safety experts concluded a seven-day mission to review the German Regulatory System, conducted from 4-10 September in Bonn, Stuttgart and Berlin. At the request of the Government of the Federal Republic of Germany, the International Atomic Energy Agency assembled a peer-review team of six high-level regulatory experts from six nations (Finland, France, the Netherlands, Switzerland, the UK, the US and three IAEA senior staff members) to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2008. This follow-up IRRS mission examined the progress in acting upon the recommendations and suggestions made during the 2008 IRRS mission and reviewed the areas of significant regulatory changes since that review at both the Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) and the Ministry of Environment of the federal state of Baden-Wurttemberg (UM BW). The first mission reviewed Germany's regulatory framework against IAEA Safety Standards and fostered the exchange of information and experience on safety regulation. This is a peer review based on IAEA Standards. It is not an inspection, nor an audit. The scope of the mission was limited to the safety regulation of nuclear power plants. IRRS team leader, Mr. McCree, of the US Nuclear Safety Commission (USNRC), said, ''This was an important IRRS mission, particularly given the recent Fukushima Daiichi Nuclear Power Plant accident and the related insights which underscore the importance of having an independent, credible nuclear safety regulator.'' ''The IRRS team identified several strengths of the German nuclear safety regulators, including the prompt and coordinated incident response activities of BMU and UM BW to the Fukushima accident. Some suggestions were also made to further strengthen nuclear safety regulations concerning the future work of BMU,'' he said. The review team found that important progress has been made toward

  14. International nuclear safety experts complete IAEA peer review of German regulatory system

    International Nuclear Information System (INIS)

    2008-01-01

    Full text: An international expert team has today completed a two-week IAEA review of Germany's nuclear regulatory system. The team identified good practices within the system and gave advice on some areas for further improvement. The IAEA has conveyed the initial findings to German authorities but the final report will be submitted within two months. At the request of the Government of the Federal Republic of Germany, the International Atomic Energy Agency (IAEA) assembled a team of 14 experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This is a peer review based on IAEA Standards. It is not an inspection, nor an audit. The scope of the mission was limited to the safety regulation of nuclear power plants. Experts from Canada, the Czech Republic, Finland, France, Japan, the Netherlands, Republic of Korea, Spain, Switzerland, the UK, the US and from the IAEA took part in the mission, which was conducted from 7 to 19 September in Bonn, Stuttgart and Berlin. The main basis for the review was a well-prepared self-assessment made by the Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) and the Ministry of Environment of the federal state of Baden-Wuerttemberg (UM BW). 'The team members were impressed by the extensive preparation and dedication of the staff both at BMU and UM BW to excellence in nuclear safety,' said Mike Weightman, IRRS Team Leader and Chief Inspector of the UK nuclear regulatory body, the Nuclear Directorate of the Health and Safety Executive. 'We hope the IRRS mission will facilitate further improvements in the safety regulation of nuclear power in Germany and throughout the world.' 'Germany's invitation to undergo such a detailed review is a clear demonstration of its openness and commitment to continuously improve nuclear safety regulation,' said Philippe Jamet, Director of the IAEA's Nuclear Installation Safety Division. Among the particular strengths of BMU and UM BW associated with their

  15. The effects of intrinsic noise on the behaviour of bistable cell regulatory systems under quasi-steady state conditions.

    Science.gov (United States)

    de la Cruz, Roberto; Guerrero, Pilar; Spill, Fabian; Alarcón, Tomás

    2015-08-21

    We analyse the effect of intrinsic fluctuations on the properties of bistable stochastic systems with time scale separation operating under quasi-steady state conditions. We first formulate a stochastic generalisation of the quasi-steady state approximation based on the semi-classical approximation of the partial differential equation for the generating function associated with the chemical master equation. Such approximation proceeds by optimising an action functional whose associated set of Euler-Lagrange (Hamilton) equations provides the most likely fluctuation path. We show that, under appropriate conditions granting time scale separation, the Hamiltonian can be re-scaled so that the set of Hamilton equations splits up into slow and fast variables, whereby the quasi-steady state approximation can be applied. We analyse two particular examples of systems whose mean-field limit has been shown to exhibit bi-stability: an enzyme-catalysed system of two mutually inhibitory proteins and a gene regulatory circuit with self-activation. Our theory establishes that the number of molecules of the conserved species is order parameters whose variation regulates bistable behaviour in the associated systems beyond the predictions of the mean-field theory. This prediction is fully confirmed by direct numerical simulations using the stochastic simulation algorithm. This result allows us to propose strategies whereby, by varying the number of molecules of the three conserved chemical species, cell properties associated to bistable behaviour (phenotype, cell-cycle status, etc.) can be controlled.

  16. The effects of intrinsic noise on the behaviour of bistable cell regulatory systems under quasi-steady state conditions

    Energy Technology Data Exchange (ETDEWEB)

    Cruz, Roberto; Alarcón, Tomás de la [Centre de Recerca Matemàtica. Edifici C, Campus de Bellaterra, 08193 Bellaterra (Barcelona) (Spain); Departament de Matemàtiques, Universitat Autònoma de Barcelona, 08193 Bellaterra (Barcelona) (Spain); Guerrero, Pilar [Department of Mathematics, University College London, Gower Street, London WC1E 6BT (United Kingdom); Spill, Fabian [Department of Biomedical Engineering, Boston University, 44 Cummington Street, Boston, Massachusetts 02215 (United States); Department of Mechanical Engineering, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, Massachusetts 02139 (United States)

    2015-08-21

    We analyse the effect of intrinsic fluctuations on the properties of bistable stochastic systems with time scale separation operating under quasi-steady state conditions. We first formulate a stochastic generalisation of the quasi-steady state approximation based on the semi-classical approximation of the partial differential equation for the generating function associated with the chemical master equation. Such approximation proceeds by optimising an action functional whose associated set of Euler-Lagrange (Hamilton) equations provides the most likely fluctuation path. We show that, under appropriate conditions granting time scale separation, the Hamiltonian can be re-scaled so that the set of Hamilton equations splits up into slow and fast variables, whereby the quasi-steady state approximation can be applied. We analyse two particular examples of systems whose mean-field limit has been shown to exhibit bi-stability: an enzyme-catalysed system of two mutually inhibitory proteins and a gene regulatory circuit with self-activation. Our theory establishes that the number of molecules of the conserved species is order parameters whose variation regulates bistable behaviour in the associated systems beyond the predictions of the mean-field theory. This prediction is fully confirmed by direct numerical simulations using the stochastic simulation algorithm. This result allows us to propose strategies whereby, by varying the number of molecules of the three conserved chemical species, cell properties associated to bistable behaviour (phenotype, cell-cycle status, etc.) can be controlled.

  17. State Regulatory Authority (SRA) Coordination of Safety, Security, and Safeguards of Nuclear Facilities: A Framework for Analysis

    International Nuclear Information System (INIS)

    Mladineo, S.; Frazar, S.; Kurzrok, A.; Martikka, E.; Hack, T.; Wiander, T.

    2013-01-01

    In November 2012 the International Atomic Energy Agency (IAEA) sponsored a Technical Meeting on the Interfaces and Synergies in Safety, Security, and Safeguards for the Development of a Nuclear Power Program. The goal of the meeting was to explore whether and how safeguards, safety, and security systems could be coordinated or integrated to support more effective and efficient nonproliferation infrastructures. While no clear consensus emerged, participants identified practical challenges to and opportunities for integrating the three disciplines’ regulations and implementation activities. Simultaneously, participants also recognized that independent implementation of safeguards, safety, and security systems may be more effective or efficient at times. This paper will explore the development of a framework for conducting an assessment of safety-security-safeguards integration within a State. The goal is to examine State regulatory structures to identify conflicts and gaps that hinder management of the three disciplines at nuclear facilities. Such an analysis could be performed by a State Regulatory Authority (SRA) to provide a self-assessment or as part of technical cooperation either with a newcomer State, or to a State with a fully developed SRA.

  18. Regulatory system reform of occupational health and safety in China.

    Science.gov (United States)

    Wu, Fenghong; Chi, Yan

    2015-01-01

    With the explosive economic growth and social development, China's regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined.

  19. Continuing education requirements among State Occupational Therapy Regulatory Boards in the United States of America

    Directory of Open Access Journals (Sweden)

    Savannah R. Hall

    2016-10-01

    Full Text Available Purpose The purpose of this study is to compare and contrast the contents of each state’s occupational therapy (OT regulatory board requirements regarding licensees’ acquisition of continuing education units in the United States of America. Methods Data related to continuing education requirements from each OT regulatory board of all 50 states and the District of Columbia in the United States were reviewed and categorized by two reviewers. Analysis was conducted based on the categorization of the continuing education requirements and activities required, allowed, and not allowed/not mentioned for continuing education units. Results Findings revealed non-uniformity and inconsistency of continuing education requirements for licensure renewal between OT regulatory boards and was coupled with lack of specific criteria for various continuing education activities. Continuing education requirements were not tailored to meet the needs of individual licensee’s current and anticipated professional role and job responsibilities, with a negative bias towards presentation and publication allowed for continuing education units. Few boards mandated continuing education topics on ethics related to OT practice within each renewal cycle. Conclusion OT regulatory boards should move towards unifying the reporting format of continuing education requirements across all states to reduce ambiguity and to ensure licensees are equipped to provide ethical and competent practice. Efforts could be made to enact continuing education requirements specific to the primary role of a particular licensee. Finally, assigning the amount of continuing education credits to be awarded for different activities should be based on research evidence rather than arbitrary determination.

  20. Regulatory control of physical protection systems

    International Nuclear Information System (INIS)

    Rajdeep; Mayya, Y.S.

    2017-01-01

    The safety of facilities in BARC is under the regulatory oversight of BSC. The security architecture for these facilities incorporates multiple layers of Physical Protection Systems. The demands of safety may sometimes conflict with the needs of security. Realizing the need to identify these interfaces and extend the regulatory coverage to Physical Protection Systems, a Standing Committee named Physical Protection System Review Committee (PPSRC) has been constituted as a 2"n"d tier entity of BSC. PPSRC includes experts from various domains concerned with nuclear security, viz. physical protection systems, cyber security, radiation safety, security operations, technical services and security administration

  1. Regulatory system reform of occupational health and safety in China

    Science.gov (United States)

    WU, Fenghong; CHI, Yan

    2015-01-01

    With the explosive economic growth and social development, China’s regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined. PMID:25843565

  2. Regulatory issues associated with the Multi-Purpose (MPC) system

    International Nuclear Information System (INIS)

    Roberts, J.P.; Desell, L.J.; Birch, M.L.; Morgan, R.G.

    1994-01-01

    The US Department of Energy Office of Civilian Radioactive Waste Management is developing a Multi-Purpose Canister system to promote compatibility between the waste program elements of storage, transportation, and disposal. The development of a Multi-Purpose Canister system requires meeting various regulatory requirements. These regulatory requirements are set forth in environmental and Nuclear Regulatory Commission (NRC) regulations. This paper discusses the more significant regulatory issues that must be addressed in the development of a Multi-Purpose Canister system by the Department of Energy

  3. Selected legal and regulatory concerns affecting domestic energy transportation systems

    International Nuclear Information System (INIS)

    Schuller, C.R.

    1979-07-01

    This report provides assessments of eight legal and regulatory concerns that may affect energy material transportation in the US during the rest of the century: state authority to regulate nuclear materials transport, divestiture of petroleum pipelines from major integrated oil companies, problems affecting the natural gas transportation system, capabilities of energy transportation systems during emergencies, Federal coal pipeline legislation, ability of Federal agencies to anticipate railroad difficulties, abandonment of uneconomic railroad lines, and impact of the Panama Canal treaty upon US energy transportation

  4. 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

  5. International Nuclear Safety Experts Conclude IAEA Peer Review of Korea's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    organizational change management are needed; Regulations and guides should be developed for decommissioning and management of spent fuel. Regulations should be changed to require a quality assurance plan for the licensing of research and test reactors; and Enhancements to the licensing process are needed to clarify and strengthen the safety information in license amendments and assessment reports. Background The IRRS mission to the Republic of Korea was conducted from 10 to 22 July, mainly in Daejeon. The team also visited several nuclear installations, including a nuclear power plant, a research reactor and the country's emergency response centres. The IRRS team reviewed the following regulatory areas: the government's responsibilities and functions in the nuclear safety regime; the responsibilities and functions of the regulatory body and its management system; the activities of the regulatory body including authorizations; review and assessment; inspection and enforcement processes; and the development of regulations and guides. Team experts came from 14 different countries: Canada, China, the Czech Republic, Finland, France, Hungary, Mexico, Slovakia, Slovenia, Sweden, Switzerland, the United Kingdom, United Arab Emirates and the United States. About IRRS Missions IRRS missions are designed to strengthen and enhance the effectiveness of the national nuclear regulatory infrastructure of States, whilst recognizing the ultimate responsibility of each State to ensure safety in this area. This is done through consideration of both regulatory, technical and policy issues, with comparisons against IAEA safety standards and, where appropriate, good practices elsewhere. (IAEA)

  6. Information system fur the management of a regulatory programme

    International Nuclear Information System (INIS)

    Ortiz, P.; Mrabit, K.; Miaw, S.

    1998-01-01

    A Regulatory Programme to monitor safety of activities involving radiation sources, implies the existence of a Regulatory Authority empowered by legislation to issue radiation protection regulations and to monitor compliance with those regulations. The core element of the programme is a system of notification and authorization (registration and licensing), inspection and enforcement. The efficiency of this system is largely dependent on the availability of reliable information on the inventory of radiation sources and installations, the administrative status of the facilities (authorization), prompt processing of inspection reports and follow up of regulatory actions, including monitoring deadlines. Essential data relevant to safety, such as personal dosimetry for occupationally exposed individuals, inspection findings and incident reports would provide, in addition, an insight on the overall safety of the country. A simple but comprehensive Regulatory Authority Information System (RAIS) linked to the authorization and inspection process will largely facilitate regulatory decisions and actions. A readily available and reliable information from the various regulatory activities will facilitate planning, optimization of resources, monitoring safety related data, disseminating safety information, making decisions and follow up regulatory actions including monitoring dead lines. The implementation of the system in more than 50 countries will contribute to experience exchange and harmonization of regulatory activities. (author)

  7. Regulatory alerts for dietary supplements in Canada and the United States, 2005-13.

    Science.gov (United States)

    Abe, Andrew M; Hein, Darren J; Gregory, Philip J

    2015-06-01

    Dietary supplement regulatory alerts published by the Food and Drug Administration (FDA) and Health Canada were evaluated and characterized. FDA MedWatch and Health Canada websites were reviewed to identify regulatory alerts regarding dietary supplements from January 1, 2005, through December 31, 2013. Alerts were analyzed to identify product characteristics that may be predictive of product quality issues and potential patient harm. A total of 1560 dietary supplement-related regulatory alerts were identified. Of those, 1287 (83%) were identified through Health Canada, and 273 (18%) were identified through FDA MedWatch. The country of origin of dietary supplements associated with regulatory alerts was not provided in most regulatory alerts; however, when their origin was provided, the United States was the most common. Dietary supplements intended for sexual enhancement were the subject of 33% of all regulatory alerts identified. Products purchased online were the most likely to be associated with a regulatory alert. Dietary supplements intended for sexual enhancement, weight loss, and bodybuilding or athletic performance appeared to pose the greatest risk for patient harm due to product contamination with a pharmaceutical such as a phosphodiesterase-5 inhibitor or sibutramine. Analysis of Canadian and U.S. regulatory alerts concerning dietary supplements revealed that more than 80% of the composite alerts were issued by Health Canada. The most common intended uses of supplements for which alerts were issued were sexual enhancement, weight loss, and bodybuilding or athletic performance. The most common reason for alerts was the presence of a pharmaceutical contaminant. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  8. Quality management of the nuclear regulatory body. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    2001-09-01

    This report is the outcome of the ninth series of peer discussions on regulatory practices entitled Nuclear Regulatory Body Quality Management, held in March and May 2001, and which involved the participation of senior nuclear regulators from 23 IAEA Member States. This report conveys the essence of two peer group discussions and highlights some good practices identified by the participating senior regulators. The objective of the discussions was to share experiences of regulatory bodies in implementing QM systems in their own work so as to ensure that the regulatory control over the licensees is effective and efficient and is commensurate with the mandate assigned by their governments. The shared experiences and good practices presented in the report, however, do not necessarily reflect the views of and good practices endorsed by the governments of the nominating Member States, the organizations to which the regulators belong, or the IAEA. The report sets down the peer group's experience in developing, implementing and evaluating QM within their regulatory bodies and identifies points to bear in mind when introducing such a system. This report is structured so that it covers the subject matter under the main headings of: application of quality management to regulatory work; development and implementation of quality management; assessment and improvement of performance; and good practices

  9. Federal and state regulatory requirements for decontamination and decommissioning at US Department of Energy Oak Ridge Operations Facilities

    International Nuclear Information System (INIS)

    Etnier, E.L.; Houlberg, L.M.; Bock, R.E.

    1994-06-01

    The purpose of this report is to address regulatory requirements for decontamination and decommissioning (D and D) activities at the Oak Ridge Reservation and Paducah Gaseous Diffusion Plant. This report is a summary of potential federal and state regulatory requirements applicable to general D and D activities. Excerpts are presented in the text and tables from the complete set of regulatory requirements. This report should be used as a guide to the major regulatory issues related to D and D. Compliance with other federal, state, and local regulations not addressed here may be required and should be addressed carefully by project management on a site-specific basis. The report summarizes the major acts and implementing regulations (e.g., Resource and Conservation Recovery Act, Clean Air Act, and Toxic Substances Control Act) only with regard to D and D activities. Additional regulatory drivers for D and D activities may be established through negotiated agreements, such as the Federal Facility Agreement and the US Environmental Protection Agency Mixed Waste Federal Facility Compliance Agreement; these are discussed in this report. The DOE orders and Energy Systems procedures also are summarized briefly in instances where they directly apply to D and D

  10. Regulatory systems-based licensing guidance documentation

    International Nuclear Information System (INIS)

    Delligatti, M.S.

    1991-01-01

    The US Nuclear Regulatory Commission (NRC) has developed a series of licensing guidance documents based on the regulatory requirements in Part 60 of Title 10 of the Code of Federal Regulations (10 CFR Part 60). This regulatory systems-based approach to licensing guidance documentation relies on the definition of the high-level waste repository in 10 CFR Part 60. A document which is important for the frame-work it gives to other programmatic licensing guidance is the Draft Regulatory Guide open-quotes Format and Content for the License Application for the High-Level Waste Repositoryclose quotes (FCRG). The FCRG describes a format and content acceptable to NRC for a high-level waste repository license application pursuant to the requirements of 10 CFR Part 60. Other licensing guidance documents will be compatible with the FCRG

  11. State Electricity Regulatory Policy and Distributed Resources: Accommodating Distributed Resources in Wholesale Markets

    Energy Technology Data Exchange (ETDEWEB)

    Weston, F.; Harrington, C.; Moskovitz, D.; Shirley, W.; Cowart, R.; Sedano, R.

    2002-10-01

    Distributed resources can provide cost-effective reliability and energy services - in many cases, obviating the need for more expensive investments in wires and central station electricity generating facilities. Given the unique features of distributed resources, the challenge facing policymakers today is how to restructure wholesale markets for electricity and related services so as to reveal the full value that distributed resources can provide to the electric power system (utility grid). This report looks at the functions that distributed resources can perform and examines the barriers to them. It then identifies a series of policy and operational approaches to promoting DR in wholesale markets. This report is one in the State Electricity Regulatory Policy and Distributed Resources series developed under contract to NREL (see Annual Technical Status Report of the Regulatory Assistance Project: September 2000-September 2001, NREL/SR-560-32733). Other titles in this series are: (1) Distributed Resource Distribution Credit Pilot Programs - Revealing the Value to Consumers and Vendors, NREL/SR-560-32499; (2) Distributed Resources and Electric System Reliability, NREL/SR-560-32498; (3) Distribution System Cost Methodologies for Distributed Generation, NREL/SR-560-32500; (4) Distribution System Cost Methodologies for Distributed Generation Appendices, NREL/SR-560-32501

  12. The regulatory control of radiation sources in Australia -- The challenges of a federal system

    International Nuclear Information System (INIS)

    Loy, J.; Colgan, P.

    2001-01-01

    The report refers to the challenges that Australia is facing, as a federal nation having a Commonwealth Government and six States and two territories, in establishing appropriate regulatory control of radiation sources. Information on the national inventory of radiation sources and existing regulatory infrastructure, including the system of notification, registration, licensing, inspection and enforcement, is explained in the report. The national provisions for the management of disused sources; the planning, preparedness and response to abnormal events and emergencies; the recovery of control over orphan sources; and education and training; are specifically emphasized. (author)

  13. Exploring the impact of permitting and local regulatory processes on residential solar prices in the United States

    International Nuclear Information System (INIS)

    Burkhardt, Jesse; Wiser, Ryan; Darghouth, Naïm; Dong, C.G.; Huneycutt, Joshua

    2015-01-01

    This article statistically isolates the impacts of city-level permitting and other local regulatory processes on residential PV prices in the United States. We combine data from two “scoring” mechanisms that independently capture local regulatory process efficiency with the largest dataset of installed PV prices in the United States. We find that variations in local permitting procedures can lead to differences in average residential PV prices of approximately $0.18/W between the jurisdictions with the least-favorable and most-favorable permitting procedures. Between jurisdictions with scores across the middle 90% of the range (i.e., 5th percentile to 95th percentile), the difference is $0.14/W, equivalent to a $700 (2.2%) difference in system costs for a typical 5-kW residential PV installation. When considering variations not only in permitting practices, but also in other local regulatory procedures, price differences grow to $0.64–$0.93/W between the least-favorable and most-favorable jurisdictions. Between jurisdictions with scores across the middle 90% of the range, the difference is equivalent to a price impact of at least $2500 (8%) for a typical 5-kW residential PV installation. These results highlight the magnitude of cost reduction that might be expected from streamlining local regulatory regimes. - Highlights: • We show local regulatory processes meaningfully affect U.S. residential PV prices. • We use regression analysis and two mechanisms for “scoring” regulatory efficiency. • Local permitting procedure variations can produce PV price differences of $0.18/W. • Broader regulatory variations can produce PV price differences of $0.64–$0.93/W. • The results suggest the cost-reduction potential of streamlining local regulations

  14. Ergonomics and regulatory politics: the Washington State case.

    Science.gov (United States)

    Silverstein, Michael

    2007-05-01

    Every year in the State of Washington more than 50,000 workers experience a work related musculoskeletal disorder (WMSD), making up more than 30% of all worker compensation cases. In 2000, the Washington State Department of Labor and Industries (L&I) adopted a workplace ergonomics rule requiring employers to reduce worker exposure to hazards that cause or contribute to WMSDs. In 2003, the ergonomics rule was repealed by a margin of 53.5-46.5 in a statewide voter initiative. The official rulemaking record of approximately 100,000 pages, along with supplementary published and unpublished material, was reviewed. The relationship between scientific deliberation and the public policy process in adopting and repealing the ergonomics rule was assessed and described. The deliberative features of the regulatory, judicial, legislative, and ballot processes were compared. The ergonomics rule was successful in the regulatory and legal arenas where the process was most transparent and open to public involvement, differing views could be presented fully, and decision makers were expected to explain their decisions in light of the record. The rule fared most poorly in the legislature and at the ballot box when these features were lost and where considered deliberation was replaced by unconstrained political conflict. Additional checks and balances are needed.

  15. Bioattractors: dynamical systems theory and the evolution of regulatory processes

    Science.gov (United States)

    Jaeger, Johannes; Monk, Nick

    2014-01-01

    In this paper, we illustrate how dynamical systems theory can provide a unifying conceptual framework for evolution of biological regulatory systems. Our argument is that the genotype–phenotype map can be characterized by the phase portrait of the underlying regulatory process. The features of this portrait – such as attractors with associated basins and their bifurcations – define the regulatory and evolutionary potential of a system. We show how the geometric analysis of phase space connects Waddington's epigenetic landscape to recent computational approaches for the study of robustness and evolvability in network evolution. We discuss how the geometry of phase space determines the probability of possible phenotypic transitions. Finally, we demonstrate how the active, self-organizing role of the environment in phenotypic evolution can be understood in terms of dynamical systems concepts. This approach yields mechanistic explanations that go beyond insights based on the simulation of evolving regulatory networks alone. Its predictions can now be tested by studying specific, experimentally tractable regulatory systems using the tools of modern systems biology. A systematic exploration of such systems will enable us to understand better the nature and origin of the phenotypic variability, which provides the substrate for evolution by natural selection. PMID:24882812

  16. 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.

  17. Information systems to support low-level waste management: perspective from the State of Illinois

    International Nuclear Information System (INIS)

    Willaford, D.M.

    1987-01-01

    The Illinois Department of Nuclear Safety (IDNS) is required by state law to develop a comprehensive regulatory system for low-level radioactive waste (LLW) management. Reliable, extensive information about LLW in Illinois is needed to plan and implement such a regulatory program. IDNS annually surveys, by mail and follow-up phone calls, approximately 260 LLW generators in Illinois. This information is being supplemented by a more detailed characterization of waste streams. Additional information needed for IDNS's regulatory program includes data on components of a waste disposal facility (e.g., concrete performance), site and performance computer models for various kinds of sites and for alternative waste disposal facility designs. In the future, all states will need more information than has been historically the case, given the changes in management and disposal systems and the increased role of the states

  18. International Nuclear and Radiation Safety Experts Conclude IAEA Peer Review of Slovenia's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: An international team of senior nuclear safety experts today concluded a 10-day mission to review the regulatory framework for nuclear and radiation safety in Slovenia. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Slovenia and a final report will be submitted by the end of 2011. At the request of the Slovenian Government, the IAEA assembled a team of 10 senior regulatory experts from nine nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Slovenian Nuclear Safety Administration (SNSA). The mission is a peer review based on the IAEA Safety Standards. Andrej Stritar, Director of Slovenian Nuclear Safety Administration, stressed ''how important it is for a small country like Slovenia to tightly follow international standards in the area of nuclear safety.'' He also expressed his gratitude to the IAEA, and the countries from which team members came, for their support and for their intensive work during the last ten days. Mission Team Leader Colin Patchett, Deputy Chief Inspector from the UK's Office for Nuclear Regulation commended ''the Slovenian authorities for their commitment to nuclear and radiation safety regulation and for sharing their experience.'' The IRRS team reviewed Slovenia's current regulatory framework and all SNSA-regulated facilities and activities, as well as the regulatory implications of the TEPCO Fukushima Daiichi accident. The IRRS team identified particular strengths in the Slovenian regulatory system, including: Through its legal framework, the Slovenian government has appointed SNSA to regulate its nuclear safety program and SNSA has in place an effective process for carrying out this responsibility; and Slovenia's response to the accident at the TEPCO Fukushima Daiichi power plant has been prompt and effective. Communications with the public, development of actions for improvement

  19. Review of regulatory requirements for digital I and C systems

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Kee Choon; Lee, Cheol Kwon; Lee, Jang Soo [and others

    2001-11-01

    This work analyzed and summarized systematically various regulatory requirements that are necessary to develop digital nuclear instrumentation and control (I and C) systems, especially safety systems. The requirements are categorized into system, hardware, software, and quality assurance aspects. This report provides the explanations of terms and abbreviations to help readers understand. Furthermore, appendices of this report summarize the code and standards corresponding to each principal regulatory requirement. The hierarchical structure of regulatory requirements has Nuclear Energy Laws, Enforcement Regulations of Nuclear Energy Laws, and Notifications of Ministry of Science and Technology as utmost level requirements [In case of the US, 10 CFR 50 Appendix A, 10 CFR 50 Appendix B, 10 CFR 50.55a(h), 10 CFR 50.49, etc.]. The requirements include the Draft Regulatory Guidelines for Digital I and C Systems [In case of the US, Standard Review Plan (NUREG-0800), Regulatory Guide, Branch Technical Position (BTP)], KEPIC as standards [In case of the US, IEEE Standards, IEC Standards, ISA, Military Standard, etc.], and various reports issued by Korea Institute of Nuclear Safety [In case of the US, NUREG reports, EPRI reports, etc.]. This report can be referred for the development of safety grade control equipment, plant protection system, and engineered safety feature actuation system.

  20. Review of regulatory requirements for digital I and C systems

    International Nuclear Information System (INIS)

    Kwon, Kee Choon; Lee, Cheol Kwon; Lee, Jang Soo

    2001-11-01

    This work analyzed and summarized systematically various regulatory requirements that are necessary to develop digital nuclear instrumentation and control (I and C) systems, especially safety systems. The requirements are categorized into system, hardware, software, and quality assurance aspects. This report provides the explanations of terms and abbreviations to help readers understand. Furthermore, appendices of this report summarize the code and standards corresponding to each principal regulatory requirement. The hierarchical structure of regulatory requirements has Nuclear Energy Laws, Enforcement Regulations of Nuclear Energy Laws, and Notifications of Ministry of Science and Technology as utmost level requirements [In case of the US, 10 CFR 50 Appendix A, 10 CFR 50 Appendix B, 10 CFR 50.55a(h), 10 CFR 50.49, etc.]. The requirements include the Draft Regulatory Guidelines for Digital I and C Systems [In case of the US, Standard Review Plan (NUREG-0800), Regulatory Guide, Branch Technical Position (BTP)], KEPIC as standards [In case of the US, IEEE Standards, IEC Standards, ISA, Military Standard, etc.], and various reports issued by Korea Institute of Nuclear Safety [In case of the US, NUREG reports, EPRI reports, etc.]. This report can be referred for the development of safety grade control equipment, plant protection system, and engineered safety feature actuation system

  1. 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

  2. Assisting IAEA Member States to Strengthen Regulatory Control, Particularly in the Medical Area

    International Nuclear Information System (INIS)

    Johnston, P.

    2016-01-01

    As per its Statue and Mandate, IAEA is developing Safety Standards and is also providing assistance for their application in Member States. One target and very large audience of this programme is the community of national regulatory bodies for radiation safety, expected to be established in all 168 Member States. Ionizing radiation is being used throughout the world in medical practices and medical exposure is the most significant manmade source of exposure to the population from ionizing radiation. Radiation accidents involving medical uses have accounted for more injuries and early acute health effects than any other type of radiation accident, including accidents at nuclear facilities. With the constant emerging of new technologies using ionizing radiation for medical diagnostic and treatment, there are on-going challenges for Regulatory bodies. The presentation will highlight some figures related to the medical exposure worldwide, and then it will introduce the main safety standards and other publications developed specifically for Regulatory Bodies and focusing on medical practices. It will also highlight the most important and recent mechanisms (tools, peer reviews and advisory services, training courses, networks) that the Agency is offering to its Member States in order to cope with the main challenges worldwide, contributing thus to the efficiency and effectiveness of the regulatory oversight of medical facilities and activities. (author)

  3. What is a comprehensive system of regulatory governance?

    International Nuclear Information System (INIS)

    Real diaz, F. J.

    2011-01-01

    The progressive evolution and diversification of regulations concerning industrial safety has made their management increasingly complex, requiring more resources of organizations. Therefore, it is advisable that this management be made more efficient through systematization, specialization and the use of computing technologies. This is supported by the implementation of integrated regulatory management systems. This article explain the concept of integrated regulatory management systems, their structure and their advantages. It also includes a model for implementing them in an organization. (Author)

  4. Integration of steady-state and temporal gene expression data for the inference of gene regulatory networks.

    Science.gov (United States)

    Wang, Yi Kan; Hurley, Daniel G; Schnell, Santiago; Print, Cristin G; Crampin, Edmund J

    2013-01-01

    We develop a new regression algorithm, cMIKANA, for inference of gene regulatory networks from combinations of steady-state and time-series gene expression data. Using simulated gene expression datasets to assess the accuracy of reconstructing gene regulatory networks, we show that steady-state and time-series data sets can successfully be combined to identify gene regulatory interactions using the new algorithm. Inferring gene networks from combined data sets was found to be advantageous when using noisy measurements collected with either lower sampling rates or a limited number of experimental replicates. We illustrate our method by applying it to a microarray gene expression dataset from human umbilical vein endothelial cells (HUVECs) which combines time series data from treatment with growth factor TNF and steady state data from siRNA knockdown treatments. Our results suggest that the combination of steady-state and time-series datasets may provide better prediction of RNA-to-RNA interactions, and may also reveal biological features that cannot be identified from dynamic or steady state information alone. Finally, we consider the experimental design of genomics experiments for gene regulatory network inference and show that network inference can be improved by incorporating steady-state measurements with time-series data.

  5. 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.

  6. DREISS: Using State-Space Models to Infer the Dynamics of Gene Expression Driven by External and Internal Regulatory Networks.

    Directory of Open Access Journals (Sweden)

    Daifeng Wang

    2016-10-01

    Full Text Available Gene expression is controlled by the combinatorial effects of regulatory factors from different biological subsystems such as general transcription factors (TFs, cellular growth factors and microRNAs. A subsystem's gene expression may be controlled by its internal regulatory factors, exclusively, or by external subsystems, or by both. It is thus useful to distinguish the degree to which a subsystem is regulated internally or externally-e.g., how non-conserved, species-specific TFs affect the expression of conserved, cross-species genes during evolution. We developed a computational method (DREISS, dreiss.gerteinlab.org for analyzing the Dynamics of gene expression driven by Regulatory networks, both External and Internal based on State Space models. Given a subsystem, the "state" and "control" in the model refer to its own (internal and another subsystem's (external gene expression levels. The state at a given time is determined by the state and control at a previous time. Because typical time-series data do not have enough samples to fully estimate the model's parameters, DREISS uses dimensionality reduction, and identifies canonical temporal expression trajectories (e.g., degradation, growth and oscillation representing the regulatory effects emanating from various subsystems. To demonstrate capabilities of DREISS, we study the regulatory effects of evolutionarily conserved vs. divergent TFs across distant species. In particular, we applied DREISS to the time-series gene expression datasets of C. elegans and D. melanogaster during their embryonic development. We analyzed the expression dynamics of the conserved, orthologous genes (orthologs, seeing the degree to which these can be accounted for by orthologous (internal versus species-specific (external TFs. We found that between two species, the orthologs have matched, internally driven expression patterns but very different externally driven ones. This is particularly true for genes with

  7. Food safety regulatory systems in Europe and China:A study of how co-regulation can improve regulatory effectiveness

    Institute of Scientific and Technical Information of China (English)

    Kevin Chen; WANG Xin-xin; SONG Hai-ying

    2015-01-01

    Food safety has received a great deal of attention in both developed and developing countries in recent years. In China, the numerous food scandals and scares that have struck over the past decade have spurred signiifcant food safety regulatory reform, which has been increasingly oriented towards the public-private partnership model adopted by the Europe Union’s (EU) food safety regulatory system. This paper analyzes the development of both the EU’s and China’s food safety regu-latory systems, identiifes the current chalenges for China and additionaly considers the role of public-private partnership. The success of co-regulation in the food regulatory system would bring signiifcant beneifts and opportunities for China. Finaly, this paper recommends additional measures like training and grants to improve the private’s sector effectiveness in co-regulating China’s food safety issues.

  8. An electronic regulatory document management system for a clinical trial network.

    Science.gov (United States)

    Zhao, Wenle; Durkalski, Valerie; Pauls, Keith; Dillon, Catherine; Kim, Jaemyung; Kolk, Deneil; Silbergleit, Robert; Stevenson, Valerie; Palesch, Yuko

    2010-01-01

    A computerized regulatory document management system has been developed as a module in a comprehensive Clinical Trial Management System (CTMS) designed for an NIH-funded clinical trial network in order to more efficiently manage and track regulatory compliance. Within the network, several institutions and investigators are involved in multiple trials, and each trial has regulatory document requirements. Some of these documents are trial specific while others apply across multiple trials. The latter causes a possible redundancy in document collection and management. To address these and other related challenges, a central regulatory document management system was designed. This manuscript shares the design of the system as well as examples of it use in current studies. Copyright (c) 2009 Elsevier Inc. All rights reserved.

  9. Constituting Market Citizenship: Regulatory State, Market Making and Higher Education

    Science.gov (United States)

    Jayasuriya, Kanishka

    2015-01-01

    The paper makes three claims: first that regulatory state making and market making in higher education is intertwined through a project of market citizenship that shapes the "publicness" of higher education. Second, we argue that these projects of market citizenship are variegated and in Australia has taken the form of accommodation--via…

  10. Canadian and United States regulatory models compared: doses from atmospheric pathways

    International Nuclear Information System (INIS)

    Peterson, S-R.

    1997-01-01

    CANDU reactors sold offshore are licensed primarily to satisfy Canadian Regulations. For radioactive emissions during normal operation, the Canadian Standards Association's CAN/CSA-N288.1-M87 is used. This standard provides guidelines and methodologies for calculating a rate of radionuclide release that exposes a member of the public to the annual dose limit. To calculate doses from air concentrations, either CSA-N288.1 or the Regulatory Guide 1.109 of the United States Nuclear Regulatory Commission, which has already been used to license light-water reactors in these countries, may be used. When dose predictions from CSA-N288.1 are compared with those from the U.S. Regulatory Guides, the differences in projected doses raise questions about the predictions. This report explains differences between the two models for ingestion, inhalation, external and immersion doses

  11. The Dessau workshop on bioaccumulation: state of the art, challenges and regulatory implications.

    Science.gov (United States)

    Treu, Gabriele; Drost, Wiebke; Jöhncke, Ulrich; Rauert, Caren; Schlechtriem, Christian

    2015-01-01

    Bioaccumulation plays a vital role in understanding the fate of a substance in the environment and is key to the regulation of chemicals in several jurisdictions. The current assessment approaches commonly use the octanol-water partition coefficient (log K OW ) as an indicator for bioaccumulation and the bioconcentration factor (BCF) as a standard criterion to identify bioaccumulative substances show limitations. The log K OW does not take into account active transport phenomena or special structural properties (e.g., amphiphilic substances or dissociating substances) and therefore additional screening criteria are required. Regulatory BCF studies are so far restricted to fish and uptake through the gills. Studies on (terrestrial) air-breathing organisms are missing. Though there are alternative tests such as the dietary exposure bioaccumulation fish test described in the recently revised OECD test guideline 305, it still remains unclear how to deal with results of alternative tests in regulatory decision-making processes. A substantial number of bioaccumulation fish tests are required in regulation. The development of improved test systems following the 3R principles, namely to replace, reduce and refine animal testing, is thus required. All these aspects stress the importance to further develop the assessment of bioaccumulation. The Dessau Workshop on Bioaccumulation which was held from June 26th to 27th 2014, in Dessau, Germany, provided a comprehensive overview of the state of the art of bioaccumulation assessment, provided insights into the problems and challenges addressed by the regulatory authorities and described new research concepts and their regulatory implications. The event was organised by UBA (Dessau, Germany) and Fraunhofer IME (Schmallenberg, Germany). About 50 participants from industry, regulatory bodies and academia listened to 14 lectures on selected topics and joined the plenary discussions.

  12. 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

  13. Hydrogen mitigation systems - a Canadian regulatory perspective

    International Nuclear Information System (INIS)

    Khosla, J.K.; Rizk, M.

    1997-01-01

    This is a discussion paper to examine the regulatory requirements that may be necessary for the design, operation and maintenance of the hydrogen mitigation systems. These systems (if deemed necessary to maintain the containment function), may be considered to be a part of the containment systems. Therefore, these requirements are derived mostly from the AECB Regulatory Document R-7, which specifies the requirements for containment systems for CANDU nuclear power plants. Some additional requirements, which are specific to these systems have also been included. These requirements relate to a systematic examination of the hazards of hydrogen, the design basis for the mitigation systems, their functional and design requirements, analytical support to justify their selection, and operating and testing requirements. The requirements for severe accident have not yet been developed. It is, however, anticipated that the design of the hydrogen mitigation system would be such that future requirement can be accommodated. These requirements are intended for application to the new reactors in Canada. For the existing reactors, their application will be subjected to practicability. (author)

  14. Regulatory practices - United States example

    International Nuclear Information System (INIS)

    Shapar, M.

    1976-01-01

    In 1954, the Atomic Energy Act of 1946 was revised to do away with the federal state monopoly in this field and to enable private industry to develop nuclear power. This evolution led the federal authorities to give the Atomic Energy Commission the powers to control the design, licensing and operation of nuclear reactors. These powers were constantly strengthened and are now exercised by the Nuclear Regulatory Commission (NRC). Since its creation in 1975, the Commission has amended the regulations on licensing of nuclear reactors in the light of experience acquired so as to shorten the duration of this procedure. These amendments concern the standardization of nuclear power plants, limited work authorizations, the methods for issuing licenses. The objective of the Commission aim to make the licensing procedure for nuclear power plants simpler and more efficient and hence, less costly, while ensuring that a very high level for safety standards and environmental protection is maintained. (NEA) [fr

  15. Regulatory decision with EPA/NRC/DOE/State Session (Panel)

    Energy Technology Data Exchange (ETDEWEB)

    O`Donnell, E.

    1995-12-31

    This panel will cover the Nuclear Regulatory Commission`s (NRC) proposed radiation limits in the Branch Technical Position on Low-Level Radioactive Waste Performance Assessment and the Environmental Protection Agency`s (EPA) draft regulation in Part 193. Representatives from NRC and EPA will discuss the inconsistencies in these two regulations. DOE and state representatives will discuss their perspective on how these regulations will affect low-level radioactive waste performance assessments.

  16. Emotion: The Self-regulatory Sense.

    Science.gov (United States)

    Peil, Katherine T

    2014-03-01

    While emotion is a central component of human health and well-being, traditional approaches to understanding its biological function have been wanting. A dynamic systems model, however, broadly redefines and recasts emotion as a primary sensory system-perhaps the first sensory system to have emerged, serving the ancient autopoietic function of "self-regulation." Drawing upon molecular biology and revelations from the field of epigenetics, the model suggests that human emotional perceptions provide an ongoing stream of "self-relevant" sensory information concerning optimally adaptive states between the organism and its immediate environment, along with coupled behavioral corrections that honor a universal self-regulatory logic, one still encoded within cellular signaling and immune functions. Exemplified by the fundamental molecular circuitry of sensorimotor control in the E coli bacterium, the model suggests that the hedonic (affective) categories emerge directly from positive and negative feedback processes, their good/bad binary appraisals relating to dual self-regulatory behavioral regimes-evolutionary purposes, through which organisms actively participate in natural selection, and through which humans can interpret optimal or deficit states of balanced being and becoming. The self-regulatory sensory paradigm transcends anthropomorphism, unites divergent theoretical perspectives and isolated bodies of literature, while challenging time-honored assumptions. While suppressive regulatory strategies abound, it suggests that emotions are better understood as regulating us, providing a service crucial to all semantic language, learning systems, evaluative decision-making, and fundamental to optimal physical, mental, and social health.

  17. Analysis of replies to an IAEA questionnaire on regulatory practices in Member States with nuclear power programmes

    International Nuclear Information System (INIS)

    1988-10-01

    The survey of regulatory practices in Member States with nuclear power programmes by means of a questionnaire is the first stage of the programme developed by the IAEA to assist the Member States in the enhancement of their regulatory practices. The questionnaire, drafted by IAEA staff members and consultants, consisted of 120 detailed questions and its structure corresponds approximately to the Structure of Code on the Safety of Nuclear Power Plants: Governmental Organizations (IAEA Safety Series No. 50-C-G-Rev.1). The questionnaire was sent to 64 Member States on 7 July 1987 and the replies received from 44 Member States have been analysed by IAEA staff members with the assistance of two consultants in order to identify the main differences in approach and the important features of regulatory practices in Member States. This technical document is the summary report of this analysis

  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. International nuclear safety experts conclude IAEA peer review of China's regulatory system

    International Nuclear Information System (INIS)

    2010-01-01

    Full text: An international team of senior experts on nuclear safety regulation today completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the People's Republic of China. The team identified good practices within the system and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of the People's Republic of China. The final report will be submitted to China by Autumn 2010. At the request of Chinese authorities, the IAEA assembled a team of 22 experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This mission is a peer review based on the IAEA Safety Standards . It is not an inspection, nor an audit. The experts came from 15 different countries: Australia, Canada, the Czech Republic, Finland, France, Hungary, Japan, Pakistan, the Republic of Korea, Slovenia, South Africa, Sweden, the United Kingdom, Ukraine and the United States. Mike Weightman, the United Kingdom's Head of Nuclear Directorate, HSE and HM Chief Inspector of Nuclear Installations said: ''I was honoured and pleased to lead such a team of senior regulatory experts from around the world, and I was impressed by their commitment, experience and hard work to provide their best advice possible. We had very constructive interactions with the Chinese authority to maximize the beneficial impact of the mission.'' The scope of the mission included the regulation of nuclear and radiation safety of the facilities and activities regulated by the Ministry of Environmental Protection (MEP) National Nuclear Safety Administration (NNSA). The mission was conducted from 18 to 30 July, mainly in Beijing. To observe Chinese regulatory activities, the IRRS team visited several nuclear facilities, including a nuclear power plant, a manufacturer of safety components for nuclear power plants, a research reactor, a fuel cycle facility, a waste management facility

  20. USNRC regulatory guidance for engineered safety feature air cleaning systems

    International Nuclear Information System (INIS)

    Bellamy, R.R.

    1991-01-01

    The need for clear, technically appropriate, and easily implementable guidance for the design, testing, and maintenance of nuclear air cleaning systems has long been recognized. Numerous industry consensus standards have been issued and revised over the last 30 years. Guidance has also been published by the US Nuclear Regulatory Commission in the form of regulations, regulatory guides, standard review plans, NUREG documents, and information notices. This paper will summarize the latest revisions to these documents and emphasize Regulatory Guide 1.52, Design, Testing, and Maintenance Criteria for Post-Accident Engineered-Safety-Feature Atmosphere Cleanup System Air Filtration and Adsorption Units of Light-Water-Cooled Nuclear Power Plants, which was last revised in 1978. The USNRC has undertaken a project to revise this regulatory guide, and the status of that revision is highlighted

  1. Targeted resequencing of regulatory regions at schizophrenia risk loci: Role of rare functional variants at chromatin repressive states.

    Science.gov (United States)

    González-Peñas, Javier; Amigo, Jorge; Santomé, Luis; Sobrino, Beatriz; Brenlla, Julio; Agra, Santiago; Paz, Eduardo; Páramo, Mario; Carracedo, Ángel; Arrojo, Manuel; Costas, Javier

    2016-07-01

    There is mounting evidence that regulatory variation plays an important role in genetic risk for schizophrenia. Here, we specifically search for regulatory variants at risk by sequencing promoter regions of twenty-three genes implied in schizophrenia by copy number variant or genome-wide association studies. After strict quality control, a total of 55,206bp per sample were analyzed in 526 schizophrenia cases and 516 controls from Galicia, NW Spain, using the Applied Biosystems SOLiD System. Variants were filtered based on frequency from public databases, chromatin states from the RoadMap Epigenomics Consortium at tissues relevant for schizophrenia, such as fetal brain, mid-frontal lobe, and angular gyrus, and prediction of functionality from RegulomeDB. The proportion of rare variants at polycomb repressive chromatin state at relevant tissues was higher in cases than in controls. The proportion of rare variants with predicted regulatory role was significantly higher in cases than in controls (P=0.0028, OR=1.93, 95% C.I.=1.23-3.04). Combination of information from both sources led to the identification of an excess of carriers of rare variants with predicted regulatory role located at polycomb repressive chromatin state at relevant tissues in cases versus controls (P=0.0016, OR=19.34, 95% C.I.=2.45-2495.26). The variants are located at two genes affected by the 17q12 copy number variant, LHX1 and HNF1B. These data strongly suggest that a specific epigenetic mechanism, chromatin remodeling by histone modification during early development, may be impaired in a subset of schizophrenia patients, in agreement with previous data. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Regulatory networks, legal federalism, and multi-level regulatory systems

    OpenAIRE

    Kerber, Wolfgang; Wendel, Julia

    2016-01-01

    Transnational regulatory networks play important roles in multi-level regulatory regimes, as e.g, the European Union. In this paper we analyze the role of regulatory networks from the perspective of the economic theory of legal federalism. Often sophisticated intermediate institutional solutions between pure centralisation and pure decentralisation can help to solve complex tradeoff problems between the benefits and problems of centralised and decentralised solutions. Drawing upon the insight...

  3. DREISS: Using State-Space Models to Infer the Dynamics of Gene Expression Driven by External and Internal Regulatory Networks

    Science.gov (United States)

    Gerstein, Mark

    2016-01-01

    Gene expression is controlled by the combinatorial effects of regulatory factors from different biological subsystems such as general transcription factors (TFs), cellular growth factors and microRNAs. A subsystem’s gene expression may be controlled by its internal regulatory factors, exclusively, or by external subsystems, or by both. It is thus useful to distinguish the degree to which a subsystem is regulated internally or externally–e.g., how non-conserved, species-specific TFs affect the expression of conserved, cross-species genes during evolution. We developed a computational method (DREISS, dreiss.gerteinlab.org) for analyzing the Dynamics of gene expression driven by Regulatory networks, both External and Internal based on State Space models. Given a subsystem, the “state” and “control” in the model refer to its own (internal) and another subsystem’s (external) gene expression levels. The state at a given time is determined by the state and control at a previous time. Because typical time-series data do not have enough samples to fully estimate the model’s parameters, DREISS uses dimensionality reduction, and identifies canonical temporal expression trajectories (e.g., degradation, growth and oscillation) representing the regulatory effects emanating from various subsystems. To demonstrate capabilities of DREISS, we study the regulatory effects of evolutionarily conserved vs. divergent TFs across distant species. In particular, we applied DREISS to the time-series gene expression datasets of C. elegans and D. melanogaster during their embryonic development. We analyzed the expression dynamics of the conserved, orthologous genes (orthologs), seeing the degree to which these can be accounted for by orthologous (internal) versus species-specific (external) TFs. We found that between two species, the orthologs have matched, internally driven expression patterns but very different externally driven ones. This is particularly true for genes with

  4. Modernizing the Regulatory System for Biotechnology Products

    Science.gov (United States)

    This Web page describes the continuing effort to modernize the federal regulatory system for biotechnology products as well as clarify various roles of EPA, FDA and USDA in evaluating new biotechnology products.

  5. Development Perspective of Regulatory Audit Code System for SFR Nuclear Safety Evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Bae, Moo Hoon; Lee, Gil Soo; Shin, An Dong; Suh, Nam Duk [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2012-05-15

    A sodium-cooled fast reactor (SFR) in Korea is based on the KALIMER-600 concept developed by KAERI. Based on 'Long-term R and D Plan for Future Reactor Systems' which was approved by the Korea Atomic Energy Commission in 2008, the KAERI designer is scheduled to apply the design certification of the prototype SFR in 2017. In order to establish regulatory infrastructure for the licensing of a prototype SFR, KINS has develop the regulatory requirements for the demonstration SFR since 2010, and are scheduled to develop the regulatory audit code systems in regard to core, fuel, and system, etc. since 2012. In this study, the domestic code systems used for core design and safety evaluation of PWRs and the nuclear physics and code system for SFRs were briefly reviewed, and the development perspective of regulatory audit code system for SFR nuclear safety evaluation were derived

  6. Emotion: The Self-regulatory Sense

    Science.gov (United States)

    2014-01-01

    While emotion is a central component of human health and well-being, traditional approaches to understanding its biological function have been wanting. A dynamic systems model, however, broadly redefines and recasts emotion as a primary sensory system—perhaps the first sensory system to have emerged, serving the ancient autopoietic function of “self-regulation.” Drawing upon molecular biology and revelations from the field of epigenetics, the model suggests that human emotional perceptions provide an ongoing stream of “self-relevant” sensory information concerning optimally adaptive states between the organism and its immediate environment, along with coupled behavioral corrections that honor a universal self-regulatory logic, one still encoded within cellular signaling and immune functions. Exemplified by the fundamental molecular circuitry of sensorimotor control in the E coli bacterium, the model suggests that the hedonic (affective) categories emerge directly from positive and negative feedback processes, their good/bad binary appraisals relating to dual self-regulatory behavioral regimes—evolutionary purposes, through which organisms actively participate in natural selection, and through which humans can interpret optimal or deficit states of balanced being and becoming. The self-regulatory sensory paradigm transcends anthropomorphism, unites divergent theoretical perspectives and isolated bodies of literature, while challenging time-honored assumptions. While suppressive regulatory strategies abound, it suggests that emotions are better understood as regulating us, providing a service crucial to all semantic language, learning systems, evaluative decision-making, and fundamental to optimal physical, mental, and social health. PMID:24808986

  7. Regulatory Control of Radiation Sources. Safety Guide

    International Nuclear Information System (INIS)

    2009-01-01

    This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.

