The future regulatory environment - a South African perspective

Energy Technology Data Exchange (ETDEWEB)

Van der Woude, S.; Leaver, J.; Metcalf, P.E. [National Nuclear Regulator, Centurion (South Africa)

2000-07-01

The South African nuclear regulatory authority, the National Nuclear Regulator, regulates nuclear fuel cycle facilities as well as a large variety of mining and minerals processing activities. The future political, social, economical and technological environment, within which these facilities operate, will present numerous challenges to those who will be regulating them. In our presentation the challenges to be fulfilled in discharging the regulatory function are discussed, particularly in the context of a country with a small nuclear programme and a substantial developing component. Amongst the challenges discussed are: As part of the growing internationalization, the need to harmonize standards applied in different countries and the need to balance standards and practice applied in developed countries with resources available in developing countries; The need to consider the impact on the environment and not only on human beings; The impact of rapid advances in information technology on regulation; The maintenance and development of the appropriate expertise in the face of uncertainties regarding the future of the nuclear industry; Public involvement; The demands by society for greater standards of safety but at the same time for more effective and cost-effective regulation; The need for regulators to match customer demands on operators in terms of quality, speed, flexibility and costs; The privatization of nuclear fuel cycle facilities; The increased trend for larger facilities to outsource work to smaller companies; and, The need to balance good practice considerations with quantitatively determined risks in regulatory decision-making. (author)

Current Status of Regulatory Science Education in Faculties of Pharmaceutical Science in Japan.

Science.gov (United States)

Tohkin, Masahiro

2017-01-01

I introduce the current pharmaceutical education system in Japan, focusing on regulatory science. University schools or faculties of pharmaceutical science in Japan offer two courses: a six-year course for pharmacists and a four-year course for scientists and technicians. Students in the six-year pharmaceutical course receive training in hospitals and pharmacies during their fifth year, and those in the four-year life science course start research activities during their third year. The current model core curriculum for pharmaceutical education requires them to "explain the necessity and significance of regulatory science" as a specific behavior object. This means that pharmacists should understand the significance of "regulatory science", which will lead to the proper use of pharmaceuticals in clinical practice. Most regulatory science laboratories are in the university schools or faculties of pharmaceutical sciences; however, there are too few to conduct regulatory science education. There are many problems in regulatory science education, and I hope that those problems will be resolved not only by university-based regulatory science researchers but also by those from the pharmaceutical industry and regulatory authorities.

Strategic Renewal in Regulatory Environments: How inter- and intra-organisational institutional forces influence European incumbent energy firms

OpenAIRE

Stienstra, Marten

2008-01-01

textabstractHow do incumbent firms strategically renew in regulatory environments? Assuming that regulation can both constrain and enable a firm’s strategic renewal opportunities, we investigate how and to what extent incumbent firms undertake exploitative and explorative strategic renewal actions in order to remain competitive. Exploitative strategic renewal involves those actions that strengthen or optimise a firm’s current resource deployments, whereas explorative strategic renewal relates...

Regulatory inspection of BARC facilities

International Nuclear Information System (INIS)

Rajdeep; Jayarajan, K.

2017-01-01

Nuclear and radiation facilities are sited, constructed, commissioned, operated and decommissioned, in conformity with the current safety standards and codes. Regulatory bodies follow different means to ensure compliance of the standards for the safety of the personnel, the public and the environment. Regulatory Inspection (RI) is one of the important measures employed by regulatory bodies to obtain the safety status of a facility or project and to verify the fulfilment of the conditions stipulated in the consent

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

Science.gov (United States)

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

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

International Nuclear Information System (INIS)

Tronea, M.

2010-01-01

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

Global Banking System Regulatory Environment

Directory of Open Access Journals (Sweden)

Oleh Mozhovyi

2017-03-01

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

Evolution of regulatory networks towards adaptability and stability in a changing environment

Science.gov (United States)

Lee, Deok-Sun

2014-11-01

Diverse biological networks exhibit universal features distinguished from those of random networks, calling much attention to their origins and implications. Here we propose a minimal evolution model of Boolean regulatory networks, which evolve by selectively rewiring links towards enhancing adaptability to a changing environment and stability against dynamical perturbations. We find that sparse and heterogeneous connectivity patterns emerge, which show qualitative agreement with real transcriptional regulatory networks and metabolic networks. The characteristic scaling behavior of stability reflects the balance between robustness and flexibility. The scaling of fluctuation in the perturbation spread shows a dynamic crossover, which is analyzed by investigating separately the stochasticity of internal dynamics and the network structure differences depending on the evolution pathways. Our study delineates how the ambivalent pressure of evolution shapes biological networks, which can be helpful for studying general complex systems interacting with environments.

Deliberations on nuclear safety regulatory system in a changing industrial environment

International Nuclear Information System (INIS)

Kim, H.J.

2001-01-01

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

The changing regulatory environment

International Nuclear Information System (INIS)

Caron, G.

1999-01-01

The role and value of regulation in the energy sector was discussed, demonstrating how, despite common perception, regulation is an essential part of Canada's strategy to find and develop new opportunities. The future vision of regulation for industry participants was presented with particular focus on issues related to streamlining the regulatory process. As far as pipelines are concerned, regulatory actions are necessary to facilitate capacity increases and to ensure the line's integrity, safety and environmental record. Furthermore, regulation provides economic solutions where market forces cannot provide them, as for example where business has elements of monopoly. It arbitrates interests of landowners, business, consumers, and environmental groups. It looks for ways to ensure conditions under which competition can flourish. It acts as the guardian of citizens' rights in a democratic society by providing citizens with an opportunity to be heard on the building or expansion of pipelines and associated facilities. As citizens become more and more concerned about their property and the land that surrounds them, citizen involvement in decision making about how industry activity affects their quality of life will become correspondingly more important. Regulatory agencies are committed to facilitate this engagement by flexible hearing procedures and by making use of evolving communication and information technology

Current status and regulatory aspects of pesticides considered to be persistent organic pollutants (POPs) in Taiwan.

Science.gov (United States)

Tsai, Wen-Tien

2010-10-01

Organochlorine pesticides (OCPs) are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs) and even as endocrine disrupting chemicals (EDCs). The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs). The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years.

Orphan drugs: the regulatory environment.

Science.gov (United States)

Franco, Pedro

2013-02-01

The definition of a rare disease is not universal and depends on the legislation and policies adopted by each region or country. The main objective of this article is to describe and discuss the legal framework and the regulatory environment of orphan drugs worldwide. Some reflections and discussions on the need for specific orphan drug legislation or policies are described at length. Furthermore, some aspects of the history of each region in respect of the orphan drug legislation evolution are outlined. This article describes and compares the orphan drug legislation or policies of the following countries or regions: United Sates of America (US), European Union (EU), Japan, Australia, Singapore, Taiwan and Canada. The incentives described in the orphan drug legislations or policies, the criteria for designation of orphan status and the authorisation process of an orphan drug are also described and compared. The legislations and policies are to some extent similar but not the same. It is important to understand the main differences among all available legislative systems to improve the international collaboration in the field of orphan drugs and rare diseases. Copyright © 2012 Elsevier Ltd. All rights reserved.

Reactors licensing: proposal of an integrated quality and environment regulatory structure for nuclear research reactors in Brazil

International Nuclear Information System (INIS)

Serra, Reynaldo Cavalcanti

2014-01-01

A new integrated regulatory structure based on quality and integrated issues has been proposed to be implemented on the licensing process of nuclear research reactors in Brazil. The study starts with a literature review about the licensing process in several countries, all of them members of the International Atomic Energy Agency. After this phase it is performed a comparative study with the Brazilian licensing process to identify good practices (positive aspects), the gaps on it and to propose an approach of an integrated quality and environmental management system, in order to contribute with a new licensing process scheme in Brazil. The literature review considered the following research nuclear reactors: Jules-Horowitz and OSIRIS (France), Hanaro (Korea), Maples 1 and 2 (Canada), OPAL (Australia), Pallas (Holand), ETRR-2 (Egypt) and IEA-R1 (Brazil). The current nuclear research reactors licensing process in Brazil is conducted by two regulatory bodies: the Brazilian National Nuclear Energy Commission (CNEN) and the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA). CNEN is responsible by nuclear issues, while IBAMA by environmental one. To support the study it was applied a questionnaire and interviews based on the current regulatory structure to four nuclear research reactors in Brazil. Nowadays, the nuclear research reactor’s licensing process, in Brazil, has six phases and the environmental licensing process has three phases. A correlation study among these phases leads to a proposal of a new quality and environmental integrated licensing structure with four harmonized phases, hence reducing potential delays in this process. (author)

Effect of environment fluctuations on a Josephson current

International Nuclear Information System (INIS)

Galaktionov, A.V.

2017-01-01

Highlights: • Josephson current is influenced differently by environment fluctuations. • Two types of environment are studied: ohmic and resonant-mode one. • A crossover to a Josephson π-junction is possible for both of them. - Abstract: An influence of an electromagnetic environment on a Josephson current through a tunnel junction is studied with the aid of Ambegaokar-Eckern-Schön effective action. Two types of environment are investigated: one, characterized by a resonant mode, and an ohmic one. The crossover to a Josephson π-junction is possible for both of them. In addition the resonant-mode environment results in an increase of a Josephson current when the ratio of the doubled superconducting gap to the frequency of the mode is close to an integer number.

CURRENT ENVIRONMENT FOR INTRODUCING HEALTH TECHNOLOGY ASSESSMENT IN GREECE.

Science.gov (United States)

Kani, Chara; Kourafalos, Vasilios; Litsa, Panagiota

2017-01-01

The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use. Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure. The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures-such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting-have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market. Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.

Current Status and Regulatory Aspects of Pesticides Considered to be Persistent Organic Pollutants (POPs in Taiwan

Directory of Open Access Journals (Sweden)

Wen-Tien Tsai

2010-10-01

Full Text Available Organochlorine pesticides (OCPs are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs and even as endocrine disrupting chemicals (EDCs. The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs. The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years.

The waste isolation pilot plant: A new regulatory environment

International Nuclear Information System (INIS)

Frei, M.W.; Schneider, S.P.; Saris, E.C.; Austin, P.W.

1993-01-01

The US Department of Energy (DOE) is ready to embark on a multiyear test program, using radioactive waste, at the Waste Isolation Pilot Plant (WIPP). The WIPP is a deep geologic repository, constructed in ancient salt beds in southeastern New Mexico. It was authorized by Congress in 1979 as a research and development facility to demonstrate safe disposal of the nation's defense transuranic (TRU) waste. Nonradioactive testing in the repository has been under way for several years. The DOE is now ready to begin underground experiments at WIPP with small amounts of TRU waste. Radioactive waste testing in an actual repository environment will reduce uncertainties associated with predictions of long-term repository performance. However, the authority for DOE to begin this new phase of the test program no longer resides within the department. The WIPP is now subject to a new level of regulatory oversight by the Environmental Protection Agency (EPA) and other federal agencies, as set forth by Public Law 102-579, the WIPP Land Withdrawal Act, signed by the President on October 30, 1992. This paper discusses the act's new regulatory requirements for WIPP

Current issues and regulatory infrastructure aspects on radioactive waste management in Romania

International Nuclear Information System (INIS)

Vieru, G.

2002-01-01

The nuclear facilities that exist throughout Romania perform a broad range of missions from research to nuclear materials production to radioactive waste management, and to deactivation and decommissioning. As a consequence, there is a broad array of external regulations and internal requirements that potentially applies to a facility or activity. Therefore, the management of radioactive waste occurs within a larger context of managing hazards, both radiological and industrial, at these facilities. At the same time, concern for upgrading existing facilities used for radioactive waste management, as called for in Article 12, fits into a larger framework of safety management. The primary objective of the Romanian Nuclear Regulatory Body-CNCAN on legislation and regulatory infrastructure for the safety of radioactive waste management is to protect human health and the environment now and in the future. It is unanimously recognized that a well developed regulated system for the management and disposal of radioactive waste is a prerequisite for both public and market acceptance of nuclear energy. It is to underline that the continuing internationalization of the nuclear industry following terrorist attacks of 11 September 2001 stresses the need for national legislation and regulatory infrastructure to be based on internationally endorsed principles and safety standards. The paper presents some aspects of the Romanian experience on the national legislative and regulatory system related to the followings aspects of the safety aspects of radioactive waste management: definition of responsibilities; nuclear and radiation safety requirements; siting and licensing procedures; regulatory functions; international co-operation and coherence on strategies and criteria in the area of safety of radioactive waste management. Finally, prescriptive and goal oriented national as well international regimes in the field of the safety of radioactive waste management are briefly commented

Current approaches to gene regulatory network modelling

Directory of Open Access Journals (Sweden)

Brazma Alvis

2007-09-01

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

Regulatory Compliance in Multi-Tier Supplier Networks

Science.gov (United States)

Goossen, Emray R.; Buster, Duke A.

2014-01-01

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

Strategies of bringing drug product marketing applications to meet current regulatory standards.

Science.gov (United States)

Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

2015-08-01

In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

Current status of developmental neurotoxicity: regulatory view

DEFF Research Database (Denmark)

Hass, Ulla

2003-01-01

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

The regulatory mechanism in the U.S. lessons learned

International Nuclear Information System (INIS)

Roberts, T.M.

1987-01-01

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

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

Mapping out the regulatory environment and its interaction with land and property markets

International Nuclear Information System (INIS)

Adams, David

2008-01-01

The purpose of this paper is to explain how the regulatory environment created by planning and building regulations interacts with land and property markets. Since this regulatory environment operates as a form of intervention within property markets in general and the development process in particular, it is essential first to understand the nature, structure and operation of land and property markets. These are covered in the first section. The second section identifies the aims and components of the planning system and building regulations. From this basis, four broad types of policy intervention are reviewed in the third section. These cover policies that seek to shape, regulate or stimulate market activity, and those that aim to build state or market capacity to produce desired outcomes. The final section uses the private residential development process as a case study to explore the extent to which state intervention can influence producer-consumer relationships in one important market sector. The paper argues that effective intervention in land and property markets requires the creation of a broad range of policy tools and their appropriate deployment to suit particular market circumstances. (author)

The Philippine Regulatory Frameworks, Support Policies, And Initiatives Encouraging Women Entrepreneurship

OpenAIRE

EDRALIN, Divina M.

2007-01-01

This paper examines the Philippine regulatory frameworks, support policies, initiatives, and barriers to encouraging women entrepreneurship. Currently, women entrepreneurship seems to be nurtured with the right environment, including regulatory frameworks, financial resources and support programs for, as well as business practices and social attitudes in the country towards women entrepreneurs and entrepreneurship in general. However, though many SME-friendly laws and policies exist, their im...

Protection of the Environment: Current ICRP Work and EC-Funded Research

International Nuclear Information System (INIS)

Larsson, C.M.; Holm, L.E.

2003-01-01

The requirement for assessments of the environmental effects of radiation, i.e. effects on non-human biota, is increasing due to growing public concern for environmental protection issues and integration of environmental impact assessments into the regulatory process. Thus, there is a strong need to establish a framework for the assessment of environmental impact of ionising radiation, as well as a system for protection of the environment from ionising radiation. These ambitions are reflected in a number of international efforts and various 'systems' have been proposed or are under development. This paper considers the current discussions on environmental protection within the International Commission on Radiological Protection (ICRP), as part of the Commission's ongoing revision of its recommendations as laid out in Publication 60. Furthermore, the paper reviews work within the EC-funded FASSET (Framework for ASSessment of Environmental impacT) project. The concepts developed both by ICRP and FASSET are similar, and the FASSET approach and results may illustrate how forthcoming ICRP recommendations could be turned into practical application. (orig.)

Top-level regulatory criteria for the standard MHTGR

Energy Technology Data Exchange (ETDEWEB)

NONE

1986-10-15

The Licensing Plan for the Standard MHTGR (Ref. 1) describes a program to support a U.S. Nuclear Regulatory Commission (NRC) design review and approval. The Plan calls for the submittal of Top-Level Regulatory Criteria to the NRC for concurrence with their completeness and acceptability for the MHTGR program. The Top-Level Regulatory Criteria are defined as the standards for judging licensability that directly specify acceptable limits for protection of the public health and safety and the environment. The criteria proposed herein are for normal plant operation and a broad spectrum of anticipated events, including accidents. The approach taken is to define a set of criteria which are general as opposed to being design specific. Specifically, it is recommended that criteria be met which: 1. Are less prescriptive than current regulation, thereby encouraging maximum flexibility in design approaches. 2. Are measurable. 3. Are not more strict than the criteria for current power plants.

Current status of herbal product: Regulatory overview

Science.gov (United States)

Sharma, Sanjay

2015-01-01

A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. PMID:26681886

Strategies for environmental restoration in an evolving regulatory environment

International Nuclear Information System (INIS)

Keller, J.F.; Geffen, C.A.

1990-03-01

The US Department of Energy (DOE) is faced with the immense challenge of effectively implementing a program to mitigate and manage the environmental impacts created by past and current operations at its facilities. Such a program must be developed and administered in accordance with the Comprehensive Environmental Response, Compensation and Liability Act and the Resource Conservation and Recovery Act. These regulations are extremely complex, burdening the environmental restoration process with a number of planning and public interaction requirements that must be met before remediation of a site may begin. Existing regulatory and institutional requirements for environmental restoration dictate that extensive planning, characterization and assessment activities be conducted. An important part of the process is the involvement of regulators and the public in the site characterization and assessment activities and in developing reasonable solutions for cleanup. This paper identifies the regulatory requirements and highlights implementation strategies for key aspects of the environmental restoration process for DOE. Trends in legislation and policy relevant to the DOE environmental restoration process are highlighted, with strategies identified for dealing with the evolution of the regulations while maintaining continuity in the technical activities required for cleaning up the DOE hazardous and mixed waste sites. 10 refs

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

International Nuclear Information System (INIS)

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

2003-01-01

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

Ethical and regulatory aspects of embryonic stem cell research.

Science.gov (United States)

Jain, Kewal K

2002-12-01

Ethical and regulatory issues concerning embryonic stem (ES) cell research are reviewed here a year after the controversy became a public and political issue in the US. The background of various issues are examined and the current regulations in various countries are reviewed. In the US, the debate is linked with abortion, as well as the status of a fetus as a human being, and is politically driven. Obtaining stem cells from embryonic tissues involves destruction of the embryo, to which objections are raised. Religious beliefs are examined and no serious impediments to ES cell research could be identified. Regulations vary from one country to another and it is unlikely that there will ever be any universally uniform ethical and regulatory standards for ES cell research. Currently, the most liberal and favourable environments for ES cell research are in the UK, Singapore, Sweden, India, Israel and China. Unless the US liberalises ES cell research, it may lose its lead in ES cell research and investments in this area may drift to countries with better environments for research. Suggestions are offered in this review to improve the ethical environment for ES cell research.

Environment and T regulatory cells in allergy.

Science.gov (United States)

Braga, M; Schiavone, C; Di Gioacchino, G; De Angelis, I; Cavallucci, E; Lazzarin, F; Petrarca, C; Di Gioacchino, M

2012-04-15

The central role of T regulatory cells in the responses against harmless environmental antigens has been confirmed by many studies. Impaired T regulatory cell function is implicated in many pathological conditions, particularly allergic diseases. The "hygiene hypothesis" suggests that infections and infestations may play a protective role for allergy, whereas environmental pollutants favor the development of allergic diseases. Developing countries suffer from a variety of infections and are also facing an increasing diffusion of environmental pollutants. In these countries allergies increase in relation to the spreading use of xenobiotics (pesticides, herbicides, pollution, etc.) with a rate similar to those of developed countries, overcoming the protective effects of infections. We review here the main mechanisms of non-self tolerance, with particular regard to relations between T regulatory cell activity, infections and infestations such as helminthiasis, and exposure to environmental xenobiotics with relevant diffusion in developing countries. Copyright © 2010 Elsevier B.V. All rights reserved.

US decommissioning strategy in today's regulatory, technical, political, and economic environments

International Nuclear Information System (INIS)

Colvin, J.F.

1995-01-01

The United States commercial nuclear power industry is nearly forty years old. Soon after the turn of the century, the United States expects to see a significant rise in the number of plants requiring decommissioning. This, coupled with recent economic pressures which are impacting the U.S. electrical generation industry and have resulted in the premature shutdown of some nuclear power plants, heighten the need for clear regulations and standards addressing facility closure and decommissioning. Since the issue of decommissioning involves public health and safety, technical, environmental and financial aspects, this complex regulatory environment poses a major challenge to the industry in this area. There are three fundamental issues facing utilities as they develop strategies for the eventual decommissioning of their nuclear power plants. These issues are the regulatory approach to decommissioning, the question of the availability of adequate funding, including the uncertainty resulting from the uncertainty of waste disposal options, and the need to meet environmental standards for the protection of health and safety. Futhermore, these issues, in particular the economic-related issues, are magnified in the event of prematurely shut down nuclear power plant. (Author)

Operating the Advanced Test Reactor in today's economic and regulatory environment

International Nuclear Information System (INIS)

Furstenau, R.V.; Patrick, M.E.; Mecham, D.C.

1999-01-01

The Advanced Test Reactor (ATR), located at the Idaho National Engineering and Environmental Laboratory, is the US Department of Energy's largest and most versatile test reactor. Base programs at ATR are planned well into the 21st century. The ATR and support facilities along with an overview of current programs will be reviewed, but the main focus of the presentation will be on the impact that today's economic and regulatory concerns have had on the operation of this test reactor. Today's economic and regulatory concerns have demanded more work be completed at lower cost while increasing the margin of safety. By the beginning of the 1990 s, federal budgets for research generally and particularly for nuclear research had decreased dramatically. Many national needs continued to require testing in the ATR; but demanded lower cost, increased efficiency, improved performance, and an increased margin of safety. At the same time budgets were decreasing, there was an increase in regulatory compliance activity. The new standards imposed higher margins of safety. The new era of greater openness and higher safety standards complemented research demands to work safer, smarter and more efficiently. Several changes were made at the ATR to meet the demands of the sponsors and public. Such changes included some workforce reductions, securing additional program sponsors, upgrading some facilities, dismantling other facilities, and implementing new safety programs. (author)

40 CFR 73.86 - State regulatory autonomy.

Science.gov (United States)

2010-07-01

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

Limits of the current EU regulatory framework on GMOs: risk of not authorized GM event-traces in imports

Directory of Open Access Journals (Sweden)

Roïz Julie

2014-11-01

Full Text Available Since their first commercialization in the 1990’s, the number of genetically modified organisms (GMOs cultivated around the world has steadily increased. This development has been accompanied by the development of regulatory and policy environments which vary from one country to another. Today, the European food and feed sectors are faced with the increasing risk of finding traces of not authorized GMOs in imports. Under the EU zero tolerance for unapproved GMOs, this situation may lead to trade disruptions with important cost implications. A regulatory environment which minimizes the risk of such disruption is therefore indispensable. To address this issue, the EU has adopted the “technical solution” but this remains insufficient to provide the necessary legal certainty which is needed to operate in such context. More comprehensive approaches are considered globally through low level presence policies.

Strategic Renewal in Regulatory Environments: How inter- and intra-organisational institutional forces influence European incumbent energy firms

NARCIS (Netherlands)

M. Stienstra (Marten)

2008-01-01

textabstractHow do incumbent firms strategically renew in regulatory environments? Assuming that regulation can both constrain and enable a firm’s strategic renewal opportunities, we investigate how and to what extent incumbent firms undertake exploitative and explorative strategic renewal actions

Regulatory aspects for nuclear and radiation applications

International Nuclear Information System (INIS)

Duraisamy, S.

2014-01-01

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

Working with Policy and Regulatory Factors to Implement Universal Design in the Built Environment: The Australian Experience.

Science.gov (United States)

Larkin, Helen; Hitch, Danielle; Watchorn, Valerie; Ang, Susan

2015-07-15

Built environments that are usable by all provide opportunities for engagement in meaningful occupations. However, enabling them in day to day design processes and practice is problematic for relevant professions. The purpose of this phenomenological study was to gain greater understanding of the policy and regulatory influences that promote or hinder the uptake of universal design in built environments, to inform better future design. Focus groups or telephone interviews were undertaken with 28 key building industry and disability stakeholders in Australia. Four themes were identified: the difficulties of definition; the push or pull of regulations and policy; the role of formal standards; and, shifting the focus of design thinking. The findings highlight the complexity of working within policy and regulatory contexts when implementing universal design. Occupational therapists working with colleagues from other professions must be aware of these influences, and develop the skills to work with them for successful practice.

Deposit Insurance and Risk Shifting in a Strong Regulatory Environment

DEFF Research Database (Denmark)

Bartholdy, Jan; Justesen, Lene Gilje

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

GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

OpenAIRE

Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

2017-01-01

Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

Steering healthcare service delivery: a regulatory perspective.

Science.gov (United States)

Prakash, Gyan

2015-01-01

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

Approaches to safety, environment and regulatory approval for the International Thermonuclear Experimental Reactor

International Nuclear Information System (INIS)

Saji, G.; Bartels, H.W.; Chuyanov, V.; Holland, D.; Kashirski, A.V.; Morozov, S.I.; Piet, S.J.; Poucet, A.; Raeder, J.; Rebut, P.H.; Topilski, L.N.

1995-01-01

International Thermonuclear Experimental Reactor (ITER) Engineering Design Activities (EDA) in safety and environment are approaching the point where conceptual safety design, topic studies and research will give way to project oriented engineering design activities. The Joint Central Team (JCT) is promoting safety design and analysis necessary for siting and regulatory approval. Scoping studies are underway at the general level, in terms of laying out the safety and environmental design framework for ITER. ITER must follow the nuclear regulations of the host country as the future construction site of ITER. That is, regulatory approval is required before construction of ITER. Thus, during the EDA, some preparations are necessary for the future application for regulatory approval. Notwithstanding the future host country's jurisdictional framework of nuclear regulations, the primary responsibility for safety and reliability of ITER rests with the legally responsible body which will operate ITER. Since scientific utilization of ITER and protection of the large investment depends on safe and reliable operation of ITER, we are highly motivated to achieve maximum levels of operability, maintainability, and safety. ITER will be the first fusion facility in which overall 'nuclear safety' provisions need to be integrated into the facility. For example, it will be the first fusion facility with significant decay heat and structural radiational damage. Since ITER is an experimental facility, it is also important that necessary experiments can be performed within some safety design limits without requiring extensive regulatory procedures. ITER will be designed with such a robust safety envelope compatible with the fusion power and the energy inventories. The basic approach to safety will be realized by 'defense-in-depth'. (orig.)

Air Emissions Damages from Municipal Drinking Water Treatment Under Current and Proposed Regulatory Standards.

Science.gov (United States)

Gingerich, Daniel B; Mauter, Meagan S

2017-09-19

Water treatment processes present intersectoral and cross-media risk trade-offs that are not presently considered in Safe Drinking Water Act regulatory analyses. This paper develops a method for assessing the air emission implications of common municipal water treatment processes used to comply with recently promulgated and proposed regulatory standards, including concentration limits for, lead and copper, disinfection byproducts, chromium(VI), strontium, and PFOA/PFOS. Life-cycle models of electricity and chemical consumption for individual drinking water unit processes are used to estimate embedded NO x , SO 2 , PM 2.5 , and CO 2 emissions on a cubic meter basis. We estimate air emission damages from currently installed treatment processes at U.S. drinking water facilities to be on the order of $500 million USD annually. Fully complying with six promulgated and proposed rules would increase baseline air emission damages by approximately 50%, with three-quarters of these damages originating from chemical manufacturing. Despite the magnitude of these air emission damages, the net benefit of currently implemented rules remains positive. For some proposed rules, however, the promise of net benefits remains contingent on technology choice.

Determinants of Effective Information Transfer in International Regulatory Standards Adoption

Science.gov (United States)

Popescu, Denisa

2010-01-01

The role of international regulatory standards within the current global environment has become of the most importance. The age of the global system and free market capitalism carried us into the unprecedented age of regulations, and standard setting. Regulations are now becoming the emerging mode of global governance. This study focuses on…

Understanding how to maintain compliance in the current regulatory climate

International Nuclear Information System (INIS)

Bignell, D.T.; Burns, R.

1995-01-01

High level radioactive waste facilities must maintain compliance with all regulatory requirements, even those requirements that have been promulgated after the facility was placed into operation. Facilities must aggressively pursue compliance because environmental laws often impose strict liability for violations; therefore, an honest mistake is no defense. Radioactive waste management is constantly under the public microscope, particularly those facilities that handle high-level radioactive waste. The Savannah River Site has effectively met the challenges of regulatory compliance in its HLRW facilities and plans are being formulated to meet future regulatory requirements as well. Understanding, aggressively achieving, and clearly demonstrating compliance is essential for the continued operations of radioactive waste management facilities. This paper examines how HLRW facilities are impacted by regulatory requirements and how compliance in this difficult area is achieved and maintained

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

Energy Technology Data Exchange (ETDEWEB)

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

2015-06-01

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

Power plant construction contracting in a changing regulatory environment

International Nuclear Information System (INIS)

Person, J.C.

1993-01-01

The 1965 blackout in the Northeast provided the wake-up call that spawned in unprecedented program of power plant construction by electric utilities. This building program began in the late 1960s and continued unabated through the 1970s. Beginning in the late 1970s, state regulators began in era of 'prudence' reviews which disallowed as imprudent significant portions of the costs of certain nuclear units being brought on line at the time. This regulatory experience brought about a fundamental change in the way in which utilities evaluated the need for additional capacity. This paper explores construction contracting trends in light of recent developments in the relationship between the electric utility and the state regulator. It is within this context that the utility decides: (1) whether to build, buy, or save; and (2) if the decision is to build, which project planning and administration considerations will maximize the utility's ability to incorporate project costs into the ratebase. In order to put these issues into their proper perspective, this paper first presents a brief overview of the prudence decisions of the past, and the chilling effect of these decisions generally on new project planning. The paper next focuses on the recent changes to the post-construction prudence review model, including the introduction of pre-approval arrangements and rolling prudence reviews. Following that will be a survey of new construction spending decisions in light of these changes. After an analysis of the bases for the prudence disallowances of the past and the application of the lessons learned from these disallowances to contract planning and administration issues of today, the paper will close with a discussion of the relative advantages and disadvantages of the most commonly used contract delivery methods in today's regulatory environment

Regulatory trends and practices related to nuclear reactor decommissioning

International Nuclear Information System (INIS)

Cantor, R.A.

1984-01-01

In the next several decades, the electric utility industry will be faced with the retirement of 50,000 megawatts (mW) of nuclear capacity. Responsibility for the financial and technical burdens this activity entails has been delegated to the utilities operating the reactors. However, the operators will have to perform the tasks of reactor decommissioning within the regulatory environment dictated by federal, state and local regulations. The purpose of this paper is to highlight some of the current and likely trends in regulations and regulatory practices that will significantly affect the costs, technical alternatives and financing schemes encountered by the electric utilities and their customers

Nanomaterials in Food - Current and Future Applications and Regulatory Aspects

Science.gov (United States)

Aschberger, K.; Gottardo, S.; Amenta, V.; Arena, M.; Botelho Moniz, F.; Bouwmeester, H.; Brandhoff, P.; Mech, A.; Quiros Pesudo, L.; Rauscher, H.; Schoonjans, R.; Vittoria Vettori, M.; Peters, R.

2015-05-01

Nanotechnology can contribute to the development of innovative applications in the agriculture, food and feed sector by e.g. enabling improved delivery of nutrients or increased efficacy of agrichemicals. It is expected that applications will increase in the near future and may therefore become a relevant source of human exposure to nanomaterials (NM). To gain more up-to date information, RIKILT and the Joint Research Centre (JRC) were commissioned by the European Food Safety Authority (EFSA) to prepare an inventory of currently used and reasonably foreseen applications of NM in agriculture and food/feed production and carried out a review of regulatory aspects concerning NM in both EU and non-EU countries. An analysis of the information records in the inventory shows that nano-encapsulates, silver and titanium dioxide are the most frequent type of NM listed and that food additives and food contact materials are the most frequent types of application. A comparison between marketed applications and those in development indicates a trend from inorganic materials (e.g. silver) towards organic materials (nano-encapsulates, nanocomposites). Applications in novel food, feed additives, biocides and pesticides are currently mostly at a developmental stage. The review of EU and non-EU legislation shows that currently a few EU legal acts incorporate a definition of a nanomaterial and specific provisions for NM, whereas in many non-EU countries a broader approach is applied, which mainly builds on guidance for industry.

Nanomaterials in Food - Current and Future Applications and Regulatory Aspects

International Nuclear Information System (INIS)

Aschberger, K; Gottardo, S; Amenta, V; Arena, M; Moniz, F Botelho; Mech, A; Pesudo, L Quiros; Rauscher, H; Bouwmeester, H; Brandhoff, P; Peters, R; Schoonjans, R; Vettori, M Vittoria

2015-01-01

Nanotechnology can contribute to the development of innovative applications in the agriculture, food and feed sector by e.g. enabling improved delivery of nutrients or increased efficacy of agrichemicals. It is expected that applications will increase in the near future and may therefore become a relevant source of human exposure to nanomaterials (NM). To gain more up-to date information, RIKILT and the Joint Research Centre (JRC) were commissioned by the European Food Safety Authority (EFSA) to prepare an inventory of currently used and reasonably foreseen applications of NM in agriculture and food/feed production and carried out a review of regulatory aspects concerning NM in both EU and non-EU countries. An analysis of the information records in the inventory shows that nano-encapsulates, silver and titanium dioxide are the most frequent type of NM listed and that food additives and food contact materials are the most frequent types of application. A comparison between marketed applications and those in development indicates a trend from inorganic materials (e.g. silver) towards organic materials (nano-encapsulates, nanocomposites). Applications in novel food, feed additives, biocides and pesticides are currently mostly at a developmental stage. The review of EU and non-EU legislation shows that currently a few EU legal acts incorporate a definition of a nanomaterial and specific provisions for NM, whereas in many non-EU countries a broader approach is applied, which mainly builds on guidance for industry. (paper)

Current Measurements and Overwash Monitoring Using Tilt Current Meters in Three Coastal Environments

Science.gov (United States)

Lowell, N. S.; Sherwood, C. R.; Decarlo, T. M.; Grant, J. R.

2014-12-01

Tilt Current Meters (TCMs) provide accurate, cost effective measurements of near-bottom current velocities. Many studies in coastal environments require current measurements, which are frequently made with Acoustic Doppler Profilers (ADPs). ADPs are expensive, however, and may not be suitable for locations where there is significant risk of damage, loss, or theft or where a large spatial array of measurements is required. TCMs, by contrast, are smaller, less expensive, and easier to deploy. This study tested TCMs in three sites to determine their suitability for use in research applications. TCMs are based on the drag-tilt principle, where the instrument tilts in response to current. The meter consists of a buoyant float with an onboard accelerometer, three-axis tilt sensor, three-axis magnetometer (compass), and a data logger. Current measurements are derived by post processing the tilt and compass values and converting them to velocity using empirical calibration data. Large data-storage capacity (4 GB) and low power requirements allow long deployments (many months) at high sample rates (16 Hz). We demonstrate the utility of TCM current measurements on a reef at Dongsha Atoll in the South China Sea, and in Vineyard Sound off Cape Cod, where the TCM performance was evaluated against ADP measurements. We have also used the TCM to record waves during an overwash event on a Cape Cod barrier beach during a winter storm. The TCM recorded waves as they came through the overwash channel, and the data were in agreement with the water-level record used as a reference. These tests demonstrate that TCMs may be used in a variety of near shore environments and have the potential to significantly increase the density of meters in future studies were current measurements are required.

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

Science.gov (United States)

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

2016-05-01

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

Development of the Regulatory Framework in Mexico

International Nuclear Information System (INIS)

Carreño Padilla, A. L.; Paz García Beltran, A.B.; Godínez Sánchez, V.

2015-01-01

The present study describes and introduces in a simplified way the process for issuing a Mexican Official Standard of Nuclear series, setting out the departments and agencies involved in this process, and also describing the main challenges identified for preparation, issuance and review of them. Furthermore, topics that are currently in the process of standardisation in Mexico in radiation and nuclear safety are mentioned. The National Commission for Nuclear Safety and Safeguards is the regulatory body empowered and commissioned in Mexico to issue and amends the Official Mexican Standards in nuclear and radiation safety, whose duties and responsibilities are set out in the Regulatory Law on Nuclear Matters of Article 27. The Mexican Standards are of social kind because they are focused to prevent risks that could affect human been health, animal or plants damages, and are also associated to safety in the workplaces, to avoid damages which may be irreparable to the environment and population. Normalization is the process by which all the activities concerning public health, environment protection, labor protection, among others, are ruled on in both, private and public sectors. Through this process, the rules, features or products specifications are set for a product or a regulated service. The objective of a standard is to get an optimum degree of order in a given activity. The objective of creating a regulation is to develop legal certainty, to avoid imminent harm or to reduce existing damages on health, the environment and the Economy. Currently, the regulation for nuclear and radiological safety, physical security, as well as for safeguards in Mexico, is under constant development, looking for to cover the safety needs of employees, licencees, environment and society in a whole; many of these needs are supported by the international recommendations of the IAEA. (author)

40 CFR 92.6 - Regulatory structure.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this part 92 are intended to...

40 CFR 94.6 - Regulatory structure.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 94.6 Section 94... for Compression-Ignition Marine Engines § 94.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this Part 94 are intended to control...

The air quality and regional climate effects of widespread solar power generation under a changing regulatory environment

Science.gov (United States)

Millstein, D.; Zhai, P.; Menon, S.

2011-12-01

used to investigate the effects of the various solar generation scenarios given emissions projections that account for changing regulatory environment, economic and population growth, and technological change. The results will help to quantify the potential air quality benefits of promotion of solar electricity generation in regions containing high penetration of coal-fired power generation. Note current national solar incentives that are based only on solar generation capacity. Further investigation of changes to regional climate due to emission reductions of aerosols and relevant precursors will provide insight into the environmental effects that may occur if solar power generation becomes widespread.

Does the Regulatory Environment for E-Cigarettes Influence the Effectiveness of E-Cigarettes for Smoking Cessation?: Longitudinal Findings From the ITC Four Country Survey.

