The EU, "Regulatory State Regionalism" and New Modes of Higher Education Governance

Science.gov (United States)

Robertson, Susan L.

2010-01-01

Jayasuriya's conceptualisation of "regulatory regionalism" is particularly useful for examining the presence, significance and effect of new higher education governance mechanisms in constituting Europe as a competitive region and knowledge-based economy. In particular he argues that we need to take sufficient account of the role of…

Governing Nanomedicine: Lessons from within, and for the EU medical technology regulatory framework.

NARCIS (Netherlands)

Dorbeck-Jung, Barbel R.; Bowman, Diana M.; van Calster, Geert

2010-01-01

Rapidly emerging technologies, such as nanotechnologies, are posing significant challenges to regulatory governance due to the uncertainties of development trajectories, product properties, and potential risk problems (Davies 2009). While nanotechnology-based products and processes fall within the

Regulatory quality assurance requirements for the operation of nuclear R and D facilities in Korea

International Nuclear Information System (INIS)

Kwon, H.I.; Lim, N.J.

2006-01-01

Full text: Korea Atomic Energy Research Institute (KAERI) has many R and D facilities in operation. including HANARO research reactor, radioactive waste treatment facility (RWTF), post-irradiation examination facility (PIEF) and irradiated material test facility (IMEF). Recently. nation-wide interest is focused on the safety and security of major industrial facilities. Safe operation of nuclear facilities is imperative because of the consequence of public disaster by radiological release/contamination, in case of an accident. Recently, Ministry of Science and Technology (MOST) of the Korean government announced amendments of Atomic Energy laws to enforce requirements of the physical protection and radiological emergency. All provisions on nuclear safety regulation and radiation protection are entrusted to the Atomic Energy Act(AEA). The Act is enacted as the main law concerning the safety regulation of nuclear installations, and is supplemented by the Enforcement Decree and Enforcement Regulation of the Act. These Atomic Energy laws include provisions on the construction permission and the operation license of nuclear installations, such as nuclear power reactors, research reactors, nuclear ships, nuclear fuel fabrication facilities, spent fuel treatment facilities, etc. Regulatory requirements for the regulatory inspection and the safety measures for operation are also defined in the laws. The Notice of the MOST prescribes specific issues including regulatory requirements and technical standards, as entrusted by the AEA, the Decree and the Regulation. Detailed QA requirements for nuclear installations are specified differently, depending upon the type of facility. The guidelines for safety reviews and regulatory inspections are developed by the Korea Institute of Nuclear Safety (KINS), which is an exclusive organization for safety regulation of nuclear installations in Korea. In this paper, the context of the Atomic Energy laws were reviewed to confirm the

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.

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

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

NARCIS (Netherlands)

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

2013-01-01

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

Regulatory capital requirements and bail in mechanisms

NARCIS (Netherlands)

Joosen, B.P.M.; Haentjens, M.; Wessels, B.

2015-01-01

With the introduction of the Capital Requirements Regulation (CRR) in the European Union, the qualitative requirements for bank regulatory capital have changed. These changes aim at implementing in Europe the Basel III principles for better bank capital that is able to absorb losses of banks,

Wombs for rent: an examination of prohibitory and regulatory approaches to governing preconception arrangements.

Science.gov (United States)

Chen, Melody

2003-02-01

On October 9, 2002, Bill C-13 had its first reading in the Canadian House of Commons. Bill C-13 was in the same form as Bill C-56 of the First Session of the Thirty-seventh Parliament, which had its first reading on May 9, 2002. Bill C-13, an Act respecting assisted human reproduction, prohibits the practice of commercial surrogacy or preconception agreements in Canada, under threat of criminal sanction. In the first half of the article, the author discusses the deficiencies of the Bill's prohibitory approach to governing surrogacy agreements. These problems include the difficulty of implementing a criminal regime, the weak constitutional basis on which the federal government claims jurisdiction to enact a criminal prohibition of commercial surrogacy and the legislation's inability to prevent exploitation and coercion of vulnerable parties in surrogacy arrangements. In the second half of the article, the author examines an alternative regulatory scheme proposed by the Ontario Law Reform Commission and compares it to the prohibitory approach. The author concludes that the regulatory approach is much more effective than the prohibitory approach in governing the practice of commercial and non-commercial surrogacy arrangements. Regulation minimises the potentially exploitative aspects of surrogacy and provides legal protection to both parties in the agreement. The regulatory scheme proposed by the Ontario Law Reform Commission is also more effective in protecting the best interests of the child born as a result of a preconception agreement.

A critical assessment of the Hong Kong Government's proposed post-2008 regulatory regime for local electricity utilities

International Nuclear Information System (INIS)

Woo, Chi-Keung; Horowitz, Ira; Tishler, Asher

2006-01-01

In December 2005, the Hong Kong Government issued a 'Consultation Paper on Future Development of the Electricity Markets in Hong Kong: Stage II Consultation,' proposing a post-2008 regulatory regime upon the expiration of the existing regulatory contract between the Hong Kong Government and each of the two local electricity utilities. We assess the proposal using the criteria of safe, reliable, and environmentally friendly service at the lowest rates that will allow the utilities reasonable returns on their investments. We caution that if fully adopted, the highly risky proposal may lead to less-reliable service without the compensating benefits to the environment

Complex Regulatory Networks Governing Production of the Glycopeptide A40926

Directory of Open Access Journals (Sweden)

Rosa Alduina

2018-04-01

Full Text Available Glycopeptides (GPAs are an important class of antibiotics, with vancomycin and teicoplanin being used in the last 40 years as drugs of last resort to treat infections caused by Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus. A few new GPAs have since reached the market. One of them is dalbavancin, a derivative of A40926 produced by the actinomycete Nonomuraea sp. ATCC 39727, recently classified as N. gerenzanensis. This review summarizes what we currently know on the multilevel regulatory processes governing production of the glycopeptide A40926 and the different approaches used to increase antibiotic yields. Some nutrients, e.g., valine, l-glutamine and maltodextrin, and some endogenous proteins, e.g., Dbv3, Dbv4 and RpoBR, have a positive role on A40926 biosynthesis, while other factors, e.g., phosphate, ammonium and Dbv23, have a negative effect. Overall, the results available so far point to a complex regulatory network controlling A40926 in the native producing strain.

Complex Regulatory Networks Governing Production of the Glycopeptide A40926.

Science.gov (United States)

Alduina, Rosa; Sosio, Margherita; Donadio, Stefano

2018-04-05

Glycopeptides (GPAs) are an important class of antibiotics, with vancomycin and teicoplanin being used in the last 40 years as drugs of last resort to treat infections caused by Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus . A few new GPAs have since reached the market. One of them is dalbavancin, a derivative of A40926 produced by the actinomycete Nonomuraea sp. ATCC 39727, recently classified as N. gerenzanensis . This review summarizes what we currently know on the multilevel regulatory processes governing production of the glycopeptide A40926 and the different approaches used to increase antibiotic yields. Some nutrients, e.g., valine, l-glutamine and maltodextrin, and some endogenous proteins, e.g., Dbv3, Dbv4 and RpoB R , have a positive role on A40926 biosynthesis, while other factors, e.g., phosphate, ammonium and Dbv23, have a negative effect. Overall, the results available so far point to a complex regulatory network controlling A40926 in the native producing strain.

78 FR 1562 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

Science.gov (United States)

2013-01-08

... agenda incorporates the objective and criteria, when applicable, of the regulatory reform program under the Executive Order and other regulatory guidance. It contains DoD issuances initiated by DoD... statutory administration requirements as required. Starting with the fall 2007 edition, the Internet became...

Multiple-camera tracking: UK government requirements

Science.gov (United States)

Hosmer, Paul

2007-10-01

The Imagery Library for Intelligent Detection Systems (i-LIDS) is the UK government's new standard for Video Based Detection Systems (VBDS). The standard was launched in November 2006 and evaluations against it began in July 2007. With the first four i-LIDS scenarios completed, the Home Office Scientific development Branch (HOSDB) are looking toward the future of intelligent vision in the security surveillance market by adding a fifth scenario to the standard. The fifth i-LIDS scenario will concentrate on the development, testing and evaluation of systems for the tracking of people across multiple cameras. HOSDB and the Centre for the Protection of National Infrastructure (CPNI) identified a requirement to track targets across a network of CCTV cameras using both live and post event imagery. The Detection and Vision Systems group at HOSDB were asked to determine the current state of the market and develop an in-depth Operational Requirement (OR) based on government end user requirements. Using this OR the i-LIDS team will develop a full i-LIDS scenario to aid the machine vision community in its development of multi-camera tracking systems. By defining a requirement for multi-camera tracking and building this into the i-LIDS standard the UK government will provide a widely available tool that developers can use to help them turn theory and conceptual demonstrators into front line application. This paper will briefly describe the i-LIDS project and then detail the work conducted in building the new tracking aspect of the standard.

Regulatory requirements for desalination plant coupled with nuclear reactor plant

International Nuclear Information System (INIS)

Yune, Young Gill; Kim, Woong Sik; Jo, Jong Chull; Kim, Hho Jung; Song, Jae Myung

2005-01-01

A small-to-medium sized reactor has been developed for multi-purposes such as seawater desalination, ship propulsion, and district heating since early 1990s in Korea. Now, the construction of its scaled-down research reactor, equipped with a seawater desalination plant, is planned to demonstrate the safety and performance of the design of the multi-purpose reactor. And the licensing application of the research reactor is expected in the near future. Therefore, a development of regulatory requirements/guides for a desalination plant coupled with a nuclear reactor plant is necessary for the preparation of the forthcoming licensing review of the research reactor. In this paper, the following contents are presented: the design of the desalination plant, domestic and foreign regulatory requirements relevant to desalination plants, and a draft of regulatory requirements/guides for a desalination plant coupled with a nuclear reactor plant

Access Requirement Analysis of E-Governance Systems

Science.gov (United States)

Kim, Tai-Hoon

The strategic and contemporary importance of e-governance has been recognized across the world. In India too, various ministries of Govt. of India and State Governments have taken e-governance initiatives to provide e-services to citizens and the business they serve. To achieve the mission objectives, and make such e-governance initiatives successful it would be necessary to improve the trust and confidence of the stakeholders. It is assumed that the delivery of government services will share the same public network information that is being used in the community at large. In particular, the Internet will be the principal means by which public access to government and government services will be achieved. To provide the security measures main aim is to identify user's access requirement for the stakeholders and then according to the models of Nath's approach. Based on this analysis, the Govt. can also make standards of security based on the e-governance models. Thus there will be less human errors and bias. This analysis leads to the security architecture of the specific G2C application.

Corporate Governance in Crisis? The Politics of EU Corporate Governance Regulation

DEFF Research Database (Denmark)

Horn, Laura

2012-01-01

on the transformation of company law and corporate governance in the last decade. Here, the article illustrates how company law has become increasingly focused on the rights of shareholders, while worker rights have been relegated to the area of social policies and labour law. The study also traces the shift from...... a legislative programme centred on company law harmonisation towards a regulatory approach based on minimum requirements and mutual recognition, increasingly geared at adjusting the governance of corporations to the demands of liberalised capital markets. The second section then reflects on the current...... developments in corporate governance regulation in the context of financial and economic crisis....

Romania - NPP PLiM Between Regulatory Requirement / Oversight and Operator Safety / Financial Interest

International Nuclear Information System (INIS)

Goicea, Lucian

2012-01-01

Cernavoda Unit 1 PLiM started in the first third of its design life, to develop as regulatory requirements of the components of standards and programmes and to benefit by earlier implementation of the measures for achieving maximum operating life. CNCAN regulatory present approach on the utility PLiM combines the regulatory requirements on management system, ageing management provisions of periodic safety review, detailed technical requirements of ageing programmes and different techniques focusing only on safety issues. (author)

Regulatory requirements for the transport of radioactive materials in Canada

Energy Technology Data Exchange (ETDEWEB)

Garg, R. [Canadian Nuclear Safety Commission, Ottawa (Canada)

2004-07-01

Canada is a major producer and shipper of radioactive material. Each year more than a million packages are transported in Canada. The safety record with the transport of RAM in Canada has historically been excellent. There have never been any serious injuries, overexposure or fatality or environmental consequences attributable to the radioactive nature of such material being transported or being involved in a transport accident. In Canada, the Canadian Nuclear Safety Commission (CNSC) is the prime agency of the federal government entrusted with regulating all activities related to the use of nuclear energy and nuclear substances including the packaging and transport of nuclear substances. The mission of the CNSC is to regulate the use of nuclear energy and materials to protect health, safety, security of the person and the environment and to respect Canada's international commitments on the peaceful use of nuclear energy. The division of responsibility for the regulation of transport of radioactive material has been split between Transport Canada and the CNSC. The governing Transport Canada's regulations are Transport of Dangerous Goods (TDG) Regulations and the CNSC regulations are Packaging and Transport of Nuclear Substances Regulations (PTNSR). Canada has actively participated in the development of the IAEA regulations for the safe transport of radioactive material since 1960. As an IAEA member state, Canada generally follows the requirements of IAEA regulations with few deviations. The Nuclear Safety and Control Act (NSCA) strongly supports Canada's international obligations to ensure safe packaging, transport, storage and disposal of nuclear substances, prescribed equipment and prescribed information. Prescribed equipment and prescribed information are defined in the CNSC General Nuclear Safety and Control Regulations. This paper presents the current CNSC regulatory requirements and initiatives taken by the CNSC to improve its effectiveness and

Regulatory requirements for the transport of radioactive materials in Canada

International Nuclear Information System (INIS)

Garg, R.

2004-01-01

Canada is a major producer and shipper of radioactive material. Each year more than a million packages are transported in Canada. The safety record with the transport of RAM in Canada has historically been excellent. There have never been any serious injuries, overexposure or fatality or environmental consequences attributable to the radioactive nature of such material being transported or being involved in a transport accident. In Canada, the Canadian Nuclear Safety Commission (CNSC) is the prime agency of the federal government entrusted with regulating all activities related to the use of nuclear energy and nuclear substances including the packaging and transport of nuclear substances. The mission of the CNSC is to regulate the use of nuclear energy and materials to protect health, safety, security of the person and the environment and to respect Canada's international commitments on the peaceful use of nuclear energy. The division of responsibility for the regulation of transport of radioactive material has been split between Transport Canada and the CNSC. The governing Transport Canada's regulations are Transport of Dangerous Goods (TDG) Regulations and the CNSC regulations are Packaging and Transport of Nuclear Substances Regulations (PTNSR). Canada has actively participated in the development of the IAEA regulations for the safe transport of radioactive material since 1960. As an IAEA member state, Canada generally follows the requirements of IAEA regulations with few deviations. The Nuclear Safety and Control Act (NSCA) strongly supports Canada's international obligations to ensure safe packaging, transport, storage and disposal of nuclear substances, prescribed equipment and prescribed information. Prescribed equipment and prescribed information are defined in the CNSC General Nuclear Safety and Control Regulations. This paper presents the current CNSC regulatory requirements and initiatives taken by the CNSC to improve its effectiveness and efficiency

Sexy splicing: regulatory interplays governing sex determination from Drosophila to mammals.

Science.gov (United States)

Lalli, Enzo; Ohe, Kenji; Latorre, Elisa; Bianchi, Marco E; Sassone-Corsi, Paolo

2003-02-01

A remarkable array of strategies is used to produce sexual differentiation in different species. Complex gene hierarchies govern sex determination pathways, as exemplified by the classic D. melanogaster paradigm, where an interplay of transcriptional, splicing and translational mechanisms operate. Molecular studies support the hypothesis that genetic sex determination pathways evolved in reverse order, from downstream to upstream genes, in the cascade. The recent identification of a role for the key regulatory factors SRY and WT1(+KTS) in pre-mRNA splicing indicates that important steps in the mammalian sex determination process are likely to operate at the post-transcriptional level.

Regulatory document R-104, Regulatory objectives, requirements and guidelines for the disposal of radioactive wastes - long-term aspects

International Nuclear Information System (INIS)

1987-01-01

The purpose and scope of this document is to present the regulatory basis for judging the long-term acceptability of radioactive waste disposal options. The basic objectives of radioactive waste disposal are given as are the regulatory requirements to be satisfied. (NEA)

Development of regulatory requirements/guides for desalination unit coupled with nuclear plant

International Nuclear Information System (INIS)

Jo, Jong Chull; Yune, Young Gill; Kim, Woong Sik

2005-10-01

The basic design of System-integrated Modular Advanced Reactor (SMART), a small-to-medium sized integral type pressurized water reactor (PWR) with the capacity of 330MWth, has been developed in Korea. In order to demonstrate the safety and performance of the SMART design, 'Development Project of SMART-P (SMART-Pilot Plant)' has been being performed as one of the 'National Mid and Long-term Atomic Energy R and D Programs', which includes design, construction, and start-up operation of the SMART-P with the capacity of 65MWth, a 1/5 scaled-down design of the SMART. At the same time, a study on the development of regulatory requirements/guides for the desalination unit coupled with nuclear plant has been carried out by KINS in order to prepare for the forthcoming SMART-P licensing. The results of this study performed from August of 2002 to October of 2005 can be summarized as follows: (1) The general status of desalination technologies has been survey. (2) The design of the desalination plant coupled with the SMART-P has been investigated. (3) The regulatory requirements/guides relevant to a desalination unit coupled with a nuclear plant have been surveyed. (4) A direction on the development of domestic regulatory requirements/guides for a desalination unit has been established. (5) A draft of regulatory requirements/guides for a desalination unit has been developed. (6) Expert technical reviews have been performed for the draft regulatory requirements/guides for a desalination unit. The draft regulatory requirements/guides developed in this study will be finalized and can be applied directly to the licensing of the SMART-P and SMART. Furthermore, it will be also applied to the licensing of the desalination unit coupled with the nuclear plant

Safety and regulatory requirements of nuclear power plants

International Nuclear Information System (INIS)

Kumar, S.V.; Bhardwaj, S.A.

2000-01-01

A pre-requisite for a nuclear power program in any country is well established national safety and regulatory requirements. These have evolved for nuclear power plants in India with participation of the regulatory body, utility, research and development (R and D) organizations and educational institutions. Prevailing international practices provided a useful base to develop those applicable to specific system designs for nuclear power plants in India. Their effectiveness has been demonstrated in planned activities of building up the nuclear power program as well as with unplanned activities, like those due to safety related incidents etc. (author)

Use of prioritization in meeting regulatory requirements

International Nuclear Information System (INIS)

Bowling, M.L.; Sommers, D.A.; Girvin, L.M.

1993-01-01

The use of prioritization in the allocation of resources is certainly not a new idea. However, the degree to which prioritization must now be used is much greater than ever before. In the past, utilities generally allocated the necessary resources to meet all regulatory requirements and commitments. Prioritization was then applied to the remaining nonregulatory but required needs. This approach to resource allocation is no longer appropriate for the current and projected economic and operating environment. Key reasons for this conclusion are discussed in this paper by staff from Virginia Power

Regulatory requirements of the integrated technology demonstration program, Savannah River Site (U)

International Nuclear Information System (INIS)

Bergren, C.L.

1992-01-01

The integrated demonstration program at the Savannah River Site (SRS) involves demonstration, testing and evaluation of new characterization, monitoring, drilling and remediation technologies for soils and groundwater impacted by organic solvent contamination. The regulatory success of the demonstration program has developed as a result of open communications between the regulators and the technical teams involved. This open dialogue is an attempt to allow timely completion of applied environmental restoration demonstrations while meeting all applicable regulatory requirements. Simultaneous processing of multiple regulatory documents (satisfying RCRA, CERCLA, NEPA and various state regulations) has streamlined the overall permitting process. Public involvement is achieved as various regulatory documents are advertised for public comment consistent with the site's community relations plan. The SRS integrated demonstration has been permitted and endorsed by regulatory agencies, including the Environmental Protection Agency (EPA) and the South Carolina Department of Health and Environmental Control. EPA headquarters and regional offices are involved in DOE's integrated Demonstration Program. This relationship allows for rapid regulatory acceptance while reducing federal funding and time requirements. (author)

Renewing governance.

Science.gov (United States)

Loos, Gregory P

2003-01-01

Globalization's profound influence on social and political institutions need not be negative. Critics of globalization have often referred to the "Impossible Trinity" because decision-making must 1. respect national sovereignty, 2. develop and implement firm regulation, and 3. allow capital markets to be as free as possible. To many, such goals are mutually exclusive because history conditions us to view policy-making and governance in traditional molds. Thus, transnational governance merely appears impossible because current forms of governance were not designed to provide it. The world needs new tools for governing, and its citizens must seize the opportunity to help develop them. The rise of a global society requires a greater level of generality and inclusion than is found in most policy bodies today. Politicians need to re-examine key assumptions about government. States must develop ways to discharge their regulatory responsibilities across borders and collaborate with neighboring jurisdictions, multilateral bodies, and business. Concepts such as multilateralism and tripartism show great promise. Governments must engage civil society in the spirit of shared responsibility and democratic decision-making. Such changes will result in a renewal of the state's purpose and better use of international resources and expertise in governance.

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)

m-government legal and regulatory framework

African Journals Online (AJOL)

Wondwossen Mulugeta

Legal Framework for Implementation of m-Government in Ethiopia: Best. Practices and Lessons ... opportunity to government and businesses to provide enhanced mobile .... provide effective governance, offer increased service delivery and ...

Regulatory and administrative requirements for practice of nuclear medicine in India

International Nuclear Information System (INIS)

Tandon, Pankaj

1998-01-01

In order to ensure safety of the patients, staff and public in the practice of nuclear medicine, including in-vivo diagnostic investigations, radionuclide therapy and in research using unsealed radioactive substances a number of administrative and regulatory procedures are adopted. The salient features of regulatory and administrative requirements for practice of nuclear medicine in India are discussed

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

Energy Technology Data Exchange (ETDEWEB)

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

2000-03-15

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

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)

25 CFR 547.4 - How does a tribal government, tribal gaming regulatory authority, or tribal gaming operation...

Science.gov (United States)

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false How does a tribal government, tribal gaming regulatory authority, or tribal gaming operation comply with this part? 547.4 Section 547.4 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM TECHNICAL STANDARDS FOR GAMING...

The public image and image shaping of the nuclear and radiation safety regulatory organization

International Nuclear Information System (INIS)

Li Zhiguo

2013-01-01

Good image is the basis of trust. It is imminent to build good public image as our society and the public pay close attention to the negative information of relevant government departments which directly or indirectly affects the public image of the government departments in recent years. In order to promote the public image of the government regulatory department, it is required for all staff to figure out how to conscientiously fulfill social responsibility, how to respond to and properly handle emergencies, and how to establish and improve a full-time public relations team. Based on nuclear and radiation safety regulatory task, this paper discussed the necessity of government departments to set up the public image, and how to shape the public image of the nuclear and radiation safety regulatory organization. (author)

China's Insurance Regulatory Reform, Corporate Governance Behavior and Insurers' Governance Effectiveness.

Science.gov (United States)

Li, Huicong; Zhang, Hongliang; Tsai, Sang-Bing; Qiu, Aichao

2017-10-17

External regulation is an important mechanism to improve corporate behavior in emerging markets. China's insurance governance regulation, which began to supervise and guide insurance corporate governance behavior in 2006, has experienced a complex process of reform. This study tested our hypotheses with a sample of 85 firms during 2010-2011, which was obtained by providing a questionnaire to all of China's shareholding insurance companies. The empirical study results generally show that China's insurance governance effectiveness has significantly improved through strict regulation. Insurance corporate governance can improve business acumen and risk-control ability, but no significant evidence was found to prove its influence on profitability, as a result of focusing less attention on governance than on management. State ownership is associated with higher corporate governance effectiveness than non-state ownership. Listed companies tend to outperform non-listed firms, and life insurance corporate governance is more effective than that of property insurers. This study not only contributes to the comprehensive understanding of corporate governance effectiveness but also to the literature by highlighting the effect of corporate governance regulation in China's insurance industry and other emerging economies of the financial sector.

Institutional change and corporate governance reform

Directory of Open Access Journals (Sweden)

Harilaos Mertzanis

2011-04-01

Full Text Available The global financial crisis has posed challenges to financial institutions governance. Meeting these challenges requires an understanding of governance dynamics in relation to institutions’ performance within a changing environment. The nature and scope of institutional response to a changing environment depends upon inherited governance structures, including socioeconomic conventions and rules of behavior at the macro level and time, expertise and common commitment of directors at the micro level. Innovation and learning-by-doing in governance can be an effective reform strategy. Innovation in governance may include the establishment of new norms of economic behavior and the transformation of decision-making process and the reallocation of responsibilities to directors and senior management. This may also inform regulatory approaches in strengthening financial institutions governance, based on improved disclosure, independent and competent boards

17 CFR 1.52 - Self-regulatory organization adoption and surveillance of minimum financial requirements.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Self-regulatory organization... Miscellaneous § 1.52 Self-regulatory organization adoption and surveillance of minimum financial requirements. (a) Each self-regulatory organization must adopt, and submit for Commission approval, rules...

75 FR 29592 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-05-26

... Corporate Governance Requirements May 19, 2010. Pursuant to Section 19(b)(1) of the Securities Exchange Act... companies to provide notification to Nasdaq of any noncompliance with the corporate governance requirements... Regulatory Authority. A Company may be denied continued listing if it fails to provide such information...

Galectin-1 is required for the regulatory function of B cells.

Science.gov (United States)

Alhabbab, R; Blair, P; Smyth, L A; Ratnasothy, K; Peng, Q; Moreau, A; Lechler, R; Elgueta, R; Lombardi, G

2018-02-09

Galectin-1 (Gal-1) is required for the development of B cells in the bone marrow (BM), however very little is known about the contribution of Gal-1 to the development of B cell regulatory function. Here, we report an important role for Gal-1 in the induction of B cells regulatory function. Mice deficient of Gal-1 (Gal-1 -/- ) showed significant loss of Transitional-2 (T2) B cells, previously reported to include IL-10 + regulatory B cells. Gal-1 -/- B cells stimulated in vitro via CD40 molecules have impaired IL-10 and Tim-1 expression, the latter reported to be required for IL-10 production in regulatory B cells, and increased TNF-α expression compared to wild type (WT) B cells. Unlike their WT counterparts, T2 and T1 Gal-1 -/- B cells did not suppress TNF-α expression by CD4 + T cells activated in vitro with allogenic DCs (allo-DCs), nor were they suppressive in vivo, being unable to delay MHC-class I mismatched skin allograft rejection following adoptive transfer. Moreover, T cells stimulated with allo-DCs show an increase in their survival when co-cultured with Gal-1 -/- T2 and MZ B cells compared to WT T2 and MZ B cells. Collectively, these data suggest that Gal-1 contributes to the induction of B cells regulatory function.

Legal requirements governing proxy voting in Denmark

DEFF Research Database (Denmark)

Werlauff, Erik

2008-01-01

The requirements in Danish company law concerning proxy voting in companies whose shares have been accepted for listing on a regulated market have been successively tightened in recent years, and corporate governance principles have also led to the introduction of several requirements concerning...... proxy holders. A thorough knowledge of these requirements is important not only for the listed companies but also for their advisers and investors in Denmark and abroad. This article considers these requirements as well as the additional requirements which will derive from Directive 2007....../36 on the exercise of shareholders' rights in listed companies, which must be implemented by 3 August 2009. It is pointed out that companies may provide with advantage in their articles of association for both the existing and the forthcoming requirements at this early stage....

UK regulatory standards - the 'Guidance on requirements for authorisation'

International Nuclear Information System (INIS)

Williams, C.R.

1999-01-01

In the United Kingdom, disposal of radioactive waste requires an authorisation under the Radioactive Substances Act 1993. The power to grant such authorisations rests with the Environment Agency for disposals in England and Wales, and with similar Agencies in Scotland and Northern Ireland - namely the Scottish Environment Protection Agency (SEPA) and the Environment and Heritage Service (EHS) of the Department of the Environment for Northern Ireland. In 1997, following two rounds of consultation, the Environment Agency jointly with SEPA and EHS published a document 'Disposal Facilities on Land for Low and Intermediate Level Radioactive Wastes: Guidance on Requirements for Authorisation' - the GRA document. The GRA document outlines the regulatory framework governing the disposal of radioactive waste, general guidance on procedures, the principles and criteria against which proposals for a disposal facility will be assessed, and the radiological and technical requirements which a facility will be expected to meet. In particular, the document states that, in the period after control is withdrawn, the assessed radiological risk from a facility to a representative member of the potentially exposed group at greatest risk should be consistent with a risk target of 10 -6 per year. The document also specifies the information which a developer will need to provide, to demonstrate that a proposal is consistent with the principles and requirements, and identifies other, non-risk-based, criteria. In March 1997, the Secretary of State for the Environment rejected a planning appeal by United Kingdom Nirex Ltd for an underground Rock Characterisation Facility located near Sellafield in Cumbria. That decision has effectively delayed the construction of any deep repository in the UK. Subsequently a House of Lords Select Committee has commenced a major review of nuclear waste management. The Environment Agency continues to be responsible for the authorisation of the shallow

Waste governance

CSIR Research Space (South Africa)

Oelofse, Suzanna HH

2018-06-01

Full Text Available of governance in Africa. The next section focuses on regulation, and the status of the regulatory frameworks in different African countries. Shortcomings in the regulatory framework are highlighted through examples in various countries. Specific policy...

Analysis of regulatory requirement for beyond design basis events of SMART

International Nuclear Information System (INIS)

Kim, W. S.; Seol, K. W.

2000-01-01

To enhance the safety of SMART reactor, safety and regulatory requirements associated with beyond design basis events (beyond BDE), which were developed and applied to advanced light water reactor designs, were analyzed along with a design status of passive reactor. And, based on these requirements, their applicability on the SMART design was evaluated. In the design aspect, severe accident prevention and mitigation features, containment performance, and accident management were analyzed. The evaluation results show that the requirement related to beyond DBE such as ATWS, loss of residual heat removal during shutdown operation, station blackout, fire, inter-system LOCA, and well-known events from severe accident phenomena is applicable to the SMART design. However, comprehensive approach against beyond DBE is not yet provided in the SMART design, and then it is required to designate and analyze the beyond DBE-related features. This study is expected to contribute to efforts to improve plant safety and to establish regulatory requirements for safety review

Does Voluntary Governance Work? : Insights from Specialty Coffee

OpenAIRE

Macgregor, Finlay

2017-01-01

Agricultural businesses contribute to sustainability problems, but they are also increasingly central to the effort to develop solutions. One way of moving toward sustainability is through regulatory governance. In this thesis, I analyze a tool of regulatory governance called voluntary market-based regulatory initiatives. Specifically, I investigate two types of initiatives, certification and disclosure, involving businesses and consumers in regulatory governance. I researched these types of ...

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...

Regulatory objectives, requirements and guidelines for the disposal of radioactive wastes - long-term aspects

International Nuclear Information System (INIS)

1987-01-01

It is the purpose of this document to present the regulatory basis for judging the long-term acceptability of radioactive waste disposal options, assuming that the operational aspects of waste emplacement and facility closure satisfy the existing regulatory framework of requirements. Basic objectives of radioactive waste disposal are given, as are the regulatory requirements which must be satisfied in order to achieve these objectives. In addition, guidelines are given on the application of the radiological requirements to assist proponents in the preparation of submissions to the Atomic Energy Control Board (AECB). The primary focus of the requirements is on radiation protection, although environmental protection and institutional controls are also addressed in a more general way since these factors stem directly from the overall objectives for radioactive waste disposal

Waste management from reprocessing: a stringent regulatory requirements for high quality conditioned residues

International Nuclear Information System (INIS)

Bordier, J. C.; Greneche, D.; Devezeaux, J. G.; Dalcorso, J.

2000-01-01

Nuclear waste production and management in France is governed by safety requirements imposed to all operators. French nuclear safety relies on two basic principles: · Responsibility of the nuclear operator, which expands to waste generated, · Safety basic objectives issued by national Safety Authority. For a long time the regulatory framework for waste production and management has been satisfactorily applied and has benefited to each actor of the process. LLW/MLW and HLW nuclear waste are currently conditioned in safe matrices or packages either likely to be disposed in surface repositories or designed with the intention to be disposed underground according to their radioactive content. France is looking into the case of VLLW and has already carried out a design for future disposal, the design being in the pipe. Other types of waste (i. e. radium bearing waste, graphite, and tritium content waste) are also considered in the whole framework of French waste management. (author)

Determining Regulatory Networks Governing the Differentiation of Embryonic Stem Cells to Pancreatic Lineage

Science.gov (United States)

Banerjee, Ipsita

2009-03-01

Knowledge of pathways governing cellular differentiation to specific phenotype will enable generation of desired cell fates by careful alteration of the governing network by adequate manipulation of the cellular environment. With this aim, we have developed a novel method to reconstruct the underlying regulatory architecture of a differentiating cell population from discrete temporal gene expression data. We utilize an inherent feature of biological networks, that of sparsity, in formulating the network reconstruction problem as a bi-level mixed-integer programming problem. The formulation optimizes the network topology at the upper level and the network connectivity strength at the lower level. The method is first validated by in-silico data, before applying it to the complex system of embryonic stem (ES) cell differentiation. This formulation enables efficient identification of the underlying network topology which could accurately predict steps necessary for directing differentiation to subsequent stages. Concurrent experimental verification demonstrated excellent agreement with model prediction.

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

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

Guidance and methods for satisfying low specific activity material and surface contaminated object regulatory requirements

International Nuclear Information System (INIS)

Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Easton, E.P.; Coodk, J.R.

1998-01-01

The U.S. Department of Transportation (DOT) and the U.S. Nuclear Regulatory Commission (NRC) have prepared a comprehensive set of draft guidance for shippers and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). These requirements represent significant departures in some areas from the manner in which these materials and objects were regulated by the earlier versions of the regulations. The proper interpretation and application of the regulatory criteria can require a fairly complex set of decisions be made. To assist those trying these regulatory requirements, a detailed set of logic-flow diagrams representing decisions related to multiple factors were prepared and included in the draft report for comment on Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects, (DOT/NRC, 1997). These logic-flow diagrams, as developed, are specific to the U.S. regulations, but were readily adaptable to the IAEA regulations. The diagrams have been modified accordingly and tied directly to specific paragraphs in IAEA Safety Series No. 6. This paper provides the logic-flow diagrams adapted in the IAEA regulations, and demonstrated how these diagrams can be used to assist consignors and inspectors in assessing compliance of shipments with the LSA material and SCO regulatory requirements. (authors)

Mission Risk Reduction Regulatory Change Management

Science.gov (United States)

Scroggins, Sharon

2007-01-01

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

Development of safety-related regulatory requirements for nuclear power in developing countries. Key issue paper no. 4

International Nuclear Information System (INIS)

Han, K.I.

2000-01-01

In implementing a national nuclear power program, balanced regulatory requirements are necessary to ensure nuclear safety and cost competitive nuclear power, and to help gain public acceptance. However, this is difficult due to the technology-intensive nature of the nuclear regulatory requirements, the need to reflect evolving technology and the need for cooperation among multidisciplinary technical groups. This paper suggests approaches to development of balanced nuclear regulatory requirements in developing countries related to nuclear power plant safety, radiation protection and radioactive waste management along with key technical regulatory issues. It does not deal with economic or market regulation of electric utilities using nuclear power. It suggests that national regulatory requirements be developed using IAEA safety recommendations as guidelines and safety requirements of the supplier country as a main reference after careful planning, manpower buildup and thorough study of international and supplier country's regulations. Regulation making is not recommended before experienced manpower has been accumulated. With an option that the supplier country's regulations may be used in the interim, the lack of complete national regulatory requirements should not deter introduction of nuclear power in developing countries. (author)

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.

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)

The effect of regulatory governance on efficiency of thermal power generation in India: A stochastic frontier analysis

International Nuclear Information System (INIS)

Ghosh, Ranjan; Kathuria, Vinish

2016-01-01

This paper investigates the impact of institutional quality – typified as regulatory governance – on the performance of thermal power plants in India. The Indian power sector was reformed in the early 1990s. However, reforms are effective only as much as the regulators are committed in ensuring that they are implemented. We hypothesize that higher the quality of regulation in a federal Indian state, higher is the efficiency of electric generation utilities. A translog stochastic frontier model is estimated using index of state-level independent regulation as one of the determinants of inefficiency. The dataset comprises a panel of 77 coal-based thermal power plants during the reform period covering over 70% of installed electricity generation capacity. The mean technical efficiency of 76.7% indicates there is wide scope for efficiency improvement in the sector. Results are robust to various model specifications and show that state-level regulators have positively impacted plant performance. Technical efficiency is sensitive to both unbundling of state utilities, and regulatory experience. The policy implication is that further reforms which empower independent regulators will have far reaching impacts on power sector performance. - Highlights: • The impact of regulatory governance on Indian generation efficiency is investigated. • Stochastic frontier analysis (SFA) on a panel dataset covering pre and post reform era. • Index of state-wise variation in regulation to explain inefficiency effects. • Results show improved but not very high technical efficiencies. • State-level regulation has positively impacted power plant performance.