  8. Development of an air-operated actuator performance monitoring system for regulatory usage

    International Nuclear Information System (INIS)

    Sung, K. Y.; Kwon, S. J.

    2004-01-01

    The performance monitoring system of air-operated actuators for regulatory usage has been being developed. Essential elements and operating parameters affecting the actuator performance have been investigated to provide basic information for system development. The monitoring system including an air-operated actuator testing facility and analysis softwares for monitoring and evaluation are also introduced in this paper. As a result of simulated tests, it was known that the system could be a useful tool for the effective monitoring of actuator performance change and fault conditions. This system would be applied to regulatory inspection for utility's data validation and to the training of regulatory staff in future after some modification and expansion

  9. The new regulatory state: the social powers of the European Union.

    Science.gov (United States)

    Walby, S

    1999-03-01

    The understanding of the European Union poses a challenge for Sociology and its traditional conceptions of the state. In particular, the impact of the social dimension has been underestimated and undervalued. This paper explores the implications of the developing social dimension of the European Union for European social relations in the context of globalization which allegedly reduces the power of states to act effectively in the social realm. It argues for a broader conceptualization of the social dimension and for a new conception of the regulatory state. It argues that the significance of a politico-legal project social justice. It concludes with a re-consideration of the powers of the state in an era of globalization

  10. Control technologies for soil vapor extraction at petroleum hydrocarbon impacted sites -- Regulatory challenges to system operations

    International Nuclear Information System (INIS)

    Cacossa, K.F.; Campbell, G.E.; Devine, K.

    1995-01-01

    Soil vapor extraction (SVE) is frequently used to remediate soils impacted by petroleum hydrocarbons. Four technologies have proven to be viable methods to control the off-gas emissions from SVE systems, namely, internal combustion, thermal oxidation, catalytic oxidation, and granular activated carbon adsorption. The optimal range of influent vapor concentrations for system operation differs for each of the technologies. Over the past several years the authors have worked proactively with the state regulatory community to develop general, all inclusive air pollution control permits which allow for the potential use of all four technologies over the life of the permit. Private industry has similarly worked with the state regulators to develop a less labor intensive sampling/monitoring procedure. Actual system performances, which were monitored using summa canisters and field equipment, provided the basis for the new procedure. System performance data indicated that field sampling with portable hydrocarbon analyzers, such as flame ionization detectors (FID), was preferable over the use of summa canister sampling. In addition, to reduce the costs associated with the analysis of samples, the new SVE monitoring protocol also reduced the number of system monitoring visits. These reductions equated into a cost effective, yet environmentally sound SVE system monitoring programs. Finally, the authors have worked with the regulatory community to establish permit limitations which allow operational flexibility

  11. State Regulatory responses to acid rain: Implications for electric utility operations

    International Nuclear Information System (INIS)

    Nagelhout, M.

    1990-01-01

    This article discusses the state regulatory responses to acid rain legislation and how this will affect electric utility operations. Topics discusses include planning and fuel procurement practices, least-cost planning, long-term supply contracts, fuel mix, cogeneration and small power production, qualifying facility contracts, avoided costs, environmental impact, lobbying expense, bill inserts, and forecasting models

  12. Qualitative Description of Electric Power System Future States

    Energy Technology Data Exchange (ETDEWEB)

    Hardy, Trevor D.; Corbin, Charles D.

    2018-03-06

    The simulation and evaluation of transactive systems depends to a large extent on the context in which those efforts are performed. Assumptions regarding the composition of the electric power system, the regulatory and policy environment, the distribution of renewable and other distributed energy resources (DERs), technological advances, and consumer engagement all contribute to, and affect, the evaluation of any given transactive system, regardless of its design. It is our position that the assumptions made about the state of the future power grid will determine, to some extent, the systems ultimately deployed, and that the transactive system itself may play an important role in the evolution of the power system.

  13. Legal and Regulatory Barriers to Reverse Innovation.

    Science.gov (United States)

    Rowthorn, Virginia; Plum, Alexander J; Zervos, John

    Reverse innovation, or the importation of new, affordable, and efficacious models to high-income countries from the developing world, has emerged as a way to improve the health care system in the United States. Reverse innovation has been identified as a key emerging trend in global health systems in part because low-resourced settings are particularly good laboratories for low-cost/high-impact innovations that are developed out of necessity. A difficult question receiving scant attention is that of legal and regulatory barriers. The objective of this paper is to understand and elucidate the legal barriers faced by innovators bringing health interventions to the United States. Semistructured qualitative interviews were conducted with 9 key informants who have directly participated in the introduction of global health care approaches to the United States health system. A purposive sampling scheme was employed to identify participants. Phone interviews were conducted over one week in July 2016 with each participant and lasted an average of 35 minutes each. Purely legal barriers included questions surrounding tort liability, standard of care, and concerns around patient-administered self-care. Regulatory burdens included issues of international medical licensure, reimbursement, and task shifting and scope of work challenges among nonprofessionals (e.g. community health workers). Finally, perceived (i.e. not realized or experienced) legal and regulatory barriers to innovative modalities served as disincentives to bringing products or services developed outside of the United States to the United States market. Conflicting interests within the health care system, safety concerns, and little value placed on low-cost interventions inhibit innovation. Legal and regulatory barriers rank among, and contribute to, an anti-innovation atmosphere in healthcare for domestic and reverse innovators alike. Reverse innovation should be fostered through the thoughtful development of

  14. Regulatory control analysis and design for sewer systems

    DEFF Research Database (Denmark)

    Mollerup, Ane Loft; Mikkelsen, Peter Steen; Thornberg, Dines

    2015-01-01

    A systematic methodology for regulatory control analysis and design is adapted for sewer system operation and evaluated. The main challenge with adapting the methodology is the handling of the stochastic and transient nature of the rainfall disturbances, inherent to sewer system operation...

  15. Regulatory activities

    International Nuclear Information System (INIS)

    2001-01-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information

  16. O Estado Regulador e o Estado Administrativo: A Expertise Política e o Governo dos Técnicos / The Regulatory State and Administrative State: The Expertise and the Government of Experts

    Directory of Open Access Journals (Sweden)

    Gilmara Joane Macedo de Medeiros

    2016-10-01

    Full Text Available Purpose – This essay analyzes the legitimacy of norms produced by the state’s regulatory activity. Underpinnings of the regulatory state and regulatory activity are discussed from the viewpoint of theories that might explain the legitimacy of its normative production, not least the administrative state theory of Dwight Waldo, who defends a government by technicians, valuing expertise. Methodology/approach/design – In the first section, the paper presents concepts of regulation and regulatory state. After that, the paper introduces the underpinnings for legitimate production of norms and the concept of public administration is addressed from the perspectives of the theory proposed by Dwight Waldo. Findings – According to Dwight Waldo, the legitimacy of regulatory decisions taken by a bureaucratic body relies on the technical expertise of its members, admitted through a meritocratic state choice.

  17. Regulatory review and barriers for the electricity supply system for distributed generation in EU-15

    DEFF Research Database (Denmark)

    Ropenus, Stephanie; Skytte, Klaus

    2005-01-01

    When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from di...... distributed generation. This paper reviews the current regulation of the grids with respect to distributed generation in EU-15 Member States and compares the different systems. Several barriers are identified.......When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from...

  18. Human factors in annunciation systems - Recommendations for a Canadian regulatory framework

    Energy Technology Data Exchange (ETDEWEB)

    Beattie, J D; Rochford, S; Vicente, K J [Humansystems Inc., ON (Canada)

    1997-09-01

    Under a contract with the Atomic Energy Control Board (AECB) of Canada, brief reviews were conducted of the annunciation systems in Canadian nuclear power plant control rooms; of regulatory practices in other countries and relevant international guidelines; and of the human factors literature related to annunciation systems. Based on these reviews, a framework is proposed for regulatory criteria which could be applied to new annunciation system designs. (author). 29 refs.

  19. Human factors in annunciation systems - Recommendations for a Canadian regulatory framework

    International Nuclear Information System (INIS)

    Beattie, J.D.; Rochford, S.; Vicente, K.J.

    1997-01-01

    Under a contract with the Atomic Energy Control Board (AECB) of Canada, brief reviews were conducted of the annunciation systems in Canadian nuclear power plant control rooms; of regulatory practices in other countries and relevant international guidelines; and of the human factors literature related to annunciation systems. Based on these reviews, a framework is proposed for regulatory criteria which could be applied to new annunciation system designs. (author). 29 refs

  20. State Electricity Regulatory Policy and Distributed Resources: Distributed Resource Distribution Credit Pilot Programs--Revealing the Value to Consumers and Vendors

    Energy Technology Data Exchange (ETDEWEB)

    Moskovitz, D.; Harrington, C.; Shirley, W.; Cowart, R.; Sedano, R.; Weston, F.

    2002-10-01

    Designing and implementing credit-based pilot programs for distributed resources distribution is a low-cost, low-risk opportunity to find out how these resources can help defer or avoid costly electric power system (utility grid) distribution upgrades. This report describes implementation options for deaveraged distribution credits and distributed resource development zones. Developing workable programs implementing these policies can dramatically increase the deployment of distributed resources in ways that benefit distributed resource vendors, users, and distribution utilities. This report is one in the State Electricity Regulatory Policy and Distributed Resources series developed under contract to NREL (see Annual Technical Status Report of the Regulatory Assistance Project: September 2000-September 2001, NREL/SR-560-32733). Other titles in this series are: (1) Accommodating Distributed Resources in Wholesale Markets, NREL/SR-560-32497; (2) Distributed Resources and Electric System Re liability, NREL/SR-560-32498; (3) Distribution System Cost Methodologies for Distributed Generation, NREL/SR-560-32500; (4) Distribution System Cost Methodologies for Distributed Generation Appendices, NREL/SR-560-32501.

  1. STATE INSPECTION METHODOLOGY OF ENVIRONMENTAL REGULATORY ACTIVITY FOCUSED ON THE LIFE CYCLE PROCESSESES

    Directory of Open Access Journals (Sweden)

    Yuniey Quiala Armenteros

    2016-10-01

    Full Text Available The Cuban Environmental Regulatory Activity has on the Environmental State Inspection an instrument for control and monitoring of compliance of current legal standards regarding environmental protection and rational use of natural resources. In this research, a design methodology for effective implementation of environmental regulatory activity in Cuba directed to processes is proposed; based on the life cycle assessment and the applicable environmental management standards, including new performance indicators, which form a new tool based on scientific criterions for the Center of Environmental Inspection and Control.

  2. Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission's dispositions

    International Nuclear Information System (INIS)

    Watanabe, Norio; Suzudo, Tomoaki

    1998-09-01

    Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission's (USNRC's) responses to the recommendations made by the NRC's study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC's dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

  3. Crisis, criticism, change: Regulatory reform in the wake of nuclear accidents

    International Nuclear Information System (INIS)

    Sexton, Kimberly A.; )

    2015-01-01

    Accidents are a forcing function for change in the nuclear industry. While these events can shed light on needed technical safety reforms, they can also shine a light on needed regulatory system reforms. The TEPCO Fukushima Daiichi nuclear power plant (NPP) accident in Japan is the most recent example of this phenomenon, but it is not the only one. In the wake of the three major accidents that have occurred in the nuclear power industry - Three Mile Island (TMI) in the United States; Chernobyl in Ukraine, in the former Soviet Union; and the Fukushima Daiichi NPP accident in Japan - a commission or committee of experts issued a report (or reports) with harsh criticism of the countries' regulatory system. And each of these accidents prompted changes in the respective regulatory systems. In looking at these responses, however, one must ask if this crisis, criticism, change approach is working and whether regulatory bodies around the world should instead undertake their own systematic reviews, un-prompted by crisis, to better ensure safety. This article will attempt to analyse the issue of regulatory reform in the wake of nuclear accidents by first providing a background in nuclear regulatory systems, looking to international and national legal frameworks. Next, the article will detail a cross-section of current regulatory systems around the world. Following that, the article will analyse the before and after of the regulatory systems in the United States, the Soviet Union and Japan in relation to the TMI, Chernobyl and Fukushima accidents. Finally, taking all this together, the article will address some of the international and national efforts to define exactly what makes a good regulator and provide conclusions on regulatory reform in the wake of nuclear accidents. (author)

  4. Contribution of a fuzzy expert system to regulatory impact analysis

    Directory of Open Access Journals (Sweden)

    Marco Antônio da Cunha

    2015-09-01

    Full Text Available Regulatory Impact Analysis (RIA has been consolidating in Brazilian regulatory agencies throughout the last decades. The RIA methodology aims to examine the regulatory process, measure the costs and benefits generated, as well as other effects of social, political or economic nature caused by a new or an existing regulation. By analysing each regulatory option, the expert or regulator faces a myriad of variables, usually of qualitative nature, that are difficult to measure and with a high degree of uncertainty. This research complements the existing literature, given the scarcity of decision support models in RIA that – regardless of the problem treated – incorporate the tacit knowledge of the regulation expert. This paper proposes an exploratory approach using a Fuzzy Expert System, which therefore helps to enrich the decision process in the final stage of comparison of the regulatory options.

  5. International Conference on Effective Nuclear Regulatory Systems: Sustaining Improvements Globally. Book of Abstracts

    International Nuclear Information System (INIS)

    2016-01-01

    The objective of this conference is to review and assess ways of further improving the effectiveness of regulatory systems for nuclear facilities and activities for both nuclear safety and nuclear security. The action items in the summary presented by the President of the conference held in 2013 in Ottawa, the lessons of the Fukushima Daiichi accident, the discussions at other international conferences and at international experts’ meetings conducted within the framework of the IAEA Action Plan on Nuclear Safety, as well as the CNS and the principles outlined in the Vienna Declaration on Nuclear Safety, will continue to have a significant impact on regulatory systems. All the aforementioned need to be taken into account to sustain improvements to regulatory systems. The expected outcomes of the conference are: - Enhanced safety and security of nuclear installations worldwide; - Challenges in regulating radiation sources and radioactive waste addressed; - Enhanced international cooperation for sustaining regulatory effectiveness; - Strengthened and sustained regulatory competence for nuclear safety and security; and - Strategies and actions for the future identified, as well as issues for consideration by governments, regulatory bodies and international organizations.

  6. The public information aspects of nuclear regulatory inspection in the United States

    International Nuclear Information System (INIS)

    Volgenau, E.

    1977-01-01

    The public information aspects of the regulation of nuclear power present a unique set of problems. Not only must the regulators communicate often complex technical information to the public, they must also assure the public, the press and the legislative bodies of the adequacy of the regulatory process and the safety of power plant operations. The United States Nuclear Regulatory Commission (NRC), recognizing the importance of a continuing, open dialogue with the public, has placed particular emphasis on informing the public of its operations. NRC's experiences have been both good and bad. On balance, however, the NRC believes it is following the best course by conducting its operations openly and candidly. (author)

  7. Nuclear Security Systems and Measures for the Detection of Nuclear and Other Radioactive Material out of Regulatory Control. Implementing Guide (Arabic Edition)

    International Nuclear Information System (INIS)

    2015-01-01

    This publication provides guidance to Member States for the development, or improvement of nuclear security systems and measures for the detection of criminal or unauthorized acts with nuclear security implications involving nuclear and other radioactive material out of regulatory control. It describes the elements of an effective nuclear security detection architecture which is composed of an integrated set of nuclear security systems and measures, and is based on an appropriate legal and regulatory framework for the implementation of the national detection strategy. The publication is an implementing guide within the IAEA Nuclear Security Series and is intended for use by national policy makers, legislative bodies, competent authorities, institutions, and individuals involved in the establishment, implementation, maintenance or sustainability of nuclear security systems and measures for the detection of nuclear and other radioactive material out of regulatory control

  8. Alternative approaches for identifying acute systemic toxicity: Moving from research to regulatory testing.

    Science.gov (United States)

    Hamm, Jon; Sullivan, Kristie; Clippinger, Amy J; Strickland, Judy; Bell, Shannon; Bhhatarai, Barun; Blaauboer, Bas; Casey, Warren; Dorman, David; Forsby, Anna; Garcia-Reyero, Natàlia; Gehen, Sean; Graepel, Rabea; Hotchkiss, Jon; Lowit, Anna; Matheson, Joanna; Reaves, Elissa; Scarano, Louis; Sprankle, Catherine; Tunkel, Jay; Wilson, Dan; Xia, Menghang; Zhu, Hao; Allen, David

    2017-06-01

    Acute systemic toxicity testing provides the basis for hazard labeling and risk management of chemicals. A number of international efforts have been directed at identifying non-animal alternatives for in vivo acute systemic toxicity tests. A September 2015 workshop, Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing, reviewed the state-of-the-science of non-animal alternatives for this testing and explored ways to facilitate implementation of alternatives. Workshop attendees included representatives from international regulatory agencies, academia, nongovernmental organizations, and industry. Resources identified as necessary for meaningful progress in implementing alternatives included compiling and making available high-quality reference data, training on use and interpretation of in vitro and in silico approaches, and global harmonization of testing requirements. Attendees particularly noted the need to characterize variability in reference data to evaluate new approaches. They also noted the importance of understanding the mechanisms of acute toxicity, which could be facilitated by the development of adverse outcome pathways. Workshop breakout groups explored different approaches to reducing or replacing animal use for acute toxicity testing, with each group crafting a roadmap and strategy to accomplish near-term progress. The workshop steering committee has organized efforts to implement the recommendations of the workshop participants. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. STATE ACID RAIN RESEARCH AND SCREENING SYSTEM - VERSION 1.0 USER'S MANUAL

    Science.gov (United States)

    The report is a user's manual that describes Version 1.0 of EPA's STate Acid Rain Research and Screening System (STARRSS), developed to assist utility regulatory commissions in reviewing utility acid rain compliance plans. It is a screening tool that is based on scenario analysis...

  10. Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission`s dispositions

    Energy Technology Data Exchange (ETDEWEB)

    Watanabe, Norio; Suzudo, Tomoaki [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    1998-09-01

    Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission`s (USNRC`s) responses to the recommendations made by the NRC`s study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC`s dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

  11. Nuclear whistleblower protection system in U.S. and its implication to Japanese regulatory system

    International Nuclear Information System (INIS)

    Tanabe, Tomoyuki; Suzuki, Tatsujiro

    2003-01-01

    The nuclear whistleblower protection system in U.S.A consists of two programs: 1) allegation program and 2) whistleblower protection system. The former is explained by basic act, definition of allegation, anonymous allegation, direct allegation to NRC (Nuclear Regulatory Commission), number of allegation from 1997 to 2001, procedure and period of investigation and notice of allegation to licensees. The latter is explained by basis act, outline of the system, enforcement by NRC and DOL (Department of Labor), number of discrimination compliant and anxiety of licensees. The system is good conditions in U.S.A depend on 1) prevent of illegal act and increase, 2) preparation of procedure and its transparency and 3) enforcement system. However, a hostile act to licensees is found in the whistleblower protection system. There are many problems in Japanese regulatory system. The improvement points of Japanese system are proposed. (S.Y.)

  12. Deliberations on nuclear safety regulatory system in a changing industrial environment

    International Nuclear Information System (INIS)

    Kim, H.J.

    2001-01-01

    Nuclear safety concern, which may accompany such external environmental factors as privatization and restructuring of the electric power industry, is emerging as an international issue. In order to cope with the concern about nuclear safety, it is important to feedback valuable experiences of advanced countries that restructured their electric power industries earlier and further to reflect the current safety issues, which are raised internationally, fully into the nuclear safety regulatory system. This paper is to review the safety issues that might take place in the process of increasing competition in the nuclear power industry, and further to present a basic direction and effective measures for ensuring nuclear safety in response thereto from the viewpoint of safety regulation. It includes a political direction for a regulatory body's efforts to rationalize and enforce efficiently its regulation. It proposes to ensure that regulatory specialty and regulatory cost are stably secured. Also, this paper proposes maintaining a sound nuclear safety regulatory system to monitor thoroughly the safety management activities of the industry, which might be neglected as a result of focusing on reduction of the cost for producing electric power. (author)

  13. Regulatory Control of Radiation Sources. Safety Guide (Arabic Edition)

    International Nuclear Information System (INIS)

    2012-01-01

    This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.

  14. Regulatory System of Radiation Protection in Taiwan

    International Nuclear Information System (INIS)

    Tang, F. T.; Huang, C. C.

    2004-01-01

    After the radioactive contaminated buildings incident occurred in Taiwan in 1993, the competent authority for radiation protection the Atomic Energy Council (AEC) started to review the structured problem of radiation protection regulatory system. Through several years' investigation and study, the AEC has improved two important tools in radiation protection regulatory system, i.e., control regulations and actual practice, and made them more rigorous and efficient. This paper will make a brief introduction of the efforts that Taiwan has made in this respect. Taiwan's radiation protection control was based on the Atomic Energy Law promulgated in 1968, but the control idea and authorization scope were not sufficient to appropriately respond to the highly developed economy and democracy in Taiwan. After several years' legislative process, the Ionizing Radiation Protection Law (IRP Law) was promulgated and entered into force on February 1, 2003. This IRP Law specifically emphasizes categorized risk management of radiation sources, establishment of personnel licenses and training system, enhancement of public safety control, and implementation of quality assurance program for medical exposure. The Legislative Yuan (Congress) fully authorized the competent authority to establish various technological control regulations according to control necessity without prior review by the Legislative Yuan in advance. As to the penalties of the violations of the IRP Law, the AEC adopts high-rated administrative fines and applies the Criminal Law to those who seriously contaminate the environment. In actual practice, the AEC has constructed a Radiation Protection Control Information System compatible with the IRP Law that fully combines the functions of computers and Internet. The information of facility operators who own radiation sources, radiation protection specialists, and operating personnel are entered into this system, starting from the submission of application of the

  15. Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings.

    Science.gov (United States)

    Chahal, Harinder Singh; Kashfipour, Farrah; Susko, Matt; Feachem, Neelam Sekhri; Boyle, Colin

    2016-05-01

    Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.

  16. Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines.

    Science.gov (United States)

    Johnston, John D; Feldschreiber, Peter

    2014-03-01

    The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed. © 2013 The British Pharmacological Society.

  17. Nuclear knowledge management system in the regulatory activity

    International Nuclear Information System (INIS)

    Nosovskij, A.V.; Klevtsov, A.L.; Kravchenko, N.A.

    2010-01-01

    Important issues on collection, storage and spread of knowledge among organisation dealing with the use of nuclear technologies, role of close cooperation between enterprises and organizations in developing knowledge management, general requirements for creating a nuclear knowledge management system are considered. Recommendations and the main mechanisms are identified to create the knowledge management system in technical support organizations of the regulatory authority.

  18. 77 FR 17569 - United States-Canada Regulatory Cooperation Council (RCC)-Transportation-Dangerous Goods Working...

    Science.gov (United States)

    2012-03-26

    ... identified in the Joint Action Plan, the Transportation--Dangerous Goods Working Group led by senior...)-- Transportation--Dangerous Goods Working Group AGENCY: Pipeline and Hazardous Materials Safety Administration...--Dangerous Goods Working Group, of the United States-Canada Regulatory Cooperation Council (RCC). Comments...

  19. The regulatory system of monitoring workers in Germany for intakes of radioactivity

    International Nuclear Information System (INIS)

    Dalheimer, A.; Henrichs, K.

    1996-01-01

    In Germany, the working group 'Incorporation Monitoring' of the German-Swiss Radiation Protection Association defined a new standard for the monitoring of workers occupationally exposed to radioactive material. During the last two years this draft has been accepted by the German government in the form of three guidelines. The purpose of the approach was the installation of a consistent state-of-the-art system: defining clear criteria for the necessity of routine and special monitoring programs, giving guidelines for monitoring programs ensuring that dose assessments are as reliable as necessary with the lowest possible expenses, standardizing as far as possible the procedures of dose assessments, and guaranteeing the necessary quality standards. The scientific basis of this regulatory system are the publications 30 and 54 of lCRP. (author)

  20. Approach of the State Office for Nuclear Safety to the regulatory incumbency

    International Nuclear Information System (INIS)

    Boehm, K.; Urbancik, L.

    1997-01-01

    The State Office for Nuclear Safety is the Czech regulatory authority responsible for supervision over the safety of nuclear facilities, over radioactive waste management and spent fuel management, over nuclear materials including accountancy and control, and over ionizing radiation protection. The State Office also coordinates the Radiation Monitoring Network of the Czech Republic and the international exchange of radiological data, and supervises more than 5000 workplaces where ionizing radiation sources are handled. In 1996 the State Office accomplished 47 inspections of nuclear materials, out of these 39 were performed in cooperation with inspectors of the IAEA. Other activities (emergency preparedness, legislative activities, international cooperation and public information) are also mentioned. (M.D.)

  1. Development of digital library system on regulatory documents for nuclear power plants

    International Nuclear Information System (INIS)

    Lee, K. H.; Kim, K. J.; Yoon, Y. H.; Kim, M. W.; Lee, J. I.

    2001-01-01

    The main objective of this study is to establish nuclear regulatory document retrieval system based on internet. With the advancement of internet and information processing technology, information management patterns are going through a new paradigm. Getting along the current of the time, it is general tendency to transfer paper-type documents into electronic-type documents through document scanning and indexing. This system consists of nuclear regulatory documents, nuclear safety documents, digital library, and information system with index and full text

  2. The core to regulatory reform

    International Nuclear Information System (INIS)

    Partridge, J.W. Jr.

    1993-01-01

    Federal Energy Regulatory Commission (FERC) Orders 436, 500, and 636, the Clean Air Act Amendments of 1990, Public Utility Holding Company Act reform, and the 1992 Energy Policy Act all can have significant effects on an LDC's operations. Such changes in an LDC's environments must be balanced by changes within the utility, its marketplace, and its state regulatory environment. The question is where to start. For Columbia Gas Distribution Cos., based in Columbus, OH, the new operating foundation begins with each employee. Internal strength is critical in designing initiatives that meet the needs of the marketplace and are well-received by regulators. Employees must understand not only the regulatory environment in which the LDC operates, but also how their work contributes to a positive regulatory relationship. To achieve this, Columbia initiated the COntinuing Regulatory Education program, or CORE, in 1991. CORE is a regulatory-focused, information-initiative program coordinated by Columbia's Regulatory Policy, Planning, and Government Affairs Department. The CORE programs can take many forms, such as emerging issue discussions, dialogues with regulators and key parties, updates on regulatory fillings, regulatory policy meetings, and formal training classes. The speakers and discussion facilitators can range from human resource department trainers to senior officers, from regulatory department staff members to external experts, or from state commissioners to executives from other LDCs. The goals of CORE initiatives are to: Support a professional level of regulatory expertise through employee participation in well-developed regulatory programs presented by credible experts. Encourage a constructive state regulatory environment founded on communication and cooperation. CORE achieves these goals via five program levels: introductory basics, advanced learning, professional expertise, crossfunctional dialogues, and external idea exchanges

  3. Reactor aging research. United States Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Vassilaros, M.G.

    1998-01-01

    The reactor ageing research activities in USA described, are focused on the research of reactor vessel integrity, including regulatory issues and technical aspects. Current emphasis are described for fracture analysis, embrittlement research, inspection capabilities, validation od annealing rule, revision of regulatory guide

  4. Regulatory authority infrastructure for Namibia

    International Nuclear Information System (INIS)

    Shangula, K.

    2001-01-01

    The Republic of Namibia is participating in the International Atomic Energy Agency's Model Project for the Improvement of National Regulatory Authority Infrastructures in Member States. The paper illustrates our experience in solving problems and difficulties confronted in establishing an effective regulatory authority operating within the existing national infrastructure that should be supported by the Government. An effective regulatory authority is seen as part of the wider administrative scope of our Government through ministerial mandates given by the State from time to time, guaranteeing its independence when implementing legal provisions under statutes. Sections of the report illustrate our experience in the following areas: 1. National radiation protection policy 2. Structure of our national regulatory authority 3. Laws and regulations 4. Provisions for notification, authorization and registration 5. In-depth security measures for radiation sources and radioactive material 6. Systems for the inspection of radiation sources, radioactive materials, enforcement of legal provisions 7. Extent of the applications of radiation sources and radioactive materials in the country. The paper provides information regarding existing Government policy on radiation protection; structure and legal aspects of the national regulatory, including statutes and regulations; the extent of application and uses of radiation sources and security of radioactive materials; human resources: strengths and constraints; management practices and financing of regulatory authority; and plans for emergency recovery of orphan sources. National plans for management of disused sources, recovery of orphan sources, abnormal emergencies, communication of information to affected persons on exposure effects, and the safety training of persons using these applications are discussed. the paper provides a summary and some suggestions of the way forward for Namibia. (author)

  5. Design and development of an informatics management system as a support for the Regulatory Authority in the Republic of Cuba

    International Nuclear Information System (INIS)

    Valdes Ramos, Maryzury; Prendes Alonso, Miguel; Jova Sed, Luis

    2008-01-01

    The regulatory activity in the country is carried out by the National Center for Nuclear Safety (CNSN) according to the international recommendations. To develop this, CNSN is supported by the Center for Radiation Protection and Hygiene (CPHR) which it's in charged of guaranteeing the technical scientific support for this activity. These centers have been working in the last years in the design and development of a computing tool that allows the management of all important information, which should be controlled by the Regulatory Authority. The authorization processes of the practices and the inspection program require the use, register and evaluation of an important volume of information that grows as the number of practices and facilities are increases. Consequently the systematizing of this information needs an automated management system. The objective of this work is to show the level of automation reached by the National Regulatory Authority using RASSYN program. This program allows an efficient management of the information related to the radiation sources nationwide, the practices ascribed to these sources, the personnel involved in these practices and the dose received, the equipment measuring and detecting of radiations, the generated waste, the occurred radiological incidents, the conditions and requisites of the granted authorizations and the results of the inspection program, among others. The possibilities of RASSYN system to process the information given by the users and the ones produced by the regulatory authority are described. The automatic generation of the annual inspections plan, according to the previously defined criteria and the system of alerts on the state of fulfillment of radiological protection requirements make RASSYN a useful tool to optimize the functioning of the regulatory system. The versatility of the statistical reports allows to guarantees not only the requirements of the regulatory authority but also the expectations coming

  6. Regulatory monitoring systems of fortified salt and wheat flour in selected ASEAN countries.

    Science.gov (United States)

    van den Wijngaart, Annoek; Bégin, France; Codling, Karen; Randall, Philip; Johnson, Quentin W

    2013-06-01

    Considerable efforts have been made over the past decade to address vitamin and mineral deficiencies. An increasing number of countries in the Association of Southeast Asian Nations (ASEAN) are adopting mandatory food fortification as one of the primary strategies to overcome these deficiencies. Experience shows that fortified foods can reach large parts of the population, including the poor, if the fortification is done on a mandatory rather than a voluntary basis and if the food vehicle is widely consumed. To review the importance of regulatory monitoring as an essential component of food fortification efforts in selected ASEAN countries, with special focus on the available information on regulatory monitoring systems for iodized salt and fortified wheat flour. The role of regulatory monitoring in strengthening food fortification programs was discussed during a joint regional meeting of the World Health Organization, UNICEF, the Flour Fortification Initiative, the Global Alliance for Improved Nutrition, the Micronutrient Initiative, and the World Bank on regulatory monitoring of salt and wheat flour fortification programs in Asia, which took place in Manila, Philippines, on 27-29 September 2011. This paper reviews the regulatory monitoring systems of selected ASEAN countries that participated in this meeting. Problems and challenges in regulatory monitoring systems for iodized salt and fortified wheat flour in selected ASEAN countries are identified, and a description of the role of regulatory monitoring in strengthening food fortification initiatives, particularly of salt and flour, and highlights of areas for improvement are presented. Regulatory monitoring consists of monitoring activities conducted at the production level, at customs warehouses, and at retail stores by concerned regulatory authorities, and at the production level by producers themselves, as part of quality control and assurance efforts. Unless there are appropriate enforcement and quality

  7. Quantification of the glycogen cascade system: the ultrasensitive responses of liver glycogen synthase and muscle phosphorylase are due to distinctive regulatory designs

    Directory of Open Access Journals (Sweden)

    Venkatesh KV

    2005-05-01

    Full Text Available Abstract Background Signaling pathways include intricate networks of reversible covalent modification cycles. Such multicyclic enzyme cascades amplify the input stimulus, cause integration of multiple signals and exhibit sensitive output responses. Regulation of glycogen synthase and phosphorylase by reversible covalent modification cycles exemplifies signal transduction by enzyme cascades. Although this system for regulating glycogen synthesis and breakdown appears similar in all tissues, subtle differences have been identified. For example, phosphatase-1, a dephosphorylating enzyme of the system, is regulated quite differently in muscle and liver. Do these small differences in regulatory architecture affect the overall performance of the glycogen cascade in a specific tissue? We address this question by analyzing the regulatory structure of the glycogen cascade system in liver and muscle cells at steady state. Results The glycogen cascade system in liver and muscle cells was analyzed at steady state and the results were compared with literature data. We found that the cascade system exhibits highly sensitive switch-like responses to changes in cyclic AMP concentration and the outputs are surprisingly different in the two tissues. In muscle, glycogen phosphorylase is more sensitive than glycogen synthase to cyclic AMP, while the opposite is observed in liver. Furthermore, when the liver undergoes a transition from starved to fed-state, the futile cycle of simultaneous glycogen synthesis and degradation switches to reciprocal regulation. Under such a transition, different proportions of active glycogen synthase and phosphorylase can coexist due to the varying inhibition of glycogen-synthase phosphatase by active phosphorylase. Conclusion The highly sensitive responses of glycogen synthase in liver and phosphorylase in muscle to primary stimuli can be attributed to distinctive regulatory designs in the glycogen cascade system. The different

  8. Regulatory authority of the Rocky Mountain states for low-level radioactive waste packaging and transportation

    International Nuclear Information System (INIS)

    Whitman, M.; Tate, P.

    1983-07-01

    The newly-formed Rocky Mountain Low-Level Radioactive Waste Compact is an interstate agreement for the management of low-level radioactive waste (LLW). Eligible members of the compact are Arizona, Colorado, Nevada, New Mexico, Utah, and Wyoming. Each state must ratify the compact within its legislature for the compact to become effective in that state and to make that state a full-fledged member of the compact. By so adopting the compact, each state agrees to the terms and conditions specified therein. Among those terms and conditions are provisions requiring each member state to adopt and enforce procedures requiring low-level waste shipments originating within its borders and destined for a regional facility to conform to packaging and transportation requirements and regulations. These procedures are to include periodic inspections of packaging and shipping practices, periodic inspections of waste containers while in the custody of carriers and appropriate enforcement actions for violations. To carry out this responsibility, each state must have an adequate statutory and regulatory inspection and enforcement authority to ensure the safe transportation of low-level radioactive waste. Three states in the compact region, Arizona, Utah and Wyoming, have incorporated the Department of Transportation regulations in their entirety, and have no published rules and regulations of their own. The other states in the compact, Colorado, Nevada and New Mexico all have separate rules and regulations that incorporate the DOT regulations. A brief description of the regulatory requirements of each state is presented

  9. System engineering in the Nuclear Regulatory Commission licensing process: Program architecture process and structure

    International Nuclear Information System (INIS)

    Romine, D.T.

    1989-01-01

    In October 1987, the U.S. Nuclear Regulatory Commission (NRC) established the Center for Nuclear Waste Regulatory Analyses at Southwest Research Institute in San Antonio, Texas. The overall mission of the center is to provide a sustained level of high-quality research and technical assistance in support of NRC regulatory responsibilities under the Nuclear Waste Policy Act (NWPA). A key part of that mission is to assist the NRC in the development of the program architecture - the systems approach to regulatory analysis for the NRC high-level waste repository licensing process - and the development and implementation of the computer-based Program Architecture Support System (PASS). This paper describes the concept of program architecture, summarizes the process and basic structure of the PASS relational data base, and describes the applications of the system

  10. Regulatory issues resolved through design certification on the System 80+trademark standard plant design

    International Nuclear Information System (INIS)

    Ritterbusch, S.E.; Brinkman, C.B.

    1996-01-01

    The US Nuclear Regulatory Commission (NRC) has completed its review of the System 80+trademark Standard Plant Design, approving advanced design features and closing severe accident licensing issues. Final Design Approval was granted in July 1994. The NRC review was extensive, requiring written responses to over 4,950 questions and formal printing of over 50,000 Safety Analysis Report pages. New safety issues never before addressed in a regulatory atmosphere had to be resolved with detailed analysis and evaluation of design features. the System 80+ review demonstrated that regulatory issues can be firmly resolved only through presentation of a detailed design and completion of a comprehensive regulatory review

  11. 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.

  12. Strengthening the regulatory system through the implementation and use of a quality management system

    Directory of Open Access Journals (Sweden)

    Reinhold Eisner

    2017-04-01

    Full Text Available ABSTRACT Quality management systems (QMS, based on ISO 9001 requirements, are applicable to government service organizations such as Health Canada’s Biologics and Genetic Therapies Directorate (BGTD. This communication presents the process that the BGTD followed since the early 2000s to implement a quality management system and describes how the regulatory system was improved as a result of this project. BGTD undertook the implementation of a quality management system based on ISO 9001 and containing aspects of ISO 17025 with the goal of strengthening the regulatory system through improvements in the people, processes, and services of the organization. We discuss the strategy used by BGTD to implement the QMS and the benefits that were realized from the various stages of implementation. The eight quality principals upon which the QMS standards of the ISO 9000 series are based were used by senior management as a framework to guide QMS implementation.

  13. Preparation of safety regulatory requirements for new technology like digital system

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG of MDEP. MDEP DICWG held in OECD/NEA gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance on digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed process and framework. The following four general common positions have been discussed in this fiscal year. The Treatment of Common Cause Failure Resulting from Software within Digital Safety Systems, The Treatment of Hardware Description Language(HDL) Programmed Devices for Use in Nuclear Safety System, Factory Acceptance Test and Site Acceptance Test, The Use of Automatic Tests to Perform Surveilance for Digital Systems. (author)

  14. Regulatory activities; Actividades regulatorias

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information.

  15. Through the regulatory hoop

    International Nuclear Information System (INIS)

    Kirner, N.P.

    1985-01-01

    There are many regulatory hoops through which waste generators, brokers, and disposal site operators must jump to dispose of waste safely. As the proposed exclusionary date of January 1, 1986, approaches, these regulatory hoops have the distinct possibility of multiplying or at least changing shape. The state of Washington, in its role as an Agreement State with the US Nuclear Regulatory Commission, licenses and inspects the commercial operator of the Northwest Compact's low-level radioactive waste disposal site on the Hanford Reservation. Washington has received as much as 53%, or 1.4 million cubic feet per year, of the nation's total volume of waste disposed. To control such a large volume of waste, a regulatory program involving six agencies has developed over the years in Washington

  16. Preparation of safety regulatory requirements for new technology like digital system

    International Nuclear Information System (INIS)

    2012-01-01

    The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG of MDEP. MDEP DICWG held in OECD/NEA gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance on digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed process and framework. The following two general common positions are discussed and to be issued in this fiscal year. Verification and Validation throughout the life cycle of safety systems using digital computers. The Impact of Cyber Security Features on Digital I and C Safety Systems. (author)

  17. Challenges in Strengthening Regulatory Infrastructure in a Non-Nuclear Country

    International Nuclear Information System (INIS)

    Bosnjak, J.

    2016-01-01

    The State Regulatory Agency for Radiation and Nuclear Safety (SRARNS) is established as the effectively independent regulatory body for radiation and nuclear safety based on the Law on Radiation and Nuclear Safety in Bosnia and Herzegovina promulgated in November 2007. After its complete reorganization in the last few years, the regulatory system is compatible with relevant IAEA Safety Standards and Guides for safety and security of radioactive sources. The paper gives an overview of the new regulatory framework in Bosnia and Herzegovina, with special focus on challenges faced by Bosnia and Herzegovina, which are actually typical challenges for regulator in small non-nuclear country in strengthening regulatory infrastructure in regulating radiation sources and radioactive waste. (author)

  18. The global regulatory system Csr senses glucose through the phosphoenolpyruvate: carbohydrate phosphotransferase system.

    Science.gov (United States)

    Pérez-Morales, Deyanira; Bustamante, Víctor H

    2016-02-01

    A novel connection between two regulatory systems controlling crucial biological processes in bacteria, the carbon storage regulator (Csr) system and the glucose-specific phosphotransferase system (PTS), is reported by Leng et al. in this issue. This involves the interaction of unphosphorylated EIIA(Glc), a component of the glucose-specific PTS, with the CsrD protein, which accelerates the decay of the CsrB and CsrC small RNAs via RNase E in Escherichia coli. As unphosphorylated EIIA(G) (lc) is generated in the presence of glucose, the PTS thus acts as a sensor of glucose for the Csr system. Interestingly, another pathway can operate for communication between the Csr system and the glucose-specific PTS. The absence of glucose generates phosphorylated EIIA(Glc) , which activates the enzyme adenylate cyclase to produce cyclic adenosine monophosphate (cAMP) that, in turn, binds to the regulator cAMP receptor protein (CRP). Leng et al. show that the complex cAMP-CRP modestly reduces CsrB decay independently of CsrD. On the other hand, a previous study indicates that the complex cAMP-CRP positively regulates the transcription of CsrB and CsrC in Salmonella enterica. Therefore, EIIA(G) (lc) could work as a molecular switch that regulates the activity of the Csr system, in response to its phosphorylation state determined by the presence or absence of glucose, in order to control gene expression. © 2015 John Wiley & Sons Ltd.

  19. Guidelines for IAEA International Regulatory Review Teams (IRRTs)

    International Nuclear Information System (INIS)

    2002-01-01

    The IAEA International Regulatory Review Team (IRRT) programme provides advice and assistance to Member States to strengthen and enhance the effectiveness of the nuclear regulatory body whilst recognizing the ultimate responsibility of each Member State for nuclear safety. The IRRT programme, initiated in 1989, is not restricted to any particular group of Member States, whether developing or industrialized, but is available to all countries with nuclear installations in operation or approaching operation. The basic concepts, purposes and functions of a national regulatory body are well recognized in all Member States having a nuclear power programme. The IAEA Safety Standards Series publication entitled 'Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, Safety: Requirements', No. GS-R-1 (2000), provides a general consensus reference for the practices necessary for a national organization to fulfil the regulatory purposes and discharge the regulatory functions. The Requirements also defines the terms used in these guidelines. The guidance given in the Requirements recognizes that the organizational structure and regulatory processes will vary from country to country depending on their existing constitutional, legal and administrative systems; the size and structure of their nuclear programme; the technical skills and professional and financial resources available to their regulatory body, and social customs and cultural traditions. The objective of this report is to provide guidance on the basic structure of an IRRT mission and provide a common reference both across the various areas covered by an IRRT mission and across all the missions in the programme. As such, it is addressed, principally, to the team members of IRRT missions but it also provides guidance to a host regulatory body receiving a mission. This report identifies the objectives of the IRRT mission and sets out the scope of the topic areas that are

  20. 17 CFR 249.821 - Form PILOT, information required of self-regulatory organizations operating pilot trading systems...

    Science.gov (United States)

    2010-04-01

    ... required of self-regulatory organizations operating pilot trading systems pursuant to § 240.19b-5 of this... Associations § 249.821 Form PILOT, information required of self-regulatory organizations operating pilot trading systems pursuant to § 240.19b-5 of this chapter. This form shall be used by all self-regulatory...

  1. United States nuclear regulatory commission program for inspection of decommissioning nuclear power plants

    International Nuclear Information System (INIS)

    Harris, P.W.

    2001-01-01

    The United States Nuclear Regulatory Commission (USNRC or Commission) has been inspecting decommissioning commercial nuclear power plants in the United States (U.S.) since the first such facility permanently shutdown in September 1967. Decommissioning inspections have principally focused on the safe storage and maintenance of spent reactor fuel; occupational radiation exposure; environmental radiological releases; the dismantlement and decontamination of structures, systems, and components identified to contain or potentially contain licensed radioactive material; and the performance of final radiological survey of the site and remaining structures to support termination of the USNRC-issued operating license. Over the last 5 years, USNRC inspection effort in these areas has been assessed and found to provide reasonable confidence that decommissioning can be conducted safely and in accordance with Commission rules and regulations. Recently, the staff has achieved a better understanding of the risks associated with particular decommissioning accidents 1 and plans to apply these insights to amendments proposed to enhance decommissioning rules and regulations. The probabilities, scenarios, and conclusions resulting from this effort are being assessed as to their applicability to the inspection of decommissioning commercial power reactors. (author)

  2. United States nuclear regulatory commission program for inspection of decommissioning nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Harris, P.W. [U.S. Nuclear Regulatory Commission, Washington, DC (United States)

    2001-07-01

    The United States Nuclear Regulatory Commission (USNRC or Commission) has been inspecting decommissioning commercial nuclear power plants in the United States (U.S.) since the first such facility permanently shutdown in September 1967. Decommissioning inspections have principally focused on the safe storage and maintenance of spent reactor fuel; occupational radiation exposure; environmental radiological releases; the dismantlement and decontamination of structures, systems, and components identified to contain or potentially contain licensed radioactive material; and the performance of final radiological survey of the site and remaining structures to support termination of the USNRC-issued operating license. Over the last 5 years, USNRC inspection effort in these areas has been assessed and found to provide reasonable confidence that decommissioning can be conducted safely and in accordance with Commission rules and regulations. Recently, the staff has achieved a better understanding of the risks associated with particular decommissioning accidents 1 and plans to apply these insights to amendments proposed to enhance decommissioning rules and regulations. The probabilities, scenarios, and conclusions resulting from this effort are being assessed as to their applicability to the inspection of decommissioning commercial power reactors. (author)

  3. Criteria adopted by the Argentine Nuclear Regulatory Authority for assessing digital systems related to safety

    International Nuclear Information System (INIS)

    Terrado, Carlos A.; Chiossi, Carlos E.; Felizia, Eduardo R.; Roca, Jose L.; Sajaroff, Pedro M.

    2004-01-01

    Following the technological evolution in Instrumentation and Control (I and C) design, analog components are replaced by digital in almost every industry. Due to growing challenges of obsolescence and increasing maintenance costs, licensees of nuclear and radioactive installations are increasingly upgrading or replacing their existing I and C analog systems and components. In existing installations, this involves analog to digital replacements. In new installations design, the use of digital I and C systems is being considered from the very beginning, becoming a good alternative, even in safety applications. Up to now, in Argentina, there is no specific rules for safety-related digital systems, every safety system, analog or digital, must comply with the same generic regulations. The Nuclear Regulatory Authority is now developing criteria to assess digital systems related to safety in nuclear and radioactive installations. In this paper some of those criteria, based on local research and the recognized state of the art, are explained. From a regulatory point of view, the use of digital technology often raises new technical and licensing issues, particularly for safety-related applications. Examples include new failure modes, the potential for common-cause failure of redundant components, electromagnetic interference (EMI), software verification and validation, configuration management and a more exhaustive quality assurance system. The mentioned criteria comprehend the design, operation, maintenance and acquisition of digital systems and components important to safety. The main topics covered are: requirements specifications for digital systems, planning and documentation for digital system development, effectiveness of a digital system, commercial off the shelf (COTS) treatment and considerations involving tools for software development. (author)

  4. International nuclear safety experts conclude IAEA peer review of Canada's regulatory system

    International Nuclear Information System (INIS)

    2009-01-01

    Full text: An international team of nuclear safety experts today completed a two-week IAEA review of the regulatory framework and effectiveness of the Canadian Nuclear Safety Commission (CNSC). The team identified good practices within the system and gave advice on some areas for improvement. The IAEA has conveyed initial findings to Canadian authorities; the final report will be submitted by autumn. The International Atomic Energy Agency (IAEA) assembled a team of nuclear, radiation, and waste safety experts at the request of the Government of Canada, to conduct an Integrated Regulatory Review Service (IRRS) mission. The mission from 31 May to 12 June was a peer review based on IAEA Standards, not an inspection, nor an audit. The scope of the mission included sources, facilities and activities regulated by the CNSC: the operation of nuclear power plants (NPPs), research reactors and fuel cycle facilities; the refurbishment or licensing of new NPPs; uranium mining; radiation protection and environmental protection programmes; and the implementation of IAEA Code of Conduct on Safety and Security of Radioactive Sources. The 21-member team from 13 IAEA States and from the IAEA itself reviewed CNSC's work in all relevant areas: legislative and governmental responsibilities; responsibilities and functions; organization; activities of the regulatory body, including the authorization process, review and assessment, inspection and enforcement, the development of regulations, as well as guides and its the management system of CNSC. The basis for the review was a well-prepared self-assessment by the CNSC, including an evolution of its strengths and proposed actions to improve its regulatory effectiveness. Mr. Shojiro Matsuura, IRRS Team Leader and President of the Japanese Nuclear Safety Research Association, said the team 'was impressed by the extensive preparation at all CNSC staff levels.' 'We identified a number of good practices and made recommendations and suggestions

  5. Regulatory Guide 1.79 safety injection recirculation test requirements, fact or fiction

    International Nuclear Information System (INIS)

    Roberts, J.K.

    1976-01-01

    The overwhelming concern of the general public in this day of state nuclear initiatives is the basic question, ''is nuclear power safe.'' Much of this concern has focused on the emergency core cooling systems. This public attention spotlights the testing organization's responsibility during startup of proving the operation and reliability of the emergency core cooling systems. The standard established by the Nuclear Regulatory Commission for testing emergency core cooling systems is Regulatory Guide 1.79 ''Preoperational Testing of Emergency Core Cooling Systems for Pressurized Water Reactors''. The nuclear industry must satisfy the testing requirements of Regulatory Guide 1.79 to meet their responsibility to the public; and to prevent future embarrassment when questioned on the adequacy of emergency core cooling systems

  6. An evaluation model for the definition of regulatory requirements on spent fuel pool cooling systems

    International Nuclear Information System (INIS)

    Izquierdo, J.M.

    1979-01-01

    A calculation model is presented for establishing regulatory requirements in the SFPCS System. The major design factors, regulatory and design limits and key parameters are discussed. A regulatory position for internal use is proposed. Finally, associated problems and experience are presented. (author)

  7. Modeling Dynamic Regulatory Processes in Stroke

    Science.gov (United States)

    McDermott, Jason E.; Jarman, Kenneth; Taylor, Ronald; Lancaster, Mary; Shankaran, Harish; Vartanian, Keri B.; Stevens, Susan L.; Stenzel-Poore, Mary P.; Sanfilippo, Antonio

    2012-01-01

    The ability to examine the behavior of biological systems in silico has the potential to greatly accelerate the pace of discovery in diseases, such as stroke, where in vivo analysis is time intensive and costly. In this paper we describe an approach for in silico examination of responses of the blood transcriptome to neuroprotective agents and subsequent stroke through the development of dynamic models of the regulatory processes observed in the experimental gene expression data. First, we identified functional gene clusters from these data. Next, we derived ordinary differential equations (ODEs) from the data relating these functional clusters to each other in terms of their regulatory influence on one another. Dynamic models were developed by coupling these ODEs into a model that simulates the expression of regulated functional clusters. By changing the magnitude of gene expression in the initial input state it was possible to assess the behavior of the networks through time under varying conditions since the dynamic model only requires an initial starting state, and does not require measurement of regulatory influences at each time point in order to make accurate predictions. We discuss the implications of our models on neuroprotection in stroke, explore the limitations of the approach, and report that an optimized dynamic model can provide accurate predictions of overall system behavior under several different neuroprotective paradigms. PMID:23071432

  8. 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.