Science.gov (United States)

Yong, Hua-Hie; Hitchman, Sara C; Cummings, K Michael; Borland, Ron; Gravely, Shannon M L; McNeill, Ann; Fong, Geoffrey T

2017-11-01

To date, no studies have explored how different regulatory environments may influence the effectiveness of electronic cigarettes (ECs) as a smoking cessation aid. This study compares the real-world effectiveness of adult smokers using ECs for quitting compared with quitting unassisted or quitting with nicotine replacement therapy (NRT) and/or prescription medications in two countries with restrictive policies towards ECs (ie, Canada and Australia) versus two countries with less restrictive policies (ie, United States and United Kingdom). Data were drawn from the International Tobacco Control Four Country surveys, from the United States and Canada (2 waves, n = 318 and 380, respectively), the United Kingdom (3 waves, n = 439) and Australia (4 waves, n = 662), collected 2010-2014. Smokers at baseline wave who reported making a quit attempt at follow-up were included. The primary outcome was self-reported abstinence for at least 30 days regardless of smoking status at follow-up assessment. Data across waves were combined and analyzed using generalized estimating equations. Compared to unassisted quitting (ie, no medications or ECs), smokers who used ECs for quitting from countries with less restrictive EC policy environments were more likely (OR = 1.95, 95%CI = 1.19-3.20, p cessation are likely highly dependent on the regulatory environment. What this study adds: This is the first study to examine the impact of regulatory environment for ECs on their real-world effectiveness for smoking cessation. This study shows that in a less restrictive EC regulatory environment, use of ECs during a quit attempt facilitates, but in a more restrictive environment, it inhibits, short-term sustained abstinence. The findings underscore the need for careful consideration on how best to regulate this emerging product so that EC benefits for smoking cessation are maximized and its risks to public health are minimized. © The Author 2017. Published by Oxford University Press on behalf of

Landfill covers for dry environments

International Nuclear Information System (INIS)

Dwyer, S.F.

1996-01-01

A large-scale landfill cover field test is currently underway at Sandia National Laboratories in Albuquerque, New Mexico. It is intended to compare and document the performance of alternative landfill cover technologies of various costs and complexities for interim stabilization and/or final closure of landfills in arid and semi-arid environments. Test plots of traditional designs recommended by the US Environmental Protection Agency for both RCRA Subtitle open-quote C close-quote and open-quote D close-quote regulated facilities have been constructed side-by-side with the alternative covers and will serve as baselines for comparison to these alternative covers. The alternative covers were designed specifically for dry environments. The covers will be tested under both ambient and stressed conditions. All covers have been instrumented to measure water balance variables and soil temperature. An on-site weather station records all pertinent climatological data. A key to acceptance of an alternative environmental technology is seeking regulatory acceptance and eventual permitting. The lack of acceptance by regulatory agencies is a significant barrier to development and implementation of innovative cover technologies. Much of the effort on this demonstration has been toward gaining regulatory and public acceptance

The case for regulatory reform in the business and healthcare environments.

Science.gov (United States)

Younis, Mustafa Z; Barhem, Belal; Hamidi, Samir; Inungu, Joseph; Prater, Gwendolyn S; O'Keefe, Arthur

2009-01-01

Government regulations affect corporations and consumers on a daily basis. For example, environmental and safety regulations in the workplace are administrated by the Occupational Safety and Health Administration (OSHA) under the Department of Labor. OSHA sets and enforces standards in work environment to ensure the safety and health of workers. Other regulatory agencies, such as the National Highway and Transportation Agency (NHTSA), oversee the transportation and the safety of the automobile and truck industry. The U.S. Food and Drug Administration (FDA) plays a major role in approving new drugs on the market and in monitoring drug safety, and it has the power to remove drugs from the market if they are proved to be safety and health problems to the public. However, the mere existence of these regulations often causes impediments to businesses, and the extent of their ultimate usefulness is examined and analyzed in this paper

Current role of the USNRC safety research program in support of the regulatory process

International Nuclear Information System (INIS)

Levine, S.

1979-01-01

The current role of the USNRC's safety research program is shown. Some aspects of this role in the wake of the TMI accident are discused as well as some historical perspective on the development of USNRC's program, its relationship with the NRC mission, an overview of the program activities and some recent research results, and finally the impact of the TMI accident in clarifiying needs for expedited and new research activities, including the need for a greatly enhanced use of probabilistic analysis techniques to improve the coherence of its regulatory process. (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

Deciphering RNA Regulatory Elements Involved in the Developmental and Environmental Gene Regulation of Trypanosoma brucei.

Science.gov (United States)

Gazestani, Vahid H; Salavati, Reza

2015-01-01

Trypanosoma brucei is a vector-borne parasite with intricate life cycle that can cause serious diseases in humans and animals. This pathogen relies on fine regulation of gene expression to respond and adapt to variable environments, with implications in transmission and infectivity. However, the involved regulatory elements and their mechanisms of actions are largely unknown. Here, benefiting from a new graph-based approach for finding functional regulatory elements in RNA (GRAFFER), we have predicted 88 new RNA regulatory elements that are potentially involved in the gene regulatory network of T. brucei. We show that many of these newly predicted elements are responsive to both transcriptomic and proteomic changes during the life cycle of the parasite. Moreover, we found that 11 of predicted elements strikingly resemble previously identified regulatory elements for the parasite. Additionally, comparison with previously predicted motifs on T. brucei suggested the superior performance of our approach based on the current limited knowledge of regulatory elements in T. brucei.

An Analysis of the Regulatory Environment Governing Hearsay Electronic Evidence in South Africa: Suggestions for Reform – Part One

Directory of Open Access Journals (Sweden)

Lee Swales

2018-03-01

Full Text Available The purpose of this two-part article is to examine the regulatory environment governing hearsay electronic evidence in South Africa – with a view to providing clear, practical suggestions for regulatory reform in the context of the South African Law Reform Commission's most recent Discussion Paper on electronic evidence. Technology has become an indispensable part of modern life. In particular, the Internet has facilitated new forms of business enterprise, and shifted basic communication norms. From a legal perspective, technology has presented several novel challenges for courts and legal practitioners to deal with – one of these key challenges relates to electronic evidence and in particular the application of the hearsay rules to the digital environment. The South African Law Reform Commission has identified the application of the hearsay rule as one of the core concerns with regard to electronic evidence, and certain academic analysis has revealed inefficiency in the current legal position which may involve multiple sources of law. Moreover, the Law Society of South Africa has stated that there is some confusion amongst members of the profession in relation to hearsay as it applies to electronic evidence. With the pervasive and burgeoning nature of technology, and with the Internet in mind, it is natural to assume that electronic evidence will be relevant in most forms of legal proceedings in future, and hearsay electronic evidence in particular will play an increasingly important role in years to come. Consequently, part one of this article will consider the key definitional concept in relation to electronic evidence – data messages - and examine whether the definition should be revised. In addition, part one of this article will answer two further critical questions posed by the South African Law Reform Commission in relation to data messages and hearsay evidence, namely: should a data message constitute hearsay? And, how should one

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

Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan

Directory of Open Access Journals (Sweden)

Yoshikazu Nakayama

2015-03-01

Full Text Available Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region.

IS Audit Considerations in Respect of Current Economic Environment

Directory of Open Access Journals (Sweden)

Vlasta Svata

2011-01-01

Full Text Available Accountancy organizations, regulatory bodies, standard setters, and other international organizations have developed guidance, articles, frameworks and resources on issues related to the global financial crisis. Now there is a clear and widely accepted need for more rigorous governance over companies´ systems of internal control. Historically there exist many different activities aiming to support effective enterprise governance (legislative acts, best practices, standards, frameworks. But all these activities may have reinforced the already-existing focus on enterprise governance, but they did not necessarily bring clarity to the topic. Therefore we can currently notice some changes aiming to improve the adoption and adaptation of best practices and standards within the area of enterprise governance. The paper discusses the changes in the Enterprise Governance of IT/IS, audit/assurance evolution, and intended Cobit improvements.

Inaccessible Built Environments in Ghana’s Universities: The Bane of a Weak Legal and Regulatory Framework for Persons with Disabilities 1

Directory of Open Access Journals (Sweden)

John Tiah Bugri

2017-05-01

Full Text Available This is a qualitative study of the role of the legal and regulatory framework in making built environments accessible to Persons with Disabilities in six universities in Ghana. It revealed that the local component of legislation dealing with accessible environments was fragile and fraught with compliance challenges, administrative laxity and the lack of a time conscious approach to issues thereby resulting in inaccessible built environments. In effect, the study gives credence to the proposition of the social model that disability is a creation of humankind and recommends an amendment of Ghana’s Persons with Disability Act.

Measuring and Modeling the U.S. Regulatory Ecosystem

Science.gov (United States)

Bommarito, Michael J., II; Katz, Daniel Martin

2017-09-01

Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

Securing classification and regulatory approval for deepwater projects: management challenges in a global environment

Energy Technology Data Exchange (ETDEWEB)

Feijo, Luiz P.; Burton, Gareth C. [American Bureau of Shipping (ABS), Rio de Janeiro, RJ (Brazil)

2008-07-01

As the offshore industry continues to develop and move into increasingly deeper waters, technological boundaries are being pushed to new limits. Along with these advances, the design, fabrication and installation of deepwater oil and gas projects has become an increasingly global endeavor. After providing an overview of the history and role of Classification Societies, this paper reviews the challenges of securing classification and regulatory approval in a global environment. Operational, procedural and technological changes which one Classification Society; the American Bureau of Shipping, known as ABS, has implemented to address these challenges are presented. The result of the changes has been a more customized service aiming at faster and more streamlined classification approval process. (author)

Protecting workers and the environment: An environmental NGO's perspective on nanotechnology

International Nuclear Information System (INIS)

Balbus, John M.; Florini, Karen; Denison, Richard A.; Walsh, Scott A.

2007-01-01

Nanotechnology, the design and manipulation of materials at the atomic scale, may well revolutionize many of the ways our society manufactures products, produces energy, and treats diseases. New materials based on nanotechnology are already reaching the market in a wide variety of consumer products. Some of the observed properties of nanomaterials call into question the adequacy of current methods for determining hazard and exposure and for controlling resulting risks. Given the limitations of existing regulatory tools and policies, we believe two distinct kinds of initiatives are needed: first, a major increase in the federal investment in nanomaterial risk research; second, rapid development and implementation of voluntary standards of care pending development of adequate regulatory safeguards in the longer term. Several voluntary programs are currently at various stages of evolution, though the eventual outputs of each of these are still far from clear. Ultimately, effective regulatory safeguards are necessary to provide a level playing field for industry while adequately protecting human health and the environment. This paper reviews the existing toxicological literature on nanomaterials, outlines and analyzes the current regulatory framework, and provides our recommendations, as an environmental non-profit organization, for safe nanotechnology development

Current standardisation for nanotechnology

International Nuclear Information System (INIS)

Bard, Delphine; Mark, David; Moehlmann, Carsten

2009-01-01

Standardisation and standards provide an important mechanism to support both innovation and the application of regulations. There is currently no specific regulation for any nanomaterials. Health, safety and environmental protection aspects associated with nanomaterials are however in principle covered to different levels by current EU regulatory framework. There are a number of national, European and international organisations developing standards associated with the development, description and use of nanomaterials as well as the protection of human health and the environment from the production and use of chemicals and consumer products, including nanomaterials. These organisations have also established specific committees on nanotechnology. This paper outlines the different relevant regulations and standards. This paper will mainly be focused on a European health and safety perspective.

Current regulatory and licensing status for byproduct sources, facilities and applications

International Nuclear Information System (INIS)

Tingey, G.L.; Jensen, G.A.; Hazelton, R.F.

1985-02-01

Public use of nuclear byproducts, especially radioactive isotopes, will require approval by various regulatory agencies. Use of cesium-137 as an irradiation source for sterilizing medical products will require US Nuclear Regulatory Commission (NRC) approval. Two applications have been filed with NRC, and approval is expected soon. Widespread use of irradiation for food products depends on a favorable ruling by the Food and Drug Administration (FDA). A ruling is pending that would permit irradiation of fruits and vegetables up to 100 krad. NRC also controls the use of isotopes in remote power generators, but little regulatory action has been required in recent years. Recent development of radioluminescent (RL) lighting for runway lights has led to interest by commercial manufacturers. At the present time, a license has been issued to at least one manufacturer for sale of tritium-powered runway lights. 28 refs., 1 fig

Innovative training techniques in the Canadian nuclear regulatory environment

International Nuclear Information System (INIS)

Martin, D.J.

1996-01-01

One of the contributors to the safety of nuclear installations is properly-trained personnel. This applies equally to the staff of a regulatory agency, as they are charged with the task of evaluating the safety of installations and operations involving radioactive materials. In 1990, the nuclear regulatory agency of Canada, the Atomic Energy Control Board, set up a Training Center to train AECB staff and to provide assistance to foreign regulatory agencies who had asked for such assistance. In setting up the Training Centre, the authors considered factors which adversely affect the efficacy of training courses. The technical content must, of course, be of sufficiently high quality, but there are other, significant factors which are independent of the content: consider a presentation in which the lecturer shows a slide which is unreadable from the back of the room. The training value of this slide is zero, even though the content may be sound. Pursuing this thought, they decided to examine the mechanics of presentations and the form of training materials, with a view to optimizing their effectiveness in training. The results of this examination were that they decided to use three technologies as the basis for production of training, support and presentation materials. This paper briefly describes these technologies and their advantages. The technologies are: desktop publishing, video and multimedia

Use and application of 'best estimate plus uncertainty' methods. A regulatory view

International Nuclear Information System (INIS)

Mendizabal, Rafael; Pelayo, Fernando

2013-01-01

Regulatory environment is characterized by its prevention to change. Any move has to be solidly founded. Application in licensing of Best Estimate Plus Uncertainty (BEPU) methods is not an exception. Typically a fully deterministic approach as described in IAEA SSG-2 is used for design bases accident analyses in current Nuclear Power Plants. In recent years the use of BEPU methodologies is gaining favor in the nuclear technology community as a way to optimize design and operation while preserving full compliance with applicable regulation. This paper has its focus on the regulatory relevance of the use of BEPU in licensing practices. A regulatory analysis describing the rationale of the evolution from classic deterministic methods to BEPU as well as a selected set of topics around the implications of the use of BEPU methods is shown. To finalize some conclusions and thoughts of possible further developments of these methods are drawn. (authors)

How are things going. Obtaining feedback in a regulatory environment

International Nuclear Information System (INIS)

McGuire, J.V.; Walsh, M.E.; Boegel, A.J.; Morisseau, D.S.; Persendky, J.J.

1984-08-01

This study tested two procedures to gather feedback for a federal agency about its regulatory actions and its licensees' practices. The procedures, a workshop and a mailed survey, targeted a data source new to the agency. Results to date find the feedback workshop useful and the new data source cooperative and valuable. Participation in the workshops is surprising, given their historical backdrop, structure, and psychological literatures. These findings suggest that agencies may be ignoring important data sources for ill-informed reasons. Also, the findings suggest a possible need to restructure existing channels of communication between a regulatory agency and its licensees

FREEDOM OF PRESS IN CURRENT SOCIO-POLITICAL ENVIRONMENT IN ROMANIA

OpenAIRE

Georgiana STĂNESCU; Ionuț SUCIU

2017-01-01

This study analyses the way journalists’ freedom of expression is protected in current socio/political context. It has started from the fact that Mass Media is the guarantee of any modern democracy, and respect for freedom of expression is essential in the current European environment. We have shown that Romania guarantees through the Constitution, but also through other international treaties to which it is a signatory, the freedom of expression of every citizen, and, implicitly, the freedom...

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

76 FR 38399 - Assessing the Current Research, Policy, and Practice Environment in Public Health Genomics

Science.gov (United States)

2011-06-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number CDC-2011-0008] Assessing the Current Research, Policy, and Practice Environment in Public Health... information helpful to assess the current research, policy, and practice environment in public health genomics...

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

Current and future applications of PRA in regulatory activities

Energy Technology Data Exchange (ETDEWEB)

Speis, T.P.; Murphy, J.A.; Cunningham, M.A. [Nuclear Regulatory Commission, Washington, DC (United States)] [and others

1995-04-01

Probabilistic Risk Assessments (PRAs) have proven valuable in providing the regulators, the nuclear plant operators, and the reactor designers insights into plant safety, reliability, design and operation. Both the NRC Commissioners and the staff have grown to appreciate the valuable contributions PRAs can have in the regulatory arena, though I will admit the existence of some tendencies for strict adherence to the deterministic approach within the agency and the public at large. Any call for change, particularly one involving a major adjustment in approach to the regulation of nuclear power, will meet with a certain degree of resistance and retrenchment. Change can appear threatening and can cause some to question whether the safety mission is being fulfilled. This skepticism is completely appropriate and is, in fact, essential to a proper transition towards risk and performance-based approaches. Our task in the Office of Nuclear Regulatory Research is to increase the PRA knowledge base within the agency and develop appropriate guidance and methods needed to support the transitioning process.

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

Current trends in nuclear material transportation

International Nuclear Information System (INIS)

Ravenscroft, Norman; Oshinowo, Franchone

1997-01-01

The business of radioactive material transportation has evolved considerably in the past 40 years. Current practices reflect extensive international experience in handling radioactive cargo within a mature and tested regulatory framework. Nevertheless, new developments continue to have an impact on how shipments of nuclear material are planned and carried out. Entities involved in the transport of radioactive materials must keep abreast of these developments and work together to find innovative solutions to ensure that safe, smooth transport activities may continue. Several recent trends in the regulatory environment and political atmosphere require attention. There are four key trends that we'll be examining today: 1) the reduction in the pool of available commercial carriers; 2) routing restrictions; 3) package validation issues; and 4) increasing political sensitivities. Careful planning and cooperative measures are necessary to alleviate problems in each of these areas. (author)

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.)

Independent regulatory control and monitoring of the environment at the uranium legacy sites under reclamation

International Nuclear Information System (INIS)

Shandala, N.K.; Titov, A.V.; Kiselev, S.M.; Isaev, D.V.; Aladova, R.A.

2012-01-01

Full text: Radiation safety at areas affected by the natural uranium mining and milling facilities is very important for the environment protection and human health. For this purpose the close operator-regulator contact is required during remedial operations. One of the key mechanisms of the operating regulatory supervision of radiation safety at uranium legacy sites is organization of independent radiation control and monitoring in the course of reclamation and after its completion. The main stages of this strategy include: detailed radiation survey at the area and in the vicinity of the former uranium mining sites; threat assessment in order to identify the regulatory priorities; environmental radiation control and monitoring. Tailings and shallow disposal sites of the uranium mining wastes are the most critical areas in terms of potential hazard for the environment. Tailings are the source of contamination of the near-land air due to the radionuclide dust resuspension from the tailing surface; surface and ground water due to washing out from by precipitation and surface streams of toxic and radioactive elements. Frequently, contamination of surface and ground waters results in some problems, especially when using the leaching fluids for the solution mining and draining hydraulic fluids. Radiation risk for the residents of areas near not operating uranium mining and milling facilities depends on the following factors: radon exhalation from the surface of dumps and tailing; radioactive dust transfer; using radioactive material in building; contamination of surface water streams and aquifers used for drinking water supply; contamination of open ponds used for fish breeding and catching; contamination of foodstuffs grown in the nuclear legacy areas. Radiation monitoring is necessary for the up-to-date response to changing radiation situation during reclamation and arrangement of adequate countermeasures. We mean here comprehensive dynamic surveillance including long

Pharmaceuticals and Personal Care Products in the Environment: What are the Big Questions?

Science.gov (United States)

Over the past 10-15 years, a significant amount of work has been done by the scientific, regulatory and business communities into effects and risks of pharmaceuticals and personal care products (PPCPs) in the environment. It is now timely to review the current knowledge and to...

Review of current activities to model and measure the orbital debris environment in low-earth orbit

Science.gov (United States)

Reynolds, R. C.

A very active orbital debris program is currently being pursued at the NASA/Johnson Space Center (JSC), with projects designed to better define the current environment, to project future environments, to model the processes contributing to or constraining the growth of debris in the environment, and to gather supporting data needed to improve the understanding of the orbital debris problem and the hazard it presents to spacecraft. This paper is a review of the activity being conducted at JSC, by NASA, Lockheed Engineering and Sciences Company, and other support contractors, and presents a review of current activity, results of current research, and a discussion of directions for future development.

The development of AECB regulatory documents

International Nuclear Information System (INIS)

Joyce, M.

1981-01-01

This document describes the Atomic Energy Control Board's (AECB) approach to the development and preparation of regulatory documents. The principal factors that have shaped the AECB'a regulatory approach are identified as background to the evolution of regulatory documents as are a number of current influences that affect the present and future development of these documents. Also described are the process by which regulatory documents are prepared and published and the points of contact between this process and the Canadian Standards Association program for nuclear standards. (author)

IPTV Market Development and Regulatory Aspects

DEFF Research Database (Denmark)

Tadayoni, Reza; Sigurdsson, Halldór Matthias

2006-01-01

The aim of this paper is to analyse the development of IPTV technology / market and to discuss major regulatory parameters. A general overview of architectures and the technologies deployed for establishing IPTV services is given and the main stake holder identified, along with, the current service...... architecture, the available content in IPTV platforms, and the current business models. Furthermore the regulatory framework of the TV broadcast and IPTV in Europe is analysed....

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.

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

Strategic Renewal in Regulatory Environments. How inter- and intra-organisational institutional forces influence European incumbent energy firms

International Nuclear Information System (INIS)

Stienstra, M.

2008-01-01

How do incumbent firms strategically renew in regulatory environments? Assuming that regulation can both constrain and enable a firm's strategic renewal opportunities, we investigate how and to what extent incumbent firms undertake exploitative and explorative strategic renewal actions in order to remain competitive. Exploitative strategic renewal involves those actions that strengthen or optimise a firm's current resource deployments, whereas explorative strategic renewal relates to actions that generate new sources of value creation for the firm. Based on old institutional theory, new institutional theory, neo-institutional theory and institutional entrepreneurship literature, a multi-level framework that combines selection and adaptation arguments has been developed and applied to investigate strategic renewal behaviour of a sample of European energy incumbents. At industry level of analysis, results show how inter-organisational institutional forces significantly impact firms' choices of exploitative and explorative strategic renewal actions through regulative, normative and cognitive forces. At organisational unit level of analysis, we find that the extent of intra-organisational regulative forces is positively related to exploitative strategic renewal actions. In addition, entrepreneurial proclivity appears to be a catalyst of both exploitative and explorative strategic renewal actions. Finally, our results provide insights how environmental selection and firm level adaptation are interrelated in the context of regulation. The extent of inter-organisational regulative forces positively moderates the relationship between intra-organisational regulative forces and exploitative strategic renewal actions.

Current Limitations and Recommendations to Improve Testing for the Environmental Assessment of Endocrine Active Substances

DEFF Research Database (Denmark)

Coady, Katherine K; Biever, Ronald C; Denslow, Nancy D

2017-01-01

In this paper existing regulatory frameworks and test systems for assessing potential endocrine-active chemicals are described, and associated challenges discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across geographies, but all basically...... evaluate whether a chemical possesses endocrine activity and whether this activity can result in adverse outcomes either to humans or the environment. Current test systems include in silico, in vitro and in vivo techniques focused on detecting potential endocrine activity, and in vivo tests that collect...... methods currently do not exist, and addressing key endocrine pathways of possible concern in addition to those associated with estrogen, androgen and thyroid signaling. This article is protected by copyright. All rights reserved....

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

Reactor safety research program. A description of current and planned reactor safety research sponsored by the Nuclear Regulatory Commission's Division of Reactor Safety Research

International Nuclear Information System (INIS)

1975-06-01

The reactor safety research program, sponsored by the Nuclear Regulatory Commission's Division of Reactor Safety Research, is described in terms of its program objectives, current status, and future plans. Elements of safety research work applicable to water reactors, fast reactors, and gas cooled reactors are presented together with brief descriptions of current and planned test facilities. (U.S.)

Risk assessment based on current release standards for radioactive surface contamination

International Nuclear Information System (INIS)

Chen, S.Y.

1993-09-01

Standards for uncontrolled releases of radioactive surface contamination have been in existence in the United States for about two decades. Such standards have been issued by various agencies, including the US Department of Energy. This paper reviews the technical basis of published standards, identifies areas in need of revision, provides risk interpretations based on current technical knowledge and the regulatory environment, and offers suggestions for improvements

Nitrogen modulation of legume root architecture signalling pathways involves phytohormones and small regulatory molecules

Directory of Open Access Journals (Sweden)

Nadiatul Akmal Mohd-Radzman

2013-10-01

Full Text Available Nitrogen, particularly nitrate is an important yield determinant for crops. However, current agricultural practice with excessive fertilizer usage has detrimental effects on the environment. Therefore, legumes have been suggested as a sustainable alternative for replenishing soil nitrogen. Legumes can uniquely form nitrogen-fixing nodules through symbiotic interaction with specialized soil bacteria. Legumes possess a highly plastic root system which modulates its architecture according to the nitrogen availability in the soil. Understanding how legumes regulate root development in response to nitrogen availability is an important step to improving root architecture. The nitrogen-mediated root development pathway starts with sensing soil nitrogen level followed by subsequent signal transduction pathways involving phytohormones, microRNAs and regulatory peptides that collectively modulate the growth and shape of the root system. This review focuses on the current understanding of nitrogen-mediated legume root architecture including local and systemic regulations by different N-sources and the modulations by phytohormones and small regulatory molecules.

Nitrogen modulation of legume root architecture signaling pathways involves phytohormones and small regulatory molecules.

Science.gov (United States)

Mohd-Radzman, Nadiatul A; Djordjevic, Michael A; Imin, Nijat

2013-10-01

Nitrogen, particularly nitrate is an important yield determinant for crops. However, current agricultural practice with excessive fertilizer usage has detrimental effects on the environment. Therefore, legumes have been suggested as a sustainable alternative for replenishing soil nitrogen. Legumes can uniquely form nitrogen-fixing nodules through symbiotic interaction with specialized soil bacteria. Legumes possess a highly plastic root system which modulates its architecture according to the nitrogen availability in the soil. Understanding how legumes regulate root development in response to nitrogen availability is an important step to improving root architecture. The nitrogen-mediated root development pathway starts with sensing soil nitrogen level followed by subsequent signal transduction pathways involving phytohormones, microRNAs and regulatory peptides that collectively modulate the growth and shape of the root system. This review focuses on the current understanding of nitrogen-mediated legume root architecture including local and systemic regulations by different N-sources and the modulations by phytohormones and small regulatory molecules.

The Regulatory Framework for Privacy and Security

Science.gov (United States)

Hiller, Janine S.

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

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

Science.gov (United States)

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

2014-05-01

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

Steam Generator tube integrity -- US Nuclear Regulatory Commission perspective

International Nuclear Information System (INIS)

Murphy, E.L.; Sullivan, E.J.

1997-01-01

In the US, the current regulatory framework was developed in the 1970s when general wall thinning was the dominant degradation mechanism; and, as a result of changes in the forms of degradation being observed and improvements in inspection and tube repair technology, the regulatory framework needs to be updated. Operating experience indicates that the current U.S. requirements should be more stringent in some areas, while in other areas they are overly conservative. To date, this situation has been dealt with on a plant-specific basis in the US. However, the NRC staff is now developing a proposed steam generator rule as a generic framework for ensuring that the steam generator tubes are capable of performing their intended safety functions. This paper discusses the current U.S. regulatory framework for assuring steam generator (SG) tube integrity, the need to update this regulatory framework, the objectives of the new proposed rule, the US Nuclear Regulatory Commission (NRC) regulatory guide (RG) that will accompany the rule, how risk considerations affect the development of the new rule, and some outstanding issues relating to the rule that the NRC is still dealing with

First update to the US Nuclear Regulatory Commission's regulatory strategy for the high-level waste repository program

International Nuclear Information System (INIS)

Johnson, R.L.; Linehan, J.J.

1991-01-01

The US Nuclear Regulatory Commission (NRC) staff has updated its initial regulatory strategy for the High-Level Waste Repository Licensing Program. The update describes changes to the initial strategy and summarizes progress and future activities. This paper summarizes the first update of the regulatory strategy. In general the overall strategy of identifying and reducing uncertainties is unchanged. Identifying regulatory and institutional uncertainties is essentially complete, and therefore, the current and future emphasis is on reducing those regulatory and institutional uncertainties identified to date. The NRC staff has improved the methods of reducing regulatory uncertainties by (1) enhancing the technical basis preparation process for potential rulemakings and guidance and (2) designing a new guidance document, called a staff position, for clarifying regulatory uncertainties. For guiding the US DOE's reduction of technical uncertainties, the NRC staff will give more emphasis to prelicense application reviews and less emphasis on preparing staff technical positions

Water reactor safety research program. A description of current and planned research

International Nuclear Information System (INIS)

1978-07-01

The U.S. Nuclear Regulatory Commission (NRC) sponsors confirmatory safety research on lightwater reactors in support of the NRC regulatory program. The principal responsibility of the NRC, as implemented through its regulatory program is to ensure that public health, public safety, and the environment are adequately protected. The NRC performs this function by defining conditions for the use of nuclear power and by ensuring through technical review, audit, and follow-up that these conditions are met. The NRC research program provides technical information, independent of the nuclear industry, to aid in discharging these regulatory responsibilities. The objectives of NRC's research program are the following: (1) to maintain a confirmatory research program that supports assurance of public health and safety, and public confidence in the regulatory program, (2) to provide objectively evaluated safety data and analytical methods that meet the needs of regulatory activities, (3) to provide better quantified estimates of the margins of safety for reactor systems, fuel cycle facilities, and transportation systems, (4) to establish a broad and coherent exchange of safety research information with other Federal agencies, industry, and foreign organization. Current and planned research toward these goals is described

Regulatory difficulties in a developing country

International Nuclear Information System (INIS)

Jacobs, W.R. Jr.

1978-01-01

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

Current understanding of organically bound tritium (OBT) in the environment.

Science.gov (United States)

Kim, S B; Baglan, N; Davis, P A

2013-12-01

It has become increasingly recognized that organically bound tritium (OBT) is the more significant tritium fraction with respect to understanding tritium behaviour in the environment. There are many different terms associated with OBT; such as total OBT, exchangeable OBT, non-exchangeable OBT, soluble OBT, insoluble OBT, tritiated organics, and buried tritium, etc. A simple classification is required to clarify understanding within the tritium research community. Unlike for tritiated water (HTO), the environmental quantification and behaviour of OBT are not well known. Tritiated water cannot bio-accumulate in the environment. However, it is not clear whether or not this is the case for OBT. Even though OBT can be detected in terrestrial biological materials, aquatic biological materials and soil samples, its behaviour is still in question. In order to evaluate the radiation dose from OBT accurately, further study will be required to understand OBT measurements and determine OBT fate in the environment. The relationship between OBT speciation and the OBT/HTO ratio in environmental samples will be useful in this regard, providing information on the previous tritium exposure conditions in the environment and the current tritium dynamics. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

The Romanian nuclear regulatory body as a nuclear communicator

International Nuclear Information System (INIS)

Cluculescu, Cristina

2000-01-01

A comprehensive nuclear law environment could be a relevant tool to promote greater confidence in the nuclear energy. Romania has had laws in place governing the regulation of nuclear activities since 1974, which remained in force throughout and subsequent to the national constitutional changes. Up to December 1996, the CNCAN activities were based on Law No. 61/1974 for the development of the nuclear activities in Romania and Law No. 61982 on the quality assurance of the nuclear facilities and nuclear power plants. The Nuclear Safety legislation has been enacted in November 1974 (Law No. 61/1974) and it followed as closely as possible (for that time) the US Atomic Energy Act of 1954, as amended subsequently. The Romanian nuclear regulatory body, called National Commission for Nuclear Activities Control (CNCAN) is a governmental organization responsible for the development of the regulatory framework, the control of its implementation and for the licensing of nuclear facilities. An important issue of CNCAN is to provide the correct and reasoning information to the public. The most important topics focused on nuclear activities for the interest of mass media in Romania are: Radioactive waste management; The cost and benefit of nuclear energy compared by conventional energy; The conditions for transportation of radioactive materials; The consequences of a suppositional nuclear accidents; The safety in operation for nuclear installations. The information provided to press and public by regulatory body is clearly and well structured. The target is to clearly explain to mass media and the public should understand very well the difference between the meaning of a nuclear accident, nuclear incident or nuclear event. CNCAN monitories and surveys the operation in safe conditions the nuclear facilities and plants, the protection against nuclear radiation of the professionally exposed personnel, of the population, of the environment and the material goods. It is also

T-regulatory cells in chronic rejection versus stable grafts.

Science.gov (United States)

Al-Wedaie, Fatima; Farid, Eman; Tabbara, Khaled; El-Agroudy, Amgad E; Al-Ghareeb, Sumaya M

2015-04-01

Studying regulatory T cells in kidney allograft acceptance versus chronic rejection may help in the understanding of more mechanisms of immune tolerance and, in the future, may enable clinicians to induce immune tolerance and decrease the use of immunosuppressive drugs. The aim of the current study was to evaluate regulatory T cells in kidney transplant patients with stable graft versus transplant with biopsy-proven chronic rejection. The 3 groups that were studied included: kidney transplanted patients with no rejection episodes (n = 43); transplanted patients with biopsy-proven renal rejection (n = 27); and healthy age-matched nontransplanted individuals as controls (n = 42).The percentage of regulatory T cells (CD4+CD25+Foxp3+) in blood was determined by flow cytometry. The regulatory T cell percentage was significantly lower in chronic rejection patients than control or stable graft groups. No significant difference was observed in regulatory T cell percentage between the stable graft and control groups. In the stable graft group, patients on rapamycin had a significantly higher regulatory T cell percentage than patients on cyclosporine. No effect of donor type, infection, or duration after transplant was observed on regulatory T cell percentage. The results of the current study are consistent with previous studies addressing the function of regulatory T cells in inducing immunotolerance after kidney transplant. Considering the established role of regulatory T cells in graft maintenance and our observation of high regulatory T cell percentage in patients receiving rapamycin than cyclosporine, we recommend including rapamycin when possible in immunosuppressive protocols. The findings from the current study on the chronic rejection group support ongoing research of having treatment with regulatory T cells, which may constitute a novel, efficient antirejection therapy in the future.

Bitcoin: a regulatory nightmare to a libertarian dream

Directory of Open Access Journals (Sweden)

Primavera De Filippi

2014-05-01

Full Text Available This article provides an overview of national policies and current discussions on the regulation of bitcoin in Europe and beyond. After presenting the potential threat that cryptocurrencies pose to governmental and financial institutions worldwide, it discusses the regulatory challenges and the difficulty for national regulators to come up with a sound regulatory framework, which the author believes explains the current (lack of regulatory responses in this field. The article concludes that regulation is needed, but that in order not to excessively stifle innovation in this nascent ecosystem, some of these challenges might better be addressed through self-regulation.

Regulatory Coherence and Standardization Mechanisms in the Trans-Pacific Partnership

Directory of Open Access Journals (Sweden)

Cai Phoenix X. F.

2016-12-01

Full Text Available This article posits a new taxonomy and framework for assessing regulatory coherence in the new generation of mega-regional, cross-cutting free trade agreements. Using the Trans-Pacific Partnership as the primary example, this article situates the rise of regulatory coherence within the current trade landscape, provides clear definitions of regulatory coherence, and argues that the real engine of regulatory coherence lies in the work of international standard setting organizations. This work has been little examined in the current literature. The article provides a detailed examination of the mechanics by which the Trans-Pacific Partnership promotes regulatory standardization and concludes with some normative implications and calls for future research.

Effectiveness of Regulatory Structure in the Power Sector of Pakistan

OpenAIRE

Afia Malik

2007-01-01

This paper is an attempt to study the regulatory environment in the electricity sector of Pakistan. NEPRA, a regulatory authority was formed in 1997 to protect consumer interests in the area of electricity provision, and to ensure an efficient and competitive environment for the electricity generators and distributors, but it has so far not been able to achieve anything. The power sector (dominated by WAPDA and KESC) is still affected by institutional and organisational weaknesses, with ineff...

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 perspective on future climates at Yucca Mountain

International Nuclear Information System (INIS)

Coleman, N.M.; Eisenberg, N.A.; Brooks, D.J.

1996-01-01

Current regulations of the U.S. Nuclear Regulatory Commission (NRC) require that any performance assessment supporting the license application for a high-level waste (HLW) repository must consider the potential for changes in hydrologic conditions caused by reasonably foreseeable climatic conditions. The requirement is important because the earth's climate will almost certainly change significantly during the thousands of years that disposed nuclear wastes will remain hazardous. More importantly, climate controls the range of precipitation, which in turn controls the rates of infiltration, deep percolation, and groundwater flux through a geologic repository located in an unsaturated environment. Therefore, future changes in climate could significantly influence waste isolation in a repository at Yucca Mountain

Strategic Renewal in Regulatory Environments. How inter- and intra-organisational institutional forces influence European incumbent energy firms

Energy Technology Data Exchange (ETDEWEB)

Stienstra, M.

2008-11-20

How do incumbent firms strategically renew in regulatory environments? Assuming that regulation can both constrain and enable a firm's strategic renewal opportunities, we investigate how and to what extent incumbent firms undertake exploitative and explorative strategic renewal actions in order to remain competitive. Exploitative strategic renewal involves those actions that strengthen or optimise a firm's current resource deployments, whereas explorative strategic renewal relates to actions that generate new sources of value creation for the firm. Based on old institutional theory, new institutional theory, neo-institutional theory and institutional entrepreneurship literature, a multi-level framework that combines selection and adaptation arguments has been developed and applied to investigate strategic renewal behaviour of a sample of European energy incumbents. At industry level of analysis, results show how inter-organisational institutional forces significantly impact firms' choices of exploitative and explorative strategic renewal actions through regulative, normative and cognitive forces. At organisational unit level of analysis, we find that the extent of intra-organisational regulative forces is positively related to exploitative strategic renewal actions. In addition, entrepreneurial proclivity appears to be a catalyst of both exploitative and explorative strategic renewal actions. Finally, our results provide insights how environmental selection and firm level adaptation are interrelated in the context of regulation. The extent of inter-organisational regulative forces positively moderates the relationship between intra-organisational regulative forces and exploitative strategic renewal actions.

The Economic Discourse of the Current Reform Aimed at Business Optimization in Ukraine

Directory of Open Access Journals (Sweden)

Purdenko Olena A.