China’s Insurance Regulatory Reform, Corporate Governance Behavior and Insurers’ Governance Effectiveness

Science.gov (United States)

Zhang, Hongliang; Qiu, Aichao

2017-01-01

External regulation is an important mechanism to improve corporate behavior in emerging markets. China’s insurance governance regulation, which began to supervise and guide insurance corporate governance behavior in 2006, has experienced a complex process of reform. This study tested our hypotheses with a sample of 85 firms during 2010–2011, which was obtained by providing a questionnaire to all of China’s shareholding insurance companies. The empirical study results generally show that China’s insurance governance effectiveness has significantly improved through strict regulation. Insurance corporate governance can improve business acumen and risk-control ability, but no significant evidence was found to prove its influence on profitability, as a result of focusing less attention on governance than on management. State ownership is associated with higher corporate governance effectiveness than non-state ownership. Listed companies tend to outperform non-listed firms, and life insurance corporate governance is more effective than that of property insurers. This study not only contributes to the comprehensive understanding of corporate governance effectiveness but also to the literature by highlighting the effect of corporate governance regulation in China’s insurance industry and other emerging economies of the financial sector. PMID:29039781

China’s Insurance Regulatory Reform, Corporate Governance Behavior and Insurers’ Governance Effectiveness

Directory of Open Access Journals (Sweden)

Huicong Li

2017-10-01

Full Text Available External regulation is an important mechanism to improve corporate behavior in emerging markets. China’s insurance governance regulation, which began to supervise and guide insurance corporate governance behavior in 2006, has experienced a complex process of reform. This study tested our hypotheses with a sample of 85 firms during 2010–2011, which was obtained by providing a questionnaire to all of China’s shareholding insurance companies. The empirical study results generally show that China’s insurance governance effectiveness has significantly improved through strict regulation. Insurance corporate governance can improve business acumen and risk-control ability, but no significant evidence was found to prove its influence on profitability, as a result of focusing less attention on governance than on management. State ownership is associated with higher corporate governance effectiveness than non-state ownership. Listed companies tend to outperform non-listed firms, and life insurance corporate governance is more effective than that of property insurers. This study not only contributes to the comprehensive understanding of corporate governance effectiveness but also to the literature by highlighting the effect of corporate governance regulation in China’s insurance industry and other emerging economies of the financial sector.

Survey of extreme load design regulatory agency licensing requirements for nuclear power plants

Energy Technology Data Exchange (ETDEWEB)

Stevenson, J D

1976-04-01

Since 1965, when extreme load requirements began to be considered explicitly in nuclear power plant design, there has been a gradual divergence in requirements imposed by national regulatory agencies. However, nuclear plant safety is an international problem because of the potential international effects of any postulated plant failure. For this reason this paper has been prepared in an attempt to highlight the differences in national criteria currently used in the extreme load design of nuclear plant facilities. No attempt has been made to evaluate the relative merit of the criteria established by the various national regulatory agencies. This paper presents the results of a recent survey made of national atomic energy regulatory agencies and major nuclear steam supply design agencies, which requested a summary of current licensing criteria associated with earthquake, extreme wind (tornado), flood, airplane crash and accident (pipe break) loads applicable within the various national jurisdictions. Also presented are a number of comparisons which are meant to illustrate the differences in national regulatory criteria.

Survey of extreme load design regulatory agency licensing requirements for nuclear power plants

International Nuclear Information System (INIS)

Stevenson, J.D.

1976-01-01

Since 1965, when extreme load requirements began to be considered explicitly in nuclear power plant design, there has been a gradual divergence in requirements imposed by national regulatory agencies. However, nuclear plant safety is an international problem because of the potential international effects of any postulated plant failure. For this reason this paper has been prepared in an attempt to highlight the differences in national criteria currently used in the extreme load design of nuclear plant facilities. No attempt has been made to evaluate the relative merit of the criteria established by the various national regulatory agencies. This paper presents the results of a recent survey made of national atomic energy regulatory agencies and major nuclear steam supply design agencies, which requested a summary of current licensing criteria associated with earthquake, extreme wind (tornado), flood, airplane crash and accident (pipe break) loads applicable within the various national jurisdictions. Also presented are a number of comparisons which are meant to illustrate the differences in national regulatory criteria. (Auth.)

Licensing evaluation of CANDU-PHW nuclear power plants relative to U.S. regulatory requirements

International Nuclear Information System (INIS)

Erp, J.B. van

1978-01-01

Differences between the U.S. and Canadian approach to safety and licensing are discussed. U.S. regulatory requirements are evaluated as regards their applicability to CANDU-PHW reactors; vice-versa the CANDU-PHW reactor is evaluated with respect to current Regulatory Requirements and Guides. A number of design modifications are proposed to be incorporated into the CANDU-PHW reactor in order to facilitate its introduction into the U.S. These modifications are proposed solely for the purpose of maintaining consistency within the current U.S. regulatory system and not out of a need to improve the safety of current-design CANDU-PHW nuclear power plants. A number of issues are identified which still require resolution. Most of these issues are concerned with design areas not (yet) covered by the ASME code. (author)

Impacts of NRC programs on state and local governments

International Nuclear Information System (INIS)

Nussbaumer, D.A.; Lubenau, J.O.

1983-12-01

This document reports the results of an NRC staff examination of the impacts of NRC regulatory programs on State and local governments. Twenty NRC programs are identified. For each, the source of the program (e.g., statutory requirement) and NRC funding availability are described and the impacts upon State and local governments are assessed. Recommendations for NRC monitoring and assessing impacts and for enhancing NRC staff awareness of the impacts are offered

Model Based User's Access Requirement Analysis of E-Governance Systems

Science.gov (United States)

Saha, Shilpi; Jeon, Seung-Hwan; Robles, Rosslin John; Kim, Tai-Hoon; Bandyopadhyay, Samir Kumar

The strategic and contemporary importance of e-governance has been recognized across the world. In India too, various ministries of Govt. of India and State Governments have taken e-governance initiatives to provide e-services to citizens and the business they serve. To achieve the mission objectives, and make such e-governance initiatives successful it would be necessary to improve the trust and confidence of the stakeholders. It is assumed that the delivery of government services will share the same public network information that is being used in the community at large. In particular, the Internet will be the principal means by which public access to government and government services will be achieved. To provide the security measures main aim is to identify user's access requirement for the stakeholders and then according to the models of Nath's approach. Based on this analysis, the Govt. can also make standards of security based on the e-governance models. Thus there will be less human errors and bias. This analysis leads to the security architecture of the specific G2C application.

Public support for government regulatory interventions for overweight and obesity in Australia.

Science.gov (United States)

Sainsbury, Emma; Hendy, Chelsea; Magnusson, Roger; Colagiuri, Stephen

2018-04-18

There is growing recognition among public health circles of the need for regulatory action for overweight and obesity, but there has been limited research into whether the Australian public supports government intervention. This study aimed to determine the level of public support for food-related regulations for obesity, and to assess the determinants of support. A nationally representative sample of Australian adults (n = 2011) was recruited by market research company Online Research Unit to complete an online survey. The survey measured respondents' perception of the obesity problem in Australia, and level of agreement on a 5-point Likert scale (strongly disagree to strongly agree) with proposed regulations in three domains; advertising, sponsorship of children's sport, and taxation. Binary logistic regression models were run to examine the association between demographic variables and support for regulation. The majority of respondents (92.5%) considered overweight and obesity to be a somewhat or very serious problem in Australia, and almost 90% felt there should be at least some government regulation to protect the public. Respondents agreed that the government should regulate food and beverage advertising (69.5%), with strongest support for restricting unhealthy food advertising to children (78.9%). There was lower support for prohibiting unhealthy food and beverage company sponsorship of children's sport (63.4% agreement), and for taxing sugar-sweetened beverages (54.5%), although the majority were still in favour. Support for fiscal policies slightly increased if revenue was to be used for health purposes. Females and tertiary educated respondents showed stronger agreement with proposed regulations (p < 0.05). The survey findings suggest the majority of the Australian population recognises obesity to be a serious health problem, and support government regulation of the food environment as a population-level preventative strategy.

42 CFR 137.32 - Is a compact required to participate in self-governance?

Science.gov (United States)

2010-10-01

...-governance? 137.32 Section 137.32 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES INDIAN HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES TRIBAL SELF-GOVERNANCE Self-Governance compact § 137.32 Is a compact required to participate in self-governance? Yes, Tribes must have a...

National legislative and regulatory activities

International Nuclear Information System (INIS)

2013-01-01

This section compiles the presentations of the following texts sorted by country. Armenia - Licensing and regulatory infrastructure: New design safety requirements adopted, New seismic hazard assessment guidelines adopted; France - Licensing and regulatory infrastructure: Decree No. 2012-1248 of 9 November 2012 authorising the ITER Organisation to create the 'ITER' basic nuclear installation in Saint-Paul-lez-Durance (Bouches-du-Rhone); - Nuclear security: Law No. 2012-1473 of 28 December 2012 authorizing the approval of the Amendment to the Convention on the Physical Protection of Nuclear Material; - Nuclear safety and radiological protection: Complementary safety assessments. Follow-up of the stress tests carried out on French nuclear power plants. Action Plan of the French Nuclear Safety Authority (ASN) - December 2012; - International cooperation: Decree No. 2012-1178 of 22 October 2012 publishing the Cooperation Agreement between the government of the French Republic and the government of the Republic of Tunisia for the development of peaceful uses of nuclear energy, signed in Tunis on 23 April 2009; Decree No. 2012-1180 of 22 October 2012 publishing the Cooperation Agreement between the government of the French Republic and the government of Mongolia in the field of nuclear energy (with annex), signed in Ulaanbaatar on 14 October 2010; Germany - General legislation: Bill to amend the Atomic Energy Act to expedite the retrieval of radioactive waste from and to decommission the Asse II Mine (2013); Act to amend the Act on Environmental Legal Remedies and other environmental provisions (2013); - Radiation protection: General administrative rules on Section 47 of the Radiation Protection Ordinance (2012); - Nuclear Safety: Safety requirements for nuclear power plants (2012); - Transport of radioactive material: International Transport of Dangerous Goods by Road (2010, 2012); - Regulations on nuclear trade (including non-proliferation): Export List (2013); Greece

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)

Regulatory requirements for radiation protection

International Nuclear Information System (INIS)

Mason, E.A.; Cunningham, R.E.; Hard, J.E.; Mattson, R.J.; Smith, R.D.; Peterson, H.T. Jr.

1977-01-01

Regulatory requirements for radiation protection have evolved and matured over several decades. Due to the wide adoption of recommendations of the International Commission on Radiation Protection (ICRP), there exists international agreement on the principles to be followed for radiation protection. This foundation will be increasingly important due to the growing need for international agreements and standards for radiation protection and radioactive materials management. During the infancy of the commercial nuclear industry, primary reliance was placed on the protection of the individual, both in the work force and as a member of the public. With the growth of nuclear power in the 1960's and 1970's, environmental impact assessments and expert reviews of bio-effects data have focused attention on statistical risks to large population groups and the use of the collective dose commitment concept to estimate potential effects. The potential release of long-lived radionuclides from the nuclear fuel cycle requires further consideration of radionuclide accumulation in the biosphere and calls for controls conceived and implemented at the international level. The initial development efforts for addressing these concerns already have been instituted by the ICRP and the IAEA. However, formal international agreements and a unified set of international standards may be required to implement the recommendations of these groups. Further international efforts in the field of radiation protection are also called for in developing waste management practices and radioactive effluent control technology, in site selection for fuel reprocessing plants and waste dispersal facilities, and for ensuring safe transport of high-level wastes in various forms. Since the regulation of very low dose rates and doses will be involved, it will be useful to reexamine dose-effect relationships and societal goals for health protection. Improved criteria and methodologies for ''as low as readily

National legislative and regulatory activities

International Nuclear Information System (INIS)

2015-01-01

This section treats of the following National legislative and regulatory activities: 1 - Australia: General legislation - Bill to amend the Australian Radiation Protection and Nuclear Safety Act 1998; 2 - France: General legislation - Law No. 2015-992 of 17 August 2015 on the energy transition for green growth; ASN Report on the state of nuclear safety and radiation protection in France in 2014; 3 - Germany: Radioactive waste management - First Ordinance to amend the 2005 Gorleben Development Freeze Ordinance (2015); 4 - Greece: Radioactive waste management - Joint Ministerial Decision establishing the national policy on the management of spent fuel and radioactive waste; 5 - Lithuania: Nuclear safety and radiological protection - Revised requirements for modifications, Plan for enhancement of nuclear safety, New requirements for the commissioning of nuclear power plants, Revised requirements regulating the provision of information on abnormal events; Radioactive waste management - Revised requirements for acceptance criteria for near surface repository; Nuclear security - Revised requirements for physical protection; 6 - Romania: Licensing and regulatory infrastructure - Government Decision No. 600/2014 for approval of National Nuclear Safety and Security; International co-operation - Government Decision No. 525/2014 for approval of the Co-operation Agreement on the radioactive waste management between the French National Radioactive Waste Management Agency (ANDRA) and Nuclear Agency and Radioactive Waste (ANDR) Strategy; Memorandum of Understanding for Co-operation and Exchange of Information in Nuclear Regulatory Matters between the National Commission for Nuclear Activities Control (CNCAN) of Romania and the President of National Atomic Energy Agency (PAA) of Poland; Government Decision No. 540/2015 for approval of the Agreement between the Government of Romania and the Government of the People's Republic of China regarding co-operation in the peaceful

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.

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

Regulatory requirement of the Juragua nuclear Power Plant PSA

International Nuclear Information System (INIS)

Valhuerdi Debesa, C.

1996-01-01

Probabilistic Safety Assessment has proved to be a powerful tool for improving the knowledge of the safety insides of Nuclear Power Plants and increasing the efficiency of the safety measures adopted by both operators and regulators. In this paper the regulatory approach adopted in Cuba with regard to the PSA , the scope of the requirement and the basis and proposal of this decision are presented

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.

Technical Support Organization Knowledge Management for Nuclear Regulatory Support

International Nuclear Information System (INIS)

Kohut, P.; Ramsey, J.; Katsenelenbogen, S.

2016-01-01

Full text: Knowledge management awareness has increased through the nuclear industrial and regulatory community leading to better understanding of the handling of critical information. Utilizing, managing and regulating the application of nuclear power require an extensive system of expertise and associated research through established organizations. The long term maintenance of the specific expertise is only viable by using scientific knowledge management principles all through the national nuclear infrastructure involving regulatory, industrial, academic and other research institutions. National governments in countries operating or planning to establish nuclear facilities have instituted regulatory regimes on the use of nuclear materials and facilities to insure a high level of operational safety. (author

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

Nanomedicine: Governing uncertainties

Science.gov (United States)

Trisolino, Antonella

Nanomedicine is a promising and revolutionary field to improve medical diagnoses and therapies leading to a higher quality of life for everybody. Huge benefits are expected from nanomedicine applications such as in diagnostic and therapeutic field. However, nanomedicine poses several issues on risks to the human health. This thesis aims to defense a perspective of risk governance that sustains scientific knowledge process by developing guidelines and providing the minimum safety standards acceptable to protect the human health. Although nanomedicine is in an early stage of its discovery, some cautious measures are required to provide regulatory mechanisms able to response to the unique set of challenges associated to nanomedicine. Nanotechnology offers an unique opportunity to intensify a major interplay between different disciplines such as science and law. This multidisciplinary approach can positively contributes to find reliable regulatory choices and responsive normative tools in dealing with challenges of novel technologies.

The Government's expectations for nuclear energy

International Nuclear Information System (INIS)

Fraser, Lord.

1997-01-01

After the thorough review of nuclear policy in 1994/95, the United Kingdom government remains committed to the view that there is no justification for, and no foreseeable to return to the large-scale public funding of new nuclear power plants. The nuclear industry's relationships with government has changed in some respects as a consequence of the privatisation of British Energy and AEA (Technology). This does not, however, mean a loss of government interest and involvement in other respects. There will be a continuing close interest in the safety, security and prosperity of the industry; the regulatory framework for the industry will be as rigorous as ever. Public expectation that nuclear liabilities will be managed safely and effectively is a responsibility both for government and the industry. Internationally, nuclear developments present considerable challenges and opportunities which require the government and the industry to work closely together in order to maximise the value of Britain's contribution. (UK)

The current regulatory requirements on optimisation and BAT in Sweden in the context of geological disposal

International Nuclear Information System (INIS)

Dverstorp, B.

2010-01-01

Bjorn Dverstorp, Swedish Radiation Safety authority (SSM) presented 'The current regulatory requirements on optimisation and BAT in Sweden in the context of geological disposal'. In Sweden, a nuclear waste repository will be evaluated according to both to general environmental legislation (the Environmental Code, SFS, 1998:808) and according to more specific requirements in the Act on Nuclear Activities (SFS, 1984:3) and the Radiation Protection Act (SFS, 1988:220). The evaluations according to these laws will be carried out according to two separate, but coordinated, legal-review and decision-making processes. This will be a basis for the siting process. Although the requirements on BAT and siting in the Environmental Code apply to radiological protection, they aim at a broader system optimisation. The more specific requirements on optimisation and BAT of radiological protection of geological disposal systems are given in the regulations associated with the Radiation Protection Act. The Swedish radiation protection regulations (SSM, 2009) comprise three corner stones: a risk target, environmental protection goals and the use of optimisation and BAT. In SSM' s guidance optimisation is defined as a means to reduce risk, guided by the results of risk calculations. In case of a conflict between BAT and optimisation, measures satisfying BAT should have priority. Application of optimisation and BAT on different timescales are described as well as for human intrusion scenarios. B. Dverstorp explained that because of uncertainties in the long term there is a need for additional arguments in the safety case in support of decision making. It is in this context that the requirements on optimisation and BAT should be seen as supplementary to the risk target, in providing evidence that the developer has taken into consideration, as far as reasonably possible, measures and options for reducing future doses and risks. Both principles focus on the proponent's work on developing

A study on the influence of the regulatory requirements of a nuclear facility during decommissioning activities

Energy Technology Data Exchange (ETDEWEB)

Park, Hee Seong; Park, Seung Kook; Park, Kook Nam; Hong, Yun Jeong; Park, Jang Jin; Choi, Jong Won [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2016-10-15

The preliminary decommissioning plan should be written with various chapters such as a radiological characterization, a decommissioning strategy and methods, a design for decommissioning usability, a safety evaluation, decontamination and dismantling activities, radioactive waste management, an environmental effect evaluation, and fire protection. The process requirements of the decommissioning project and the technical requirements and technical criteria should comply with regulatory requirements when dismantling of a nuclear facility. The requirements related to safety in the dismantling of a nuclear facility refer to the IAEA safety serious. The present paper indicates that a decommissioning design and plan, dismantling activities, and a decommissioning project will be influenced by the decommissioning regulatory requirements when dismantling of a nuclear facility. We hereby paved the way to find the effect of the regulatory requirements on the decommissioning of a whole area from the decommissioning strategy to the radioactive waste treatment when dismantling a nuclear facility. The decommissioning requirements have a unique feature in terms of a horizontal relationship as well as a vertical relationship from the regulation requirements to the decommissioning technical requirements. The decommissioning requirements management will be conducted through research that can recognize a multiple relationship in the next stage.

Arrangement between the US Nuclear Regulatory Commission (USNRC) and the Belgian Government for Exchange of Technical Information in Regulatory Matters and in Cooperation in Safety Research and in Standards Development

International Nuclear Information System (INIS)

1978-01-01

This Arrangement was concluded on 6 June 1978 between the United States Nuclear Regulatory Commission and the Belgian Government for exchange of technical information in regulatory matters and in co-operation in safety research and in standards development. Both Parties agree to exchange, as available, technical information related to the regulation of safety and the environmental impact of designated nuclear energy facilities and to safety research of designated types of nuclear facilities. As regards co-operation in safety research, the execution of joint programmes and projects under which activities are divided between the two Parties will be agreed on a case by case basis. The Parties further agree to co-operate in the development of regulatory standards applicable to the designated nuclear facilities. The Arrangement is valid for 5 years and may be extended. (NEA) [fr

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.

Ethical and legal challenges in bioenergy governance

DEFF Research Database (Denmark)

Gamborg, Christian; Anker, Helle Tegner; Sandøe, Peter

2014-01-01

of regulatory measures and options). We present ethical and legal analyses of the current stalemate on bioenergy governance in the EU using two illustrative cases: liquid biofuels for transport and solid biomass-based bioenergy. The two cases disclose some similarities between these two factors......, but the remaining differences may partly explain, or justify, contrasting forms of governance. While there seems to be no easy way in which the EU and national governments can deal with the multiple sustainability issues raised by bioenergy, it is argued that failure to deal explicitly with the underlying value...... disagreements, or to make apparent the regulatory complexity, clouds the issue of how to move forward with governance of bioenergy. We suggest that governance should be shaped with greater focus on the role of value disagreements and regulatory complexity. There is a need for more openness and transparency...

Joint ventures between industry and government

International Nuclear Information System (INIS)

Vant, T.R.

1991-01-01

Joint venture projects undertaken between government and industry in western Canada are reviewed. The first significant involvement of the Alberta government was with the Syncrude oil sands project. In 1974, one of the original participants, Atlantic Richfield, pulled out of Syncrude for financial reasons. After a government review and search for replacement participation, three provincial governments took equity positions in the project. The Syncrude project has since had a very significant impact on Alberta and Canada in terms of oil production, employment, investment, and profits. The Other Six Leases Operation (OSLO), the OSLO New Ventures Project, and the Lloydminster Bi-Provincial Upgrader would also not have advanced to their present stages of development without government participation. Since oil sand/heavy oil development requires significant capital investment over long lead times, and since there are few private companies that can undertake such a commitment, government assistance is often required. It also makes sense for governments to share upfront risk in such projects for both the long-term economic gain and such immediate benefits as job creation and energy supply security. An industry/government joint venture provides a means of getting large, inherently economic projects such as oil sands developments under way while protecting taxpayers' interests. The success of such a joint venture depends not only on the financing brought to the project but also on the expertise, decision making capability, and balanced management of regulatory and policy issues

Accounting for Technological Change in Regulatory Impact Analyses: The Learning Curve Technique

Energy Technology Data Exchange (ETDEWEB)

Taylor, Margaret [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Fujita, K. Sydny [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

2013-04-30

Regulatory impact assessment is formally required by the U.S. and many other nations in order to help governments weigh the costs and benefits of proposed regulations, particularly as they compare to those of alternative actions and other government priorities. 1 One of the “best practices” of regulatory impact assessments, as established by the OECD, is to use estimates of costs that are grounded in economic theory. Economic theory indicates that changes in compliance costs should be expected over time as a result of factors related to technological innovation. But many U.S. regulatory impact assessments have traditionally employed a practice that is in conflict with this expectation: they take current estimates of the costs of complying with a proposed regulation and project that those costs will remain unchanged over the full time period that the regulation would be in effect.

Methods for ensuring compliance with regulatory requirements: regulators and operators

International Nuclear Information System (INIS)

Fleischmann, A.W.

1989-01-01

Some of the methods of ensuring compliance with regulatory requirements contained in various radiation protection documents such as Regulations, ICRP Recommendations etc. are considered. These include radiation safety officers and radiation safety committees, personnel monitoring services, dissemination of information, inspection services and legislative power of enforcement. Difficulties in ensuring compliance include outmoded legislation, financial and personnel constraints

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

The regulatory application of authorization in radiological protection

International Nuclear Information System (INIS)

Lazo, T.; Frullani, S.

2004-01-01

Authorization is the process used by governments and regulatory authorities to decide what regulatory controls or conditions, if any, should be applied to radioactive sources or radiation exposure situations in order to protect the public, workers and the environment appropriately. Over the years, governments and regulatory authorities have used various approaches to the authorization process under differing circumstances. Now, with the new draft recommendations from the International Commission on Radiological Protection (ICRP), there is the prospect of being able to use a single, simple and self-coherent approach for the process of regulatory authorization under all circumstances. Previously, the ICRP recommended the use of various approaches to manage radiological protection situations. For what were called practices, exposures were subject to limits, and optimisation was required below these limits. What were called interventions were subject to intervention levels, above which some action could be considered justified, and which should be optimised based on consideration of how much dose could be averted by the countermeasure considered. Radon in homes was subject to action levels, above which some sort of countermeasure could be recommended. These approaches are all philosophically distinct and logically constructed, but their differences, particularly in the types of numerical criteria used (limits, intervention levels, action levels, etc.) contributed to confusion and misunderstanding. (author)

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

International Nuclear Information System (INIS)

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

1988-01-01

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

Regulatory requirements for designing PET-CT facility in India

International Nuclear Information System (INIS)

Tandon, Pankaj

2010-01-01

In India, cyclotron-produced radionuclides are gaining importance in molecular imaging in Nuclear Medicine (NM) departments. The importance of this modality among others is due to the fact that it provides valuable clinical information, which was lacking in other available modalities. Presently, every well-established hospital would like to procure Medical Cyclotron or positron emission tomography-computed tomography (PET-CT) facility in their NM department. Because cyclotron-produced radionuclides have higher energy than the other routinely used radionuclides for diagnosis, it becomes essential for the user to know about the regulatory requirement and radiation safety precautions that one has to take for the installation of this new modality in their premises. The various stages of approval of PET-CT facility by the Atomic Energy Regulatory Board (AERB) and important steps that one has to know/follow before planning for this new facility are summarized

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

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

International Nuclear Information System (INIS)

2000-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-08-01

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

The Canadian Government perspective on cost-effective regulation

International Nuclear Information System (INIS)

Martin, J.K.; Iwankow, C.

1996-01-01

Fiscal constraint, globalization of markets, and accelerated technological change have resulted in a new focus on the cost-effectiveness of government activities and, in turn, on methods of policy evaluation. An exploration of regulatory problems, and the use of regulation as a public policy instrument, reveals a commonalty of experience in all industrialized countries. This paper provides a brief synopsis of the Government of Canada's perspective on cost-effective regulation. To understand cost-effective regulation, this paper examines the principles of regulatory reform which underlie the current strategy of the federal government (collaborative decision-making mechanisms., methods of clear policy evaluation, and well defined lines of accountability). It discusses the nature of, and rationale for, government regulation, the reasons for regulatory reform in the economy, and the principal aims of Canadian regulatory reform and regulatory policy assessment. It does so by specifically addressing the role of cost-benefit analysis in the process of regulatory assessment - a method which involves systematically identifying, and quantifying where possible, the social benefits and costs associated with alternative public policy actions - with a particular focus on regulation which affects the Canadian nuclear industry. (author). 51 refs

The Canadian Government perspective on cost-effective regulation

Energy Technology Data Exchange (ETDEWEB)

Martin, J K; Iwankow, C [Treasury Board of Canada Secretariat, Ottawa, ON (Canada)

1997-12-31

Fiscal constraint, globalization of markets, and accelerated technological change have resulted in a new focus on the cost-effectiveness of government activities and, in turn, on methods of policy evaluation. An exploration of regulatory problems, and the use of regulation as a public policy instrument, reveals a commonalty of experience in all industrialized countries. This paper provides a brief synopsis of the Government of Canada`s perspective on cost-effective regulation. To understand cost-effective regulation, this paper examines the principles of regulatory reform which underlie the current strategy of the federal government (collaborative decision-making mechanisms., methods of clear policy evaluation, and well defined lines of accountability). It discusses the nature of, and rationale for, government regulation, the reasons for regulatory reform in the economy, and the principal aims of Canadian regulatory reform and regulatory policy assessment. It does so by specifically addressing the role of cost-benefit analysis in the process of regulatory assessment - a method which involves systematically identifying, and quantifying where possible, the social benefits and costs associated with alternative public policy actions - with a particular focus on regulation which affects the Canadian nuclear industry. (author). 51 refs.

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

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

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

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.

Trust in regulatory regimes

NARCIS (Netherlands)

Six, Frédérique; Verhoest, Koen

2017-01-01

Within political and administrative sciences generally, trust as a concept is contested, especially in the field of regulatory governance. This groundbreaking book is the first to systematically explore the role and dynamics of trust within regulatory regimes. Conceptualizing, mapping and analyzing

Regulatory philosophy and requirements for radiation control in Canadian uranium mine-mill facilities

International Nuclear Information System (INIS)

Dory, A.B.

1981-10-01

The approach the Canadian Atomic Energy Control Board takes in licensing uranium mine/mill facilities is based on a minimum of rigidly set regulatory requirements. The regulations state only the basic objectives: the obligation to acquire a licence, some administrative and reporting requirements, and exposure limits. The regulations are supported by a set of regulatory guides. The operator always has the option of following different procedures if he can demonstrate that they will produce the same or better results. Good relationships exist between the AECB and mine management as well as trade unions. Under this approach, however, it is difficult to take action against uncooperative parties. The Board has decided that a somewhat more formalized system is necessary. New regulations are being drafted, giving more detailed licensing and administrative requirements and covering the areas of ventilation and worker and supervisor education more thoroughly

Review of regulatory requirements relevant to calibration of monitoring instruments in research reactors

Energy Technology Data Exchange (ETDEWEB)

Gomaa, Hassan; Khedr, Ahmed; El-Din Talha, Kamal [Egyptian Nuclear and Radiological Regulatory Authority, Cairo (Egypt). Nuclear Safety Engineering Dept.

2015-05-15

The objective of this work is to demonstrate the regulatory requirements pertaining to calibration of monitoring instruments in research reactors. The regulatory statements concerning this subject in IAEA safety standards and the implementation of such regulations in twelve countries with different levels of nuclear programs are surveyed: Australia, Bulgaria, Canada, Egypt, Finland, Germany, Hungary, Slovenia, South Korea, Spain, United Kingdom of England and United States of America. In addition, the requirements of ISO/IEC17025 and NUPIC (Nuclear Utilities Procurement Issues Committee) are compared. Seven technical and administrate aspects are suggested as the comparison criteria and the explicit expression of the statements, the level of document (i.e.: act, requirement or guide) are the considered resources. The main differences and similarities between the different approaches are identified in order to provide an input for future development of the national regulations.

Strengthening Regulatory Competence through Techno-managerial Knowledge Integration: Indian Experience

International Nuclear Information System (INIS)

Kuchibhotla, S.

2016-01-01

Competence development is the process of identifying the competencies required to perform a given job, role or set of tasks successfully at workplace. Strengthening regulatory competence, for the nuclear regulator, is essential to ensure skilled and competent human resources for performing the functions of the Regulatory Body. The strengthening of existing competence level for the Indian nuclear regulator, takes into account the understanding of the elements such as legal basis and regulatory processes governing operations of regulatory body, technological competences for performing regulatory functions, competences pertinent to regulatory practices, and competences related to personal and interpersonal effectiveness within the organization. Competency data from AERB divisions was compiled to identify gaps at various positions with recommendations for making specialized training modules and modifications to basic and refresher training modules. The exercise is aimed at providing continual improvement in skills and knowledge of human resources at AERB in a phased manner. (author)

Private financing and operation of a space station: Investment requirements, risk, government support and other primary business management considerations

Science.gov (United States)

Simon, M.

1982-01-01

Private investment in a manned space station is considered as an alternative to complete government sponsorship of such a program. The implications of manned space operations are discussed from a business perspective. The most significant problems and risks which would be faced by a private company involved in a space station enterprise are outlined and possible government roles in helping to overcome these difficulties suggested. Economic factors such as inflation and the rate of interest are of primary concern, but less obvious conditions such as antitrust and appropriate regulatory laws, government appropriations for space activities, and national security are also considered.

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)

Romanian regulatory requirements on nuclear field specific education needs

International Nuclear Information System (INIS)

Biro, L.; Velicu, O.

2004-01-01

This work is intended as a general presentation of the educational system and research field, with reference to nuclear sciences, and the legal system, with reference to requirements established by the regulatory body for the professional qualification and periodic training of personnel involved in different activities in the nuclear field. Thus, part 2 and 3 of the work present only public information regarding the education in nuclear sciences and nuclear research in Romania; in part 4 the CNCAN requirements for the personnel training, specific to nuclear activities are slightly detailed; part 5 consists of few words about the public information activities in Romania; and part 6 tries to draw a conclusion. (authors)

Regulatory requirements to the thermal-hydraulic and thermal-mechanical computer codes

International Nuclear Information System (INIS)

Vitkova, M.; Kalchev, B.; Stefanova, S.

2006-01-01

The paper presents an overview of the regulatory requirements to the thermal-hydraulic and thermal-mechanical computer codes, which are used for safety assessment of the fuel design and the fuel utilization. Some requirements to the model development, verification and validation of the codes and analysis of code uncertainties are also define. Questions concerning Quality Assurance during development and implementation of the codes as well as preparation of a detailed verification and validation plan are briefly discussed

Government regulation to promote healthy food environments--a view from inside state governments.

Science.gov (United States)

Shill, J; Mavoa, H; Allender, S; Lawrence, M; Sacks, G; Peeters, A; Crammond, B; Swinburn, B

2012-02-01

Food policy interventions are an important component of obesity-prevention strategies and can potentially drive positive changes in obesogenic environments. This study sought to identify regulatory interventions targeting the food environment, and barriers/facilitators to their implementation at the Australian state government level. In-depth interviews were conducted with senior representatives from state/territory governments, statutory authorities and non-government organizations (n =45) to examine participants' (i) suggestions for regulatory interventions for healthier food environments and (ii) support for pre-selected regulatory interventions derived from a literature review. Data were analysed using thematic and constant comparative analyses. Interventions commonly suggested by participants were regulating unhealthy food marketing; limiting the density of fast food outlets; pricing reforms to decrease fruit/vegetable prices and increase unhealthy food prices; and improved food labelling. The most commonly supported pre-selected interventions were related to food marketing and service. Primary production and retail sector interventions were least supported. The dominant themes were the need for whole-of-government and collaborative approaches; the influence of the food industry; conflicting policies/agenda; regulatory challenges; the need for evidence of effectiveness; and economic disincentives. While interventions such as public sector healthy food service policies were supported by participants, marketing restrictions and fiscal interventions face substantial barriers including a push for deregulation and private sector opposition. © 2011 The Authors. obesity reviews © 2011 International Association for the Study of Obesity.

75 FR 65881 - Ownership Limitations and Governance Requirements for Security-Based Swap Clearing Agencies...

Science.gov (United States)

2010-10-26

... it determines they are necessary or appropriate to improve the governance of, or to mitigate systemic... Part IV Securities and Exchange Commission 17 CFR Part 242 Ownership Limitations and Governance... Ownership Limitations and Governance Requirements for Security- Based Swap Clearing Agencies, Security-Based...

42 CFR 137.285 - Are Self-Governance Tribes required to accept Federal environmental responsibilities to enter...

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Are Self-Governance Tribes required to accept..., DEPARTMENT OF HEALTH AND HUMAN SERVICES TRIBAL SELF-GOVERNANCE Construction Nepa Process § 137.285 Are Self-Governance Tribes required to accept Federal environmental responsibilities to enter into a construction...

Governing Governance : A formal framework for analysing institutional design and enactment governance

NARCIS (Netherlands)

King, T.C.

2016-01-01

This dissertation is motivated by the need, in today’s globalist world, for a precise way to enable governments, organisations and other regulatory bodies to evaluate the constraints they place on themselves and others. An organisation’s modus operandi is enacting and fulfilling contracts between

The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review.

Science.gov (United States)

Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno

2017-01-01

Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine.

The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review

Science.gov (United States)

Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno

2017-01-01

Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine. PMID:29629018

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

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.

A Corporate Governance Index : Convergence and Diversity of National Corporate Governance Regulations

NARCIS (Netherlands)

Martynova, M.; Renneboog, L.D.R.

2010-01-01

The issue of appropriate corporate governance framework has been a focal point of recent reforms in many countries. This study provides a comprehensive comparative analysis of corporate governance regulatory systems and their evolution over the last 15 years in 30 European countries and the US. It

Risk-informing special treatment requirements for reactors

International Nuclear Information System (INIS)

McKenna, E.M.; Reed, T.A.