  9. Improving regulatory effectiveness in Federal/State siting actions. Need for power: determinants in the state decisionmaking processes. Final report

    International Nuclear Information System (INIS)

    Noble, J.B.; Hemphill, J.B.

    1978-03-01

    The Department of Energy's Nuclear Siting and Licensing Act of 1978 (S. 2775; H. R. 11704) proposes Federal/State coordination in need for facility decisionmaking for nuclear power stations. The present study examines the decisionmaking criteria used by forty-four States in making a determination of need for power/facility. Specific criteria are identified along with the number of States which make those criteria a primary or a secondary consideration in determining need for facility. Individual profiles of the studied States' decisionmaking criteria are provided. In addition, the study examines the different organizational and functional patterns found in the States' regulatory process to certificate power stations. The coordination or lack of coordination of the issuance of associated environmental permits required for power stations is outlined for each State. Information concerning States' rate treatment of expenses associated with the construction and operation of a power station is provided. The relationship between the need for power decisionmaking process and the ratemaking process is explored

  10. Fisheries regulatory regimes and resilience to climate change.

    Science.gov (United States)

    Ojea, Elena; Pearlman, Isaac; Gaines, Steven D; Lester, Sarah E

    2017-05-01

    Climate change is already producing ecological, social, and economic impacts on fisheries, and these effects are expected to increase in frequency and magnitude in the future. Fisheries governance and regulations can alter socio-ecological resilience to climate change impacts via harvest control rules and incentives driving fisher behavior, yet there are no syntheses or conceptual frameworks for examining how institutions and their regulatory approaches can alter fisheries resilience to climate change. We identify nine key climate resilience criteria for fisheries socio-ecological systems (SES), defining resilience as the ability of the coupled system of interacting social and ecological components (i.e., the SES) to absorb change while avoiding transformation into a different undesirable state. We then evaluate the capacity of four fisheries regulatory systems that vary in their degree of property rights, including open access, limited entry, and two types of rights-based management, to increase or inhibit resilience. Our exploratory assessment of evidence in the literature suggests that these regulatory regimes vary widely in their ability to promote resilient fisheries, with rights-based approaches appearing to offer more resilience benefits in many cases, but detailed characteristics of the regulatory instruments are fundamental.

  11. A population dynamics analysis of the interaction between adaptive regulatory T cells and antigen presenting cells.

    Directory of Open Access Journals (Sweden)

    David Fouchet

    Full Text Available BACKGROUND: Regulatory T cells are central actors in the maintenance of tolerance of self-antigens or allergens and in the regulation of the intensity of the immune response during infections by pathogens. An understanding of the network of the interaction between regulatory T cells, antigen presenting cells and effector T cells is starting to emerge. Dynamical systems analysis can help to understand the dynamical properties of an interaction network and can shed light on the different tasks that can be accomplished by a network. METHODOLOGY AND PRINCIPAL FINDINGS: We used a mathematical model to describe a interaction network of adaptive regulatory T cells, in which mature precursor T cells may differentiate into either adaptive regulatory T cells or effector T cells, depending on the activation state of the cell by which the antigen was presented. Using an equilibrium analysis of the mathematical model we show that, for some parameters, the network has two stable equilibrium states: one in which effector T cells are strongly regulated by regulatory T cells and another in which effector T cells are not regulated because the regulatory T cell population is vanishingly small. We then simulate different types of perturbations, such as the introduction of an antigen into a virgin system, and look at the state into which the system falls. We find that whether or not the interaction network switches from the regulated (tolerant state to the unregulated state depends on the strength of the antigenic stimulus and the state from which the network has been perturbed. CONCLUSION/SIGNIFICANCE: Our findings suggest that the interaction network studied in this paper plays an essential part in generating and maintaining tolerance against allergens and self-antigens.

  12. Preservation and Implementation of Decommissioning Lessons Learned in the United States Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Rodriguez, Rafael L.

    2008-01-01

    Over the past several years, the United States Nuclear Regulatory Commission (NRC) has actively worked to capture and preserve lessons learned from the decommissioning of nuclear facilities. More recently, NRC has involved industry groups, the Organization of Agreement States (OAS), and the Department of Energy (DOE) in the effort to develop approaches to capture, preserve and disseminate decommissioning lessons learned. This paper discusses the accomplishments of the working group, some lessons learned by the NRC in the recent past, and how NRC will incorporate these lessons learned into its regulatory framework. This should help ensure that the design and operation of current and future nuclear facilities will result in less environmental impact and more efficient decommissioning. In summary, the NRC will continue capturing today's experience in decommissioning so that future facilities can take advantage of lessons learned from today's decommissioning projects. NRC, both individually and collectively with industry groups, OAS, and DOE, is aggressively working on the preservation and implementation of decommissioning lessons learned. The joint effort has helped to ensure the lessons from the whole spectrum of decommissioning facilities (i.e., reactor, fuel cycle, and material facilities) are better understood, thus maximizing the amount of knowledge and best practices obtained from decommissioning activities. Anticipated regulatory activities at the NRC will make sure that the knowledge gained from today's decommissioning projects is preserved and implemented to benefit the nuclear facilities that will decommission in the future

  13. Safety Justification of Software Systems. Software Based Safety Systems. Regulatory Inspection Handbook

    International Nuclear Information System (INIS)

    Dahll, Gustav; Liwang, Bo; Wainwright, Norman

    2006-01-01

    The introduction of new software based technology in the safety systems in nuclear power plants also makes it necessary to develop new strategies for regulatory review and assessment of these new systems that is more focused on reviewing the processes at the different phases in design phases during the system life cycle. It is a general requirement that the licensee shall perform different kinds of reviews. From a regulatory point of view it is more cost effective to assess that the design activities at the suppliers and the review activities within the development project are performed with good quality. But the change from more technical reviews over to the development process oriented approach also cause problems. When reviewing development and quality aspects there are no 'hard facts' that can be judged against some specified criteria, the issues are more 'soft' and are more to build up structure of arguments and evidences that the requirements are met. The regulatory review strategy must therefore change to follow the development process over the whole life cycle from concept phase until installation and operation. Even if we know what factors that is of interest we need some guidance on how to interpret and judge the information.For that purpose SKl started research activities in this area at the end of the 1990s. In the first phase, in co-operation with Gustav Dahll at the Halden project, a life cycle model was selected. For the different phases a qualitative influence net was constructed of the type that is used in Bayesian Believe Network together with a discussion on different issues involved. In the second phase of the research work, in co-operation with Norman Wainwright, a former NII inspector, information from a selection of the most important sources as guidelines, IAEA and EC reports etc, was mapped into the influence net structure (the total list on used sources are in the report). The result is presented in the form of questions (Q) and a

  14. Safety Justification of Software Systems. Software Based Safety Systems. Regulatory Inspection Handbook

    Energy Technology Data Exchange (ETDEWEB)

    Dahll, Gustav (OECD Halden Project, Halden (NO)); Liwaang, Bo (Swedish Nuclear Power Inspectorate, Stockholm (Sweden)); Wainwright, Norman (Wainwright Safety Advice (GB))

    2006-07-01

    The introduction of new software based technology in the safety systems in nuclear power plants also makes it necessary to develop new strategies for regulatory review and assessment of these new systems that is more focused on reviewing the processes at the different phases in design phases during the system life cycle. It is a general requirement that the licensee shall perform different kinds of reviews. From a regulatory point of view it is more cost effective to assess that the design activities at the suppliers and the review activities within the development project are performed with good quality. But the change from more technical reviews over to the development process oriented approach also cause problems. When reviewing development and quality aspects there are no 'hard facts' that can be judged against some specified criteria, the issues are more 'soft' and are more to build up structure of arguments and evidences that the requirements are met. The regulatory review strategy must therefore change to follow the development process over the whole life cycle from concept phase until installation and operation. Even if we know what factors that is of interest we need some guidance on how to interpret and judge the information.For that purpose SKl started research activities in this area at the end of the 1990s. In the first phase, in co-operation with Gustav Dahll at the Halden project, a life cycle model was selected. For the different phases a qualitative influence net was constructed of the type that is used in Bayesian Believe Network together with a discussion on different issues involved. In the second phase of the research work, in co-operation with Norman Wainwright, a former NII inspector, information from a selection of the most important sources as guidelines, IAEA and EC reports etc, was mapped into the influence net structure (the total list on used sources are in the report). The result is presented in the form of

  15. A systems biology approach to construct the gene regulatory network of systemic inflammation via microarray and databases mining

    Directory of Open Access Journals (Sweden)

    Lan Chung-Yu

    2008-09-01

    Full Text Available Abstract Background Inflammation is a hallmark of many human diseases. Elucidating the mechanisms underlying systemic inflammation has long been an important topic in basic and clinical research. When primary pathogenetic events remains unclear due to its immense complexity, construction and analysis of the gene regulatory network of inflammation at times becomes the best way to understand the detrimental effects of disease. However, it is difficult to recognize and evaluate relevant biological processes from the huge quantities of experimental data. It is hence appealing to find an algorithm which can generate a gene regulatory network of systemic inflammation from high-throughput genomic studies of human diseases. Such network will be essential for us to extract valuable information from the complex and chaotic network under diseased conditions. Results In this study, we construct a gene regulatory network of inflammation using data extracted from the Ensembl and JASPAR databases. We also integrate and apply a number of systematic algorithms like cross correlation threshold, maximum likelihood estimation method and Akaike Information Criterion (AIC on time-lapsed microarray data to refine the genome-wide transcriptional regulatory network in response to bacterial endotoxins in the context of dynamic activated genes, which are regulated by transcription factors (TFs such as NF-κB. This systematic approach is used to investigate the stochastic interaction represented by the dynamic leukocyte gene expression profiles of human subject exposed to an inflammatory stimulus (bacterial endotoxin. Based on the kinetic parameters of the dynamic gene regulatory network, we identify important properties (such as susceptibility to infection of the immune system, which may be useful for translational research. Finally, robustness of the inflammatory gene network is also inferred by analyzing the hubs and "weak ties" structures of the gene network

  16. Construction of an integrated gene regulatory network link to stress-related immune system in cattle.

    Science.gov (United States)

    Behdani, Elham; Bakhtiarizadeh, Mohammad Reza

    2017-10-01

    The immune system is an important biological system that is negatively impacted by stress. This study constructed an integrated regulatory network to enhance our understanding of the regulatory gene network used in the stress-related immune system. Module inference was used to construct modules of co-expressed genes with bovine leukocyte RNA-Seq data. Transcription factors (TFs) were then assigned to these modules using Lemon-Tree algorithms. In addition, the TFs assigned to each module were confirmed using the promoter analysis and protein-protein interactions data. Therefore, our integrated method identified three TFs which include one TF that is previously known to be involved in immune response (MYBL2) and two TFs (E2F8 and FOXS1) that had not been recognized previously and were identified for the first time in this study as novel regulatory candidates in immune response. This study provides valuable insights on the regulatory programs of genes involved in the stress-related immune system.

  17. Impact of State and Federal regulatory policy on natural gas

    International Nuclear Information System (INIS)

    Malloy, K.

    1992-01-01

    This paper presents information which demonstrates the decline in the use and subsequent demand of natural gas as the result of regulatory constraints. These regulations have allowed for a 10 percent decline in the use of natural gas in the last 20 years. The author believes that the major reason for this decline is the existence of State and Federal regulatory requirements which prevent the natural gas industry from effectively responding to new market opportunities. The paper goes on to discuss historical regulations such as the Fuel Use Act and the Natural Gas Policy Act which caused severe impacts to development in the gas industry by placing incremental price controls on natural gas. The author then discusses the effect of deregulation and how it has boosted the gas industry. He specifically discusses the US Canada Free-Trade Agreement and the new negotiations which would greatly enhance the gas sales to Mexico. Finally the author goes on to discuss deregulatory stances proposed as part of the National Energy Strategy regarding natural gas. These include the removal of obstacles to building new pipeline capacities; reformation of rates policies; assurances of nondiscriminatory access to natural gas pipeline services and facilities; and removal of impediments to free and open international trade in natural gas

  18. Survey of state regulatory activities on least cost planning for gas utilities

    International Nuclear Information System (INIS)

    Goldman, C.A.; Hopkins, M.E.

    1991-04-01

    Integrated resource planning involves the creation of a process in which supply-side and demand-side options are integrated to create a resource mix that reliably satisfies customers' short-term and long-term energy service needs at the lowest cost. Incorporating the concept of meeting customer energy service needs entails a recognition that customers' costs must be considered along with the utility's costs in the economic analysis of energy options. As applied to gas utilities, an integrated resource plan seeks to balance cost and reliability, and should not be interpreted simply as the search for lowest commodity costs. All state commissions were surveyed to assess the current status of gas planning and demand-side management and to identify significant regulatory issues faced by commissions during the next several years. The survey was to determine the extent to which they have undertaken least-cost planning for gas utilities. The survey included the following topics: (1) status of state PUC least-cost planning regulations and practices for gas utilities; (2) type and scope ofnatural gas DSM programs in effect, includeing fuel substitution; (3) economic tests and analysis methods used to evaluate DSM programs; (4) relationship between prudence reviews of gas utility purchasing practices and integrated resource planning; and (5) key regulatory issues facing gas utilities during the next five years. 34 refs., 6 figs., 10 tabs

  19. State Office for Nuclear Safety - New Regulatory Body in Croatia

    International Nuclear Information System (INIS)

    Novosel, N.; Prah, M.; Valcic, I.; Cizmek, A.

    2006-01-01

    The Act on Nuclear Safety was adopted by the Croatian Parliament on 15 October 2003, and it is published in the Official Gazette No. 173/03. This Act regulates safety and protective measures for using nuclear materials and specified equipment and performing nuclear activities, and establishes the State Office for Nuclear Safety. Provisions of this Act apply on nuclear activities, nuclear materials and specified equipment. Also, by accession to international conventions and agreements, Croatia took the responsibility of implementing the provisions of those international treaties. In the process of European and international integrations, Croatia has to make harmonization with European and international standards also in the field of nuclear safety. The State Office for Nuclear Safety as an independent regulatory authority started its work on 1st June 2005 by taking over responsibility for activities relating to nuclear safety and cooperation with the International Atomic Energy Agency from the Ministry of the Economy, Labour and Entrepreneurship. In this paper responsibilities, organization and projects of the State Office for Nuclear Safety will be presented, with the accent on development of regulations and international cooperation. (author)

  20. On the Concept of Cis-regulatory Information: From Sequence Motifs to Logic Functions

    Science.gov (United States)

    Tarpine, Ryan; Istrail, Sorin

    The regulatory genome is about the “system level organization of the core genomic regulatory apparatus, and how this is the locus of causality underlying the twin phenomena of animal development and animal evolution” (E.H. Davidson. The Regulatory Genome: Gene Regulatory Networks in Development and Evolution, Academic Press, 2006). Information processing in the regulatory genome is done through regulatory states, defined as sets of transcription factors (sequence-specific DNA binding proteins which determine gene expression) that are expressed and active at the same time. The core information processing machinery consists of modular DNA sequence elements, called cis-modules, that interact with transcription factors. The cis-modules “read” the information contained in the regulatory state of the cell through transcription factor binding, “process” it, and directly or indirectly communicate with the basal transcription apparatus to determine gene expression. This endowment of each gene with the information-receiving capacity through their cis-regulatory modules is essential for the response to every possible regulatory state to which it might be exposed during all phases of the life cycle and in all cell types. We present here a set of challenges addressed by our CYRENE research project aimed at studying the cis-regulatory code of the regulatory genome. The CYRENE Project is devoted to (1) the construction of a database, the cis-Lexicon, containing comprehensive information across species about experimentally validated cis-regulatory modules; and (2) the software development of a next-generation genome browser, the cis-Browser, specialized for the regulatory genome. The presentation is anchored on three main computational challenges: the Gene Naming Problem, the Consensus Sequence Bottleneck Problem, and the Logic Function Inference Problem.

  1. Knowledge, workflow and electronic document management in the system of the State Nuclear Regulatory Inspectorate of Ukraine. Preparing the platform development and implementation of the Knowledge Portal

    International Nuclear Information System (INIS)

    Bozhko, S.G.; Shevchenko, Yi.A.; Pecheritsya, O.V.; Singayivs'kij, A.M.

    2016-01-01

    The previous paper considered the creation of the system for management of nuclear knowledge, workflow and electronic documents (hereinafter called the Knowledge Portal) in the field of safe nuclear energy use. It presented initial steps needed to make an informed decision on the feasibility of implementing the Knowledge Portal and proposed methodological approaches based on practical experience of the State Nuclear Regulatory Inspectorate of Ukraine and the SSTC NRS. Further pre - project activities of the state body, local authorities, enterprises, institutions and organizations irrespective of ownership (hereinafter called the Institution) involve the development and drawing attention to the package of analytical, technical and feasibility documents. In particular, it is recommended to take into account the results of analyzing world trends in the development of information technology, audit status information and telecommunication systems (hereinafter - ITS) of the Institution, detailed strategy for the development of ITS Institution (hereinafter - the Strategy), the concept of the Knowledge Portal (hereinafter - the Concept) and preliminary technical solution The results of review and approval of the Concept and architecture solution by scientific and technical council of the Institution is the basis for the preparation of Ter ms of Reference (hereinafter - TOR) on the development of the Knowledge Portal, forming schedules for the procurement of hardware and software, works on the development and implementation of portal solutions and information security systems

  2. The regulatory function of self-esteem: testing the epistemic and acceptance signaling systems.

    Science.gov (United States)

    Stinson, Danu Anthony; Logel, Christine; Holmes, John G; Wood, Joanne V; Forest, Amanda L; Gaucher, Danielle; Fitzsimons, Grainné M; Kath, Jennifer

    2010-12-01

    The authors draw on sociometer theory (e.g., Leary, 2004) and self-verification theory (e.g., Swann, 1997) to propose an expanded model of the regulatory function of self-esteem. The model suggests that people not only possess an acceptance signaling system that indicates whether relational value is high or low but also possess an epistemic signaling system that indicates whether social feedback is consistent or inconsistent with chronic perceived relational value (i.e., global self-esteem). One correlational study and 5 experiments, with diverse operationalizations of social feedback, demonstrated that the epistemic signaling system responds to self-esteem consistent or inconsistent relational-value feedback with increases or deceases in epistemic certainty. Moreover, Studies 3-6 demonstrated that the acceptance and epistemic signaling systems respond uniquely to social feedback. Finally, Studies 5 and 6 provide evidence that the epistemic signaling system is part of a broader self-regulatory system: Self-esteem inconsistent feedback caused cognitive efforts to decrease the discrepancy between self-views and feedback and caused depleted self-regulatory capacity on a subsequent self-control task. PsycINFO Database Record (c) 2010 APA, all rights reserved.

  3. Improvement of the regulatory system by implementation new safety demands

    International Nuclear Information System (INIS)

    Iglesias, R.; Alfonso, C.

    1996-01-01

    The work describes in broad terms, the analysis that is being performed aiming at the adoption of a regulatory system that could meet the current safety demands, but which, at the same time, could be a general system that might allow different safety assessments to be done by making use of more specific technical standards of the technology supplier

  4. Strengthening Regulatory Competence in a Changing Nuclear Regulatory Environment

    International Nuclear Information System (INIS)

    Illizastigui, P.F.

    2016-01-01

    The paper addresses the approach followed by the Cuban National Center for Nuclear Safety for the management of current and new competences of its regulatory staff with the aim of allowing those staff to effectively fulfill their core regulatory functions. The approach is realized through an Integrated System for Competence Building, which is based on the IAEA recommendations, shown to be effective in ensuring the necessary competence in the relevant areas. In the author’s opinion, competence of the regulatory staff in the area of human and organizational factors is of paramount importance and needs to be further strengthened in order to be able to assess safety performance at the facilities and detect early signs of deteriorating safety performance. The former is defined by the author as the core regulatory function “Analysis” which covers the entire spectrum of assessment tasks carried out by the regulatory staff to: a) detect declining safety performance, b) diagnose latent weaknesses (root causes) and c) make effective safety culture interventions. The author suggests that competence associated with the fulfillment of the analysis function is distinctly identified and dealt with separately in the current system of managing regulatory competence. (author)

  5. Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States

    Directory of Open Access Journals (Sweden)

    Mark I. Avigan

    2016-03-01

    Full Text Available In the United States (US, the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists. Based on current US law, all dietary supplements sold domestically, including botanical supplements, are regulated by the Food and Drug Administration (FDA as a special category of foods. Under this designation, regulatory scientists do not routinely evaluate the efficacy of these products prior to their marketing, despite the content variability and phytochemical complexity that often characterizes them. Nonetheless, there has been notable progress in the development of advanced scientific methods to qualitatively and quantitatively measure ingredients and screen for contaminants and adulterants in botanical products when hepatotoxicity is recognized.

  6. Nuclear Security Systems and Measures for the Detection of Nuclear and Other Radioactive Material out of Regulatory Control. Implementing Guide

    International Nuclear Information System (INIS)

    2013-01-01

    Nuclear terrorism and the illicit trafficking of nuclear and other radioactive material threaten the security of all States. There are large quantities of diverse radioactive material in existence, which are used in areas such as health, the environment, agriculture and industry. The possibility that nuclear and other radioactive material may be used for terrorist acts cannot be ruled out in the current global situation. States have responded to this risk by engaging in a collective commitment to strengthen the protection and control of such material, and to establish capabilities for detection and response to nuclear and other radioactive material out of regulatory control. Through its nuclear security programme, the IAEA supports States to establish, maintain and sustain an effective nuclear security regime. The IAEA has adopted a comprehensive approach to nuclear security. This approach recognizes that an effective national nuclear security regime builds on: the implementation of relevant international legal instruments; information protection; physical protection; material accounting and control; detection of and response to trafficking in nuclear and other radioactive material; national response plans; and contingency measures. Within its nuclear security programme, the IAEA aims to assist States in implementing and sustaining such a regime in a coherent and integrated manner. Each State carries the full responsibility for nuclear security, specifically: to provide for the security of nuclear and other radioactive material and associated facilities and activities; to ensure the security of such material in use, storage or in transport; to combat illicit trafficking; and to detect and respond to nuclear security events. This is an Implementing Guide on nuclear security systems and measures for the detection of nuclear and other radioactive material out of regulatory control. The objective of the publication is to provide guidance to Member States for the

  7. Characteristics of regulatory regimes

    Directory of Open Access Journals (Sweden)

    Noralv Veggeland

    2013-03-01

    Full Text Available The overarching theme of this paper is institutional analysis of basic characteristics of regulatory regimes. The concepts of path dependence and administrative traditions are used throughout. Self-reinforcing or positive feedback processes in political systems represent a basic framework. The empirical point of departure is the EU public procurement directive linked to OECD data concerning use of outsourcing among member states. The question is asked: What has caused the Nordic countries, traditionally not belonging to the Anglo-Saxon market-centred administrative tradition, to be placed so high on the ranking as users of the Market-Type Mechanism (MTM of outsourcing in the public sector vs. in-house provision of services? A thesis is that the reason may be complex, but might be found in an innovative Scandinavian regulatory approach rooted in the Nordic model.

  8. Genetic control of mammalian T-cell proliferation with synthetic RNA regulatory systems

    OpenAIRE

    Chen, Yvonne Y.; Jensen, Michael C.; Smolke, Christina D.

    2010-01-01

    RNA molecules perform diverse regulatory functions in natural biological systems, and numerous synthetic RNA-based control devices that integrate sensing and gene-regulatory functions have been demonstrated, predominantly in bacteria and yeast. Despite potential advantages of RNA-based genetic control strategies in clinical applications, there has been limited success in extending engineered RNA devices to mammalian gene-expression control and no example of their application to functional res...

  9. Computational Genetic Regulatory Networks Evolvable, Self-organizing Systems

    CERN Document Server

    Knabe, Johannes F

    2013-01-01

    Genetic Regulatory Networks (GRNs) in biological organisms are primary engines for cells to enact their engagements with environments, via incessant, continually active coupling. In differentiated multicellular organisms, tremendous complexity has arisen in the course of evolution of life on earth. Engineering and science have so far achieved no working system that can compare with this complexity, depth and scope of organization. Abstracting the dynamics of genetic regulatory control to a computational framework in which artificial GRNs in artificial simulated cells differentiate while connected in a changing topology, it is possible to apply Darwinian evolution in silico to study the capacity of such developmental/differentiated GRNs to evolve. In this volume an evolutionary GRN paradigm is investigated for its evolvability and robustness in models of biological clocks, in simple differentiated multicellularity, and in evolving artificial developing 'organisms' which grow and express an ontogeny starting fr...

  10. [Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

    Science.gov (United States)

    Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

    2016-05-01

    Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

  11. Environmental and state-level regulatory factors affect the incidence of autism and intellectual disability.

    Directory of Open Access Journals (Sweden)

    Andrey Rzhetsky

    2014-03-01

    Full Text Available Many factors affect the risks for neurodevelopmental maladies such as autism spectrum disorders (ASD and intellectual disability (ID. To compare environmental, phenotypic, socioeconomic and state-policy factors in a unified geospatial framework, we analyzed the spatial incidence patterns of ASD and ID using an insurance claims dataset covering nearly one third of the US population. Following epidemiologic evidence, we used the rate of congenital malformations of the reproductive system as a surrogate for environmental exposure of parents to unmeasured developmental risk factors, including toxins. Adjusted for gender, ethnic, socioeconomic, and geopolitical factors, the ASD incidence rates were strongly linked to population-normalized rates of congenital malformations of the reproductive system in males (an increase in ASD incidence by 283% for every percent increase in incidence of malformations, 95% CI: [91%, 576%], p<6×10(-5. Such congenital malformations were barely significant for ID (94% increase, 95% CI: [1%, 250%], p = 0.0384. Other congenital malformations in males (excluding those affecting the reproductive system appeared to significantly affect both phenotypes: 31.8% ASD rate increase (CI: [12%, 52%], p<6×10(-5, and 43% ID rate increase (CI: [23%, 67%], p<6×10(-5. Furthermore, the state-mandated rigor of diagnosis of ASD by a pediatrician or clinician for consideration in the special education system was predictive of a considerable decrease in ASD and ID incidence rates (98.6%, CI: [28%, 99.99%], p = 0.02475 and 99% CI: [68%, 99.99%], p = 0.00637 respectively. Thus, the observed spatial variability of both ID and ASD rates is associated with environmental and state-level regulatory factors; the magnitude of influence of compound environmental predictors was approximately three times greater than that of state-level incentives. The estimated county-level random effects exhibited marked spatial clustering, strongly

  12. COST EFFECTIVE REGULATORY APPROACHES TO ENHANCE DOMESTIC OIL & GAS PRODUCTION AND ENSURE THE PROTECTION OF THE ENVIRONMENT

    Energy Technology Data Exchange (ETDEWEB)

    Ben Grunewald; Paul Jehn; Tom Gillespie; Ben Binder

    2004-12-21

    The Environmental Information Management Suite/Risk Based Data Management System (EIMS/RBDMS) and Cost Effective Regulatory Approach (CERA) programs continue to be successful. All oil and gas state regulatory programs participate in these efforts. Significant accomplishments include: streamline regulatory approaches, enhancing environmental protection, and making oil and gas data available via the Internet. Oil and gas companies worldwide now have access to data on state web sites. This reduces the cost of exploration and enables companies to develop properties in areas that would have been cost prohibited for exploration. Early in project, GWPC and State Oil and Gas agencies developed the EIMS and CERA strategic plan to prioritize long term development and implementation. The planning process identifies electronic commerce and coal bed methane as high priorities. The group has involved strategic partners in industry and government to develop a common data exchange process. Technical assistance to Alaska continues to improve their program management capabilities. New initiatives in Alaska include the development of an electronic permit tracking system. This system allows managers to expedite the permitting process. Nationwide, the RBDMS system is largely completed with 22 states and one Indian Nation now using this nationally accepted data management system. Additional remaining tasks include routine maintenance and the installation of the program upon request for the remaining oil and gas states. The GWPC in working with the BLM and MMS to develop an XML schema to facilitate electronic permitting and reporting (Appendix A, B, and C). This is a significant effort and, in years to come, will increase access to federal lands by reducing regulatory barriers. The new initiatives are coal bed methane and e-commerce. The e-commerce program will provide industry and BLM/MMS access to the millions of data points housed in the RBDMS system. E-commerce will streamline

  13. Sharing regulatory data as tools for strengthening health systems in the Region of the Americas

    Directory of Open Access Journals (Sweden)

    Varley Dias Sousa

    Full Text Available ABSTRACT Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs and Regional Reference Authorities (RRAs. This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report as tools for strengthening health systems. Based on a narrative (nonsystematic review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data and data- and work-sharing (inter-agency data. The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1 the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics and 2 the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.

  14. Sharing regulatory data as tools for strengthening health systems in the Region of the Americas.

    Science.gov (United States)

    Sousa, Varley Dias; Ramalho, Pedro I; Silveira, Dâmaris

    2016-05-01

    Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs) and Regional Reference Authorities (RRAs). This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report) as tools for strengthening health systems. Based on a narrative (nonsystematic) review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data) and data- and work-sharing (inter-agency data). The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1) the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics) and 2) the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.

  15. Technical Status Report of the Regulatory Assistance Project: October 2001-February 2003

    Energy Technology Data Exchange (ETDEWEB)

    2003-08-01

    This report details the work undertaken from October 2001 to February 2003 by the Regulatory Assistance Project under subcontract to the National Renewable Energy Laboratory. The objectives of this work were to develop regulatory policy options that would reduce the institutional and infrastructure barriers to full-value deployment of distributed power systems. Specific tasks included leading technical workshops on removing or overcoming regulatory barriers to distributed resources for state utility regulators and developing a draft model rule on emission performance standards for distributed generation.

  16. Multiple regulatory systems coordinate DNA replication with cell growth in Bacillus subtilis.

    Science.gov (United States)

    Murray, Heath; Koh, Alan

    2014-10-01

    In many bacteria the rate of DNA replication is linked with cellular physiology to ensure that genome duplication is coordinated with growth. Nutrient-mediated growth rate control of DNA replication initiation has been appreciated for decades, however the mechanism(s) that connects these cell cycle activities has eluded understanding. In order to help address this fundamental question we have investigated regulation of DNA replication in the model organism Bacillus subtilis. Contrary to the prevailing view we find that changes in DnaA protein level are not sufficient to account for nutrient-mediated growth rate control of DNA replication initiation, although this regulation does require both DnaA and the endogenous replication origin. We go on to report connections between DNA replication and several essential cellular activities required for rapid bacterial growth, including respiration, central carbon metabolism, fatty acid synthesis, phospholipid synthesis, and protein synthesis. Unexpectedly, the results indicate that multiple regulatory systems are involved in coordinating DNA replication with cell physiology, with some of the regulatory systems targeting oriC while others act in a oriC-independent manner. We propose that distinct regulatory systems are utilized to control DNA replication in response to diverse physiological and chemical changes.

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-10-01

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

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

    International Nuclear Information System (INIS)

    1995-10-01

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

  19. The enforcement program of the nuclear regulatory commission in the United States

    International Nuclear Information System (INIS)

    Thornburg, H.D.

    1977-01-01

    The enforcement program of the United States Nuclear Regulatory Commission consists of a clearly spelled out, evenly applied program of deterrents which escalate according to the nature of the offense and the past history of the licensee's noncompliances. Ninety-eight percent of all enforcement actions are normally handled by the five Regional offices. Only one percent of noncompliances have been classed as violations where significant safety consequences occurred. A strong and timely enforcement program is essential to insure that licensees fulfill their obligations to protect the public and the environment. (Auth.) [fr

  20. A system-level model for the microbial regulatory genome.

    Science.gov (United States)

    Brooks, Aaron N; Reiss, David J; Allard, Antoine; Wu, Wei-Ju; Salvanha, Diego M; Plaisier, Christopher L; Chandrasekaran, Sriram; Pan, Min; Kaur, Amardeep; Baliga, Nitin S

    2014-07-15

    Microbes can tailor transcriptional responses to diverse environmental challenges despite having streamlined genomes and a limited number of regulators. Here, we present data-driven models that capture the dynamic interplay of the environment and genome-encoded regulatory programs of two types of prokaryotes: Escherichia coli (a bacterium) and Halobacterium salinarum (an archaeon). The models reveal how the genome-wide distributions of cis-acting gene regulatory elements and the conditional influences of transcription factors at each of those elements encode programs for eliciting a wide array of environment-specific responses. We demonstrate how these programs partition transcriptional regulation of genes within regulons and operons to re-organize gene-gene functional associations in each environment. The models capture fitness-relevant co-regulation by different transcriptional control mechanisms acting across the entire genome, to define a generalized, system-level organizing principle for prokaryotic gene regulatory networks that goes well beyond existing paradigms of gene regulation. An online resource (http://egrin2.systemsbiology.net) has been developed to facilitate multiscale exploration of conditional gene regulation in the two prokaryotes. © 2014 The Authors. Published under the terms of the CC BY 4.0 license.

  1. Review of SFR Design Safety using Preliminary Regulatory PSA Model

    International Nuclear Information System (INIS)

    Na, Hyun Ju; Lee, Yong Suk; Shin, Andong; Suh, Nam Duk

    2013-01-01

    The major objective of this research is to develop a risk model for regulatory verification of the SFR design, and thereby, make sure that the SFR design is adequate from a risk perspective. In this paper, the development result of preliminary regulatory PSA model of SFR is discussed. In this paper, development and quantification result of preliminary regulatory PSA model of SFR is discussed. It was confirmed that the importance PDRC and ADRC dampers is significant as stated in the result of KAERI PSA model. However, the importance can be changed significantly depending on assumption of CCCG and CCF factor of PDRC and ADRC dampers. SFR (sodium-cooled fast reactor) which is Gen-IV nuclear energy system, is designed to accord with the concept of stability, sustainability and proliferation resistance. KALIMER-600, which is under development in Korea, includes passive safety systems (e. g. passive reactor shutdown, passive residual heat removal, and etc.) as well as active safety systems. Risk analysis from a regulatory perspective is needed to support the regulatory body in its safety and licensing review for SFR (KALIMER-600). Safety issues should be identified in the early design phase in order to prevent the unexpected cost increase and delay of the SFR licensing schedule that may be caused otherwise

  2. Preparation of safety regulatory requirements for new technology like digital system

    International Nuclear Information System (INIS)

    Ito, Juichiro; Takita, Masami

    2011-01-01

    The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG (Digital Instrumentation and Control Working Group) of MDEP (Multinational Design Evaluation Program). MDEP DICWG held in OECD/NEA (Organisation for Economic Co-operation and Development/Nuclear Energy Agency) gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance regarding digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed upon process and framework. Five general common positions are under discussion in this fiscal year. Simplicity in Design, Software Common Cause Failures, Software Tools, Data communication, Verification and Validation throughout the life cycle of safety systems using digital computers. In addition, the technical evaluation of standards of the Japan Electric Association about digital system for safety was made to support NISA (Nuclear and Industrial Safety Agency). (author)

  3. Regulatory aspects of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1985-01-01

    Regulatory systems in the field of radiopharmaceuticals have two main purposes: efficacy and safety. Efficacy expresses the quality of the diagnostic and therapeutic process for the patient. Safety involves the patient, the staff, and the environment. The world situation regarding regulations for radiopharmaceuticals is reviewed on the basis of a survey in WHO Member States. The main content of such regulations is discussed. The special properties of radiopharmaceuticals compared with ordinary drugs may call for modified regulations. Several countries are preparing such regulations. Close co-operation and good understanding among scientists working in hospital research, industry and regulatory bodies will be of great importance for the fast and safe introduction of new radiopharmaceuticals for the benefit of the patient. Before introducing new legislation in this field, a radiopharmaceutical expert should analyse the situation in the country and the relationship to the existing regulations. It is expected that the most important factor in promoting the fast introduction of new, safe and effective radiopharmaceuticals will be the training of people working within the regulatory bodies. It is foreseen that the IAEA and WHO will have an important role to play by providing expert advice and training in this area. (author)

  4. Steering healthcare service delivery: a regulatory perspective.

    Science.gov (United States)

    Prakash, Gyan

    2015-01-01

    The purpose of this paper is to explore regulation in India's healthcare sector and makes recommendations needed for enhancing the healthcare service. The literature was reviewed to understand healthcare's regulatory context. To understand the current healthcare system, qualitative data were collected from state-level officials, public and private hospital staff. A patient survey was performed to assess service quality (QoS). Regulation plays a central role in driving healthcare QoS. India needs to strengthen market and institutional co-production based approaches for steering its healthcare in which delivery processes are complex and pose different challenges. This study assesses current healthcare regulation in an Indian state and presents a framework for studying and strengthening regulation. Agile regulation should be based on service delivery issues (pull approach) rather than monitoring and sanctions based regulatory environment (push approach). Healthcare pitfalls across the world seem to follow similar follies. India's complexity and experience is useful for emerging and developed economies. The author reviewed around 70 publications and synthesised them in healthcare regulatory contexts. Patient's perception of private providers could be a key input towards steering regulation. Identifying gaps across QoS dimensions would be useful in taking corrective measures.

  5. Pre-salt new regulatory mark and the economic order: constitutionality analysis

    International Nuclear Information System (INIS)

    Pinheiro, Marcela Brasil Pedrosa; Araujo, Mayara de Carvalho; Xavier, Yanko Marcius; Guimaraes, Patricia Borba Vilar

    2010-01-01

    The discovery of vast reserves of hydrocarbons in the pre-salt layer that extends from Espirito Santo to Santa Catarina, added with the economic and strategic value of oil and natural gas, has brought discussion about the reasonableness of the regulatory model adopted so far. Would be prudent to explore these resources through the concession model? From detailed analysis of the doctrinal and bills that aim to inaugurate the new regulatory bills, we sought to answer this question, based majorly on the principles of economic activity applied in our constitutional system. Motivated by the analysis of these constitutional principles proposed, the State is seen as a regulating agent of the economic activities, fulfilling its role to supervise, encourage and plan the direction of national economic system. The sharing model gives greater state involvement and is able to convert the wealth of pre-salt in citizenship, but only if well implemented. Thus, based on constitutional principles and the notion of development as freedom, the conclusion of this paperwork is for the constitutionality of the new regulatory bills. (author)

  6. A model of gene expression based on random dynamical systems reveals modularity properties of gene regulatory networks.

    Science.gov (United States)

    Antoneli, Fernando; Ferreira, Renata C; Briones, Marcelo R S

    2016-06-01

    Here we propose a new approach to modeling gene expression based on the theory of random dynamical systems (RDS) that provides a general coupling prescription between the nodes of any given regulatory network given the dynamics of each node is modeled by a RDS. The main virtues of this approach are the following: (i) it provides a natural way to obtain arbitrarily large networks by coupling together simple basic pieces, thus revealing the modularity of regulatory networks; (ii) the assumptions about the stochastic processes used in the modeling are fairly general, in the sense that the only requirement is stationarity; (iii) there is a well developed mathematical theory, which is a blend of smooth dynamical systems theory, ergodic theory and stochastic analysis that allows one to extract relevant dynamical and statistical information without solving the system; (iv) one may obtain the classical rate equations form the corresponding stochastic version by averaging the dynamic random variables (small noise limit). It is important to emphasize that unlike the deterministic case, where coupling two equations is a trivial matter, coupling two RDS is non-trivial, specially in our case, where the coupling is performed between a state variable of one gene and the switching stochastic process of another gene and, hence, it is not a priori true that the resulting coupled system will satisfy the definition of a random dynamical system. We shall provide the necessary arguments that ensure that our coupling prescription does indeed furnish a coupled regulatory network of random dynamical systems. Finally, the fact that classical rate equations are the small noise limit of our stochastic model ensures that any validation or prediction made on the basis of the classical theory is also a validation or prediction of our model. We illustrate our framework with some simple examples of single-gene system and network motifs. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-09-15

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

  8. Spent fuel management systems, burnup credit approach experience in expert activity of State Scientific and Technical Centre for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    Kovbasenko, Y.

    2010-01-01

    Implementing new devices and mechanisms, including those developed and manufactured abroad, at enterprises of the Ukrainian power industry makes it necessary to license them in advance by the Ukrainian Regulatory Authority. From time to time, situations occur when these systems or their close analogues have been already used in some countries and have successively passed licensing by the relevant Regulatory Authorities; however, they do not meet the regulatory requirements in force in Ukraine. Preliminary analysis of the regulations in Ukraine concerning nuclear safety of spent nuclear fuel (SNF) management systems shows that some regulatory requirements in force are too conservative in view of current international practice. The extent of conservatism can be reduced, if necessary, only on the base of improving our level of understanding the processes occurring in nuclear dangerous systems and improving our capabilities as regards accuracy, correctness, and reliability in numerical modeling these processes. Such activity is consistent with the state-of-the-art production requirements. This work was intended to demonstrate that the excessive conservatism laid previously into the requirements on nuclear safety in Ukraine due to insufficient development of tools for modeling processes in nuclear fuel can be considerably decreased through using more modern and real modeling fuel systems. If such modeling is performed with the use of state-of-the-art methods, based on more complete understanding the processes in fuel systems, then removal of the excessive conservatism will not reduce the safety of nuclear dangerous systems

  9. Regulatory Concerns on the In-Containment Water Storage System of the Korean Next Generation Reactor

    International Nuclear Information System (INIS)

    Ahn, Hyung-Joon; Lee, Jae-Hun; Bang, Young-Seok; Kim, Hho-Jung

    2002-01-01

    The in-containment water storage system (IWSS) is a newly adopted system in the design of the Korean Next Generation Reactor (KNGR). It consists of the in-containment refueling water storage tank, holdup volume tank, and cavity flooding system (CFS). The IWSS has the function of steam condensation and heat sink for the steam release from the pressurizer and provides cooling water to the safety injection system and containment spray system in an accident condition and to the CFS in a severe accident condition. With the progress of the KNGR design, the Korea Institute of Nuclear Safety has been developing Safety and Regulatory Requirements and Guidances for safety review of the KNGR. In this paper, regarding the IWSS of the KNGR, the major contents of the General Safety Criteria, Specific Safety Requirements, Safety Regulatory Guides, and Safety Review Procedures were introduced, and the safety review items that have to be reviewed in-depth from the regulatory viewpoint were also identified

  10. The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

    Energy Technology Data Exchange (ETDEWEB)

    Hughes, P. J. [HM Nuclear Installations Inspectorate Marine Engineering Submarines Defence Nuclear Safety Regulator Serco Assurance Redgrave Court, Merton Road, Bootle L20 7HS (United Kingdom); Westwood, R.N; Mark, R. T. [FLEET HQ, Leach Building, Whale Island, Portsmouth, PO2 8BY (United Kingdom); Tapping, K. [Serco Assurance,Thomson House, Risley, Warrington, WA3 6GA (United Kingdom)

    2006-07-01

    The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety cases for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)

  11. Association of Regulatory Boards of Optometry

    Science.gov (United States)

    ... website of the Association of Regulatory Boards of Optometry (ARBO). ARBO's web site is designed to provide resources to regulatory boards of optometry throughout the world. State/Provincial/Territorial Boards of ...

  12. Multiple regulatory systems coordinate DNA replication with cell growth in Bacillus subtilis.

    Directory of Open Access Journals (Sweden)

    Heath Murray

    2014-10-01

    Full Text Available In many bacteria the rate of DNA replication is linked with cellular physiology to ensure that genome duplication is coordinated with growth. Nutrient-mediated growth rate control of DNA replication initiation has been appreciated for decades, however the mechanism(s that connects these cell cycle activities has eluded understanding. In order to help address this fundamental question we have investigated regulation of DNA replication in the model organism Bacillus subtilis. Contrary to the prevailing view we find that changes in DnaA protein level are not sufficient to account for nutrient-mediated growth rate control of DNA replication initiation, although this regulation does require both DnaA and the endogenous replication origin. We go on to report connections between DNA replication and several essential cellular activities required for rapid bacterial growth, including respiration, central carbon metabolism, fatty acid synthesis, phospholipid synthesis, and protein synthesis. Unexpectedly, the results indicate that multiple regulatory systems are involved in coordinating DNA replication with cell physiology, with some of the regulatory systems targeting oriC while others act in a oriC-independent manner. We propose that distinct regulatory systems are utilized to control DNA replication in response to diverse physiological and chemical changes.

  13. Multiple Regulatory Systems Coordinate DNA Replication with Cell Growth in Bacillus subtilis

    Science.gov (United States)

    Murray, Heath; Koh, Alan

    2014-01-01

    In many bacteria the rate of DNA replication is linked with cellular physiology to ensure that genome duplication is coordinated with growth. Nutrient-mediated growth rate control of DNA replication initiation has been appreciated for decades, however the mechanism(s) that connects these cell cycle activities has eluded understanding. In order to help address this fundamental question we have investigated regulation of DNA replication in the model organism Bacillus subtilis. Contrary to the prevailing view we find that changes in DnaA protein level are not sufficient to account for nutrient-mediated growth rate control of DNA replication initiation, although this regulation does require both DnaA and the endogenous replication origin. We go on to report connections between DNA replication and several essential cellular activities required for rapid bacterial growth, including respiration, central carbon metabolism, fatty acid synthesis, phospholipid synthesis, and protein synthesis. Unexpectedly, the results indicate that multiple regulatory systems are involved in coordinating DNA replication with cell physiology, with some of the regulatory systems targeting oriC while others act in a oriC-independent manner. We propose that distinct regulatory systems are utilized to control DNA replication in response to diverse physiological and chemical changes. PMID:25340815

  14. Recent Status of Indonesian Nuclear Regulatory System Development in Responding the Results of IRRS Mission

    International Nuclear Information System (INIS)

    Pramono, Y.

    2016-01-01

    BAPETEN as Nuclear Energy Regulatory Agency of Indonesia faces challenges in performing its tasks for assuring the safety, security, and safeguards in nuclear energy utilization through the regulatory system. Based on the recent IRRS mission to Indonesia, hosted by BAPETEN, several recommendations and suggestions shall require special attention to provide strategic action plans in following them up. Some of the recommendations include the necessity of the Government to develop and document a national policy and strategy for safety, to provide BAPETEN with human and financial resources to ensure adequate discharge of its statutory regulatory obligations, to ensure that prime responsibility of safety is assigned to the person or organization responsible for a facility or an activity through the legal framework, to ensure appropriate coordination and liaison between BAPETEN and other relevant authorities in the areas of medical application of radiation and transport of radioactive material. The suggestions cover, among others, the need of having a graded approach policy in implementing all regulatory functions, clarifying the responsibility of the individual reporting on the performance of the management system to senior management, establishing procedures for assessing the safety and appropriateness of the working environment and enhancing the implementation of self-assessments by including safety culture aspects. As part of the action plans, BAPETEN is currently drafting the national policy and strategy on nuclear and radiation safety. Furthermore, BAPETEN is revising the existing act on nuclear energy in order to assign the prime responsibility of safety to be borne by the licensees, to ensure the adequacy of its human and financial resources, and to provide clearer distinction of responsibilities between BAPETEN and other relevant authorities in the areas of medical application of radiation and transport of radioactive material. To counter the issue on

  15. Institutional and Organizational Structure of the Federal Procurement System of the United States

    Directory of Open Access Journals (Sweden)

    Vovchenko Natalya Gennadyevna

    2015-09-01

    Full Text Available The paper deals with the role of the Federal procurement system of the United States as a regulatory tool of the U.S. economy. The scope of research is focused on organizational and institutional aspects of forming and developing the U.S. Federal procurement system. The main purpose of the paper is to study up-to-date mechanism of government acquisition in the United States and to consider all its structural elements taken in conjunction with each other, such as the President, the Office of Management and Budget (OMB, the Office of Federal Procurement Policy (OFPP, the General Services Administration (GSA, other executive and regulatory agencies. The methodological background of the research is based on normative, system-wide, statistical and complex approaches to the study of structural elements of the U.S. Federal procurement system. The theoretical and practical material of the present research can be used in teaching and learning activities at economic faculties, for instance, in the course of lectures on government contacting and public procurement management. It also can be used in training and advanced training of specialists who draft public procurement regulations in the Russian Federation. The statutory regulation of the U.S. Federal procurement system constitutes an organizational framework of executive agencies, their functions and responsibilities, specifics of government control over contract performance, competition requirements and contracting methods. The paper considered interrelated components of the U.S. Federal procurement system, which operates in furtherance of efficient utilization of Federal budget.

  16. The renin-angiotensin-aldosterone system and calcium-regulatory hormones.

    Science.gov (United States)

    Vaidya, A; Brown, J M; Williams, J S

    2015-09-01

    There is increasing evidence of a clinically relevant interplay between the renin-angiotensin-aldosterone system and calcium-regulatory systems. Classically, the former is considered a key regulator of sodium and volume homeostasis, while the latter is most often associated with skeletal health. However, emerging evidence suggests an overlap in regulatory control. Hyperaldosteronism and hyperparathyroidism represent pathophysiologic conditions that may contribute to or perpetuate each other; aldosterone regulates parathyroid hormone and associates with adverse skeletal complications, and parathyroid hormone regulates aldosterone and associates with adverse cardiovascular complications. As dysregulation in both systems is linked to poor cardiovascular and skeletal health, it is increasingly important to fully characterize how they interact to more precisely understand their impact on human health and potential therapies to modulate these interactions. This review describes the known clinical interactions between these two systems including observational and interventional studies. Specifically, we review studies describing the inhibition of renin activity by calcium and vitamin D, and a potentially bidirectional and stimulatory relationship between aldosterone and parathyroid hormone. Deciphering these relationships might clarify variability in outcomes research, inform the design of future intervention studies and provide insight into the results of prior and ongoing intervention studies. However, before these opportunities can be addressed, more effort must be placed on shifting observational data to the proof of concept phase. This will require reallocation of resources to conduct interventional studies and secure the necessary talent.

  17. Regulatory controls for NORM contamination: Emerging issues and strategies

    International Nuclear Information System (INIS)

    Wennerberg, Linda

    1992-01-01

    Naturally occurring and accelerator-produced radioactive material (NORM) faces the increasing likelihood of federal or state regulatory control. Public concern and limited preliminary survey data fuel the debate over the necessity, approach, and jurisdiction of a NORM regulatory strategy. This debate requires the resolution of technical controversies and potentially competing state and federal agency interests. An additional facet of the debate is the impact of regulation upon traditionally non-nuclear industries, such as oil and gas production. Regulatory response has been initiated in several states, such as Louisiana's controls on equipment used in oil and gas production, to control specific industrial activities which generate NORM. A more comprehensive, generic federal strategy to control NORM contamination is also under review by the Environmental Protection Agency. This paper will detail the emerging technical issues, federal and state regulatory strategies under consideration, and evaluate the efficacy of selected regulatory approaches. (author)

  18. 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.

  19. Improving regulatory effectiveness in federal/state siting actions: water supplies and the nuclear licensing process

    International Nuclear Information System (INIS)

    Davenport, F.S.