2016-05-01

Full Text Available The aim of the article is to study the strengths and weaknesses of the current reforms and provide appropriate recommendations and proposals to improve the regulatory and economic business environment. The article analyzes the introduced reforms in the aspect of the regulatory field and the active current system of taxation with the detailing of the type and content of the basic implemented measures. There have been justified the advantages and disadvantages of the introduced system of taxation with respect to the main budget forming taxes, such as the enterprise income taxes, value added tax, individual income tax considering changes in the administering of unified social tax (UST and war tax, excise duty. On the basis of the results of the study it has been found that the introduced reforms only partially improved the tax administration system and in no way reduced the announced tax burden, the time spending of business for preparing the current report was not significantly reduced.

Ionizing radiation sources: very diversified means, multiple applications and a changing regulatory environment. Conference proceedings

International Nuclear Information System (INIS)

2011-11-01

This document brings together the available presentations given at the conference organised by the French society of radiation protection about ionizing radiation source means, applications and regulatory environment. Twenty eight presentations (slides) are compiled in this document and deal with: 1 - Overview of sources - some quantitative data from the national inventory of ionizing radiation sources (Yann Billarand, IRSN); 2 - Overview of sources (Jerome Fradin, ASN); 3 - Regulatory framework (Sylvie Rodde, ASN); 4 - Alternatives to Iridium radiography - the case of pressure devices at the manufacturing stage (Henri Walaszek, Cetim; Bruno Kowalski, Welding Institute); 5 - Dosimetric stakes of medical scanner examinations (Jean-Louis Greffe, Charleroi hospital of Medical University); 6 - The removal of ionic smoke detectors (Bruno Charpentier, ASN); 7 - Joint-activity and reciprocal liabilities - Organisation of labour risk prevention in case of companies joint-activity (Paulo Pinto, DGT); 8 - Consideration of gamma-graphic testing in the organization of a unit outage activities (Jean-Gabriel Leonard, EDF); 9 - Radiological risk control at a closed and independent work field (Stephane Sartelet, Areva); 10 - Incidents and accidents status and typology (Pascale Scanff, IRSN); 11 - Regional overview of radiation protection significant events (Philippe Menechal, ASN); 12 - Incident leading to a tritium contamination in and urban area - consequences and experience feedback (Laurence Fusil, CEA); 13 - Experience feedback - loss of sealing of a calibration source (Philippe Mougnard, Areva); 14 - Blocking incident of a 60 Co source (Bruno Delille, Salvarem); 15 - Triggering of gantry's alarm: status of findings (Philippe Prat, Syctom); 16 - Non-medical electric devices: regulatory changes (Sophie Dagois, IRSN; Jerome Fradin, ASN); 17 - Evaluation of the dose equivalent rate in pulsed fields: method proposed by the IRSN and implementation test (Laurent Donadille, IRSN

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

International Nuclear Information System (INIS)

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

2014-01-01

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

Institutional barriers to DSM (demand side management): Reviewing the regulatory bargain

Energy Technology Data Exchange (ETDEWEB)

Warwick, W.M.

1990-09-01

The paper discusses traditional arguments for utility regulation in the context of the current utility environment. It reviews several DSM delivery options using a matrix of key financial considerations for utilities and consumers. The strengths and weaknesses of each option are discussed and an assessment of current prospects for DSM implementation is provided. The premise of the paper is that adoption of DSM by utilities and consumers has lagged because of technical and behavioral uncertainties. In addition, regulatory practices and DSM delivery mechanisms have not provided adequate means to extract the benefits of DSM and allocate the risks in a way that offers clear advantages over generating options. The paper concludes with a brief discussion of the potential for value of service approaches to resolve these problems.

The Built Environment and Child Health: An Overview of Current Evidence.

Science.gov (United States)

Gascon, Mireia; Vrijheid, Martine; Nieuwenhuijsen, Mark J

2016-09-01

Urbanization and the shaping of the built environment have provided a number of socioeconomic benefits, but they have also brought unwanted side effects on health. We aimed to review the current epidemiological evidence of the associations between the built environment, closely related exposures, and child health. We focused on growth and obesity, neuropsychological development, and respiratory and immune health. We used existing review articles and supplemented these with relevant work published and not included in existing reviews. The present review shows that there is good evidence for an association between air pollution and fetal growth restriction and respiratory health, whereas for other exposure and outcome combinations, further evidence is needed. Future studies should make efforts to integrate the different built environment features and to include the evaluation of environments other than home, as well as accessibility, qualitative and perception assessment of the built environment, and, if possible, with improved and standardized tools to facilitate comparability between studies. Efforts are also needed to conduct longitudinal and intervention studies and to understand potential mechanisms behind the associations observed. Finally, studies in low- and middle-income countries are needed.

Regulatory agencies and regulatory risk

OpenAIRE

Knieps, Günter; Weiß, Hans-Jörg

2008-01-01

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

Mathematical model of a current of two plastic environments in the forming channel extruders at coextrusion

Directory of Open Access Journals (Sweden)

V. N. Vasilenko

2012-01-01

Full Text Available On the basis of the classical equations of an isothermal pressure head current of two rheology the various not mixing up viscou- plastic environments in the cylindrical channel, Ostvald-de-Vil submitting to the law, the model of a current of two viscous-plastic environments in the moulding channel extruder is synthesised at co-extrusion on which basis the technique of a choice of diameter of a dosing out branch pipe on the demanded value of the ratio of volume expenditures of two viscous-plastic environments (extrudat and stuffings is offered.

REACH and nanomaterials: current status

International Nuclear Information System (INIS)

Alessandrelli, Maria; Di Prospero Fanghella, Paola; Polci, Maria Letizia; Castelli, Stefano; Pettirossi, Flavio

2015-01-01

New challenges for regulators are emerging about a specific assessment and appropriate management of the potential risks of nanomaterials. In the framework of European legislation on chemicals, Regulation (EC) No. 1907/2006 REACH aims to ensure the safety of human health and the environment through the collection of information on the physico-chemical characteristics of the substances and on their profile (eco) toxicological and the identification of appropriate risk management linked to 'exposure to these substances without impeding scientific progress and the competitiveness of industry. In order to cover the current shortage of information on the safety of nanomaterials and tackle the acknowledged legal vacuum, are being a rich activities, carried out both by regulators both by stake holders, and discussions on the proposals for adapting the European regulatory framework for chemicals . The European Commission is geared to strengthen the REACH Regulation by means of updates of its annexes. The importance of responding to the regulatory requirements has highlighted the need for cooperation between European organizations, scientists and industries to promote and ensure the safe use of nanomaterials. [it

Developing regulatory approaches

International Nuclear Information System (INIS)

Axelsson, Lars

2012-01-01

Lars Axelsson presented SSM progress on oversight of LMfS/SC since the Chester 1 Workshop in 2007. Current SSM approaches for safety culture oversight include targeted safety management and safety culture inspections, compliance inspections which cover aspects of safety management/safety culture and multi-disciplinary team inspections. Examples of themes for targeted inspections include management of ambiguous operational situations or other weak signals, understanding of and attitudes to Human Performance tools, the Safety Department's role and authority and Leadership for safety. All regulatory activities provide inputs for the SSM yearly safety evaluation of each licensee. A form has been developed to capture safety culture observations from inspections and other interactions with licensees. Analysis will be performed to identify patterns and provide information to support planning of specific Safety Culture activities. Training has been developed for regulatory staff to enhance the quality of regulatory interventions on safety culture. This includes a half-day seminar to provide an overview of safety culture, and a workshop which provides more in-depth discussion on cultural issues and how to capture those during regulatory activities. Future plans include guidance for inspectors, and informal seminars on safety culture with licensees

Safeguards inventory and process monitoring regulatory comparison

Energy Technology Data Exchange (ETDEWEB)

Cavaluzzi, Jack M. [Texas A & M Univ., College Station, TX (United States); Gibbs, Philip W. [Brookhaven National Lab. (BNL), Upton, NY (United States)

2013-06-27

Detecting the theft or diversion of the relatively small amount of fissile material needed to make a nuclear weapon given the normal operating capacity of many of today’s running nuclear production facilities is a difficult task. As throughput increases, the ability of the Material Control and Accountability (MC&A) Program to detect the material loss decreases because the statistical measurement uncertainty also increases. The challenge faced is the ability of current accounting, measurement, and material control programs to detect small yet significant losses under some regulatory approaches can decrease to the point where it is extremely low if not practically non-existent at normal operating capacities. Adding concern to this topic is that there are variations among regulatory bodies as far as what is considered a Significant Quantity (SQ). Some research suggests that thresholds should be lower than those found in any current regulation which if adopted would make meeting detection goals even more difficult. This paper reviews and compares the current regulatory requirements for the MA elements related to physical inventory, uncertainty of the Inventory Difference (ID), and Process Monitoring (PM) in the United States Department of Energy (DOE) and Nuclear Regulatory Commission (NRC), Rosatom of the Russian Federation and the Chinese Atomic Energy Agency (CAEA) of China. The comparison looks at how the regulatory requirements for the implementation of various MA elements perform across a range of operating capacities in example facilities.

Network regulation and regulatory institutional reform: Revisiting the case of Australia

International Nuclear Information System (INIS)

Nepal, Rabindra; Menezes, Flavio; Jamasb, Tooraj

2014-01-01

It is well-understood that the success of liberalizing the electricity supply industry depends crucially on the quality and design of the regulatory and institutional framework. This paper analyses the regulatory arrangements that underpin the work of the Australian Energy Regulator (AER). These arrangements are contrasted with the regulatory structure of electricity provision in Norway. A key difference between the reform processes in the two countries relates to the lack of privatization in Norway and the co-existence of private and publicly owned generators and distributors in Australia. This comparative analysis allows us to make several recommendations to improve regulatory arrangements in Australia. These include greater independence for the AER, better coordination among regulatory institutions, greater use of benchmarking analysis, greater customer involvement, and improving market transparency and privatization of government-owned corporations. However, the success of privatization will hinge upon the effectiveness of the regulatory environment. - Highlights: • Rising electricity prices and network costs is of great concern in Australia. • Flaws in the existing regulatory environment and economic efficiency exist. • The AER should be provided with adequate resources (financial and staff experts) and discretion. • Robust benchmarking techniques should be adopted in the incentive regulation framework for cost efficiency. • Privatization of the state-owned assets also remains an option

Development and Delivery of Coursework: The Legal/Regulatory/Policy Environment of Cyberforensics

Directory of Open Access Journals (Sweden)

John W. Bagby

2006-06-01

Full Text Available This paper describes a cyber-forensics course that integrates important public policy and legal issues as well as relevant forensic techniques. Cyber-forensics refers to the amalgam of multi-disciplinary activities involved in the identification, gathering, handling, custody, use and security of electronic files and records, involving expertise from the forensic domain, and which produces evidence useful in the proof of facts for both commercial and legal activities. The legal and regulatory environment in which electronic discovery takes place is of critical importance to cyber-forensics experts because the legal process imposes both constraints and opportunities for the effective use of evidence gathered through cyber-forensic techniques. This paper discusses different pedagogies that can be used (including project teams, research and writing assignments, student presentations, case analyses, class activities and participation and examinations, evaluation methods, problem-based learning approaches and critical thinking analysis. A survey and evaluation is provided of the growing body of applicable print and online materials that can be utilized. Target populations for such a course includes students with majors, minors or supporting elective coursework in law, information sciences, information technology, computer science, computer engineering, financial fraud, security and information assurance, forensic aspects of cyber security, privacy, and electronic commerce.

Regulatory practices for nuclear power plants in India

International Nuclear Information System (INIS)

Bajaj, S.S.

2013-01-01

The Atomic Energy Regulatory Board (AERB) is the national authority for ensuring that the use of ionizing radiation and nuclear energy does not cause any undue risk to the health of workers, members of the public and to the environment. AERB is responsible for the stipulation and enforcement of rules and regulations pertaining to nuclear and radiological safety. This paper describes the regulatory process followed by AERB for ensuring the safety of nuclear power plants (NPPs) during their construction as well as operation. This regulatory process has been continuously evolving to cater to the new developments in reactor technology. Some of the recent initiatives taken by AERB in this direction are briefly described. Today, AERB faces new challenges like simultaneous review of a large number of new projects of diverse designs, a fast growing nuclear power program and functioning of operating plants in a competitive environment. This paper delineates how AERB is gearing up to meet these challenges in an effective manner. (author)

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

Balancing regulatory control, scientific knowledge, and public understanding.

Science.gov (United States)

Kingsbury, D T

1988-01-01

In summary, I would like to emphasize the continued need for broad and vigorous basic research, with a balance between the fundamental work that may eventually lead to commercial products and the fundamental work that is necessary for an understanding of the interaction of many types of organisms within the environment. I would like also to reiterate the need for balance in the regulatory approach so that we do not repress innovation in research and development. Over-regulation has many side effects. In addition to repressing innovation and not taking advantage of our research base, over-regulation leads to reluctance by the capital markets to invest in the future of our new industries, thereby halting their development at an early stage. At the same time, under-regulation leads to lack of confidence by the public and paralysis of the industry based on public outcry and legal proceedings. It is my personal belief that the combination of a sound approach to regulatory practice, based on current scientific knowledge, combined with appropriate communication with the public regarding the new products, will lead to an exciting future for all sectors of industry that use the new biotechnology.

Canada's regulatory framework: The Canadian Nuclear Safety Commission's regulatory framework

International Nuclear Information System (INIS)

Howard, D.

2011-01-01

This paper will discuss the Canadian Nuclear Safety Commission and Canada's Regulatory Framework with respect to Low- and Intermediate-Level Radioactive Waste. The management of low and intermediate level radioactive waste must be ensured in a consistent, environmentally responsible and economical manner throughout its lifecycle -- from its production to the final disposal option. Radioactive waste has been produced in Canada since the early 1930s when the first radium/uranium mine began operating at Port Radium in the Northwest Territories. Pitchblende ore was transported from the Port Radium mine to Port Hope, Ontario where it was refined to produce radium for medical purposes. At present, radioactive waste is generated in Canada from the various stages and uses associated with the nuclear fuel cycle from uranium mining/milling to nuclear reactor operations to radioisotope manufacture and use. The Canadian Nuclear Safety Commission (CNSC regulates the use of nuclear energy and materials to protect the health, safety and security of Canadians and the environment; and to implement Canada's international commitments on the peaceful use of nuclear energy. The CNSC was established in 2000 under the Nuclear Safety and Control Act and reports to Parliament through the Minister of Natural Resources. The CNSC was created to replace the former Atomic Energy Control Board (AECB), which was founded in 1946. Under the Nuclear Safety and Control Act, CNSC's mandate involves four major areas: regulation of the development, production and use of nuclear energy in Canada to protect health, safety and the environment; regulation of the production, possession, use and transport of nuclear substances, and the production, possession and use of prescribed equipment and prescribed information; implementation of measures respecting international control of the development, production, transport and use of nuclear energy and substances, including measures respecting the

Reactor aging research. United States Nuclear Regulatory Commission

International Nuclear Information System (INIS)

Vassilaros, M.G.

1998-01-01

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

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

Alternatives to animal experimentation: The regulatory background

International Nuclear Information System (INIS)

Garthoff, Bernward

2005-01-01

The framework, in which alternatives to animal experiments can be developed, standardized, respectively formally validated, has to be seen in a global context. The ever increasing demand of testing for hazard and risk assessment in health and environment, exemplified by the EU REACH program, subsequently triggers laboratory animal testing. This holds especially true, if no valid alternative methods agreed to by the regulatory authorities and the scientific community are available. At least for regulatory toxicity testing, the global frame and network are given by institutions such as OECD, ICH, and alike. However, due to the necessity of global consent of states, organizations, and stakeholders, the time gap between availability of a novel alternative test method and its final acceptance by authorities and implementation thereafter is widening. The lack of new technologies or opportunities for alternative method application such as, for example, the broad use of transgenic animals for refinement of existing tests, adds to the problem. The bare existence of certain in vivo tests increases also the gap between public demands for testing versus availability of alternative tests. Industries operating on a worldwide basis support the alternative test development in their respective area of research and operational business. However, a more coordinating approach such as that of the ecopa-organization (European Consensus Platform on Alternatives) is needed to exploit the existing possibilities within the current regulatory framework. This will speed up the process of acceptance and challenge the political worldto feel responsible for the sequels of their demanding more testing, that is, by funding alternative method development in academia and industry

On-line monitoring of base current and forward emitter current gain of the voltage regulator's serial pnp transistor in a radiation environment

Directory of Open Access Journals (Sweden)

Vukić Vladimir Đ.

2012-01-01

Full Text Available A method of on-line monitoring of the low-dropout voltage regulator's operation in a radiation environment is developed in this paper. The method had to enable detection of the circuit's degradation during exploitation, without terminating its operation in an ionizing radiation field. Moreover, it had to enable automatic measurement and data collection, as well as the detection of any considerable degradation, well before the monitored voltage regulator's malfunction. The principal parameters of the voltage regulator's operation that were monitored were the serial pnp transistor's base current and the forward emitter current gain. These parameters were procured indirectly, from the data on the voltage regulator's load and quiescent currents. Since the internal consumption current in moderately and heavily loaded devices was used, the quiescent current of a negligibly loaded voltage regulator of the same type served as a reference. Results acquired by on-line monitoring demonstrated marked agreement with the results acquired from examinations of the voltage regulator's maximum output current and minimum dropout voltage in a radiation environment. The results were particularly consistent in tests with heavily loaded devices. Results obtained for moderately loaded voltage regulators and the risks accompanying the application of the presented method, were also analyzed.

Regulatory capture by default: Offshore exploratory drilling for oil and gas

International Nuclear Information System (INIS)

Portman, Michelle E.

2014-01-01

This article examines a form of regulatory capture that occurs when significant ambiguity exists regarding the environmental protection standards for new types of activities in the marine environment. To begin with, there is little research that categorizes the typologies of regulatory capture despite the ubiquity of the phenomenon. After a discussion of theoretical approaches to regulatory capture, I describe the operative definition and theory appropriate to the situation related to authorization of oil and natural gas production in Israel following the discovery of large offshore reserves in 2010. This approach, embodying several facets of existing typologies, is applied to decisions made authorizing construction of the Gabriella offshore exploratory drilling platform. The analysis highlights the nature of capture in the absence of clear agency jurisdiction over new activities located in offshore environs organized as temporal and spatial “vacuums”. I conclude that comprehensive marine spatial planning would result in less capture and the development of more capture-resistant regulations. - Highlights: • Regulatory capture occurs when ambiguity exists about environmental protection standards for new types of activities in the marine environment. • A typology is developed from theories of regulatory capture (RC) and applied to cases of offshore exploratory drilling. • The typology is applied to offshore natural gas reserves discovered in 2010 offshore of Israel in the Mediterranean Sea. • Temporal aspects (anachronistic laws and regulations) and spatial aspects (jurisdictional ambiguity) have created regulatory vacuums leading to RC. • Comprehensive marine spatial planning would result in less capture and the development of more capture-resistant regulations

Views from the japanese regulatory authority

International Nuclear Information System (INIS)

Aoyama, S.

2004-01-01

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

Are better sleepers more engaged workers? A self-regulatory approach to sleep hygiene and work engagement.

Science.gov (United States)

Barber, Larissa; Grawitch, Matthew J; Munz, David C

2013-10-01

Previous research has emphasized facets of both the organizational environment and individual differences as predictors of work engagement. This study explored sleep hygiene as another important behavioural factor that may be related to work engagement. With a sample of 328 adult workers, we tested a multiple mediator model in which sleep hygiene predicts work engagement through one's appraisals of resource depletion stemming from demands (psychological strain) and general self-regulatory capacity (self-control). Results indicated that individuals who frequently engaged in poor sleep hygiene behaviours had lower self-regulatory capacity, experienced higher subjective depletion and were less engaged at work. Additionally, the path from poor sleep hygiene to decreased work engagement was attributed to perceptions of personal resources that are needed to exert self-regulatory energy at work. This is consistent with current self-regulatory theories suggesting that individuals have a limited amount of resources to allocate to demands and that the depletion of these resources can lead to stress and lower self-regulatory functioning in response to other demands. Specifically, poor sleep hygiene results in the loss of self-regulatory resources needed to be engaged in work tasks by impairing the after-work recovery process. Practical and research implications regarding sleep hygiene interventions for well-being and productivity improvement are discussed. Copyright © 2012 John Wiley & Sons, Ltd.

Tritium : health risks, regulatory issues and the nuclear future

International Nuclear Information System (INIS)

Chambers, D. B.; Garva, A.

2010-10-01

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

Pollution prevention: A regulatory update

International Nuclear Information System (INIS)

Walzer, A.E.; Maynard, J.W.

1993-01-01

Pollution prevention is the emphasis of the 1990s environmental philosophy. This new environmental era was ushered in when President Bush signed the Pollution Prevention Act in October 1990. This law, with its accompanying philosophy, was in response to the realization that end-of-the-pipe treatment, which frequently changed the media in which a pollutant or waste was discharged, was inadequate to protect the environment and human health. Pollution prevention advocates source reduction, where material substitutions and engineering solutions are sought to reduce the volume and toxicity of waste and pollutants. This proactive approach reduces environmental impacts such as those of former waste sites which have produced environmental legacies that will cost billions of dollars and take decades to remediate. This paper describes pollution prevention philosophy and summarizes regulatory pollution prevention requirements. It describes current regulatory trends in the area of pollution prevention, including voluntary programs and enforcement actions. The Pollution Prevention Act of 1990 is described, and pollution prevention initiatives embodied in other laws, including the Clean Air Act, the Clean Water Act, the Emergency Planning and Community Right-To-Know Act, the Resource Conservation and Recovery Act, and the Toxic Substances Control Act, are discussed. A historical overview of waste minimization initiatives within the Department of Energy is given, and other pollution prevention initiatives that affect federal facilities, such as Executive Order 12780, which mandates recycling and the procurement of recycled materials, are also outlined

A system-level model for the microbial regulatory genome.

Science.gov (United States)

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

2014-07-15

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

Establishment of regulatory framework for the development reactor licensing

International Nuclear Information System (INIS)

Jo, Jong C.; Yune, Young G.; Kim, Woong S.; Ahn, Sang K.; Kim, In G.; Kim, Hho J.

2003-01-01

With a trend that various types of advanced reactor designs are currently under development worldwide, the Korea Atomic Energy Research Institute has been developing an advanced reactor called ' System-integrated Modular Advanced Reactor (SMART)', which is a small sized integral type pressurized water reactor with a rated thermal power of 330 MW. To demonstrate the safety and the performance of the SMART reactor design, the SMART Research and Development Center has embarked to build a scaled-down pilot plant of SMART, called 'SMART-P' with a rated thermal power of 65 MW. In preparation for the forthcoming applications for both construction permit and operating license of SMART-P in the near future, the Korea Institute of Nuclear Safety is developing a new regulatory framework for licensing review of such a development reactor, which covers establishment of licensing process, identification and resolution of technical and safety issues, development of regulatory evaluation or verification-purpose computer codes and analytical methods, and establishment of design-specific, general design and operating criteria, regulations, and associated regulatory guides. This paper presents the current activities for establishing a regulatory framework for the licensing of a research and development reactor. Discussions are made on the SMART-P development program, the current Korean regulatory framework for reactor licensing, the SMART-P licensing-related issues, and the approach and strategy for developing an effective regulatory framework for the SMART-P licensing

Introducing nuclear power into currently non-nuclear states

International Nuclear Information System (INIS)

Gert, Claassen

2007-01-01

As the nuclear renaissance gains momentum, many countries that currently have no nuclear power plants will begin to consider introducing them. It is anticipated that smaller reactors such as the Pebble Bed Modular Reactor (PBMR) will not only be sold to current nuclear states to also to states where there is currently no nuclear experience. A range of issues would have to be considered for nuclear plants to be sold to non-nuclear states, such as the appropriate regulatory environment, standardization and codes, non-proliferation, security of supply, obtaining experienced merchant operators, appropriate financial structures and education and training. The paper considers nine major issues that need to be addressed by governments and vendors alike: 1) political enabling framework, 2) regulatory framework, 3) responsible owner, 4) responsible operator, 5) finance, 6) contact management, 7) fuel supply and waste management framework, 8) training and education, and 9) industrial infrastructure. International cooperation by organisations such as the IAEA, financial institutions and international suppliers will be required to ensure that developing countries as well as developed ones share the benefits of the nuclear renaissance. The opportunities that the nuclear industry affords to develop local skills, create job opportunities and to develop local manufacturing industries are among the important reasons that the South African Government has decided to support and fund the development of the Pebble Bed Modular Reactor project. (author)

Development of regulatory guidance on safety reviews of nuclear power plants in Germany. A survey on accomplished and current PSA activities

International Nuclear Information System (INIS)

Berg, H.-P.; Froehmel, T.; Goertz, R.; Rehs, B.

2005-01-01

The paper describes the key points of the accomplished and current regulatory activities in order to revise PSA guide and the corresponding technical documents in Germany. The regulatory German PSA guide covers the fundamental requirements concerning the performance of PSAs in the frame of comprehensive safety reviews. The technical details regarding the performance of PSA are set out in two technical documents (PSA Methods and PSA Data) that have been developed by a working group of PSA experts (FAK PSA). Based on the experiences from the first series of PSRs, international experiences and the fact that PSR is mandatory since April 2002 revisions of all guides are underway. The first guide to be updated is the PSA guide together with the corresponding technical documents. The working programme and the revision process of FAK PSA was finished at the end of 2004 and the technical documents have recently been republished. (author)

Regulatory authority information system RAIS

International Nuclear Information System (INIS)

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

2000-01-01

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

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)

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

NARCIS (Netherlands)

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

2007-01-01

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

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

NARCIS (Netherlands)

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

2007-01-01

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

A regulatory perspective on the radiological impact of NORM industries: the case of the Spanish phosphate industry

International Nuclear Information System (INIS)

Garcia-Talavera, M.; Matarranz, J.L.M.; Salas, R.; Ramos, L.

2011-01-01

Radioactive and chemical risks coexist in NORM industries although they are usually addressed separately by regulations. The European Union (EU) has developed extensive legislation concerning both matters, which has been diversely reflected in national policies. We consider the case of the Spanish phosphate industry and analyse to which extent regulatory mandates have reduced the historical and ongoing radiological impact on the environment of phosphate facilities. Although no specific radiological constraints on effluent monitoring and release or on waste disposal have yet been imposed on NORM industries in Spain, other environmental regulations have achieved a substantial reduction on the phosphate industry impact. Nevertheless, a more efficient control could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks in NORM industries. We highlight research needs to accomplish so and propose shorter-term measures that require active cooperation among the regulatory bodies involved. - Research highlights: → The radiological impact of the Spanish phosphate industry has substantially decreased as a side result of environmental regulations on chemical pollution.→ A more efficient control of NORM industries could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks.→ Further research is needed on how interactions between radiation and chemicals might affect regulatory limits and on a systematic way to input stakeholder preferences in MCDA.→ On shorter-term, administrative measures that require active cooperation among the regulatory bodies involved can be taken.

Reactors licensing: proposal of an integrated quality and environment regulatory structure for nuclear research reactors in Brazil; Licenciamento de reatores: proposta de uma estrutura regulatoria integrada com abordagem em qualidade e meio ambiente para reatores de pesquisa no Brasil

Energy Technology Data Exchange (ETDEWEB)

Serra, Reynaldo Cavalcanti

2014-07-01

A new integrated regulatory structure based on quality and integrated issues has been proposed to be implemented on the licensing process of nuclear research reactors in Brazil. The study starts with a literature review about the licensing process in several countries, all of them members of the International Atomic Energy Agency. After this phase it is performed a comparative study with the Brazilian licensing process to identify good practices (positive aspects), the gaps on it and to propose an approach of an integrated quality and environmental management system, in order to contribute with a new licensing process scheme in Brazil. The literature review considered the following research nuclear reactors: Jules-Horowitz and OSIRIS (France), Hanaro (Korea), Maples 1 and 2 (Canada), OPAL (Australia), Pallas (Holand), ETRR-2 (Egypt) and IEA-R1 (Brazil). The current nuclear research reactors licensing process in Brazil is conducted by two regulatory bodies: the Brazilian National Nuclear Energy Commission (CNEN) and the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA). CNEN is responsible by nuclear issues, while IBAMA by environmental one. To support the study it was applied a questionnaire and interviews based on the current regulatory structure to four nuclear research reactors in Brazil. Nowadays, the nuclear research reactor’s licensing process, in Brazil, has six phases and the environmental licensing process has three phases. A correlation study among these phases leads to a proposal of a new quality and environmental integrated licensing structure with four harmonized phases, hence reducing potential delays in this 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

Mitigation of pollutants for clean environment: proceedings of the fifteenth national symposium on environment

International Nuclear Information System (INIS)

Puranik, V.D.; Pandit, G.G.; Ramachandran, T.V.; Tripathi, R.M.; Saradhi, I.V.; Hegde, A.G.

2007-01-01

The main theme of this volume is mitigation of pollutants for clean environment. The topics covered are technologies for clean environment, monitoring and modeling of pollutants and their transport, environmental radioactivity, environmental awareness, education and regulatory aspects. Papers relevant to INIS are indexed separately

Plastics, the environment and human health: current consensus and future trends

OpenAIRE

Thompson, Richard C.; Moore, Charles J.; vom Saal, Frederick S.; Swan, Shanna H.

2009-01-01

Plastics have transformed everyday life; usage is increasing and annual production is likely to exceed 300 million tonnes by 2010. In this concluding paper to the Theme Issue on Plastics, the Environment and Human Health, we synthesize current understanding of the benefits and concerns surrounding the use of plastics and look to future priorities, challenges and opportunities. It is evident that plastics bring many societal benefits and offer future technological and medical advances. However...

Regulatory Accessibility and Social Influences on State Self-Control

OpenAIRE

vanDellen, Michelle R.; Hoyle, Rick H.

2009-01-01

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

Regulatory oversight of nuclear safety in Finland. Annual report 2011

Energy Technology Data Exchange (ETDEWEB)

Kainulainen, E. (ed.)

2012-07-01

The report constitutes the report on regulatory control in the field of nuclear energy which the Radiation and Nuclear Safety Authority (STUK) is required to submit once a year to the Ministry of Employment and the Economy pursuant to Section 121 of the Nuclear Energy Decree. The report is also delivered to the Ministry of Environment, the Finnish Environment Institute, and the regional environmental authorities of the localities in which a nuclear facility is located. The regulatory control of nuclear safety in 2011 included the design, construction and operation of nuclear facilities, as well as nuclear waste management and nuclear materials. The first parts of the report explain the basics of nuclear safety regulation included as part of STUK's responsibilities, as well as the objectives of the operations, and briefly introduce the objects of regulation. The chapter concerning the development and implementation of legislation and regulations describes changes in nuclear legislation, as well as the progress of STUK's YVL Guide revision work. The section concerning the regulation of nuclear facilities contains an overall safety assessment of the nuclear facilities currently in operation or under construction. The chapter concerning the regulation of the final disposal project for spent nuclear fuel de-scribes the preparations for the final disposal project and the related regulatory activities. The section concerning nuclear non-proliferation describes the nuclear non-proliferation control for Finnish nuclear facilities and final disposal of spent nuclear fuel, as well as measures required by the Additional Protocol of the Safeguards Agreement. The chapter describing the oversight of security arrangements in the use of nuclear energy discusses oversight of the security arrangements in nuclear power plants and other plants, institutions and functions included within the scope of STUK's regulatory oversight. The chapter also discusses the national and

Categorization and selection of regulatory approaches for nuclear power plants

International Nuclear Information System (INIS)

Sugaya, Junko; Harayama, Yuko

2009-01-01

Several new regulatory approaches have been introduced to Japanese nuclear safety regulations, in which a prescriptive and deterministic approach had traditionally predominated. However, the options of regulatory approaches that can possibly be applied to nuclear safety regulations as well as the methodology for selecting the options are not systematically defined. In this study, various regulatory approaches for nuclear power plants are categorized as prescriptive or nonprescriptive, outcome-based or process-based, and deterministic or risk-informed. 18 options of regulatory approaches are conceptually developed and the conditions for selecting the appropriate regulatory approaches are identified. Current issues on nuclear regulations regarding responsibilities, transparency, consensus standards and regulatory inspections are examined from the viewpoints of regulatory approaches to verify usefulness of the categorization and selection concept of regulatory approaches. Finally, some of the challenges at the transitional phase of regulatory approaches are discussed. (author)

Handbook for value-impact assessments of NRC regulatory actions

International Nuclear Information System (INIS)

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

1985-01-01

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

Fronting Integrated Scientific Web Applications: Design Features and Benefits for Regulatory Environments

Science.gov (United States)

Integrated decision support systems for regulatory applications benefit from standardindustry practices such as code reuse, test-driven development, and modularization. Theseapproaches make meeting the federal government’s goals of transparency, efficiency, and quality assurance ...

Regulatory control of radiation sources and radioactive materials in the Czech Republic

International Nuclear Information System (INIS)

Drabova, D.; Prouza, Z.

2001-01-01

The paper describes legal and regulatory provisions for radiation protection and safe use of sources of ionizing radiation in the Czech Republic with special emphasis on aspects of bringing activities under regulatory control and releasing them from it. It covers the development of a new legal framework, the work of the regulatory body, an overview of sources in use and provisions to achieve effective regulatory control of facilities and releases of radioactive material into the environment. Also, it describes reported unusual events with a proposed scheme for their classification and evaluation. (author)

Management of Excess Reactive Nitrogen in the Environment

Science.gov (United States)

Galloway, J. N.; Theis, T.; Doering, O.

2011-12-01

problem. Such silos have to be broken down if the excess Nr problem is to be dealt with holistically. (3) Essential Monitoring and Research. The Committee recommends improved monitoring and research to enhance our understanding of Nr in the environment. In some cases our knowledge has such wide margins of error that we cannot identify or quantify important concentrations or flows sufficiently for necessary decisions. In other cases there is incomplete knowledge about the indirect impacts of Nr, while in still others there is a need for much better understanding of the efficacy of actions that might be taken to control Nr. (4) Setting Goals for Action. In spite of knowledge gaps identified by the Committee, there is sufficient understanding of the Nr problem to enable the responsible regulatory agencies to begin to decrease excess Nr entering the environment. The Committee suggests actions that might be taken by EPA or other management authorities using current technologies and regulatory authority to decrease Nr in the environment by 25% over the near (10-20 year) term, without negatively impacting dietary needs or economic trends.

Regulatory aspects of radiopharmaceuticals

International Nuclear Information System (INIS)

Kristensen, K.

1985-01-01

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

The stress and underground environment

Science.gov (United States)

Chama, A.

2009-04-01

Currently,the program of prevention in occupational health needs mainly to identify occupational hazards and strategy of their prevention.Among these risks,the stress represents an important psycho-social hazard in mental health,which unfortunately does not spare no occupation.My Paper attempts to highlight and to develop this hazard in its different aspects even its regulatory side in underground environment as occupational environment.In the interest of better prevention ,we consider "the information" about the impact of stress as the second prevention efficient and no expensive to speleologists,hygienists and workers in the underground areas. In this occasion of this event in Vienna,we also highlight the scientific works on the stress of the famous viennese physician and endocrinologist Doctor Hans Selye (1907-1982),nicknamed "the father of stress" and note on relation between biological rhythms in this underground area and psychological troubles (temporal isolation) (Jurgen Aschoff’s works and experiences out-of time).

IFR fuel cycle process equipment design environment and objectives

International Nuclear Information System (INIS)

Rigg, R.H.

1993-01-01

Argonne National laboratory (ANL) is refurbishing the hot cell facility originally constructed with the EBR-II reactor. When refurbishment is complete, the facility win demonstrate the complete fuel cycle for current generation high burnup metallic fuel elements. These are sodium bonded, stainless steel clad fuel pins of U-Zr or U-Pu-Zr composition typical of the fuel type proposed for a future Integral Fast Reactor (IFR) design. To the extent possible, the process equipment is being built at full commercial scale, and the facility is being modified to incorporate current DOE facility design requirements and modem remote maintenance principles. The current regulatory and safety environment has affected the design of the fuel fabrication equipment, most of which will be described in greater detail in subsequent papers in this session

Application of Resource Portfolio Concept in Nuclear Regulatory Infrastructure Support

International Nuclear Information System (INIS)

Lee, Y. E.; Ha, J. T.; Chang, H. S.; Kam, S. C.; Ryu, Y. H.

2010-01-01

As the new entrants in the global nuclear construction market are increasing and the establishment of an effective and sustainable regulatory infrastructure becomes more important, they have requested international assistance from the international nuclear communities with mature nuclear regulatory programmes. It needs to optimize the use of limited resources from regulatory organization providing support to regulatory infrastructure of new comers. This paper suggests the resource portfolio concept like a GE/Mckinsey Matrix used in business management and tries to apply it to the current needs considered in the regulatory support program in Korea as the case study

Regulatory issues of digital instrumentation and control system in Lungmen project

International Nuclear Information System (INIS)

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

2004-01-01

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

European regulatory framework for person carrier robots

NARCIS (Netherlands)

Fosch Villaronga, E.; Roig, A.

The aim of this paper is to establish the grounds for a future regulatory framework for Person Carrier Robots, which includes legal and ethical aspects. Current industrial standards focus on physical human–robot interaction, i.e. on the prevention of harm. Current robot technology nonetheless

Management systems for regulatory authorities

International Nuclear Information System (INIS)

Mpandanyama, Rujeko Lynette

2015-02-01

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

Safety research programs sponsored by Office of Nuclear Regulatory Research

International Nuclear Information System (INIS)

Weiss, A.J.; Azarm, A.; Baum, J.W.

1989-07-01

This progress report describes current activities and technical progress in the programs at Brookhaven National Laboratory sponsored by the Division of Regulatory Applications, Division of Engineering, Division of Safety Issue Resolution, and Division of Systems Research of the US Nuclear Regulatory Commission, Office of Nuclear Regulatory Research following the reorganization in July 1988. The previous reports have covered the period October 1, 1976 through September 30, 1988

Assessing the assessments: Pharmaceuticals in the environment

International Nuclear Information System (INIS)

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

2007-01-01

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

Confidential data in a competitive utility environment: A regulatory perspective

Energy Technology Data Exchange (ETDEWEB)

Vine, E.