2001-01-01

The U.S. Nuclear Regulatory Commission (NRC) is proposing to make regulatory changes to the scope of structures, systems, and components (SSCs) requiring special treatment. ''Special treatment requirements'' refers to those specific examples of regulations that are applied in order to provide a high degree of assurance that SSC will be capable of performing their intended functions when needed. The current scope of SSCs covered by the special treatment requirements governing commercial nuclear reactors is deterministically based and stems primarily from the evaluation of selected design basis events, as described in updated final safety analysis reports (UFSARs). This regulatory framework provides reasonable assurance of no undue risk to the health and safety of the public. However, recent advances in technology, coupled with operating reactor experience, have suggested that an alternative approach that would use a risk-informed process for evaluating SSC safety significance, would, in turn, result in a more focused determination of which SSCs should receive special treatment requirements. (author)

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

Governance, Government, and the Search for New Provider Models

Directory of Open Access Journals (Sweden)

Richard B. Saltman

2016-01-01

Full Text Available A central problem in designing effective models of provider governance in health systems has been to ensure an appropriate balance between the concerns of public sector and/or government decision-makers, on the one hand, and of non-governmental health services actors in civil society and private life, on the other. In tax-funded European health systems up to the 1980s, the state and other public sector decision-makers played a dominant role over health service provision, typically operating hospitals through national or regional governments on a command-and-control basis. In a number of countries, however, this state role has started to change, with governments first stepping out of direct service provision and now de facto pushed to focus more on steering provider organizations rather than on direct public management. In this new approach to provider governance, the state has pulled back into a regulatory role that introduces market-like incentives and management structures, which then apply to both public and private sector providers alike. This article examines some of the main operational complexities in implementing this new governance reality/strategy, specifically from a service provision (as opposed to mostly a financing or even regulatory perspective. After briefly reviewing some of the key theoretical dilemmas, the paper presents two case studies where this new approach was put into practice: primary care in Sweden and hospitals in Spain. The article concludes that good governance today needs to reflect practical operational realities if it is to have the desired effect on health sector reform outcome.

Governance, Government, and the Search for New Provider Models.

Science.gov (United States)

Saltman, Richard B; Duran, Antonio

2015-11-03

A central problem in designing effective models of provider governance in health systems has been to ensure an appropriate balance between the concerns of public sector and/or government decision-makers, on the one hand, and of non-governmental health services actors in civil society and private life, on the other. In tax-funded European health systems up to the 1980s, the state and other public sector decision-makers played a dominant role over health service provision, typically operating hospitals through national or regional governments on a command-and-control basis. In a number of countries, however, this state role has started to change, with governments first stepping out of direct service provision and now de facto pushed to focus more on steering provider organizations rather than on direct public management. In this new approach to provider governance, the state has pulled back into a regulatory role that introduces market-like incentives and management structures, which then apply to both public and private sector providers alike. This article examines some of the main operational complexities in implementing this new governance reality/strategy, specifically from a service provision (as opposed to mostly a financing or even regulatory) perspective. After briefly reviewing some of the key theoretical dilemmas, the paper presents two case studies where this new approach was put into practice: primary care in Sweden and hospitals in Spain. The article concludes that good governance today needs to reflect practical operational realities if it is to have the desired effect on health sector reform outcome. © 2016 by Kerman University of Medical Sciences.

Creating a safety culture in the regulatory authority: The Cuban experience

International Nuclear Information System (INIS)

Ferro Fernandez, R.; Guillen Campos, A.

2002-01-01

The Cuban regulatory authority has been working during several years for the fostering and development of a high Safety Culture level in nuclear activities in the country. As starting point to achieve this objective the assessment of the Safety Culture level in the regulatory authority performance was considered an important issue. For this purpose a preliminary diagnosis was carried out by means of a national survey that allowed identifying some areas of the regulatory activity that required improvements in order to achieve a higher Safety Culture and to immediately implement appropriate actions. Two of the most important actions undertaken were: the statement of the regulatory authority Safety Policy which governs and determines the performance of this organization and its staff and also the implementation of a new interaction practice at top level between the regulatory authority and the utilities of the nuclear sector through the Annual Regulatory Conference. The present paper summarizes these two introduced practices into the Cuban regulatory activity. (author)

Regulatory requirements important to Hanford single-shell tank waste management decisions

International Nuclear Information System (INIS)

Keller, J.F.; Woodruff, M.G.

1989-06-01

This report provides an initial analysis of the regulations that may be pertinent to SST management activities (e.g., characterization, disposal, retrieval, processing, etc.) and the interrelationships among those regulations. Waste disposal decisions regarding SST waste must consider the regulatory requirements against which technical solutions will be evaluated. Regulatory requirements can also be used as guidelines for management and disposal of waste in a manner that protects human health and safety and the environment. Also, in cases where waste management regulations do not specifically address a waste form, such as radioactive mixed waste, the SST waste may come under the purview of a number of regulations related to radioactive waste management, hazardous waste management, and water and air quality protection. This report provides a comprehensive review of the environmental pollution control and radioactive waste management statutes and regulations that are relevant to SST waste characterization and management. Also, other statutes and regulations that contain technical standards that may be used in the absence of directly applicable regulations are analyzed. 8 refs., 4 figs

3 CFR - Regulatory Review

Science.gov (United States)

2010-01-01

... as a means of promoting regulatory goals. The fundamental principles and structures governing... review. In this time of fundamental transformation, that process—and the principles governing regulation... the Office of Management and Budget (OMB) has reviewed Federal regulations. The purposes of such...

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)

Hybridization of governance : The challenge of balancing policy impacts

NARCIS (Netherlands)

van der Heijden, J.J.

2009-01-01

This paper focuses on the impacts of hybrid forms of governance. Such hybrids are characterized by an arrangement of tasks and responsibilities, regarding regulatory governance, between public and private sector agencies. Empirically the paper is based on regulatory reforms in Australian and

Regulatory Requirements to Combat Illicit Trafficking of Hazardous Materials

International Nuclear Information System (INIS)

Hussein, A.Z.; Zakaria, Kh.M.

2011-01-01

Since more than a decade illicit Trafficking of hazardous ( CBRNE), materials ( chemical, biological, radiological, nuclear and explosive ) has been identified as a key threat in national, regional, inter regional and international strategies. An Effective response to hazardous materials (CBRNE) risk and threat were realized to require a very high level of cooperation and coordination between various governments and their responsible organizations and authorities of regional and international partner. While improper policy of actions may easily be exploited by non- state members to (CBRNE) trafficking which may lead to develop weapon of mass destruction (WMD). Such strategy are of paramount important between all levels of the states and among regional agreements through comprehensive tailored assistance packages (e.g. export control, illicit trafficking of hazardous materials, redirection of scientist, emergency planning, crisis response safety and security culture. Capacity building, action plans and instruments for stability are necessary actions for efficient combating against illicit trafficking of hazardous materials. Regarding the needs of assessment phase, assistance must be based on data collection, analysis and prioritization of implanting the regulatory controls. Several activities have to be conducted to reduce CBRNE threat. The one- by- one approach, covering either nuclear and radioactive or chemical or biological materials has to be implanted on the country basis performance to mitigate CBRNE hazardous risk. On several consequent phases of intervention dealing with CBRNE risk mitigation the country has to establish a network of local, regional and international capabilities. Such network is setting up the mechanism for the country needs identifications, the guidelines for data collection, for data platform maintenance and update, the data assessment and the competent and operative organizations. This network will be to strengthen the long - term

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”.

48 CFR 752.245-70 - Government property-USAID reporting requirements.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Government property-USAID reporting requirements. 752.245-70 Section 752.245-70 Federal Acquisition Regulations System AGENCY FOR... recommendation, USAID contracts, except for those for commercial items, must contain the following preface and...

42 CFR 137.351 - Is a Self-Governance Tribe required to submit construction project progress and financial reports...

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Is a Self-Governance Tribe required to submit..., DEPARTMENT OF HEALTH AND HUMAN SERVICES TRIBAL SELF-GOVERNANCE Construction Roles of Self-Governance Tribe in Establishing and Implementing Construction Project Agreements § 137.351 Is a Self-Governance Tribe required to...

42 CFR 137.293 - Are Self-Governance Tribes required to adopt a separate resolution or take equivalent Tribal...

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Are Self-Governance Tribes required to adopt a...-GOVERNANCE Construction Nepa Process § 137.293 Are Self-Governance Tribes required to adopt a separate... project agreement? No, the Self-Governance Tribe may adopt a single resolution or take equivalent Tribal...

WIPP Waste Characterization: Implementing Regulatory Requirements in the Real World

International Nuclear Information System (INIS)

Cooper Wayman, J.D.; Goldstein, J.D.

1999-01-01

It is imperative to ensure compliance of the Waste Isolation Pilot Project (WIPP) with applicable statutory and regulatory requirements. In particular, compliance with the waste characterization requirements of the Resource Conservation and Recovery Act (RCRA) and its implementing regulation found at 40 CFR Parts 262,264 and 265 for hazardous and mixed wastes, as well as those of the Atomic Energy Act of 1954, as amended, the Reorganization Plan No. 3 of 1970, the Nuclear Waste Policy Act of 1982, as amended, and the WIPP Land Withdrawal Act, as amended, and their implementing regulations found at 40 CFR Parts 191 and 194 for non-mixed radioactive wastes, are often difficult to ensure at the operational level. For example, where a regulation may limit a waste to a certain concentration, this concentration may be difficult to measure. For example, does the definition of transuranic waste (TRU) as 100 nCi/grain of alpha-emitting transuranic isotopes per gram of waste mean that the radioassay of a waste must show a reading of 100 plus the sampling and measurement error for the waste to be a TRU waste? Although the use of acceptable knowledge to characterize waste is authorized by statute, regulation and DOE Orders, its implementation is similarly beset with difficulty. When is a document or documents sufficient to constitute acceptable knowledge? What standard can be used to determine if knowledge is acceptable for waste characterization purposes? The inherent conflict between waste characterization regulatory requirements and their implementation in the real world, and the resolution of this conflict, will be discussed

Government Policies for Corporate Social Responsibility in Europe:

DEFF Research Database (Denmark)

Knudsen, Jette Steen; Moon, Jeremy; Slager, Rieneke

2015-01-01

This paper analyses policies of 22 European Union member governments, designed to encourage corporate social responsibility (CSR) between 2000 and 2011. It categorises these policies by their regulatory strength and identifies the range of issues to which CSR policies are directed. The paper argues...... that Northern European, Scandinavian and UK governments are reconstructing their respective institutional structures to embed CSR concerns more explicitly therein. It concludes that these government CSR initiatives are converging, particularly around their increased regulatory strength and the broadening...

An international corporate governance index

NARCIS (Netherlands)

Martynova, M.; Renneboog, L.D.R.; Wright, M.; Siegel, D.; Keasey, K.; Filatotchev, I.

2013-01-01

This chapter presents a comparative analysis of corporate governance regulatory systems and their development since 1990 in the United States and in 30 European countries. It introduces a proposed methodology that would help create detailed corporate governance indices which describe the primary

The dynamics of the transnational food chain regulatory governance

DEFF Research Database (Denmark)

Chatzopoulou, Sevasti

2015-01-01

dynamics of the interactions among public and private actors operate within the transnational food standards setting process. The study identifies the groups of interdependent actors (public and private) that interact within the transnational food chain regulatory process and develop public...... in detail how these interactions operate empirically on specific regulations. Practical implications – The paper offers an integrative thorough understanding of the food chain regulatory standard setting process, relevant for academics, policy makers, the industry, and society. Originality/value – The paper...

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)

Unique Regulatory Approach for Licensing the Port Hope Remediation Project in Canada - 13315

International Nuclear Information System (INIS)

Kostova, M.; Howard, D.; Elder, P.

2013-01-01

The Port Hope remediation project is a part of a larger initiative of the Canadian Federal Government the Port Hope Area Initiative (PHAI) which is based upon a community proposal. The Government of Canada, through Natural Resources Canada (NRCan) is investing $1.28 billion over 10 years to clean up historic low-level radioactive waste in the Port Hope Area and to provide long-term safe management of the low-level radioactive wastes in the Port Hope Area. These wastes arose from the activities of a former Federal Crown Corporation (Eldorado Nuclear) and its private sector predecessors. In Canada, historic waste are defined as low-level radioactive waste that was managed in a manner no longer considered acceptable, but for which the original producer cannot reasonably be held responsible or no longer exists and for which the Federal Government has accepted responsibility. In Canada, under the current regulatory framework, the environmental remediation is not considered as a distinct phase of the nuclear cycle. The regulatory approach for dealing with existing sites contaminated with radioactive residues is defined on the basis of risk and application of existing regulations. A unique regulatory approach was taken by the Canadian Nuclear Safety Commission (CNSC) to address the various licensing issues and to set out the requirements for licensing of the Port Hope Project within the current regulatory framework. (authors)

Unique Regulatory Approach for Licensing the Port Hope Remediation Project in Canada - 13315

Energy Technology Data Exchange (ETDEWEB)

Kostova, M.; Howard, D.; Elder, P. [Directorate of Nuclear Cycle and Facilities Regulation, Canadian Nuclear Safety Commission, 280, Slater Street, Ottawa, Ontario K1P 5S9 (Canada)

2013-07-01

The Port Hope remediation project is a part of a larger initiative of the Canadian Federal Government the Port Hope Area Initiative (PHAI) which is based upon a community proposal. The Government of Canada, through Natural Resources Canada (NRCan) is investing $1.28 billion over 10 years to clean up historic low-level radioactive waste in the Port Hope Area and to provide long-term safe management of the low-level radioactive wastes in the Port Hope Area. These wastes arose from the activities of a former Federal Crown Corporation (Eldorado Nuclear) and its private sector predecessors. In Canada, historic waste are defined as low-level radioactive waste that was managed in a manner no longer considered acceptable, but for which the original producer cannot reasonably be held responsible or no longer exists and for which the Federal Government has accepted responsibility. In Canada, under the current regulatory framework, the environmental remediation is not considered as a distinct phase of the nuclear cycle. The regulatory approach for dealing with existing sites contaminated with radioactive residues is defined on the basis of risk and application of existing regulations. A unique regulatory approach was taken by the Canadian Nuclear Safety Commission (CNSC) to address the various licensing issues and to set out the requirements for licensing of the Port Hope Project within the current regulatory framework. (authors)

Nanotechnology and the need for risk governance

International Nuclear Information System (INIS)

Renn, O.; Roco, M. C.

2006-01-01

After identifying the main characteristics and prospects of nanotechnology as an emerging technology, the paper presents the general risks associated with nanotechnology applications and the deficits of the risk governance process today, concluding with recommendations to governments, industry, international organizations and other stakeholders. The International Risk Governance Council (IRGC) has identified a governance gap between the requirements pertaining to the nano- rather than the micro-/macro- technologies. The novel attributes of nanotechnology demand different routes for risk-benefit assessment and risk management, and at present, nanotechnology innovation proceeds ahead of the policy and regulatory environment. In the shorter term, the governance gap is significant for those passive nanostructures that are currently in production and have high exposure rates; and is especially significant for the several 'active' nanoscale structures and nanosystems that we can expect to be on the market in the near future. Active nanoscale structures and nanosystems have the potential to affect not only human health and the environment but also aspects of social lifestyle, human identity and cultural values. The main recommendations of the report deal with selected higher risk nanotechnology applications, short- and long-term issues, and global models for nanotechnology governance

Electricity and telecommunications regulatory institutions in small and developing countries

Energy Technology Data Exchange (ETDEWEB)

Stern, J. [London Business School, London (United Kingdom)

2000-09-01

The spread of utility liberalisation and privatisation to middle and low income developing countries raises the problem of whether and how they can establish an effective regulatory capability of whether the supply of regulatory services is likely to be insufficient. The paper presents evidence on the size of electricity regulatory agencies in 24 mainly middle and lower income countries as well as the number of high-level, specialist regulatory staff and the potential resource pool from post-school education. The paper also discusses how far the problem can be alleviated and/or avoided by the use of regulation by contract, regulation by multi-national regulatory agency or contracting-out. The paper concludes that such solutions are unlikely to be generally effective but that informal exchanges of information and pooling of resources between national regulators on a market-driven basis, as seen in Southern Africa and the EU, is a promising option. The paper concludes by pointing to the need to ascertain the minimum required regulatory capability in developing countries as perceived by Governments and potential investors. (author)

Regulatory requirements for demonstration of the achieved safety level at the Mochovce NPP before commissioning

International Nuclear Information System (INIS)

Lipar, M.

1997-01-01

A review of regulatory requirements for demonstration of the achieved safety level at the Mochovce NPP before commissioning is given. It contains licensing steps in Slovakia during commissioning; Status and methodology of Mochovce safety analysis report; Mochovce NPP safety enhancement program; Regulatory body policy towards Mochovce NPP safety enhancement; Recent development in Mochovce pre-operational safety enhancement program review and assessment process; Licensing steps in Slovakia during commissioning

Relationship between Saskatchewan government regulatory agencies and the oil and gas industry

International Nuclear Information System (INIS)

Lechner, L.J.; Mathieson, B.

1998-01-01

The roles and responsibilities of various government agencies as they interact with the oil and gas industry in Saskatchewan were described. The regulatory agencies featured in this paper were Saskatchewan Energy and Mines (SEM), Saskatchewan Environment and Resource Management (SERM), and Saskatchewan Agriculture and Food (SAF). The management of land sales, seismic activities, exploration and oil and gas production activities were reviewed. While each of the agencies has a different mandate, they have a common goal regarding petroleum resources, and that is to ensure that the oil and gas industry carries out its activities in a sustainable manner while protecting and conserving the environment. The mandate of SEM is to facilitate the discovery, development and use of Saskatchewan's energy and mineral resources. SERM's mandate is to manage, enhance and protect Saskatchewan's natural and environmental resources such as fish, wildlife, lands, forests, parks, air, water and soil, for conservation, recreation, social and economic purposes. The mandate of SAF is to manage crown land in the province and to control surface access to these lands

Regulatory requirements on the calibration and use of survey instruments

International Nuclear Information System (INIS)

Domondon, D.B.

1989-01-01

Regulatory requirements on the provision, calibration and occasions of use of survey instruments are enumerated for a number of licensed activities. Two methods of calibrating survey instruments are described. Factors that must be taken into consideration in conducting calibrations, contents of calibration reports and of the sticker attached to the instrument which are needed for the correct use of the instrument are discussed. The precautions to be observed in order to insure correct use of survey instruments are described. (Auth.)

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

A study for the establishment of regulatory requirement and evaluation guide for station blackout in nuclear power plants

International Nuclear Information System (INIS)

Lim, J. H.; Koo, C. S.; Joo, W. P.; Oh, S. H.; Shin, W. K.

1999-01-01

The consequence of SBO event could be a severe accident unless AC power was restored within a proper time, because many safety systems depend upon AC power. Based on the severity, the SBO has been extensively studied since it was identified as Unresolved Safety Issue at USNRC. The resolution of those studies is a rule-making such as 10 CFR 50.63 and Regulatory Guide 1.155. But there is no regulatory requirements of SBO for an operating domestic nuclear power plant up to the present time. This tudy has established SBO rule(regulatory requirements and evaluation guides) for an operating PWR type of the operating nuclear power plants in Korea

Evolution of New cis-Regulatory Motifs Required for Cell-Specific Gene Expression in Caenorhabditis.

Directory of Open Access Journals (Sweden)

Michalis Barkoulas

2016-09-01

Full Text Available Patterning of C. elegans vulval cell fates relies on inductive signaling. In this induction event, a single cell, the gonadal anchor cell, secretes LIN-3/EGF and induces three out of six competent precursor cells to acquire a vulval fate. We previously showed that this developmental system is robust to a four-fold variation in lin-3/EGF genetic dose. Here using single-molecule FISH, we find that the mean level of expression of lin-3 in the anchor cell is remarkably conserved. No change in lin-3 expression level could be detected among C. elegans wild isolates and only a low level of change-less than 30%-in the Caenorhabditis genus and in Oscheius tipulae. In C. elegans, lin-3 expression in the anchor cell is known to require three transcription factor binding sites, specifically two E-boxes and a nuclear-hormone-receptor (NHR binding site. Mutation of any of these three elements in C. elegans results in a dramatic decrease in lin-3 expression. Yet only a single E-box is found in the Drosophilae supergroup of Caenorhabditis species, including C. angaria, while the NHR-binding site likely only evolved at the base of the Elegans group. We find that a transgene from C. angaria bearing a single E-box is sufficient for normal expression in C. elegans. Even a short 58 bp cis-regulatory fragment from C. angaria with this single E-box is able to replace the three transcription factor binding sites at the endogenous C. elegans lin-3 locus, resulting in the wild-type expression level. Thus, regulatory evolution occurring in cis within a 58 bp lin-3 fragment, results in a strict requirement for the NHR binding site and a second E-box in C. elegans. This single-cell, single-molecule, quantitative and functional evo-devo study demonstrates that conserved expression levels can hide extensive change in cis-regulatory site requirements and highlights the evolution of new cis-regulatory elements required for cell-specific gene expression.

Public consultation: regulatory requirement or business principle?

International Nuclear Information System (INIS)

Seeley, R.

1999-01-01

A summary is included of knowledge and experiences related to planning and implementing a public consultation program over a number of years in Shell Canada's Athabasca Oil Sands development. This project consists of three major sub- projects with a total estimated capital investment of $4 billion. The three sub- projects are: the Muskeg River Mine, the Scotford Upgrader, and the Corridor Pipeline. The facilities will produce 150,000 bbl/day of synthetic crude for over 25 years and are targeted to begin production in late 2002. From the title of the paper, although public consultation is required under environmental legislation, many companies are adopting a more pro-active approach to public consultation and participation as a business principle. This commitment to engage in and dialogue with stakeholders must be open, transparent and long term, not just during the regulatory process. Successful consultation begins with the prerequisites: senior management commitment, buy-in from the project or operating team that the process adds value, and the ability to listen and make changes. A consultation program is not a short term activity, but is rather an ongoing process linked to a business or operating principle. It requires long term resources and follow through on agreements and commitments made to stakeholders and communities

Public consultation: regulatory requirement or business principle?

Energy Technology Data Exchange (ETDEWEB)

Seeley, R. [Shell Canada Oil Sands, Calgary, AB (Canada)

1999-07-01

A summary is included of knowledge and experiences related to planning and implementing a public consultation program over a number of years in Shell Canada's Athabasca Oil Sands development. This project consists of three major sub- projects with a total estimated capital investment of $4 billion. The three sub- projects are: the Muskeg River Mine, the Scotford Upgrader, and the Corridor Pipeline. The facilities will produce 150,000 bbl/day of synthetic crude for over 25 years and are targeted to begin production in late 2002. From the title of the paper, although public consultation is required under environmental legislation, many companies are adopting a more pro-active approach to public consultation and participation as a business principle. This commitment to engage in and dialogue with stakeholders must be open, transparent and long term, not just during the regulatory process. Successful consultation begins with the prerequisites: senior management commitment, buy-in from the project or operating team that the process adds value, and the ability to listen and make changes. A consultation program is not a short term activity, but is rather an ongoing process linked to a business or operating principle. It requires long term resources and follow through on agreements and commitments made to stakeholders and communities.

Information Requirements and Consumer Protection in Future M-Commerce

DEFF Research Database (Denmark)

Cleff, Evelyne Beatrix; Henschel, Rene Franz

2006-01-01

The aim of this article is to discuss information requirements and consumer protection in mobile commerce. On the basis of a brief introduction to the characteristics of mobile commerce and the regulatory framework that governs mobile commerce in the European Union today, the article presents...

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)

Government Procurement and the Year 2000

National Research Council Canada - National Science Library

Curtis, Brent

1999-01-01

...) as it relates to federal government information technology (IT) buys. The scope is limited, focusing on the regulatory and legislative efforts to minimize Y2K impacts as the government buys commercial and non-commercial IT supply items...

76 FR 12645 - Ownership Limitations and Governance Requirements for Security-Based Swap Clearing Agencies...

Science.gov (United States)

2011-03-08

... 3235-AK74 Ownership Limitations and Governance Requirements for Security- Based Swap Clearing Agencies... the Dodd-Frank Act, the Commission shall adopt such rules if it determines that they are necessary or appropriate to improve the governance of, or to mitigate systemic risk, promote competition or mitigate...

FORECAST: Regulatory effects cost analysis software manual -- Version 4.1. Revision 1

International Nuclear Information System (INIS)

Lopez, B.; Sciacca, F.W.

1996-07-01

The FORECAST program was developed to facilitate the preparation of the value-impact portion of NRC regulatory analyses. This PC program integrates the major cost and benefit considerations that may result from a proposed regulatory change. FORECAST automates much of the calculations typically needed in a regulatory analysis and thus reduces the time and labor required to perform these analyses. More importantly, its integrated and consistent treatment of the different value-impact considerations should help assure comprehensiveness, uniformity, and accuracy in the preparation of NRC regulatory analyses. The Current FORECAST Version 4.1 has been upgraded from the previous version and now includes an uncertainty package, an automatic cost escalation package, and other improvements. In addition, it now explicitly addresses public health impacts, occupational health impacts, onsite property damage, and government costs. Thus, FORECAST Version 4.1 can treat all attributes normally quantified in a regulatory analysis

Implementation of the waste management transfer act. Requirements from a regulatory point of view

International Nuclear Information System (INIS)

Mueller-Dehn, Christian

2017-01-01

In future in Germany, the state will be responsible for financing and handling the interim and final storage of radioactive waste from nuclear power plants. With regard to interim storage, this objective is achieved with the provisions of the Waste Management Transfer Act. Regulatory implementation is based on these regulations. BGZ Gesellschaft fuer Zwischenlager mbH is responsible for interim storage on behalf of the Federal Government. Simultaneously with the transfer of interim storage facilities to BGZ a legal transfer of approval is carried out. Insofar as there is a technical, organisational or personnel conjunction with the nuclear power plant operation, which continues to exist beyond this deadline and is relevant for regulatory purposes, a regulation is made via a service contract with the BGZ. This ensures compliance with the licensing regulations. Irradiated fuel assemblies and the waste from reprocessing can be handed over to BGZ from 1 January 2019 onwards and waste with negligible heat generation can be disposed of as of the determination of their proper packaging.

Learning by the Market: Regulatory Regionalism, Bologna, and Accountability Communities

Science.gov (United States)

Jayasuriya, Kanishka

2010-01-01

Over the last two decades institutions of higher education have been subject to new modes of regulatory governance. This essay applies a "regulatory lens" to higher education governance with a view to understanding the sometimes contradictory relationship between the globalisation and regionalisation of higher education and the…

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

Closing the Incentive Gap: The Role of Public and Private Actors in Governing Indonesia's Tuna Fisheries

NARCIS (Netherlands)

Bailey, M.L.; Miller, A.M.M.; Bush, S.R.; Zwieten, van P.A.M.; Wiryawan, B.

2016-01-01

Indonesia is one of the world's largest tuna producing countries, yet regulatory oversight remains weak and management is poor. Incentive-based approaches are a way to improve state-based resource management, but they often require strong government regulation. In this paper, we use principal–agent

PecS is an important player in the regulatory network governing the coordinated expression of virulence genes during the interaction between Dickeya dadantii 3937 and plants.

Science.gov (United States)

Mhedbi-Hajri, Nadia; Malfatti, Pierrette; Pédron, Jacques; Gaubert, Stéphane; Reverchon, Sylvie; Van Gijsegem, Frédérique

2011-11-01

Successful infection of a pathogen relies on the coordinated expression of numerous virulence factor-encoding genes. In plant-bacteria interactions, this control is very often achieved through the integration of several regulatory circuits controlling cell-cell communication or sensing environmental conditions. Dickeya dadantii (formerly Erwinia chrysanthemi), the causal agent of soft rot on many crops and ornamentals, provokes maceration of infected plants mainly by producing and secreting a battery of plant cell wall-degrading enzymes. However, several other virulence factors have also been characterized. During Arabidopsis infection, most D. dadantii virulence gene transcripts accumulated in a coordinated manner during infection. This activation requires a functional GacA-GacS two-component regulatory system but the Gac system is not involved in the growth phase dependence of virulence gene expression. Here we show that, contrary to Pectobacterium, the AHL-mediated ExpIR quorum-sensing system does not play a major role in the growth phase-dependent control of D. dadantii virulence genes. On the other hand, the global regulator PecS participates in this coordinated expression since, in a pecS mutant, an early activation of virulence genes is observed both in vitro and in planta. This correlated with the known hypervirulence phenotype of the pecS mutant. Analysis of the relationship between the regulatory circuits governed by the PecS and GacA global regulators indicates that these two regulators act independently. PecS prevents a premature expression of virulence genes in the first stages of colonization whereas GacA, presumably in conjunction with other regulators, is required for the activation of virulence genes at the onset of symptom occurrence. © 2011 Society for Applied Microbiology and Blackwell Publishing Ltd.

An Assessment of the Efficiency of Government Regulatory Agencies in Nigeria. Case of the National Agency for Food and Drugs Administration and Control

Directory of Open Access Journals (Sweden)

Aiwanehi Barbara Ofuani

2015-09-01

Full Text Available This study examines Business, Government and Society interrelationships. It eventually narrowed down to assessing the efficiency of government regulatory agencies, in fulfilling the role of government in protecting consumers from unscrupulous practices of businesses. The National Agency for Food and Drugs Administration and Control (NAFDAC was chosen for the study. Since the expectations of the consumers are paramount here, the stakeholder approach method was used for assessing the efficiency of NAFDAC. Literature and previous empirical studies on the topic were examined. For representativeness, data was collected utilizing the survey research design through Questionnaire distributed to 200 respondents in some areas of Lagos Mainland in Lagos state, using the convenience sampling method. 187 copies of the questionnaire representing 93.5% were returned and usable. Descriptive statistics was used to analyze the responses to questions regarding the efficiency of NAFDAC and a hypothesis tested using a one-sample T-test. The findings ran contrary to results from some previous studies. Instead, consumer awareness of the existence of NAFDAC as a regulatory agency and its functions were established, along with a high rate of consumer education. The assessment of its efficiency also showed a high rating. Recommendations were made that the study be replicated in other states of Nigeria and further studies carried out to evaluate its efficiency under previous and current directors for improvement purposes.

Theoretical Ideas of Local Government and State Government Development

Directory of Open Access Journals (Sweden)

Nikolay I. Churinov

2016-03-01

Full Text Available In this article the characteristic of a theoretical component of model of interaction of local government bodies with the central government, and also development of scientific base in the course of history is given. Relevance to this subject in the conditions of the Russian reality is added by federalism of a state system of Russia, namely a thin side in questions of competences between bodies of one hierarchy. This article, will be useful to those who deal with issues in the field of the theory of the state and the right and the municipal right. Historic facts in the form of the regulatory legal acts adopted earlier which subsequently, were a source for development of theoretical ideas of local self-government and the government are given in article.

Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders.

Science.gov (United States)

Kim, Katherine K; Browe, Dennis K; Logan, Holly C; Holm, Roberta; Hack, Lori; Ohno-Machado, Lucila

2014-01-01

There is currently limited information on best practices for the development of governance requirements for distributed research networks (DRNs), an emerging model that promotes clinical data reuse and improves timeliness of comparative effectiveness research. Much of the existing information is based on a single type of stakeholder such as researchers or administrators. This paper reports on a triangulated approach to developing DRN data governance requirements based on a combination of policy analysis with experts, interviews with institutional leaders, and patient focus groups. This approach is illustrated with an example from the Scalable National Network for Effectiveness Research, which resulted in 91 requirements. These requirements were analyzed against the Fair Information Practice Principles (FIPPs) and Health Insurance Portability and Accountability Act (HIPAA) protected versus non-protected health information. The requirements addressed all FIPPs, showing how a DRN's technical infrastructure is able to fulfill HIPAA regulations, protect privacy, and provide a trustworthy platform for research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Improving democratic governance through institutional design

DEFF Research Database (Denmark)

Torfing, Jacob; Skelcher, Chris

2010-01-01

the democratic governance of regulatory policies in Europe, and highlight the way in which civic participation and democratic ownership is given equal weight to economic competitiveness. We then discuss the potential for institutionalized participatory governance to develop and its prospects for improving...

19 CFR 200.735-123 - Effect of employees' and special Government employees' statements on other requirements.

Science.gov (United States)

2010-04-01

... 19 Customs Duties 3 2010-04-01 2010-04-01 false Effect of employees' and special Government... Employment and Financial Interests § 200.735-123 Effect of employees' and special Government employees... statements required of employees and special Government employees are in addition to, and not in substitution...

76 FR 47630 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and...

Science.gov (United States)

2011-08-05

... data and other products available to persons that are not members of the self-regulatory organization... in self-regulatory organization governance was mandated by the Act, non-members should be given the... the evolution of self-regulatory organization governance and competitive market structure have...

Workplace wellness programs: how regulatory flexibility might undermine success.

Science.gov (United States)

Pomeranz, Jennifer L

2014-11-01

The Patient Protection and Affordable Care Act revised the law related to workplace wellness programs, which have become part of the nation's broader health strategy. Health-contingent programs are required to be reasonably designed. However, the regulatory requirements are lax and might undermine program efficacy in terms of both health gains and financial return. I propose a method for the government to support a best-practices approach by considering an accreditation or certification process. Additionally I discuss the need for program evaluation and the potential for employers to be subject to litigation if programs are not carefully implemented.

Hungary : Corporate Governance Country Assessment

OpenAIRE

World Bank

2003-01-01

This report assesses the corporate governance policy framework and enforcement and compliance practices in Hungary. Hungary has already invested considerable resources in upgrading its legislation to meet European Union Directives, and the legislative and regulatory framework dealing with corporate governance issues is robust. The major issues identified by this review include: (1) the gen...

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)

Autogoverno, Regulação, Função Normativa e Independência Interna no Judiciário / Self-Government, Regulatory Power and Judicial Independence

Directory of Open Access Journals (Sweden)

André Melo Gomes Pereira

2016-10-01

Full Text Available Purpose – This paper focuses on the relationship between the performed normative function and the judges’ internal independence, often by general and abstract commands, for self-government agencies with regulation functions in the Judiciary. Methodology/approach/design – This study implements analyses of standards and regulation literature, normative function, self-government and judicial independence. Illustratively, courts’ decisions on specific cases were analyzed. Special attention was given to the theoretical bases of regulation, the normative function of government agencies and to the democratization proposal of judicial self-government, a model notedly proposed by Zaffaroni. Findings – Self-government implies regulation. Regulation involves the exercise of normative function. Internal democratization of judicial self-government and participation of all regulated agents in the Judiciary are necessary tools to ensure legitimacy and the internal independence for the exercise of normative functions and the whole set of activities put forward by self-government agencies. Practical implications – The paper discusses a change in the institutional design of self-government in the Judiciary and the limits imposed by its the normative function. Originality/value – It correlates the regulatory function developed by self-government agencies with the assurance of judges’ internal independence.

45 CFR 2520.60 - What government-wide requirements apply to staff fundraising under my AmeriCorps grant?

Science.gov (United States)

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false What government-wide requirements apply to staff fundraising under my AmeriCorps grant? 2520.60 Section 2520.60 Public Welfare Regulations Relating to Public... C PROGRAMS § 2520.60 What government-wide requirements apply to staff fundraising under my Ameri...

Regulatory requirements on PSA level 2: Review, aspects and applications

International Nuclear Information System (INIS)

Husarcek, J.

2003-01-01

The general requirements concerning utility obligations, probabilistic safety criteria (CDF should not exceed 1.0E-4/reactor year and LERF should not exceed 1.0E-5/reactor year), documentation and results, living PSA requirements and major steps in level 2 PSA are presented. PSA developments in Slovakia, collection and assembly of information, plant damage states, containment performance and failure modes, severe accident progression analyses, containment failure modes and source terms as a part of performed level 2 PSA are discussed. The PSA applications in design and operation evaluation, support to plant upgrade and modifications are also described. At the end, the following conclusion is made: more extensive PSA application needs to foster the exchange of experience and communication between PSA specialists, non-PSA engineers, designers, and the regulatory body staff responsible for safety assessment, inspection and enforcement

Report of the working group 'Regulatory requirements on AM - Concept of nuclear and radiation safety during beyond-design-basis accidents'

International Nuclear Information System (INIS)

Bobaly, P.

2001-01-01

The developed working group report contains the following main paragraphs: legal basis and basis for regulatory requirements for on-site and off-site Accident Management (AM), regulatory requirements or recommendations for on-site AM and for emergency preparedness, background information concerning the implementation and review of an AM program as a basis for an AM guideline. Overview about AM/SAM implementation in member countries of the SAMINE project; measure and candidates for high level actions based upon US SAMG; interactions of severe accident research and the regulatory positions, relationship between different components of an accident management programme are also given

Regulatory requirements for nuclear power plant site selection in Malaysia-a review.

Science.gov (United States)

Basri, N A; Hashim, S; Ramli, A T; Bradley, D A; Hamzah, K

2016-12-01

Malaysia has initiated a range of pre-project activities in preparation for its planned nuclear power programme. Clearly one of the first steps is the selection of sites that are deemed suitable for the construction and operation of a nuclear power plant. Here we outline the Malaysian regulatory requirements for nuclear power plant site selection, emphasizing details of the selection procedures and site characteristics needed, with a clear focus on radiation safety and radiation protection in respect of the site surroundings. The Malaysia Atomic Energy Licensing Board (AELB) site selection guidelines are in accord with those provided in International Atomic Energy Agency (IAEA) and United Stated Nuclear Regulatory Commission (USNRC) documents. To enhance the suitability criteria during selection, as well as to assist in the final decision making process, possible assessments using the site selection characteristics and information are proposed.