    1977-07-01

    The Interstate Conference on Water Problems (ICWP) is a national association of State, intrastate, and interstate officials concerned with water resources administration and related matters. The Conference was established in 1959 as an outgrowth of regional conferences on water problems as recognized in the same year by action of the General Assembly of the States. This report was produced by the Interstate Conference on Water Problems in an effort to provide a compilation and summary of the views of selected States regarding relationships of water supplies to the nuclear power plant licensing process. This publication does not represent the official position of the U.S Water Resources Council, or the U.S. Nuclear Regulatory Commission, nor does it represent the position of any single state or the ICWP

  20. From trial to triumph: How Canada’s past financial crises helped shape a superior regulatory system

    Directory of Open Access Journals (Sweden)

    Lawrie Savage

    2015-09-01

    Full Text Available As anyone paying attention during the 2008–2009 financial crisis is aware, the Canadian financial system weathered the storm uniquely well. Exactly why Canada’s system remained so comparatively stable, while so many other foreign systems broke down, is a question that remains largely unsettled. One explanation may be that the regulatory system that emerged from a very specific history of prior crises had both prepared Canada well for such a crisis, and responded effectively as the crisis unfolded. But the very regulatory system that provided stability in recent years may also be at risk of becoming warped by its own success, with regulators so emboldened by the acclaim for their recent achievements that they overreach to ensure their track record remains unblemished in the future. The stunning collapse of a pair of western Canadian banks, a number of major Canadian trust companies and several insurance companies, as well as some other precarious near misses in the 1980s and 1990s, were a shock to the financial regulatory system, highlighting deficiencies that would be addressed with new regulations and, most notably, the creation of the Office of the Superintendent of Financial Institutions (OSFI. Canada’s centralized regulatory approach, through the OSFI and just four other major regulatory bodies, has proved both more elegant and effective than, for instance, the more complicated, more convoluted and more decentralized American financial-oversight system. But some regulated companies, insurers in particular, have long maintained that the concentration of power in Canada’s large banks has resulted in a one-size-fits-all regulatory approach that does not offer a relatively lighter burden for smaller institutions, potentially stifling growth. In other words, an over-emphasis on stability may be hampering market efficiency. Nor is there any economic evidence to shed light on whether those and other costs of regulating stability are

  1. From Trial to Triumph: How Canada’s Past Financial Crises Helped Shape a Superior Regulatory System

    Directory of Open Access Journals (Sweden)

    Lawrie Savage

    2014-05-01

    Full Text Available As anyone paying attention during the 2008–2009 financial crisis is aware, the Canadian financial system weathered the storm uniquely well. Exactly why Canada’s system remained so comparatively stable, while so many other foreign systems broke down, is a question that remains largely unsettled. One explanation may be that the regulatory system that emerged from a very specific history of prior crises had both prepared Canada well for such a crisis, and responded effectively as the crisis unfolded. But the very regulatory system that provided stability in recent years may also be at risk of becoming warped by its own success, with regulators so emboldened by the acclaim for their recent achievements that they overreach to ensure their track record remains unblemished in the future. The stunning collapse of a pair of western Canadian banks, a number of major Canadian trust companies and several insurance companies, as well as some other precarious near misses in the 1980s and 1990s, were a shock to the financial regulatory system, highlighting deficiencies that would be addressed with new regulations and, most notably, the creation of the Office of the Superintendent of Financial Institutions (OSFI. Canada’s centralized regulatory approach, through the OSFI and just four other major regulatory bodies, has proved both more elegant and effective than, for instance, the more complicated, more convoluted and more decentralized American financial-oversight system. But some regulated companies, insurers in particular, have long maintained that the concentration of power in Canada’s large banks has resulted in a one-size-fits-all regulatory approach that does not offer a relatively lighter burden for smaller institutions, potentially stifling growth. In other words, an over-emphasis on stability may be hampering market efficiency. Nor is there any economic evidence to shed light on whether those and other costs of regulating stability are

  2. A Point Source of a Different Color: Identifying a Gap in United States Regulatory Policy for “Green” CSO Treatment Using Constructed Wetlands

    Directory of Open Access Journals (Sweden)

    Zeno F. Levy

    2014-04-01

    Full Text Available Up to 850 billion gallons of untreated combined sewer overflow (CSO is discharged into waters of the United States each year. Recent changes in CSO management policy support green infrastructure (GI technologies as “front of the pipe” approaches to discharge mitigation by detention/reduction of urban stormwater runoff. Constructed wetlands for CSO treatment have been considered among suites of GI solutions. However, these wetlands differ fundamentally from other GI technologies in that they are “end of the pipe” treatment systems that discharge from a point source, and are therefore regulated in the U.S. under the National Pollution Discharge Elimination System (NPDES. We use a comparative regulatory analysis to examine the U.S. policy framework for CSO treatment wetlands. We find in all cases that permitting authorities have used best professional judgment to determine effluent limits and compliance monitoring requirements, referencing technology and water quality-based standards originally developed for traditional “grey” treatment systems. A qualitative comparison with Europe shows less stringent regulatory requirements, perhaps due to institutionalized design parameters. We recommend that permitting authorities develop technical guidance documents for evaluation of “green” CSO treatment systems that account for their unique operational concerns and benefits with respect to sustainable development.

  3. Pressures on the dental care system in the United States.

    Science.gov (United States)

    Wotman, S; Goldman, H

    1982-07-01

    A number of significant pressures are creating tensions in the dental profession and the dental care delivery system. These pressures may be categorized in five major areas: 1) regulation and deregulation pressures involve changes in the state dental practice acts, court decisions concerning antitrust and advertising, and the inclusion of consumers on State professional regulatory boards; 2) cost of services includes factors involving the out-of-pocket cost of dental care and the growth of dental insurance; 3) dentist-related factors include the increased number of dentists and the indebtedness of dental graduates; 4) the pressures of changes in the American populations include the decline in population growth and the increase in proportion of elderly people; 5) changes in the distribution of dental care are based on new epidemiologic data concerning dental caries and progress in the prevention of periodontal disease. Many of these pressures are inducing competition in the dental care system. It is clear that the dental care system is in the process of change as it responds to these complex pressures.

  4. United States Nuclear Regulatory Commission staff practice and procedure digest

    International Nuclear Information System (INIS)

    1991-02-01

    This Revision 9 of the fifth edition of the NRC Staff Practice and Procedure Digest contains a digest of a number of Commission, Atomic Safety and Licensing Appeal Board, and Atomic Safety and Licensing Board decisions issued during the period from July 1, 1972 to September 30, 1990 interpreting the NRC's Rules of Practice in 10 CFR Part 2. This Revision 9 replaces in part earlier editions and revisions and includes appropriate changes reflecting the amendments to the Rules of Practice effective through September 30, 1990. This edition of the Digest was prepared by attorneys from Aspen Systems Corporation pursuant to Contract number 18-89-346. Persons using this Digest are placed on notice that it may not be used as an authoritative citation in support of any position before the Commission or any of its adjudicatory tribunals. Persons using this Digest are also placed on notice that it is intended for use only as an initial research tool, that it may, and likely does, contain errors, including errors in analysis and interpretation of decisions, and that the user should not rely on the Digest analyses and interpretations but must read, analyze and rely on the user's own analysis of the actual Commission, Appeal Board and Licensing Board decisions cited. Further, neither the United States, the Nuclear Regulatory Commission, Aspen Systems Corporation, nor any of their employees makes any expressed or implied warranty or assumes liability or responsibility for the accuracy, completeness or usefulness of any material presented in the Digest. The Digest is roughly structured in accordance with the chronological sequence of the nuclear facility licensing process as set forth in Appendix A to 10 CFR Part 2. Those decisions which did not fit into that structure are dealt with in a section on general matters. Where appropriate, particular decisions are indexed under more than one heading. (JF)

  5. Legitimacy challenges of intermediary gatekeeping in the Chinese internet regulatory system

    NARCIS (Netherlands)

    Wei, Lulu

    2018-01-01

    Legitimacy Challenges of Intermediary Gatekeeping in the Chinese Internet Regulatory System In the Chinese legal and political framework, in order for the government to maintain control over information posted on social media platforms, commercial internet intermediaries are assigned the role of

  6. Regulatory facility guide for Ohio

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, S.S.; Bock, R.E.; Francis, M.W.; Gove, R.M.; Johnson, P.E.; Kovac, F.M.; Mynatt, J.O. [Oak Ridge National Lab., TN (United States); Rymer, A.C. [Transportation Consulting Services, Knoxville, TN (United States)

    1994-02-28

    The Regulatory Facility Guide (RFG) has been developed for the DOE and contractor facilities located in the state of Ohio. It provides detailed compilations of international, federal, and state transportation-related regulations applicable to shipments originating at destined to Ohio facilities. This RFG was developed as an additional resource tool for use both by traffic managers who must ensure that transportation operations are in full compliance with all applicable regulatory requirements and by oversight personnel who must verify compliance activities.

  7. The use of information systems to transform utilities and regulatory commissions: The application of geographic information systems

    Energy Technology Data Exchange (ETDEWEB)

    Wirick, D.W.; Montgomery, G.E.; Wagman, D.C.; Spiers, J.

    1995-09-01

    One technology that can assist utilities remain financially viable in competitive markets and help utilities and regulators to better serve the public is information technology. Because geography is an important part of an electric, natural gas, telecommunications, or water utility, computer-based Geographic Information Systems (GIS) and related Automated Mapping/Facilities Management systems are emerging as core technologies for managing an ever-expanding variety of formerly manual or paper-based tasks. This report focuses on GIS as an example of the types of information systems that can be used by utilities and regulatory commissions. Chapter 2 provides general information about information systems and effects of information on organizations; Chapter 3 explores the conversion of an organization to an information-based one; Chapters 4 and 5 set out GIS as an example of the use of information technologies to transform the operations of utilities and commissions; Chapter 6 describes the use of GIS and other information systems for organizational reengineering efforts; and Chapter 7 examines the regulatory treatment of information systems.

  8. Regulatory Considerations for the Long Term Cooling Safe Shutdown Requirements of the Passive Residual Heat Removal Systems in Advanced Reactors

    International Nuclear Information System (INIS)

    Sim, S. K.; Bae, S. H.; Kim, Y. S.; Hwang, Min Jeong; Bang, Young Seok; Hwang, Taesuk

    2016-01-01

    USNRC approved safe shutdown at 215.6 .deg. C for a safe and long term cooling state for the redundant passive RHRSs by SECY-94-084. USNRC issued COLA(Combined Construction and Operating License) for the Levy County NP Unit-1/2 for the AP1000 passive RHRSs in 2014. Korea Hydro and Nuclear Power(KHNP) is developing APR+ and adopted Passive Auxiliary Feedwater System(PAFS) as a new passive RHRS design. Korea Institute of Nuclear Safety(KINS) has been developing regulatory guides for the advanced safety design features of the advanced ALWRs which has plan to construct in near future in Korea[5]. Safety and regulatory issues as well as the safe shut down requirements of the passive RHRS are discussed and considerations in developing regulatory guides for the passive RHRS are presented herein. Passive RHRSs have been introduced as new safety design features for the advanced reactors under development in Korea. These passive RHRSs have potential advantages over existing active RHRS, however, their functions are limited due to inherent ability of passive heat removal processes. It is high time to evaluate the performance of the passive PRHRs and develop regulatory guides for the safety as well as the performance analyses of the passive RHRS

  9. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2012-01-01

    This section gathers the following national legislative and regulatory activities sorted by country: Bulgaria: General legislation; Czech Republic: General legislation; France: General legislation, Regulatory infrastructure and activity; Germany: General legislation; India: Liability and compensation, Organisation and structure; Ireland: Radiation protection, General legislation; Korea (Republic of): Organisation and structure; Lithuania: Regulatory infrastructure and activity, Radioactive waste management, Radiation protection, international cooperation, Nuclear safety; Poland: General legislation; Romania: Environmental protection; Russian Federation: Radioactive waste management; Slovenia: Nuclear safety; Spain: Liability and compensation, Nuclear security; Sweden: Nuclear safety; Turkey: Radiation protection, Regulatory infrastructure and activity, Nuclear safety, Liability and compensation; United States: General legislation

  10. A DegU-P and DegQ-Dependent Regulatory Pathway for the K-state in Bacillus subtilis

    Directory of Open Access Journals (Sweden)

    Mathieu Miras

    2016-11-01

    Full Text Available The K-state in the model bacterium Bacillus subtilis is associated with transformability (competence as well as with growth arrest and tolerance for antibiotics. Entry into the K-state is determined by the stochastic activation of the transcription factor ComK and occurs in about ~15% of the population in domesticated strains. Although the upstream mechanisms that regulate the K-state have been intensively studied and are well understood, it has remained unexplained why undomesticated isolates of B. subtilis are poorly transformable compared to their domesticated counterparts. We show here that this is because fewer cells enter the K-state, suggesting that a regulatory pathway limiting entry to the K-state is missing in domesticated strains. We find that loss of this limitation is largely due to an inactivating point mutation in the promoter of degQ. The resulting low level of DegQ decreases the concentration of phosphorylated DegU, which leads to the de-repression of the srfA operon and ultimately to the stabilization of ComK. As a result, more cells reach the threshold concentration of ComK needed to activate the auto-regulatory loop at the comK promoter. In addition, we demonstrate that the activation of srfA transcription in undomesticated strains is transient, turning off abruptly as cells enter the stationary phase. Thus, the K-state and transformability are more transient and less frequently expressed in the undomesticated strains. This limitation is more extreme than appreciated from studies of domesticated strains. Selection has apparently limited both the frequency and the duration of the bistably expressed K-state in wild strains, likely because of the high cost of growth arrest associated with the K-state. Future modeling of K-state regulation and of the fitness advantages and costs of the K-state must take these features into account.

  11. Regulatory T-Cell-Associated Cytokines in Systemic Lupus Erythematosus

    Directory of Open Access Journals (Sweden)

    Akiko Okamoto

    2011-01-01

    Full Text Available Systemic lupus erythematosus (SLE is an autoimmune disease characterized by autoantibody production, complement activation, and immune complex deposition, resulting in tissue and organ damage. An understanding of the mechanisms responsible for homeostatic control of inflammation, which involve both innate and adoptive immune responses, will enable the development of novel therapies for SLE. Regulatory T cells (Treg play critical roles in the induction of peripheral tolerance to self- and foreign antigens. Naturally occurring CD4+CD25+ Treg, which characteristically express the transcription factor forkhead box protein P3 (Foxp3, have been intensively studied because their deficiency abrogates self-tolerance and causes autoimmune disease. Moreover, regulatory cytokines such as interleukin-10 (IL-10 also play a central role in controlling inflammatory processes. This paper focuses on Tregs and Treg-associated cytokines which might regulate the pathogenesis of SLE and, hence, have clinical applications.

  12. Analysis of regulatory structure for a potential fusion reactor industry

    Energy Technology Data Exchange (ETDEWEB)

    1981-03-01

    The report is divided into eight sections. The preface describes the authors of the report, the methodology used in its preparation, and some basic legal terms. The summary describes the principal features of the proposed regulatory system and also includes two flow charts comparing our model with present NRC practices and a summary table briefly outlining the reasoning behind our recommendations. The main body of the report is divided into six sections. This part of the report discusses the existing federal and state programs for regulating electric energy, describes NRC operations and the criticisms of that agency, discusses the features of our proposed regulatory model, recommends certain steps for implementing the proposed model, and states the conclusions of the report.

  13. Analysis of regulatory structure for a potential fusion-reactor industry

    International Nuclear Information System (INIS)

    1981-03-01

    The report is divided into eight sections. The preface describes the authors of the report, the methodology used in its preparation, and some basic legal terms. The summary describes the principal features of the proposed regulatory system and also includes two flow charts comparing our model with present NRC practices and a summary table briefly outlining the reasoning behind our recommendations. The main body of the report is divided into six sections. This part of the report discusses the existing federal and state programs for regulating electric energy, describes NRC operations and the criticisms of that agency, discusses the features of our proposed regulatory model, recommends certain steps for implementing the proposed model, and states the conclusions of the report

  14. Regulatory Oversight of Safety Culture in Nuclear Installations

    International Nuclear Information System (INIS)

    2013-03-01

    Experience across the international nuclear industry and in other technical fields over the past few decades has demonstrated the importance of a healthy safety culture in maintaining the safety of workers, the public and the environment. Both regulators and the nuclear industry recognize the need for licensees to develop a strong safety culture in order to support successful and sustainable nuclear safety performance. Progress over recent years can be observed in the rapid development of approaches to overseeing licensees' safety culture. This publication follows on and complements earlier publications on safety culture, from the publication Safety Culture (Safety Series No. 75-INSAG-4 (1991)), published after the Chernobyl accident, to the more recently published Safety Requirements on The Management System for Facilities and Activities (IAEA Safety Standards Series No. GS-R-3 (2006)), which states that the management system is to be used to promote and support a strong safety culture. A number of attempts have been made at both the international and national levels to establish practical approaches to regulatory oversight of safety culture. During 2010 and 2011, two projects were conducted by the IAEA under the scope of the Safe Nuclear Energy - Regional Excellence Programme within the Norwegian Cooperation Programme with Bulgaria and Romania. These projects were implemented at the Bulgarian and Romanian regulatory bodies. They encompassed the development of a specific process to oversee licensees' safety culture, and involved 30 experts from 17 countries and 22 organizations. The IAEA continues to support Member States in the area of safety culture through its projects on safety management and capacity building. This publication addresses the basics of regulatory oversight of safety culture, describes the approaches currently implemented at several regulatory bodies around the world and, based on these examples, proposes a path to developing such a process

  15. Review of Technical Studies in the United States in Support of Burnup Credit Regulatory Guidance

    International Nuclear Information System (INIS)

    Wagner, John C.; Parks, Cecil V.; Mueller, Don; Gauld, Ian C.

    2010-01-01

    Taking credit for the reduction in reactivity associated with fuel depletion can enable more cost-effective, higher-density storage, transport, disposal, and reprocessing of spent nuclear fuel (SNF) while maintaining sufficient subcritical margin to establish an adequate safety basis. Consequently, there continues to be considerable interest in the United States (U.S.), as well as internationally, in the increased use of burnup credit in SNF operations, particularly related to storage, transport, and disposal of commercial SNF. This interest has motivated numerous technical studies related to the application of burnup credit, both domestically and internationally, as well as the design of SNF storage, transport and disposal systems that rely on burnup credit for maintaining subcriticality. Responding to industry requests and needs, the U.S. Nuclear Regulatory Commission (NRC) initiated a burnup credit research program in 1999, with support from the Oak Ridge National Laboratory (ORNL), to develop regulatory guidance and the supporting technical bases for allowing and expanding the use of burnup credit in pressurized-water reactor SNF storage and transport applications. Although this NRC research program has not been continuous since its inception, considerable progress has been achieved in many key areas in terms of increased understanding of relevant phenomena and issues, availability of relevant information and data, and subsequently updated regulatory guidance for expanded use of burnup credit. This paper reviews technical studies performed by ORNL for the U.S. NRC burnup credit research program. Examples of topics include reactivity effects associated with reactor operating characteristics, fuel assembly characteristics, burnable absorbers, control rods, spatial burnup distributions, cooling time, and assembly misloading; methods and data for validation of isotopic composition predictions; methods and data for validation of criticality calculations; and

  16. Comparing genomes to computer operating systems in terms of the topology and evolution of their regulatory control networks.

    Science.gov (United States)

    Yan, Koon-Kiu; Fang, Gang; Bhardwaj, Nitin; Alexander, Roger P; Gerstein, Mark

    2010-05-18

    The genome has often been called the operating system (OS) for a living organism. A computer OS is described by a regulatory control network termed the call graph, which is analogous to the transcriptional regulatory network in a cell. To apply our firsthand knowledge of the architecture of software systems to understand cellular design principles, we present a comparison between the transcriptional regulatory network of a well-studied bacterium (Escherichia coli) and the call graph of a canonical OS (Linux) in terms of topology and evolution. We show that both networks have a fundamentally hierarchical layout, but there is a key difference: The transcriptional regulatory network possesses a few global regulators at the top and many targets at the bottom; conversely, the call graph has many regulators controlling a small set of generic functions. This top-heavy organization leads to highly overlapping functional modules in the call graph, in contrast to the relatively independent modules in the regulatory network. We further develop a way to measure evolutionary rates comparably between the two networks and explain this difference in terms of network evolution. The process of biological evolution via random mutation and subsequent selection tightly constrains the evolution of regulatory network hubs. The call graph, however, exhibits rapid evolution of its highly connected generic components, made possible by designers' continual fine-tuning. These findings stem from the design principles of the two systems: robustness for biological systems and cost effectiveness (reuse) for software systems.

  17. Modular and coordinated expression of immune system regulatory and signaling components in the developing and adult nervous system.

    Science.gov (United States)

    Monzón-Sandoval, Jimena; Castillo-Morales, Atahualpa; Crampton, Sean; McKelvey, Laura; Nolan, Aoife; O'Keeffe, Gerard; Gutierrez, Humberto

    2015-01-01

    During development, the nervous system (NS) is assembled and sculpted through a concerted series of neurodevelopmental events orchestrated by a complex genetic programme. While neural-specific gene expression plays a critical part in this process, in recent years, a number of immune-related signaling and regulatory components have also been shown to play key physiological roles in the developing and adult NS. While the involvement of individual immune-related signaling components in neural functions may reflect their ubiquitous character, it may also reflect a much wider, as yet undescribed, genetic network of immune-related molecules acting as an intrinsic component of the neural-specific regulatory machinery that ultimately shapes the NS. In order to gain insights into the scale and wider functional organization of immune-related genetic networks in the NS, we examined the large scale pattern of expression of these genes in the brain. Our results show a highly significant correlated expression and transcriptional clustering among immune-related genes in the developing and adult brain, and this correlation was the highest in the brain when compared to muscle, liver, kidney and endothelial cells. We experimentally tested the regulatory clustering of immune system (IS) genes by using microarray expression profiling in cultures of dissociated neurons stimulated with the pro-inflammatory cytokine TNF-alpha, and found a highly significant enrichment of immune system-related genes among the resulting differentially expressed genes. Our findings strongly suggest a coherent recruitment of entire immune-related genetic regulatory modules by the neural-specific genetic programme that shapes the NS.

  18. A parallel attractor-finding algorithm based on Boolean satisfiability for genetic regulatory networks.

    Directory of Open Access Journals (Sweden)

    Wensheng Guo

    Full Text Available In biological systems, the dynamic analysis method has gained increasing attention in the past decade. The Boolean network is the most common model of a genetic regulatory network. The interactions of activation and inhibition in the genetic regulatory network are modeled as a set of functions of the Boolean network, while the state transitions in the Boolean network reflect the dynamic property of a genetic regulatory network. A difficult problem for state transition analysis is the finding of attractors. In this paper, we modeled the genetic regulatory network as a Boolean network and proposed a solving algorithm to tackle the attractor finding problem. In the proposed algorithm, we partitioned the Boolean network into several blocks consisting of the strongly connected components according to their gradients, and defined the connection between blocks as decision node. Based on the solutions calculated on the decision nodes and using a satisfiability solving algorithm, we identified the attractors in the state transition graph of each block. The proposed algorithm is benchmarked on a variety of genetic regulatory networks. Compared with existing algorithms, it achieved similar performance on small test cases, and outperformed it on larger and more complex ones, which happens to be the trend of the modern genetic regulatory network. Furthermore, while the existing satisfiability-based algorithms cannot be parallelized due to their inherent algorithm design, the proposed algorithm exhibits a good scalability on parallel computing architectures.

  19. Independent regulatory authorities - a comparative study of European energy regulators

    International Nuclear Information System (INIS)

    Sander Johansen, K.; Holm Pedersen, L.; Moll Soerensen, E.

    2004-04-01

    Independent regulatory authorities are widely recommended as part of the institutional design of liberalised energy markets - not least by the European Commission. This report describes and compares the regulatory authorities for energy in the EU. Arguments for regulatory independence are presented and discussed, and an index is developed to measure the degree of conformance to theories of regulatory independence. It is established that the main pattern of variation is that countries, which formerly had strong state-owned companies, have chosen to create regulatory authorities at state level with many institutional safeguards for independence. (au)

  20. Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options

    Energy Technology Data Exchange (ETDEWEB)

    Carter, Sarah R. [J. Craig Venter Inst., Rockville, MD (United States); Rodemeyer, Michael [Univ. of Virginia, Charlottesville, VA (United States); Garfinkel, Michele S. [EMBO, Heidelberg (Germany); Friedman, Robert M. [J. Craig Venter Inst., Rockville, MD (United States)

    2014-05-01

    Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options Sarah R. Carter, Ph.D., J. Craig Venter Institute; Michael Rodemeyer, J.D., University of Virginia; Michele S. Garfinkel, Ph.D., EMBO; Robert M. Friedman, Ph.D., J. Craig Venter Institute In recent years, a range of genetic engineering techniques referred to as “synthetic biology” has significantly expanded the tool kit available to scientists and engineers, providing them with far greater capabilities to engineer organisms than previous techniques allowed. The field of synthetic biology includes the relatively new ability to synthesize long pieces of DNA from chemicals, as well as improved methods for genetic manipulation and design of genetic pathways to achieve more precise control of biological systems. These advances will help usher in a new generation of genetically engineered microbes, plants, and animals. The JCVI Policy Center team, along with researchers at the University of Virginia and EMBO, examined how well the current U.S. regulatory system for genetically engineered products will handle the near-term introduction of organisms engineered using synthetic biology. In particular, the focus was on those organisms intended to be used or grown directly in the environment, outside of a contained facility. The study concludes that the U.S. regulatory agencies have adequate legal authority to address most, but not all, potential environmental, health and safety concerns posed by these organisms. Such near-term products are likely to represent incremental changes rather than a marked departure from previous genetically engineered organisms. However, the study also identified two key challenges for the regulatory system, which are detailed in the report. First, USDA’s authority over genetically engineered plants depends on the use of an older engineering technique that is no longer necessary for many applications. The shift to synthetic biology and other newer genetic

  1. End of FY10 report - used fuel disposition technical bases and lessons learned : legal and regulatory framework for high-level waste disposition in the United States.

    Energy Technology Data Exchange (ETDEWEB)

    Weiner, Ruth F.; Blink, James A. (Lawrence Livermore National Laboratory, Livermore, CA); Rechard, Robert Paul; Perry, Frank (Los Alamos National Laboratory, Los Alamos, NM); Jenkins-Smith, Hank C. (University of Oklahoma, Norman, OK); Carter, Joe (Savannah River Nuclear Solutions, Aiken, SC); Nutt, Mark (Argonne National Laboratory, Argonne, IL); Cotton, Tom (Complex Systems Group, Washington DC)

    2010-09-01

    This report examines the current policy, legal, and regulatory framework pertaining to used nuclear fuel and high level waste management in the United States. The goal is to identify potential changes that if made could add flexibility and possibly improve the chances of successfully implementing technical aspects of a nuclear waste policy. Experience suggests that the regulatory framework should be established prior to initiating future repository development. Concerning specifics of the regulatory framework, reasonable expectation as the standard of proof was successfully implemented and could be retained in the future; yet, the current classification system for radioactive waste, including hazardous constituents, warrants reexamination. Whether or not consideration of multiple sites are considered simultaneously in the future, inclusion of mechanisms such as deliberate use of performance assessment to manage site characterization would be wise. Because of experience gained here and abroad, diversity of geologic media is not particularly necessary as a criterion in site selection guidelines for multiple sites. Stepwise development of the repository program that includes flexibility also warrants serious consideration. Furthermore, integration of the waste management system from storage, transportation, and disposition, should be examined and would be facilitated by integration of the legal and regulatory framework. Finally, in order to enhance acceptability of future repository development, the national policy should be cognizant of those policy and technical attributes that enhance initial acceptance, and those policy and technical attributes that maintain and broaden credibility.

  2. Cooperation of technical support organizations of state nuclear regulatory committee of Ukraine in sip safety regulation

    International Nuclear Information System (INIS)

    Bikov, V.O.; Kyilochits'ka, T.P.; Bogorins'kij, P.; Vasil'chenko, V.M.; Kondrat'jev, S.M.; Smishlyajeva, S.P.; Troter, D.

    2002-01-01

    The main task of the technical support in the Shelter Implementation Plan (SIP) licensing process consists in Technical Evaluation of SIP projects and documents submitted by the Licensee to State Nuclear Regulatory Committee to substantiate the safety of Shelter-related work. The goal of this task is to evaluate the submitted materials whether they meet the requirements of nuclear and radiation safety

  3. Safety culture as a matter of regulatory control and regulatory effectiveness

    International Nuclear Information System (INIS)

    Camargo, C.T.M.; Furieri, E.B.; Arrieta, L.A.I.; Almeida, C.U.C.

    2002-01-01

    More than 15 years have passed since the term 'safety culture' was introduced by the International Nuclear Safety Advisory Group (INSAG), and although the concept now is widely accepted, practical applications and characteristics have been disseminated mainly for nuclear power plant operating organizations. There is still a lack of international guidance on the use of safety culture as a regulatory matter and on the application of the concept within regulatory organizations. This work explores the meaning of safety culture in two different fields: as an element of safety management systems it shall be a matter of regulatory control; as a complementary tool for quality management it should be used to enhance regulatory effectiveness. Brazilian recent experience on regulating nuclear power reactors provide some examples on how the concept of safety culture may influence regulatory strategies and regulatory management. (author)

  4. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (Spanish Edition)

    International Nuclear Information System (INIS)

    2010-01-01

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered

  5. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (French Edition)

    International Nuclear Information System (INIS)

    2010-01-01

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered

  6. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (Chinese Edition)

    International Nuclear Information System (INIS)

    2010-01-01

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered

  7. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (Arabic Edition)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-09-15

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

  8. Nuclear Regulatory Legislation

    International Nuclear Information System (INIS)

    1989-08-01

    This compilation of statutes and material pertaining to nuclear regulatory legislation through the 100th Congress, 2nd Session, has been prepared by the Office of the General Counsel, US Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document. Persons using this document are placed on notice that it may not be used as an authoritative citation in lieu of the primary legislative sources. Furthermore, while every effort has been made to ensure the completeness and accuracy of this material, neither the United States Government, the Nuclear Regulatory Commission, nor any of their employees makes any expressed or implied warranty or assumes liability for the accuracy or completeness of the material presented in this compilation

  9. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - United States

    International Nuclear Information System (INIS)

    2015-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Special nuclear material; Source material; By-product material; Agreement state programmes); 4. Nuclear installations (Initial licensing; Operation and inspection, including nuclear safety; Operating licence renewal; Decommissioning; Emergency response); 5. Radiological protection (Protection of workers; Protection of the public); 6. Radioactive waste management (High-level waste; Low-level waste; Disposal at sea; Uranium mill tailings; Formerly Utilized Sites Remedial Action Program - FUSRAP); 7. Non-proliferation and exports (Exports of source material, special nuclear material, production or utilisation facilities and sensitive nuclear technology; Exports of components; Exports of by-product material; Exports and imports of radiation sources; Conduct resulting in the termination of exports or economic assistance; Subsequent arrangements; Technology exports; Information and restricted data); 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Nuclear Regulatory Commission - NRC; Department of Energy - DOE; Department of Labor - DOL; Department of Transportation - DOT; Environmental Protection Agency - EPA); 2. Public and semi-public agencies: A. Cabinet-level departments (Department of

  10. Inspection and enforcement by the regulatory body for nuclear power plants

    International Nuclear Information System (INIS)

    1980-01-01

    This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the Code of Practice on Governmental Organization for the Regulation of Nuclear Power Plants, IAEA Safety Series No.50-C-G and should be used in conjunction with that document. The purpose of this Guide is to provide information, guidance and recommendations to assist Member States in (1) establishing and conducting a regulatory inspection programme for nuclear power plants, (2) establishing requirements for the applicant/licensee in regard to regulatory inspection, (3) establishing a system for enforcing compliance with the requirements and decisions of the regulatory body

  11. Substate federalism and fracking policies: does state regulatory authority trump local land use autonomy?

    Science.gov (United States)

    Davis, Charles

    2014-01-01

    State officials responsible for the regulation of hydraulic fracturing (fracking) operations used in the production of oil and gas resources will inevitably confront a key policy issue; that is, to what extent can statewide regulations be developed without reducing land use autonomy typically exercised by local officials? Most state regulators have historically recognized the economic importance of industry jobs and favor the adoption of uniform regulatory requirements even if these rules preempt local policymaking authority. Conversely, many local officials seek to preserve land use autonomy to provide a greater measure of protection for public health and environmental quality goals. This paper examines how public officials in three states-Colorado, Pennsylvania, and Texas-address the question of state control versus local autonomy through their efforts to shape fracking policy decisions. While local officials within Texas have succeeded in developing fracking ordinances with relatively little interference from state regulators, Colorado and Pennsylvania have adopted a tougher policy stance favoring the retention of preemptive oil and gas statutes. Key factors that account for between state differences in fracking policy decisions include the strength of home rule provisions, gubernatorial involvement, and the degree of local experience with industrial economic activities.

  12. Redesigning the regulatory framework for ambulatory care services in New York.

    Science.gov (United States)

    Chokshi, Dave A; Rugge, John; Shah, Nirav R

    2014-12-01

    Policy Points: The landscape of ambulatory care services in the United States is rapidly changing on account of payment reform, primary care transformation, and the rise of convenient care options such as retail clinics. New York State has undertaken a redesign of regulatory policy for ambulatory care rooted in the Triple Aim (better health, higher-quality care, lower costs)-with a particular emphasis on continuity of care for patients. Key tenets of the regulatory approach include defining and tracking the taxonomy of ambulatory care services as well as ensuring that convenient care options do not erode continuity of care for patients. While hospitals remain important centers of gravity in the health system, services are increasingly being delivered through ambulatory care. This shift to ambulatory care is giving rise to new delivery structures, such as retail clinics and urgent care centers, as well as reinventing existing ambulatory care capacity, as seen with the patient-centered medical home model and the movement toward team-based care. To protect the public's interests, oversight of ambulatory care services must keep pace with these rapid changes. With this purpose, in January 2013 the New York Public Health and Health Planning Council undertook a redesign of the regulatory framework for the state's ambulatory care services. This article describes the principles undergirding the framework as well as the regulatory recommendations themselves. We explored and analyzed the regulation of ambulatory care services in New York in accordance with the available gray and peer-reviewed literature and legislative documents. The deliberations of the Public Health and Health Planning Council informed our review. The vision of high-performing ambulatory care should be rooted in the Triple Aim (better health, higher-quality care, lower costs), with a particular emphasis on continuity of care for patients. There is a pressing need to better define the taxonomy of ambulatory

  13. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2016-01-01

    This section treats of the following National legislative and regulatory activities: 1 - France: General legislation, regulations and instruments; Nuclear trade (including non-proliferation); International co-operation; 2 - India: Licensing and regulatory infrastructure; Liability and compensation; 3 - Ireland: Nuclear safety and radiological protection (including nuclear emergency planning); Transport of radioactive material; Nuclear trade (including non-proliferation); 4 - Lithuania: Licensing and regulatory infrastructure; Nuclear safety and radiological protection (including nuclear emergency planning); Radioactive waste management; 5 - Luxembourg: Nuclear safety and radiological protection (including nuclear emergency planning); 6 - Slovak Republic: International co-operation; General legislation, regulations and instruments; 7 - Spain: Radioactive materials (including physical protection); Radioactive waste management; 8 - United States: Licensing and regulatory infrastructure

  14. Regulatory and Non-regulatory Responses to Hydraulic Fracturing in Local Communities

    Science.gov (United States)

    Phartiyal, P.

    2015-12-01

    The practice of extracting oil and gas from tight rock formations using advances in technology, such as hydraulic fracturing and directional drilling, has expanded exponentially in states and localities across the country. As the scientific data collection and analysis catches up on the many potential impacts of this unconventional oil and gas development, communities are turning to their local officials to make decisions on whether and how fracking should proceed. While most regulatory authority on the issue rests with the state agencies, local officials have experimented with a wide range of regulatory, non-regulatory, and fiscal tools to manage the impacts of fracking. These impacts can occur on the local air, water, seismicity, soil, roads, schools, and affect residents, on-site workers, emergency and social services. Local officials' approaches are often influenced by their prior experience with minerals extraction in their localities. The speaker will present examples of the kinds of information sources, tools and approaches communities across the country are using, from noise barriers to setback requirements to information sharing in order to be able to balance the promise and perils of oil and gas development in their jurisdictions.

  15. What is a comprehensive system of regulatory governance?; Que es un sistema Integral de Gestion Reglamentaria?

    Energy Technology Data Exchange (ETDEWEB)

    Real diaz, F. J.

    2011-07-01

    The progressive evolution and diversification of regulations concerning industrial safety has made their management increasingly complex, requiring more resources of organizations. Therefore, it is advisable that this management be made more efficient through systematization, specialization and the use of computing technologies. This is supported by the implementation of integrated regulatory management systems. This article explain the concept of integrated regulatory management systems, their structure and their advantages. It also includes a model for implementing them in an organization. (Author)

  16. Incident and Trafficking Database: New Systems for Reporting and Accessing State Information

    International Nuclear Information System (INIS)

    Dimitrovski, D.; Kittley, S.

    2015-01-01

    The IAEA's Incident and Trafficking Database (ITDB) is the Agency's authoritative source for information on incidents in which nuclear and other radioactive material is out of national regulatory control. It was established in 1995 and, as of June 2014, 126 States participate in the ITDB programme. Currently, the database contains over 2500 confirmed incidents, out of which 21% involve nuclear material, 62% radioactive source and 17% radioactively contaminated material. In recent years, the system for States to report incidents to the ITDB has been evolving — moving from fax-based to secure email and most recently to secure on-line reporting. A Beta version of the on-line system was rolled out this June, offering a simple, yet secure, communication channel for member states to provide information. In addition the system serves as a central hub for information related to official communication of the IAEA with Member States so some communication that is traditionally shared by e-mail does not get lost when ITDB counterparts change. In addition the new reporting system incorporates optional features that allow multiple Member State users to collaboratively contribute toward an INF. States are also being given secure on-line access to a streamlined version of the ITDB. This improves States' capabilities to retrieve and analyze information for their own purposes. In addition, on-line access to ITDB statistical information on incidents is available to States through an ITDB Dashboard. The dashboard contains aggregate information on number and types of incidents, material involved, as well some other statistics related to the ITDB that is typically provided in the ITDB Quarterly reports. (author)

  17. Experience and regulatory activities on advanced instrumentation and control systems applied to nuclear power plants in Korea

    International Nuclear Information System (INIS)

    Kim, B.R.

    1995-01-01

    This paper describes the status for applying microprocessor-based systems to nuclear power plants in Korea and the regulatory activities performed by Korea Institute of Nuclear Safety (KINS). And this presents the development of safety and regulatory technology for advanced I and C systems that has been carried out as a part of the next generation reactor development program in Korea. (author). 3 refs, 4 figs, 1 tab

  18. Environment, safety, and health regulatory implementation plan

    International Nuclear Information System (INIS)

    1993-01-01

    To identify, document, and maintain the Uranium Mill Tailings Remedial Action (UMTRA) Project's environment, safety, and health (ES ampersand H) regulatory requirements, the US Department of Energy (DOE) UMTRA Project Office tasked the Technical Assistance Contractor (TAC) to develop a regulatory operating envelope for the UMTRA Project. The system selected for managing the UMTRA regulatory operating envelope data bass is based on the Integrated Project Control/Regulatory Compliance System (IPC/RCS) developed by WASTREN, Inc. (WASTREN, 1993). The IPC/RCS is a tool used for identifying regulatory and institutional requirements and indexing them to hardware, personnel, and program systems on a project. The IPC/RCS will be customized for the UMTRA Project surface remedial action and groundwater restoration programs. The purpose of this plan is to establish the process for implementing and maintaining the UMTRA Project's regulatory operating envelope, which involves identifying all applicable regulatory and institutional requirements and determining compliance status. The plan describes how the Project will identify ES ampersand H regulatory requirements, analyze applicability to the UMTRA Project, and evaluate UMTRA Project compliance status

  19. Regulatory perspective on digital instrumentation and control systems for future advanced nuclear power plants

    International Nuclear Information System (INIS)

    Chiramal, M.

    1993-01-01

    This paper deals with the question of using digital technology in instrumentation and control systems for modern nuclear power reactors. The general opinion in the industry and among NRC staff is that such technology provides the opportunity for enhanced safety and reliable reactor operations. The major concern is the safe application of this technology so as to avoid common mode or common cause failures in systems. There are great differences between digital and analog system components. SECY-91-292 identifies some general regulatory concerns with regard to digital systems. There is clearly a lack of adequate regulatory direction on the application of digital equipment at this time, but the issue is being addressed by the industry, outside experts, and NRC staff. NRC staff presents a position on the issue of defense-in-depth and diversity with regard to insuring plant safety. Independent manual controls and readouts must be available to allow safe shutdown and monitoring of the plant in the event of safety system failures

  20. Development of a Carbon Management Geographic Information System (GIS) for the United States

    Energy Technology Data Exchange (ETDEWEB)

    Howard Herzog; Holly Javedan

    2009-12-31

    In this project a Carbon Management Geographical Information System (GIS) for the US was developed. The GIS stored, integrated, and manipulated information relating to the components of carbon management systems. Additionally, the GIS was used to interpret and analyze the effect of developing these systems. This report documents the key deliverables from the project: (1) Carbon Management Geographical Information System (GIS) Documentation; (2) Stationary CO{sub 2} Source Database; (3) Regulatory Data for CCS in United States; (4) CO{sub 2} Capture Cost Estimation; (5) CO{sub 2} Storage Capacity Tools; (6) CO{sub 2} Injection Cost Modeling; (7) CO{sub 2} Pipeline Transport Cost Estimation; (8) CO{sub 2} Source-Sink Matching Algorithm; and (9) CO{sub 2} Pipeline Transport and Cost Model.

  1. Distributed Solar PV for Electricity System Resiliency: Policy and Regulatory Considerations (Brochure)

    Energy Technology Data Exchange (ETDEWEB)

    2014-11-01

    Distributed Solar PV systems have the potential of increasing the grid's resiliency to unforeseen events, such as extreme weather events and attacks. This paper presents the role that distributed PV can play in electric grid resiliency, introduces basic system design requirements and options, and discusses the regulatory and policy options for supporting the use of distributed PV for the purpose of increased electricity resiliency.

  2. Regulatory aspects of NPP safety

    International Nuclear Information System (INIS)

    Stuller, J.; Brandejs, P.; Miasnikov, A.; Svab, M.

    1999-01-01

    In beginning, a history of legislative process regulating industrial utilisation of nuclear energy is given, including detailed list of decrees issued by the first regulatory body supervising Czech nuclear installations - Czechoslovak Atomic Energy Commission (CSKAE). Current status of nuclear regulations and radiation protection, especially in connection with Atomic Act (Act No 18/1997 Coll.), is described. The Atomic Act transfers into the Czech legal system a number of obligations following from the Vienna Convention on Civil Liability for Nuclear Damage and Joint Protocol relating to the Application of the Vienna and Paris Convention, to which the Czech Republic had acceded. Actual duties and competence of current nuclear regulatory body - State Office for Nuclear Safety (SUJB) - are given in detail. Execution of the State supervision of peaceful utilisation of nuclear energy and ionising radiation is laid out in several articles of the Act, which comprises: control activities of the SUJB, remedial measures, penalties. Material and human resources are sufficient for fulfilment of the basic functions for which SUJB is authorised by the law. For 1998, the SUJB allotted staff of 149, approximately 2/3 of that number are nuclear safety and radiation protection inspectors. The SUJB budget for 1998 is approximately 180 million Czech crowns (roughly 6 million US dollars). Inspection activity of SUJB is carried out in three different ways: routine inspections, planned specialised inspections, inspections as a response to a certain situation (ad-hoc inspections). Approach to the licensing of major plant upgrades and backfittings are mainly illustrated on the Temelin NPP licensing. Regulatory position and practices concerning review activities are presented. (author)

  3. The regulatory regime for gas: a system in danger of coming off the rails

    International Nuclear Information System (INIS)

    Nangle, B.

    2000-01-01

    The Australian Gas Association (AGA) and its members are getting restless as it becomes more apparent the promised benefits of deregulation are imposing more costs and controls on an industry that owns and operates infrastructure valued at $15bn in heavily regulated markets. AGA Chief Executive Bill Nable used the Northern Territory Electricity and Gas Review in Darwin to examine the state of the gas regulatory regime. The pure reform model envisaged: 1. Multiple producers dealing often directly with large customers and retailers; 2. Open and transparent third party access to transmission (high pressure pipelines) and distribution (local low pressure pipeline networks) systems; and 3. A greater number of energy retailers competing for customers who are free to choose who they purchase their gas from. Energy sector reforms were generally pursued in a coordinated fashion through Commonwealth and State leaders forum - COAG. For gas, as with electricity, this meant separating out (unbundling) previously integrated gas utilities to engender competition and to lower prices - initially for major export and import competing sectors and eventually residential and small business customers. Although the reforms are laudable and have industry support, senior gas industry executives spoke about their concerns and caution about the negative impact the 'Third Party Access Code for Natural Gas and Pipeline Systems' may have for the gas supply industry

  4. The regulatory framework of accounting and accounting standard-setting bodies in the European Union member states

    Directory of Open Access Journals (Sweden)

    Ivana Mamić-Sačer

    2015-12-01

    Full Text Available One of the principal features of accounting in the 21st century is harmonisation and stanardisation. Regulation of the European Parliament and European Council No. 1606/2002 harmonizes financial reporting for certain companies in the EU. However, national accounting principles are of great importance for financial reporting. The main purpose of this research was to investigate the application of generally accepted accounting principles, the regulatory accounting framework and the standard-setting bodies of EU member states. The analysis of these accounting issues was conducted with respect to all 28 EU member states. The results indicate that EU member states regulate their principal accounting issues through separate accounting acts or implement those issues in companies acts. Some EU member states do not have national accounting standards, the national accounting principles being incorporated in companies acts and accounting acts. Nevertheless, national accounting standard-setting bodies are governmental organisations in almost half the member states.

  5. 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

  6. 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...

  7. Cooperation of Ukrainian regulatory authorities in the SIP

    Energy Technology Data Exchange (ETDEWEB)

    Kutina, L.; Bachner, D.; Bykov, V.; Erickson, L.; Kondralyev, S.; Redko, V.; Simonov, I.; Vasilchenko, V. [SSTC NRS, Stusa St. 35-37, 03142, Kyiv (Ukraine)

    2003-07-01

    The State Nuclear Regulatory Committee of Ukraine (SNRCU) supported by the State Scientific and Technical Center (SSTC) and the Licensing consultant (LC - RISKAUDIT/SCIENTECH) coordinates the activities of other regulatory authorities (RA) within the Shelter Implementation Plan (SIP) licensing. A protocol on cooperation and differentiation of competence in the SIP has been agreed between SNRCU and other RA (Ecology, Health, Construction, Occupational safety, Fire). The RA intended to carry out their activities such that SIP be implemented in the most efficient way by: - providing the Chernobyl NPP with a possibility to choose optimal variants for Shelter transformation; - minimizing required regulatory steps for SIP; - reviewing SIP documents at the initial stages of development of SIP designs; - providing consultative support by technical support organizations (TSO) on the SIP designs; - relating regulatory decisions on safety issues to the competence of the inspection at the Chernobyl NPP site. Coordination of regulatory activity and cooperation in safety areas are presented.

  8. Federal and state regulatory requirements for the D ampersand D of the Alpha-4 Building, Y-12 Plant, Oak Ridge, Tennessee

    International Nuclear Information System (INIS)

    Etnier, E.L.; Houlberg, L.M.; Bock, R.E.

    1994-01-01

    The US Department of Energy (DOE) has begun the decontamination and decommissioning (D ampersand D) of Building 9201-4 (Alpha-4) at the Oak Y-12 Plant, Oak Ridge, Tennessee, The Alpha-4 Building was used from 1953--1962 to house a column exchange (Colex) process for lithium isotope separation. This process involved electrochemical and solvent extraction processes that required substantial quantities of mercury. Presently there is no law or regulation mandating decommissioning at DOE facilites or setting de minimis or ''below regulatory concern'' (BRC) radioactivity levels to guide decommissioning activities at DOE facilities. However, DOE Order 5820.2A, Chap. V (Decommissioning of Radioactively Contaminated Facilities), requires that the regulatory status of each project be identified and that technical engineering planning must assure D ampersand D compliance with all environmental regulations during cleanup activities. To assist in the performance of this requirement, this paper gives a brief overview of potential federal and state regulatory requirements related to D ampersand D activities at Alpha-4. Compliance with other federal, state, and local regulations not addressed here may be required, depending on site characterization, actual D ampersand D activities, and wastes generated

  9. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, le...... they arise. In short, I expose the regulatory anatomy of the policy landscape....

  10. Suggested state requirements and criteria for a low-level radioactive waste disposal site regulatory program

    International Nuclear Information System (INIS)

    Ratliff, R.A.; Dornsife, B.; Autry, V.; Gronemyer, L.; Vaden, J.; Cashman, T.

    1985-08-01

    Description of criteria and procedure is presented for a state to follow in the development of a program to regulate a LLW disposal site. This would include identifying those portions of the NRC regulations that should be matters of compatibility, identifying the various expertise and disciplines that will be necessary to effectively regulate a disposal site, identifying the resources necessary for conducting a confirmatory monitoring program, and providing suggestions in other areas which, based on experiences, would result in a more effective regulatory program

  11. A regulatory perspective on design and performance requirements for engineered systems in high-level waste

    International Nuclear Information System (INIS)

    Bernero, R.M.

    1992-01-01

    For engineered systems, this paper gives an overview of some of the current activities at the U.S. Nuclear Regulatory Commission (NRC), with the intent of elucidating how the regulatory process works in the management of high-level waste (HLW). Throughout the waste management cycle, starting with packaging and transportation, and continuing to final closure of a repository, these activities are directed at taking advantage of the prelicensing consultation period, a period in which the NRC, DOE and others can interact in ways that will reduce regulatory, technical and institutional uncertainties, and open the path to development and construction of a deep geologic repository for permanent disposal of HLW. Needed interactions in the HLW program are highlighted. Examples of HLW regulatory activities are given in discussions of a multipurpose-cask concept and of current NRC work on the meaning of the term substantially complete containment

  12. Regulatory aspects for nuclear and radiation applications

    International Nuclear Information System (INIS)

    Duraisamy, S.

    2014-01-01

    The Atomic Energy Regulatory Board (AERB) is the national authority for ensuring that the use of ionizing radiation and nuclear energy does not cause any undue risk to the health of workers, members of the public and to the environment. AERB was constituted on November 15, 1983 and derives its regulatory power from the rules and notifications promulgated under the Atomic Energy Act, 1962 and the Environment (Protection) Act, 1986. AERB is provided with the necessary powers and mandate to frame safety policies, lay down safety standards and requirements for monitoring and enforcing the safety provisions. AERB follows multi-tier system for its review and assessment, safety monitoring, surveillance and enforcement. While regulating various nuclear and radiation facilities, AERB adopts a graded approach taking into account the hazard potential associated with the facilities being regulated. The regulatory process has been continuous evolving to cater to the new developments in reactor and radiation technologies. The regulatory effectiveness and efficiency of AERB have grown over the last three decades to make it into a robust organization. The radiation protection infrastructure in the country is on a sound footing and is constantly being strengthened based on experience and continued research and development. As one of its mandates AERB prescribes radiation dose limits for the occupational workers and the public, in line with the IAEA Safety Standard and ICRP recommendations. The current dose limits and the radiation safety requirements are more stringent than past. To meet the current safety standards, it is important for the facilities to have state of art radiation monitoring system and programme in place. While recognizing the current system in place, this presentation also highlights certain key radiation protection challenges associated with the implementation of radiation protection standards in the nuclear and radiation facilities especially in the areas of

  13. Proceedings of the specialists' meeting on regulatory inspection practices in nuclear power plants

    International Nuclear Information System (INIS)

    1977-01-01

    The sessions and contributions of this conference are dealing with: the general problems of regulatory inspection of nuclear power plants and overall national practices (in Canada, France, Germany, Italy, Spain, the United States), specific problems and practical experience of regulatory inspection during site study, evaluation, design, manufacturing and construction of nuclear plants (in Finland, Germany, Spain, Sweden, Great-Britain, United States), quality insurance issues, pressure component regulations, specific problems and practical experience of regulatory inspection during commissioning (in Spain, Sweden, Great-Britain and United States), specific problems and practical experience of regulatory inspection during operation (in Spain, Great-Britain, Unites States, Italy and Sweden), special aspects of regulatory inspection (notably public information issues in Sweden and in Great-Britain, inspection of nuclear fuel transportation in Spain, enforcement programme in the USA)

  14. Changes to Regulatory Systems for more Efficient Nuclear Energy Deployment: An Industry Viewpoint

    International Nuclear Information System (INIS)

    Pelin, H.