1996-08-01

Historically, the electric utility industry has been regarded as one of the most open industries in the United States in sharing information but their reputation is being challenged by competitive energy providers, the general public, regulators, and other stakeholders. As the prospect of competition among electricity power providers has increased in recent years, many utilities have been requesting that the data they submit to their utility regulatory commissions remain confidential. Withholding utility information from the public is likely to have serious and significant policy implications with respect to: (1) consumer education, the pursuit of truth, mutual respect among parties, and social cooperation; (2) the creation of a fair market for competitive energy services; (3) the regulatory balance; (4) regional and national assessments of energy-savings opportunities; (5) research and development; and (6) evaluations of utility programs, plans, and policies. In a telephone survey of all public utility commissions (PUCs) that regulate electric and gas utilities in the U.S., we found that almost all PUCs have received requests from utility companies for data to be filed as confidential, and confidential data filings appear to have increased (both in scope and in frequency) in those states where utility restructuring is being actively discussed. The most common types of data submitted as confidential by utilities dealt with specific customer data, market data, avoided costs, and utility costs.

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

Institute of Scientific and Technical Information of China (English)

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

2015-01-01

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

The U.S. Nuclear Regulatory Commission Thermal-Hydraulic Research Program: Maintaining expertise in a changing environment

International Nuclear Information System (INIS)

Sheron, B.W.; Shotkin, L.M.; Baratta, A.J.

1993-01-01

Throughout the 1970s and early 1980s, the U.S. Nuclear Regulatory Commission's (NRC's) thermal-hydraulic research program enjoyed ample funding, sponsored extensive experimental and analytical development programs, and attracted worldwide expertise. With the completion of the major experimental programs and with the promulgation of the revised emergency core-cooling system rule, both the funding and prominence of thermal-hydraulic research at the NRC have declined in recent years. This has led justifiably to the concern by some that the program may no longer have the minimal elements needed to maintain both expertise and world-class status. The purpose of this article is to describe the NRC's current thermal-hydraulic research program and to show how this program ensures maintenance of a viable, robust research effort and retention of needed expertise and international leadership

The EbpA-RpoN Regulatory Pathway of the Pathogen Leptospira interrogans Is Essential for Survival in the Environment

Science.gov (United States)

Hu, Wei-Lin; Pappas, Christopher J.; Zhang, Jun-Jie; Yang, You-Yun; Yan, Jie

2016-01-01

achieves its long-term survival in the aquatic environment. By utilizing bioinformatic, genetic, and biochemical methods, we discovered a regulatory pathway in L. interrogans, the EbpA-RpoN pathway, and demonstrated that this pathway plays an important role in environmental survival of this pathogen. PMID:27864172

The EbpA-RpoN Regulatory Pathway of the Pathogen Leptospira interrogans Is Essential for Survival in the Environment.

Science.gov (United States)

Hu, Wei-Lin; Pappas, Christopher J; Zhang, Jun-Jie; Yang, You-Yun; Yan, Jie; Picardeau, Mathieu; Yang, X Frank

2017-02-01

long-term survival in the aquatic environment. By utilizing bioinformatic, genetic, and biochemical methods, we discovered a regulatory pathway in L. interrogans, the EbpA-RpoN pathway, and demonstrated that this pathway plays an important role in environmental survival of this pathogen. Copyright © 2017 American Society for Microbiology.

Radio-frequency electromagnetic field (RF-EMF) exposure levels in different European outdoor urban environments in comparison with regulatory limits.

Science.gov (United States)

Urbinello, Damiano; Joseph, Wout; Huss, Anke; Verloock, Leen; Beekhuizen, Johan; Vermeulen, Roel; Martens, Luc; Röösli, Martin

2014-07-01

Concerns of the general public about potential adverse health effects caused by radio-frequency electromagnetic fields (RF-EMFs) led authorities to introduce precautionary exposure limits, which vary considerably between regions. It may be speculated that precautionary limits affect the base station network in a manner that mean population exposure unintentionally increases. The objectives of this multicentre study were to compare mean exposure levels in outdoor areas across four different European cities and to compare with regulatory RF-EMF exposure levels in the corresponding areas. We performed measurements in the cities of Amsterdam (the Netherlands, regulatory limits for mobile phone base station frequency bands: 41-61 V/m), Basel (Switzerland, 4-6 V/m), Ghent (Belgium, 3-4.5 V/m) and Brussels (Belgium, 2.9-4.3 V/m) using a portable measurement device. Measurements were conducted in three different types of outdoor areas (central and non-central residential areas and downtown), between 2011 and 2012 at 12 different days. On each day, measurements were taken every 4s for approximately 15 to 30 min per area. Measurements per urban environment were repeated 12 times during 1 year. Arithmetic mean values for mobile phone base station exposure ranged between 0.22 V/m (Basel) and 0.41 V/m (Amsterdam) in all outdoor areas combined. The 95th percentile for total RF-EMF exposure varied between 0.46 V/m (Basel) and 0.82 V/m (Amsterdam) and the 99th percentile between 0.81 V/m (Basel) and 1.20 V/m (Brussels). All exposure levels were far below international reference levels proposed by ICNIRP (International Commission on Non-Ionizing Radiation Protection). Our study did not find indications that lowering the regulatory limit results in higher mobile phone base station exposure levels. Copyright © 2014 Elsevier Ltd. All rights reserved.

Regulatory and licensee surveys

International Nuclear Information System (INIS)

2009-01-01

Prior to the workshop two CSNI/WGHOF surveys were distributed. One survey was directed at regulatory bodies and the other was directed at plant licensees. The surveys were: 1 - Regulatory Expectations of Licensees' Arrangements to Ensure Suitable Organisational Structure, Resources and Competencies to Manage Safety (sent to WGHOF regulatory members). The survey requested that the respondents provide a brief overview of the situation related to plant organisations in their country, their regulatory expectations and their formal requirements. The survey addressed three subjects: the demonstration and documentation of organisational structures, resources and competencies, organisational changes, issues for improvement (for both current and new plants). Responses were received from eleven regulatory bodies. 2 - Approaches to Justify Organisational Suitability (sent to selected licensees). The purpose of the survey to was to gain an understanding of how licensees ensure organisational suitability, resources and competencies. This information was used to assist in the development of the issues and subjects that were addressed at the group discussion sessions. Responses were received from over fifteen licensees from nine countries. The survey requested that the licensees provide information on how they ensure effective organisational structures at their plants. The survey grouped the questions into the following four categories: organisational safety functions, resource and competence, decision-making and communication, good examples and improvement needs. The findings from these surveys were used in conjunction with other factors to identify the key issues for the workshop discussion sessions. The responses from these two surveys are discussed briefly in Sections 4 and 5 of this report. More extensive reviews of the regulatory and licensee responses are provided in Appendix 1

Biodiversity maintenance in food webs with regulatory environmental feedbacks.

Science.gov (United States)

Bagdassarian, Carey K; Dunham, Amy E; Brown, Christopher G; Rauscher, Daniel

2007-04-21

Although the food web is one of the most fundamental and oldest concepts in ecology, elucidating the strategies and structures by which natural communities of species persist remains a challenge to empirical and theoretical ecologists. We show that simple regulatory feedbacks between autotrophs and their environment when embedded within complex and realistic food-web models enhance biodiversity. The food webs are generated through the niche-model algorithm and coupled with predator-prey dynamics, with and without environmental feedbacks at the autotroph level. With high probability and especially at lower, more realistic connectance levels, regulatory environmental feedbacks result in fewer species extinctions, that is, in increased species persistence. These same feedback couplings, however, also sensitize food webs to environmental stresses leading to abrupt collapses in biodiversity with increased forcing. Feedback interactions between species and their material environments anchor food-web persistence, adding another dimension to biodiversity conservation. We suggest that the regulatory features of two natural systems, deep-sea tubeworms with their microbial consortia and a soil ecosystem manifesting adaptive homeostatic changes, can be embedded within niche-model food-web dynamics.

Glycoconjugate Vaccines: The Regulatory Framework.

Science.gov (United States)

Jones, Christopher

2015-01-01

Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine-or vaccines in general-on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.

Strengthening the Canadian alcohol advertising regulatory system.

Science.gov (United States)

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

2012-05-24

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

Regulatory issues in accreditation of toxicology laboratories.

Science.gov (United States)

Bissell, Michael G

2012-09-01

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

A study on the implement of regulatory issue problems about service business

International Nuclear Information System (INIS)

Kim, In Hwan; Shim, H. S.; Yoon, K. H.; Jun, I. Y.; Kang, W. S.; Chang, J. H.

2004-12-01

This study is intended to derive a proposal for revision of the Atomic Energy Law, with understanding of differences between regulatory requirements and current issues based on findings during safety review and regular inspection. The contents and scope of this study is as follows: - Deep review for service business in 'the rationalization of the radiation protection system related with use of radionuclide', studied by Korea Isotope Association and presentation in the Korea Association for radiation protection, - Efficient regulatory activity through pre-finding of current regulatory issues to be derived during safety review and regular inspection

Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.

Science.gov (United States)

Hussaarts, Leonie; Mühlebach, Stefan; Shah, Vinod P; McNeil, Scott; Borchard, Gerrit; Flühmann, Beat; Weinstein, Vera; Neervannan, Sesha; Griffiths, Elwyn; Jiang, Wenlei; Wolff-Holz, Elena; Crommelin, Daan J A; de Vlieger, Jon S B

2017-11-01

Biotechnology and nanotechnology provide a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron-carbohydrate complexes, drug-carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1-day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U.S. Food and Drug Administration, the European Medicines Agency, the World Health Organization) to approve these complex drug products and their follow-on versions. One of the key questions remains how to assess equivalence of these complex products. We identify a number of points for which consensus was found among the stakeholders who were present: scientists from innovator and generic/follow-on companies, academia, and regulatory bodies from different parts of the world. A number of topics requiring follow-up were identified: (1) assessment of critical attributes to establish equivalence for follow-on versions, (2) the need to publish scientific findings in the public domain to further progress in the field, (3) the necessity to develop worldwide consensus regarding nomenclature and labeling of these complex products, and (4) regulatory actions when substandard complex drug products are identified. © 2017 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of New York Academy of Sciences.

As to achieve regulatory action, regulatory approaches

International Nuclear Information System (INIS)

Cid, R.; Encinas, D.

2014-01-01

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

Mitochondrial Plasticity With Exercise Training and Extreme Environments

DEFF Research Database (Denmark)

Boushel, Robert; Lundby, Carsten; Qvortrup, Klaus

2014-01-01

Mitochondria form a reticulum in skeletal muscle. Exercise training stimulates mitochondrial biogenesis, yet an emerging hypothesis is that training also induces qualitative regulatory changes. Substrate oxidation, oxygen affinity and biochemical coupling efficiency may be differentially regulated...... with training and exposure to extreme environments. Threshold training doses inducing mitochondrial up-regulation remain to be elucidated considering fitness level. SUMMARY: Muscle mitochondrial are responsive to training and environment, yet thresholds for volume vs. regulatory changes and their physiological...

Changing our regulatory structure to accommodate a competitive environment

International Nuclear Information System (INIS)

Roman, A. J.

1996-01-01

The efficiency of various regulatory schemes were assessed based on the assumption that certain aspects of transmission and distribution will have to be regulated even after deregulation comes into effect. Price regulation and incentive regulation are the two main forms used to ensure equitable availability of various transmission/wheeling services to distributors, and service quality, wheeling, and prices to be charged by distributors to customers. It was found on balance that only effective market forces spur efficiency, and regulations are only second best. Incentive regulation was not considered to be significantly more efficient than price regulation. The effectiveness of either form will depend upon market conditions and the skill of the regulator

Side Impact Regulatory Trends, Crash Environment and Injury Risk in the USA.

Science.gov (United States)

Prasad, Priya; Dalmotas, Dainius; Chouinard, Aline

2015-11-01

Light duty vehicles in the US are designed to meet and exceed regulatory standards, self-imposed industry agreements and safety rating tests conducted by NHTSA and IIHS. The evolution of side impact regulation in the US from 1973 to 2015 is discussed in the paper along with two key industry agreements in 2003 affecting design of restraint systems and structures for side impact protection. A combination of all the above influences shows that vehicles in the US are being designed to more demanding and comprehensive requirements than in any other region of the world. The crash environment in the US related to side impacts was defined based on data in the nationally representative crash database NASS. Crash environment factors, including the distribution of cars, light trucks and vans (LTV's), and medium-to-heavy vehicles (MHV's) in the fleet, and the frequency of their interactions with one another in side impacts, were considered. Other factors like, crash severity in terms of closing velocity between two vehicles involved in crash, gender and age of involved drivers in two-vehicle and single vehicle crashes, were also examined. Injury risks in side impacts to drivers and passengers were determined in various circumstances such as near-side, far-side, and single vehicle crashes as a function of crash severity, in terms of estimated closing speed or lateral delta-V. Also injury risks in different pairs of striking and struck cars and LTV's, were estimated. A logistic regression model for studying injury risks in two vehicle crashes was developed. The risk factors included in the model include case and striking vehicles, consisting of cars, SUV's, vans, and pickup trucks, delta-V, damage extent, occupant proximity to the impact side, age and gender of the occupant, and belt use. Results show that car occupants make up the vast majority of serious-to-fatally injured occupants. Injury rates of car occupants in two-vehicle collision are highest when the car is struck by a

UK medicines regulation: responding to current challenges.

Science.gov (United States)

Richards, Natalie; Hudson, Ian

2016-12-01

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk-proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand. © 2016 The British Pharmacological Society.

Nova Scotia Environment Act: Report

Energy Technology Data Exchange (ETDEWEB)

1994-01-01

In January 1993, a comprehensive review and consolidation of 13 statutes currently under the Department of the Environment's administration began to create a more rational, efficient, and user-friendly framework for environmental management; to fulfill outstanding commitments for regulatory reform; and to provide an opportunity for focused stakeholder consultations on substantive changes to the legislative framework. Draft legislation was released for public comment in November 1993. This report summarizes the public comments but also includes comments by the Public Consultation Committee. Issues addressed include administration, environmental education and research, environmental assessment process, approvals and certificates, release of substances, hazardous substances and pesticides, contaminated sites, waste management, water management, inspections and investigations, orders, appeals, civil remedies, penalties and prosecutions, and documentary evidence.

Criteria of exemption of regulatory control for radioactive material

International Nuclear Information System (INIS)

Marco A. Medrano Lopez

1991-01-01

Being based on the information contained in the 10 CFR Part 20, of the section 20.301 until the 20.306 where the mechanisms by means of which can prepare the waste of low level are indicated. While the Nuclear Regulatory Commission (NRC) it amended in the year of 1985 the Act of Politics on Low level Wastes, in particular the section 10 of the amendment of the Act, relative to the concept BRC treats those groups of radioactive waste in that their activity contents are so low that they could be exempt of the regulatory control, either liberating them toward the environment or to exempt people or organizations of the regulatory control

Economic regulation of Canada's natural gas delivery industry : policy and regulatory principles

International Nuclear Information System (INIS)

Gormley, B.

2006-03-01

This policy paper demonstrated how restoring balance and clarity to Canada's regulatory environment will ensure the continued strength of the economy, environment, and communities. It was noted that regulatory outcomes that reflect the broad public interest can be achieved if 4 basic principles for economic regulation are pursued. These principles include strength, balance, efficiency, and clarity. In particular, this paper addressed the challenge facing Canada's natural gas delivery industry in terms of increased energy demand, tight supply, ageing infrastructure and increasing cost pressures on the energy system. It emphasized that transparent, efficient energy policy developed through informed debate can provide the foundation for a reliable, environmentally acceptable and sustainable energy future. It was suggested that immediate attention be given to rebalancing the regulatory processes that have placed short term considerations above the longer term strength of the natural gas system; improving the support for new natural gas supply development; reconsidering pricing in some energy markets where information has been distorted; and revisiting the regulatory processes that have become inefficient

Regulatory Oversight of Safety Culture in Nuclear Installations

International Nuclear Information System (INIS)

2013-03-01

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

The path from biomarker discovery to regulatory qualification

CERN Document Server

Goodsaid, Federico

2013-01-01

The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book-it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site:  http://tinyurl.com/ClassicBiomarkers Contains a collection of experiences of different...

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)

Radioactive waste management regulatory framework in Mexico

International Nuclear Information System (INIS)

Barcenas, M.; Mejia, M.

2001-01-01

The purpose of this paper is to present an overview of the current regulatory framework concerning the radioactive waste management in Mexico. It is intended to show regulatory historical antecedents, the legal responsibilities assigned to institutions involved in the radioactive waste management, the sources of radioactive waste, and the development and preparation of national standards for fulfilling the legal framework for low level radioactive waste. It is at present the most important matter to be resolved. (author)

A global regulatory science agenda for vaccines.

Science.gov (United States)

Elmgren, Lindsay; Li, Xuguang; Wilson, Carolyn; Ball, Robert; Wang, Junzhi; Cichutek, Klaus; Pfleiderer, Michael; Kato, Atsushi; Cavaleri, Marco; Southern, James; Jivapaisarnpong, Teeranart; Minor, Philip; Griffiths, Elwyn; Sohn, Yeowon; Wood, David

2013-04-18

The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products. Regulatory science builds on high-quality basic research, and encompasses at least two broad categories. First, there is laboratory-based regulatory science. Illustrative examples include development of correlates of immunity; or correlates of safety; or of improved product characterization and potency assays. Included in such science would be tools to standardize assays used for regulatory purposes. Second, there is science to develop regulatory processes. Illustrative examples include adaptive clinical trial designs; or tools to analyze the benefit-risk decision-making process of regulators; or novel pharmacovigilance methodologies. Included in such science would be initiatives to standardize regulatory processes (e.g., definitions of terms for adverse events [AEs] following immunization). The aim of a global regulatory science agenda is to transform current national efforts, mainly by well-resourced regulatory agencies, into a coordinated action plan to support global immunization goals. This article provides examples of how regulatory science has, in the past, contributed to improved access to vaccines, and identifies gaps that could be addressed through a global regulatory science agenda. The article also identifies challenges to implementing a regulatory science agenda and proposes strategies and actions to fill these gaps. A global regulatory science agenda will enable

Regulatory Aspect of an Ageing Management Program

International Nuclear Information System (INIS)

Basic, I.; Zabric, I.; Savli, S.

2006-01-01

The aspects of plant ageing management (AM) gained increasing attention over the last ten years. Numerous technical studies have been performed to study the impact of ageing mechanisms on the safe and reliable operation of nuclear power plants. National research activities have been initiated or are in progress to provide the technical basis for decision making processes. The long-term operation of nuclear power plants is influenced by economic considerations, the socio-economic environment including public acceptance, developments in research and the regulatory framework, the availability of technical infrastructure to maintain and service the systems, structures and components as well as qualified personnel. Besides national activities there are a number of international activities in particular under the umbrella of the IAEA, the OECD and the EU. The paper will provide the summary on Nuclear Plant Life Management (PLIM) (or Ageing Management Program (AMP)) and Plant Life Extension (PLEX) development in USA and European countries. Also, insights from such effort currently performing in Slovenia will be discussed.(author)

Regulatory accessibility and social influences on state self-control.

Science.gov (United States)

vanDellen, Michelle R; Hoyle, Rick H

2010-02-01

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

Regulatory compliance analysis for the closure of single-shell tanks

International Nuclear Information System (INIS)

Smith, E.H.; Boomer, K.D.; Letourneau, M.; Oakes, L.; Lorang, R.

1991-08-01

This document provides a regulatory compliance analysis of the baseline environmental protection requirements for the closure of single-shell tanks. In preparing this document, the Westinghouse Hanford Company has analyzed the regulatory pathways and decisions points that have been identified to data through systems engineering and related studies as they relate to environmental protection. This regulatory compliance analysis has resulted in several conclusions that will aid the US Department of Energy in managing the single-shell tank waste and in developing strategies for the closure of these tanks. These conclusions include likely outcomes of current strategies, regulatory rulings that are required for future actions, variances and exemptions to be pursued, where appropriate, and potential rulings that may affect systems engineering and other portions of the single-shell tank closure effort. The conclusions and recommendations presented here are based on analysis of current regulations, regulatory exemptions and variances, and federal facility agreements. Because the remediation of the single-shell tanks will span 30 years, regulations that have yet to be promulgated and future interpretations of existing laws and regulations may impact the recommendations and conclusions presented here. 50 refs., 22 figs

Design of the corona current measurement sensor with wide bandwidth under dc ultra-high-voltage environment

International Nuclear Information System (INIS)

Liu, Yingyi; Yuan, Haiwen; Yang, Qinghua; Cui, Yong

2011-01-01

The research in the field of corona discharge, which is one of the key technologies, can help us to realize ultra-high-voltage (UHV) power transmission. This paper proposes a new sampling resistance sensor to measure the dc UHV corona current in a wide band. By designing the structural and distributed parameters of the sensor, the UHV dielectric breakdown performance and the wide-band measuring characteristics of the sensor are satisfied. A high-voltage discharge test shows that the designed sensor can work under a 1200 kV dc environment without the occurrence of corona discharge. A frequency characteristic test shows that the measuring bandwidth of the sensor can be improved from the current 4.5 to 20 MHz. The test results in an actual dc UHV transmission line demonstrate that the sensor can accurately measure the corona current under the dc UHV environment

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

Science.gov (United States)

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

2007-04-11

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

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

International Nuclear Information System (INIS)

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

2007-01-01

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

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

Conductor of high electrical current at high temperature in oxygen and liquid metal environment

Science.gov (United States)

Powell, IV, Adam Clayton; Pati, Soobhankar; Derezinski, Stephen Joseph; Lau, Garrett; Pal, Uday B.; Guan, Xiaofei; Gopalan, Srikanth

2016-01-12

In one aspect, the present invention is directed to apparatuses for and methods of conducting electrical current in an oxygen and liquid metal environment. In another aspect, the invention relates to methods for production of metals from their oxides comprising providing a cathode in electrical contact with a molten electrolyte, providing a liquid metal anode separated from the cathode and the molten electrolyte by a solid oxygen ion conducting membrane, providing a current collector at the anode, and establishing a potential between the cathode and the anode.

Hormesis in Regulatory risk assessment - Science and Science Policy.

Science.gov (United States)

Gray, George

2011-01-01

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

Pharmaceuticals and personal care products in the aquatic environment in China: a review.

Science.gov (United States)

Bu, Qingwei; Wang, Bin; Huang, Jun; Deng, Shubo; Yu, Gang

2013-11-15

Pharmaceuticals and personal care products (PPCPs) have been detected as contaminants of emerging concern ubiquitously in the aquatic environment in China and worldwide. A clear picture of PPCP contamination in the Chinese aquatic environment is needed to gain insight for both research and regulatory needs (e.g. monitoring, control and management). The occurrence data of 112 PPCPs in waters and sediments in China has been reviewed. In most cases, the detected concentration of these PPCPs in waters and sediments were at ng/L and ng/g levels, which were lower than or comparable to those reported worldwide. A screening level risk assessment (SLERA) identified six priority PPCPs in surface waters, namely erythromycin, roxithromycin, diclofenac, ibuprofen, salicylic acid and sulfamethoxazole. The results of SLERA also revealed that the hot spots for PPCP pollution were those river waters affected by the megacities with high density of population, such as Beijing, Tianjin, Guangzhou and Shanghai. Limitations of current researches and implications for future research in China were discussed. Some regulatory issues were also addressed. Copyright © 2013 Elsevier B.V. All rights reserved.

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

International Nuclear Information System (INIS)

Holburn, Guy L.F.

2012-01-01

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

Current-Voltage Characteristics of DC Discharge in Micro Gas Jet Injected into Vacuum Environment

International Nuclear Information System (INIS)

Matra, K; Furuta, H; Hatta, A

2013-01-01

A current-voltage characteristic of direct current (DC) gas discharge operated in a micro gas jet injected into a secondary electron microscope (SEM) chamber is presented. Ar gas was injected through a 30 μm orifice gas nozzle (OGN) and was evacuated by an additional pump to keep the high vacuum environment. Gas discharges were ignited between the OGN as anode and a counter electrode of Si wafer. The discharge was self-pulsating in most of the cases while it was stable at lower pressure, larger gap length, and larger time averaged current. The self-pulsating discharge was oscillated by the RC circuit consisting of a stray capacitor and a large ballast resistor. The real time plots of voltage and current during the pulsating was investigated using a discharge model.

Digital publication of EDF's regulatory files

International Nuclear Information System (INIS)

Picard, Pauline

2012-06-01

The Engineering Centre of Deconstruction and Environment wants to modernize the distribution of its regulatory filings in digital form. This project requires a prior upstream of its implementation to determine the best publishing solution suited to the constraints of diffusion and heritage protection of EDF

Breeding and regulatory opportunities and constraints for developing broccoli cultivars adapted to organic agriculture

NARCIS (Netherlands)

Renaud, E.N.C.

2014-01-01

This thesis is about the regulatory and technical challenges to the organic seed and breeding sector. This study specifically explored the mutual influence of the regulatory environment for organic seed sector development in the United States (US), Europe Union (EU) and Mexico, and the extent to

78 FR 61424 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of...

Science.gov (United States)

2013-10-03

... decommission the DTCC Trade Risk Pro service as more fully described below. II. Self-Regulatory Organization's... no Members that currently use Trade Risk Pro. (C) Self-Regulatory Organization's Statement on...-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of Proposed Rule Change...

IFRIC 12, ICPC 01 and Regulatory Accounting: Influences on Formation of Tariffs in the Electricity Sector

Directory of Open Access Journals (Sweden)

Natan Szuster

2012-12-01

Full Text Available The objective of this study was to investigate to what extent the IFRIC12 and ICPC01 accounting characteristics can influence in the formation of tariffs in the electricity sector in Brazil. The choice of this sector is justified by its economic relevance, its importance for the development of the country and mainly because it uses specific regulatory accounting rules. With a purely qualitative approach - justified by the incipient stage of the current research in this area – we conducted a theoretical study, focusing on qualitative information, through research of the literature and documents. The results show that the pricing model may change under the IFRIC 12 and ICPC 01 standards, which makes the effective application of these accounting standards in the environment regulated by the National Electric Energy Agency (ANEEL a difficult and complex task. The study also indicates that the main difference between the regulatory accounting system promoted by ANEEL and the international standards is the impossibility of recognizing regulatory assets and liabilities under the latter system. Therefore, the Brazilian electricity sector is one of those that may have its financial statements most affected by the convergence of Brazilian accounting standards to international standards.

Pesticide authorization in the EU-environment unprotected?

Science.gov (United States)

Stehle, Sebastian; Schulz, Ralf

2015-12-01

Pesticides constitute an integral part of high-intensity European agriculture. Prior to their authorization, a highly elaborated environmental risk assessment is mandatory according to EU pesticide legislation, i.e., Regulation (EC) No. 1107/2009. However, no field data-based evaluation of the risk assessment outcome, i.e., the regulatory acceptable concentrations (RACs), and therefore of the overall protectiveness of EU pesticide regulations exists. We conducted here a comprehensive meta-analysis using peer-reviewed literature on agricultural insecticide concentrations in EU surface waters and evaluated associated risks using the RACs derived from official European pesticide registration documents. As a result, 44.7 % of the 1566 cases of measured insecticide concentrations (MICs) in EU surface waters exceeded their respective RACs. It follows that current EU pesticide regulations do not protect the aquatic environment and that insecticides threaten aquatic biodiversity. RAC exceedances were significantly higher for insecticides authorized using conservative tier-I RACs and for more recently developed insecticide classes, i.e., pyrethroids. In addition, we identified higher risks, e.g., for smaller surface waters that are specifically considered in the regulatory risk assessment schemes. We illustrate the shortcomings of the EU regulatory risk assessment using two case studies that contextualize the respective risk assessment outcomes to field exposure. Overall, our meta-analysis challenges the field relevance and protectiveness of the regulatory environmental risk assessment conducted for pesticide authorization in the EU and indicates that critical revisions of related pesticide regulations and effective mitigation measures are urgently needed to substantially reduce the environmental risks arising from agricultural insecticide use.

Decommissioning of uranium mines and mills - Canadian regulatory approach and experience

International Nuclear Information System (INIS)

Whitehead, W.

1986-09-01

At the time of the recent closures of the Agnew Lake, Beaverlodge and Madawaska Mines Limited uranium mining and milling facilities, several relevant regulatory initiatives, including the development of decommissioning criteria, were underway, or contemplated. In the absence of precedents, the regulatory agencies and companies involved adopted approaches to the decommissioning of these facilities that reflected site specific circumstances, federal and provincial regulatory requirements, and generally accepted principles of good engineering practice and environmental protection. This paper summarizes related historical and current regulatory policies, requirements and guidelines; including those implemented at the three decommissioned sites

Turning research on the psychosocial working environment into regulatory practice

DEFF Research Database (Denmark)

Hansen, Agnete Meldgaard; Nielsen, Klaus Tranetoft; Starheim, Liv

The psychosocial working environment is an expanding field of research. Within the last decades a lot of knowledge has been developed in the field. The question however remains how this knowledge can be, and is being, utilized in the regulation of the psychosocial working environment. This question...... we understand this process as a translation of knowledge into policies, tools and actors dealing with the psychosocial working environment. Drawing on this understanding we develop a model that illustrates the utility of different types of research on the psychosocial working environment...

Regulatory guide in support of ECCS rule revision

International Nuclear Information System (INIS)

Tovmassian, H.S.

1987-01-01

The US Nuclear Regulatory Commission staff is proposing to amend 10 CFR 50.46 and Appendix K to allow licensees to use best estimate calculations to estimate emergency core cooling system performance. This estimate in conjunction with an estimate of the uncertainty in the calculation would then be used to assure that the licensing limits set forth in 10 CFR 50.46(b) are not exceeded. The NRC staff has prepared a draft regulatory guide to assist licensees and applicants in complying with these proposed amendments. This paper sets forth the objectives of this regulatory guide, the approach taken, the difficulties encountered, and the current status of this effort

Remedial action plan for the inactive uranium processing site at Naturita, Colorado. DOE responses to comments from U.S. Nuclear Regulatory Commission and Colorado Department of Public Health and Environment

International Nuclear Information System (INIS)

1998-01-01

This report contains responses by the US Department of Energy to comments from the US Nuclear Regulatory Commission and the Colorado Department of Public Health and Environment on the Naturita remedial action plan. This was done in an attempt to clarify information. The site is an inactive uranium processing site at Naturita, Colorado

Emotion: The Self-regulatory Sense.

Science.gov (United States)

Peil, Katherine T

2014-03-01

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

Emotion: The Self-regulatory Sense

Science.gov (United States)

2014-01-01

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

78 FR 38053 - Regulatory Systems Strengthening

Science.gov (United States)

2013-06-25

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

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

Science.gov (United States)

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

2015-06-01

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

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

Science.gov (United States)

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

2014-03-01

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

Regulatory aspects of oncology drug safety evaluation: Past practice, current issues, and the challenge of new drugs

International Nuclear Information System (INIS)

Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M. Stacey; McGuinn, W. David; Verbois, S. Leigh

2010-01-01

The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

Canadian uranium mines and mills evolution of regulatory expectations and requirements for effluent treatment

International Nuclear Information System (INIS)

LeClair, J.; Ashley, F.

2006-01-01

The regulation of uranium mining in Canada has changed over time as our understanding and concern for impacts on both human and non-human biota has evolved. Since the mid-1970s and early 1980s, new uranium mine and mill developments have been the subject of environmental assessments to assess and determine the significance of environmental effects throughout the project life cycle including the post-decommissioning phase. Water treatment systems have subsequently been improved to limit potential effects by reducing the concentration of radiological and non-radiological contaminants in the effluent discharge and the total loadings to the environment. This paper examines current regulatory requirements and expectations and how these impact uranium mining/milling practices. It also reviews current water management and effluent treatment practices and performance. Finally, it examines the issues and challenges for existing effluent treatment systems and identifies factors to be considered in optimizing current facilities and future facility designs. (author)

Low-income minority fathers' control strategies and children's regulatory skills

Science.gov (United States)

Malin, Jenessa L.; Cabrera, Natasha J.; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith

2015-01-01

The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24-months and children's regulatory skills at pre-kindergarten (pre-K). Using a sample of low-income minority families with 2-year-olds from the Early Head Start Evaluation Research Program (n = 71) we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24-months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at pre-kindergarten. There were three main findings. First, fathers' overwhelmingly use commands (e.g., do that) to promote compliance in their 24-month old children. Second, children's vocabulary skills predict fathers' regulatory behaviors during a father-child interaction, whereas children's gender predicts fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24-months predict children's sustained attention at pre-kindergarten whereas fathers' regulatory language at 24-months predicts children's emotion regulation at pre-kindergarten. Our findings highlight the importance of examining paternal contributions to children's regulatory skills. PMID:25798496

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 study on the regulatory approach of major technical issues

Energy Technology Data Exchange (ETDEWEB)

Chang, Keun Sun; Oh, S. H.; Kang, H. J.; Kim, G. S. [Sunmoon Univ., Asan (Korea, Republic of); Lee, S. H.; Baek, W. P.; Yang, S. H.; Jeong, Y. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

1999-02-15

This project is to provide the regulatory direction of 4 major technical issues for the Korean Next Generation Reactors, which are parts of major technical issues resulted from the safety regulation R and D on the KNGR. The outstanding results are are as follows : related to the classification and acceptance criteria of plant conditions, currently used classification and safety requirement were reviewed and regulatory direction was proposed. Among multiple failures, it is identified that SBO, TLOFW, multiple SGTR and ATWS are basically to be considered for additional requirements for advanced reactors. This study reviewed risk aspects, design consideration, and trends of safety requirements, and proposed fundamental safety requirements to be applied for KNGR. Multiple steam generator tube failure is a significant safety concern because of the possibility of release of radionuclides to the environment through containment bypass. Proposed safety requirement for this event can be categorized mainly as analysis requirement, design evaluation requirement and PSA requirement; For protection of containment failure, a reasonable safety position is necessary through and integrated review of possibility of severe accident occurrence, effects of sever accident mitigation features and cost effects of these design features. With this consideration safety requirements developed are the analysis requirement, provision of protective measures and survivability/availability of protective measures.

The expanding regulatory universe of p53 in gastrointestinal cancer.

Science.gov (United States)

Fesler, Andrew; Zhang, Ning; Ju, Jingfang

2016-01-01

Tumor suppresser gene TP53 is one of the most frequently deleted or mutated genes in gastrointestinal cancers. As a transcription factor, p53 regulates a number of important protein coding genes to control cell cycle, cell death, DNA damage/repair, stemness, differentiation and other key cellular functions. In addition, p53 is also able to activate the expression of a number of small non-coding microRNAs (miRNAs) through direct binding to the promoter region of these miRNAs.  Many miRNAs have been identified to be potential tumor suppressors by regulating key effecter target mRNAs. Our understanding of the regulatory network of p53 has recently expanded to include long non-coding RNAs (lncRNAs). Like miRNA, lncRNAs have been found to play important roles in cancer biology.  With our increased understanding of the important functions of these non-coding RNAs and their relationship with p53, we are gaining exciting new insights into the biology and function of cells in response to various growth environment changes. In this review we summarize the current understanding of the ever expanding involvement of non-coding RNAs in the p53 regulatory network and its implications for our understanding of gastrointestinal cancer.

LOW-INCOME, MINORITY FATHERS’ CONTROL STRATEGIES AND THEIR CHILDREN'S REGULATORY SKILLS

OpenAIRE

Malin, Jenessa L.; Cabrera, Natasha J.; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith Lee

2014-01-01

The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24-months and children's regulatory skills at pre-kindergarten (pre-K). Using a sample of low-income minority families with 2-year-olds from the Early Head Start Evaluation Research Program (n = 71) we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24-months (e.g., regulatory behavior and regulatory language), an...

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

Science.gov (United States)

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

2015-01-01

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

Human Factors Regulatory Research Program Plan, FY 1989--FY 1992

International Nuclear Information System (INIS)

Coffman, F.; Persensky, J.; Ryan, T.; Ramey-Smith, A.; Goodman, C.; Serig, D.; Trager, E; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC

1989-10-01

This report describes the currently ongoing (FY 1989) and planned (FY 1989-1992) Human Factors Regulatory Research Program in the NRC Office of Nuclear Regulatory Research (RES). Examples of the influence of human factors on nuclear safety are presented, and the role of personnel is discussed. Current regulatory issues associated with human factors in the nuclear system and the purpose of the research plan are provided. The report describes the research process applied to the human factors research issues and the program activities: Personnel Performance Measurement, Personnel Subsystem, Human-System Interface. Organization and Management, and Reliability Assessment. The research being conducted within each activity is summarized along with the objectives, background information, and expected regulatory products. Budget and personnel forecasts are provided along with a summary of contractors performing some of the ongoing research. Appendices contain a chronology of human factors research at NRC, a description of the research approach, an update on human factors programs and initiatives in RES and other NRC offices, and the integration among these programs. 46 refs., 5 tabs

Nuclear energy's future: lifting the regulatory cloud

International Nuclear Information System (INIS)

Walske, C.

1983-01-01

Nuclear energy provides 13% of US and 10% of world electricity, with an exemplary safety record and less insult to the environment than any other power source. Walske argues that nuclear power is 15% cheaper than coal despite the high capital and regulatory costs, but regulatory delays in the construction and licensing periods have increased 70% to 10 to 14 years, more than twice the lead time in France and Japan. The long lead time exaggerates the difficulty in forecasting demand, and allows interruptions for fundamental design changes after construction has begun. Walske outlines new legislation for site pre-approval, plant standardization, combined construction and operating licenses, and hybrid procedures for public hearings that would make regulation less uncertain

Considering public confidence in developing regulatory programs

International Nuclear Information System (INIS)

Collins, S.J.

2001-01-01

In the area of public trust and in any investment, planning and strategy are important. While it is accepted in the United States that an essential part of our mission is to leverage our resources to improving Public Confidence this performance goal must be planned for, managed and measured. Similar to our premier performance goal of Maintaining Safety, a strategy must be developed and integrated with our external stake holders but with internal regulatory staff as well. In order to do that, business is to be conducted in an open environment, the basis for regulatory decisions has to be available through public documents and public meetings, communication must be done in clear and consistent terms. (N.C.)