4th IEA International CCS Regulatory Network Meeting

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-01

On 9 and 10 May 2012, the IEA International CCS Regulatory Network (Network), launched in Paris in May 2008 to provide a neutral forum for CCS regulators, policy makers and stakeholders to share updates and views on CCS regulatory developments, held its fourth meeting at the International Energy Agency (IEA) offices in Paris, France. The aim of the meeting was to: provide an update on government efforts to develop and implement carbon capture and storage (CCS) legal and regulatory frameworks; and consider ways in which governments are dealing with some of the more difficult or complex aspects of CCS regulation. This report summarises the proceedings of the meeting.

A framework for regulatory requirements and industry standards for new nuclear power plants

International Nuclear Information System (INIS)

Duran, Felicia A.; Camp, Allen L.; Apostolakis, George E.; Golay, Michael W.

2000-01-01

This paper summarizes the development of a framework for risk-based regulation and design for new nuclear power plants. Probabilistic risk assessment methods and a rationalist approach to defense in depth are used to develop a framework that can be applied to identify systematically the regulations and standards required to maintain the desired level of safety and reliability. By implementing such a framework, it is expected that the resulting body of requirements will provide a regulatory environment that will ensure protection of the public, will eliminate the burden of requirements that do not contribute significantly to safety, and thereby will improve the market competitiveness of new plants. (author)

Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

International Nuclear Information System (INIS)

Goldammer, Wolfgang; Batandjieva, Borislava; Nasvit, Oleg; German, Olga

2009-06-01

The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

Energy Technology Data Exchange (ETDEWEB)

Goldammer, Wolfgang; Batandjieva, Borislava (Private Consultants (Ukraine)); Nasvit, Oleg (National Security and Defence Council of Ukraine, Kyiv (Ukraine)); German, Olga (Swedish Radiation Safety Authority, Stockholm (Sweden))

2009-06-15

The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

Regulatory requirements and quality assurance of radiation monitoring instruments

International Nuclear Information System (INIS)

Narasimharao, K.L.; Sharma, Ranjit

2005-01-01

The successful utilisation of radiation sources in the fields of medicine and industry requires the accurate measurement of activity, exposure rate and dose. Many varieties of instruments are in use for measurement of these parameters and new ones are being developed. The criteria for the design of the radiation monitoring instrument include the type and intensity of the radiation, purpose of measurement and ruggedness of the instrument. Quality and reliability of radiation monitoring instruments ensure that individuals are adequately protected. Accuracy, response time and ruggedness are required to be as per the approved/ prescribed guidelines. Regulatory authorities outline the design and performance criteria for radiation monitoring instruments and prescribe the recommendations of international agencies such as IAEA, ICRU and ISO for radiological measurement assurance programme. National Standards Laboratories all over the world prescribe procedures for calibration of various radiation monitoring instruments. The instruments should be calibrated as per these guidelines and should be traceable to national standards. The calibration traceable to national/ international standards and documentation as well as limits stipulated by the competent authority ensures the expected performance of the instrument. (author)

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)

Nuclear regulatory communication with the public: 10 years of progress

International Nuclear Information System (INIS)

Gauvain, J.; Jorle, A.; Chanial, L.

2008-01-01

The NEA has an acknowledged role to assist its member countries in maintaining and developing, through international co-operation, the scientific, technological and legal bases required for a safe, environmentally friendly and economical use of nuclear energy. In this context, the NEA Committee on Nuclear Regulatory Activities (CNRA) provides a forum for senior representatives from nuclear regulatory bodies to exchange information and experience on nuclear regulatory policies and practices in NEA member countries and to review developments which could affect regulatory requirements. Public confidence in government and in risk management structures is important to all developed countries with an open society. The use of nuclear power in a democracy is built upon a certain trust in the political system and the national authorities. To foster and maintain such trust in a period of greater public scrutiny of nuclear activities, a number of nuclear regulatory organisations (NROs) initiated various processes to pro-actively inform the public about their supervision and control of nuclear activities, or when appropriate to involve the public in decision making. In 1998 the question was raised within the CNRA of whether public trust in the regulator might be very different from one country to another, and an activity was started among member countries to exchange experience and best practices and to learn lessons about NRO communication with their publics. Three workshops were organised by the NEA, and a Working Group on Public Communication of Nuclear Regulatory Organisations was set up in 2001. The activities and findings are summarised below. (author)

Development of Regulatory Technical Requirements for the Advanced Integral Type Research Reactor

International Nuclear Information System (INIS)

Jo, Jong Chull; Yune, Young Gill; Kim, Woong Sik; Kim, Hho Jung

2004-01-01

This paper presents the current status of the study on the development of regulatory technical requirements for the licensing review of an advanced integral type research reactor of which the license application is expected in a few years. According to the Atomic Energy Act of Korea, both research and education reactors are subject to the technical requirements for power reactors in the licensing review. But, some of the requirements may not be applicable or insufficient for the licensing reviews of reactors with unique design features. Thus it is necessary to identify which review topics or areas can not be addressed by the existing requirements and to develop the required ones newly or supplement appropriately. Through the study performed so far, it has been identified that the following requirements need to be developed newly for the licensing review of SMART-P: the use of proven technology, the interfacial facility, the non-safety systems, and the metallic fuels. The approach and basis for the development of each of the requirements are discussed. (authors)

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

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

Regulatory requirements for the use of consumer products containing radioactive substances

International Nuclear Information System (INIS)

Mason, G.C.; Paynter, R.A.; Schmitt-Hannig, A.; Sztanyik, L.B.

1996-01-01

In almost 100 years since the discovery of radioactivity, the properties of radioactive materials have been exploited in products such as clocks and watches incorporating luminous paint which are freely available to members of the public. Over time, regulatory authorities have felt it necessary to apply some degree of control to the supply and use of such products in order to protect public health. In many areas of radiation protection, national authorities take note of international recommendations when developing national standards, but the existing detailed guidance of the International Atomic Energy Agency (IAEA) for consumer products is incomplete and out of date. Recently, a thorough revision of the International Basic Safety Standards (BSS) has occurred, which has prompted a review and revision of the related guidance published by the IAEA. A draft Guide on Regulatory Requirements for the Use of Consumer Products Containing Radioactive Substances has now been completed and is currently under review within the IAEA's system for development of documents in its Safety Series of publications. (author)

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

Environmental challenges and opportunities of the evolving North American electricity market : European electricity generating facilities: an overview of European regulatory requirements and standardization efforts

International Nuclear Information System (INIS)

Nichols, L.

2002-06-01

Several factors are affecting power generating facilities, such as the opening of both electricity and gas markets, and the pressure applied on generators and governments to ensure a steady energy supply for consumers. An additional factor is the pressure for the closing of nuclear power facilities. European siting and emissions requirements for coal-fired and natural gas generating facilities were presented in this background paper. In addition, the author provided an overview of the standardization process in place in Europe. The European Union and its functioning were briefly described, as well as a listing of relevant organizations. The current trends were examined. The document first introduced the European Union, and the next section dealt with Regulatory regime: the internal energy market. The third section examined the issue of Regulatory regime: generation and environmental regulations. Section four presented environmental management systems, followed by a section on standardization. Section six discussed European organizations involved in electricity issues, while the following section dealt with European commission programs. The last section briefly looked at the trends in the electricity sector, broaching topics such as compliance, electricity generation, and emissions trading. 52 refs., 2 tabs

Beyond Section 508: The Spectrum of Legal Requirements for Accessible e-Government Web Sites in the United States

Science.gov (United States)

Jaeger, Paul T.

2004-01-01

In the United States, a number of federal laws establish requirements that electronic government (e-government) information and services be accessible to individuals with disabilities. These laws affect e-government Web sites at the federal, state, and local levels. To this point, research about the accessibility of e-government Web sites has…

Regulatory activities of government: analysis of determinants

Directory of Open Access Journals (Sweden)

Primož Pevcin

2006-12-01

Full Text Available International comparisons show that large cross-country differences exist in the overall macro extent of regulation of the economy. In this context, the main purpose of the article is to investigate, why such differences exist by identifying and empirically verifying the effect of various factors that could potentially shape those differences. Empirical analysis based on the sample of 32 developed and democratic countries revealed that almost 70 % of variation in the macro extent of regulation could be explained with 7 statistically significant explanatory variables. The econometric analysis revealed that the macro extent of regulation decreases with income inequality in society, with the level of economic development, with the sizeof economy, with the share of transfer spending in GDP and with the share of government employment in labour force. On the other hand, the extent of regulation is positively related to government ownership of enterprises and to presidential political regime

People, Governance and Forests—The Stumbling Blocks in Forest Governance Reform in Latin America

Directory of Open Access Journals (Sweden)

Arnoldo Contreras-Hermosilla

2011-01-01

Full Text Available This article examines common barriers to achieving adequate levels of forest resource governance in countries of Latin America. It looks at the deficiencies of the policy and regulatory frameworks affecting forests, the common failure to impose the rule of law, the main factors that constrain the effectiveness of government actions in the forest sector and at the political barriers to introducing reforms for change in governance structures. The elimination of these barriers acquires new importance in the implementation of successful REDD+ programs in the countries of the region.

Governance matters: an ecological association between governance and child mortality.

Science.gov (United States)

Lin, Ro-Ting; Chien, Lung-Chang; Chen, Ya-Mei; Chan, Chang-Chuan

2014-09-01

Governance of a country may have widespread effects on the health of its population, yet little is known about the effect of governance on child mortality in a country that is undergoing urbanization, economic development, and disease control. We obtained indicators of six dimensions of governance (perceptions of voice and accountability, political stability and absence of violence, government effectiveness, regulatory quality, rule of law, and control of corruption) and national under-5 mortality rates for 149 countries between 1996 and 2010. We applied a semi-parametric generalized additive mixed model to examine associations after controlling for the effects of development factors (urbanization level and economy), disease control factors (hygienic conditions and vaccination rates), health expenditures, air quality, and time. Governance, development, and disease control showed clear inverse relations with the under-5 mortality rate (pcountry's need for better governance is as important as improvements in development and disease control. © The Author 2014. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

Regulatory reform in Mexico's natural gas sector

International Nuclear Information System (INIS)

1996-01-01

In recent years Mexico has implemented remarkable structural changes in its economy. However, until recently its large and key energy sector was largely unreformed. This is now changing. In 1995 the Mexican Government introduced legislative changes permitting private sector involvement in natural gas storage, transportation and distribution. Subsequent directives set up a detailed regulatory framework. These developments offer considerable promise, not only for natural gas sector development but also for growth in the closely linked electricity sector. This study analyses the changes which have taken place and the rationale for the regulatory framework which has been established. The study also contains recommendations to assist the Government of Mexico in effectively implementing its natural gas sector reforms and in maximizing the benefits to be realised through the new regulatory framework. (author)

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

International Nuclear Information System (INIS)

2011-01-01

, including: The Korean government, through the activities of MEST and KINS, has implemented a technically capable and effective nuclear safety regulatory program. KINS is an entrusted governmental corporation that functions as a nuclear safety regulation body. The team's findings note of the fact that the current Korean nuclear regulator is a combination of MEST and KINS; Transition to a new regulatory framework has the potential to enhance regulatory independence, expertise and transparency; however implementation details have yet to be finalized. Therefore, the team could not make a conclusion regarding the planned framework's effectiveness; and Korea's response to the accident at Fukushima has been prompt and effective. Communications with the public, development of actions for improvement and coordination with international stakeholders were of high quality. Among the good practices identified by the IRRS Review Team are the following: The regulatory body of Korea has a clear and structured national approach for nuclear safety; Korea strongly supports the global nuclear safety regime and provides training at national and international levels; KINS has a high level of technical competence and has implemented an effective human capital program; KINS performs detailed and comprehensive safety assessment using a broad range of deterministic and probabilistic codes and methods; and KINS has a comprehensive integrated computerized information and data management system. The IRRS Review Team identified certain issues warranting attention or in need of improvement and believes that consideration of these would enhance the overall performance of the future regulatory system. Transition to the new regulatory framework will require development of key implementation details that will impact the effectiveness of the new regulatory framework for safety; Enhancements to the management system in the areas of resource management, description of the internal safety culture, and

Current radiation protection requirements governing the use of radioactive sources for medical purposes

International Nuclear Information System (INIS)

Dumenigo Gonzalez, Cruz; De la Fuente Punch, Andres; Quevedo Garcia, Jose; Diaz Guerra, Pedro; Lopez Forteza, Yamil

2004-01-01

With the recent endorsement of the Regulations Basic Standard for Radiological Safety, and the Guides For the implementation of the Safety Regulations in the Practice of the Radiotherapy and For the implementation of the Safety Regulations in the Practice of the Nuclear Medicine, the basic regulatory framework for the conduction of these two practices in the Republic of Cuba has been completed. Principles of these regulations are in total agreement with the recommendations of the International Atomic Energy Agency and the World Health Organization. To the purpose of establishing the police that rules the implementation of this new Regulations, the Regulatory Authority (CNSN), carried out an evaluation of the achievability of the requirements included. The present paper shows the results of the evaluation of the Safety carried out for the users' institutions in the light of the new Regulations. Such evaluation was based in the analysis of the documentation submitted by users when applying for Licence, as well as on the results of the periodic inspections conducted by the Regulatory Authority. The authors of this paper developed a methodology for identifying the non correspondences with the requirements in the regulation prevailing in each one of the users' institutions. Categorizing the non correspondences as function of its importance for the safety, the methodology makes it possible to establish a prioritization order in resolving such n on correspondence , and the optimization of the existing limited resources in the country can be achieved. Authors of this paper considered that in spite of the non correspondence identified, the safety in the development of the practice is not compromised

Characterizing costs and benefits of uncertain future regulatory requirements on the U.S. natural gas industry

International Nuclear Information System (INIS)

Godec, M.L.; Smith, G.E.; Fitzgibbon, T.

1995-01-01

Environmental regulatory requirements at both the state and federal level are constantly changing, making it difficult for industry and R ampersand D program managers to project future compliance requirements and costs. Even if a company is trying to keep abreast of various proposed regulatory initiatives, the number of possible combinations of initiatives that could occur in the future seems virtually limitless. Uncertainty associated with potential future environmental compliance requirements makes the identification and evaluation of future investment and R ampersand D opportunities exceedingly difficult, and makes the process of systematic strategic planning increasingly complex. This paper describes a methodology for accounting for uncertain future environmental compliance costs in a systematic, comprehensive manner. Through analysis of proposed initiatives for making future environmental requirements more stringent, forecasting the likelihood of occurrence and potential timing of each initiative, and estimating potential future compliance costs associated with each initiative, a thorough process for incorporating regulatory uncertainty into strategic planning and project evaluation is described. This approach can be used for evaluating R ampersand D opportunities to determine where development of new technologies or assessment of risks posed by industry operations may have the greatest impact on future industry costs of compliance. This approach could also be used to account for the uncertainty of future environmental costs in corporate strategic planning or for factoring future compliance costs into project evaluation. This approach could also be enhanced through use in conjunction with other modeling and forecasting systems that could consider a broad range of impacts, including impacts on gas production, industry activity levels, and tax revenues

The major cellular sterol regulatory pathway is required for Andes virus infection.

Directory of Open Access Journals (Sweden)

Josiah Petersen

2014-02-01

Full Text Available The Bunyaviridae comprise a large family of RNA viruses with worldwide distribution and includes the pathogenic New World hantavirus, Andes virus (ANDV. Host factors needed for hantavirus entry remain largely enigmatic and therapeutics are unavailable. To identify cellular requirements for ANDV infection, we performed two parallel genetic screens. Analysis of a large library of insertionally mutagenized human haploid cells and a siRNA genomic screen converged on components (SREBP-2, SCAP, S1P and S2P of the sterol regulatory pathway as critically important for infection by ANDV. The significance of this pathway was confirmed using functionally deficient cells, TALEN-mediated gene disruption, RNA interference and pharmacologic inhibition. Disruption of sterol regulatory complex function impaired ANDV internalization without affecting virus binding. Pharmacologic manipulation of cholesterol levels demonstrated that ANDV entry is sensitive to changes in cellular cholesterol and raises the possibility that clinically approved regulators of sterol synthesis may prove useful for combating ANDV infection.

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

Institutional effectiveness of REDD+ MRV: Countries progress in implementing technical guidelines and good governance requirements

NARCIS (Netherlands)

Ochieng, R.M.; Visseren-Hamakers, Ingrid; Arts, B.; Brockhaus, M.; Herold, M.

2016-01-01

The UNFCCC requires REDD+ countries wishing to receive results-based payments to measure, report and verify (MRV) REDD+ impacts; and outlines technical guidelines and good governance requirements for MRV. This article examines institutional effectiveness of REDD+ MRV by assessing countries’ progress

Government Performance and Results Act: Performance plan FY 1999, U.S. Nuclear Regulatory Commission. Volume 1

International Nuclear Information System (INIS)

Fuches, J.L.

1998-02-01

The Nuclear Regulatory Commission's (NRC) strategic plan [NUREG-1614, Vol. 1, September 1997] establishes a strategic framework that will guide future decision-making and will help the NRC continue to meet its responsibility for protecting public health and safety, promoting the common defense and security, and protecting the environment. This performance plan complements the agency's strategic plan by setting annual goals with measurable target levels of performance for FY 1999, as required by the Government Performance and Results Act. No significant contribution was made to the preparation of the performance plan by any non-Federal entity. However, a contractor was used to help facilitate discussions and resolution of issues. Within six months after the close of FY 1999, the NRC will submit to the President and the Congress a report on program performance for FY 1999. This performance report will review the success of the agency in achieving the performance goals established for FY 1999. Where those goals have been achieved, the underlying assumptions and strategies will be examined to ensure that continued applicability is warranted in the future. If any of the FY 1999 performance goals are not met, the agency will conduct a thorough analysis of why it did not meet the goal and the actions necessary to meet-the goal in the future. One result of this analysis will be the documentation of plans and schedules for achieving the established performance goal. If the analysis should indicate that the performance goal is impractical or infeasible, the performance report will document why that is the case and what action is recommended

Government of Canada Initiatives in Support of the Joint Convention

International Nuclear Information System (INIS)

Brown, P.A.; Metcalfe, D.E.; Lojk, R.

2006-01-01

The Government of Canada strongly supported international efforts to bring into force the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management (the Joint Convention), and was the second country to ratify it. The Joint Convention places a number of obligations on Contracting Parties aimed at achieving and maintaining a high level of safety worldwide in spent fuel and radioactive waste management, ensuring that effective defenses against potential hazards are in place during all management stages, preventing accidents with radiological consequences and mitigating their consequences should they occur. In addition to establishing and maintaining a modem regulatory framework and an independent regulatory body through the 2000 Nuclear Safety and Control Act, the Government of Canada has implemented a number of initiatives that address its responsibilities and serve to further enhance Canada's compliance with the Joint Convention. For nuclear fuel waste, the Government of Canada brought into force the Nuclear Fuel Waste Act in 2002 to require waste owners to develop, fund, organize and implement a long-term solution for Canada's nuclear fuel waste. The Act clearly reserves for Government the decision on the solution to be implemented in the best interests of Canadians, as well as oversight to ensure that waste owners are fulfilling their responsibilities. In the case of low-level radioactive waste, long-term solutions are being developed to ensure the protection of health, safety, and the environment, both now and in the future. Regarding uranium mine and mill tailings, current operators have state-of-the-art waste management facilities in place. The Government of Canada works with provincial governments to ensure that any potential abandoned or legacy mines sites where no owner can be held responsible are safely decommissioned and managed over the long term. (authors)

Environmentally acceptable thread compounds: Requirements defined

International Nuclear Information System (INIS)

Stringfellow, W.D.; Hendriks, R.V.; Jacobs, N.L.

1993-01-01

New environmental regulations on thread compounds are now being enforced in several areas with strong maritime tradition and a sensitive environment. These areas include Indonesia, Alaska and portions of Norway. The industry generally recognizes the environmental concerns but, with wider enforcement of regulations imminent, has not been able to define clearly the requirements for environmental compliance. This paper, written in collaboration with The Netherlands State Supervision of Mines, is based on the National Policy on Thread Compounds of The Netherlands. This national policy is representative of policies being followed by other North Sea governments. Similar policies might well be adopted by other governments worldwide. These policies will affect the operator, drilling contractor, and supplier. This paper provides a specific and detailed definition of thread compound requirements by addressing four relevant categories. The categories of interest are regulatory approval, environmental, health, and performance

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.

Regulatory challenges of historic uranium mines in Canada

International Nuclear Information System (INIS)

Clement, C.H.; Stenson, R.E.

2002-01-01

The radium and uranium mining industry began in Canada in 1930 with the discovery of the Port Radium deposit in the Northwest Territories. During the 1950s more uranium mines opened across Canada. Most of these mines ceased operation by the end of the 1960s. Some were remediated by their owners, while others were abandoned. The Atomic Energy Control Board (AECB), predecessor to the Canadian Nuclear Safety Commission (CNSC), was created in 1946. However, it was not until the mid-1970s that the AECB took an active role in regulating health, safety and environmental aspects of uranium mining; so many of the older mines have never been licensed. With the coming into force of the Nuclear Safety and Control Act (NSCA) in May 2000, this situation has been reviewed. The NSCA requires a licence for the possession of nuclear substances (including uranium mine tailings), or the decommissioning of nuclear facilities (including uranium mines and mills). Furthermore, governments (federal and provincial) are also subject to the NSCA, a change from the previous legislation. The CNSC has an obligation to assess these sites, regardless of ownership, and to proceed with licensing or other appropriate regulatory action. The CNSC has reviewed the status of the twenty sites in Canada where uranium milling took place historically. Eight are already licensed. Licensing actions are being pursued at the other sites. A review of nearly 100 small uranium mining or exploration sites is also underway to determine the most appropriate regulatory approach. This paper focuses on regulatory issues surrounding the historic mining and milling sites, and the regulatory approach being taken, including licensing provincial and federal government bodies who own some of the sites, and ensuring the safe management of sites that were abandoned. (author)

A simplified ALARA approach to demonstration of compliance with surface contaminated object regulatory requirements

International Nuclear Information System (INIS)

Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Cook, J.C.

1998-02-01

The US Department of Transportation (DOT) and the US Nuclear Regulatory Commission (NRC) have jointly prepared a comprehensive set of draft guidance for consignors and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). The guidance is being developed to facilitate compliance with the new LSA material and SCO requirements, not to impose additional requirements. These new requirements represent, in some areas, significant departures from the manner in which packaging and transportation of these materials and objects were previously controlled. On occasion, it may be appropriate to use conservative approaches to demonstrate compliance with some of the requirements, ensuring that personnel are not exposed to radiation at unnecessary levels, so that exposures are kept as low as reasonably achievable (ALARA). In the draft guidance, one such approach would assist consignors preparing a shipment of a large number of SCOs in demonstrating compliance without unnecessarily exposing personnel. In applying this approach, users need to demonstrate that four conditions are met. These four conditions are used to categorize non-activated, contaminated objects as SCO-2. It is expected that, by applying this approach, it will be possible to categorize a large number of small contaminated objects as SCO-2 without the need for detailed, quantitative measurements of fixed, accessible contamination, or of total (fixed and non-fixed) contamination on inaccessible surfaces. The method, which is based upon reasoned argument coupled with limited measurements and the application of a sum of fractions rule, is described and examples of its use are provided

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.

Information Requirements and Consumer Protection in Future M-Commerce

DEFF Research Database (Denmark)

Cleff, Evelyne Beatrix; Henschel, Rene Franz

2007-01-01

  The aim of this article is to discuss information requirements and consumer protection in mobile commerce. On the basis of a brief introduction to the characteristics of mobile commerce and the regulatory framework that governs mobile commerce in the European Union today, the article presents...... that the solution may be relaxed enforcement of the regulatory framework and/or self-regulation, e.g. by codes of conduct. However, the article argues that other possible solutions should be considered, e.g. the use of specific symbols and sounds that - like road traffic rules - could help the consumer to navigate...

Summary of key directives governing permanent disposal in a geologic repository

International Nuclear Information System (INIS)

Sands, S.C. III.

1993-11-01

This document was developed in support of the Idaho National Engineering Laboratory (INEL) Spent Fuel and Waste Management Technology Development Program (SF ampersand WMTDP). It is largely comprised of flow diagrams summarizing the key regulatory requirements which govern permanent disposal in a geologic repository. The key purposes are (1) to provide an easy and effective tool for referencing or cross referencing federal directives (i.e., regulations and orders), (2) to provide a method for examining the requirements in one directive category against the requirements in another, and (3) to list actions that must be taken to ensure directive compliance. The document is categorically broken down into a Transportation section and a Mined Geologic Disposal System (MGDS) section to ensure that the interrelationship of the entire disposal system is considered. The Transportation section describes the transportation packaging requirements, testing methods, and safety requirements imposed on fissile material shipments. The MGDS section encompasses technical aspects involved in siting, licensing, waste interaction with the container, container design features, physical characteristics of the surrounding environment, facility design features, barrier systems, safety features, criticality considerations, migration restrictions, implementation guidelines, and so forth. For purposes of illustration, the worst case scenario is outlined. It is important that the approaches and considerations contained in this document be integrated into the efforts of the SF ampersand WMTDP so that every applicable aspect of the regulatory requirements can be evaluated to avoid investing large sums of money into projects that do not take into account all of the aspects of permanent waste disposal. Not until an overall picture and clear understanding of these regulations is established can a basis be developed to govern the direction of future activities of the SF ampersand WMTDP

A Paradigm Shift in Water Quality Governance in a Transitional Context: A Critical Study about the Empowerment of Local Governance in Georgia

Directory of Open Access Journals (Sweden)

Sisira S. Withanachchi

2018-01-01

Full Text Available The management of water quality is an important part of natural resource governance. Assurance of water quality therefore requires formulation of the regulatory framework and institutional process. Water quality-related problems and their management are mainly recognized as local responsibilities in Integrated Water Resources Management (IWRM. The politics of environmental policy-making should consider the political economic dynamics and socio-ecological patterns. Decentralization by providing more power to the local level and moving to a new spatial management system that is based on water basins are the two strong entreaties in the new water governance paradigm. Transitional countries facing rapid institutional adjustment, restructuring of regulations, and political-economic changes are encountering these demands internally and externally in their policy formulations. In this context, this study critically examines the case of Georgia, a transitional country. In particular, the focus is on how local governance entities can be empowered and what obstacles water quality governance encounters in Georgia. Qualitative research design is the main research method implemented in this study. The key findings from the research analysis are as follows: the existing regulations and governance system do not facilitate the active engagement of local entities in water quality governance. The application of new water polices may fail again if a top-down governance model is put in place that only creates a narrow space for local governance entities to effectively govern water quality.

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

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.

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.

Requirements, needs, and concepts for a new broad-application test reactor

International Nuclear Information System (INIS)

Ryskamp, J.M.; Fletcher, C.D.; Denison, A.B.; Liebenthal, J.L.

1992-01-01

For a variety of reasons, including (a) the increasing demands of the 1990s regulatory environment, (b) limited existing test capactiy and capability to satisfy projected future testing missions, and (c) an expected increasing need for nuclear information to support development of advanced reactors, there is a need for requirements and preliminary concepts for a new broad-application test reactor (BATR). These requirements must include consideration not only for a broad range of projected testing missions but also for current and projected regulatory compliance and safety requirements. The requirements will form the basis for development and assessment of preconceptual reactor designs and lead to the identification of key technologies to support the government's long-term strategic and programmatic planning. This paper outlines the need for a new BATR and suggests a few preliminary reactor concepts that can meet that need

Data Quality Objectives for Regulatory Requirements for Dangerous Waste Sampling and Analysis

International Nuclear Information System (INIS)

MULKEY, C.H.

1999-01-01

This document describes sampling and analytical requirements needed to meet state and federal regulations for dangerous waste (DW). The River Protection Project (RPP) is assigned to the task of storage and interim treatment of hazardous waste. Any final treatment or disposal operations, as well as requirements under the land disposal restrictions (LDRs), fall in the jurisdiction of another Hanford organization and are not part of this scope. The requirements for this Data Quality Objective (DQO) Process were developed using the RPP Data Quality Objective Procedure (Banning 1996), which is based on the U.S. Environmental Protection Agency's (EPA) Guidance for the Data Quality Objectives Process (EPA 1994). Hereafter, this document is referred to as the DW DQO. Federal and state laws and regulations pertaining to waste contain requirements that are dependent upon the composition of the waste stream. These regulatory drivers require that pertinent information be obtained. For many requirements, documented process knowledge of a waste composition can be used instead of analytical data to characterize or designate a waste. When process knowledge alone is used to characterize a waste, it is a best management practice to validate the information with analytical measurements

78 FR 76757 - Regulatory Guidance on Hours of Service of Drivers Rest Break Requirement; Drivers Who Become...

Science.gov (United States)

2013-12-19

... limitations for unforeseen reasons, is the driver in violation of the Sec. 395.3 rest break provision if more... unforeseen reasons, is not in violation of the Sec. 395.3 rest-break requirements if 8 or more hours have... Regulatory Guidance on Hours of Service of Drivers Rest Break Requirement; Drivers Who Become Ineligible for...

Broadening Industry Governance to Include Nonproliferation

Energy Technology Data Exchange (ETDEWEB)

Hund, Gretchen; Seward, Amy M.

2008-11-11

As industry is the first line of defense in detecting and thwarting illicit trade networks, the engagement of the private sector is critical to any government effort to strengthen existing mechanisms to protect goods and services throughout the supply chain. This study builds on previous PNNL work to continue to evaluate means for greater industry engagement to complement and strengthen existing governmental efforts to detect and stem the trade of illicit goods and to protect and secure goods that could be used in making a weapon of mass destruction. Specifically, the study evaluates the concept of Industry Self Regulation, defined as a systematic voluntary program undertaken by an industry or by individual companies to anticipate, implement, supplement, or substitute for regulatory requirements in a given field, generally through the adoption of best practices. Through a series of interviews with companies with a past history of non-compliance, trade associations and NGOs, the authors identify gaps in the existing regulatory infrastructure, drivers for a self regulation approach and the form such an approach might take, as well as obstacles to be overcome. The authors conclude that it is at the intersection of industry, government, and security that—through collaborative means—the effectiveness of the international nonproliferation system—can be most effectively strengthened to the mutual benefit of both government and the private sector. Industry has a critical stake in the success of this regime, and has the potential to act as an integrating force that brings together the existing mechanisms of the global nonproliferation regime: export controls, physical protection, and safeguards. The authors conclude that industry compliance is not enough; rather, nonproliferation must become a central tenant of a company’s corporate culture and be viewed as an integral component of corporate social responsibility (CSR).

Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Shankman, S.F.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issuance of the guidance in 1997

Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Shankman, S.F.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the U.S. Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issue of the guidance in 1997. (Author)

Electoral Governance: More than Just Electoral Administration

OpenAIRE

Medina Torres, Luis Eduardo; Ramírez Díaz, Edwin Cuitláhuac

2015-01-01

The meaning of "electoral governance" is often equated with "electoral administration". The process, however, can be divided into three distinct stages: 1) formation of regulatory bodies and norms; 2) implementation of these norms; and 3) dispute resolution. Given these three parts, electoral governance amounts to much more than just administration. In this article we explain why many academic studies of electoral governance have neglected the role of conflict resolution, focusing instead on ...

Sustainable and responsible supply chain governance: challenges and opportunities

NARCIS (Netherlands)

Boström, M.; Jönsson, A.M.; Lockie, S.; Mol, A.P.J.; Oosterveer, P.J.M.

2015-01-01

This paper introduces the Special Volume on sustainable and responsible supply chain governance. As globalized supply chains cross multiple regulatory borders, the firms involved in these chains come under increasing pressure from consumers, NGOs and governments to accept responsibility for social

Self-identity and regulatory focus in governance of online communities

DEFF Research Database (Denmark)

Li-Ying, Jason

A fast growing stream of literature has shown tremendous interests in the ‘wisdom of crowds’, which is embedded in various forms of online communities (OCs). However, studies on the governance of OCs are rather scattered. Our knowledge on how key governance mechanisms are interrelated is very much...

Government Performance and Results Act: Performance plan FY 1999, U.S. Nuclear Regulatory Commission. Volume 1

Energy Technology Data Exchange (ETDEWEB)

Fuches, J.L.

1998-02-01

The Nuclear Regulatory Commission`s (NRC) strategic plan [NUREG-1614, Vol. 1, September 1997] establishes a strategic framework that will guide future decision-making and will help the NRC continue to meet its responsibility for protecting public health and safety, promoting the common defense and security, and protecting the environment. This performance plan complements the agency`s strategic plan by setting annual goals with measurable target levels of performance for FY 1999, as required by the Government Performance and Results Act. No significant contribution was made to the preparation of the performance plan by any non-Federal entity. However, a contractor was used to help facilitate discussions and resolution of issues. Within six months after the close of FY 1999, the NRC will submit to the President and the Congress a report on program performance for FY 1999. This performance report will review the success of the agency in achieving the performance goals established for FY 1999. Where those goals have been achieved, the underlying assumptions and strategies will be examined to ensure that continued applicability is warranted in the future. If any of the FY 1999 performance goals are not met, the agency will conduct a thorough analysis of why it did not meet the goal and the actions necessary to meet-the goal in the future. One result of this analysis will be the documentation of plans and schedules for achieving the established performance goal. If the analysis should indicate that the performance goal is impractical or infeasible, the performance report will document why that is the case and what action is recommended.

Global Governance Mechanisms to Address Antimicrobial Resistance.

Science.gov (United States)

Padiyara, Ponnu; Inoue, Hajime; Sprenger, Marc

2018-01-01

Since their discovery, antibiotics, and more broadly, antimicrobials, have been a cornerstone of modern medicine. But the overuse and misuse of these drugs have led to rising rates of antimicrobial resistance, which occurs when bacteria adapt in ways that render antibiotics ineffective. A world without effective antibiotics can have drastic impacts on population health, global development, and the global economy. As a global common good, antibiotic effectiveness is vulnerable to the tragedy of the commons, where a shared limited resource is overused by a community when each individual exploits the finite resource for their own benefit. A borderless threat like antimicrobial resistance requires global governance mechanisms to mitigate its emergence and spread, and it is the responsibility of all countries and relevant multilateral organizations. These mechanisms can be in the form of legally binding global governance mechanisms such as treaties and regulatory standards or nonbinding mechanisms such as political declarations, resolutions, or guidelines. In this article, we argue that while both are effective methods, the strong, swift, and coordinated action needed to address rising rates of antimicrobial resistance will be better served through legally binding governance mechanisms.

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

Nuclear regulatory decision making

International Nuclear Information System (INIS)

Wieland, Patricia; Almeida, Ivan Pedro Salati de

2011-01-01

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

Nuclear regulatory decision making

International Nuclear Information System (INIS)

2005-01-01

The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear utilities operate their plants at all times in an acceptably safe manner. In meeting this objective, the regulatory body should strive to ensure that its regulatory decisions are technically sound, consistent from case to case, and timely. In addition, the regulator must be aware that its decisions and the circumstances surrounding those decisions can affect how its stakeholders, such as government policy makers, the industry it regulates, and the public, view it as an effective and credible regulator. In order to maintain the confidence of those stakeholders, the regulator should make sure that its decisions are transparent, have a clear basis in law and regulations, and are seen by impartial observers to be fair to all parties. Based on the work of a Nuclear Energy Agency (NEA) expert group, this report discusses some of the basic principles and criteria that a regulatory body should consider in making decisions and describes the elements of an integrated framework for regulatory decision making. (author)

The Defence in Depth Concept Applied to the New Regulatory Requirements in Japan

Energy Technology Data Exchange (ETDEWEB)

Yamagata, H., E-mail: hiroshi_yamagata@nsr.go.jp [Nuclear Regulation Authority, Minato-ku, Tokyo (Japan)

2014-10-15

Full text: The new regulatory requirements based on lessons learnt from Fukushima Daiichi accident, which places emphasis on Defense-in-Depth concept, was put into effect in Japan on 8th July, 2013. It is required to prepare multi-layered protective measures. Each layer should achieve the objective only in that layer regardless of the measures in the other layers. The challenge is how to enhance independence of measures between layers. In the third layer, the current concept of design regarding safety relies on “single failure”, whose condition is elimination of common cause failure (CCF). To eliminate CCFs we introduced a more accurate approach in assessment of earthquake and tsunami, and introduction of measures against tsunami inundation. Redundancy of safety systems could not eliminate CCF by extreme natural hazards. Safety system should be designed by due consideration of diversity and independence including spatial dispersement. In the fourth layer, multi-layered protective measures are also applied for severe accidents, which consists of “prevention of core damage” under multiple failure, “prevention of containment failure”, and “prevention of large release, that is controlled release by venting”. In the fifth layer, we also require operators to prepare measures for “suppression of radioactive materials dispersion”. Of course, off-site emergency preparedness and response has been enhanced by introduction of PAZ and UPZ. Introduction of “Specialized Safety Facility” against intentional aircraft crash will contribute enhancement of some layers by providing electricity and water under extremely severe conditions. The new regulatory requirements are not our goal, just a first step. It is expected for regulator and operators to improve safety continuously by periodic comprehensive safety assessments including IPE, IPEEE, Margin test, and etc. We have to make an upward spiral of nuclear safety. (author)

EU Water Governance: Striking the Right Balance between Regulatory Flexibility and Enforcement?