    2016-01-01

    Nuclear energy is required to play a much larger role in the energy mix in most credible energy scenarios that address climate change (680 GW additional capacity by 2050 according to IEA, 1000 GW according to World Nuclear Association). To reach these ambitious targets, a concerted effort will be required involving industry, governments and regulators. Changes to regulatory systems and processes – including licensing (design, site, operation), export control, security and waste - is one important area that can stimulate faster and more cost effective development of nuclear capacity. In the past, regulators were mainly concerned with authorizing a limited number of reactors from a limited number of designs under a national standard. Today regulators need resources to assess a wider range of designs, while each licensee needs to complete a thorough safety assessment even if the design has been assessed and approved elsewhere. These developments are the inevitable consequence of globalization and competition within the industry. This paper examines the current state of nuclear regulation in relation to the main attributes of good regulation as defined by the OECD. It further looks at ongoing efforts among regulators to share experience or harmonize requirements, such as within MDEP, or to agree common safety levels, such as in WENRA, in order to reach common positions and improve their regulatory approaches. Finally, it will assess the work of industry to demonstrate the benefits – both in terms of efficiency as well as safety – of harmonised regulations notably through the activities of the World Nuclear Association/CORDEL Working Group. (author)

  15. Integrated Regulatory Review Service (IRRS) Guidelines for the Preparation and Conduct of IRRS Missions

    International Nuclear Information System (INIS)

    2013-01-01

    The IAEA Integrated Regulatory Review Service (IRRS) was established to strengthen and enhance the effectiveness of national regulatory infrastructure for nuclear safety, radiation safety, radioactive waste and transport safety, and the security of radioactive sources, while recognizing the ultimate responsibility of each Member State to ensure safety in these areas. The IRRS process sets out to accomplish this expressed purpose through consideration of both technical and policy issues of a regulatory nature against IAEA safety standards and, where appropriate, good practice elsewhere. The regulatory review process directly draws upon the wide-ranging international experience and expertise of IRRS review team members. Peer exchange on technical and policy issues gives insight into the efficiency and effectiveness of the legal and governmental framework and regulatory infrastructure for safety. Through this process, opportunities for improvement are explored and potential improvement strategies identified which may be shared with other States. IRRS missions provide an opportunity for sharing regulatory experiences, harmonizing regulatory approaches among States, and creating mutual learning opportunities among regulators. IRRS discussions focus on issues arising from the State's self-assessment and the evaluation of technical areas and policy issues. The IAEA Fundamental Safety Principles (IAEA Safety Standards Series No. SF-1) provide the basis for IAEA safety standards and IAEA safety related programmes. In support of effective regulation, the IAEA has established safety standards in the area of the Governmental, Legal and Regulatory Framework for Safety (IAEA Safety Standards Series No. GSR Part 1). These safety standards form a core component of an IRRS review. Other requirements and guidance, such as The Management System for Facilities and Activities (IAEA Safety Standards Series No. GS-R-3) and Radiation Protection and Safety of Radiation Sources

  16. Legal and regulatory issues affecting compressed air energy storage

    Energy Technology Data Exchange (ETDEWEB)

    Hendrickson, P.L.

    1981-07-01

    Several regulatory and legal issues that can potentially affect implementation of a compressed air energy storage (CAES) system are discussed. This technology involves the compression of air using base load electric power for storage in an underground storage medium. The air is subsequently released and allowed to pass through a turbine to generate electricity during periods of peak demand. The storage media considered most feasible are a mined hard rock cavern, a solution-mined cavern in a salt deposit, and a porous geologic formation (normally an aquifer) of suitable structure. The issues are discussed in four categories: regulatory issues common to most CAES facilities regardless of storage medium, regulatory issues applicable to particular CAES reservoir media, issues related to possible liability from CAES operations, and issues related to acquisition of appropriate property rights for CAES implementation. The focus is on selected federal regulation. Lesser attention is given to state and local regulation. (WHK)

  17. Regulatory Oversight of Safety Culture in Finland: A Systemic Approach to Safety

    International Nuclear Information System (INIS)

    Oedewald, P.; Väisäsvaara, J.

    2016-01-01

    In Finland the Radiation and Nuclear Safety Authority STUK specifies detailed regulatory requirements for good safety culture. Both the requirements and the practical safety culture oversight activities reflect a systemic approach to safety: the interconnections between the technical, human and organizational factors receive special attention. The conference paper aims to show how the oversight of safety culture can be integrated into everyday oversight activities. The paper also emphasises that the scope of the safety culture oversight is not specific safety culture activities of the licencees, but rather the overall functioning of the licence holder or the new build project organization from safety point of view. The regulatory approach towards human and organizational factors and safety culture has evolved throughout the years of nuclear energy production in Finland. Especially the recent new build projects have highlighted the need to systematically pay attention to the non-technical aspects of safety as it has become obvious how the HOF issues can affect the design processes and quality of construction work. Current regulatory guides include a set of safety culture related requirements. The requirements are binding to the licence holders and they set both generic and specific demands on the licencee to understand, monitor and to develop safety culture of their own organization but also that of their supplier network. The requirements set for the licence holders has facilitated the need to develop the regulator’s safety culture oversight practices towards a proactive and systemic approach.

  18. United States Nuclear Regulatory Commission information digest: 1997 edition. Volume 9

    International Nuclear Information System (INIS)

    1997-05-01

    The Nuclear Regulatory Commission Information Digest (digest) provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, NRC licensed activities, and general information on domestic and world-wide nuclear energy. The digest, published annually, is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and the industry it regulates. In general, the data cover 1975 through 1996, with exceptions noted. Information on generating capacity and average capacity factor for operating US commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed

  19. Key Regulatory Issues for Digital Instrumentation and Control Systems at Nuclear Power Plants

    International Nuclear Information System (INIS)

    Korsah, Kofi; Wood, Richard Thomas

    2008-01-01

    To help reduce the uncertainty associated with application of digital instrumentation and controls (I and C) technology in nuclear power plants, the Nuclear Regulatory Commission (NRC) has issued six Interim Staff Guidance (ISG) documents that address the current regulatory positions on what are considered the significant digital I and C issues. These six documents address the following topics: Cyber Security, Diversity and Defense-in-Depth, Risk Informed Digital I and C Regulation, Communication issues, Human Factors and the Digital I and C Licensing Process (currently issued as Draft). After allowing for further refinement based on additional technical insight gathered by NRC staff through near-term research and detailed review of relevant experience, it is expected that updated positions ultimately will be incorporated into regulatory guides and staff review procedures. This paper presents an overview of the guidance provided by the NRC-issued ISGs on key technology considerations (i.e., the first five documents above) for safety-related digital I and C systems.

  20. Introduction of regulatory guide on cyber security of L and C systems in nuclear facilities

    International Nuclear Information System (INIS)

    Kang, Y.; Jeong, C. H.; Kim, D. I.

    2008-01-01

    In the case of unauthorized individuals, systems and entities or process threatening the instrumentation and control systems of nuclear facilities using the intrinsic vulnerabilities of digital based technologies, those systems may lose their own required functions. The loss of required functions of the systems can seriously affect the safety of nuclear facilities. Consequently, digital instrumentation and control systems, which perform functions important to safety, should be designed and operated to respond to cyber threats capitalizing on the vulnerabilities of digital based technologies. To make it possible, the developers and licensees of nuclear facilities should perform appropriate cyber security activities throughout the whole life cycle of digital instrumentation and control systems. Under the goal of securing the safety of nuclear facilities, this paper presents the regulatory on cyber security activities to remove the cyber threats that exploit the vulnerabilities of digital instrumentation and control systems and to mitigate the effect of such threats. Presented regulatory guide includes establishing the cyber security policy and plan, analyzing and classifying the cyber threats and cyber security assessment of digital instrumentation and control systems. (authors)

  1. Adaptation of Regulatory Systems in Schoolchildren, Residing in Industrial Area

    Directory of Open Access Journals (Sweden)

    Aiman E. Konkabaeva

    2013-01-01

    Full Text Available The article presents the results of the study of heart rate variability (HRT in apparently healthy volunteers of both sexes without bad habits, aged 16-18, residing in industrial region (Temirtau and the ones, studying under innovative technologies. HRT was registered with the help of computer-controlled devices “Varikard” (Russia. The changes of HRT spectral indexes towards integral impact of vegetative regulation mechanisms and parasympathetic activity decrease and regulatory systems overexertion, demanding correction methods implementation

  2. MIRA: An R package for DNA methylation-based inference of regulatory activity.

    Science.gov (United States)

    Lawson, John T; Tomazou, Eleni M; Bock, Christoph; Sheffield, Nathan C

    2018-03-01

    DNA methylation contains information about the regulatory state of the cell. MIRA aggregates genome-scale DNA methylation data into a DNA methylation profile for independent region sets with shared biological annotation. Using this profile, MIRA infers and scores the collective regulatory activity for each region set. MIRA facilitates regulatory analysis in situations where classical regulatory assays would be difficult and allows public sources of open chromatin and protein binding regions to be leveraged for novel insight into the regulatory state of DNA methylation datasets. R package available on Bioconductor: http://bioconductor.org/packages/release/bioc/html/MIRA.html. nsheffield@virginia.edu.

  3. Environmental regulatory reform in Poland: lessons for industrializing economies

    Energy Technology Data Exchange (ETDEWEB)

    Brown, H.S.; Angel, D. [Clark University, Worcester, MA (USA). George Perkins Marsh Institute

    2000-09-01

    This paper examines the environmental regulatory reform in Poland during the 1990s and uses the findings to consider the extent to which elements of successful regulatory systems are transferable across national boundaries. Drawing on five case studies of privatized firms, a mailed questionnaire, and policy and institutional analysis, it investigates how Poland developed an effective system for managing industrial pollution while also achieving considerable socioeconomic progress. The fundamental legitimacy of the regulators and regulatory process, the availability of information about firms and regulatory intents, and the capacity for case-specific decision-making are among the key explanatory factors. The study also shows how in Poland a good 'fit' between regulatory institutions and policies on one hand and their social context on the other hand has evolved, and how it contributes to the effectiveness of the regulatory system. Industrializing economies can indeed simultaneously pursue environmental protection and socioeconomic welfare, but elements of a proven regulatory system cannot be automatically adopted among countries and cultures. Learning from each other's experience must be sensitive to the cultural and institutional context of each regulatory system. 42 refs., 3 figs., 1 tab.

  4. The Regulatory Framework for Privacy and Security

    Science.gov (United States)

    Hiller, Janine S.

    The internet enables the easy collection of massive amounts of personally identifiable information. Unregulated data collection causes distrust and conflicts with widely accepted principles of privacy. The regulatory framework in the United States for ensuring privacy and security in the online environment consists of federal, state, and self-regulatory elements. New laws have been passed to address technological and internet practices that conflict with privacy protecting policies. The United States and the European Union approaches to privacy differ significantly, and the global internet environment will likely cause regulators to face the challenge of balancing privacy interests with data collection for many years to come.

  5. Statutory Rewards to Environmental Self-Auditing: Do They Reduce Pollution and Save Regulatory Costs? Evidence from a Cross-State Panel

    OpenAIRE

    Guerrero, Santiago; Innes, Robert

    2008-01-01

    State-level statutes provide firms that engage in environmental self-audits, and that self-report their environmental violations, with a variety of different regulatory rewards, including "immunity" from penalties and "privilege" for information contained in self-audits. This paper studies a panel of State-level industries from 1989-2003, in order to determine the effects of the different statutes on toxic pollution and government inspections. We find that, by encouraging self-auditing, privi...

  6. Zooming in on regulatory intermediaries: The impact of non-state regulators on sustainable construction practice

    NARCIS (Netherlands)

    van der Heijden, J.

    2014-01-01

    Levi-Faur and Starobin (2013) have recently drawn our attention to the important role of regulatory intermediates in contemporary regulatory regimes. Among others they argue that regulatory intermediaries come in a wide variety of appearances, and that these can influence the outcomes of regulatory

  7. Safety system upgrades to a research reactor: A regulatory perspective

    International Nuclear Information System (INIS)

    Lamarre, G.B.; Martin, W.G.

    2003-01-01

    The NRU (National Research Universal) reactor, located at the Chalk River Laboratories of Atomic Energy of Canada Limited (AECL), first achieved criticality November 3, 1957. AECL continues to operate NRU for research to support safety and reliability studies for CANDU reactors and as a major supplier of medical radioisotopes. Following a detailed systematic review and assessment of NRU's design and the condition of its primary systems, AECL formally notified the Canadian Nuclear Safety Commission's (CNSC) predecessor - the Atomic Energy Control Board - in 1992 of its intention to upgrade NRU's safety systems. AECL proposed seven major upgrades to provide improvements in shutdown capability, heat removal, confinement, and reactor monitoring, particularly during and after a seismic event. From a CNSC perspective, these upgrades were necessary to meet modern safety standards. From the start of the upgrades project, the CNSC provided regulatory oversight aimed at ensuring that AECL maintained a structured approach to the upgrades. The elements of the approach include, but are not limited to, the determination of project milestones and target dates; the formalization of the design process and project quality assurance requirements; the requirements for updated documentation, including safety reports, safety notes and commissioning reports; and the approval and authorization process. This paper details, from a regulatory perspective, the structured approach used in approving the design, construction, commissioning and subsequent operation of safety system upgrades for an existing and operating research reactor, including the many challenges faced when attempting to balance the requirements of the upgrades project with AECL's need to keep NRU operating to meet its important research and production objectives. (author)

  8. Regulatory guidance document

    International Nuclear Information System (INIS)

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7

  9. Regulatory requirements for replacement of analog systems with digital upgrades

    International Nuclear Information System (INIS)

    Loeser, P.J.

    1993-01-01

    This paper reviews briefly the regulatory guidelines which must be met in order to replace analog systems in nuclear power plants with digital systems. There is a move to do such replacements for a number of reasons: analog systems are aging, and showing considerable drift; few vendors manufacture analog systems today; support and parts are hard to get; digital systems provide flexibility. There is a safety concern however about undesirable and unpredictable effects to digital safety equipment due to plant transients, accidents, post-accident condition, and EMI/RF environmental interferences. License holders must comply with the requirements of 10 C.F.R. 50.59, which deals with safety concerns with respect to any changes to operating plants which may have an impact on the safety of the plant. NRC staff is taking the position that all digital upgrades will require an evaluation under this regulation

  10. STATE_SYSTEM

    Data.gov (United States)

    Kansas Data Access and Support Center — This dataset is a single centerline highway network representation of the 10,000 miles Kansas State Highway System (Interstate, U.S., and Kansas routes). The state...

  11. Regulatory dendritic cells in autoimmunity: A comprehensive review.

    Science.gov (United States)

    Liu, Juan; Cao, Xuetao

    2015-09-01

    Dendritic cells (DCs) are professional antigen-presenting cells (APC) with significant phenotypic heterogeneity and functional plasticity. DCs play crucial roles in initiating effective adaptive immune responses for elimination of invading pathogens and also in inducing immune tolerance toward harmless components to maintain immune homeostasis. The regulatory capacity of DCs depends on their immature state and distinct subsets, yet not restricted to the immature state and one specialized subset. The tolerogenicity of DC is controlled by a complex network of environmental signals and cellular intrinsic mechanisms. Regulatory DCs play an important role in the maintenance of immunological tolerance via the induction of T cell unresponsiveness or apoptosis, and generation of regulatory T cells. DCs play essential roles in driving autoimmunity via promoting the activation of effector T cells such as T helper 1 and T helper 17 cells, and/or suppressing the generation of regulatory T cells. Besides, a breakdown of DCs-mediated tolerance due to abnormal environmental signals or breakdown of intrinsic regulatory mechanisms is closely linked with the pathogenesis of autoimmune diseases. Novel immunotherapy taking advantage of the tolerogenic potential of regulatory DCs is being developed for treatment of autoimmune diseases. In this review, we will describe the current understanding on the generation of regulatory DC and the role of regulatory DCs in promoting tolerogenic immune responses and suppressing autoimmune responses. The emerging roles of DCs dysfunction in the pathogenesis of autoimmune diseases and the potential application of regulatory DCs in the treatment of autoimmune diseases will also be discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. Controlling Methane Emissions in the Natural Gas Sector. A Review of Federal and State Regulatory Frameworks Governing Production, Gathering, Processing, Transmission, and Distribution

    Energy Technology Data Exchange (ETDEWEB)

    Paranhos, Elizabeth [Energy Innovation Partners, Seoul (South Korea); Kozak, Tracy G. [Energy Innovation Partners, Seoul (South Korea); Boyd, William [Univ. of Colorado, Boulder, CO (United States); Bradbury, James [U.S. Department of Energy, Washington, DC (United States); Steinberg, D. C. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Arent, D. J. [Joint Inst. for Strategic Energy Alaysis, Washington, DC (United States)

    2015-04-23

    This report provides an overview of the regulatory frameworks governing natural gas supply chain infrastructure siting, construction, operation, and maintenance. Information was drawn from a number of sources, including published analyses, government reports, in addition to relevant statutes, court decisions and regulatory language, as needed. The scope includes all onshore facilities that contribute to methane emissions from the natural gas sector, focusing on three areas of state and federal regulations: (1) natural gas pipeline infrastructure siting and transportation service (including gathering, transmission, and distribution pipelines), (2) natural gas pipeline safety, and (3) air emissions associated with the natural gas supply chain. In addition, the report identifies the incentives under current regulatory frameworks to invest in measures to reduce leakage, as well as the barriers facing investment in infrastructure improvement to reduce leakage. Policy recommendations regarding how federal or state authorities could regulate methane emissions are not provided; rather, existing frameworks are identified and some of the options for modifying existing regulations or adopting new regulations to reduce methane leakage are discussed.

  13. Regulatory Circuits Linking Energy Status to Growth

    NARCIS (Netherlands)

    Jansen, W.M.

    2017-01-01

    Plant growth and development critically depend on carbon nutrient status. Over the past years several core regulatory systems that link plant carbon status to growth have emerged. The core regulatory systems studied include the trehalose 6-phosphate (T6P) signaling system and the Target of Rapamycin

  14. Development of Regulatory Documents for Creation (Upgrade) of Physical Protection Systems under the Russian/American MPC and A Program

    International Nuclear Information System (INIS)

    Izmaylov, Alexandr V.; Babkin, Vladimir; Kurov, Valeriy; Piskarev, Alexander; O'Brien, Patricia E.; Wright, Troy L.; Schlegel, Stephen C.; Hazel, Michael J.; Miller, Daniel R.; Tuttle, John D.; Kovchegin, Dmitry

    2009-01-01

    The development of new or the upgrade of existing physical protection systems (PPS) for nuclear facilities involves a multi-step and multidimensional process. The process consists of conceptual design, design, and commissioning stages. The activities associated with each of these stages are governed by Russian government and agency regulations. To ensure a uniform approach to development or upgrading of PPS at Russian nuclear facilities, the development of a range of regulatory and methodological documents is necessary. Some issues of PPS development are covered by the regulatory documents developed by Rosatom, as well as other Russian agencies with nuclear facilities under their control. This regulatory development has been accomplished as part of the U.S.-Russian MPC and A cooperation or independently by the Russian Federation. While regulatory coverage is extensive, there are a number of issues such as vulnerability analysis, effectiveness assessment, upgrading PPS, and protection of information systems for PPS that require additional regulations be developed. This paper reports on the status of regulatory coverage for PPS development or upgrade, and outlines a new approach to regulatory document development. It describes the evolutionary process of regulatory development through experience gained in the design, development and implementation of PPS as well as experience gained through the cooperative efforts of Russian and U.S. experts involved the development of MPC and A regulations.

  15. Synchronous versus asynchronous modeling of gene regulatory networks.

    Science.gov (United States)

    Garg, Abhishek; Di Cara, Alessandro; Xenarios, Ioannis; Mendoza, Luis; De Micheli, Giovanni

    2008-09-01

    In silico modeling of gene regulatory networks has gained some momentum recently due to increased interest in analyzing the dynamics of biological systems. This has been further facilitated by the increasing availability of experimental data on gene-gene, protein-protein and gene-protein interactions. The two dynamical properties that are often experimentally testable are perturbations and stable steady states. Although a lot of work has been done on the identification of steady states, not much work has been reported on in silico modeling of cellular differentiation processes. In this manuscript, we provide algorithms based on reduced ordered binary decision diagrams (ROBDDs) for Boolean modeling of gene regulatory networks. Algorithms for synchronous and asynchronous transition models have been proposed and their corresponding computational properties have been analyzed. These algorithms allow users to compute cyclic attractors of large networks that are currently not feasible using existing software. Hereby we provide a framework to analyze the effect of multiple gene perturbation protocols, and their effect on cell differentiation processes. These algorithms were validated on the T-helper model showing the correct steady state identification and Th1-Th2 cellular differentiation process. The software binaries for Windows and Linux platforms can be downloaded from http://si2.epfl.ch/~garg/genysis.html.

  16. Regulatory Lessons for Internet Traffic Management from Japan, the European Union, and the United States: Toward Equity, Neutrality and Transparency

    Directory of Open Access Journals (Sweden)

    John Harris Stevenson

    2010-01-01

    Full Text Available As network neutrality has been one of the most contentious Internet public policy issues of the past decade, this article provides a comparative overview of events, policies, and legislation surrounding Internet traffic management practises (ITMPs (e.g., network neutrality in Japan, the European Union, the United States, and Canada. Using the frame provided by Richard Rose of “hybrid lessons”to create a policy synthesis, the paper details the telecom policy environment, Internet Service provider competition, legislative jurisdiction, remedies for ITMPs, consumer transparency, and adherence to privacy protection in each country. The analysis focuses on Canada’s first significant regulatory effort to address network neutrality, which came during the Canadian Radio-television and Telecommunications Commission 2009 process on Internet traffic management. This paper presents a brief overview of the Canadian regulatory environment and the specific questions which were the subject of the CRTC review. Employing Richard Rose’s methods for comparative public policy analysis, we offer a number of regulatory “lessons” from Japan, the European Union, and the United States based on their experiences with traffic management issues. Applying these lessons to the Canadian context, we make several specific policy recommendations, among them that competition be encouraged within the Internet service provider space, that network management practises be reasonable and limited, and that ISPs provide full disclosure of network management policies and practises.

  17. 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 ...

  18. Cost-benefit and regulatory decision making

    International Nuclear Information System (INIS)

    Harvie, J.

    1996-01-01

    The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost benefit issues and work towards some consensus of opinion among stake holders: a task force on the subject could be an appropriate starting point'. (author)

  19. Regulatory difficulties in a developing country

    International Nuclear Information System (INIS)

    Jacobs, W.R. Jr.

    1978-01-01

    The regulatory agency assigned the task of regulating the initial entry into the field of nuclear power generation by a developing country has a very difficult job. Based on the authors' experience during the start-up and initial operation of Ko-Ri Unit I, the first power reactor in the Republic of Korea, observations on regulatory difficulties and recommendations for improved regulatory effectiveness are offered. The problem areas can be loosely grouped into three general categories: (1) Lack of adequate technical knowledge which is the basis for all effective regulation; (2) Difficulties with understanding and utilization of the required regulatory documentation; (3) Failure to establish the proper regulatory environment. Examples are cited from actual experience during the Ko-Ri Unit I start-up to demonstrate the impact that regulatory activities can have on a plant construction and testing programme. The problems encountered are not unique to developing countries but also exist in the United States of America. Recommendations are offered which should be beneficial to either newly formed regulatory agencies or agencies wishing to improve their abilities and effectiveness. These include: (1) Additional training of regulatory inspectors in plant operations; (2) Additional experience gained by participation in regulatory activities in other countries; (3) Increased attention given to regulatory documents, especially plant technical specifications; (4) Establishment of formal lines of communication between the utility and the regulatory agency; (5) Clear definition of regulatory responsibilities to avoid areas of overlapping jurisdiction; (6) Active participation by the regulatory staff very early in the project. It is hoped that these and other recommendations offered will greatly improve regulatory effectiveness and at the same time demonstrate that when the decision is made to 'go nuclear', a strong commitment must be made to develop and support a technically

  20. Synthetic tetracycline-inducible regulatory networks: computer-aided design of dynamic phenotypes

    Directory of Open Access Journals (Sweden)

    Kaznessis Yiannis N

    2007-01-01

    Full Text Available Abstract Background Tightly regulated gene networks, precisely controlling the expression of protein molecules, have received considerable interest by the biomedical community due to their promising applications. Among the most well studied inducible transcription systems are the tetracycline regulatory expression systems based on the tetracycline resistance operon of Escherichia coli, Tet-Off (tTA and Tet-On (rtTA. Despite their initial success and improved designs, limitations still persist, such as low inducer sensitivity. Instead of looking at these networks statically, and simply changing or mutating the promoter and operator regions with trial and error, a systematic investigation of the dynamic behavior of the network can result in rational design of regulatory gene expression systems. Sophisticated algorithms can accurately capture the dynamical behavior of gene networks. With computer aided design, we aim to improve the synthesis of regulatory networks and propose new designs that enable tighter control of expression. Results In this paper we engineer novel networks by recombining existing genes or part of genes. We synthesize four novel regulatory networks based on the Tet-Off and Tet-On systems. We model all the known individual biomolecular interactions involved in transcription, translation, regulation and induction. With multiple time-scale stochastic-discrete and stochastic-continuous models we accurately capture the transient and steady state dynamics of these networks. Important biomolecular interactions are identified and the strength of the interactions engineered to satisfy design criteria. A set of clear design rules is developed and appropriate mutants of regulatory proteins and operator sites are proposed. Conclusion The complexity of biomolecular interactions is accurately captured through computer simulations. Computer simulations allow us to look into the molecular level, portray the dynamic behavior of gene regulatory

  1. Legal principles of regulatory administration and nuclear safety regulation

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Kyeong Hui; Cheong, Sang Kee [Hannam Univ., Taejon (Korea, Republic of)

    2000-12-15

    This research presents a critical analysis and evaluation of principles of administrative laws in order to provide framework of structural reform on the nuclear safety regulation system. The focus of this analysis and evaluation is centered around the area of origin of regulatory administrative laws; authorities of regulation; procedures of regulatory actions; regulatory enforcement; and administrative relief system. In chapter 2 the concept of regulatory administration is analysed. Chapter 3 identifies the origin of regulatory administration and the principles of administration laws. It also examines legal nature of the nuclear safety standard. In relation to regulatory authorities. Chapter 4 identifies role and responsibility of administration authorities and institutions. It also examines fundamental principles of delegation of power. Then the chapter discusses the nuclear safety regulation authorities and their roles and responsibilities. Chapter 5 classifies and examines regulatory administration actions. Chapter 6 evaluates enforcement measure for effectiveness of regulation. Finally, chapter 7 discusses the administrative relief system for reviewing unreasonable regulatory acts.

  2. International Nuclear Safety Experts Conclude IAEA Peer Review of Swiss Regulatory Framework

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: A team of international nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the regulatory framework for nuclear safety in Switzerland. The Integrated Regulatory Review Service (IRRS) mission noted good practices in the Swiss system and also made recommendations for the nation's nuclear regulatory authority, the Swiss Federal Nuclear Safety Inspectorate (ENSI). ''Our team developed a good impression of the independent Swiss regulator - ENSI - and the team considered that ENSI deserves particular credit for its actions to improve Swiss safety capability following this year's nuclear accident in Japan,'' said IRRS Team Leader Jean-Christophe Niel of France. The mission's scope covered the Swiss nuclear regulatory framework for all types of nuclear-related activities regulated by ENSI. The mission was conducted from 20 November to 2 December, mainly at ENSI headquarters in Brugg. The team held extensive discussions with ENSI staff and visited many Swiss nuclear facilities. IRRS missions are peer reviews, not inspections or audits, and are conducted at the request of host nations. For the Swiss review, the IAEA assembled a team of 19 international experts from 14 countries. The experts came from Belgium, Brazil, the Czech Republic, Finland, France, Germany, Italy, the Republic of Korea, Norway, Russia, Slovakia, Sweden, the United Kingdom, and the United States. ''The findings of the IRRS mission will help us to further improve our work. That is part of our safety culture,'' said ENSI Director General Hans Wanner. ''As Switzerland argued at international nuclear safety meetings this year for a strengthening of the international monitoring of nuclear power, we will take action to fulfil the recommendations.'' The IRRS team highlighted several good practices of the Swiss regulatory system, including the following: ENSI requires Swiss nuclear operators to back-fit their facilities by continuously upgrading

  3. AEC Regulatory view of the reliability of air cleaning systems in nuclear facilities

    International Nuclear Information System (INIS)

    Bellamy, R.R.; Zavadoski, R.W.

    1975-01-01

    Air cleaning systems in nuclear facilities can be divided into three categories: ventilation exhaust systems, containment atmosphere cleanup systems, and process offgas systems. These systems have been the subject of numerous reports, regulatory guides, discussions, and meetings. Some of the analyses have been critical of the operation and design of these air cleaning systems--in particular, the engineered safety features containment atmosphere cleanup systems. Although for the most part the criticism is applicable, and recognizing that there are a number of unresolved issues pertaining to gaseous waste management systems, there are data to show that air cleaning systems in use in nuclear facilities are performing their intended function. (U.S.)

  4. 77 FR 60956 - State Graduated Driver Licensing Incentive Grant

    Science.gov (United States)

    2012-10-05

    ... and proficiency to move through each level of the system before graduating to the next. States have.... How do I prepare and submit comments? Your comments must be written and in English. To ensure that.... Regulatory Analyses and Notices A. Executive Order (E.O.) 12866 (Regulatory Planning and Review), E.O. 13563...

  5. Annual Report 2010. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2010. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

  6. Annual Report 2011. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2011. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

  7. GIS-assisted spatial analysis for urban regulatory detailed planning: designer's dimension in the Chinese code system

    Science.gov (United States)

    Yu, Yang; Zeng, Zheng

    2009-10-01

    By discussing the causes behind the high amendments ratio in the implementation of urban regulatory detailed plans in China despite its law-ensured status, the study aims to reconcile conflict between the legal authority of regulatory detailed planning and the insufficient scientific support in its decision-making and compilation by introducing into the process spatial analysis based on GIS technology and 3D modeling thus present a more scientific and flexible approach to regulatory detailed planning in China. The study first points out that the current compilation process of urban regulatory detailed plan in China employs mainly an empirical approach which renders it constantly subjected to amendments; the study then discusses the need and current utilization of GIS in the Chinese system and proposes the framework of a GIS-assisted 3D spatial analysis process from the designer's perspective which can be regarded as an alternating processes between the descriptive codes and physical design in the compilation of regulatory detailed planning. With a case study of the processes and results from the application of the framework, the paper concludes that the proposed framework can be an effective instrument which provides more rationality, flexibility and thus more efficiency to the compilation and decision-making process of urban regulatory detailed plan in China.

  8. New state roles in the management and disposal of commercial nuclear waste

    International Nuclear Information System (INIS)

    Udall, M.K.

    1977-01-01

    Arguments are presented for the need for congressional action to clarify the respective regulatory responsibilities of the state and Federal Governments as they relate to commercial nuclear power. Three case studies in radioactive waste management and disposal are reviewed which are proported to illustrate the inadequacy of the existing regulatory framework to effectively manage and dispose of nuclear wastes. Examples of instances in which state legislatures have taken the initiative in the waste disposal problem are cited. It is concluded that regulatory reform should be in the direction of a dual system that provides states with new authority and leverage to control nuclear energy development patterns within their borders

  9. Improving nuclear regulatory effectiveness

    International Nuclear Information System (INIS)

    2001-01-01

    Ensuring that nuclear installations are operated and maintained in such a way that their impact on public health and safety is as low as reasonably practicable has been and will continue to be the cornerstone of nuclear regulation. In the past, nuclear incidents provided the main impetus for regulatory change. Today, economic factors, deregulation, technological advancements, government oversight and the general requirements for openness and accountability are leading regulatory bodies to review their effectiveness. In addition, seeking to enhance the present level of nuclear safety by continuously improving the effectiveness of regulatory bodies is seen as one of the ways to strengthen public confidence in the regulatory systems. This report covers the basic concepts underlying nuclear regulatory effectiveness, advances being made and future requirements. The intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  10. Techniques of analyzing the impacts of certain electric-utility ratemaking and regulatory-policy concepts. Bibliography

    Energy Technology Data Exchange (ETDEWEB)

    None

    1980-08-01

    This bibliography provides documentation for use by state public utility commissions and major nonregulated utilities in evaluating the applicability of a wide range of electric utility rate design and regulatory concepts in light of certain regulatory objectives. Part I, Utility Regulatory Objectives, contains 2084 citations on conservation of energy and capital; efficient use of facilities and resources; and equitable rates to electricity consumers. Part II, Rate Design Concepts, contains 1238 citations on time-of-day rates; seasonally-varying rates; cost-of-service rates; interruptible rates (including the accompanying use of load management techniques); declining block rates; and lifeline rates. Part III, Regulatory Concepts, contains 1282 references on restrictions on master metering; procedures for review of automatic adjustment clauses; prohibitions of rate or regulatory discrimination against solar, wind, or other small energy systems; treatment of advertising expenses; and procedures to protect ratepayers from abrupt termination of service.

  11. Improving regulatory effectiveness in Federal/State siting actions. Success factor evaluation panel. Final report

    International Nuclear Information System (INIS)

    Haggard, J.

    1977-06-01

    An independent appraisal of the factors that determine efficiency in reaching environmental decisions with respect to nuclear facilities was addressed. The Panel recommended to substitute 'effectiveness' for 'efficiency.' Thus, an effective decision is: 'A timely final decision, that provides for necessary change, consistent with societal objectives and law, and which is equitable and practical, and is based upon fully and candidly expressed premises utilizing a commonly available data base.' The measurement criteria for evaluating the effectiveness of the environmental decision making process are: timely decision, final decision, provision for change, consistency with societal goals and law, equitable, practical, fully and candidly expressed premises, commonly available data base, and public confidence. The Panel evaluated the 8 policies proposed by NRC staff as essential to licensing reform: national fuels policy, regional review, early disclosure, State role, technical assistance to State, role of utilities, radiation health and safety, and modification of the Atomic Energy Act. The five NRC scenarios were evaluated in terms of regulatory effectiveness

  12. Development of the personnel training and qualification system of the Russian Federation Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Kapralov, E.; Kapralov, Y.; Kozlov, V.

    2006-01-01

    The new personnel training and qualification system is being developed for russian regulatory body, having a very big number of employees and invited experts and widly territorially distributed structure. (author)

  13. The Independence of Vietnam Regulatory Body

    International Nuclear Information System (INIS)

    Nguyen, Hoang Anh; Choi, Kwang Sik

    2011-01-01

    In the field of peaceful purposes, the activity of nuclear agencies is often divided into 2 systems: the nuclear application system and the safety system. Depending on the magnitude of atomic energy application development, the responsibility of the safety system was assigned to a few agencies in each country. In Vietnam, the nuclear safety responsibility is assigned primarily to the radiation and nuclear safety agency. However, the provisions of the normative system of law prevailing in other sectors such as investment, construction, electricity or environmental protection, many agencies are responsible for ensuring safety in each sector, leading to a conflict of interest among those agencies. This is the weakness in the management system of Vietnam compared to other countries with nuclear power development. The purpose of this paper is to analyze the state of Vietnam's legal framework in nuclear safety regulation and its dependence of regulatory body aspects and promoting the way to overcome it

  14. Standardization of nuclear power plants in the United States: recent regulatory developments

    International Nuclear Information System (INIS)

    Cowan, B.Z.; Tourtellotte, J.R.

    1992-01-01

    On April 18, 1989, the United States (U.S.) Nuclear Regulatory Commission (NRC) amended the regulations governing the process for licensing nuclear power plants in the United States to provide for issuance of early site permits, standard design certifications and combined construction permits and operating licenses for nuclear power reactors. The new regulations are designed to achieve early resolution of licensing issues and facilitate standardization of nuclear power plants in the United States. The program for design standardization is central to efforts mounted by the U.S. government and industry to ensure that there will be a next generation of nuclear power facilities in the U.S. The most significant changes are provisions for certification of standard designs and for issuance prior to start of construction of combined licenses which incorporate a construction permit and an operating license with conditions. Such certifications and combined licenses must contain tests, inspections and analyses, and acceptance criteria, which are necessary and sufficient to provide reasonable assurance that the facility has been constructed and will operate in accordance with the combined license. A number of significant implementation issues have arisen. In addition a major court case brought by several anti-nuclear groups is pending, challenging NRC authority to issue combined licenses. It is the goal of the U.S. nuclear industry to have the first of the next generation of standardized nuclear power plants ordered, licensed, constructed and on-line by the year 2000. (author)

  15. Construction and development of an auto-regulatory gene expression system in Bacillus subtilis.

    Science.gov (United States)

    Guan, Chengran; Cui, Wenjing; Cheng, Jintao; Zhou, Li; Guo, Junling; Hu, Xu; Xiao, Guoping; Zhou, Zhemin

    2015-09-21

    Bacillus subtilis is an all-important Gram-positive bacterium of valuable biotechnological utility that has been widely used to over-produce industrially and pharmaceutically relevant proteins. There are a variety of expression systems in terms of types of transcriptional patterns, among which the auto-inducible and growth-phase-dependent promoters are gaining increasing favor due to their inducer-independent feature, allowing for the potential to industrially scale-up. To expand the applicability of the auto-inducible expression system, a novel auto-regulatory expression system coupled with cell density was constructed and developed in B. subtilis using the quorum-sensing related promoter srfA (PsrfA). The promoter of the srf operon was used to construct an expression plasmid with the green fluorescent protein (GFP) downstream of PsrfA. The expression displayed a cell-density-dependent pattern in that GFP had a fairly low expression level at the early exponential stage and was highly expressed at the late exponential as well as the stationary stages. Moreover, the recombinant system had a similar expression pattern in wild-type B. subtilis 168, WB600, and WB800, as well as in B. subtilis 168 derivative strain 1681, with the complete deletion of PsrfA, indicating the excellent compatibility of this system. Noticeably, the expression strength of PsrfA was enhanced by optimizing the -10 and -35 core sequence by substituting both sequences with consensus sequences. Importantly, the expression pattern was successfully developed in an auto-regulatory cell-density coupling system by the simple addition of glucose in which GFP could not be strongly expressed until glucose was depleted, resulting in a greater amount of the GFP product and increased cell density. The expression system was eventually tested by the successful over-production of aminopeptidase to a desired level. The auto-regulatory cell density coupling system that is mediated by PsrfA is a novel expression

  16. Post-Transcriptional Regulation by the Csr Global Regulatory System in Escherichia coli

    OpenAIRE

    Suzuki, Kazushi; 鈴木, 一史

    2007-01-01

    In many species of bacteria, the Csr (carbon storage regulator) global regulatory system coordinates the expression of various genes. In Escherichia coli, the central component of this system, CsrA, is a RNA-binding protein. The CsrA is a homodimer and binds to leader segments of target mRNAs, affecting their translation and stability. CsrA activity is regulated by two small non-coding RNAs, CsrB and CsrC. These RNAs contain multiple CsrA-binding sequences and act by sequestering CsrA. In thi...

  17. Social insect colony as a biological regulatory system: modelling information flow in dominance networks.

    Science.gov (United States)

    Nandi, Anjan K; Sumana, Annagiri; Bhattacharya, Kunal

    2014-12-06

    Social insects provide an excellent platform to investigate flow of information in regulatory systems since their successful social organization is essentially achieved by effective information transfer through complex connectivity patterns among the colony members. Network representation of such behavioural interactions offers a powerful tool for structural as well as dynamical analysis of the underlying regulatory systems. In this paper, we focus on the dominance interaction networks in the tropical social wasp Ropalidia marginata-a species where behavioural observations indicate that such interactions are principally responsible for the transfer of information between individuals about their colony needs, resulting in a regulation of their own activities. Our research reveals that the dominance networks of R. marginata are structurally similar to a class of naturally evolved information processing networks, a fact confirmed also by the predominance of a specific substructure-the 'feed-forward loop'-a key functional component in many other information transfer networks. The dynamical analysis through Boolean modelling confirms that the networks are sufficiently stable under small fluctuations and yet capable of more efficient information transfer compared to their randomized counterparts. Our results suggest the involvement of a common structural design principle in different biological regulatory systems and a possible similarity with respect to the effect of selection on the organization levels of such systems. The findings are also consistent with the hypothesis that dominance behaviour has been shaped by natural selection to co-opt the information transfer process in such social insect species, in addition to its primal function of mediation of reproductive competition in the colony. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

  18. 78 FR 69732 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-11-20

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend FINRA Rule 8312 (FINRA BrokerCheck Disclosure) To Include Information About Members and Their Associated Persons of Any Registered National Securities Exchange That Uses the CRD System for...

  19. Regulating incentives: the past and present role of the state in health care systems.

    Science.gov (United States)

    Saltman, Richard B

    2002-06-01

    The desire of national policymakers to encourage entrepreneurial behavior in the health sector has generated not only a new structure of market-oriented incentives, but also a new regulatory role for the State. To ensure that entrepreneurial behavior will be directed toward achieving planned market objectives, the State must shift modalities from staid bureaucratic models of command-and-control to more sensitive and sophisticated systems of oversight and supervision. Available evidence suggests that this structural transformation is currently occurring in several Northern European countries. Successful implementation of that shift will require a new, intensive, and expensive strategy for human resources development, raising questions about the financial feasibility of this incentives-plus-regulation model for less-well-off CEE/CIS and developing countries.

  20. National regulatory authorities with competence in the safety of radiation sources and the security of radioactive materials. Proceedings

    International Nuclear Information System (INIS)

    2001-01-01

    The Buenos Aires Conference, hosted by the Government of Argentina, was attended by 89 regulatory officials from 57 Member States. The conference provided a forum for fostering the exchange of information and experience on the development of adequate regulatory systems for effective control of the safety of radiation sources and security of radioactive materials. This publication contains 64 individual presentations delivered at the Conference. Each of them was indexed separately

  1. National regulatory authorities with competence in the safety of radiation sources and the security of radioactive materials. Proceedings

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-08-01

    The Buenos Aires Conference, hosted by the Government of Argentina, was attended by 89 regulatory officials from 57 Member States. The conference provided a forum for fostering the exchange of information and experience on the development of adequate regulatory systems for effective control of the safety of radiation sources and security of radioactive materials. This publication contains 64 individual presentations delivered at the Conference. Each of them was indexed separately.

  2. The IAEA Integrated Regulatory Review Service (IRRS) - Information Meeting Dublin

    International Nuclear Information System (INIS)

    Al Khatibeh, Ahmad

    2014-05-01

    IRRS is developed to help States evaluate the current status of compliance of their regulatory infrastructures for safety with IAEA Standards. This report discusses the function of IRRS missions as a tool for evaluating the regulatory structure for Member States. It was presented to RPII staff in a Powerpoint document in preparation for the IRRS Mission to Ireland in August 2015

  3. Regulatory frameworks for decentralised energy

    International Nuclear Information System (INIS)

    Woodman, Bridget; Baker, Philip

    2008-01-01

    This paper considers aspects of the current regulatory frameworks for markets and infrastructure which can inhibit the deployment of decentralised energy. The government has stated that decentralised energy can make a positive contribution to reducing the UK's carbon emissions, but recognises that at the moment the technologies face market and regulatory barriers. If it is to become a viable alternative to centralised generation, energy market design and the regulation of energy infrastructure will have to evolve to ensure that decentralised options are no longer locked out. (author)

  4. The regulatory process for the decommissioning of nuclear facilities

    International Nuclear Information System (INIS)

    1990-01-01

    The objective of this publication is to provide general guidance to Member States for regulating the decommissioning of nuclear facilities within the established nuclear regulatory framework. The Guide should also be useful to those responsible for, or interested in, the decommissioning of nuclear facilities. The Guide describes in general terms the process to be used in regulating decommissioning and the considerations to be applied in the development of decommissioning regulations and guides. It also delineates the responsibilities of the regulatory body and the licensee in decommissioning. The provisions of this Guide are intended to apply to all facilities within the nuclear fuel cycle and larger industrial installations using long lived radionuclides. For smaller installations, however, less extensive planning and less complex regulatory control systems should be acceptable. The Guide deals primarily with decommissioning after planned shutdown. Most provisions, however, are also applicable to decommissioning after an abnormal event, once cleanup operations have been terminated. The decommissioning planning in this case must take account of the abnormal event. 28 refs, 1 fig

  5. Business oriented EU human cell and tissue product legislation will adversely impact Member States' health care systems.

    Science.gov (United States)

    Pirnay, Jean-Paul; Vanderkelen, Alain; De Vos, Daniel; Draye, Jean-Pierre; Rose, Thomas; Ceulemans, Carl; Ectors, Nadine; Huys, Isabelle; Jennes, Serge; Verbeken, Gilbert

    2013-12-01

    The transplantation of conventional human cell and tissue grafts, such as heart valve replacements and skin for severely burnt patients, has saved many lives over the last decades. The late eighties saw the emergence of tissue engineering with the focus on the development of biological substitutes that restore or improve tissue function. In the nineties, at the height of the tissue engineering hype, industry incited policymakers to create a European regulatory environment, which would facilitate the emergence of a strong single market for tissue engineered products and their starting materials (human cells and tissues). In this paper we analyze the elaboration process of this new European Union (EU) human cell and tissue product regulatory regime-i.e. the EU Cell and Tissue Directives (EUCTDs) and the Advanced Therapy Medicinal Product (ATMP) Regulation and evaluate its impact on Member States' health care systems. We demonstrate that the successful lobbying on key areas of regulatory and policy processes by industry, in congruence with Europe's risk aversion and urge to promote growth and jobs, led to excessively business oriented legislation. Expensive industry oriented requirements were introduced and contentious social and ethical issues were excluded. We found indications that this new EU safety and health legislation will adversely impact Member States' health care systems; since 30 December 2012 (the end of the ATMP transitional period) there is a clear threat to the sustainability of some lifesaving and established ATMPs that were provided by public health institutions and small and medium-sized enterprises under the frame of the EUCTDs. In the light of the current economic crisis it is not clear how social security systems will cope with the inflation of costs associated with this new regulatory regime and how priorities will be set with regard to reimbursement decisions. We argue that the ATMP Regulation should urgently be revised to focus on delivering

  6. Regulatory control of the use of contractors by operating organizations. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    2000-09-01

    This report arises from the eighth series of peer discussions on regulatory practices entitled 'Regulatory control of the use of contractors by operating organizations'. Senior regulators from 19 Member States participated in two peer group discussions in March 2000 and May 2000. This report gives an account of the outcomes of these meetings and of practical suggestions put forward by senior regulators. These suggestions do not necessarily reflect the views of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. The objective of this document is to share experience between regulatory bodies and provide practical suggestions for controlling the use of contractors and subcontractors by the operating organizations during all stages, especially operation, of a nuclear power plant, so as to ensure that the quality of work and services delivered is commensurate with the safety importance of the activities and that these are carried out in a manner that will not adversely affect the safe or reliable operation of the facility. These documented practical suggestions and experiences are the result of a series of peer discussions at the IAEA in 2000. It is considered that the manner in which control is exercised, and the various challenges connected to this control, are highly dependent upon the legislative framework, maturity of the nuclear programme, the size of the national nuclear industry and the culture in each country. The report is structured so that it covers the subject matter under the following main headings: Legal Provisions, Regulatory Strategy and Requirements; Regulatory Approaches for Controlling the Use of Contractors; Types of Contracts; Practical Suggestions

  7. Regulatory issues in accreditation of toxicology laboratories.

    Science.gov (United States)

    Bissell, Michael G

    2012-09-01

    Clinical toxicology laboratories and forensic toxicology laboratories operate in a highly regulated environment. This article outlines major US legal/regulatory issues and requirements relevant to accreditation of toxicology laboratories (state and local regulations are not covered in any depth). The most fundamental regulatory distinction involves the purposes for which the laboratory operates: clinical versus nonclinical. The applicable regulations and the requirements and options for operations depend most basically on this consideration, with clinical toxicology laboratories being directly subject to federal law including mandated options for accreditation and forensic toxicology laboratories being subject to degrees of voluntary or state government–required accreditation.

  8. Acid rain compliance: Coordination of state and federal regulation

    International Nuclear Information System (INIS)

    Nordhaus, R.R.

    1992-01-01

    The Clean Air Act (CAA) Amendments of 1990 impose new controls on emissions by electric utilities of the two major precursors of acid rain: sulfur dioxide (SO2) and oxides of nitrogen (NOx). Utilities, and the utility holding company systems and power pools of which they are members, will be subject to extensive and costly compliance obligations under the new statute. Most of these utilities, utility systems, and power pools are regulated by more than one utility regulatory authority. Some utilities are regulated by several states, some by a single state and by the Federal Energy Regulatory Commission (FERC), and some by multiple states, by the FERC, and by the Securities and Exchange Commission (SEC). Utility regulators will need to coordinate their policies for ratemaking and for reviewing acid rain compliance strategies if least cost solutions are to be implemented without imposing on ratepayers and utility shareholders the costs and risks of inconsistent regulatory determinations. This article outlines the scope of the coordination problem and addresses possible approaches that utility regulators may take to deal with this problem

  9. Regulatory System for Stem/Progenitor Cell Niches in the Adult Rodent Pituitary

    Science.gov (United States)

    Yoshida, Saishu; Kato, Takako; Kato, Yukio

    2016-01-01

    The anterior lobe of the pituitary gland is a master endocrine tissue composed of five types of endocrine cells. Although the turnover rate of pituitary endocrine cells is as low as about 1.6% per day, recent studies have demonstrated that Sex-determining region Y-box 2 (SOX2)+-cells exist as pituitary stem/progenitor cells in the adult anterior lobe and contribute to cell regeneration. Notably, SOX2+-pituitary stem/progenitor cells form two types of niches in this tissue: the marginal cell layer (MCL-niche) and the dense cell clusters scattering in the parenchyma (parenchymal-niche). However, little is known about the mechanisms and factors for regulating the pituitary stem/progenitor cell niches, as well as the functional differences between the two types of niches. Elucidation of the regulatory mechanisms in the niches might enable us to understand the cell regeneration system that acts in accordance with physiological demands in the adult pituitary. In this review, so as to reveal the regulatory mechanisms of the two types of niche, we summarize the regulatory factors and their roles in the adult rodent pituitary niches by focusing on three components: soluble factors, cell surface proteins and extracellular matrixes. PMID:26761002

  10. Regulatory System for Stem/Progenitor Cell Niches in the Adult Rodent Pituitary

    Directory of Open Access Journals (Sweden)

    Saishu Yoshida

    2016-01-01

    Full Text Available The anterior lobe of the pituitary gland is a master endocrine tissue composed of five types of endocrine cells. Although the turnover rate of pituitary endocrine cells is as low as about 1.6% per day, recent studies have demonstrated that Sex-determining region Y-box 2 (SOX2+-cells exist as pituitary stem/progenitor cells in the adult anterior lobe and contribute to cell regeneration. Notably, SOX2+-pituitary stem/progenitor cells form two types of niches in this tissue: the marginal cell layer (MCL-niche and the dense cell clusters scattering in the parenchyma (parenchymal-niche. However, little is known about the mechanisms and factors for regulating the pituitary stem/progenitor cell niches, as well as the functional differences between the two types of niches. Elucidation of the regulatory mechanisms in the niches might enable us to understand the cell regeneration system that acts in accordance with physiological demands in the adult pituitary. In this review, so as to reveal the regulatory mechanisms of the two types of niche, we summarize the regulatory factors and their roles in the adult rodent pituitary niches by focusing on three components: soluble factors, cell surface proteins and extracellular matrixes.