Challenging the current strategy of radiological protection of the environment: arguments for an ecosystem approach

International Nuclear Information System (INIS)

Brechignac, F.; Doi, Masahiro

2009-01-01

The system of radiological protection of the environment that is currently under development is one contribution to the general need to adequately protect the environment against stress. Dominated by operational goals, it emphasizes conceptual and methodological approaches that are readily accessible today: reference organisms supported by individual-based traditional ecotoxicological data. Whilst there are immediate advantages to this approach (pragmatism, consistency with other approaches in use for man and biota), there are also clear limitations, especially in a longer run perspective, that need to be acknowledged and further considered. One can mention a few: uncertainties generated by the need for various extrapolations (from lower to higher levels of biological organisation, ...), various features missed such as potential ecological impact through impairment of ecosystem processes, trans-generational impacts as mediated through genomic instability, indirect effects mediated through trophic interactions or disruption of ecological balances, ... Such limitations have already been faced in other fields of environmental protection against other stressors, pushing a number of environment professionals to assign stronger emphasis on more systemic approaches. This review discusses the advantages and limitations of the current approach designed for the radiological protection of non-human biota in the broader context of environment protection as a whole, with especial reference to upcoming trends and evolutions. This leads in particular to advocating the need to boost scientific and methodological approaches featuring the ecosystem concept as a mean to access a unified goal of protection: preserving life sustainability through protection of ecosystem structure and functioning.

Challenging the current strategy of radiological protection of the environment: arguments for an ecosystem approach

Energy Technology Data Exchange (ETDEWEB)

Brechignac, F., E-mail: francois.brechignac@irsn. [Institute for Radioprotection and Nuclear Safety (IRSN), Centre d' Etudes de Cadarache, Blg 229, 13115 Saint-Paul-lez-Durance (France); Doi, Masahiro [National Institute of Radiological Sciences, NIRS, Center for Radiation Protection, Regulatory Sciences Research Group, 4-9-1, Anagawa, Inage, Chiba, 263-8555 (Japan)

2009-12-15

The system of radiological protection of the environment that is currently under development is one contribution to the general need to adequately protect the environment against stress. Dominated by operational goals, it emphasizes conceptual and methodological approaches that are readily accessible today: reference organisms supported by individual-based traditional ecotoxicological data. Whilst there are immediate advantages to this approach (pragmatism, consistency with other approaches in use for man and biota), there are also clear limitations, especially in a longer run perspective, that need to be acknowledged and further considered. One can mention a few: uncertainties generated by the need for various extrapolations (from lower to higher levels of biological organisation, ...), various features missed such as potential ecological impact through impairment of ecosystem processes, trans-generational impacts as mediated through genomic instability, indirect effects mediated through trophic interactions or disruption of ecological balances, ... Such limitations have already been faced in other fields of environmental protection against other stressors, pushing a number of environment professionals to assign stronger emphasis on more systemic approaches. This review discusses the advantages and limitations of the current approach designed for the radiological protection of non-human biota in the broader context of environment protection as a whole, with especial reference to upcoming trends and evolutions. This leads in particular to advocating the need to boost scientific and methodological approaches featuring the ecosystem concept as a mean to access a unified goal of protection: preserving life sustainability through protection of ecosystem structure and functioning.

Regulatory challenges for independent organization and licensing procedures for Egypt first nuclear power program

International Nuclear Information System (INIS)

Elsheikh, B.M.

2012-01-01

In March 2010 the Government of Egypt issued an Ordinance creating an independent regulatory body the Egypt Nuclear and Radiological Regulatory Authority (NRRA) reporting directly to the Prime Minister and responsible for matters dealing with protection of the radiation worker, public and environment from the harmful effects of ionizing radiation. A little more than 2 years have elapsed since this date. Some of the challenges faced by NRRA to its regulatory independence are given below. This paper will discuss the major challenges relating to Egyptian nuclear power program and specially the regulatory effectiveness and licensing procedures compared to international comparison.

Regulatory Body of Egypt: Practices and Challenges

International Nuclear Information System (INIS)

El-Messiry, A.

2016-01-01

In past, Egypt issued the law No. 59 of year 1969 for regulating the use of ionizing radiations inside the country, this law assigns the responsibilities of Egypt Atomic Energy Authority EAEA to control reactors, open sources, and all nuclear and radiation facilities inside its premises, while the ministry of health was responsible for controlling x-ray machine, sealed sources and accelerators. In 1982 EAEA established within its structure a new regulatory body called national centre for Nuclear Safety and radiation Control NC-NSRC as a dependent regulatory body, science EAEA is the operator of reactors and many nuclear and radiation facilities. On 30 March 2010 Egypt issued a nuclear law No 7 of year 2010, followed by its executive regulation in October 2011, the new law replaced the old law 59 of year 1969, in addition, the prime minster issued a decree on march 5td 2012 of establishing an independent regulatory body reported directly to him, it has the name of Egypt Nuclear and Radiological Regulatory Authority ENRRA, it is responsible for regulating all nuclear and radiation facilities and activities inside the country, except X-ray machines and linear accelerators for the medical uses, that still remains under the control of ministry of health. The new nuclear law defines the responsibility of the government to establish, support and determine the authorization and the responsibilities of the independent regulatory body. ENRRA is managed by a board of directors comprises from chairman, vice chairman, head of national security, interior, exterior, customs, export & import, standards, environment, justice organizations, besides two scientific experts from ENRRA. The board of council is the supreme authority of the dominant, and the conduct of ENRRA affairs, and take decisions within the framework of the national plan of Egypt, to achieve the objectives for which the ENRRA was established. ENRRA was organized from the old NC-NSRC staff into three regulatory

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

International Nuclear Information System (INIS)

Kim, Wong Sik; Kim, Hho Jung

2004-01-01

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

Regulatory change and monetary policy

OpenAIRE

Bank for International Settlements

2015-01-01

Report submitted by a Working Group established by the Committee on the Global Financial System and the Markets Committee. The Group was chaired by Ulrich Bindseil (European Central Bank) and William R Nelson (Federal Reserve Board). Financial regulation is evolving, as policymakers seek to strengthen the financial system in order to make it more robust and resilient. Changes in the regulatory environment are likely to have an impact on financial system structure and on the behaviour of finan...

Regulatory aspects of NPP safety

International Nuclear Information System (INIS)

Kastchiev, G.

1999-01-01

Extensive review of the NPP Safety is presented including tasks of Ministry of Health, Ministry of Internal Affairs, Ministry of Environment and Waters, Ministry of Defense in the field of national system for monitoring the nuclear power. In the frame of national nuclear safety legislation Bulgaria is in the process of approximation of the national legislation to that of EC. Detailed analysis of the status of regulatory body, its functions, organisation structure, responsibilities and future tasks is included. Basis for establishing the system of regulatory inspections and safety enforcement as well as intensification of inspections is described. Assessment of safety modifications is concerned with complex program for reconstruction of Units 1-4 of Kozloduy NPP, as well as for modernisation of Units 5 and 6. Qualification and licensing of the NPP personnel, Year 2000 problem, priorities and the need of international assistance are mentioned

76 FR 40943 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2011-07-12

... Criterion III, ``Design Control,'' of Appendix B, ``Quality Assurance Criteria for Nuclear Power Plants and... high functional reliability, design quality, and a secure development and operational environment for... Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2011-17441 Filed...

Evaluation of Current Computer Models Applied in the DOE Complex for SAR Analysis of Radiological Dispersion & Consequences

Energy Technology Data Exchange (ETDEWEB)

O' Kula, K. R. [Savannah River Site (SRS), Aiken, SC (United States); East, J. M. [Savannah River Site (SRS), Aiken, SC (United States); Weber, A. H. [Savannah River Site (SRS), Aiken, SC (United States); Savino, A. V. [Savannah River Site (SRS), Aiken, SC (United States); Mazzola, C. A. [Savannah River Site (SRS), Aiken, SC (United States)

2003-01-01

The evaluation of atmospheric dispersion/ radiological dose analysis codes included fifteen models identified in authorization basis safety analysis at DOE facilities, or from regulatory and research agencies where past or current work warranted inclusion of a computer model. All computer codes examined were reviewed using general and specific evaluation criteria developed by the Working Group. The criteria were based on DOE Orders and other regulatory standards and guidance for performing bounding and conservative dose calculations. Included were three categories of criteria: (1) Software Quality/User Interface; (2) Technical Model Adequacy; and (3) Application/Source Term Environment. A consensus-based limited quantitative ranking process was used to base an order of model preference as both an overall conclusion, and under specific conditions.

WhatsApp in Stroke Systems: Current Use and Regulatory Concerns.

Science.gov (United States)

Calleja-Castillo, Juan M; Gonzalez-Calderon, Gina

2018-01-01

Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use.

WhatsApp in Stroke Systems: Current Use and Regulatory Concerns

Directory of Open Access Journals (Sweden)

Juan M. Calleja-Castillo

2018-05-01

Full Text Available Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use.

Adipose-Derived Stem Cells in Aesthetic Surgery: A Mixed Methods Evaluation of the Current Clinical Trial, Intellectual Property, and Regulatory Landscape.

Science.gov (United States)

Arshad, Zeeshaan; Halioua-Haubold, Celine-Lea; Roberts, Mackenna; Urso-Baiarda, Fulvio; Branford, Oliver A; Brindley, David A; Davies, Benjamin M; Pettitt, David

2018-02-17

Adipose tissue, which can be readily harvested via a number of liposuction techniques, offers an easily accessible and abundant source of adipose-derived stem cells (ASCs). Consequently, ASCs have become an increasingly popular reconstructive option and a novel means of aesthetic soft tissue augmentation. This paper examines recent advances in the aesthetic surgery field, extending beyond traditional review formats to incorporate a comprehensive analysis of current clinical trials, adoption status, and the commercialization pathway. Keyword searches were carried out on clinical trial databases to search for trials using ASCs for aesthetic indications. An intellectual property landscape was created using commercial software (Thomson Reuters Thomson Innovation, New York, NY). Analysis of who is claiming what in respect of ASC use in aesthetic surgery for commercial purposes was analyzed by reviewing the patent landscape in relation to these techniques. Key international regulatory guidelines were also summarized. Completed clinical trials lacked robust controls, employed small sample sizes, and lacked long-term follow-up data. Ongoing clinical trials still do not address such issues. In recent years, claims to intellectual property ownership have increased in the "aesthetic stem cell" domain, reflecting commercial interest in the area. However, significant translational barriers remain including regulatory challenges and ethical considerations. Further rigorous randomized controlled trials are required to delineate long-term clinical efficacy and safety. Providers should consider the introduction of patient reported outcome metrics to facilitate clinical adoption. Robust regulatory and ethical policies concerning stem cells and aesthetic surgery should be devised to discourage further growth of "stem cell tourism." © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com

Regulatory dendritic cells in autoimmunity: A comprehensive review.

Science.gov (United States)

Liu, Juan; Cao, Xuetao

2015-09-01

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

Regulatory and extra-regulatory testing to demonstrate radioactive material packaging safety

International Nuclear Information System (INIS)

Ammerman, D.J.

1997-01-01

Packages for the transportation of radioactive material must meet performance criteria to assure safety and environmental protection. The stringency of the performance criteria is based on the degree of hazard of the material being transported. Type B packages are used for transporting large quantities of radioisotopes (in terms of A 2 quantities). These packages have the most stringent performance criteria. Material with less than an A 2 quantity are transported in Type A packages. These packages have less stringent performance criteria. Transportation of LSA and SCO materials must be in open-quotes strong-tightclose quotes packages. The performance requirements for the latter packages are even less stringent. All of these package types provide a high level of safety for the material being transported. In this paper, regulatory tests that are used to demonstrate this safety will be described. The responses of various packages to these tests will be shown. In addition, the response of packages to extra-regulatory tests will be discussed. The results of these tests will be used to demonstrate the high level of safety provided to workers, the public, and the environment by packages used for the transportation of radioactive material

Regulatory issues for nuclear power plant life management

International Nuclear Information System (INIS)

Roe, J.

2000-01-01

The workshop of 26-27 june 2000, on nuclear power Plant LIfe Management (PLIM), also included working groups in which major issues facing PLIM activities for nuclear power plants were identified and discussed. The second group was on Regulation. The Regulatory Working Group will attempt to identify some of the more pertinent issues affecting nuclear plant regulation in a changing PLIM environment, to identify some possible actions to be taken to address these issues, and to identify some of the parties responsible for taking these actions. Some preliminary regulatory issues are noted below. This is not intended to be a comprehensive list of such issues but rather is intended to stimulate discussion among the experts attending this Workshop. One of the concerns in the regulatory arena is how the structural integrity of the plants can be assured for an extended lifetime. Technological advances directed toward the following are likely to be important factors in the regulatory process of life extension. - Preventive and corrective maintenance (e.g., water chemistry control, pressure vessel annealing, and replacement of core internals). - Ageing and degradation mechanisms and evaluation (e.g., embrittlement, wear, corrosion/erosion, fatigue, and stress corrosion). - Monitoring, surveillance, and inspection (e.g., fatigue monitoring and non-destructive testing). - Optimisation of maintenance (e.g., using risk-based analysis). On the business side, there is concern about technical support by manufacturers, fuel companies, and construction companies. Maintaining a strong technical base and skilled workers in a potentially declining environment is another concern in the regulatory community. Waste management and decommissioning remain significant issue regarding PLIM. These issues affect all three areas of concern - technology, business, and regulation. It is against this background, that the issues put forth in this paper are presented. The objective of presenting these

Innovative farmers and regulatory gatekeepers: Genetically modified crops regulation and adoption in developing countries.

Science.gov (United States)

Sinebo, Woldeyesus; Maredia, Karim

2016-01-02

The regulation of genetically modified (GM) crops is a topical issue in agriculture and environment over the past 2 decades. The objective of this paper is to recount regulatory and adoption practices in some developing countries that have successfully adopted GM crops so that aspiring countries may draw useful lessons and best practices for their biosafatey regulatory regimes. The first 11 mega-GM crops growing countries each with an area of more than one million hectares in 2014 were examined. Only five out of the 11 countries had smooth and orderly adoption of these crops as per the regulatory requirement of each country. In the remaining 6 countries (all developing countries), GM crops were either introduced across borders without official authorization, released prior to regulatory approval or unapproved seeds were sold along with the approved ones in violation to the existing regulations. Rapid expansion of transgenic crops over the past 2 decades in the developing world was a result of an intense desire by farmers to adopt these crops irrespective of regulatory roadblocks. Lack of workable biosafety regulatory system and political will to support GM crops encouraged unauthorized access to GM crop varieties. In certain cases, unregulated access in turn appeared to result in the adoption of substandard or spurious technology which undermined performance and productivity. An optimal interaction among the national agricultural innovation systems, biosafety regulatory bodies, biotech companies and high level policy makers is vital in making a workable regulated progress in the adoption of GM crops. Factoring forgone opportunities to farmers to benefit from GM crops arising from overregulation into biosafety risk analysis and decision making is suggested. Building functional biosafety regulatory systems that balances the needs of farmers to access and utilize the GM technology with the regulatory imperatives to ensure adequate safety to the environment and human

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

International Nuclear Information System (INIS)

Al Khatibeh, Ahmad

2014-05-01

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

Impact of a Fragmented Regulatory Environment on Sustainable Urban Development Design Management

Directory of Open Access Journals (Sweden)

Kerry Anne London

2009-12-01

Full Text Available The building project development approval process is increasingly complex and fraught with conflict due to the rise of the sustainable urban development movement and inclusive decision making. Coupled with this, government decision-making decentralization has resulted in a fragmented and over-regulated compliance system. Problems arising from the process include wasted resources, excessive time delays, increased holding and litigation costs, inadequate planning coordination, high levels of advocacy costs and a divisive politicized approval process. In Australia, despite attempts by government and industry associations, numerous problems are still unresolved. Design managers increasingly assume a liaison role during the approval phase. There is a long tradition of planning theory literature which provides context for understanding the knowledge-power-participation relationship for this paper. This study investigated the policy, process and practice conflicts during the approval stage in achieving sustainable urban developments. Three regional local government areas within one state jurisdiction and observations from detailed structured focus group interviews involving 23 stakeholders, proposers and assessors were analysed to explore this conflictual environment. As a result of regulatory fragmentation and excessive consultation, various persuasion tactics have been developed by all stakeholders of which `reciprocity' and `authority' were identified as the most common. Two challenges for design managers were thus identified: first, the emergence of the role of a by default central informal arbitrator across conflicting planning instruments; and, second, as a navigator through a set of persuasion tactics. An inclusive knowledge-based design management framework for sustainable urban development is proposed considering Habermas' communicative planning theory, Foucaltian governance and discursive powers thesis and Cialdini's persuasion theory, as

Role of cooperation activities for capacity building of Romanian Regulatory Authority (CNCAN)

International Nuclear Information System (INIS)

Biro, L.; Ciurea-Ercau, C.

2010-01-01

With a slow but active nuclear development program of sector since 1980, Romanian regulatory authority had to permanently adapt to the changes in national and international environment in order ensure continuously increase of capacity building and effectiveness, commensurate with the growing nuclear sector. Limited human resources available at the national level put the Romanian Regulatory Authority in the position of building the Technical Support Organization as part of its on organization. International cooperation played an important role in capacity building of Romanian regulatory body and providing necessary assistance in performing regulatory activities or support in development of regulatory framework. Fellowships and technical visits, workshops and training courses provided through IAEA TC at national or regional level, technical assistance provided by European Commission (EC) through PHARE Projects, all provided valuable contribution in assuring training of regulatory staff and development of proper regulatory framework in Romania. Therefore, Romanian Regulatory Authority is putting a strong accent on strengthening and promoting international cooperation through IAEA Technical Cooperation Programme, Molls between regulatory bodies, as one of the key elements in supporting capacity building of regulatory authorities in countries having small or embarking on nuclear power program. Building networks between training centers and research facilities and establishments of regional training centers represent one of the future viable options in preserving knowledge in nuclear field. (author)

FREEDOM OF PRESS IN CURRENT SOCIO-POLITICAL ENVIRONMENT IN ROMANIA

Directory of Open Access Journals (Sweden)

Georgiana STĂNESCU

2017-08-01

Full Text Available This study analyses the way journalists’ freedom of expression is protected in current socio/political context. It has started from the fact that Mass Media is the guarantee of any modern democracy, and respect for freedom of expression is essential in the current European environment. We have shown that Romania guarantees through the Constitution, but also through other international treaties to which it is a signatory, the freedom of expression of every citizen, and, implicitly, the freedom of press. But in laws and treaties things seem simple, while in reality in the courts, the situation is completely different and, above all, extremely complicated. The study highlights the case of a journalist from Constanţa, who was sued by the former mayor of the city on the grounds that his image was damaged in a TV show on a local television station. Thus, the views of the Romanian institutions, on the one hand, and the one of the European Court of Human Rights on the other, were analyzed. The ECHR ruled for the journalist in the case against the former mayor of Constanţa (Ghiulfer vs. Romania, instead, two Romanian courts forced the journalist to pay moral damages and make him publicly apologize in a large circulation newspaper.

Low-income, minority fathers' control strategies and their children's regulatory skills.

Science.gov (United States)

Malin, Jenessa L; Cabrera, Natasha J; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith L

2014-01-01

The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24 months, and children's regulatory skills at prekindergarten (pre-K). Using a sample of low-income, minority families with 2-year-olds from the Early Head Start Research and Evaluation Project (n = 71), we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24 months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at prekindergarten. There were three main findings. First, fathers overwhelmingly used commands (e.g., "Do that.") to promote compliance in their 24-month-old children. Second, children's vocabulary skills predicted fathers' regulatory behaviors during a father-child interaction whereas children's gender predicted fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24 months predicted children's sustained attention at pre-K whereas fathers' regulatory language at 24 months predicted children's emotion regulation at pre-K. Our findings highlight the importance of examining paternal contributions to children's regulatory skills. © 2014 Michigan Association for Infant Mental Health.

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

International Nuclear Information System (INIS)

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

2002-01-01

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

Safety culture in regulatory expert organization : analysis result of survey for KINS employees

International Nuclear Information System (INIS)

Choi, G. S.; Choi, Y. S.

2003-01-01

Much has been discussed on safety culture of operating organizations, however, little has been done on that of regulatory organization. Current issues and activities related to nuclear safety culture at IAEA, OECD/NEA, etc. were investigated and relevant literatures were reviewed. Elements essential for safety culture of regulatory organization were proposed and survey questionnaire for employees of regulatory expert organization, KINS, was developed based on the elements proposed. The survey result was presented and its implications were discussed. Based on the result, elements of safety culture in regulatory organization were proposed. The result of this survey can be used in developing safety culture model of regulatory organization, measurement method and also promotion of safety culture in regulatory organization

Towards a predictive theory for genetic regulatory networks

Science.gov (United States)

Tkacik, Gasper

When cells respond to changes in the environment by regulating the expression levels of their genes, we often draw parallels between these biological processes and engineered information processing systems. One can go beyond this qualitative analogy, however, by analyzing information transmission in biochemical ``hardware'' using Shannon's information theory. Here, gene regulation is viewed as a transmission channel operating under restrictive constraints set by the resource costs and intracellular noise. We present a series of results demonstrating that a theory of information transmission in genetic regulatory circuits feasibly yields non-trivial, testable predictions. These predictions concern strategies by which individual gene regulatory elements, e.g., promoters or enhancers, read out their signals; as well as strategies by which small networks of genes, independently or in spatially coupled settings, respond to their inputs. These predictions can be quantitatively compared to the known regulatory networks and their function, and can elucidate how reproducible biological processes, such as embryonic development, can be orchestrated by networks built out of noisy components. Preliminary successes in the gap gene network of the fruit fly Drosophila indicate that a full ab initio theoretical prediction of a regulatory network is possible, a feat that has not yet been achieved for any real regulatory network. We end by describing open challenges on the path towards such a prediction.

Computer simulations of a generic truck cask in a regulatory fire using the Container Analysis Fire Environment (CAFE) code

International Nuclear Information System (INIS)

Ju, H.; Greiner, M.; Suo-Anttila, A.

2002-01-01

The Container Analysis Fire Environment (CAFE) computer code is designed to predict accurately convection and radiation heat transfer to a thermally massive object engulfed in a large pool fire. It is well suited for design and risk analyses of spent nuclear fuel transport systems. CAFE employs computational fluid dynamics and several fire and radiation models. These models must be benchmarked using experimental results. In this paper, a set of wind velocity conditions are determined which allow CAFE accurately to reproduce recent heat transfer measurements for a thick walled calorimeter in a ST-1 regulatory pool fire. CAFE is then used to predict the response of an intack (thin walled) generic legal weight truck cask. The maximum temperatures reached by internal components are within safe limits. A simple 800 deg. C, grey-radiation fire model gives maximum component temperatures that are somewhat below those predicted by CAFE. (author)

Regulatory Oversight for New Projects - Challenges and Improvement in Regulation

International Nuclear Information System (INIS)

Lall, F.

2016-01-01

From inception, there has been rise in number of Nuclear Power Plants (NPP) even though very few accidents / events led to intermittent setbacks. However these accidents / events have posed challenges towards enhancement of safety and scope of regulation in all phases of NPP such as siting, design, construction, commissioning and decommissioning. It is essential to ensure compliance to these enhanced safety requirements during all phases of NPP. New and evolutionary reactors are under threshold for regulatory consideration world over. The variety of technologies and genres by themselves pose challenges to regulatory bodies. These challenges are to be addressed through systematic enhancement of the regulation including updating of regulatory documents. The paper touches upon some key elements to be considered towards such enhancement of regulation during all stages of NPP. These being; ensuring quality assurance, regulatory oversight especially over supply chain and contractors, counterfeit material specifically in case of international dealings, emergency handling in case of multi-unit site, feedback and associated enhancements from international events, construction experience database and feedback for safety enhancement, qualification and acceptance of first of a kind systems, regulatory enforcement specifically in case of imported reactors and maintaining interface between safety and security. Regulation in present context has become dynamic and Regulatory bodies need to continue enhancement of its current regulation taking into account the technological developments, feedback from construction, operation and accidents in the current fleet of plants. The paper touches upon some of these elements and highlights the challenges and improvements in regulation. (author)

Regulatory practices of radiation safety of SNF transportation in Russia

International Nuclear Information System (INIS)

Kuryndina, Lidia; Kuryndin, Anton; Stroganov, Anatoly

2008-01-01

This paper overviews current regulatory practices for the assurance of nuclear and radiation safety during railway transportation of SNF on the territory of Russian Federation from NPPs to longterm-storage of reprocessing sites. The legal and regulatory requirements (mostly compliant with IAEA ST-1), licensing procedure for NM transportation are discussed. The current procedure does not require a regulatory approval for each particular shipment if the SNF fully comply with the Rosatom's branch standard and is transported in approved casks. It has been demonstrated that SNF packages compliant with the branch standard, which is knowingly provide sufficient safety margin, will conform to the federal level regulations. The regulatory approval is required if a particular shipment does not comply with the branch standard. In this case, the shipment can be approved only after regulatory review of Applicant's documents to demonstrate that the shipment still conformant to the higher level (federal) regulations. The regulatory review frequently needs a full calculation test of the radiation safety assurance. This test can take a lot of time. That's why the special calculation tools were created in SEC NRS. These tools aimed for precision calculation of the radiation safety parameters by SNF transportation use preliminary calculated Green's functions. Such approach allows quickly simulate any source distribution and optimize spent fuel assemblies placement in cask due to the transport equation property of linearity relatively the source. The short description of calculation tools are presented. Also, the paper discusses foreseen implications related to transportation of mixed-oxide SNF. (author)

Regulatory activities

International Nuclear Information System (INIS)

2001-01-01

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

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

Science.gov (United States)

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

2007-10-01

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

Different regulatory strategies in regulation of nuclear power projects: An Indian experience

International Nuclear Information System (INIS)

Khan, Sohail Ahmad

2002-01-01

Regulatory strategy needed for management of safety and safety culture involves careful planning and use of engineering concepts keeping in mind feasibility to implement certain safety requirements. It also requires adequate attention on working environment and mental conditions of designers, operating and maintenance staff and regulators. Different strategies followed during safety review and regulatory inspection of nuclear power projects for improving status of safety management and safety cultures have given certain results. The present paper brings out certain experience gained during regulation of Indian Nuclear Power Projects by Atomic Energy Regulatory Board of India in the area of management of safety and safety culture. (author)

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).

Regulatory Approach To and Lessons Learned with Licensing of Service Life Extension at PAKS NPP

International Nuclear Information System (INIS)

Petofi, G.

2012-01-01

Paks Nuclear Power Plant of Hungary decided to extend the original design lifetime of the plant by 20 years, which expires on December 31, 2012 concerning unit 1. The Hungarian Atomic Energy Authority established the legal environments in order to license the extension using an approach similar to that followed in the United States. The regulation specifies the pre-conditions for the extension, defines the scoping and screening process for the passive and long lived systems, structures and components to be involved in the licensing and the respective methods of treatment and also determines how the active components shall be dealt with during the extended lifetime. The regulatory procedure is a two-step process including the oversight of the preparatory programme of the operator for the extension that started 4 years before the expiry of the lifetime and the licensing process itself, which is currently under way for unit 1 after the submittal of the licensee's application at the end of 2011. The first experiences with the regulatory assessment of the application are available yet and presented in this paper. (author)

Phylogeny based discovery of regulatory elements

Directory of Open Access Journals (Sweden)

Cohen Barak A

2006-05-01

Full Text Available Abstract Background Algorithms that locate evolutionarily conserved sequences have become powerful tools for finding functional DNA elements, including transcription factor binding sites; however, most methods do not take advantage of an explicit model for the constrained evolution of functional DNA sequences. Results We developed a probabilistic framework that combines an HKY85 model, which assigns probabilities to different base substitutions between species, and weight matrix models of transcription factor binding sites, which describe the probabilities of observing particular nucleotides at specific positions in the binding site. The method incorporates the phylogenies of the species under consideration and takes into account the position specific variation of transcription factor binding sites. Using our framework we assessed the suitability of alignments of genomic sequences from commonly used species as substrates for comparative genomic approaches to regulatory motif finding. We then applied this technique to Saccharomyces cerevisiae and related species by examining all possible six base pair DNA sequences (hexamers and identifying sequences that are conserved in a significant number of promoters. By combining similar conserved hexamers we reconstructed known cis-regulatory motifs and made predictions of previously unidentified motifs. We tested one prediction experimentally, finding it to be a regulatory element involved in the transcriptional response to glucose. Conclusion The experimental validation of a regulatory element prediction missed by other large-scale motif finding studies demonstrates that our approach is a useful addition to the current suite of tools for finding regulatory motifs.

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)

Interview about nuclear regulatory supervision with Stefan Mappus, Baden-Wuerttemberg State Minister for the Environment and for Transport; Interview zur Kernenergieaufsicht mit Stefan Mappus, Minister fuer Umwelt und Verkehr des Landes Baden-Wuerttemberg

Energy Technology Data Exchange (ETDEWEB)

Anon.

2005-02-01

Stefan Mappus, member of the Baden-Wuerttemberg State Parliament, has been State Minister for the Environment since July 14, 2004. He has criticized deficiencies in nuclear power plants, but also has expressed himself in favor of continuing to use nuclear power. This interview covers the safety of nuclear power plants in Baden-Wuerttemberg; the fines to be imposed within the framework of nuclear regulatory supervision; and ''new accents'' in supervision, among others. Mr. Mappus also comments on the activities of his Ministry in connection with events at the Philippsburg nuclear power station and the consequences drawn by the regulatory authority. (orig.)

Isotope production technologies from a regulatory perspective

Energy Technology Data Exchange (ETDEWEB)

Murthy, K. [Canadian Nuclear Safety Committee, Ottawa, Ontario (Canada)

2012-07-01

This paper discusses isotope production technologies from a regulatory perspective. The regulator is the CNSC which has the mandate to protect the health, safety and security of persons and the environment and to implement Canada's international commitments on the peaceful use of nuclear energy. Nuclear facilities regulated by CNSC include linear accelerator (medical), pool irradiator (industrial) and Pelletron (research) as well as cyclotrons.

International regulatory activities

International Nuclear Information System (INIS)

Anon.

2003-01-01

Among international regulatory activities we find resolutions adopted by the IAEA general conference (2003), through European Union we find proposals for directives on nuclear safety and radioactive waste management, new regulation on the application of EURATOM safeguards, control of high activity sealed radioactive sources, recommendation on the protection and information of the public with regard to the continued contamination of certain wild food products following the Chernobyl accident, proposals for decisions authorizing the Member states to sign and ratify the Protocol to amend the Paris convention, p)proposals for a directive on environment liability with regard to the prevention and remedying of environmental damage, proposal of a regulation on the law applicable to non-contractual obligation. (N.C.)

Regulatory analysis and lessons learned from the LLRW [low-level radioactive waste] disposal area at West Valley, New York: Final report

International Nuclear Information System (INIS)

1986-12-01

The New York State Energy Research and Development Authority has sponsored a project to develop an integrated set of site management plans for the West Valley low-level radioactive waste (LLRW) disposal area. The plans were directed to upgrade the disposal area so that passive custodial care and monitoring activities would be sufficient to protect public health and safety and the environment. Tasks 5 and 6, Regulatory Analysis and Lessons Learned, are the subject of this report. The regulatory analysis identified areas of inconsistencies between the historic site operations and the current state and federal LLRW disposal regulations and guidelines. The lessons learned task identified the causes of the disposal problems at West Valley, discussed the lessons learned, and described the responses developed by the NRC and industry to the lessons learned. 85 refs., 6 figs., 19 tabs

Clostridium difficile infection: current, forgotten and emerging treatment options.

Science.gov (United States)

Drekonja, Dimitri M

2014-09-01

Clostridium difficile infection (CDI) has increased in incidence and severity, and is now among the most common nosocomial infections. Several agents are available for the initial treatment of CDI, some of which are rarely used, and none of which is clearly superior for initial clinical cure. Fidaxomicin appears to offer a benefit in terms of preventing recurrent disease, although the cost-benefit ratio is debated. Recurrent CDI is a major challenge, occurring after 15-30% of initial episodes. The treatment of recurrent CDI is difficult, with sparse evidence available to support any particular agent. Fecal microbiota therapy, also known as 'stool transplantation', appears to be highly effective, although availability is currently limited, and the regulatory environment is in flux. Synthetic stool products and an orally available fecal microbiota therapy product are both under investigation, which may address the problem of availability. As with most infectious diseases, an effective vaccine would be a welcome addition to our armamentarium, but none is currently available.

Regulatory adequacy of aquatic ecotoxicity testing of nanomaterials

DEFF Research Database (Denmark)

Hjorth, Rune; Skjolding, Lars Michael; Sørensen, Sara Nørgaard

2017-01-01

between studies, which question the regulatory reliability of the data currently available. Accordingly, lack of data suited for regulatory decision-making is still a pressing issue in nanoecotoxicology even though the data availability has increased. Nevertheless, we emphasize that by deliberately...... to question whether ecotoxicity testing is now able to facilitate regulatory decision-making on manufactured nanomaterials (MNs). In this paper, we review the state of aquatic ecotoxicity testing of MNs as well as the overarching issues that challenge the reliability and relevance of such testing. We conclude...... that within the field there is an increased focus on characterization of the exposure rather than controlling exposure as it is traditionally done in guideline testing of chemicals. However, the lack of characterization options under actual testing conditions makes it difficult to make meaningful comparisons...

Improving nuclear regulation. NEA regulatory guidance booklets volumes 1-14

International Nuclear Information System (INIS)

2011-01-01

A common theme throughout the series of NEA regulatory guidance reports, or 'green booklets', is the premise that the fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are continuously maintained and operated in an acceptably safe manner. In meeting this objective the regulator must bear in mind that it is the operator that has responsibility for safely operating the nuclear facility; the role of the regulator is to assess and to provide assurance regarding the operator's activities in terms of assuming that responsibility. The full series of these reports was brought together in one edition for the first time in 2009 and was widely found to be a useful resource. This second edition comprises 14 volumes, including the latest on The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services. The reports address various challenges that could apply throughout the lifetime of a nuclear facility, including design, siting, manufacturing, construction, commissioning, operation, maintenance and decommissioning. The compilation is intended to serve as a knowledge management tool both for current regulators and the new nuclear professionals and organisations entering the regulatory field. Contents: Executive Summary; Regulatory Challenges: 1. The Role of the Nuclear Regulator in Promoting and Evaluating Safety Culture; 2. Regulatory Response Strategies for Safety Culture Problems; 3. Nuclear Regulatory Challenges Related to Human Performance; 4. Regulatory Challenges in Using Nuclear Operating Experience; 5. Nuclear Regulatory Review of Licensee Self-assessment (LSA); 6. Nuclear Regulatory Challenges Arising from Competition in Electricity Markets; 7. The Nuclear Regulatory Challenge of Judging Safety Back-fits; 8. The Regulatory Challenges of Decommissioning Nuclear Reactors; 9. The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services

Implementation of the 3Rs (refinement, reduction, and replacement): validation and regulatory acceptance considerations for alternative toxicological test methods.

Science.gov (United States)

Schechtman, Leonard M

2002-01-01

Toxicological testing in the current regulatory environment is steeped in a history of using animals to answer questions about the safety of products to which humans are exposed. That history forms the basis for the testing strategies that have evolved to satisfy the needs of the regulatory bodies that render decisions that affect, for the most part, virtually all phases of premarket product development and evaluation and, to a lesser extent, postmarketing surveillance. Only relatively recently have the levels of awareness of, and responsiveness to, animal welfare issues reached current proportions. That paradigm shift, although sluggish, has nevertheless been progressive. New and alternative toxicological methods for hazard evaluation and risk assessment have now been adopted and are being viewed as a means to address those issues in a manner that considers humane treatment of animals yet maintains scientific credibility and preserves the goal of ensuring human safety. To facilitate this transition, regulatory agencies and regulated industry must work together toward improved approaches. They will need assurance that the methods will be reliable and the results comparable with, or better than, those derived from the current classical methods. That confidence will be a function of the scientific validation and resultant acceptance of any given method. In the United States, to fulfill this need, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and its operational center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), have been constituted as prescribed in federal law. Under this mandate, ICCVAM has developed a process and established criteria for the scientific validation and regulatory acceptance of new and alternative methods. The role of ICCVAM in the validation and acceptance process and the criteria instituted toward that end are described. Also

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.

Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

Science.gov (United States)

Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

2014-01-01

International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

Politically Induced Regulatory Risk and Independent Regulatory Agencies

OpenAIRE

Strausz, Roland

2015-01-01

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

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

Regulatory aspects of NPP safety

International Nuclear Information System (INIS)

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

1999-01-01

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

ARTIST (Asian regional tobacco industry scientist team): Philip Morris' attempt to exert a scientific and regulatory agenda on Asia.

Science.gov (United States)

Tong, E K; Glantz, S A

2004-12-01

To describe how the transnational tobacco industry has collaborated with local Asian tobacco monopolies and companies to promote a scientific and regulatory agenda. Analysis of previously secret tobacco industry documents. Transnational tobacco companies began aggressively entering the Asia market in the 1980s, and the current tobacco industry in Asia is a mix of transnational and local monopolies or private companies. Tobacco industry documents demonstrate that, in 1996, Philip Morris led an organisation of scientific representatives from different tobacco companies called the Asian Regional Tobacco Industry Science Team (ARTIST), whose membership grew to include monopolies from Korea, China, Thailand, and Taiwan and a company from Indonesia. ARTIST was initially a vehicle for PM's strategies against anticipated calls for global smoke-free areas from a World Health Organization secondhand smoke study. ARTIST evolved through 2001 into a forum to present scientific and regulatory issues faced primarily by Philip Morris and other transnational tobacco companies. Philip Morris' goal for the organisation became to reach the external scientific and public health community and regulators in Asia. The Asian tobacco industry has changed from an environment of invasion by transnational tobacco companies to an environment of participation with Philip Morris' initiated activities. With this participation, tobacco control efforts in Asia face new challenges as Philip Morris promotes and integrates its scientific and regulatory agenda into the local Asian tobacco industry. As the local Asian tobacco monopolies and companies can have direct links with their governments, future implementation of effective tobacco control may be at odds with national priorities.

Lagrangian statistics of mesoscale turbulence in a natural environment: The Agulhas return current.

Science.gov (United States)

Carbone, Francesco; Gencarelli, Christian N; Hedgecock, Ian M

2016-12-01

The properties of mesoscale geophysical turbulence in an oceanic environment have been investigated through the Lagrangian statistics of sea surface temperature measured by a drifting buoy within the Agulhas return current, where strong temperature mixing produces locally sharp temperature gradients. By disentangling the large-scale forcing which affects the small-scale statistics, we found that the statistical properties of intermittency are identical to those obtained from the multifractal prediction in the Lagrangian frame for the velocity trajectory. The results suggest a possible universality of turbulence scaling.

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.)

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)

Environment protection: The current challenge in radioecology

Science.gov (United States)

Bréchignac, F.