Directory of Open Access Journals (Sweden)

Olivia O. Green

2013-06-01

Full Text Available Considering the challenges and threats currently facing water management and the exacerbation of uncertainty by climate change, the need for flexible yet robust and legitimate environmental regulation is evident. The European Union took a novel approach toward sustainable water resource management with the passage of the EU Water Framework Directive in 2000. The Directive promotes sustainable water use through long-term protection of available water resources, progressively reduces discharges of hazardous substances in ground and surface waters, and mitigates the effects of floods and droughts. The lofty goal of achieving good status of all waters requires strong adaptive capacity, given the large amounts of uncertainty in water management. Striking the right balance between flexibility in local implementation and robust and enforceable standards is essential to promoting adaptive capacity in water governance, yet achieving these goals simultaneously poses unique difficulty. Applied resilience science reveals a conceptual framework for analyzing the adaptive capacity of governance structures that includes multiple overlapping levels of control or coordination, information flow horizontally and vertically, meaningful public participation, local capacity building, authority to respond to changed circumstances, and robust monitoring, system feedback, and enforcement. Analyzing the Directive through the lens of resilience science, we highlight key elements of modern European water management and their contribution to the resilience of the system and conclude that the potential lack of enforcement and adequate feedback of monitoring results does not promote managing for resilience. However, the scale-appropriate governance aspects of the EU approach promotes adaptive capacity by enabling vertical and horizontal information flow, building local capacity, and delegating control at multiple relevant scales.

Regulatory Safety Requirements for Operating Nuclear Installations

International Nuclear Information System (INIS)

Gubela, W.

2017-01-01

The National Nuclear Regulator (NNR) is established in terms of the National Nuclear Regulator Act (Act No 47 of 1999) and its mandate and authority are conferred through sections 5 and 7 of this Act, setting out the NNR's objectives and functions, which include exercising regulatory control over siting, design, construction etc of nuclear installations through the granting of nuclear authorisations. The NNR's responsibilities embrace all those actions aimed at providing the public with confidence and assurance that the risks arising from the production of nuclear energy remain within acceptable safety limits -> Therefore: Set fundamental safety standards, conducting pro-active safety assessments, determining licence conditions and obtaining assurance of compliance. The promotional aspects of nuclear activities in South Africa are legislated by the Nuclear Energy Act (Act No 46 of 1999). The NNR approach to regulations of nuclear safety and security take into consideration, amongst others, the potential hazards associated with the facility or activity, safety related programmes, the importance of the authorisation holder's safety related processes as well as the need to exercise regulatory control over the technical aspects such as of the design and operation of a nuclear facility in ensuring nuclear safety and security. South Africa does not have national nuclear industry codes and standards. The NNR is therefore non-prescriptive as it comes to the use of industry codes and standards. Regulatory framework (current) provide for the protection of persons, property, and environment against nuclear damage, through Licensing Process: Safety standards; Safety assessment; Authorisation and conditions of authorisation; Public participation process; Compliance assurance; Enforcement

Generating political priority for regulatory interventions targeting obesity prevention: an Australian case study.

Science.gov (United States)

Baker, Phillip; Gill, Timothy; Friel, Sharon; Carey, Gemma; Kay, Adrian

2017-03-01

Effective obesity prevention requires a synergistic mix of population-level interventions including a strong role for government and the regulation of the marketing, labelling, content and pricing of energy-dense foods and beverages. In this paper we adopt the agenda of the Australian Federal Government (AFG) as a case study to understand the factors generating or hindering political priority for such 'regulatory interventions' between 1990 and 2011. Using a theoretically-guided process tracing method we undertook documentary analysis and conducted 27 interviews with a diversity of actors involved in obesity politics. The analysis was structured by a theoretical framework comprising four dimensions: the power of actors involved; the ideas the actors deploy to interpret and portray the issue; the institutional and political context; and issue characteristics. Despite two periods of sustained political attention, political priority for regulatory interventions did not emerge and was hindered by factors from all four dimensions. Within the public health community, limited cohesion among experts and advocacy groups hampered technical responses and collective action efforts. An initial focus on children (child obesity), framing the determinants of obesity as 'obesogenic environments', and the deployment of 'protecting kids', 'industry demonization' and 'economic costs' frames generated political attention. Institutional norms within government effectively selected out regulatory interventions from consideration. The 'productive power' and activities of the food and advertising industries presented formidable barriers, buttressed by a libertarian/neolibertarian rhetoric emphasizing individual responsibility, a negative view of freedom (as free from 'nanny-state' intervention) and the idea that regulation imposes an unacceptable cost on business. Issue complexity, the absence of a supportive evidence base and a strict 'evidence-based' policy-making approach were used as

Efficient Reverse-Engineering of a Developmental Gene Regulatory Network

Science.gov (United States)

Cicin-Sain, Damjan; Ashyraliyev, Maksat; Jaeger, Johannes

2012-01-01

Understanding the complex regulatory networks underlying development and evolution of multi-cellular organisms is a major problem in biology. Computational models can be used as tools to extract the regulatory structure and dynamics of such networks from gene expression data. This approach is called reverse engineering. It has been successfully applied to many gene networks in various biological systems. However, to reconstitute the structure and non-linear dynamics of a developmental gene network in its spatial context remains a considerable challenge. Here, we address this challenge using a case study: the gap gene network involved in segment determination during early development of Drosophila melanogaster. A major problem for reverse-engineering pattern-forming networks is the significant amount of time and effort required to acquire and quantify spatial gene expression data. We have developed a simplified data processing pipeline that considerably increases the throughput of the method, but results in data of reduced accuracy compared to those previously used for gap gene network inference. We demonstrate that we can infer the correct network structure using our reduced data set, and investigate minimal data requirements for successful reverse engineering. Our results show that timing and position of expression domain boundaries are the crucial features for determining regulatory network structure from data, while it is less important to precisely measure expression levels. Based on this, we define minimal data requirements for gap gene network inference. Our results demonstrate the feasibility of reverse-engineering with much reduced experimental effort. This enables more widespread use of the method in different developmental contexts and organisms. Such systematic application of data-driven models to real-world networks has enormous potential. Only the quantitative investigation of a large number of developmental gene regulatory networks will allow us to

Corporate Governance in Singapore : Recent Developments For the Next Millennium

OpenAIRE

Mak Yuen Teen; Phillip H. Phan

2000-01-01

This paper surveys the regulatory and structural environment as it relates to corporate governance in Singapore, and present empirical evidence on corporate governance practices in areas such as ownership structure, disclosure, board and directors, the use of share option schemes, and the impact of government corporate ownership. It reviews corporate governance reforms that have been implemented or proposed, and assesses their likely impact on future corporate governance practices in Singapor...

40 CFR Appendix A to Part 31 - Audit Requirements for State and Local Government Recipients

Science.gov (United States)

2010-07-01

... that a single audit provides Federal agencies with information and assurance they need to carry out... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Audit Requirements for State and Local... AGREEMENTS TO STATE AND LOCAL GOVERNMENTS Pt. 31, App. A Appendix A to Part 31—Audit Requirements for State...

In situ vitrification of mixed wastes: Progress and regulatory status

International Nuclear Information System (INIS)

Kindle, C.H.; Barich, J.J. III

1991-08-01

In situ vitrification (ISV) technology targets mixed wastes in in situ near-surface environments. Federal laws governing toxic substances (TSCA), hazardous waste (RCRA), and abandoned sites (Superfund) create the need for remediation technology and define the required performance characteristics. The need for ISV depends, in part, on the extent of regulation and how well ISV's demonstrated performance characteristics match up with regulatory criteria. The regulatory requirements are easier to identify and meet in short-duration site- and situation-specific applications of the technology than they are simpler in long-term, generalized applications. ISV's ability to treat both inorganics and organics in a single process supports applications for mixed, hazardous, and radioactive sites of moderate depth (20 ft). The durability of the ISV waste form is a major advantage of the technology when demonstrating permanence of a waste management strategy. Achieving depth and vapor containment assurance are issues being addressed as the ISV process is refined for new applications having different processing concerns. Refinements include moveable electrodes and sheet steel as the material for the containment structure. 16 refs., 4 figs., 6 tabs

Fuel utilization experience in Bohunice NPP and regulatory requirements for implementation of progressive fuel management strategies

Energy Technology Data Exchange (ETDEWEB)

Patenyi, V [Nuclear Regulatory Authority, Bratislava (Slovakia); Darilek, P; Majercik, J [Vyskumny Ustav Jadrovych Elektrarni, Trnava (Slovakia)

1994-12-31

The experience gained in fuel utilization and the basic requirements for fuel licensing in the Slovak NPPs is described. The original project of WWER-440 reactors supposes 3-year fuel cycle with cycle length of about 320 full power days (FPD). Since 1984 it was reduced to 290 FPD. Based on the experience of other countries, a 4-year fuel cycle utilization started in 1987. It is illustrated with data from the Bohunice NPP units. Among 504 fuel assemblies left for the fourth burnup cycle no leakage was observed. The mean burnup achieved in the different units varied from 33.1 to 38.5 Mwd/kg U. The new fuel assemblies used are different from the recent ones in construction, thermohydraulics, water-uranium ratio, enrichment and material design. To meet the safety criteria, regulatory requirements for exploitation of new fuel in WWER-440 were formulated by the Nuclear Regulatory Authority of Slovak Republic. 1 tab., 5 refs.

Prospects and Challenges of Corporate Governance in Ghana

OpenAIRE

Agyemang, Otuo Serebour; Aboagye, Emmanuel; Ahali, Aaron Yao Ofoe

2013-01-01

The relevance of corporate governance principles in the management of corporate organisations cannot be underestimated. The increasing influence of principles of corporate governance across the globe has been greatly linked to the recent corporate frauds and scandals. These frauds and scandals largely resulted from the failure of authorities of countries to effectively implement the legal and regulatory frameworks pertaining to corporate governance. Ghana is archetypal in regards to the failu...

Governing the moral economy: Animal engineering, ethics and the liberal government of science

Science.gov (United States)

Harvey, Alison; Salter, Brian

2012-01-01

The preferred Western model for science governance has come to involve attending to the perspectives of the public. In practice, however, this model has been criticised for failing to promote democracy along participatory lines. We argue that contemporary approaches to science policy making demonstrate less the failure of democracy and more the success of liberal modes of government in adapting to meet new governance challenges. Using a case study of recent UK policy debates on scientific work mixing human and animal biological material, we show first how a ‘moral economy’ is brought into being as a regulatory domain and second how this domain is governed to align cultural with scientific values. We suggest that it is through these practices that the state assures its aspirations for enhancing individual and collective prosperity through technological advance are met. PMID:22507952

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)

The Energy Regulatory Commission (1). Law of the Comision Reguladora de Energia

International Nuclear Information System (INIS)

1995-01-01

The Energy Regulatory Commission. Reforms to the Electric Energy Public Service Law (1992) and the Regulatory Law of Article 27 on Petroleum (1995) have brought about fundamental changes in the electric and natural gas industries. The legal reforms explicitly permit the private sector to construct, operate, and own, systems of electric generation and natural gas transportation, storage and distribution. The participation of the private sector in these areas required a redefinition in the government regulatory institutions. Accordingly the Federal Congress enacted the law of the Comision Reguladora de Energia (CRE) in 1995. The CRE law expands the scope of the CRE's authority and the breadth of its powers beyond those established when it was initially created in 1993. The CRE commenced operations in January 1994 as a decentralized technical and consultative body of the Energy Ministry. The decree that created the Commission limited the scope of its authority to an analysis and consultative role applicable only to the electric industry. (Author)

Regulatory inspection of nuclear facilities and enforcement by the regulatory body. Safety guide

International Nuclear Information System (INIS)

2002-01-01

The purpose of this Safety Guide is to provide recommendations for regulatory bodies on the inspection of nuclear facilities, regulatory enforcement and related matters. The objective is to provide the regulatory body with a high level of confidence that operators have the processes in place to ensure compliance and that they do comply with legal requirements, including meeting the safety objectives and requirements of the regulatory body. However, in the event of non-compliance, the regulatory body should take appropriate enforcement action. This Safety Guide covers regulatory inspection and enforcement in relation to nuclear facilities such as: enrichment and fuel manufacturing plants; nuclear power plants; other reactors such as research reactors and critical assemblies; spent fuel reprocessing plants; and facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Section 2 sets out the objectives of regulatory inspection and enforcement. Section 3 covers the management of regulatory inspections. Section 4 covers the performance of regulatory inspections, including internal guidance, planning and preparation, methods of inspection and reports of inspections. Section 5 deals with regulatory enforcement actions. Section 6 covers the assessment of regulatory inspections and enforcement activities. The Appendix provides further details on inspection areas for nuclear facilities

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

International Nuclear Information System (INIS)

2012-01-01

Full text: An international team of senior nuclear safety and radiation protection experts yesterday concluded an 11-day mission to review the regulatory framework for nuclear and radiation safety in Greece. The Integrated Regulatory Review Service (IRRS) mission, which was conducted at the request of the Government of the Hellenic Republic, noted good practices in the country's nuclear regulatory system and also identified issues for improvement for the Greek Atomic Energy Commission (GAEC) and the Greek competent authorities. These are aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards. ''The IRRS team enjoyed excellent cooperation from the GAEC throughout its mission,'' said Tom Ryan, mission leader and Director of Regulations and Information Management at the Radiological Protection Institute of Ireland. ''The GAEC staff were very open and candid in their discussions and provided the fullest practicable assistance.'' The main observations of the IRRS Review team included: While the Greek Government's commitment to safety is being demonstrated through its actions, the development of a comprehensive national policy and strategy expressed in a consolidated statement would provide a valuable framework and guidance for future actions in terms of safety; and GAEC has effective independence. The Greek government has ensured that GAEC is effectively independent in its safety-related decision-making and that it has functional separation from entities having responsibility or interests that could unduly influence its decision making. Strengths and good practices identified by the IRRS team included: Greece actively participates in the global safety regime including all relevant safety conventions; The nation's radiation monitoring system for the detection of illicit trafficking contributes significantly to identifying potential radiation emergencies due to events within or outside the country

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

International Nuclear Information System (INIS)

Ritterbusch, S.E.

2000-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

Ritterbusch, S.E.

2000-08-01

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

Oil spill emergency response: Fulfilling regulatory requirements on the Grand Banks

International Nuclear Information System (INIS)

Horvath, C.L.

1991-01-01

Offshore well licensing under Canadian regulations requires the operator to conduct a practice exercise of oil spill countermeasures and emergency response procedures at least yearly, once the drilling program starts. The relevant parts of the Newfoundland Offshore Petroleum Drilling Regulations are summarized and the objectives and benefits of the practice exercises are reviewed. In addition to ensuring regulatory compliance, the exercises also provide the opportunity to test operational procedures, to provide in-house training, and improve response efficiency by regular repetition of the exercise. Exercises in communications during a spill incident in the offshore and in deployment of offshore spill response equipment conducted by Petro-Canada in Newfoundland are described. Problems identified during the exercises are noted

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

Regulatory Impact Analysis Practice in New Zealand in the Light of Models of Evaluation Use – Inspiration for the Polish Government

Directory of Open Access Journals (Sweden)

Tomasz Kupiec

2015-06-01

Full Text Available Purpose: The paper describes the functioning of the RIA system in New Zealand using the analogy of RIA and the evaluation of public interventions. Presented solutions can provide nspiration for the Polish government in the process of improving the quality and extent of the use of RIA. Methodology: The analysis is based on a review of government documents and literature, as well as individual interviews and correspondence with representatives of the government of NZ. Conclusions: The RIA system in NZ is not error-free and its shortcomings include inter alia the lack of solutions with respect to ex-post analysis and insufficiently rigorous methodological approach. At the same time, a number of solutions can be regarded as good practice, e.g.: regular external quality reviews of RIS, obligation to supplement each RIS with ‘quality assessment’ and a ‘disclosure statement’ outlining their credibility and utility. Practical implications: The presented strengths of the RIA system in NZ may serve as an inspiration for modifying the RIA system in Poland. Originality: The RIA system is presented through the prism of the model of evaluation use, which is a related tool of collecting information about non-regulatory interventions.

Shariah Governance Framework For Islamic Co-Operatives As An Integral Social Insitution In Malaysia

Directory of Open Access Journals (Sweden)

Muhammad Issyam Itam

2017-01-01

Full Text Available In Malaysia, Islamic cooperatives are recognized as providers of some form of Islamic financial service similar to Islamic Banks and Takaful Operators. An Islamic Co-operative refers to a co-operative conducting activities and businesses based on Shariah principles. Being a non-banking financial institution, its main objective is to enhance social economic welfare of its members. As a form of captive social institution, it enables the less economically privileged members of society to pool resources as a cooperative. Malaysia is spearheading the Islamic banking and finance industry globally by having in place a proper and well-designed legal and regulatory framework for Islamic Financial Institutions, which includes the area of Shariah governance. However, the Shariah governance framework for the Islamic Co-operative in Malaysia is still in its infancy stage. In this paper, this area will be given focus and properly highlighted. Later, comparison will be made with the Shariah governance framework for the Islamic financial institutions. This paper will conclude that the requirements with regard to Shariah governance for the Islamic Co-operative are flexible and not as strict as required for the Islamic financial institutions.

Government regulation of forestry practices on private forest land in the United States: an assessment of state government responsibilities and program performance

Science.gov (United States)

Paul V. Ellefson; Michael A. Kilgore; James E. Granskog

2006-01-01

In 2003, a comprehensive assessment of state government, forest practice regulatory programs in the United States was undertaken. Involved was an extensive review of the literature and information gathering h m program administration in all 50 states. The assessment determined that regulatory programs focus on a wide range of forestry practices applied to private...

Data Quality Objectives for Regulatory Requirements for Dangerous Waste Sampling and Analysis; FINAL

International Nuclear Information System (INIS)

MULKEY, C.H.

1999-01-01

This document describes sampling and analytical requirements needed to meet state and federal regulations for dangerous waste (DW). The River Protection Project (RPP) is assigned to the task of storage and interim treatment of hazardous waste. Any final treatment or disposal operations, as well as requirements under the land disposal restrictions (LDRs), fall in the jurisdiction of another Hanford organization and are not part of this scope. The requirements for this Data Quality Objective (DQO) Process were developed using the RPP Data Quality Objective Procedure (Banning 1996), which is based on the U.S. Environmental Protection Agency's (EPA) Guidance for the Data Quality Objectives Process (EPA 1994). Hereafter, this document is referred to as the DW DQO. Federal and state laws and regulations pertaining to waste contain requirements that are dependent upon the composition of the waste stream. These regulatory drivers require that pertinent information be obtained. For many requirements, documented process knowledge of a waste composition can be used instead of analytical data to characterize or designate a waste. When process knowledge alone is used to characterize a waste, it is a best management practice to validate the information with analytical measurements

Radiological and administrative criteria and procedures required by the Radiation Protection Ordinance for exemption from regulatory control

International Nuclear Information System (INIS)

Birkholz, W.

2000-01-01

The system of required radioactivity measurements and limits as well as methods, based on the 10 μSv concept, constitutes the regulatory regime for exemption of radioactive waste materials from regulatory control according to atomic energy law. The methods and administrative procedures are suitable both for smaller amounts of materials, such as those resulting from the use of radioactive substances in scientific research and medical applications, and for the large waste volumes emanating from the dismantling of nuclear installations. The system provided for in the Radiation Protection Ordinance ensures harmonized administrative action of all public authorities involved. (orig./CB) [de

Information security governance: a risk assessment approach to health information systems protection.

Science.gov (United States)

Williams, Patricia A H

2013-01-01

It is no small task to manage the protection of healthcare data and healthcare information systems. In an environment that is demanding adaptation to change for all information collection, storage and retrieval systems, including those for of e-health and information systems, it is imperative that good information security governance is in place. This includes understanding and meeting legislative and regulatory requirements. This chapter provides three models to educate and guide organisations in this complex area, and to simplify the process of information security governance and ensure appropriate and effective measures are put in place. The approach is risk based, adapted and contextualized for healthcare. In addition, specific considerations of the impact of cloud services, secondary use of data, big data and mobile health are discussed.

Governance of nanotechnology and nanomaterials: principles, regulation, and renegotiating the social contract.

Science.gov (United States)

Kimbrell, George A

2009-01-01

Good governance for nanotechnology and nanomaterials is predicated on principles of general good governance. This paper discusses on what lessons we can learn from the oversight of past emerging technologies in formulating these principles. Nanotechnology provides us a valuable opportunity to apply these lessons and a duty to avoid repeating past mistakes. To do that will require mandatory regulation, grounded in precaution, that takes into account the uniqueness of nanomaterials. Moreover, this policy dialogue is not taking place in a vacuum. In applying the lessons of the past, nanotechnology provides a window to renegotiate our public's social contract on chemicals, health, the environment, and risks. Emerging technologies illuminate structural weaknesses, providing a crucial chance to ameliorate lingering regulatory inadequacies and provide much needed updates of existing laws.

An overview of exhaust emissions regulatory requirements and control technology for stationary natural gas engines

International Nuclear Information System (INIS)

Ballard, H.N.; Hay, S.C.; Shade, W.N. Jr.

1992-01-01

In this paper a practical overview of stationary natural gas engine exhaust emissions control technology and trends in emissions regulatory requirements is presented. Selective and non-selective catalytic reduction and lean burn technologies are compared. Particular emphasis is focussed on implications of the Clean Air Act of 1990. Recent emissions reduction conversion kit developments and a practical approach to continuous monitoring are discussed

The process of regulatory authorization. A report by the CRPPH expert group on the regulatory application of Authorization (EGRA)

International Nuclear Information System (INIS)

2006-01-01

Governments and regulatory authorities are responsible for the definition of regulatory controls or conditions, if any, that should be applied to radioactive sources or radiation exposure situations in order to protect the public, workers and the environment. Although countries use different policy and structural approaches to fulfill this responsibility, the recommendations of the International Commission on Radiological Protection (ICRP) are generally used as at least part of the basis for protection. Previously, the ICRP recommended the use of variable approaches to protection. New ICRP recommendations are proposing a single, conceptually simple and self-coherent approach to defining appropriate protection under all circumstances. While the ICRP has been reviewing the broad principles of protection, the NEA Committee on Radiation Protection and Public Health (CRPPH) has been focusing its efforts on how radiological protection could be better implemented by governments and/or regulatory authorities. To this end, the CRPPH has developed a concept that it calls ''the process of regulatory authorization''. It is described in detail in this report, and is intended to help regulatory authorities apply more transparently, coherently and simply the broad recommendations of the ICRP to the real-life business of radiological protection regulation and application. In developing this concept, the CRPPH recognizes the importance of an appropriate level of stakeholder involvement in the process. (author)

A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements

Directory of Open Access Journals (Sweden)

Giannakou C

2016-06-01

Full Text Available Christina Giannakou,1,2 Margriet VDZ Park,1 Wim H de Jong,1 Henk van Loveren,1,2 Rob J Vandebriel,1 Robert E Geertsma1 1Centre for Health Protection, National Institute for Public Health and the Environment (RIVM, Bilthoven, 2Department of Toxicogenomics, Maastricht University, Maastricht, the Netherlands Abstract: Nanomaterials (NMs are attractive for biomedical and pharmaceutical applications because of their unique physicochemical and biological properties. A major application area of NMs is drug delivery. Many nanomedicinal products (NMPs currently on the market or in clinical trials are most often based on liposomal products or polymer conjugates. NMPs can be designed to target specific tissues, eg, tumors. In virtually all cases, NMPs will eventually reach the immune system. It has been shown that most NMs end up in organs of the mononuclear phagocytic system, notably liver and spleen. Adverse immune effects, including allergy, hypersensitivity, and immunosuppression, have been reported after NMP administration. Interactions of NMPs with the immune system may therefore constitute important side effects. Currently, no regulatory documents are specifically dedicated to evaluate the immunotoxicity of NMs or NMPs. Their immunotoxicity assessment is performed based on existing guidelines for conventional substances or medicinal products. Due to the unique properties of NMPs when compared with conventional medicinal products, it is uncertain whether the currently prescribed set of tests provides sufficient information for an adequate evaluation of potential immunotoxicity of NMPs. The aim of this study was therefore, to compare the current regulatory immunotoxicity testing requirements with the accumulating knowledge on immunotoxic effects of NMPs in order to identify potential gaps in the safety assessment. This comparison showed that immunotoxic effects, such as complement activation-related pseudoallergy, myelosuppression, inflammasome

Private governance, public purpose? Assessing transparency and accountability in self-regulation of food advertising to children.

Science.gov (United States)

Reeve, Belinda

2013-06-01

Reducing non-core food advertising to children is an important priority in strategies to address childhood obesity. Public health researchers argue for government intervention on the basis that food industry self-regulation is ineffective; however, the industry contends that the existing voluntary scheme adequately addresses community concerns. This paper examines the operation of two self-regulatory initiatives governing food advertising to children in Australia, in order to determine whether these regulatory processes foster transparent and accountable self-regulation. The paper concludes that while both codes appear to establish transparency and accountability mechanisms, they do not provide for meaningful stakeholder participation in the self-regulatory scheme. Accordingly, food industry self-regulation is unlikely to reflect public health concerns or to be perceived as a legitimate form of governance by external stakeholders. If industry regulation is to remain a feasible alternative to statutory regulation, there is a strong argument for strengthening government oversight and implementing a co-regulatory scheme.

Carbon Capture and Storage Legal and Regulatory Review. Edition 3

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-01

The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA estimates that emissions can be reduced to a level consistent with a 2°C global temperature increase through the broad deployment of low-carbon energy technologies – and that CCS would contribute about one-fifth of emission reductions in this scenario. Achieving this level of deployment will require that regulatory frameworks – or rather a lack thereof – do not unnecessarily impede environmentally safe demonstration and deployment of CCS, so in October 2010 the IEA launched the IEA Carbon Capture and Storage Legal and Regulatory Review. The CCS Review is a regular review of CCS regulatory progress worldwide. Produced annually, it collates contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum to support CCS framework development. Each two page contribution provides a short summary of recent and anticipated CCS regulatory developments and highlights a particular, pre-nominated regulatory theme. To introduce each edition, the IEA provides a brief analysis of key advances and trends, based on the contributions submitted. The theme for this third edition is stakeholder engagement in the development of CO2 storage projects. Other issues addressed include: regulating CO2-EOR, CCS and CO2-EOR for storage; CCS incentive policy; key, substantive issues being addressed by jurisdictions taking steps to finalise CCS regulatory framework development; and CCS legal and regulatory developments in the context of the Clean Energy Ministerial Carbon Capture, Use and Storage Action Group.

77 FR 8082 - Regulatory Flexibility Agenda

Science.gov (United States)

2012-02-13

... Required: Yes. Agency Contact: Alicia Goldin, Division of Trading and Markets, Securities and Exchange.../01/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alicia Goldin, Division of... Withdrawn 10/01/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alicia Goldin, Division of...

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

State governance versus dentists' autonomy - the case of Swedish dental care.

Science.gov (United States)

Franzén, Cecilia

2018-03-01

A trend towards the state governance of healthcare through quality indicators and national clinical guidelines has been observed, and it is argued that this trend can be a challenge to the autonomy of healthcare professionals. In Sweden, these regulatory tools have been implemented in combination with subsidies for adult dental care that are based on guideline recommendations which serve to ensure that dental care is evidence-based and cost-effective. This paper aims to analyse the implications of these changes regarding dentists' autonomy and whether the government's political intentions can be fulfilled. The paper is based on documents from government authorities and professional theories. The financial control over Swedish dental care has been strengthened, and it can be argued that this is a step in the right direction from a societal point of view, as public resources are limited. Dentists' professional autonomy with their patients is not affected, which is appropriate, as patients should be treated according to their individual needs and expectations. This article shows that the state's governance does not directly detail dentists' work, which indicates a balance between state governance and dentists' autonomy. However, further research is required to get knowledge on Swedish dentists' view of the governance.

Modes and Approaches of Groundwater Governance: A Survey of Lessons Learned from Selected Cases across the Globe

Directory of Open Access Journals (Sweden)

Robert G. Varady

2016-09-01

Full Text Available The crucial role of groundwater and the centrality of water governance in accommodating growing water demands sustainably are becoming well recognized. We review 10 case studies of groundwater governance—representing diverse global regions and local contexts—from the perspective of four well-established elements: (1 institutional setting; (2 availability and access to information and science; (3 robustness of civil society; and (4 economic and regulatory frameworks. For institutional setting, we find that governing is often a thankless task that paradoxically requires popularity; legislation does not always translate to implementation; conflict resolution is central to governance; and funding is critical for governance. In terms of information access, we see: a need for research for natural systems, social systems, and institutions; trust as an essential element in research; and that urbanized landscapes are critical components of groundwater governance. Looking at civil society robustness, we observe that equity is an essential element for governance; community-based governance requires intention; and leaders can play a powerful role in uniting stakeholders. As for frameworks, the cases suggest that economic incentives sometimes yield unintended results; “indirect” management should be used cautiously; and economic incentives’ effectiveness depends on the system employed. Collectively, the lessons speak to the need for shared governance capacities on the part of governments at multiple levels and civil society actors.

Transcription regulatory networks analysis using CAGE

KAUST Repository

Tegné r, Jesper N.; Bjö rkegren, Johan L M; Ravasi, Timothy; Bajic, Vladimir

2009-01-01

and the fine interplay between regulatory proteins and the promoter structure governing the combinatorial regulation of gene expression. In this chapter we review how the CAGE data can be integrated with other measurements such as expression, physical

A study on the role adjustment between central and local government II

International Nuclear Information System (INIS)

Yuk, D. I.; Ahn, S. K.

2004-01-01

The goal of this research is to construct new system and feasible action plans by seeking solutions for more effective redistribution of the nuclear regulatory roles between central and local governments. From 1995 on, since local autonomy system has been reimplemented in Korea, it is imperative to develop reformative alternatives for the decentralization of powers between central and local governments. The core devolution is to redistribute administrative roles and functions which have been centralized, toward both self-governing bodies and communities including NGO. The level of devolution in nuclear regulatory system depends on how to redistribute nuclear related roles and functions among central/local government with KINS. Therefore, it is very important to examine general principles criteria and type of domestic/foreign role adjustment for effective/rational/democratic nuclear regulation. Based on previous model and system proposed, role adjustment action plans are reviewed taking account of the nuclear environmental changes in the localization era. In the long run, the result of this research will be expected to utilize the optimal and democratic regulatory system in Korea

A study on the role adjustment between central and local government II

Energy Technology Data Exchange (ETDEWEB)

Yuk, D. I. [Chungnam National University, Taejon (Korea, Republic of); Ahn, S. K. [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of)

2004-07-01

The goal of this research is to construct new system and feasible action plans by seeking solutions for more effective redistribution of the nuclear regulatory roles between central and local governments. From 1995 on, since local autonomy system has been reimplemented in Korea, it is imperative to develop reformative alternatives for the decentralization of powers between central and local governments. The core devolution is to redistribute administrative roles and functions which have been centralized, toward both self-governing bodies and communities including NGO. The level of devolution in nuclear regulatory system depends on how to redistribute nuclear related roles and functions among central/local government with KINS. Therefore, it is very important to examine general principles criteria and type of domestic/foreign role adjustment for effective/rational/democratic nuclear regulation. Based on previous model and system proposed, role adjustment action plans are reviewed taking account of the nuclear environmental changes in the localization era. In the long run, the result of this research will be expected to utilize the optimal and democratic regulatory system in Korea.

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

Regulatory control of radiation sources. Safety guide

International Nuclear Information System (INIS)

2004-01-01

The basic requirements for the protection of persons against exposure to ionizing radiation and for the safety of radiation sources were established in the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (the Basic Safety Standards), jointly sponsored by the Food and Agriculture Organization of the United Nations (FAO), the International Atomic Energy Agency (IAEA), the International Labour Organization (ILO), the OECD Nuclear Energy Agency (OECD/ NEA), the Pan American Health Organization (PAHO) and the World Health Organization (WHO) (the Sponsoring Organizations). The application of the Basic Safety Standards is based on the presumption that national infrastructures are in place to enable governments to discharge their responsibilities for radiation protection and safety. Requirements relating to the legal and governmental infrastructure for the safety of nuclear facilities and sources of ionizing radiation, radiation protection, the safe management of radioactive waste and the safe transport of radioactive material are established in the Safety Requirements on Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, Safety Standards Series No. GS-R-1. This Safety Guide, which is jointly sponsored by the FAO, the IAEA, the International Labour Office, the PAHO and the WHO, gives detailed guidance on the key elements for the organization and operation of a national regulatory infrastructure for radiation safety, with particular reference to the functions of the national regulatory body that are necessary to ensure the implementation of the Basic Safety Standards. The Safety Guide is based technically on material first published in IAEA-TECDOC-10671, which was jointly sponsored by the FAO, the IAEA, the OECD/NEA, the PAHO and the WHO. The requirements established in GS-R-1 have been taken into account. The Safety Guide is oriented towards national

The Independence of the Media and Its Regulatory Agencies: Shedding new light on formal and actual independence against the national context

NARCIS (Netherlands)

Schultz, W.; Valcke, P.; Irion, K.

2014-01-01

Media independence is vital for democracies, and so is the independence of the regulatory bodies governing it. The Independence of the Media and its Regulatory Agencies explores the complex relationship between media governance and independence of media regulatory authorities within Europe, which

Governing the moral economy: animal engineering, ethics and the liberal government of science.

Science.gov (United States)

Harvey, Alison; Salter, Brian

2012-07-01

The preferred Western model for science governance has come to involve attending to the perspectives of the public. In practice, however, this model has been criticised for failing to promote democracy along participatory lines. We argue that contemporary approaches to science policy making demonstrate less the failure of democracy and more the success of liberal modes of government in adapting to meet new governance challenges. Using a case study of recent UK policy debates on scientific work mixing human and animal biological material, we show first how a 'moral economy' is brought into being as a regulatory domain and second how this domain is governed to align cultural with scientific values. We suggest that it is through these practices that the state assures its aspirations for enhancing individual and collective prosperity through technological advance are met. Copyright © 2012 Elsevier Ltd. All rights reserved.

Telecommunications in South Africa: Governance of who is actually regulating?

Directory of Open Access Journals (Sweden)

L-F Pau

2013-09-01

Full Text Available Although the Republic of South Africa telecommunications market is a maturing one with a large customer base to serve, it has been repeatedly been observed over the past few years that many good intentions were formulated in the regulatory sphere with sometimes poor outcomes and unclear governance. A number of surprising observations have been made on the outcomes, the delays or other process related events linked to regulatory measures. The paper thus researches first, from a governance point of view, who is actually regulating the telecommunications industry; it identifies next opportunities and bottlenecks whereby a change might happen to reach the expected outcomes. A political economy methodology is taken, backed up by extensive field work over 2010 and 2011, leading to a web of conjectures providing answers to the first question, based on an extensive analysis of key stakeholders goals, positions and interactions. Finally, a number of measures are proposed to improve the governance, regulatory impact and efficiency, and evolve the South African telecommunications eco-system.

Using SCOR as a Supply Chain Management Framework for Government Agency Contract Requirements

Science.gov (United States)

Paxton, Joseph; Tucker, Brian

2010-01-01

This paper will present a model that uses the Supply-Chain Operations Reference (SCOR) model as a foundation for a framework to illustrate the information needed throughout a product lifecycle to support a healthy supply chain management function and the subsequent contract requirements to enable it. It will also show where in the supply chain the information must be extracted. The ongoing case study used to exemplify the model is NASA's (National Aeronautics and Space Administration) Ares I program for human spaceflight. Effective supply chain management and contract requirements are ongoing opportunities for continuous improvement within government agencies, specifically development of systems for human spaceflight operations. Multiple reports from the Government Accountability Office (GAO) reinforce this importance. The SCOR model is a framework for describing a supply chain with process building blocks and business activities. It provides a set of metrics for measuring supply chain performance and best practices for continuously improving. This paper expands the application of the SCOR to also provide the framework for defining information needed from different levels of the supply chain and at different phases of the lifecycle. These needs can be incorporated into contracts to enable more effective supply chain management. Depending on the phase of the lifecycle, effective supply chain management will require involvement from different levels of the organization and different levels of the supply chain.

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

Public Governance and Economic Growth in the Transitional Economies of the European Union

Directory of Open Access Journals (Sweden)

Yilmaz BAYAR

2016-06-01

Full Text Available According to new growth theories, public governance is an important determinant for sustained economic growth. This study examines the impact of six public governance indicators, including voice and accountability, political stability and the absence of violence/terrorism, government effectiveness, regulatory quality, rule of law and control of corruption, on the economic growth in the transitional economies of the European Union during the 2002-2013 period. The results show that all governance indicators except regulatory quality had a statistically significant positive impact on economic growth. Our findings also indicate that control of corruption and rule of law had the largest impact on economic growth, while political stability had the lowest impact.