  11. The state of internal audit’s regulatory mandate

    Directory of Open Access Journals (Sweden)

    Christo Ackermann

    2016-08-01

    Full Text Available The importance of an effective internal audit function in South African municipalities have been recognised insofar as internal audit functions are legally mandated to exist within municipalities. This also means that legally, internal audit has certain mandates which must be fulfilled in order to add value to management and audit committees, and ultimately, to the board of directors. Even though internal audit is sanctioned by this important legal mandate, evidence shows that internal audit does not always fulfil this mandate. This state of affairs has prompted a detailed review of the relevant laws and regulations governing the work of internal audit in South African municipalities in order to determine the extent to which key stakeholders find the regulatory work of internal audit useful in discharging their (stakeholders’ oversight responsibilities. Questionnaires were administered to audit committees. The results summarise the extent to which internal audit’s work assists audit committees in their oversight responsibilities as this ultimately affects the ability of audit committees to fulfil these responsibilities to the board of directors. The results indicate that audit committees are greatly dependent on internal audit as a provider of assurance on a variety of legally mandated variables. The results of this study can be used as a measure of best practice of the legally mandated duties performed by internal audit. It can also be used by other researchers in comparative studies and by practitioners to benchmark their work in order to better serve audit committees and ultimately, the board of directors

  12. Regulatory practices and safety standards for nuclear power plants

    International Nuclear Information System (INIS)

    1989-01-01

    The International Symposium on Regulatory Practices and Safety Standards for Nuclear Power Plants was jointly organized by the International Atomic Energy Agency (IAEA), for Nuclear Energy Agency of the OECD and the Government of the Federal Republic of Germany with the objective of providing an international forum for the exchange of information on regulatory practices and safety standards for nuclear power plants. The Symposium was held in Munich, Federal Republic of Germany, from 7 to 10 November 1988. It was attended by 201 experts from some 32 Member States and 4 international organizations. Fifty-one papers from 19 Member States and 2 international organizations were presented and discussed in 5 technical sessions covering the following subjects: National Regulatory Practices and Safety Standards (14 papers); Implementation of Regulatory Practices - Technical Issues (8 papers); Implementation of Regulatory Practices - Operational Aspects (8 papers); Developments and Trends in Safety Standards and Practices (11 papers); International Aspects (10 papers). A separate abstract was prepared for each of these papers. Refs, figs and tabs

  13. Organic Coasts? Regulatory Challenges of Certifying Integrated Shrimp-Mangrove Production Systems in Vietnam

    Science.gov (United States)

    Ha, Tran Thi Thu; Bush, Simon R.; Mol, Arthur P. J.; van Dijk, Han

    2012-01-01

    The Vietnamese government aims to expand the scale of Naturland certified organic production in integrated shrimp-mangrove farming systems across the coast of Ca Mau province by 2015. In doing so the division between public and private regulation has become blurred. We analyze the government's goal by examining the regulatory challenges of using…

  14. 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

  15. [Individual, community, regulatory, and systemic approaches to tobacco control interventions].

    Science.gov (United States)

    Gorini, Giuseppe

    2011-01-01

    During the 60s and the 70s strategies for decreasing initiation or quitting have been developed, in order to find those with high success rates. Unfortunately, interventions with an individual approach involved few smokers, so their impact in decreasing smoking prevalence was limited. The socio-ecological model offers a theoretical framework to community interventions for smoking cessation developed during the 80s, in which smoking was considered not only an individual, but also a social problem. In the 80s and the 90s smoking cessation community trials were developed, such as the Community Intervention Trial for Smoking Cessation (COMMIT). Afterwards, policy interventions (price policy; smoking bans in public places; advertising bans; bans of sales to minors) were developed, such as the American Stop Smoking Intervention Study for Cancer Prevention (ASSIST). California has been the first State all over the world to develop a comprehensive Tobacco Control Program in 1988, becoming the place for an ever-conducted natural experiment. All policy interventions in tobacco control have been finally grouped together in the World Health Organization - Framework Convention on Tobacco Control (WHO-FCTC), the first Public Health Treaty. Study designs have changed, according to the individual, community, or regulatory approaches: the classical randomized controlled trials (RCTs), in which the sampling unit is the individual, have been carried out for the evaluation of smoking cessation treatments, whereas cluster RCTs, in which the sampling unit is the community, have been conducted for evaluating community interventions, such as COMMIT. Finally, quasi-experimental studies (before/after study; prospective cohorts, both with a control group), in which the observational unit is a State, have been used for evaluating tobacco control policies, such as ASSIST and the International Tobacco Control Policy Evaluation Project. Although the successes of the last 20 years, tobacco

  16. Vehicle electrical system state controller

    Science.gov (United States)

    Bissontz, Jay E.

    2017-10-17

    A motor vehicle electrical power distribution system includes a plurality of distribution sub-systems, an electrical power storage sub-system and a plurality of switching devices for selective connection of elements of and loads on the power distribution system to the electrical power storage sub-system. A state transition initiator provides inputs to control system operation of switching devices to change the states of the power distribution system. The state transition initiator has a plurality of positions selection of which can initiate a state transition. The state transition initiator can emulate a four position rotary ignition switch. Fail safe power cutoff switches provide high voltage switching device protection.

  17. Regulatory Experience of the Embedded Digital Devices for Safety I and C Systems on Nuclear Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Y. M.; Lee, H. K.; Park, H. S. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2016-10-15

    Conventional I and C(Instrumentation and Control) systems are tend to becoming unavailable and being replaced by smart equipment. These smart equipment is usually called embedded digital devices (EDDs) or industrial digital devices of limited functionality. Usually, some of these devices are found embedded in plant equipment such as sensing instrumentation, motors, pumps, actuators and breakers. They typically have a micro-processor, RAM, communication interface, a power source, etc. The U.S. Nuclear Regulatory Commission (US NRC) is concerning that these EDDs might exist in procured equipment used in safety systems without the devices having been explicitly identified in procurement documentation. This paper addresses the regulatory experiences of KINS of the EDDs for safety I and C systems and the future works for them. In this paper, we showed regulatory experiences of EDDs which used for safety grade equipment. EDDs might exist in safety grade procured equipment without explicit identification. Undetected defects of EDDs might be the potential safety concerns. EDDs should meet certain specific requirements in order to be selected and used in safety I and C system. We have plan to develop technical positions for identification and qualifying them. The technical position will address, but may not be limited to, quality and reliability, CCFs via software errors, EMC, and CGID for EDDs.

  18. Notas acerca da atuação do Estado Regulador brasileiro sobre o setor educacional no âmbito dos cursos jurídicos: impasses e ajustes no sistema avaliativo como técnica de controle / Notes about the Brazilian regulatory State action in the educational sector within the law courses: deadlocks and adjustments in the evaluation system as control technique

    Directory of Open Access Journals (Sweden)

    Ramon Rebouças Nolasco de Oliveira

    2016-10-01

    Full Text Available Purpose – This study aims to analyze the performance of the Brazilian state, especially from the 90s of the twentieth century, as regulatory body of the legal education sector, considering criticisms on the evaluation model that has been used and the understanding of authors about the history of the creation of legal courses in the country in the nineteenth century and its development until nowadays. It also includes debates about the autonomy of educational institutions and of the democratic and participative criteria in the evaluation processes. Methodology/approach/design – It applied the documentary research method, which consisted of qualitative analysis of legislation and of the regulatory norms of the Brazilian educational sector, as well as bibliographical review of the literature produced in the two decades of the twenty-first century on the subject, especially about the Regulatory State, which indicated the research theoretical framework. Findings – Brazil has adopted a regulatory model based on assessment, as evidenced by the regulations. The Brazilian Regulatory State faces deadlocks and adjustments in the evaluative system used as control technique as far as law courses are concerned. Several authors pinpoint the shortcomings of legal education. This article pursues innovative ways of addressing the requirements for courses and the evaluation processes in order to tackle tensions with the private sector, to ensure increased access to higher education, without neglecting the quality level of the courses, according to the principles laid down by the legal framework on the subject.

  19. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2014-01-01

    This section of the Bulletin presents a summary of the recent national legislative and regulatory activities sorted by country and topic: - Algeria: Nuclear security. - France: Radioactive waste management; Nuclear safety and radiological protection; General legislation; International co-operation. - Germany: International trade. - Indonesia: Nuclear security, General legislation. - Ireland: Nuclear safety and radiological protection; General legislation. - Lithuania: Nuclear security; Nuclear safety and radiological protection. - Slovak Republic: International co-operation; Liability and compensation; Environmental protection. - Switzerland: Radioactive waste management. - United Arab Emirates: Liability and compensation. - United States: Radioactive waste management; Licensing and regulatory infrastructure

  20. Constitutive, Institutive and Up-Regulation of Carotenogenesis Regulatory Mechanism via In Vitro Culture Model System and Elicitors

    International Nuclear Information System (INIS)

    Rashidi Othman; Fatimah Azzahra Mohd Zaifuddin; Norazian Mohd Hassan

    2015-01-01

    Phyto hormone abscisic acid (ABA) plays a regulatory role in many physiological processes in plants and is regulated and controlled by specific key factors or genes. Different environmental stress conditions such as water, drought, cold, light, and temperature result in increased amounts of ABA. The action of ABA involves modification of gene expression and analysis of in vitro callus model system cultures revealed several potential of constitutive, institutive and up-regulation acting regulatory mechanisms. Therefore, this study was aimed at establishing in vitro cultures as potential research tools to study the regulatory mechanisms of the carotenoid biosynthesis in selected plant species through a controlled environment. The presence and absence of zeaxanthin and neoxanthin in callus cultures and intact plants could be explained by changes in gene expression in response to stress. Abiotic stress can alter gene expression and trigger cellular metabolism in plants. This study suggested that the key factors which involved in regulatory mechanisms of individual carotenoid biosynthesis in a particular biology system of plants can be either be silenced or activated. Therefore, based on the results in this study environmental stress is made possible for enhancement or enrichment of certain carotenoid of interest in food crops without altering the genes. (author)

  1. Innovative approach to training radiation safety regulatory professionals

    International Nuclear Information System (INIS)

    Gilley, Debbie Bray

    2008-01-01

    Full text: The supply of human resources required to adequately manage a radiation safety regulatory program has diminished in the last five years. Competing professional opportunities and a reduction in the number of health physics secondary schools have made it necessary to look at alternative methods of training. There are limited educational programs in the US that prepare our professionals for careers in the Radiation Regulatory Programs. The state of Florida's radiation control program embraced a new methodology using a combination of didactic and work experience using qualification journals, subject matter experts, and formalized training to develop a qualified pool of employees to perform the regulatory functions and emergency response requirements of a state radiation control program. This program uses a task-based approach to identify training needs and draws upon current staff to develop and implement the training. This has led to a task-oriented staff capable of responding to basic regulatory and emergency response activities within one year of employment. Florida's program lends itself to other states or countries with limited resources that have experienced staff attrition due to retirement or competing employment opportunities. Information on establishing a 'task-based' pool of employees that can perform basic regulatory functions and emergency response after one year of employment will be described. Initial task analysis of core functions and methodology is used to determine the appropriate training methodology for these functions. Instructions will be provided on the methodology used to 'mentor' new employees and then incorporate the new employees into the established core functions and be a useful employee at the completion of the first year of employment. New training philosophy and regime may be useful in assisting in the development of programs in countries and states with limited resources for training radiation protection personnel. (author)

  2. Regulatory point of view of SAT application

    International Nuclear Information System (INIS)

    Juhasz, L.

    2002-01-01

    I present the regulatory system for monitoring operator training and check competency of operator personnel in Hungary and the effects of SAT to the regulatory framework/practice related to recruitment, training and authorisation of operating personnel. Also I introduce an application to manage the initial and refreshing training to regulatory bodies. (author)

  3. Study on the establishment of efficient plan for regulatory activities at NPPs

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Sang Hun; Son, Mun Gyu [Korea Association for Nuclear Technology, Taejon (Korea, Republic of); Kang, Chang Sun; Yun, Jeong Ik; Ko, Hyun Seok; Lee, Young Wook [Seoul National Univ., Seoul (Korea, Republic of)

    2001-03-15

    In-operation regulatory activities at sites are very important and it should be improved to cope with accidents efficiently and quickly. In case of site survey and safety regulatory inspection regulatory system based on not regulatory headquarter but site regional office should be constructed. In other words, safety assurance and pending problem management considering site situation are needed. In this study, regulatory system at Nuclear Power Plant sites all over the world were reviewed and effective regulatory system of Korea are suggested to maximize the efficiency of license and regulatory manpower and consider the interest of local government and residents.

  4. Cost-benefit considerations in regulatory decision-making

    International Nuclear Information System (INIS)

    Harvie, J.D.

    1996-01-01

    The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost-benefit issues and work towards some consensus of opinion among stakeholders; a task force on the subject could be an appropriate starting point'. (author)

  5. Biological data warehousing system for identifying transcriptional regulatory sites from gene expressions of microarray data.

    Science.gov (United States)

    Tsou, Ann-Ping; Sun, Yi-Ming; Liu, Chia-Lin; Huang, Hsien-Da; Horng, Jorng-Tzong; Tsai, Meng-Feng; Liu, Baw-Juine

    2006-07-01

    Identification of transcriptional regulatory sites plays an important role in the investigation of gene regulation. For this propose, we designed and implemented a data warehouse to integrate multiple heterogeneous biological data sources with data types such as text-file, XML, image, MySQL database model, and Oracle database model. The utility of the biological data warehouse in predicting transcriptional regulatory sites of coregulated genes was explored using a synexpression group derived from a microarray study. Both of the binding sites of known transcription factors and predicted over-represented (OR) oligonucleotides were demonstrated for the gene group. The potential biological roles of both known nucleotides and one OR nucleotide were demonstrated using bioassays. Therefore, the results from the wet-lab experiments reinforce the power and utility of the data warehouse as an approach to the genome-wide search for important transcription regulatory elements that are the key to many complex biological systems.

  6. Management and share of regulatory information through web; development of regulatory information management system for Korea next generation reactors

    International Nuclear Information System (INIS)

    Lee, J. S.; Lee, J. H.; Jeong, Y. H.; Lee, S. H.; Yun, Y. C.; Park, M. I.

    2001-01-01

    The Regulatory Information Management System developed by the Korea Institute of Nuclear Safety supports researchers who are in charge of developing SRRG for the Korea Next Generation Reactors, manage the developed SRRG and development process, and make it possible to share the SRRG information and background knowledge through the internet with the nuclear-related personnel and the public. From the experience of the system operation, the search engine is repalced to manage the native SRRG files directly. This change eliminates the inconsistency between native files and database files and improve the search exactness by automatic indexing function. The user interface of the internet homepage (http://kngr.kins.re.kr) is completely rebuilded and allows SRRG developers to manage the search system and the atomic energy regulations database on the Web without the help of the client programs. General users are also able to utilize more convenient search function and additional information by the improved interface. The system is running under the backup system and firewall system for the data protection and security

  7. Management and share of regulatory information through web; development of regulatory information management system for Korea next generation reactors

    Energy Technology Data Exchange (ETDEWEB)

    Lee, J. S.; Lee, J. H.; Jeong, Y. H.; Lee, S. H. [KINS, Taejon (Korea, Republic of); Yun, Y. C.; Park, M. I. [LG-EDS Systems, Seoul (Korea, Republic of)

    2001-05-01

    The Regulatory Information Management System developed by the Korea Institute of Nuclear Safety supports researchers who are in charge of developing SRRG for the Korea Next Generation Reactors, manage the developed SRRG and development process, and make it possible to share the SRRG information and background knowledge through the internet with the nuclear-related personnel and the public. From the experience of the system operation, the search engine is repalced to manage the native SRRG files directly. This change eliminates the inconsistency between native files and database files and improve the search exactness by automatic indexing function. The user interface of the internet homepage (http://kngr.kins.re.kr) is completely rebuilded and allows SRRG developers to manage the search system and the atomic energy regulations database on the Web without the help of the client programs. General users are also able to utilize more convenient search function and additional information by the improved interface. The system is running under the backup system and firewall system for the data protection and security.

  8. State estimation for Markov-type genetic regulatory networks with delays and uncertain mode transition rates

    International Nuclear Information System (INIS)

    Liang Jinling; Lam, James; Wang Zidong

    2009-01-01

    This Letter is concerned with the robust state estimation problem for uncertain time-delay Markovian jumping genetic regulatory networks (GRNs) with SUM logic, where the uncertainties enter into both the network parameters and the mode transition rate. The nonlinear functions describing the feedback regulation are assumed to satisfy the sector-like conditions. The main purpose of the problem addressed is to design a linear estimator to approximate the true concentrations of the mRNA and protein through available measurement outputs. By resorting to the Lyapunov functional method and some stochastic analysis tools, it is shown that if a set of linear matrix inequalities (LMIs) is feasible, the desired state estimator, that can ensure the estimation error dynamics to be globally robustly asymptotically stable in the mean square, exists. The obtained LMI conditions are dependent on both the lower and the upper bounds of the delays. An illustrative example is presented to demonstrate the feasibility of the proposed estimation schemes.

  9. Interrogating the topological robustness of gene regulatory circuits by randomization.

    Directory of Open Access Journals (Sweden)

    Bin Huang

    2017-03-01

    Full Text Available One of the most important roles of cells is performing their cellular tasks properly for survival. Cells usually achieve robust functionality, for example, cell-fate decision-making and signal transduction, through multiple layers of regulation involving many genes. Despite the combinatorial complexity of gene regulation, its quantitative behavior has been typically studied on the basis of experimentally verified core gene regulatory circuitry, composed of a small set of important elements. It is still unclear how such a core circuit operates in the presence of many other regulatory molecules and in a crowded and noisy cellular environment. Here we report a new computational method, named random circuit perturbation (RACIPE, for interrogating the robust dynamical behavior of a gene regulatory circuit even without accurate measurements of circuit kinetic parameters. RACIPE generates an ensemble of random kinetic models corresponding to a fixed circuit topology, and utilizes statistical tools to identify generic properties of the circuit. By applying RACIPE to simple toggle-switch-like motifs, we observed that the stable states of all models converge to experimentally observed gene state clusters even when the parameters are strongly perturbed. RACIPE was further applied to a proposed 22-gene network of the Epithelial-to-Mesenchymal Transition (EMT, from which we identified four experimentally observed gene states, including the states that are associated with two different types of hybrid Epithelial/Mesenchymal phenotypes. Our results suggest that dynamics of a gene circuit is mainly determined by its topology, not by detailed circuit parameters. Our work provides a theoretical foundation for circuit-based systems biology modeling. We anticipate RACIPE to be a powerful tool to predict and decode circuit design principles in an unbiased manner, and to quantitatively evaluate the robustness and heterogeneity of gene expression.

  10. Annual Report 2008. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2009-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2008. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  11. Annual Report 2007. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2008-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across tree parts and seven annexes the activities developed by the organism during 2007. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  12. The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

    Science.gov (United States)

    Keyter, Andrea; Gouws, Joey; Salek, Sam; Walker, Stuart

    2018-01-01

    The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

  13. Waste management strategy for nuclear fusion power systems from a regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Heckman, R.A.

    1977-12-06

    A waste management strategy for future nuclear fusion power systems is developed using existing regulatory methodology. The first step is the development of a reference fuel cycle. Next, the waste streams from such a facility are identified. Then a waste management system is defined to safely handle and dispose of these wastes. The future regulator must identify the decisions necessary to establish waste management performance criteria. The data base and methodologies necessary to make these decisions must then be developed. Safe management of nuclear fusion wastes is not only a technological challenge, but encompasses significant social, political, and ethical questions as well.

  14. Waste management strategy for nuclear fusion power systems from a regulatory perspective

    International Nuclear Information System (INIS)

    Heckman, R.A.

    1977-01-01

    A waste management strategy for future nuclear fusion power systems is developed using existing regulatory methodology. The first step is the development of a reference fuel cycle. Next, the waste streams from such a facility are identified. Then a waste management system is defined to safely handle and dispose of these wastes. The future regulator must identify the decisions necessary to establish waste management performance criteria. The data base and methodologies necessary to make these decisions must then be developed. Safe management of nuclear fusion wastes is not only a technological challenge, but encompasses significant social, political, and ethical questions as well

  15. Nuclear power reactor licensing and regulation in the United States

    International Nuclear Information System (INIS)

    Shapar, H.K.

    1979-01-01

    The report is devoted to four subjects: an explanation of the origins, statutory basis and development of the present regulatory system in the United States; a description of the various actions which must be taken by a license applicant and by the Nuclear Regulatory Commission before a nuclear power plant can be constructed and placed on-line, an account of the current regulatory practices followed by the US NRC in licensing nuclear power reactors; an identification of some of the 'lessons learned' from the Three Mile Island accident and some proposed regulatory and legislative solutions. (NEA) [fr

  16. Regulatory dendritic cell therapy: from rodents to clinical application

    OpenAIRE

    Raïch-Regué, Dalia; Glancy, Megan; Thomson, Angus W.

    2013-01-01

    Dendritic cells (DC) are highly-specialized, bone marrow-derived antigen-presenting cells that induce or regulate innate and adaptive immunity. Regulatory or “tolerogenic” DC play a crucial role in maintaining self tolerance in the healthy steady-state. These regulatory innate immune cells subvert naïve or memory T cell responses by various mechanisms. Regulatory DC (DCreg) also exhibit the ability to induce or restore T cell tolerance in many animal models of autoimmune disease or transplant...

  17. Energy reduction for a dual circuit cooling water system using advanced regulatory control

    International Nuclear Information System (INIS)

    Muller, C.J.; Craig, I.K.

    2016-01-01

    Highlights: • Potentially reduce energy required by a dual circuit cooling water system by 30%. • Accomplished using an advanced regulatory control and switching strategy. • No formal process model is required. • Can be implemented on control system hardware commonly used in industry. - Abstract: Various process utilities are used in the petrochemical industry as auxiliary variables to facilitate the addition/removal of energy to/from the process, power process equipment and inhibit unwanted reaction. Optimisation activities usually focus on the process itself or on the utility consumption though the generation and distribution of these utilities are often overlooked in this regard. Many utilities are prepared or generated far from the process plant and have to be transported or transmitted, giving rise to more losses and potential inefficiencies. To illustrate the potential benefit of utility optimisation, this paper explores the control of a dual circuit cooling water system with focus on energy reduction subject process constraints. This is accomplished through the development of an advanced regulatory control (ARC) and switching strategy which does not require the development of a system model, only rudimentary knowledge of the behaviour of the process and system constraints. The novelty of this manuscript lies in the fact that it demonstrates that significant energy savings can be obtained by applying ARC to a process utility containing both discrete and continuous dynamics. Furthermore, the proposed ARC strategy does not require a plant model, uses only existing plant equipment, and can be implemented on control system hardware commonly used in industry. The simulation results indicate energy saving potential in the region of 30% on the system under investigation.

  18. As to achieve regulatory action, regulatory approaches

    International Nuclear Information System (INIS)

    Cid, R.; Encinas, D.

    2014-01-01

    The achievement of the effectiveness in the performance of a nuclear regulatory body has been a permanent challenge in the recent history of nuclear regulation. In the post-Fukushima era this challenge is even more important. This article addresses the subject from two complementary points of view: the characteristics of an effective regulatory body and the regulatory approaches. This work is based on the most recent studies carried out by the Committee on Nuclear Regulatory Activities, CNRA (OECD/NEA), as well as on the experience of the Consejo de Seguridad Nuclear, CSN, the Spanish regulatory body. Rafael Cid is the representative of CSN in these project: Diego Encinas has participated in the study on regulatory approaches. (Author)

  19. Bölgesel Yenilik Sistemlerinde Devletin Rolü: Düzey 2 Bölgelerine İlişkin Ampirik Bir Analiz(The Role of State in Regional Innovation System: An Empirical Analysis of NUTS 2 Region

    Directory of Open Access Journals (Sweden)

    Gökhan DÖKMEN

    2012-01-01

    Full Text Available The state has a regulatory role in regional innovation systems. The regulatory role of the state in systemic approach covers a variety of areas such as building habitats for innovation and entrepreneurship, promotion of clustering and supporting innovative networks. This study examines the impact of public policies such as public investment, investment subsidies and advanced technology investment in state university on regional innovation. The relation between regional innovation and public policy tools has been tested for 1999-2008 period on 20 NUTS 2 regions by using panel DOLS (dynamic ordinary least square method. The result showed a positive and statistically significant equilibrium relation regional innovation and public expenditure. Further, investment subsidies and advanced technology investment have no significant impact on regional innovation capacity in NUTS2 regions.

  20. Investigating relationship between self- and co-regulatory learning processes in a workplace e-learning system

    NARCIS (Netherlands)

    Rahimi, E.; Tampinongkol, S.; Sedighi, M.; Van den Berg, J.; Veen, W.

    2014-01-01

    While supporting regulatory learning processes in work environments is increasingly becoming important, there is not a clear picture of the interaction between self- and coregulatory processes performed by learners in workplace e-learning systems. In this paper, by following a design-based research

  1. 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.

  2. United States Nuclear Regulatory Commission staff practice and procedure digest

    International Nuclear Information System (INIS)

    1990-03-01

    This document contains procedures for review by US Nuclear Regulatory Commission for reviewing and deciding on matters pertaining to nuclear power plant licensing. Also, contained within the document are decisions the Commission has made between July 1972 to September 1989. (F.S.D.)

  3. Regulatory control of nuclear power plants

    International Nuclear Information System (INIS)

    2002-01-01

    The purpose of this book is to support IAEA training courses and workshops in the field of regulatory control of nuclear power plants as well as to support the regulatory bodies of Member States in their own training activities. The target group is the professional staff members of nuclear safety regulatory bodies supervising nuclear power plants and having duties and responsibilities in the following regulatory fields: regulatory framework; regulatory organization; regulatory guidance; licensing and licensing documents; assessment of safety; and regulatory inspection and enforcement. Important topics such as regulatory competence and quality of regulatory work as well as emergency preparedness and public communication are also covered. The book also presents the key issues of nuclear safety such as 'defence-in-depth' and safety culture and explains how these should be taken into account in regulatory work, e.g. during safety assessment and regulatory inspection. The book also reflects how nuclear safety has been developed during the years on the basis of operating experience feedback and results of safety research by giving topical examples. The examples cover development of operating procedures and accident management to cope with complicated incidents and severe accidents to stress the importance of regulatory role in nuclear safety research. The main target group is new staff members of regulatory bodies, but the book also offers good examples for more experienced inspectors to be used as comparison and discussion basis in internal workshops organized by the regulatory bodies for refreshing and continuing training. The book was originally compiled on the basis of presentations provided during the two regulatory control training courses in 1997 and 1998. The textbook was reviewed at the beginning of the years 2000 and 2002 by IAEA staff members and consistency with the latest revisions of safety standards have been ensured. The textbook was completed in the

  4. The Regulatory Cooperation Forum, an Opportunity to Strengthen International Cooperation

    International Nuclear Information System (INIS)

    Lachaume, J.L.; Mamoru, M.

    2016-01-01

    The Regulatory Cooperation Forum (RCF) is a member-driven forum of nuclear power regulators created in 2010 that promotes the sharing of regulatory knowledge and experience through international cooperation and collaboration using the IAEA Safety Standards as its basis. The RCF involves countries with advanced nuclear power programmes, countries embarking on nuclear power for the first time and countries with smaller programmes considering expansion. The primary objectives of the RCF are: • To promote collaboration and cooperation among RCF members to improve coordination of support for regulatory infrastructure development; • To contribute to achieving and sustaining a high level of nuclear safety, consistent with the IAEA Safety Standards and Guidance; • To optimize resources among RCF members and avoid unnecessary support duplication through improved coordination. Membership of the RCF is open to all Member States of the IAEA. Participants in RCF activities will normally be senior representatives from regulatory bodies in Member States and from other providers, including the IAEA, European Commission (EC) and the Nuclear Energy Agency (NEA) of the Organization for Economic Co-operation and Development (OECD). So far, more than 30 countries are members of the RCF. The RCF has developed Action Plans to support Jordan, Vietnam, Belarus and Poland. The IAEA’s Nuclear Safety Action Plan urges Member States to strengthen the effectiveness of national regulatory bodies as well as base the development of their nuclear infrastructures on IAEA Safety Standards. The RCF assists Member States in implementing both of these actions for embarking, existing and expanding nuclear programmes. (author)

  5. IAEA Mission Concludes Peer Review of UK's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: Senior international nuclear safety and radiation protection experts today concluded a ten-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in the United Kingdom (UK). The Integrated Regulatory Review Service (IRRS) mission team said in its preliminary findings that the UK had made considerable progress since reviews in 2006 and 2009. It also identified good practices in the country's nuclear regulatory system. In addition to following up previous missions, a key objective was to review the effectiveness of the role of the Office of Nuclear Regulation (ONR), the UK's nuclear regulator, in ensuring the safety of radioactive waste management and decommissioning, occupational radiation protection, and public and environmental exposures, including emergency planning and response. The mission also considered the response of the UK's regulatory regime to the implications of the Fukushima Daichi accident had been timely and effective. Recommendations and suggestions were made to the ONR and the Government aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards, the control of radioactive discharges and environmental monitoring. 'The staff of ONR is clearly dedicated to their mission to secure the protection of people and society from the hazards of the nuclear industry. I am confident that ONR will use the results of this mission to further enhance their regulatory programs', said Bill Borchardt, mission leader and former Executive Director of the United States Nuclear Regulatory Commission (NRC). 'The staff were open and cooperative in their discussions; they provided the fullest practicable assistance, and accepted advice from the Team for continuous improvement in their regulatory work'. ONR's Chief Executive, John Jenkins, said that the full report of the IRRS mission will enhance regulatory effectiveness in the UK

  6. IAEA Team Concludes Peer Review of Greece's Regulatory Framework for Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    ; and GEAC exhibits a strong commitment to education and training in radiation protection. The IRRS Review team identified issues warranting attention or in need of improvement, including: The Radiation Protection Regulations require updating to bring them in line with the current IAEA Safety Requirements. Consideration should be given to the adoption of a more flexible hierarchy of safety regulations; The nation's legal framework is dated, lacks the flexibility of a risk-based regulatory framework which provides for a graded approach to safety and has gaps particularly in respect of waste and decommissioning; A consolidated management system requires senior management commitment to allocate sufficient resources with the appropriate authority, and to actively involve all staff; and The prime responsibility for safety, the responsibilities of employers and workers with respect to occupational exposure, and responsibilities with respect to emergency preparedness and response need to be explicitly assigned in the legal and regulatory framework for safety. In a preliminary report, the IAEA has conveyed the team's main conclusions to GAEC, and a final report will be submitted to the commission in about three months. Background The IRRS team carried out a review of Greece's nuclear legal and regulatory framework for safety. The IRRS review addressed the facilities and activities regulated by GAEC which involve radiation sources in addition to the waste management facilities. The research reactor GRR-1 in the National Centre for Scientific Research ''Demokritos'' was out of the scope of this IRRS review but will be included in the follow-up mission. The mission took place from 20 to 30 May 2012 at the GAEC headquarters in Agia Paraskevi. A Press Conference was conducted at the end of the mission on 30 May. The IRRS team consisted of nine senior regulatory experts from nine IAEA Member States and five IAEA staff members. About IRRS Missions IRRS missions are designed to

  7. Role of the state in the regulation of low-level radioactive waste

    International Nuclear Information System (INIS)

    Brenneman, F.N.; Salomon, S.N.

    1983-03-01

    This document describes the role of the State in the regulation of low-level radioactive waste in the context of the Low-Level Radioactive Waste Policy Act of 1980 (Public Law 96-573), which recognizes that the States are responsible for disposal of the waste and as such may develop interstate compacts. The perspective is the present national regulatory framework for the waste system, including generation, transport, treatment, storage and disposal. Although not a definitive legal statement of the area in which States may properly act, the regulatory authority of all Compact States as Agreement States, States with a limited Agreement, and as non-Agreement States is described. The analysis is based on the assumption that the disposal site is State land

  8. Regulation of the life cycle of nuclear installations. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    1999-06-01

    This report arises from the sixth series of peer discussions on regulatory practices entitled 'Regulation of Life Cycle of Nuclear Installations'. Senior regulators from 18 Member States participated in three peer group discussions during 1997-1998. 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 nominating organizations, or the IAEA. The purpose of this report is to disseminate the views which the senior regulators presented at the meetings relating to the policies, principles and requirements imposed by regulatory bodies for the safe management of the life cycle of a nuclear installation. The intention of doing this is to assist Member States in the formulation and enhancement of their regulatory control over PLCM by identifying commonly accepted good practices. This report is structured to cover the subject matter under the following main headings: Policies and Principles for the Life Cycle Management of Nuclear Installations; Responsibilities of the Regulatory Body and the Operating Organization; Requirements and Criteria Imposed by the Regulatory Body; Licensing and Regulatory Assessment for Plant Life Cycle Management; and Good Practices

  9. Annual Report 2009. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2009. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  10. Strengthening Regulatory Competence in Pakistan

    International Nuclear Information System (INIS)

    Sadiq, M.

    2016-01-01

    Capacity building of Pakistan Nuclear Regulatory Authority is considered an essential element in pursuit of its vision to become a world class regulatory body. Since its inception in 2001, PNRA has continuously endeavoured to invest in its people, develop training infrastructure and impart sound knowledge and professional skills with the aim to improve its regulatory effectiveness. The use of nuclear and radioactive material in Pakistan has increased manifold in recent years, thus induction of more manpower was needed for regulatory oversight. PNRA adopted two pronged approach for meeting the manpower demand (a) employment of university graduates through fast track recruitment drive and (b) induction of graduates by offering fellowships for Master degree programs. Although, the newly employed staff was selected on the basis of their excellent academic qualifications in basic and applied sciences, but they required rigorous knowledge and skills in regulatory perspectives. In order to implement a structured training program, PNRA conducted Training Needs Assessment (TNA) and identified competency gaps of the regulatory staff in legal, technical, regulatory practice and behavioural domains. PNRA took several initiatives for capacity building which included establishment of a training centre for sustainability of trainings, initiation of a fellowship scheme for Master program, attachment of staff at local institutes for on-the-job training and placement at foreign regulatory bodies and organizations for technical development with the assistance of IAEA. The above strategies have been very beneficial in competence building of the PNRA staff to perform all regulatory activities indigenously for nuclear power plants, research reactors and radiation facilities. Provision of vibrant technical support to IAEA and Member States in various programs by PNRA is a landmark of these competence development efforts. This paper summarizes PNRA initiatives and the International Atomic

  11. Regulatory viewpoint on nuclear fuel quality assurance

    International Nuclear Information System (INIS)

    Tripp, L.E.

    1976-01-01

    Considerations of the importance of fuel quality and performance to nuclear safety, ''as low reasonably achievable'' release of radioactive materials in reactor effluents, and past fuel performance problems demonstrate the need for strong regulatory input, review and inspection of nuclear fuel quality assurance programs at all levels. Such a regulatory program is being applied in the United States of America by the US Nuclear Regulatory Commission. Quality assurance requirements are contained within government regulations. Guidance on acceptable methods of implementing portions of the quality assurance program is contained within Regulatory Guides and other NRC documents. Fuel supplier quality assurance program descriptions are reviewed as a part of the reactor licensing process. Inspections of reactor licensee control of their fuel vendors as well as direct inspections of fuel vendor quality assurance programs are conducted on a regularly scheduled basis. (author)

  12. Regulatory Guidance for Lightning Protection in Nuclear Power Plants

    International Nuclear Information System (INIS)

    Kisner, Roger A.; Wilgen, John B.; Ewing, Paul D.; Korsah, Kofi; Antonescu, Christina E.

    2006-01-01

    Oak Ridge National Laboratory (ORNL) was engaged by the U.S. Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) to develop the technical basis for regulatory guidance to address design and implementation practices for lightning protection systems in nuclear power plants (NPPs). Lightning protection is becoming increasingly important with the advent of digital and low-voltage analog systems in NPPs. These systems have the potential to be more vulnerable than older analog systems to the resulting power surges and electromagnetic interference (EMI) when lightning strikes facilities or power lines. This paper discusses the technical basis for guidance to licensees and applicants covered in Regulatory Guide (RG) 1.204, Guidelines for Lightning Protection of Nuclear Power Plants, issued August 2005. RG 1.204 describes guidance for practices that are acceptable to the NRC staff for protecting nuclear power structures and systems from direct lightning strikes and the resulting secondary effects.

  13. A flexible regulatory framework

    International Nuclear Information System (INIS)

    Silvennoinen, T.

    2000-01-01

    Regulatory reform of the Finnish electricity market meant opening up potentially competitive parts of the electricity sector to competition and eliminating all unnecessary forms of regulation covering generation, wholesale supply, retail supply, and foreign trade in electricity. New types of control and regulatory mechanisms and institutions were set up for those parts of the electricity industry that were excluded from competition, such as network operations. Network activities now have to be licensed, whereas no licence is needed for generation or supply. A new sector-specific regulatory authority was established in 1995 to coincide with the implementation of the Electricity Market Act, known as the Electricity Market Authority. This is responsible for regulating network activities and retail supply to captive customers. The core function of the authority, which employs some 14 people, is to promote the smooth operation of the Finnish electricity market and to oversee the implementation of the Electricity Market Act and its provisions. Its most important duties are linked to overseeing the process by which network companies price their electricity. As price regulation no longer exists, all the companies in the electricity sector set their tariffs independently, even network companies. The job of controlling the pricing of network services is handed by the Electricity Market Authority, following the principles of competition control. Pricing control takes place ex post - after a pricing system has been adopted by a company and concentrates on individual cases and companies. There is no ex ante system of setting or approving prices and tariffs by the regulator. The tariffs and pricing of network services can be evaluated, however, by both the Electricity Market Authority and the Finnish Competition Authority, which have overlapping powers as regards the pricing of network activities. The Finnish regulatory framework can be described as a system of light

  14. Cyber Security in Nuclear Power Plants - U.S. NRC Regulatory Guide 5.71

    International Nuclear Information System (INIS)

    Pogacic, Goran

    2014-01-01

    We have already made a big step into new millennia and with it there is no more dilemma about presence of computers and internet in our lives. Almost all modern facilities struggle with this new dimension of information flow and how to use it to their best interest. But there is also the other side of the coin- the security threat. For nuclear power plants this threat poses even greater risk. In addition to protecting their trade secrets, personal data or other common targets of cyber attacks, nuclear power plants need to protect their digital computers, communication systems and networks up to and including the design basis threat (DBT). As stated in U.S. Nuclear Regulatory Commission (NRC) Regulatory Commission Regulations, Title 10, Code of Federal Regulations (CFR), section 73.1, 'Purpose and Scope' this includes protection against acts of radiological sabotage and prevention of the theft or diversion of special nuclear material. The main purpose of this paper is to explore the NRC Regulatory Guide (RG) 5.71 and its guidance in implementing cyber security requirements stated in NRC 10 CFR, section 73.54, 'Protection of Digital Computer and Communication Systems and Networks'. In particular, this section requires protection of digital computers, communication systems and networks associated with the following categories of functions: · safety-related and important-to-safety functions, · security functions, · emergency preparedness functions, including offsite communication, and · support systems and equipment which, if compromised, would adversely impact safety, security, or emergency preparedness functions. This section requires protection of such systems and networks from those cyber attacks that would act to modify, destroy, or compromise the integrity or confidentiality of data or software; deny access to systems, services or data; and impact the operation of systems, networks, and equipment. This paper will also present some of

  15. Responsividade do Sistema Sancionatório da Radiodifusão Brasileira / Responsiveness of the Brazilian broadcasting regulatory system of sanctions

    Directory of Open Access Journals (Sweden)

    Marcelo Barros da Cunha

    2016-05-01

    Full Text Available Purpose – The purpose of this paper is to evaluate the responsiveness of the system of sanctions applicable to broadcasting concessionaires in Brazil. Methodology/approach/design – The research considered the theory of responsive regulation proposed by Ayres and Braithwaite as parameter for the critical analysis of the Brazilian broadcasting regulatory system of sanctions. Findings – The research concluded that the system of sanctions does not encourage concessionaires to comply with its legal, contractual and regulatory obligations, as penalties do not promote dialogue between regulator and regulated firms. There are legal obstacles for the application of the maximum penalty of revocation of concession, and some fines imposed on concessionaires in the past could not be collected as they were barred by statute of limitations. Practical implications – The findings of this research may be considered by Brazilian regulators on the development of a more responsive and effective system of sanctions for broadcasting. Originality/value (optional – The research introduces the discussion on responsiveness regarding the Brazilian broadcasting regulatory model.

  16. Regulatory use the classification security systems of I and C in VVER type reactors

    International Nuclear Information System (INIS)

    Ilizastegui Perez, F.

    1998-01-01

    Presently work the author proposes a classification to the system I and C to the VVER 440 type reactor in categories the regulatory control with a view to establishing the degree to the attention that the regulator should pay to these systems, leaving the importance that have the same ones for the security the installation, during the execution the works that are carried out with this equipment in the stages construction, setting in service and exploitation

  17. Fixed Points in Discrete Models for Regulatory Genetic Networks

    Directory of Open Access Journals (Sweden)

    Orozco Edusmildo

    2007-01-01

    Full Text Available It is desirable to have efficient mathematical methods to extract information about regulatory iterations between genes from repeated measurements of gene transcript concentrations. One piece of information is of interest when the dynamics reaches a steady state. In this paper we develop tools that enable the detection of steady states that are modeled by fixed points in discrete finite dynamical systems. We discuss two algebraic models, a univariate model and a multivariate model. We show that these two models are equivalent and that one can be converted to the other by means of a discrete Fourier transform. We give a new, more general definition of a linear finite dynamical system and we give a necessary and sufficient condition for such a system to be a fixed point system, that is, all cycles are of length one. We show how this result for generalized linear systems can be used to determine when certain nonlinear systems (monomial dynamical systems over finite fields are fixed point systems. We also show how it is possible to determine in polynomial time when an ordinary linear system (defined over a finite field is a fixed point system. We conclude with a necessary condition for a univariate finite dynamical system to be a fixed point system.

  18. The Political Economy of Regulatory Change

    DEFF Research Database (Denmark)

    Buch-Hansen, Hubert

    2012-01-01

    This article aims to explain the broader evolution of British merger control. To this end it outlines a novel critical political economy perspective on regulation and regulatory change which differs from established political economy approaches, such as the regulatory capitalism/state perspectives...... to the analysis of the evolution of British merger control provides some important new insights, most notably that the content, form, and scope of merger control in Britain have been deeply transformed in accordance with neoliberal ideas since the 1980s and that this process, which was part of a broader...

  19. State-Dependent Resource Harvesting with Lagged Information about System States.

    Directory of Open Access Journals (Sweden)

    Fred A Johnson

    Full Text Available Markov decision processes (MDPs, which involve a temporal sequence of actions conditioned on the state of the managed system, are increasingly being applied in natural resource management. This study focuses on the modification of a traditional MDP to account for those cases in which an action must be chosen after a significant time lag in observing system state, but just prior to a new observation. In order to calculate an optimal decision policy under these conditions, possible actions must be conditioned on the previous observed system state and action taken. We show how to solve these problems when the state transition structure is known and when it is uncertain. Our focus is on the latter case, and we show how actions must be conditioned not only on the previous system state and action, but on the probabilities associated with alternative models of system dynamics. To demonstrate this framework, we calculated and simulated optimal, adaptive policies for MDPs with lagged states for the problem of deciding annual harvest regulations for mallards (Anas platyrhynchos in the United States. In this particular example, changes in harvest policy induced by the use of lagged information about system state were sufficient to maintain expected management performance (e.g. population size, harvest even in the face of an uncertain system state at the time of a decision.

  20. State-dependent resource harvesting with lagged information about system states

    Science.gov (United States)

    Johnson, Fred A.; Fackler, Paul L.; Boomer, G Scott; Zimmerman, Guthrie S.; Williams, Byron K.; Nichols, James D.; Dorazio, Robert

    2016-01-01

    Markov decision processes (MDPs), which involve a temporal sequence of actions conditioned on the state of the managed system, are increasingly being applied in natural resource management. This study focuses on the modification of a traditional MDP to account for those cases in which an action must be chosen after a significant time lag in observing system state, but just prior to a new observation. In order to calculate an optimal decision policy under these conditions, possible actions must be conditioned on the previous observed system state and action taken. We show how to solve these problems when the state transition structure is known and when it is uncertain. Our focus is on the latter case, and we show how actions must be conditioned not only on the previous system state and action, but on the probabilities associated with alternative models of system dynamics. To demonstrate this framework, we calculated and simulated optimal, adaptive policies for MDPs with lagged states for the problem of deciding annual harvest regulations for mallards (Anas platyrhynchos) in the United States. In this particular example, changes in harvest policy induced by the use of lagged information about system state were sufficient to maintain expected management performance (e.g. population size, harvest) even in the face of an uncertain system state at the time of a decision.

  1. Views from the japanese regulatory authority

    International Nuclear Information System (INIS)

    Aoyama, S.

    2004-01-01

    The legislation system for regulation of radioisotope in Japan was established in 1957. The system has been revised gradually since its establishment. Major amendments of the law were made in 1988 on the basis of ICRP Publication 26 and in 2000 on the basis of Publication 60. Main principles provided in the publication have been already introduced into the law. However, some concepts proposed in the recommendations are still under discussion. The current status of implementation of the ICRP recommendations in the Japanese regulatory system is summarised. Views from the regulatory authority of Japan on the points to be improved in the current system of radiological protection are presented. (author)

  2. NRC regulatory information conference: Proceedings

    International Nuclear Information System (INIS)

    1989-09-01

    This volume of the report provides the proceedings from the Nuclear Regulatory Commission (NRC) Regulatory Information Conference that was held at the Mayflower Hotel, Washington, DC, on April 18, 19, and 20, 1989. This conference was held by the NRC and chaired by Dr. Thomas E. Mosley, Director, Office of Nuclear Reactor Regulations (NRR) and coordinated by S. Singh Bajwa, Chief, Technical Assistance Management Section, NRR. There were approximately 550 participants from nine countries at the conference. The countries represented were Canada, England, Italy, Japan, Mexico, Spain, Taiwan, Yugoslavia, and the United States. The NRC staff discussed with nuclear industry its regulatory philosophy and approach and the bases on which they have been established. Furthermore, the NRC staff discussed several initiatives that have been implemented recently and their bases as well as NRC's expectations for new initiatives to further improve safety. The figures contained in Appendix A to the volume correspond to the slides that were shown during the presentations. Volume 2 of this report contains the formal papers that were distributed at the beginning of the Regulatory Information Conference and other information about the conference

  3. Regulatory approaches to obesity prevention: A systematic overview of current laws addressing diet-related risk factors in the European Union and the United States.

    Science.gov (United States)

    Sisnowski, Jana; Handsley, Elizabeth; Street, Jackie M

    2015-06-01

    High prevalence of overweight and obesity remains a significant international public health problem. Law has been identified as a tool for obesity prevention and selected high-profile measures have been reported. However, the nature and extent of enacted legislation internationally are unclear. This research provides an overview of regulatory approaches enacted in the United States, the European Union, and EU Member States since 2004. To this end, relevant databases of primary and secondary legislation were systematically searched to identify and explore laws addressing dietary risk factors for obesity. Across jurisdictions, current regulatory approaches to obesity prevention are limited in reach and scope. Target groups are rarely the general population, but instead sub-populations in government-supported settings. Consumer information provision is preferred over taxation and marketing restrictions other than the regulation of health and nutrition claims. In the EU in particular, product reformulation with industry consent has also emerged as a popular small-scale measure. While consistent and widespread use of law is lacking, governments have employed a range of regulatory measures in the name of obesity prevention, indicating that there is, in principle, political will. Results from this study may serve as a starting point for future research and policy development. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  4. 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

  5. National legislative and regulatory activities: Armenia, Brazil, Canada, France, Georgia, Greece, India, Ireland, Japan, Lithuania, Switzerland, Ukraine, United Arab Emirates, United States

    International Nuclear Information System (INIS)

    Anon.

    2012-01-01

    Armenia: Nuclear safety and radiological protection (Initiation of process relating to the life extension of nuclear power plant unit 2). Brazil: General legislation (Authorisation for the construction of nuclear submarines). Canada: Environmental protection (Changes to the federal environmental assessment law). France: Radioactive waste management (Changes to the National Plan for Management of Radioactive Materials and Waste). Georgia: Nuclear safety and radiological protection (New law on nuclear and radiation safety). Greece: Nuclear safety (Presidential decree on nuclear safety transposing European Council directive into national legislation); Emergency preparedness and response (Establishment of national plan for nuclear, radiological, biological and chemical threats). India: Licensing and regulatory infrastructure (Pending invitation for the IAEA's Integrated Regulatory Review Services to conduct a peer review); Liability and compensation (Committee on Subordinate Legislation Report on the Civil Liability for Nuclear Damage Rules, 2011). Ireland: Nuclear safety and radiological protection (Adoption of revised regulations regarding radiological protection). Japan: Nuclear Regulation Authority Act (Structure, Functions, New Nuclear Emergency Preparedness System). Lithuania: General legislation (New laws affecting Visaginas nuclear power plant project implementation); Licensing and regulatory infrastructure (Revised rules for issuing licenses and permits); Nuclear security (Revised physical protection requirements, New rules for the preparation of security plans); Radioactive waste management (Revised Rules of Procedure of Submission of Data on Activities Involving Radioactive Waste Disposal to the European Commission). Switzerland: General legislation (Draft energy strategy open for public comment until January 2013). Ukraine: Radioactive waste management (New law on development of a central repository); General legislation (Law providing for the location

  6. State-of-art report on digital I and C system reliability issues for nuclear power plants

    International Nuclear Information System (INIS)

    Hwang, In Koo; Lee, Dong Gyoung; Cha, Kyung Ho; Kwon, Kee Choon; Wood, Richard T.

    2000-01-01

    As the instrumentation and control (Iand C) equipment suppliers tend to provide digital components rather than conventional analog type components for instrument and control systems of nuclear power plants(NPPs), it is unavoidable to adopt digital equipment for safety I and C systems as well as non-safety systems. However, the full introduction of digital equipment to I and C systems of nuclear power plants raises several concerns which have not been considered for conventional analog I and C systems. The two major examples of the issues of digital systems are electromagnetic compatibility (EMC) and software reliability. KAERI invited a technical expert, Dr. Richard T. Wood, from Oak Ridge National Laboratory (ORNL) in Unites States and held seminars to recognize the state-of-art of the above issues and to share the information on techniques dealing with the problems. Dr. Wood has been working on the development of EMC guidelines and technical basis in using digital equipment for safety systems in nuclear power plants on the sponsorship of US Nuclear Regulatory Commission (NRC). Being based on his statements and discussions during his visit, this report describes technical considerations and issues on digital safety I and C system application in NPPs, EMC methods, environmental effects vulnerable to digital components, reliability assurance methods, etc. (author)

  7. Decisions by regulatory agencies: are they evidence-based?

    Directory of Open Access Journals (Sweden)

    Furberg Curt D

    2007-04-01

    Full Text Available Abstract Contradictory statements about the non-steroidal anti-inflammatory drugs from the European Medicines Agency and the United States Food and Drug Administration have raised questions about whether regulatory decisions are evidence-based. For the selective COX-2 inhibitors, there are clear contraindications and warnings in Europe, but only a vaguely worded Black Box warning in the United States. All the non-selective agents are given an almost "clean bill of health" in Europe, while all of them are judged to have a similar risk-benefit ratio as celecoxib in the United States. The regulatory agencies have failed to recognize the clinical trial evidence that the risk of cardiovascular events varies substantially among the non-selective agents, with diclofenac carrying the highest risk of harm.