2012-04-01

Radioecology, a multifaceted scientific discipline which addresses environmental issues relevant to radioprotection, has for a long time been focused on environmental transfers through the environment to feed the needs of human radioprotection. This quite anthropocentric initial scope is now moving to a more ecocentric view capable of assessing ecological risk mediated by ionising radiation. The central issue consists in reaching an ability to understand the effects of radiation on the environment components, from individual organisms up to populations of species and ecosystems, together with their interaction with the abiotic compartments. Dominated by operational goals, the system of radiological protection of the environment which is under development emphasises a concept based upon reference organisms supported by traditional toxicological data on individual organisms. Whilst there are immediate advantages to this approach (pragmatism, consistency with other approaches in use for man and biota), there are also clear limitations which need to be acknowledged and further considered. The most important probably is to rely on effects data gathered almost exclusively for individual organisms to meet protection goals which are usually set at population and ecosystem levels. Overcoming this limitation leads to scientific and methodological approaches featuring the ecosystem concept.

[Future Regulatory Science through a Global Product Development Strategy to Overcome the Device Lag].

Science.gov (United States)

Tsuchii, Isao

2016-01-01

Environment that created "medical device lag (MDL)" has changed dramatically, and currently that term is not heard often. This was mainly achieved through the leadership of three groups: government, which determined to overcome MDL and took steps to do so; medical societies, which exhibited accountability in trial participation; and MD companies, which underwent a change in mindset that allowed comprehensive tripartite cooperation to reach the current stage. In particular, the global product development strategy (GPDS) of companies in a changing social environment has taken a new-turn with international harmonization trends, like Global Harmonization Task Force and International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. As a result, this evolution has created opportunities for treatment with cutting-edge MDs in Japanese society. Simultaneously, it has had a major impact on the planning process of GPDS of companies. At the same time, the interest of global companies has shifted to emerging economies for future potential profit since Japan no longer faces MDL issue. This economic trend makes MDLs a greater problem for manufacturers. From the regulatory science viewpoint, this new environment has not made it easy to plan a global strategy that will be adaptable to local societies. Without taking hasty action, flexible thinking from the global point of view is necessary to enable the adjustment of local strategies to fit the situation on the ground so that the innovative Japanese medical technology can be exported to a broad range of societies.

DOE regulatory reform initiative vitrified mixed waste

International Nuclear Information System (INIS)

Carroll, S.J.; Holtzscheiter, E.W.

1997-01-01

The US Department of Energy (DOE) is charged with responsibly managing the largest volume of mixed waste in the United States. This responsibility includes managing waste in compliance with all applicable Federal and State laws and regulations, and in a cost-effective, environmentally responsible manner. Managing certain treated mixed wastes in Resource Conservation and Recovery Act (RCRA) permitted storage and disposal units (specifically those mixed wastes that pose low risks from the hazardous component) is unlikely to provide additional protection to human health and the environment beyond that afforded by managing these wastes in storage and disposal units subject to requirements for radiological control. In October, 1995, the DOE submitted a regulatory reform proposal to the Environmental Protection Agency (EPA) relating to vitrified mixed waste forms. The technical proposal supports a regulatory strategy that would allow vitrified mixed waste forms treated through a permit or other environmental compliance mechanism to be granted an exemption from RCRA hazardous waste regulation, after treatment, based upon the inherent destruction and immobilization capabilities of vitrification technology. The vitrified waste form will meet, or exceed the performance criteria of the Environmental Assessment (EA) glass that has been accepted as an international standard for immobilizing radioactive waste components and the LDR treatment standards for inorganics and metals for controlling hazardous constituents. The proposal further provides that vitrified mixed waste would be responsibly managed under the Atomic Energy Act (AEA) while reducing overall costs. Full regulatory authority by the EPA or a State would be maintained until an acceptable vitrified mixed waste form, protective of human health and the environment, is produced

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

Regulatory issues for deep borehole plutonium disposition

International Nuclear Information System (INIS)

Halsey, W.G.

1995-03-01

As a result of recent changes throughout the world, a substantial inventory of excess separated plutonium is expected to result from dismantlement of US nuclear weapons. The safe and secure management and eventual disposition of this plutonium, and of a similar inventory in Russia, is a high priority. A variety of options (both interim and permanent) are under consideration to manage this material. The permanent solutions can be categorized into two broad groups: direct disposal and utilization. The deep borehole disposition concept involves placing excess plutonium deep into old stable rock formations with little free water present. Issues of concern include the regulatory, statutory and policy status of such a facility, the availability of sites with desirable characteristics and the technologies required for drilling deep holes, characterizing them, emplacing excess plutonium and sealing the holes. This white paper discusses the regulatory issues. Regulatory issues concerning construction, operation and decommissioning of the surface facility do not appear to be controversial, with existing regulations providing adequate coverage. It is in the areas of siting, licensing and long term environmental protection that current regulations may be inappropriate. This is because many current regulations are by intent or by default specific to waste forms, facilities or missions significantly different from deep borehole disposition of excess weapons usable fissile material. It is expected that custom regulations can be evolved in the context of this mission

Ethical principles and the environment in a democratic society

International Nuclear Information System (INIS)

Ahearne, J.F.

1994-01-01

This work deals with ethical principles and the environment in a democratic society and more particularly, it refers to spent fuels : commercial wastes in Usa. After having given the positions for the permanent solution of high-level wastes of the official government, the atomic energy commission, the national academy of sciences, the nuclear regulatory commission, the nuclear waste policy act and the U.S. environmental protection agency different views concerning the nuclear waste disposal are indicated. Then, the author answers to the questions : can risk or responsibility for essential action be imposed (on future generations) when the benefits are perceived to be incurred by others ( the current generations) and if so under what conditions? do current generations have the right to make decisions today which would foreclose options of future generations? and gives the legal, administrative and financial procedures taken for the long-term management of radioactive wastes. (O.L.)

Regulatory criteria for the disposal of radioactive wastes

International Nuclear Information System (INIS)

Wagstaff, K.P.

1986-09-01

Radiological protection criteria have been proposed by the Atomic Energy Control Board for judging the potential long-term impacts of radioactive waste disposal options in which the wastes are contained and isolated from the human environment. This paper reviews the proposed criteria and the regulatory guidelines for their application in performance assessments, taking note of the public comments received to-date

Sustainability, natural and organic cosmetics: consumer, products, efficacy, toxicological and regulatory considerations

Directory of Open Access Journals (Sweden)

Bruno Fonseca-Santos

2015-03-01

Full Text Available The interest in sustainable products has increased along the years, since the choice of products, packaging and production processes have a great impact on the environment. These products are classified by regulatory agencies in different categories, aggregating advantages to the product and increasing the demand by consumers. However, there is no harmonization in guidelines of these certifying agencies and each cosmetic industry formulates their product and packaging in a more rational way, which causes less damage to the environment. Many cosmetic products have in their formulation natural products that perform a specific biological function, but these products should be evaluated on efficacy and toxicological aspects. The aim of this article is to approach sustainability, natural and organic cosmetics, considering the consumer and the efficacy, toxicological and regulatory aspects.

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

Energy Technology Data Exchange (ETDEWEB)

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

2015-06-01

In this report, we will present a descriptive and organizational framework for incremental and fundamental changes to regulatory and utility business models in the context of clean energy public policy goals. We will also discuss the regulated utility's role in providing value-added services that relate to distributed energy resources, identify the "openness" of customer information and utility networks necessary to facilitate change, and discuss the relative risks, and the shifting of risks, for utilities and customers.

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

Science.gov (United States)

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

2015-07-15

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

Impact of regulatory science on global public health

Directory of Open Access Journals (Sweden)

Meghal Patel

2012-07-01

Full Text Available Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies.

Impact of regulatory science on global public health.

Science.gov (United States)

Patel, Meghal; Miller, Margaret Ann

2012-07-01

Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies. Copyright © 2012. Published by Elsevier B.V.

Evolution of context dependent regulation by expansion of feast/famine regulatory proteins.

Science.gov (United States)

Plaisier, Christopher L; Lo, Fang-Yin; Ashworth, Justin; Brooks, Aaron N; Beer, Karlyn D; Kaur, Amardeep; Pan, Min; Reiss, David J; Facciotti, Marc T; Baliga, Nitin S

2014-11-14

Expansion of transcription factors is believed to have played a crucial role in evolution of all organisms by enabling them to deal with dynamic environments and colonize new environments. We investigated how the expansion of the Feast/Famine Regulatory Protein (FFRP) or Lrp-like proteins into an eight-member family in Halobacterium salinarum NRC-1 has aided in niche-adaptation of this archaeon to a complex and dynamically changing hypersaline environment. We mapped genome-wide binding locations for all eight FFRPs, investigated their preference for binding different effector molecules, and identified the contexts in which they act by analyzing transcriptional responses across 35 growth conditions that mimic different environmental and nutritional conditions this organism is likely to encounter in the wild. Integrative analysis of these data constructed an FFRP regulatory network with conditionally active states that reveal how interrelated variations in DNA-binding domains, effector-molecule preferences, and binding sites in target gene promoters have tuned the functions of each FFRP to the environments in which they act. We demonstrate how conditional regulation of similar genes by two FFRPs, AsnC (an activator) and VNG1237C (a repressor), have striking environment-specific fitness consequences for oxidative stress management and growth, respectively. This study provides a systems perspective into the evolutionary process by which gene duplication within a transcription factor family contributes to environment-specific adaptation of an organism.

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

Science.gov (United States)

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

2010-01-01

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

Impact of radioactivity on the environment: problems, state of current knowledge and approaches for identification of radioprotection criteria

International Nuclear Information System (INIS)

Brechignac, F.

2001-01-01

There is currently a revitalized concern about the potential impact of ionizing radiation on the environment that calls for the construction of a system ensuring an adequate radioprotection of the non-human biota and their associated biotopes. This paper first sets the context of the problem both, with respect to the general philosophy of environmental protection as a whole, but also with respect to the consideration of the environment achieved so far in the purpose of human radioprotection. The current accumulated knowledge on the effects of ionizing radiation to biota (fauna and flora) is then briefly reviewed, encompassing effects at individual and community/ecosystem level, situations of acute and chronic exposure to high and low doses, finally leading to the identification of the most critical gaps in scientific knowledge: effects of mixed low dose rates in chronic exposure to communities and ecosystems. The most significant current international efforts towards the identification of environmental radioprotection criteria and standards are finally presented along with some relevant national examples. (author)

Plastics, the environment and human health: current consensus and future trends.

Science.gov (United States)

Thompson, Richard C; Moore, Charles J; vom Saal, Frederick S; Swan, Shanna H

2009-07-27

Plastics have transformed everyday life; usage is increasing and annual production is likely to exceed 300 million tonnes by 2010. In this concluding paper to the Theme Issue on Plastics, the Environment and Human Health, we synthesize current understanding of the benefits and concerns surrounding the use of plastics and look to future priorities, challenges and opportunities. It is evident that plastics bring many societal benefits and offer future technological and medical advances. However, concerns about usage and disposal are diverse and include accumulation of waste in landfills and in natural habitats, physical problems for wildlife resulting from ingestion or entanglement in plastic, the leaching of chemicals from plastic products and the potential for plastics to transfer chemicals to wildlife and humans. However, perhaps the most important overriding concern, which is implicit throughout this volume, is that our current usage is not sustainable. Around 4 per cent of world oil production is used as a feedstock to make plastics and a similar amount is used as energy in the process. Yet over a third of current production is used to make items of packaging, which are then rapidly discarded. Given our declining reserves of fossil fuels, and finite capacity for disposal of waste to landfill, this linear use of hydrocarbons, via packaging and other short-lived applications of plastic, is simply not sustainable. There are solutions, including material reduction, design for end-of-life recyclability, increased recycling capacity, development of bio-based feedstocks, strategies to reduce littering, the application of green chemistry life-cycle analyses and revised risk assessment approaches. Such measures will be most effective through the combined actions of the public, industry, scientists and policymakers. There is some urgency, as the quantity of plastics produced in the first 10 years of the current century is likely to approach the quantity produced in the

Plastics, the environment and human health: current consensus and future trends

Science.gov (United States)

Thompson, Richard C.; Moore, Charles J.; vom Saal, Frederick S.; Swan, Shanna H.

2009-01-01

Plastics have transformed everyday life; usage is increasing and annual production is likely to exceed 300 million tonnes by 2010. In this concluding paper to the Theme Issue on Plastics, the Environment and Human Health, we synthesize current understanding of the benefits and concerns surrounding the use of plastics and look to future priorities, challenges and opportunities. It is evident that plastics bring many societal benefits and offer future technological and medical advances. However, concerns about usage and disposal are diverse and include accumulation of waste in landfills and in natural habitats, physical problems for wildlife resulting from ingestion or entanglement in plastic, the leaching of chemicals from plastic products and the potential for plastics to transfer chemicals to wildlife and humans. However, perhaps the most important overriding concern, which is implicit throughout this volume, is that our current usage is not sustainable. Around 4 per cent of world oil production is used as a feedstock to make plastics and a similar amount is used as energy in the process. Yet over a third of current production is used to make items of packaging, which are then rapidly discarded. Given our declining reserves of fossil fuels, and finite capacity for disposal of waste to landfill, this linear use of hydrocarbons, via packaging and other short-lived applications of plastic, is simply not sustainable. There are solutions, including material reduction, design for end-of-life recyclability, increased recycling capacity, development of bio-based feedstocks, strategies to reduce littering, the application of green chemistry life-cycle analyses and revised risk assessment approaches. Such measures will be most effective through the combined actions of the public, industry, scientists and policymakers. There is some urgency, as the quantity of plastics produced in the first 10 years of the current century is likely to approach the quantity produced in the

Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

Science.gov (United States)

Fregni, F; Nitsche, MA; Loo, C.K.; Brunoni, AR; Marangolo, P; Leite, J; Carvalho, S; Bolognini, N; Caumo, W; Paik, NJ; Simis, M; Ueda, K; Ekhitari, H; Luu, P; Tucker, DM; Tyler, WJ; Brunelin, J; Datta, A; Juan, CH; Venkatasubramanian, G; Boggio, PS; Bikson, M

2014-01-01

The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. PMID:25983531

Monitoring of radioactivity in the UK environment. An annotated bibliography of current programmes

International Nuclear Information System (INIS)

2001-01-01

With the continuing use of radioactive materials in industry, research and medicine, the public's awareness about the potential impact on human health and safety of any enhanced levels of radiation in the environment has heightened. All those involved recognise this concern and there has developed over the years a network of comprehensive monitoring systems designed to determine the levels of radiation to which members of the public are exposed. In the UK, many organisations carry out regular radioactivity monitoring programmes, and summaries of these programmes have been published in 1983, 1988 and 1992. The number of organisations carrying out monitoring, particularly in the local authority sector, increased rapidly following the Chernobyl incident in 1986 and later levelled off. This report updates those previous summaries, giving synopses of regular UK programmes whose results are published in report form, and of which the Department of the Environment, Transport and the Regions is currently aware

Codes and standards and other guidance cited in regulatory documents. Revision 1

International Nuclear Information System (INIS)

Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R.

1994-08-01

As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. 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, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800)

Codes and standards and other guidance cited in regulatory documents. Revision 1

Energy Technology Data Exchange (ETDEWEB)

Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R. [Pacific Northwest Lab., Richland, WA (United States)

1994-08-01

As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. 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, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800).

Regulatory Roles for Long ncRNA and mRNA

International Nuclear Information System (INIS)

Karapetyan, Armen R.; Buiting, Coen; Kuiper, Renske A.; Coolen, Marcel W.

2013-01-01

Recent advances in high-throughput sequencing technology have identified the transcription of a much larger portion of the genome than previously anticipated. Especially in the context of cancer it has become clear that aberrant transcription of both protein-coding and long non-coding RNAs (lncRNAs) are frequent events. The current dogma of RNA function describes mRNA to be responsible for the synthesis of proteins, whereas non-coding RNA can have regulatory or epigenetic functions. However, this distinction between protein coding and regulatory ability of transcripts may not be that strict. Here, we review the increasing body of evidence for the existence of multifunctional RNAs that have both protein-coding and trans-regulatory roles. Moreover, we demonstrate that coding transcripts bind to components of the Polycomb Repressor Complex 2 (PRC2) with similar affinities as non-coding transcripts, revealing potential epigenetic regulation by mRNAs. We hypothesize that studies on the regulatory ability of disease-associated mRNAs will form an important new field of research

Regulatory Roles for Long ncRNA and mRNA

Energy Technology Data Exchange (ETDEWEB)

Karapetyan, Armen R.; Buiting, Coen; Kuiper, Renske A.; Coolen, Marcel W., E-mail: M.Coolen@gen.umcn.nl [Department of Human Genetics, Nijmegen Centre for Molecular Life Sciences (NCMLS), Radboud University Nijmegen Medical Centre, P.O. Box 9101, Nijmegen 6500 HB (Netherlands)

2013-04-26

Recent advances in high-throughput sequencing technology have identified the transcription of a much larger portion of the genome than previously anticipated. Especially in the context of cancer it has become clear that aberrant transcription of both protein-coding and long non-coding RNAs (lncRNAs) are frequent events. The current dogma of RNA function describes mRNA to be responsible for the synthesis of proteins, whereas non-coding RNA can have regulatory or epigenetic functions. However, this distinction between protein coding and regulatory ability of transcripts may not be that strict. Here, we review the increasing body of evidence for the existence of multifunctional RNAs that have both protein-coding and trans-regulatory roles. Moreover, we demonstrate that coding transcripts bind to components of the Polycomb Repressor Complex 2 (PRC2) with similar affinities as non-coding transcripts, revealing potential epigenetic regulation by mRNAs. We hypothesize that studies on the regulatory ability of disease-associated mRNAs will form an important new field of research.

Current issues and strategies for transmission planning

Energy Technology Data Exchange (ETDEWEB)

Isaacs, A.L. [Electranix, Winnipeg, MB (Canada); Rajapakse, A. [Manitoba Univ., Winnipeg, MB (Canada)

2008-07-01

Following the widespread deregulation of the electric power industry in the early 1990s, significant changes occurred in the regulatory and planning environments of the industry. Several regions of North America remain fully or partially regulated in the traditional sense including most Canadian provinces, except for Alberta and Ontario. Although the Mexican system has separate generation and transmission companies and current restructuring efforts are underway, all companies are state-owned, and private investment in energy is heavily constrained by the Mexican constitution. In these regulated regions, traditional generation and transmission expansion planning methods remain in use. This paper presented an overview of current trends in transmission planning strategies that have evolved in response to the restructuring of the power industry, and a conceptual framework of a procedure that would guide planners faced with the challenges of incorporating large scale wind generation in deregulated environments. The paper provided background information on the effect of deregulation on transmission planning. Planning strategies that were discussed included quantifying risk to help identify best alternatives; use of reference systems to estimate generator costs and reduce uncertainty; project based transmission expansion; transmission construction ahead of generation; and generation ahead of transmission. The impact of wind on transmission planning as well as future work addressing challenges posed by wind were also addressed. Research is continuing in this area to illustrate the concepts proposed through a detailed case study. 15 refs., 2 figs.

Advancing towards commonsense regulation of mixed waste: Regulatory update

International Nuclear Information System (INIS)

Porter, C.L.

1996-01-01

The author previously presented the basis for regulating mixed waste according to the primary hazard (either chemical or radiological) in order to avoid the inefficient practice of open-quotes dual regulationclose quotes of mixed waste. In addition to covering the technical basis, recommendations were made on how to capitalize upon a window of opportunity for implementation of a open-quotes primary hazards approachclose quotes. Some of those recommendations have been pursued and the resulting advances on the regulatory front are exciting. This paper chronicles those pursuits, presents in capsule form the massive amount of data assembled, and summarizes the changing regulatory framework. The data supports the premise that disposal of stabilized mixed waste in a low-level radioactive waste (LLW) disposal facility is protective of human health and the environment. Based on that premise, proposed regulatory changes, if finalized, will eliminate much of the open-quotes dual regulationclose quotes of mixed waste

Swine brucellosis: current perspectives

Directory of Open Access Journals (Sweden)

Olsen SC

2016-12-01

Full Text Available SC Olsen, FM Tatum Infectious Bacterial Diseases of Livestock Research Unit, National Animal Disease Center, Agricultural Research Service, United States Department of Agriculture, Ames, IA, USA Abstract: Brucella suis is a significant zoonotic species that is present in domestic livestock and wildlife in many countries worldwide. Transmission from animal reservoirs is the source of human infection as human-to-human transmission is very rare. Although swine brucellosis causes economic losses in domestic livestock, preventing human infection is the primary reason for its emphasis in disease control programs. Although disease prevalence varies worldwide, in areas outside of Europe, swine brucellosis is predominantly caused by B. suis biovars 1 and 3. In Europe, swine are predominantly infected with biovar 2 which is much less pathogenic in humans. In many areas worldwide, feral or wild populations of swine are important reservoir hosts. Like other Brucella spp. in their natural host, B. suis has developed mechanisms to survive in an intracellular environment and evade immune detection. Limitations in sensitivity and specificity of current diagnostics require use at a herd level, rather for individual animals. There is currently no commercial vaccine approved for preventing brucellosis in swine. Although not feasible in all situations, whole-herd depopulation is the most effective regulatory mechanism to control swine brucellosis. Keywords: livestock, transmission, pathogenicity, vaccine, host, infection

Carbon trading: Current schemes and future developments

International Nuclear Information System (INIS)

Perdan, Slobodan; Azapagic, Adisa

2011-01-01

This paper looks at the greenhouse gas (GHG) emissions trading schemes and examines the prospects of carbon trading. The first part of the paper gives an overview of several mandatory GHG trading schemes around the world. The second part focuses on the future trends in carbon trading. It argues that the emergence of new schemes, a gradual enlargement of the current ones, and willingness to link existing and planned schemes seem to point towards geographical, temporal and sectoral expansion of emissions trading. However, such expansion would need to overcome some considerable technical and non-technical obstacles. Linking of the current and emerging trading schemes requires not only considerable technical fixes and harmonisation of different trading systems, but also necessitates clear regulatory and policy signals, continuing political support and a more stable economic environment. Currently, the latter factors are missing. The global economic turmoil and its repercussions for the carbon market, a lack of the international deal on climate change defining the Post-Kyoto commitments, and unfavourable policy shifts in some countries, cast serious doubts on the expansion of emissions trading and indicate that carbon trading enters an uncertain period. - Highlights: → The paper provides an extensive overview of mandatory emissions trading schemes around the world. → Geographical, temporal and sectoral expansion of emissions trading are identified as future trends. → The expansion requires considerable technical fixes and harmonisation of different trading systems. → Clear policy signals, political support and a stable economic environment are needed for the expansion. → A lack of the post-Kyoto commitments and unfavourable policy shifts indicate an uncertain future for carbon trading.

Bioattractors: dynamical systems theory and the evolution of regulatory processes

Science.gov (United States)

Jaeger, Johannes; Monk, Nick

2014-01-01

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

Regulatory uncertainty and the associated business risk for emerging technologies

International Nuclear Information System (INIS)

Hoerr, Robert A.

2011-01-01

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

Regulatory uncertainty and the associated business risk for emerging technologies

Science.gov (United States)

Hoerr, Robert A.

2011-04-01

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

Optical Estimation of Depth and Current in a Ebb Tidal Delta Environment

Science.gov (United States)

Holman, R. A.; Stanley, J.

2012-12-01

A key limitation to our ability to make nearshore environmental predictions is the difficulty of obtaining up-to-date bathymetry measurements at a reasonable cost and frequency. Due to the high cost and complex logistics of in-situ methods, research into remote sensing approaches has been steady and has finally yielded fairly robust methods like the cBathy algorithm for optical Argus data that show good performance on simple barred beach profiles and near immunity to noise and signal problems. In May, 2012, data were collected in a more complex ebb tidal delta environment during the RIVET field experiment at New River Inlet, NC. The presence of strong reversing tidal currents led to significant errors in cBathy depths that were phase-locked to the tide. In this paper we will test methods for the robust estimation of both depths and vector currents in a tidal delta domain. In contrast to previous Fourier methods, wavenumber estimation in cBathy can be done on small enough scales to resolve interesting nearshore features.

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

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.

Nuclear Regulatory Authority Act, 2015 (Act 895)

International Nuclear Information System (INIS)

2015-04-01

An Act to establish a Nuclear Regulatory Authority in Ghana. This Act provides for the regulation and management of activities and practices for the peaceful use of nuclear material or energy, and to provide for the protection of persons and the environment against the harmful effects of radiation; and to ensure the effective implementation of the country’s international obligations and for related matters. This Act replaced the Radiation Protection Instrument, of 1993 (LI 1559).

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

Energy Technology Data Exchange (ETDEWEB)

Ben Grunewald; Paul Jehn; Tom Gillespie; Ben Binder

2004-12-21

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

Regulatory Technology Development Plan - Sodium Fast Reactor. Mechanistic Source Term - Trial Calculation. Work Plan

International Nuclear Information System (INIS)

Grabaskas, David; Bucknor, Matthew; Jerden, James; Brunett, Acacia J.

2016-01-01

The overall objective of the SFR Regulatory Technology Development Plan (RTDP) effort is to identify and address potential impediments to the SFR regulatory licensing process. In FY14, an analysis by Argonne identified the development of an SFR-specific MST methodology as an existing licensing gap with high regulatory importance and a potentially long lead-time to closure. This work was followed by an initial examination of the current state-of-knowledge regarding SFR source term development (ANLART-3), which reported several potential gaps. Among these were the potential inadequacies of current computational tools to properly model and assess the transport and retention of radionuclides during a metal fuel pool-type SFR core damage incident. The objective of the current work is to determine the adequacy of existing computational tools, and the associated knowledge database, for the calculation of an SFR MST. To accomplish this task, a trial MST calculation will be performed using available computational tools to establish their limitations with regard to relevant radionuclide release/retention/transport phenomena. The application of existing modeling tools will provide a definitive test to assess their suitability for an SFR MST calculation, while also identifying potential gaps in the current knowledge base and providing insight into open issues regarding regulatory criteria/requirements. The findings of this analysis will assist in determining future research and development needs.

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

Science.gov (United States)

Johnston, John D; Feldschreiber, Peter

2014-03-01

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

Computational challenges in modeling gene regulatory events.

Science.gov (United States)

Pataskar, Abhijeet; Tiwari, Vijay K

2016-10-19

Cellular transcriptional programs driven by genetic and epigenetic mechanisms could be better understood by integrating "omics" data and subsequently modeling the gene-regulatory events. Toward this end, computational biology should keep pace with evolving experimental procedures and data availability. This article gives an exemplified account of the current computational challenges in molecular biology.

Clinical potential of regulatory T cell therapy in liver diseases: An overview and current perspectives

Directory of Open Access Journals (Sweden)

Hannah Claire Jeffery

2016-09-01

Full Text Available The increasing demand for liver transplantation and the decline in donor organs has highlighted the need for alternative novel therapies to prevent chronic active hepatitis, which eventually leads to liver cirrhosis and liver cancer. Liver histology of chronic hepatitis is composed of both effector and regulatory lymphocytes. The human liver contains different subsets of effector lymphocytes, that are kept in check by a subpopulation of T cells known as Regulatory T cells (Treg. The balance of effector and regulatory lymphocytes generally determines the outcome of hepatic inflammation: resolution, fulminant hepatitis or chronic active hepatitis. Thus, maintaining and adjusting this balance is crucial in immunological manipulation of liver diseases. One of the options to restore this balance is to enrich Treg in the liver disease patients.Advances in the knowledge of Treg biology and development of clinical grade isolation reagents, cell sorting equipment and Good Manufacturing Practice (GMP facilities have paved the way to apply Treg cells as a potential therapy to restore peripheral self-tolerance in autoimmune liver diseases, chronic rejection and post-transplantation. Past and on-going studies have applied Treg in type-1 diabetes mellitus, systemic lupus erythematosus, graft versus host diseases (GVHD and solid organ transplantations. There have not been any new therapies for the autoimmune liver diseases for more than three decades; thus the clinical potential for the application of autologous Treg cell therapy to treat autoimmune liver disease is an attractive and novel option. However, it is fundamental to understand the deep immunology, genetic profiles, biology, homing behavior and microenvironment of Treg before applying the cells to the patients.

Adolescent threat-related interpretive bias and its modification: the moderating role of regulatory control

NARCIS (Netherlands)

Salemink, E.; Wiers, R.W.

2012-01-01

Dual process models describe psychopathology as the consequence of an imbalance between a fast, impulsive system and a regulatory control system and have recently been applied to anxiety disorders. The aim of the current study was to specifically examine the role of a regulatory control system in

75 FR 73946 - Worker Safety and Health Program: Safety Conscious Work Environment

Science.gov (United States)

2010-11-30

... Environment AGENCY: Office of the General Counsel, Department of Energy (DOE). ACTION: Notice of denial of... Nuclear Regulatory Commission's ``Safety-Conscious Work Environment'' guidelines as a model. DOE published.... Second, not only would instituting a ``Safety-Conscious Work Environment'' by regulation be redundant...

Resilient Prosumer Scenario in a Changing Regulatory Environment—The UniRCon Solution

Directory of Open Access Journals (Sweden)

Mihai Sanduleac

2017-11-01

Full Text Available Technological developments are pushing for new solutions based upon massive integration of renewable electricity generation in networks already facing many challenges. This paper presents a novel approach to managing the energy transfer towards prosumers making use of smart management of local energy storage. The proposed design (including storage dimensioning is based on several operating scenarios in which the prosumer might operate as: (i a “load only” entity (from a grid perspective, thus exhibiting investment resiliency against regulatory changes and high energy efficiency; or (ii a prosumer, in case regulatory opportunistic profit might be available. This can be realized within a newly proposed Uni-directional Resilient Consumer (UniRCon architecture. The major aim of the proposed architecture is to achieve optimal self-consumption while avoiding curtailment even in a changing regulatory environment like, for example, the total lack of incentives for generation based on renewable energy sources (RES. One of the major advantages of the proposed architecture consists in the adaptability to changes in the regulatory and market environment. The term resilience is used with multiple meanings: (a the prosumer’s financial resilience against regulatory changes when investment calculations assume no-grid injections; (b the prosumer’s technical resilience, with electrical design based on standalone operation; (c the resilience of clusters of interconnected end-user installations with enabled community-level electricity exchange, independent of the existing main grid supply; (d the contribution to grid resilience, by enabling AC microgrid (MG operation in island mode when large portions of the grid are formed by clusters of UniRCon prosumers (the ease of islanding segmentation of the local grid in case of emergencies. For proof of concept, three use-cases are detailed: (i photovoltaic (PV installations connected behind the meter; (ii PV and

THE FORMATION OF INSTITUTIONAL ENVIRONMENT OF AGRICULTURAL LAND CONSOLIDATION IN UKRAINE

Directory of Open Access Journals (Sweden)

Andriy Popov

2015-11-01

Full Text Available Every theory requires an application tool. Land consolidation is the multidisciplinary tool for sustainable rural development with its dynamic structure that gives possibilities getting the best solutions for land management decision. That is why the main purpose of the article is a theoretical study and development of scientific and practical recommendations concerning the formation of institutional environment of agricultural land consolidation in Ukraine. The subject of study is the formation of agricultural land consolidation. Methodology. The study used the following methods: dialectical, logical and abstract, system analysis (theoretical and methodological generalizations, defining the essence of the content of institutional environment of agricultural land consolidation. This paper identifies the role of the institutions in economic development and characterised the regulatory, procedural, distributive, informational, development and accumulation functions of agricultural land consolidation institution. As a novelty items offered and provided the detailed description of the main components of the institutional environment of agricultural land consolidation such as: traditional and mental, legal, causal, organizational and structural, and procedural. The essence of institutions of each of these components and their meaning and relationships are presented. Theoretically investigated that the formation of institutional mechanism of consolidation should be a symbiosis of both traditional and market institutions based on democratic principles under community participation. The article focuses on the feasibility of the formation of mechanism for monitoring the effectiveness of institutions. As the result of the study the author proposed to consider the institutional environment of agricultural land consolidation as a regulatory system harmonizing relations of the agricultural production, social and natural resources, designed to optimize the

Ergonomics in the office environment

Science.gov (United States)

Courtney, Theodore K.

1993-01-01

Perhaps the four most popular 'ergonomic' office culprits are: (1) the computer or visual display terminal (VDT); (2) the office chair; (3) the workstation; and (4) other automated equipment such as the facsimile machine, photocopier, etc. Among the ergonomics issues in the office environment are visual fatigue, musculoskeletal disorders, and radiation/electromagnetic (VLF,ELF) field exposure from VDT's. We address each of these in turn and then review some regulatory considerations regarding such stressors in the office and general industrial environment.

78 FR 55339 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Capital Adequacy...

Science.gov (United States)

2013-09-10

... countercyclical capital buffer was designed to take into account the macro-financial environment in which large... ability to raise capital to meet the increased minimum requirements in the current environment and upon...

Lessons learnt from stakeholder engagement in the UK Environment Agency

International Nuclear Information System (INIS)

Chandler, Steve

2004-01-01

The Environment Agency has many reasons and occasions for engaging with stakeholders and does so very frequently. Many of these are relatively formal, often statutory, consultations which are part of the determination of regulatory permits. Other consultations are part of the Agency's role as developer, for example in the construction of flood defence schemes. The Agency also consults nationally on its significant policies, such as the stocking of salmon fisheries. This paper gives some examples of lessons learnt from the Agency's own stakeholder engagements and also from our participation in those led by other organizations. In the next section it also describes the Agency's current approach to stakeholder consultation and engagement. (author)

Current means for plasma diagnostics and their application for materials and environment control. Materials of IV Russian seminar

International Nuclear Information System (INIS)

2003-01-01

The collection contains reports made at the Fourth Russian seminar Current means of plasma diagnostics and their application for materials and environment control. The seminar took place in Moscow, November 12-14, 2003. The content of the collection covers both questions of plasma diagnostics in thermonuclear reactors and problems of diagnostics of pulsed and stationary gas discharges in research and technological installations. The reports on plasma diagnostics applied for some tasks of medicine and environment control are presented [ru

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

OpenAIRE

Kerber, Wolfgang; Wendel, Julia

2016-01-01

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

Field intercomparison of three current meters in an environment free from high frequency motion

Science.gov (United States)

Larouche, Pierre; Deguise, Jean-Claude

1989-06-01

An intercomparison of three different types of current meter was performed in an Arctic environment where wave action was absent, permitting the evaluation of the instruments under natural conditions of weak currents and cold water. The instruments were an Aanderaa RCMS4S, an Inter Ocean S4 and an EG&G-Neil Brown Smart Acoustic Current Meter (SACM). The S4 and the SACM both showed their ability to measure very small currents as opposed to the RCM4S which is limited by a mechanical rotor threshold. The agreement of the direction was better between the RCM4S and the SACM than between the RCM4S and the S4. Due to the misalignment of the Aanderaa vane in very weak currents, direction differences between the instruments of either pair can, however, reach 180°. The misalignment also shields the Aanderaa rotor leading to underestimation of current speed. The threshold for a good speed reading for the Aanderaa can be put conservatively at 5 cm s -1. Above this value, the RCM4S over-responded compared to both the S4 and the SACM. The source of that problem seems to be related to different calibrations of the instruments. Finally a power spectrum analysis showed that the RCM4S, when not influenced by wave action, can produce a measure of the energy as good as that of a vector averaging instrument.

Argentina's regulatory body: its communication activities

International Nuclear Information System (INIS)

Cesario, Pablo A.; Terigi, Gabriel E.

2008-01-01

Full text: The Nuclear Regulatory Authority of Argentina (ARN) is empowered to regulate and control the nuclear activity with regard to radiation and nuclear safety, physical protection and nuclear non-proliferation issues. It must also advise the Executive on issues under its purview. The objective of the Nuclear Regulatory Authority is to establish, develop and enforce a regulatory system applicable to all nuclear activities carried out in Argentina. Two of the goals of this regulatory system are to provide an appropriate standard of protection for individuals against the harmful effects of ionizing radiation, and to maintain a reasonable degree of radiological and nuclear safety in the nuclear activities performed in Argentina. The responsibility of the radiation protection community in performing the tasks to accomplish this goals is twofold. On one hand, it must ensure a high technical quality in performing these functions. It must also provide information on its activities which has to be accurate, comprehensive and understandable. The way a society understands the concept of 'risk' needs to be kept in mind. Risk perception is the subjective judgment that people make about the characteristics and severity of a risk. Cultural theory refers to theories of risk perception that focus on culture, rather than individual psychology as an explanation for differences in risk judgments. It is widely agreed that trust is a key factor in influencing people's perceptions of risk. It is understood there are two main ways trust may impact in risk perceptions: an activity is perceived as more risky if the people or agencies managing it are perceived as untrustworthy; and information presented by trusted sources is given more credibility than information from untrusted sources. One of the primary purposes of ARN's Communication Program is to provide a means whereby those engaged in radiation protection activities may communicate more readily with each other and the public and

Deposition and interception of radionuclides. Current knowledge and future requirements

International Nuclear Information System (INIS)

1998-12-01

Following an accidental or routine release of radionuclides into the environment, a good knowledge of deposition processes is necessary in order to accurately predict the radiation dose to members of the public. In order to understand the environmental impact of released radionuclides and their transfer through the environment, including the food chain to man, there have been numerous studies on deposition of radionuclides to a range of surfaces such as bare soil, crops, forests, water bodies and urban surfaces. The RADREM committee provides a forum for liaison on UK research and monitoring in the areas of radioactive substances and radioactive waste management. RADREM has set up four sub-committees to cover issues related to radioactivity in the atmospheric, terrestrial and aquatic environments as well as those related radioactive waste management. One of the sub-committee tasks is to organise seminars and workshops on specific topics of interest. The first of these was the workshop on 'Deposition and Interception of Radionuclides: Current knowledge and future requirements' organised last year by the Ministry of Agriculture, Fisheries and Food (MAFF), acting as secretariat for the Terrestrial Environment Sub-Committee (TESC) of RADREM. The intent of this workshop was to provide an opportunity to exchange information on deposition-related aspects between representatives from various interested parties including government, regulatory bodies, industry and research organisations. Through presentations and discussions, this workshop addressed current developments in the areas of deposition and interception of radionuclides by various surfaces and served to identify areas which need further research. Papers were presented on various aspects of deposition and interception of radionuclides including deposition into grass, fruits and other crops as well as deposition into urban areas and forests

An Evaluation of the Physical Environments of a Nuclear Power Plants for Human Factors Review in Periodic Safety Review

International Nuclear Information System (INIS)

Kim, Dae Ho; Lee, Yong Hee

2006-01-01

Currently, operation of a nuclear power plants(NPP) is highly emphasized by the integrity of the H/W and the human factors security, so the periodic safety review(PSR) is performed to NPP. The PSR activities on human factors include physical environments (illumination, noise, vibration, temperature and humidity etc). The review on these physical environments is to verify the possible affect to the human error during the operation of the man machine interface. Physical environments affect the health, job stress and job satisfaction of NPP's employees. On the ground of the reason, we need integrating the management program for the sufficient satisfaction of the regulatory basis and standards of physical environment and considering a health, a job stress and satisfaction of NPP's employees. So, this paper describes the planning of the setup procedures of physical environments and the adequate management program for the field applications in NPPs

An Evaluation of the Physical Environments of a Nuclear Power Plants for Human Factors Review in Periodic Safety Review

Energy Technology Data Exchange (ETDEWEB)

Kim, Dae Ho; Lee, Yong Hee [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

2006-07-01

Currently, operation of a nuclear power plants(NPP) is highly emphasized by the integrity of the H/W and the human factors security, so the periodic safety review(PSR) is performed to NPP. The PSR activities on human factors include physical environments (illumination, noise, vibration, temperature and humidity etc). The review on these physical environments is to verify the possible affect to the human error during the operation of the man machine interface. Physical environments affect the health, job stress and job satisfaction of NPP's employees. On the ground of the reason, we need integrating the management program for the sufficient satisfaction of the regulatory basis and standards of physical environment and considering a health, a job stress and satisfaction of NPP's employees. So, this paper describes the planning of the setup procedures of physical environments and the adequate management program for the field applications in NPPs.