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.

Regulating Corporate Governance in the EU

DEFF Research Database (Denmark)

Horn, Laura

In the context of the financial and economic crisis, corporate governance and regulatory supervision failures are at the centre of public debates. Who controls the modern corporation, and why, has become one of the defining social power relations in contemporary capitalism. Regulation Corporate...... transformation of company law and corporate governance regulation. Her findings about the marketization of corporate control are at the core to a better understanding of the broader context of capitalist restructuring in the European Union....

Corporate Governance Structure and Audit Quality

OpenAIRE

ZENG, SHIWEN

2012-01-01

Audit quality has always been the focus of attention by government regulatory authorities, the legislature, public investment and other stakeholders. This paper is going to investigate the effects of corporate governance structure on audit quality for the UK evidence. The sample study consists of 226 companies among FTSE 350 listed on the London Stock Exchange (LSE) for the fiscal year of 2011. The regression results and analysis are used to investigate the relationship between the audit qual...

The dynein regulatory complex is required for ciliary motility and otolith biogenesis in the inner ear.

Science.gov (United States)

Colantonio, Jessica R; Vermot, Julien; Wu, David; Langenbacher, Adam D; Fraser, Scott; Chen, Jau-Nian; Hill, Kent L

2009-01-08

In teleosts, proper balance and hearing depend on mechanical sensors in the inner ear. These sensors include actin-based microvilli and microtubule-based cilia that extend from the surface of sensory hair cells and attach to biomineralized 'ear stones' (or otoliths). Otolith number, size and placement are under strict developmental control, but the mechanisms that ensure otolith assembly atop specific cells of the sensory epithelium are unclear. Here we demonstrate that cilia motility is required for normal otolith assembly and localization. Using in vivo video microscopy, we show that motile tether cilia at opposite poles of the otic vesicle create fluid vortices that attract otolith precursor particles, thereby biasing an otherwise random distribution to direct localized otolith seeding on tether cilia. Independent knockdown of subunits for the dynein regulatory complex and outer-arm dynein disrupt cilia motility, leading to defective otolith biogenesis. These results demonstrate a requirement for the dynein regulatory complex in vertebrates and show that cilia-driven flow is a key epigenetic factor in controlling otolith biomineralization.

Animal Health Ireland: providing national leadership and coordination of non-regulatory animal health issues in Ireland.

Science.gov (United States)

More, S J; Doherty, M L; Downey, L; McKenzie, K; Devitt, C; O'Flaherty, J

2011-12-01

Livestock production plays an important role in the Irish economy. Regulatory animal health issues are the responsibility of government, but until recently there has been no national coordination of non-regulatory animal health issues. This gap has recently been filled with the establishment of Animal Health Ireland (AHI), a not-for-profit, partnership-based organisation providing national leadership and coordination of non-regulatory animal health issues in Ireland. Animal Health Ireland provides benefits to livestock producers and processors by providing the knowledge, education and coordination required to establish effective control strategies, both on-farm and nationally. This paper presents a brief overview of the context for AHI, and of its establishment and initial activities. Non-regulatory animal health issues have been prioritised. A series of work programmes (each focusing on a high-priority issue) have been established. Partnership is critical to success, both for AHI as an organisation and for effective farm-level transfer of knowledge. This model for national leadership and coordination of non-regulatory animal health issues may be of relevance elsewhere.

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

OpenAIRE

International Monetary Fund

2007-01-01

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

Sensitivity analysis for missing data in regulatory submissions.

Science.gov (United States)

Permutt, Thomas

2016-07-30

The National Research Council Panel on Handling Missing Data in Clinical Trials recommended that sensitivity analyses have to be part of the primary reporting of findings from clinical trials. Their specific recommendations, however, seem not to have been taken up rapidly by sponsors of regulatory submissions. The NRC report's detailed suggestions are along rather different lines than what has been called sensitivity analysis in the regulatory setting up to now. Furthermore, the role of sensitivity analysis in regulatory decision-making, although discussed briefly in the NRC report, remains unclear. This paper will examine previous ideas of sensitivity analysis with a view to explaining how the NRC panel's recommendations are different and possibly better suited to coping with present problems of missing data in the regulatory setting. It will also discuss, in more detail than the NRC report, the relevance of sensitivity analysis to decision-making, both for applicants and for regulators. Published 2015. This article is a U.S. Government work and is in the public domain in the USA. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

Science.gov (United States)

2010-04-26

... Regulatory Commission Federal Housing Finance Agency Federal Maritime Commission Federal Mediation and... that the Regulatory Flexibility Act may require a Regulatory Flexibility Analysis, actions selected for.... Regulatory Flexibility Analysis Required -- whether an analysis is required by the Regulatory Flexibility Act...

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

International Nuclear Information System (INIS)

Lee, Chang Ju; Choi, Jong Soo

2005-01-01

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

Nuclear regulatory regime in Lithuania

International Nuclear Information System (INIS)

Kutas, S.

1999-01-01

The Law on Nuclear Energy establishes the legal basis for nuclear safety in the Republic of Lithuania. It assigns the responsibility for safety to the operating organization of a nuclear facility and outlines the tasks of the operator and the regulatory authority. According to this Law, the Nuclear Power Safety Inspectorate (VATESI) shall implement state regulation of nuclear safety. Standards and rules, guides and regulations of nuclear safety and radiation protection approved by the Government or by the institutions authorised. It is mandatory for all public and local authorities, enterprises, institutions, organisations, their associations, the officials and other persons whose activities are related to the operation of nuclear facilities, to the use and management of nuclear and radioactive materials therein. Safety guarantee in nuclear energy based on the requirements of the laws and regulations of the Republic of Lithuania, on the requirements of the international treaties to which the Republic of Lithuania is a party, also on the recommendations of the IAEA and other international organisations and authorities

A regulatory adjustment process for the determination of the optimal percentage requirement in an electricity market with Tradable Green Certificates

International Nuclear Information System (INIS)

Currier, Kevin M.

2013-01-01

A system of Tradable Green Certificates (TGCs) is a market-based subsidy scheme designed to promote electricity generation from renewable energy sources such as wind power. Under a TGC system, the principal policy instrument is the “percentage requirement,” which stipulates the percentage of total electricity production (“green” plus “black”) that must be obtained from renewable sources. In this paper, we propose a regulatory adjustment process that a regulator can employ to determine the socially optimal percentage requirement, explicitly accounting for environmental damages resulting from black electricity generation. - Highlights: • A Tradable Green Certificate (TGC) system promotes energy production from renewable sources. • We consider an electricity oligopoly operated under a TGC system. • Welfare analysis must account for damages from “black” electricity production. • We characterize the welfare maximizing (optimal) “percentage requirement.” • We present a regulatory adjustment process that computes the optimal percentage requirement iteratively

IAEA Mission Sees Significant Progress in Georgia’s Regulatory Framework, Challenges Ahead

International Nuclear Information System (INIS)

2018-01-01

An International Atomic Energy Agency (IAEA) team of experts said Georgia has made significant progress in strengthening its regulatory framework for nuclear and radiation safety. The team also pointed to challenges ahead as Georgia seeks to achieve further progress. The Integrated Regulatory Review Service (IRRS) team concluded a 10-day mission on 28 February to assess the regulatory safety framework in Georgia. The mission was conducted at the request of the Government and hosted by the Agency of Nuclear and Radiation Safety (ANRS), which is responsible for regulatory oversight in the country. IRRS missions are designed to strengthen the effectiveness of the national safety regulatory infrastructure, while recognizing the responsibility of each State to ensure nuclear and radiation safety. Georgia uses radioactive sources in medicine and industry and operates radioactive waste management facilities. It has decommissioned its only research reactor and has no nuclear power plants. In recent years, the Government and ANRS, with assistance from the IAEA, introduced new safety regulations and increased the number of regulatory inspections.

Policy and Regulatory Challenges in the Tourism Collaborative Economy

DEFF Research Database (Denmark)

Dredge, Dianne

2017-01-01

The choice of policy approach and regulatory framework in dealing with the collaborative economy rests on two fundamental factors—that government decisions should be based on good sound knowledge and that this knowledge should be above politics. In the newly emerging and rapidly growing collabora......The choice of policy approach and regulatory framework in dealing with the collaborative economy rests on two fundamental factors—that government decisions should be based on good sound knowledge and that this knowledge should be above politics. In the newly emerging and rapidly growing......-sectors of the collaborative economy. However, these solutions are often based on assumptions about government sovereignty and power relations that do not necessarily apply in the slippery global world of platform capitalism. This chapter seeks to undertake a critical exploration of the factors and values that permeate...

Economics of the specification 6M safety re-evaluation and regulatory requirements

International Nuclear Information System (INIS)

Hopper, C.M.

1985-01-01

The objective of this work was to examine the potential economic impact of the DOT Specification 6M criticality safety re-evaluation and regulatory requirements. The examination was based upon comparative analyses of current authorized fissile material load limits for the 6M, current Federal regulations (and interpretations) limiting the contents of Type B fissile material packages, limiting aggregates of fissile material packages, and recent proposed fissile material mass limits derived from specialized criticality safety analyses of the 6M package. The work examines influences on cost in transportation, handling, and storage of fissile materials. Depending upon facility throughput requirements (and assumed incremental costs of fissile material packaging, storage, and transport), operating, facility storage capacity, and transportation costs can be reduced significantly. As an example of the pricing algorithm application based upon reasonable cost influences, the magnitude of the first year cost reductions could extend beyond four times the cost of the packaging nuclear criticality safety re-evaluation. 1 tab

Regulatory framework for nuclear power plant operation

International Nuclear Information System (INIS)

Perez Alcaniz, T.; Esteban Barriendos, M.

1995-01-01

As the framework of standards and requirements covering each phase of nuclear power plant project and operation developed, plant owners defined their licensing commitments (codes, rules and design requirements) during the project and construction phase before start-up and incorporated regulatory requirements imposed by the regulatory Body during the licensing process prior to operation. This produces a regulatory framework for operating a plant. It includes the Licensing Basis, which is the starting point for analyzing and incorporating new requirements, and for re-evaluation of existing ones. This presentation focuses on the problems of applying this regulatory framework to new operating activities, in particular to new projects, analyzing new requirements, and reconsidering existing ones. Clearly establishing a plant's licensing basis allows all organizations involved in plant operation to apply the requirements in a more rational way. (Author)

Quality requirements for allergen extracts and allergoids for allergen immunotherapy.

Science.gov (United States)

Zimmer, J; Bonertz, A; Vieths, S

2017-12-01

All allergen products for allergen immunotherapy currently marketed in the European Union are pharmaceutical preparations derived from allergen-containing source materials like pollens, mites and moulds. Especially this natural origin results in particular demands for the regulatory requirements governing allergen products. Furthermore, the development of regulatory requirements is complicated by the so far missing universal link between certain quality parameters, in particular biological potency, on the one hand and clinical efficacy on the other hand. As a consequence, each allergen product for specific immunotherapy has to be assessed individually for its quality, safety and efficacy. At the same time, biological potency of allergen products is most commonly determined using IgE inhibition assays based on human sera relative to product-specific in house references, ruling out full comparability of products from different manufacturers. This review article aims to summarize the current quality requirements for allergen products including the special requirements implemented for control of chemically modified allergen extracts (allergoids). Copyright © 2017 SEICAP. Published by Elsevier España, S.L.U. All rights reserved.

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.

Privatrechtliche Regelsetzung, Governance und Verhaltensökonomik

Directory of Open Access Journals (Sweden)

Florian Möslein

2014-05-01

Full Text Available ENGLISH: Governance and behavioral economics can enrich private law theory especially insofar as they contribute to effective rulemaking, i.e. to the choice of targeted regulatory instruments and the design of meaningful regulatory strategies. Conversely, both instruments are methodologically much less suited to define themselves protection objectives or to determine the substance matter of regulation. This task should be left to another, upstream level. Legal policy and regulation are to be separated, at least analytically. It is therefore not desirable, but (unfortunately not excluded in legal reality, that governance and behavioral economics are exploited as instruments of a hidden agenda of legal policy, regardless of their methodological suitability. DEUTSCH: Governance und Verhaltensökonomik können die Privatrechtswissenschaft vor allem insofern bereichern, als sie zu effektiver Regelsetzung, also zur Auswahl zielführender Regelungsinstrumente und zur Entwicklung sinnvoller Regelungsstrategien beitragen. Umgekehrt sind beide Instrumente methodisch ungleich weniger geeignet, selbst Schutzziele zu definieren und dadurch materielle Regelungsinhalte zu determinieren. Diese Aufgabe sollte einer anderen, vorgelagerten Ebene vorbehalten bleiben; Rechtspolitik und Regelsetzung sind zumindest analytisch voneinander zu trennen. Dass Governance und Verhaltensökonomik ungeachtet ihrer methodischen Eignung in der Rechtswirklichkeit instrumentalisiert werden, um versteckte Rechtspolitik zu betreiben, ist mithin nicht wünschenswert – aber (leider auch nicht ausgeschlossen.

Requirements for growth and IL-10 expression of highly purified human T regulatory cells

OpenAIRE

Bonacci, Benedetta; Edwards, Brandon; Jia, Shuang; Williams, Calvin; Hessner, Martin J.; Gauld, Stephen; Verbsky, James

2012-01-01

Human regulatory T cells (TR) cells have potential for the treatment of a variety of immune mediated diseases but the anergic phenotype of these cells makes them difficult to expand in vitro. We have examined the requirements for growth and cytokine expression from highly purified human TR cells, and correlated these findings with the signal transduction events of these cells. We demonstrate that these cells do not proliferate or secrete IL-10 even in the presence of high doses of IL-2. Stimu...

Lessons learned from the Fukushima Dai-ichi accident and responses in NRA regulatory requirements

International Nuclear Information System (INIS)

Fuketa, Toyoshi

2014-01-01

The author would like to present significant lessons learned from the TEPCO’s Fukushima Dai-ichi accident and responses in regulatory requirements developed by the Nuclear Regulation Authority for power-producing light water reactors. The presentation will cover prevention of structures, systems and components failures, measures to prevent common cause failures, prevention of core damage, mitigation of severe accidents, emergency preparedness, continuous improvement of safety, use of probabilistic risk assessment, and post-accident regulation on the Fukushima Dai-ichi. (author)

Recent Developments in German Corporate Governance

NARCIS (Netherlands)

Goergen, M.; Manjon, M.C.; Renneboog, L.D.R.

2004-01-01

We contrast the features of the German corporate governance system with those of other systems and discuss the recent regulatory initiatives.For example, the rules on insider trading and anti-trust have been strengthened.The Restructuring Act has been revised to prevent minority shareholders from

77 FR 7930 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

Science.gov (United States)

2012-02-13

... the Regulatory Flexibility Act (5 U.S.C. 602), the Department of Defense's printed agenda entries... section 610 of the Regulatory Flexibility Act. Printing of these entries is limited to fields that contain...D Intelligence Interrogations, Detainee Debriefings, and Tactical Questioning. This rule only...

Evaluating e-Government and Good Governance Correlation

Directory of Open Access Journals (Sweden)

Suhardi Suhardi

2016-03-01

Full Text Available Assessing the achievement of Indonesian government institutions in implementing e-government has been conducted since around a decade ago. Several national assessments are available with almost the same ranking results. There is an agreement that the ultimate goal of e-government implementation is to achieve good government governance (GGG, while success stories of e-government require good governance practices. This study explored the correlation between e-government achievement and GGG achievement in Indonesia. Spearman’s rank correlation was used to characterize the relationship strength between e-government assessment results and good governance assessment results. The data were collected from institutions that participated in e-government and good governance assessments. The results showed that the correlation between these two entities is not very strong. Most cases showed that e-government implementation and the achievement of good governance have only a moderate positive correlation and none of the studied cases indicated a significant connection. This result can be attributed to the lack of emphasis on goals achievement in the assessments. Thus, it is recommended that future Indonesian e-government assessments should involve impact indicators.

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

Diagnosis of the Brazilian Nuclear Regulatory body

International Nuclear Information System (INIS)

Santos Gomes, Rogerio dos; Magalhaes Ennes Ennes, Edson Carlos

2008-01-01

This work has the objective to present the diagnosis of the existing structure in the Brazilian Government to ensure the radioprotection and nuclear safety in the country, being compared the current situation with the conclusions presented in another studies, carried through in last 30 years, with special attention in the existence of the necessary available to support and independence of the national regulatory body for the development of the regulatory inspections activities in the radioprotection and nuclear safety. (author)

34 CFR 400.9 - What additional requirements govern the Vocational and Applied Technology Education Programs?

Science.gov (United States)

2010-07-01

... Applied Technology Education Programs? 400.9 Section 400.9 Education Regulations of the Offices of the... VOCATIONAL AND APPLIED TECHNOLOGY EDUCATION PROGRAMS-GENERAL PROVISIONS § 400.9 What additional requirements govern the Vocational and Applied Technology Education Programs? In addition to the Act, applicable...

Liberalization, Bank Governance, and Risk Taking

NARCIS (Netherlands)

M. Illueca (Manuel); L. Norden (Lars); G.F. Udell (Gregory)

2011-01-01

textabstractWe study the effects of the interplay between deregulation and governance on risk taking in the financial industry. We consider a large natural experiment in Spain where the removal of regulatory geographic constraints for savings banks led to a nationwide expansion of these banks during

Constraining Government Regulatory Authority: Tobacco Industry Trade Threats and Challenges to Cigarette Package Health Warning Labels

OpenAIRE

Crosbie, Eric

2016-01-01

This dissertation investigates the rising authority of non-state actors vis-à-vis the state by examining how tobacco companies are using trade agreements to constrain governments from implementing progressive public health policies that require placing pictorial health warning labels (HWLs) on cigarette packages. In particular, the dissertation seeks to address two different but related puzzles. First, despite being developed countries and global health leaders, it is unclear why Australia ha...

Legal and regulatory education and training needs in the healthcare industry.

Science.gov (United States)

Henson, Steve W; Burke, Debra; Crow, Stephen M; Hartman, Sandra J

2005-01-01

As in any other industry, laws and regulations significantly impact the functioning of the healthcare industry. Some laws, such as those relating to malpractice and social insurance systems, affect the manner in which the industry operates. Other laws, such as those regulating antitrust and employment practices, affect the organization and the environment in which the industry operates. It is increasingly important that practitioners and managers be cognizant of this complex and dynamic legal minefield. This study examined healthcare managers and executives' knowledge of 9 key issues in the legal and regulatory environment of the healthcare industry. Specifically, the study focused on knowledge concerning tort and contract liability, insurance law, labor and employment regulation, criminal and ethical responsibility, antitrust regulation, the law governing business associations and recent developments. Findings suggest that the levels of knowledge required to manage legal and regulatory issues are much greater than the existing levels of knowledge.

78 FR 44237 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

Science.gov (United States)

2013-07-23

... Federal Regulatory and Deregulatory Actions is composed of the regulatory status reports, including... Ownership of Offeror 0750-AH58 (DFARS Case 2011-D044). 120 Release of Fundamental 0750-AH92 Research... (DFARS Case 2009-D031). 122 Proposal Adequacy 0750-AH47 Checklist (DFARS Case 2011-D042). Office of...

Inspection of radiation sources and regulatory enforcement (supplement to IAEA Safety Standards Series No. GS-G-1.5)

International Nuclear Information System (INIS)

2010-08-01

The achievement and maintenance of a high level of safety in the use of radiation sources depends on there being a sound legal and governmental infrastructure, including a national regulatory body with well-defined responsibilities and functions. These responsibilities and functions include establishing and implementing a system for carrying out regulatory inspections, and taking necessary enforcement actions. The Safety Requirements publication entitled Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety establishes the requirements for legal and governmental infrastructure. The term 'infrastructure' refers to the underlying structure of systems and organizations. This includes requirements concerning the establishment of a regulatory body for radiation sources and the responsibilities and functions assigned to it. The International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (the Basic Safety Standards or the BSS) establish basic requirements for protection against risks associated with exposure to ionizing radiation and for the safety of radiation sources. The application of the BSS is based on the presumption that national infrastructures are in place to enable governments to discharge their responsibilities to for radiation protection and safety. This TECDOC provides practical guidance on the processes for carrying out regulatory inspections and taking enforcement actions. It includes information on the development and use of procedures and standard review plans (i.e. checklists) for inspection. Specific procedures for inspection of radiation practices and sources are provided in the Appendices

Inspection of radiation sources and regulatory enforcement (supplement to IAEA Safety Standards Series No. GS-G-1.5)

International Nuclear Information System (INIS)

2007-04-01

The achievement and maintenance of a high level of safety in the use of radiation sources depends on there being a sound legal and governmental infrastructure, including a national regulatory body with well-defined responsibilities and functions. These responsibilities and functions include establishing and implementing a system for carrying out regulatory inspections, and taking necessary enforcement actions. The Safety Requirements publication entitled Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety establishes the requirements for legal and governmental infrastructure. The term 'infrastructure' refers to the underlying structure of systems and organizations. This includes requirements concerning the establishment of a regulatory body for radiation sources and the responsibilities and functions assigned to it. The International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (the Basic Safety Standards or the BSS) establish basic requirements for protection against risks associated with exposure to ionizing radiation and for the safety of radiation sources. The application of the BSS is based on the presumption that national infrastructures are in place to enable governments to discharge their responsibilities to for radiation protection and safety. This TECDOC provides practical guidance on the processes for carrying out regulatory inspections and taking enforcement actions. It includes information on the development and use of procedures and standard review plans (i.e. checklists) for inspection. Specific procedures for inspection of radiation practices and sources are provided in the Appendices

Regulatory problems relating to energy in Hungary

International Nuclear Information System (INIS)

Remenyi, K.

2002-01-01

One of basic problems of the transition in the energy economy is, how far the process of liberalisation and privatisation could go, i.e. to what extent the control of state/government would be given up, and how the breakdown of the commanding positions of the government would be managed. The transition in the energy sector toward a market economy is characterised by restructuring the regulatory framework of the energy industry, changing the operational structure of the sector and profound reshaping of ownership structures of the enterprises. In Hungary the government, being convinced of the importance of the implementation of the market forces, in 1991 made the first step on the way of restructuring the energy sector in order to increase economic efficiency, to enable companies to react to market forces and to privatise them. Parallel and partly after the restructuring, a profound modification of legal and regulatory framework took place and finally a relatively large scale of privatisation has newly emerged, which will continue in future, too. The process of the energy sector liberalisation in Hungary has a stop and go character and the game is not over. The process can be characterised by institutional restructuring in the energy sector (coal, oil/gas, power ), which is the basic condition for market liberalisation and privatisation, and by the creation of an appropriate environment (regulatory framework, pricing policy, etc. ) for the smooth implementation of the liberation process(author)

[Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

Science.gov (United States)

Kuhlmann-Gottke, Johanna; Duchow, Karin

2015-11-01

At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

Regulatory aspects of criticality control in Australia

International Nuclear Information System (INIS)

Zimin, Sergei

2003-01-01

With the creation of Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) the Australian approach to criticality safety was revisited. Consistency with international best practices is required by the Act that created ARPANSA and this was applied to practices in criticality safety adopted in other countries. This required extensive regulatory efforts both in auditing the major Australian Nuclear Operator, Australian Nuclear Science and Technology Organisation (ANSTO), and assessing the existing in Australia criticality safety practices and implementing the required changes using the new legislative power of ARPANSA. The adopted regulatory approach is formulated through both the issued by ARPANSA licenses for nuclear installations (including reactors, fuel stores and radioactive waste stores) and the string of new regulatory documents, including the Regulatory Assessment Principles and the Regulatory Assessment Guidelines for criticality safety. The main features of the adopted regulation include the requirements of independent peer-review, ongoing refresher training coupled with annual accreditation and the reliance on the safe design rather than on an administrative control. (author)

78 FR 77181 - Self-Regulatory Organizations; The Options Clearing Corporation; Advance Notice Concerning the...

Science.gov (United States)

2013-12-20

... financial system because it will enhance the transparency of OCC's governance arrangements. The advance...-Regulatory Organizations; The Options Clearing Corporation; Advance Notice Concerning the Governance... Advance Notice This advance notice concerns the charter of the Governance Committee (``GC Charter'') of...

Regulatory analysis technical evaluation handbook. Final report

International Nuclear Information System (INIS)

1997-01-01

The purpose of this Handbook is to provide guidance to the regulatory analyst to promote preparation of quality regulatory analysis documents and to implement the policies of the Regulatory Analysis Guidelines of the US Nuclear Regulatory Commission (NUREG/BR-0058 Rev. 2). This Handbook expands upon policy concepts included in the NRC Guidelines and translates the six steps in preparing regulatory analyses into implementable methodologies for the analyst. It provides standardized methods of preparation and presentation of regulatory analyses, with the inclusion of input that will satisfy all backfit requirements and requirements of NRC's Committee to Review Generic Requirements. Information on the objectives of the safety goal evaluation process and potential data sources for preparing a safety goal evaluation is also included. Consistent application of the methods provided here will result in more directly comparable analyses, thus aiding decision-makers in evaluating and comparing various regulatory actions. The handbook is being issued in loose-leaf format to facilitate revisions. NRC intends to periodically revise the handbook as new and improved guidance, data, and methods become available

IAEA Mission Concludes Peer Review of Jordan's Nuclear Regulatory Framework

International Nuclear Information System (INIS)

2014-01-01

Senior international nuclear safety and radiation protection experts today concluded an 11-day International Atomic Energy Agency (IAEA) Integrated Regulatory Review Service (IRRS) mission to review the regulatory framework for nuclear and radiation safety in Jordan. The mission team said in its preliminary findings that Jordan's nuclear regulator, the Energy and Minerals Regulatory Commission (EMRC), faces challenges because it is a relatively new body that handles a high workload while also working to recruit, train and keep competent staff. The team also noted that a recent merger provided the regulator with more of the resources it needs to perform its duty. The team made recommendations and suggestions to the regulatory body and the Government to help them strengthen the effectiveness of Jordan's regulatory framework and functions in line with IAEA Safety Standards. The main observations of the IRRS Review team comprised the following: The regulatory body, founded in 2007 and merged with other regulators in April 2014 to form EMRC, faces large challenges in terms of its regulatory workload, management system building and staff recruitment and training; The new EMRC structure and revision of the radiation and nuclear safety law represents an important opportunity to strengthen Jordan's radiation and nuclear safety infrastructure; The Government has shown commitment to radiation and nuclear safety through measures including becoming party to international conventions. It could further demonstrate its commitment by adopting a formal national policy and strategy for safety that defines the role of the Minister of Energy in relation to EMRC and protects the independence of regulatory decision-making

Cryptocurrencies & the Challenge of Global Governance

Directory of Open Access Journals (Sweden)

Garry Jacbs

2018-05-01

Full Text Available The recent explosive development of new forms of digital currency opens up unprecedented opportunities and poses significant regulatory challenges. This new form of digital currency lowers the costs and other barriers to the global movement of money, international trade, foreign investment and speculation, while simultaneously enhancing the anonymity on which tax evasion, money-laundering and other illegal activities thrive. It also liberates the creation of money and regulation of economic activities from the political control of national governments and central banks. Since the value of a currency is related to the size of the population, strength of the economy and value of transactions that utilize it, a basket of cryptocurrencies could emerge as the first prototype of a world currency whose value is backed by the total productive capacity of the entire human community. Moreover, the triad of Internet, distributed ledger technologies and cryptocurrencies could serve as the basis for the development of new global economic potentials in a manner similar and a degree far exceeding the economic impact of the World Wide Web over the past two decades. At the same time, the rapid deployment of cryptocurrencies could have profound impact on the capacity of governments to tax transactions, income and wealth, one of the main pillars of the modern nation state. The development of autonomous global cryptocurrencies could dramatically reduce the control and effectiveness of existing regulatory mechanisms at the national level and generate considerable pressure for the evolution of more effective institutions for global governance. They could provide compelling incentives for national governments to enhance international cooperation and strengthen the functioning of international institutions to fill the regulatory void. International organizations will play an important role in harnessing the potentials and minimizing the risks arising from the growing

42 CFR 137.205 - Will this voluntary uniform data set reporting activity be required of all Self-Governance Tribes...

Science.gov (United States)

2010-10-01

... resources, hardware, software, and technical assistance to the Self-Governance Tribes to facilitate data... 42 Public Health 1 2010-10-01 2010-10-01 false Will this voluntary uniform data set reporting activity be required of all Self-Governance Tribes entering into a compact with the IHS under Title V? 137...

Evaluation of the applicability of existing nuclear power plant regulatory requirements in the U.S. to advanced small modular reactors.

Energy Technology Data Exchange (ETDEWEB)

LaChance, Jeffrey L.; Wheeler, Timothy A.; Farnum, Cathy Ottinger; Middleton, Bobby D.; Jordan, Sabina Erteza; Duran, Felicia Angelica; Baum, Gregory A.

2013-05-01

The current wave of small modular reactor (SMR) designs all have the goal of reducing the cost of management and operations. By optimizing the system, the goal is to make these power plants safer, cheaper to operate and maintain, and more secure. In particular, the reduction in plant staffing can result in significant cost savings. The introduction of advanced reactor designs and increased use of advanced automation technologies in existing nuclear power plants will likely change the roles, responsibilities, composition, and size of the crews required to control plant operations. Similarly, certain security staffing requirements for traditional operational nuclear power plants may not be appropriate or necessary for SMRs due to the simpler, safer and more automated design characteristics of SMRs. As a first step in a process to identify where regulatory requirements may be met with reduced staffing and therefore lower cost, this report identifies the regulatory requirements and associated guidance utilized in the licensing of existing reactors. The potential applicability of these regulations to advanced SMR designs is identified taking into account the unique features of these types of reactors.

A study on the role adjustment between central and local government

Energy Technology Data Exchange (ETDEWEB)

Yook, Dong Il; Ji, Min Gu; Yun, Yo Il; Kim, Yong Cheon; Lee, Sang In; Lee, Chan Won [Chunnam National Univ., Taejon (Korea, Republic of)

2003-02-15

The goal of this study is to develop new model and feasible alternatives by seeking solutions for rational redistribution of the nuclear regulatory roles between central and local governments. Since local autonomy system has been reimplemented in Korea, It is imperative to improve reform measures for the decentralization of power between central and local governments. The core of decentralization is to redistribute administrative authorities and roles which have been centralized, toward both self-governing body and communities. The level of decentralization depends on how to redistribute roles and functions between central and local government. Therefore, it is necessary to examine principle and type of domestic foreign role adjustment for effective nuclear regulation. Based on three prerequisite studies, role adjustment model for more effective nuclear regulation is made taking account of the current domestic environments and conditions. In the long run, the outcomes of this study will be expected to improve the optimal and democratic regulatory system in Korea.

A study on the role adjustment between central and local government

International Nuclear Information System (INIS)

Ahn, S. K.; Yook, D. R.

2003-01-01

The goal of this study is to develop new model and feasible alternatives by seeking solutions for national redistribution of the nuclear regulatory roles between central and local governments. Since local autonomy system has been reimplemented in Korea, it is imperative to improve reform measures for the decentralization of powers between central and local governments. The core of decentralization is to redistribute administrative authorities and roles which have been centralized, toward both self-governing body and communities. The level of decentralization depends on how to redistribute roles and functions between central and local government. Therefore, it is necessary to examine principle and type of domestic foreign role adjustment for effective nuclear regulation. Based on three prerequisite studies, role adjustment model for more effective nuclear regulation is made taking account of the current domestic environments and conditions. In the long run, the outcomes of this study will be expected to improve the optimal and democratic regulatory system in Korea

Policy uncertainty and corporate performance in government-sponsored voluntary environmental programs.

Science.gov (United States)

Liu, Ning; Tang, Shui-Yan; Zhan, Xueyong; Lo, Carlos Wing-Hung

2018-08-01

This study combines insights from the policy uncertainty literature and neo-institutional theory to examine corporate performance in implementing a government-sponsored voluntary environmental program (VEP) during 2004-2012 in Guangzhou, China. In this regulatory context, characterized by rapid policy changes, corporate performance in VEPs is affected by government surveillance, policy uncertainty, and peer pressures. Specifically, if VEP participants have experienced more government surveillance, they tend to perform better in program implementation. Such positive influence of government surveillance is particularly evident among those joining under high and low, rather than moderate uncertainty. Participants also perform better if they belong to an industry with more certified VEP firms, but worse if they are located in a regulatory jurisdiction with more certified VEP firms. At a moderate level of policy uncertainty, within-industry imitation is most likely to occur but within-jurisdiction imitation is least likely to occur. Copyright © 2018 Elsevier Ltd. All rights reserved.

Should states and local governments regulate dietary supplements?

Science.gov (United States)

Starr, Ranjani

2016-01-01

Federal regulation of dietary supplements in the United States is governed by the Dietary Supplement Health and Education Act of 1994. The law has been criticized as weak and ineffective. Alarming research has emerged demonstrating that supplements may be mislabelled, contaminated, adulterated with dangerous or unknown compounds, or sold at toxic doses. As a result, the health community has raised concerns about the safety and quality of dietary supplements. Increased federal oversight is an important avenue for improving supplement safety; however, states and local governments may also pursue strategies to strengthen the overall regulatory control of dietary supplements. States and local governments have substantial experience in regulating other products that pose a risk to public health, such as tobacco. Additionally, much has been learned about the tactics the tobacco industry has employed to protect its interests. Lessons learned may be applied to new regulatory efforts aimed at improving the safety of dietary supplements at the state and local levels. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Requirements, guidance and logic in planning environmental investigations: Approval versus implementation

International Nuclear Information System (INIS)

Brice, D.A.; Meredith, D.V.; Harris, M.Q.

1993-01-01

In today's litigious society, it is important for both private parties and government to plan and conduct environmental investigations in a scientifically sound manner, documenting the purpose, methods, and results in a consistent fashion throughout the exercise. Planning documents are prepared during the initial phases of environmental investigations. Project objectives, including data quality requirements, specific work to be conducted to fulfill data needs, and operating procedures are specified. Regulatory agency approval of these documents is often required prior to plan implementation. These approvals are necessary and appropriate to fulfilling the agency's mandated role. Many guidance documents prepared by regulatory agencies suggest the content and format of various scoping documents. These guidances help standardize thought processes and considerations in planning, and provide a template to ensure that both the plan and the proposed work will fulfill regulatory requirements. This work describes the preparation and use of guidance documents for planning environmental studies. The goals and some of the pitfalls of such documents are discussed. Guidance should include the following elements: the purpose of the guidance and a description of where it applies; the type of items to be addressed in planning; identification of requirements are applicable to all projects for which the guidance is intended; identification of requirements only applicable in certain situations; a description of items to facilitate planning; a suggested format for fulfilling requirements; example applications of the guidance. Disagreements arise between planners and reviewers/approvers when elements of guidance are used as leverage to require work not directly related to project objectives. Guidance may be inappropriately used as a milestone by which site-specific plans are judged. Regulatory agency review and approval may be regarded as a primary objective of the plan

The IAEA Regional Training Course on Regulatory Control of Radiation Sources

International Nuclear Information System (INIS)

2000-01-01

Materials of the IAEA Regional Training Course contains 8 presented lectures. Authors deals with regulatory control of radiation sources. The next materials of the IAEA were presented: Organization and implementation of a national regulatory infrastructure governing protection against ionizing radiation and the safety of radiation sources. (IAEA-TECDOC-1067); Safety assessment plants for authorization and inspection of radiation sources (IAEA-TECDOC-1113); Regulatory authority information system RAIS, Version 2.0, Instruction manual

Development of regulatory policy for SMART-P

Energy Technology Data Exchange (ETDEWEB)

Lee, S. H.; Lee, Y. H.; Moo, Philip; Koh, B. J.; Son, M. K.; Han, G. H.; Kim, D. H. [Korea Association for Nuclear Technology, Daejeon (Korea, Republic of)

2004-06-15

KAERI promoted the construction of a research reactor, SMART-P, the reduced scale of SMART, with intent to demonstrate the safety and performance of SMART. According to this progress, the development of regulatory process for SMART-P became necessary. The establishment of regulatory policy, based on the current regulatory guidelines as well as technical aspect, became essential matters. Considering the on-going small and medium size reactors in near future, the selection of the appropriate measure in the existing regulatory process to SMART-P is very important. Thus the schematic study for the applicable licensing procedure and regulatory requirements suitable for SMART-P is required.

Development of regulatory policy for SMART-P

Energy Technology Data Exchange (ETDEWEB)

Lee, S. H.; Moon, S. H.; Lee, Y. H.; Son, M. K.; Han, K. H.; Kim, D. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

2003-06-15

KAERI promoted the construction of a research reactor, SMART-P, the reduced scale of SMART, with intent to demonstrate the safety and performance of SMART. According to this progress, the development of regulatory process for SMART-P became necessary. The establishment of regulatory policy, based on the current regulatory guidelines as well as technical aspect, became essential matters. Considering the on-going small and medium size reactors m near future, the selection of the appropriate measure in the existing regulatory process to SMART-P is very important. Thus the schematic study for the applicable licensing procedure and regulatory requirements suitable for SMART-P is required.