  8. Maintenance of radiation safety information system

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Ho Sun [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of); Park, Moon Il; Chung, Chong Kyu; Lim, Bock Soo; Kim, Hyung Uk; Chang, Kwang Il; Nam, Kwan Hyun; Cho, Hye Ryan [AD center incubation LAB, Taejon (Korea, Republic of)

    2001-12-15

    The objectives of radiation safety information system maintenance are to maintain the requirement of users, change of job process and upgrade of the system performance stably and effectively while system maintenance. We conduct the code of conduct recommended by IAEA, management of radioisotope inventory database systematically using analysis for the state of inventory database integrated in this system. This system and database will be support the regulatory guidance, rule making and information to the MOST, KINS, other regulatory related organization and general public optimizationally.

  9. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2013-04-26

    ...] Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food... announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical... on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This...

  10. Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

    Energy Technology Data Exchange (ETDEWEB)

    MULKEY, C.H.

    1999-07-06

    This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants.

  11. Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

    International Nuclear Information System (INIS)

    MULKEY, C.H.

    1999-01-01

    This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants

  12. Field observations of the developing legal recreational cannabis economy in Washington State.

    Science.gov (United States)

    Jensen, Eric L; Roussell, Aaron

    2016-07-01

    Washington State legalized the sale of recreational cannabis in 2012. This paper describes the unfolding of the market regulatory regime in an eastern portion of the state, including field descriptions to illustrate the setting. We made observations and conducted interviews of the local supply chain comprising a producer/processor, analytic facility, and retail establishments as well as querying the state director of the regulatory board. Interviews and observations of facilities suggest an overwhelming concern for black market diversion drives state regulatory efforts. The ongoing dialogue between market actors and the state has resulted in a more equitable distribution of profits at different stages in the process. State safety regulations have thus far been shifted to independent laboratories. Banks and insurance companies have slowly begun making inroads into the industry, despite federal prohibition. The law was conceived as a social justice remedy, but the bulk of the legal and regulatory activity surrounds cannabis marketplace management. This has been characterized by concerns for black market diversion, producer/processor profits, and a hands-off approach to safety regulation. Minor cannabis violations as a pathway to criminal justice system involvement have been reduced substantially but disproportionate enforcement upon racial/ethnic minorities continues. Copyright © 2016 Elsevier B.V. All rights reserved.

  13. International Expert Team Concludes IAEA Peer Review of Bulgaria's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    the notification of nuclear and radiation safety-related events; Provisions established by the BNRA to manage its technical support organisations provide a good basis to use them effectively; The process to establish and keep updated regulations and guidelines is well structured and involves, as necessary, relevant interested parties; The BNRA has a policy of transparency and openness with the public, which covers in an effective manner the provision of information on safety-related events and protective actions during emergencies; and There is a complete national dose registry system that includes provision for comprehensive information gathering, which allows for thorough cause-effect analyses to be performed. The IRRS team identified the following areas where the overall performance of the regulatory system could be enhanced: Demarcation of the respective roles of state authorities in the area of radiation protection safety, and establishment of formal coordination and cooperation of their regulatory functions; BNRA's resources and competence for oversight of future facilities and activities; BNRA's establishment of an integrated management system that contributes to meeting its goals in an efficient manner; BNRA procedures used for the review and assessment process for all facilities and activities; and Inspection processes, including the development and implementation of planned and systematic inspection programmes that cover all facilities and activities, and coordination among different regulatory organisations. A final report will be submitted to the Government of Bulgaria in about three months. The BNRA announced to the mission that the report will be made publicly available. The IAEA encourages nations to invite a follow-up IRRS mission about two years after the initial mission has been completed. Background The team reviewed the legal and regulatory framework for nuclear and radiation safety, addressing all facilities and activities regulated by BNRA

  14. Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 2: Appendices

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-31

    On July, 1993, a Regulatory Oversight (RO) organization was established within the US DOE, Oak Ridge Operations to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the OR program was to ensure continued plant safety, safeguards and security while the plants were transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). Volume 2 contains copies of the documents which established the relationship between NRC, DOE, USEC, and DOL (Dept of Labor) required to facilitate regulatory oversight transition.

  15. Regulatory Oversight Program, July 1, 1993 - March 3, 1997. Volume 2: Appendices

    International Nuclear Information System (INIS)

    1997-01-01

    On July, 1993, a Regulatory Oversight (RO) organization was established within the US DOE, Oak Ridge Operations to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the OR program was to ensure continued plant safety, safeguards and security while the plants were transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). Volume 2 contains copies of the documents which established the relationship between NRC, DOE, USEC, and DOL (Dept of Labor) required to facilitate regulatory oversight transition

  16. Argentine influence on regulatory activities in Latin America

    International Nuclear Information System (INIS)

    Palacios, Elias

    1998-01-01

    An analysis of the nuclear regulatory systems and the nuclear regulations of many Latin American countries shows a substantial influence of the Argentine regulatory structure. This influence is attributed to the early Argentine development of a regulatory and control organization, the teaching of regional training courses and the advice of Argentine experts to Latin-American governments

  17. Nuclear security recommendations on nuclear and other radioactive material out of regulatory control: Recommendations

    International Nuclear Information System (INIS)

    2011-01-01

    The purpose of this publication is to provide guidance to States in strengthening their nuclear security regimes, and thereby contributing to an effective global nuclear security framework, by providing: - Recommendations to States and their competent authorities on the establishment or improvement of the capabilities of their nuclear security regimes, for carrying out effective strategies to deter, detect and respond to a criminal act, or an unauthorized act, with nuclear security implications, involving nuclear or other radioactive material that is out of regulatory control; - Recommendations to States in support of international cooperation aimed at ensuring that any nuclear or other radioactive material that is out of regulatory control, whether originating from within the State or from outside that State, is placed under regulatory control and the alleged offenders are, as appropriate, prosecuted or extradited

  18. Regulatory peptides in the upper respiratory system and oral cavity of man. An immunocytochemical and radioimmunological study

    International Nuclear Information System (INIS)

    Hauser-Kronberger, C.

    1992-01-01

    In the present study a dense network of peptide-immunoreactive nerve fibres in the upper respiratory system and the oral cavity of man was investigated. The occurrence, distribution and concentrations of regulatory peptide immunoreactivities in human nasal mucosa, soft palate, ventricular fold, vocal cord, epiglottis, subglottis, glandula submandibularis and glandula parotis were investigated using highly efficient immunocytochemical and radio-immunological methods. In the tissues investigated vasoactive intestinal polypeptide (VIP) and other derivatives from the VIP-precursor (peptide histidine methionine = PHM), prepro VIP (111-122)), neuropeptide tyrosine (NPY) and its C-flanking peptide (CPON), calcitonin gene-related peptide (CGRP), substance P, neurokinin A, bombesin-flanking peptide and somatostatin were detected. The regulatory peptides demonstrated also included the recently isolated peptides helospectin and pituitary adenylate cyclase activating peptide (PACAP). Single endocrine-like cells were for the first time demonstrated within the respiratory epithelium and in the lamina propria of the nasal mucosa and soft palate and in groups within ducts. Ultrastructural immunelectronmicroscopy was performed using an ABC-pre-embedding method. In addition, semithin Epon resin sections were immunostained. The concentrations of VIP, NPY, CGRP, substance P and neurokinin A were measured using radioimmunological methods. The peptide immunoreactivities demonstrated in a dense network of neuronal structures and endocrine cells give indication for the presence of a complex regulatory system with potent physiological mechanisms in the upper respiratory system and allocated tissues of man

  19. Essays on the investment behavior of independent power producers in the United States electricity industry under regulatory restructuring

    Science.gov (United States)

    Yan, Jingming

    2002-09-01

    In recent years, there have been efforts at both the federal and state level to introduce greater competition and markets into the US electricity industry through regulatory restructuring. A key to the success of such efforts is the ability of the restructuring to attract investment from non-utility, independent power producers (IPPs). The two essays in this dissertation examine empirically the investment behavior of IPPs under the regulatory restructuring between 1996 and 2000. In both essays, the effects of restructuring on a firm's investment decision are decomposed into the effects that work through the investment cost and that through the expected profit from the investment. The first essay studies the entry behavior of IPPs under the restructuring. The main finding of the essay is that the restructuring has done little to lower the entry barrier faced by IPPs-high fixed cost to entry is still a main factor that hinders IPP investment. The second essay studies IPPs' decisions between investing through building new power plants ("make") and investing through acquiring divested plants ("buy"). It finds that the availability of the "buy" option does not "squeeze" out investment on new capacities. IPPs that chose to "buy" did so because they expected a lower return from "make" and hence would not have switched their investment to new capacities even if the "buy" option were not available. Therefore, divestiture is a viable policy tool for state regulators to attract more IPP investment.

  20. A Review on Regulatory Enforcement Policy

    International Nuclear Information System (INIS)

    Lim, Ji Han; Lee, Kyung Joo; Choi, Young Sung

    2017-01-01

    This paper examine the meaning and principle of enforcement through examples from other countries. Regulatory enforcement is the last stage of safety regulation and how it is exercised when one failing to meet regulatory requirements can have significant ripple effect across the industry. Thus, right philosophy and principle should be established. It is not recommended to emphasize neither deterrence approach nor behavior modification approach. This should be also taken into consideration when setting up the principle and system of regulatory enforcement. In the process of Vienna Declaration, Europe and the U.S showed the fundamental differences in their approaches to safety regulation. Considering this, it is required to remain cautious at all times on what to be improved in the aspect of internal consistency within our system and also in the aspect of procedure.

  1. Component state-based integrated importance measure for multi-state systems

    International Nuclear Information System (INIS)

    Si, Shubin; Levitin, Gregory; Dui, Hongyan; Sun, Shudong

    2013-01-01

    Importance measures in reliability engineering are used to identify weak components and/or states in contributing to the reliable functioning of a system. Traditionally, importance measures do not consider the possible effect of groups of transition rates among different component states, which, however, has great effect on the component probability distribution and should therefore be taken into consideration. This paper extends the integrated importance measure (IIM) to estimate the effect of a component residing at certain states on the performance of the entire multi-state systems. This generalization of IIM describes in which state it is most worthy to keep the component to provide the desired level of system performance, and which component is the most important to keep in some state and above for improving the performance of the system. An application to an oil transportation system is presented to illustrate the use of the suggested importance measure

  2. IAEA Mission Concludes Peer Review of Pakistan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    An international team of senior nuclear safety experts today concluded a nine-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for the safety of operating nuclear power plants in the United States of America (USA). The Integrated Regulatory Review Service (IRRS) mission was a follow-up to the IRRS mission to the US Nuclear Regulatory Commission (NRC) that was conducted in 2010, with the key additional aim of reviewing whether the response of the US regulatory regime to the implications of the accident at TEPCO's Fukushima Daiichi Plant had been timely and effective. The mission team concluded that the recommendations and suggestions made by the 2010 IRRS mission have been taken into account systematically under the NRC's subsequent action plan, with significant progress in many areas and many improvements carried out. One of two recommendations and 19 out of 20 suggestions made by the 2010 IRRS mission have been effectively addressed and can therefore be considered closed. The outstanding recommendation relates to the NRC's review of its Management System, which is in the process of being finalised. The IRRS team also found that the NRC acted promptly and effectively after the Fukushima accident in the interests of public health and safety, and that the report of its Near-Term Task Force represents a sound and ample basis for taking into account the lessons learned from the accident

  3. Regulatory inspection of the implementation of quality assurance programmes

    International Nuclear Information System (INIS)

    1989-01-01

    This Manual provides guidance to Member States in the organization and performance of their regulatory inspection functions regarding the implementation of nuclear power plant quality assurance programmes. It addresses the interface between, and is consistent with, the IAEA Nuclear Safety Standards (NUSS programme) documents on quality assurance and governmental organization. The Manual offers a practical model and examples for performing regulatory inspections to ensure that the quality assurance programme is operating satisfactorily in the siting, design, manufacturing, construction, commissioning, operation and decommissioning of nuclear power plants. The primary objective is to confirm that the licensee has the capability to manage and control the effective performance of all quality assurance responsibilities during all phases of a nuclear power project. The guidance provided through this Manual for proper establishment and execution of the regulatory inspections helps to enforce the effective implementation of the quality assurance programme as a management control system that the nuclear industry should establish and use in attaining the safety and reliability objectives for nuclear installations. This enforcement action by national regulatory bodies and the emphasis on the purposes and advantages of quality assurance as an important management tool integrated within the total project task have been recommended by the IAEA International Nuclear Safety Advisory Group (INSAG). The primary intended users of this Manual are the management personnel and high level staff from regulatory bodies but it will also be helpful to management personnel from nuclear utilities and vendors. They all are inevitable partners in a nuclear power project and this document offers all of them valuable information on the better accomplishment of quality assurance activities to ensure the common objective of safe and reliable nuclear power production

  4. Take it of leave it : Mechanisms underlying bacterial bistable regulatory networks

    NARCIS (Netherlands)

    Siebring, Jeroen; Sorg, Robin; Herber, Martijn; Kuipers, Oscar; Filloux, Alain A.M.

    2012-01-01

    Bistable switches occur in regulatory networks that can exist in two distinct stable states. Such networks allow distinct switching of individual cells. In bacteria these switches coexist with regulatory networks that respond gradually to environmental input. Bistable switches play key roles in high

  5. Excited states in biological systems

    International Nuclear Information System (INIS)

    Cilento, G.; Zinner, K.; Bechara, E.J.H.; Duran, N.; Baptista, R.C. de; Shimizu, Y.; Augusto, O.; Faljoni-Alario, A.; Vidigal, C.C.C.; Oliveira, O.M.M.F.; Haun, M.

    1979-01-01

    Some aspects of bioluminescence related to bioenergetics are discussed: 1. chemical generation of excited species, by means of two general processes: electron transference and cyclic - and linear peroxide cleavage; 2. biological systems capable of generating excited states and 3. biological functions of these states, specially the non-emissive ones (tripletes). The production and the role of non-emissive excited states in biological systems are analysed, the main purpose of the study being the search for non-emissive states. Experiences carried out in biological systems are described; results and conclusions are given. (M.A.) [pt

  6. Experience Transformed into Nuclear Regulatory Improvements in Russia

    International Nuclear Information System (INIS)

    Sapozhnikov, A.

    2016-01-01

    The third International Conference on Effective Nuclear Regulatory Systems (Canada, 2013) identified the main action items that should be addressed, implemented and followed up. The key technical and organizational areas important to strengthening reactor and spent fuel safety have been determined as following: • Regulatory lessons learned and actions taken (since the accident at the Fukushima Daiichi NPP); • Waste management and spent fuel safety; • Emergency management; • Emerging programmes; • Human and organizational factors, safety and security culture. Over time many activities based on results of the IAEA Integrated Regulatory Review Service in the Russian Federation, 2019, and post-mission, 2013, have been implemented. At present there is progress for the national action plan on nuclear safety, preparation and conducting of long term spent fuel management, complementary reviews for nuclear facilities other than Nuclear Power Plants, emergency exercises with the regulatory body participation, improving communication, development of national regulations and improvement of regulatory system in the whole. The regulatory body ensures assistance in development of national regulatory infrastructure, safety culture to the countries planning to construct Russian design facilities (NPPs, RRs). The report outlines the results and future actions to improve nuclear regulation based on systematic approach to safety and particularly reflects the specificity of taking measures for the research reactors. (author)

  7. Four essays on offshore wind power potential, development, regulatory framework, and integration

    Science.gov (United States)

    Dhanju, Amardeep

    Offshore wind power is an energy resource whose potential in the US has been recognized only recently. There is now growing interest among the coastal states to harness the resource, particularly in states adjacent to the Mid-Atlantic Bight where the shallow continental shelf allows installation of wind turbines using the existing foundation technology. But the promise of bountiful clean energy from offshore wind could be delayed or forestalled due to policy and regulatory challenges. This dissertation is an effort to identify and address some of the important challenges. Focusing on Delaware as a case study it calculates the extent of the wind resource; considers one means to facilitate resource development---the establishment of statewide and regional public power authorities; analyzes possible regulatory frameworks to manage the resource in state-controlled waters; and assesses the use of distributed storage to manage intermittent output from wind turbines. In order to cover a diversity of topics, this research uses a multi-paper format with four essays forming the body of work. The first essay lays out an accessible methodology to calculate offshore wind resource potential using publicly available data, and uses this methodology to access wind resources off Delaware. The assessment suggests a wind resource approximately four times the average electrical load in Delaware. The second essay examines the potential role of a power authority, a quasi-public institution, in lowering the cost of capital, reducing financial risk of developing and operating a wind farm, and enhancing regional collaboration on resource development and management issues. The analysis suggests that a power authority can lower the cost of offshore wind power by as much as 1/3, thereby preserving the ability to pursue cost-competitive development even if the current federal incentives are removed. The third essay addresses the existing regulatory void in state-controlled waters of Delaware

  8. Russian Experience in the Regulatory Supervision of the Uranium Legacy Sites - 12441

    Energy Technology Data Exchange (ETDEWEB)

    Kiselev, M.F.; Romanov, V.V. [Federal Medical Biological Agency, Moscow (Russian Federation); Shandala, N.K.; Titov, A.V.; Kiselev, S.M.; Seregin, V.A.; Metlyaev, E.G.; Novikova, N. [Burnasyan Federal Medical Biophysical Centre, Moscow (Russian Federation); Khokhlova, E.A. [Regional Management-107 under FMBA of Russia, Krasnokamensk (Russian Federation)

    2012-07-01

    Management of the uranium legacy is accompanied with environmental impact intensity of which depends on the amount of the waste generated, the extent of that waste localization and environmental spreading. The question is: how hazardous is such impact on the environment and human health? The criterion for safety assurance is adequate regulation of the uranium legacy. Since the establishment of the uranium industry, the well done regulatory system operates in the FMBA of Russia. Such system covers inter alia, the uranium legacy. This system includes the extent laboratory network of independent control and supervision, scientific researches, regulative practices. The current Russian normative and legal basis of the regulation and its application practice has a number of problems relating to the uranium legacy, connected firstly with the environmental remediation. To improve the regulatory system, the urgent tasks are: -To introduce the existing exposure situation into the national laws and standards in compliance with the ICRP system. - To develop criteria for site remediation and return, by stages, to uncontrolled uses. The similar criteria have been developed within the Russian-Norwegian cooperation for the purpose of remediation of the sites for temporary storage of SNF and RW. - To consider possibilities and methods of optimization for the remediation strategies under development. - To separate the special category - RW resulted from uranium ore mining and dressing. The current Russian RW classification is based on the waste subdivision in terms of the specific activities. Having in mind the new RW-specific law, we receive the opportunity to separate some special category - RW originated from the uranium mining and milling. Introduction of such category can simplify significantly the situation with management of waste of uranium mining and milling processes. Such approach is implemented in many countries and approved by IAEA. The category of 'RW originated

  9. US Nuclear Regulatory Commission annual report, 1985. Volume 2

    International Nuclear Information System (INIS)

    1986-01-01

    The decisions and actions of the Nuclear Regulatory Commission (NRC) during fiscal year 1985 are reported. Areas covered include reactor regulation, cleanup at Three Mile Island, analysis and evaluation of operational experience, nuclear materials, waste management, safeguards, inspection, enforcement, quality assurance, emergency preparedness, and nuclear regulatory research. Also, cooperation with the states, international programs, proceedings and litigation, and management are discussed

  10. Objective of the regulatory system for the physical protection of facilities and nuclear materials

    International Nuclear Information System (INIS)

    Polo, Rolando

    1996-01-01

    During the work that is developed in our country in order to have a regulatory system, recommendation on the issue have been considered. Such recommendation are gathered in the informative regulation 225 rev, 3 of the IAEA and the requirements are collected in the Informative Regulation 274 rev 1 of the IAEA, as well as the good national and international practices

  11. The Tumorigenic Roles of the Cellular REDOX Regulatory Systems

    Directory of Open Access Journals (Sweden)

    Stéphanie Anaís Castaldo

    2016-01-01

    Full Text Available The cellular REDOX regulatory systems play a central role in maintaining REDOX homeostasis that is crucial for cell integrity, survival, and proliferation. To date, a substantial amount of data has demonstrated that cancer cells typically undergo increasing oxidative stress as the tumor develops, upregulating these important antioxidant systems in order to survive, proliferate, and metastasize under these extreme oxidative stress conditions. Since a large number of chemotherapeutic agents currently used in the clinic rely on the induction of ROS overload or change of ROS quality to kill the tumor, the cancer cell REDOX adaptation represents a significant obstacle to conventional chemotherapy. In this review we will first examine the different factors that contribute to the enhanced oxidative stress generally observed within the tumor microenvironment. We will then make a comprehensive assessment of the current literature regarding the main antioxidant proteins and systems that have been shown to be positively associated with tumor progression and chemoresistance. Finally we will make an analysis of commonly used chemotherapeutic drugs that induce ROS. The current knowledge of cancer cell REDOX adaptation raises the issue of developing novel and more effective therapies for these tumors that are usually resistant to conventional ROS inducing chemotherapy.

  12. Current approaches to gene regulatory network modelling

    Directory of Open Access Journals (Sweden)

    Brazma Alvis

    2007-09-01

    Full Text Available Abstract Many different approaches have been developed to model and simulate gene regulatory networks. We proposed the following categories for gene regulatory network models: network parts lists, network topology models, network control logic models, and dynamic models. Here we will describe some examples for each of these categories. We will study the topology of gene regulatory networks in yeast in more detail, comparing a direct network derived from transcription factor binding data and an indirect network derived from genome-wide expression data in mutants. Regarding the network dynamics we briefly describe discrete and continuous approaches to network modelling, then describe a hybrid model called Finite State Linear Model and demonstrate that some simple network dynamics can be simulated in this model.

  13. Strengthening the Canadian alcohol advertising regulatory system.

    Science.gov (United States)

    Heung, Carly M; Rempel, Benjamin; Krank, Marvin

    2012-05-24

    Research evidence points to harmful effects from alcohol advertising among children and youth. In particular, exposure to alcohol advertising has been associated with adolescents drinking both earlier and heavier. Although current federal and provincial guidelines have addressed advertising practices to prevent underage drinking, practice has not been supported by existing policy. While protective measures such as social marketing campaigns have the potential for counteracting the effects from alcohol advertising, the effectiveness of such measures can be easily drowned out with increasing advertising activities from the alcohol industry, especially without effective regulation. Research reviewed by the European Focus on Alcohol Safe Environment (FASE) Project has identified a set of key elements that are necessary to make alcohol advertising policy measures effective at protecting children and youth from the harmful effects of alcohol marketing. Using these key elements as an evaluation framework, there are critical components in the Canadian alcohol advertising regulatory system that clearly require strengthening. To protect impressionable children and youth against the harmful effects of alcohol advertising, 13 recommendations to strengthen current alcohol advertising regulations in Canada are provided for Canadian policy-makers, advertising standard agencies, and public health groups.

  14. 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

  15. 77 FR 58022 - Montana Regulatory Program

    Science.gov (United States)

    2012-09-19

    ... precludes in situ gasification projects from including carbon capture and sequestration (CCS) under the... Conservation as the regulatory authority for CCS activities within the State. SB498 generally established that..., the Board would regulate any proposed CCS activities appropriately. CCS operations have potential...

  16. Implementation of a Quality Management System in regulatory inspection activities

    International Nuclear Information System (INIS)

    Pires do Rio, Monica; Ferreira, Paulo Roberto; Cunha, Paulo G. da; Acar, Maria Elizabeth

    2005-01-01

    The Institute for Radioprotection and Dosimetry - IRD -, of the Brazilian National Nuclear Energy Commission, CNEN, started in 2001, the implementation of a quality management system (SGQ), in the inspection, testing and calibration activities. The SGQ was an institutional guideline and is inserted in a larger system of management of the IRD started in 1999, with the adoption of the National Quality Award criteria - PNQ, within the Project for Excellence in Technological Research of Associacao Brasileira das Instituicoes de Pesquisas Tecnologicas - ABIPTI (Brazilian Association of Technological Research institutions). The proposed quality management system and adopted at the IRD was developed and implemented in accordance with the requirements of NBR ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories, and ISO/IEC 17020 - General criteria for operation of various types of bodies performing inspections. For regulatory inspection activities, the quality system was implemented on three program inspection services of radiological protection led, respectively, by clinics and hospitals that operate radiotherapy services; industries that use nuclear gauges in their control or productive processes and power reactor operators (CNAAA) - just the environmental part. It was formed a pioneering team of inspectors for standardizing the processes, procedures and starting the implementation of the system in the areas. This work describes the implementation process steps, including difficulties, learning and advantages of the adoption of a quality management system in inspection activities

  17. Low-level radioactive waste disposal in the United States

    International Nuclear Information System (INIS)

    Ozaki, Calvin B.; Kerr, Thomas A.; Williams, R. Eric

    1991-01-01

    Two national systems comprise the low-level radioactive waste management system in the United States of America. The U.S. Nuclear Regulatory Commission regulates low-level radioactive waste produced in the public sector (commercial waste), and the U.S. Department of Energy manages low-level radioactive waste produced by government-sponsored programs. The primary distinction between the two national systems is the source of regulatory control. This paper discusses two issues critical to the success of each system: the site selection process used by the commercial low-level waste disposal system, and the evaluation process used to determine configuration of the DOE waste management system. The two national systems take different approaches to reach the same goals, which are increased social responsibility, protection of public health and safety, and protection of the environment

  18. Mapping regulatory models for medicinal cannabis: a matrix of options.

    Science.gov (United States)

    Belackova, Vendula; Shanahan, Marian; Ritter, Alison

    2017-05-30

    Objective The aim of the present study was to develop a framework for assessing regulatory options for medicinal cannabis in Australia. Methods International regulatory regimes for medicinal cannabis were reviewed with a qualitative policy analysis approach and key policy features were synthesised, leading to a conceptual framework that facilitates decision making across multiple dimensions. Results Two central organising dimensions of medicinal cannabis regulation were identified: cannabis supply and patient authorisation (including patient access). A number of the different supply options can be matched with a number of different patient authorisation options, leading to a matrix of possible regulatory regimes. Conclusions The regulatory options, as used internationally, involve different forms of cannabis (synthetic and plant-based pharmaceutical preparations or herbal cannabis) and the varying extent to which patient authorisation policies and procedures are stringently or more loosely defined. The optimal combination of supply and patient authorisation options in any jurisdiction that chooses to make medicinal cannabis accessible will depend on policy goals. What is known about the topic? Internationally, regulation of medicinal cannabis has developed idiosyncratically, depending on formulations that were made available and local context. There has been no attempt to date in the scientific literature to systematically document the variety of regulatory possibilities for medicinal cannabis. What does this paper add? This paper presents a new conceptual schema for considering options for the regulation of medicinal cannabis, across both supply and patient authorisation aspects. What are the implications for practitioners? The design of regulatory systems in Australia, whether for pharmaceutical or herbal products, is a vital issue for policy makers right now as federal and state and territory governments grapple with the complexities of medicinal cannabis

  19. A balance of activity in brain control and reward systems predicts self-regulatory outcomes.

    Science.gov (United States)

    Lopez, Richard B; Chen, Pin-Hao A; Huckins, Jeremy F; Hofmann, Wilhelm; Kelley, William M; Heatherton, Todd F

    2017-05-01

    Previous neuroimaging work has shown that increased reward-related activity following exposure to food cues is predictive of self-control failure. The balance model suggests that self-regulation failures result from an imbalance in reward and executive control mechanisms. However, an open question is whether the relative balance of activity in brain systems associated with executive control (vs reward) supports self-regulatory outcomes when people encounter tempting cues in daily life. Sixty-nine chronic dieters, a population known for frequent lapses in self-control, completed a food cue-reactivity task during an fMRI scanning session, followed by a weeklong sampling of daily eating behaviors via ecological momentary assessment. We related participants' food cue activity in brain systems associated with executive control and reward to real-world eating patterns. Specifically, a balance score representing the amount of activity in brain regions associated with self-regulatory control, relative to automatic reward-related activity, predicted dieters' control over their eating behavior during the following week. This balance measure may reflect individual self-control capacity and be useful for examining self-regulation success in other domains and populations. © The Author (2017). Published by Oxford University Press.

  20. Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis; FINAL

    International Nuclear Information System (INIS)

    MULKEY, C.H.

    1999-01-01

    This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants

  1. State distribution and reliability of some multi- state systems with ...

    African Journals Online (AJOL)

    mn : G series systems and second, the multi-state consecutive kn-out-of-mn : G parallel systems (see denitions 1 and 2).We begin by giving a non recursive formula which calculates the state distribution and the reliability of multi-state ...

  2. Experts Complete IAEA Follow-up Review of Australia's Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    use of the opportunity to revise the ARPANS Act in 2012; Completing implementation of the reorganization of ARPANSA; Influencing enhancement of the national framework for nuclear and radiation emergency preparedness; Establishing a coordinating function for ARPANSA's Emergency Preparedness and response arrangements; Better utilizing the expertise within ARPANSA with respect to the regulation of patient protection; and Increasing ARPANSA's leadership role in the implementation of Codes of Practice in patient protection. The IRRS team identified areas where the Australian Government should take actions to enhance the national regulatory infrastructure for nuclear safety and security. These include: Revise the ARPANS Act to take full account of international principles, recommendations and IAEA safety standards and guides; and Enhance the national framework for nuclear and radiation emergency preparedness by clearly identifying and assigning responsibilities to ARPANSA and other appropriate organizations. Carl-Magnus Larsson, Chief Executive Officer of ARPANSA, said, ''ARPANSA has benefitted from the IRRS mission using the contribution from senior regulators which has resulted and will certainly lead in further improvements in our regulatory system.'' He also encouraged other countries that are yet to have an IRRS mission to make use of the IAEA's services in the area of nuclear safety. About IRRS Missions IRRS missions are designed to strengthen and enhance the effectiveness of the national nuclear regulatory infrastructure of States, while recognizing the ultimate responsibility of each State to ensure safety in this area. This is done through consideration of both regulatory, technical and policy issues, with comparisons against IAEA Safety Standards and, where appropriate, good practices elsewhere. (IAEA)

  3. 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

  4. A Framework for Organizing Current and Future Electric Utility Regulatory and Business Models

    Energy Technology Data Exchange (ETDEWEB)

    Satchwell, Andrew [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Cappers, Peter [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Schwartz, Lisa C. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Fadrhonc, Emily Martin [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2015-06-01

    Many regulators, utilities, customer groups, and other stakeholders are reevaluating existing regulatory models and the roles and financial implications for electric utilities in the context of today’s environment of increasing distributed energy resource (DER) penetrations, forecasts of significant T&D investment, and relatively flat or negative utility sales growth. When this is coupled with predictions about fewer grid-connected customers (i.e., customer defection), there is growing concern about the potential for serious negative impacts on the regulated utility business model. Among states engaged in these issues, the range of topics under consideration is broad. Most of these states are considering whether approaches that have been applied historically to mitigate the impacts of previous “disruptions” to the regulated utility business model (e.g., energy efficiency) as well as to align utility financial interests with increased adoption of such “disruptive technologies” (e.g., shareholder incentive mechanisms, lost revenue mechanisms) are appropriate and effective in the present context. A handful of states are presently considering more fundamental changes to regulatory models and the role of regulated utilities in the ownership, management, and operation of electric delivery systems (e.g., New York “Reforming the Energy Vision” proceeding).

  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. The regulatory mechanism in the U.S. lessons learned

    International Nuclear Information System (INIS)

    Roberts, T.M.

    1987-01-01

    The U.S. Nuclear Regulatory Commission is responsible for the regulation of the commercial uses of nuclear power in the United States in order to protect the public health and safety. The NRC has undertaken a number of initiatives to incorporate the experience gained from the over 25 years of commercial nuclear power plant operation. These initiatives are aimed at improving the regulatory structure currently in place by providing for a more predictable and stable regulatory environment and by more efficiently and effectively focusing the activities of utilities on the safe operation of their facilities. (author)

  7. Applicability of federal and state hazardous waste regulatory programs to waste chemical weapons and chemical warfare agents.; TOPICAL

    International Nuclear Information System (INIS)

    Haffenden, R.; Kimmell, T.

    2002-01-01

    This report reviews federal and state hazardous waste regulatory programs that govern the management of chemical weapons or chemical warfare agents. It addresses state programs in the eight states with chemical weapon storage facilities managed by the U.S. Army: Alabama, Arkansas, Colorado, Indiana, Kentucky, Maryland, Oregon, and Utah. It also includes discussions on 32 additional states or jurisdictions with known or suspected chemical weapons or chemical warfare agent presence (e.g., disposal sites containing chemical agent identification sets): Alaska, Arizona, California, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, the U.S. Virgin Islands, Virginia, Washington, Washington, D.C., and Wyoming. Resource Conservation and Recovery Act (RCRA) hazardous waste programs are reviewed to determine whether chemical weapons or chemical warfare agents are listed hazardous wastes or otherwise defined or identified as hazardous wastes. Because the U.S. Environmental Protection Agency (EPA) military munitions rule specifically addresses the management of chemical munitions, this report also indicates whether a state has adopted the rule and whether the resulting state regulations have been authorized by EPA. Many states have adopted parts or all of the EPA munitions rule but have not yet received authorization from EPA to implement the rule. In these cases, the states may enforce the adopted munitions rule provisions under state law, but these provisions are not federally enforceable

  8. Wetlands: The changing regulatory landscape

    International Nuclear Information System (INIS)

    Glick, R.M.

    1993-01-01

    Protection of wetlands became a national issue in 1988 when President George Bush pledged no net loss of wetlands in the US under his open-quotes environmental presidency.close quotes As wetlands became a national issue, the job of protecting them became an obligation for many groups, including hydro-power developers. Now, when a site selected for development includes an area that may be classified as a wetland, the developer quickly discovers the importance of recognizing and protecting these natural habitats. Federal legislation severely limits development of wetland, and most states increase the restrictions with their own wetlands regulations. The difficulty of defining wetlands complicates federal and state enforcement. Land that appears to be dry may in fact be classified as a wetland. So, even if a site appears dry, potential hydro developers must confirm whether or not any jurisdictional wetlands are present. Regulated lands include much more than marshes and swamps. Further complicating the definition of wetlands, a recent court decision found that even artificially created wetlands, such as man-made ponds, may be subject to regulation. Hydro developers must be aware of current regulatory requirements before they consider development of any site that may contain wetlands. To be certain that a site is open-quotes buildableclose quotes from the standpoint of wetlands regulation, a developer must verify (with the help of state agencies) that the property does not contain any jurisdictional wetlands. If it does, the regulatory process before development becomes much more complicated. For the short term, uncertainty abounds and extreme caution is in order. Because the regulatory process has become so complex and an agreeable definition of wetlands so elusive, the trend among the Corps and collaborating agencies is to constrict nationwide permits in favor of narrowing the jurisdictional definition of wetlands

  9. Annual Report 2013. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across seven parts and eight annexes the activities developed by the organism during 2013. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication has annexes with the following content: regulatory documents; inspections to medical; presentations of publications from ARN staff; measurement and evaluation of the drinking water of Ezeiza; international expert report on the implementation of international standards on radiation protection in the Ezeiza Atomic Center; Code of Ethics of the Nuclear Regulatory Authority.

  10. State Policies to Transform Struggling Schools: How Various State Policies Can Be Used to Enable School & District Turnaround. Meeting the Turnaround Challenge: Strategies, Resources & Tools to Transform a Framework into Practice

    Science.gov (United States)

    Mass Insight Education (NJ1), 2009

    2009-01-01

    State governments wield significant authority in the management of public schools. As a nexus for federal funding, state funding, and regulatory authority, states have both the legal and financial power to help drive school change. The "No Child Left Behind Act" has required each state to create a system of standards-based assessment and…

  11. Energy Projects, Social Licence, Public Acceptance and Regulatory Systems in Canada: A White Paper

    Directory of Open Access Journals (Sweden)

    John Colton

    2016-05-01

    Full Text Available It has become increasingly difficult in Canada to gain and sustain public acceptance of energy projects. Increased levels of protest, combined with traditional media and social media coverage of opposition, combine to suggest decreased public acceptance of energy projects. Decision-makers have responded accordingly, and a variety of energy projects have either been delayed or put on hold indefinitely. This is true for both conventional and renewable energy projects and in many different regions across the country. A number of proposed energy projects have recently faced opposition from various stakeholder groups. For instance, the decision of the Joint Review Panel for the Northern Gateway Pipeline is being challenged in Canada’s court system. First Nations groups have issued an ultimatum to the Federal Government that it must choose between Site C (a proposed hydro dam and liquefied natural gas development in B.C. Rapid expansion of wind energy projects in Ontario has engendered lengthy and costly appeals and the rise of an anti-wind social movement. In Nova Scotia, tidal energy development is being positioned as a new renewable energy option; gaining public acceptance is critical in light of recent opposition to wind energy development. As these experiences suggest, not only has the regulatory process become more contentious, but also an apparently new concept — social licence — has had popular appeal. This white paper reports on the results of a year-long interdisciplinary collaboration aimed at identifying and summarizing extant research regarding social licence and related concepts, with a particular emphasis on understanding its implications for public acceptance of energy projects in Canada, and their related regulatory processes. In particular, this research addressed the following questions: 1. What is the history and scope of the term ‘social licence’, both in the context of energy project development and more generally? What

  12. Information management systems for integrating the technical data and regulatory requirements of environmental restoration activities

    International Nuclear Information System (INIS)

    Geffen, C.A.; Garrett, B.A.; Walter, M.B.

    1990-03-01

    Current environmental regulations require that comprehensive planning be conducted before remediating a hazardous waste site to characterize the nature and extent of site contamination, calculate the risk to the public, and assess the effectiveness of various remediation technologies. Remediation of Department of Energy (DOE) sites contaminated with hazardous or mixed wastes will require the effective integration of scientific and engineering data with regulatory and institutional requirements. The information management challenge presented by waste site cleanup activities goes beyond merely dealing with the large quantity of data that will be generated. The information must be stored, managed, and presented in a way that provides some consistency in approach across sites, avoids duplication of effort, and facilitates responses to requests for information from the regulators and the public. This paper provides background information on the regulatory requirements for data gathering and analysis for environmental restoration activities, and outlines the data and information management requirements for completing the pre-remediation phases of an environmental restoration project. Information management systems for integrating the regulatory and institutional requirements of the environmental restoration process with the technical data and analysis requirements are also described. 7 refs

  13. Regulatory Support of Treatment of Savannah River Site Purex Waste

    International Nuclear Information System (INIS)

    Reid, L.T.

    2009-01-01

    This paper describes the support given by federal and state regulatory agencies to Savannah River Site (SRS) during the treatment of an organic liquid mixed waste from the Plutonium Extraction (Purex) process. The support from these agencies allowed (SRS) to overcome several technical and regulatory barriers and treat the Purex waste such that it met LDR treatment standards. (authors)

  14. In silico analysis of cis-acting regulatory elements in 5' regulatory regions of sucrose transporter gene families in rice (Oryza sativa Japonica) and Arabidopsis thaliana.

    Science.gov (United States)

    Ibraheem, Omodele; Botha, Christiaan E J; Bradley, Graeme

    2010-12-01

    The regulation of gene expression involves a multifarious regulatory system. Each gene contains a unique combination of cis-acting regulatory sequence elements in the 5' regulatory region that determines its temporal and spatial expression. Cis-acting regulatory elements are essential transcriptional gene regulatory units; they control many biological processes and stress responses. Thus a full understanding of the transcriptional gene regulation system will depend on successful functional analyses of cis-acting elements. Cis-acting regulatory elements present within the 5' regulatory region of the sucrose transporter gene families in rice (Oryza sativa Japonica cultivar-group) and Arabidopsis thaliana, were identified using a bioinformatics approach. The possible cis-acting regulatory elements were predicted by scanning 1.5kbp of 5' regulatory regions of the sucrose transporter genes translational start sites, using Plant CARE, PLACE and Genomatix Matinspector professional databases. Several cis-acting regulatory elements that are associated with plant development, plant hormonal regulation and stress response were identified, and were present in varying frequencies within the 1.5kbp of 5' regulatory region, among which are; A-box, RY, CAT, Pyrimidine-box, Sucrose-box, ABRE, ARF, ERE, GARE, Me-JA, ARE, DRE, GA-motif, GATA, GT-1, MYC, MYB, W-box, and I-box. This result reveals the probable cis-acting regulatory elements that possibly are involved in the expression and regulation of sucrose transporter gene families in rice and Arabidopsis thaliana during cellular development or environmental stress conditions. Copyright © 2010 Elsevier Ltd. All rights reserved.

  15. Regulatory approaches to hydrocarbon contamination from underground storage tanks

    International Nuclear Information System (INIS)

    Daugherty, S.J.

    1991-01-01

    Action or lack of action by the appropriate regulatory agency is often the most important factor in determining remedial action or closure requirements for hydrocarbon contaminated sites. This paper reports that the diversity of regulatory criteria is well known statewide and well documented nationally. In California, the diversity of approaches is due to: that very lack of a clear understanding of the true impact of hydrocarbon contamination: lack of state or federal standards for soil cleanup, and state water quality objectives that are not always achievable; vagueness in the underground storage tank law; and the number and diversity of agencies enforcing the underground storage tank regulations

  16. Smart grids and power systems efficiency: regulatory tools and demand-side management impacts

    International Nuclear Information System (INIS)

    Bergaentzle, Claire

    2015-01-01

    The physical architecture of electricity grids and the organizational structure of power systems implemented after the reforms have traditionally be achieved according to the characteristics of the transmission infrastructures and power mixes. However, the new challenges related to energy transition favor a greater participation of decentralized generation and final consumers to system exploitation and competitive markets. This latter participation is made possible thanks to recent innovations in the fields of communication and remote control technologies. Significant evolutions are expected in power industries that share common characteristics. First, these evolutions suppose massive capital investments to modernize and adapt current power distribution grids. Second, it is expected the activation of distribution grids and final consumers will unleash substantial unexploited economic efficiency gains as well as impose new constraints. Taking these simple facts as a starting point, the objective of the thesis is twofold. In the first place, we provide a theoretical analysis of the regulatory instruments that monitor the system operators' expenses. Relying on the literature, we aim at characterizing what regulatory tools and incitation are suitable for investing in smart grids technologies. Since it is necessary to compare theoretical formulation to facts, we use an empirical approach that allows us to designate key benefits pursued by the development of smart grids and to compare our theoretical results with practical regulatory applications. Our findings eventually allow us to formulate recommendations. In the second place, the thesis focuses on the impacts of demand-side management during peak periods. We structure our approach around two general observations. Large benefits should be generated in lowering substantially peak demand. However, such situation also creates losses of profit for generators. We provide an estimation of efficiency gains and revenue losses

  17. A guide to approaching regulatory considerations for lentiviral-mediated gene therapies.

    Science.gov (United States)

    White, Michael; Whittaker, Roger; Stoll, Elizabeth Ann

    2017-06-12

    Lentiviral vectors are increasingly the gene transfer tool of choice for gene or cell therapies, with multiple clinical investigations showing promise for this viral vector in terms of both safety and efficacy. The third-generation vector system is well-characterized, effectively delivers genetic material and maintains long-term stable expression in target cells, delivers larger amounts of genetic material than other methods, is non-pathogenic and does not cause an inflammatory response in the recipient. This report aims to help academic scientists and regulatory managers negotiate the governance framework to achieve successful translation of a lentiviral vector-based gene therapy. The focus is on European regulations, and how they are administered in the United Kingdom, although many of the principles will be similar for other regions including the United States. The report justifies the rationale for using third-generation lentiviral vectors to achieve gene delivery for in vivo and ex vivo applications; briefly summarises the extant regulatory guidance for gene therapies, categorised as advanced therapeutic medicinal products (ATMPs); provides guidance on specific regulatory issues regarding gene therapies; presents an overview of the key stakeholders to be approached when pursuing clinical trials authorization for an ATMP; and includes a brief catalogue of the documentation required to submit an application for regulatory approval of a new gene therapy.

  18. CDC STATE System Tobacco Legislation - Licensure

    Data.gov (United States)

    U.S. Department of Health & Human Services — 1995-2018. Centers for Disease Control and Prevention (CDC). State Tobacco Activities Tracking and Evaluation (STATE) System. Legislation—Licensure. The STATE System...

  19. CDC STATE System Tobacco Legislation - Tax

    Data.gov (United States)

    U.S. Department of Health & Human Services — 1995-2017. Centers for Disease Control and Prevention (CDC). State Tobacco Activities Tracking and Evaluation (STATE) System. Legislation-Tax. The STATE System...

  20. CDC STATE System Tobacco Legislation - Tax

    Data.gov (United States)

    U.S. Department of Health & Human Services — 1995-2018. Centers for Disease Control and Prevention (CDC). State Tobacco Activities Tracking and Evaluation (STATE) System. Legislation-Tax. The STATE System...

  1. Quantum Computing in Solid State Systems

    CERN Document Server

    Ruggiero, B; Granata, C

    2006-01-01

    The aim of Quantum Computation in Solid State Systems is to report on recent theoretical and experimental results on the macroscopic quantum coherence of mesoscopic systems, as well as on solid state realization of qubits and quantum gates. Particular attention has been given to coherence effects in Josephson devices. Other solid state systems, including quantum dots, optical, ion, and spin devices which exhibit macroscopic quantum coherence are also discussed. Quantum Computation in Solid State Systems discusses experimental implementation of quantum computing and information processing devices, and in particular observations of quantum behavior in several solid state systems. On the theoretical side, the complementary expertise of the contributors provides models of the various structures in connection with the problem of minimizing decoherence.

  2. Regulatory Promotion of Emergent CCS Technology

    Energy Technology Data Exchange (ETDEWEB)

    Davies, Lincoln; Uchitel, Kirsten; Johnson, David

    2014-01-01

    Despite the growing inevitability of climate change and the attendant need for mitigation strategies, carbon capture and sequestration (CCS) has yet to gain much traction in the United States. Recent regulatory proposals by the U.S. Environmental Protection Agency (EPA), limited in scope to new-build power plants, represent the only significant policy initiative intended to mandate diffusion of CCS technology. Phase I of this Project assessed barriers to CCS deployment as prioritized by the CCS community. That research concluded that there were four primary barriers: (1) cost, (2) lack of a carbon price, (3) liability, and (4) lack of a comprehensive regulatory regime. Phase II of this Project, as presented in this Report, assesses potential regulatory models for CCS and examines where those models address the hurdles to diffusing CCS technology identified in Phase I. It concludes (1) that a CCS-specific but flexible standard, such as a technology performance standard or a very particular type of market-based regulation, likely will promote CCS diffusion, and (2) that these policies cannot work alone, but rather, should be combined with other measures, such as liability limits and a comprehensive CCS regulatory regime.

  3. ResDE Two-Component Regulatory System Mediates Oxygen Limitation-Induced Biofilm Formation by Bacillus amyloliquefaciens SQR9.

    Science.gov (United States)

    Zhou, Xuan; Zhang, Nan; Xia, Liming; Li, Qing; Shao, Jiahui; Shen, Qirong; Zhang, Ruifu

    2018-04-15

    Efficient biofilm formation and root colonization capabilities facilitate the ability of beneficial plant rhizobacteria to promote plant growth and antagonize soilborne pathogens. Biofilm formation by plant-beneficial Bacillus strains is triggered by environmental cues, including oxygen deficiency, but the pathways that sense these environmental signals and regulate biofilm formation have not been thoroughly elucidated. In this study, we showed that the ResDE two-component regulatory system in the plant growth-promoting rhizobacterium Bacillus amyloliquefaciens strain SQR9 senses the oxygen deficiency signal and regulates biofilm formation. ResE is activated by sensing the oxygen limitation-induced reduction of the NAD + /NADH pool through its PAS domain, stimulating its kinase activity, and resulting in the transfer of a phosphoryl group to ResD. The phosphorylated ResD directly binds to the promoter regions of the qoxABCD and ctaCDEF operons to improve the biosynthesis of terminal oxidases, which can interact with KinB to activate biofilm formation. These results not only revealed the novel regulatory function of the ResDE two-component system but also contributed to the understanding of the complicated regulatory network governing Bacillus biofilm formation. This research may help to enhance the root colonization and the plant-beneficial efficiency of SQR9 and other Bacillus rhizobacteria used in agriculture. IMPORTANCE Bacillus spp. are widely used as bioinoculants for plant growth promotion and disease suppression. The exertion of their plant-beneficial functions is largely dependent on their root colonization, which is closely related to their biofilm formation capabilities. On the other hand, Bacillus is the model bacterium for biofilm study, and the process and molecular network of biofilm formation are well characterized (B. Mielich-Süss and D. Lopez, Environ Microbiol 17:555-565, 2015, https://doi.org/10.1111/1462-2920.12527; L. S. Cairns, L. Hobley, and

  4. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1, Revision 1 (Chinese Edition)

    International Nuclear Information System (INIS)

    2016-01-01

    This publication establishes requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered. A review of Safety Requirements publications was commenced in 2011 following the accident in the Fukushima Daiichi nuclear power plant in Japan. The review revealed no significant areas of weakness and resulted in just a small set of amendments to strengthen the requirements and facilitate their implementation, which are contained in the present publication.

  5. Experience of regulatory body functioning in energy industry of Ukraine: Prospects for future development of state regulation of energy

    International Nuclear Information System (INIS)

    Oruskaya, M.

    2002-01-01

    Materials collected (presented) in the paper introduce to (familiarise) the audience with the main forms, methods and phases of the state regulation of energy industry in Ukraine in the period of transition to market economy. Special attention was paid to the following aspects: 1. Necessity and history of establishment of special regulatory body in Ukraine - The National Electricity Regulatory Commission (NERC); 2. The main tasks and authorities of NERC according to the Ukraine Law on Energy Sector; 3. Regulation mechanisms of the main processes in the energy industry used by the Commission on the current level of energy sector development and economic results of its introduction; 4. Problems with functioning of the wholesale energy market specifically as the main component of the Ukraine energy industry and trends of future development (improvement of energy industry's financial situation, intensification of competition between energy producers and suppliers, improvement of tariff and investment policies, etc.); 5. Necessity and ways of future improvement of the standards and legal basis for regulation in Ukraine. (author)

  6. Safety Culture Implementation in Indonesian Nuclear Energy Regulatory Agency (BAPETEN)

    International Nuclear Information System (INIS)

    Nurwidi Astuti, Y.H.; Dewanto, P.

    2016-01-01

    The Indonesia Nuclear Energy Act no. 10 of 1997 clearly stated that Nuclear Energy Regulatory Agency (BAPETEN) is the Nuclear Regulatory Body. This is the legal basis of BAPETEN to perform regulatory functions on the use of nuclear energy in Indonesia, including regulation, authorisation, inspection and enforcement. The Independent regulatory functions are stipulated in Article 4 and Article 14 of the Nuclear Energy Act no. 10 (1997) which require the government to establish regulatory body that is reporting directly to the president and has responsibility to control of the use of nuclear energy. BAPETEN has been start fully its functioning on January 4, 1999. In it roles as a regulatory body, the main aspect that continues and always to be developed is the safety culture. One of the objectives of regulatory functions is “to increase legal awareness of nuclear energy of the user to develop safety culture” (Article 15, point d), while in the elucidation of article 15 it is stipulated that “safety culture is that of characteristics and attitudes in organizations and individual that emphasise the importance of safety”.

  7. The role of the US regulatory process in public acceptance of nuclear power

    International Nuclear Information System (INIS)

    Rowden, M.A.