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

International Nuclear Information System (INIS)

Bernero, R.M.

1992-01-01

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

Regulatory aspects of radiation protection in Indian nuclear plants

International Nuclear Information System (INIS)

Chander, Vipin; Pawar, S.K.; Duraisamy, S.

2012-01-01

Atomic Energy Act of 1962 covers the radiation safety aspects in the development, control and use of atomic energy. To carry out certain regulatory and safety functions under this act, Atomic Energy Regulatory Board (AERB) was constituted in November 15, 1983. Operating Nuclear Power Plants (NPPs) account for about 60% of occupational collective dose and about 65% of the number of radiation workers in the nuclear fuel cycle facilities. Therefore radiation protection aspects in NPPs are of prime importance. In 1970s and 1980s the high radiation exposures in NPPs was an issue with TAPS-1 and 2 reaching annual collective dose of 50 Person-Sv. In response to this, AERB constituted an expert committee to investigate the possibility of reducing collective doses in NPPs in 1988. Subsequently the recommendations of this committee were implemented in all NPPs. In 1990, International Commission on Radiological Protection (ICRP) recommended a downward revision of occupational dose limit to 20 mSv/yr from the earlier limit of 50 mSv/yr. Regulatory body endorsed these recommendations and gradually brought down the annual dose limits from 40 mSv in 1991 to 30 mSv in 1994 with the limit of 100 mSv averaged over a five year period in line with ICRP recommendations. Over the years, the regulatory body has put in place a sound regulatory frame work and mechanism to ensure adequate protection of occupational workers, members of public and environment due to operation of NPPs. Vast experiences in the field of radiation protection vis-à-vis stringent regulatory requirements such as review of exposure cases and special regulatory inspections during Biennial Shut Down (BSD) has helped in downward trends in occupational and public doses. This paper highlights the role of regulatory body in controlling the radiation doses to both occupational workers and members of public in the NPPs through a three-tier review system. The regulatory oversight, inspections and reviews has resulted in

Expanding the modeling capabilities of the cognitive environment simulation

International Nuclear Information System (INIS)

Roth, E.M.; Mumaw, R.J.; Pople, H.E. Jr.

1991-01-01

The Nuclear Regulatory Commission has been conducting a research program to develop more effective tools to model the cognitive activities that underlie intention formation during nuclear power plant (NPP) emergencies. Under this program an artificial intelligence (AI) computer simulation called Cognitive Environment Simulation (CES) has been developed. CES simulates the cognitive activities involved in responding to a NPP accident situation. It is intended to provide an analytic tool for predicting likely human responses, and the kinds of errors that can plausibly arise under different accident conditions to support human reliability analysis. Recently CES was extended to handle a class of interfacing loss of coolant accidents (ISLOCAs). This paper summarizes the results of these exercises and describes follow-on work currently underway

Safety culture as a matter of regulatory control and regulatory effectiveness

International Nuclear Information System (INIS)

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

2002-01-01

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

Meta-Analysis of Single-Case Design Research on Self-Regulatory Interventions for Academic Performance

Science.gov (United States)

Perry, Valerie; Albeg, Loren; Tung, Catherine

2012-01-01

The current study examined the effects of self-regulatory interventions on reading, writing, and math by conducting a meta-analysis of single-case design research. Self-regulatory interventions have promise as an effective approach that is both minimally invasive and involves minimal resources. Effects of the interventions were analyzed by…

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

CAFE: A Computer Tool for Accurate Simulation of the Regulatory Pool Fire Environment for Type B Packages

International Nuclear Information System (INIS)

Gritzo, L.A.; Koski, J.A.; Suo-Anttila, A.J.

1999-01-01

The Container Analysis Fire Environment computer code (CAFE) is intended to provide Type B package designers with an enhanced engulfing fire boundary condition when combined with the PATRAN/P-Thermal commercial code. Historically an engulfing fire boundary condition has been modeled as σT 4 where σ is the Stefan-Boltzman constant, and T is the fire temperature. The CAFE code includes the necessary chemistry, thermal radiation, and fluid mechanics to model an engulfing fire. Effects included are the local cooling of gases that form a protective boundary layer that reduces the incoming radiant heat flux to values lower than expected from a simple σT 4 model. In addition, the effect of object shape on mixing that may increase the local fire temperature is included. Both high and low temperature regions that depend upon the local availability of oxygen are also calculated. Thus the competing effects that can both increase and decrease the local values of radiant heat flux are included in a reamer that is not predictable a-priori. The CAFE package consists of a group of computer subroutines that can be linked to workstation-based thermal analysis codes in order to predict package performance during regulatory and other accident fire scenarios

Regulatory Roles for Long ncRNA and mRNA

Directory of Open Access Journals (Sweden)

Marcel W. Coolen

2013-04-01

Full Text Available Recent advances in high-throughput sequencing technology have identified the transcription of a much larger portion of the genome than previously anticipated. Especially in the context of cancer it has become clear that aberrant transcription of both protein-coding and long non-coding RNAs (lncRNAs are frequent events. The current dogma of RNA function describes mRNA to be responsible for the synthesis of proteins, whereas non-coding RNA can have regulatory or epigenetic functions. However, this distinction between protein coding and regulatory ability of transcripts may not be that strict. Here, we review the increasing body of evidence for the existence of multifunctional RNAs that have both protein-coding and trans-regulatory roles. Moreover, we demonstrate that coding transcripts bind to components of the Polycomb Repressor Complex 2 (PRC2 with similar affinities as non-coding transcripts, revealing potential epigenetic regulation by mRNAs. We hypothesize that studies on the regulatory ability of disease-associated mRNAs will form an important new field of research.

Introducing nuclear power into currently non-nuclear states

International Nuclear Information System (INIS)

Claassen, Gert

2007-01-01

As the nuclear renaissance gains momentum, many countries that currently have no nuclear power plants will begin to consider introducing them. It is anticipated that smaller reactors such as the Pebble Bed Modulator Reactor (PBMR) will not only be sold to current nuclear states to also to states where there is currently no nuclear experience. A range of issues would have to be considered for nuclear plants to be solid to non-nuclear states, such as the appropriate regulatory environment, standardization and codes, non-proliferation, security of supply, obtaining experienced merchant operators, appropriate financial structures and education and training. The paper considers nine major issues that need to be addressed by governments and vendors alike. International cooperation by organisations such as the IAEA, financial institutions and international suppliers will be required to ensure that developing countries as well as developed ones share the benefits of the nuclear renaissance. The opportunities that the nuclear industry affords to develop local skills, create job opportunities and to develop local manufacturing industries are among the important reasons that the South African Government has decided to support and fund the development of the Pebble Bed Modular Reactor project. These considerations are included in the paper. (author)

Regulatory experience in nuclear power station decommissioning

International Nuclear Information System (INIS)

Ross, W.M.; Waters, R.E.; Taylor, F.E.; Burrows, P.I.

1995-01-01

In the UK, decommissioning on a licensed nuclear site is regulated and controlled by HM Nuclear Installations Inspectorate on behalf of the Health and Safety Executive. The same legislative framework used for operating nuclear power stations is also applied to decommissioning activities and provides a continuous but flexible safety regime until there is no danger from ionising radiations. The regulatory strategy is discussed, taking into account Government policy and international guidance for decommissioning and the implications of the recent white paper reviewing radioactive waste management policy. Although each site is treated on a case by case basis as regulatory experience is gained from decommissioning commercial nuclear power stations in the UK, generic issues have been identified and current regulatory thinking on them is indicated. Overall it is concluded that decommissioning is an evolving process where dismantling and waste disposal should be carried out as soon as reasonably practicable. Waste stored on site should, where it is practical and cost effective, be in a state of passive safety. (Author)

E-learning tools for education: regulatory aspects, current applications in radiology and future prospects.

Science.gov (United States)

Pinto, A; Selvaggi, S; Sicignano, G; Vollono, E; Iervolino, L; Amato, F; Molinari, A; Grassi, R

2008-02-01

E-learning, an abbreviation of electronic learning, indicates the provision of education and training on the Internet or the World Wide Web. The impact of networks and the Internet on radiology is undoubtedly important, as it is for medicine as a whole. The Internet offers numerous advantages compared with other mass media: it provides access to a large amount of information previously known only to individual specialists; it is flexible, permitting the use of images or video; and it allows linking to Web sites on a specific subject, thus contributing to further expand knowledge. Our purpose is to illustrate the regulatory aspects (including Internet copyright laws), current radiological applications and future prospects of e-learning. Our experience with the installation of an e-learning platform is also presented. We performed a PubMed search on the published literature (without time limits) dealing with e-learning tools and applications in the health sector with specific reference to radiology. The search included all study types in the English language with the following key words: e-learning, education, teaching, online exam, radiology and radiologists. The Fiaso study was referred to for the regulatory aspects of e-learning. The application of e-learning to radiology requires the development of a model that involves selecting and creating e-learning platforms, creating and technologically adapting multimedia teaching modules, creating and managing a unified catalogue of teaching modules, planning training actions, defining training pathways and Continuing Education in Medicine (CME) credits, identifying levels of teaching and technological complexity of support tools, sharing an organisational and methodological model, training the trainers, operators' participation and relational devices, providing training, monitoring progress of the activities, and measuring the effectiveness of training. Since 2004, a platform--LiveLearning--has been used at our

Nanoparticulate materials and regulatory policy in Europe: An analysis of stakeholder perspectives

International Nuclear Information System (INIS)

Helland, Aasgeir; Kastenholz, Hans; Thidell, Aake; Arnfalk, Peter; Deppert, Knut

2006-01-01

The novel properties of nanoparticulate materials (NPM) and the rapid development of NPM based products have raised many unanswered questions and concerns by different stakeholders over its consequences for the environment and human health. These concerns have led to an increasing discussion in both the US and Europe about possible regulatory policies for NPM. In this article a comparative study of stakeholders' perceptions on regulatory policy issues with NPM in Europe is presented. It was found that industry wants to regulate this area if the scientific evidence demonstrates that NPM are harmful, but also that the regulatory bodies do not find it necessary at this point of time to regulate until scientific evidence demonstrates that NPM are harmful. This research therefore shows that there will most likely not be any regulatory interventions until there is an established and convincing scientific knowledge base demonstrating that NPM can be hazardous. It is furthermore discussed in this article the different roles and responsibilities of the stakeholders in financing the research required to establish the necessary level of fundamental scientific evidence. It was also found that the activity of the regulatory bodies on this issue differ between the European countries

Deciphering RNA regulatory elements in trypanosomatids: one piece at a time or genome-wide?

Science.gov (United States)

Gazestani, Vahid H; Lu, Zhiquan; Salavati, Reza

2014-05-01

Morphological and metabolic changes in the life cycle of Trypanosoma brucei are accomplished by precise regulation of hundreds of genes. In the absence of transcriptional control, RNA-binding proteins (RBPs) shape the structure of gene regulatory maps in this organism, but our knowledge about their target RNAs, binding sites, and mechanisms of action is far from complete. Although recent technological advances have revolutionized the RBP-based approaches, the main framework for the RNA regulatory element (RRE)-based approaches has not changed over the last two decades in T. brucei. In this Opinion, after highlighting the current challenges in RRE inference, we explain some genome-wide solutions that can significantly boost our current understanding about gene regulatory networks in T. brucei. Copyright © 2014 Elsevier Ltd. All rights reserved.

76 FR 21932 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

Science.gov (United States)

2011-04-19

... statement therein, as follows: I. Introduction On February 4, 2011, the Financial Industry Regulatory...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting Approval of a... Financial Industry Regulatory Authority, Inc. (``FINRA'') to amend Rule 13806 of the Code of Arbitration...

Bioremediation, regulatory agencies and public acceptance of this technology

International Nuclear Information System (INIS)

Westlake, D. W. S.

1997-01-01

The technology of bioremediation, i.e. the utilization of microorganisms to degrade environmental pollutants, the dangers and consequences inherent in the large-scale use of microbial organisms in such processes, and the role of regulatory agencies in the utilization and exploitation of bioremediation technologies, were discussed. Factors influencing public acceptance of bioremediation as a satisfactory tool for cleaning up the environment vis-a-vis other existing and potential rehabilitation techniques were also reviewed. The ambiguity of regulatory agencies in the matter of bioremediation was noted. For example, there are many regulatory hurdles relative to the testing, use and approval of transgenic microorganisms for use in bioremediation. On the other hand, the use and release of engineered plants is considered merely another form of hybrid and their endorsement is proceeding rapidly. With regard to public acceptance, the author considered bioremediation technology as too recent, with not enough successful applications to attract public attention. Although the evidence suggests that bioremediation is environmentally safe, the efficacy, reliability and predictability of the various technologies have yet to be demonstrated. 25 refs

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

Regulatory Assessment Technologies for Aging of Reactor Vessel Internals

Energy Technology Data Exchange (ETDEWEB)

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

2013-10-15

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

Computational modeling identifies key gene regulatory interactions underlying phenobarbital-mediated tumor promotion

Science.gov (United States)

Luisier, Raphaëlle; Unterberger, Elif B.; Goodman, Jay I.; Schwarz, Michael; Moggs, Jonathan; Terranova, Rémi; van Nimwegen, Erik

2014-01-01

Gene regulatory interactions underlying the early stages of non-genotoxic carcinogenesis are poorly understood. Here, we have identified key candidate regulators of phenobarbital (PB)-mediated mouse liver tumorigenesis, a well-characterized model of non-genotoxic carcinogenesis, by applying a new computational modeling approach to a comprehensive collection of in vivo gene expression studies. We have combined our previously developed motif activity response analysis (MARA), which models gene expression patterns in terms of computationally predicted transcription factor binding sites with singular value decomposition (SVD) of the inferred motif activities, to disentangle the roles that different transcriptional regulators play in specific biological pathways of tumor promotion. Furthermore, transgenic mouse models enabled us to identify which of these regulatory activities was downstream of constitutive androstane receptor and β-catenin signaling, both crucial components of PB-mediated liver tumorigenesis. We propose novel roles for E2F and ZFP161 in PB-mediated hepatocyte proliferation and suggest that PB-mediated suppression of ESR1 activity contributes to the development of a tumor-prone environment. Our study shows that combining MARA with SVD allows for automated identification of independent transcription regulatory programs within a complex in vivo tissue environment and provides novel mechanistic insights into PB-mediated hepatocarcinogenesis. PMID:24464994

Environmental protection and regulatory compliance at the Elk Hills field

International Nuclear Information System (INIS)

Chappelle, H.H.; Donahoe, R.L.; Kato, T.T.; Ordway, H.E.

1991-01-01

Environmental protection has played an integral role in the development and operation of the Elk Hills field since production at the maximum efficient rate was authorized in 1976. The field is located in a non-attainment area for California and National Ambient Air Quality Standards for two criteria pollutants and their associated precursors, is home to four endangered species, and operates within the California regulatory framework. Environmental protection and regulatory compliance is a multi-faceted program carried out through a substantial commitment of resources and workforce involvement. This paper describes the actions taken and resources employed to protect the environment, specific technologies and projects implemented, and the ongoing nature of these efforts at Elk Hills

Regulatory Myeloid Cells in Transplantation

Science.gov (United States)

Rosborough, Brian R.; Raïch-Regué, Dàlia; Turnquist, Heth R.; Thomson, Angus W.

2013-01-01

Regulatory myeloid cells (RMC) are emerging as novel targets for immunosuppressive (IS) agents and hold considerable promise as cellular therapeutic agents. Herein, we discuss the ability of regulatory macrophages (Mreg), regulatory dendritic cells (DCreg) and myeloid-derived suppressor cells (MDSC) to regulate alloimmunity, their potential as cellular therapeutic agents and the IS agents that target their function. We consider protocols for the generation of RMC and the selection of donor- or recipient-derived cells for adoptive cell therapy. Additionally, the issues of cell trafficking and antigen (Ag) specificity following RMC transfer are discussed. Improved understanding of the immunobiology of these cells has increased the possibility of moving RMC into the clinic to reduce the burden of current IS agents and promote Ag-specific tolerance. In the second half of this review, we discuss the influence of established and experimental IS agents on myeloid cell populations. IS agents believed historically to act primarily on T cell activation and proliferation are emerging as important regulators of RMC function. Better insights into the influence of IS agents on RMC will enhance our ability to develop cell therapy protocols to promote the function of these cells. Moreover, novel IS agents may be designed to target RMC in situ to promote Ag-specific immune regulation in transplantation and usher in a new era of immune modulation exploiting cells of myeloid origin. PMID:24092382

Application of best available science to the regulatory process

International Nuclear Information System (INIS)

Moghissi, A.A.

1991-01-01

The current grant is a continuation of a previous grant awarded to the Institute for Regulatory Science. In July, 1989, the functions of the Institute were transferred to the University of Maryland and the studies started at the Institute were continued at the University. The current grant started February 1, 1990. Therefore, much of the discussion in this progress report relies upon the grant funded at the Institute for Regulatory Science. This progress report covers the period from February 1, 1990 to January 31, 1991. The objective of the project is to assure that societal decisions are based on the best available science (BAS). A great deal of progress was made to establish relevant organizations for the development of consensus on relevant scientific information. During the next year, emphasis will be placed on Resource Conservation and Recovery Act (RCRA), particularly as related to its reauthorization and mixed waste

International news about radiation protection of the environment

International Nuclear Information System (INIS)

Beaugelin-Seiller, K.; Garnier-Laplace, J.

2016-01-01

The new European Basic Safety Standards in Radiation Protection (2013/59/Euratom) introduce 'environmental criteria' to protect human health in the long term. This innovation results from work in progress and from the recent positioning of international organizations and authorities in charge of radiation protection and its implementation, regarding the protection of wildlife against ionizing radiation. On the basis of the international state of the art, from the current regulatory context to existing approaches, the ERICA method has been identified as fully consistent with the ICRP approach and the most operational at the moment, due to its richness, flexibility and traceability. Most of the radiological risk assessments for wildlife published in the 5 last years used part or all of the ERICA approach, generally screening the radiological risk for wildlife from the first stage of the assessment, except for a few areas among those most impacted by radioactive contamination (Chernobyl area, uranium mining sites in Central Asia, etc.). This update of the knowledge in the field at the international level and the feedback on the analysis of regulatory files presented by nuclear operators led to 10 recommendations from the IRSN on the radiation protection of the environment and its implementation. (authors)

Nuclear Plant Modification in a Risk-Informed Environment

International Nuclear Information System (INIS)

Gallucci, Raymond H.V.

2002-01-01

This paper examines a specific nuclear power plant modification performed in a risk-informed regulatory environment. It quantifies both the permanent and temporary effects of the modification, and performs a cost-benefit evaluation. (authors)

Regulatory body core competencies: when should a regulator contract a TSO?

International Nuclear Information System (INIS)

Wieland, Patricia; Salati de Almeida, Ivan P.; Almeida, Claudio U.; Costa, Eduardo M.

2008-01-01

The main nuclear regulatory functions are authorization, safety review and assessment, inspection and enforcement and development of regulations and guides. Additionally, the following supplementary functions may be executed by the regulatory body: research and development, emergency response and international cooperation. In order to function properly, the regulatory body should also have the following support functions: general management, logistics, training, communication and information, information technology support, institutional relationship, internal controls and audits, ombudsman and legal support. Technical Support Organizations (TSOs) may assist the regulatory body in meeting the challenges in a rapid growing and changing environment. Specially when there is a temporary need for a wider technical expertise diversity, short time to finish a project or when the cost of developing and maintaining infrastructure of their own laboratories for analysis and research is too high and may deviate the focus on the regulator's mission. Decision on the 'size' of the regulatory body and on what can be contracted to a Technical Support Organization (TSO) depends on the resources and capabilities needed to fulfil the regulatory functions efficiently. It is important to establish the core competencies that must be at the regulatory body, keeping the focus on the regulatory goals and define the real need to contract a TSO, weighting the benefits and disadvantages. As a contribution to the definition of the regulatory core competencies, the paper discusses what is essential to be kept at the regulatory body and what can be delegated to a TSO; how to manage and control the work of the TSO; the cost effectiveness of contracting, sharing of tacit knowledge; how to handle eventual conflicts between the parties involved in the licensing process; contract types and risk evaluation, concerning the dependence on a TSO, eventual change of partners and the intellectual capital

Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

DEFF Research Database (Denmark)

Yacobi, Avraham; Shah, Vinod P; Bashaw, Edward D

2014-01-01

This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic...

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

Mapping cis-Regulatory Domains in the Human Genome UsingMulti-Species Conservation of Synteny

Energy Technology Data Exchange (ETDEWEB)

Ahituv, Nadav; Prabhakar, Shyam; Poulin, Francis; Rubin, EdwardM.; Couronne, Olivier

2005-06-13

Our inability to associate distant regulatory elements with the genes that they regulate has largely precluded their examination for sequence alterations contributing to human disease. One major obstacle is the large genomic space surrounding targeted genes in which such elements could potentially reside. In order to delineate gene regulatory boundaries we used whole-genome human-mouse-chicken (HMC) and human-mouse-frog (HMF) multiple alignments to compile conserved blocks of synteny (CBS), under the hypothesis that these blocks have been kept intact throughout evolution at least in part by the requirement of regulatory elements to stay linked to the genes that they regulate. A total of 2,116 and 1,942 CBS>200 kb were assembled for HMC and HMF respectively, encompassing 1.53 and 0.86 Gb of human sequence. To support the existence of complex long-range regulatory domains within these CBS we analyzed the prevalence and distribution of chromosomal aberrations leading to position effects (disruption of a genes regulatory environment), observing a clear bias not only for mapping onto CBS but also for longer CBS size. Our results provide a genome wide data set characterizing the regulatory domains of genes and the conserved regulatory elements within them.

Regulatory Office for Network Industries

International Nuclear Information System (INIS)

2005-01-01

The main goal of the economic regulation of network industries is to ensure a balance between the interests of consumers and investors and to encourage providing high-quality goods and services. The task of the regulatory authority is to protect the interests of consumers against monopolistic behaviour of regulated enterprises. At the same time, the regulatory office has to protect the interests of investors by giving them an opportunity to achieve an adequate return on their investments. And last, but not least, the regulatory office has to provide regulated enterprises with appropriate incentives to make them function in an efficient and effective manner and to guarantee the security of delivery of energies and related services. All this creates an efficient regulatory framework that is capable of attracting the required amount and type of investments. This also means providing third party access to the grids, the opening of energy markets, the un-bundling of accounts according to production, distribution, transmission and other activities and the establishment of a transparent and stable legislative environment for regulated companies, investors and consumers. Otherwise, in the long run consumers may suffer from a serious deterioration of service quality, although in the short run they are protected against increased prices. Under the Act No. 276/2001 Coll. on Regulation of Network Industries and on amendment of some acts the Office for Regulation of Network Industries has been commissioned to implement the main objectives of regulation of network industries. By network industries the Act No. 276/2001 Coll. on Regulation means the following areas: (a) Production, purchase, transit and distribution of electricity; (b) Production, purchase, transit and distribution of gas; (c) Production, purchase and distribution of heat; (d) Water management activities relating to the operation of the public water supply system or the public sewerage system; (e) Water management

Hiring and keeping qualified personnel in a growing regulatory organisation

International Nuclear Information System (INIS)

Marchildon, P.

1993-01-01

Although no new nuclear stations are currently committed in Canada, the regulatory authority, the Atomic Energy Control Board (AECB), has started, in 1989, an expansion program which, when completed in 1994 will represent a 60 pc increase in its workforce. The new personnel resources are being used to improve the AECB effectiveness in a number of regulatory activities. This paper reviews some of the key factors which relate to the hiring and integration of the new AECB employees: selection process, timing, fees, scholarship program, subsequent training of qualified personnel, woman quotas. 2 figs

Health claims on food products in Southeast Asia: regulatory frameworks, barriers, and opportunities.

Science.gov (United States)

Tan, Karin Y M; van der Beek, Eline M; Chan, M Y; Zhao, Xuejun; Stevenson, Leo

2015-09-01

The Association of Southeast Asian Nations aims to act as a single market and allow free movement of goods, services, and manpower. The purpose of this article is to present an overview of the current regulatory framework for health claims in Southeast Asia and to highlight the current barriers and opportunities in the regulatory frameworks in the Association of Southeast Asian Nations. To date, 5 countries in Southeast Asia, i.e., Indonesia, Malaysia, the Philippines, Singapore, and Thailand, have regulations and guidelines to permit the use of health claims on food products. There are inconsistencies in the regulations and the types of evidence required for health claim applications in these countries. A clear understanding of the regulatory frameworks in these countries may help to increase trade in this fast-growing region and to provide direction for the food industry and the regulatory community to develop and market food products with better nutritional quality tailored to the needs of Southeast Asian consumers. © The Author(s) 2015. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Regulatory aspects of fusion power-lessons from fission plants

International Nuclear Information System (INIS)

Natalizio, A.; Brunnader, H.; Sood, S.K.

1993-01-01

Experience from fission reactors has shown the regulatory process for licensing a nuclear facility to be legalistic, lengthy, unpredictable, and costly. This experience also indicates that much of the regulatory debate is focused on safety margins, that is, the smaller the safety margins the bigger the regulatory debate and the greater the amount of proof required to satisfy the regulatory. Such experience suggests that caution and prudence guide the development of a regulatory regime for fusion reactors. Fusion has intrinsic safety and environmental advantages over fission, which should alleviate significantly, or even eliminate, the regulatory problems associated with fission. The absence of a criticality concern and the absence of fission products preclude a Chernobyl type accident from occurring in a fusion reactor. Although in a fusion reactor there are large inventories of radioactive products that can be mobilized, the total quantity is orders of magnitude smaller than in fission power reactors. The bulk of the radioactivity in a fusion reactor is either activation products in steel structures, or tritium fuel supplies safely stored in the form of a metal tritide in storage beds. The quantity of tritium that can be mobilized under accident conditions is much less than ten million curies. This compares very favorably with a fission product inventory greater than ten billion curies in a fission power reactor. Furthermore, in a fission reactor, all of the reactivity is contained in a steel vessel that is pressurized to about 150 atmospheres, whereas in a fusion reactor, the inventory of radioactive material is dispersed in different areas of the plant, such that it is improbable that a single event could give rise to the release of the entire inventory to the environment. With such significant intrinsic safety advantages there is no a priori need to make fusion requirements/regulations more demanding and more stringent than fission

Regulatory Challenges for Cartilage Repair Technologies.

Science.gov (United States)

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

Improving clinical drug development regulatory procedures for anticonvulsants

Directory of Open Access Journals (Sweden)

Janković Slobodan

2015-01-01

Full Text Available Background: Clinical development of antiepileptic drugs is demanding due to complex character of the disorder and to diversity of its forms and etiologies. Objective: The aim of this review was to suggest improvements in regulatory procedures for clinical development of antiepileptic drugs. Methods: The following databases of scientific articles were searched: MEDLINE, SCOPUS and SCINDEKS. In total 558 publications were retrieved. The types of articles selected were reviews, reports on clinical trials and letters to the Editor. Results: There are several changes of regulatory documents necessary for improving process of clinical development of antiepileptic drugs: preference of parallel groups design for add-on trials should be explicit; the noninferiority design for monotherapy clinical trials should be acceptable; restrictive formulations when trials of antiepileptic drugs in children are in question should be avoided; requirements in regard to the efficacy measures should be harmonized among the regulatory bodies; proactive attitude towards discovery of adverse events; and precise requirements for clinical trials specifically designed to prove anti-epileptogenic effects should be made clear. Conclusion: Current regulatory documents are incomplete in many aspects; an international effort to improve and harmonize guidelines for clinical development of antiepileptic drugs is necessary for improvement of this process.

Regulatory Framework and Radiation Protection as Basis for Evaluation

International Nuclear Information System (INIS)

Elegba, S.B.

2010-01-01

Regulatory Framework for Nuclear Safety and Radiation Protection International Instruments: Conventions; Safety Fundamentals; Codes of Conduct; Safety Requirements and Guide, and National Instruments:-Legislation; Regulations; Guidance Documents. The Sustainable Development Principle recognizes a duty to prevent undue burden and degradation of the environment for future generations. The prime responsibility for safety must rest with the person or organization responsible for facilities…that give rise to radiation risks” (IAEA Safety Fundamentals – SF-1). Compliance with regulations and requirements imposed by the Regulatory Body shall not relieve the organization of its prime responsibility for safety. The regulatory body shall establish and implement appropriate arrangements for a systematic approach to quality management which extend throughout the range of responsibilities and functions undertaken.”. The IAEA self-assessment model for a Regulatory Body is based on a three tier approach. This model is modular and can be used and adopted for implementation by any regulator at any stage of maturity “Start up”, “On the way”, “Mature” Small, medium size, big. The IAEA is required by its Statute to promote international cooperation while regulating safety is a national responsibility. However, radiation risks may transcend national borders and international cooperation that serves to promote and enhance safety globally by exchanging experience and by improving capabilities to control hazards, to prevent accidents, to respond to emergencies and to mitigate any harmful consequences

Regulatory review of probabilistic safety assessment (PSA) Level 2

International Nuclear Information System (INIS)

2001-07-01

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

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

Selected review of regulatory standards and licensing issues for nuclear power plants

International Nuclear Information System (INIS)

Stevenson, J.D.; Thomas, F.A.

1982-11-01

This report presents a compilation and description of current foreign regulatory standards and licensing issues in the areas of interest associated with Siting, Structural Engineering, Metallurgy and Materials, and Mechanical Engineering. In addition, summary comparisons of the requirements of both the US and foreign nuclear power plant regulatory standards are provided. The selected foreign countries surveyed include Canada, France, Japan, Sweden, United Kingdom of Great Britain and Northern Ireland, and the Federal Republic of Germany

Regulatory Framework of Safety for HTGR

International Nuclear Information System (INIS)

Huh, Chang Wook; Suh, Nam Duk

2011-01-01

Recent accident in Fukushima Daiichi plant in Japan makes big impacts on the future of nuclear business. Many countries are changing their nuclear projects and increased safety of nuclear plants is asked for from the public. Without providing safety the society accepts, it might be almost impossible to build new plants further. In this sense high temperature gas-cooled reactor (HTGR) which is under development needs to be licensed reflecting this new expectation regarding safety. It means we should have higher level of safety goal and a systematic regulatory framework to assure the safety. In our previous paper, we evaluated the current safety goal and design practice in view of this new safety expectation after Fukushima accident. It was argued that a top-down approach starting from safety goal is necessary to develop safety requirements or to assure safety. Thus we need to propose an ultimate safety goal public accepts and then establish a systematic regulatory framework. In this paper we are going to provide a conceptual regulatory framework to guarantee the safety of HTGR. Section 2 discusses the recent trend of IAEA safety requirements and then summarize the HTGR design approach. Incorporating these discussions, we propose a conceptual framework of regulation for safety of HTGR

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

Science.gov (United States)

Yu, Yang; Zeng, Zheng

2009-10-01

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

Safety research programs sponsored by Office of Nuclear Regulatory Research: Progress report, January 1--June 30, 1988

Energy Technology Data Exchange (ETDEWEB)

Baum, J W; Boccio, J L; Diamond, D; Fitzpatrick, R; Ginsberg, T; Greene, G A; Guppy, J G; Hall, R E; Higgins, J C; Weiss, A J [comp.

1988-12-01

This progress report describes current activities and technical progress in the programs at Brookhaven National Laboratory sponsored by the Division of Regulatory Applications, Division of Engineering, Division of Safety Issue Resolution, and Division of Systems Research of the US Nuclear Regulatory Commission, Office of Nuclear Regulatory Research following the reorganization in July 1988. The previous reports have covered the period October 1, 1976 through December 31, 1987.

Safety research programs sponsored by Office of Nuclear Regulatory Research: Progress report, October 1--December 31, 1988

Energy Technology Data Exchange (ETDEWEB)

Weiss, A J; Azarm, A; Baum, J W; Boccio, J L; Carew, J; Diamond, D J; Fitzpatrick, R; Ginsberg, T; Greene, G A; Guppy, J G; Haber, S B

1989-07-01

This progress report describes current activities and technical progress in the programs at Brookhaven National Laboratory sponsored by the Division of Regulatory Applications, Division of Engineering, Division of Safety Issue Resolution, and Division of Systems Research of the US Nuclear Regulatory Commission, Office of Nuclear Regulatory Research following the reorganization in July 1988. The previous reports have covered the period October 1, 1976 through September 30, 1988.

Safety research programs sponsored by Office of Nuclear Regulatory Research: Progress report, January 1--June 30, 1988

International Nuclear Information System (INIS)

Baum, J.W.; Boccio, J.L.; Diamond, D.

1988-12-01

This progress report describes current activities and technical progress in the programs at Brookhaven National Laboratory sponsored by the Division of Regulatory Applications, Division of Engineering, Division of Safety Issue Resolution, and Division of Systems Research of the US Nuclear Regulatory Commission, Office of Nuclear Regulatory Research following the reorganization in July 1988. The previous reports have covered the period October 1, 1976 through December 31, 1987

Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices

Science.gov (United States)

Rowe, Laura A; Vossenaar, Marieke; Garrett, Greg S

2015-01-01

While fortification of staple foods and condiments has gained enormous global traction, poor performance persists throughout many aspects of implementation, most notably around the critical element of regulatory monitoring, which is essential for ensuring foods meet national fortification standards. Where coverage of fortified foods is high, limited nutritional impact of fortification programs largely exists due to regulatory monitoring that insufficiently identifies and holds producers accountable for underfortified products. Based on quality assurance data from 20 national fortification programs in 12 countries, we estimate that less than half of the samples are adequately fortified against relevant national standards. In this paper, we outline key findings from a literature review, key informant interviews with 11 fortification experts, and semi-quantitative surveys with 39 individuals from regulatory agencies and the food fortification industry in 17 countries on the perceived effectiveness of regulatory monitoring systems and barriers to compliance against national fortification standards. Findings highlight that regulatory agencies and industry disagree on the value that enforcement mechanisms have in ensuring compliance against standards. Perceived political risk of enforcement and poorly resourced inspectorate capacity appear to adversely reinforce each other within an environment of unclear legislation to create a major hurdle for improving overall compliance of fortification programs against national standards. Budget constraints affect the ability of regulatory agencies to create a well-trained inspector cadre and improve the detection and enforcement of non-compliant and underfortified products. Recommendations to improve fortification compliance include improving technical capacity; ensuring sustained leadership, accountability, and funding in both the private and the public sectors; and removing political barriers to ensure consistent detection of

75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

Science.gov (United States)

2010-03-10

... the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission March 2, 2010. The Federal Energy Regulatory Commission (FERC) and the Nuclear Regulatory Commission (NRC) will hold...

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

International Nuclear Information System (INIS)

Korsah, Kofi; Wood, Richard Thomas

2008-01-01

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

Regulatory review of probabilistic safety assessment (PSA) level 1

International Nuclear Information System (INIS)

2000-02-01

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

Computational Genetic Regulatory Networks Evolvable, Self-organizing Systems

CERN Document Server

Knabe, Johannes F

2013-01-01

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

75 FR 63878 - Self-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate...

Science.gov (United States)

2010-10-18

...-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of...(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory...

Thermoelectricity viability in Brazil through changes in the regulatory environment of the natural gas industry; Viabilizacao da termoeletricidade no Brasil atraves de mudancas no ambiente regulatorio da industria do gas natural

Energy Technology Data Exchange (ETDEWEB)

Borelli, Samuel [Sao Paulo Univ., SP (Brazil). Inst. de Eletrotecnica e Energia. Programa de Pos-graduacao Interunidades em Energia; Promon Engenharia, Rio de Janeiro, RJ (Brazil)]. E-mail: samuel.borelli@promon.com.br

2003-07-01

The electric power generated through natural gas in large thermal plants in Brazil presents many severe competitive barriers compared to the hydroelectric power available. Among the motives that cause such situation are relatively high fuel costs associated to the thermal power. The objective of this paper is discuss the available tools in the regulatory environment whose application may lead to the reduction of the price of the natural gas, that represents up to 60% of the total cost of the generated power. (author)

Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies-the German Cancer Consortium approach.