Regulatory requirements for groundwater monitoring networks at hazardous waste sites

International Nuclear Information System (INIS)

Keller, J.F.

1989-10-01

In the absence of an explicit national mandate to protect groundwater quality, operators of active and inactive hazardous waste sites must use a number of statutes and regulations as guidance for detecting, correcting, and preventing groundwater contamination. The objective of this paper is to provide a framework of the technical and regulatory considerations that are important to the development of groundwater monitoring programs at hazardous waste sites. The technical site-specific needs and regulatory considerations, including existing groundwater standards and classifications, will be presented. 14 refs., 2 tabs

Can complex cellular processes be governed by simple linear rules?

Science.gov (United States)

Selvarajoo, Kumar; Tomita, Masaru; Tsuchiya, Masa

2009-02-01

Complex living systems have shown remarkably well-orchestrated, self-organized, robust, and stable behavior under a wide range of perturbations. However, despite the recent generation of high-throughput experimental datasets, basic cellular processes such as division, differentiation, and apoptosis still remain elusive. One of the key reasons is the lack of understanding of the governing principles of complex living systems. Here, we have reviewed the success of perturbation-response approaches, where without the requirement of detailed in vivo physiological parameters, the analysis of temporal concentration or activation response unravels biological network features such as causal relationships of reactant species, regulatory motifs, etc. Our review shows that simple linear rules govern the response behavior of biological networks in an ensemble of cells. It is daunting to know why such simplicity could hold in a complex heterogeneous environment. Provided physical reasons can be explained for these phenomena, major advancement in the understanding of basic cellular processes could be achieved.

Good collaborative practice: reforming capacity building governance of international health research partnerships.

Science.gov (United States)

Ward, Claire Leonie; Shaw, David; Sprumont, Dominique; Sankoh, Osman; Tanner, Marcel; Elger, Bernice

2018-01-08

In line with the policy objectives of the United Nations Sustainable Development Goals, this commentary seeks to examine the extent to which provisions of international health research guidance promote capacity building and equitable partnerships in global health research. Our evaluation finds that governance of collaborative research partnerships, and in particular capacity building, in resource-constrained settings is limited but has improved with the implementation guidance of the International Ethical Guidelines for Health-related Research Involving Humans by The Council for International Organizations of Medical Sciences (CIOMS) (2016). However, more clarity is needed in national legislation, industry and ethics guidelines, and regulatory provisions to address the structural inequities and power imbalances inherent in international health research partnerships. Most notably, ethical partnership governance is not supported by the principal industry ethics guidelines - the International Conference on Harmonization Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) Good Clinical Practice (ICH-GCP). Given the strategic value of ICH-GCP guidelines in defining the role and responsibility of global health research partners, we conclude that such governance should stipulate the minimal requirements for creating an equitable environment of inclusion, mutual learning, transparency and accountability. Procedurally, this can be supported by i) shared research agenda setting with local leadership, ii) capacity assessments, and iii) construction of a memorandum of understanding (MoU). Moreover, the requirement of capacity building needs to be coordinated amongst partners to support good collaborative practice and deliver on the public health goals of the research enterprise; improving local conditions of health and reducing global health inequality. In this respect, and in order to develop consistency between sources of research governance, ICH

78 FR 44275 - Semiannual Regulatory Agenda

Science.gov (United States)

2013-07-23

... Rights. National Park Service--Completed Actions Regulation Sequence No. Title Identifier No. 200 Winter.... Timetable: Action Date FR Cite NPRM 07/00/13 Final Action 05/00/14 Regulatory Flexibility Analysis Required...: Action Date FR Cite NPRM 10/00/14 Final Action 10/00/14 Regulatory Flexibility Analysis Required: Yes...

Settling into the midstream? Lessons for governance from the decade of nanotechnology

International Nuclear Information System (INIS)

Bosso, Christopher

2016-01-01

This paper analyzes scholarly papers published from 2003 through 2013 on the general theme of nanotechnology and governance. It considers three general points: (1) the “problem” of nanotechnology; (2) general lessons for governance obtained; and (3) prospects for aligning the US regulatory system to the next generation of complex engineered nano-materials. It argues that engineered nano-materials and products are coming to market within an already mature regulatory framework of decade-old statutes, long-standing bureaucratic rules and routines, narrowly directive judicial decisions, and embedded institutional norms. That extant regulatory regime shapes how policymakers perceive, define, and address the relative benefits and risks of both proximate and yet-to-be idealized nano-materials and applications. The paper concludes that fundamental reforms in the extant regime are unlikely short of a perceived crisis.

Settling into the midstream? Lessons for governance from the decade of nanotechnology

Science.gov (United States)

Bosso, Christopher

2016-06-01

This paper analyzes scholarly papers published from 2003 through 2013 on the general theme of nanotechnology and governance. It considers three general points: (1) the "problem" of nanotechnology; (2) general lessons for governance obtained; and (3) prospects for aligning the US regulatory system to the next generation of complex engineered nano-materials. It argues that engineered nano-materials and products are coming to market within an already mature regulatory framework of decade-old statutes, long-standing bureaucratic rules and routines, narrowly directive judicial decisions, and embedded institutional norms. That extant regulatory regime shapes how policymakers perceive, define, and address the relative benefits and risks of both proximate and yet-to-be idealized nano-materials and applications. The paper concludes that fundamental reforms in the extant regime are unlikely short of a perceived crisis.

Settling into the midstream? Lessons for governance from the decade of nanotechnology

Energy Technology Data Exchange (ETDEWEB)

Bosso, Christopher, E-mail: c.bosso@neu.edu [Northeastern University, School of Public Policy and Urban Affairs (United States)

2016-06-15

This paper analyzes scholarly papers published from 2003 through 2013 on the general theme of nanotechnology and governance. It considers three general points: (1) the “problem” of nanotechnology; (2) general lessons for governance obtained; and (3) prospects for aligning the US regulatory system to the next generation of complex engineered nano-materials. It argues that engineered nano-materials and products are coming to market within an already mature regulatory framework of decade-old statutes, long-standing bureaucratic rules and routines, narrowly directive judicial decisions, and embedded institutional norms. That extant regulatory regime shapes how policymakers perceive, define, and address the relative benefits and risks of both proximate and yet-to-be idealized nano-materials and applications. The paper concludes that fundamental reforms in the extant regime are unlikely short of a perceived crisis.

Basic elements of a regulatory programme for radiation safety

International Nuclear Information System (INIS)

Bilbao, A.A.

2000-01-01

In this lecture the objectives of IAEA TECDOC 1067: Organization and implementation of a national regulatory infrastructure governing protection against ionizing radiation and the safety of sources (1999) is presented

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.

Regulatory philosophy and requirements for radiation control in Canadian uranium mine-mill facilities

International Nuclear Information System (INIS)

Dory, A.B.

1981-10-01

With the point made that radiation exposure is one of the health hazards of uranium mining and accordingly has to be controlled, the Canadian regulatory philosophy is outlined as it pertains to the uranium mining industry. Two extremes in regulatory approach are examined, and the joint regulatory process is explained. Two examples of poor management performance are given, and the role of mine unions in the regulatory process is touched upon. The development of new regulations to cover ventilation and employee training is sketched briefly. The author concludes with a general expression of objectives for the eighties which include improved personal dosimetry

Safety Committees for Argentinean Research Reactor - Regulatory Issues

International Nuclear Information System (INIS)

Perrin, Carlos D.

2009-01-01

In the field of radiological and nuclear safety, the Nuclear Regulatory Authority (ARN) of Argentina controls three research reactors and three critical assemblies, by means of evaluations, audits and inspections, in order to ensure the fulfillment of the requirements established in the Licenses, in the Regulatory Standards and in the Mandatory Documentation in general. From the Nuclear Regulatory Authority's point of view, within the general process of research reactors safety management, the Operational Organization self verification of radiological and nuclear safety plays an outstanding role. In this aspect the ARN has established specific requirements in the Regulatory Standards, in the Operation Licenses and in the Operational Limits and Conditions. These requirements include the figure of different safety committees, which act as reviewers or advisers in diverse situations. This paper describes the main characteristics of the committees, their function, scope and the regulatory documents where the requirements are included. (author)

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

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.

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

The practice and regulatory requirements of naturopathy and western herbal medicine in Australia

Directory of Open Access Journals (Sweden)

Vivian Lin

2009-02-01

Full Text Available Vivian Lin1, Pauline McCabe1, Alan Bensoussan3,4, Stephen Myers5, Marc Cohen6, et al1School of Public Health; 2Cochrane Consumers and Communication Review Group, Australian Institute for Primary Care, La Trobe University, Bundoora, Victoria, Australia; 3National Institute for Complementary Medicine; 4University of Western Sydney, Bankstown, New South Wales, Australia; 5NatMed-Research, Department of Natural and Complementary Medicine, Southern Cross University, Lismore, New South Wales, Australia; 6Department of Complementary Medicine, RMIT University, Bundoora West, Victoria, Australia; La Trobe University, Bundoora, Victoria, AustraliaAbstract: Australian health workforce regulation is premised on the need to protect public health and safety. Specific criteria are set out by governments to ascertain the degree of risk and the need for government intervention. A study was undertaken to understand the current state of usage and the practice of naturopathy and western herbal medicine, and to ascertain whether statutory regulation was warranted. We found increased use of these complementary therapies in the community, with risks arising from both the specific practices as well as consumers negotiating a parallel primary health care system. We also found highly variable standards of training, a myriad of professional associations, and a general failure of current systems of self-regulation to protect public health and safety. Statutory regulation was the preferred policy response for consumers, insurers, general practitioners, and most of the complementary therapists. While we found a case for statutory registration, we also argue that a minimalist regulatory response needs to be accompanied by other measures to educate the public, to improve the standards of practice, and to enhance our understanding of the interaction between complementary and mainstream health care.Keywords: health workforce regulation, complementary health care, protection of

45 CFR 73.735-902 - Reporting requirements for certain employees not covered by the Ethics in Government Act of 1978.

Science.gov (United States)

2010-10-01

... covered by the Ethics in Government Act of 1978. 73.735-902 Section 73.735-902 Public Welfare DEPARTMENT... Interests § 73.735-902 Reporting requirements for certain employees not covered by the Ethics in Government... decision-making responsibility for the following matters: (i) Contracting or procurement, (ii...

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

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

Government Policies for Corporate Social Responsibility in Europe

DEFF Research Database (Denmark)

Knudsen, Jette Steen; Moon, Jeremy; Slager, Rieneke

This paper analyses policies of twenty two EU member governments designed to encourage corporate social responsibility (CSR) over the first decade of the century. Our paper categorizes policies for CSR into different types depending on their expected degree of regulatory strength. Secondly, whilst...... it identifies a wide range of issues to which government CSR policies are directed, it notes a tendency for these to have expanded from social affairs and employment issues, through environmental issues, to economic and trade and development issues. Thirdly, governments act as agents in their respective...... institutional structures to embed CSR concerns explicitly into these frameworks....

Nudging Healthy Lifestyles – Informing Regulatory Governance with Behavioural Research

OpenAIRE

Alemanno , Alberto; Amir , On; Bovens , Luc; Burgess , Adam; Lobel , Orly; Powys Whyte , Kyle; Selinger , Evan

2012-01-01

At a time when policy makers want to change the behaviour of citizens to tackle a broad range of social problems, such as climate change, excessive drinking, obesity and crime, a promising new policy approach has appeared that seems capable of escaping the liberal reservations typically associated with all forms of regulatory action. The approach, which stems from the increasingly ubiquitous findings of behavioural research, is generally captured under the evocative concept of ‘nudge.’ Inspir...

Public health implications of differences in U.S. and European Union regulatory policies for breast implants.

Science.gov (United States)

Zuckerman, Diana; Booker, Nyedra; Nagda, Sonia

2012-12-01

The recall of tens of thousands of defective breast implants in Europe in 2011-12 as well as new data on risks have raised questions about regulatory standards for these and other medical implants in the United States (U.S.) and European Union (EU). In the U.S., breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in the EU; approval is based on other information. As a result of these differing standards, the PIP breast implants that were recalled across Europe had been removed from the market years earlier in the U.S. than in the EU, a decision U.S. government health agencies can point to with pride. Nevertheless, the FDA track record on post-marketing breast implant research indicates poorly implemented studies and little meaningful enforcement to ensure that studies have been conducted correctly or findings reported accurately or acted upon. In sum, neither the EU nor the US has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation. Copyright © 2012 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

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

The importance of the practical training, the retraining and the accreditation of the personnel with regulatory functions

International Nuclear Information System (INIS)

Menossi, Carlos A.

2004-01-01

Medicine, industry, hydrology, research, development and academic scenarios are, nowadays the focus for a wide application of radioisotope techniques of permanently increasing use. This situation should move the governments towards the improvement of their infrastructures and the updating of the nuclear regulatory authorities knowledge. The regulation and control of radioactive sources and its associated practices, to guarantee its safe use and minimize the derived risks from those practices, constitute the main tasks of nuclear regulatory institutions. On the other hand, it is known that personnel with regulatory functions has further interaction with people responsible of facilities and practices (users). In fact, most of these people only have contact with the regulatory authority through the inspector visits, the documents, notes or requirements received. For such a reason, nuclear regulatory authority management success or failure depends fundamentally on the successes or errors occurring in the course of these interactions. Due to it, it should be kept in mind that a successful management of a Nuclear Regulatory Authority implies: a) The users accomplish the effective standards and satisfy the authority requirements, and b) An attitude of respect is induced in the users by the appropriate regulatory function. That is to say because the 'inspectors' possess the necessary technical knowledge. In that sense, with the experience of many years, improvements have been introduced in the radiological protection Post Graduate Course program. This course sponsored by the IAEA has been given in Argentina for 24 years. Such improvements have been made to allow participants that will perform regulatory functions to have enough sessions of practical training, demonstrations, laboratory exercises, case studies and technical visits. This formation course will be supplemented by an accreditation and training on the job. The scope and dimension of the improvements are

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

International Nuclear Information System (INIS)

2010-01-01

international experience and cooperation should be provided; - With the very significant increase in regulatory work and associated resources, the structure of the MEP NNSA should be enhanced; - In line with the development of the nuclear power industry, a commensurate increase to other parts of the fuel cycle and to waste management should be required. Associated with this, it was recommended that a comprehensive national policy and strategy for the management of radioactive and spent fuel should be established, as well as a single agency to implement the national strategy for radioactive waste; and - At a detailed level, improvements in the various regulatory activities should be undertaken, such as greater utilisation of risk-informed and graded approaches. IAEA Deputy Director General Tomihiro Taniguchi said, ''I witnessed myself the very intensive work of the team and correspondingly commitment of the Chinese Government to achieve a high level of safety against a background of massive expansion of the nuclear energy programme.'' General information about the Integrated Regulatory Review Service (IRRS) and previous missions can be found on the IAEA website. (IAEA)

Plagiarism governance in nurse education; dispositions, dimensions and tensions.

Science.gov (United States)

Welsh, Marion

2017-11-01

The reality of managing plagiarism in nurse education is indicative of multilayered and cumulative governance processes, which exist to fit with the needs of both the higher education institution and that of the Professional Statutory and Regulatory Body. However, the relationship between these entities is diffuse, particularly when this involves major plagiarism by post-qualified learners. This study sought to explore the strategic governance of plagiarism in Scottish higher education institutions offering nurse education and its articulation with the professional requirements of nurse education. The design involved a retrospective quantitative documentary analysis of plagiarism policies within 11 Scottish higher education institutions and a national on-line survey involving nurse educators with an active teaching role (n = 187). The documentary analysis demonstrated deficits and variations in how Scottish higher education institutions communicated the dimensions of plagiarism, and its subsequent management. Statistically significant findings from the on-line survey provided a clear mandate for educational providers to make visible the connectivity between organisational and professional governance processes to support responsive and proportional approaches to managing plagiarism by nurse learners. Significant findings also confirmed role implications and responsibilities, which nurse educators in this study, viewed as primarily pedagogical but crucially remain professionally centric. Copyright © 2017 Elsevier Ltd. All rights reserved.

75 FR 4431 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness...

Science.gov (United States)

2010-01-27

... regulatory operations in the Concept Release Concerning Self-Regulation \\22\\ and the release on the Fair Administration and Governance of Self- Regulatory Organizations.\\23\\ In the Concept Release, the Commission... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61388; File No. SR-BX-2010-001] Self-Regulatory...

Alignment between business process governance and IT governance

DEFF Research Database (Denmark)

Rahimi, Fatemeh; Møller, Charles; Hvam, Lars

2014-01-01

frameworks to enable business-IT strategic alignment, efficient process and IT requirements specification, and IT-enabled business value realization. We examine the actuality of this alignment in practice through a case study conducted in a relatively mature multinational corporation. The findings indicate......The importance of business processes and the increasing centrality of IT to an organization's performance have called for a specific focus on business process governance and IT governance in contemporary enterprises. Despite the wide scope of business process management, which covers both business...... and IT domains, and the profound impact of IT on process innovations, the association between business process governance and IT governance remains under-explored. Analyzing the constituting elements of the two governance concepts, we propose the necessity of alignment between business process and IT governance...

Regulatory design governing progression of population growth phases in bacteria.

Directory of Open Access Journals (Sweden)

Agustino Martínez-Antonio

Full Text Available It has long been noted that batch cultures inoculated with resting bacteria exhibit a progression of growth phases traditionally labeled lag, exponential, pre-stationary and stationary. However, a detailed molecular description of the mechanisms controlling the transitions between these phases is lacking. A core circuit, formed by a subset of regulatory interactions involving five global transcription factors (FIS, HNS, IHF, RpoS and GadX, has been identified by correlating information from the well- established transcriptional regulatory network of Escherichia coli and genome-wide expression data from cultures in these different growth phases. We propose a functional role for this circuit in controlling progression through these phases. Two alternative hypotheses for controlling the transition between the growth phases are first, a continuous graded adjustment to changing environmental conditions, and second, a discontinuous hysteretic switch at critical thresholds between growth phases. We formulate a simple mathematical model of the core circuit, consisting of differential equations based on the power-law formalism, and show by mathematical and computer-assisted analysis that there are critical conditions among the parameters of the model that can lead to hysteretic switch behavior, which--if validated experimentally--would suggest that the transitions between different growth phases might be analogous to cellular differentiation. Based on these provocative results, we propose experiments to test the alternative hypotheses.

Regulatory design governing progression of population growth phases in bacteria.

Science.gov (United States)

Martínez-Antonio, Agustino; Lomnitz, Jason G; Sandoval, Santiago; Aldana, Maximino; Savageau, Michael A

2012-01-01

It has long been noted that batch cultures inoculated with resting bacteria exhibit a progression of growth phases traditionally labeled lag, exponential, pre-stationary and stationary. However, a detailed molecular description of the mechanisms controlling the transitions between these phases is lacking. A core circuit, formed by a subset of regulatory interactions involving five global transcription factors (FIS, HNS, IHF, RpoS and GadX), has been identified by correlating information from the well- established transcriptional regulatory network of Escherichia coli and genome-wide expression data from cultures in these different growth phases. We propose a functional role for this circuit in controlling progression through these phases. Two alternative hypotheses for controlling the transition between the growth phases are first, a continuous graded adjustment to changing environmental conditions, and second, a discontinuous hysteretic switch at critical thresholds between growth phases. We formulate a simple mathematical model of the core circuit, consisting of differential equations based on the power-law formalism, and show by mathematical and computer-assisted analysis that there are critical conditions among the parameters of the model that can lead to hysteretic switch behavior, which--if validated experimentally--would suggest that the transitions between different growth phases might be analogous to cellular differentiation. Based on these provocative results, we propose experiments to test the alternative hypotheses.

Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

Science.gov (United States)

Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

2010-01-01

The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

Guidelines on how to meet the requirement to keep all exposures as low as reasonably achievable. Regulatory guide

International Nuclear Information System (INIS)

1997-01-01

The purpose of Regulatory Guide G-129 (E) is to provide Atomic Energy Control Board (AECB) licensees with guidelines on how to meet the forthcoming AECB regulatory requirement to keep doses received by workers and members of the public As Low As Reasonably Achievable (ALARA), social and economic factors taken into account. it is realized that the scope for realistic dose reductions will vary depending on the nature of the licensed activity. Therefore, criteria are given in section D for determining if doses can be deemed to be as low as reasonably achievable without further evaluation. The elements that the AECB considers to be essential in the approach to ALARA are described in section E and are summarized as follows: a demonstrated management commitment to the ALARA principle; the implementation of ALARA through a licensee's organization and management, provision of resources, training, establishment of action levels, documentation and other measures; and regular operational reviews. The above elements will be the focus of any AECB assessment to verify compliance with the requirement to keep radiation exposures as low as reasonably achievable. (author)

The missing link in nanomaterials governance: industrial dynamics and downstream policies

OpenAIRE

Rafols, Ismael; van Zwanenberg, Patrick; Morgan, Molly; Nightingale, Paul; Smith, Adrian

2009-01-01

In this article we explore the analytical and policy implications of widening the governance of nanomaterials from the focus on risk regulation to a broader focus on the governance of innovation. To do this, we have analysed the impact of industrial activities on nanotechnology governance, while previous studies have concentrated on risk appraisal, public perceptions, public engagement, regulatory frameworks and related policies. We argue that the specific characteristics of the industrial dy...

Governing the Nexus for Sustainability

Directory of Open Access Journals (Sweden)

Marx Sina

2015-01-01

Full Text Available This report summarizes the challenges of and requirements for effective governance of the water, energy and food nexus. With global dynamics such as climate change, urbanization and changing consumption patterns, governing resources in a coherent manner becomes both more complex and more relevant for sustainable development. Governance challenges include nexus economics (costs and benefits of different approaches to resource management, institutional design (like questions of how decision-making should be best distributed and good governance (how to make sure that nexus governance adheres to certain agreed upon principles and values. In terms of economics, a balance between sector specific actions and nexus governance is required. For effective decision-making it is important that power among different institutions is both distributed and coordinated. Good nexus governance requires targets that can be monitored to make sure that basic principles are followed and to examine whether progress toward sustainable development is being made.

IAEA Mission Says Chile Committed to Enhancing Safety, Sees Regulatory Challenges

International Nuclear Information System (INIS)

2018-01-01

An International Atomic Energy Agency (IAEA) team of experts said Chile is committed to strengthening its regulatory framework for nuclear and radiation safety. To help achieve this aim, the team said the country should address challenges in some areas, including the need to ensure effective independence in regulatory decision-making. The Integrated Regulatory Review Service (IRRS) team today concluded a 12-day mission to assess the regulatory safety framework in Chile. The mission was conducted at the request of the Government and hosted by the Chilean Nuclear Energy Commission (CCHEN), which is responsible for regulatory supervision together with the Ministry of Health (MINSAL). The review mission covered all civilian nuclear and radiation source facilities and activities regulated in Chile.

48 CFR 22.604-2 - Regulatory exemptions.

Science.gov (United States)

2010-10-01

... SOCIOECONOMIC PROGRAMS APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Walsh-Healey Public Contracts Act 22.604-2 Regulatory exemptions. (a) Contracts for the following acquisitions are fully exempt from the... contractor where the stipulations of the Act were not included in the defaulted contract. (4) Newspapers...

Status report on NRC's current below regulatory concern activities

International Nuclear Information System (INIS)

Dragonette, K.S.

1988-01-01

The concept of below regulatory concern (BRC) is not new to the Nuclear Regulatory Commission (NRC) or its predecessor agency, the Atomic Energy Commission. The regulations and licensing decisions have involved limited and de facto decisions on BRC since the beginning. For example, consumer products containing radioactive materials have been approved for distribution to persons exempt from licensing for some time and procedures for survey and release of equipment have traditionally been a part of many licensees' radiation safety programs. However, these actions have generally been ad hoc decisions in response to specific needs and have not been necessarily consistent. The need to deal with this regulatory matter has been receiving attention from both Congress and the NRC Commissioners. NRC response has grown from addressing specific waste streams, to generic rulemaking for wastes, and finally to efforts to develop a broad generic BRC policy. Section 10 of the Low-Level Radioactive Waste Policy Amendments Act of 1985 addressed NRC actions on specific waste streams. In response, NRC issued guidance on rulemaking petitions for specific wastes. NRC also issued an advance notice of proposed rulemaking indicating consideration of Commission initiated regulations to address BRC wastes in a generic manner. The Commissioners have directed staff to develop an umbrella policy for all agency decisions concerning levels of risk or dose that do not require government regulation

Transcription regulatory networks analysis using CAGE

KAUST Repository

Tegnér, Jesper N.

2009-10-01

Mapping out cellular networks in general and transcriptional networks in particular has proved to be a bottle-neck hampering our understanding of biological processes. Integrative approaches fusing computational and experimental technologies for decoding transcriptional networks at a high level of resolution is therefore of uttermost importance. Yet, this is challenging since the control of gene expression in eukaryotes is a complex multi-level process influenced by several epigenetic factors and the fine interplay between regulatory proteins and the promoter structure governing the combinatorial regulation of gene expression. In this chapter we review how the CAGE data can be integrated with other measurements such as expression, physical interactions and computational prediction of regulatory motifs, which together can provide a genome-wide picture of eukaryotic transcriptional regulatory networks at a new level of resolution. © 2010 by Pan Stanford Publishing Pte. Ltd. All rights reserved.

The Chinese health care regulatory institutions in an era of transition.

Science.gov (United States)

Fang, Jing

2008-02-01

The purpose of this paper is to contribute to a better understanding of Chinese health care regulation in an era of transition. It describes the major health care regulatory institutions operating currently in China and analyzes the underlying factors. The paper argues that in the transition from a planned to a market economy, the Chinese government has been employing a hybrid approach where both old and new institutions have a role in the management of emerging markets, including the health care market. This approach is consistent with the incremental reform strategy adopted by the Party-state. Although a health care regulatory framework has gradually taken shape, the framework is incomplete, with a particular lack of emphasis on professional self-regulation. In addition, its effectiveness is limited despite the existence of many regulatory institutions. In poor rural areas, the effectiveness of the regulatory framework is further undermined or distorted by the extremely difficult financial position that local governments find themselves in. The interpretations of the principle of 'rule of law' by policy makers and officials at different levels and the widespread informal network of relations between known individuals (Guanxi) play an important role in the operation of the regulatory framework. The findings of this paper reveal the complex nature of regulating health care in transitional China.

Applying TOGAF for e-government implementation based on service oriented architecture methodology towards good government governance

Science.gov (United States)

Hodijah, A.; Sundari, S.; Nugraha, A. C.

2018-05-01

As a Local Government Agencies who perform public services, General Government Office already has utilized Reporting Information System of Local Government Implementation (E-LPPD). However, E-LPPD has upgrade limitation for the integration processes that cannot accommodate General Government Offices’ needs in order to achieve Good Government Governance (GGG), while success stories of the ultimate goal of e-government implementation requires good governance practices. Currently, citizen demand public services as private sector do, which needs service innovation by utilizing the legacy system as a service based e-government implementation, while Service Oriented Architecture (SOA) to redefine a business processes as a set of IT enabled services and Enterprise Architecture from the Open Group Architecture Framework (TOGAF) as a comprehensive approach in redefining business processes as service innovation towards GGG. This paper takes a case study on Performance Evaluation of Local Government Implementation (EKPPD) system on General Government Office. The results show that TOGAF will guide the development of integrated business processes of EKPPD system that fits good governance practices to attain GGG with SOA methodology as technical approach.

Regulatory science requirements of labeling of genetically modified food.

Science.gov (United States)

Moghissi, A Alan; Jaeger, Lisa M; Shafei, Dania; Bloom, Lindsey L

2018-05-01

This paper provides an overview of the evolution of food labeling in the USA. It briefly describes the three phases of agricultural development consisting of naturally occurring, cross-bred, and genetically engineered, edited or modified crops, otherwise known as Genetically Modified Organisms (GMO). It uses the Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims (MERSC) to evaluate the scientific validity of claims applicable to GMO and the Best Available Public Information (BAPI) to evaluate the pronouncements by public media and others. Subsequently claims on health risk, ecological risk, consumer choice, and corporate greed are evaluated based on BARS/MERSC and BAPI. The paper concludes by suggesting that labeling of food containing GMO should consider the consumer's choice, such as the food used by those who desire kosher and halal food. Furthermore, the consumer choice is already met by the exclusion of GMO in organic food.

Regulatory requirements on management of radioactive material safe transport in China

International Nuclear Information System (INIS)

Chu, C.

2016-01-01

Since 1980s, the IAEA Regulation for safe transport of radioactive material was introduced into China; the regulatory system of China began with international standards, and walked towards the institutionalized. In 2003 the National People’s Congress (NPC) promulgated “the Act on the Prevention of Radioactive Pollution of the People's Republic of China”. In 2009 “Regulation for the Safe Transport of Radioactive Material” (Referred to “Regulation”) was promulgated by the State Council. Subsequently, the National Nuclear Safety Administration (NNSA) began to formulate executive detailed department rules, regulations guidelines and standards. The present system of acts, regulations and standards on management of safe transport of radioactive material in China and future planning were introduced in this paper. Meanwhile, the paper described the specific administration requirements of the Regulation on classification management of radioactive materials, license management of transport packaging including design, manufacture and use, licensing management of transport activities and the provisions of illegal behaviors arising in safe transport of radioactive material. (author)

Risk perception, safety goals and regulatory decision-making

International Nuclear Information System (INIS)

Hoegberg, Lars

1998-01-01

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

Regime complexity and expertise in transnational governance: Strategizing in the face of regulatory uncertainty

Directory of Open Access Journals (Sweden)

Sigrid Quack

2013-01-01

Full Text Available The rise and spread of transnational governance arrangements has added to the legal indeterminacy of existing regime complexes. The combined regulatory uncertainty resulting from international regime complexes and transnational polycentric governance heightens the role of expertise in managing this institutional complexity. The rising importance of knowledgeable actors with claims to policy-relevant expertise, according to many scholars, is expected further to advantage well-resourced and powerful actors. However, attention to recent developments in accounting and copyright, as two transnational governance fields that have been dominated by a small group of powerful actors for more than three decades, sheds doubt on the generalizability of such arguments. Although representing least likely cases for change, the empirical evidence presented in this paper shows how apparently weak or marginalized actors – whether they are part of public bureaucracies or civil society – developed expertise-based strategies to claim greater involvement and influence in rule and standard-setting. Their strategizing on regime complexity opened up previously shielded policy spaces to broader audiences, thereby transforming actor constellations, preferences and problem definitions in the two policy fields. These findings suggest that under conditions of complexity, indeterminacy and uncertainty, claims to expertise-based rule are becoming increasingly contested – even in transnational governance fields that have a long-established trajectory of rule-setting and rule-implementation monopolized by small groups of professionals, industrialists or technical diplomats. El surgimiento y la difusión de las disposiciones de gobierno transnacional ha contribuido a la indeterminación jurídica de los complejos regímenes existentes. La incertidumbre regulatoria resultante de los complejos regímenes internacionales y del gobierno policéntrico transnacional realza el

Regulatory issues associated with closure of the Hanford AX Tank Farm ancillary equipment

International Nuclear Information System (INIS)

Becker, D.L.

1998-01-01

Liquid mixed, high-level radioactive waste has been stored in underground single-shell tanks at the US Department of Energy's (DOE's) Hanford Site. After retrieval of the waste from the single-shell tanks, the DOE will proceed with closure of the tank farm. The 241-AX Tank Farm includes four one-million gallon single-shell tanks in addition to sluice lines, transfer lines, ventilation headers, risers, pits, cribs, catch tanks, buildings, well and associated buried piping. This equipment is classified as ancillary equipment. This document addresses the requirements for regulatory close of the ancillary equipment in the Hanford Site 241-AX Tank Farm. The options identified for physical closure of the ancillary equipment include disposal in place, disposal in place after treatment, excavation and disposal on site in an empty single-shell tank, and excavation and disposal outside the AX Tank Farm. The document addresses the background of the Hanford Site and ancillary equipment in the AX Tank Farm, regulations for decontamination and decommissioning of radioactively contaminated equipment, requirements for the cleanup and disposal of radioactive wastes, cleanup and disposal requirements governing hazardous and mixed waste, and regulatory requirements and issues associated with each of the four physical closure options. This investigation was conducted by the Sandia National Laboratories, Albuquerque, New Mexico, during Fiscal Year 1998 for the Hanford Tanks Initiative Project

Reconstructing the public in old and new governance: a Korean case of nuclear energy policy.

Science.gov (United States)

Kim, Hyomin

2014-04-01

Korean nuclear energy regulatory policies started to change from earlier exclusively technocratic policies into open dialogues after several anti-nuclear protests in the 1990s. However, technocratic policies still coexist with the new regulatory orientation towards openness, participation and institutional accountability. This paper analyzes Korean nuclear regulatory policies since approximately 2005 as a blend of old and new governance. The aim of the paper is not to decide whether new nuclear governance is deliberative or not by completely reviewing Korean nuclear policies after the 2000s. Instead, it provides an empirical account of how seemingly more participatory processes in decision-making entail new problems while they work with and reproduce social assumptions of different groups of the public.

Philippine Corporate Governance : Environment and Policy and their Impact on Performance and Finance

OpenAIRE

Cesar G. Saldaña

2000-01-01

The Asian Development Bank initiated a study of Corporate Governance and Finance in Selected developing Member Countries in November 1998. The objectives of the study for the Philippines are to evaluate the history and current state of corporate governance in the Philippines; establish a sound analytic basis for policy and regulatory reform measures to strengthen corporate governance of Philippine companies and recommend reform measures for the Philippine government and the Bank. It analyzes ...

Digital government and public health.

Science.gov (United States)

Fountain, Jane E

2004-10-01

Digital government is typically defined as the production and delivery of information and services inside government and between government and the public using a range of information and communication technologies. Two types of government relationships with other entities are government-to-citizen and government-to-government relationships. Both offer opportunities and challenges. Assessment of a public health agency's readiness for digital government includes examination of technical, managerial, and political capabilities. Public health agencies are especially challenged by a lack of funding for technical infrastructure and expertise, by privacy and security issues, and by lack of Internet access for low-income and marginalized populations. Public health agencies understand the difficulties of working across agencies and levels of government, but the development of new, integrated e-programs will require more than technical change - it will require a profound change in paradigm.

Computational methods to dissect cis-regulatory transcriptional ...

Indian Academy of Sciences (India)

The formation of diverse cell types from an invariant set of genes is governed by biochemical and molecular processes that regulate gene activity. A complete understanding of the regulatory mechanisms of gene expression is the major function of genomics. Computational genomics is a rapidly emerging area for ...

Governments' role in decommissioning nuclear power facilities

International Nuclear Information System (INIS)

Guindon, S.; Wendling, R.D.; Gordelier, S.; Soederberg, O.; Averous, J.; Orlando, D.

2005-01-01

essential that mechanisms are in place to ensure that the real value of assets in the fund guard against periods of high inflation. Last but not least, competent administration of the funding system is of paramount importance. To conclude, the cost of decommissioning is an important criterion in deregulated markets where competition calls for a lowering of costs of producing electricity. In this regard, the NEA Study on the Role of Government concluded that one duty of government is to ensure that funds will be available to carry out decommissioning for facilities that may not close for a century or more. This may require fairly sophisticated financial management of billion dollar sums of money and ongoing attention of national governments. Enhanced dialogue at the international level will be particularly beneficial to governments, regulatory bodies and industry

Risk-based Regulatory Evaluation Program methodology

International Nuclear Information System (INIS)

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

1987-01-01

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

Mutational robustness of gene regulatory networks.

Directory of Open Access Journals (Sweden)

Aalt D J van Dijk

Full Text Available Mutational robustness of gene regulatory networks refers to their ability to generate constant biological output upon mutations that change network structure. Such networks contain regulatory interactions (transcription factor-target gene interactions but often also protein-protein interactions between transcription factors. Using computational modeling, we study factors that influence robustness and we infer several network properties governing it. These include the type of mutation, i.e. whether a regulatory interaction or a protein-protein interaction is mutated, and in the case of mutation of a regulatory interaction, the sign of the interaction (activating vs. repressive. In addition, we analyze the effect of combinations of mutations and we compare networks containing monomeric with those containing dimeric transcription factors. Our results are consistent with available data on biological networks, for example based on evolutionary conservation of network features. As a novel and remarkable property, we predict that networks are more robust against mutations in monomer than in dimer transcription factors, a prediction for which analysis of conservation of DNA binding residues in monomeric vs. dimeric transcription factors provides indirect evidence.