    1977-01-01

    This paper focuses, on NRC's regulatory responsibilities in relation to public acceptance of nuclear power. Since public attitudes in the United States may influence reaction to nuclear power in other nations, it is fair to say that the credibility of our regulatory program has international significance. Stated simply, unless the public is convinced that the regulatory process is effective in assuring safety, safeguarding nuclear facilities and materials, and protecting the environment, the use of nuclear power could be curtailed or even brought to a halt. Not only must the regulatory process be effective, it must at the same time be recognized by the public as being effective. Opinion polls in the United States have shown consistently that a majority of Americans believe it is important to develop nuclear power to help meet our future energy needs. The direction of public concern has shifted from year to year. Most recently, public apprehension has been expressed about the potential hazards of long-term storage of the high-level wastes from spent fuel reprocessing, and about the risks that nuclear materials and facilities may be subject to theft or diversion or sabotage. Uppermost in the public mind is the question whether the regulatory process can cope with these potential threats to public health and safety. The licensing process of the NRC is conducted in full public view. Issues of a generic nature are aired in rulemaking hearings, while each proposal to construct and operate a nuclear power plant or a facility such as fuel reprocessing plant is the subject of public hearings, which are held near the site of the proposed plant. During the last two years, we have noted that some persons who object to nuclear power plants have indicated that they believe that decisions to permit construction of such plants should be made at the State government level, rather than by a Federal agency. As a result, there now are movements to enact State laws and to set up State

  8. The Chemistry of Conscious States - Toward a Unified Model of the ...

    Indian Academy of Sciences (India)

    wakefulness, deep sleep, and dreaming, and draws interesting parallels between the dreaming brain and psychotic states. These. 'mind' states emerge from the interplay between two of the major brain regulatory chemicals, in the cholinergic and aminergic systems. He illustrates how the mind itself can go out of kilter when ...

  9. Regulatory Oversight Program, July 1, 1993 - March 3, 1997. Volume 1

    International Nuclear Information System (INIS)

    1997-09-01

    On July 1, 1993, a Regulatory Oversight (RO) organization was established within the United States Department of Energy (DOE), Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the RO program was to ensure continued plant safety, safeguards and security while the Paducah and Portsmouth gaseous diffusion plants (GDPs) transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). These activities were performed under the authority of the lease agreement between DOE and USEC until NRC issued a Certificate of Compliance or approved a Compliance Plan pursuant to Section 1701 of the Atomic Energy Act of 1954, as amended, and assumed regulatory responsibility. This report chronicles the formal development, operation and key activities of the RO organization from its beginning in July 1993, until the turnover of the regulatory oversight responsibility to the NRC on March 3, 1997. Through its evolution to closure, the RO program was a formal, proceduralized effort designed to provide consistent regulation and to facilitate transition to NRC. The RO Program was also a first-of-a-kind program for DOE. The process, experience, and lessons learned summarized herein should be useful as a model for transition of other DOE facilities to privatization or external regulation

  10. Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-09-01

    On July 1, 1993, a Regulatory Oversight (RO) organization was established within the United States Department of Energy (DOE), Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the RO program was to ensure continued plant safety, safeguards and security while the Paducah and Portsmouth gaseous diffusion plants (GDPs) transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). These activities were performed under the authority of the lease agreement between DOE and USEC until NRC issued a Certificate of Compliance or approved a Compliance Plan pursuant to Section 1701 of the Atomic Energy Act of 1954, as amended, and assumed regulatory responsibility. This report chronicles the formal development, operation and key activities of the RO organization from its beginning in July 1993, until the turnover of the regulatory oversight responsibility to the NRC on March 3, 1997. Through its evolution to closure, the RO program was a formal, proceduralized effort designed to provide consistent regulation and to facilitate transition to NRC. The RO Program was also a first-of-a-kind program for DOE. The process, experience, and lessons learned summarized herein should be useful as a model for transition of other DOE facilities to privatization or external regulation.

  11. Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 3

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-31

    On July, 1993, a Regulatory Oversight (RO) organization was established within the US DOE, Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the OR program was to ensure continued plant safety, safeguards and security while the plants were transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). Volume 3 contains copies of two reports that document the DOE/ORO regulatory oversight inspection and enforcement history for each gaseous diffusion plant site. Each report provides a formal mechanism by which DOE/ORO could communicate the inspection and enforcement history to NRC. The reports encompass the inspection activities that occurred during July 1, 1993 through March 2, 1997.

  12. Access to the decision-making process: opportunities for public involvement in the facility decommissioning process of the United States Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Cameron, F.X.

    1996-01-01

    This paper discusses recent initiatives taken by the United States Nuclear Regulatory Commission NRC) to effectively involve the public in decommissioning decisions. Initiatives discussed include the Commission's rulemaking to establish the radiological criteria for decommissioning, as well as public involvement methods that have been used on a site-by-site basis. As un example of public involvement, the NRC is currently in the process of developing generic rules on the radiological criteria for the decontamination and decommissioning of NRC-licensed sites. Not only was this proposed rule developed through an extensive and novel approach for public involvement, but it also establishes the basic provisions that will govern public involvement in future NRC decisions on the decommissioning of individual sites. The aim is to provide the public with timely information about all phases of the NRC staff to express concerns and make recommendations. Th NRC recognizes the value and the necessity of effective public involvement in its regulatory activities and has initiated a number of changes to its regulatory program to accomplish this. From the NRC's perspective, it is much easier and less costly to incorporate these mechanisms for public involvement into the regulatory program early in the process, rather than try to add them after considerable public controversy on an action has already been generated. The historical antecedents for initiatives mentioned, as well as 'lessons learned' from prior experience are also discussed. (author)

  13. Regulatory analysis of the Underground Storage Tank-Integrated Demonstration Program

    International Nuclear Information System (INIS)

    Smith, E.H.

    1992-01-01

    The Underground Storage Tank-Integrated Demonstration (UST-ID) Program has been developed to identify, demonstrate, test, and evaluate technologies that will provide alternatives to the current underground storage tank remediation program. The UST-ID Program is a national program that consists of five participating US Department of Energy (DOE) sites where technologies can be developed an ultimately demonstrated. Once these technologies are demonstrated, the UST-ID Program will transfer the developed technology system to industry (governmental or industrial) for application or back to Research and Development for further evaluation and modification, as necessary. In order to ensure that the UST-ID Program proceeds without interruption, it will be necessary to identify regulatory requirements along with associated permitting and notification requirements early in the technology development process. This document serves as a baseline for identifying certain federal and state regulatory requirements that may impact the UST-ID Program and the demonstration of any identified technologies

  14. Regulatory policy issues and the Clean Air Act: Issues and papers from the state implementation workshops

    Energy Technology Data Exchange (ETDEWEB)

    Rose, K. [ed.; Burns, R.E.

    1993-07-01

    The National Regulatory Research Institute (NRRI), with funding from the US Environmental Protection Agency (EPA) and the US Department of Energy (DOE), conducted four regional workshops` on state public utility commission implementation of the Clean Air Act Amendments of 1990 (CAAA). The workshops had four objectives: (1) to discuss key issues and concerns on CAAA implementation, (2) to encourage a discussion among states on issues of common interests, (3) to attempt to reach consensus, where possible, on key issues, and (4) to provide the workshop participants with information and materials to assist in developing state rules, orders, and procedures. From the federal perspective, a primary goal was to ensure that workshop participants return to their states with a comprehensive background and understanding of how state commission actions may affect implementation of the CAAA and to be able to provide guidance to their jurisdictional utilities. It was hoped that this would reduce some of the uncertainty utilities face and assist in the development of an efficient allowance market. This report is divided into two main sections. In Section II, eleven principal issues are identified and discussed. These issues were chosen because they were either the most frequently discussed or they were related to the questions asked in response to the speakers` presentations. This section does not cover all the issues relevant to state implementation nor all the issues discussed at the workshops; rather, Section II is intended to provide an overview of the,planning, ratemaking, and multistate issues. Part III is a series of workshop papers presented by some of the speakers. Individual papers have been cataloged separately.

  15. State regulation of the biotechnology (GM agricultural products: analysis of different approaches in the world

    Directory of Open Access Journals (Sweden)

    Irina Vladimirovna Yakovleva

    2015-06-01

    Full Text Available Although GM crops are cultivated on 175 million hectares in 27 countries, the regulation of agricultural biotechnology is in its becoming. In the future, many countries, of course, will lead to market biotech products, and the main focus will be biosafety issues for humans and the environment. Some countries have special regulatory mechanisms, others do not have the original national regulatory system, but their actions are under the provisions of international treaties for the production and handling of GM products. What are the main components of a strict but not stifling regulatory system? What are the disadvantages of existing systems? The article presents an overview of the state regulation systems of biotech agricultural products in the US, the EU, Argentina, South Africa and Brazil.

  16. Quality Management System at the Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    Husarcek, J.; Novak, S.

    2008-01-01

    The process-oriented quality management system (QMS) implemented at the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in compliance with the EN ISO 9001:2001 standard is described. The history of the establishment and development of the QMS is given. The main, managerial and supporting processes with respect to defined activities are specified, and a scheme of their interactions is presented. The contents of the Quality Manual content and the structure of the system documentation are briefly described. The responsibilities for the operation and improvements of the QMS are described along with the methods applied (internal and external audits, self-assessment - Common Assessment Framework (CAF)). Examples of established quality objectives and indicators for some processes are provided. A future development of the QMS is expected in accordance with the relevant ISO Standard and IAEA recommendations and based on evaluation of the effectiveness of the critical system. (orig.)

  17. Modulation of dynamic modes by interplay between positive and negative feedback loops in gene regulatory networks

    Science.gov (United States)

    Wang, Liu-Suo; Li, Ning-Xi; Chen, Jing-Jia; Zhang, Xiao-Peng; Liu, Feng; Wang, Wei

    2018-04-01

    A positive and a negative feedback loop can induce bistability and oscillation, respectively, in biological networks. Nevertheless, they are frequently interlinked to perform more elaborate functions in many gene regulatory networks. Coupled positive and negative feedback loops may exhibit either oscillation or bistability depending on the intensity of the stimulus in some particular networks. It is less understood how the transition between the two dynamic modes is modulated by the positive and negative feedback loops. We developed an abstract model of such systems, largely based on the core p53 pathway, to explore the mechanism for the transformation of dynamic behaviors. Our results show that enhancing the positive feedback may promote or suppress oscillations depending on the strength of both feedback loops. We found that the system oscillates with low amplitudes in response to a moderate stimulus and switches to the on state upon a strong stimulus. When the positive feedback is activated much later than the negative one in response to a strong stimulus, the system exhibits long-term oscillations before switching to the on state. We explain this intriguing phenomenon using quasistatic approximation. Moreover, early switching to the on state may occur when the system starts from a steady state in the absence of stimuli. The interplay between the positive and negative feedback plays a key role in the transitions between oscillation and bistability. Of note, our conclusions should be applicable only to some specific gene regulatory networks, especially the p53 network, in which both oscillation and bistability exist in response to a certain type of stimulus. Our work also underscores the significance of transient dynamics in determining cellular outcome.

  18. Development of measures to assess the safety of existing NPPs and the effectiveness of regulations and regulatory actions (including 'prescriptive' and 'performance based' approaches). Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    1996-09-01

    This report arises from the fourth series of peer discussions on regulatory practices entitled D evelopment of measures to assess the safety of existing nuclear power plants and the effectiveness of regulations and regulatory actions (including 'prescriptive' and 'performance based' approaches) . Senior regulators from 23 Member States participated in four peer group discussions during 1995-1996. This report presents the outcome of these meetings and recommendations of good practices identified by these senior regulators. The purpose of this report is to disseminate the views which the senior regulators presented at the meetings relating to measures used for assessing the safety of existing nuclear power plants and evaluating the effectiveness of regulators and regulatory actions. The intention in doing this is to assist Member States in the enhancement of their regulatory practices by identifying commonly accepted good practices. This report is structured so that it covers the subject matter under the following main headings: 'Prescriptive and Performance Based' Approaches to Regulation; Common Features of Regulatory Approaches; Effectiveness of the Regulator and Regulatory Actions; Recommendations of Good Practice. It is important to note that recommendations of good practice are included if they have been identified by at least one of the groups. It does not follow that all of the groups or individual Member States would necessarily endorse all of the recommendations. However, it is considered that if a single group of senior regulators judge that a particular practice is worthy of recommendation then it should be included for serious consideration. In some cases the same recommendations arise from all of the Groups

  19. Nuclear Regulatory Commission Information Digest: 1993 edition

    International Nuclear Information System (INIS)

    1993-03-01

    The Nuclear Regulatory Commission Information Digest (digest) provides a summary of information about the U.S. Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, the activities NRC licenses, and general information on domestic and worldwide nuclear energy. The digest, published annually, is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and the industry it regulates. In general, the data cover 1975 through 1992, with exceptions noted. Information on generating capacity and average capacity factor for operating U.S. commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed. Comments and/or suggestions on the data presented are welcomed and should be directed to Karen Olive, United States Nuclear Regulatory Commission, Office of the Controller, Division of Budget and Analysis, Washington, D.C. 20555. For detailed and complete information about tables and figures, refer to the source publications

  20. Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool.

    Science.gov (United States)

    Romero, Klaus; Clay, Robert; Hanna, Debra

    2015-08-15

    The first nonclinical drug development tool (DDT) advanced by the Critical Path to TB Drug Regimens (CPTR) Initiative through a regulatory review process has been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbiological outcomes are needed to support decision making. Regulatory endorsement of these DDTs is critical for drug developers, as it promotes confidence in their use in Investigational New Drug and New Drug Application filings. The in vitro hollow fiber system model of tuberculosis (HFS-TB) is able to recapitulate concentration-time profiles (exposure) observed in patients for single drugs and combinations, by evaluating exposure measures for the ability to kill tuberculosis in different physiologic conditions. Monte Carlo simulations make this quantitative output useful to inform susceptibility breakpoints, dosage, and optimal combination regimens in patients, and to design nonclinical experiments in animal models. The Pre-Clinical and Clinical Sciences Working Group within CPTR executed an evidence-based evaluation of the HFS-TB for predictive accuracy. This extensive effort was enabled through the collaboration of subject matter experts representing the pharmaceutical industry, academia, product development partnerships, and regulatory authorities including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A comprehensive analysis plan following the regulatory guidance documents for DDT qualification was developed, followed by individual discussions with the FDA and the EMA. The results from the quantitative analyses were submitted to both agencies, pursuing regulatory DDT endorsement. The EMA Qualification Opinion for the HFS-TB DDT was published 26 January 2015 (available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp). © The Author 2015. Published by Oxford University Press on behalf of the

  1. The United States nuclear regulatory commission license renewal process

    International Nuclear Information System (INIS)

    Holian, B.E.

    2009-01-01

    The United States (U.S.) Nuclear Regulatory Commission (NRC) license renewal process establishes the technical and administrative requirements for the renewal of operating power plant licenses. Reactor ope-rating licenses were originally issued for 40 years and are allowed to be renewed. The review process for license renewal applications (L.R.A.) provides continued assurance that the level of safety provided by an applicant's current licensing basis is maintained for the period of extended operation. The license renewal review focuses on passive, long-lived structures and components of the plant that are subject to the effects of aging. The applicant must demonstrate that programs are in place to manage those aging effects. The review also verifies that analyses based on the current operating term have been evaluated and shown to be valid for the period of extended operation. The NRC has renewed the licenses for 52 reactors at 30 plant sites. Each applicant requested, and was granted, an extension of 20 years. Applications to renew the licenses of 20 additional reactors at 13 plant sites are under review. As license renewal is voluntary, the decision to seek license renewal and the timing of the application is made by the licensee. However, the NRC expects that, over time, essentially all U.S. operating reactors will request license renewal. In 2009, the U.S. has 4 plants that enter their 41. year of ope-ration. The U.S. Nuclear Industry has expressed interest in 'life beyond 60', that is, requesting approval of a second renewal period. U.S. regulations allow for subsequent license renewals. The NRC is working with the U.S. Department of Energy (DOE) on research related to light water reactor sustainability. (author)

  2. Exemption from Regulatory Control of Goods Containing Small Amounts of Radioactive Material

    International Nuclear Information System (INIS)

    2012-01-01

    Small amounts of radioactive material may be added to various goods for functional reasons. Several such items are currently available for either professional or personal use. These include ionization chamber smoke detectors, thoriated-tungsten welding rods, luminous dials, electrical devices and electric discharge lamps. Some of these goods may be intended for particular types of market such as cinemas or other places to which the public may have access, but they are unlikely to be provided directly to members of the public. Other goods may be intended for wide scale use and therefore readily available on the market as consumer products through commercial outlets where personal and household products are normally purchased. Members of the public may be exposed to ionizing radiation as a consequence of activities such as transport, storage, use and disposal of such goods. The IAEA safety standards provide the basic requirements for regulatory control of such goods. The most relevant documents are the Governmental, Legal and Regulatory Framework for Safety and the International Basic Safety Standards (hereafter referred to as the BSS). These requirements include notification of a practice to the regulatory body and authorization of the practice by the regulatory body. Provision is made for the exemption of practices from these and other regulatory requirements based on general criteria given in the BSS or any exemption levels specified by the regulatory body on the basis of these criteria. The BSS, which are jointly sponsored by the IAEA and several other international organizations, apply to all facilities and all activities for peaceful purposes that give rise to exposure to radiation. In the interest of harmonization of approaches among Member States, some guidance on the application of the criteria for exemption has been provided in a number of Safety Guides, e.g. Regulatory Control of Radiation Sources, IAEA Safety Standards Series No. GS-G-1.5 (2004) and the

  3. Pre-salt new regulatory mark and the economic order: constitutionality analysis; Novo marco regulatorio do pre-sal e a ordem economica: analise de constitucionalidade

    Energy Technology Data Exchange (ETDEWEB)

    Pinheiro, Marcela Brasil Pedrosa; Araujo, Mayara de Carvalho; Xavier, Yanko Marcius; Guimaraes, Patricia Borba Vilar [Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN (Brazil)

    2010-07-01

    The discovery of vast reserves of hydrocarbons in the pre-salt layer that extends from Espirito Santo to Santa Catarina, added with the economic and strategic value of oil and natural gas, has brought discussion about the reasonableness of the regulatory model adopted so far. Would be prudent to explore these resources through the concession model? From detailed analysis of the doctrinal and bills that aim to inaugurate the new regulatory bills, we sought to answer this question, based majorly on the principles of economic activity applied in our constitutional system. Motivated by the analysis of these constitutional principles proposed, the State is seen as a regulating agent of the economic activities, fulfilling its role to supervise, encourage and plan the direction of national economic system. The sharing model gives greater state involvement and is able to convert the wealth of pre-salt in citizenship, but only if well implemented. Thus, based on constitutional principles and the notion of development as freedom, the conclusion of this paperwork is for the constitutionality of the new regulatory bills. (author)

  4. Regulatory Framework for the Maintenance of the Relevant Knowledge in the Atomic Energy Use Sector

    International Nuclear Information System (INIS)

    Sapozhnikov, A.

    2016-01-01

    Full text: In accordance with the Atomic Act of the Russian Federation the employees and workers (personnel) of nuclear industry organisations, who occupy certain positions or perform specific activities in the field of atomic energy use can start to fulfil their duties only after getting a special permit issued by the state safety regulatory authority. Rostechnadzor issues permits for the specified kinds of activities to personal of nuclear facilities, organizations engaged in transportation of nuclear and radioactive materials, and enterprises performing physical protection and account of nuclear materials and radioactive substances. To enforce the provisions of the Atomic Act Rostechnadzor has developed a regulatory system (requirements, procedures and methodology) for continued supervision over the maintenance of the required level of knowledge and adequate understanding of the nuclear safety requirements by the nuclear personnel, depending on the nature of their job duties and work in the sphere of nuclear energy use. The report presents a long-term experience of Rostechnadzor in implementing an effective regulatory system for maintaining an adequate level of knowledge and expertise of personnel of nuclear industry organisations and ensuring a competent workforce in the nuclear energy sector. (author

  5. The State Public Health Laboratory System.

    Science.gov (United States)

    Inhorn, Stanley L; Astles, J Rex; Gradus, Stephen; Malmberg, Veronica; Snippes, Paula M; Wilcke, Burton W; White, Vanessa A

    2010-01-01

    This article describes the development since 2000 of the State Public Health Laboratory System in the United States. These state systems collectively are related to several other recent public health laboratory (PHL) initiatives. The first is the Core Functions and Capabilities of State Public Health Laboratories, a white paper that defined the basic responsibilities of the state PHL. Another is the Centers for Disease Control and Prevention National Laboratory System (NLS) initiative, the goal of which is to promote public-private collaboration to assure quality laboratory services and public health surveillance. To enhance the realization of the NLS, the Association of Public Health Laboratories (APHL) launched in 2004 a State Public Health Laboratory System Improvement Program. In the same year, APHL developed a Comprehensive Laboratory Services Survey, a tool to measure improvement through the decade to assure that essential PHL services are provided.

  6. Generic Properties of Random Gene Regulatory Networks.

    Science.gov (United States)

    Li, Zhiyuan; Bianco, Simone; Zhang, Zhaoyang; Tang, Chao

    2013-12-01

    Modeling gene regulatory networks (GRNs) is an important topic in systems biology. Although there has been much work focusing on various specific systems, the generic behavior of GRNs with continuous variables is still elusive. In particular, it is not clear typically how attractors partition among the three types of orbits: steady state, periodic and chaotic, and how the dynamical properties change with network's topological characteristics. In this work, we first investigated these questions in random GRNs with different network sizes, connectivity, fraction of inhibitory links and transcription regulation rules. Then we searched for the core motifs that govern the dynamic behavior of large GRNs. We show that the stability of a random GRN is typically governed by a few embedding motifs of small sizes, and therefore can in general be understood in the context of these short motifs. Our results provide insights for the study and design of genetic networks.

  7. Improving regulatory effectiveness in federal/state siting actions: state regulatory activity involved in need for power

    International Nuclear Information System (INIS)

    Nassikas, J.

    1977-04-01

    The individual views are presented of the panel members relating to the basic issues and framework for improvements of the Federal/state process for licensing of nuclear power plants, associated facilities, transmission lines, reprocessing of fuel and uranium enrichment. The synopsis supplements the initial synopsis of the views presented to the National Governors Conference Workshop ''State Perspectives on Energy Facility Siting'' in Atlanta, Georgia on December 15--16, 1976. Both synopses constitute the report of this panel

  8. The Regulatory Independence of FANR

    International Nuclear Information System (INIS)

    ALNuaimi, Fatema; Choi, Kwang Shik

    2012-01-01

    Regulatory independence is meant to provide a conservative system of policy making in order to comply with the problems that are forecasted upon the basis of assumptions. The Federal Authorization of Nuclear Regulation (FANR) is a regulatory commission that was formed to be regulatory body that governs the generation of nuclear power in United Arab Emirates. It was established under the UAE nuclear law (9/2009) as an independent regulatory body that was tasked with the regulation of all nuclear activities in the United Arab Emirates. As an independent body, FANR was tasked with ensuring that the regulation of the nuclear sector is done in effective and transparent manner to ensure its accountability to the people. Being independent, the regulatory body develops national nuclear regulations based on laid down safety standards by the International Atomic Energy Agency, ensuring that they are based on scientific and proven technologies The role of FANR is to ensure that the all corporations that undertake nuclear activities follow the laid down procedures and objectives and ensure safety measures are taken keenly to ensure the safety of the workers and the general public while at the same time ensuring the environment is free from nuclear radiations

  9. The Regulatory Independence of FANR

    Energy Technology Data Exchange (ETDEWEB)

    ALNuaimi, Fatema; Choi, Kwang Shik [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of)

    2012-05-15

    Regulatory independence is meant to provide a conservative system of policy making in order to comply with the problems that are forecasted upon the basis of assumptions. The Federal Authorization of Nuclear Regulation (FANR) is a regulatory commission that was formed to be regulatory body that governs the generation of nuclear power in United Arab Emirates. It was established under the UAE nuclear law (9/2009) as an independent regulatory body that was tasked with the regulation of all nuclear activities in the United Arab Emirates. As an independent body, FANR was tasked with ensuring that the regulation of the nuclear sector is done in effective and transparent manner to ensure its accountability to the people. Being independent, the regulatory body develops national nuclear regulations based on laid down safety standards by the International Atomic Energy Agency, ensuring that they are based on scientific and proven technologies The role of FANR is to ensure that the all corporations that undertake nuclear activities follow the laid down procedures and objectives and ensure safety measures are taken keenly to ensure the safety of the workers and the general public while at the same time ensuring the environment is free from nuclear radiations

  10. WhatsApp in Stroke Systems: Current Use and Regulatory Concerns.

    Science.gov (United States)

    Calleja-Castillo, Juan M; Gonzalez-Calderon, Gina

    2018-01-01

    Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use.

  11. WhatsApp in Stroke Systems: Current Use and Regulatory Concerns

    Directory of Open Access Journals (Sweden)

    Juan M. Calleja-Castillo

    2018-05-01

    Full Text Available Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use.

  12. Collaborative Systems – Finite State Machines

    Directory of Open Access Journals (Sweden)

    Ion IVAN

    2011-01-01

    Full Text Available In this paper the finite state machines are defined and formalized. There are presented the collaborative banking systems and their correspondence is done with finite state machines. It highlights the role of finite state machines in the complexity analysis and performs operations on very large virtual databases as finite state machines. It builds the state diagram and presents the commands and documents transition between the collaborative systems states. The paper analyzes the data sets from Collaborative Multicash Servicedesk application and performs a combined analysis in order to determine certain statistics. Indicators are obtained, such as the number of requests by category and the load degree of an agent in the collaborative system.

  13. Regulatory requirements on the design and construction of nuclear power plant control and instrumentation systems in Finland

    International Nuclear Information System (INIS)

    Heikkila, M.A.

    1978-01-01

    The Department of Reactor Safety of the Institute of Radiation Protection, being the nuclear regulatory authority in Finland, has set up regulations which govern the design and construction of NPP systems and components. The regulations are partly compiled from existing codes and standards, published primarily in the United States and Federal Republic of Germany, and partly worked out at the Institute. The regulations are collected to a special set of YVL guides (guides for nuclear power plants), and one of these gives requirements on the design and construction of NPPCI systems and components. The scope of the requirements is based on the safety classification of the CI systems and components. Three safety classes have been singled out: the first for CI systems which take part in reactor protection, the second for other directly safety related, and the third for remaining CI systems important enough to deserve supervision. The safety class for CI components is inherited from the system they belong to. The safety classification of IC systems has direct bearing on the initial assumptions of plant accident analysis. The design principles of IC systems are inspected as part of the preliminary and final safety reports. Focus is directed on the principles of redundancy, separation, diversity, testability, etc. The requirements on IC components are directed to different stages of manufacture, installation and operation. The type tests shall be adequate and acceptably documented. The manufacture of components is followed, the test reports reviewed and the efficiency of manufacturers quality assurance program evaluated. Further requirements concern the installation phase and tests at the end of it, and finally guides include directions for maintenance and testing during the operations phase. (author)

  14. Design reviews from a regulatory perspective

    International Nuclear Information System (INIS)

    Foster, B.D.

    1991-01-01

    This paper presents views on the role of the licensing engineer in the design process with specific emphasis on design reviews and the automated information management tools that support design reviews. The licensing engineer is seen as an important member of a design review team. The initial focus of the licensing engineer during design reviews is shown to be on ensuring that applicable regulatory requirements are addressed by the design. The utility of an automated tool, such as a commitments management system, to support regulatory requirements identification is discussed. The next responsibility of the licensing engineer is seen as verifying that regulatory requirements are transformed into measurable performance requirements. Performance requirements are shown to provide the basis for developing detailed design review criteria. Licensing engineer input during design reviews is discussed. This input is shown to be especially critical in cases where review findings may impact application of regulatory requirements. The use of automated tools in supporting design reviews is discussed. An information structure is proposed to support design reviews in a regulated environment. This information structure is shown to be useful to activities beyond design reviews. Incorporation of the proposed information structure into the Licensing Support System is proposed

  15. RAF/9/049: Enhancing and Sustaining the National Regulatory Bodies for safety

    International Nuclear Information System (INIS)

    Keter, C.J.

    2017-01-01

    The main objective of this project is to enhance regulatory infrastructure, sustainability and cooperation among national regulatory bodies. This will support strengthening of the existing regulatory framework and capacity building in the region. Self-Assessment using the Self-Assessment Regulatory Infrastructure for Safety (SARIS) was completed on 26th May 2016. Changes made to the legislation is ongoing. The Nuclear Regulatory Bill 2017 is at an advanced stage and about to be tabled to Cabinet. The project objectives shall be addressed under a new project, RAF/9/058 – Improving the Regulatory Framework for the Control of Radiation Sources in Member States. Two major tasks for Kenya to focus include Review of regulations on waste safety, radiation sources and on safety of NPP and advising on drafting of radiation safety guides

  16. 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.

  17. State of the Art of Fuzzy Methods for Gene Regulatory Networks Inference

    Directory of Open Access Journals (Sweden)

    Tuqyah Abdullah Al Qazlan

    2015-01-01

    Full Text Available To address one of the most challenging issues at the cellular level, this paper surveys the fuzzy methods used in gene regulatory networks (GRNs inference. GRNs represent causal relationships between genes that have a direct influence, trough protein production, on the life and the development of living organisms and provide a useful contribution to the understanding of the cellular functions as well as the mechanisms of diseases. Fuzzy systems are based on handling imprecise knowledge, such as biological information. They provide viable computational tools for inferring GRNs from gene expression data, thus contributing to the discovery of gene interactions responsible for specific diseases and/or ad hoc correcting therapies. Increasing computational power and high throughput technologies have provided powerful means to manage these challenging digital ecosystems at different levels from cell to society globally. The main aim of this paper is to report, present, and discuss the main contributions of this multidisciplinary field in a coherent and structured framework.

  18. A balance of activity in brain control and reward systems predicts self-regulatory outcomes

    OpenAIRE

    Lopez, Richard B.; Chen, Pin-Hao A.; Huckins, Jeremy F.; Hofmann, Wilhelm; Kelley, William M.; Heatherton, Todd F.

    2017-01-01

    Abstract Previous neuroimaging work has shown that increased reward-related activity following exposure to food cues is predictive of self-control failure. The balance model suggests that self-regulation failures result from an imbalance in reward and executive control mechanisms. However, an open question is whether the relative balance of activity in brain systems associated with executive control (vs reward) supports self-regulatory outcomes when people encounter tempting cues in daily lif...

  19. State estimation in networked systems

    NARCIS (Netherlands)

    Sijs, J.

    2012-01-01

    This thesis considers state estimation strategies for networked systems. State estimation refers to a method for computing the unknown state of a dynamic process by combining sensor measurements with predictions from a process model. The most well known method for state estimation is the Kalman

  20. Development of regulatory techniques for operational performance evaluation of nuclear power plants

    International Nuclear Information System (INIS)

    Sung, K. Y.; Lee, C. J.; Choi, J. S.; Lee, S. Y.; Kim, M. C.

    2003-04-01

    In order to provide the technical rationale for future risk-informed regulatory applications, four essential regulatory areas, i.e., PSA regulatory audit model, quality certification procedure on PSA, risk-informed performance indicator, and risk monitoring were surveyed, and the corresponding state-of- technology for each area was summarized. Actually, this study was performed by way of the analysis and in-depth survey on the previous experience done by any individual organizations like USNRC or US NEI, as well as the international organizations like IAEA or OECD/NEA. Through the survey results, we might look for the regulatory positions on national development

  1. Regulatory application of seismic experience data for nuclear power plants in the United States

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Pei-Ying [Nuclear Regulatory Commission, Washington, DC (United States)

    1997-03-01

    On the basis of its review and evaluation (Reference 3) of the SQUG GIP (Reference 2) and on the basis of the differences between current seismic qualification requirements and the criteria and procedures provided in the GIP, the NRC staff does not consider the USI A-46 methodology given in the GIP to be a `seismic qualification` procedure. Rather, the staff considers the GIP methodology to be a seismic adequacy verification procedure, which was developed on the basis of generic equipment earthquake experience data, supplemented by generic equipment test data. The implementation of the GIP approach for USI A-46 plants provides safety enhancement, in certain aspects, beyond the original licensing bases. Therefore, the GIP methodology is an acceptable evaluation method, for USI A-46 plants only, to verify the seismic adequacy of the safe-shutdown equipment installed in the NPPs in the United States. With the new development in the experience-based approach for seismic qualification of equipment currently underway in the U.S. nuclear industry, there is a potential for future regulatory application of an experience-based approach as a seismic qualification method for certain selected equipment installed in NPPs in the United States. However, industry`s use of the experience-based approach will be dependent on the submittal and staff approval of this approach. (J.P.N.)

  2. The State of Emergency Medical Services (EMS) Systems in Africa.

    Science.gov (United States)

    Mould-Millman, Nee-Kofi; Dixon, Julia M; Sefa, Nana; Yancey, Arthur; Hollong, Bonaventure G; Hagahmed, Mohamed; Ginde, Adit A; Wallis, Lee A

    2017-06-01

    Introduction Little is known about the existence, distribution, and characteristics of Emergency Medical Services (EMS) systems in Africa, or the corresponding epidemiology of prehospital illness and injury. A survey was conducted between 2013 and 2014 by distributing a detailed EMS system questionnaire to experts in paper and electronic versions. The questionnaire ascertained EMS systems' jurisdiction, operations, finance, clinical care, resources, and regulatory environment. The discovery of respondents with requisite expertise occurred in multiple phases, including snowball sampling, a review of published scientific literature, and a rigorous search of the Internet. The survey response rate was 46%, and data represented 49 of 54 (91%) African countries. Twenty-five EMS systems were identified and distributed among 16 countries (30% of African countries). There was no evidence of EMS systems in 33 (61%) countries. A total of 98,574,731 (8.7%) of the African population were serviced by at least one EMS system in 2012. The leading causes of EMS transport were (in order of decreasing frequency): injury, obstetric, respiratory, cardiovascular, and gastrointestinal complaints. Nineteen percent of African countries had government-financed EMS systems and 26% had a toll-free public access telephone number. Basic emergency medical technicians (EMTs) and Basic Life Support (BLS)-equipped ambulances were the most common cadre of provider and ambulance level, respectively (84% each). Emergency Medical Services systems exist in one-third of African countries. Injury and obstetric complaints are the leading African prehospital conditions. Only a minority (<9.0%) of Africans have coverage by an EMS system. Most systems were predominantly BLS, government operated, and fee-for-service. Mould-Millman NK , Dixon JM , Sefa N , Yancey A , Hollong BG , Hagahmed M , Ginde AA , Wallis LA . The state of Emergency Medical Services (EMS) systems in Africa. Prehosp Disaster Med. 2017;32(3):273-283.

  3. Regulatory requirements related to maintenance and compliance monitoring

    International Nuclear Information System (INIS)

    Ling, A.K.H.

    1997-01-01

    The maintenance related regulatory requirements are identified in the regulatory documents and licence conditions. Licensee complies with these requirements by operating the nuclear power plant within the safe operating envelope as given in the operating policies and principles and do maintenance according to approved procedures and/or work plans. Safety systems are regularly tested. AECB project officers review and check to ensure that the licensee operates the nuclear power plant in accordance with the regulatory requirements and licence conditions. (author). 6 tabs

  4. Comparison of regulatory framework among bench marking countries for improving regulatory effectiveness in Malaysia

    International Nuclear Information System (INIS)

    Khairuddin, Nik Mohd Faiz Bin; Choi, Kwang Sik

    2010-01-01

    Nowadays some of developing countries in Asian region are announcing their planning to embark the nuclear power program. This progression are rising due to four factor: increasing political instabilities in fossil-fuel exporting countries; declining domestic natural energy resources; growing concerns about greenhouse gas emissions; and increasing demand for electricity. This paper gives a study on the comparison between Canada, Republic of South Korea and Malaysia regarding to their regulatory framework as well as the licensing procedures in controlling the nuclear power plants establishment. Canada and Korea were selected to study because of both of the countries have different system in controlling the nuclear power plants in terms of its regulatory framework as well as the licensing process. The idea is to compare these countries along with the guidelines by the IAEA and to find out what Malaysia could be learn to start the nuclear power program and find out the best practice in nuclear licensing. Factors taken into consideration are the regulatory framework, especially the nature of the licensing authority, the licensing process and enforcement actions. Together, these give a way to evaluate the effectiveness of the regulatory body due to the licensing authorization of nuclear power plant

  5. Comparison of regulatory framework among bench marking countries for improving regulatory effectiveness in Malaysia

    Energy Technology Data Exchange (ETDEWEB)

    Khairuddin, Nik Mohd Faiz Bin [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2010-05-15

    Nowadays some of developing countries in Asian region are announcing their planning to embark the nuclear power program. This progression are rising due to four factor: increasing political instabilities in fossil-fuel exporting countries; declining domestic natural energy resources; growing concerns about greenhouse gas emissions; and increasing demand for electricity. This paper gives a study on the comparison between Canada, Republic of South Korea and Malaysia regarding to their regulatory framework as well as the licensing procedures in controlling the nuclear power plants establishment. Canada and Korea were selected to study because of both of the countries have different system in controlling the nuclear power plants in terms of its regulatory framework as well as the licensing process. The idea is to compare these countries along with the guidelines by the IAEA and to find out what Malaysia could be learn to start the nuclear power program and find out the best practice in nuclear licensing. Factors taken into consideration are the regulatory framework, especially the nature of the licensing authority, the licensing process and enforcement actions. Together, these give a way to evaluate the effectiveness of the regulatory body due to the licensing authorization of nuclear power plant

  6. Antioxidant and Ex Vivo Immune System Regulatory Properties of Boswellia serrata Extracts

    Directory of Open Access Journals (Sweden)

    Daniela Beghelli

    2017-01-01

    Full Text Available Boswellia serrata (BS is an important traditional medicinal plant that currently represents an interesting topic for pharmaceutical research since it possesses several pharmacological properties (e.g., anti-inflammatory, antimicrobial, and antitumour. The safety and versatility of this dietary supplement should allow for its use in numerous pathological conditions; however the quality of the extracts needs to be standardized to increase the clinical success rate resulting from its use. In the present study, different commercially available B. serrata extracts were employed to compare their AKBA content and in vitro antioxidant power. Furthermore, their ability to modulate the immune system regulatory properties was investigated. Our results showed that the AKBA content varied from 3.83±0.10 to 0.03±0.004%, with one sample in which it was not detectable. The highest antioxidant power and phenolic content were shown by the same extract, which also exhibited the highest AKBA concentration. Finally, the BS extracts showed the ability to influence the regulatory and effector T-cell compartments. Our results suggest that frankincense should be further investigated for its promising potentiality to modulate not only inflammation/oxidative stress but also immune dysregulation, but attention should be paid to the composition of the commercial extracts.

  7. 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.

  8. 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...

  9. Regulatory criteria for final disposal of radioactive wastes

    International Nuclear Information System (INIS)

    Petraitis, E.; Ciallella, N.; Siraky, G.

    1998-01-01

    This paper describes briefly the legislative and regulatory framework in which the final disposal of radioactive wastes is carried out in Argentina. It also presents the criteria developed by the Nuclear Regulatory Authority (ARN) to assess the long-term safety of final disposal systems for high level radioactive wastes. (author)

  10. 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

  11. A regulatory perspective of the role of construction in revitalizing the United States nuclear industry

    International Nuclear Information System (INIS)

    Stello, V. Jr.

    1983-01-01

    Technical and managerial experience in nuclear power plant construction is presented from the perspective of the United States Nuclear Regulatory Commission (NRC). In the context of actions that would contribute to revitalizing the nuclear industry in the United States of America, greater effectiveness of utility management during construction is proposed. The reasons why management effectiveness is so important are developed beginning with summaries of defects that were built into several US plants under construction. The root causes of these significant defects were management failures. In terms of benefits, effective management is important because of its effects on nuclear safety, project construction costs, and future reliability of the plant after commissioning. Actions that would enhance good management include emphasizing the inseparable nature of production and quality, that quality cannot be inspected into a plant, and that a strong construction management staff and exchanges of experience and information are essential. Techniques that have been used successfully in construction management are discussed. NRC and industry initiatives are in progress to improve management responsibility and learning from experience. Projects include Owner's Certification, assessments of licensee performance, fostering good practices across the industry, and improving the NRC inspection programme. Revitalization will not be easy, but it is achievable. (author)

  12. Status of nuclear regulatory research and its future perspectives

    International Nuclear Information System (INIS)

    Lee, J. I.; Kim, W. S.; Kim, M. W.

    1999-01-01

    A comprehensive investigation of the regulatory research comprising an examination of the research system, its areas and contents, and the goals and financial resources is undertaken. As a result of this study, the future direction of regulatory research and its implementation strategies are suggested to resolve the current issues emerging from this examination. The major issues identified in the study are; (a) an insufficient investment in nuclear regulatory and safety research, (b) an interfacial discrepancy between similar research areas, and (c) a limitation of utilizing research results. To resolve these issues, several measures are proposed : (1) developing a lead project to establish a comprehensive infrastructure for enhancing research cooperation between nuclear organizations including institutes, industry, and universities, with an aim to improve cooperation between projects and to strengthen overall coordination functions among research projects, (2) introducing a certification system on research outcome to promote the proliferation of both research results themselves and their application with a view to enhancing the research quality, (3) strengthening the cooperative system to promote the international cooperative research, and (4) digitalizing all documents and materials relevant to safety and regulatory research to establish KIMS (knowledge and information based management system). It is expected that the aforementioned measures suggested in this study will enhance the efficiency and effectiveness of both nuclear regulatory and safety research, if they are implemented after deliberating with the government and related nuclear industries in the near future

  13. Regulatory adequacy of aquatic ecotoxicity testing of nanomaterials

    DEFF Research Database (Denmark)

    Hjorth, Rune; Skjolding, Lars Michael; Sørensen, Sara Nørgaard

    2017-01-01

    between studies, which question the regulatory reliability of the data currently available. Accordingly, lack of data suited for regulatory decision-making is still a pressing issue in nanoecotoxicology even though the data availability has increased. Nevertheless, we emphasize that by deliberately...... to question whether ecotoxicity testing is now able to facilitate regulatory decision-making on manufactured nanomaterials (MNs). In this paper, we review the state of aquatic ecotoxicity testing of MNs as well as the overarching issues that challenge the reliability and relevance of such testing. We conclude...... that within the field there is an increased focus on characterization of the exposure rather than controlling exposure as it is traditionally done in guideline testing of chemicals. However, the lack of characterization options under actual testing conditions makes it difficult to make meaningful comparisons...

  14. Information Management system of the safety regulatory requirements and guidance for the Korea next generation reactors

    International Nuclear Information System (INIS)

    Yun, Y. C.; Lee, J. H.; Lee, H. C.; Lee, J. S.

    2000-01-01

    In order to achieve the safety of the Korea Next Generation Reactors (KNGR), the Korea Institute of Nuclear Safety has carried out the Safety and Regulatory Requirements and Guidance (SRRG) development program from 1992 such as establishment of the SRRG hierarchy, development of technical requirements and guidance, and consideration of new licensing system. The SRRG hierarchy for the KNGR was consisted of five tiers; Safety Objectives, Safety Principles, General Safety Criteria, Specific Safety Requirements and Safety Regulatory Guides. The developed SRRG have been compared the criteria in 10CFR and Reg. Guide in the U.S.A and the IAEA documents for assuring internationally acceptable level of the SRRG. To improve the efficiency and accuracy of SRRG development, the construction of database system was required in the course of development. Therefore, the Information Management System of SRRG for the KNGR has been developed which enables developers to quickly and accurately seek and systematically manage whole contexts of the SRRG, reference requirements, and current atomic energy regulation rules. Moreover, through homepage whose URL is 'http://kngr.kins.re.kr', the concerned persons and public can acquire the information related with SRRG and KNGR project, and post his/her thought to the opinion forum in the homepage

  15. Information Management system of the safety regulatory requirements and guidance for the Korea next generation reactors

    Energy Technology Data Exchange (ETDEWEB)

    Yun, Y. C. [LG-EDS Systems, Seoul (Korea, Republic of); Lee, J. H.; Lee, H. C.; Lee, J. S. [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of)

    2000-05-01

    In order to achieve the safety of the Korea Next Generation Reactors (KNGR), the Korea Institute of Nuclear Safety has carried out the Safety and Regulatory Requirements and Guidance (SRRG) development program from 1992 such as establishment of the SRRG hierarchy, development of technical requirements and guidance, and consideration of new licensing system. The SRRG hierarchy for the KNGR was consisted of five tiers; Safety Objectives, Safety Principles, General Safety Criteria, Specific Safety Requirements and Safety Regulatory Guides. The developed SRRG have been compared the criteria in 10CFR and Reg. Guide in the U.S.A and the IAEA documents for assuring internationally acceptable level of the SRRG. To improve the efficiency and accuracy of SRRG development, the construction of database system was required in the course of development. Therefore, the Information Management System of SRRG for the KNGR has been developed which enables developers to quickly and accurately seek and systematically manage whole contexts of the SRRG, reference requirements, and current atomic energy regulation rules. Moreover, through homepage whose URL is 'http://kngr.kins.re.kr', the concerned persons and public can acquire the information related with SRRG and KNGR project, and post his/her thought to the opinion forum in the homepage.

  16. Regulatory aspects of radiation protection in Indian nuclear plants

    International Nuclear Information System (INIS)

    Chander, Vipin; Pawar, S.K.; Duraisamy, S.

    2012-01-01

    Atomic Energy Act of 1962 covers the radiation safety aspects in the development, control and use of atomic energy. To carry out certain regulatory and safety functions under this act, Atomic Energy Regulatory Board (AERB) was constituted in November 15, 1983. Operating Nuclear Power Plants (NPPs) account for about 60% of occupational collective dose and about 65% of the number of radiation workers in the nuclear fuel cycle facilities. Therefore radiation protection aspects in NPPs are of prime importance. In 1970s and 1980s the high radiation exposures in NPPs was an issue with TAPS-1 and 2 reaching annual collective dose of 50 Person-Sv. In response to this, AERB constituted an expert committee to investigate the possibility of reducing collective doses in NPPs in 1988. Subsequently the recommendations of this committee were implemented in all NPPs. In 1990, International Commission on Radiological Protection (ICRP) recommended a downward revision of occupational dose limit to 20 mSv/yr from the earlier limit of 50 mSv/yr. Regulatory body endorsed these recommendations and gradually brought down the annual dose limits from 40 mSv in 1991 to 30 mSv in 1994 with the limit of 100 mSv averaged over a five year period in line with ICRP recommendations. Over the years, the regulatory body has put in place a sound regulatory frame work and mechanism to ensure adequate protection of occupational workers, members of public and environment due to operation of NPPs. Vast experiences in the field of radiation protection vis-à-vis stringent regulatory requirements such as review of exposure cases and special regulatory inspections during Biennial Shut Down (BSD) has helped in downward trends in occupational and public doses. This paper highlights the role of regulatory body in controlling the radiation doses to both occupational workers and members of public in the NPPs through a three-tier review system. The regulatory oversight, inspections and reviews has resulted in

  17. Radiation and the regulatory landscape of neo2-Darwinism

    International Nuclear Information System (INIS)

    Rollo, C. David

    2006-01-01

    Several recently revealed features of eukaryotic genomes were not predicted by earlier evolutionary paradigms, including the relatively small number of genes, the very large amounts of non-functional code and its quarantine in heterochromatin, the remarkable conservation of many functionally important genes across relatively enormous phylogenetic distances, and the prevalence of extra-genomic information associated with chromatin structure and histone proteins. All of these emphasize a paramount role for regulatory evolution, which is further reinforced by recent perspectives highlighting even higher-order regulation governing epigenetics and development (EVO-DEVO). Modern neo 2 -Darwinism, with its emphasis on regulatory mechanisms and regulatory evolution provides new vision for understanding radiation biology, particularly because free radicals and redox states are central to many regulatory mechanisms and free radicals generated by radiation mimic and amplify endogenous signalling. This paper explores some of these aspects and their implications for low-dose radiation biology

  18. Radiation and the regulatory landscape of neo2-Darwinism.

    Science.gov (United States)

    Rollo, C David

    2006-05-11

    Several recently revealed features of eukaryotic genomes were not predicted by earlier evolutionary paradigms, including the relatively small number of genes, the very large amounts of non-functional code and its quarantine in heterochromatin, the remarkable conservation of many functionally important genes across relatively enormous phylogenetic distances, and the prevalence of extra-genomic information associated with chromatin structure and histone proteins. All of these emphasize a paramount role for regulatory evolution, which is further reinforced by recent perspectives highlighting even higher-order regulation governing epigenetics and development (EVO-DEVO). Modern neo2-Darwinism, with its emphasis on regulatory mechanisms and regulatory evolution provides new vision for understanding radiation biology, particularly because free radicals and redox states are central to many regulatory mechanisms and free radicals generated by radiation mimic and amplify endogenous signalling. This paper explores some of these aspects and their implications for low-dose radiation biology.

  19. The Energy Regulatory Commission. The Regulation of Natural Gas in Mexico

    International Nuclear Information System (INIS)

    1995-01-01

    In May of 1995 the Congress approved amendments to the Regulatory Law of Constitutional article 27 on Petroleum. This legal reform fundamentally redefined the petroleum industry and authorizes the private sector to construct, operate, and own natural gas transportation, storage and distribution systems-activities previously reserved to the state. To complement these reforms and to implement the legislative mandate of the Regulatory Law on Petroleum, the Natural Gas Regulation (Reglamento de Gas Natural) was issued in November 1995. The regulation reconciles the interests of the various natural gas industry participants and signifies a Federal Commitment to promote comprehensive development of the industry. In parallel with the development of the substantive legal framework, the law of the Comision Reguladora de Energia (CRE) was also enacted by Congress in October 1995 to strength the institutional framework and implemented the legal changes. This law defines the CRE as an agency of the Energy Ministry with technical, operational, and budgetary autonomy, and responsibility for implementing natural gas industry regulation. (Author)

  20. Low-rank coal study. Volume 4. Regulatory, environmental, and market analyses

    Energy Technology Data Exchange (ETDEWEB)

    1980-11-01

    The regulatory, environmental, and market constraints to development of US low-rank coal resources are analyzed. Government-imposed environmental and regulatory requirements are among the most important factors that determine the markets for low-rank coal and the technology used in the extraction, delivery, and utilization systems. Both state and federal controls are examined, in light of available data on impacts and effluents associated with major low-rank coal development efforts. The market analysis examines both the penetration of existing markets by low-rank coal and the evolution of potential markets in the future. The electric utility industry consumes about 99 percent of the total low-rank coal production. This use in utility boilers rose dramatically in the 1970's and is expected to continue to grow rapidly. In the late 1980's and 1990's, industrial direct use of low-rank coal and the production of synthetic fuels are expected to start growing as major new markets.

  1. A regulatory perspective on the abuse potential evaluation of novel stimulant drugs in the United States.

    Science.gov (United States)

    Calderon, Silvia N; Klein, Michael

    2014-12-01

    In the United States of America (USA), the abuse potential assessment of a drug is performed as part of the safety evaluation of a drug under development, and to evaluate if the drug needs to be subject to controls that would minimize the abuse of the drug once on the market. The assessment of the abuse potential of new drugs consists of a scientific and medical evaluation of all data related to abuse of the drug. This paper describes the regulatory framework for evaluating the abuse potential of new drugs, in general, including novel stimulants. The role of the United States Food and Drug Administration (FDA) in the evaluation of the abuse potential of drugs, and its role in drug control are also discussed. A definition of abuse potential, an overview of the currently accepted approaches to evaluating the abuse potential of a drug, as well as a description of the criteria that applies when recommending a specific level of control (i.e., a Schedule) for a drug under the Controlled Substances Act (CSA). This article is part of the Special Issue entitled 'CNS Stimulants'. Published by Elsevier Ltd.

  2. US Nuclear Regulatory Commission 1983 annual report

    International Nuclear Information System (INIS)

    1984-01-01

    The thirteen chapters of this annual report are titled: 1983 highlights/1984 planning; reactor regulation; cleanup at TMI-2; operational experience; nuclear materials; safeguards; waste management; inspection, enforcement and emergency preparedness; cooperation with the states; international programs; nuclear regulatory research; proceedings and litigation; and management and communication

  3. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (French Edition); Cadre gouvernemental, legislatif et reglementaire de la surete. Prescriptions generales de surete. Partie 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-11-15

    The objective of this publication is to establish requirements in respect of the gov