Science.gov (United States)

Krackhardt, Angela M; Anliker, Brigitte; Hildebrandt, Martin; Bachmann, Michael; Eichmüller, Stefan B; Nettelbeck, Dirk M; Renner, Matthias; Uharek, Lutz; Willimsky, Gerald; Schmitt, Michael; Wels, Winfried S; Schüssler-Lenz, Martina

2018-04-01

Adoptive transfer of T cells genetically modified by TCRs or CARs represents a highly attractive novel therapeutic strategy to treat malignant diseases. Various approaches for the development of such gene therapy medicinal products (GTMPs) have been initiated by scientists in recent years. To date, however, the number of clinical trials commenced in Germany and Europe is still low. Several hurdles may contribute to the delay in clinical translation of these therapeutic innovations including the significant complexity of manufacture and non-clinical testing of these novel medicinal products, the limited knowledge about the intricate regulatory requirements of the academic developers as well as limitations of funds for clinical testing. A suitable good manufacturing practice (GMP) environment is a key prerequisite and platform for the development, validation, and manufacture of such cell-based therapies, but may also represent a bottleneck for clinical translation. The German Cancer Consortium (DKTK) and the Paul-Ehrlich-Institut (PEI) have initiated joint efforts of researchers and regulators to facilitate and advance early phase, academia-driven clinical trials. Starting with a workshop held in 2016, stakeholders from academia and regulatory authorities in Germany have entered into continuing discussions on a diversity of scientific, manufacturing, and regulatory aspects, as well as the benefits and risks of clinical application of CAR/TCR-based cell therapies. This review summarizes the current state of discussions of this cooperative approach providing a basis for further policy-making and suitable modification of processes.

The expanding regulatory universe of p53 in gastrointestinal cancer [version 1; referees: 2 approved

Directory of Open Access Journals (Sweden)

Andrew Fesler

2016-04-01

Full Text Available Tumor suppresser gene TP53 is one of the most frequently deleted or mutated genes in gastrointestinal cancers. As a transcription factor, p53 regulates a number of important protein coding genes to control cell cycle, cell death, DNA damage/repair, stemness, differentiation and other key cellular functions. In addition, p53 is also able to activate the expression of a number of small non-coding microRNAs (miRNAs through direct binding to the promoter region of these miRNAs.  Many miRNAs have been identified to be potential tumor suppressors by regulating key effecter target mRNAs. Our understanding of the regulatory network of p53 has recently expanded to include long non-coding RNAs (lncRNAs. Like miRNA, lncRNAs have been found to play important roles in cancer biology.  With our increased understanding of the important functions of these non-coding RNAs and their relationship with p53, we are gaining exciting new insights into the biology and function of cells in response to various growth environment changes. In this review we summarize the current understanding of the ever expanding involvement of non-coding RNAs in the p53 regulatory network and its implications for our understanding of gastrointestinal cancer.

Current Status of On-Site Wastewater Management

Science.gov (United States)

Senn, Charles L.

1978-01-01

Wastewater management is becoming an important environmental issue nationally. This article reports the history and current status of wastewater management. Regulatory programs are discussed with specific state examples. Needs assessment is also included. (MA)

77 FR 32159 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate...

Science.gov (United States)

2012-05-31

... the proposed rule change is available on the Exchange's Web site ( http://www.c2exchange.com/Legal... responsibilities. To more accurately reflect the current regulatory and compliance functions of the Regulatory... market and a national market system, and, in general, to protect investors and the public interest. The...

Current regulatory developments concerning the implementation of probabilistic safety analyses for external hazards in Germany

International Nuclear Information System (INIS)

Krauss, Matias; Berg, Heinz-Peter

2014-01-01

The Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) initiated in September 2003 a comprehensive program for the revision of the national nuclear safety regulations which has been successfully completed in November 2012. These nuclear regulations take into account the current recommendations of the International Atomic Energy Agency (IAEA) and Western European Nuclear Regulators Association (WENRA). In this context, the recommendations and guidelines of the Nuclear Safety Standards Commission (KTA) and the technical documents elaborated by the respective expert group on Probabilistic Safety Analysis for Nuclear Power Plants (FAK PSA) are being updated or in the final process of completion. A main topic of the revision was the issue external hazards. As part of this process and in the light of the accident at Fukushima and the findings of the related actions resulting in safety reviews of nuclear power plants at national level in Germany and on European level, a revision of all relevant standards and documents has been made, especially the recommendations of KTA and FAK PSA. In that context, not only design issues with respect to events such as earthquakes and floods have been discussed, but also methodological issues regarding the implementation of improved probabilistic safety analyses on this topic. As a result of the revision of the KTA 2201 series 'Design of Nuclear Power Plants against Seismic Events' with their parts 1 to 6, part 1 'Principles' was published as the first standard in November 2011, followed by the revised versions of KTA 2201.2 (soil) and 2201.4 (systems and components) in 2012. The modified the standard KTA 2201.3 (structures) is expected to be issued before the end of 2013. In case of part 5 (seismic instrumentation) and part 6 (post>seismic actions) draft amendments are expected in 2013. The expert group 'Probabilistic Safety Assessments for Nuclear Power Plants' (FAK PSA) is an advisory body of the Federal

Challenges in orphan drug development and regulatory policy in China.

Science.gov (United States)

Cheng, Alice; Xie, Zhi

2017-01-18

While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements have begun to support rare disease patients and facilitate drug discovery through research. Recently, the Chinese FDA set new regulatory guidelines for drugs being developed in China, including an expedited review process for life-saving treatments. In this review, we discuss the effects of these new policy changes on and suggest potential solutions to innovate orphan drug development in China.

Evolution of Cis-Regulatory Elements and Regulatory Networks in Duplicated Genes of Arabidopsis.

Science.gov (United States)

Arsovski, Andrej A; Pradinuk, Julian; Guo, Xu Qiu; Wang, Sishuo; Adams, Keith L

2015-12-01

Plant genomes contain large numbers of duplicated genes that contribute to the evolution of new functions. Following duplication, genes can exhibit divergence in their coding sequence and their expression patterns. Changes in the cis-regulatory element landscape can result in changes in gene expression patterns. High-throughput methods developed recently can identify potential cis-regulatory elements on a genome-wide scale. Here, we use a recent comprehensive data set of DNase I sequencing-identified cis-regulatory binding sites (footprints) at single-base-pair resolution to compare binding sites and network connectivity in duplicated gene pairs in Arabidopsis (Arabidopsis thaliana). We found that duplicated gene pairs vary greatly in their cis-regulatory element architecture, resulting in changes in regulatory network connectivity. Whole-genome duplicates (WGDs) have approximately twice as many footprints in their promoters left by potential regulatory proteins than do tandem duplicates (TDs). The WGDs have a greater average number of footprint differences between paralogs than TDs. The footprints, in turn, result in more regulatory network connections between WGDs and other genes, forming denser, more complex regulatory networks than shown by TDs. When comparing regulatory connections between duplicates, WGDs had more pairs in which the two genes are either partially or fully diverged in their network connections, but fewer genes with no network connections than the TDs. There is evidence of younger TDs and WGDs having fewer unique connections compared with older duplicates. This study provides insights into cis-regulatory element evolution and network divergence in duplicated genes. © 2015 American Society of Plant Biologists. All Rights Reserved.

Safety research programs sponsored by Office of Nuclear Regulatory Research: Progress report, July 1--September 30, 1988

Energy Technology Data Exchange (ETDEWEB)

Weiss, A J [comp.

1989-02-01

This progress report describes current activities and technical progress in the programs at Brookhaven National Laboratory sponsored by the Division of Regulatory Applications, Division of Engineering, Division of Safety Issue Resolution, and Division of Systems of the US Nuclear Regulatory Commission, Office of Nuclear Regulatory Research following the reorganization in July 1988. The previous reports have covered the period October 1, 1976 through June 30, 1988. 71 figs., 24 tabs.

Safety research programs sponsored by Office of Nuclear Regulatory Research: Progress report, July 1--September 30, 1988

International Nuclear Information System (INIS)

Weiss, A.J.

1989-02-01

This progress report describes current activities and technical progress in the programs at Brookhaven National Laboratory sponsored by the Division of Regulatory Applications, Division of Engineering, Division of Safety Issue Resolution, and Division of Systems of the US Nuclear Regulatory Commission, Office of Nuclear Regulatory Research following the reorganization in July 1988. The previous reports have covered the period October 1, 1976 through June 30, 1988. 71 figs., 24 tabs

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

Science.gov (United States)

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

2017-03-01

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

Food irradiation—US regulatory considerations

Science.gov (United States)

Morehouse, Kim M.

2002-03-01

The use of ionizing radiation in food processing has received increased interest as a means of reducing the level of foodborne pathogens. This overview discusses the regulatory issues connected with the use of this technology in the United States. Several recent changes in the FDA's review process are discussed. These include the current policy that utilizes an expedited review process for petitions seeking approval of additives and technologies intended to reduce pathogen levels in food, and the recent USDA rule that eliminates the need for a separate rulemaking process by USDA for irradiation of meat and poultry. Recently promulgated rules and pending petitions before the FDA associated with the use of ionizing radiation for the treatment of foods are also discussed along with the current FDA labeling requirements for irradiated foods and the 1999 advanced notice of proposed rule on labeling. Another issue that is presented is the current status of the approval of packaging materials intended for food contact during irradiation treatment of foods.

Food irradiation--US regulatory considerations

International Nuclear Information System (INIS)

Morehouse, Kim M.

2002-01-01

The use of ionizing radiation in food processing has received increased interest as a means of reducing the level of foodborne pathogens. This overview discusses the regulatory issues connected with the use of this technology in the United States. Several recent changes in the FDA's review process are discussed. These include the current policy that utilizes an expedited review process for petitions seeking approval of additives and technologies intended to reduce pathogen levels in food, and the recent USDA rule that eliminates the need for a separate rulemaking process by USDA for irradiation of meat and poultry. Recently promulgated rules and pending petitions before the FDA associated with the use of ionizing radiation for the treatment of foods are also discussed along with the current FDA labeling requirements for irradiated foods and the 1999 advanced notice of proposed rule on labeling. Another issue that is presented is the current status of the approval of packaging materials intended for food contact during irradiation treatment of foods

Regulatory analyses for severe accident issues: an example

International Nuclear Information System (INIS)

Burke, R.P.; Strip, D.R.; Aldrich, D.C.

1984-09-01

This report presents the results of an effort to develop a regulatory analysis methodology and presentation format to provide information for regulatory decision-making related to severe accident issues. Insights and conclusions gained from an example analysis are presented. The example analysis draws upon information generated in several previous and current NRC research programs (the Severe Accident Risk Reduction Program (SARRP), Accident Sequence Evaluation Program (ASEP), Value-Impact Handbook, Economic Risk Analyses, and studies of Vented Containment Systems and Alternative Decay Heat Removal Systems) to perform preliminary value-impact analyses on the installation of either a vented containment system or an alternative decay heat removal system at the Peach Bottom No. 2 plant. The results presented in this report are first-cut estimates, and are presented only for illustrative purposes in the context of this document. This study should serve to focus discussion on issues relating to the type of information, the appropriate level of detail, and the presentation format which would make a regulatory analysis most useful in the decisionmaking process

Conformity check of JMTR to new regulatory standards

International Nuclear Information System (INIS)

Watahiki, Shunsuke; Ide, Hiroshi; Hanakawa, Hiroki; Yamaura, Takayuki; Kaminaga, Masanori

2015-01-01

With the lesson learned from the accident of TEPCO Fukushima Daiichi Nuclear Power Station, also based on the international standards, the 'New regulatory standards for nuclear facilities for research! was enforced by the Nuclear Regulatory Authority in December 2013. The main requirements of the new standards are as follows: (1) measures for earthquake, tsunami, and damage from the outside, (2) severity classification, (3) fire protection, (4) flood protection, (5) communication and contacting, (6) measures for the loss of external power supply, (7) monitoring equipment, and (8) expansion prevention of accident that releases a large amounts of radioactive materials. Under the new regulatory standards, it is demanded that the constructions, systems, and equipment with safety functions of the current nuclear facilities should maintain the safety functions in accordance with their importance against the basic ground motions and possible natural phenomena. For the buildings, equipment, and machineries of JMTR nuclear facilities, the severity classification was performed on each of safety function and seismic resistance. Based on the classification results, seismic evaluation and safety analysis were carried out. (A.O.)

Regulatory challenges for GM crops in developing economies: the African experience.

Science.gov (United States)

Nang'ayo, Francis; Simiyu-Wafukho, Stella; Oikeh, Sylvester O

2014-12-01

Globally, transgenic or genetically modified (GM) crops are considered regulated products that are subject to regulatory oversight during trans-boundary movement, testing and environmental release. In Africa, regulations for transgenic crops are based on the outcomes of the historic Earth Summit Conference held in Rio, Brazil two decades ago, namely, the adoption of the Convention on Biological Diversity (CBD) and the subsequent adoption of the Cartagena Protocol on Biosafety. To exploit the potential benefits of transgenic crops while safeguarding the potential risks on human health and environment, most African countries have signed and ratified the CBD and the Cartagena Protocol on Biosafety. Consequently, these countries are required to take appropriate legal, administrative and other measures to ensure that the handling and utilization of living modified organisms are undertaken in a manner that reduces the risks to humans and the environment. These countries are also expected to provide regulatory oversight on transgenic crops through functional national biosafety frameworks (NBFs). While in principle this approach is ideal, NBFs in most African countries are steeped in a host of policy, legal and operational challenges that appear to be at cross-purposes with the noble efforts of seeking to access, test and deliver promising GM crops for use by resource-limited farmers in Africa. In this paper we discuss the regulatory challenges faced during the development and commercialization of GM crops based on experiences from countries in Sub-Saharan Africa.

Analysis of NRC Regulatory Guide 1.21 Revision 2

Energy Technology Data Exchange (ETDEWEB)

Kim, Sung Il; Yook, Dae Sik; Lee, Byung Soo [KINS, Daejeon (Korea, Republic of)

2015-05-15

It is essential to have a degree of uniformity in the methods used for measuring, evaluating, recording, and reporting data on radioactive material in effluents and solid wastes. For this purpose, the U.S. Nuclear Regulatory Commission (NRC) released a revised version of the Regulatory Guide 1.21 'Measuring, evaluating, and reporting radioactive material in liquid and gaseous effluents and solid waste' (revision 2) in 2009, updating the revision 1 version released in 1974. This study compares the previous revision 1 (1974) version with the revision 2 (2009) version to elaborate on the application of the guidelines to Korea. This study consists of an analysis of the 2009 Revision 2 version of the U.S. NRC Regulatory Guidelines 1.21 and an exposition of methods for its application in the domestic environment. Major revisions were made to allow for the adoption of a risk informed approach. Radionuclides with lower than 1% contribution to emission or radiation levels can be selected as principal radionuclides. Requirements for analysis of leaks and spills have been reinforced, with additional groundwater monitoring and hydrological data analysis becoming necessary.

Improving nuclear regulation. Compilation of Nea regulatory guidance booklets

International Nuclear Information System (INIS)

2009-01-01

A common theme throughout the series of NEA regulatory guidance reports, or 'green booklets', is the premise that the fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are operated at all times and later decommissioned in an acceptably safe manner. In meeting this objective the regulator must keep in mind that it is the operator that has responsibility for safely operating a nuclear facility; the role of the regulator is to oversee the operator's activities as related to assuming that responsibility. For the first time, the full series of these reports have been brought together in one edition. As such, it is intended to serve as a knowledge management tool both for current regulators and the younger generation of nuclear experts entering the regulatory field. While the audience for this publication is primarily nuclear regulators, the information and ideas may also be of interest to nuclear operators, other nuclear industry organisations and the general public. (author)

Regulatory T cell derived Exosomes: possible therapeutic and diagnostic tools in transplantation

Directory of Open Access Journals (Sweden)

Akansha eAgarwal

2014-11-01

Full Text Available Exosomes are extracellular vesicles released by many cells of the body. These small vesicles play an important part in intercellular communication both in the local environment and systemically, facilitating in the transfer of proteins, cytokines as well as miRNA between cells. The observation that exosomes isolated from immune cells such as dendritic cells (DCs modulate the immune response has paved the way for these structures to be considered as potential immunotherapeutic reagents. Indeed clinical trials using DC derived exosomes to facilitate immune responses to specific cancer antigens are now underway. Exosomes can also have a negative effect on the immune response and exosomes isolated from regulatory T cells (Tregs and other subsets of T cells have been shown to have immune suppressive capacities. Here we review what is currently known about Treg derived exosomes and their contribution to immune regulation, as well as highlighting their possible therapeutic potential for preventing graft rejection, and their possible use as diagnostic tools to assess transplant outcome.

Regulatory activities; Actividades regulatorias

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-07-01

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

A Lactobacillus rhamnosus strain induces a heme oxygenase dependent increase in Foxp3+ regulatory T cells.

Directory of Open Access Journals (Sweden)

Khalil Karimi

Full Text Available We investigated the consequences of feeding with a Lactobacillus species on the immune environment in GALT, and the role of dendritic cells and heme oxygenase-1 in mediating these responses. Feeding with a specific strain of Lactobacillus rhamnosus induced a significant increase in CD4+CD25+Foxp3+ functional regulatory T cells in GALT. This increase was greatest in the mesenteric lymph nodes and associated with a marked decrease in TNF and IFNγ production. Dendritic cell regulatory function and HO-1 expression was also increased. The increase in Foxp3+ T cells could be prevented by treatment with a heme oxygenase inhibitor. However, neither inhibition of heme oxygenase nor blockade of IL-10 and TGFβ prevented the inhibition of inflammatory cytokine production. In conclusion Lactobacillus feeding induced a tolerogenic environment in GALT. HO-1 was critical to the enhancement of Foxp3+ regulatory T cells while additional, as yet unknown, pathways were involved in the down-regulation of inflammatory cytokine production by T cells.

Costs of regulatory compliance: categories and estimating techniques

International Nuclear Information System (INIS)

Schulte, S.C.; McDonald, C.L.; Wood, M.T.; Cole, R.M.; Hauschulz, K.

1978-10-01

Use of the categorization scheme and cost estimating approaches presented in this report can make cost estimates of regulation required compliance activities of value to policy makers. The report describes a uniform assessment framework that when used would assure that cost studies are generated on an equivalent basis. Such normalization would make comparisons of different compliance activity cost estimates more meaningful, thus enabling the relative merits of different regulatory options to be more effectively judged. The framework establishes uniform cost reporting accounts and cost estimating approaches for use in assessing the costs of complying with regulatory actions. The framework was specifically developed for use in a current study at Pacific Northwest Laboratory. However, use of the procedures for other applications is also appropriate

FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.

Science.gov (United States)

Wilson, Carolyn A; Simonyan, Vahan

2014-01-01

Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and

A High-Sensitivity Flexible Eddy Current Array Sensor for Crack Monitoring of Welded Structures under Varying Environment.

Science.gov (United States)

Chen, Tao; He, Yuting; Du, Jinqiang

2018-06-01

This paper develops a high-sensitivity flexible eddy current array (HS-FECA) sensor for crack monitoring of welded structures under varying environment. Firstly, effects of stress, temperature and crack on output signals of the traditional flexible eddy current array (FECA) sensor were investigated by experiments that show both stress and temperature have great influences on the crack monitoring performance of the sensor. A 3-D finite element model was established using Comsol AC/DC module to analyze the perturbation effects of crack on eddy currents and output signals of the sensor, which showed perturbation effect of cracks on eddy currents is reduced by the current loop when crack propagates. Then, the HS-FECA sensor was proposed to boost the sensitivity to cracks. Simulation results show that perturbation effect of cracks on eddy currents excited by the HS-FECA sensor gradually grows stronger when the crack propagates, resulting in much higher sensitivity to cracks. Experimental result further shows that the sensitivity of the new sensor is at least 19 times that of the original one. In addition, both stress and temperature variations have little effect on signals of the new sensor.

Improvement of Regulatory Framework for Long-Term Operation and Ageing Management of NPPs

International Nuclear Information System (INIS)

Kostenko, S.P.

2015-01-01

The regulatory framework for long-term operation and ageing management of NPP units in Ukraine was reviewed and deficiencies were identified. The procedure for improving regulatory framework for long-term operation and ageing management is presented. It takes into consideration IAEA recommendations and international practices, as well as experience obtained in long-term operation efforts for Rivne NPP-1, 2 and South Ukraine NPP-1. The paper demonstrates interrelations between standards and technical documents on long-term operation and ageing management. The information is presented regarding the current state of regulatory and legal documentation development and industry-specific standards on long-term operation and ageing management of NPP units in Ukraine

Alternate Endpoints for Deep Vadose Zone Environments: Challenges, Opportunities, and Progress - 13036

International Nuclear Information System (INIS)

Wellman, Dawn M.; Freshley, Mark D.; Truex, Michael J.; Lee, M. Hope

2013-01-01

Current requirements for site remediation and closure are standards-based and are often overly conservative, costly, and in some cases, technically impractical to achieve. Use of risk-informed alternate endpoints provide a means to achieve remediation goals that are permitted by regulations and are protective of human health and the environment. Alternate endpoints enable establishing a path for cleanup that may include intermediate remedial milestones and transition points and/or regulatory alternatives to standards-based remediation. A framework is presented that is centered around developing and refining conceptual models in conjunction with assessing risks and potential endpoints as part of a system-based assessment that integrates site data with scientific understanding of processes that control the distribution and transport of contaminants in the subsurface and pathways to receptors. This system-based assessment and subsequent implementation of the remediation strategy with appropriate monitoring are targeted at providing a holistic approach to addressing risks to human health and the environment. This holistic approach also enables effective predictive analysis of contaminant behavior to provide defensible criteria and data for making long-term decisions. Developing and implementing an alternate endpoint-based approach for remediation and waste site closure presents a number of challenges and opportunities. Categories of these challenges include scientific and technical, regulatory, institutional, and budget and resource allocation issues. Opportunities exist for developing and implementing systems-based approaches with respect to supportive characterization, monitoring, predictive modeling, and remediation approaches. (authors)

Alternate Endpoints for Deep Vadose Zone Environments: Challenges, Opportunities, and Progress - 13036

Energy Technology Data Exchange (ETDEWEB)

Wellman, Dawn M.; Freshley, Mark D.; Truex, Michael J.; Lee, M. Hope [Pacific Northwest National Laboratory, 902 Battelle Blvd, Richland, WA, 99352 (United States)

2013-07-01

Current requirements for site remediation and closure are standards-based and are often overly conservative, costly, and in some cases, technically impractical to achieve. Use of risk-informed alternate endpoints provide a means to achieve remediation goals that are permitted by regulations and are protective of human health and the environment. Alternate endpoints enable establishing a path for cleanup that may include intermediate remedial milestones and transition points and/or regulatory alternatives to standards-based remediation. A framework is presented that is centered around developing and refining conceptual models in conjunction with assessing risks and potential endpoints as part of a system-based assessment that integrates site data with scientific understanding of processes that control the distribution and transport of contaminants in the subsurface and pathways to receptors. This system-based assessment and subsequent implementation of the remediation strategy with appropriate monitoring are targeted at providing a holistic approach to addressing risks to human health and the environment. This holistic approach also enables effective predictive analysis of contaminant behavior to provide defensible criteria and data for making long-term decisions. Developing and implementing an alternate endpoint-based approach for remediation and waste site closure presents a number of challenges and opportunities. Categories of these challenges include scientific and technical, regulatory, institutional, and budget and resource allocation issues. Opportunities exist for developing and implementing systems-based approaches with respect to supportive characterization, monitoring, predictive modeling, and remediation approaches. (authors)

U.S. Nuclear Regulatory Commission bases for control of solid materials

International Nuclear Information System (INIS)

Meck, R.A.; Cardille, F.P.; Feldman, C.; Gnugnoli, G.N.; Huffert, A.M.; Klementowicz, S.P.

2002-01-01

The U.S. Nuclear Regulatory Commission (NRC) is considering whether to proceed with rulemaking on the control of solid materials with very low levels of associated radioactivity. The current implementation of clearance by NRC licensees is the context for the decision. Inputs to the decision include information gathering efforts of the Commission in the areas of public workshops, dose assessments and inventories, the recommendations of the National Academies' National Research Council (NAs) on regulatory alternatives, and participation in international efforts by the International Atomic Energy Agency (IAEA). (author)

Use of electronic cigarettes across 13 ITC countries with different regulatory environments

Directory of Open Access Journals (Sweden)

Shannon Gravely

2018-03-01

With minor exceptions (e.g. Australia, awareness, trial, and use of e-cigarettes across the 13 countries generally reflected the de facto environment rather than the statutory environment implied by the law(s. Country income classification and survey year also appear to be strongly associated with use.

76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Science.gov (United States)

2011-10-26

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

75 FR 17456 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Science.gov (United States)

2010-04-06

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... terms. For more information about the rulebook consolidation process, see Information Notice, March 12...

Dark current spectroscopy of space and nuclear environment induced displacement damage defects in pinned photodiode based CMOS image sensors

International Nuclear Information System (INIS)

Belloir, Jean-Marc

2016-01-01

CMOS image sensors are envisioned for an increasing number of high-end scientific imaging applications such as space imaging or nuclear experiments. Indeed, the performance of high-end CMOS image sensors has dramatically increased in the past years thanks to the unceasing improvements of microelectronics, and these image sensors have substantial advantages over CCDs which make them great candidates to replace CCDs in future space missions. However, in space and nuclear environments, CMOS image sensors must face harsh radiation which can rapidly degrade their electro-optical performances. In particular, the protons, electrons and ions travelling in space or the fusion neutrons from nuclear experiments can displace silicon atoms in the pixels and break the crystalline structure. These displacement damage effects lead to the formation of stable defects and to the introduction of states in the forbidden bandgap of silicon, which can allow the thermal generation of electron-hole pairs. Consequently, non ionizing radiation leads to a permanent increase of the dark current of the pixels and thus a decrease of the image sensor sensitivity and dynamic range. The aim of the present work is to extend the understanding of the effect of displacement damage on the dark current increase of CMOS image sensors. In particular, this work focuses on the shape of the dark current distribution depending on the particle type, energy and fluence but also on the image sensor physical parameters. Thanks to the many conditions tested, an empirical model for the prediction of the dark current distribution induced by displacement damage in nuclear or space environments is experimentally validated and physically justified. Another central part of this work consists in using the dark current spectroscopy technique for the first time on irradiated CMOS image sensors to detect and characterize radiation-induced silicon bulk defects. Many types of defects are detected and two of them are identified

Legislative and regulatory aspects of nuclear power reactor licensing in the U.S.A

International Nuclear Information System (INIS)

Malsch, M.G.

1976-01-01

An explanation of the origins, statutory basis and development of the present regulatory system in the US. A description of the various actions which must be taken by a license applicant and by the USNRC before a nuclear power plant can be constructed and placed on-line. Account of the current regulatory practices followed by the USNRC in licensing nuclear power reactors. (orig./HP) [de

Colloid-facilitated radionuclide transport: a regulatory perspective

Science.gov (United States)

Dam, W. L.; Pickett, D. A.; Codell, R. B.; Nicholson, T. J.

2001-12-01

What hydrogeologic-geochemical-microbial conditions and processes affect migration of radionuclides sorbed onto microparticles or native colloid-sized radionuclide particles? The U.S. Nuclear Regulatory Commission (NRC) is responsible for protecting public health, safety, and the environment at numerous nuclear facilities including a potential high-level nuclear waste disposal site. To fulfill these obligations, NRC needs to understand the mechanisms controlling radionuclide release and transport and their importance to performance. The current focus of NRC staff reviews and technical interactions dealing with colloid-facilitated transport relates to the potential nuclear-waste repository at Yucca Mountain, Nevada. NRC staff performed bounding calculations to quantify radionuclide releases available for ground-water transport to potential receptors from a Yucca Mountain repository. Preliminary analyses suggest insignificant doses of plutonium and americium colloids could be derived from spent nuclear fuel. Using surface complexation models, NRC staff found that colloids can potentially lower actinide retardation factors by up to several orders of magnitude. Performance assessment calculations, in which colloidal transport of plutonium and americium was simulated by assuming no sorption or matrix diffusion, indicated no effect of colloids on human dose within the 10,000 year compliance period due largely to long waste-package lifetimes. NRC staff have identified information gaps and developed technical agreements with the U.S. Department of Energy (DOE) to ensure sufficient information will be presented in any potential future Yucca Mountain license application. DOE has agreed to identify which radionuclides could be transported via colloids, incorporate uncertainties in colloid formation, release and transport parameters, and conceptual models, and address the applicability of field data using synthetic microspheres as colloid analogs. NRC is currently

Single-Session Transcranial Direct Current Stimulation Temporarily Improves Symptoms, Mood, and Self-Regulatory Control in Bulimia Nervosa: A Randomised Controlled Trial.

Science.gov (United States)

Kekic, Maria; McClelland, Jessica; Bartholdy, Savani; Boysen, Elena; Musiat, Peter; Dalton, Bethan; Tiza, Meyzi; David, Anthony S; Campbell, Iain C; Schmidt, Ulrike

2017-01-01

Evidence suggests that pathological eating behaviours in bulimia nervosa (BN) are underpinned by alterations in reward processing and self-regulatory control, and by functional changes in neurocircuitry encompassing the dorsolateral prefrontal cortex (DLPFC). Manipulation of this region with transcranial direct current stimulation (tDCS) may therefore alleviate symptoms of the disorder. This double-blind sham-controlled proof-of-principle trial investigated the effects of bilateral tDCS over the DLPFC in adults with BN. Thirty-nine participants (two males) received three sessions of tDCS in a randomised and counterbalanced order: anode right/cathode left (AR/CL), anode left/cathode right (AL/CR), and sham. A battery of psychological/neurocognitive measures was completed before and after each session and the frequency of bulimic behaviours during the following 24-hours was recorded. AR/CL tDCS reduced eating disorder cognitions (indexed by the Mizes Eating Disorder Cognitions Questionnaire-Revised) when compared to AL/CR and sham tDCS. Both active conditions suppressed the self-reported urge to binge-eat and increased self-regulatory control during a temporal discounting task. Compared to sham stimulation, mood (assessed with the Profile of Mood States) improved after AR/CL but not AL/CR tDCS. Lastly, the three tDCS sessions had comparable effects on the wanting/liking of food and on bulimic behaviours during the 24 hours post-stimulation. These data suggest that single-session tDCS transiently improves symptoms of BN. They also help to elucidate possible mechanisms of action and highlight the importance of selecting the optimal electrode montage. Multi-session trials are needed to determine whether tDCS has potential for development as a treatment for adult BN.

78 FR 62784 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Science.gov (United States)

2013-10-22

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer... 5210 (Publication of Transactions and Quotations) October 4, 2013. I. Introduction On August 15, 2013, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

Regulatory research / Pesquisa regulatória

Directory of Open Access Journals (Sweden)

Altair Souza de Assis

2013-05-01

Full Text Available We present in this paper the concept, importance, and scope of research into the regulatory framework of regulation and legislation, with a particular focus on legislation related to legal metrology. This study also describes a comparative analysis of the various forms of regulation and the associated regulatory research, with the ultimate goal of better defi ning the concept and to validate the need to have research groups within a country’s regulatory bodies. Based on this work, we conclude that regulatory research is a key factor in the success of any regulatory body’s activities. Such research helps to avoid the creation of absurd or impractical regulatory barriers to a country’s technological development, or worse, to permit “orphans,” that is, technologies that are outside regulatory control, as is currently the case. Indeed, for a country to have a robust technological infrastructure, especially if it is still a developing country, strong and competent regulatory control is essential. However, this must be balanced by an atmosphere that fosters continuous and consistent technological innovation, and such development must also be self-sustainable from economic, social, and environmental viewpoints. ------------------------------------------------ Apresenta-se neste trabalho o conceito, a importância e a abrangência da pesquisa regulatória no âmbito da regulação e da regulamentação, com foco particular na regulamentação relacionada à metrologia legal. Faz-se também uma análise comparativa entre as várias formas de regular e regulamentar, e as suas pesquisas regulatórias afi ns, tendo como meta principal situar melhor o conceito e validar a necessidade de se fazer pesquisa nos órgãos e agências regulatórias do país. Com base neste trabalho, concluímos que a pesquisa regulatória é um fator chave para o sucesso de qualquer plano de ação de regulação para os agentes regulatórios do país. Ela ajuda a

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

International Nuclear Information System (INIS)

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

2001-01-01

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

76 FR 24836 - Regulatory Approach for Commercial Orbital Human Spaceflight

Science.gov (United States)

2011-05-03

... human spaceflight. The FAA will share its current philosophy, but is most interested in the public's... for Commercial Orbital Human Spaceflight AGENCY: Federal Aviation Administration (FAA), DOT. ACTION... information from the public on the regulatory approach to commercial orbital human spaceflight by the FAA...

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

International Nuclear Information System (INIS)

Sexton, Kimberly A.; )

2015-01-01

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

Regulatory issues and assumptions associated with polymers for subsurface barriers surrounding buried waste

International Nuclear Information System (INIS)

Heiser, J.; Siskind, B.

1993-01-01

One of the options for control of contaminant migration from buried waste sites is the construction of a subsurface barrier that consists of a wall of low permeability material. Subsurface barriers will improve remediation performance by removing pathways for contaminant transport due to groundwater movement, meteorological water infiltration, vapor- and gas-phase transport, transpiration, etc. Subsurface barriers may be used to open-quotes directclose quotes contaminant movement to collection sumps/lysimeters in cases of unexpected remediation failures or transport mechanisms, to contain leakage from underground storage tanks, and to restrict in-situ soil cleanup operation and chemicals. Brookhaven National Laboratory is currently investigating advanced polymer materials for subsurface barriers. This report addresses the regulatory aspects of using of non-traditional polymer materials as well as soil-bentonite or cement-bentonite mixtures for such barriers. The regulatory issues fall into two categories. The first category consists of issues associated with the acceptability of subsurface barriers to the Environmental Protection Agency (EPA) as a method for achieving waste site performance improvement. The second category encompasses those regulatory issues concerning health, safety and the environment which must be addressed regarding barrier installation and performance, especially if non-traditional materials are to be used. Since many of EPA's concerns regarding subsurface barriers focus on the chemicals used during installation of these barriers the authors discuss the results of a search of the Federal Register and the Code of Federal Regulations for references in Titles 29 and 40 pertaining to key chemicals likely to be utilized in installing non-traditional barrier materials. The use of polymeric materials in the construction industry has been accomplished with full compliance with the applicable health, safety, and environmental regulations

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

Science.gov (United States)

2010-04-26

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

Structural radioactive waste from 'retubing/refurbishment' of Embalse nuclear power plant. Regulatory perspective

International Nuclear Information System (INIS)

Alvarez, Daniela E.; Lee Gonzales, Horacio M.; Medici, Marcela A.; Piumetti, Elsa H.

2009-01-01

Unlike the building of a new nuclear reactor, the 'retubing / refurbishment' of nuclear reactors that have been in operation for many years, involves the replacement of components in a radioactive environment. This requires a carefully planned radiation protection program to ensure protection of workers, the public and the environment as well as a radioactive waste management program for those radioactive waste generated during the process, which go beyond those generated during the normal operation and maintenance of the plant. Nucleoelectrica Argentina Sociedad Anonima (NA-SA) is scheduled to conduct the Life Extension Process of Embalse Nuclear Power Plant (CNE) which essentially consist of 'retubing / refurbishment' of the installation. The Nuclear Regulatory Authority (ARN) will then have an important activity related to the above process. In particular, this paper will describe some points of interest related to the generation and management of radioactive waste during the 'retubing / refurbishment' of the CNE, from the regulatory point of view. (author)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Portugal

International Nuclear Information System (INIS)

2011-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Ministry of Health; Minister of Science, Technology and Higher Education; Ministry of Economy and Innovation; Ministry of Environment and Territorial Planning; Other authorities); 2. Advisory bodies (Independent Commission for Radiological Protection and Nuclear Safety - CIPRSN; National Radiation Protection Commission - CNPCR; National Commission for Radiological Emergencies - CNER; Other advisory bodies); 3. Public and semi-public agencies

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Mexico

International Nuclear Information System (INIS)

2009-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; 11. Nuclear terrorism; II. Institutional Framework - The federal government: 1. Regulatory and supervisory authorities (Ministry of Energy; Ministry of Health; Ministry of Labour and Social Security; Ministry of the Environment and Natural Resources; Ministry of Communications and Transport); 2. Public and semi-public agencies: (National Nuclear Safety and Safeguards Commission; National Nuclear Research Institute)

Status of nuclear regulatory research and its future perspectives

International Nuclear Information System (INIS)

Lee, J. I.; Kim, W. S.; Kim, M. W.

1999-01-01

A comprehensive investigation of the regulatory research comprising an examination of the research system, its areas and contents, and the goals and financial resources is undertaken. As a result of this study, the future direction of regulatory research and its implementation strategies are suggested to resolve the current issues emerging from this examination. The major issues identified in the study are; (a) an insufficient investment in nuclear regulatory and safety research, (b) an interfacial discrepancy between similar research areas, and (c) a limitation of utilizing research results. To resolve these issues, several measures are proposed : (1) developing a lead project to establish a comprehensive infrastructure for enhancing research cooperation between nuclear organizations including institutes, industry, and universities, with an aim to improve cooperation between projects and to strengthen overall coordination functions among research projects, (2) introducing a certification system on research outcome to promote the proliferation of both research results themselves and their application with a view to enhancing the research quality, (3) strengthening the cooperative system to promote the international cooperative research, and (4) digitalizing all documents and materials relevant to safety and regulatory research to establish KIMS (knowledge and information based management system). It is expected that the aforementioned measures suggested in this study will enhance the efficiency and effectiveness of both nuclear regulatory and safety research, if they are implemented after deliberating with the government and related nuclear industries in the near future

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

International Nuclear Information System (INIS)

2008-01-01

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

Team structure and regulatory focus: the impact of regulatory fit on team dynamic.

Science.gov (United States)

Dimotakis, Nikolaos; Davison, Robert B; Hollenbeck, John R

2012-03-01

We report a within-teams experiment testing the effects of fit between team structure and regulatory task demands on task performance and satisfaction through average team member positive affect and helping behaviors. We used a completely crossed repeated-observations design in which 21 teams enacted 2 tasks with different regulatory focus characteristics (prevention and promotion) in 2 organizational structures (functional and divisional), resulting in 84 observations. Results suggested that salient regulatory demands inherent in the task interacted with structure to determine objective and subjective team-level outcomes, such that functional structures were best suited to (i.e., had best fit with) tasks with a prevention regulatory focus and divisional structures were best suited to tasks with a promotion regulatory focus. This contingency finding integrates regulatory focus and structural contingency theories, and extends them to the team level with implications for models of performance, satisfaction, and team dynamics.

Lactic acid bacteria in a changing legislative environment

NARCIS (Netherlands)

Feord, J.

2002-01-01

The benefits of using lactic acid bacteria in the food chain, both through direct consumption and production of ingredients, are increasingly recognised by the food industry and consumers alike. The regulatory environment surrounding these products is diverse, covering foods and food ingredients,

75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Science.gov (United States)

2010-02-01

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Science.gov (United States)

2012-08-08

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal of Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...