Global Regulatory Differences for Gene- and Cell-Based Therapies

DEFF Research Database (Denmark)

Coppens, Delphi G M; De Bruin, Marie L; Leufkens, Hubert G M

2017-01-01

Gene- and cell-based therapies (GCTs) offer potential new treatment options for unmet medical needs. However, the use of conventional regulatory requirements for medicinal products to approve GCTs may impede patient access and therapeutic innovation. Furthermore, requirements differ between...... jurisdictions, complicating the global regulatory landscape. We provide a comparative overview of regulatory requirements for GCT approval in five jurisdictions and hypothesize on the consequences of the observed global differences on patient access and therapeutic innovation....

NRC regulatory agenda

International Nuclear Information System (INIS)

1993-07-01

The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter. The rules on which final action has been taken since March 31, 1993 are: Repeal of NRC standards of conduct; Fitness-for-duty requirements for licensees who possess, use, or transport Category I material; Training and qualification of nuclear power plant personnel; Monitoring the effectiveness of maintenance at nuclear power plants; Licensing requirements for land disposal of radioactive wastes; and Licensees' announcements of safeguards inspections

Legislative framework and regulatory requirements for the introduction of nuclear power

International Nuclear Information System (INIS)

Ha-Vinh, Phuong

1975-01-01

The adoption of appropriate legislation is to be considered as a prerequisite to the introduction of nuclear power in view of the issues that need to be regulated. Preparatory steps should be started at the earliest stage in conjunction with the planning of nuclear power projects. The primary objectives of a licensing scheme are to ensure safety, public health and environmental protection as well as financial protection for third parties in case of nuclear incident. For licensing purposes, a legislative framework and regulatory determinations are required. Within such a framework and pursuant to such regulatory determinations, the elaboration of safety standards, rules, guides and enforcement procedures is to be considered of paramount importance. To this end a number of international recommendations and advisory material prepared by the IAEA provide useful guidance. A licensing process would normally be split into several stages relating to site approval, construction permit, pre-operational tests, and operating licence, each stage being subject to safety assessments and reviews as determined by regulations. Financial protection against nuclear damage has also to be insured. A special regime of nuclear liability has been established by international conventions, based on the principle of strict liability of the operator of a nuclear installation. As a result of such channelling of liability to him, his liability is limited in amount and time. This liability system has the dual purpose of ensuring appropriate protection for potential victims and of relieving the nuclear industry from unlimited liability risks, which would impede practical applications of atomic energy. For the elaboration of nuclear legislation and specialized regulations the Agency's advisory services have proved to be of help to countries embarking on a nuclear power programme. (author)

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

National legislative and regulatory activities

International Nuclear Information System (INIS)

Anon.

2001-01-01

comprising the front end of the nuclear fuel cycle, 1999); Sweden (amendment to the nuclear liability act, 2001); Switzerland (increase in the amount of nuclear third party liability insurance, 2000); Ukraine (decree establishing the state nuclear regulatory committee of Ukraine, 2000); UK (nuclear safeguards act, 2000); USA (amendment to the radiation exposure compensation act, 2000; amendment to NRC export and import regulations, 2000; amendment to NRC regulations governing the licensing of special nuclear material, 2000; amendment to NRC regulations governing the requirements for certain generally licensed industrial devices containing by-product material, 2001); Uzbekistan (law on radiation protection, 2000). (J.S.)

Towards a single European electricity market. A structured approach to regulatory mode decision-making

International Nuclear Information System (INIS)

De Jong, H.M.

2009-01-01

This study focuses on the processes through which the rules and regulations that govern European electricity markets - and inherently, their integration process - are established. So far, European policy makers have largely followed a 'trial-and-error' approach to finding an appropriate regulatory mode (process) for dealing effectively with market integration issues. This unstructured approach to regulatory mode selection leads to several problems: - Today's trial-and-error strategy of shifting from one regulatory mode to another is time-consuming. - In the regulatory mode selection process, certain key principles of good governance are insufficiently considered. - European regulatory processes are experienced as vague, intransparent, and illegitimate by 'outside' stakeholders. This study develops a 'structured approach to regulatory mode decision-making' (STARMODE) based on the theory of decision modelling in policy management and a case study exploring three key market integration issues in the field of electricity markets: interconnector investment, congestion management and market transparency. The main objective is to present a systematic and comprehensive framework for analysing and improving regulatory mode decision-making in the context of the European Union, focusing on electricity market integration. The STARMODE approach is generally applicable to (and relevant for) European market integration issues in industries characterized by a natural monopoly and/or an essential service. The approach may also contribute to national regulatory mode decision-making and multi-state decision-making in other continents.

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

International Nuclear Information System (INIS)

Ritterbusch, Stanley E.

2000-01-01

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

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

Civilian Radioactive Waste Management System Requirements Document

International Nuclear Information System (INIS)

1992-12-01

This document specifies the top-level requirements for the Civilian Radioactive Waste Management System (CRWMS). The document is referred to herein as the CRD, for CRWMS Requirements document. The OCRWM System Engineering Management Plan (SEMP) establishes the technical document hierarchy (hierarchy of technical requirements and configuration baseline documents) for the CRWMS program. The CRD is the top-level document in this hierarchy. The immediate subordinate documents are the System Requirements Documents (SRDS) for the four elements of the CRWMS and the Interface Specification (IFS). The four elements of the CRWMS are the Waste Acceptance System, the Transportation System, the Monitored Retrievable Storage (MRS) System and the Mined Geologic Disposal System (MGDS). The Interface Specification describes the six inter-element interfaces between the four elements. This hierarchy establishes the requirements to be addressed by the design of the system elements. Many of the technical requirements for the CRWMS are documented in a variety of Federal regulations, DOE directives and other Government documentation. It is the purpose of the CRD to establish the technical requirements for the entire program. In doing so, the CRD summarizes source documentation for requirements that must be addressed by the program, specifies particular requirements, and documents derived requirements that are not covered in regulatory and other Government documentation, but are necessary to accomplish the mission of the CRWMS. The CRD defines the CRWMS by identifying the top-level functions the elements must perform (These top-level functions were derived using functional analysis initially documented in the Physical System Requirements (PSR) documents). The CRD also defines the top-level physical architecture of the system and allocates the functions and requirements to the architectural elements of the system

77 FR 30998 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Government...

Science.gov (United States)

2012-05-24

..., Government Property, DFARS section 211.274, Reporting of Government-Furnished Equipment in the DoD Item... surplus Government property. Under paragraph (b), a contractor may be directed by the plant clearance... plant clearance officer to purchase or retain Government property at less than cost if the plant...

Quality assurance within regulatory bodies

International Nuclear Information System (INIS)

1999-06-01

The IAEA directed extensive efforts during the years 1991 to 1995 to the integral revision of all NUSS quality assurance publications, which were approved and issued as Safety Series No.50-C/SG-Q, Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations (1996). When these quality assurance publications were developed, their prime focus was on requirements against which work performed by the licensees could be measured and assessed by the regulatory bodies. In this way, they only helped to facilitate the functions of regulators. No requirements or recommendations were provided on how the regulators should ensure the effective implementation of their own activities. The present publication is a first attempt to collect, integrate and offer available experience to directly support performance of regulatory activities. It presents a comprehensive compilation on the application of quality assurance principles and methods by regulatory bodies to their activities. The aim is consistent good performance of regulatory activities through a systematic approach

Nuclear Regulatory Commission: more aggressive leadership needed

International Nuclear Information System (INIS)

Staats, E.B.

1980-01-01

The Energy Reorganization Act of 1974 which established the Nuclear Regulatory Commission required GAO to evaluate the Commission's performance by January 18, 1980. This report responds to that requirement. GAO concluded that, although improvements have been made, the Commission's nuclear regulatory performance can be characterized best as slow, indecisive, cautious - in a word, complacent. This has largely resulted from a lack of aggressive leadership as evidenced by the Commissioners' failure to establish regulatory goals, control policymaking, and most importantly, clearly define their roles in nuclear regulation

The Norwegian Noark Model Requirements for EDRMS in the context of open government and access to governmental information

Directory of Open Access Journals (Sweden)

Olav Hagen Sataslåtten

2017-11-01

Full Text Available This article analyses the relationship between the Norwegian Noark Standard and the concepts of Open Government and Freedom of Information. Noark is the Norwegian model requirements for Electronic Documents and Records Management Systems (EDRMS. It was introduced in 1984, making it not only the world’s first model requirement for EDRMS, but also, through the introduction of versions from Noark 1 to the present Noark 5, internationally the model requirement with the longest continuation of implementation.

Neuron-mediated generation of regulatory T cells from encephalitogenic T cells suppresses EAE

DEFF Research Database (Denmark)

Liu, Yawei; Teige, Ingrid; Birnir, Bryndis

2006-01-01

Neurons have been neglected as cells with a major immune-regulatory function because they do not express major histocompatibility complex class II. Our data show that neurons are highly immune regulatory, having a crucial role in governing T-cell response and central nervous system (CNS) inflamma......Neurons have been neglected as cells with a major immune-regulatory function because they do not express major histocompatibility complex class II. Our data show that neurons are highly immune regulatory, having a crucial role in governing T-cell response and central nervous system (CNS......) inflammation. Neurons induce the proliferation of activated CD4+ T cells through B7-CD28 and transforming growth factor (TGF)-beta1-TGF-beta receptor signaling pathways, resulting in amplification of T-cell receptor signaling through phosphorylated ZAP-70, interleukin (IL)-2 and IL-9. The interaction between...... neurons and T cells results in the conversion of encephalitogenic T cells to CD25+ TGF-beta1+ CTLA-4+ FoxP3+ T regulatory (Treg) cells that suppress encephalitogenic T cells and inhibit experimental autoimmune encephalomyelitis. Suppression is dependent on cytotoxic T lymphocyte antigen (CTLA)-4...

Regulatory barriers to pollution prevention: A position paper of the implementation council of the American institute for pollution prevention

International Nuclear Information System (INIS)

Byers, R.L.

1991-01-01

Pollution prevention/waste minimization is a win-win-win situation for government, industry, and the public, which offers more than just protection of the environment for all. Industry gains from reduced capital and operating costs, reduced liabilities, cleaner and safer working conditions, conservation of energy and material resources, and the opportunity for government and industry to work together in a cooperative manner. However, a number of regulatory barriers exist which discourage pollution prevention/waste minimization. This paper provides examples for the aluminum, chemical, petroleum, and wood treating industries of how these regulatory barriers become disincentives. To promote pollusion prevention/waste minimization, Congress and the US EPA need to reexamine those RCRA provisions which support a command and control strategy that creates the barriers. The barriers include the distinction between value and valueless materials, offsite storage requirements prior to reuse/recycle, the Derived from Rule, the Burning for Fuel Rule, land ban technology standards, and RD and D restrictions. A new RCRA Pollution Prevention/Waste Minimization subtitle is proposed to eliminate or minimize these barriers

Evaluation of research reactor fuel reliability in support of regulatory requirements

International Nuclear Information System (INIS)

Sokolov, Eugene N.

2005-01-01

This standards, codes and practices survey is devoted to the problem of reliability of R and D especially research reactor fuel (RRF) performance-related processes. Regulatory R and D evaluations were based on one standard and just few of them provide correlation to other relative standards whereas synthetic process approach reflects actual status of particular R and D practices. Fuel performance regulatory parameters are based on quality standards. A reliability process-based method similar to PSA/FMEA is proposed to evaluate RRF performance- related parameters in terms of reactor safety. (author)

Evaluation of research reactor fuel reliability in support of regulatory requirements

Energy Technology Data Exchange (ETDEWEB)

Sokolov, Eugene N [Chalk River Laboratories, AECL, Chalk River, ON, K0J 1J0 (Canada)

2005-07-01

This standards, codes and practices survey is devoted to the problem of reliability of R and D especially research reactor fuel (RRF) performance-related processes. Regulatory R and D evaluations were based on one standard and just few of them provide correlation to other relative standards whereas synthetic process approach reflects actual status of particular R and D practices. Fuel performance regulatory parameters are based on quality standards. A reliability process-based method similar to PSA/FMEA is proposed to evaluate RRF performance- related parameters in terms of reactor safety. (author)

Ethical Responsibility of Governance for Integrating Disaster Risk Reduction with Development

Science.gov (United States)

Parkash Gupta, Surya

2015-04-01

The development in the public as well as the private sectors is controlled and regulated, directly or indirectly by the governments at federal, provincial and local levels. If this development goes haphazard and unplanned, without due considerations to environmental constraints and potential hazards; it is likely to cause disasters or may get affected by disasters. Therefore, it becomes an ethical responsibility of the people involved in governance sector to integrate disaster risk reduction with development in their administrative territories through enforcement of appropriate policies, guidelines and regulatory mechanisms. Such mechanisms should address the social, scientific, economic, environmental, and legal requirements that play significant role in planning, implementation of developmental activities as well as disaster management. The paper focuses on defining the ethical responsibilities for the governance sector for integrating disaster risk reduction with development. It highlights the ethical issues with examples from two case studies, one from the Uttarakhand state and the other Odhisa state in India. The case studies illustrates how does it make a difference in disaster risk reduction if the governments own or do not own ethical responsibilities. The paper considers two major disaster events, flash floods in Uttarakhand state and Cyclone Phailin in Odhisa state, that happened during the year 2013. The study points out that it makes a great difference in terms of consequences and response to disasters when ethical responsibilities are owned by the governance sector. The papers attempts to define these ethical responsibilities for integrating disaster risk reduction with development so that the governments can be held accountable for their acts or non-actions.

Development of guidance on applications of regulatory requirements for regulating large, contaminated equipment and large decommissioning and decontamination (D and D) components

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Cook, J.R.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant were major changes to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). As these requirements were adopted into regulations in the United States, it was recognised that guidance on how to apply these requirements to large, contaminated/activated pieces of equipment and decommissioning and decontamination (D and D) objects would be needed both by the regulators and those regulated to clarify technical uncertainties and ensure implementation. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance which will present examples of acceptable methods for demonstrating compliance with the revised rules for large items. Concepts being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment before final issuance in 1997. (Author)

Development of guidance on applications of regulatory requirements for regulating large, contaminated equipment and large decommissioning and decontamination (D and D) components

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Cook, J.R.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant were major changes to requirements for Low Specific Activity material and Surface Contaminated Objects. As these requirements were adopted into regulations in the US, it was recognized that guidance on how to apply these requirements to large, contaminated/activated pieces of equipment and decommissioning and decontamination objects would be needed both by the regulators and those regulated to clarify technical uncertainties and ensure implementation. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance which will present examples of acceptable methods for demonstrating compliance with the revised rules for large items. Concepts being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment before final issuance in 1997

47 CFR 1.1160 - Refunds of regulatory fees.

Science.gov (United States)

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Refunds of regulatory fees. 1.1160 Section 1... Statutory Charges and Procedures for Payment § 1.1160 Refunds of regulatory fees. (a) Regulatory fees will be refunded, upon request, only in the following instances: (1) When no regulatory fee is required or...

Regulatory cross-cutting topics for fuel cycle facilities.

Energy Technology Data Exchange (ETDEWEB)

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

2013-10-01

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

How Governance Regimes Shape the Implementation of Water Reuse Schemes

OpenAIRE

Frijns, Jos; Smith, Heather M.; Brouwer, Stijn; Garnett, Kenisha; Elelman, Richard; Jeffrey, Paul

2016-01-01

The governance dimensions of water reuse scheme development and operation, such as policies and regulatory frameworks, and public involvement and stakeholder collaboration, can serve to both facilitate and constrain wider adoption of water reuse practices. This paper explores the significance and underlying structure of the key governance challenges facing the water reuse sector in Europe. It presents empirical evidence from interviews and focus group sessions conducted at four water reuse sc...

Building regulatory enforcement regimes : Comparative analysis of private sector involvement in the enforcement of public building regulations

NARCIS (Netherlands)

Van der Heijden, J.J.

2009-01-01

It is often assumed that traditional regulatory regimes centered on governmental action will benefit from greater private sector involvement. And, under the catchy phrase "from government to governance" globally a wide variety of hybrid forms of governance has emerged. However, little empirical

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.

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.

13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

Science.gov (United States)

2010-01-01

... basis in accordance with Generally Accepted Accounting Principles (GAAP) as promulgated by the Financial Accounting Standards Board (FASB), supplemented by Regulatory Accounting Principles (RAP) as identified by... set forth in FASB Statement of Financial Accounting Standards No. 15, Accounting by Debtors and...

Beyond Cost-Benefit Analysis in the Governance of Synthetic Biology.

Science.gov (United States)

Wallach, Wendell; Saner, Marc; Marchant, Gary

2018-01-01

For many innovations, oversight fits nicely within existing governance mechanisms; nevertheless, others pose unique public health, environmental, and ethical challenges. Synthetic artemisinin, for example, has many precursors in laboratory-developed drugs that emulate natural forms of the same drug. The policy challenges posed by synthetic artemisinin do not differ significantly in kind from other laboratory-formulated drugs. Synthetic biofuels and gene drives, however, fit less clearly into existing governance structures. How many of the new categories of products require new forms of regulatory oversight, or at least extensive forms of testing, remains unclear. Any effort to improve the governance of synthetic biology should start with a rich understanding of the different possible science-policy interfaces that could help to inform governance. CBA falls into a subset of the overall range of possibilities, and which interface is appropriate may turn out to depend on context, on the demands of the decision at hand. In what follows, we lay out a typology of interfaces. After that, we turn to the question of how to draw upon the range of possible interfaces and effectively address the factual and moral complexities of emerging technologies. We propose a governance model built around structures that we call "governance coordinating committees." GCCs are intended to be mechanisms for accommodating the complexities of innovations that have far-ranging societal impacts. The production of biofuels, for example, could contaminate water supplies and have a destructive environmental impact if not managed correctly. The introduction of a gene drive could have economic and environmental impacts that are not restricted to one nation. Forging appropriate means for determining and evaluating those societal impacts, to the best of a corporation's, industry's, or government's ability, is central to responsible research and innovation. Public policy must be shaped in a manner that

Medical revalidation as professional regulatory reform: Challenging the power of enforceable trust in the United Kingdom.

Science.gov (United States)

Spendlove, Zoey

2018-05-01

For more than two decades, international healthcare crises and ensuing political debates have led to increasing professional governance and regulatory policy reform. Governance and policy reforms, commonly representing a shift from embodied trust in professionals to state enforceable trust, have challenged professional power and self-regulatory privileges. However, controversy remains as to whether such policies do actually shift the balance of power and what the resulting effects of policy introduction would be. This paper explores the roll-out and operationalisation of revalidation as medical regulatory reform within a United Kingdom National Health Service hospital from 2012 to 2013, and its impact upon professional power. Revalidation policy was subject to the existing governance and management structures of the organisation, resulting in the formal policy process being shaped at the local level. This paper explores how the disorganised nature of the organisation hindered rather than facilitated robust processes of professional governance and regulation, fostering formalistic rather than genuine professional engagement with the policy process. Formalistic engagement seemingly assisted the medical profession in retaining self-regulatory privileges whilst maintaining professional power over the policy process. The paper concludes by challenging the concept of state enforceable trust and the theorisation that professional groups are effectively regulated and controlled by means of national and organisational objectives, such as revalidation. Copyright © 2018 Elsevier Ltd. All rights reserved.

Role of in-house safety analysis and research activities in regulatory decision making

International Nuclear Information System (INIS)

Pradhan, Santosh K.; Nagrale, Dhanesh B.; Gaikwad, Avinash J.

2015-01-01

Achievement of an acceptable level of nuclear safety is an essential requirement for the peaceful utilization of nuclear energy. The success of Global Nuclear Safety Regime is built upon a foundation of research. Such research has been sponsored by Governments and industry and has led to improved designs, safer and more reliable plant operation, and improvements in operating plant efficiency. A key element of this research has been the nuclear safety research performed or sponsored by regulatory organizations. In part, it has been the safety research performed or sponsored by regulatory organizations that has contributed to improved safety and has laid the foundation for activities such as risk-informed regulation, plant life extension, improved plant performance (e.g. power uprates) and new plant designs. The regulatory research program is meant to improve the regulatory authority’s knowledge where uncertainty exists, where safety margins are not well-characterized, and where regulatory decisions need to be confirmed in existing or new designs and technologies. The regulatory body get research initiated either in-house or by the licensee or through technical support organizations (TSOs). Research and analysis carried out within the regulatory body is of immense value in this context. This could be in the form of analysis of safety significant events, analysis of severe accidents, review of operating experience, independent checks of critical designs and even review of operator responses under different situations towards arriving at modifications to training programmes and licensing procedures for operating personnel. A latent benefit of regulatory research carried out by the regulators themselves is that it improves their technical competence considerably which in turn leads to high quality safety reviews and improved regulation in general. The aim of the present paper is to provide an overview of role of regulatory research and the in-house regulatory safety

Virginia Power's regulatory reduction program

International Nuclear Information System (INIS)

Miller, G.D.

1996-01-01

Virginia Power has two nuclear plants, North Anna and Surry Power Stations, which have two units each for a total of four nuclear units. In 1992, the Nuclear Regulatory Commission solicited comments from the nuclear industry to obtain their ideas for reducing the regulatory burden on nuclear facilities. Pursuant to the new regulatory climate, Virginia Power developed an internal program to evaluate and assess the regulatory and self-imposed requirements to which they were committed, and to pursue regulatory relief or internal changes where possible and appropriate. The criteria were that public safety must be maintained, and savings must be significant. Up to the date of the conference, over US$22 million of one-time saving had been effected, and US$2.75 million in annual savings

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

disenfranchisement, is hardly a novel phenomenon: historical context and the lessons learned therefrom are essential in evaluating the idea and situating the debate within a meaningful framework. Social licence entails an additional layer of ‘regulation’, albeit an amorphous one. A central lesson of the 20th century experience is that regulation comes at a cost, and that excessive regulation and intervention can lead to paralysis and ‘government failure’. The implication is that regulation should be relied upon where it is necessary, and should be implemented in sensible ways. One of the conclusions of this report is that public trust and confidence can be enhanced by rationalizing existing regulatory vehicles to reduce the common perception that decisions are sometimes politically motivated and ensuring that decisions are made at the right levels of government. The institutionalization of social licence also has identifiable risks. It is likely to increase incentives for “rent-seeking behaviour.” The threat of veto, or even obstruction, endows the affected group with leverage that can result in extraction of rents that are disproportionate to impacts. It also increases regulatory and political uncertainty associated with a given project, discouraging investment, or requiring returns higher than are merited by the inherent riskiness of the proposed undertaking. The term “social licence” needs to be further analyzed, and, if used, used with care. The concept originated in the mining sector as the “social licence to operate,” and as the concept has migrated to the energy sector, it appears to have broadened in scope so that its meaning has become unclear, amorphous and confusing. Other terms such as “acceptance,” “support” or “public confidence” may be more appropriate in the energy sphere. Regulators, policy-makers and politicians should refrain from the use of these terms without a clear understanding of their implications. Our specific

Orchestrating Transnational Environmental Governance in Maritime Shipping

DEFF Research Database (Denmark)

Lister, Jane; Taudal Poulsen, René; Ponte, Stefano

2015-01-01

Maritime shipping is the transmission belt of the global economy. It is also a major contributor to global environmental change through its under-regulated air, water and land impacts. It is puzzling that shipping is a lagging sector as it has a well-established global regulatory body—the Interna......Maritime shipping is the transmission belt of the global economy. It is also a major contributor to global environmental change through its under-regulated air, water and land impacts. It is puzzling that shipping is a lagging sector as it has a well-established global regulatory body......—the International Maritime Organization. Drawing on original empirical evidence and archival data, we introduce a four-factor framework to investigate two main questions: why is shipping lagging in its environmental governance; and what is the potential for the International Maritime Organization to orchestrate......, and growing regulatory fragmentation and uncertainty. The paper concludes with pragmatic recommendations for the International Maritime Organization to acknowledge the regulatory difficulties and seize the opportunity to orchestrate environmental progress....

76 FR 6587 - Pennsylvania Regulatory Program

Science.gov (United States)

2011-02-07

... [PA-159-FOR; OSM 2010-0017] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... remove a required amendment to the Pennsylvania regulatory program (the ``Pennsylvania program'') under... program amendment codified in the Federal regulations, Pennsylvania has submitted information that it...

Government Services Information Infrastructure Management

Energy Technology Data Exchange (ETDEWEB)

Cavallini, J.S.; Aiken, R.J.

1995-04-01

The Government Services Information Infrastructure (GSII) is that portion of the NII used to link Government and its services, enables virtual agency concepts, protects privacy, and supports emergency preparedness needs. The GSII is comprised of the supporting telecommunications technologies, network and information services infrastructure and the applications that use these. The GSII is an enlightened attempt by the Clinton/Gore Administration to form a virtual government crossing agency boundaries to interoperate more closely with industry and with the public to greatly improve the delivery of government services. The GSII and other private sector efforts, will have a significant impact on the design, development, and deployment of the NII, even if only through the procurement of such services. The Federal Government must adopt new mechanisms and new paradigms for the management of the GSII, including improved acquisition and operation of GSII components in order to maximize benefits. Government requirements and applications will continue to evolv. The requirements from government services and users of form affinity groups that more accurately and effectively define these common requirements, that drive the adoption and use of industry standards, and that provide a significant technology marketplace.

Towards adaptive and integrated management paradigms to meet the challenges of water governance.

Science.gov (United States)

Halbe, J; Pahl-Wostl, C; Sendzimir, J; Adamowski, J

2013-01-01

Integrated Water Resource Management (IWRM) aims at finding practical and sustainable solutions to water resource issues. Research and practice have shown that innovative methods and tools are not sufficient to implement IWRM - the concept needs to also be integrated in prevailing management paradigms and institutions. Water governance science addresses this human dimension by focusing on the analysis of regulatory processes that influence the behavior of actors in water management systems. This paper proposes a new methodology for the integrated analysis of water resources management and governance systems in order to elicit and analyze case-specific management paradigms. It builds on the Management and Transition Framework (MTF) that allows for the examination of structures and processes underlying water management and governance. The new methodology presented in this paper combines participatory modeling and analysis of the governance system by using the MTF to investigate case-specific management paradigms. The linking of participatory modeling and research on complex management and governance systems allows for the transfer of knowledge between scientific, policy, engineering and local communities. In this way, the proposed methodology facilitates assessment and implementation of transformation processes towards IWRM that require also the adoption of adaptive management principles. A case study on flood management in the Tisza River Basin in Hungary is provided to illustrate the application of the proposed methodology.

ENSI’s regulatory framework strategy

International Nuclear Information System (INIS)

2015-03-01

This short brochure issued by the Swiss Federal Nuclear Safety Inspectorate ENSI defines the organisation’s regulatory framework strategy. Six guiding principles are declared and discussed: Comprehensive harmonisation with relevant international requirements, basing the regulatory framework on existing, tried-and-tested regulations, issuing of its own guidelines only when it is necessary to do so, guidelines to be drawn up transparently and with the involvement of all stakeholders and basing the level of detail of its regulatory framework on hazard potential and risk

Alberta Energy and Utilities Board, regulatory highlights for 1998

International Nuclear Information System (INIS)

1999-01-01

This new publication informs readers about what the Alberta Energy and Utilities Board (EUB) did in the past year, including important regulatory issues, trends and initiatives. The EUB is an agency of the provincial government, established to regulate Alberta's energy resource and utility sectors. It is part of the Alberta Ministry of Energy. The four main functions of the Board are regulatory initiatives, license applications, enforcement and information. This publication summarized the EUB's position regarding flaring (both solution gas flaring and well test flaring), and Board activities in the areas of animal health concerns, the gas over bitumen controversy, the deregulation of the electric industry and what it means to the EUB, improvements in data quality as a result of improved industry compliance in reporting, and a variety of issues related to the oil sands and the negotiated settlement process. Also, the Board has been proactive in the area of oilfield waste management guidelines, proliferation policies for gas processing facilities, sulphur recovery guidelines, and the expansion of the orphan well program to include facilities and pipelines. As a measure of the success of the EUB, a recent survey of 19 randomly selected focus groups praised EUB for its impartiality, fair and equitable enforcement and independence. It was also praised for its technically competent and experienced staff, its access to quality information and the clarity of its mandate, regulatory requirements and processes. The Board's efforts in the area of timely stakeholder consultation was highlighted. tabs., figs

Ego depletion and positive illusions: does the construction of positivity require regulatory resources?

Science.gov (United States)

Fischer, Peter; Greitemeyer, Tobias; Frey, Dieter

2007-09-01

Individuals frequently exhibit positive illusions about their own abilities, their possibilities to control their environment, and future expectations. The authors propose that positive illusions require resources of self-control, which is considered to be a limited resource similar to energy or strength. Five studies revealed that people with depleted self-regulatory resources indeed exhibited a less-optimistic sense of their own abilities (Study 1), a lower sense of subjective control (Study 2), and less-optimistic expectations about their future (Study 3). Two further studies shed light on the underlying psychological process: Ego-depleted (compared to nondepleted) individuals generated/retrieved less positive self-relevant attributes (Studies 4 and 5) and reported a lower sense of general self-efficacy (Study 5), which both partially mediated the impact of ego depletion on positive self-views (Study 5).

14 CFR 313.4 - Major regulatory actions.

Science.gov (United States)

2010-01-01

...) PROCEDURAL REGULATIONS IMPLEMENTATION OF THE ENERGY POLICY AND CONSERVATION ACT § 313.4 Major regulatory... of actions shall not be deemed as major regulatory actions requiring an energy statement: (1) Tariff...

Implementation of the waste management transfer act. Requirements from a regulatory point of view; Zur Umsetzung des Entsorgungsuebergangsgesetzes. Anforderungen aus regulatorischer Sicht

Energy Technology Data Exchange (ETDEWEB)

Mueller-Dehn, Christian [PreussenElektra GmbH, Hannover (Germany). Regulierung, Grundsatzfragen

2017-11-15

In future in Germany, the state will be responsible for financing and handling the interim and final storage of radioactive waste from nuclear power plants. With regard to interim storage, this objective is achieved with the provisions of the Waste Management Transfer Act. Regulatory implementation is based on these regulations. BGZ Gesellschaft fuer Zwischenlager mbH is responsible for interim storage on behalf of the Federal Government. Simultaneously with the transfer of interim storage facilities to BGZ a legal transfer of approval is carried out. Insofar as there is a technical, organisational or personnel conjunction with the nuclear power plant operation, which continues to exist beyond this deadline and is relevant for regulatory purposes, a regulation is made via a service contract with the BGZ. This ensures compliance with the licensing regulations. Irradiated fuel assemblies and the waste from reprocessing can be handed over to BGZ from 1 January 2019 onwards and waste with negligible heat generation can be disposed of as of the determination of their proper packaging.

Regulatory framework and safety requirements for new (gen III) reactors

International Nuclear Information System (INIS)

Mourlon, Sophie

2014-01-01

Sophie Mourlon, ASN Deputy General Director, described the international process to enhance safety between local safety authorities through organizations such as WENRA. Then she explained to the participants the regulatory issues for the next generation of NPPs

Regulatory Activities on Civil Nuclear Safety Equipment in China

International Nuclear Information System (INIS)

Gaoshang, Lu; Choi, Kwang Sik

2011-01-01

It is stipulated in IAEA Fundamental Safety Principles (SF1) that the fundamental safety objective is to protect people and the environment from harmful effects of ionizing radiation. The fundamental safety objective applies for all facilities and activities and for all stages over the lifetime of a facility or radiation source, including planning, sitting, design, manufacturing, construction, commissioning and operation, as well as decommissioning and closure. So, according to the requirement, the related activities such as design, manufacturing, installation and non-destructive test that conducted on civil nuclear equipment should be well controlled by the vendors, the owner of the nuclear power plants and the regulatory body. To insure the quality of those equipment, Chinese government had taken a series of measures to regulate the related activities on them

Codes and standards and other guidance cited in regulatory documents

International Nuclear Information System (INIS)

Nickolaus, J.R.; Bohlander, K.L.

1996-08-01

As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800)

Codes and standards and other guidance cited in regulatory documents

Energy Technology Data Exchange (ETDEWEB)

Nickolaus, J.R.; Bohlander, K.L.

1996-08-01

As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800).

76 FR 77883 - Self-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-12-14

... funding of an SRO's regulatory operations in the Concept Release Concerning Self-Regulation \\18\\ and the release on the Fair Administration and Governance of Self- Regulatory Organizations.\\19\\ In the Concept... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65913; File No. SR-NASDAQ-2011-163] Self...

76 FR 13442 - Joint Industry Plan; Order Approving Amendment No. 25 to the Joint Self-Regulatory Organization...

Science.gov (United States)

2011-03-11

..., Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on... Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange LLC...-Regulatory Organization Plan Governing the Collection, Consolidation, and Dissemination of Quotation and...

78 FR 66788 - Joint Industry Plan; Order Approving Amendment No. 30 to the Joint Self-Regulatory Organization...

Science.gov (United States)

2013-11-06

..., Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on... Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange LLC...-Regulatory Organization Plan Governing the Collection, Consolidation, and Dissemination of Quotation and...

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

Government capacities and stakeholders: what facilitates ehealth legislation?

Science.gov (United States)

2014-01-01

Background Newly established high-technology areas such as eHealth require regulations regarding the interoperability of health information infrastructures and data protection. It is argued that government capacities as well as the extent to which public and private organizations participate in policy-making determine the level of eHealth legislation. Both explanatory factors are influenced by international organizations that provide knowledge transfer and encourage private actor participation. Methods Data analysis is based on the Global Observatory for eHealth - ATLAS eHealth country profiles which summarizes eHealth policies in 114 countries. Data analysis was carried out using two-component hurdle models with a truncated Poisson model for positive counts and a hurdle component model with a binomial distribution for zero or greater counts. Results The analysis reveals that the participation of private organizations such as donors has negative effects on the level of eHealth legislation. The impact of public-private partnerships (PPPs) depends on the degree of government capacities already available and on democratic regimes. Democracies are more responsive to these new regulatory demands than autocracies. Democracies find it easier to transfer knowledge out of PPPs than autocracies. Government capacities increase the knowledge transfer effect of PPPs, thus leading to more eHealth legislation. Conclusions All international regimes – the WHO, the EU, and the OECD – promote PPPs in order to ensure the construction of a national eHealth infrastructure. This paper shows that the development of government capacities in the eHealth domain has to be given a higher priority than the establishment of PPPs, since the existence of some (initial) capacities is the sine qua non of further capacity building. PMID:24410989

AUDIT REPORTING AND CORPORATE GOVERNANCE: LINKS AND IMPLICATIONS

Directory of Open Access Journals (Sweden)

George Silviu CORDOȘ

2014-04-01

Full Text Available Financial scandals of the last decade have had a negative effect upon the trust and perception of investors regarding auditor responsibility and their part in fraud and error detection. As a result of legal conditions and regulations, audit firms in some jurisdictions have recently started to compile transparency reports, which contain information regarding corporate governance compliance of audit firms. This study aims to investigate if corporate governance has a significant effect on audit reporting and audit quality. Thus, our starting point is the definition of corporate governance, with an emphasis on the transparency principle for efficient corporate governance. We aim to analyse how this principle influences the quality level of the audit report, through a qualitative study. Keeping in mind that corporate governance in audit firms is considered to have a noteworthy effect on audit quality, we expect to find that regulatory bodies expect more transparency from these firms, therefore increasing competitiveness among audit firms concerning audit quality.

Private Equity and Regulatory Capital

NARCIS (Netherlands)

Bongaerts, D.; Charlier, E.

2008-01-01

Regulatory Capital requirements for European banks have been put forward in the Basel II Capital Framework and subsequently in the Capital Requirements Directive (CRD) of the EU. We provide a detailed discussion of the capital requirements for private equity investments under the simple risk weight

Tackling the global NCD crisis: innovations in law and governance.

Science.gov (United States)

Thomas, Bryan; Gostin, Lawrence O

2013-01-01

35 million people die annually of non-communicable diseases (NCDs), 80% of them in low- and middle-income countries - representing a marked epidemiological transition from infectious to chronic diseases and from richer to poorer countries. The total number of NCDs is projected to rise by 17% over the coming decade, absent significant interventions. The NCD epidemic poses unique governance challenges: the causes are multifactorial, the affected populations diffuse, and effective responses require sustained multi-sectorial cooperation. The authors propose a range of regulatory options available at the domestic level, including stricter food labeling laws, regulation of food advertisements, tax incentives for healthy lifestyle choices, changes to the built environment, and direct regulation of food and drink producers. Given the realities of globalization, such interventions require global cooperation. In 2011, the UN General Assembly held a High-level meeting on NCDs, setting a global target of a 25% reduction in premature mortality from NCDs by 2025. Yet concrete plans and resource commitments for reaching this goal are not yet in the offing, and the window is rapidly closing for achieving these targets through prevention - as opposed to treatment, which is more costly. Innovative global governance for health is urgently needed to engage private industry and civil society in the global response to the NCD crisis. © 2013 American Society of Law, Medicine & Ethics, Inc.

Nuclear Regulatory Infrastructure in the Philippines